Texas MPJE 2022
What must pharmacies provide patients under HIPAA for Notice and Acknowledgement?
"Notice of Privacy Practices" and make good faith to obtain a written acknowledgement of receipt Must be provided upon first service Requires mandatory provisions in the Notice
Requirements for Inventory in a pharmacy
- PIC is in charge in taking inventory (or sign off on someone taking it) - be available for inspection for 2 years - include "on hand" stocks of controlled substance (including expired) -
who can prescribe controlled substances in Texas?
- Physicians (MD or DO) - Dentists -Podiatrists -Veterinarians - Optometric Glaucoma Specialists (very limited formulary) - Advanced Practice Registered Nurses or PAs practicing in Texas.
Federal Hazard Communication Standard
- Requires employers (including) pharmacies that deal with hazardous materials to meet the Hazard communication standard (OSHA) -Manufacturers and importers to provide labels and Safety Data Sheets (SDS)/Material Safety Data Sheets (MSDS) - Hazardous drug from USP 800 products not in solid/final dosage form may be covered --> to have a written Hazard Communication Plan - the plan must include list of hazardous chemicals in the workplace and contain SDS and include trainng for all workers, appropriate measures, and where and how to obtain additional information.
If counseling is needed for a new RX when pharmacist is temporarily absent?
- counseling provided by giving WRITTEN information about the drug and a notice that the patient can call the pharmacist if the patient has any questions
Kefauver-Harris Amendment of 1962
-New drugs proven safe and effective -increase safety requirements and Good Manufacturing Practices
Formularies in Class D pharmacies
-antiinfective drugs -MSK drugs -vitamins -obstretrical and gynecological drugs -topical -serums, toxoids, and vaccines
503A: states not in MOU
-pharmacy cannot distribute out of the state in which they are compounded in quantities that exceed 5% of the total prescription orders dispensed/distributed by such pharmacy
what must the National Drug Code (NDC #) contain?
1) 10 unique characters - first 4/5 digits = labeler code - next 3/4 digits = specific drug/strength, and dosage form - last 1/2 digits = package size
what must NSAIDs contain?
1) NSAID on it 2) "stomach bleeding"
What must the manufacturer have on the label for an animal RX drug product?
"Caution: federal law restricts this drug to use by or on the order of a licensed veterinarian"
amount of beds in hospital to have on-site supervision continuously
101 beds or more
how many member's of TSBP are there?
11-members: 7 pharmacists 1 technicians 3 public members
How many days to give pt a copy of the PHI?
15 days for Texas 30 days for federal
how far must the remote dispensing site be from the onsite pharmacy?
22 miles or more cannot dispense CII drugs
how long to keep CE records for?
3 years
how many days can a PCP not part of narcotic tx program dispens narcotic drugs for?
3-days until pt can be enrolled in a narcotic treatment proram
what strength of methadone is voluntarily restricted to retail pharamcies but allowed in hospitals or narcotic tx clinics?
40 mg
limited % of interstate distribution of compounded drugs in Section 503A pharmacy
5%
Loperamide for child-resistant cap?
>0.045 mg in a single package
Class A B C D E
A: community B: nulcear C: institutional D: clinic E: nonresident [A, C, E can compound sterile products]
who else needs to be registered under DEA?
CI-CV : - manufacturing - distirbuting - dispensing (PCP and pharmacies) -conducting research - conducting narcotic TX program - conducting chemical analysis - importing -exporting
Narcotic Tx Center must be regiester by who?
DEA & center for Substance Abuse Treatment (CSAT) & Mental health Services Adminstration (SAMHSA) of HHS [U.S. health and human services] in TEXAS, these programs need a license issued by Texas Department of health and Human Servicess
Who must manufacturers/distributors register under when handling controlled substances?
DEA q3years for pharmacies/dispensers
Form to report Pseudophed lost/theft
Form 107 written report w/in 15 days and must include description of circumstances
FDA Purple Book official name
Lists of Licensed Biological Products with Reference Product Exclusivity and Biosimilarity or Interchangeability Evaluations
can tax-free alcohol be resold or used in beverage products?
NO
how many days to inform DEA about theft or lost of Controlled Substances
ONE day (TSBP requires notification to the board of a theft or significant loss immediately upon discovery)
What is the designated Privacy Official do?
Responsible for development and implementation of HIPAA-related policies and procedures and compliance - may receive complaints
which schedules is allowed to implement automatic refills?
Schedule IV & V not Schedule III
what is the only FDA designated produce as interchangeable?
Semglee and Lantus (insulin glargine)
Dispensing Records of Controlled Substances (pts receiving controls)
Storage Requirements for hard copies (TSBP require a 3-file storage system) i. File 1: Schedule II ii. File 2: Schedule III-V iii. File 3 - nonscheduled (dangerous drgus and OTC rx)
TSBP allows faxed RX to serve as the original but does TCSA?
TSBP does but not TCSA so we are stil able to, as long it contains the Texas Official RX Form
inventories for Scheduled drugs
TSBP: annualy + signature by PIC and notarized w/in 3 days inventory is taken TCSA/FCSA: q2years
what other drug is in the REMS program?
Thalomid (thalidomide) - immunomodulator
Who is responsible for alcohol regulations for tax-free alcohol?
The Alcohol and Tobacco Tax and Trade Bureau (TTB) with the Federal Bureau of Alcohol, Tobaccos, Firearms, and Explosives (ATF) (ATF responsible for enforcements)
what do most chain pharmacies have for naloxone?
a standing order that covers allk pharmacies in Texas [pharmacies to be able to have in hand]
Prohibited Acts under FDCA
adulteration misbranding both applied to pharmacies: dispensing RX w/o authorization causes drug to be misbranded even if it is labeled correctly by the pharmacist
how to change Robitussin AC and Cheracol from schedule V to schedule III?
by even adding 1 mg of codeine to these products
what should provider pharmacy be concerned about dispensing controlled substances at automated dispensing and delivery systems?
cautious about provided controls b/c a location that is not regiestered with DEA or should seek confirmation from DEA that this is allowed (just not with TSBP)
What are Listed chemicals?
chemical used in manufacturing a controlled substance OTC products containing ephdrine, pseudoephedrine or phnylpropanolamine
What class of pharmacy must be required to stored Schedule II substances in locked storages?
class C (institutional, hospital, ambulatory)
RX for <2 yos by PAs/APRN?
consultation must be noted in patient's chart with delegating physician
example of medical devices that require RX
contact lens, inhaler spacers, pen needles, etc
what must Sulfites contain?
contain allergy warning in "warnings" section due to them containing preservatives
which OTC products are exempt from tamper-evident packaging?
dermatological, dentifrice, insulin, or lozenge products
When can a RX be delivered to the office?
for a dangerous drug or single dose of a controlled substance for adminsitration to the pt in office
What is not a valid RX to be filled?
from a PA or APRN prescribing a controlled III - V substance that is from OUT-OF-STATE & mexican/canadaian practioners
examples of Schedule I Drugs
heroin, marijuana, LSD (lysergic acid diethylamide) peyote and mescaline methaqualone (depressant)
what is needed for controlled RX in texas?
i. #20 & twenty to be written out ii. intended use (all RX but PCP can opt out)
What must Class A pharmacy contain in the library?
i. Laws and Rules from TPA, Texas Danger drug act, Texas Controlled Substances Act, Federal Controlled Substances Act ii. least 1 general drug information reference, including DDI iii. refernce on veterinary drugs iv. antidote info and phone number of the nearest regional poison control center
Summary for methamphetamine controls for SUDAFED
i. display restriction in locked cabinet w/in 30 ft ii. age 16 for texas (no age limit federally) iii. logging system real-time electronically
Rural Hospitals (75 beds or population <50,000)
i. if no RPh on hand, nurse/PCP can withdraw medication from pharmacy in sufficient quantities ii. RPh must verify withdrawal w/ Drug regimen review no later than 7 days
Multiple RX for Schedule II drugs
i. limits PCP to issue multiple Schedule II RX on same day (no more than 90 day supply of scheudle II controlled substance) ii. earliest fill date must be on
what must be transmitted to TSBP within that business day?
i. official RX control number ii. prescriber's DEA registration number iii. pt's name, age/DOB, and address iv. date RX was issued and filled v. NDC number of controlled substanced dispense vi. quantity controlled substance dispensed vii. pharmacy's RX number viii. pharmacy's DEA registration number
which products can be dispensed fully of entire units for emergency supply?
i. oral contraceptives, inhalers, and ophthalmic solutions
when can permissive substitution occur? (dispense a generically equivalent drug)
i. product costs less ii. pt does not refuse the substitution iii. PCP not prohibiting substitution
What are some additional requirments on labeling for a compounded product?
name(s) of principal active ingredient(s) of the compounded prepartion and Statement that the preparation has been compounded by the pharmacy
what must the RX from PA/APRN contain?
name, address, telephone, and identifying number of supervising physician and APRN/PA as well; both DEA#s [LABEL: only needs to contain PA/APRN name]
are the RX for office-use
no such thing
is there a grace period to renew your license?
no, if you do not renew on time, then you cannot legally practice
Can techs recieve verbal RX?
only if it is for dangerous drugs
Exceptions for pharmacies to sell, purchase, trade, or possess drug samples:
owned by charitable organization by city, state, or country government --> providing to indigent or low-income patients at nor or reduced cost
patient cannot purchase a smaller quantity OTC produce unless what?
patient has a prescription for smaller quantity and OTC drug is filled as a RX - OTC labeling requirements do not have to be followed. - include PCP directions for use - instructions for refills would apply, as would beyond-use dates (valid for 1 year)
< 100 beds, pharmacy services continously or part time?
pharmacist at least part time or on a consulting basis, but pharmacist must be on-site at least once every 7 days
what warnings must be on Phenacetin(acetophenetidin)
possible kidney damage when taken in large amounts/long duration
Drug Recalls under TSBP rules:
requires PIC to have policies/proceures for handling RX drug recalls - ensuring a recalled drug has been removed from inventory w/in 24 hours of notice of recall
what is the DEA Rule 1302.27?
requires automated dispensing systems in LTCF to be registered with DEA
where can RX be delivered to?
residen of pt place of employment (if present to accept delivery) hospital/medical care facility the pt is receiving tx
tech duties w/ <100 beds
same w/ less work
what inventory substance must have an exact count?
schedule II by PIC [estimated count fo CIII-V if container has fewer than 1000 tablets/caps]
Where can drugs being collected by receptacles be destroyed?
sent to DEA regiestered reverse distributor or onsite if available (form 41)
how to counsel pt with new RX being delivered?
statement must be written "Written information about this RX has been provided for you. Please read this information before you take the medication. If you have any questions concerning this RX, a pharmacist is available during normal business hours to answer those questions at (xxx-xxx-xxxx)"
Purpose of TPA and TSBP:
to promote, preserve, and protect the public health,s afety, and welfare of Texans
when can any Original RX containing controll substance be transfer?
transfer to another pharmacy if both have the capability to forward and receive the EPCS using an electronic sharing program
what mustbe met for faxed RX of Shcedule III-V
under an emegency requirements under TCSA
Return of RX drugs under TSBP rules:
unlawful to accept RX drugs that have been dispensed for purposes of resale
how does FDA Orange book indicate equivalency?
using a 2-letter coding system: A & B
how many days to correct dispensing data to PMP when noticing an error, omission, or inaccuracy?
w/in 7 days
how many hrs to notify PCP if an emergency epinenphrine occurs?
w/in 72 hours and call 911 right away
What's a LOW risk level for sterile compounding?
w/in ISO Class 5 or better - ampules, bottles, and vials using sterile syringes; needles - stored 48 hours at room temp or 14 days if refridgerated or 45 days frozen
Transfers of CONTROLLED rx are only allowed to occur once, except:
when they share an electronic, real-time database
when is a valid patient-prescriber relationship not required?
when treating STDs if the patient has an illness determined to be a pandemic by CDC or WHO in notherapeutic dispening in telemedicine
when to send controlled RX info to TSBP electronically?
withint the next business day; if partial, within the next business day once all filled
what can TSBP representative provide to pharmacy?
written warning notice listing specific violations & providing reasonablea mount of time to comply w/ laws and rules (reasonable time <10 days)
Can techs contact PCP for information regarding an existing RX?
yes
Do each pharmacy have different DEA registration?
yes
In class F, are you able to supply outpt drugs?
yes, in a prepackaged quantities no to exceed 72-hour supply
automated Medication Supply System
"Pyxis" i. tested and verfied for accuracy ii. operate according to quality assurance program --> monitor/tests for accuracy every 6months/upgrade/change made iii. restocked by tech after RPh verfies iv. written plan for recovery from disaster/situation disrupting automated systems
OTC Nonoxynol 9 contraceptives warning?
"STDs does not protect against HIV/AIDS and may increase the risk of getting HIV from an infected partner"
what do Optometric Gluacoma Specialist license contain?
"TG" at the end
What must the qualified practitioner have on DEA registered number to prescribe Subutex/suboxone?
"X" code - RPh verify w/ DATA waiver at the SAMHSA websties Buprenorphine Pharmacy lookup
What must be in BOXED RED LETTERING for Ipecac Syrup?
"for emergency use to cause vomiting in poisoning. Before using, call physician, the poison prevention center, or hospital ER immediately for advice" + "warning: keep out of reach of children. Do not use in unconscious persons" + dosage of medication must APPEAR --> 1 tablespoon (15 mL) in over 1 year of age.
what is ephedrine, pseudophed and phenylpropanolamine in?
"listed chemical products" [Combat methamphetamin epidemic Act applies only to pseduophed since the other 2 have been removed from market]
what warnings do sore throat must contain?
"temporary relief" & "warning-severe or persistent sore throat accompanied by high fever, HA, N/V may be serious. consult physician promptly. Do NOT use more than 2 days or administer to children under 3 years of age"
Poison Prevention Packaging Act of 1970 (PPPA)
- Administered by Consumer Product Safety Commission - Requires Child-resistance containers for all RX drugs
Misbranding:
- Labeling of a product that is false or misleading - manufacturer label must contain: i. name and address of manufacturer/distributer ii. brand and/or generic name iii. net quantity (weight, dosage units, quantity) iv. weight of active ingredient / dosage unit v. "Rx only" vi. specific ROA if not PO vii. storage instructions viii. lot number ix. expiration date x. package insert/medication guide or "black boxed warning" for opioids and BZDs - OTC drug fails to contain: i. identity ii. name and address of manufacturer iii. net quantity of contents iv. cautions/warnings to protect users v. adequate directions for safe and effective us vi. "drug Facts" including: -active ingredients -purpose -use(s)-indications -warnings -directions -other info -inactive ingredients (alphabetical order) - questions? (telephone number needed) - drug liable to deterioration unless labeled accordingly - container is misleading - drug is an exact imitation of another drug or under the name of another drug - dangerous to health when used in dosage or manner of SUGGESTED in labeling - packaged/labeled in violation of the Poison Prevention Packaging Act
what does FDA purple book contain
- Lists biological products with biosimilars and provides interchangeability evaluations for these products
some "Red Flags" for pharmacies RX
- PCP writing same RX for numerous pt (lack of individual drug therapy) - contain nonspecific or no diagnoses on RX - RX for highest strength or large quantities - different hand writing - PCP office not giving additional information - drug prescribed are inconsistant with the prescriber's area of practice - significant distance of the PCP's office - PCP subject to disciplinary action by licensing board - Texas PMP system indicates person are obtainng RX for the same drugs from multiple PCPs
Specific drugs exempted for child-resistant packaging
- PO contraceptimes - medroxyprogesterone - SL nitroglycerin (<10mg) - aspirin and apap in effervescent tablets/granules - Potassium supplements in unit-doses - sodium flouride <264 mg - Anhydrous cholestyramine and colestipol packets - erythromycin granuesl for PO suspension < 8 gram - erythromycin tablets <16 g packages - prednisone tabs < 105 mg per package - Methylprednisolone tabs < 84 mg per package - Mebendazole tabs < 600 mg per package - Betamethasone tabs < 12.6 mg per package - prep for aerosol containers intended for inhalation - pancrealipase preparation - sucrose preps - Hormone replacement
Formal Conference (Public Hearing)
- a hearing conducted in front of an Administrative Law Judge (ALJ) - ALJ issues findings of facts and conclusions of law and recommends sanctions to the Board in a Board Order (BO) - the board accepts, denies, or modified the board order - a board order can be appealed to a TX district court, but a motion for a rehearing must first be filed with TSBP
Electronic Ordering Through the Controlled Substance Ordering System (CSOS)
- allows electronic orders based on digital certificates issued by the DEA Certification Authority - certificate must never be used by anyone other than the individual subscriber (person, not location) to whom the certificate was issued - all CSOS applicants must be audited by an independent 3rd party prior to use
Some unfamiliar things that must be on RX label
- beyond use date (not greater than 1 year) -" Substituted for Brand Name" when generically sub occured (computer normally automatically does it) - "do not flush unused medication or pour down a sink or drain"
how to be an authorized nuclear pharmacist
- board of pharmaceutical specialties (BPS) certified Nuclearn Pharmacy or - complet 700 hrs of strucuted education program: 200hrs didactic trainng approved by TDSHS Radiation Control program; AND 500 hrs of supervised experiece
Automated Counting Devices in Class A
- calibrated - records of loading - RPh verify and sign that it is loaded prior to use
Whats the adminsitrative penalty for anyone in the pharmacy?
- cannot exceed $5k per violation but every day a violation occurs is a separate violation - civil penalties for license violations and unlawful practice can be as much as $1k a day
what authorithies does TSBP not have?
- cannot regulate wholesalers - cannot regulate pharmaceutical manufacturers' representatives
Acute pain does not include:
- chronic pain - pain being treated as part of cancer - paing being treated as part of hospice/end-of-life care - pain being treated as part of palliative care
Information about Med Pak
- customized patient med pack holding >2 medical, labeled w/ the day and/or time each drug is to be taken - RX # on it - Beyond-use-date not exceeding one year
Adulteration:
- drug is filty, putrid, or decomposed substance - drug prepared under unsanitary conditions (contaminated) - drug not performed under GMP - drug that has been processed, packed or held in any factory, warehouse/establishment has DENIED or LIMITS an inspection or REFUSES to permit entry of inspection. - drug has been placed in toxicated/poisonous/deleterious containers - drug containing unsafe color additive - when drug strength differs from or its quality or purity falls below the compendium standard (unless if differences is clearly stated on label) - if drug quality falls below what it represent (on label) - drug is mixed or packed w/ subsstance that reduces its strength or quality
What can techs do in rural areas w/o RPh on duty?
- enter medication orders and drug distribution info into computer system - prepare/package/label RX pursuant to medication orders if a licensed nurse/practioner/RPh verifies the accuracy by ELECTRONIC supervision before administration to pt - fill medication carts - distribute stock supplies to areas - acces/restock automated medication supply cabinets
Outsourcing Facilities/Section *503 B*
- have licensed pharmacist - FDA contains a list of each facility registered and it's location - they report to Secretary of HHS q6mos; including drugs sold in the previous 6 months - inspected by FDA to risk-based inspection and pay annual fees - report serious ADRs w/in 15 days and conduct a follow-up investigations - label products identifying as compounded drug and other specified info
INformal conference (non-public/voluntarily)
- licensee and attorney meet w/ TSBP panel (1 Board member, Executive director, and director of enforcement) - Board's attorny presents allegations from Preliminary Notice Letter and licensee must show compliance - resolve with Agreed Board Order (ABO) and licensee can accept or reject )rejected: formal discriplinary process)
Risk evaluation and Mitigation Strategies (REMS)
- managing known or potential serious risk -FDA requires REMS if found necessary to ensure benefits outweigh the risks of the product - REMS include meguide, PPI communication plan, elements to assure safe use, and an implementation system; and timetable
Animal Drugs@FDA
- need to be determined as safe and effective - FDA determines if an animal drug must be sold as RX or OTC drug
when a pharmacy runs on 1 pharmacist and is temporarily out:
- one technicians must be there (not trainee) - pharmacist must remain on premises - intern acts as a tech - pts can pick up RX that have already been filled/verified
Ordering of Schedule II Drugs
- only 1 item may be ordered on each number line - # of lines completed must be noted on the form - name & address of supplier from whom are being ordered must be entered - must be signed (or electronically) by registrant and by the person being authorized to execute DEA form 2222 - Registrant may authorize other individuals to execute forms by creating a Power of Attorney (POA) - incomplete, not legible, properly prepared, or signed, will not be accepted - forms that show alteration, erasure, or changes will not be accepted -stolen/lost form, purchaser must provide another DEA Form 222 + the serial number and date of the lost form (stating first order was not received) - supplier may prepare order from fax but not ship until original copy is received
Ordering Schedule III-V drugs
- ordered through normal ordering processes from a wholesaler/manufacturer (documented by pharmacy w/ invoice) - all invoices must be initialed by a receiving pharmacist in Texas
A collector pharmacy (that takes controlled substances to destroy) requirements?
- provide a mail-back program may only accept packages that he collector made available, collector notifies DEA w/in 3 business days of receipt
how to notify a pt on how to dispose their CII medication when the pharmacy isn't a collector?
- provide pt info on locations that accept CII substaces for safe disposal - alternatively provide internet website address specified by the TSBP to seach location that accept CII - can be give electronically if requested and document the request
When does an automatic denial or revocatin occurs?
- registered sex offender - treath of orce - offense committed while licensed
When are pharmacies exempted from notifying pts where to dispose their CII medication?
- registered w/ DEA as "authorized collector" - provide mail-in-pouch for surrendering unused controlls/chemicals to render any unused controlls
what pharmacist must do to register under iPLEDGE?
- select Responsible Site Pharmacist to obtain iPLEDGE program into and registration materials via (www.ipledgeprogram.com) to sign and return completed registration form
elements in REMS to assure safe use includes:
- special training/experience/certification of healthcare practitioners prescribing the drugs - special certification for pharmacies that dispense the drugs -dispensing drugs to patients only in certain settings (hospitals) -monitoring patients - ENROLLING each patient using the drug in a registry
Patient Package Inserts (PPIs)
- supplied by manufacturer and written for a layperson - required to be given to pts (community) if pt is new to RX or refills on certain RX -hospital/institutional: PPI provided to patient prior to first administration of drug and every 30 days thereafter
Automated Pharmacy Dispensing System
- test and found to be accurate - continuous monitoring and tests accuracy at least every 12 months - operate under witten policies and procedures -plans for recovery in disasters/interruptions
When can outsource facility compound drug produce that contains bulk drug substance?
- the bulk substance appears on a list identifying bulk drug substance which there is clinical need (503b BULKS LIST) or - drug product compounded from bulk substance appears on FDA's drug shortage at the time of compounding, distribution and dispensing.
when is child-resistant container NOT needed for APAP?
-Effervescent tablets or granules containing < 10% of APAP w/ median lethal dose > 5g/kg of body weight and release at least 85 mL of CO2 per grain of APAP when placed in water - < 13 grains/unit dose powder form
Durham-Humphrey Amendments of 1951
-Established RX and OTC -Authorized verbal RX and refills
How to "readily retrieve" controlled substacnes records
-asterisked -redlined -redialy identifiable
Prescription Drug Marketing Act of 1987 (PMDA)
-bans sale, trade, or purchase of RX samples -bans reimportation of RX drugs and insulin products -mandates storage, handling, and recordkeeping of drug samples -prohibits resale of RX purchased by hospitals or healthcare facilities
When can more interstate distribution of compounded drugs occur?
-compounder is located in a state that entered memorandum of understanding (MOU) w/ FDA addressing inordinate amounts of compounded drugs in interstate commerce and providing for appropriate investigation of complaints by state.
Mandatory counseling
-new drug: different strength, dose, dosage form, transferred in, or not dispensed within last 12 months. -BOTH verbal and written counseling required. -must place initials or ID of pharmacist providing counseling on the original rx or in the computer.
Drug Supply Chain Security Act (DSCSA) [track and trace]
-provides uniform national framework for electronic track and trace system for RX (to license drugs wholesaler distributors) -applies RX for human use in finished dosage form -Manufacturers provide "transaction data" for each product sold --> to distributor --> to buyer(pharmacies) --> to further distribution need transaction data -pharmacies may only receive drugs w/ product identifiers (SNI) --> contains national drug code + unique alphanumeric serial number; a lot number; an expiration date. -Pharmacies must investigate and properly handle suspect and illegitimate products - pharmacies that are "distributing" must have a wholesale distribution license and pass DSCSA transaction data with that distribution.
DQSA: Drug compounding Quality Act (DCQA)
-traditional compounding regulations under Section 503A -BUT 503B; register for "Outsourcing Facility" when compounding sterile drugs that are not based on patient specific RX (exempt from new drug provisions, adequate directions for sue, and drug track and trace provisions) - Outsourcing facilities are regulated by FDA and subject to FDA's current GMP w/o patient-specific RX or medication orders
how many retakes for NAPLEX and MPJE?
1 + 4 [after 5 times, additional coursework]
The 2 types of CSOS Certificates
1) CSOS Administrative Certificates are used to digitally sign communications with DEA; issued to coordinator and are not valid for electronic ordering 2) CSOS Signing Certificates are used for digitally signing controlled substance orders. Issued to approved Registrant and Power of Attorney applicants
Advertising and Promotion of RX Drugs
1) RX advertising is regulated by FDA 2) OTC drug advertising is regulated by Federal Trade Commission (FTC) 3) Advertising of RX drug prices under FDA regulations 4) a pharmacy that compounds products may advertise that it provides compounding SERVICES, including specific products. (therapeutic claims regarding products, would be subject to FDA's rules)
what must OTC APAP contain?
1) acetaminophen on it 2) liver toxicity warning 3) avoid use with other APAP containing products 4) ask if taking with warfarin (supratherapeutic/bleeding)
which medications require PPIs?
1) contraceptives PO 2) estrogen-containing products
iPLEDGE importance:
1) only docotors regiester in iPLEDGE can prescribe isotretinoin and agree to the RESPONSIBILITY for pregnancy counseling of female pts and enter negative results test 2) only patients registered under iPLEDGE can be prescribed isotretinoin and comply with requirements 3) only pharmacies regiestered in iPLEDGE can be prescribed isotretinoin 4) to dispense isotretinoin, pharmacist must obtain authorization from iPLEDGE, signifying patient is registered, has received counseling and education, and is not pregnant 5) product is dispensed in blister packages, which cannot be broken
What must pharmacies do to suspect or suspect for in illegitimate products? (DSCSA)
1) potentially counterfeit, diverted, stolen, fraudulent transaction, adulterated, unfit for distribution (serious ADR health consequences) 2) Illegitmate products which credible evidence shows ^^^ 3) pharmacies must investigate products as part of investigation --> must verify product identifier of at least 3 products or 10% of the suspect produce, whichever is greater, or all of the packages if there are fewer than 3.
Medication Guides (MedGuides)
1) similar to PPI w/ amended requirements for INSTITUTIONALIZED pts 2) For all new/refilled RX dispensed in community setting when: labeling could prevent serious ADRs, product has serious risk relative to benefits, patient adherence to directions is crucial 3)written in standard format/language suitable for pts 4) manufacturers must obtain FDA approval before distributing Medication Guides 5) FDA maintains serchable medication guide database on its website (over 1000 products needing medications guides)
Centers For Medicare and Medicaid Services (CMS) Requirements
1) tamper-resistant RX: to prevent unauthorized copyng and to prevent counterfeiting 2) Pharmacy Services at Long-Term Care Facilities
why have a distribution license? (DSCSA)
1) when distribution is b/w 2 entities that are affiliated or under common ownership 2) when dispenser is providing product to another dispenser on a patient-specific basis 3) when dispenser is distributing under emergency medication reasons OR 4) when dispenser id distributing "minimal quantities" to a licensed practitioner for office use
Max quanitity for opioids in texas for acute pain
10-day supply and not refills
Reasonable font size for RX labels
10-point Times Roman
What is the Single Copy DEA Form 222?
10/20/2019 from triplicate to SINGLE copy with additional security features - new ones contain 20 order lines per form - purchaser fills out a single copy and must make a copy of the original form for its records and submit the original form to the supplier (paper or electronic) - forms must be readily retrievable at the registered location - supplier may only fill from the ORIGINAL copy - purchaser fill out the DEA number of the supplier (but the supplier may also do it if it is missing) - purchaser must record number of containers received and the date received for reach item on the copy of the DEA Form 222
How long must a licensee wait to request the reissuing of a license that has been revoked or to remove a resitrction from their license?
12 months MINIMUM
Patients under what age need a RX for vaccines?
14 7 for the flu
how many days to administer controlled substance that has been delivered to a DATA waived practitioner from pharmacy?
14 days
A temporary suspension can take place immediately WITHOUT notice if a hearing is scheudle dno later than _____ after supension or restriction
14 days due to continuing to be a threat to public welfare
how long can pts be on pscyhotropic drugs if used as needed?
14 days, unless PCP documents the rationale for extending an order beyond 14 days
how old to purchase sudfed in texas?
16 years old
Dextromethorphan (Delsym)
18 yo to purchase OTC in TX - need identfication - ignore if it is a RX
Ratios of RPh to techs/trainees Class A
1:6 (as long maximum of trainees is 3) if only trainees (1:3) [no limitation ins Class C or G]
Drug Quality and Security Act of 2013 (DQSA)
2 primary topics: - large-scale compounding by pharmacies, and establishment of a framework for a uniform trace and trace system for RX throughout the supply chain
how long must records be kept for DTM?
2 years - must keep copy of written protocol and any pt-specific deviations - document all interventions - review protocol annually
How long to maintain records for Class A
2 years (original copies)
how long are records kept in Class C settings?
2 years and be supplied w/in 72 hours upon request
how long must records of controlled substance be maintaine?
2 years for both Texas and Federal
how long must the original statement of an UNaccepted electronic order be retained for
2 years with it be placed with the original order
how many CE for a tech?
20 hours every 2 years w/ 1 hours being Texas Law
DEA allows compounding of schedule II-IV if the final solution,copound or mixture concentration is no great than?
20%
What's the limited concentration of aqueous or oleaginous solutions/dosage forms being compounded for narcotic?
20% (narcotic substance must be compounded with one or more nonnarcotic therapeutic ingredients)
when will the DSCSA be fully implemented?
2023 w/ enhanced electronic tracking and tracing of products at individual package level using unique product identifiers on each package
how long is the confirmation number to dispense Thalomid valid for?
24 hours and must be entered on the RX - must be dispensed w/in 24 hours
How many days to notify PCP of a vaccine issued?
24 hrs if PCP issued it initially and 14 days w/in administration of not issued by PCP
TSBP record requirements
3 separate files for storage of Controlled RX - FIle 1 - CII rx -File 2 - CIII-V rx - File 3 - Dangerous drugs and OTC
Retail sale limits for Pseudophed
3.6 grams per day and 9 grams per month/30 days 3.6g equals: - 146 of 30mg tablets - 73 of 60mg tablets - 36 of 120mg tablets
maximum quantity to dispense isotretinoin
30 - day supply
For medicaid patient, how many days to PCP have to mail/fax written prescription after a verbal RX was given?
30 days [same with electronic RX for medicaid pts]
Schedule II RX filled w/in ______ days
30 days after the date issued or the first date authorized to fill
how many days when a pharmacist changes locations?
30 days to notify TSBP
TSBP CE hours requirements for a RPh
30 hours - 1 hour based on pharmacy laws/regulations - renewels during 8/31/21 - 9/01/23 ( must meet 1 hr of best practices, alterantive tx and multi-modal to pain management; and mental health wellness ) - 2 hours related to prescirbing and monitoring controlled substances (pmp)
how many pts are qualified practitioners allow to treat up to?
30,100, OR 275 based on authorization
Requirement hours for student interns
300 hrs of IPPE and 1440 hrs of APPE - no more than 50 hrs/week
how long to transfer RX after request from pt?
4 business hours
max amount of thalidomide dispensed at a time
4-weeks (28 days) with NO refills
if supplier cannot supply the whole order of controlled substance, how many days do they have until they have to supply?
60 days
max physician supervisions for PAs/APRNs?
7 (except in medically underserved areas or facility-based practice hospital/LTCF)
every dispensed/refilled RX, RPh verify info is correct by signing and dating the hardcopy printout w/in ______ from date of dispesning
7 days
how many days to obtain rx when an emergency schedule II drugs was verbally prescribed?
7 days
how many days for PCP to send electronic/written RX after emergency verbal RX of a CII substance?
7 days [texas prefers electronic unless PCP has a waiver]
how long are authorization numbers valid from the date of the last pregnancy test for Thalomid
7 days females of reproductive potential - 30 days from the date issued for other patients
Partial Depsensing of CII RX includes:
72 hour rule 30 day rule 60 day rule
how many hours do Class E pharmacies have to dispense records for TSBP?
72 hours
in non-rural area, how much time until pharmacist verify withdrawal medications when pharmacy is clsoed?
72 hours
the daily hard copy printout shall be produced w/in ____ of the date on which the RX drug orders were dispensed and shall be maintained in a separate file at the pharmacy
72 hours
Imidazoline Child-resistant packaging?
> 0.08 mg
When is THC considered Schedule I and when it is not
> 0.3% THC = Schedule I < 0.3% THC = not controlled
Dibucaine for child-resitant?
> 0.5mg in a single package including all dosage forms
When does ibuprofen need child-resistant cap?
> 1 gram in a single package
Child-resistant container when APAP contains more than...
> 1 gram of APAP in a single package
Naproxen for child-resistant
> 250 mg in a single pacakge
Lidocaine for child-resistant cap?
> 5 mg in a single package (include all dosage form, creams/sprays/ and transdermal patches)
What amount of diphenhydramine needs child-resistant cap?
> 66mg in a single package
If a remote dispensing site dispenses an average of more than ____ prescriptions each day the site is open (calculated annually), it must apply for a class A license:
>125 [pharmacist must make monthly visits to the site for on-hand inventory and reconcile perpetual inventory of controlled drugs]
amount of iron to be in child-resistant container
>250mg
what % of wintergreen oil (methyl salicylate) must include warning that use other than directed may be dangerous/kept out of reach of children?
>5%
Ketoprofen (Ketofen) and Fluoride child-resistant
>50 mg in a single package (flouride also >0.5%)
What is a remote healthcare site?
A Class A or C pharmacy may provide services using a telepharmac system at: i. rural health clinics ii. health centers (serving medically underserved populations/254b) iii. federally qualified health centers iv. healthcare facilities located in medically underserved area or health professions shortage area as defined by HHS
Automated Checking Device
A fully automated device which confirms, after dispensing but prior to delivery to the patient, that the correct drug and drug strength have been labeled with the correct label for the correct patient
Satellite pharmacy
A specialty pharmacy located away from the central pharmacy, such as an operating room (OR), emergency department (ED), or a neonatal pharmacy; satellite pharmacies typically are staffed by a pharmacist and a pharmacy technician - not separately licensed from Class A/C pharmacy - RX dropped of at satellite location and then sent to Class A/C pharmacy to be filled; filled RX sent back to satellite location where pt picks up the RX and counseling is provided - no bulk RX allowed
What do practitioners registrations start with?
A, B or F second letter (first letter of the practitioner's last name or first letter of a pharmacy's/hospital's name)
Which drugs must contain alcohol warning for patients consuming more than 3 alcoholic bev./day?
APAP, ibuprofen, aspirin, naproxen, ketoprofen, etc
Which drugs/classes/ biologicals require medications guides?
Accutane (isotretinoin) Andtidepressants in children/teenagers coumadin (warfarin) Epogen (epoetin alfa) Forteo (teriparatide) Lindane (antiparasite shampooo and lotion) Lotronex (alosetron HCl for diarrhea/IBS) Nolvadex (tamoxifen) NSAIDs Remicade (inflximab for RA) Trizivar (HIV) Opioid and cough products BZDs
Preceptor requirements
Active license, 1 year experience/6 months residency training, 3 hours ACPE preceptor training (then every 2 years) - license that has not been disciplined - may only supervise 1 intern
Who can use a hospital's DEA number?
Any prescriber-- physician, mid-level, intern, resident [Each person must have a specific code that serves as the suffix to the hospital's DEA number] Can be filled at a pharmacy outside of the hospital's pharmacy
FDA Orange Book official name
Approved Drug Products with Therapeutic Equivalence Evaluations - available on FDA's website
which drugs needed child-resistant containers
Aspirin methyl salicylate (Wintergreen oil) Controlled drugs Methyl Alcohol (methanol) containing >4% by weight Iron-Containing Drugs (except animal feeds used as vehicles) dietary supplements containing iron tylenol/APAP Diphenhydramine Ibuprofen Loperamide Lidocaine Dibucaine Naproxen Flouride Minoxidil imidazolines RX --> OTC
Automated Checking Device vs Automated Pharmacy Dispensing System
Automated dispensing system fills RX while checking for accuracy. w/ checking device, RX are checked for accuracy after dispensing using technology such as barcoding
Pharmacy Balance Registration/Inpection?
Balance for nonsteril compounding inspection for accuracy by TSBP
Remote Pharmacy services using Automated DISPENSING and DELIVERY SYSTEMS
Both Class A/C pahrmacy - a mechanical that dispenses and delivers RX drugs to pts at a remote delivery site and maintains related transaction information - RX already laeled, packaged, and dispensed by provider pharmacy or store bulk RX. - apply to TSBP for theses services - approrpiate Controlled registry - must provided counseling via audio or video direct link by Texas Licensed RPh - RPh available at all time for patients and healthcare providers for questions - really good security when closed + cameras - stocking must be under supervision of RPh
What drugs cannot be on auto-refill programs?
CII-III - may not be dispensed by an auto-refill program
Concentration limit for Morphine
CIII = 50mg/100mL
Concentration limit for Opium Federal and Texas
CIII limit = 500mg/100mL & 25 mg/dosage unit Federal = 100mg/100mL Texas = 50mg/100mL [schedule III controlled substances under Texas and require a RX]
TCSA allows which rx to be communicated verybally in an emergency?
CIII-V, not II (TCSA requires w/in 7 days of issuing an emergency verbal RX CIII-V to be electronically sent)
what other ways to obtain CEs?
CPR (1 hr) Advanced Cardiac Life Support Courses leading to certification (12hours); 4 hours for recertification TSBP meetings (3 hours) Programs presented by TSBP
Concentration limits for dihydrocodeine CIII and CV
CV = 100mg/mL CIII = 1.8 g/100mL & 90mg/dosage unit (anything above would b schedule II)
concentration limits of codeine for CIII and CV
CV = 200mg/100mL CIII = 1.8 g/100mL & 90 mg/dosage unitI
BUD for 797
Category 1: - <12 hours RT - < 24 hours in refridgerator Category 2: - aseptically processed/no sterility, only sterile components - 4 days at RT - 10 days in fridge - 45 days frozen - aseptically provcessed/no sterility, one or more non-sterile components - 1 day RT - 4 days fridge - 45 days frozen
What is a Class G pharmacy?
Central Prescription Drug Order or Medication Order Processing
which classes of pharmacy may compound non-sterile product?
Class A, C, E community insitutional non-resident/out-of-state
Which environment/situation contains perpetual inventory to occur (in real-time and everytime)?
Class C schedule II Class F: all controlled substances all pharmacies must main perpetual inventory of any controlled substances [example, recounting controlled substances when filling an rx order]
FDA Drug and Device Recall Classifications Class I Class II Class III
Class I: serious ADRs on health/death Class II: cause temporary reversible ADR Class III: not likely to cause ADR health consequences
State, who can change, add, delete or reschedule substances
Commissioner of the Texas Department of State but cannot override actions by the legislature
What kind of products must "danger" be on?
Corrosive, extremely inflammable and highly toxic products
What form is needed to transfer a schedule II drug?
DEA FORM 222
What form to fill out Loss/Theft of controlled substances?
DEA Form 106 (on DEA's website)
What is the DEA form to order schedule II controlled substances?
DEA Form 222
what form do PCPs and pharmacies (dispensers) need to registered for DEA?
DEA Form 224
What drugs are not allowed to be mailed?
Dangerous Drugs (controlled meds)
what to do when transferring controlled substances to another facility to be destroyed?
Documented w/ an invoice for Schedule III-V and DEA Form 222 for Schedule II
When are the exemptions of requirements to meet Hazard Communication Standard?
Drugs in solid, final dosage form for administration to pts (tablets/capsules)
Disposal of controlled substances of a hospice patient
Employees of the hospice (SUPPORT Act) are qualified to hand controlled substances for purpose of destruction(DEA has yet to adopt regulations to implement this law and practice)
What listed chemicals have been removed from the market by FDA for safety reasons?
Ephedrine and Phenylpropanolamine
What is no longer a controlled substance and once was Schedule V?
Epidiolex (cannabidiol)
which orders containing these drugs, may only be on this order?
Etorphine HCl and Diprenorphine must only contain only orders for these substances
Federal vs TX opium schedule V max:
FCSA: 100mg/100mL TCSA: 50mg/100mL [containg more would be CII/III]
where can the drug on REMS list be found?
FDA's website
what is a Class F pharmacy
Freestanding Emergency Medical Care Facilities (FEMCF) are licensed by the Texas Department of State Health Services to provide emergency care to patients - must have one PIC or contracted consultant/part-time basis
Personnel Cleansing and Garbing
Hand hygiene and garbing in ISO Class 8
for a tech to receieve sterile compounding license and CE?
I. 40 HOURS of ACPE-approved course II. renew is 2 hours for low/med risk and 4 hours of high-risk preparations
what must the invoice of the Schedule III-V contain?
I. Name of controlled substance II. dosage form & strength III. number of units per container (100-tab bottle) IV. Quantity received (containers) V. date of receipt VI. Name, address and DEA number of registrant from where controlled substance was received
Prescriber requirments for Electronic RX for controlled susbtances (EPCS)
I. Third party certfication of system II. Credentialing to verify a provider has the authorization to prescribe controlled susbtances III. 2-factor authentication for providers who sign an EPCS RX
what does "transaction data" include? (DSCSA)
Information: NDC #, container size, # of containers, date of transaction, name/address of person from whom ownership of being transferred; serialized numerical identifier (SNI) History: includes prior transaction information for each prior transaction back to the manufacturer Statement: statement by seller (licensed) to receive from an authorized person (licensed), receive the transaction info and history from the prior owner if required. (to not knowingly ship a suspect or illegitimate product to comply w/ verification requirements.
when does a license expire?
Last day of pharmacist's birth month [can be renewed online] - if late less than 90 days, pay a renewel fee of 1.5x the original w/ CE hours documented
Schedule IV (C-IV)
Less abuse potential than Schedule III with minimal liability for physical or psychological dependence (certain sedative/hypnotics, certain antianxiety agents, some barbiturates, benzodiazepines, chloral hydrate, pentazocine, and propoxyphene). Phentermine Outpatient prescriptions can be refilled 6 times within 6 mo from date of issue if authorized by prescriber. Telephone orders are acceptable.
Schedule V Drugs
Less potential for abuse May lead to limited physical or psychological dependence Pregabalin (Lyrica) Antitussive containg codeine Brivact (Brivaracetam and Lacosamide (Vimpat)
Mid-level practitioner's DEA numbers start with the letter "__"
M nurse practitioners and PAs
Peer Review Program
May be set up by pharmacy owners or associations to evaluate the quality of care in pharmacies by reviewing errors or near errors or other quality issues; statue provides legal protections in civil litigation to peer review documents; setting up a peer review committee is voluntary how some pharmacies may be mandated as part of disciplinary action
What is MAT?
Medication Assisted Treatment - trained QUALIFIED Practitioner to prescribe narcotics III-V to treat opioid dependence through risk management program + counseling/behavioral therapies -Drug addiction treatment act (DATA)
Medication order vs RX drug order
Medication order: for administration RX drug order: to be dispensed
Pharmacist is off-site (pharmacy is CLOSED)
NO techs allowed in pharmacy HOWEVER: - agent of pharmacist may deliver previously verified RX (new/refilled) to pt in the pharmacy provided in short periods time (2hrs) *pharamcy maintain record of date of delivery, RX #, pt's name and phone number, and signature of person picking up the RX*
is Texas in an MOU with FDA?
NO: beginning in october 22, 2022; pharmacies cannot distribute compounded drug produce out of state in quantities that exceed 5% of the total prescription orders dispensed or distributed by such pharmacy
what formularies cannot be in Class D settings?
Nalbuphine (Nubain) Drugs to treat Erectile dysfunction Controlled substances
example of FDA 3-character code (AB1, AB2) and are both reference drugs w/ same dosage form and active ingredients, but they are not rated as bioequivalent to one another.
Nifedipine: AB1: Adalat CC AB2: Procardia Xl
Where can additional information be found of Hazardous Communication Plan?
OSHA's publication "Small Entity Compliance Guided for Employers that Use Hazardous Chemicals"
PA/APRN vs PCP on controlled substance RX
PCP: can exceed 90-day supply, but not with opioids for acute pain APRN/PAs: cannot exceed 90-day supply
PIC in Class D (clinic) responsibilties:
PIC maybe at numerous clinics - continuous supervision (not on-site_ of nurses, PAs -document on-site visits - development of a formulary -provision of drugs according to written policies/procedures and completion of the drug label
Difference between Phenmetrazine, phendimetrazine and phentermine
Phenmetrazine (CII) Phedimetrazine (CIII) Phentermine (CIV)
Schedule III Substances
Potential for abuse but lower than C-I and C-II Currently accepted medical use in the US Abuse can lead to limited/moderate physical dependence or high psychological dependence Narcotics diluted or mixed with non-controlled: - No more than 1.8 g codeine per 100 mL - Codeine with APAP up to 60 mg/dose unit Buprenorphine Barbiturates (suppositories) - secobarbital Butalbital with Aspirin (Fiornal) Dronabinol (THC in FDA approved form) Anabolic steroids (testosterone gel)
Minoxidil Child-Resistant Packaging
Products w/ this drug need child-resistant packaging if more than 14 mg in a single package
RPh or Techs with alcohol or drug problems may join ____
Professional Recovery Network (PRN) and are not reported to TSBP if they joined voluntarily can also be placed in PRN from TSBP and stays confidential Program only pays for evaluation and not treatment
What is PHI under HIPAA?
Protected health information --> patient-identifiable information
Destruction of Stocked Drugs/dangerous drugs:
RPh licensed by TSBP may destroy stock dangerou drugs if in a manner to render drugs unfit for human consumption and disposed in compliance w/ state/federal requirements
What must Class A who compounds must have?
RX balance or analytical balance and weights which are subject to inspection by TSBP
Therapeutically equivalent definition
Refers to drug products that are pharmaceutically equivalent and bio-equivalence has been demonstrated --> same clinical effect and safety profile - drug is bioequivalent to the reference drug product
Two types of remote sites that used telepharmacy system:
Remote healthcare sites and remote dispensing sites
Inventory Counts
Schedule IIs: EXACT count Schedule III-V estimated count unless container holds more than 1000 tablets or capsules
Short-term vs long-term detoxification of Narcotics?
Short-term: dispensing narcotic in decreasind doses for a period NOT to exceed 30 days Long-term: decreasing doses in excess of 30 days but not in excess of 180 days
what can interns NOT do?
Sign documents that require pharmacist signature (controlled substance invoices) Supervise technicians [function as a tech w/o supervision; does not count in any ratio of pharmacy tech to pharmacists]
How to verify a DEA number
Step 1: Add the 1st, 3rd, & 5th digits Step 2: Add 2nd, 4th, & 6th digits, then multiply by 2 of the sum Step 3: add step 1 and step 2 sum together The last digit of the DEA # must match the last number of Step 4 answer. Last digit is called "check digit"
drugs being able to be dispensed under MAT?
Subutex (buprenorphine) & Suboxone (buprenorphine/naloxone) -both have SL
Prescription Monitoring Program (PMP)
TEXAS PMP collect all scheduled RX being dispensed by a pharmacy in Texas or a Texas resident from an out-of-state pharmacy - assist pharamcists and PCP to see pts getting multiple RX from PCPs or having RX filled by multiple RPh. - everyone in the pharmacy has access
Complaints to TSBP
TSBP adopt plicies/procedures concerning the investigation of complaints filed w/ Board Confidentialiy of person who files complaint to Board Immunity - filing in good faith to Board is immune from civil liability
USP <800> (Hazardous drugs)
TSBP has not adopted rules for pharmacies to comply with USP 800 This describes the practice standards for handling hazardous drugs The aim of USP 800 is to promote patient safety, worker safety, and environmental protection Handling hazardous drugs include: -Receipt, storage, compounding, dispensing, administration, disposal, etc. This applies to ALL healthcare professionals and ALL entities (pharmacies, hospitals, veterinary offices) who handle HD The National Institute for Occupational Safety and Health (NIOSH) has a list of hazardous drugs used in healthcare which can be found at http://www.cdc.gov/niosh/docs/2014-138/ This list should be reviewed at least once every 12 months 3 types of hazardous drugs -Antineoplastic drugs -Drugs that carry a reproductive risk to males or females -Non-antineoplastic drugs that meet one or more of the NIOSH criteria for a hazardous drug (teratogenic, carcinogenic, Genotoxic, etc.)
Who regulates Class B (nuclear) pharmacy?
Texas Department of State Health Services through its Radation Control Program -Federal Department of Transportation (DOT) regulations must be met
other schedule III drugs
Tylenol #3 Amobarbital, secobarbital, pentobarbital Stims: chlorphentermine, phendimetrazine, and benzphetamine steroids: testosterone Ketamine and paregoric (relieves diarrhea)
Federal, who can change, add, delete, or reschedule substances?
U.S. Attorney General while obtaining scientific and medical recommendation from FDA
how to onsite destroyed controlled substances?
Using DEA Form 41 - requires NDC, amount, strength, dosage form, package size. - requires 2 signtaure of 2 witnesses of the destruction
what minimum standard does not apply to Patient Rights?
When disclosing information to heatlh-care providers for treatment purposes (transfers/info) OR patient has signed authorization
must the destruction of dangerous drugs be witnessed? and by whom? for pharmacist consultant
YES, by: - peace officer - agent of TSBP - Tx department of health services - 2 persons from the following facilities: facility admin, direct of nursing, licensed nurse
can pharmacists obtain verbal RX for Schedule III-V?
YES; w/o emergency [TCSA wants it to be an emergency] still provide electronic/written in 7 days
What do Therapeutic optometrist have on their DEA registration?
a "T" at the end
What is needed on suppliers invoices?
a pharmacist intials except in Class C-ASC and F.
ER outpt must be dispensed by who?
a pharmacist still considering it's outpatient
What must the tamper-evident features include?
a. >1 industry-recognized features designed to prevent unauthorized copying RX form b. >1 industry-recognized features designed to prevent the erasure or modification of information written on the RX pad c. >1 industry-recognized features designed to prevent the use of counterfeit RX forms
What kind of Pharmacy services are there for LTCFs?
a. Medication Regimen Reviews: CMS requires consultant RPh for all long-term care pts q30days and report any irregularities b. each pt's drug therapy must be free of unnecessary drugs (excessive doses, duration) and limit psychotropic drugs c. clearing out PRN drugs d. Reduce medication waste e. ensure routine and emergency drugs are provided in a timely manner
What is the HITECH Act?
adds breach notification requirements to HIPAA Covered Entities (pharmacies) must notify individuals of breach within 60 days of discovery If <500pts affected, must maintain a log and notify HHS annually If >500pts affected, must notify the security of HHS and Prominent Local Media within 60 days
when does the DEA Certification of Authority foe electronic orders of controlled substance expires?
after 3 years
Who are exempted from DEA registration?
agent/employee of any registered manufacturer, distributor or dispenser - i do not need to common/contract carrier or warehouseman patient who possess a controlled substance for a lawful purpose officials of the U.S. armed services, public health service, or Bureau of Prisons acting in the course of their official duties
What does Tax-Free alcohol mean?
alcohol (95% ethanol) that is used for scientific, medicinal or mechanical purposes or to treat patients
lirbrary requirements for Class C facilities
all the texas acts and rules - DI reference - general drug info ref. - injectable drug products ref. - basic antidote info and phone number of near regional poison control center - metric apothercary weight and measure conversion chart
emergency refills by TCSA/TSBP
allow emergency refills using pharmacist's professional judgement (not allowed for CII)
how many days to notify TSBP about changes?
almost every thing is 10 DAYS, except: - w/in 30 days for pharmacy location changes - immediately for singificiant loss/therft of controlled substances/dangerous drugs - immediately for forged RX of controlled or dangerous drugs
Nurse Practitioners and PA on DATA drugs
also need to be DATA-waived
Written schedule II RX must be written on what?
an official Texas Rx Form
methadone can only legally be disepnsed as a what?
analgesic (pain treatment); even though it assists in detoxification [can only be provided at narcotic tx center]
when must an inventory be done?
annually when change of ownership occurs: - on date of change of ownership consitutes closing inventory for seller and initial inventory for buyer or change in PIC
Annual inventory
annually for controlled substances (compared to 2 years DEA)
In Texas, how often is inventory done?
annually, when schedule drugs are being added or changed DEA (every 2 years)
How long can members be apart of TSBP?
appointed 6-year term; serve 2 consecutive full terms
Salicylates special warnings?
aspirin have warnings for use in children including warning regarding Reye's syndrome OTC (1 1/4 grain pediatric aspirin cannot be sold in containers holding more than 36 tablets)
When can a pharmacy not provide a remote pharmacy service?
at the Class A/C site directly or w/in 10 miles (community area), only at places mentioned before
for out-of-state RX, can they prohibit or authorize substitutions?
authorize substitution [where in Texas, PCP can prohibit it by saying "brand only"]
TSBP rules in inventories
be signed by PIC and person taking inventory and the PIC signature be notarized W/IN 3 days (excluding weekends and holidays)
display Resitrctions for Pseudophed
behinh a counter or locked cabinet (Texas, be w/in 30 feet and in direct line of sight of the pharmacy counter)
What does biosimilar mean?
biological product is "highly similar" to reference product with no clinically meaningful differences in terms of safety or efficacy (purity or potency)
Class I-III FDA medical devices based on risk associated?
class I: deemed to be low risk (dental floss) class II: higher risk and required regulatory controls (syringes) class III: highest risk and subject to highest level of regulatory control, and pose significant risk of illness or injury (replacement heart valves or ventilators)
which CV substance be sold OTC in SMALL amounts?
codein in Robitussin AC and opium for diarrhea products [NOT APPLICABLE IN TEXAS - requires an RX]
Glove fingertipe sampling procedure
complete with no fewer than 3 times before initially allowing to compound sterile preparations (all risk levels) if yields unacceptable results, evaluation and testing annualy for low/med risk and biennualy for high-risk
what requirements from patients are needed to be prescribed isotretinoin?
completing and informed consents form obtaining counseling about risks complying with a required pregnancy testing and use of contraception
High-risk compounding level
components are exposed to air quality inferior to ISO Class 5 for more than ONE hour - dissolving bulk drug powders to make solutions which will be temrinally sterilized - 24 hrs room temp, 3 days refridgerated, and 45 days frozen
how to change dosage form?
consent from both PCP and pt - if pt wnats liquid isntead of tablets - must contain same amount of active ingredient - does not alter clinical outcomes
what must Aspartame contain?
contain warning in "precautions" section of labeling to the following effect: Phenylketonurics: contains phenylalnine __ mg per __ (dosage unit)
what is the standard for billing and claims submission for NDC #?
containing an 11-digit number character - by inserting a leading 0 into one of the segments (first segment if contains 4 only, second segment if it contains 3 only, or added to the beginning of third segment if it only has 1 number)
Disbursement Records (leaving pharmacy)
controlled substances leaving include DEA Form 106 (loss/theft) form 41 (destruction) for 222 - schedule II drug made under 5 % rule and invoice for schedule III-V distributions made under the 5 % rule
FD&C Yellow No.5 and No.6:
disclose presence and provide warning in "precautions" section of label that may cause allergic reaction in certain susceptible persons
Accelerated Refills and 90-day supply
dispense up to 90-days of dangerous drugs from RX that specifies for a LESSER amount if: - totall quanitity dispensed does not exceed total prescribed (including refills) - pt consents to the dispensing - PCP has been notified electronically/telephone - drug is not a psychotropic drug - pt is at least 18 years of age
What must compounding pharmacies have?
documented quality assurance and quality control programs
requirements of an epinephrine order?
does NOT need a pt name but needs: - name of PCP/PA/APRN - name of entitiy which is ordered for (a place) - qty of epi auto-injectors - date the order was issued
A coding System
drug products that the FDA considers therapeutically and pharmaceutically equivalent
Schedule I drugs are
drugs with no accepted medical use, a high potential for abuse, and lacking safety measures.
if another drug is written on the Offical RX Form with CII substance, is it valid?
each drug is valid [due to RX filing requirements; direct image must be maintained separately for each category of RX in the pharmacy's RX records]
how often do floor stock records be reviewed by RPh?
every 30 days
how often to have a retrospective random drug regiment review to verify proper usage of drug in a Class F pharmacy?
every 31 days
What records shall not be maintained at he central record location/
executed DEA order forms RX drug orders controlled substance inventories (all at the pharmacy)
when can your intern license be revoked?
fails NAPLEX/MPJE fails to take NAPLEX/MPJE w/in 6 months of graduation ceases enrollment at an accredited school
Example where a pharmacy can be disciplined?
fails to engage in business as described in application of license w/in 6 months of the date inssuance of th elicense
What does DEA not allow for central fills?
for central fills to deliver controlled substance RX directly to pt, but TSBP allows a central fill pharmacy to deliver dangerous drug prescriptions directly to a pt.
what are not considered facility-based practices?
freestanding clinics or medical practices owned/operated by a hospital or long-term care facility [PAs and APRN cannot prescribed under these circumstances]
Schedule II Controlled Substances
high potential for abuse-->SEVERE physical and psychological dependence -NARCS: morphine, opium, dilaudid, Demerol, OxyContin/oxycodone, Vicodin (APAP/HYDROCODONE), methadone -STIMS: Dexedrine, Adderall, Ritalin, phenmetrazine -Depressants: amobarbital, pentobarbital, secobarbital, glutethimide and phencyclidine
When a dangerous drug is returned to a pharmacy:
i must be destroyed in a mannerly way ii. document date of destruction, name and address, RX number, name and strength of drug, and signture of RPh
TSBP disciplining Pharmacist license holder when:
i violating TPA/TSBP rule ii. Unprofessional conduct: - dispensing fradulent RX for not legitimate medical purpose - delivering RX in violation of law - refusing inspection - engaging in conduct of NAPLEX/MJPE - failnig to practice pharmacy in acceptable manner consistne w/ public health - obstructing a Board employee in lawful performance - demonstrating abusive/intimidating/threatening behavior toward board member/employee - failing to correct issues identified in a warning notice by specified time
Pharmacist continuin education for sterile compounding
i. 20 hours of instruction through college of pharmacy or ACPE-approvied course and on-the-job training (cannot be transferred to another pharmacy) ii. renew by completing 2 hours of CE related to compounding if in low/med ris preparation or 4 hours of CE if engaged in compounding high-risk preparations
Orange Book: Products with NO known/suspected bio-equivalence issues: i. AA ii. AN iii. AO iv. AP v. AT
i. AA - conventional drug form ii. AN - solutions and powders for aerosolization iii. AO - injectable oil solutions iv. AP - injectable aqueous solutions v. AT - topical products
Brand names of depressants Amobarbital Pentobarbital Secobarbital Glutethimide Phencyclidine
i. Amytal Sodium/Tuinal ii. Nembutal iii. Seconal iv. Doriden, Elrodorm, Noxyron v. none
Inspection summary for controlled substances:
i. DEA needs RPh conset for financial/sales/pricing data ii.TSBP inspect pharmacy's financial records in course of complaint w/o consent
Rules for both remote healthcare/dispensing sites:
i. DEA registration needed if site stores controlled substances ii. may only deliver to pt at the remote site iii. pharmacy can only supervise 2 sites iv. application to TSBP v. perpetual inventory maintained same day as provder's pharmacy inventory vi. RX records shall be kept at remote site, and provider pharmacy have electronic access
what must the label of the hazardous product contain?
i. Name and business address ii. chemical name of each ingredient iii. "Danger" iv. "caution" or "warning" for all hazardous drugs v. "Flammable", "harmful if swallowed", "Causes Burns", "vapor harmful", etc. vi. Precautions on what pt do or actions they must avoid to protect themselves vii. instructions for first aid treatment if injured viii. "Poison" that is highly toxic + "Danger" ix. Special car ein handling and storage x. "Keep out of the reach of children"
4 types of RX that CANNOT be dispensed for dangerous drugs
i. Oral/verbal RX by physician-delegated texas pharmacist performing Drug Therapy mangement [but can if as designated agent] ii. electronic RX from Canadian/Medican doctors iii. faxed " " iv. verbal " "
when is it MANDATORY to use PMP?
i. PCP and RPh checking PMP before prescribibng or dispensing ii. if a RPH uses a pharmacy management system that integrates date from PMP to be reviewed
Final checks of Automated Pharmacy Dispensing System:
i. RPh checking completed RX prior to delivery to patient or ii. RPh verifying bulk stock drugs and checks accuracy of data entry of each RX into system (since no RPh is checking at the end of the process, tested for accuracy monthly)
CII cannot be dispensed when:
i. RPh is doing DTM ii. optometrists iii out-of-state physcian, dentist, vets, or podiatrist iv. out-of-state APRN/PA v. Canadian/Mexican practioner
what is the 72 hour rule for CII rx partial dispense?
i. RPh unable to fill full quantitity, partial may be provided--> remaining quantity filled w/in 72 hours [pt is not required to pick it up w/in 72 hour period tho] ii. if cannot w/in 72 hours, notify PCP iii. aplies during emergency verbal as well
Exemptions from electronically controlled substance RX
i. RX written by vet ii. electronic prescirbing is not available (technologica/electronic failure) iii. by a PCP locationed outside of Texas iv. PCP/dispenser under the same location/license v. drug requiring DEA additional information that is not possible with E-RX vi. in response to publich health emergency vii. drug under research protocol viii. circumstances in electronic delays that would effet patient's medical condition ix. medication order written for a pt admitted to a hospital at he time the order is written and filled
what is the 60 day rule for CII rx partial dispensing?
i. TERMINALLY ILL pts and LTCF pt, both feral and Texas law allow partial fills of CII RX as many times as needed as long as the partial filling are recorded on the RX or maintained in pharmacy's computer system ii. all partial fills must be completed w/in 60 days
TSBP Inspections and Investigations:
i. TSBP representative myst have appropriate credentials and a written notice of inspection authority for pharmacy owners ii. no search warrant iii. Board can inspect & make copies of documents; inspect facility's stoage, equipment, security, RX or devices; perform inventory and take samples iv. inspect financial records in relation to complaint (financial data, sales, pricing) obtain by Board is confidential and not subject to Texas Open Records Act
Pharmacy Requirement for EPCS
i. Third party certification of system ii. ability to sign and archive controlled substance RX iii. system must electronically accept and store all information that DEA requires to document the dispensing of RX iv. system allow pharmacy to limit access for the annotation, alteration, or deletion of controlled substances RX to specific individuals/roles v. system have internal audit trail that documents RX is received, altered, annotated or deleted vi. conduct internal audit daily that identifies any potential security problems and generate a report vii. system must be backed up daily viii. e-rx record must be kept electronically (no hard copy is required to be kept)
What drugs cannot be prescribed in Texas through telephonice or internet-based consultations?
i. abortifacients or device terminating pregnancy ii. treatment of chronic pain w/ controlled substances
Board Powers and Duties
i. administrating and enforcing TPA and rules, and other laws related to practice of pharmacy ii. regulating the practice of pharmacy by: - issuing new licenses - determining and issuing standards for recognizing and approving degree requirments of colleges of pharmacy - specifying and enforcing the requirements for practical training (internship) - regulating the training/qualifications, and employment of pharmcist interns/technicians
Out-of-state and mexican/Canadaian practitioners for dangerous drug (non-controlled)
i. any of these PCPs from these locations can prescribe dangerous drugs under Texas law. ii. must be WRITTEN from canada and mexico practitioners
Standard operations for Class F pharmacies
i. area contain drugs/rx must be capable of being locked ii. pharmacy shall have locked storage for CII substances iii. absence of RPh, only a licensed nurse or practitioner may take out a sufficient amount of drug iv. must reconciled perpetual inventory of controlled sbstances once in every calender week that the pahramcy is open
Training requirements for Sterile compounding
i. aseptic technique ii. critical area contamination facctors iii. environmental monitoring iv. facilities v. equipment and supplies vi sterile preparation calculations, terminology, compounding documentation vii. quality assurance procedures viii. aseptic preparation procedure ix. handling of cytotoxic and hazardous drugs, if applicable x. general conduct in the clean room
Automated Compounding or Counting Devices in Class C settings
i. calibrated and tested for accuracy ii. loaded by tech but verified by RPh prior to use
what can public member's not do?
i. cannot be a healthcare professional ii. employed by a business regulated by the Board or receiving funds from the baord iii. owner who controls >10% interest in a business regulated by the Board iv. officer, employee, or paid consultant to Texas trade association in healthcare field
when can a RPh signed a RX for dangerous drug?
i. delegatios follow diagnosis, initial assessment, and drug therapy by physician ii. RPh practicing in a federal qualified health center, hospital, clinic or academic healthcare institution
What does drug therapy management include when authorized by physician?
i. drug hx ii. POC testing iii. ordering lab tests iv. implementing or modifying drug therapy v. signing a RX order for dangerou drug (not controlled)
what can be changed on a controlled substance RX?
i. drug strength ii. dosage form iii. quantity iv. directions [contacting PCP and receives verbal permission; documents on the RX that the change was authorized, name/anitials of individual granting authroziation & RPh initials]
Class C pharmacies in Freestanding Ambulatory Srugical Center (C-ASC)
i. drugs w/drawn be reviewed w/in 72 hrs w/ full-time pharmacist for controlled substacnes ii. partime/consultant RPh, RPh verify w/drawal of all drugs at reasonable itnerval (at least once every calender week the pharmacy is open) iii. perpetual inventory of all controlls iv. invoices of dangerous and controlled drugs v. conduct random audit of records w/ medication orders at least every 30 days vi. prepackaged quanities supplied to pt not exceed 72 hour supply
when can emergency refills occur w/o prescriber's authorization? (does not apply to schedule II)
i. failure to refill ends up creating pts to suffer ii. natural/manmade disaster has occurred where RPh can't contact PCP iii. quantity does not exceed 72 hr (3 day) supply iv. governor declares disaster and if notified by TSBP, pharmacist may dispense a 30-day supply
When does the DEA allow faxing of RX schedule II NARCOTICS?
i. faxed by PCP/agent for CII substance compounded to be administrated to pt by parenteral, IV, IM, Sq or intraspinal infusion ii. RX faxed by PCP/agent for CII for a resident of long-term care facility iii. for pt enrolled in hospice care program certified and/or paid by Medicare/licensed by the state (RX must note pt is in hospice)
Operational standards of Class C Facilities
i. formulary required ii. drug regimen review on prospective basis when RPh on duty and retrospective when not on duty (check within 72 hours)
When can there be an emergency verbal RX for CII Substance?
i. from PCP and not agent ii. emergency - immediate administration needed; no alternative tx available; not possible to provide written iii. quanitity limited to amount needed to tx pt during emergency period iv. RPh must immediately write it down and no PCP signature needed v. RPh must know PCP is an authorized licensed personnel
When can PCPs be exempted to use the Official RX Form? [for CII substances]
i. hospital inpt medication orders ii. hospital inpt require emergency wuanitity of CII up discharge (limit 7 day supply & dispensed by hospital pharmacy) iii. from flgith helicopter medical team, emergency medical ambulance crew, or paramedic medical team iv. pt is an inmate in correctional facility operated by Texas department of Criminal Justic v. animals admitted to hospitals/wildlife parks, exotic game ranches, wildlife mangement programs/state or federal research facilities vi. optometrist adminstering TOPICAL cocaine under Texas Optometry Act vii. rx from out-of-state PCPs if the pharmacy has a plan approved by TSBP viii. Electronic Rx
what points must pharmacist attest to in www.ipledgeprogram.com?
i. i know the risk and severity of fetal injury/birth defects from isotretinoin. ii. I will train all pharmacists on the iPLEDGE program requirements iii. i will comply and seek to ensure that all pharmacists comply with iPLEDGE program requirements iv. I will obtain isotretinoin from iPLEDGE registered wholesalers v. I will return to the manufacturer any unused product vi. I will not fill isotretinoin for any party other than a qualified patient
what is the 30 day rule for CII RX partial dispense?
i. if requested by pt or PCP, pharmacist provide partial quanitity of a CII substance RX and the pt may obtain additional quantities for up to 30 days [ have 30 days to pick up remaining] ii. the total quantity NOT eceeed original quantity prescribed iii. applies to written/electronic only; not emergency verbal
Destruction of Dispensed Dangerous Drugs by consultant pharmacist?
i. inventory required ii. destroyed in manner to render drugs unfit for human consumption and disposed in compliance of state/federal requirements
Destruction of dangerous drugs by waste disposal service:
i. inventory required ii. placed in sealed container w/ witness (from before card) iii. destroyed render to unfit for human consumption iv. provided facility with proof of destruction fo sealed container
What devices must be obtaine dfor compounding sterile prepartions?
i. laminar air flow hoods (certified q6mos) ii. biological safety cabinets iii. compounding aseptic isolators (ISO class 7 buffer area) iv. compunding aseptic containment isolator (low/med ISO 7 and high risk, ISO 8)
mail service limitations on sudafed
i. mail service must CONFIRM identity of purchasers ii. limited 7.5 g per 30-day period
CIII-V general Rules
i. may not be dispensed after 6 months from date of issuance ii. must be transmitted electronically unless exemption is met (same as CII) iii. may be refilled as indicated on the original RX up to 5 times or 6 months unless it is an opioid for acute pain iv. Texas laws permit emergency refills of CIII-V under specific circumstances
Requirements from pharmacies when dispensing Thalomid
i. must be certified in Thalomid REMs program w/ Celgene ii. need authorization # to accept Rx and pt risk category iii. pharmacy must obtain a confirmation number prior to dispensing vial toll free number or online iv. no automatic refills or telephone RX are permitted (need RX w/ authorization #) v. no refills allowed, but subsequent RX may be dispensed only if there are <7 days remaining on the existing RX. vi. certified REMS counselor must counsel the patient and counseling must be documented
what requirements are there for remote dispensing site compared to healthcare sites?
i. must be staffed at remote location by an onsite tech who is under continuous supervision of a pharmacist ii. tech must worked at least 1 year at retail durign the past 3 years and must complte board training program on proper use of telepharmacy iii. tech cannot perform extemporaneous sterile or nonsterile compounding but may prepare commercially available medicatiosn for dispensing (reconstitutions of PO powder abx) iv. max of 2 remote dispensing site per provider pharmacy
Central fill RX dispensing (centralizined RX Dispensing)
i. must be under common ownerhsip/have written contract/agreement ii. shared/common database or technology to all access to info. iii. provide notice to pt or a sign in the pharmacy
may not changed items on RX controlled substances:
i. name of pt ii. name of drug iii. name of PCP iv. date of RX
Labeling Requirement for nuclear coumpounds
i. name/address/phone # of pharmacy ii. date dispensed iii. directions for use iv. RX# v. name of pt OR "for physician use" vi. radiation symbol vii. "Caution-radioactive material" or "danger-radioactive material" viii. name of radipharmaceutical/abbreviation ix. amount of radioactivity in millicuries/microcuries/bequerels x. initial/code of person preparing it xi. if liquid, volume in mLs xii. requested calibration date and time xiii. exipration date and time
New pharmacist owner can use the previous owner's DEA registration under what requirements?
i. new owner must expeditiously apply for an appropriate DEA registration and state licensure ii. previous owner grans a Power of Attorney to the new owner that provides: - previous owner agreements to controlled substance activities of the pharmacy - previous owner acknowledges that he/she will be held accountable for any violations of controlled substance laws which may occur - previous owner egress that the controlled substance activities of the pharmacy may be carried out under his/her DEA registration and shall remain in effect for no more than 45 days after the purchase date.
what needs to occur when a pharmacy is closing down?
i. notify DEA w.in 14 days prior to closing by PIC ii. post closing notice informing pts w/in 14 days iii. closing inventory on closing day and transferring RX files and pt medication records on closing day; remove all signs that indicate location is a pharmacy on closing day. iv. After closing: w/in 10 days, PIC provide TSBP written notice of actual date of closing, pharmacy license, statement inventory (of dangerous/controlled drugs transferred/disposed of, and name and address of pharmacy to which records were transferred v. notification sent to DEA office explaining closed pharmacy, with DEA certificant and any unused DEA Forms 222
TSBP notifications
i. notify pts to complain to TSBP if any ii. pharmacy's webpage on homepage where a sale of RX occurs: - info of ownership - address and phone number consumer may report medication/device problems to pharmacy - infor about each pharmacy that dispenses RX for the website including name, address, number; PIC, Texas License #, link to internet site of TSBP; names of which pharmacy located outside Texas - verified by NABP to be in compliance w/ Texas laws
Price advertising are exempt from FDA when which conditions are met?
i. only advertising purpose is to provide info on price, no on drug's safety, efficacy, or indications ii. advertising contains name of drug, strength, dosage form, and price charged for specific quantity of the drug iii. advertising include information such as, availability of professional or other types of services (not misleading) iv. price stated in advertising include all charges to the consumer; mailing and delivery fees.
RPh not on duty in emergency room settings, when can dangerous drugs and controlled substance be supplied to pts admitted in ER?
i. only drugs on ER list may be provided ii.. drugs supplied prepackaged quantities no exceeding 72 hour supply iii. drugs on preapackged but when delivered to pts, label must include (name/address/phone # of facility, date supplied, name of PCP, name of pt, directions for use, RX #, brand/generic name and strength, quantity supplied) iv. RPh verifies ER drug list records at least every 7 days
Minimum Standard of the Patient Rights and Administrative Requirements
i. pharmacies must make effort to limit PHI to the minimum necessary to accomplish the intended purpose ii. disclosure to payment
What is the 5% rule of the Transfer of Controlled Substance b/w Registrants?
i. pharmacy does not need to register with DEA as a distributor as long as total quantities of controlled substances distributed (in 12month period) does NOT exceed 5% of the total quantity of all controlled substances dispensed and distributed during those periods. e.g. a pharmacy dispenses/distributes 10,000 DOSES of controlled substances. the pharmacy is allowed to transfer 500 doses without being registered with DEA as a distributor
Controlled substances returned to a pharmacy
i. pharmacy must be a collector under DEA destruction rules
Normally, PCP cannot dispense unless...
i. physican provide 72 hours upply of dangerous drugs (no controlled) to pt in PCP's office to meet patient's immediate therapeutic needs ii. PCP in certain rural areas where there is no pharmacy; can be reimbursed for cost iii. Veterinarians are allowed to dispense own patient's w/o being licensed as a pharmacy
Tech duties w/ >101 beds (w/ RPh supervision)
i. prepackage and labeling unit dose/multiple dose ii. compounding or labeling RX drugs to med orders iii. compounding sterile and non-sterile after appropriate training (Class C-S only for sterile) iv. routin orders for stock supplies to areas v. accessing automated medication supply systems
Requirements from prescribers to prescribe Thalomid
i. prescriber enrolls and becomes certified with CELGENE ii. prescriber counsels patients on benefits and risks iii. prescriber provides contraception and emergency contraception counseling iv. prescriber verifies negative pregnancy test v. prescriber must complete Patient-Physician Agreement Form with each patient and sends to Celgene vi. Prescriber/patient completes applicable mandatory confidential survey vii. prescriber obtains an authorization number from Celgene and writes it on every prescription with pt risk category viii. prescriber sends Thalomid RX to certified pharmacy
Goal objectives of an intern:
i. providing drug products ii. communicating w/ pts about RX iii. communicatin w/ pts about non-rx, devices, dietary supplements, diet, nutrition, traditional non-drug therapy, complementary and alternative therapies, and diagnostic aids iv. communicating w/ healthcare professionals v. maintaining ethical standards vi. compounding vii. retrieving and evaluating drug info viii. managing pharmacy operations ix. participating in public health, community service, or professional activities
Opioid antagonist can be dispensed to whom?
i. pt w/ valid RX at risk for opioid overdose OR ii. family member/friend in position to assist
additional requirements in Texas for WRITTEN controlled substance RX
i. quantity written numerically (twenty and #20) ii. date of birth or age iii. practitioner's telephone number iv. intended use of the drug unless the practitioner determines the furnishing of this information is not in the best interest of the patient (ii.-iv. all RX not just controlled RX in Texas)
Class G canNOT possess, store, or dispense but may perform:
i. receieve/interpret/clarify RX drug or medication drug orders ii. data entering iii. perfomring a drug reimen review iv. obtaining refill/substitution authorization v. verifyign accurate RX data entry vi. interpreting clinical dat for prior authorization for dispensing vii. therapeutic interventions viii. providing drug information concernign a pt's RX
When are child-resistant packaging exempted or not needed?
i. request from PCP/Patient ii. bulk containers (not intended for household use) iii. drugs distributed to institutionalized pts iv. RX packaged for residents of LTCFs and personnel facility who administer medication to pts. v. one package size of OTC drugs designed for elderly
What is the written program of quality assurance/policies for automated dispensing/delivery systems?
i. requires continuous supervision ii. mechanisms and procedure to routinely test accuracy of the system every 12 months and whenever any upgrade/changes is made to the system and documents each activity
Requirement for a pharmacist member
i. resident of texas ii. licensed for 5 years iii. good standing with TSBP iv. actively practicing pharmacy v. CANNOT be lobbyist or trade association
Requirements for WRITTEN controlled substace RX
i. signed and dated on the date issued ii. full name and address of patient iii. quantity prescribed iv. name, address, and DEA number of practitioner v. schedule II - filled at a later date, the earliest date on which a pahrmacy may fill
Responsibilities of pharmacy practicing telemedicine:
i. sound professional judgement w/ respect to accuracy/authenticity of RX dispensed and verify order if any questions ii. ensure controlls are issued for legitmate medical purpose by practitioner to all RX including dangerous drug iii. cannot dispense RX that was issued by means of internet unless pursuant o valid RX wirtten for legitimate medical purpose.
inner container label for nuclear products
i. standard radiation symbol ii. "caution/danger-radioactive material iii. name of radipharmaceutical/abbreviation iv. RX#
what is required from patient to buy sudafed?
i. state license's ii. sign in logbook w/ name, address, date/time of sale [make sure what is written is the same on the licenses]
what drugs can be purchased, store/transported by nurses?
i. sterile water for injection/irrigation ii. sterile saline for injection/irrigation iii. Hep B vaccine iv. Flu vaccine v. TB testing vi. No more than 5 dosage units of: - heparin lock flush (10UI/mL or 100UI/ml) - Epinehprine 1:1000 - diphenydramien 50 mg/mL - methlyprednisolone 125mg/2mL - naloxone 1mg/mL in 2mL vial - promethazine 25 mg/Ml - glucagon inj. 1 mg/mL - Furosemide 10 mg/mL - Lidocaine 2.5% and prilocaine 2.5% in a 5 g tube - Lidocaine soln. 1% in a 2mL vial
requirements to use expanded formulary: TSBP allows if at least serving 80% indigent/poor pts to provide other drugs
i. supportive personnel as in nurses/practitioners ii. policies/procedures for drugs on formulary that require special monitoring iii. retrospective drug regimen reviews quaterly basis randomly iv. if RPh provides antipsychotic drugs, must be initiated by physician of the clinic and PCP monitor ongoing therapy; pt examined annually
what's the Federal Hazardous Substances Act of 1966?
i. the Consumer Product Safety Commission administers and enforces this act which is intended to PROTECT consumers ii. Requires the label on the immediate package of hazardous product AND outer wrapping/container iii. does not apply to drugs regulated by FDA but may apply to other products sold in a pharmacy (bleach, cleaning fluids, antifreeze)
When can a controlled medication be delivered?
i. the RX container is labeled in compliance with RX labeling rules ii. outer wrapper must be free of markings that would indicate the nature of the contents (do not include pharmacy name) iii. no markings of any kind may be placed on the package to indicate the nature of contents
When can an electronic order NOT be filled?
i. the required date field have not been completed. ii. order is not signed using a digital certificate issued by DEA iii. digital certificate used has expired/been provoked iv. purchaser's public key will not validate the digital certificate v. validation of the order shows that the order is invalid for any reasons
what are securty features of the Official RX Forms issued by TSBP to PCPs? [for CII Substances]
i. unique control number ii. pantorgraph that reveals the word 'VOID' when the form is copied; iii. thermochronim ink on the front with the symbol "RX" that disappears briefly when rubbed iv. watermark of the Seal of Texas that is visible from either side in regular light.
valid RX from which healthcare professionals
i.. MD & DO ii. Dentists (DDS/DMD) iii. Podiatrists (DPM) iv. Veterinarians (DVM) v. OD (optometrists) vi PAs (dependent authority) vii. Advanced Practice Registered Nurses (APRN) - dependent authority
Isotretinoin (accutane) under which REMS Program?
iPLEDGE
Pharmaceutical equivalent definition
identical dosage forms and route(s) of administration that contains identical amounts of the identical active drug ingredient
when can a pharmacy be permitted to reuse a glass container?
if a new safety cap is provided with each fill?
when can a dosage form not be changed?
if enteric-coated or timed-release production
When is a notification required to PCP if a product has been substituted?
if it is a biological product and w/in 3 days to notify PCP
Can pharmacies add flavoring?
if request by pt AND it does not effect or alter clinical outcomes only OTC drugs if prescribed
When are the drug labeling requirements NOT needed?
if the drug is for admisntration to an ultimate user who is institutionalized (hospital/nursing home) and no more than a 90-day supply is dispensed at one time
Perpetual inventory of Schedule IIs
in class C -ASCs (amulatory surgical centers) class F pharmacies
When can PA/APRN prescribe CII?
in hospital settings when pt has stayed 24 hrs or in ED/have terminal illness/hospice care [no limits to CIII-V] but CANNOT EXCEED 90-DAY SUPPLY
what record does TSBP require to keep for 7 years?
initials and identification code shall be unique and this logg shall be kept for 7 years
what does medical devices include?
instruments, machines, implants, etc
Facilities w/ part-time or consultant pharmacist , how many days to verify withdrawal of drugs?
interval do not exceed 7 days but review drug regimen w/in 96 hours if daily census is above 10 and w/in 7 days if census is <10
You can only transfer a controll RX when:
it has already be filled at the other pharmacy
when can you not recieve a Texas RPH license?
license in another state has been restricted, suspended, revoked, or surrendered.
Remote pharmacy services using an emergency medication kit:
locations where pharmacists are not present to dispense controlled substances - allows pharmacies w/in 20 miles of a facility (nursing homes, etc) to provide services to facilities (under Health and safety Code Chapter 242) or (chapter 252: intermediate care facilites for the mentally retarded) using an emergency kit - allows VA pharmacies to dispense emergency medication kit to Texas State verterans Home - need an application to TSBP first
where are controlled substances able to be transferred to?
made to the address listed on a DEA registration.
What are required from NDC numbers
manufacturer must lists its product with FDA NDC # technically not required on the drug's label; they are there to facilitate automated processing of drug data by government agencies, third-party payers, wholesalers, and manufacturers
When do we need a signed authorization for patient's PHI?
marketing purposes (patient must be informed about remuneration/Compensation for advertisement)
Max amount of days optometrists can prescribe for controlled substance in CIII-V?
max 3 day supply of CONTROLLED substances
Noncontrolled substances that are dangerous drugs info on mailing
may be delivered by the pharmacy to the ultimate user provided that the medications are not alcoholic beverages, poisons, or flammable substances
Privileges of Glaucoma Specialists
may prescribe PO or parenteral drugs to treat glaucoma
failure to provide PPIs is misbranded or adulteration
misbranded
failure to provide a medication guide is misbranded or adulteration?
misbranded
violating PPPA is misbranding or adulterating?
misbranding
Remote Pharmacy Services Using Telepharmacy Systems
monitors rx being dispensed and provided drug regimens and pt counseling through audio, vidia, image capture, and store/forward.
how often should computer sytems be backed up
monthly
how often do PIC/consultant/staff RPh visit the Class D clinic?
monthly; but state/governed clincis can petition TSBP for an alternative visitation schedule
Medium risk sterile compounding level:
multiple sterile products combined to multiple pts or complex aseptic manipulations - TPN fluids w/ multiple injections; filling resevoir and infusion devices; transfer of volumes from multiple ampules/vials into single final sterile product -stored 30 hours at room temp, 9 days refridgerated, 45 days frozen
Media-fill tests (to check purity area for sterile compounding)
must be conducted at each pharmacy where an individual compounds high-risk sterile preparations
notifying DTM and CE requirements:
must notify TSBP prior to engaging in DTM - 6 hrs of CE annually related to drug therapy
How do Class E compound sterile RX?
need to register with TSBP as a Class E-S pharmacy
Do PCPs need to register with DEA again if in the same state but at different locations?
no
can pharmacies sell, purchase, trade or possess RX drug samples
no
are pharmacists subject to crimnial, civil, or admisntrative penalties for dispensing or refusing to dispense a controlled substance under a RX that exceeds the limits provided?
no (thank god) where a PCP can prescribe a patient in a follow-up appointment and receive another opioid RX for up to 10 days
does the class C with Class A need another onsite inspection?
no because they have already been inspected for Class C and can be waived
Can Officials in the u.s. armed service prescribe Schedule II outside their base?
no filling off base or out of the facility where they practice (because they would not be written on a Texas Official RX form)
What's the highest amount for optometrist/Glaucoma specialist can prescribe for cocaine eye drops?
no more than 10% in prepackaged liquid form (can't be compounded) [cannot dispense unless DEA registrations allows them to, and up to 2 vials only]
how many hour to review withdrawal of controlled substances in Class F?
no more than 72 hours reasonable time for dangerous drugs (w/in a week at least) or part-time RPh must check w/in a calender week
Limited amount of Sodium Phosphates in OTC container?
no more than 90 mL of sodium phosphate per OTC container
are practioners able to self=prescribe or prescribe for family members?
no prohibitory to prevent that; everyone can be prescribed by PCP for both controlled and dangerous products [inappropriate prescribing is against though]
are facsimile RX valid for schedule II?
no the are not (aka copies/verbal)
are there ratio of pharmacist to techs in Class C settings?
no there is not [tech-check-tech if preivous order has been verified by RPh]
are refills available for radioactive medications?
no they are not
are optometrists able to treat patients with oral drugs?
no they are not, neither with parenteral drugs, to treat glaucoma [but may treat dangerous drugs for eyes as long as they aren't PO or IV/IM
Can a pharmacy compound a non-sterile product that essentially copies a commercially available product?
no, UNLESS the prescribing physician specifically orders the strength or dosage form and specifies why the pt needs the product compounded [for sterile product as well]
Can both remote healthcare and dispensing site dispense CII susbstances?
no, only at the healthcare sites (resitricted at dispensing site)
can original RX be transfer for CIII-V?
no, only refills
can a Thalomid RX be transferred?
no, unless there is prior authorization from Celgene.
In Texas, must anyone register to manufacture, distribute or dispense controlled substances?
no.....
What are considered Exempted RX Drug Products (to not be controlled)?
non-narcotic containing small amounts of Pehnobarbital, butalbarbital, chlordiazepoxide or meprobamate e.g. Fioricet (butalbital, APAP and caffeine)
What's a Class E pharmacy?
non-resident (not located in Texas) - deliver RX to patients in Texas/process RX order for pt in Texas/ or perform pharmaceutical services defined by Board Rule
B coding system
not therapeutically and pharmaceutically equivalent
What pharmacies must do to notify FDA of illegitimate products? (DSCSA)
notify FDA using Form FDA 3911 and notify trading partners w/in 24 HOURS; pharmacies must work w/ manufacturer to PREVENT illegitimate products from reaching patients.
what must the RPh do if PCP fail to send RX for the verbal SCHEDULE II within 7 days?
notify nearest DEA office
how many tiems can CIII-V be transfered?
one time basis [if within same pharmacies that share computer system in real-time, may transfer up to maximum number of refills permitted]
What is the remote dispensing site for telepharmacy?
only Class A (community) can provide services at these remote areas staffed by techs. -a locationed licensed as a telepharamcy, authorized by provider pharmacy to store and dispesne drugs and devices (including dangerous drugs and controlled substances)
in Texas only, who can verbally communicate emergency CII RX to a pharmacist?
only PCPs, not agents/nurses of their officies DEA is not resitricted to PCP's only
Where can a RX pick up location occur?
only a location/pharmacy licensed by the Board (no firm, business, etc.) - request by the patient, at prescribers office/home; place of employment of pt, or hospital/medical care facility were pt is receiving tx
In Texas, how can a biosimilar be substituted?
only biological products that be seen DESIGNATED "interchangeable" may be substituted for the original reference product by a pharmacist
How can animal prescription be dispensed?
only by a lawful written order of a licensed veterinarian
how many facility can a PIC be for if more than 101 beds?
only one facility [if <100 beds, max 3 facilities or max 150 beds]
Do Class E Pharmacies need a Texas License?
only the PIC, not individual pharmacist working there
how to dispensed dangerous drugs in Class D Pharmacy
only the pharmacist can dispense a dangerous drug based on a drug order
what medications must PCP and RPh check PMP for?
opioids BZDs barbiturates carisoprodol (soma)
What are business associations (BAs)?
persons/entities that are not members of a pharmacy's workforce who perform a function or service on behalf of the pharmacy that requires the use or disclosure of PHI (collection agencies, external auditors); meet same requirements for protecting PHI
RX side effect statements
pharmacies/pharmacist need to provide SEs statement to patients when dispensing new and refil RX in outpt setting statement: "Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088" - Can be on container, separate sheet of paper, cap, medguides or CMI
what happens when a PCP dies?
pharmacist can dispense 30-day supply and notify patients to find a new PCP
what does it mean when a state enters a MOU w/ FDA? -503A: compounded drugs based on individually identified patient
pharmacy is considered to have distributed an inordinate amount of compounded drug products in interstate commerce - distributed interstate during calendar year is >50%: when RX orders the pharmacy sent out during the same calendar year PLUS # of RX dispensed at the pharmacy during the same calendar year.
if a pharmacist is not actively working, what can they do?
place their license in an inactive status - to activate again, must pay fee and meet specific CE requirements
How can a controlled substance be delivered to other DEA registrants (PCPS, other pharmacies, etc.)
placed in a plain outer container/securely over-wrapped in plain paper and all record keeping requirements are met
how long back must the pharmacy continue to pt medication records?
previous 12 months for drug regimen review but 2 years for list of all drug orders dispensed to pt
For high-risk compounding, in addition to low/med risk; must require:
primary engineering device located in buffer area that provides physical sepraration through walls/door/spass-throughs and a minimum differential positive presure of 0.02 to 0.05 inches water column
what does interchangeable product mean?
product that has been shown to be biosimilar to the reference product and can be expected to produce the same clinical result in any given pt
example when drug is both misbranded and adulterated
product's strength differs from what is represented on its label
what does the rating AB mean?
products with actual or potential bioequivalence problems, but has been established as bioequivalence for those products
when do we not check PMP?
pt diagnose with cancer or in the hospice program, or has sickle cell disease - if PCP & RPh is unable to access PMP after making and documenting a good faith effort to do so
what must be placed in warning section when potassium salt is taken with enteric coated thiazides?
regarding non-specific small bowel lesions consisting of stenosis, w/ or w/o ulceration
What pharmacies can compound sterile products?
registed Class A-S, Class C-S Must follow 503A/B
Reporting losses of pseudophed
reported to DEA earliest practicable opportunity
Whats the Federal Transfer Warning?
required on label of Schedule II-IV substances when dispensed to patient - "caution: Federal alw prohibits the transfer of this drug to any person other than the patient for whome it was prescribed"
Computers must have the capcity to produce a daily hardcopy prinout of:
rx# date of dispensing PCP's name name/strength of drug dispensed quantity initials/code of RPh
ratio for Nueclear Pharmacy
same 1:6 (no more than 3 trainees)
How do Class E Pharmacies counsel pts on delivered medications?
same as Class A pharmacies in Texas; provide written information regarding RX drug, along w/ RPh being available via toll-free telephone number for counseling
The unique rule in Texas (mentioned previous)
texas allows filled RX to be deliverd to pts in the pharmacy for up to 2 hours after pharmacy department is closed - useful in location such as grovery stores where RX department is closed but rest of the store remains open (HEB; Wal-Mart)
who regulates companies that manufacture and repackage MEDICAL DEVICES?
the FDA does
Which license can you make a copy of?
the POCKET license
FDA Orange book definition
to be generically equivalent, drug must be both pharmaceutically and therapeutically equivalent to the brand-name drug
What warnings must Mineral Oil contain?
to be taken only at bedtime and not be used in infants unless under advice of a physician (label cannot encourage use during pregnancy)
Requirements from techs/trainees
to finish training manual with PIC from TSBP
what warnings must isoproterenol inhalation preparations contain?
to not exceed dose prescribed and to contact prescriber if difficulty in breathing persists.
more practitioners to seek DATA waiver
under HHS to limit tx no more than 30 pts to apply for waiver w/o having to meet DEA requirements (training, counseling, and other ancillary services)
Remote pharmacy services using automated pharmacy systems
under Health and Safety code chapter 142 (home and community support service agencies; hopsices) and 242 (nursing homes), 247 (assisted living facilities, and 252 (facilities for mentally retarded pts), jails/prisons - DEA registration needed for controlled substacned in automated system with name of pharamcy providing remote pharmacy services and TSBP application - pharmacist approved release of initial dose after receiving valid prescription drug order (can do it electronically and track electronically) - drugs in automated system must be packaged by original container or packaged in providing pharmacy. - keep records of drugs going to and returning from remote location - perpetual inventory maintained at each remote location of controlled substances on same day as the provider pharmacy's inventory
What is Texas HIPAA to privacy laws when patients request for confidential records/
w/in 15 days federal (30 days)
how many days to comply with a request to amend an accounting of disclosures?
w/in 60 days (+30 days delay with notifiable reason to patient)
waivers for electronic prescribing:
waivers must be issuded by agency that licenses the practitioner and are valid for one year but can be renewed
what must OTC products containing iron include?
warnings on "accidental overdose of iron-containing products is a leading cause of fatal poisoning in children under 6. Keep this product out of reach of children, in case of accidental overdose, call a doctors or poison control center immediately."
when does the 90-day supply of Schedule applies?
when PCP issuing multiple RX for Schedule II on same day w/ instrcutions that some RX are not to be filled until a later date except opioid drugs for treatment of acute pain (10 day supply) .
When do the limits of opioid NOT apply?
when an authorized practititoner for the treatment of substance addiction
disease reporting for bioterrorism, epidemic/pandemic
when increase in # of RX (abx) to treat respiratory or GI complaints or fever
When can a tech initiate transfer requests?
when it is between pharamcies sharing a common database
When does a Class A balance is needed
when the pharmacy compounds RX drug orders
When are products exempted from in track and trace? (DSCSA)
when they are blood/blood components, radioactive drugs, imaging drugs, certain IV products for fluid replacement, dialysis solutions, medical gases, compounded drugs, medical convenience kits containing drugs, sterile water, and products for irrigation
When can a person be a PIC to 2 Class A pharmacy?
when they are not opened at the same time or during an emergency (if they work at each pharmacy at least 10hr/week but not for 30 day excutively)
When can pharmacies use patients PHI w/o authorizations?
when they need to provide payment for treatment and for healthcare operations may disclose for certain governmental functions w/o authorization when reporting ADRs to FDA, or state drug monitoring programs and to law enforcement
are opioids on REMS list?
yes
Do we keep records of schedule II and Schedule III-V separately?
yes Records include DEA Form 222 and suppliers Invoice
do remote pharmacy services using automate dispensing and delivery systems need to be renewed and if so, how often?
yes and every 2 years
can the TSBP representative/office initiat disciplinary action?
yes if i previously cited violations are continuing to occur ii violations are of nature written warning notice would not be in the best interest of the public
are CIII-V allow emergency refills?
yes they are, both TSBP and DEA have not regulated a rule for this
do we need to document when compounding a commercial product when it is not available?
yes we document lack of availability and prescriber has request the drug to be compounded
When a pharmacy is closed, can it use the Automated dispensing and delivery device to deliver RX?
yes, and not restricted to the 2 hour limitation
do pharmacies need to be licensed itself?
yes, each location needs their own license [hospital w/ outpt only needs a Class C license but must follow Class A rules]
does DEA and TSBP allow a controlled substance to be transfer even if not filled yet?
yes, if the original RX was transmitted electronically and it can be forwarded electronically
if a medical device or dietary supplement contains a NDC number, is it misbranded or not?
yes, misbranded medical devices have UDIs (unique device identifiers)
Can the public check validity of a license?
yes, they can request proof of each pharmacist, tech, intern, trainne to hold appropriate license/registration
if a patient presents a claim to a RPh, tech/intern, must they report it to TSBP?
yes, they must report claim to TSBP and inital report is required w/in 30 days of receiving claim notice - follow-up notice w/in 105 days after disposition (settlement, dimissial, judgment) of claim
are pharmacist allow to compound drugs for animals?
yes, under certain circumstances (when the source of the active ingredient is a finished FDA-approved drug, and not a bulk drug substance)
are pharmacist able to dispense human drugs for animals?
yes, veterinarians can legally prescribe human drugs for animals --> extra label or off-label use