Virginia MPJE
Request for prescription data to agent within
48 hours
Time after pharmacy access by non-pharmacy personnel that code must be changed
48 hours
Time w/in which off-site records or records stored electronically must be retreived if requested by the Board
48 hours
request for rx data to agent within
48 hours
Tech: Pharmacist supervision ratio
4:1
what is the max ratio of technicians to pharmacist that the pharmacist can supervise in an ambulatory care or institutional setting? does this include interns?
4:1 no, unless the interns are acting as techs
Max frequency that Board can require reports after approval of an innovator/pilot program
4x/year
Max number of refills on C III-Vs
5
The provider of a CE must keep records for ________ years
5 -records, participants and hours awarded
How many CE does a tech need to complete annually?
5 CE
The vendor contacts you and says the data submitted is corrupted or has errors how long do you have to fix this?
5 business days
Max amt of pseudoephedrine that can be in a single package that does not require recording in a logbook
60mg (as long as only 1 packet purchased)
Max amount of ethylmorphine in 48 hours as an OTC C-V
65mg (state) 24 dosage units or 4 oz (federal)
Max supply of a solid oral dosage form in a unit-dose system that pharmacy may provide to hospitals or LTCFs if licensed persons administering
7 days
Time after dispensing that must report to the PMP (CII-IV)
7 days
Time w/in which nonresident pharmacy or distributor must provide dispensing records of VA patients or distribution into VA to the Board or police if requested
7 days
Time in which an opened EMS kit must be returned to the pharmacy, with signed orders for all the drugs used
7 days from opening
Explain the caution label requirements for Sched II-V CS
"CAUTION: Federal law prohibits the transfer of this drug to any person other than the patient for whom it was prescribed"
Can you give a patient a copy of their prescription after you have transferred it?
"For Information Only"
Time after authorizing an emergency oral C-II prescription that a provider must deliver or postmark a hard-copy C-II to the pharmacist. What must pharmacist do if he/she does not?
7 days. Must report provider to local DEA office & BOP
Number of forms in each 222 book
7 or 14
Max amt of ephedrine/pseudoephedrine a distributor can sell w/out being registered to report these transactions. What are they still required to do?
72 g in 30 days Fax a hard-copy log to the Dept of Health every 7 days
Max amt of compounded medication that a veterinarian can DISPENSE to a companion animal in an emergency if compounding pharmacy not immediately accessible
72 hour supply
Emergency drug kit replenishment & prescriber signature within
72 hours
Max supply of solid oral dosage forms in a unit-dose system that pharmacy may supply to a LTCF in which unlicensed persons administer drugs
72 hours
Prescriber must sign verbal order for schedule II within
72 hours
Resolve discrepancy for controls within
72 hours
Time after an oral order, reduced to writing by a nurse or RPh, for a C-II that it must be signed by provider
72 hours
Time from discovery in which a discrepancy must be resolved if found during the monthly audit of an automated dispensing device (Pyxis) in a hospital
72 hours
When dispensing to an unlicensed persons at a facility how many days supply is allowed?
72 hours
When providing unit dose systems to a facility where any unlicensed persons administer the drugs, how many days supply is allowed?
72 hours
emergency drug kit replenishment & prescriber signature within
72 hours
prescriber must sign verbal order for CII within
72 hours
resolve discrepancy for controls within
72 hours
Open LTC emergency kits must be returned to the pharmacy in
72 hours also any drug used requires a signed prescription within 72 hours
Time in which the balance of a partially filled C-II must be filled before it is voided. What must you do if it cannot be completed?
72 hours. Notify provider
Partial fills for schedule II due to insufficient quantity within
72hrs
partial fills for CII due to insufficient qty within
72hrs
if a pharmacy ceases business, what are its responsibilities to the DEA?
-notify the DEA -surrenders the registration and unexecuted DEA forms -dispose properly control substances
WHat if the opening date for the pharmacy changes?
-notify the board -RPh continues to be on site on a daily basis
What info does the purchaser add to copy 3 when the order is received?
-number of package received -date each package was received
what activities are restricted during the absence of a pharmacist?
-only Rxs checked by the pharmacist may be sold -Still need to offer to counsel, pt can wait until pharmacist is on duty again or give the pharmacist the pt's phone # - when pharmacist returns, should immediately try to contact the pt -pharmacy may or may not shut down
Can an electronic prescription be converted to a fax and printed out on the pharmacy's fax machine?
-only c6 -VA law prohibited the printing and converting c2-5 to a faxed prescription
Vet prescriptions
-only for animals (non-human) -must contain full name and address of owner -species -Vets full name address and registry number if required
when can a Rx for a CII drug be faxed?
-only for informational purpose and *does NOT count as original* Rx. (like to allow you to get Rx ready, but can't dispense until you get actual Rx) -can *actually* be filled if: LTCF pt, home infusion pt, and Medicare certified hospice pt (prescriber must note on Rx pt is in hospice)
What medications are OD allowed to prescribe and administer?
-oral C3-6 for eye -topical c6 -intramuscular admin of epinephrine to treat emergency case of anaphylactic shock
How do registrants get additional DEA 222 forms?
-order by using DEA 222a forms -order online at deadiversion.usdoj.gov (1 book in quantity of 7 or 14)
subpoena quashed
-order to bring relevant document is dismissed
WHat if the patient is an animal?
-owner's name -owner's address -animal species
what is special packaging?
-packaging designed to be difficult for children under 5 yrs to open -this is VA's version of a safety closure container
what patient info must be on a Rx? what if pt is an animal?
-patient's first and last name and address (*not DOB*) -owner's name and address and species of animal Note: prescriber doesn't need to write pt's address on Rx, can be added by dispenser or kept in pt's electronic record in pharmacy
What will happen if the pharmacy fail the initial inspection?
-pay re-inspection fee -can reschedule with 24 hrs advance notice to reschedule the date for reinspection without additional fee
what must the pharmacist do with the emergency oral CII oral Rx? prescriber?
-pharmacist must reduce it to writing so it has all required elements for written Rx except prescriber's signature -prescriber must provide pharmacy with original signed CII written Rx to cover the dispensing, dated and signed on date of emergency fill and include "authorization for emergency dispensing" on face, within *7 days*
Time that log of pharmacy access by non-pharmacy personnel must be retained on premises
1 year
Time that log of prescriptions dispensed while pharmacist not on duty must be retained
1 year
Time that pharmacy must keep record of EMS exchange of drug kit
1 year
Time that record of bin-filling for automated counting machines must be kept
1 year
Time that record of destrution must be retained by a CSB, BHA, or PACE site
1 year
Time that record of drug carts in hospitals must be maintained
1 year
Time that record of repackaging must be retained by a CSB, BHA, or PACE site
1 year
Time that records of after-hours access to the pharmacy in a hospital by a nurse must be kept
1 year
Time that unit dose filling records must be maintained by hospital pharmacy
1 year
Unit dose dispensing records kept for
1 year
how long does the tech entry record need to be maitained
1 year
manuafacturers register with DEA every
1 year
unit dose dispensing records kept for
1 year
Prescription is good for
1 year ( or 2 years if specified by physician)
Time that a CSB, BHA, or PACE site must keep documentation of completion of med repackaging training by personnel who are not pharmacist/tech/nurse
1 year from termination of employment or repackaging activities
How long is c6 valid in VA and how many times can be refilled?
1 year if no additional notations (up to 2 years) no specific limits
what is the time limit on Rx refills?
1 year is the default unless a prescriber specifically authorizes a longer time period (not to exceed 2 years)
How long do pharmacie have to keep records of bulk reconstitution, bul compounding or repackaging drugs?
1 year of until expiration which ever is greater
Time that must keep records of bulk reconstitution, bulk compounding, or repackaging/prepackaging
1 year or until expiration, whichever is longer
bulk compounding or repackaging records kept for
1 yr
rx good for
1 yr ( or 2 if specified by dr)
Time in advance of acquisition that pharmacy acquiring another must notify patients if their records will be accessed by anyone other than for purposes of continuity of services
14 days
Time in advance of closing that a pharmacy must notify the Board
14 days
Time in advance of destroying controlled (CII-V) drugs that PIC must notify Board in writing
14 days
Time in advance that a pharmacy must mail a notice (to all customers with active refills) if it is going to close for more than 1 week
14 days
Time in advance that pharmacy must give Board if requesting a specific inspection date
14 days
Time in advance that pharmacy must notify Board & public if hours of operating are changing (except if they are expanding)
14 days
Time in which technician training program must report to the Board any substantial changes (program name, program director, instructors, name of institution or business, address, program content, length of program, or location of records)
14 days
Time that a location which stocks, manufacturers, or distributes drugs must file for a new registration after a change in ownership, location, authority, or supervising physician
14 days
Time w/in which intpharmacist, intern, or tech must notify Board of a change in address of record
14 days
WHen a PIC leaves, how long deos a pharmacy need to designate a new PIC?
14 days
When a pharmacist leaves, how long does the pharmacy have to file an application naming a new one?
14 days
must notify public of decreasing hrs or closing for more than 1 wk by LETTER within
14 days
Max amt of time in advance that drugs can be moved to or stocked in a pharmacy
14 days before opening date
How long do you have to replace a PIC if he quits or is terminated?
14 days to pay the fees and apply for permit designating new PIC unless extension approved which will only add up to 14 additional days
Time after preliminary scheduling of a drug into C-I or II that that schedule will expire, unless enacted into general law
18 months
Tier 1 2 3 4
1: generics and least expensive 2: preferred BN 3: non-preferred BN 4:rarer, high cost drugs
Explain requirements and responsibilities for supervising intern practical experience
1:1 intern to pharmacist? Intern may preform both pharmacist and technician tasks in the course of training under direct supervision of rph.
Max ratio of Physician to NP
1:6
Max amount of difenoxin in a C-IV (otherwise it's a C-I)
1mg w/ at least 25mcg atropine sulfate per dosage unit
Who gets exclusive rights to generic market and for how long
1st applicant to complete formal review 6 months
NDC
1st set of numbers (5) : Manufacturer 2nd set (4): ID of specific drug Last (2): ID of package They actually are not required to be on package labels or single dispense
after hours pharmacy entry records kept for
1year
Max number of pharmacies for which a pharmacist can be PIC
2
Explain the use of official DEA order forms in ordering and transferring Sched II CS (21 CFR 1305)
222 forms used for ordering and transferring CII medications.. ReCEIVING registrant must issue the form or electronic equivalent. CIII-V must be documented and can do so using invoice type format.
DEA form used to order more 222s
222a
DEA application form for pharmacy registration
224
Time that pharmacies must keep training records for technicians
2 years from termination of employment
How long are these audit reports and documentation kept
2 years min
If there is a change in ownership (cvs to wag) what records must be transferred?
2 years of -dispensing records -patient records
How long do the pharmacies need to keep the transferred prescription record?
2 years on both sides
how long does a tech have to keep their records of completion of CE?
2 yrs (same as pharmacist)
DEA form for pharmacy renewal
224a
DEA form for chain pharmacy renewal
224b
Refrigerator temperature
2-8 degrees C
Time w/in which, after receiving a controlled drug sample for analysis, pharmacist must send it off to laboratory
24 hours
What is the allowable concentration of Diphenoxylate and Atropine in Schedule 5?
2.5mg per 25 mcg
Max amount of diphenoxylate in a C-V
2.5mg w/ at least 25mcg atropine sulfate per dosage unit
Time in which pharmacy must notify Board if not ready for or need to reschedule inspection, in order to avoid reinspection fee
24 hours in advance
How long do you have to transmit data to the PMP?
24 hours or the dispenser's next business day; whichever is longer.
WHat pharmacy is not required a security system?
24 hours pahrmacy
Minimum square footage of a pharmacy
240 -doesn't count waiting or counseling areas
Minimum size for a prescription department
240 square feet
Max amount of codeine in 48 hours as an OTC C-V
270mg (state) 24 dosage units or 4 oz (federal)
Time in advance that a pharmacy must post a notice if it is going to close for more than 1 week
30 days
Time in advance that an authorized collector must notify Board if wishes to stop collecting
30 days
Time w/in which wholesale distributor must notify Board of any substantive changes in information provided on application form
30 days
audit of automated dispensing machines every
30 days
must notify public of decreasing hours or closing more than 1 wk by POSTED SIGN within
30 days
Number of patients that DATA-waived practitioners may treat at one time
30 or 100
Temp for storing drugs: Warm
30 to 40 C
Warm temp
30-40 degrees C
Dr. must give written rx after emergency fill within
7days
Physician must give written prescription after emergency fill within
7days
Record of EMS drugs used must be given to pharmacy within
7days
Max amounts that can be in a stat drug box
20 solid oral dosage forms of each CII-V schedule, OR 20 liquid units (≤30mL) of each CII-V schedule
Controlled room temperature
20-25 degrees C
record of EMS drugs used must be given to pharmacy within
7days
Cool temp
8 to 15 C (46 to 59 F)
Temp for storing drugs: Cool
8 to 15C
Cool temp
8-15 degrees C
Dispensing limits of CV OTC substance per 48 hour period
200 mg of opium 270 mg of codeine 130 mg f dihydrocodeinone 65 mg of ethylmorphine 32.5 mg of diphenoxylate
Max amount of opium in 48 hours as an OTC C-V
200mg (state) 48 dosage units or 8 oz (federal)
DEA form used to purchase or transfer C-IIs
222
Safety closure container
85% of 200 kids aged 41-52 months are unable to open the container in a five minute period and that 80% fail in another 5 minutes after being shown how to open the container, but 90% of 100 adults must be able to open and close the container
how many compliance officers/inspectors does VA BOP have?
9 - 5 pharmacist inspectors assigned to inspect pharmacies, 4 non-pharmacist inspectors assigned to inspect other facilities licensed by the BOP
Duration of time that a tech can perform tech functions without being registered (ie. while in a training program)
9 months
How long can a tech work without a registration in VA
9 months
How long can a technician trainee work before getting certified?
9 months
How long can you be a pharmacy trainee
9 months
how long can a tech trainee work before obtaining their registration?
9 months
Minimum time that a donated drug should have until expiration
90 days
CII- CIV record of administration to pharmacy within
90days
Schedule II- schedule IV record of administration to pharmacy within
90days
Explain the restrictions on dispensing narcotics for the purpose of maintenance or detox
Must be prescribed by a DEA registered provider in the course of treatment w DEA registration X
What are the prescribing restriction on NP and PA?
NP: based on agreement with a patient care team physician PA: based on agreement with a licensed physician or podiatrist
What drug information must go on the Rx?
Name/strength/dosage form/quantity/direction *quantity is NOT required for c6 in VA
Describe the conditions and documentation for sale of controlled paraphernalia
Needles, syringes, capsules, quinine: in excess of 1/4 oz restricted to rph or others w license from board. Device: ID/proof of age (>16 unless rx), written legitimate purpose, log of dispensing (date, name and qty of device or substance, price, name and address of person, reason, initials.
In what situations may you sell, purchase, or trade a drug sample
Never
When can pharmacies dispense a drug to a long-term care facility without a valid order
Never
When can technicians and interns have access to the pharmacy without a pharmacist present?
Never, but
NDI
New DIETARY Ingredient Was not a substance being marketed as a dietary supplement prior to 10/15/1994
Chemical Classification IV
New combination of 2 or more drugs
Chemical Classification II
New derivative of a molecular structure already approved
Chemical Classification III
New formulation of an already available drug
Chemical Classification VI
New indication for a drug
Chemical Classification I
New molecular structure
One medical gas must be locked up all the time, even when authorized staff is present. Which one?
Nitrous oxide
Are patients allowed to return drugs to the pharmacy?
No
Are there any special record keeping when selling insulin
No
Are you allowed to compound a drug for distribution to pharmacies or other entities under common ownership?
No
Are you allowed to transfer a Schedule 2 drug prescription?
No
Can Part D deny 90 day supplies from local pharmacies
No
Can Part D mandate mail order
No
Can a nurse anesthetist prescribe Schedule 2 through 6 drugs?
No
Can a prescriber with a DEA # prescribe for maintenance and detoxification of addiction treatment?
No
Can the pharmacy operate with no pharmacist on duty?
No
Can you carry extra hours of continuing education (CE) over to the next year?
No
Can you coorporate with anyone in denying a patient the opportunity to select his supplier of prescribed medications?
No
Can you interfere in the patient's right to choose a supplier of medications?
No
Do you need to use a DEA 222 form to transfer schedule 2 drugs from a central fill pharmacy to a retail pharmacy
No
The nursing home returns a prescription to the pharmacy. When the drug is re-dispensed, can it be assinged an expiration date later than the expiration date it had previously.
No
Date that pharmacists, if initially licensed after, do not have to renew until following year
Oct 1
OPDP
Office of Prescription Drug Promotion Receives reports of bad or misleading advertisements
Who can call in a RX
Prescriber or agent of his choice if they are an employee, if not an employee person must be licensed to administer or dispense drugs and specifically instructed by the physician
Prescriber information every Virginia prescription must contain
Prescriber's name, address, phone number, signature (except for oral Rx), and DEA number if a control
How may a pharmacy legally dispoe of FEDERAL controled substanceS?
Submit DEA 41 to the Special Agent in Cahrge. The Special Agent incharge then can athorize the pharmacy to dispoe the controlled substances by: 1. transfer the substance to a regiestered agent to dispose 2. deliever the drug to the DEA 3. destroy the drug in the presence of a authorzied person
What do you do if you know a pharmacist has done something that endangers public health?
Submit allegations in writing to the Board of Pharmacy
What if the destruction date is changed or the destruction doesn't occur
The board must be notified
What other information is required
The date faxed, the name, the address, phone and fax number of the prescriber, and the address, phone number, and fax number of the institution faxed from.
Drugs returned from a long-term care facility are going to be destroyed at the long-term care facility. Who needs to witness the destruction
The direction of Nursing (or the facility administrator, if there is no direction of nursing) and one other person. This could be a pharmacist providing pharmacy services to the facility, or another employee authorized to administer medication
What if the conviction is not final when you get your license suspended?
The director can decline to suspend the license if there is a likelihood of injury to the public if the pharmacist's services aren't available.
What if the conviction is not final?
The director can decline to suspend the license if there is a likelihood of injury to the public if the pharmacist's services aren't available.
How long do you have to start reporting?
The director will give you at least 90 days.
Hospital PIC can store and put non-pharmacy personnel in charge of stock of which medicines?
The following CVI given monthly inspections occur: -Large volume parenteral solutions w/out active ingredient -Irrigation solution -Contrast media -Medical gases -Sterile sealed surgical trays which include a schedule VI drug -Blood components and derivatives All of these need to be locked up but medical gases (nitrous oxide though does need to be locked)
Where do registrants get DEA 222 forms
The forms are given to registrants by the DEA when they are first registered. Subsequent forms are ordered using for 222a
How many hours of CE can you submit for volunteering at places such as a free clinic or health department for a technician?
Up to 1 hour total 3 hours of work = 1 hour
How many hours of CE can you submit for volunteering at places such as a free clinic or health department for a pharmacist?
Up to 2 hours 3 working hours =1 hour
How long can a PIC be absent for a scheduled leave?
Up to 30 days. If longer, must notify the BOP and designate a new PIC.
Can you see your PMP
Yes, you must submit a photocopy of a valid government issued ID, be >18yo, have a notarized signature
If you are authorized to prescribe, does this also mean you are authorized to provide manufacturer's professional samples for controlled substances and devices
Yes.
Is proof of identity required to dispense a CII drug to a person if the person is not known to the pharmacy or their agent?
Yes. Acceptable forms: driver's license, government issued ID, or other photo ID along with documentation of current address
If the pharmacy is changing locations, or if structural changes are being made, does the Board need to be notified?
Yes. The pharmacy needs to be inspected by an agent of the Board. Give the Board at least 14 days notice before you would like the inspection. The dispensing area needs to comply with requirements at the time of the inspection. If re-inspection is required, there is a fee.
Is it possible to get a special or limited-use pharmacy permit?
Yes. This is up to the discretion of the Board of Pharmacy. You need to list the regularoty requirements you want waived and why. You must also maintain a policy and procedure manual outlining the type of operation and schedule of drugs maintained.
Can Schedule 1 inventories and records be maintained with Schedule 3-5 inventories and records
Yes. You can keep Schedule 6 records on their own or with Schedule 3-5, but not with other pharmacy records
When is a supplier prohibited from filling an order written on a dea 222?
when the dea 222 is: -incomplete -illegible -not properly prepared, executed or endorsed -altered -erased -or has a change in drug description
when can a tech at a nuclear pharmacy accept oral Rxs?
for diagnostic non-patient specific radiopharmaceuticals
where can pharmacies obtain kits to have on-hand for dispensing intranasal naloxone prefilled syringes?
from REVIVE! program at Dept. of Behavioral Health and Developmental Services
This drug requires the medical need be written on the prescription
gamma-hydroxybutyric acid (ghb), rohypnol (flunitrazepam)
when must the security system of a pharmacy be activated?
whenever the Rx department is closed for business
does VA require tablet ID (description, such as number, shape, and color) on the container label?
no
does VA require the ability to provide pts with visual impairment a larger container label type size, such as 12-pt sans serif type?
no
does VA treat refills on CVs differently than refills on non-controlled meds?
no
does the controlled substance cabinet need to be locked when a pharmacist is working throughout the day?
no
has VA designated a list of drugs that are not substitutable (i.e., narrow therapeutic index drugs)?
no
if a pharmacist is on a break, does a sign have to be posted saying the pharmacist is not on duty?
no
is a Rx order needed to buy syringes/needles in VA?
no
is a dea form required to transfer c2 drugs from a central fill pharmacy to a retail pharmacy?
no
is prescriber ownership of a pharmacy prohibited?
no
may techs in the hospital or community setting accept called-in Rx from physician's office?
no
may techs in the hospital or community setting check the work of other techs in VA?
no
may techs in the hospital or community setting transfer Rx orders?
no
Does VA law has a minimum age requirement to purchase slpc?
no federal prphibits the sale to minor under 16
does BOP require licensure/registration of training sites? preceptors?
no no must have a current and unrestricted license
how many times can a CVI Rx be refilled?
no limit on # of refills, pharmacist can continue to refill until it expires
Virginia expiration date of CII
no more than 6 months from written date
are syringes/needles restricted to sale only in pharmacy?
no, a medical equipment supplier may deliver hypodermic syringes and needles to the ultimate consumer pursuant to a valid Rx from a practitioner
does VA set a limit of the max number of syringes that can be purchased at one time without a Rx?
no, but need their ID and purpose of purchase
Explain records required for reconstitution, bulk compounding, and repackaged drugs
Records: kept x 1 year or until expiration (whichever is greater) - name of drug(s), strength, date of repackaging, qty prepared, rph initials, assigned lot or control #, mfg/dist name and lot or control number and an expiration date.
Insulin available without a prescription
Regular, NPH, and 70/30 insulins. No special record keeping required.
What constitutes "unprofessional conduct" in VA?
Relate to patient and staff 1. patient related -fail to comply with Hippa -breaching (leaking) pt confidentiality -violate confidentiality provisions of PMP -engaging in disruptive behavior in a healthcare setting -engaging in inappropriate relationship with a pt -failing to response to a known dispensing error -failing to maintain adequate safeguarg against a drug diversion -fail to use professional judgement before dispensing a medication 2. pharmacy staff -delegate a task to a person who is not adequately trained -failure to ensure that all personnell are currently license (As a PIC)
3 years
Renew pharmacy DEA permit
3 years
Renew pharmacy DEA permit Record of sample distribution by manufacturer
Explain packaging and labeling requirements to include determination of appropriate expiration date for repackaged drugs
Repackaging: Drug name, strength, assigned lot or control number or the mfg/dist name and control number, appropriate expiration date determined by the pharmacist in accordance with USP guidelines. Place this information on any subsequent repackaged or rcon units.
does the inspection/assessment form used by VA pharmacists need to be completed on a scheduled basis?
no, for personal use only, completed by PIC
does VA require identification for controlled substance Rxs other than CIIs?
no, pharmacist professional judgment
is a BOP hearing required when issuing a pharmacists license through licensure transfer?
no, unless application indicates grounds for denial
does BOP have regulatory oversight of PBMs?
no, unless performing the practice of pharmacy
what limits does VA set on prescribing non-controlled drugs to oneself or family members?
none
What is the allowable concentration of Dihydrocodeinone for Schedule 5?
not greater than 130mg
What is the allowable concentration for Morphine in Schedule 3?
not greater than 50 mg per 100 ml
What to do if you change address?
notify the board within 14 days
CII verbal orders in a hospital
nurse or pharmacist can take immediately write down Provider must sign within 72 hours
Internet pharmacy required to submit a monthly report to DEA of all controlled substances dispensed IF: What about if criteria not met?
o> 100 prescriptions for controlled substances filled that month, OR o>5,000 dosage units of controlled substances dispensed that month If not met, still have to submit report stating that
how many times can a CIII-V Rx be transferred?
one time only, unless pharmacies share a common database, then until the Rx is out of refills or expires
when can a prescriber use a completely preprinted Rx form?
only for CVI Rxs and they will still need to sign the Rx
WHen can a prescriber use a completely preprinted prescription form?
only for c6, and need to sign
when 1 pharmacy is being acquired by another, do current patients need to be notified?
only if Rx records are going to be used for something other than continuity of pharmacy services at substantially the same level. If so, written notice must be given 14 days prior to acquisition
can electronic Rxs be converted to a fax and printed out on the pharmacy's fax machine?
only if for CVI
what limits does VA set on prescribing controlled drugs to oneself or family members?
only in an emergency situation or isolated setting where there is no other qualified practitioner, or for a single episode of an acute illness
what if the prescriber requests that a patinet's medicine be dispensed in non-special packaging?
only one rx is complied
Which drugs go in a stat-drug box
only those which delaying their use may result in harm
Is a pharmacy allowed to accepted, for re-dispensing, a prescription that was already dispensed to a patient?
only when the medication is in the menufacturer's original sealed container (be careful on relying upon a laypersons's words of how the med was stored- mostly only accepted if the drug has not left the pharmacy)
if a non 24 hours invenotry, what additional info is needed when conducting a inventory?
whether the inventory is taken before or after the opening
What to do with DEA 41 form?
whoever conducts the destruction must maintain the dea 41 for 2 years
How long does a LTC facility have to destroy or return discontinued drugs
within 30 days
Will the alarm code need to be change
within 48 hrs
what must a pharmacist do if he declines to fill a Rx for any reason other than unavailability of the drug?
write the following on the back of the Rx: -"declined" -name, address, and phone # of pharmacy -date Rx was declined -pharmacist's signature
Are pharmacists usually required to dispense prescriptions in special packaging?
yes
Can a pharmacist accept oral or telephone presription for c3-6 in VA?
yes
Can a prescriber write multiple c2 prescriptions for the same drug for a single patient on the same day and place the instructions on the prescriptions as to when they may be filled?
yes
Does the prescriber's name need to appear on rx label
yes
In a hospital, can a nursing unit return drugs to an on-site hopsital pharmacy
yes
are pt profiles mandated in VA?
yes
can Rxs for CIII-CVI drugs be faxed?
yes
does BOP allow centralized Rx filling facilities to be utilized?
yes
does BOP report intern hours to other boards?
yes
does BOP require compliance with USP 797 and 800?
yes
does BOP require pharmacies to maintain any type of continuous quality improvement program to monitor/prevent quality-related events?
yes
does VA allow drug repository/donation program?
yes
does VA allow electronic prescribing of controlled substances?
yes
does VA allow sale of schedule V Rxs OTC?
yes
does VA have freedom of choice legislation?
yes
does VA permit substitution of narrow therapeutic index drugs unless action has been taken by prescriber and/or pt?
yes
does VA require discussion with the pt prior to generic substitution?
yes
is Rx transfer b/w in-state pharmacy computers or from out-of-state to in-state pharmacy computers allowed?
yes
is Rx transmission from in-state or out-of-state prescriber computer to pharmacy computer allowed?
yes
is documentation of "offer to counsel" and pt's refusal for counseling required by VA?
yes
may pharmacists in VA administer vaccines?
yes
may pharmacists in VA initiate, modify, and/or D/C drug therapy pursuant to a CPA or protocol?
yes
Is pharmacy required to keep hard copies (electronic rx) of rx on site?
yes c6: electronic image is ok, but hard copy has to be available in 48 hrs -oral rx must be reduced to writing
may techs in the hospital or community setting enter Rx into the pharmacy computer?
yes pharmacist must verify, check, and/or is responsible for allowed activities
Can a pharmacy ever act as a wholesale distributor of small quantities of prescription drugs without being a licensed wholsaler?
yes wholesale controlled substance sales cant exceed 5% of pharmacy's total c2-5 annual dispense in dosage units
does VA allow Rxs to be faxed? controlled substances Rxs to be faxed?
yes yes
do nonresident pharmacies have to be licensed/registered in VA? nonresident pharmacists?
yes yes, one state-licensed PIC for the state permit (not required for PBM pharmacy)
Are hospital pharmacists required to review drug therapy for hospital patients?
yes for each order
Are community pharmacists allowed to partially fill a prescription for a c2?
yes if pharmacy doesnt have enough
does VA participate in the NAPLEX Score Transfer program? what is the validity period for a Score Transfer?
yes, 1 year
Can a pharmacist be a PIC of more than 1 pharmacy?
yes, 2 max
does VA have technician CPE requirements?
yes, 5 hrs/yr
How do registrants get their initial DEA222 forms?
the forms are given to registrants by the DEA when they are first registed if requested on the application form
since medical interns and some residents do not have a DEA #, what do they use in place of their own DEA #?
the hospital's DEA number plus a suffix assigned to the intern/resident by the institution (e.g. BB1438901-1234)
Misbranding
the label
What are the specific requirements for partial fill of c2?
the remainder has to be filled within 72 hrs
what about invoices for c2-5?
they can be sotred offsite, but must be readly retreivable
t/f? in VA, the drug dispensed must be less or no more expensive than the drug prescribed
true
what are the reporting requirements for sale of SLCPs?
unless pharmacy has obtained exemption, must use an electronic recordkeeping and monitoring system to report all nonRx sales of SLCPs
How many times can a c6 be transferred?
until running out of refills
how long can a PIC be absent for a scheduled leave before the pharmacy has to notify BOP and designate a new PIC?
up to 30 days
in which academic year does BOP recognition of pharmacy internship/externship credit begin?
upon enrollment of ACPE-accredited school of pharmacy when practical experience conforms to current ACPE standards
what is the SIG for naloxone 2 mg autoinjector?
use 1 autoinjector upon signs of opioid overdose. Call 911. Additional doses may be given every 2-3 min until emergency medical assistance arrives
does VA have a state drug formulary related to drug product selection laws?
uses FDA Therapeutic Equivalency List (Orange Book)
what happens if you fail the MPJE?
wait 30 days to retake
When do nuclear pharmacists have to put the patient's name on the label
when it is a therapeutic radiopharmaceutical or radiopharmaceutical blood product
Cold temp
< 8 degrees C
how do you inventory c3-5?
<1000: estimate if open bottles
cold temperature
<8C
Excessive heat
> 40 C
Excessive heat
> 40 degrees C
Amount od Rxs originaing from online soliciation that requires nonresident pharmacy to be credentialed, inspected, & certified by NABP that it is a Verified Internet Pharmacy
> 50%
a pharmacist in VA working > ____ hours is allowed to take a _____ minute break
>6 hours, 30 min break
What is a well closed container?
A container that protects the content from extraneous solids and drug loss during normal shipping and storage
Define "well-closed container"
A container that protects the contents from extraneous solids during normal shipping and storage
What documents must be maintained by a pharmacy that employs technicians?
A site-specific training program and manual; Documentation of completion of this training for each technician (kept for 2 years after they leave the job); For technician trainees, proof that they are enrolled in an approved training program.
Automated dispensing of drugs requires
A specific access code which identifies the person accessing the device. This should eliminate the sharing or theft of access codes by including biometric identification or other coded identification after the initial log on
When can a pharmacy technician at a nuclear pharmacy accept oral prescriptions?
A technician at a nuclear pharmacy can accept oral prescriptions for non-patient specific radiopharmaceuticals.
Approved CE can come from?
ACPE Category 1 CME CE approved by board of pharmacy
Where are the executed forms kept
At the location printed on the form
which entity has the broadest inspection powers?
Board of pharmacy no notice needed
What i the pharmacy fails to dispose the drugs and devices?
Board will seize
How long do pharmacies need to keep their records
Both the original and transferred prescription must be maintained for 2 years from the date of last refill
How long must records of an SII transfer be kept
Both the purchaser and receiver need to keep a copy for 2 years
Use of Emergency Drug Box is for
Emergency Use
Frequency at which a CE provider has to renew
Every 2 years
Interval at which controlled substance (CI-V) inventories must occur
Every 2 years
Drug review is done by a pharmacist at a long term care facility how often?
Every 30 days
MTM
Every Part D plan must establish MTM programs for individuals with high drug costs resulting from multiple chronic conditions
How many unit dose day supply may be dispensed to hospital or LTC
Everyone administering is licensed to do so no more than 7 days for solid PO doses Otherwise no more than 72 hours for solid PO doses
What schedule 2 through 5 forms have to be stored on site?
Executed forms Prescriptions Inventories
Expiration date vs BUD
Expiration manufacturer or packaging company puts on stock bottle. BUD is when the integrity can no longer be assured and it is deemed to be adulterated or misbranded
what's the conversion from Fahrenheit to Celsius?
F = (1.8 x C) + 32
Who regulate (regulative body) pharmacy practice in VA?
FDA, DEA, and VA Board of Pharmacy
What if a DEA form 222 is lost or stolen (but not lost in the mail)
Report it to the special agent in charge of the DEA divisional office for that area. If the form(s) are found later, that must be reported too.
What is the Food, Drug, and Cosmetic Act of 1938?
Law that gave the FDA the authority to oversee safety of food, drugs, and cosmetics -have to be SAFE
Brand name dispensing
Required if -Indicated by the prescriber -Insisted upon by the pateint
Sink
Required to be in the pharmacy and run both hot and cold water
can a pharmacist partially fill a CII for a reason other than not having enough drug?
yes, LTCF pt or terminally ill (practitioner must classify pt as terminally ill and pharmacist verifies and records on the Rx
does VA provide an impaired pharmacist recovery program?
yes, Virginia Pharmacists Aiding Pharmacists Program (VaPAPP)
does an SLCP purchaser have to present photo ID?
yes, and it must be issued by governmental or education institution
Does FDA need to provide a notice prior to an inspection
yes, but not a warrant
can the pharmacy get the drug back from being seized by the board?
yes, by paying the storage cost and have to provide proper disposition of the drugs within 6 months
can a pharmacist accept oral or telephone Rxs for CIII-CVI drugs in VA?
yes, called in by prescriber or their agent (e.g., nurse or pharmacist)
are there restrictions on who a pharmacy can employ and provide with access to Federal controlled substances?
yes, cannot employ anyone convicted of felony offense related to controlled substances, OR any person who had a DEA registration application *denied or registration revoked or surrendered* for cause
Does a prescription need to be dated?
yes, date and sign by prescriber
may pharmacists in VA administer drugs?
yes, definition of dispense includes "administer"
Are there speical requriments for c2 inventory?
yes, discrepancy every month
can a prescriber write multiple CII Rxs for the same drug for the same pt on the same day and place instructions on the Rxs as to when they may be filled?
yes, each Rx (other than first to be filled) must indicated *earliest date* it can be filled, and *max days supply is 90* for multiple issued Rxs
For bins that can hold more than one lot, what procedure is required to ensure that drugs are in the bin are always in date
Let the bin "run dry" (all product removed prior to filling) once every 60 days with a record made of the run dry dates
Is a waiver for non safety closure container
May be for a single fill or a period of time but removes civil liability for the RPh
How will you know if a NP or PA is prescribing a drug that is NOT allowed under his agreement with a team care physician, physician or podiatrist?
May not be able to tell but you should examine the practice the prescriber is in.
how may a pharmacy dispose a controlleddrugs when it goes out of business?
Maybe: -transfer to another pharmacy -transfer to another DEA registrant -transfer to a manufacturer or wolsaler
What prescriber have unlimited prescribing authority and can write valid prescriptions for CS in Virginia?
Medical Doctor: M.D. Osteopath: D.O. Dentist: D.D.S or D.M.D Veterinarian: D.V.M. Podiatrist: D.P.M
Part B
Medical insurance for physician services
ASP
Medicare brings higher reimbursement prices into a lower rang by paying Average Sales Price which is somewhere between the AAP and the AWP
3 months
Medication administration record can be used as documentation of floor stock drugs administered in the hospital as long as MAR is returned to the pharmacy for filing within 3 months of administration
A Narcotic Treatment Program allows a practitioner to administer and dispense but NOT PRESCRIBE which 2 drugs?
Methadone LAAM (Levo-alpha-acetylmethadol)
A Narcotic Treatment Program allows a practitioner to administer and dispense but NOT PRESCRIBE which 2 drugs?
Methadone LAAM
Drug carts
Must be locked when not around Have no more than 1 extra dose of a drug in that specific pt's drawer/tray or special storage area Record must be kept for 1 year (2 years for CII through V) 1.date filled 2.location of cart 3. initials of the person who filled it 4.initials of RPh that checked it
Drugs in a nursing home automated dispensing device
Must be in single dispense packaging
Intangible requirements of a Virginia prescription
Must be issued for a medicinal or therapeutic purpose and must be to a patient with whom the prescriber has a bonefide practioner-patient relationship
Review prescriptions for legality: Ensure written in good faith within the context of a bona fide physician-patient relationship for a medicinal or therapeutic purpose
Must be physician-patient relationship.
After hours pharmacy entry records kept for
1 year
Bulk compounding or repackaging records kept for
1 year
CII pickup records kept for
1 year
EMS BOX DRUG EXCHANGE RECORDS KEPT FOR
1 year
Time in advance of a change in ownership that a pharmacy must notify the Board
14 days
How long do pharmacies have to keep records or bulk reconstitution, bulk compounding or prepackaging of drugs
1 year
Length of time that a doctor's certificate for cannabidiol oil or THC-A oil use for epilepsy is valid
1 year
what is the initial certificate fee for pharmacists?
$180
what is the VA technician registration fee? what is the renewal schedule?
$25 annual (Dec. 31st)does
Celcius to Farenheit
(1.8 X C) + 32
Fahrenheit conversion
(C x 1.8) + 32
Describe the method for handling prescriptions that are declined for the reasons other than nonavailability for the drug
- "declined" on back of prescription - Name address and ph # of pharmacy, date declined, rph name/sig - if forgery rph shall not return to pt.
Explain the requirements for completing CE and maintaining documentation
- 15 hours per year. - Required to attest to compliance with renewal. (CE requirements not required in first year in 54.1-3314.1) - Board may grant extension of 1 yr w/ written request. - Maintain records of original certificates w date title hours x 2 years. - ACPE approved or get approval from board prior to educational event.
If a pharmacy accepts drugs from a nursing home, for the purpose of re-dispensing to the indigent free of charge, what records, does the pharmacy need to keep?
- A written agreement with the nursing home - A current policy and procedure manual describing how medications are delivered and tracked -A procedure for assuring the integrity of drugs (including proper storage) -A procedure for assigning a beyond use date on re-dispensed drugs
Changes pharmacists are allowed to make to a written CII prescription
- Add or correct the pt's name after verifying it - Add the pt's address after verifying it - Add the prescriber's DEA - Add or change the dosage form, drug strength, directions for use, drug quantity, or issue dates (only after consultation with the prescriber)
Explain unit dose dispensing systems
- All dosages labels with drug name, strength, lot#, exp. - Pt individual drug drawer/tray labelled in manner to ID pt and location. - no more than 1 back-up dose per drug - records x 1 YEAR: date filling cart, location, initials, rph. - disp record = pt medication card. if CII-V drugs on pt profile or medication record maintain x 2 years. - Only dispense 7 day supplies to LTCF/Hosp w/ licensed individuals. - Only dispense 72 hour supplies to LTCF w/o licensed individuals.
Explain the requirement for drug storage and security outside of the pharmacy, throughout hospitals and LTCF.
- Any equip housed outside the pharmacy to be admin in unit dose shall be fitted with a locking mechanism and locked at all times when un attended. - Floor stock is authorized in storage area outside the pharmacy. Must have security, storage, distribution PPs. Storage area must be locked when auth staff is not present in the area. - Emergency Room: Drugs kept in secure place where unauth personnel and general public not allowed. - LTCF: Drugs for each pt are kept and stored in the originally received containers and not transferred to another pt. Each cabinet, cart, storage area is locked and only accessible to auth pers., Storage is well lit, sufficient size, app temp, poisons and external use medications are kept separate from other medications.
Explain the requirements and procedures involved in obtaining and renewing a pharmacy permit
- Application to Board. - only 1 pharmacy per location. Shall not engage in distribution or wholesale, mfg. - Can not operate from a private residence or dwelling. - $270 - special or limited use permit - waiver with breif explanation of why this license would apply. PP with hours, method, drug schedules, documenation. Free clinics with volunteer pharmacists waiver for resricted access provisions. - PIC change new application, and CS inventory. - Expiration? - Renew annually.
Requirements and Procedures involved in obtaining a pharmacist license
- At least 18 yo, good moral character. - 1,500 hours practical experience (register w BOP as intern - be enrolled in pharm school or grad from foreign school, awaiting exam - 3 mo expiration, reinstatement), All practical experience evidenced by affidavit w board - ACPE-accredited SOP - Pass exams, NAPLEX, and Law (3 attempts) - if not +1,000 hrs practical experience. Fail law - can't re-take w/i 30 days. - Licensure by endorsement: verification that worked as pharmacist in another state. - Foreign-trainined: FPGEC certificate, Practical experience, examinations. - $180 fee - unlawful to practice without license. - display license at primary place of practice.
60 Days
- CII prescription is good for in a Long term care facility - Run dry automated bins every 60 days - Completed DEA 22 forms valid for 60 days
Describe PDMP requirements for reporting covered substances
- CII-IV - Data transmitted to the dept or its agents within 7 days of dispensing. (DEA#, total number of refills, new/refill, date written) basic file layout provided. - Waivers: file a request in writing on form provided. (hardship, research, case-by-case basis) - Report the following information: recipients name and address, dob, CS dispensed, date, MD #, dispensers #, method of payment
Requirements for dispensing CV without RX
-dispensed directly to the person requesting -person is 18yo -person furnishes suitable ID including proof of age
2 years
- Completed CE records - Power of attorney signature authorization forms - CII-VI inventory records and drug invoices - Executed DEA form 222 - Prescription dispense data - Original (hard copy and eRx) and transferred prescriptions records - Record of drugs administered from "unit dose systems" - dispensing record, patient profile or medication card all count as a valid record of administration - Central processing pharmacy records - Floor stock distribution records - Delivery receipt of drugs given for floor stock and fill of "automated dispensing systems." Must be signed by nurse receiving them (CII-V) - ED dispense records - Emergency Drug Kit Administration and EMT Box admin records - Drug destruction records/ DEA 41 forms -Theft or loss reports (DEA 106) - Ephedrine/pseudoephedine sales - Technician training documentation - Remote processing records - Inventories of lost controls - Automated dispensing audit records - Non-special packaging requests - CV OTC non-Rx sale records - Compounding records - need to be kept x2yrs and retrievable within 72 hours
Describe the requirements for conducting a prospective DUR prior to dispensing
- Conduct prospective drug review before each NEW prescription is dispensed or delivered to a patient which includes the following; potential drug therapy problems, therapeutic duplication, drug-disease contraindications, drug-drug interactions, incorrect dose or duration, drug-allergy interactions, clinical abuse or misuse. - May conduct prospective DUR before refilling a prescription if rph deems appropriate in professional judgement.
Recordkeeping requirements when a technician enters the pharmacy in an emergency when a RPh is not present
- Date and time of entry - Name and signature of the tech - Name, title, signature of the person accompanying them - Pharmacist's name who granted the tech permission to enter - The telephone number the RPh was reached - The name of the patient initially requesting the needed med - The nature of the emergency - A listing of all prescriptions retried during that entnry - The time the technician exited and re-secured the prescription department
What information must a faxed refill authorization include?
- Date of authorization - Pts name and address - Drug name, strength and quantity - Directions for use - Prescribers name - Prescriber's signature or agent's first and last name for an oral script
What do bulk compounding or repackaging records need to contain
- Date repackaged - Drug name and strength if applicable - Quantity prepared - Assigned lot or control number - Manufacturer or distributor name and lot/control number - Expiration date - Pharmacist's initials
What are the label requirements when a pharmacist repackages a drug?
- Drug name - Drug strength - Lot or control number - Appropriate expiration date determined by the pharmacist in accordance with USP standards
Explain procedures and required records for dispensing drugs for emergency drug kits
- Emergency Drug Kits: Only RN, Rph, MD, sealed with identifier, absence would threaten survival of patients (IV, inhalation, Nitro SL). Form filled out upon opening kit (date, time, name), anything used covered with rx w/i 72 hours. - Hosp, LTCF, Correctional (w/ licensed personell)
What is the PIC of a hospital pharmacy responsible for?
- Establishing procedures for and assuring maintenance of the proper storage, security and dispensing of all drugs used throughout the hospital. -Providing reviews of drug therapy.
Renewing a pharmacist license
- Expire Dec 31st annually. (Fee, form, statement of compliance with CE) - October 1 newly licensed cut off. - Fails to renew w/i 1 year, late fee - Fails to renew >1 year application for reinstatement, documentation of CE for # years not active NTE 60 hours - >5 years, application, 60 hours CE, Law exam, proof of active practice in another state or practical experience at least 160 hours. - Notfiy change of address w/i 14 days
Explain the conditions under which Sched II CS may be filled to include limitations, conditions for partial filling and the issuance of multiple prescriptions for the same drug.
- Expires 6 months after issuance, no refills except partial fill situations (LTCF/Hospice). - may disp up to three rxs (90 days) to be dispensed at later dates, - Emergency oral prescriptions limited to amt adequate to cover. - Partial Filling: If cannot supply fully amount disp partial qty, remaining portion must be dispensed w/i 72 hours. LTCF/Hospice: Partial filling: record qty, date, rph, qty remaining. Total qty dispensed shall not exceed total qty prescribed. Partial fill prescription invalid after 60 DAYS from date of issuance. LTCF partial dispensing info may be maintained electronically.
Describe the responsibilities for the PIC
- Full responsibility for legal operation of pharmacy. Hospital: PP, assure proper compliance, PP re reviews of drug therapy, notify board prior to opening stelite pharmacy, May auth storage in an area of the hospital outside the pharmacy, must be locked when auth staff not present (large volume parenteral, irrigation soln, contrast media, medical gases, sterile sealed surgical trays, blood components) - Can't be PIC of more than 2 pharmacies. - Control all aspects of the practice of pharmacy. - Change of PIC: Return pharmacy permit to the board indicating the effective date on which ceased to be PIC. Application for permit designating new PIC shall be filed w/i 14 days. - Absent >30 days deemed no longer PIC. Hospital: establishing PP for proper maint, storage, security, dispensing, reviews of drug therapy, notify board prior to opening satellite pharmacy, may auth storage area (floor stock) for Sched VI drugs outside of pharmacy
Explain the conditions under which drugs and devices previously dispensed may be accepted for return to stock for resale
- Has never left the pharmacy premises or control of the pharmacy delivery agent. If left control of the pharmacy can not be taken back. Except: hospital, in mfg w seal storage requirements assured. - hosp/LTCF can be re-dispensed to indigent patients with written forms. No product re-dispensed more than once. - Must have expiration date or be 1 year from date of original dispensing. - Must be the next dispensed of that drug. - Devices may be accepted for return or exchange provided the device is in the mfg original sealed packaging.
Explain the conditions under which an inventory needs to be taken following a drug loss
- If unable to determine exact qty/kind - CS Inventory.
Explain the reporting requirements for the theft or loss of CS
- Immediately report the loss or theft to the board. Furnish information of los within 30 days - Immediately notify DEA, law enforcement (optional) - If unable to determine exact qty/kind - CS Inventory. - Keep records x 2 YEARS - DEA Theft/loss form (106) - doesn't need to be filed if after initial investigation no theft or loss occurred. - Must be done in 1 business day - Suppliers are responsible for reporting "in-transit" losses.
Explain the requirements for compounding
- In accordance with USP-NF compounding standards. -pursuant to valid prescription - Label product with appropriate beyond use date. - May prepare products ahead of time. - Limit vet clinic compounds to amount needed for emergent situations. - May disp compounded drugs to practitioners to administer in the course of their practice. "For administration in prescriber practice location only" - Rph supervise and conduct final check - Records of prescriptions, formula book, log or record. - Formal written quality assurance plan - monitoring and evaluation - OOS pharmacy must inform board if performing sterile compounding.
What is required if a generic substitution is dispensed in place of the brand name drug prescribed?
- Inform the patient - Indicate on the patient record and prescription label the therapeutically equivalent drug and the name of the manufacturer/distributor - Label the prescription vial with the drug dispensed followed by "generic for" and the brand name - Charge the patient less than the cost of the brand name product
Explain the requirements for an alarm system and when it should be activated
- Must have alarm system in accordance w industry standards (exception 24 hours pharmacies) - Access restricted to refs - Activated whenever rx dept closed.
Time that must keep records of names & addresses or copies of IDs of persons picking up a C-II for someone else
1 month
Sched II-V Inventory. Inventory requirements; dates, required records, format, count requirements, filing, and newly scheduled drugs; perform perpetual inventory of Sched II CS
- Inventory on first date of business. CII - actual physical count, CIII-V estimated physical count (if container holds more than 1,000 tablets in which case an exact count of content must be made_ - Inventory at least every 2 years (biennial) CI-V on any date with in 2 years of the previous inventory. - PIC change - Inventories: Signed and dated by person taking inventory and indicated open or close of business. - All records filed chronologically and maintained not let than 2 years. 222 forms, CS invoices, POA, inventories, distribution records, CV logbook, DEA 106 (loss), DEA 41 (disposal) - Inventory of newly controlled Drug.
Describe the record requirements for loss of drugs
- Keep records/reports x 2 YEARS
The PIC can delegate ordering and distribution of certain drugs to non-pharmacy personnel. Which drugs?
- Large volume parenteral solutions that contain no active therapeutic drug other than electrolytes; - Irrigation solution; - Contrast media; - Medical gases; - Sterile sealed surgical trays that may include a Schedule VI drug; - Blood components and derivatives, and synthetic blood components and products.
Explain procedures and required records for dispensing drugs for licensed emergency medical services agencies
- Licensed Emergency Medical Services: drug kits, rph check before disp, drug kit is sealed, administered via oral or standing orders, document all use of medications. when drug kit opened return to pharmacy and exchange for unopened. Pharmacy keep records of exchanges x 1 YEAR. Records of administration x 2 YEARS. IV may be stored outside kit.
1 year
- Log of prescriptions delivered to patient when pharmacist not present -Quality Control temperature records • Drug cart filling records (who filled them, pharmacist who checked them, who accepted them) need to be kept on hand for 1 year - Unit dose filling Cart Log • Keep a log of emergency drug kits, their numbers, and when they were exchanged. - Pharmacy permit renewal is annually • Keep control records of bulk reconstitutions of injectables, bulk compounding, or repackaging for 1 year OR until the product expires - whichever is GREATER. - Manufacturer DEA registration renewal is annually - CII pick-up records - Record of technician or nurse entry to pharmacy when RPh not present - Manufacturer and distributor DEA inspections are annual - Keep MAR from correctional facility
Descrive PDMP confidentiality of data and disclosure of information
- Mandatory disclosure: Auth agent shall only request disclosure of information related to specific investigation. Include attestation that info will not be further disclosed - Director may disclose to: Patient (w valid photo ID), prescriber, reg agency conducting investigation, govt entities invest/prosecution, dispenser (pharmacy). W/ attestation will not be further disclosed - Unlawful to disclose confidential information.
Explain the requirements for disposition of d/c drugs for LTCF, to include records
- May be returned to the pharmacy for resale or transfer to another pharmacy for redispensing to the indigent or disposed of by appropriate means. - Drug destruction witnessed by PIC and by another employee. or to another entity. At the facility witnessed by director of nursing. - Complete and accurate record of drugs returned or destroyed, signed by witnesses, maintained at LTCF x 2 years, copay at pharmacy x 2 years - destroy/return d/c drugs w/i 30 days.
Describe the requirements for performing monthly reviews of drug therapy for patients in hospital or LTCF
- Monthly review of drug therapy by a pharmacist is conducted for each patient in LTCF. Pharmacist shall sign and date the notation of the review. All significant irregularities shall be brought to the attention of the attending practitioner. - PIC must maintain PP for providing reviews of drug therapy and any irregularities in drug therapy.
Manufacturers register with DEA every
1 year
Explain the requirements for implementing a pharmacy Continuous Quality Improvement program
- Must report errors to safety organizations OR implement a program for continuous quality improvement. - Rph must contact pt regarding error. - Documentation of the dispensing error NTE 3 days, -PIC or designee shall perform a systematic, ongoing analysis of dispensing errors w/i 30 days. Notify staff of changes in PP, - Keep records x 12 months (dates of analysis, names of participants, description of actions, zero report if applicable)
Explain the requirements for making an offer to counsel and describe the components of counseling
- NEW: Rph or designated person shall OFFER to counsel any person who presents a NEW prescription for filling. Made in any manner deemed appropriate (face to face by rph or designee, sign posted, notation on bag or bottle, telephone) - REFILL: rph may offer to counsel as deemed appropriate. - Does not apply to hospital or LTCF. - Reasonable effort to obtain pt information. - if pt refuses counsel rph is not required to. - Offer toll free phone number to pts out of area.
What are grounds for revocation or suspension of a pharmacist's license?
- Negligence - Fraud - Unprofessional conduct - Incompetence due to a mental or physical condition - Use of drugs or alcohol to the extent that the pharmacist is rendered unsafe to practice - Fraude or deceit - Engaging in activities beyond the scope of the license - Allowing unlicensed persons to practice duties for which a license is required - Violating or cooperating in violating a law or regulation relating to pharmacy
What are grounds for revocation or suspension of a pharmacist's license?
- Negligence - Unprofessional conduct - Incompetence due to a mental or physical condition - Use of drugs or alcohol to the extent that the pharmacist is rendered unsafe to practice - Fraudulent or deceitful conduct - Engaging in activities beyond the scope of the license - Allowing unlicensed persons to practice duties for which a license is required - Violating or cooperating in violating a law or regulation relating to pharmacy
Explain the requirements for physical standards and minimum equipment required for pharmacies
- Not less than 240 sq ft. - Access to stock rooms, restrooms and other non-pharmacy areas shall not be throughou the rx dept. - Constructed of permanent, secure materials, well lit, ventilated, proper temp, sink with hot and cold water, adequate refrigeration facilities. - Sanitary with trash disposal. Equiptment: Reference source, prescription balances (sensitive to 15mg) or electric, other quilt w.i scope of practice.
Explain procedures and required records for dispensing drugs from automated dispensing devices
- PP Manual - personell accessing w code identifying who is accessing. - delivery record of all drugs to be placed in automated dispensing device (date, drug, dose form, strength, qty, unit). Initials of person loading, rph initials checking product, delivery record. Loading CII-V loader will verify that the count of that drug is correct. - produce hard copy record of distribution. - Discrepency reports when ct of drug on hand in the device differs. resolved by PIC in 72 hours. if theft report to board immediately. - Monthly review for compliance and audit of CS distribution. Review admin records, distribution records. Exempt if software which provides statistical analysis monthly. - Inpections: monthly to verify proper storage, location, exp dates, security, barcode technology, temp, - Records: 2 YEARS, chronologic order. LTCF: removal of drugs pursuant to valid rx - rph must review prior to dispensing. Emergency drug kit drugs can be accessed prior to review. Drugs in mfg unit dose or repackaged in unit dose.
Understand requirements for participation in collaborative agreements.
- Patient consent. - May include implementation,
Explain scope of practice: supervision, personal supervision
- Pharmacist must be physically present and render direct, personal control over the entire service being rendered. Prior nor future instructions shall be sufficient, nor telephone, written instructions, etc. -
Who can be a pharmacy technician trainee program director
- Pharmacist with a current license in any jurisdiction -Technician with at least 1 year experience as a tech and has a current Virginia or PTCB certification -Another person approved and deemed qualified by the board
When is a pharmacy required to take an inventory of CI-V drugs?
- Prior to opening on its first day of business (initial inventory) - At least every 2 years after its last full inventory (biennial inventory) - When there is a new PIC (before opening for business that day) - When there is theft or loss of CI-V drugs and what was taken is not known - When the pharmacy closes or transfers business
Pharmacy permit renewal good for
1 year
Describe prohibitions regarding patients right to choose and disclosure of kickbacks, fee-splitting
- Pt has right to choose pharmacy of choice. - Rph shall not solicit prescription practice w MD providing rebates, kickbacks, fee splitting or special charges in exchange for prescription orders unless fully disclosed in writing to the pt and any third party payor.
Explain the conditions under which prescriptions for ached VI CS may be filled or refilled to include time limitations
- Refilled only as expressed by practitioner. If no auth given, the prescription shall not be refilled. - Shall not be dispensed or refilled more than 1 year after the date of issuance unless the prescriber specifically authorizes dispensing or refilling for a longer period of time not to exceed 2 years. - Timing of dispensing of refills shall be within reasonable conformity with directions for use. A refill may be dispensed early provided the rph documents a valid reason for the necessity of the early refill. - Emergency filling if MD is not available and pt is at eminent danger. - Pt address on all rxs.
Describe the appropriate terms necessary for lawful dispensing;
- Repackaged Drug: Any drug removed from mrf packaging and placed in different packaging. - Safety Closure Container: a container that meets federal poison prevention packaging act 1970, 85% of 300 children 41-52 months are unable to open w/i 5 minutes and 80% fail in another 5 minutes while 90% of 100 adults are able to open and close. - Special Packaging: Designed or constructed to be significantly difficult for children <5 to open and not difficult for normal adults to use properly, but does not mean packaging which all such children cannot open. - Terminally Ill: Pt with terminal condition. Compounding: Device: Dispense: Drug: Administer: Label: Written, printed, graphic matter upon immediate container of any article. Labeling: Al labels and other written, printed, or graphic matter on any containers, wrappers or accompanying material. Prescription: Schedule VI Device: Same as below but device. Schedule VI: Any prescription drug that has not been places in another schedule "Rx Only", "Caution: Federal Law prohibits dispensing without a prescription" CS: Drug Sample:
What are grounds for revocation or suspension of a pharmacist's license?
- Revocation of registration by DEA or other federal agency - Engaging in theft or diversion of controlled substances - Violating any federal or state drug law - Revocation of license in another state - Conviction of any felony or misdemeanor involving moral turpitude - Issuing statements intended to deceive or defraud a professional service regulated by the board - Has practiced in such a manner as to be a danger to the health and welfare of the public - Has failed to comply with CE requirements
What are grounds for revocation or suspension of a pharmacist's license?
- Revocation of registration by DEA or other federal agency - Engaging in theft or diversion of controlled substances - Violating any federal or state drug law - Revocation of license in another state - Conviction of any felony or misdemeanor involving moral turpitude - Issuing statements intended to deceive or defraud about his professional service - Has practiced in such a manner as to be a danger to the health and welfare of the public - Has failed to comply with continuing education requirements
Explain the conditions under which a pharmacist may engage in generic substitution (what is the definition of therapeutically equivalent drug products)
- Rph may dispense therapeutically eq drug product for a product that is written for brand unless: i. Md indicated "brand medically necessary" ii. Pt insist on brand name. - on rx blanks check box of "dispense as written" may sub if "voluntary formulary permitted" is checked. - If dispensing drug product other than the brand name - inform purchaser, indicated on prescription record and label "generic for" - therapetic eq shall be at a lower cost. - Rph may dispense biosimilar that has been licensed by FDA as interchangeable. - Therapeutically interchangeable: drug products that contain the same active ingredients and are identical strength or concentration, form rout, and classified as being there eq in the FDA orange book.
Explain procedures and required records for dispensing drugs for stat drug boxes
- Stat drug boxes: used for initiating therapy prior to receipt of rx. RN, Rph, MD only. Rx must exist prior to removing from box, sealed w identifier. When accessed form filled out with name, date, time, name and qty of items removed. When opened return to pharmacy. Contain no more than 20 solid dosage units per schedule - Hosp, LTCF, Correctional (w/ licensed personell)
Explain scope of practice: Pharmacy Intern
- Supervised by Rph - Registration only valid while enrolled - practical experience gained in another state - register w pharmacy - All practical experience evidenced by affidavit w board - currently enrolled in pharm school or grad, registered w board for purpose of gaining practical experience for licensure.
Information that must be on a prescription label
- The pharmacy OR pharmacist's name - The pharmacy's address - Prescriber's name - Rx number - Date of the prescription or of its filling - The patient's name - The owner's name and species of the animal if applicable - Drug name - Drug strength if applicable - Directions for use (including cautionary statements if on the Rx) - Quantity dispensed - Generic name if brand dispensed - The words "generic for" followed by the brand name if generic dispensed for a Rx written w/ the brand name then generic's manufacturer - CII-IV drugs: Caution: Federal law prohibits the transfer of this drug to any person other than the patient for whom it was prescribed.
What has to be on the application to for the permit to operate a pharmacy?
- The pharmacy's corporate name and trade name - any pharmacist in addition to the PIC who will work there - The hour the pharmacy will be open; - The pharmacy owner (if someone other than the pharmacist making the application) - The type of ownership and names of the partners, directors, or officers
Explain the requirements and documentation for managing after-hours access to the pharmacy in a hospital
- When auth by PIC, RN may have access to emergency medications help outside pharmacy (provided in mfg bottle or pre-packaged units) - Records maintained x 1 year. -Date of withdrawal, pt name, drug, strength, dose form, dose prescribed, number of doses removed, RN name. - If staffed 24 hours does not need to be alarmed. If not staffed continusouly alarm required with area is closed.
Requirements for transferring pharmacy when transferring a prescription
- Write VOID on the face of the Rx - record the date of the transfer - name and address of the receiving pharmacy - the DEA number for CIII-CV drugs - first and last name of he pharmacist receiving the transfer (for oral transfers only)
What can a long ter care facility do with the discontinued drugs?
- drugs may be returned to the pharmacy for destruction or donation to an indigent program. -mThe facility can destroy the drugs at
Explain the conditions under which drugs may be ordered or purchased
- except for emergency purchase from another pharmacy, a pharmacist may only purchase ached II-VI drugs from a wholesale distributer or warehouse registered by the board.
Explain conditions under which sched III-V CS may be filled or refilled to include time limitations, restrictions, and requirements for partial filling
- expires 6 months after issuance, rx can not be authorized to be refilled more than 5 times. INCLUDES CV! - partial filling permissible given total qty of drug dispensed doe not exceed total qty prescribed. - Timing of dispensing of refills shall be within reasonable conformity with directions for use. If directions have not been provided, than any refills may only be dispensed in a reasonable conformity with the recommended dosage and w/i sound professional judgement. A refill may be dispensed early provided the rph documents a valid reason for the necessity of the early refill. - Full name and address of pt, full name and address of person prescribing, dated and signed upon issuance.
Describe registration procedures for obtaining and renewing registration for pharmacy technicians
- fee and application to board (working in free clinic, board may waive fees) - satisfactory completion of an approved training program and pass board-approved examination OR PTCB certification evidence. - Trainee may perform tech tasks for no more than 9 months prior to becoming registered. Renewing: Expire Dec 31 annually (july 1st cut off for newly registered) CE: 5 hours per year. May grant extension up to 1 yr w approval. Keep records of original certificates x 2 years.
Procedure for filing application to open a new pharmacy, change location, make structural changes, make changes to a previously approved security system
- file application with board - Acquisition: owner of acquiring pharmacy notify patients 14 DAYS in advance. - Proposed location or structural changes shall be inspected prior to license. 14 DAY notice prior to inspection. If fails, rein spection is required. - No drugs stocked until approved. and not placed prior to 2 weeks before opening.
Explain the conditions and documentation for dispensing schedule V CS without a prescription
- must be dispensed Rph to Pt. - Pt must be at least 18 yo - ID - No more than 200mg opium, 270mg codeine within 48 hours. - Log: date of dispensing, name and sty of preparation, name and address of person, initials.
Determine the conditions for legally transferring Sched II-VI CS between registrants (ordering and receiving)
- official written order. 222 form. preserve copy x 2 YEARS - Follow federal guides for using order forms. II: to mfg/wholesaler, rph/pharmacy, CS registrant, master of ship w/ physician pursuant to written order form. III-VI: All of the above w/o official written order. Pharmacies may distribute small qty w/o wholesaler license as long as gross dollars or qty doesn't exceed 5% of annual amount sold/dispensed.
Describe powers of inspection and inspection procedures and access to records by board agents and state police. Describe access to prescription records during inspections
- power to inspect drugs, cosmetics and devices. Right to enter business during business hours. - Board, state police, or their agents has access and copy records.
Discuss the limitations upon accepting prescriptions from medical interns or residents and the purpose of the suffix assigned to the intern or resident for CS prescribing
- prescribe only in a hospital, signature, printed name, address, ph#, ID number assigned by hospital. - CS prescribing ID Number is DEA number assigned to hospital plus a suffix assigned by the institution. - Only valid within course of duties as part of residency program.
Explain the requirements for transferring prescriptions between pharmacies
- pt given permission for transfer - If oral between 2 pharmacists. May also be via fax or electronic transmission. CIII-VI: Transferring Pharmacy: "VOID" on rx, pharmacy name, address DEA# (if CS), rph name (if oral), date of transfer Receiving Pharmacy: "TRANSFER" rx#, Original date, original refills, original fill date, refills remaining, last refill, pharmacy name, address, DEA# (if CS), transferring rph (if oral) - keep original and copy in records x 2 years. - "For information only" give to pt.
Explain procedures and required records for the use of robotic pharmacy systems
- rph review accuracy and appropriateness of prescription orders. -packaging, repackaging, stocking, restocking by rph or tech. rph verify and check accuracy of all - repacking record w appropriate Beyond use date - PP - rph perform daily random check of accuracy for 5% of all pt's bins and 5% of al first doses or chart updates. If robot picks incorrect medication 100% checks until documentation of correction in error. - Quarterly reports of accuracy Records: 2 YEARS
Explain Dispensing activities which are restricted to pharmacists
- supervision of compounding, interns, techs - Verify prescription accuracy (initial) - Rx Validity/review/Prospective DUR - Receipt of oral prescription. - Counseling - Comm w/ provider re any modification other than refill authorization of rx. Interns: May preform acts to be performed by pharmacist for the purpose of obtaining experience, under supervision. Nuclear Techs: may accept oral rxs for diagnostic, non patient specific orders.
Explain how to properly label prescriptions
- unless otherwise noted by MD, label shall bear: Drug name, strength, qty. - generic name included on label if Brand disp - If generic disp when brand prescribed include "generic for" (exempt for LTCF/hospital) - name and address of dispenser, serial number, date of prescription or filling, name of patient and prescriber, directions for use, andy cautionary statements. - Name of species, name of owner.
how can you prevent generic substitution in VA?
-"Brand Medically Necessary" handwritten on face of Rx by prescriber for Medicaid pts, or product selection is allowed -for all non-Medicaid pts, phrase must be included, but not required to be handwritten
what are the requirements for the pharmacy security system's device?
-"generally accepted" device for industry, such as sound, microwave, photoelectric, or ultrasonic -in working order and have backup power supply -able to send an alarm even if communication line not working (line cut) -must fully protect Rx area and detect any type of breaking
what is the fee for licensure transfer? do transferring pharmacists have to take MPJE?
-$180 -yes
Max scheduled shift? Min time off between shifts? Entitled a break after _____ hours
-12 hours (unless emergency exists) -6 hours off -6 hours; 30 minute break
Schedule II pickup records kept for
1 year
what is the max length of time in 1 day a pharmacist can work? when can this be longer? must there be a specific time length between working?
-12 hr/day, unless they volunteer to work longer -need at least 6 hrs between
when the PIC leaves, how long does the pharmacy have to designate a new PIC? what happens if the pharmacy doesn't?
-14 days -pharmacy can't keep operating or even maintain a stock of Rx drugs unless they request an extension from BOP of the time allowed to designate a new PIC -executive director of BOP can give additional 14 days for good cause shown, but request must be received prior to original deadline
What do you need to obtain RPh in VA?
-18 or older -graduate from a ACPE school -1500 hr intern -passing naplex and mpje -good moral characters
Pure Food and Drug Act
-1908 -Prohibited food and drugs distributed through the interstate system to be adulterated or misbranded -Did not require ingredients or instructions -Did not regulate cosmetic products or devices
Food, Drug and Cosmetic Act
-1938 -All new drugs could not be marketed until proven SAFE -Required labels to have adequate instructions -Warnings for habit-forming drugs
Durham-Humphrey Ammendment
-1951 -Created legend drugs (prescription only)
Kefauver-Harris Ammendment
-1962 -Drugs had to be proven effective in addition to the already required safe -Put the FDA in charge of advertising of RX drugs (OTC is FTC) -Created GMP -Thalidomide scare in Europe brought this about
Medical Device Ammendment
-1976 -Protects the public from potentially dangerous or useless devices
Orphan Drug Act
-1983 -Tax and licensing incentives to manufactures to develop drugs for rare disease (affects less than 200,000 persons in the US
Prescription Drug Marketing Act
-1987 -Wholesalers must be licensed by states -Cannot re-import drugs -Cannot sell trade or purchase samples -Storage, handling, and recorkeeping of samples
FDA Modernization Act
-1997 -Expediated drug approval when such drug may save lives -Additional 6 month patent extension when studied in peds -Changed legend to RX only -NDA encouragement for additional indications
How many pharmacies can a pharmacist be PIC?
-2
How long do pharmacists keep CE records? Technicians?
-2 years -2 years
Freezer temp
-20 to -10 C (-4 to 14 F)
Freezer temperature
-20 to -10 degrees C
Medicare Prescription Drug Improvement, and Modernization Act
-2003
Patient Protection and Affordable Care Act
-2010
individuals and institutions (including prescribers, hospitals, and pharmacies) submit the DEA Form ____ to apply for a DEA number/registration, and use Form ____ to renew it
-224 -224a to renew
when will the initial DEA registration for a pharmacy expire?
-28-39 months -DEA varies initial expiration dates so it can assign new registrants to a cohort for renewal, preventing all registrations from having to be renewed at the same time
what is the term length of VA BOP members? is there a limit to how many terms?
-4 years -2 terms this is for pharmacist and public members
how many pharmacist members are there on VA BOP? public members?
-8 pharmacist -2 public
Requirements for the person who is supervising an intern who is in the process of gaining hours?
-Active RPh license in good standing -Full responsibilities on the intern
When can you start gaining practical experience to count towards 1,500 hours
-After 2 full semesters of school (this only goes towards hours outside of school programs) -Must hit 1500 school hours to be exempt from this -Must be >20 hours but <50 per week to count
Who can a manufacturer or wholesaler sell schedule 2-5 drugs to?
-Another manufacturer/wholesaler -A licensed practitioner: pharmacist, pharmacy,MD,DO, podiatrist, Dentist or Vet -An official (federal,state, territory,district,county, municipality) on government business -A ship or aircraft captain, if there is no regular doctor on board, for the actual medical needs of people on board. The vesssel cannot be in port. -A person in a foreign country, in compliance with relevant federal laws
can there be exemptions for the pharmacist CE requirement in VA?
-BOP can grant exemption if pharmacist gives evidence that failure to comply was beyond their control -upon written request, BOP can grant extension of 1 yr (still have to do that yr's CE too)
Generally not covered
-Barbiturates -BZDs -Weight loss or weight gain drugs -Hair growth drugs -Drugs that increase fertility -Prescription vitamins (other than prenatal and fluoride) -Outpt drugs requiring monitoring by manufacturer
what meds are TPA certified optometrists allowed to prescribe and administer?
-CIII-VI oral analgesics to relieve ocular pain -other oral CVI controlled substances to tx dx of eye and its adnexa -topically applied CVI drugs (for tx of eye/adnexa) -IM administration of epinephrine to tx emergency cases of anaphylactic shock
C5 drugs that can be purchased without prescription
-CODED Codeine Opium Dihydrocodeinone Ethylmorphine Diphenoxylate (lomotil)
How to be on the board of pharmacy
-Resident of VA and US citizen -Appointed by the governor for no more than 2 full terms --If you take over during someone else's term, then you fulfill their term and it doesn't count as a full term
14 days
-Change in Address or ownership -Change in hours open if lasting > 1 week -When PIC resigns, you have 14 days to notify board and obtain new PIC. Unlawful for pharmacy to practice for more than 14 days without PIC if they have resigned with no return date for sure. -Closure for > 1 week and send letter to patients -New Acquisition notification for patients -Pharmacy Permit application indicating inspection date -Once Permitted cannot hold drugs until 14 days prior to opening -Notify Board of planned destruction of CII-V 14 days prior -Notify DEA of business transfer
when is Consumer Medication Information required to be dispensed? Patient Package Inserts? Med Guides?
-Consumer: new Rx only -PPI: new Rx and refills -Med Guides: new Rx and refills
Virginia requires the following to be required data
-DEA # of the dispenser -NPI of the prescriber -Total # of refills ordered -If the fill is new/refill -If it is a partial -Gender -Species -Electronic reference number or electronic prescription order number IF its an electronic RX -Date RX written
What must be in CV dispensing log
-Date of dispensing -name and quantity of preparation -name and address of the person receving -Enter his initials
What infromation is the receiving pharmacy requried to record
-Date of issuance of original prescription -Original number of refill authorized on the original prescription -Date or original dispensing, if applicable -Number of valid refills remaining and date of last dispensing -Pharmacy name, address, DEA registry number except for Schedule 6 prescriptions, and original prescription number from which the prescription information was transferred -Name of transferring pharmacist, if transferred orally
DI
-Dietary ingredient -may be a vitamin, mineral, herb, or other botanical, AA, or other dietary substance that supplements diet
What do these records need to contain
-Drug name and strength,quantity prepared -Manufacturer or distributor's name and lot/control number -Date,expiration date -Initials of pharmacist verifying th process
What can technicians do
-Entry/drug hx -prepare labels or pt info -remove drugs to be dispensed from inventory -count, measure, compound -package and label the drug to be dispensed and the repackaging thereof -Stocking or loading automated dispensing devices -Accept refill authorization with no changes
When can a fax come from somewhere other than the prescriber's practice location?
-Faxing an oral order -Forwarding a chart from --LTC --Hospice -Forwarding a written prescription by an authorized agent at a LTC --Must receive hard copy within 7 days
Drug Price Competition and Patent-Term Restoration
-Hatch-Waxman Amendment -Generic companies only have to submit ANDA (abbreviated new drug application) --Shows proof of bioequivalence with brand-name counterpart -BN manufacturers received additional 5 years of patent protection
What info is a person purchasing controlled paraphernalia required to produce?
-ID -written legitimate purpose for buying (not required for customer of known good standing)
When is a prescription not a valid prescription
-If it is not written for a medical or therapeutic purpose -If it is not written for people or animals with whom the practitioner has a bona fide practitioner-patient relationship
How does initially licensed RPh renew their license?
-If obtain license on or after 10/01, does not renew until next year -if obtain prior to 10/01, need to renew for this year but doe not need 15hr CE
Reporting errors record keeping
-If you use a patient safety organization to report your errors then you are compliant (this doesn't cover unprofessional practice though) with the law and just keep a record indicating the date a report was submitted and maintain that record for 12 months. If no dispensing errors occur within past 30 days then log a zero report in the record - If you don't use PSO then you have to retain documentation until systemic analysis is complete then a separate record maintained and available for inspection for 12 months from the date of error including 1. dates analysis initiated (w/in 3 days of error) and completed (w/in 30 days of error) 2. names of participants in analysis 3. general description of remedial action to prevent or reduce future errors 4. also that 0 report date for going 30 days without error
Some controlled substances are missing from the pharmacy. What is the pharmacy responsible for doing?
-Immediately notify the Board -If the exact kind or quanitty of the drug loss is unknown, do a complete inventory of all SI-V drugs -Within 30 days of discovery of the loss, furnish the board with a listing of kind, quantity, and strength or the drugs lost. -Notify the area field division office of the DEA in writing within 1 business dya -Complete DEA form 106
Eligible drugs to be donated
-In original packaging or single dispense -Expiration date >90 days -Not misbranded or adulterated -Not schedule II-V -REMS drugs -Previously compounded drugs
Describe situations in which a drug would be considered misbranded
-Its labeling is false or misleading -The package is missing the name and location of the manufacturer, packer, or distributor - The label or labelin is missing required information -A habit-forming drug is missing the name and amount of substance, or the statement "Warning-May be Habit forming" -The established (generic) name of the drug is not printed on its label prominently and in type at least half as large as that used for the proprietary (brand) name -It is missing adequate directions for use or adequate warnings -If it is dangerous to health when used in the dosage, or with the frequency or duration prescribed, recommended, or suggested in the labeling or advertising. -If it is insulin or an antibiotic, and does not have a certificate of release in effect. -If a trademark, tradename, or other identifying mark was placed on the drug or container with intent to defraud.
Exemptions to PMP reporting
-Samples/donated by manufacturer for indigent care -Dispensed in a medical emergency by a practitioner of the healing arts/pharmaceutical services not available -Administering -Dispensed by a narcotic maintenance treatment program -Hospitals and nursing homes -Inpatient hospice -Vets
What can an optometrist prescribe
-Schedule 3-6 oral analgesics tor relieve ocular pain -Other oral Schedule 6 controlled substances to treat diseases of the eye. -Topically applied Schedule 6 drugs -Intramuscular administration of epinerphrine to treat emergency cases of anaphylactic shock
30 days
-Keep a suspected forged prescription before can destroy - Long term care facility must destroy or return unused drugs to pharmacy - Post notice of closure if > 1 week - Automated dispensing machine audits by PIC are monthly - Controls perpetual inventory reconciliation - Drug review by PIC at LTC facility - Keep identification records for CII Rx - To do inventory and give the Board of Pharmacy a list of all schedule I-V drugs stolen or lost - inspect automated dispense devices -For a correctional facility to return any unused or discontinued drugs - PIC should perform monthly checks on compliance with policy and procedure manual and storage of CVI substances that are able to be stored offsite of the pharmacy
Who can administer vaccines to adults for immunization per Board of Nursing protocol, when a practitioner with prescriptive authority is not physically present
-Licensed pharmacist -Registered nurses -Licensed practical nurses under the immediate and direct supervision of a registered nurse.
who has dispensing authority in VA?
-MD and DO (must be certified by BOP, except for samples, emergencies, and geographic hardship) -Dentist and Vet (only to their own pts) -Podiatrist (except for samples, must be licensed/certified by BOP) -PA, NP, nurse midwife (if allowed to prescribe, dispense only samples they're authorized to prescribe)
who can possess non-controlled legend drugs in VA?
-MD, DO, dentist, podiatrist, vet, pharmacist -optometrist (only drugs related to diagnosis/tx of eye and adjacent structure) -PAs and NPs (if have been certified to have prescriptive authority may possess drugs that they are allowed to prescribe only within their scope)
are Rxs from foreign countries valid in VA?
-MD, DO, dentist, podiatrist, vet: yes, as long as Rx meets VA standards -NP, PA, optometrist: not valid unless also licensed in VA
What is quorum
-Majority attendance
What are the separate business activities that each require their own DEA registration number?
-Manufacturer -Distributing -Exporting/importing -reverse distributing -dispensing -research (c1) -research (c2-5) -chemical analysis -narcotic treatment
Bonafide practitioner pt relationship
-Medical hx obtained -Benefits and risks of tx discussed -Performed or have performed an appropriate examination -Initiate additional interventions and f/u care
What are requirements for intern hour that obtained outside of school curriculum?
-Min: 20 hr/wk -Max: 50 hr/wk
Requirements for selling a CV OTC substance without a prescription
-Must be dispensed by a pharmacist - Must be dispensed directly to the person requesting it - Customer must provide proof of age ( At least 18) - RPh must use discretion to ensure it is being used for medicinal use only - Must record: date of sale, name and quantity of the preparation, name and address of the person to whom the prescription is dispensed, the initials of the dispensing pharmacist (kept for 2 years)
Health Practitioners' Monitoring Program Committee
-Must exist -An alternative to disciplinary action -9 members, one civilian 8 licensed, certufued, or registered practitioners -1 must be a physician DO or MD practicing -1 must be a nurse knowledgable about impairment and rehab
Counseling
-Must perform prospective drug review before each new RX is dispensed -Must offer to counsel on all new RX -Refills are professional judgement -If you don't document pt's refusal to be counseled then it is assumed you offered and counseled
Humane/rescues records of administration must include
-Name and strength of drug -Date of administration -Species -Weight of animal -Amount of drug administered -Signature of person administering
What does the practitioner have to do to ensure a bona fide practitioner-patient relationship
-Obtain a medical or drug history -Provide information to the patient about the benefits and risks or the drug being prescribed -Perform an appropriate examination of the patient, either physically or by using equipment to electronically transmit images and medical records. -Except for medical emergencies, the examination of the patient should be performed by the practitioner within the group in which he or she practices or by a consulting practitioner -Initiate additional interventions and follow-up care, if necessary, especially if a prescribed drug may have serious side effects
When is the cut-off for newly licensed pharmacists to not have to renew by the upcoming 12/31 deadline What about technicians?
-On or After 10/01 -On or after July 1
How can a prescription be transferred
-Orally by direct communicat between two pharmacists -BY fax machine -By electronic transmission
Who witnesses destruction fo drugs at LTC facility
-PIC and another pharmacy employee -If at a facility then the director of nursing, if no director exists then the facility administrator, and by a pharmacist providing services to the facility or authorized employee
In order to use PMP as a dispenser you must
-Post signage at drop-off OR -Provide written material to the recipient -Obtain written consent from the recipient
In order to use PMP as a provider you must
-Post signage at where public can easily view OR -Provide written material to the recipient -Obtain written consent from the recipient
Correctional facility administration record includes
-Pt name -Drug name and strength -# of dosage units -Prescriber's name -Date, time, and signature of the person administering the individual dose of drug
When are IDs required to pick up RX
-RPh can require it at any time for CIII-V -If the person picking up CII is unknown to the pharmacist or his agent -If the person is not the pt and unknown pharmacist/agent must photocopy or electronic copy or record the full name and address of person from a proof of identity ID (driver's licensed, gvt issued)
What does "supervision" mean?
-RPh has to be physically present and available for direct oral conversation
What sanctions in addition to suspension or revocation of a RPh license can a BOP do?
-Reprimand (khien trach) -Monetary penalty -Probation (thu thach) -Imposition of terms on the RPh license (restriction, additional CE)
Minimum age to buy OTC C-V meds
18
What if a drug is unused or d/c
-Schedule VI it goes back to the primary or secondary pharmacy within 30 days -Schedule II-V it gets destroyed at the facility within 30 days by a pharmacist nurse or physician and witnessed by one of those people too
What can a dentist authorize to be administered by either a dental hygienist or by an authorized agent of the dentist
-Schedule VI topical drugs -Oral fluorides -Topical oral anesthetics -Topical and directly applied antimicrobial agents for treatment of periodontal pocket lesions -Any other schedule 6 topical drug approved by the board of dentistry -Schedule 6 nitrous oxide and oxygen inhalation analgesia -Schedule 6 local anethesia, to patients 18 years of age or older
Describe situations in which a drug would be considered adulterated
-The drug is contaminated (contains any filthy, putrid, or decomposed substance) or contains a harmful substance in the drug or its container -the facilities used to make, pack, or hold it don't conform to cGMP -It doesn't actually contain the strength, quality, or purity of the drug that it claims to contain. -It is mixed or packed with something so as to reduce its quality or strength
Where does a faxed prescritpion need to come from
-The prescriber's practice location -A long term care facility or hospice
When can you fill a verbal order for CII
-The quantity prescribed AND dispensed is limited to the amount adequate to tx the pt during an emergency period -it is immediately written and contains all needed information but provider signature -If provider is unknown to RPh every effort is made to verify the RPh is speaking to the practitioner. Hopefully, calling from the office number on file -RPh receives hardcopy within 7 days (this can be in person, electronic, postmarked within 7 days) and the front of the RX says "Authorization for Emergency Dispensing" with the date of the oral order -RPh will attach verbal order to hardcopy
Who can access the PMP
-The recipient -The provider/ his agent -A regulatory authority processing a license or certificate request AND there is an allegation of controlled substance violation. The head of that department/business must sign the request -Government entities involved in investigation and prosecution recipient/provider/dispenser participating in VA medicaid. Request must be signed by the Office of Attorney General -A designated employee of the Department of Medical Assistance Services or of the Office of the Chief Medical Examiner
The exception allowing pharmacy technicians to enter a pharmacy without a pharmacist on duty
-They are retrieving a prescription already verified -There was an unforeseen, unplanned absence -Alternative pharmacist is not readily available -They are accompanied by a member of the pharmacy management or administration -A log is kept -The alarm code is changed within 48 hours
How can a Virginia pharmacy legally dispose of controlled substances?
-Transfer the drugs to an entity with a valid DEA registration (manufacturer, wholesaler, practitioner, another pharmacy, any other person that is authorized to dispose of drugs) -May also destory the drugs by burning in an incinerator or other Board-approved method but must give board 14 days notice w/ the date and time and manner of destruction and names of the RPhs that will witness
You want to destroy some drugs
-Transfer the drugs to another person or entity authorized to do such or -Destroy by burning in an incinerator or other board-approved method in compliance with all local state and federal laws, BUT if its a control (2-5) o at least fourteen days prior to the destruction date provide written notice to the board of the following --Date, time, manner, and place of destruction --The names of the pharmacists who will witness the destruction ---PIC and another pharmacist not employed by pharmacy must witness ---DEA drug destruction form must be filled out and filed with pharmacy inventory records
Official Compendia of the US
-USP/NF -Homepathic Pharmacopoeia of the US
What government entities have the authorities to inspect a VA pharmacy?
-VA board of pahrmacy -VA police Diversion units -DEA -FDA
does VA law have a minimum age requirement to purchase SLCPs? Federal law?
-VA law: no -Federal law: cannot be under age of 16
When can a CII be faxed
-With orders to be administered in a LTC facility and home infusion patients -Narcotic for hospice pt with hospice written on RX
What are the responsibilities of the transferring pharmacy
-Write "VOID" on the face of the invalidated prescription -Record information about the receiving pharmacy (name,address, and DEA number for controlled drugs) -For an oral transfer, the name of the pharmacist receiving the prescription -Record the date of the transfer
What are the responsibilities of the receiving pharmacy
-Write the word "TRANSFER" on the face of the transferred prescription -Record required information.
What information is required on the transferred prescription at the receiving pharmacy?
-Write the word TRANSFER on the face - record the date of the original prescription written - original number of refills - date of original dispensing if applicable - # of valid refills remaining -date of last dispensing - transferring pharmacy's name, address, DEA # if CIII-V - original prescription number -first and last name of transferring pharmacist if oral trasnfer
Is there a limit on the amount of CE the Board will require for a reinstatement of an inactive license?
-Yes, max 60 CE (4 years of inactive license)
If there is a change in ownership, does the board need to be notified?
-Yes, the board needs to be notified 14 days, and the pic needs to get new permit
Can a prescriber give an oral prescription to his agent to be faxed
-Yes, the faxed order must have prescriber's name and signature -oral rx does not need a signature
WHat must be done on the date of pahrmacy transfer regarding DEA registration?
-a complete inventory of c1-5 for both sides -DEA222 if transfer c1-2 -all required records of controlled substances -final reports if needed
Who are allowed to phone in c2 in a hospital?
-a hospital nurse or pharmacist -written rx within 72 hours
Time after reporting an error to a patient safety organization that record of that reporting must be retained
1 year
What does the supplier do after a lost dea 222 in the mail?
-accept the new order. get copies 1,2 of the lost and new order and the statement *if supplier ever reveices the lost form, mark "not accepted" and return to the purchaser. the purchaser will keep these once lost copies 1,2 with the lost copy 3 and the statment together
what info does an electronically transmitted Rx need to include?
-all info required for written Rs -full name of prescriber's agent if prescriber not transmitting -date of transmission
What information does an electronically transmitted prescription need to include?
-all of the info required for a written rx -full name of the authorized agent if needed -date of transmission
WHo may act as the prescriber's authorized agent?
-and employee under the prescriber's supervision -a nurse or a pharmacist directed by the prescriber
what is the pharmacist license renewal schedule? renewal fee? expiration date? notification date?
-annual -$90 ($45 inactive) -expiration Dec. 31 -notification November
Who is allowed to purchase c2-6 from a manufacturer or wholesaler?
-another permitted manufacturer/wholesaler -licensed pharmacist, permitted pharmacy, or licensed practitioner of medicine, osteopathy, podiatrym dentistry, or veterinary -person authorized by the certificate issued by VA controlled substance registration certification -federal or government officials -a ship or aircraft captain if there is no regular doctor on board with approval by a US public health service official -person in a foreign country in compliance with federal law
A facility wants to handle CI drugs for research purposes. The facility already has a DEA number. What else is the facility required to do?
-apply for a modified DEA registration by submitting 3 copies of the research protocol
What does a new PIC have to do when taking over a pharmacy?
-apply for a new permit -inventory controlled substances (I to V) on the date he becomes the PIC. The inventory must be done before the pharmacy opens.
what are the physical requirements for a VA licensed Rx department?
-at least *240 sq. ft.* (not including areas for waiting, counseling, devices, cosmetics, and proprietary medicines) -rest rooms and stock rooms not accessed thru Rx area (if there is rest room there, must be pharmacy staff only) -*sink* with hot and cold running water -*fridge with monitoring thermometer* for drugs requiring cold storage if those are stocked in pharmacy -well lit, well ventilated, and temp must meet USP standards
what is the pharmacist required to do with a hard copy emergency prescription for a CII when received? what if they don't receive it?
-attach to the emergency oral Rx and file it -contact prescriber to find out if it was mailed within the 7 day time frame - should call earlier to make sure prescriber doesn't miss deadline -if not mailed/received, pharmacist has to notify DEA (if not notified, pharmacist's authority to dispense emergency CII is revoked and can be found guilty of *illegally distributing a CII*!)
AMP
-average manufacturer price -the average of what wholesalers paid manufacturers for a drug
What if you fail to renew your license for more than 1 year?
-become "inactive" -have to reapply thru "reinstatement"
when is a pharmacist required to conduct a prospective drug review?
-before *each new Rx* is dispensed or delivered -before refilling a Rx, if needed based on professional clinical judgment
When is a pharmacist required to conduct a prospective drug review?
-before each NEW prescription is dispensed or delivered (mandatory) -before refilling a rx if needed
do PAs and NPs have prescribing authority in VA?
-both have dependent authority - NPs and PAs who have applied, met criteria, and have been approved for prescriptive authority may prescribe and possess CII-V and legend drugs that have been approved by supervising medical physician (have a written agreement deciding on prescribing authority) -NPs also have limited prescribing authority
if a pharmacist's license is suspended, how do you apply for a reinstatement?
-bring counsel and witness to the board hearing and will need 3/4 of the board members to vote for reinstatement -board may also reinstate only upon terms or conditions as it deems appropriate
subpoena (record) duces tecum
-bring relevant document to a court
how are inventory records filed?
-c2 -c3-5 (ok wiht 6)
Discontinued drugs at LTC facility
-can be returned to the pharmacy for resale -sold to a pharmacy providing service to the indigent -destroyed
special rules for the defense supply center if they want to order c2 to arm services in the us?
-can get partial shipments within 6 months (instead of 2 months) from the order date
Rules to partial CII fills
-can give 72 hour supply, but must notate on the face of the RX the amount dispensed --the remaining quantity must be given within 72 hours or the rest is forfeited --if the remainder is forfeited the RPh must notify the prescriber -LTC CII can be partial filled including individual dose units for up to 60 days from the written date if being dispensed as long as each time it is documented on the back of the RX or another appropriate record that is just as easily retrievable LTC can use computerized system pertaining to current CII orders if all the same information is present and the computer updates the RX in real time -Terminally ill pt's can fill partial quantities --Pharmacist must verify and document on RX --Can't exceed 60 days from issue date -Pt or provider may request partial fills (THIS IS NEW SEPTEMBER 2017) --Can't exceed 30 days of written date (THIS UPDATE was done to decrease potential cost to pt but primarily to decrease the amount of unused opioids in patients homes)
What happens if a person fails NAPLEX?
-can retake 3 times -after 3 times, has to repeat 1000 intern hours
what are the restrictions regarding sale of OTC dextromethorphan?
-cannot sell to anyone <18 yo -if pharmacist can't reasonably presume purchaser is at least 25, purchaser must produce federal, state, or local govt issued ID with DOB and picture -DM restrictions do NOT apply if drug is dispensed pursuant to Rx
What does a pharmacist have to do when she receives a paper or oral prescription that was originally electronically transmitted to the pharmacy?
-check to make sure that the electronic version was not received and dispensed -if both were received, void one of the prescription
What does a pharmacist have to do when she receives a oral prescription that was originally electronically transmitted to ANOTHER pharmacy?
-check with the other pharmacy to determined if it was received and dispensed by the other pharmacy -if they did not dispensed, they need to void the rx -if they already dispensed, must void and return the med to stock
do advanced registered nurse practitioners, clinical nurse specialists, nurse midwives, midwives, and certified nurse anesthetists have prescribing authority in VA?
-clinical nurse specialists, midwives, and certified nurse anesthetists have no prescribing authority -advanced registered nurse practitioners, and nurse midwives have limited and dependent prescribing authority
How to renew a RPh license in VA?
-complete and submit renewal orm -pay renewal fee of $90 -complete CE requirements
How to renew your license thru "reinstatement"
-complete reinstatement form -submit CE hour -renewal fee -reinstatement fe
what are the Rx department enclosure requirement?
-constructed so it protects against unauthorized entry and theft of controlled substances at all times -Rx department enclosure must be locked and alarmed when pharmacist not on duty -capable of being locked when on duty pharmacist not in Rx dept (like in bathroom or lunch)
DEscribe situations in which a drug would be considered adulterated
-contaminated -the drug or its container contain harmful substances -unsafe color additives -facility that makes the drug do not conform with cGMP -drugs subjected to insanity conditions -doesnt contain strength, quality, purity that claimed to contain -differ from USP conpendium of requirements -mixed with something that reduces its quality or strength
what limitations does VA set on medication delivery (by couriers, pharmacy employees, or kiosk dispensing)?
-controlled substances should be hand delivered to pt, his agent, or residence -need a notice regarding chemical degradation of drugs may occur under certain circumstances and provide a toll-free # or local # pt can call with questions
where does the triplicates DEA form go?
-copies 1 and 2 go to supplier (supplier sends copy 2 to dea agent after the order is filled) -purchaser keeps copy 3
what is the counseling requirement for dispensing naloxone?
-counsel patient on opioid overdose prevention, recognition, response, administration, dosing, adverse effects, storage, shelf-life, and safety and provide *current REVIVE! brochure* from Dept. of Behavioral Health and Developmental Services website -Recipient *can't* waive counseling unless pharmacist verifies successful completion of REVIVE! training program -if naloxone being delivered to an alternate site, counseling should be provided by physician, NP, PA, nurse, or approved REVIVE! trainer there
what minimum equipment is required for a pharmacy?
-current dispensing info reference source -either electronic scale or set of Rx balances (sensitive to 15 mg) and weights if the dispensing activities require weighing -other equipments and references consistent with scope of practice and public safety
What minimum equipment is required in a pharmacy?
-current dispensing info reference source -sclae/balance/weight (sensitivity to 15 mg) -other equipment consistent with the scope practice
WHen the pahrmacy sells controlled paraphernalia, what info must be recorded?
-date -name and quantity of device -price -name/address of buyer (16 or older) -reason -pharmacist initials
what are the record-keeping requirements when a tech enters the pharmacy in an emergency situation without a pharmacist present?
-date and time of entry -name and signature of tech -name, title, and signature of person accompanying tech -pharmacist's name who granted tech permission -phone # where that pharmacist was reached -name of pt initially requesting the needed med -nature of emergency -listing of all Rxs retrieved during that entry -time of tech exit and re-secured pharmacy dept *keep for 1 yr* *alarm code must be changed within 48 hrs of entry*
What information is pre-printed on dea222 form?
-date it was issued -registrant's dea number/name/address -registrant's business -schedules drugs that registrant is allowed to order -dea222 serial number
What information must be recorded when selling CV OTC?
-date of sale -name and quantity of drug -name and address of the person purchasing it -initial of the dispensing pharmacist
What info is required ot be on theinventory?
-date of the inventory -time (initial, after theft, transfer business, new PIC, or biennial) -drugname/from/quanity/commercial containers -signature of the person who does the inventory
What do these record need to contain?
-date repackaged -drug name/strength/ quanity -assigned lot control number -manufacture lot. ndc -exp date -rph signature
Additional requirements for a faxed prescription
-date the prescription is faxed -name, address, phone number and fax number of prescriber -name, address, phone and fax number of the institution
WHat is included in dea 41?
-deate of destruction -drusg/qunaity -signature of PIC -sinature of witness
who can possess controlled substances in VA?
-dentist, podiatrist, vet, pharmacist -MD, DO (if they hold a valid state registration) -PA (if they hold valid DEA registration and are not under board restrictions) -nurse midwife, NP, optometrist (limited)
pharmacy, wholesale distributor, third party logistics provider, or manufacturer may distribute naloxone via invoice to who else?
-designated law enforcement officers or firefighters who successfully completed training program -designated employees of Dept of Forensic Science, Office of Chief Med. Examiner, Dept. of General Services Division of Consolidated Lab. Services who have successfully completed training program
Waht are the requriements for selling a OTC CV?
-dipsnesed by a pharmacist directly to the person who wants it -must be 18 and older
what information is required to be on the dispensed Rx label? is anything different with CII-IV?
-dispenser's name and address -serial Rx # -date of filling (or initial fill) -prescriber's name -pt's name (owner + species if vet) -directions for use -drug name and strength -quantity -for a brand also include generic name, for generic also include "generic for _____" and the generic's manufacturer/distributor -if *CII-IV*: "Caution: Federal law prohibits the transfer of this drug to any person other than the pt for whom it was prescribed"
Storage of CII
-dispersed throughout the shelves or -locked in a cabinet, drawer, or safe --these may remain unlocked while the pharmacist is on duty
if the pharmacy doesn't have a PIC and receives a notice from BOP that it does not have a valid permit, what does the pharmacy have to do?
-dispose of all CII-VI drugs and devices within 15 days -if they don't, BOP will seize them and notify the owner -owner can claim them by paying storage costs and providing proper disposition of the drugs *within 6 months*
do doctors of homeopathy, optometrists, EMT paramedics, and naturopathic doctors have prescribing authority in VA?
-doctor of homeopathy and EMT paramedics - no -optometrists have independent authority -naturopathic doctors are not licensed
what drug info must go on a Rx?
-drug name -drug strength -drug dosage form -directions for use -quantity prescribed (*CII-V*, not required on CVI as some require calculation by pharmacist using directions for use and duration)
when a pharmacist repackages a drug, what info must go on the label?
-drug name and strength -lot or control # (can be assigned by pharmacy or can list manufacturer's/distributor's name and it's lot/control #) -BUD determined by pharmacist in accordance with USP guidelines
When a rph repackage a drug, what info must go on the label?
-drug name, strength -lot or control number -exp date
what 2 changes are prohibited for a pharmacist to make on a CII prescription?
-drug prescribed -add prescriber's signature
How can a VA pahrmacy legally dispose of controlled substance c2-5?
-drugs be transferred to a dea regiastraion entities (they have to fill out dea222) -pharmacy can destroy the drugs by themselves after: -give the BOARD 14 days notce, indicate time, date and pharmacist who will conduct the process -witness by another pharmacist not working at the location
What are the requiremetns for the issuance of multiple c2 prescriptions at the same time?
-each rx must indicate the earliest date it can be filled -max day supply for multiple issued prescriptions is 90 days
WHich practioners are exempt from registering with the DEA?
-employees of a dea registrant -practitioners affilated with a dea registrant -law enforcement officers
WHo is a pharmacy intern?
-enroll in a school of pharmacy -register with board to gain experience
A pharmacy is planning to serve a long-term care facility. What is the pharmacy responsible for
-ensuring that a valid order is received prior to dispensing any drug -training personnel who will be administering the drugs in the dispensing system that the pharmacy provides -ensuring that drugs for each patient are kept in the originally received containers and that one patient's medication is not transferred to another patient. -Ensuring that each cabinet , cart, or other drug storage area is locked and accesible only to authorized personnel -ensuring that the drug storage area is well lighted, big enough to permit storage without crowding and maintained at appropriate temperature -ensuring that poison and drugs for "external use only" are kept in a cabinet separate from other medications -providng for the disposition of discontinued drugs -ensuring that appropriate drug references are available in the facility units -Performing a 30 day drug review by a pharmacist for each patient
what methamphetamine precursors/SLCPs are regulated in VA? and what are the quantity limits on the sale of these
-ephedrine and pseudoephedrine base along with their salts, isomers, and salts of their isomers -3.6 g/day -9 g/30 day period -7.5 g/30 day period via mail order (Federal limit)
Describe situations in which a drug is misbranded
-false or misleading labeling -missing name of manufacturer, packer, distributor -label missing required information -missing "warning..mabe habit forming" on habit-forming drugs -missing generic name (established name) or not at least half size of brand (proprietary) name -missing quantity (mg) of active ingredient -missing direction for use -not label as described in the usp compendium -drug is dangerous when use according to labeling or advertising -missing a required batch certificate of release in effect in INSULIN, ABX -counterfeit trademark -missing side effects, CI, effectiveness as described by FDCA
What does a prescriber need to prescribe c2-5 electronically in VA?
-federally approved Credential Service Provider (CSP) OR -CErtification authority (CA) THese certificates will give prescriber a two-factor authentication credential or a digital certificate
What patient information must be on a prescription?
-first and last name -address (can be added by the dispenser)
WHat is compliance packaging?
-for solid oral form -had a series of container designed to assist the user with correct admin or self admin in accordance with direction for use
what temperature ranges are specified in the BOP's regulations?
-freezer: -20 to -10 C (-4 to 14 F) -fridge: 2 to 8 C (36 to 46 F) - goal is 40 F -cold: <8 C (46 F) -cool: 8 to 15 C (46 to 59 F) -room temp: work area temp -controlled room temp: 20 to 25 C (68 to 77 F) -warm: 30 to 40 C (86 to 104 F) -excessive heat: >40 C (104 F) -protection from freezing: means freezing drug subjects it to a change in potency
how many meds can be on a single Rx form? what are exceptions?
-general rule is *1 med* -exceptions: chart orders in hospital, LTCF, home infusion, hospice, corrections/juvenile justice, health, behavioral health and development services, pts residing in detention centers, jails, or work release centers operated by corrections
WHat if a pharmacy is changing its location?
-giving 14 days notice to the board -being inspected on both the old and new locations
Minimum age to buy OTC dextromethorphan (ie. Mucinex-DM)
18
what do you need to do to obtain a pharmacist's license in VA?
-graduate from ACPE approved school -obtain 1500 hrs practical experience as an intern *within the US* (can gain hrs outside of school once you're a P2) -obtain a passing NAPLEX score -obtain a passing MPJE score -be of good moral character -≥18 years old
what do you need to do to obtain a pharmacist's license in VA?
-graduate from ACPE approved school -obtain 1500 hrs practical experience as an intern *within the US* (can gain hrs outside of school once you're a P2) -obtain a passing NAPLEX score -obtain a passing MPJE score -be of good moral character and ≥18 years old
How does a tech get registration in VA?
-hold a PTCB certification or complete an approved training program -pass the VA exam -complete the application -pay fee
What controlled paraphernalia may only be sold by a pharmacist?
-hypodermic needles and syringes -gelatin capsules -quinine or any of its salt in excess of 1/4 ozWhat
what do you need to do if you want to close your pharmacy?
-if closed more than 1 week, must post notice 30 days prior or mail a notice 14 days prior to closing to every patient with available refills -notice must include date of closing and name of pharmacy that records will be transferred to unless pts indicate a preference to the contrary
what if a pharmacy fails to designate a new pic in 14 days?
-if inform the board prior to the original deadline, maybe extend by the director of the board. -otherwise, will receive a notive from the board to dispose all drugs from c2-6 and devices within 15 days
does the date of initial licensure change the expiration date for the 1st year? does it change CE requirements?
-if pharmacist received license on or after October 1st, then don't need to renew until December 31st the next year, but will need to complete CE -if receive license before October 1st, have to renew December 31st the same year, but no CE required
What is a pharmacist required to do when she dispenses a generic drug in place of brand name prescribed?
-inform pt -indicate on pt record and rx the name of generic, manufacturer/distributor -"generic for" brand name -charge less than brand cost
what is the initial licensure/registration fee for pharmacies in VA? renewal fee? renewal schedule? initial controlled substance fee? controlled substance renewal fee? controlled substance renewal schedule?
-initial and renewal $270 -1 year renewal schedule -no controlled substance fees or schedules
what's the initial fee for interns? renewal fee? what's the duration of registration?
-initial: $15 -renewal: none -varies
what info other than the ID # must go on an Rx written by a medical intern/resident?
-intern/resident's signature and legibly printed name, address, and phone # -address and phone # usually pre-printed on the hospital Rx blank but intern/resident's info is often not included and must be added by hand
How do you obtain 1500 hrs in VA?
-internship during pharmD school (ACPE accredited) -must be in US -if outside of schoold curriculum, must obtained after 2 semesters being in school
what does a standing order for naloxone mean?
-issued by an individual prescriber or by Health Commissioner to all pharmacies located and permitted in VA -authorizes pharmacist to dispense ≥1 of the specified naloxone formulations to *any* person seeking naloxone
what entities are required to register with the FDA?
-manufacturer -compounder -distributer
WHat is a safety closure container?
-meet requirement of Federal Poison Prevention Packaging Act of 1970: +85% of children under 4 cannot open in 5 min -80% of children still cant open it in 5 min after demonstration -90% of adults can open and close it
what are the CE requirements for pharmacists in VA?
-minimum 15 hrs/yr thru CE approved by BOP -not required for 1st renewal -if you already do 15 hrs for other states, you don't have to do extra -BOP can require up to 2 CE hrs in a specific subject area - if they do, they'll publish it by Jan. 1
what additional requirements are there regarding # of hrs of practical experience required by BOP to be licensed as a pharmacist?
-must be gained within the US -hrs cannot exceed 50 hrs/wk -must include a minimum avg of 20 hrs/wk for any month wherein practical experience hrs are claimed
WHat pt health information should the pharmacy make reasonable efforts to contact?
-name, dob, gender, phone number -medical history (allergy, drug interactions) -list of current medication and devices -accept or fail to accept counsel offer
Are there any special requirements for a rx written for a gamma-hydroxybutyric acid (rohypnol)?
-need to state MEDICAL NEED
do pharmacist members of the VA BOP have to be actively practicing? is there a minimum numbers of years of practice required?
-no -not stated
is a kit required for all naloxone formulations?
-no kit required for naloxone auto-injector or Narcan Nasal Spray -kit *required* for intranasal naloxone 2 mg/2 mL prefilled syringe - must dispense with *2 prefilled syringes and 2 atomizers and instructions for administration* -optional items for kits: rescue breathing masks, latex-free gloves
What are the requirements for a RPh whose license has been inactive for 5 years?
-no reinstatement -retake MPJE -been practicing in another state within that 5 years or 160 hrs intern in last 6 months
does VA allow emergency filling of non-controlled drugs without the prescriber's authorization? CIII-IV?
-non-controlled: yes (day supply allowed not specified) -CIII-IV: no
When is a pharmacist prohibited from substituting a generic drug for the brand name drug when filling a prescription?
-not available therapeutically equivalent -"brand medically necessary" -orally requested by the prescriber -patient requests
if a pharmacy ceases business, what are its responsibilities to the DEA?
-notify DEA -return certificate of registration and unexecuted DEA 222 forms -dispose of federal controlled substances properly
Hat if dea 222 lost but not during transport?
-pharmacy immediately report to DEA division for that area -the report must include serial number of the lost form -if the entire book was lost and serial number cannot be found, pharmacist reports the approximate dates it was issued -immediately report back to the dea if the form was found
WHat pharmacy info needs to be on a label of a rx vial dispensed to a pt?
-pharmacy or pharmacist's name -pharmacy address
what pharmacy info needs to be on the label of a Rx vial dispensed to a pt?
-pharmacy or pharmacist's name -pharmacy address
what has to be on the application for the permit to operate a pharmacy?
-pharmacy's corporate name and trade name -any pharmacists in addition to PIC who will be practicing at the pharmacy -hours it will be open -pharmacy owner, if not PIC -type of ownership (corporation, partnership) and names of partners, directors, or officers
What must be done if you want to close your pharmacy for more than 1 week?
-post a 30 days notice OR -mail to inform pts 14 days prior NOTICE has: -date of closing -name of pharmacy that record will be transferred to
What factors does the us attorney general consider when adding or removing a drug from schedules 1-5?
-potential for abuse -history and current pattern of abuse -scope, duration, and significance of abuse -scientific evidence of pharmacologic effects -current scientific knowledge regarding the drugs -any risk to public health -potential of physiological dependence dependence -precursor of a drug that is already schedule
where can a faxed Rx originate?
-prescriber's practice location -faxed order received by LTCF or hospice may be forwarded to a pharmacy -written Rx can be faxed by authorized agent of LTCF if pharmacy has written procedures (hard copy must be delivered to pharmacy within *7 days* and attached to faxed copy
how long is a Rx valid if a prescriber writes for prn refills? 99 refills? 30 day supply w/ 12 refills? 30 day supply with 11 refills?
-prn = valid x 1 year -99 refills: valid x 2 years -30 ds w/ 12 refills: valid x 2 years -30 ds w/ 11 refills: valid x 1 year
what types of CE programs are acceptable in VA?
-programs approved by ACPE -CME (continuing medical education) that focus on pharmacy, pharmacology or drug therapy -any other program specifically approved by BOP
what types of CE programs are acceptable in VA?
-programs approved by ACPE -Category 1 continuing medical education that is focused on pharmacy, pharmacology, or drug therapy -any other program specifically approved by BOP
in addition to applying for reinstatement, what else would you have to do if your license was inactive for >5 years?
-provide proof of practice in another state within last 5 yrs or obtain 160 hrs of practical experience as VA pharmacy intern within previous 6 months -complete 60 hrs CE -retake MPJE
what info do you have to keep regarding pharmacist CE?
-provider of CE must give certificate for the specified # of hours -certificates must be maintained by pharmacist for *2* years following renewal of license -upon request by BOP, must provide certificate to them
what are the recordkeeping requirements for sale of SLCPs?
-purchaser's name and address -purchaser's DOB and signature -product name and quantity sold -date and time of transaction -must keep sales transaction records for at least *2 yrs* from date of last entry
what is a pharmacist required to do if he determines that a Rx is forgery?
-refrain from returning it to pt -maintain Rx for minimum 30 days prior to destroying -provide Rx to law enforcement official who is investigating the forgery
When is a DEA registration considered terminated?
-registrant dies or surrenders the registration to the DEA -discontinues business -business ceases legal existence
is patient counseling required for medicaid pts? all other pts? new Rxs? refills?
-required for all pts -required for new Rxs -pharmacist professional judgment for refills
what must the pharmacy do with the rejected dea 222?
-retain the 3 copies with the refusal letter for record -all dea copies should be kept for at least 2 years
The doctor discontinues a drug for a patient living in a long-term care facility. What can the facility do with the discontinued drugs
-return them to the pharmacy for resale -transfer them to another pharmacy authorize d to re-dispense them to the indigent -destroy them at the pharmacy or at the facility
What other info needs to appear on the rs label?
-rx number -date of rx or its filling -pt name (owner name and species if animal) -drug name (generic in addition to brand; "generic for" if written in brand), strength, quantity -direction for use, cautionary statements -for c2-4 "caution: federal law prohibits the transfer of this drug to any person other than the pt for whom it was prescribed"
What is a therapeutically equivalent product?
-same active ingredient, strength or concentration, dosage form, route -classified in FDA's Orange Book
what documents must be maintained by a pharmacy that employs techs?
-site specific training program and manual -documentation of completion of this training for each tech (must keep for 2 yrs after tech leaves employer) -for trainees, proof they are enrolled in an approved training program
What if you fail to renew your license on Dec 31?
-still complete renewal form -submit CE hours -pay renewal fee -pay a late fee
how do you renew your pharmacist's license?
-submit completed renewal form prior to Dec. 31 -pay annual fee ($90) -submit statement of compliance with CE requirements
how is "supervision" and "personal supervision" different in VA pharmacy law?
-supervision: pharmacist must be physically present and available for immediate oral communication -personal supervision: physically present and directly controlling the service or act
What info does the purchaser fill on the DEA form?
-supplier: name, address -date it was filled -drugs name -number of packages, size of packages -signature of person filling the form
what sanctions are available to the BOP to give to a pharmacist's license?
-suspension -revocation -reprimand -monetary penalty -probation -imposition of terms on license (e.g., additional CE or restricted practice)
What info does the suplier add to copy 1 and 2 of the dea 222 when the order is shipped?
-the NDC -number of package shipped -date of each package shipped
EMS kits
-the PIC of the pharmacy that stocked the kit is responsible for the contents -Must be sealed or locked in a way that it cannot be resealed, seal cannot be duplicated, or re-locked -reconciliations are done when an open kit is exchanged for a new kit and these records are kept for 1 year from the exchange -the record of drugs/devices administered is kept for 2 years
Where can a faxed prescription originate?
-the prescriber's practice location -LTCF -home hospice, hospice care -if the fax came from an authorized agent of a LCTF, the hard copy must be delivered within 7 days
SInce interns and some residents do not have their own DEA number, what do they use in place of their own number?
-use hospital DEA number plus a suffix assigned to them -include the inter/resident name/address/phone number
WHat type of packaging are pharmacists allowed to use to dispense prescription?
-usp-nf approved packaging -well-closed container -compliance packaging requested by pts, or for use in hospital or ltcf
how long is a standing order for naloxone valid? What information should the order contain at a minimum?
-valid no more than 2 years from date of issuance -name of pharmacy (if issued by prescriber for ≥1 pharmacies) -contents of kit to be dispensed for intranasal naloxone (including quantity of drug and directions for administration) -prescriber's signature -date of issuance
What happens if a person fails MPJE?
-wait 30 days
What if a tech renew his license late?
-within 1 year: pay late fee -1 year to 5 year: reinstatement fee, plus renewal fee -more than 5 years: re-certification as if never been licensed
what happens if a tech renews their registration late?
-within 1st yr, pay *late* fee, renewal fee, complete renewal form, and certify completion of CE -after 1 yr, pay *reinstatement* fee, renewal fee, complete app for reinstatement, and certify CE -after ≥5 yrs, apply for *recertification* - same requirements as initial registration
what is the receiving pharmacy of a transfer required to do?
-write TRANSFER on face of Rx and record all required info for a regular Rx AND -written date -original # refills -date of original dispensing -# of valid refills remaining -date of last dispensing -transferring pharmacy's name, address, DEA # (unless CVI) -original Rx # -first and last name of pharmacist, if oral
what is the transferring pharmacy required to do?
-write VOID on face of Rx write on back: -date of transfer -name and address of receiving pharmacy -DEA # if CIII-V -for oral transfers, first and last name of pharmacist
How does a RPh gets an extension on CE completion?
-written request to the board -have 1 year extension to complete the previous CE hours -still have to complete the coming CE requirements
does VA require FPGEC certification for foreign educated pharmacists? practical experience? appearance before BOP?
-yes -1500 hours *in the US* -no
does VA have laws/regulations on the disposal of medications?
-yes -if a PIC wishes to dispose of unwanted drugs, they can: 1. transfer drugs to another person/entity authorized to possess or provider for proper disposal of drugs OR 2. destroy them by burning in incinerator in compliance with all laws -if CII-V are to be destroyed, additional procedures apply -disposal by authorized collectors is allowed following conditions in regulation 18VAC110-20-211
can pharmacists partially fill a CII Rx if they do not have enough medication?
-yes -must record amount partially dispensed on face of Rx and date -remainder must be dispensed within *72 hours* of partial dispensing
if the pharmacist is unavailable, can a tech go into the Rx department to get a Rx that has already been filled and checked?
-yes, but only in an emergency and must be accompanied by a member of the pharmacy's management or administration -needs verbal permission (via phone) of PIC or another pharmacist regularly employed there
can a pharmacist ever accept an oral Rx for a CII in a community pharmacy?
-yes, but only in emergencies and quantity dispensed must be limited to that necessary to cover the emergency time period -should make a reasonable effort to confirm Rx really came from prescriber (look up prescriber in phonebook and call that # to confirm)
may techs in the hospital or community setting call the physician for refill authorization?
-yes, can accept refills if no changes -if there are any changes to Rx and/or if professional consultation is involved, pharmacist must handle call
can a VA pharmacy fill Rxs written by out of state practitioners?
-yes, if prescriber is MD, DO, dentist, podiatrist, or vet and the Rx meets all other requirements for valid VA issued Rx -if NP, PA, or optometrist, Rx not valid unless prescriber is licensed in VA in addition to other state (supervising MD also)
does VA require identification for dispensing CII Rxs?
-yes, if unknown to the pharmacy staff, using driver's license, government-issued ID card, or other photo ID along with documentation of name and address -must keep ID records at least 1 month
does a pharmacy need to document a pt's request for non-special packaging? how can a pharmacist avoid civil liability when using non-special packaging?
-yes, notation must be made on dispensing record or other retrievable record and maintained for at least 2 yrs -have pt sign a release covering a period of time or single delivery, that releases pharmacist from civil liability for not using safety closure container
How long are Rx for c6 are valid?
1 tear, unless specified by prescriber
Describe the conditions under which a prescription may be faxed or electronically transmitted
...- Faxed III-VI or II for Hospice/LTCF with same federal regulations. on fax: date faxed, prescriber information, institution information. - Only to pharmacy of pt choice. Written rx, have md signature. Oral rx record the faxed rx of agent sending and working indicating oral rx. - Valid only if form MD practice location except: chart order from LTCF/Hospice, forwarding written rx by auth agent from LTCF (obtain original rx via mail w/i 7 days and attach) CII Faxed: only for information purposes except for LTCF and home infusion patients. If for hospice note on the rx "terminally ill" or "hospice" - if of poor quality reduce to writing on permanent prescription paper. - E-scribe II-VI with proper state and federal security requirements.
How many times can a rx for c2 be transferred?
0
Max amount of morphine in a C-III
0.05%
Max amount of dihydrocodeine in a C-V
0.1%
Max amount of ethylmorphine in a C-V
0.1%
Max amount of codeine in a C-V
0.2%
Max amount of ethylmorphine in a C-III
0.3% or 15mg per dosage unit
How many CEUs are needed per year for a technician
0.5
Max amount of opium in a C-III
0.5% or 25mg per dosage unit
Max amount of difenoxin in a C-V
0.5mg w/ at least 25mcg atropine sulfate per dosage unit
how many pharmacy license categories are there in VA?
1
HOw many times can a rx for c 3-5 be transferred?
1 (unless common database)
Time w/in which a registrant must report a significant loss of controlled drugs to the DEA. Using what form?
1 business day. Form 106
Notify DEA of loss of control within
1 day
notify DEA of loss of control within
1 day
Minimum height of red C that must be in bottom right corner of CIII-V Rxs if filed w/ CVIs
1 inch
Properties of controlled substance theft that require DEA get involved
1) >$500 worth of merchandise taken 2) If interstate or foreign commerce involved 3) If a person was killed or suffered significant bodily injury
When is a fax C-II ok?
1) LTCF patient 2) Hospice (inc home hospice)- narcotics only (provider must write "hospice" on Rx) 3) Home infusion- narcotics only
When is partial filling of a C-II ok?
1) LTCF patient 2) Hospice pt (provider must annotate on Rx)
Must notify public of decreasing hrs or closing for more than 1 week by LETTER within
14 days
Persons involved in a theft of controlled substances will be subject to:
1) Plain burglary/robbery- $25,000 or 20 years 2) If dangerous weapon used- $35,000 or 25 years 3) If death resulted- $50,000 or life
Form 222 copies
1- supplier 2- DEA 3- purchaser
Are there any restrictions on the prescribing of drugs by MD, DO, DDS, DPM, and DVM?
1. cannot write Rx for animal if not DVM 2. cannot write for human if a DVM 3. DDS only can do for mouth conditions 4. DPM only can write for foot and ankle
What requirements does a new pharmacy need to pass the inspection to approve the issuance of the permit?
1. 240 sq ft in the Rx department 2. security system standard 3. minimum equipments and resources standards 4. rx department enclosure and access standard 5. sanitary conditiosn
WHat are the grounds for sanctions, suspension, or revocation of a RPh's license?
1. In the practice of pharmacy: -incompetent -unprofessional -negligent -practice beyond the scope of his practice -allowed unlicensed person to involve in practice that requires license -violate or coop. with other activities that violate the law/regulation of pharmacy practice -has license/permit/registration issued by DEA/Fed agency revoked/denied/suspended -fail to comply CE requirements -dangerous practie to the public 2. unsafe to public -abuse alcohol/drug -theft or diversion of controlled substances -violate federal/state drug law -convicted of a felony -convicted of misdemeanor -deceptive/fraudulent statements
Who gets buprenorphine without naloxone
1. Pregos 2. Pts being converted from methadone to suboxone may get subutex NTE 7 days 3. As permitted by other boards (medicine, nursing, or vets)
Identify the procedure for the destruction or disposition of unwanted Sched II-VI CS
1. Transfer drugs to another person or entity, wholesaler, etc. (DEA 222) 2. Destroy drugs by burning: notify board w/i 14 days of burning w date, time, place, names of pharmacists that will witness. Must be witnessed by PIC and another rph not employed by pharmacy, DEA destruction form (DEA 41) shall be fully completed and used as the record - retain with other inventory records (x 2 years).
What is the receiving pharmacy required to do?
1. Write "TRANSFER" on the face of the transferred rx 2. obtain and record all required inofmration for a regular rx -obtain date of issue -original number of refills -date of original dispense -number of refills remaining -transferring pharmacy name/address/dea (unless c6) -original rx number -first and last name of transferring pharmacist
What is the transferring pharmacise requireed to do?
1. Write VOID on the rx 2. record on the back of the rx with: -date of transfer -name and address of the receiving pharmacy -DEA of the receving if involves in c3-5 -first and last name of the pharmacist receiving it
What happens if the rph cannot suply the remainder within 72 hours?
1. cannot dispense the remainder if passes 72 hours 2. contact prescriber that pt only received the quantity of the partial dispensing 3. new rx is needed
Max amount of dihydrocodeine in a C-III
1.8% or 90mg per dosage unit
What are the exceptions to the general rule?
1. chart order for patients in hospitals 2. chart orders for pts in LTCF 3. home infusion services 4. hospice patients 5. Rx being filled at: corrections, juvenile justice, health, behavioral health and development services
What if the prescriber fails to provide a written rx in 7 days?
1. contact the prescriber 2. contact the DEA
What has to be on a permit to operate a pharmacy?
1. corporate name and trade name 2. types of ownership and names of partner/directors 3. PIC name and other RPh who will practice there 4. owner's name if other than the PIC 5. operation hours
What two changes are prohibited for c2 prescriptions?
1. drug name (other than generic) 2. add prescriber's signature
Any restriction on who a pharmacy can employ?
1. felony conviected 2. DEA registration application denied
Schedule 2 drugs under VA law
1. high potential for abuse 2 currently accepted medical use 3. may lead to severe psychic or physical dependence
Schedule 1 drug under VA law
1. high potential for abuse 2. no accepted medical use
Schedule 4 under VA law
1. lower potential for abuse 2. accepted medical use . may lead to limited psychic and physical dependence
schedule 5 under VA law
1. lower potential for abuse 2. accepted medical use 3. may lead to limited psychic and physical abuse
schedule 3 drugs under VA law
1. lower potential for abuse 2. currently accepted medical use 3. may lead to high psychic and moderate/low physical dependence
What prescriber information must every VA prescription contain?
1. name 2, address 3. Phone 4. signature (except for oral rx) 5. DEA if c2-5
What must be included in the transfer notice request?
1. name, addresses, DEA number, and authorized business activities of both transferring and receiving registrants 2. date the transfer of controlled substances will occur 3. any quota the transferor had to manufacture or procure c1 or c2 drugs
What does the practictioner have to do to create a bone fide practictioner-patient relationship?
1. obtain a medical or drug history 2. provide information to the patient about the benefits and risks of the drug being prescribed 3. perform an appropriate examniation of the patient, either physically or by using equipment to electronically transmit images and medical records 4. follow up care
What is a pharmacist required to do if he determines that a prescription is a forgery?
1. refrain from retuerning the rx to the pt 2. maintain the rx for min of 30 days before destroying it 3. provide the rx to a law enforcement official who is investigating the forgery
Duties specific to a RPh
1. review of a prescription 2.receive an oral RX 3. Prospective drug review/counsel 4.Provide information concerning the therapeutic value and use of drugs 5.Communicating with prescriber's or their agents in any manner other than taking an unchanged refill 6.Verification 7.Supervise interns and technicians
What federal requirements do electronic prescriptions have to meet?
1. security and authentication 2. Required recordkeeping by the prescriber and the pharmacy
What documents must be maintain at a pharmacy when a tech is hired?
1. tech license 2. training completion of each tech, maintained for 2 yrs after tech leaves the employer 3. if a trainee, proof that they are enrolled in a approved program
WHat issues are screened for during a prospective drug review?
1. therapeutic duplication 2. drug-disease contraindications 3. drug-drug interaction (including non-prescription drugs) 4. incorrect drug dosage 5. Incorrect duration of drug treatment 6. drug-allergy interactions 7. clinical abuse or misuse
What must a pharmacist do if he declines to fill a rx?
1. write :DEcline 2. name/address/phone # of the phamracy 3. date it was declined 4. rph signature
How many CEUs are needed per year for a pharmacist
1.5 A CEU =10 contact hours
Max amount of codeine in a C-III
1.8% or 90mg per dosage unit
What must be on a RX label in regard to content and quantity?
1.Drug NAME, STRENGTH (when applicable) --any drug with a single active ingredient must have the generic name --IF a generic is dispensed and it was written for brand the generic name must be on the label or the manufacture or distributor AND the words "Generic for BN" --(THESE two things do not apply to hospitals or LTC) 2. The number of dosage units or mL dispensed
How many members of the BoP
10 -8 pharmacists -2 public
Unprofessional Conduct
10 Items -Inappropriate disclosure of patient protected information -Failing to maintain confidentiality of PMP -Willful or negligent breach of patient's confientiality -Taking advantage (ie sexual) of pts -Failure to maintain safeguards against diversion of controlled substances -Failure to respond to a known dispensing error -Delegating tasks to untrained persons -PIC fails to ensure interns and techs are currently registered -Failure to exercise professional judgement that a RX meets the requirements of law
BOP makeup
10 members (8 pharmacists, 2 citizen members)
Phase II
100 or more patients have the disease or sx being treated Looks at -*Efficacy* -Adequate dosing -Relative Safety -ADRs
Extra experience hours required if fail NAPLEX 3 times
1000 hours
DEA form for theft or significant loss
106
Time after which, if a drug is federally scheduled/descheduled/redscheduled and so published in the Federal Register, the VA Board may similarly schedule it without adhering to the 18 months rule
120 days
Max amount of dihydrocodeine in 48 hours as an OTC C-V
130mg (state) 24 dosage units or 4 oz (federal)
Maximum supply of dispensed solid oral dosage forms that can be repackaged at a CSB, BHA, or PACE site
14 day supply
Maximum day supply of repackaged drugs at a CSB, BHA, or PACE site
14 days
Time after submitting written notification to local DEA Office of intent to store records centrally that a pharmacy may begin doing so (if has not received reply denying so w/in that time). What must still be stored locally?
14 days. Executed official order forms
Time after resignation of a PIC that new one must be designated. If this does not happen, time in which pharmacy has to remove all drugs from premises.
14 days. 15 days
Time in advance that a pharmacy must post notice to its customers if its hours are going to change for longer than 1 week (unless they are expanding). What else must it do?
14 days. Notify the Board in writing
Must assign new PIC within
14days
Notice of change of hours if decreasing within
14days
must assign new PIC within
14days
notice of change of hours if decreasing within
14days
How many CE requirements for RPh in VA each year?
15 CE or 1.5 CEU each year
How long can a PIC be absent for an unscheduled leave?
15 days
Amount of CE required annually for pharmacists
15 hours (2 could be required in a specific subject area. BOP will announce that by 1 Jan)
How many hours of continuing education (CE) do you need to renew a license?
15 hours of CE that can be skipped for the first renew.
Required sensitivity of a balance
15 mg
Sensitivity to which a balance must measure in the pharmacy if pharmacy compounds
15 mg
Minimum hours of experience required for licensure by examination
1500 hours
How many hours of practical experience are required in VA?
1500 hours (300 outside school) of practical experience in the United States
How many hours of practical experience are required in VA?
1500 hours of practical experience as an intern
Minimum age to buy SLCPs (pseudoephedrine, ephedrine)
16
Minimum age to buy controlled paraphernalia w/out an Rx
16
Does VA law has a minimum age requirement to purchase dextromethorphan
18
Describe the records required for dispensing, refilling, or partially filling Sched II-VI CS and record keeping
2 Years Hard copy prescriptions shall be placed on file and maintained x 2 YEARS. (can be electronic data) - CII Prescriptions maintain in separate file. - CIII-V prescriptions maintained either separate or in a form that is readily retrievable from other records. consecutively numbered prescription file. Red C in lower right hand corner - if using electronic data this reg is waived. - Chart orders, filed chronologically by date of initial dispensing. if CII on order file with CII. Automated data processing: CVI Electronic image may be maintained in elec database - available w/i 48 hours. II-V only ok if allowed by federal law. Print out of dispensing history. Documentation providing who entered rx, rph. Printout is maintained of each days prescription dispensing data - verified, signed by rph (verify data is correct) If bound log book is maintained each pharmacist involved in dispensing shall sign a statement each day in the log attesting to accuracy. Keep x 2 years.
Fridge temp
2 to 8 C (36 to 46 F)
Duration of time you have to keep records of biosimilar substitutions
2 year
After last fill, original/transferred prescription kept for
2 years
After last fill, original/transferred rx kept for
2 years
After termination, records of technician training kept
2 years
Automated dispensing records kept for
2 years
CE certification records kept for
2 years
Dispensing records from ER kept
2 years
Drug destruction records kept for
2 years
Drug invoices kept for
2 years
EMS drug administration record kept for
2 years
Frequency at which a technician training program has to renew
2 years
Frequency at which repackaging training programs must renew
2 years
HOw long must the inventory record be kept?
2 years
How long do records of the loss need to be maintained
2 years
Inventories of lost controls kept for
2 years
Inventory of schedule I- schedule V records kept
2 years
Length of time that an internet pharmacy must keep records of its monthly reports of controlled substances to the DEA
2 years
Length of time that must keep copies of 222 or CSOS records
2 years
Max length of time that a standing order (like for naloxone) can be valid for
2 years
Non-special packaging request record kept
2 years
Records of floor stock dispensing, disposition, and administration along with matched returns, audits, and inventory are kept for?
2 years
Remote processing records kept for
2 years
The record of drug destruction for a long term care facility is kept for how long?
2 years
Time that records of drug administration by EMS must be kept
2 years
Time that technician training program must retain records
2 years
Turation of time that records of receipt or disposition (including loss/theft) of controlled medications must be kept
2 years
a standing order for naloxone issued by a prescriber or Health Commissioner shall be maintained by the pharmacist for how long from the date of last dispensing prior to expiration or D/C of the order?
2 years
after termination, records of tech training kept
2 years
automated dispensing records kept for
2 years
dispensing records from ER kept
2 years
drug destruction records kept for
2 years
drug invoices kept for
2 years
how long does VA require the pt profile be kept after the last fill?
2 years
how long does the pharmacy have to mainatin the OTC CV record?
2 years
how long must Rx records be maintained in VA?
2 years
inventories of lost controls kept for
2 years
inventory of CI- CV records kept
2 years
non-special packaging request record kept
2 years
remote processing records kept for
2 years
How long are you require to keep a record of your CE completion?
2 years after license renewal
Length of time that Rx records must be retained
2 years from date of last refill
Length of time that CE records must be kept
2 years from renewal date
PSE logs kept for
2years
Pseudoephedrine logs kept for
2years
A pharmacy fails to do this for 3 days. How many separate offenses does this constitute
3
if apharmacy fails to complete its initial inventory for 3 days, how many separate offenses does it constitute?
3
Time from discovery in which dispensing error must be documented. Time in which an analysis of the error must occur.
3 days from discovery. 30 days from discovery.
Time after use of a floor stock CII-V drug that record of disposition must be returned to pharmacy
3 months
Time that an intern license is valid for somone who has completed the required hours but is waiting to take licensure test
3 months
Time w/in which, if a drug placed into an automated counting device has since been recalled, all drugs must be removed from bin (unless can be certain that drug is no longer in there)
3 months
DEA registration for pharmacy every
3 years
Frequency at which pharmacies have to renew their DEA registration
3 years
How long are records kept of requests for samples
3 years
Time that a pharmacist must keep records of delivery (certified mail or hand-delivered receipt) after sending a controlled drug sample to a laboratory
3 years
Time that manufacturer must keep receipt of drug samples distributed to providers
3 years
Time must wait to reapply for license if revoked. If revoked for unprofessional conduct?
3 years 5 years
Minimum period for reinstatement after revocation
3 years unless its the taking sexual advantage of a patient then the minimum is 5 years
Quantity limits on the OTC sale of scheduled listed chemical products (SLCPs - ephedrine and pseudophedrine)
3.6 g per day 9 g in 30 day period Federal mail order limit is 7.5 g per 30 day period
What are the sale limits of SLCP in VA?
3.6 g per day 9 g per month the Federal mail order limit is 7.5 g per 30 days limit
A long term care facility must destroy or return unused drugs to the pharmacy in how long?
30 days
After the medication is discontinued, how long does the pharmacy have to return,transfer, or destroy it
30 days
Audit of automated dispensing machines every
30 days
How long can a PIC be absent for a scheduled leave before the pharmacy has to designate a new PIC?
30 days
Max amount of cannabidoil to be dispensed?
30 days
Max length of consecutive time a PIC can be absent before new PIC must be designated
30 days
Minimum time that a forged prescription must be retained before being destroyed (or better yet hand it over to law enforcement)
30 days
Must notify public of decreasing hours or closing more than 1 week by POSTED SIGN within
30 days
Time after discontinuation of a med for a LTCF pt that it must be destroyed or returned to the pharmacy for destruction
30 days
Time after discontinuation of a med that a LTCF or correctional facility has to return it to the pharmacy
30 days
Time after expiration that a CSB, BHA, or PACE site must destroy meds it is holding for a patient
30 days
Time before beginning sale of controlled substances via an Internet pharmacy that online pharmacy must notify DEA & state pharmacy boards in every state where it will deliver of its intent to operate
30 days
Time before changing internet address that online pharmacy must notify DEA of change
30 days
Provide board with list of lost control medication within
30days
Reconciliation of schedule II drugs every
30days
provide board with list of lost control meds within
30days
reconciliation of CII drugs every
30days
Max amount of diphenoxylate in 48 hours as an OTC C-V
32.5mg (state) 24 dosage units or 4 oz (federal)
DEA form for narcotic treatment program registration
363
Max number of technicians that a pharmacist can supervise
4
How many techs can a RPh supervise at one time?
4 (techs, trainees, intern who performs tech activities)
Max number of technicians, technician trainees, and interns at one time
4 people can be supervised doing technician duties at one time by 1 pharmacist
Term length for BOP members
4 years
Minimum time that a nonresident pharmacy must provide a pharmacist available for patient consultation via a toll-free number
40 hours per week, 6 days per week
DEA form for destruction
41
Time w/in which wholesale distributor must notify Board if ceases delivery of CII-V drugs to a pharmacy or physician dispenser due to suspicious orders
5 days
Amount of CE required annually for technicians
5 hours
How much CE is required each year for a registered technician?
5 hours of CE. It is possible to get an extension of 1 year with written request - but the technician still needs to do the full amount of CE.
Max length of time a license can be expired for overseas service members
5 years
Time that a CE provider must keep records
5 years
Amount of patients' bins & first doses in a robotic pharmacy system (hospital or LTCF) that must be randomly checked daily by a pharmacist
5%
In order to not register as a distributor, wholesale distribution must be less than:
5% of total annual sales, 5% of total controlled dosage units, or 5% of total oxygen sales
Max number of nurse practitioners that a MD can serve as patient care team physician for
6
Generally covered drugs (Medicare)
6 classes -Anticonvulsants -Antidepressants -Antipsychotics -Antineoplastics -Antiretrovirals -Immunosuppressants
Length of time after writing that a C II-V Rx is valid
6 months
How long is a c2 valid in VA and how many times can it be refilled?
6 months 0 refill
HOw long are c3-5 rx valid in VA and how many times it can be refilled?
6 months 5 refills
refills on CIII-IV Rxs must be filled within what time period from the issue date?
6 months (max 5 refills)
How long are prescription for c2-5 valid?
6 months from the date of issuance
how long is a CII Rx valid in VA and how many times can it be refilled?
6 months, none
how long are CIII-V Rxs valid in VA and how many times can they be refilled?
6 months, refilled max of 5 times
DEA registration renewal notices are sent out ____ days prior to expiration
60
Automated bins should be allowed to "run dry" every
60 days
Completed DEA 222 forms valid for
60 days
Frequency that automated dispensing bins must be allowed to "run dry"
60 days
Time after return from deployment that an active duty service member or spouse has to renew/pay fees w/out penalty
60 days
Time in which supplier has to fill (or complete partial fill of) a C-II from a 222`
60 days
automated bins should be allowed to "run dry" every
60 days
completed DEA 222 forms valid for
60 days
How long can a terminally ill or lctf pts continue to receive partial fills of a c2 drug?
60 days (2 months) from the issuance date rphs must continually verify the need
how long can a terminally ill or LTCF pt continue to receive partial fills of a CII?
60 days from date of 1st partial filling unless Rx expires earlier or is D/Ced by prescriber
How long is a completed dea 222 valid?
60 days from executed to fill the order
Max amount of time after beginning partial fills that a C-II can be partially filled in
60 days from start of partial filling
How long is a completed form 222 good for
60 days from when it is executed
Donut hole
A dollar range in which the beneficiary must pay for all RX drugs
Define "Prescription"
A drug that is safe to use only under the direction of a practicioner licensed to prescribe or administer
If a pharmacy uses automated counting devices in which drugs are removed from manufacturer's original packaging and placed in bulk bins, what record must be kept
A filling record which must contain -drug name and strength, quantity prepared -manufacturer or distributor's name and lot/ control number -Expiration date -Any assigned lot number
What is a pedigree?
A mean of recording each distribution of controlled substance Board has authority to implement this
Citizen member
A member of the board who is -not by training or experience a practitioner of the profession or occupation regulated by the board, -not the spouse parent child or sibling of a practitioner -has no direct or indirect financial interest except as a consumer in the practice of the profession
Define proprietary medicine
A nonprescription compounded drug promoted to the public under a privately owned trade symbol. It cannot be marketed only to Mds or contain narcotics
Who can write a prescript for a controlled substance
A practitioner of medicine, osteopathy, podiatry, dentistry, or veterinary medicine who is authorized to prescribe controlled substances, or by a licensed nurse practitioner, a licensed PA, or a TPA-certified optometrist.
Understand the restrictions which are imposed on the hiring of persons having access to Sched II-V CS (21 CFR 1301.76)
A registrant must not employ in a position which allows access to CD any person who has been convicted of a felony relating to CS or who has at any time been denied DEA registration. - Can file for waiver.
What are the intangible prescription requirements in VA?
A rx is not valid unless it was? 1. issued for a medicinal or therapeutic purpose 2. bone fide practictioner-patient relationship
What is required to become certified as a pharmacy technician?
A technician must hold current certification by the Pharmacy Technician Certification Board (PTCB) OR complete an approved training program and pass an exam.
Define "unit dose container"
A unit dose container holds a single dose of a drug not to be administered parenterally
Define "Unit dose package"
A unit dose package contains a particular dose order for a patient
Who is in charge of controlled substances at a humane society or animal shelter
A vet is in charge of training persons responsible for administering drugs The person in charge of administering drugs must obtain permit and controlled substance registration from the board
What's required for a drug company to give out samples
A written request from a prescriber, and a written receipt of samples given. The prescriber may authorize the drugs to go to a hospital or pharmacy instead of his or her office. The manufacturer must keep the records for 3 years
Evaluate drugs to determine whether they meet all legal requirements for selling, distributing, or dispensing and recognizing the conditions under which drugs are adulterer or misbranded while being held for dispensing.
ADULTERED: whole or in part of any filth, putrid, decomposed substance. Produced, prepared, packed, or held under insanitary conditions, mfg process or held, packaged not in conformity w good mfg practices. drug or container is decomposed or poisonous. unsafe color additive, misrepresenting drug strength, quality or purity. mixed or packed to reduce quality or strength. MISBRANDED: label is false or misleading, missing information. not prominently placed Narcotics must have "habit forming" label. Label must bear adequate directions for use, adequate warnings for children, unsafe dosage or duration. If dangerous to health at the labeled dose.
List of Schedule II controlled drugs:
Alfentanil (Alfenta) Amobarbital(Amytal, Tuinal) Amphetamine (Dexedrine, Biphetamine) Coca Leaves Cocaine Codeine Dextropropoxyphene, bulk (non-dosage forms) Dihydrocodeine Diphenoxylate Diprenorphine Ecgonine (Cocaine precursor, in Coca leaves) Ethylmorphine Fentanyl (Innovar, Sublimaze, Duragesic) Glutethimide (Doriden) Hydrocodone (dihydrocodeinone) Hydrocodone and isoquinoline alkaloid Hydrocodone combination product (Tussionex, Tussend, Lortab, Vicodin, Hycodan, Anexsia) Hydromorphone (Dilaudid, dihydromorphinone) Levo-alpha acetylmethadol (LAAM, long acting methadone, levomethadyl acetate) Lisdexamfetamine, its salts, isomers, and salts of its isomers Meperidine (Demerol, Mepergan, pethidine) Methadone (Dolophine, Methadose, Amidone) Methamphetamine (Desoxyn, D-desoxyephedrine, ICE, Crank, Speed) Methylphenidate (Ritalin) Morphine (MS Contin, Roxanol, Duramorph, RMS, MSIR) Nabilone Opium poppy, tincture, granulated, powdered, raw Oxycodone (OxyContin, Percocet, Tylox, Roxicodone, Roxicet) Oxymorphone (Numorphan) Pentobarbital (Nembutal) Poppy Straw Concentrate Remifentanil (Ultiva) Secobarbital (Seconal, Tuinal) Sufentanil (Sufenta)
Pt is discharged or leaves LTC for a short period
All medicine dispensed must follow appropriate packaging and labeling as done by outside pharmacies
Schedule VI
All prescription drugs and devices which have not been placed in another schedule are in SVI. This includes any drug or device which is not in another schedule, but which is required by federal law to bear on its label one of the following legends: 1. Rx only or caution: federal law prohibits dispensing without a prescription 2. Caution: federal law restricts this device to sales by or use on the order of a physician 3. Caution: federal law restricts this drug to use by or on the order of a veterinarian
Schedule VI
All prescription drugs and devices which have not been placed in another schedule are in SVI. This includes any drug or device which is not in another schedule, but which is required by federal law to bear on its label one of the following legends: 1. Rx only or caution: federal law prohibits dispensing without a prescription 2. Caution: federal law restricts this device to sales by or use on the order of a physician 3. Caution: federal law restricts this drug to use by or on the order of a veterinarian
Schedule VI
All prescriptions and devices not in another schedule and any drug only side when used under the supervision of practitioner. - Req to bear on it's label "Rx Only" or :Caution federal law prohibits dispensing without a prescription" digoxin (Lanoxin) Penicillin V. (Penicillin VK) bupropion hydrochloride (Wellbutrin) amoxicillin (Amoxil) cephalexin (Keflex)
List of Schedule III controlled drugs:
Amobarbital and noncontrolled active ingredients Amobarbital suppository dosage form Anabolic steroids Barbituric acid derivative Benzphetamine (Didrex) Buprenorphine (Buprenex, Temgesic) Butabarbital (Butisol, Butibel) Butalbital (Fiorinal, Butalbital with aspirin) Codeine and isoquinoline alkaloid (Codeine with papaverine or noscapine) Codeine combination product (Empirin, Fiorinal, Tylenol, ASA or APAP w/codeine) Dronabinol in sesame oil in soft gelatin capsule (Marinol) Lysergic acid Lysergic acid amide Methyltestosterone (Android, Oreton, Testred, Virilon) Nalorphine (Nalline) Nandrolone (Deca-Durabolin, Durabolin) Norethandrolone Opium combination product (Paregoric) Pentobarbital and noncontrolled active ingredients Pentobarbital suppository dosage form Phendimetrazine (Bontril) Secobarbital and noncontrolled active ingredients Secobarbital suppository dosage form Testosterone (Android-T, Depotest, Delatestryl) Thiopental (Pentothal)
What is the Kefauver-Harris Amendment?
An amendment to the Federal Food, Drug, and Cosmetic Act that requires drug companies to prove that new drugs are effective as well as safe -have to be EFFECTIVE
What is a drug?
An article intended for use in the diagnosis, mitigation, treatment or prevention of disease in human or animals. An article, other than food, that is intended to affect the structure or function of the body. Is also a drug if recognized by the official US Pharmacopoeia National Formulary (USP-NF), Homeopathic Pharmacopoeia of the US, or a supplement to one of these pharmacopoeia
Non-DI
An excipient or something used in the manufacturing of DS
What is required to transfer SII drugs
An official written order-The DEA 222 form
Frequency at which permits (from BOP) renewed for pharmacies/outsourcing facilities/warehousers/medical equipment suppliers/manufacturers/ distributors
Annually
Frequency that policy & procedure manuals for remote processing must be reviewed
Annually
How often does a pharmacy permit have to be renewed?
Annually
When is the pharmacy required to renew its permit?
Annually
Frequency with which nonresidents pharmacies must report to the Board the location, names, and titles of all principal corporate officers and the name and VA license number of the PIC
Annually (& w/in 30 days of a change)
Who can suspend the license of a pharmacist?
Any health regulatory board
Explain the conditions under which insulin can be dispensed
Any insulin preparation shall be dispensed only under the supervision of a licensed pharmacist. OTC Insulin: R or N, 70/30 preparations (humulin, novolin)
Who can a manufacturer or wholesaler sell schedule 6 drugs/devices
Anybody who is authorized to administer prescribe or dispense the drug or device
What if you would like to get a VA license after having had an inactive license for more than one year?
Apply for reinstatement, pay a renewal fee, complete all CE. You need CE for all of the inactive years (up to 60 hours CE).
Which types of programs count for CE?
Approved by the ACPE (American Council on Pharmacy Education); Category 1 Continuing Medical Education (CME) on a pharmacy topic; Approved by the Board of Pharmacy.
Nembutal- Pentobarbital Seconal - Secobarbital Amobarbital -Amytal
Are schedule II drugs BUT when in suppository form are Schedule III drugs
Notify the board in _______ days of changing ownership
At least 14 -must give records of prescriptions for the last 2 years to new owners and other important records -Former owner is held responsible for the transfer of files
What are the physical requirements for a VA licensed Rx department?
At least 240 sq ft
does VA have quantity limits for controlled substances?
no
When do you need to renew your license?
Before December 31st each year.
When does a technician need to renew his or her license?
Before December 31st each year. A technician who is newly licensed July 1st or later doesn't need to renew the license until December of next year.
You are newly licensed in October, November or December. When do you need to renew it?
Before December 31st of next year.
You are newly licensed on or after October 1st. When do you need to renew it?
Before December 31st of next year.
When is a pharmacist required to do a prospective drug review?
Before each new prescription is dispensed Before refilling a script, if needed based on clinical judgement
When are inventories done
Before or after business and documented If its a 24 hour pharmacy must indicate if inventory was done prior to the receipt or distribution of drugs or after
Schedule IV
Benzodiazepines Pentazocine- Talwin Propoxyphene- Darvon Diethylproprion- Tepanil, Tenuate Mazindol- Sanorex Fenfluramine- Pondimin Phenteramine- Fastin, Ionamin, Adipex-P
How often does a pharmacy need to take an inventory of schedule 1-5 drugs
Biennially (every 2 years)
Explain requirements for use of automated counting or dispensing devices
Bin filling record x 1 year from filling. -Drug name, strength, mfg/dist, lot #, exp date, date of filling, rph verification initials.
How soon does Copy 2 need to get to the DEA
By the close of the month in which the shipment is filled. If filled in partial shipments, the close of the month in which the last shipment was sent or the 60 days validity period expires.
Fiorinal schedule
C-III (federally)
Tramadol schedule
C-IV (federally)
Explain the criteria used for the general classification of CS I-V
CI: high potential for abuse. No medicines use CII: high potential for abuse may lead to dependence. Have medicinal use CIII: potential for abuse may lead to mod physical dependence or high psychological dependence CIV: lower potential for abuse CV: Low potential for abuse
are CIIs that have not been filled transferrable?
CII Rxs cannot be transferred
CII by mail
CII drug orders must require the signature of the recipient as confirmation of receipt
Describe the general requirements for receipt and documentation of oral prescriptions
CII: Only for in "authorization for Emergency Dispensing". Only qty sufficient for emergency situation, imm reduce to writing, reasonable effort to verify validity. Within 7 days MD mail hard copy rx with "auth.." written on it. Attach oral rx to written rx. Notify DEA if haven't received rx. Unit Dose Dispensing: for hospital pt for CII may be transmitted at the hops who shall imm reduce to writing in the pts chart. Such and order shall be signed by MD w/i 72 hours. - Only Rph can take oral prescription. CIII-V: provide same information needed on a written prescription (except MD signature); date, full name and address of the patient, full name and address of the prescriber. If animal state the species. Full name of the agent transmitting the prescription. CVI: May be refilled without authorization from the prescriber if reasonable effort has been made to communicate with the prescriber, and rph determined that pt's health would be in imminent danger. Not rationale on back side of prescription. inform MD of dispensing.
Review prescriptions for legality: List which health care practitioners have prescriptive authority in VA
CS: MD, Osteopathy (DO), podiatry (DPM), dentistry (DDS, DMD), vet (DVM), NP (CII-VI w/ written agreement w MD), PA (CII-VI, w written agreement w MD), TPA-certified optometrist (DO). -CS OOS: MD, Osteopathy, podiatry, dentistry, veterinary medicine. - Must have practitioner-pt relationship. - If rx appears questionable rph must contact md or agent and verify drug, qty. - Prescription not issued in normal course of treatment is not valid. Do NOT have authority: chiropractic (DC)
Review prescriptions for legality: Describe the conditions under which an out-of state prescription may be filled
CS: MD, Osteopathy, podiatry, dentistry, veterinary medicine authorized to issue such a prescription. (NOTE: No PA, RN, TPA-certified optometrist)
Repackaging of already dispensed prescriptions
Can be done by the primary pharmacy of LTC facility from RX dispensed by another pharmacy if it is done to maintain uniform or more accurate administration (like compliance packaging or unit dose). Must be recorded If not repackaged then it can be given to the resident or kept for subsequent repackaging at the pharmacy in the original container kept separate from other stock and only used for that pt
Secure area of verified prescriptions
Can be outside the pharmacy area A person approved by the pharmacist may access this area A log must be kept for 1 year of prescriptions that went out while pharmacist not on duty Counseling requirements exist
Are partial fills allowed in Schedule 3 through 5 drugs?
Can occur with more refills than indicated if all partial fills not exceed a total quantity on the prescription and no dispensing beyond 6 months
Explain the limitation for transferring a prescription for Sched III-V for refill purposes (21 CFR 1306.25)
Can only be transferred once unless pharmacies share realtime electronic computer system.
Are partial fills allowed in Schedule 3 through 5 drugs?
Can partially fill if the provided quantity dispensed does not exceed the total quantity prescribed, all partial fills take place before the 6 month expiration of the script, and the partial fills are done with reasonable conformity with the directions for use
What are the ways a pharmacy can dispose of drugs?
Can transfer to a reverse distributor Can destroy on site. If Schedule 2 through 5 and destroying then must notify board of pharmacy 14 days in advance by written notice giving the time, place and pharmacist's that will be present.
Nursing home access to automated dispensing devices
Cannot remove drugs until a pharmacist has verified the order, unless those drugs could be stocked in an emergency kit and withholding them endangers the pt
CMS
Centers for medicare and medicaid services
Describe the requirements for delivery of dispensed medications
Central Fill: CVI to another pharmacy, practitioner w/ CS registration, or an authorized person holding CS registration. CII-V can not be delivered to alternate delivery location. - 2 pharmacies same owner or contract. - PP, HIPAA - all pharmacies involved are listed on prescription label. - Inform pt and obtain consent. - Prescriptions waiting to be picked up by pt at alternate site shall be stored in lockable room or cabinet. When delivered by mail, common courier (not in person): - written notice of possible degradation, written notice of toll-free phone number pt can call - If delivered to business must hold current permit with board, can be held in free clinic, behavioral center, if repackaged must be rph. CII: Patient must show ID, make copy or write name and address, unless known to agent, may need to show ID CIII-V (pharmacy/cist discretion). If CII by mail must require signature upon receipt.
Explain the requirements for central or remote processing of prescriptions
Central or remote processing: (think remote F1/F4) receiving, interpreting, analyzing, clarifying prescriptions, entering rx or pt data, transferring rx information, performing DUR, obtaining refill/substituion authorizations, interpreting clinical data, providing drug information or counseling. - Pharmacies shall have the same owner or contract for services. - Techs shall be registered in VA or equivalent. - RPH must have VA license. - Pharmacies share a common electronic file or technology. - Provide information to pts regarding outsourcing (written or signage). - PP manual (annual review) - Be able to ID who engaged in steps of processing. - Maintain separate or joint electronic files. Maintain x 2 years from dispensing.
Notify Board of Pharmacy in 14days for
Change in Address Change in hours open Change in ownership any changes New PIC application Closure New Acquisition notification of patients Pharmacy Permit application indicating inspection date Once Permitted cannot hold drugs until 14 days prior to opening Planned destruction of CII-V
In what order must the records be stored
Chronologically (arranged in the order it happened ex. 1992-1997)
How are inventory records filed?
Chronologically. CII records have to be filed separately from CIII-V inventories. CIII-V records can be filed with CVI records but they must be readily retrievable.
What are the dispensing limits on each CV OTC per 48 hours period?
Codeine -270 mg Opium - 200 mg Dihydrocodeinone - 130 mg Ethylmorphine - 65 mg Diphenoxylate - 32.5 mg
List of Schedule V controlled drugs:
Codeine preparations - 200 mg per 100 ml or 100 gm (Robitussin AC, Phenergan with Codeine) Difenoxin preparations - 0.5 mg Difenoxin + 25mcg Atropine sulfate (Motofen) Dihydrocodeine preparations 100 mg per 100 ml or 100 gm Diphenoxylate preparations- 2.5 mg Diphenoxylate + 25mcg Atropine sulfate (Lomotil, Logen) Ethylmorphine preparations 100 mg per 100 ml or 100 gm Opium preparations - 100 mg per 100 ml or gm (Parepectolin, Kapectolin PG, Kaolin Pectin P.G.) Lacosamide = Vimpat Ezogabine = Potiga Pregabalin = Lyrica
Schedule III
Codeine w/ APAP (Tylenol w/ Codeine) codeine w/ ASA (Empirin w/ codeine) butabarbital (Butisol) butalbital (Butisol) - CVI if in combo w/ APAP thiopental sodium (Petothal) benzphetamine (Didrex) phendimetrazine (Didrex) nandrolone (anabolin, andralone, durabolin) stanozolol (Winstrol) oxandrolone (Anavar) Dronabinol (Marinol)
How does the DEA 224 registrant authorize his agents (other pharmacists) to order CII drugs?
Complete a Power of Attorney form
When there is a change in PIC what are the inventory requirments for the new PIC
Complete an inventory of Schedule 1-5 drugs on the date he or she becomes PIC and prior to opening for business
When there is a change in PIC, what are the inventory requirements for the Old PIC
Complete an inventory of Schedule 1-5 drugs, and return the pharmacy permit to the Board
Things that you must keep for 2 years
Completed CE Schedule 2 through 6 inventory records including filled out DEA form 222 Prescription dispense data Original and transferred prescriptions Patient profile and Medication Card for schedule 2 through 5 from Unit dose Dispense System Floor stock distribution records E.R. dispense records Emergency Drug Kit Administration records Drug destruction records Executed forms Sale records of Ephedrine and Pseudoephedrine
Adulturated
Composition of a product
Cannabidiol oil
Contains at least 15% cannabidiol but no more than 5% THC OR a dilution of the resin of the cannabis plant that contains 50 mg of cannabidiol per mL but no more than 5% THC
what law categorized drugs that were addictive and/or subject to abuse based on relative risk posed by them and created a closed system of distribution?
Controlled Substances Act (CSA)
Age limits for nonRX OTCs
Controlled paraphernalisa: 16 or older SLCPs: 16 or older Dextromethorphan: 18 or older
Which copies of the DEA form 222 are the purchaser and supplier responsible for retaining? For how long?
Copy 1-kept by supplier for 2 years Copy 2-kept by the DEA Copy 3-Kept by the purchaser for 2 years unaccepted or defective forms-kept by purchaser for 2 years, along with statement of reason rejected
Terminal condition
Covers both imminent death and vegetative state due to injury, illness/disease considering medical probability
Are there any special requirements when the transfer involves a c2 drug?
DEA 222
What form does a pharmacy complete to obtain DEA registration?
DEA 224 DEA 224a is for registration renewal
Explain record keeping requirements for destruction or disposition of CS
DEA destruction form shall be fully completed and used as the record - retain with other inventory records (x 2 years). DEA Form 41 (registrants inventor of drugs surrendered)- damaged goods. can also be through reverse distributer with 222 Form
WHen does a tech need to renew his license in VA?
DEc 31 if gets the license on or after July 1, do not need to renew until next year
Frequency at which electronic prescription records must be backed up (DEA rule)
Daily
How often do robots get checked by the pharmacist
Daily random 5% check for all patients' bins and 5% of all first doses or cart updates If an a robot picks the wrong drug 100% checks until the problem is identified and solved and reported to the board and the board reduces the percent of checks Quarterly QA required at minimum and must be documented
When schedule 1-5 drugs are received, what does the receiver need to record
Date Name and address of supplier Kind annd quanity of drug received If receiving coca leaves or crude opium, the amount of morphine, cocaine, or ecgonine that can be made from them
What information must be recorded when controlled paraphernalia is sold?
Date of dispensing Name and quantity of the item Price Name and address of the person buying it Reason for its purchase Pharmacist's initials
What must the norification to the board include
Date,time,manner, and place of destruction, plus the names of the pharmacists who will witness the destruction (the PIC and one pharmacist not employed by the pharmacy)
Date that registration must be renewed annually (for both techs and pharmacists)
Dec 31
When will VA RPh license expire?
Dec 31 annually
Schedule IV
Diazepam (Valium) lorazepam (ativan) alprazolam (xanax) chlordiazepoxide (librum) oxazepam (serax) prazepam (centrax) triazolam (Halcion) clonazepam (Klonopin) flurazepam (Dalmane) zolpidem (Ambien) temazepam (restoril) phenobarbital pentazocine (talwin) propoxyphene (Darvon) phentermine (Adipex-P, Fastin, Lonamin) diethylproprion (tepanil, Tenuate) fenfluramine (Pondimin) mazindol (Sanorex) tramadol (Ultram) carisoprodol (Soma)
List of Schedule I controlled drugs:
Difenoxin Dihydromorphine Heroin (Diacetylmorphine, diamorphine) Lysergic acid diethylamide (LSD, lysergide) Marijuana (Cannabis, marijuana) Mescaline Peyote
At a long term care facility who can witness the destruction of drugs?
Director of nursing or facility administrator or RPh
What can't remote pharmacists do for hospitals or LTC facilities
Dispense a drug, but they can authorize the administration of a drug
If the pharmacy does not have a PIC, the pharmacy receives a notice that it has no valid permit, and is required to do what?
Dispose properly of all Schedule II through IV drugs and devices on the premises within fifteen days.
90 days
Disposition/administration records of CII-V floor stock must be returned to pharmacy w/in 90 days
Chemical Classification V
Drug being manufactured by new company
Type E
Drug for life threatening or severely debilitating disease
Type F
Drug has been placed on hold until submitted data is further validated
What are the labeling requirements for unit dose containers?
Drug name, strength, Lot number, expiration date
Drug information required on a Virginia prescription
Drug name, strength, dosage form, quantity prescribed (CII-CV), directions for use *Don't specifically need a quantity for CVI drugs provided the pharmacist can calculate the quantity using the directions and duration.
Part D
Drugs
what law divided drugs into classes of Rx and non-Rx?
Durham Humphrey Amendment
How is the offer to counsel to be accomplished?
Face to face Sign posted Notation on the bag By telephone
How is the offer to counsel to be accomplished?
Face to face Sign posted Note on prescription label By telephone
Are there any organization that are exempt from paying DEA registration fees (but not exempt from getting the appropriate DEA registration)
Facilities operated by a US agency
what law increased labeling requirements and implemented the first drug safety requirements?
Federal Food, Drug, and Cosmetic Act
Records that are off limits to the Board or drug diversion officers when they inspect
Financial data Sales data, other than shipment data Pricing data Personnel data Research data
Explain procedures and required records for dispensing drugs for floor stock.
Floor stock: Hospital or LTCF. Limited to determination of Rph in consultation (IV Flushes, Irrigation, Heparin flush, Medicinal gases, sterile h20, saline). RPh checks all CII-VI drugs delivered, initial record of distribution. Delivery receipt for CS to floor stock. Record of disposition/administration returned to pharmacy w/i 3 months of it's issue. Match returned records with delivery receipts, periodically audit for completeness, verify all additions to inventory are recorded. File chronologically and maintain x 2 years.
If a pt wants a copy of their prescription what do you write on it?
For Information Only
When can a c2 prescription be faxed?
For informational purpose only. This is to give the pharmacy time to prepare for the prescription.
Emergency Drug Kit
For licensed Emergency Medical Services program (ambulance) Records for the exchange of drug kit are kept 1 year Records for the administration are kept for 2 years Physician must sign prescription after use in 72 hours
Emergency Drug Kit
For licensed Medical Services Agency Records for the exchange of drug kit are kept 1 year Records for the administration are kept for 2 years Physician must sign prescription after use in 72 hours
What is the maximum number of technicians a pharmacist can supervise?
Four. As many as two of them can be trainees who aren't registered technicians yet.
What is the maximum number of technicians a pharmacist can supervise?
Four. This includes technician trainees and interns who are performing technician activities.
Limited-use technician
Free clinic technician who had their registration and exam fee waived if the tech failed the examination they do have to pay to retake the exam May only do tech duties in a free clinic, if wants to work outside just pay the board for registration
does VA issue separate licenses for sterile compounding pharmacies?
no
Schedule III
Generic- Brand Codeine/APAP--- Tylenol with codeine #2,3,4 or Phenaphen with codeine #2,3,4 Codeine/ASA----- Empirin with codeine #2,3,4 Thiopental sodium- Penthothal Hydrocodone- Lorcet, Lortab, Hycodan, Anexsia, Vicodin, Zydone, Tussionex Marinol-Dronabinol Anavir- Oxandrolone Winstrol- Stanozolol Anabolin, Androlone, Deca-Durabolin, Durabolin, Hybolin, Nandrobolic---Nandrolone Butisol- Butabarbital Fiorinal, Fiorinal w/codeine- Butalbital ( unless in combination with APAP, then SVI Penthothal -Thiopental sodium Didrex- Benzphetamine Bontril, Preli-2- Phendimetrazine
Schedule II
Generic- Brand Morphine - MS Contin, Roxanol Oxycodone- Percodan, Percocet, Tylox, Oxycontin Hydromorphone- Dilaudid Methadone- Dolophine Meperidine- Demerol Dextroamphetamine- Dexedrine Methamphetamine- Desoxyn Phenmetrazine- Desoxyn Methylphenidate- Ritalin Sufentanil- Sufenta Alfentanyl- Alfenta Fentanyl- Sublimaze Amphetamine- Biphetamine Nembutal- Pentobarbital ( suppositories are Schedule III) Seconal - Secobarbital (suppositories are Schedule III) Amobarbital -Amytal ( suppositories are Schedule III)
Pt brings in a prescription to a CSB, BHA, or PACE site, but it expires before it can all be used. What is the responsibility of the site?
Get a written agreement from the client and destroy the drug within 30 days of expiration date. It can not be given to the pt
What records cannot be stored off-site or electronic-only?
Hard-copies for CII-V Executed order forms for CII-V Inventories for CII-V
Oil with no less than 12% THC by weight
Hashish oil Not considered marijuana
Part A
Hospital insurance
Controlled paraphernalia that may only be sold by a pharmacist
Hypodermic needles and syringes Gelatin capsules Quinine or any of its salts in excess of 1/4 ounce *Person purchasing must show identification, including proof of age, and a written, legitimate purpose for which it is being purchased - Must be 16 or older (unless prescribed)
What are controlled paraphernalia?
Hypodermic needles/syringes, gelatin capsules, quinine (or any of its salts) > 0.25 oz
Explain requirements for maintaining records of receipt for Sched II-VI CS
I-II: Separate from all other records of the pharmacy. Maintain perpetual inventory of all CII received and dispensed. Reconcile at least monthly. III-V: May be separate of with VI but not with other records. VI: Shall be maintained but may be stored in electronic database. Executed order forms II-V: maintained at same address. If auth by DEA can be kept off-site retrievable w/i 48 hours. - All records filed chronologically and maintained not let than 2 years. Records: date of receipt, name and address of person from whom received, kind and qty of drugs
If the pharmacy is not open 24 hrs/day, the inventory must indicate what
IF it was taken at the close of business or opening of business
Nursing home floor stock
IV fluids Irrigation Heparin flush kits Medical gases Sterile water and saline prescription devices
How does a pharmacist whose license is suspended apply for a reinstatement?
If 3/4 of the board members at the hearing vote for reinstatement
When can a pharmacy tech take a verbal prescription in a nuclear pharmacy?
If it is for diagnostic non patient specific medication A nuclear medicine tech can transmit a prescribers verbal or written order
When can a pharmacy tech take a verbal prescription in a nuclear pharmacy?
If it is for diagnostic non-patient specific medication A nuclear medicine tech can transmit a prescribers verbal or written order
What happen if you renew your license late?
If renewing after more than a year late, you must apply for reinstatement, pay renewal fee, pay reinstatement fee, and submit the amount of CE would have needed to renew the license each year inactive (3 years inactive = 45 hours) (max of 60 hours).
What happen if you renew your license late?
If renewing after the first year that is late, you must first apply for reinstatement, then renew.
When is it OK to store order forms, prescriptions, invoices, and inventories of schedule 2-5 records offsite
If the DEA authorizes it and the records are retrievable within 48 hours
What must be done if the hours of operation of the pharmacy change?
If the change last for more than 1 week, has to notify the board and pharmacy must post a conspicuous notice 14 days before to inform the pharmacy pharmacy's patients
What must be done if the hours of operation of the pharmacy change?
If the change will last more than a week, report the change to the Board in writing AND post a notice 14 days in advance in a conspicuous place.
What if the pharmacy delivery driver brought it to her and she refused it?
If the dispensed drug has not been out of possession of a delivery agen of the pharmacy, it can be returned and re-dispensed.
When is a supplier prohibited from filling an order written on a DEA 222 form
If the order is illegible or altered
In what circumstances does the PIC need to turn in the pharmacy permit and make a new application?
If there is any change in ownership of the pharmacy, such as change in partnership composition or acquisitions.
Generic dispensing
If written for brand name, but substitution allowed; the substitution must be less expensive than the product on the RX
If your licence is revoked or suspended in another jurisdiction, or if you have been convicted of a felony or adjudicated incapacitated, what will the director of the Department of Health professions do?
Immeadiately suspend the license without a hearing
Time w/in which registrant must report the kind, quantity, & strength of controlled drugs lost to the Board
Immediately, & then a detailed report w/in 30 days
What's the exception to the rule that a pharmacist may only buy from a licensed distributor
In an emergency, a pharmacy may purchase drugs from another pharmacy
WHat about in case of an emergency?
In case of an emergencey, a pharmacy can purchase drugs c2-6 from another pharmacy with the use of DEA222
Type AA
Indicated for AIDS/HIV usually fast-tracked
How often are other dea registrants (pharmacy) being inspected by DEA
PRN
Time period w/in which facility inspection must be done for a nonresident pharmacy
Initial application: w/in the last 6 months Renewal: w/in the last 2 years
Time period w/in which facility inspection must be done for an outsourcing facility (resident or nonresident)
Initial application: w/in the past year Renewal: w/in the past 2 years
Frequency at which electronic prescribing application must undergo third-party audit if processing controlled substances (DEA rule)
Initially, every 2 years, and whenever there is a change in functionality
What does a pharmacist have to do after an order has been prepared, prior to delivery?
Inspect and initial it to certify accuracy
What is the next step after the permit application is submitted?
Inspection
What does a new PIC have to do when taking over responsibility for a pharmacy?
Inventory all Schedule I, II, III, IV and V drugs on the day he or she becomes PIC. The inventory must be completed before opening for business.
IND
Investigational New Drug -FDA has 30 days to decide whether it is suitable for testing
What Schedule 2 through 5 forms can be stored offsite to be retrieved within 48 hours when needed?
Invoices
Electronic CII reconciliation
Is allowed as long as alerts are reviewed monthly
Permitted physician
Is licensed to dispense drugs to pts who pharmacy services are not reasonably available
RX is determined to be a forgery
It cannot be returned to the patient. It can be given to law-enforcement investigating the forgery or it must be held in the pharmacy at least 30 days before being destroyed
Can the prescriber decide where to fax the prescription
It has to be faxed to the pharmacy of the patient's choice
You would like to manufacture or wholesale distribute out of your pharmacy when is this approved by the board?
It is not. A designated prescription space can only have 1 function
What are the requirements for the prescription department?
It must be at least 240 square feet (not incluiding patient waiting area or the area used for counseling, devices, cosmetics, and proprietary medicines).
What are the physical requirements for the prescription department?
It must be at least 240 square feet (not incluiding patient waiting area or the area used for counseling, devices, cosmetics, and proprietary medicines). Restrooms (unless used by pharmacy personnel only) and stock rooms cannot be accessed through the prescription area. Sink w/ hot/cold water. Refrigerator w/ monitoring thermometer. Well lighted, ventilated, and temp must meet USP standards for drug storage.
Date that techs, if initially licensed after, do not have to renew until following year
July 1
When will prescriptions for opioids have to be e-scribed
July 1, 2020
When does PMP registration expires
June 30 of even number years, or you become ineligible, change employment
Things that you have only 30 days to complete
Keep a suspected forged prescription before can destroy Long term care facility must destroy or return unused drugs to pharmacy Post notice of closure Automated dispensing machine audits by PIC are monthly
what law required that drugs actually be efficacious?
Kefauver Harris Amendment
CIII-V record keeping
Kept together or readily accessible in CVI files with a stamped RED C in the right lower corner (likely not using separate prescription numbers in this example)
Special packaging
Kids less than 5 have a difficult time opening a package that is harmful or toxic in a reasonable amount of time, but adults can easily open
6 months
Laminar flow hood needs to be inspected and certified initially, then every 6 months
Phase 3
Large groups (sometimes thousands) in several geopgraphic locations are part of controlled clinical studies -Typically double-blind placebo controlled and run by an independent group
Things to keep for 1 year
Log of prescriptions delivered to patient when pharmacist not present Quality Control temperature records Bin filling records Unit dose filling Cart Log Emergency Drug Kit exchange records
MAC
MAximum allowable cost
What practitioners can write valid prescriptions for controlled substances in VA?
MD DO (osteopath) DPM (podiatrist) DDS (dentist) DVM (veterinary) NP PA (physician assistant) OD (optometrist)
WHich practioners are allowed to treat almost any human condition
MD and osteopath (DO), even with their specialty (like psychiatrist or surgeon)
which prescribers have unrestricted prescribing authority and can write for CII-CVI Rxs to treat pts without need for an agreement with any other practitioner?
MD, DO, dentist, podiatrist, vet
Which population is covered under MMA
MEDICARE (its the old way of saying CMS) IT IS NOT MEDICARE AND MEDICAID
Restrictions to optometrists in prescribing
MUST HAVE TPA certificate -Only CII is hydrocodone + APAP combos -CIII-VI PO analgesics -VI PO agents which treat conditions of the human eye and its adnexa -VI topicals -IM EPI for the tx of shock
A Narcotic Treatment Program uses Schedule 2 drug for?
Maintenance or Detoxification
Part C
Managed care (Medicare advantage)
What entities must register with the FDA?
Manufacturers, compounders, and distributors. Pharmacies are not required.
does VA issue temporary pharmacist licenses?
no
Controlled substance perpetual inventory of items received and dispense shall be reconciled how often?
Monthly
Controlled substance perpetual inventory of items received and dispensed shall be reconciled how often?
Monthly
Frequency at which must reconcile C-II perpetual inventory
Monthly
Frequency at which review/audit/inspection of automated dispensing devices in hospitals must be conducted
Monthly
How often are automated dispensing records of drugs dispensed audited? What drugs are audited? What about drugs which were administered?
Monthly audits must be performed for CII through V, if software keeps a perpetual inventory then only discrepancies must be checked. Also monthly and must look at CII-V for a period of no less than 24 hours; if software is used to generate a report then they are exempt from this but must conduct a focused audit for deviations and discrepencies
How often does review of drug therapy occur for patients in LTC facilities
Monthly, a pharmacist must check for irregularities included but not limited to drug therapy, drug interactions, drug administration or transcription errors
Schedule V
Most codeine cough syrups diphenoxylate (Lamotil)
Schedule V
Most cough syrups containing codeine Diphenoxylate- Lomotil
Define "Unit dose system"
Multiple drugs in unit dose packaging dispensed in a single container (such as a medication bin) labeled with a patient's name. Directions for administration do not need to be on the labeling
Explain the requirements for filling chart orders for outpatients
Must be written for a pt while in a hospital or LTCF. All information available for valid rx. Direction that chart order is to be prescription. Orders related to dispensing qty.
Review prescriptions for legality: Determine whether a prescription is written within a prescriber's authority and scope of practice
Must be written within scope of practice.
Things that must occur in 48 hours
Must change alarm code access after authorized tech entry Must retrieve and make available for inspection when records offsite
Explain authorized duties of registered pharmacy technicians
Must first be registered pharm tech with board. But can preform this tasks as part of training. - Prescription preparation - Compounding under supervision - prescription and drug history entry. - stocking of automated disp. - Acceptance of refill authorization (as long as no changes) Site specific training program for pharmacy technicians (maintain record while employed and 2 years after)
Robotic systems
Must have daily random checks for 5% of all patient bins and 5% of all 1st doses by Pharmacist
What is the requirement of daily random checks when using a robotic system?
Must have daily random checks for 5% of the medications the robot selected
Pharmacies that outsource services
Must have posted sign or a one-time written notification stating the name of the contract pharmacy or if its part of the same ownership chain. An RPh registered in VA either at the dispensing pharmacy or central site must verify the accuracy on all processing done. Technicians can be registered in Virginia or possess substantially equivalent credentials
What happens if the robot selects the wrong medication?
Must immediately institute a 100% check of all doses and report error to the board of pharmacy 100% check continues until provide cause of error to board of pharmacy Records are kept for 2 years
Robotic systems if it is discovered that a wrong medication was picked?
Must immediately institute a 100% check of all patients bins or doses and report error to the board of pharmacy immediately 100% check continues until provide cause of error to board of pharmacy Records are kept for 2 years
What happens if the pharmacist is unable to supply the remainder of the partially filled CII script in 72 hours?
Must notify the prescriber of the partial fill and the patient will need a new script to receive any additional medication
Authorized collector
Must register with the DEA as a collector to take drugs back and destroy the drugs you take back Must submit in writing to the board the: -Name, address, license number, if applicable, of the facility -intended method or methods of collections (ie mail back, collection receptable -Signature of PIC or if at a narcotic treatment program the medical direction --if narcotic treatment program does not have an in-house pharmacy must obtain a controlled substance registration
Rules to changing hours
Must report to the board and post changes 14 days in advance unless those changes lead to expanding hours or there is an emergency
When stocking automated devices with controls II through V
Must verify the count of the control in the device when stocking that control. Discrepancies are the responsibility of the PIC
When can a retail pharmacy have samples from a manufacturer?
NEVER this is considered diversion
Determine the need for and describe the procedures involved in obtaining and renewing DEA Registration (21CFR 1301)
NEW pharmacy: Complete a DEA 224 form. RENEWAL Dea registration: DEA 224a form can renew online nmt 60 days prior to expiration.
Can a pharmacist substitue a generic and charge more than brand name?
NO
Can a pharmacy process an electronic prescription and dispense a c2-5 drug before the certification report is received?
NO
Can medicare use its purchasing power to negotiate prices with pharmaceutical manufacturers to obtain lower cost drugs for the elderly and disabled
NO
Does pharmacy need to register with FDA
NO
Is a pharmacist required to counsel a pt in a hospital or a nursing home?
NO
Are c2 that has NOT been filled transferrable?
NO transfer of c2
If a pharmacist satisfies VA requirements for handling a questionable prescription, are the federal DEA requirements satisfied?
NO, except for c6
Are pharmacist allowed to refill c3-6 any time the patient requests a refill?
NO, has to follow prescriber's direction of use. Pharmacist can refill early with documentation of the reason
Is a RPh always entitled to a hearing prior to the suspension of his license?
NO, his license can be immediately suspended if: -he appears to be a danger to the public -convicted of a felony -incapacitated (incompetent) being adjudicated by court -license being revoked or suspended in another state
Fioricet schedule
NONE
Pseudoephedrine schedule
NONE (so C-VI)
Are refills allowed for Schedule 2 drugs?
No Exceptions are as follows Emergency fill with an oral authorization, Physician must sign in 7 days Emergency fill in Hospital or Long Term Care Facility with an oral authorization, Physician must sign in 72 hours Multiple prescriptions authorizing 90 day supply of Schedule 2, must have written instructions on every prescription with earliest date that may fill
Are refills allowed for Schedule 2 drugs?
No Exceptions are as follows -Emergency fill with an oral authorization, Physician must sign in 7 days -Emergency fill in Hospital or Long Term Care Facility with an oral authorization, Physician must sign in 72 hours -Multiple prescriptions authorizing up to 90 day supply of Schedule 2, must have written instructions on every prescription with earliest date that may fill
Can a rx be written in pencil?
No Must be ink, typed, or printed
Does an electronic prescription have to be manually signed?
No the electronic or digital signature that identify the prescriber as the source of the prescription and indicate his approval of the information on the Rx
Are you allowed to take a verbal order for a Schedule 2 drug?
No Except in Emergency however, quantity must be limited must reduce to writing physician must sign within 7 days and if not signed must report to board of pharmacy
Are Faxed prescriptions allowed for Schedule 2 drugs?
No Except in Long term care facility and home infusion
Is the PIC still considered the PIC if absent greater than 30 consecutive days?
No Must notify the board immediately and return the permit
Pre Printed prescription rules regarding advertising and coupons?
No advertising on face of prescription Coupons or pharmacy name will be on the back
Does an order on a chart need to contain all the same information as a written prescription?
No if: 1. information on the chart order is readily achievable 2. follow pharmacy's policy and procedure 3. compliant with state and federal law
When new PIC do you have to do a Schedule 2 through 5 inventory?
No is not law but is recommended. Can be denied by owner if writes to board.
How many interns can a pharmacist in VA supervise at once?
No longer limits Max: 4 techs (if intern is functioning as tech) or 4 techs +1 intern if the intern is to gain practical experience
CE registration is good for_____
No more than 2 years, each date given should be on initial application or submitted to the board at least 5 business days prior to the event
Max quantities of CII - V in a stat-box
No more than 20 solid dosage units Liquid dosage units cannot exceed 30 mL when substituted for a solid dosage unit and if multiple doses of a liquid exist the remainder is assigned to that patient and placed with other medications
Emergency Drug Box is allowed to contain?
No more than 20 solid dosage units of Schedule 2 through 5 and 1 unit liquid not greater than 30ml
Stat Drug Box is allowed to contain?
No more than 20 solid dosage units of each Schedule. Liquid dosage units may be substituted for solid (bulk bottle cannot be used for multiple pts)
How long can a PIC be out and remain PIC
No more than 30 days. PICs knowing they will be gone for longer than 30 days must return permit to the board. Unanticipated absences > 15 days the board expects the owner to notify the board and obtain a new PIC in the following 15 days
Pharmacist to Technician ratio is?
No more than 4 to 1 Pharmacist decides how many
Schedule III-V Refills
No more than 5 refills; may not be refilled beyond 6 months of written date
Working hour requirements when gaining intern experience for licensure by examination
No more than 50 hours per week, no less than an average of 20 hours per week in any month
Max you can charge for a generic drug
No more than the usual and customary retail price
When can a pharmacy stock drugs after passing the inspection?
No sooner than 14 days prior to the designated opening dates RPh has to be there then on a daily basis
How long do you have to get a prescription to cover drugs taken from a stat-drug box?
No time, you must have a valid order or prescription for a nurse, RPh, or prescriber to take drugs out of a stat-box
Can you transfer a prescription for an SII drug if you haven't filled it
No transfers are allowed on SII drugs
Can medicare D deny a pharmacy from participating
No, "any willing provider"
A patient brings in an unused, unopened bottle of tablets that she picked up earlier today. The patient's doctor started her on a different drug this afternoon. The drug is in the manufacturer's original container, and the seal over the top is intact. Can you re-dispense it to somebody else
No, It's been out of possession of pharmacy personnel, so you don't have any assurance it was stored properly
Before the inspection, can you stock drugs in the pharmacy?
No, and they can't be moved into a new location either. If you don't have a permit, you can't stock drugs.
If your license is inactive, are you still responsible for the CE every year?
No, but if you convert back to active status, must complete the equivalent hours of CE for the inactive period (max 60 hours)
Is the PIC of a hospital pharmacy required to attend meetings of the Pharmacy & Therapeutics (P&T) Committee?
No, but most of them do.
does VA require expiration date or BUD on Rx vial labels in community practice?
no
Is a control inventory (II- V) required by law when PIC changes?
No, but the opportunity must be offered to the outgoing PIC unless the owner submits written notice to the board showing good cause for why this was not offered
does the outgoing PIC required to take a inventory?
No, but this should be done for yourself
Can you stock drugs before the inspection?
No, cannot stock drugs until having the permit
Unit dose drug dispensing system, is labeling required?
No, just requires patient name and room number and is kept in room or patient drawer
Do you have to put the address, registry number of the prescriber or the address of a patient on all prescriptions?
No, not CVI if it is readily retrievable
Can free clinics dispense expired drugs
No, not even if they are donated
Do the SLCP provisions apply to prescriptions for medications that contain slcp?
No, only OTC SLCP
If the pharmacy is being sold, can the pharmacy permit be transferred to the new owners?
No, the permit is nontransferable.
Is a prescription order form allowed to contain more than 1 prescription?
No, unless is hospital, long term care facility, home infusion, hospice, department of corrections, department of health, juvenile center
Is there a refill limit on CVI prescriptions?
No. CVI scripts are valid for one year unless the prescriber specifically writes to extend the prescription to be filled for 2 years. There are no specific limits on the # of refills a prescriber can write for and an RPh can refill the CVI until it expires
Can a pharmacy keep operating if it fails to designate a new PIC after the old one leaves?
No. It is not even allowed to maintain a stock of prescription drugs.
Define supervision - Can a pharmacist supervise over the phone? Leave written instructions? Use any kind of electronic monitoring?
No. Supervision must be in person, by a pharmacist that is physically present and available for immediate oral communication.
Can the non-pharmacist owner of a pharmacy make decisions that override the decisions of the PIC or the pharmacist on duty?
No. That would be considered practicing pharmacy without a license.
Is a hearing required?
No. The license may be immediatelly suspended if there is danger to public health or safety. A hearing will be scheduled within a reasonable time.
Type N
Non-RX
Unit dose container
Non-parenteral
Are Faxed prescriptions allowed for Schedule 2 drugs?
Not as the original prescription. A CII script copy may be faxed for information purposes only to allow the pharmacy to prepare the script prior to receipt of the actual hard copy before being dispensed. Except in Long term care facility and home infusion or medicare certified hospice pts
If a patient transfers a prescription from one CVS to another, do both pharmacies need a hard copy on file
Not if they have a common database that is capable of generating a hard copy of the transferred prescription upon request
Explain the procedures for closing a pharmacy, changing hours of operation, changing ownership, and appropriate disposition of drugs and records
Notify the board 14 days prior to all changes. Closing: Report disposition of all drugs, rx dips records, pt records, and other records. If the drug stock is to be transferred to another pharmacy - name & address. Public notice of closure (post notice 30 days prior or mail notice 14 days prior give name and info of pharmacy that records transferred to). Change in ownership: transfer last 2 years of records to new owner. Changing hours: Notice to public
What must you do when you close a pharmacy?
Notify the board within 14 days of when the pharmacy will close. Tell them what you plan to do with all drugs, dispensing records, patient information, and other records. If xfer drugs must tell them who is getting them and their license #. Must send prescription records for RX with active refills to another pharmacy. Emergencies are exceptions (ie fire, foreclosure)
If you want to stop being a collector
Notify the board within 30 days (PIC or medical director does this)
When can techs take a new verbal order
Nuclear tech may accept RX for diagnostic, nonpt specific radiopharmaceuticals
OBRA
Omnibus Budget Reconciliation Act -passed every year by congress
Who (besides wholesalers) can sell Schedule 1-5 drugs
On an emergency basis, drugs can be transferred (sold or borrowed) between pharmacies. Drugs may also be transferred within health care entities such as hospitals that are under common control
When is an internet pharmacy's monthly report of controlled substances to the DEA due?
On or before the 15th of the following month
When can Medicare pt change his provider
Once a year
How many interns may a pharmacist supervise?
One (1) pharmacist supervises one (1) intern
How many interns may a pharmacist supervise?
One (1) pharmacist supervises one (1) intern if the intern is not engaged in technician functions. Interns acting as techs are included in the max of 4 techs per pharmacist (i.e. could have 4 interns for 1 pharmacist if they are doing technician duties)
Who is on the board of health professions
One member from each health regulatory board appointed by the Governor and 5 members to be appointed by the Governor -If you stop being a member of a regulatory board you cease to be on the board of health
How many medications can be on a single prescription form?
One per Rx
How long is the pharmacy permit good for?
One year
Grandfathered drugs
Ones available prior to 1938 were not required to be proven safe: levothyroxine, digoxin, NTG, and phenobarb are examples)
Can prescribers use preprinted prescription forms?
Only for CVI prescriptions and still needs a signature
Can a written prescription for a SII drug be faxed
Only for informational purposes. A faxed prescription does not count as the original written prescription
Are Partial fills allowed for a Schedule 2 drug?
Only if initially unable to fill due to lack of supply, must fill the remaining amounts within 72 hours Cannot be done under patient request for partial fill Allowed in terminally ill, receiving home infusion, hospice or long term care facility
Are partial fills allowed for a Schedule 2 drug?
Only if initially unable to fill due to lack of supply, must fill the remaining amounts within 72 hours. Must write on the face of the rx the amount partially dispensed and the date. Cannot be done under patient request for partial fill Allowed in terminally ill or long term care facility patients
Can the pharmacy accept a prescription that was already dispensed to a patient?
Only if it is in the manufacturer's original sealed container and USP storage requirements are assured (can rarely assure USP requirements were kept) Can accept it if it hasn't left the pharmacy premises
One pharmacy is being acquired by another. Do current patients need to be notified?
Only if prescriptions records are going to be used for something other than continuity of pharmacy services at substantially the same level. If so, written notice must be given 14 days prior to the acquisition.
Can an electronic prescription be converted to a fax?
Only if the script is for a CVI drug. CII-V cannot be converted to fax.
Who can administer drugs from an emergency kit at a LTC facility
Only nurse, RPh, or prescriber
Identify any additional information required for a valid CS prescription
Prescriber DEA number
Explain how to properly package prescriptions
Only packaged in USP-NF approved packaging for that drug, if no set reg - well-closed container. - May be dips in compliance packaging for self-administatrion for use in hospital/LTCF. Compliance packaging: separation of individual containers - label for each ind container shall be labeled with identity of each of the drugs products contained within. Main packaging label contain all required elements for outpatient label w/ physical description of each solid dosage form. - each drug disp shall be in special packaging (child proof) except when otherwise directed by Md, purchaser, or when drug exempted (SL Nitro). If non special packaging is requested a notation shall be made on the dispensing record.
Restroom in the pharmacy
Only pharmacist and personnel assisting with dispensing functions may use it. -There must also be another restroom outside the pharmacy for other associates and the public
What drugs can be stocked in crisis stabilization units
Only schedule VI approved by the medical director in consultation with a pharmacist
What drugs can be in an emergency kit at LTC
Only those which in absence survival would be threatened Limited to injector or inhalation except for NTG SL and diazepam rectal gel Must be sealed with same criteria of other kits
Exceptions for providers checking the PMP
Opioid for hospice or palliative care Opioid is no more than 14 day supply written for surgical or invasive procedure Opioid is prescribed during an inpatient admission or at discharge Opioid for a patient living in nursing home or assisted living that uses a sole source pharmacy PMP is down -If provider cannot access PMP it must be documented in chart
CV controlled substances that can be dispensed without a prescription
Opium, codein, dihydrocodeinone, ethylmorphine, and diphenoxylate (Most common is Robitussin w/ codeine)
What Prescription and samples can a TPA optometrist issue?
Oral Analgesics Schedule 3 through 6 for ocular pain and eye disease or topical CVI drugs for the eye/adnexa
What Prescription and samples can a TPA optometrist issue?
Oral Analgesics Schedule 3 through 6 for ocular pain and eye disease
WHat method can be used to trasnfer a prescription?
Oral between 2 pharmacies fax electronic
VA permits generic substitution according to _____, unless certain action(s) have been taken by the prescriber and/or pt
Orange Book
Type V
Orphan drug
Who must witness destruction of controlled drugs in a retail/hospital pharmacy
PIC + another pharmacist not employed there
what happens to the pharmacy permit if the PIC leaves their position with the pharmacy?
PIC must immediately surrender the permit to BOP (remember, permit is issued to PIC, not pharmacy)
How long do you have to resolve a discrepancy report of an automated device
PIC or his designee has 72 hours to resolve the discrepancy. If theft or an unusual loss of drugs is determined the board must be immediately notified
Who obtains a permit from the board to conduct a pharmacy in VA?
PIC, not a business entity
Which ways are new drugs expedited in their review?
PRIORITY REVIEW -reduces time from 10 months to 6 FAST TRACK -when medical need is unmet BREAKTHROUGH THERAPY -Must show early clinical evidence of substantial improvement over existing therapies ACCELERATED APPROVAL -Intended for drugs with long-term endpoints that are not easily or efficiently measured in trials (decreased morbidity, increased survival) and easily measured but rely on inference (tumor shrinkage)
Define "compliance packaging"
Packing for solid oral dosage forms designed to assist the user with the correct administration or self-administration
What RX can be written in excess of recommended dosages
Pain medicine when the pt has intractable pain. Provider must document in the medical record
Length of time of records that must be transferred to new owner when pharmacy changes onwership
Past 2 years
Patient information required on a Virginia prescription
Patient first, last name, address. If it is for an animal, must have the owner's name, address, and species of animal *Don't have to write the pt's address on every prescription if their address in the their electronic record
What must be reported when a pharmacist dispenses a drug covered by the Prescription Monitoring Program?
Patients name, address, DOB Drug and quantity dispensed Date of dispensing Prescriber and dispensers identifier numbers Method of payment
Schedules of the bitals
Pentobarbital----- CII Secobarbital- CII Amobarbital--- CII Butabarbital and Butalbital- CIII Phenobarbital----- CIV
Specific rules for an outsourcing facility
Pharmacist supervision required at all times Records must be kept for 5 years
Remote Pharmacists and technicians must be licensed
Pharmacists in VA Techs possess credentials substantially equivalent to those required in Virginia
Describe the requirements for display of pharmacy permit
Pharmacy License - Must display permit in conspicuous place at place of business which issued. Pharmacist License - Display at place in which regularly practice.
Schedules they belong to
Phenmetrazine-------- CII Benzphentamine-------- CIII Phentermine--------CIV
Requirements after an oral emergency CII prescription
Physician must provide with a signed written prescription to cover the emergency dispensing. It must be dated and signed on the date of the emergency oral prescription and must include the words " authorization for emergency dispensing". Pharmacist must attach the hard copy written Rx to the emergency oral Rx. RPh must notify the DEA if they do not receive the written Rx.
Phase 4
Postmarketing data health professionals are encouraged to report any problems with the drug FDA can use this data to pull the drug
Explain the 3 day rule ?
Practitioner not separately registered is allowed to administer but not prescribe to relieve Acute Withdrawal Symptoms 1 day of medication per day Continue no greater than 72 hours Cannot renew beyond 72 hours Buprenex cannot be used
Explain requirements for the enclosures to the prescription department and access to the prescription department both in the presence or absence of a pharmacist
Prescription Dept: Any contiguous or noncontiguous area used for compounding, dispensing, and storage of all Sched II-VI drugs and devices and ached I investigational. - Enclosure shall be constructed in such a manner protects from unauth entry -Shall remain locked and alarmed at all times with rph not on duty or not present in the prescription dept. - Keys or other means of entry into locked pharm and alarm code access code shall be restricted to rph practicing and auth by pic EXCEPT: 1. emergency access, may place a key to rx dept and alarm code in seal envelope w rph signature in safe or vault - only for pharmacist or techs 2. Intern, tech, or other may possess key for entry when rph on duty. - Upon request by a pt to obtain an already-dispensed rx, a tech may enter the pharmacy for the sole purpose of retrieving filled prescriptions that have already been reviewed and are ready to delivery if: unforeseen rph absence, alternate rph cannot be immediately obtained, Tech accompanied by mgmt or administration, - Requirements for entry into rx dept in absence of rph: 1. Prescriptions awaiting delivery 2. tech obtains verbal permission from PIC or other regular rph. 3. Record of tech entry inc, date and time, name and title of accompaniant, rph granting permission, pt name, nature of emergency, rxs retrieved, 4. Tech reseal keye and alarm code. PIC shall have access code changed w/i 48 hours. records x 1 year.
Explain the requirements for appropriate storage for drugs, devices, CS, Controlled paraphernalia and expired drugs
Prescriptions awaiting delivery: May be placed in a secured area outside of the rx dept, no accessible to the public, where access is restricted to individuals dest. by rph. May be transferred to the pt when rph not on duty. written procedures shall be established which detail security and compliance with counseling req. Log maintained of all prescriptions delivered what rph not present. Maintian x 1 year. Sched II Drugs: Dispersed with other drugs or in locked cabinet. May remain unlocked during hours rx dept open. Cont paraphernalia and Sched VI meds: Shall not be placed in area removed from rx dept where patrons have free access. Expired, misbranded, adultered: separated from stock until proper disposal. - controlled paraphernalia: ensure that meds are not diverted if used for other than lawful: class I misdemeanor.
When must an offer to counsel be made?
Prior to dispensing a new prescription. It is not required to offer to counsel for refills, unless the pharmacist deems it necessary.
What is the Pure Food and Drug Act of 1906?
Prohibits the shipment of adulterated or misbranded drugs in interstate commerce -have to meet quality and purity standards
If person accepting a delivery or pick up of a Schedule 2 drug what is required?
Proof of ID Record full name and address
does VA require pharmacies to conduct self-inspections?
no
STAT drug box
Provided for initiating therapy prior to receipt of ordered drug from pharmacy
Recordkeeping requirements for the sale of SLCPs
Purchaser's name and address, date of birth (must be 16 or older), signature, product name and quantity sold and date and time of the transaction Purchaser's must sign the record acknowledging the sales limit
what law prohibited shipment of adulterated or misbranded drugs in interstate commerce?
Pure Food and Drug Act of 1906
Frequency at which quality assurance reports of robotic pharmacy systems must be done
Quarterly
WHat insulins available without prescriptions?
REgular, NPH, 70/30
WHat is required when a pharmacist delivers a c2 drug by mail, common carrier or delivery service to a VA address?
REquire signature of recipient as confirmation of receipt
What if the provider doesn't send you the hardcopy for a emergency CII fill
RPh must notify the board and the nearest office of the DEA
Explain the regulations governing discontinuance of practice 21 CFR 1301.52, 21 CFR 1307.21)
Return DEA registration certificate and unused order forms (222) to the local DEA registration specialist. DEA may ask about location of inventories, prescriptions and other records during the requisite 2 year retention period. - Unwanted CS must be disposed of in accordance. - Complete inventory on day of closing
What dispensing activities can only be done by pharmacists, and not pharmacy technicians?
Review prescriptions; Take an oral prescription; Conduct prospective drug review; Counsel patients and provide drug information; Communicate with prescriber or agent abount any change to therapy except a refill; Verify a prescription prior to dispensing; Supervise pharmacy interns and technicians.
schedule 6 under VA law
Rx only drugs or devices, not listed in c1-5
A sample is dispensed in the ED what occurs?
Same as if other medicine is dispensed: A record is maintained for 2 years showing: -Date and time of dispensing -Patient's name -Prescriber's name -Name, strength, dosage form, quantity and dose of the drug
What Schedules are covered for purpose of PMP?
Schedule 2 , 3 and 4
Things with 60 day dating
Schedule 2 prescription is good for in a Long term care facility
What is the allowable concentration of Codeine in schedule 3? In schedule 5?
Schedule 3 not greater than 1.8 grams per 100ml or 90mg per dosage unit Schedule 5 not greater than 270mg
What is the allowable concentration of Codeine in schedule 3? In schedule 5?
Schedule 3 not greater than 1.8 grams per 100ml or 90 dosage units Schedule 5 not greater than 270mg
What is the allowable concentration for Hydrocodone in Schedule 3? In schedule 5?
Schedule 3 not greater than 300mg per 100ml or 15mg per dosage unit Schedule 5 not greater than 65mg Same concentrations for EthylMorphine for same schedules
What is the allowable concentration for Opium in Schedule 3 and Schedule 5?
Schedule 3 not greater than 500mg per 100ml or 25mg per dosage unit Schedule 5 not greater than 200mg
Things that are good for 6 months
Schedule 3 through 5 prescriptions or 5 refills
6 months
Schedule 3 through 5 prescriptions (or 5 refills) Schedule 2 prescription
Schedule I
Schedule I drugs are drugs which have a high potential for abuse, but which have no accepted medical use in treatment in the US or which lack accepted safety for use in treatment even under medical supervision
Schedule VI
Schedule VI also includes any drugs not listed in schedule I- schedule lV which because of toxicity, potential for harm, method of use, or collateral measures necessary to its use is not recognized among experts as being safe for use except by or under the supervision of a practitioner licensed to prescribe Digoxin- Lanoxin Penicillin V- Penicillin VK Bupropion HCl- Wellbutrin Amoxicillin- Amoxil Cephalex- Keflex Tramadol HCl- Ultram
Phase I
Small group of humans get a drug Looks at -Toxicology -PK -Pharmacologic properties -*Safety*
What are the work arounds to no samples in retail?
Starter packs are not considered samples Vouchers and coupons
Understand the use and Application of the Following Terms;
Storage Temperature: Tight Container: Unit Dose Container: Unit Dose Packaging: Unit Dose System: Well-Closed Container: Compliance Packaging: Beyond-use Date: Expiration Date:
what certification does an optometrist need in order to prescribe?
TPA (Therapeutic Pharmaceutical Agents) certification - a VA certification that ODs must obtain from VABOP
What certification does an optometrist need in order to prescribe
TPA certification
What certification does an optometrist (OD) need in order to prescribe?
TPA certification (therapeutic pharmaceutical agents
Temp for storing drugs: Controlled Room T
Temperature maintained thermostatically that encompasses the usual and customary working environment (20 to 25 C) Excursions can be between 15 and 30C
Board consists of how many members?
Ten
Board consists of how many members?
Ten (8 pharmacists, 2 civil members)
What must the posted signage indicate
That the prescriber/pharmacist may access information contained in the program files on all schedule II-IV RX dispensed to the pt
What if the pharmacy fails to dispose of all CII-IV drugs and devices if a PIC leaves and there is no valid permit anymore?
The Board of Pharmacy will seize all Schedule II through IV drugs and devices still on the premises and notify the owner. To claim the drugs, the owner must pay a fee for the storage cost and provide for proper disposition of the drugs. If the owner has not claimed the drugs after six months, the drugs may be destroyed.
does VA require pharmacies to provide translation services to LEP pts?
no
What if the pharmacy fails to do that?
The Board of Pharmacy will seize all Schedule II through IV drugs and devices still on the premises and notify the owner. To claim the drugs, the owner must pay a fee for the storage cost and provide for proper disposition of the drugs. If the owner has not claimed the drugs after six months, the drugs may be destroyed.
What entity has the broadest inspection powers?
The Board of Pharmacy. They do not need a warrant or probable cause.
What record must be kept of the destruction
The DEA drug destruction form is used to record the destruction and kept with the pharmacy inventory
Drugs returned from a long-term care facility are going to be destroyed at the pharmacy, Who must witness the destruction
The PIC and another pharmacy employee. The drugs may also be transferred to another pharmacy licensed to accept returns for destruction
How long can a PIC be gone on a scheduled absence before you have to notify the Board and designate a new PIC? Unsceduled absence?
The PIC may be gone 30 days scheduled absence, or 15 days unscheduled absence with no known return date within the next 15 days
When can non-pharmacists enter a locked pharmacy?
The PIC must permit it and a waiver must be granted to a special-use pharmacy at a free-clinic that is only open <20 hours and uses volunteers to staff. A log must be kept (1 year). 2 people must enter and remain present the entire time 1 of those people must be a licensed nurse, physician, or PA. The alarm code must be changed by the PIC within 48 hours.
When a permit to conduct a pharmacy is issued, who or what is it issued to?
The Pharmacist-In-Charge (PIC)
What federal official assigns drugs to federal schedule?
The United states attorney general
What is Required on the face of a transfer prescription
The Word TRANSFER
How will a pharmacy know that the application provide is certified?
The application provider must provide a copy of its certification report to the pharmacy
How will the pharmacy know if the prescriber sending a electronic prescription is certified to do so?
The application provider must provide a copy of the certification report to the pharmacy or provider. The pharmacy cannot process or dispense CII-V e-scripts until the report is received.
If more than one lot is in the bin at the same time, what is the expiration date
The lot that expires first is used to determine the expiration date
What is considered the opening inventory
The most recent one, the inventory taken in december
After the drugs are destroyed, what records are kept
The original record of destruction is signed and dated by the people witnessing the destruction, and kept at the long-term care facility for 2 years. A copy is kept at the provider pharmacy for 2 years
Who fills out the DEA 222 form, the purchaser or the distributors
The party receiving the drugs. The pharmacy fills out the form when purchasing drugs. However, if the pharmacy is returning drugs, the distributor must fill out the form
What information does a faxed refill authorization need to include
The patient name and address, drug name and strength, quantity, directions for use, prescriber's name, prescriber's signature or agent's name and date of authorization
Who signs and dates the inventory
The person taking the inventory, This could be the pharmacist or technician.
Two changes prohibited for CII prescriptions
The pharmacist may never change the drug prescribed (other than generic substitution) or add the prescriber's signature
Who is responsible for determining the suitability of the product for redispensing?
The pharmacist-in-charge is ultimately responsible
What happens if the PIC leaves the job?
The pharmacy permit must be surrendered to the Board and an application for a new permit made.
What has to be on the application to conduct a pharmacy?
The pharmacy's corporate name and trade name; any pharmacist in addition to the PIC who will work there; the hour the pharmacy will be open; the pharmacy owner (if someone other than the pharmacist making the application)
What information does an electronically transmitted prescription need to include
The phone number of the prescriber, the full name of the prescriber's agent if other than the prescriber transmitting, and date of transmission
Define a bona fide practitioner-patient pharmacist relationship
The practitioner prescribes, and a pharmacist dispenses, controlled substances in good faith to his patient for a medicinal or therapeutic purpose within the course of his professional practice.
Who can call in a prescription
The prescriber or his or her authorized agent. The agen must be specifically directed by the prescriber and must be either. -An employee under the prescriber's immediate and personal supervision or -An individual holding a valid license allowing administration or dispensing of drugs
What if a DEA form 222 gets lost in the mail
The purchaser executes another,attaches a statement with the serial number and date of lost form, and a statement that the drugs weren't received. The purchaser keeps copy 3 of the lost form, plus copy 3 of the new form, plus the statement. The supplier gets copies 1&2 of the new form and fills the order as usual. If the supplier eventually gets the lost form, they must mark it "Not Accepted" and return it to the purchaser.
Where do the 3 copies of the DEA form 222 go when drugs are purchased
The purchaser fill out the form and keeps copy3. Copies 1 and 2 are sent to the supplier. After the order is filled, Copy 1 is kept by the supplier and Copy 2 is sent to the DEA.
What are the recordkkeeping requirements for elcetronic prescriptions
The same as for written prescription records
What happens if an order is refused
The supplier returns form 222 (copies 1&2) to the purchaser with a statemnt of reason for refusal. The purchaser retains all 3 copies plus the statement from the purchaser in their files. The purchaser can't re-use the form
Temp for storing drugs: Room T
The temperature prevailing in a working area (so not well defined)
What is a TPA optometrist?
Therapeutic Pharmaceutical Agent
What is a TPA optometrist?
Therapeutic Pharmaceutical Agent = a Virginia certification obtained by ODs that allows them to prescribe
Type P
Therapeutic classification by FDA while reviewing drugs -P think Priority review -Major therapeutic gain
Type S
Therapeutic classification by FDA while reviewing drugs -S think similar -Standard review
How does VA refer to drugs approved for generic substitutions?
Therapeutically equivalent
A new pharmacy opens for business. What are the inventory requirements
There must be a complete inventory of Schedule 1-5 drugs on the first day of business. if there are no controlled substances on hand, record that as the inventory
What about the rx written as chart orders for a hospital or LCTF whip is then being discharged?
These hart orders can be filled at a outpatient pharmacy if: 1. the pahrmacist has all the information necessary for a valid outpatient prescription 2. there is a written or verbal directions indicating that the chart orders are intended to serve as prescription order 3. the orders include some directions related to the quantity to be dispensed or duration of the orders
What can a drug donation site charge?
They cannot charge the owner They may be able to charge another charitable pharmacy for the transfer of the drug but they cannot charge that pharmacy or a patient beyond an adminstrative or dispensing fee that literally only covers the cost of doing such. If a patient cannot afford a fee it must be waived
If a supplier can't fill all or part of an order, what can they do with the 222 form
They may endorse it to another supplier to fill. Only the original supplier can do this
What are special rules for the Defense Supply Center of the Defense Logistics Agency
They may get partial shipments at different times, to locations other than the location printed on the form 222, for a period of 6 months from the date of the order. They must be buying for delivery to armed services establishments within the US
How do the drugs that can be handled by non-pharmacy personnel have to be stored?
They must be locked when authorized staff is not present.
List of Schedule IV controlled drugs:
Tramadol (Ultram) Carisoprodol (Soma) Alprazolam (Xanax) AND OTHER BENZOs Barbital (Barbitone) Butorphanol (Stadol, Stadol NS) Chloral hydrate (Noctec) Chlordiazepoxide (Librium, Libritabs, Limbitrol, SK-Lygen) Clorazepate (Tranxene) Dexfenfluramine (Redux) Dichloralphenazone (Midrin) Difenoxin 1 mg/ Atropine 25 mcg (Motofen) Ethchlorvynol (Placidyl) Fenfluramine (Pondimin, Ponderal) Mazindol (Sanorex, Mazanor) Meprobamate (Miltown, Equanil, Deprol, Equagesic, Meprospan) Modafinil (Provigil) Pemoline (Cylert) Pentazocine (Talwin, Talwin NX, Talacen, Talwin Compound) Phenobarbital (Luminal, Donnatal, Bellergal-S) Phentermine (Ionamin, Fastin, Adipex-P, Obe-Nix, Zantryl) Sibutramine (Meridia) Zaleplon (Sonata) Zolpidem (Ambien) Zopiclone (Lunesta)
What are acceptable procedures for disposing of unwanted drugs
Transfer the drugs to another entity authorized to possess or dispose of them. Destroy by burning in incinerator For SII-V drugs, the PIC must notify the Board in writing 14 days prior to the destruction date
How long do you keep records of your CE?
Two years
How long is a technician required to keep records of CE?
Two years. The technician maintains these, not the employer.
Who pass law (legislative body) that govern pharmacy practice in VA?
U.S congress and VA general assembly
_____ is the official standard for Rx format, appearance, content, and language instructions
USP 17
USP DI
USP Dispensing information A set of 3 volumes -I:information about individual drugs for health professionals -II:DI in lay language -III: USP/NF and oragne book info
Generic drug names come from
USP-NF USAN (US adopted names) USP Dictionary of Drug Names
Official Compendium
USP-NF official Homeopathic Pharmacopoeia of the US
What can a rph do if the patient needs a refill for a c6 drug and the prescriber is not available?
VA allows a c6to be refilled without authorization if 1. the pharmacist makes a reasonable effort to contact the prescriber and 2. patient's health would be in imminent danger without the drug
What is special packaging?
VA version of safety closure container -children under 5 cannot open
What prescriptions can be pre-printed
VI
Nominations for the BoP
VPhA may nominate a list of at least 3 persons to the Governor, but the Governor is not bound to appoint one of those people
VIPPS
Verified internet pharmacy practice site
what is the name of the inspection or assessment form used by pharmacists in VA?
Virginia Board of Pharmacy Universal Pharmacy Inspection Form
What information is required to be on a transferred RX
W -written date O -orginal RX # O -original # of refills O -original fill date (if applicable) L - last fill date R -refills remaining P -pharmacy name, address, DEA # (if not VI) P -Pharmacist transferring
What do you do if you refuse to fill a RX for any reason other than not having it in stock
Write declined on the back of the RX, the name, address and phone number of the pharmacy, the date of denial and the pharmacists signature
does VA require pharmacy phone # on container label?
no
When should the board be notified of unanticipated absences by the PIC?
When greater than 15 days of unanticipated absences and there is no known return date within the next 15 days.
When can prescriber's dispense in the ED?
When it is an emergency or when pharmaceutical services are not readily available and if permitted by the hospital
When do you not have to have an alarm on floor stock?
When it is kept in an area that is always staffed and people are around
When can a drug be dispensed in special packaging
When pt requests or provider puts it in RC Item is exempt from Poison Prevention Packaging Act You have to keep a record of this request
When do providers have to check PMP
When starting a new treatment to a human including opioids anticipated at the onset to last more than 7 consecutive days If you are licensed to treat opioid addiction with therapy you must check what controlled substances the pt is currently being prescribed
When can technicians and interns have a key to the pharmacy
When that key only works when a pharmacist is on duty
When should the board be notified of unscheduled absences by the PIC?
When the PIC has greater than 15 days of unanticipated absences and there is no known return date within the next 15 days.
Must notify Board of Pharmacy immediately
When there is no longer a PIC and must turn in pharmacy permit
WHen must the security system be activated?
Whenever the prescription department is closed for business
If the Pharmacy is open 24hrs/day, the inventory must indicate what
Whether the receipt or distribution of drugs on the inventory, date occurred before or after the inventory was taken.
If controlled substances are lost or stolen while being transported by common contract carrier (such as UPS) between a central fill pharmacy and a retail pharmacy, who is responsible for notifying the DEA
Whichever pharmacy contracted with the contract carrier
FRom what entities are pharmacists allowed to purchase their c2-6 medications?
Wholeslaer and warehouses that have a license or registration from the board
How often is do you have to do a control inventor and what schedules?
Within 2 years of the last one CI-V -If you have loss or theft and you are unsure of the exact kind and quantity you have to do a complete control inventory count
What if a technician renews his or her license late?
Within the first year, must pay a late fee, a renewal fee and show proof of CE. After 1 year, the technician pays a reinstatement fee, a renewal fee and shows proof of CE. After 5 years or more, the technician will need to apply for recertification. The same requirements apply as getting certified for the first time.
What if a technician renews his or her license late?
Within the first year, must pay a late fee, a renewal fee, complete the renewal form, and show proof of CE. After 1 year, the technician completes the reinstatement application, pays a reinstatement fee, a renewal fee and shows proof of CE. After 5 years or more, the technician will need to apply for recertification. The same requirements apply as getting certified for the first time.
Can precriptions for c3-6 drugs be faxed to a pharmacy?
Yes, with prescriber's signature
What is required if a pharmacist declines to fill a prescription?
Write on the back the word declined, the name, address, phone number of the pharmacy, the date the script was declined, and the RPh's signature Refrain from returning the script to the patient, maintain the script for at least 30 days, and provide it to law enforcement
What must be on an RX
Written in INK, typed, or printed -Name, address, phone # of prescriber (DEA # if not VI) -Full name and address of pt (address can be in an electronic prescription dispensing record) -Date RX written which must be the date prescriber signed -Only one prescription per written form (unless its an order for hospice, infusion, LTC, correctional facility, etc)
Describe the information that must appear on any prescription
Written: INk, typed, or printed, name address ph# of prescriber, CS - DEA number. Prescribers information preprited, typed, stamped or printed by hand. First and Last name of pt, address, dated and signed by MD on day of issue - Can have preprinted prescriptions for CVI. - Only 1 prescription per rx (exc chart orders, corrections) - Vetrinary: Species of the animal. - Oral: agent transmitting rx
Are veterinarians allowed to write c2 rx for animals?
YEs
Are Np and PA allowed to write c2-c6?
Yes
Are you allowed to compound a drug in anticipation of a prescription?
Yes
Are you allowed to make compounds for practitioner of Medicine, Osteo, Podiatry, dentistry or Vetrinary for administration to their patients?
Yes
Are you allowed to take a verbal order for a Schedule 3 through 6 drug?
Yes
Are you allowed to transfer Schedule 3 through 6 drugs?
Yes
At a long term care facility can the primary pharmacy provider repackage a residents prescription drugs dispensed by another pharmacy into unit dose or compliance packaging?
Yes
Can a Nurse Practitioner prescribe Schedule 2 through 6 drugs?
Yes
Can a Physician Assistant authorized to fill Schedule drugs issue prescriptions and samples?
Yes
Can a prescriber fax a refill authorization
Yes
Can a prescriber transmit prescriptions electriconically
Yes
Can a refill authorization for CIII-VI scripts be faxed?
Yes
Can drugs from a long term care facility be returned for redispense or for use in the indigent?
Yes
Can the VA Board of Pharmacy schedule or deschedule drugs?
Yes
Can the board suspend a pharmacist license for not paying student loan?
Yes
Can you put more than one lot into a bulk bin
Yes
Does CE earned for a license in another state count toward your VA CE?
Yes
Does VA restric the sale of certain controlled paraphernalia?
Yes
Does the pharmacy need to maintain Schedule 1 and schedule 2 inventories and records separate from the others
Yes
If a hospital has a standing order or protocol for administration of influenza or pneumococcal vaccine, does that count as a bona fide practitioner- patient relationship
Yes
If your license is inactive, are you still responsible for the CE?
Yes
Instead of writing the info on the transferred prescription, can the transferring pharmacy record this information electronically
Yes
Is a separate registration from the DEA required for a Narcotic Treatment Program?
Yes
Is an electronic prescription allowed for Schedule 2 through 6 drugs?
Yes
The pharmacy opened for business on Jan 1, and opening inventory was taken. There is a theft in December, nearly 2 years later, and an inventory was done. Does the pharmacy still have to take a biennial inventory a few weeks later in January
Yes
Are there exceptions to the special packaging requirements?
Yes -Sl nitroglycerin -medrol dosepack -non-oral dosage forms
Are there any conditions that TPA-certified optometrists are specifically prohibited from treating?
Yes -cannot treat infantile or congenital glaucoma -can only treat closed angle glaucoma in emergency situation
Are pharmacists allowed to make any changes to a written c2 prescriptions?
Yes 1. add or correct a pt's name after verifying it 2. add a pt's address after verifying it 3. add the prescriber's DEA number 4. add or change dosage form, strength, quantity, issue date, direction for use after direct consultation and agreement with the prescriber
CAn a prescriber fax a c3-6 refill authorization?
Yes 1. date of authorization 2. pt's name and address 3. drug name, strength and quantity, direction for use 4. prescriber's names, signature or agnet's first and last name for an oral rx
Can a DEA registration be transferred to new owner after being acquired?
Yes Submit written request to the Deputy Assistant Administrator, office of diversion control in DC
Can a DEA registration be transferred to another registrant after discontinuation of the business?
Yes in person or mail the Special agent in charge of his area a notice 14 days of the proposed transfer
Are pre printed prescriptions allowed?
Yes All coupons of pharmacy names must be on 2nd sheet or back
Can a pt pick the drug supplier?
Yes, you can't interfere with this
Can a Control substance inventory done in result of a theft be used as an opening inventory within current biennial period?
Yes But it does not prevent taking of require inventory on required biennial inventory date
Are Faxed prescriptions allowed for Schedule 3 through 6 drugs?
Yes Oral prescription sent by fax is okay also Faxing refills are allowed also
Are you allowed to take a verbal order for a Schedule 3 through 6 drug?
Yes (3-5 can only be transferred once unless transferring between pharmacies that share an electronic database)
Is an electronic prescription allowed for Schedule 2 through 6 drugs?
Yes - as long as a federally approved credential service provider (CSP) or certification authority (CA) is used which uses a two-factor authentication or digital certificate
Is a separate registration from the DEA required for a Narcotic Treatment Program?
Yes - in order to prescribe CIII-V drugs for maintenance or detoxification
Are you allowed to refill a prescription without authorized refills?
Yes allowed if a reasonable effort made to obtain and medically needed
Are you allowed to refill a CVI prescription without authorized refills?
Yes allowed if a reasonable effort made to obtain and medically needed. The RPh must inform the pt the refill is being made without MD authorization, inform the prescriber of the refill, and document on the back of the script the date and quantity of the refill, the prescriber's unavailability, and the reason for the refill
Can a pharmacy act as a wholesale distributor of small quantities of prescription drugs without being licensed as a wholesaler?
Yes but wholesale controlled substances sales cannot exceed 5% of the pharmacy's total CII-V annual sales in dosage units Also, wholesale oxygen sales cannot exceed 5% of total oxygen sales
Are you allowed to dispense a controlled substance written by a practitioner that is out of state?
Yes for Medical, Osteopath, Podiatrist, Dentist and Vet. Rx must be for legitimate purpose and meet VA requirements
Are you allowed to dispense a controlled substance written by a practitioner that is out of state?
Yes for Medical, Osteopath, Podiatrist, Dentist and Vet. Rx must be for legitimate purpose
Can a c2 be phoned in?
Yes if 1. Emergency phoned in with the according quantity 2. the prescriber phones it in directly 3. written rx has to follow within 7 days
Is a pharmacy allowed to store its c2 drugs with other schedules?
Yes if they are dispensed throughout the pharmacy or c2 can be locked in a drawer, cabinet, or safe (can remained unlocked when there is a pharmacist on duty)
Can drugs be transferred between a healthcare entities' hospitals?
Yes if they are under common control, with the involve of dea222
Are there time when a c2 can be faxed and filled?
Yes if: 1. LTCF 2. home infusion 3. medicare certified hospice pts (with MD note "hospice" on Rx)
Does VA allow pharmacies to transfer prescriptions to other pharmacies?
Yes if: 1. pt consent 2. rx eligible for filling or refilling
Can an oral prescription be faxed
Yes it has to have the agent's full name and wording that clearly indicates that the prescription being transmitted is an oral prescription. If the prescription is oral, the prescriber's signature isn't needed
Can a patient get a birth control prescription form a psychiatrist
Yes, a psychiatrist is an MD, and has the smae prescribing authrority as any other M.D.
Are there any exceptions to this
Yes, an order for SII drugs for nursing homes or home infusion patients may be faxed. SII prescriptions for hospice patients may be faxed if the prescriber notes on the prescription that the patient is a hospice patient. These prescriptions must meet same requirements as written prescriptions, including signature.
Can drugs be imported from Canada
Yes, and other countries if permitted and HHS certifies the importation poses no additional risks to public health
Is the patient package insert part of the labeling
Yes, any written material accompanying the product is labeling
Can you accept a controlled substance prescription from an out of state practitioner
Yes, as long as they are authorized to prescribe in Virginia
Can a unregistered technician work while training to get registered?
Yes, as long as they are directly supervised by a pharmacist.
Can a technician compound extemporaneous preparations?
Yes, but a pharmacist must personally supervise the preparation.
Can a pharmacist require proof of identity from any patient presenting a CIII-V prescription or requesting a refill of one?
Yes, but it is not mandatory
Can you get an exemption from the CE requirements?
Yes, but it is rare and only granted for circumstances out of your control. You can get a 1-year extension with a writen request, and further extensions only with a good reason. You are still responsible for all of the CE required for that time period.
Can you participate in "kickbacks", fee-splitting, or special charges in exchange for prescriptions orders?
Yes, but it must be fully disclosed in writing to the patient and any third party payor.
Can a prescription be written by a medical intern or resident who works only in a hospital
Yes, but only within their duties as part of the residency program. It needs the prescriber's signature, the legibly printed name, address, and telephone number of the prescriber and an identification number assigned by the hospital
Are imprints on solid oral dosage forms mandatory
Yes, but some exceptions like NTG SL
Can oral orders be faxed
Yes, but the agent must indicate it is an oral order and provider her full name
Can you be PIC of more than one pharmacy?
Yes, you may be PIC of a maximum of 2 pharmacies
Can you return drugs to stock from WILL-CALL
Yes, but they get the expiration date of 1 year from the date filled or the expiration date of the bottle they came from (if known) and its whichever date is earlier If you don't have a lot number on the RTS bottle then if there is any recall of that drug you have to pull it The law says the RTS bottle should be used for the NEXT fill of that drug
Can you store or execute blank DEA forms at an address other than the one on the form
Yes, but they must be easily accessible if investigated by law enforcement
Can remote pharmacists authorize the administration of drugs?
Yes, for hospitals or LTC
Are there any other situations when a pharmacy may partially dispense c2 prescription?
Yes, for pts in LCTF or terminally ill, record: 1. date of dispensing 2. quantity dispense 3. remaining quantity 4. rph identity
A patient asks a pharmacist or physician to take one of their drugs and mail it off to a lab. Is this allowed?
Yes, for qualitative or quantitative analysis. It can be mailed or dropped off. Receipt of drop off or mail (must be sent registered or certified) must be kept as a record for 3 years
Can a community pharmacy fill a chart order
Yes, if -the chart order was written in a LTC or hospital while the pt was in that location -all the information necessary to constitute a valid RX is present -Written or verbal instructions that the chart is not for information purposes but for outpatient RX -Quantity or duration is present
Can a pharmacy intern do pharmacist specific duties?
Yes, if a pharmacist directly supervises the intern.
Can a pharmacy intern do these things?
Yes, if a pharmacist directly supervises the intern.
CAn the inspection date be requested in the permit application?
Yes, if given within 14 days at least
Can a Physician Assistant or NP authorized write CII-VI prescriptions?
Yes, if it is covered in their practice agreement.
Does CE earned for a license in another state count toward your VA CE?
Yes, if it meets VA requirements
Can it be taken orally using a recording device
Yes, if promptly reduced to writing
Is a pharmacy allowed to transfer a prescription to another pharmacy
Yes, if the patient has given permission, and the prescription may be filled or refilled.
Can a CVI be issued for more than 1 year
Yes, if the provider specifically authorizes dispensing or refilling for a longer period, but not longer than 2 years
Can you dispense to the pt in compliance packaging for self-administration
Yes, if the pt asks, but it also has to have labels so IDK how that would work
Do providers have to be registered with the PMP
Yes, if they are authorized to write RX
Are CII drugs allowed to be stored with other schedules of drugs?
Yes, if they are dispersed throughout the pharmacy. Or they can be stored in separately in a locked cabinet (which can remain unlocked when there is a pharmacist on duty)
Can devices be retured for resale
Yes, in the original sealed packaging
Does VA allow you to partial fill c3-5?
Yes, is: 1. quantity dispensed NOT exceed quantity written 2. all partial dispenses done before expiration date (6 months) 3. follow direction for use 4. record each partial fill as an actual refill
Is the pharmacy required to display its permit?
Yes, it must be displayed prominently.
Are there any special requirements for reviewing drug therapy in pts in ltcf?
Yes, need to conduct a monthly review
Are medical interns and residents who work in a hospital allowed to write Rx?
Yes, only with their duties as part of their residency program
Are there any other requirements for unauthorizes refill of c6?
Yes, pharmacist has to: 1. inform pt that the refill is made without the prescriber's authorization 2. inform the prescriber the refill 3. Document on the back of the rx: date and quantity of refill, prescribers unavailability, and reason for refill
When a pharmacy is closing, does the board need to be notified?
Yes, pharmacy has to notify the board: 1. how its gonna dispose all c2-6 2. who receive the transfer, dispensing records and patient records
When new PIC do you have to do a Schedule 2 through 5 inventory?
Yes, prior to opening on first day as PIC
Can a tech compound extemporaneous preparations?
Yes, rph must personally supervise
Is the PIC allowed to keep a key available for emergencies?
Yes, the alarm code and key maybe placed in a sealed envelope or other container with the pharmacist signature across the seal. kept in a safe place within the pharmacy for use by another pharmacist to gain access to the pharmacy
Can a registrant delegate the ordering of Schedule II drugs to someone else
Yes, the registrant can give power of attorney to one or more agents
Are there any records off limits to the board and drug division officers?
Yes, these include: -financial data -sales data other than shipment data -pricing data -personnel data -research dataa
Can a nursing home donate unused drugs to a free clinic
Yes, they may donate the drugs directly to a hospital or pharmacy, under the following conditions. -The physical transfer is done by a person authorized by the pharmacy -The oringinal patient (or his authorized representative) gives written consent, and the nursing home keeps a record -The drug name, strength, and expiration date stay on the label, but patient-identifying information is obliterated -The transfer includes an inventory list of drugs, strengths, expiration dates, and quantities transferred -No outdated drugs are transferred -The drugs were not originally dispensed for use by Medicaid, Medicare and SCHIP patients
Are computer generated prescriptions allowed in VA?
Yes, with hand signed
Can a pharmacy ever act as a wholesale distributer of small quantities of prescription drugs without being a licensed wholesaler?
Yes. wholesale controlled substances sale can't exceed 5% of controlled substance sales. Wholesale oxygen sales can't exceed 5% of total oxygen sales
Is the pahrmacy allowed to store unexecuted DEA 222 forms at an address other than the one on the form?
Yesbut the forms must be promptly provided to the registered location if it is being inspected
Typically qualifies for an exemption of the PMP
You are an upstanding place of business and: -Substantial hardship has occurred (ie natural disaster or emergency beyond your control) -Doing controlled research approved by a regionally accredited institution of higher education or under the supervision of a government agency
If your license is suspended, how do you apply for reinstatement?
You can bring counsel and witnesses to the hearing. You need 3/4 of the board members at the the hearing to vote for reinstatement, and the Board might reinstate upon terms or conditions it deems appropriate.
What if you get a fax that when you print its not legible
You can re-write the RX and attach it to the fax
What happen if you renew your license late (within one year)?
You have to pay a renewal fee, plus a late fee, and complete all CE .You are still responsible for the same amount of CE as if you'd renewed on time.
What happen if you renew your license late (within one year)?
You have to submit a renewal form, pay the annual renewal fee, plus a late fee, and submit all CE. You are still responsible for the same amount of CE as if you'd renewed on time.
Can you give a patient a copy of their prescription after you've transferred it
You may give a prescription marked "For Information Only" to the patient
What if you can't get in touch with the prescriber for a refill
You may issue a refill after every reasonable effort has been made to contact him and you decide he is unavailable and the patient's health is in imminent danger without the benefits of the drug You must write on the back of the RX the date/quantity/prescriber's unavailability and rationale for the refill
If it is permissible to sell a CI do you need a RX
You need a written order from the practitioner or other authorized person
What if you would like to get a VA license after having had an inactive license for more than five years?
You need proof of practice in another state or 160 hours as a VA intern in the previous 6 months, and you must retake the VA law exam.
What if you would like to get a VA license after having had an inactive license for more than five years?
You need proof of practice in another state or 160 hours as a VA intern in the previous 6 months, submit 60 hours completed CE, and you must retake the VA law exam.
How to verify a bonafide prescriber pt relationship
You see a questionable RX and the pharmacist must call prescriber or his agent and verify -Pt name -Drug name -# -Drug prescribed
Who maintain the records of your CE?
You, not your employer
can a VA pharmacy fill Rxs written by out of state practitioners?
except for written by NP, PA, or OD if they dont have a license in VA
AAC
actual acquisition cost -typically less than AWP
what is the SIG for Narcan nasal spray 4 mg?
administer a single spray intranasally into 1 nostril. administer additional doses using new nasal spray with each dose, if pt does not respond or responds then relapses into respiratory depression. Call 911. Additional doses may be given every 2-3 min until emergency medical assistance arrives
WHat if a patient requests for non-special packaging?
all of his rx will be complied (pt must sign a release form
THC-A oil and cannabidiol oil indication
alleviate sx of a patient's intractable epilepsy (must be a written certification that expires no more than 1 year from written date)
Electronic prescription record keeping
allowed for schedule VI if it was entered through automation and easily retrievable within 48 hours (this can be printout or on a monitor) Controls are up to the federal gvt
Electronic records of receiving drugs
allowed for schedule VI must be accessible
WHat does the DEA need to show a judge to receive an administrative warrant?
an administrative probable cause
What is a prescription under VA law?
an order for drugs or medical supplies given to a pharmacist by a practioner authorized to prescribe
How often does a manufacturer need to re-register with the DEA?
annually
How often does a pharmacy permit have to be renewed?
annually
how often does a pharmacy permit have to be renewed?
annually
WHo is allowed to purchase c6 drugs and devices from a manufacturer or wholesalers?
anybody who is authorized to admonister, prescribe, or dispnese the drug/device
how does a prescriber apply for authorization to issue electronic Rxs for CII-V drugs?
applies to federally approved credential service provider (CSP) or certification authority (CA) to obtain a 2-factor authentication credential or a digital certificate
t/f? register with the DEA before obtaining a state license
false, other way around
Hos long does the pharmacy have to keep the ID records of the person who picking up c2?
at least 1 month
Explain the requirements for DEA registration modification and transfer (2 CFR 1301.51, 21 CFR 1301.52)
at least 14 days in advance the following information: Name address, DEA#, of transferor. Name address DEA # of transferred, location change or continuation? date on which transfer will occur. Change or address/modifications: in same manner as applications. request online or in writing.
how deos a 24 hours store conduct an inventory?
based on the receipt or distribution of the drugs (before or after the inventory)
how long do pharmacies need to keep the transferred Rx records?
both original and transferred Rx must be maintained for 2 years from date of last refill
how soon does copy 2 of the dea222 go to the dea?
by the close of the month inwhich the order was filled, or within 60 days vailidity of the order was filled partially
COntrolled substances under federal law
c1 to c5
controlled substances under VA law
c1-c5 and other drugs that require prescription c6
What schedules of drugs can be transmitted electronically?
c2-6
what's the penalty under VA law for any person who willfully violates the SLCP provisions?
can be found guilty of Class I misdemeanor
Inventory of C-III through VI
can do controls (3-5) separate from from 6 or together but should not be maintained with other pharmacy records
if a supplier is unable to fill all or part of an order, what can the supplier do with the dea 222?
can partially fill and provide the balance in additional shipment during the 60 days vailidity of the dea 222
What CV can be dispensed without a RX
cannot provide more than 48 hours -200 mg opium -270 mg codeine -130 mg dihydrocodeinone -65 mg ethylmorphine -Max 32 5/10 mg diphenoxylate
CDER
center for drug evaluation and research
If the pharmacist violates the laws that control the storage, distribution or recordkeeping of controlled paraphernalia, what are the possible legal consequences?
class 1 misdemeanor
What is the penalty under VA law for any person who wilfully violates the slpc provision?
class 1 msdemeanor
how can a DEA registrant authorize their agent(s) to order CII drugs, complete DEA 222 forms, and renew their DEA registration?
completing a Power of Attorney
CAM
complimentary and alternative medicine
what is a safety closure container?
container that meets requirements of Federal Poison Prevention Packaging Act of 1970: -85% of 200 children age 41-52 months can't open package in 5 min -after a demonstration of how to open it, and 5 more min, 80% children *still* can't open -90% of adults *can* open and close it
is pt ID required in VA in order to dispense all drugs or controlled substances only in the community pharmacy setting?
controlled substances only
How do you inventory c2?
count
what is required when a pharmacist delivers a CII drug by mail, common carrier, or delivery service to a VA address?
delivery method must require signature of recipient as confirmation of receipt
Destruction of partially used CS from EMS kits
destroyed by 2 people, one has to be EMS provider the other can be another EMS provider, nurse, prescriber, tech, pharmacist
DRG
diagnosis related groups classification system for hospitalized patients based on the principal diagnosis
What is the Durham-Humphrey Amendment?
differentiated prescription drugs from nonprescription drugs
What conditions are TPA certified optometrists allowed to treat?
diseases of the eyes and itsadnexa (tissues adjoining the eye)
DME
durable medical equipment -Stand repeated use -Primarily serves a medical purpose -It ca be used in the home (ie wheelchairs, O2 tanks)
What does the DEA need to inspect a pharmacy?
either a adminitration warrant or a pharmacy's written consent
EAC
estimated acquisition cost
How often does a manufacturer being inspceted by FDA
every 2 years
How often does a pharmacy renew its DEA 224?
every 3 years
after the initial DEA registration is renewed, how often does a pharmacy need to renew its registration with DEA?
every 3 years
what are the recordkeeping requirements when dispensing partial fills for CIIs for terminally ill or LTCF pts?
every time, must record on back of Rx: -date of dispensing -quantity dispensed -remaining quantity authorized to be dispensed -pharmacist's identity
how often are manufacturer/distributors being inspected by DEA?
every year
how often does a manufacturer need to re-register with the DEA?
every year
Which practitioners have unrestricted prescribing authorities without the need for an aggreement with other practioners in writing c2-6?
except for NP, PA and OD
Forgery
falsely created, signed or altered
what if an agent takes the original record?
he must leave a receipt and a copy of the record within a reasonable time frame
does the date of initial registration of a tech change the expiration date for the 1st year?
if newly registered on July 1st or later, doesn't need to renew until Dec. 31st the following year (same as pharmacy but different cutoff date)
When can a tech at a nuclear pharmacy accept oral Rx?
if rx is for diagnostic non-patient specific radiopharmaceuticals
under what circumstances does the PIC need to turn in the pharmacy permit and make a new application?
if there are any changes in ownership, such as a change in partnership composition or acquisition
what happens if an applicant fails the NAPLEX multiple times?
if you fail 3 times, you have to get an additional 1,000 hrs of practical experience before allowed to retake exam
what are the enrollment conditions for the VA pharmacist recovery program?
impacted by drug/alcohol addiction pharmacist can enroll themselves
what do you have to do when you give an emergency supply in VA?
inform pt, inform MD, document date/quantity/MD unavailability/reason for refill on back of Rx
after an order has been prepared in the hospital, what is a pharmacist required to do before the order can be delivered to the pt?
inspect the order, verify its accuracy in all respects, and *initial the dispensing record* to certify accuracy of the Rx
what does a new PIC have to do when taking over responsibility for a pharmacy?
inventory all Schedule I, II, III, IV, and V drugs on the day they become PIC *before* pharmacy opens for business that day
Where are expired meds stored?
kept in prescription dept separated from other drugs
Temp for storing drugs: Cold
less than or equal to 8 C -A fridge is cold (2-8 C) -A freezer is cold (-20 to -10 C)
what is the next step in the process of getting a pharmacy permit after the application has been submitted?
location of new pharmacy must be inspected by an agent of BOP before permit can be issued
What are the potential consequences for a pharmacist who knowingly fill an invalid prescription?
may be criminally prosecuted for drug distribution
Schedule II Drugs
meperidine (Demerol) morphine sulfate (MS Contin, Roxanol) oxycodone (Percodan, Percocet, Tylox, OxyContin) hydromorphone (Dilaudid) methadone (Dolophine) codeine - as single drug entity fentanyl (Sublimaze) alfentanyl (Alfenta) sufentanil (Sufenta) Opium Cocaine methylphenidate (Ritalin) amphetamine (Biphetamine) dextroamphetamine (Dexedrine) phenmetrazine methamphetamine (Desoxyn) pentobarbital (Nembutal), secobarbital (Seconal), amobarbital (Amytal) - Suppositories of these 3 are CIII hydrocodone (Tussionex, Vicodin, Lorcet Plus, Lortab, Hycodan, Zydone, Anexsia)
what are the schedule listed chemical products SLCP
metamphetamines precursors (ephedrine and pseudoephedrine)
Unit dose system
multiple drugs in unit dose packaging are dispensed in a single container, such as a medication drawer or bin labeled only with pt name and location
may pharmacists in VA prescribe naloxone?
must be in accordance with a protocol
Control inventory
must be kept at the same address as the stock drugs unless authorized by the dea, but must be accessible within 48 hours of a request by the board
CI and CII inventory
must be maintained seperately from other inventories
CII inventory
must be perpetual with a monthly reconciliation
what do you do if you move and have a new address?
must inform BOP of current address within 14 days, in writing or electronically via the BOP's online web based application
when a pharmacy is changing ownership, does the BOP need to be notified?
must notify BOP 14 days prior to change in ownership and transfer the preceding 2 yrs Rx and dispensing records AND PIC will need to get new permit
how is the labeling of each vial/syringe of naloxone different than other Rxs?
name of patient does not have to appear on label
Can the pahramcy store executed dea 222 form, inventories and prescription for c2-5 offiste?
no
are criminal history record checks required for initial licensure as a pharmacist?
no
does VA have additional requirements for compounding that go beyond federal requirements?
no
what are the recordkeeping requirements when a tech enters the pharmacy in an emergency situation without the pharmacist presence?
page 74
in VA is drug product selection permissive or mandatory?
permissive
what happens if a pharmacist is unable to supply the remainder of a partially filled CII Rx in the 72 hr time frame?
pharmacist cannot dispense the remainder and must notify the prescriber that the pt only received the quantity of the partial dispensing. Patient will need new Rx to receive additional medication
WHo is allowed to have the keys and alarm code to the pharmacyy
pharmacist on duty
who may have the code to access the alarm system of the pharmacy?
pharmacist on duty
who may have the code to access the alarm system of the pharmacy?
pharmacists working at the pharmacy who have been authorized by the PIC to have the code
who can enroll in VA's pharmacist recovery program?
pharmacists, students, techs
WWHat if the pahrmacy is returning drugs to a distributors?
pharmacy will let the distributor know that c2 is being returned. Distributor will fill out its dea 222 and send it to the pahrmacy
WHo is allowed to call in an oral prescription?
prescriber or his authorized agent
what if a 222 form lost in the mail?
purchaser executes ANOTHER form, attaches a statment with the serial number and date of the lost form, and statment that the drugs were not received -the purchaser then keep copy 3 of the lost form, copy 3 of the new form, and copy of the statment
Explain the requirements for obtaining, recording, and maintaining patient information
reasonable efforts shall be made to obtain, record and maintain pt information. - name, address, ph number, DOB, age, Gender - Allergies, drug reactions, - Additional comments relevant to drug use, including any failure to accept the rph's offer to counsel.
does VA permit the return and reuse of medications?
refer to 54.1-3411.1
does VA license or register technicians?
register
what will the supplier do if it refuese to fill a dea 222 order?
return both copies 1 and 2 to the purchser with the reason for refusal
What does VA law require a pharmacist to do when presented with a questionable rx?
rph must contact the prescriber or his agent and verify: 1. patient's identity 2. name of medication prescribed 3. quantity of med prescribed
Are there any additional documentation requirements that aply when a pharmacist partially fills a c2 for lack of drug?
rph must record on the back of rx the amount partially dispensed and date
where are the executed dea 222 copies 3 kept?
separately from c3-6
what is the SIG for intranasal naloxone 2 mg/2 mL prefilled syringe?
spray 1/2 of the syringe into each nostril upon signs of opioid overdose. Call 911. Additional doses may be given every 2-3 min until emergency medical assistance arrives
THC-A oil
the A is for acid so it contains at least 15% THC acid but not more than 5% THC OR a dilution of the resin of cannabis plant that contains 50 mg THC-A per mL but not more than 5% THC
who obtains a permit from the BOP to operate a pharmacy in VA?
the PIC, the permit will not be issued to a business entity
Where can a pharmacist find more info regarding the Poison PRevention Packaging Act?
the U.S Consumer Product Safety Commissions' website
must pt counseling be performed personally, face-to-face, by the pharmacist in VA?
yes, face-to-face if Rx is delivered to the pt within the pharmacy. otherwise, by telephone or in writing via a sign posted at pharmacy or a notation on the bag
can a prescriber give an oral Rx to his agent to be faxed?
yes, faxed Rx must contain agent's full name and language that indicates it is an oral Rx. If Rx is oral, prescriber's signature does not have to be on Rx
are oral orders for CIIs allowed in a hospital?
yes, hospital pharmacist or nurse can take oral order for CII. Has to be immediately reduced to writing and signed by prescriber within *72 hrs*
Are pharmacies required to obtain a DEA registration?
yes, if it possesses c1-5. Does not need if only possesses c6
does VA license/register manufacturers separately from wholesalers?
yes, if located in the state
may pharmacists in VA practice MTM outside of a pharmacy setting?
yes, if the service is not a required function for dispensing of the drug (i.e., an element of remote processing, a limited-use pharmacy permit may be issued to an entity whose primary business model is providing MTM)
are any devices included in Schedule VI?
yes, if they are considered safe for use only under the supervision of a licensed practitioner (like an insulin pump)
is Rx order valid for a non-controlled substance legend drug from an out-of-state prescriber? controlled substance?
yes, ismust meet same requirements are in-state Rx
can a pharmacist be the PIC for more than 1 pharmacy?
yes, max of 2
are there any special requirements for a Rx that is written for gamma-hydroxybutyric acid (rohypnol)?
yes, medical need must be written on Rx
If a pharmacist is unavalable in an emergency situation, can a technician go into the prescription department to get a rx that already filled and checked?
yes, must be accompanied by pharmacy management or administration
do Rxs need to be dated?
yes, must be dated on date it is signed by prescriber. postdating of Rxs is not allowed and is illegal
are faxed Rxs required to have any additional info on them?
yes, must have: -date of fax -printed name, address, phone#, and fax # of prescriber -if faxed from institution, name, address, phone#, and fax # of institution
when a pharmacist receives an oral Rx, are they required to place any additional info on the Rx?
yes, must reduce Rx to writing and include *first and last name of person calling in Rx* and *notation that Rx was an oral order*, and must write (not sign) prescriber's name on Rx as well
if a pharmacist receives an oral Rx but doesn't have the med, can they phone the Rx in to another pharmacy of the pt's choice?
yes, pharmacist is licensed to dispense drugs and was specifically directed by the prescriber to have the medication dispensed to the pt
when a pharmacy is closing, does the BOP need to be notified?
yes, pharmacy must report how it intends to dispose of all CII-VI drugs, Rx dispensing and pt records, including name and address of any licensee who will receive the drugs and records, and the date of transfer
does VA have mandatory PMP reviewing requirements?
yes, prescriber required to check PMP for new Rxs written for BZDs and opiates anticipated to last more than 90 consecutive days
does VA allow use of preprinted Rx forms for non-controlled substance Rxs?
yes, prescriber's signature may not be preprinted
if a Rx is delivered to a pt when pharmacist is not present, are there any additional record keeping requirements?
yes, pt name, Rx #, date of delivery, signature of person receiving Rx *keep for 1 yr*
does BOP have regulations aimed at relieving pharmacist workload?
yes, regulations to address max hours worked and meal breaks are pending (LOOK THIS UP)
are there exceptions to the special packaging requirements?
yes, sublingual nitroglycerin, medrol dose packs, and non-oral dosage forms not required to be in special packaging
Is a registrant allowed to delegate the ordering of DEA 222 and c2 drugs to other person?
yes, the registrant can give power of attorney to other agents. -the power of attorney can be revoked at any time -the POA must be retained in the files with the executed dea222 forms
does VA have technician training requirements?
yes, to be eligible for registration they must either hold current PCTB certification or must have passed a training program and exam approved by BOP
may techs in the hospital or community setting compound medications for dispensing?
yes, under the direct supervision of a licensed pharmacist who must verify, check, and/or is responsible for allowed activities
Does the tech need permission to enter the rx department in the absence of a pharmacist?
yes, verbal permission of the pic or staff pharmacist
can a medical intern/resident use their ID # to write for CII-CVI controlled substances?
yes, when it is in furtherance of the person's duties at the hospital
does a tech who only works in a free clinic have to be registered?
yes. BOP can issue a limited-use registration (free clinic only). BOP will waive initial registration fee and 1st exam fee. If tech wants to switch to unlimited registration later, just have to pay current renewal fee.
what happens if you don't renew your license before Dec. 31st but still want to?
you can still renew license within 1 year of expiration: -submit completed renewal form -pay annual renewal fee ($90) -submit statement of compliance with CE -pay late fee
what happens if you wait more than a year to renew your license?
your license is "inactive" and you will have to apply for reinstatement of license: -submit application for reinstatement -pay renewal fee -pay late fee -submit documentation of completion of CE (for as many years as license inactive: 3 yrs inactive = 45 CE hours) - 60 hrs max
DEA numbers
• 1st letter = A or B for physician, M for mid level practioner • 2nd letter = 1st letter of practioner's last name • Numbers o Add together the first, third and fifth digits o Add together the second, fourth and sixth digits and multiply the sum by 2 o Add the above 2 numbers o The last digit (the ones value) of this last sum is used as the seventh digit in the DEA number • Example o MJ3614511 3+1+5=9 6+4+1=11x2=22 9+22=31
DEA Forms
• 222 - to order CII's - 222a: to order more 222 forms • 224 - to register with the DEA - 224a registration renewal • 106 - to report theft or loss to the DEA • 41 - to report drugs surrendered for disposal
DEA Forms
• 222 - to order CII's • 224 - to register with the DEA - check box to get 222 forms with registration • 106 - to report theft or loss to the DEA • 41 - to report drugs surrendered for disposal
Brief Summary of Adulteration and Misbranding
• Adulteration o Putrid o Unsanitary o Current good manufacturing process (cGMP) not used o Poisonous o Unsafe color added o Unsafe animal feed or drug o Decreased strength or purity from what on label o Strength differs from what on label o Mixed / packed / substituted with any other substance • Misbranding o False label o Misleading label o Label without name and place of manufacture o Label without weight, measure, or numerical count of contents o Not packaged or labeled in conformity with official compendium o Habit forming label not present if necessary o Name of each active ingredient not listed o Warnings and directions for use not present o Directions on label are not correct and would cause danger if followed o Insulin or antibiotic without batch o Color added for color only o Established name not ½ the size of trade name o Main side effects must be listed o Trademark present that should not be in attempt to defraud patient o Drug released in imitation of another drug o Drug deterioration occurred because not properly packaged o Non-child resistant-container when child-resistant-container is necessary o If name of patient, name of practitioner, name of pharmacist, date, RX number, and directions are not on the RX label o Oral contraceptive, estrogen or progesterone containing product, or IUD dispensed without the package insert. o Prescription filled by a pharmacist without a valid prescription or refill o OTC drug not in a tamper resistant container o Ophthalmic preparation that is not sterile o OTC drug not labeled properly
7 days
• For the operational medical director to sign EMT's drug administration log if the patients physician refuses to, or if patient does not go to the hospital • If an emergency occurs and a schedule II prescription is called in to your pharmacy you have 7 days to get a valid written prescription that is signed by the physician.
7 days
• For the operational medical director to sign EMT's drug administration log if the patients physician refuses to, or if patient does not go to the hospital • If an emergency occurs and a schedule II prescription is called in to your pharmacy you have 7 days to get a valid written prescription that is signed by the physician. - Report dispensing of drug covered by PMP
Temperatures Ranges Specified by the Board
• Freezer: -4°-14° F (-20°C- -10°C) • Fridge: 36°-46°F (2°-8°C) • "Cold" Place: not > 46° F (8°C) • "Cool" Place: 46°-59° F (8°-15°C) • Controlled Room Temperature: 68°-77° F (20°-25°C) • "Warm" Place: 86°-104° F (30°-40°C) • "Excessive Heat": any temperature above 104°F (40°C)
Temperatures
• Freezer: -4°-14° F (-20°C- -10°C) • Fridge: 36°-46°F (2°-8°C) • "Cold" Place: not > 46° F (8°C) • "Cool" Place: 46°-59° F (8°-15°C) • Controlled Room Temperature: 68°-77° F (20°-25°C) • "Warm" Place: 86°-104° F (30°-40°C) • "Excessive Heat": any temperature above 104°F (40°C)
2 years
• IMPORTANT RECORDS TO BE KEPT IN EVERY PHARMACY o 222 forms o Power of attorney signature authorization forms o Receipts and invoices (invoices may be kept off site) o Inventory records o Original prescriptions that were distributed or dispensed o Theft / loss reports (106) o Disposal records (41) o Record of transfer of drugs between pharmacies o DEA registration certificate • Record of all drugs dispensed in the ER • Record of drugs administered from drug kit by an EMT • Signed waiver that "special packaging" is not necessary for that particular patient's prescription must be kept for 2 years. • Audits conducted of automated drug dispensing systems should be kept on hand for 2 years • Keep MAR's used to document use of floor stock drugs in the hospital for 2 years • Bound record of CV prescriptions sold without a RX (e.g. codeine cough syrup) - remember no more than 120 ml or 24 dosage units in 48 hours without a prescription • Compounding records - need to be kept x2yrs and retrievable within 72 hours • Record of drugs administered from "unit dose systems" - dispensing record, patient profile or medication card all count as a valid record of administration • Delivery receipt of drugs given for floor stock and fill of "automated dispensing systems." Must be signed by nurse receiving them (CII-V)
15 days
• If pharmacy no longer holds a permit, the director shall notify owner, who then has 15 days for proper disposition of all schedule II-schedule VI drugs • PIC absent for unplanned 15 consecutive days with no known return date, within the next 15 days the owner must notify the board and obtain another PIC
5 % rule
• It is beyond the scope of pharmacy practice to: o Repackage o Compound o Transfer More than 5% of your total number of prescriptions filled. • If you do you will be required to register as a manufacturer or distributer
Exceptions to Remember
• Long term care facilities and patients with terminal illness can have unlimited partial CII orders filled (valid for only 60 days) • Long term care facilities and hospitals do not require the pharmacist to offer counseling with every new prescription • Long term care facilities and home infusion can have CII orders faxed with no signature. Hospice can have CII orders faxed too, but must have signature. • Long term care facilities, the indigent, hospitals, narcotic treatment programs, hospice, and vets are exempt from reporting to the Prescription Monitoring Program
Parenterals
• Non-preserved o Room temperature - stable 28 hours o Refrigerated - stable 7 days o Frozen - stable 30 days • Preserved - stable maximum of 30 days
48 hours
• Pharmacist must be able to provide a print-out within 48 hours of request (by patient, Board of Pharmacy, etc.) • To change alarm access code after a pharmacy technician retrieves a prescription when no pharmacist is present
48 hours
• Pharmacist must be able to provide a print-out within 48 hours of request (by patient, Board of Pharmacy, etc.) • To change alarm access code after a pharmacy technician retrieves a prescription when no pharmacist is present Must retrieve and make available for inspection when records offsite
1 year
• Renew your pharmacy license • Do 15 CE's for pharmacists • Do 5 CE's for pharmacy technicians • Keep control records of bulk reconstitutions of injectables, bulk compounding, or repackaging for 1 year OR until the product expires - whichever is GREATER. • Keep entry log of when pharmacy technician entered the pharmacy without the pharmacy present. On the premises • Keep list of all prescriptions given to patients when pharmacist is not on duty. • Keep entry log of a nurses entry to the pharmacy to get drugs for emergency when no pharmacist is present (hospital). • Keep a log of emergency drug kits, their numbers, and when they were exchanged. • Keep the Medication Administration Record (MAR) from the correctional facility. • Drug cart filling records (who filled them, pharmacist who checked them, who accepted them) need to be kept on hand for 1 year
30 days
• To do inventory and give the Board of Pharmacy a list of all schedule I-V drugs stolen or lost • For a LTCF to return or appropriately destroy discontinued drugs • For a correctional facility to return any unused or discontinued drugs • PIC should perform monthly checks on compliance with policy and procedure manual and storage of CVI substances that are able to be stored offsite of the pharmacy • Monthly drug reviews must be conducted by a pharmacist for patients in LTCF • Monthly audits of automated drug dispensing systems by pharmacy personnel
72 hours
• To install a security system if the pharmacy changes hours and is no longer a 24 hour pharmacy law changed. Its now has to be installed prior to closing • For an opened emergency kit to be returned to the pharmacy for replenishing • For any drug used in an emergency kit or stat drug box to be covered by a valid prescription • Control drug print-out must be verified, dated, and signed by the pharmacist that filled the control drugs within 72 hours of their fill (II-V) • Verbal order for a schedule II drug to be administered in a hospital must be reduced to writing and signed by the physician • If a schedule II prescription is partially filled the rest of it must be picked up within 72 hours (exceptions patients with terminal illnesses and in LTCF) • PIC has 72 hours to correct a "discrepancy" in an automated drug dispensing system
14 days
• You must write a letter to the DEA if you want to keep any financial or shipping records offsite. If you have not received a response in 14 days than you can make the move. • You must make a list and write a letter regarding the destruction of drugs. You must send this letter 14 days prior to date of planned destruction (UNLESS a law enforcement agent is going to be present - then you just tell them afterwards) • You must give the Board of Pharmacy a 14 day notice if your pharmacy is going out of business. You must tell them what will be done with all schedule drugs, records, etc... • When PIC resigns, you have 14 days to notify board and obtain new PIC. Unlawful for pharmacy to practice for more than 14 days without PIC if they have resigned with no return date for sure. • If a pharmacy is going out of business they must mail a letter at least 14 days before closing to all patients with prescription records with active refills on file or post a sign 30 days prior to
