Minnesota MPJE
To transfer license (reciprocity) RPh must: (practical hours needed per grad time frame)
-Take MN MPJE through NABP -if grad before 1973: 2080 hrs practical experience -grad 1973-2003: 1500 hrs. - grad after 2003 1600 hrs. 800 in dispensing
How many sq ft required for dispensing and drug storage area?
250 excludes satellite
how big does the pharmacy have to be?
250 sq. ft.
Tech: RPh ratio?
2:1 hospital 3:1 (plus 1 if one is certified) this does not include interns from school
How many hours of CE are required?
30 hours every 2 years
How wide does the aisle behind the counter need to be?
36 in wide the full length
How wide is the aisle behind the Rx dispensing counter?
36"
Date limit for dimension or security change? How soon until approved?
60 days If not informed within 30 days by the board, consider it approved
Date limit for establishment of a satellite? How soon until approved?
60 days If not informed within 30 days, consider it approved
How long is a CII Rx valid for a patient in a LTCF or a Terminally Ill patient?
60 days May be partially filled as many times as necessary, as long as the total dispensed quantity over time does not exceed the quantity it was written for
How long does the board have to grant approval or denial of a CE course?
60 days (so you better get it in before 45 days...)
What is the maximum amount of pseudoephedrine that can be sold OTC to an individual in a given day? Fed and MN: daily limit vs 30-day limit
Daily limit: 3.6 grams (Federal), 6 grams (MN) Monthly (30 day) limit: 9 grams (Federal), 6 grams (MN) Overall limit (strict laws preside): Daily 3.6 g Monthly 6 g
What do you need to record when destroying portions of meds left behind by boarding care home residents?
Date name of drugs quantity destroyed rx # Record this in their personal care record!
What is requried on label of parenteral soln dispensed for pt for home infusion therapy?
Date of compouding BUD storage requirements if other than RT infusion rate admin times/freqeuncy
What has to be recorded w/ each refill of an rx?
Date of refill initials of pharmacist/intern that verified
Can you project over/under payments during an audit based on the number of pts with a condition/receiving that rx?
No Cannot assess any chargebacks if no financial harm to pt or plan
Can the brand name be placed on the label when a generic is dispensed? If so, what wording is required?
No explicit provision
How many members are in the CE Advisory Task Force?
No more than 10 members: a. 3 from MN State Pharmaceutical Assoc. b. 3 from MSHP c. 2 from U of M COP d. 2 from the board
How many doses of a controlled substance may be in an emergency kit?
No more than 6
How often can you refill C3-4?
No more than 6 mo, or 5 refills.
Who decides what is in an emergency kit?
Quality Assurance and Assessment Committee
How often does the RPh need to prepare a written report on the status of the service?
Quarterly
How often does the CE advisory task force meet? How is their leadership selected?
Quarterly Elect chair and vice chair from membership Executive director of BOP serves as secretary
Can a patient refuse to give certain information for their profile?
Reasonable effort must be made to get the info No reference to refusing certain info or documentation If info is obtained by nonpharmacist, pharmacist must review the info with the patient
T/F Someone knowing of someone else's unsafe practice HAS to report it to the board?
The language says 'may report,' and this fullfills the reporting requirement in the professions own practice act
What is the max beyond use date for both blister, Rx vials, and unit dose?
1 yr from date of packaging or manuf exp date- whichever is sooner.
What addtl references must pharmacies that serve LTCF have?
1. Mn Dept Health rules pertaining to med handling in LTCF 2. current general reference on geriatric pharmacotherapy
How does one become a cancer drug repository? (2)
a pharmacy or medical facility notifies board of volunteer choses: full: store & admin, or limited: store only. (can withdraw anytime with notice)
What needs to be done after delivery of completed Rx?
certifying the completed Rx and counseling
What changes do interns need to notify BOP of?
change of address or employment
A RPh must approve all drugs going into ADS except?
circumstances and drugs specifically approved by a P&T committee
What training must PIC have to provide home health care services? Where training from?
compounding, sterile prep. Usually from residency, CE programs, or prior work experience in IV admin facility.
How frequently must data be submitted to the program?
daily *board may grant permission to submit less often if only occasionally dispense CS rxs or for some other valid reason *can find form on board website
can RPh admin drugs?
first dose and medical emergencies
What type of drug delivery system cannot be the primary type?
floor stock distribution (Need a system that keeps people out of pharmacy when a pharmacist is not around.)
Can C Rxs be sent electronically?
follow Fed DEA regulations
What are the regulations of C faxed Rxs?
follow Fed DEA regulations
Who appoints members?
governor (to reflect state geography, mix of pharmacy practices)
Who appoints members to the BOP?
governor MNPhA and MSHP may jointly recommend 5 names for each pharmacist to be appointed
When does any board regulated person need to notify board of a change in address/employment?
immediately
When does a PIC successor need to be named?
immediately after
How much can the contracting pharmacy charge LTCF pts?
monthly fee ≤250% of medical assistance program dispensing fee for each drug repackaged, but no more than $100 for each indvl resident
What needs to be on IV admin label? (9)
name/vol. soln pt name control number PRN name/quantity additive inf rate storage requirements date/time to admin beyond use date aux labels PRN
When must BOP know of tech name/address change?
with in 10 days
When must the final audit report be delivered to the pharmacy?
within 120 days of receiving the preliminary report or the final appeal, whichever is later
Where must the training for supportive personnel be?
written in training manual
Are those who report to the database in good faith immune from liability?
yes
Can RPh do MTM outside O.P. setting?
yes
Can a dispenser be subject to disciplinary action for failing to submit data?
yes
Can a pharmacy exclusively handling radioactives be exempt from building/equipment standards?
yes
Can a pharmacy maintain one pt profile for all family members living at same address w/ same last name?
yes
Can cs be in unit dose?
yes
Can pharmacists sell topical ocular drugs to optometrists that are certified to work with them?
yes
Can prescribers in another state, who have valid DEA # in that state, prescribe and fill orphan drugs here?
yes
Can tech call MD for refill auth in hospital/ O.P?
yes
Can tech compound is hospital/ O.P?
yes
Can tech lose license for breaking rule in another state?
yes
Can the above be waived for a satellite pharmacy?
yes
Can the commissioner prescribe mass dispensing for TB or other communicable diseases?
yes
Can unit dose come connected on a card?
yes
Can you give discounted meds to > 65 yo?
yes
Do APNP need own DEA number?
yes
Do med storage areas need security system?
yes
Do precursor drugs have to be kept behind the counter?
yes
Do pt have freedom to choose any pharmacy?
yes
Do techs need to be registered?
yes
Do they need to share common electronic software?
yes
Do users of ADS need biometric ID?
yes
Do wholesale facilites also need a separate place for expired, misbranded, adulterated meds?
yes
Do wholesale facilities need an alarm system?
yes
Does BOP need to maintain record of approved CE/hrs?
yes
Does MN BOP have laws regarding home O2 dispensing?
yes
Does MN have dangerous drug law?
yes
Does MN recognize VAWD?
yes
Does MN support Expedited Partner Therapy?
yes
Does a Rx from an ADS need to be verified by RPh before dispensing?
yes
Does a pt need to be notified of central fill?
yes
Does an MD treating a pt w. intractable pain need to document the discussion?
yes
Does attempting to circumvent the consulting requirment constitute misconduct?
yes
Does each pharmacy need its own license?
yes
Is a separate license needed per each location?
yes
Is it the duty of the board to enforce the provisions of the chapter?
yes
Must each incoming/outgoing shipment be examined for contamination?
yes
can support personnel participate in unit dose?
yes
Does one need to register as an intern? what submit? What get from BOP? How long good for?
yes -submit progress reports -get intern card -complete manual if >400 hr in MN -good for two years while resident
Does PBM need to give pharmayc notice of audit? if so, how many days
yes 14 days
Are RPh prohibited from accepting meds to reuse from pts? What is the exception?
yes hospital when meds never left pharmacy control
Does each pharmacy need a PIC? Does board need to know who?
yes name must be on designated on the license
If somone gets license revoked/suspended can it be reinstated?
yes (w/o examiniation) if BOP decides to and fee is paid and no more than 2 yrs has passed.
Do pharmacy and central fill need same owner?
yes OR written contract outlining services
Can a Rx that has never been filled be transfered?
yes as long as all the data was properly entered into the computer system and placed on hold/profiled
can one buy syringe/needle w/o Rx in MN?
yes if 10 or less
Can the meds be returned and reused if in pharmacy blister packs?
yes if blister pack is class B or better and if no commingling with other lots
Can meds returned from jail be reused?
yes if locked storage, and personnel 24/7
What must Pharmacy do that sells needles/syringes to the commissioner?
certify to commissioner of health that they support proper disposal
Can pharmacy advertise they sell hypodermic syringes?
no must be stored in manner where not openly available to customers
Can tech accept called in Rx in I.P/O.P? Transfer Rx?
no no
When do the requirements for pt med profiles not apply?
nursing home where consultant pharmacist is performing regular med reviews
What drug related things can optometrists NOT do?
o Administer legend drugs IV, IM, or by injection except for tx of anaphylaxis o Perform invasive surgery including w/ lasers o Administer or prescribe C2/3 oral drugs o Prescribe or administer oral antivirals for more than 10 days o prescribe or administer oral carbonic anhydrase inhibitors for more than 7 days
what additionally must outpt iv drugs have on label
o Date of compounding o BUD o Storage requirements if other than RT o Admin times, freq, both o Other accessory cautionary info which deemed necessary or desirable by pharmacist
What information do dispensers need to submit to the electronic reporting system?
o Name of prescriber o NPI of prescriber o Name of dispenser o NPI of dispenser o Rx # o Name of pt for whom rx was written o Address of pt o DOB of pt o Date rx written o Date rx filled o Name and strength of CS o Quantity of CS prescribed o Quantity of CS dispensed o # of days supply
Requirements for inpt AND outpt labels
o Name, address, phone # pharmacy (central pharmacies use info of dispensing pharm) o Pts name o Rx # o Name of prescriber o Directions for use o Name of mfr/distributor of finished dosage form o Auxiliary labels prn o Date of original issue/renewal o Generic or trade name and strength except when specified by provider to the contrary In cmpd basic pharm ingredients, the common name and strengths of principal active ingredients or category of use name shall suffice o Identifier that indicates central service pharmacy if applicable o Physical description including any ID code that may appear on tabs/caps (does not apply to drugs dispensed as part of investigational study)
Which drug specifically always needs an Rx, no matter how much in compound?
phenobarbital
Can needles/syringes be accessable? Can you advertise buying them w/o Rx?
need to be behind counter or locked up CANNOT advertise them
What type of formualry does MN use?
negative- annual list of med excluded from substitution
Can C's be in home health emergency box?
no
Can a license go to place of business = personal residence?
no
Can optometrists dispense legend drugs at retail?
no
Can vets write CS rxs for humans?
no
Does RPh need to sub cheapest if 3rd party then wont cover or is not on formulary?
no
Does a beyond yse date need to be on a Rx vial?
no
Does the licensing fee increase if licensing in 1+ category?
no
Does PA have full prescribing rights?
no, dependant under MD
Do all health care boards need to be apart of this committee?
no, they can enter and leave with written notice by each Janaury 1st of the biennium.
Does the BOP certify techs?
no, they register them annually
Are gifts allowed to by manuf/wholesale to practitioner?
no, unlawful, unless: -sample for free - < 50$ value per year - payment to sponsor a program not going directly to MD - compensation for genuine research project/consulting
Does closing pharmacy need to send final inventory to DEA?
no, unless requested.
Are RX public records?
no- HIPAA
Can a RPh participate in a plan that limits pt choice of pharmacy?
no.
When must a pharmacy provide a copy of its Notice of Privacy Practices to a patient or other person requesting one?
A "Notice of Privacy Practices" must be given to each patient when first provided service in the pharmacy. Ideally, the pharmacy should receive and retain an acknowledgement that the above notice was given. The acknowledgement is needed only the first time service is provided.
Can a regulated person voluntarily leave the program?
yes, then the board has 30 days to investigate and temp. suspend the person's license.
Does pharmacist license have to be on display?
yes- can be original or official copy
Are meds for LTCF pt required to be discounted?
yes- under either fed or private health plan
is it the law to have imprints on pills? Can some pills be exempt?
yes. manuf/distributors need to to BOP printed info. Can ask to exempt certain pill types
Does documentation of training for the ADS need to be kept?
yes: names, initials, of both trainee and trainer with date
What is tech CE requirement?
20 CE due every two years, every *odd numbered* year.
How many days notice must pharmacist be provided of a hearing?
20 days
How long must PSE/Methamphetamine sales records be kept?
5 years
How long does pharmacy have to alert BOP if loses dispensing info due to unscheduled system shutdown?
72 hrs.
When do used meds need to be replaced by?
72 hrs. (and boxed sealed by then too)
what level must major work areas be lit to?
75 foot candles or more
What are the sterile and non-sterile compounding standards?
795 and 797
What requirements need to be meet for sterile space?
797
How many hrs need to be from dispensing?
800
How many hours must be dispensing?
800 hours
What type of CS must be reported?
All C2, 3, 4 rxs dispensed in MN *includes drugs that are C3 in MN but C5 federally *includes for non-MN residents but dispensed in MN, even mail order
How much of the hospital is under RPh control? How often inspect these areas?
All areas with drug storage monthly inspections with records
Is OBRA counseling required for Medicaid only or all patients? (specific requirements, 3)
All patients 1. Every pharmacy must develop and maintain a written patient consultation procedure providing for direct oral communication between the patient and the pharmacist. 2. The pharmacist must consult with the patient/agent/caregiver and inquire about the patient's understanding. 3. New prescriptions: following a review of the patient's record, the pharmacist shall personally initiate discussion to enhance or optimize drug therapy. The discussion shall be in person, whenever applicable, can be supplemented with written material, and shall include appropriate elements of patient counseling. (NOTE: The pharmacist must also counsel the patient on a refilled prescription if deemed necessary according to the pharmacist's professional judgment. The consultation must be in person whenever applicable.)
What must be on the label of a multiple-dose container dispensed for a patient in a hospital? (3 drug things, 4 other things)
Hospital multiple-dose label for an inpatient chart order: 1. patient name 2. drug name, strength, route (when necessary) 3. auxiliary labels (as needed) 4. exp 5. date dispensed
How soon must theft of controlled substances be reported to the DEA?
IMMEDIATELY
How soon should an RPh or intern notify the board of a change in address or place of employment?
IMMEDIATELY
What are the requirements for an Immunization Protocol? (6)
Protocol requirements: (A) the name, dose, and route of each vaccine (B) the patient population (C) contraindications and precautions (D) the procedure for handling an adverse reaction (E) the name, signature, address, and telephone of the physician, PA or APRN (F) date and time period protocol is valid
how can you label a small container?
Pt name and Rx number on little vial rest of info on label on outer container
What is the status of carisoprodol? Tramadol?
State is same as federal: Carisoprodol (Soma): Schedule IV Tramadol (Ultram): Schedule IV
What is punishment if dispenser does not submit the data?
Subject to disciplinary action by appropriate health licensing board
Can printed materials satisfy the counseling requirement?
They can be a supplement to the in person counseling that must be provided whenever applicable If delivered or mailed, printed materials can satisfy the counseling requirement if toll free number with availability of pharmacist to answer questions
T/F: BOP can deny/revoke license due to lack experience
True
Where can cutotoxic drugs be compounded?
Vertical, Class 2 biologic safety cabinet
What does a RPh need to do to reactivate an inactive license that's inactive > 5 yrs.?
take the MPJE
Using tech to do non-tech work is misconduct on:
tech, supervising RPh, and PIC
Who can request a varience from any rule of the BOP? How request?
the PIC or operations manager of manuf/wholesaler. submitted in writing
What pricing info needs to be given to pt who has 3rd party?
the amount the pharmacy got paid by the 3rd party
Who is ultimately responsible for the tech?
the licensed pharmacist working under
How must all papers be captioned?
"Before the MN BOP" and "In the manner of the suspension or revocation of the ___ of ____ respondant" -respondant is party whose license is involved.
What two statements need to be on all C Rx's?
"Caution, taking this alone or w/alcohol may impair your ability to drive" "Caution, Federal law prohibits transfer to any person other than who prescribed"
What must be on all packaging, inside and outside, of radioactive meds?
"Caution-Radioactive Material"
What statement must be on medical gas?
"Caution: fed law prohibits dispense w/o Rx"
All legend Rx need what saying:
"Caution: fed law prohibits dispensing w/o Rx"
What statement must be on vets meds?
"Caution: fed law restricts this drug to vets"
If legit copy of RX is given- what needs to be on it?
"Copy for information only"
Is there any provision for dispensing an emergency refill supply of legend drugs when there are no refills left and the prescriber cannot be contacted? What is allowed/required?
"No prescription shall be refilled except with the written or verbal consent of the prescriber"
What can CE programs publicize regarding board approval?
"This program is approved by the MN BOP for ___ hours of CE credit."
What must a pharmacy post regarding dispensing the cheapest med?
"Whenever possible, we'll sub a FDA approved, unless you object."
What must be on a poison/done to sell? (3)
"poison" name/address seller for legitimate use
What must RPh put on face of Rx?
"terminally ill" "LTCF pt"
How are BOP members compensated?
$55/day spent on board activities reimbursed child care expenses
What does require a PDR?
(1). A patient visits a physician in the physician's office and receives a prescription. The patient has the prescription filled in a retail pharmacy. (2). A pharmacist fills a prescription for a patient who lives in a personal care home (3). A pharmacist in a hospital pharmacy fills an outpatient prescription for a hospital employee (4). A patient is treated on a non-emergency basis in an outpatient clinic of a hospital and is given a prescription (5). The patient has the prescription filled either in the hospital pharmacy or in a retail pharmacy
What does not require a PDR?
(1). An order for a drug for an inpatient of an institution (2). A drug dispensed in an emergency room (3). A drug dispensed by a medical practitioner (4). A drug dispensed by a pharmacist to a medical practitioner who will administer it to a patient
The Prescription Electronic Reporting Advisory Committee consists of whom? (9)
(1). the Department of Health (2). the Department of Human Services (3). each health-related licensing board that licenses prescribers (4). a professional medical association, which may include an association of pain management and chemical dependency specialists (5). a professional pharmacy association (6). a professional nursing association (7). a professional dental association (8). a consumer privacy or security advocate (9). a consumer or patient rights organization
For each drug repackaged by a contract pharmacy under this section, the contract pharmacy shall maintain a record of what information? (10)
(1). the name, manufacturer, manufacturer's lot number, manufacturer's expiration date, and quantity of the drug prescribed; (2). the name and address of the resident for whom the drug was repackaged; (3). the name and address or other identifier of the prescriber; (4). the date the prescription was issued and the date the drug was repackaged; (5). the date the repackaged drug was delivered to the long-term care facility; (6). the directions for use; (7). a copy of the label that was affixed to the repackaged drug; (8). the initials of the packager; (9). the initials of the supervising pharmacist; and (10). the name and business address of the original dispensing pharmacy
Pharmacotherapy reference examples
(Goodman/Gilman's, Applied Therapeutics, Pharmacotherapy: A Physiologic Approach, Conn's Current Therapy
What supplies must every pharmacy have?
- 1 rx balance, Class A as defined in USP-NF w/ accurate metric weights from 50 mg to 100 g or electronic balance -Measuring devices 1 ml to at least 500 mL -Mortars, pestles, spatulas, funnels, stirring rods, heading apparatus as necessary -Other equipment necessary to comply w/ requirements of USP, chapter 795 -Refrigerator used only for drug storage or separate compartment used only for drug storage w/I general use refrigerator, electromechanical/electronic temperature recording equipment/devices/logs -Sink w/ hot and cold running water -Toilet w/ hand washing lavatory and disposable towels in location that is reasonably accessible
Who can recieve donated product?
- MN pt Dx w/ Cx - 18+ yo - uninsured/ MN MA
Requirements for becoming pharmacy intern
- good moral character -not physically or mentally unfit -Successfully completed educational requirements for intern registration prescribed by board • Board shall prescribe training requirements for interns, preceptors, and internship training but may not require >1 year of such training • Board may accept internship experience obtained in another state provided requirements in the other state are in equivalent in the opinion of the board
Rx or drug order for WHICH DRUGS is not valid unless can be established that rx or order based on DOCUMENTED PT EVALUATION that is adequate to establish diagnosis, identify underlying conditions and CI to tx.
-CS -Muscle relaxants -Centrally acting analgesics w/ opioid activity -Drugs containing butalbital -PDE5 inhibitors when used for ED
What is punishment if indvl authorized to access database knowingly discloses data in violation of state/federal law?
-Civil penalties AND -Disciplinary action by appropriate health licensing board
Removal of high alert drug needs a witness except?
-When RPh has verified order prior to -licensed practitioner is getting/admin med -MD needs before RPh can verifiy
When can the board release the name of a prescriber on the database?
-With the written consent of the provider -search warrant -court order
What info needs to be on a Rx dispensed other than inpatient?
-all info on regular Rx -name of central fill pharmacy if applicable -physical description of med if not in original manuf btl
For what acts can a RPh lose license over?
-any conviction of felony -habitual indulgence -physical/mental disability -lose of license in another state -aiding suicide of a pt
What must USA grad submit to apply for licensure? (6)
-application -affidavits of internship -copy certified birth certificate -recent photo -official transcript -register/pay NABP
When can the drug database be used?
-by dispensers when they fear unsafe practice -looking into forged Rx -prescriber to look into a pt they will write C Rx for -individual receiving the Rx or guardian of -board doing an investigation -vendor/maintainer of the system -law enforcement w/ valid search warrant.
what steps must RPh take in certification of Rx?
-check original container unless computerized process w/ pics -check new vial label -check that the contents are correct -prospective DUR on pt profile -RPh initials/elec name on record
What info must be given to the pt about the closing?
-date of closing -name/address/phone number receiving pharmacy
Ground for disciplinary action if board finds out that any person in advisory role sets policies to prevent counseling/providing DUR . Who could be held responsible?
-individual owner or sole proprietor -in case of partnership, each partner -in case of association, each member -in case of corporation, each officer or director and each shareholder owning 30% or more of voting stock
What are the conditions of an emergency kit? (6)
-life treatening -72 hours supply -max 15 different oral meds (not counting Abx) -sealed container -replaced by pharmacy -checked monthly
What cannot be done in presence of child/vulnerable adult (or in area where they may be expected to be)? What is the punishment?
-mfr meth/attempt -store chemicals/waste pdts/paraphenalia Punishment: Felony, max 5 years and/or $10,000 *probation only if has been accepted by tx program approved by commissioner of human services
LTCF pharmacies must also have what reference? (2)
-most recent MN Dept of Health rules -general reference on geriatric pharmacotherapy
What references must a pharmacy have on hand? (7)
-most recent laws -DEA regulations -Code of federal regulations -pharmacotherapy reference: ie. Depiro -*Hardcopy* dosage/toxicology: ie. facts and comparisons -general reference: ie. orange book, PDR, remington... - The Merck Manual (all can be electronic except toxicology)
When is C data not need to be reported?
-nursing home pt -assissted living with waiver -IV med admin -home care pt
What are BOP duties?
-regulate pharmacy practice -regulate manuf/wholesale/retail sale -regulate labeling, purity, quality all drugs dispense in MN -enter and inspect, secure samples, make copies - examine/license RPh, wholesalers - deny/revoke license
When does an employer need to report?
-regulated person diverts C's
What does PIC need to do day of closing? (5)
-return license to BOP -notify BOP of disposal plan -If computerized, give printout of all pt profiles to receiving pharmacy -Ensure all drugs go to licensed pharmacy, not anywhere else, even if in custody of a RPh. -Take final C inventory, (also serves as initial inventory for pharmacy receiving)
How long do records for IV admixtures need to be kept?
5 years identifying each RPh involved
How many technician CE hours is required in a 2-year period?
20 hours
CE rqrmts? TECH
20 hours every 2 years due 7/31 ODD YEARS
How many C drugs can be in a matrix drawer?
1, all rest need to be non-C.
What are the requirements for a computer system in a hospital that is used to track CS inventory? (4)
1-allow for retrieval of all information for two years 2-provide for at least weekly transaction printouts, unless a secure daily 24-hour backup is performed which allows for restoration of info 3-maintain a complete online transaction file that is printable or has a "lock-out" feature that prevents editing 4-allow for the printing of a report of transactions for a minimum of two years ***Stored info must include user identity, date and time CS's distributed or removed, the quantity CS's distributed or removed, CS name/strength/form, patient name, practitioner name***
When does the above 'immunity' not apply?
1. C 2-5 used to Tx chem dependancy 2. MD knew C was for non-therpaeutic uses 3. C 2-5 was to help terminate life 4. C was not an FDA approved C
What should be completed as a drug use review for each patient upon receiving an Rx for them? (7)
1. Over-/under- utilization 2. Therapeutic duplication 3. Drug-disease CI's 4. DI's 5. Incorrect dosage, duration 6. Drug-allergy interactions 7. Clinical abuse/misuse
What info may be changed on a C-II script?
1. Patient address 2. Dosage form 3. Drug strength 4. Drug quantity 5. Directions for use 6. Issue date 7. Add the DEA #
What can't an RPh change on an Rx?
1. Patient name 2. Med prescribed 3. Prescriber's signature
Who can compound Rx's in Minnesota?
1. Pharmacist 2. Pharmacy intern
3 types of reference books
1. Pharmacotherapy references 2. Dosage and toxicology 3. General reference
What 7 items must a pharmacy have for equipment?
1. Rx balance (50 mg - 100 g or electronic) 2. Measuring devices for volumes 1 mL to 500 mLs (at least) 3. Mortar, pestle, spatula, funnel, stirring rod, heating apparatus 4. Comply with US 795 5. Refrigerator only for drug storage with daily temp logs 6. Sink with hot and cold water 7. Toilet with hand-washing and disposable towels
When can a pharmacy audit NOT take place?
1st 5 business days of month unless consented by pharmacy
Do pts have the option of demanding the brand name when substitution is permitted? How about pts whose rxs are paid for by public funds?
1. Yes 2. No restrictions for publically funded prescriptions
When destroying unused portions of rx drugs or CS, what must be documented in the clinical record?
1. date 2. quantity name 3. rx # 4. signature of person destroying + witness
What are the 3 ways C's can be accounted for I.P?
1. proof of use signout sheet 2. dispensing from pharmacy directly to pt after drug order 3. computer system that stores records for 2 yrs., provides weekly transaction printouts if no daily backup.
Date limit for location change?
60 days
What is required on a hardcopy C 2-5 or else it's void? (6)
1. written in ink, w/ pt name and address 2. states amount to compound/dispense and Sig. 3. handwritten sig, address, title, DEA # (oral can skip signature) 4. Date
What amount of codeine would be necessary to create a CIII medication?
1.8 grams in 100 mLs
How many members are on the advisory task force for CE?
10
How soon must a technician notify the board of a change of address, name, or place of employment?
10 days
Who is on the CE advisory task force?
10 members 3 designated by MSHP 3 designated by MPhA 2 designated by BOP 2 designated by UMN COP
How many hypodermic needles may be sold to an individual without an Rx?
10 or less
Earlier CS conviction is no longer valid if how much time has elapsed?
10 years
How many intern hours are required?
1600 hours
How many hrs do interns need total?
1600 in 4th year
how old does tech need to be? min education for initial registration? Min education to renew registration?
18 -High school diploma/GED -tech training from vocaitonal school/national -organization/ armed forces/public health -employer based min 240 hours on 1 yr period
How big does the counter need to be?
18 in deep by 2 feet long min.
What is the max # interns a preceptor can have at once?
2 if in 4th year (&dispensing/compounding) only 1 if year 2-3 and doing dispensing/compounding
How long does RPh have to get recalled drugs back from floor?
24 hours from notice
How many hours must a technician be trained for over a 1-year period?
240 hours
What is the maximum ratio of technicians to pharmacists? Of interns to pharmacists?
2:1 (+1 if certified tech) -This is OK as long as the pharmacist assumes responsibility for all the functions performed by the technicians Certified tech definition: valid cert from PTCB or another national cert body for pharmacy technicians that requires passage of a "nationally recognized, psychometrically valid" examination as determined by the Board of Pharmacy ***Note: The BOP may set ratios >2:1 for functions specified in a rule***
Tech ratio?
2:1, +1 (per pharmacy) if certified tech
How long must pseudoephedrine logbook entries be kept?
3 years
What is max amt of pseudoephedrine that can be sold OTC in given day?
3.6 grams (federal more strict here, MN 6 g) No more than 2 packages containing ephedrine or pseudoephedrine can be purchased at one time Max 3 g per package Calculated based on the amt of the base- not the salt!
How much CE do RPh need and when? Can they get an extension?
30 CE hours in every previous 2 yr period submitted every *even numbered* year. Can get extension for 1 yr to make up.
How many days does BOP have to make determination?
30 days
How many days notice must a pharmacy give to remodel?
30 days
How many days notice to give LTCF/nursing home?
30 days
How mnay days do they have to provide BOP w/policies?
30 days
How soon must the board be notified of any change in a wholesalers information?
30 days
If BOP embargoes a med, how many days to petition the court to have condemned?
30 days
When do you need to notify board of changes in manufacturers and wholesalers?
30 days
How long is the term for a board member?
4 years (ends 1st Monday of January) Can serve another term if no successor is appointed by July 1st
What are max number of hrs from concurrent?
400
max doses of any CS narcotic analgesic in emergency kit
6
How long can board temporarily suspend license in order to investigate claim?
60 days max * if board finds that pharmacist has violated statue/rule that board is empowered to enforce and if continued practice would cause imminent risk of harm to others w/o a hearing
When do you need to notify board of establishment of satellite (community/hospital)?
60 days prior to establishment If board does not respond in 30 days= approved
How far in advance does pharmacy have to notify board of automated dispensing system?
60 days prior to initial use or replacement (where located, mfr, model) * must notify when it is taken permanently out of service
When do you need to notify board of change in dimension or security of the pharmacy?
60 days prior to proposed changes with supporting documents. If board does not respond in 30 days= approved
When do you need to notify board of change of pharmacy address?
60 days prior with supporting documents
Community pharmacy consultation area requirements
7' high 24" deep Dull-sounding partitions
What is a emeritus license?
A formal recognition of completion of a career in good standing. It is NOT a license to practice. No renwal needed.
Who is eligible?
A person regulated by the board who can't practice safely
When can techs load an automated dispensing system
Alone if barcoded, can also be performed by nurse continuously supervised by 2 way audiovisual system
What are Board approved continuing education providers for a pharmacist?
ACPE Accreditation Council for Pharmacy Education
Under what circumstances can pharmacists participate in managing and modifying drug therapy?
According to written protocol between the specific pharmacist and individual dentist, optometrist, physician, podiatrist, or veterinarian who is responsible for the pt's care and authorized to independently prescribe drugs. *Any significant changes in drug therapy must be reported by the pharmacist to the pt's medical record *protocol must specify the circumstances under which the legend drug is to be prescribed and administered *no special education/skill requirements for pharmacists to participate *board has interpreted current statutes to allow pharmacists to perform laboratory tests waived under CLIA
After when can a member be removed from the board?
After missing 3 consecutive meetings.
Dosage and toxicity reference examples
American Hospital Formulary Service, Facts and Comparisons, Drug Information Handbook
Is there any requirement for a daily printout of prescriptions that were entered into the computer? Who must sign the printout? (electronic system must, 3)
An electronic system used to store prescription information, must: 1. Produce a daily hard copy summary of CS transactions 2. RP on duty must sign CS printout verifying that refill information is correct 3. Be capable of producing a hard copy printout of legend drug transactions going back two years (unless already available in hard copy form)
What must optometrist report to board within 10 working days?
Any adverse rxns that occur while administering drug
What is the rule about expunging of old marijuana charges?
Anyone found guilty of small amt of marijuana prior to 1976 whose conviction would have been petty misdemeanor at that time may petition court to expunge all records related to arrest/ indictment/ trial/conviction of an offense more serious than a petty misdemeanor -If court satisfied that small amount was involved, will order all records expunged -Cannot be guilty of perjury or otherwise giving false statement for failure to acknowledge conviction of offense greater than petty misdemeanor unless possession of marijuana is material to a proceeding
How far in advance must provider submit CE for approval to board?
At least 45 days in advance board assigns credit hours to it board will notify of decision within 60 days
How large must the counseling area be?
At least 7 feet tall and 24 inches deep cannot have any items for sale in it pharmacist must have access to pt profiles
How often does the CE Advisory Task force meet? How often do they elect a chair/vice chair?
At least quarterly Annually
When/how can you request inactive status from the BOP?
At the time of renewal w/ sworn statement that not practicing pharmacy in MN
• If dispensing info is lost dt unsched system interruption...
BOP must be notified w/I 72 hrs
Who report C losses to? by when?
BOP and DEA immediately
How long must the pharmacy maintain the following records: original prescriptions, refill records, drug purchase records, patient profiles? Are any of these different for CSAs? If any of these can be maintained on computer, how long do they need to be maintained "on-line?"
Basically, 2 years for everything: Original Rxs: (same for CS's) shall be kept on file at the location from which dispensing occurs for a period of at least two years. -ERx's must be kept on file in the format in which they were originally received. -Written/printed/verbal Rx's must be kept on file as received or transcribed, except that such orders may be kept in an electronic format as allowed by the board. -Rx's stored in an electronic format may be kept on file at a remote location as long as they are readily and securely accessible from the dispensing location Refill Records: No wording on how long to maintain record. -The date of refills must be recorded and initialed upon the original prescription drug order, or within the electronically maintained record Drug Purchase Records: Must maintain records of receipted invoices for drugs, chemicals, and pharmaceutical supplies purchased and received over the immediately preceding two years. Patient Profiles: must be maintained for 2+ years from the DATE OF THE LAST ENTRY in the profile record, which may be in a hard copy or a computerized form. Profile must be capable of indicating all drugs being taken and the dates and quantities of fills or refills, and shall be kept in the computer system, immediately retrievable, for 2+ years.
What must optometrists do in order to prescribe or administer legend drugs?
Be board certified- issued certificate and... -at least 60 hours of study in general and ocular pharmacology -at least 100 hours of study in the examination, diagnosis, and tx of conditions of the human eye w/ legend drugs -2 years of supervised clinical experience in differential diagnosis of eye disease or disorders as part of optometric training or 1 year of that experience and 10 years of actual clinical experience as licensed optometrist -passing examination
When is technician CE reported?
By July 31st of each odd-numbered year
When is CE reported?
By September 30th of each even-numbered year
How can patients see their data in the PMP?
By request to the board, can find form on their website
Can C be in the unit dose system?
C 2-4 can when follow applicable rules
What can Vets prescribe, dispense, or admin?
C 2-5 to animals only
How long are prescriptions for each of the following valid: C-2s, C-3s, C-4s, C-5s?
C- II and C-V = 12 months C- III and C- IV = 6 months
What schedule is Fiorinal?
C-III 325 mg of aspirin (ASA), 50 mg of butalbital, and 40 mg of caffeine
Is there a maximum number of fills allowed for C-5s? What is it? Are the number of refills for C-3s and C-4s the same as federal or less?
C-V = No, no laws on maximum number of fills for C-V's, still no refills past 12 months of written date. C-III and C-IV = 5 refills max, state and federal laws are the same here.
How long are prescriptions for legend drugs valid from the date issued?
C2 = 12 months C3-C4 = 6 months C5 = 12 months
Is there a maximum number of refills allowed for legend drugs? What is it?
C3-4 = 5 refills before 6 months from written date Legend non-controlled = no limit on # of refills However, refills cannot be filled more than 12 months from the written date. Note the language: "After 12 months from the date of issuance of a prescription drug order, no additional authorizations may be accepted for that prescription drug order."
How must the offer to counsel be made? (4 things about procedure, 10 elements of counseling)
COUNSELING (not an offer to counsel) is REQUIRED FOR ALL NEW PRESCRIPTIONS. Pharmacists are not required to offer or give counseling for refills based on their professional judgement. Must follow a written pharmacy procedure for counseling. Procedure must provide for (1) direct oral communication between patient & pharmacist, (2) the pharmacist must inquire about understanding on the use of the drug, (3) may be supplemented by written material, and (4) shall include 10 appropriate elements (see other flashcard).
To what extent are collaborative practice agreements (CPAs) allowed?
CPA's can be made between: (i) one or more pharmacists and one or more dentists, optometrists, physicians, podiatrists, or veterinarians; or (ii) one or more pharmacists and one or more PAs/APRNs Any changes in drug therapy made pursuant to a protocol or CPA must be documented by the pharmacist in the patient's medical record or reported by the pharmacist to a practitioner
What are the restrictions regarding anhydrous ammonia? What is the punishment?
Cannot: -Steal any amt of AA -Purchase, possess, transfer, distribute any amt of anhydrous knowing will be used to unlawfully mfr CS -Place/transport in container not designed/authorized to transport -Tamper w/ any equipment or facility used to contain, store, or transport AA Punishment: Felony, max 5 years prison and/or $10,000 fine
When must the Board of Pharmacy be notified of a change of change of pharmacy address?
Change in pharmacy address: 60 days before proposed change in location
When must the Board of Pharmacy be notified of a change of pharmacist-in- charge?
Change of PIC: immediately upon knowledge of
When must the Board of Pharmacy be notified of a change of an intern's address?
Change of intern address:Immediately.
When must the Board of Pharmacy be notified of a change of a person's name?
Change of person's name: Within 10 days of change.
When must the Board of Pharmacy be notified of a change of an individual pharmacist's address?
Change of pharmacist address: Immediately.
When must the Board of Pharmacy be notified of a change of pharmacy telephone number?
Change of pharmacy telephone number: There is no law/rule regarding this (per Cody W.)
When must the Board of Pharmacy be notified of a change of closing or sale of a pharmacy?
Closing or sale of a pharmacy: At least 14 days before closing
Which drugs can the optometrist use: (3)
Commercially prepared: -topical anesthetics: proparacaine 0.5%, tetracaine 0.5%, benoxinate 0.4% -mydriatics: phenylephrine <2.5%, hydroxyamphetamine < 1% -cycloplegics: tropicamide < 1%, cyclopentolate < 1%
Under Minnesota State Pharmacy Law, any adverse healthcare-related event shall be forwarded to whom?
Commissioner of Health, within 30 days
What is max punishment for falsifying info in pseudoephedrine logbook?
Crime- prison x5 years, max $250,000 fine *logbook must contain notice of this
What form is required to purchase or transfer CI's and CII's?
DEA 222
What rules do you follow for transferring C Rx?
DEA laws
What is the renewal deadline date for a pharmacy technician?
December 31
When do pharmacy technician licenses expire each year?
December 31st Must file for renewal before December 1st
What should a pharmacist do if they do not include one aspect of counseling based on professional judgment on best serving the pt?
Document on rx, pt records, or specially developed log
Licensed practitioner that dispenses for profit a legend drug to be administered orally, is ordinarily dispensed by a pharmacist, and is not a vaccine must file w/ practitioner's licensing board a statement indication they dispense legend drugs for profit and types of drugs generally dispensed
Does not apply to veterinarian
What are distressed drugs?
Drugs or medicines that have been subjected to accident, fire, flood, adverse temperatures, or other physical influences which could affect the potency, quality, purity, or efficacy of such drug or medicine, or could otherwise cause the drug or medicine to be adulterated or misbranded
What are distressed drugs? When does BOP need to be notified?
Drugs subjected to fire, flood, temperatures...etc not necessarily ruined. -notify BOP immediately
Who decides what constitutes spending a day working for the board?
Each own board does.
Must information regarding the transfer of legend drugs be recorded on the hard copy of the original prescription, or can it merely be recorded in the computer? What information must be recorded by the transferring pharmacy?
Either is OK: document on hard copy or computer (but not both): Hard Copy: 1. Write the word "VOID" across the face of the hard copy, or void all remaining refills in the electronic record. 2. Record on the reverse side or in the electronic record the: A. name, address, telephone number of the receiving pharmacy B. name of the receiving pharmacist or intern C. the date of the transfer D. If C3-C5, record on the reverse side or in the ERx the DEA# of the receiving pharmacy and the names of the receiving & transferring RPs/interns **transfering by cancelling an electronic prescription is acceptable only when the quality assurance check has been completed on the prescription drug order being transferred**
Does the offer to counsel need to be documented? Does the refusal of the offer need to be documented? How? (3 places/options for documenting variation/omission)
Even though counseling is required all new prescriptions, a patient may refuse a counsel or a pharmacist may "vary or omit patient information if, in the pharmacist's professional judgment, it serves the best interest of the patient". Anytime a "material" variation/omission/refusal occurs resulting in counseling not meeting the minimum requirements, the circumstances AND pharmacist name shall be documented on: 1. the prescription, or 2. the patient's record, or 3. in a specially developed log NOTE: The counseling may be provided by an Intern WITHOUT immediate and direct supervision of a pharmacist, but must be reviewed/approved by a licensed pharmacist prior to counseling. The pharmacist is responsible for accuracy and completeness of counseling.
How often should a controlled substance inventory be performed?
Every 2 years
When can an audit not take place w/o pharmacy permission?
First 5 business days of the month
When must pharmacy provide copy of Notice of Privacy Practices to pt or other person requesting one?
First fill and @ pt request
What ages and vaccines can RPh give?
Flu shot to 10 and older All other vaccines to 18 and older - due to physician standing order/protocol - RPh is trained by approved program - RPh reports vaccine to pt clinic
Who can receive vaccines from pharmacists?
Flu: children 10 years and older Other: 18 years and older
What practices do manufactures in MN need to follow?
GMP
For what can a pharmacy supply to a nursing home for prophylaxis from body fluid exposure?
HIV regimen recommended by CDC
General reference examples
Handbook of Non-Rx Drugs, Physician's Desk Reference, Remington, US Pharmacopeia, Orange Book, Merck Manual
How can a suspended license be reinstated?
Holder pays all costs of proceedings in addition to fee set by the board
What is required on the label of a parenteral solution dispensed to a patient for home infusion therapy? (12)
IV admixtures dispensed for a patient, other than a hospitalized patient: 1. pharmacy name, address, phone # 2. patient name 3. Drug name, strength 3. Rx # 4. prescriber name 5. directions for use 6. manufacturer name 7. auxiliary labels (as needed) 8. OD, BUD 9. If filled at central operation, must bear identifier of pharmacy and date compounded 10. storage requirements (if not room temp) 11. admin rate, times, frequency 12. other accessory cautionary info (prof judge) ***A pharmacy dispensing outpatient IV admixtures shall develop a 5-YR AUDIT TRAIL SYSTEM that will ID the DISPENSING PHARMACIST for each unit dispensed.
What CS can optometrists prescribe?
IV and V
What extra component must be on CS label in MN?
If alone or in conjunction w/ alcoholic beverages may impair ability to operate motor vehicle
Under what circumstances can pharmacist fill rxs written in another state?
If the prescriber is licensed in that state
When can person be put on probation for CS (instead of charged)?
If this is not a subsequent conviction (has not participated in diversion program, has not previously been on probation) Probation cannot be longer than the maximum sentence for the crime. In its discretion, court can discharge person from probation before expiration of the max period. If discharged from probation w/o adjudication of guilt, non public record is kept by Bureau of Criminal Apprehension for use by courts in determining merits of subsequent proceedings against the person. Record can only be opened upon court order for criminal investigation, prosecution, or sentencing
What needs to be done when receiving a non-C faxed Rx? what is the exception?
If with ink lasting 5+ yrs: all faxed Rx need to have hard copy with in 72 hours or be immediately reduced to writing by the RPh -fax sender must be known -except I.P. orders faxed within the hospital
What happens if pharmacist does not pay renewal or late fee?
Illegal to practice pharmacy in MN Any person licensed that defaulted in payment of renewal fee may be reinstated within 2 years of default without examination
What are the restrictions on ephedrine? What is the penalty?
Illegal to: -Market/advertise/label pdt for indication of stimulation, mental alertness, weight loss, appetitie control, or energy (may consider packaging, name/labeling, manner of distribution/advertising, verbal representations made about the pdt) -Sell, distribute, or otherwise make available pdts that contain ephedrine Must obtain rx from prescriber Penalty is a misdemeanor
What is required on the label of a radiopharmaceutical agent? (inner BULK [3] vs inner DISPENSED [4] containers)
Immediate BULK container: A. radiation symbol with words... ***"Caution - Radioactive Material"*** B. drug name/abbreviation C. lot Immediate DISPENSED container: A. radiation symbol with words... ***"Caution - Radioactive Material"*** B. drug name/abbreviation C. prescription/lot # D. patient name
When do you need to notify board of change of intern address or employer?
Immediately
When do you need to notify board of change of pharmacist address or employer?
Immediately
When can a compounded product exp exceed 7 days?
In-house data or data in literature assuring stability/sterility
What are the requirements for immunizations administered by pharmacists? (4)
Influenza vaccines: 10 years of age and older Other vaccines: 18 years of age and older Requires: 1. written protocol with a physician, physician assistant authorized to prescribe drugs, or an APRN authorized to prescribe drugs 2. pharmacist has successfully completed a program approved by the ACPE specifically for the administration of immunizations or a program approved by the board; 3. the pharmacist reports the vax admin to the patient's PCP or CLINIC or MIIC 4. the pharmacist complies with guidelines established by the Federal Advisory Committee on Immunization Practices (ACIP) NOTE: RP does not need to comply with guidelines/schedules when administering a vax pursuant to a valid, patient-specific order provided that the order is consistent with the FDA approved labeling
How is the data on the regulated person handled?
It is classified and private while the person is in treatment and once they successfully complete treatment.
CE deadline for technicians
July 31 of odd numbered years
When do licenses expire for manufacturers and wholesalers?
June 1st Must file for renewal by May 1st
What is renewal date deadline for manufacturers and wholesalers?
June 1st (file before May 1)
What is the renewal deadline date for a pharmacy?
June 30 (file before June 1) New pharmacy- 60 days before opening
When do PHARMACY licenses expire?
June 30th of each year Must file for renewal by June 1st
When does each pharmacy license expire?
June 3o of each year, renew yearly
What can retail pharmacies advertise?
Legend drug price info -No representation or suggestion concerning safety, effectiveness, indications for use, competitive comparison is made -No reference to CS listed -Termination date for prices must be listed
Under what circumstances are FAXed CSA prescriptions allowed? (2 times for C2's)
Like all faxed Rx's (CS's included), it must contain the practitioner's manual signature (& cannot be faxed by patient to pharmacy). In MN, Rx's for C2-C4 received by fax shall be handled according to federal law. FEDERAL LAW: -C2 The only C2 faxed Rx's that can serve as the original are: 1. emergency fills for pt's in LTCF or Hospice (home or facility OK) 2. home infusion rcvg Rx for C2 for parenteral admin -C3-C4 (and C5) Fax must be written/signed and transmitted by prescriber/agent to the pharmacy.
What has to be available at each nurses station in a nursing home?
List of staff authorized to administer meds
Who can write a prescription for CII?
MD DO doctor dental surgery doctor of dental medicine vet podiatrist *lawfully licensed to prescribe in MN or from practitioner licensed to prescribe CS by state in which rx was issued and having current federal DEA #
Who can prescribe, dispense, admin C 2-5?
MD doctor osteopathy DDS/DDM podiatrist
How rapidly must a pharmacy respond to a patient's request to amend the information in his or her medication record?
MN law does not address this issue
When is counseling ok to do in a written format?
Mail order or delivery service Must include any thing mentioned in normal counseling, availability of RPh to answer questions, instructions on what to do if delivery parcel is compromised
When does a MN RPh license expire?
March 1 of each year. Renew annually.
What is the renewal deadline date for a pharmacist?
March 1st (file before Feb 1)
When does a PHARMACIST license expire?
March 1st each year Must file for renewal by February 1st $105
How can BOP be removed from their position?
Missing 3 or more consecutive board meetings- secretary informs member in writing after 2nd consecutive missed meeting after notice and hearing
What must a MN long term care pharmacy have on file?
Most recent edition of the MN Department of Health rules on medication handling AND General reference on geriatric pharmacy
When pt is transferred or discharged, what happens to their meds?
Must be given to pt/guardian EXCEPT for CS This must be recorded in the clinical record
What happens to meds for pts of boarding care homes that are discharged or transferred?
Must be given to pt/guardian if authorized by the physician
How must the offer to counsel be made?
Must be in person whenever applicable
What are the rules for substitution?
Must dispense generic drug if less expensive equivalent is available that in pharmacist's professional judgment is safely interchangeable w/ prescribed drug As long as no DAW indicated Must first disclose the substitution to the purchaser
What are the requirements for pharmacists to administer vaccines?
Must have standing orders from a licensed physician or by written protocol with a physician provided that: 1. The pharmacist is trained in a program approved by the American Council of Pharmaceutical Education for the administration of vaccinations or graduated from a college of pharmacy in 2001 or after, and 2. The pharmacist reports the administration of the vaccinations to the patient's primary physician or clinic.
What is a condition for having pharmacy license renewed?
Must pass inspection conducted by authorized representative of board If pharmacy located out of state, board may require applicant to pay for cost of inspection unless applicant furnishes board w/ a report that inspection has occurred w/I 24 months immediately preceding receipt of license application by board Board may deny licensure unless applicant submits documentation satisfactory to board that any deficiencies have been corrected
What notices must be displayed to the public in pharmacies?
Must post sign in conspicuous location and in typeface easily seen at the counter where prescriptions are dispensed stating: "In order to save you money, this pharmacy will substitute whenever possible an FDA-approved, less expensive, generic drug product, which is therapeutically equivalent to and safely interchangeable with the one prescribed by your doctor, unless you object to this substitution."
What standards does another state need to have for internship for MN to accept them?
NABP standards
Can you redispense repackaged meds for LTCF pts that have been returned?
NO
What is required on label of parenteral solution dispensed for pt in a hospital?
Name of solution, lot number, volume of solution pts name Bottle sequence # or other control # system if appropriate name and quantity of each additive infusion or admin rate if appropriate storage requirements if other than RT identify of pharmacist preparing/certifying date and time of admin exp date date and time of compounding ancillary precaution labels
What info is required on the pt profile?
Name, address, telephone #, DOB, gender, sig indvl hisotry (allergy, DI, other meds), pharmacist comments
Can a C2 ever be transferred?
Never
Are rxs on file in a pharmacy public record?
No
Is OBRA counseling only required for Medicaid pts?
No, all patients under MN law
Does RPh need to continue CE with inactive license?
No, but if may want to reactivate: 15 per year, up to 75 hrs., if want to reactivate it in < 5 yrs.
What schedule is Fioricet?
Non-scheduled 325 mg of acetaminophen (APAP), 50 mg of butalbital, and 40 mg of caffeine
What is the ratio of pharmacists to technicians? Does it differ by setting? (4 excepted ratios)
Normal ratio is 2:1 (+1 per pharmacy if have a certified tech) 4 specific functions have ratios of 3:1.... 1. IV admixture prep 2. Unit dose or modified unit dose packaging 3. Prepackaging 4. Compounding
Can doctor homeopathy/ naturopathes prescribe?
Not doctor homepathy naturopathes can prescribe food extracts, supplements, vit...
Does a pharmacist need to be on site of the automated dispensing cabinet?
Not if it is continuously electronically monitored by the pharmacy Pharmacist must be continually available to address problems/answer staff questions
Can a physician tx-ing intractable pain with C2-5, be subject to disciplinary action?
Not if they keep accurate records of: purpose, use, Rx and C disposal.
Do pharmacy interns count in the technician ratio?
Not if working towards the 1600 hours necessary for licensure
Where else can you compound drugs besides a pharmacy?
Nowhere
What must be on the label of a multiple-dose container dispensed for a patient in a nursing home? (11)
Nursing home multiple-dose label: 1. pharmacy name, address, phone 2. patient name 3. Drug name, strength, quantity 4. Rx #, directions for use 5. prescriber name 6. manufacturer name 7. auxiliary labels (as needed) 8. OD (if refill, most recent refill date) 9. Exp if a time-dated drug 10. If at central pharmacy, must bear an identifier that indicates the pharmacy at which they were filled 11. physical description (imprint/shape/color) ***UNLESS AN INVESTIGATIONAL DRUG***
Under what circumstances may a pharmacist fill prescriptions written in another state?
OK to fill if the prescriber is licensed to practice/prescribe in the state that it was written (and it is within their scope of practice)
What can APNP dispense? (4)
OTC legend C's samples
What can be in the general stock supply at a LTCF?
OTC meds that are kept in original containers
When does license suspension for a pharmacist take effect?
Once they have received the notice specifying the statute/rule violated At this time board will schedule hearing that will be held under Administrative Powers Act
How many dosage/toxicity references must be in hard copy form?
One
What is an automated dispensing system?
One that is not located in the same building as the original pharmacy. Those in the same building are considered extensions of the pharmacy.
What is a 'public' member of the board?
One who has never been a member of the profession, nor has any financial interest.
Under what conditions if any is therapeutic substitution allowed?
Only when there is a formulary made by P&T
Differences between Opthamologist, Optometrist, and Optician
Ophthalmologist Is an MD or DO who specializes in eye and vision care. An ophthalmologist is licensed to practice medicine and surgery. An ophthalmologist diagnoses and treats all eye diseases, performs eye surgery and prescribes and fits eyeglasses and contact lenses to correct vision problems. Optometrist An optometrist is not an MD or DO. An optometrist receives a doctor of optometry (OD) degree after completing four years of optometry school, preceded by three years or more years of college. They are licensed to practice optometry, which primarily involves performing eye exams and vision tests, prescribing and dispensing corrective lenses, detecting certain eye abnormalities, and prescribing medications for certain eye diseases. Optician Opticians are technicians. They use prescriptions supplied by ophthalmologists or optometrists, but do not test vision or write prescriptions for visual correction. Opticians are not permitted to diagnose or treat eye diseases.
What is required on the label of a radiopharmaceutical agent? (outer BULK [8 + 2 optional] vs outer DISPENSED containers [11])
Outer BULK container: A. radiation symbol with words... ***"Caution - Radioactive Material"*** B. drug name/abbreviation C. amount of radioactivity D. calibration date and time E. exp date/time F. volume (liquid), weight (solid), #vials/ampoules (gas), #capsules G. additives (stabilizers,preservatives) H. lot # ***If transferred for commercial distribution: A. nuclear pharmacy name, address, telephone B. RP initials Outer DISPENSED container: A. radiation symbol with words... ***"Caution - Radioactive Material"*** B. drug name/abbreviation C. amount of radioactivity D. calibration date/time E. expdate/time F. volume (liquid), weight (solid), #vials/ampoules (gas), #capsules G. additives (stabilizers,preservatives) H. prescription/lot # I. pharmacy name, address, telephone J. patient name K. RP initials
What are the requirements for storage and accountability for controlled substances in a long- term care facility? (not really answered here... instead, what about partial dispensing and record keeping of partial dispensing?)
PARTIAL DISPENSING: -C2's for patients in LTCF or terminally ill may be dispensed in partial quantities, including individual dosage units -shall record on the back of the prescription (or other system) the date of the partial dispensing, the quantity, the remaining quantity, and the identity of the RP -The pharmacist MUST record on the prescription whether the patient is "terminally ill" or an "LTCF patient" - total quantity dispensed must not exceed the total quantity prescribed -the C2 prescription shall be valid for a period not to exceed 60 days from the issue date (unless terminated sooner) C2 prescription info may be maintained in a computerized record keeping system if the system can: A. output by display or printout of the original prescription number; date of issue; identification of prescribing individual practitioner; identification of patient; identification of long-term care facility; identification of medication authorized, including dosage form, strength, and quantity; listing of partial dispensings that have been dispensed under each prescription drug order B. immediate or real time updating of the prescription drug order record each time a partial dispensing of the prescription is conducted; and C. retrieval of partially dispensed Schedule II prescription drug order information, the same as required by federal law for Schedule III and IV prescription refill information
Who all in the care of home health pt need to decide who dose what? (4)
PCP, home care agency, pt., and RPh
What are the requirements for use of computers to process prescriptions? (P&P must include, 4) (Electronic equipment must have, 11)
P&P shall be developed and maintained that explains the operation of the electronic data system. The P&P shall include: 1. OUTPUT EXAMPLES; include examples of output documentation provided by the electronic data processing system that pertain to dispensing or drug control records 2. STEPS IF INOPERATIVE; outline steps to be followed when the electronic data processing system is not operational due to scheduled or unscheduled system interruption 3. BACKUP PROCEDURES; outline regular and routine backup file procedures and file maintenance 4. AUDIT PROCEDURES; outline audit procedures, personnel code assignments, and personnel responsibilities Operational requirements for electronic equipment: 1. UNIQUE IDENTIFIERS; The unique identifier of the person entering the prescription drug order must be retained in the computer record 2. NO INTERVENING PERSONS; all prescription drug orders, communicated electronically must be transmitted with no intervening person having access 3. FREEDOM OF CHOICE; not infringe on a patient's freedom of choice of pharmacy provider 4. CONFIDENTIAL; guarantee confidentiality of stored info 5. CS DAILY SUMMARY; produce a hard copy daily summary of controlled substance transactions 6. 2 YR LEGEND HX; capable of producing a hard copy printout of legend drug transactions going back two years (unless already available in hard copy form) 7. REFILL DATES AND RP; capable of recording all dates of refills and the unique identifier of the pharmacist 8. PATIENT PROFILE; capable of producing a patient profile indicating all drugs being taken and the dates and quantities of fills or refills 9. IMMEDIATELY RETREIVABLE 2 YR; for hospital/LTCF, records shall be kept in the computer system OR on hard copy and be immediately retrievable for two years; in all other cases the data shall be kept in the computer system and be immediately retrievable for at least two years 10. RECONSTRUCTION CAPABILITY; capable of being reconstructed in the event of a computer malfunction or accident resulting in destruction of the system's storage devices or databases 11. CS REFILL AUDIT TRAIL; capable of printout of refill-by-refill audit trail for any controlled substance, the audit trail must include: A. the name of prescribing practitioner B. the name and location of patient C. the quantity dispensed on each refill D. the date of dispensing of each refill E. the name or unique identifier of the dispensing pharmacist F. the prescription number 12. IDENTIFY CHANGES MADE TO RX; capable of identifying any changes (drug, quantity, directions) and should include the date of the change, the identity of the individual, and the original info (**alternatively a new prescription drug order may be created for each authorized change**) 13. PREVENT UNAUTHORIZED ACCESS; capable of preventing unauthorized access/modification of prescription data
How does hazardous waste need to be disposed of?
Per Pollution Control Agency
Which 2 pharmacy services need separate written agreements for nursing homes?
Pharmaceutical services Pharmaceutical consulting services
What minimum references/equipment are required in all pharmacies compounding STERILE products? (3)
Pharmacies preparing compounded STERILE products are required to have: 1. Minimum equipment to comply with USP797 (with appropriate to risk-level requirements) 2. Current reference materials or books for sterile products or intravenous incompatibilities 3. Current copy of USP797
How can pharmacies opt out of the reporting requirement?
Pharmacies that only dispense CS for exempted pts can request exemption from the board. If they also serve regular ambulatory pts though, they must still report those.
How do drugs for emergency use need to be labeled? (7)
Pharmacy name drug name/strength/amount aux label PRN exp date usual dose control number or date issue
What is the max ratio of interns to pharmacists
Preceptor : Intern 1:2 1:1 if compounding, dispensing (unless part of experiential program)
Can transfers of refill information be faxed between pharmacies?
Yes
What must be on the label of a unit-dose or single- dose package of a legend drug dispensed for a patient in a hospital or nursing home? (3 required, 2 possibly required)
Prepackaging into unit-dose containers shall be done according to USP 1146, under the direct supervision of a pharmacist. The supervising pharmacist shall keep a packaging control record. The prepackaged container shall bear a label containing: 1. Drug name & strength 2. Manufacturer/distributor name 3. BUD, Internal control number or date 4. Physical description or a bar code (NDC) ***unless <72 hr supply or dispensing with outer packaging that contains a physical description of the drug*** 5. Radiopharmaceuticals have special label requirements
What info must each dispenser present: (15)
Prescriber name, NPI, Dispenser name, NPI, Rx number Pt name, address, date of birth date Rx written and date filled drug name, strength, quantity/ quantity dispensed, days supply
How does a pharmacist determine whether a particular generic drug is suitable as a substitute for a brand name drug?
Professional judgment
What is a PDR?
Prospective Drug Review
May pharmacists administer drugs? By which route(s)? (3)
RP's may administer: 1. Drugs for first dosage (i.e. insulin for a diabetic) 2. Drugs for medical emergencies (Epinephrine injection) 3. Immunizations (IM, SQ, ID)
Who can sell a stimulant or depressant drug (that meets all other guidelines)?
RPh assistant RPh, intern
What are the requirements to be a PIC?
Regularly employed in the pharmacy dept and designated in the application for license and each renewal
What minimum equipment are required in all community pharmacies? (7)
Required minimum equipment that is clean and in good working order: 1. One class A prescription balance or an electronic balance 2. Measuring devices that measure 1 ml to at least 500 ml 3. Mortars, pestles, spatulas, funnels, stirring rods, and heating apparatus 4. Other equipment as necessary to comply with the requirements of USP, chapter 795 5. Refrigerator used only for drug storage (**also, temperature recording equipment and logs used to document daily temperature**) 6. Sink with hot and cold running water 7. Toilet with a hand-washing lavatory
Who only can input drug info into elec system?
Rph or Prescriber - other agents enter, then need to verify -unique identifier of all involved needs to be retained
Who can communicate a Rx transfer?
Rph or intern to another RPh or intern
What types of meds can unlicensed personnel administer if they are qualified to do so in LTCF?
Scheduled meds PRNs if authorized by nurse or reported to nurse within time period specified by nursing home policy
Do pharmacists have to disclose co-payment amt, U&C, amt paid by insurance?
Yes
When is CE due?
September 30 of each even numbered year
How can a RPh reactive an inactive license?
Show proof of CE for another state with active license up to 5 years.
Who appoints members of the Board of Pharmacy?
The Governor
What is required on the label of a parenteral solution WHEN AN ADD'L DRUG IS ADDED TO THE ADMIXTURE? (5)
The admixtures shall be labeled on (A) the original label -OR- with (B) a distinctive supplementary label, indicating: 1. drug name, amount 2. date/time of addition 3. expiration 4. unique identifier of the person adding the drug
Who does the PIC notify when quitting? and when?
The board, immediately
To whom must the original dispensing pharmacy deliver the LTCF meds to?
The contract pharmacist or pharmacy
Is separate pt counseling area required?
Yes
Is the offer to counsel sufficient?
Yes
Who is responsible for either application or prohibition of a rule?
The owner and their PIC
What documentation is required of the pharmacist when product interchange is performed?
The pharmacist must inform the purchaser of the interchange via a sign in the pharmacy: "In order to save you money, this pharmacy will substitute whenever possible an FDA-approved, less expensive, generic drug product, which is therapeutically equivalent to and safely interchangeable with the one prescribed by your doctor, unless you object to this substitution." Note: the sign must be in a conspicuous location and in a typeface easily seen at the counter where prescriptions are dispensed
What use of the profile is required? Review prior to dispensing new Rx's? Review prior to refills? What is expected to be looked for during profile review? (8 things RP must look for)
There is no difference between new Rx's and refills. For every prescription, the RP must examine the pt profile to determine the possibility of: 1. Harmful drug interaction/reaction 2. Overutilization/underutilization 3. Therapeutic duplication 4. Drug-disease contraindications 5. Drug-drug interactions 6. Incorrect drug dose/duration 7. Drug-allergy interactions 8. Clinical abuse/misuse Next, the pharmacist shall take appropriate steps to avoid or resolve the problem which shall, if necessary, include consultation with the prescriber.
Can a patient refuse to give certain information for the profile? If so, must the refusal be documented, and how?
There is no specific wording on pt refusal to provide information for the patient profile, nor a requirement to document such refusal. The rules simply state: "A reasonable effort must be made by the pharmacy to obtain, record, and maintain at least the following information regarding individuals obtaining prescription services at the pharmacy" Note that each subpart has the word "generally" listed after it.
Who is ineligible?
Those who diverted to sell to someone else Those who have previously failed any state program Those currently under discipline those accused of sexula misconduct Those whose continued practice would cause serious public harm
Who is immune from liability/prosecution?
Those who report in good faith.
Why do drug use review?
To assure appropriate pt outcomes
General MN rules for a "valid" prescription... (5)
To be valid, MN law says that a prescription must be issued for an individual patient by a practitioner within the scope and usual course of the practitioner's practice, and must contain: 1. the date of issue 2. name and address of the patient 3. name and quantity of the drug prescribed 4. directions for use 5. name, address, telephone of the practitioner
What is the board's authority?
To protect the public from persons regulated by the board who are unable to practice safely due to: illness, alcohol/drug/chemical use, or due to mental/physical/psychological condition.
What is the pharmacy audit program?
To provide standards for an audit of pharmacy reocrds by a PBM
Special availability requirements for mail order pharmacies?
Toll-free number 6 days/week 40 hours/week
Are tech-check-tech programs allowed? Under what circumstances? Hospital requirements = 7 TCT program requirements = 2 PIC/RP requirements = 3
To participate in the Tech-Check-Tech program, the hospital pharmacy must meet the following requirements.. HOSPITAL: 1. hospital must work with specific committees and/or groups for acceptance and approval before the T-C-T program can be implemented.... groups should represent hospital administration, nursing, pharmacy, risk management, patient safety and care (e.g., P&T committee, Patient Safety committee, Nursing and Pharmacy committee, etc.) 2. hospital must have 1 pharmacist designated as the responsible person for meeting the T-C-T program requirements (shall be called the "T-C-T Site Coordinator") 3. hospital must have a drug distribution system that is structured to allow for one additional check of the dispensed medications by a licensed nurse after delivery of checked meds (or other HCP with authority to administer) 4. hospital must have adequate staffing to support a consistent T-C-T program 5. hospital should develop a P&P for the T-C-T program and have available for board inspectors (should include a list of high-risk medications that are exceptions to T-C-T) 6. hospital must obtain a T-C-T variance from the MN BOP 7. hospital must incorporate the T-C-T program into the department's general orientation process TCT PROGRAM REQUIREMENTS: 1. T-C-T must not be used as a mechanism to reduce pharmacist staff, it is a tool to allow the re-direction of pharmacists from a distributive task to cognitive tasks 2. drug description on the batch fill document must contain the same description as the one on the labeling of the unit of use PIC/RP REQUIREMENTS: 1. hospital must include T-C-T as a technician duty and PIC must submit it to the MN BOP 2. RP must perform a daily review of patient profile and must check the preparation of all products and IVs compounded in the pharmacy 3. PIC must review all records on an annual basis to assure compliance
What price is used for compounded meds to determine recoupment during audits by PBMs?
U&C
Nuclear pharmacies need to comply with what regulation?
U.S. Nuclear Regulatory Commission
Required resources for preparing sterile products
US 797 compliance US 797 copy available Current reference on sterile products or IV incompatabilities
What is it called when a distributor (not retail) charges one buyer more than another?
Unfair Price Discrimination The one charged more can sue civilly
Who can administer meds in a licensed boarding care home?
Unlicensed nusing personnel must have completed a med admin training program for unlicensed personnel in nursing home offered thru a MN postsecondary educational institution
How many consecutive terms can a board member serve?
Unlimited
How many times can legend drugs be transferred?
Unlimited
Licensed optometrists, who are not board certified, need what to admin topical eye drugs?
Valid topical ocular drug certificate
What are 5 things a TRADITIONAL MIDWIFE can prescribe?
Vit K Postpartum antihemorrhagic meds Local anesthetics Oxygen Prophylactic eye agent to newborn
How far in advance must pharmacies provide LTCF notice that they are closing?
WRITTEN notice to pts, caregivers, or LTC facilities at least 30 days prior to closure
How is the RPh required to counsel the pt with new Rx?
When dispensing a new Rx, RPh must consult pt/cargiver to optimize drug therapy. -In person when possible -Written material may supplement
When can C2 be partially dispensed?
When for LTCF pt terminally ill
What is "intractable pain?"
When the cause of the pain cannot be Tx or removed.
when can disciplinary action be taken?
When the person violates the terms of the agreement
When do you have to see an ID of a pt p/u a CS?
When they are picking up a CII or CIII that is not covered in part or all by insurance and if the person purchasing the prescription is unknown to you (does not have to be the pt)
What is an embargoed drug?
Whenever duly authorized agent of board finds or has probably cause to belive that any drug or medicine is adulterated or misbranded, agent shall affix an appropriate marking giving notice that article is suspected of being adulterated, misbranded, sold, delivered, offered for sale and has been embargoed
When can drugs in automated dispensing cabinets be accessed before pharmacist review?
With approval of P&T Specify what circumstances, drugs allowed, who can access
Under what circumstances are faxed CS rxs allowed?
With handwritten signature on faxed rx
Who must MD file with to dispense for profit?
With practitioner's licensing board
Within what period of time/how many times can you retake NAPLEX?
Within 18 months Must petition to board to take again if have failed 3 times already
What about prescriptions that are delivered or mailed to the patient?
Written counseling is required for NEW prescriptions (and appropriate refill prescriptions) that are mailed/delivered. Pharmacist must still make reasonable effort for in-person/telephone contact. Must include availability of pharmacist to answer questions and a toll free # for long distance calls. **Patient must receive instructions on what to do if integrity of package/medication is compromised.**
Can pseudoephedrine/ephedrine be sold OTC?
YES
Is prospective DUR required before new AND refill prescriptions?
YES
Must every pharmacy have a pharmacist-in-charge?
YES!
Are there any special requirements to be pharmacist-in-charge? (9 duties)
YES! A PIC must be a pharmacist regularly employed in the pharmacy department and must be designated in the application/renewal for pharmacy license. The PIC's duties consist of: 1. Establishing P&P (procurement, storage, compounding, dispensing, public communications, tech activities [make tech procedures available to the board]) 2. To supervise all of the professional employees 3. To assure all interns/residents/fellow/techs are appropriately licensed 4. To supervise all of the nonprofessional employees 5. To establish and supervise the storing/safekeeping of drugs 6. To establish and supervise the record keeping system for the purchase, sale, possession, storage, safekeeping, and return of drugs 7. To notify the board immediately if his/her services will be terminated 8. To respond to deficiency reports 9. To ensure that Q/A policies are developed for decreasing and monitoring Rx errors Deficiency reports: -If deficiencies are noted by the board, PIC shall submit in writing the steps taken/proposed to eliminate deficiency within 30 days of notice. Multiple locations: -No pharmacist shall be designated a PIC of more than one pharmacy. **May be waived if serving a hospital pharm part-time.** Termination: -Pharmacy shall notify the board immediately upon termination of PIC and shall immediately designate a new PIC and notify the board. The successor PIC shall submit an acknowledgement of an awareness and understanding of any variances.
Are patient profiles required for all patients?
Yes
Can an intern transfer refills?
Yes
Can NPs prescribe drugs?
Yes, may prescribe and admin drugs and ther devices within the scope fo the written agreement w/ a physician that defines the delegated responsibilities related to the prescription of drugs and therapeutic devices
Do pharmacist licenses have to be on display? The original or official copy? Is a photocopy ok? Can you obscure your address on the copy displayed to the public?
Yes. RP licenses need to be displayed. Photocopies are acceptable. Licenses must be "readily visible to public" (6800.1150)
How many people in the pharmacy can have access to the main supply of C2's?
a limited number
What does the board need to maintain of person's accessing it?
a log
Pharmacy employee who violates selling of pseudoephedrine/ephedrine restrictions is guilty of...
a misdemeanor same for person unlawfully purchasing it- 90 days prison, fine $1000 or both for both employee and indvl
What records can board NOT take:
any financial, sales, pricing data
What must surround the pharmacy?
a wall, from floor to ceiling, with doors that securly lock
How is the offer to counsel made?
a. Counseling is not just offered, it MUST be completed for ALL NEW RX's b. Counseling may be given on refills, per the RPh's judgement c. Interns may counsel without direct supervision
If drug contains unsafe color additive it is...
adulterated
When is an application/NAPLEX/MPJE reg. invalid?
after 18 months.
PIC is responsible for quality of what drugs?
all drugs, medicines, chemicals, and poisons procured for use and sold- except for meds/articles sold in original package of the mfr
When does the 'concurrent intership' take place?
all hours gained while in 2-4th year pharmacy school
What annual report must drug manufactuer send to BOP
all payment/honoraria/reimbursement / compensation
What payments to providers must drug mfrs report?
all payments, honoraria, reimbursement, or other compensation paid to practitioners (>$100) in MN during preceding calendar year This is public information.
Who can dispense? Who can possess non-C? Who can possess C? What need?
all providers except doctor of homeopathy, naturopath and midwife for all. Need valid DEA number
What is an "Electronic signature"?
an electronic sound, symbol, or process attached to or associated with a record and executed or adopted by a person with the intent to sign the record
What is an ADS considered compared to the managing pharmacy?
an extension of
Everyone selling legend medical gases that are not licensed pharmacy shall apply to BOP how often?
annually
How often do researchers need to inventory C's?
annually
How often do researchers using C need to register?
annually
Hwo often techs renew registration?
annually
How often so researchers need to register with BOP? When exempt?
annually (exempt if federal research project)
What is reporting immunity?
any indvl, agency, institution, facility, business, or organization is immune from civil liability or criminal prosecution for submitting a report in good faith to the program under this section or for cooperating w/ an investigation of a report or with staff of the program o Reports are confidential and are privileged communication
what must you do to become cs researcher?
apply annually on or before June1 for registration by the board, pay $25 o Inventory must be done annually
When can a RPh request a license go inactive? Do they need to continue to pay the renewal fee?
at a renewal time. Still pay fee every year
How often must RPh be accessible for pt/home health care providers questions?
at all times
Where and how long MD store rx files?
at each location for 2 yrs.
how large must dispensing counter be?
at least 18 inches deep and provide 2 linear feet clear of all merchandise and other materials not currently in use in pharmacy practice
Where can unused meds go that were from ADS?
back to pharmacy system's secure return bin (only to be restocked by pharmacy personel)
What kind of ADS policies and procedures are needed?
calibration, prevention of cross contamination, method to verify drug in cassette, QA
What can one do if they fail the examination?
can retake it in next 18 months, for max of 3 fails.
Who can do limited non-professional duties?
clerical personnel
Who selects the person/research organization to be in charge of the medical study under the THC therapeutic research act?
commissioner of health in consultation w/ rep chosen by BOP and board of medical examiners
How do compounds need to be named? (3)
common pharmaceutical name or name/strength principle ingredients or category of use name
What are the 10 types of pharmacy licenses BOP uses? (10)
community hospital home health care long term nuclear central nonsterile sterile vet limited
License categories
community hospital parenteral/enteral home health care long term care nuclear central nonsterile preparation compounding sterile preparation compounding veterinary limited service
What are the ways a pharmacy can be licensed? (10)
community/outpt hospital home health care long term care nuclear central service nonsterile compounding sterile compounding veterinary limited service
Where does the RPh need to be displayed?
community: in public place all other pharmacies: conspicuous place
How must separate charges be filed?
consecutively in separate paragraphs
When can an RN dispense a medication?
contraceptives when prescribed by licensed practitioner while working in a family planning agency as long as the patient is not <12
Whose duty is it to prosecute?
county attorney, or city attorney
What info must be kept when unit-dosing by the spervising RPh? (7)
date all drug/manuf info. container specification(?) copy of new label packager/RPh initials quantity per container internal control number
What info needs to be on label for IV admixture? (6)
date compounded beyond use date storage if not room temp inf rate admin time, freq or both cautionary statements PRN
What is a 'deficiency report' and how many days to deal with it?
deficiencies noted upon inspection submit steps to correct to BOP within 30 days
"Drug administration" in hospital means? What does it include?
deliver per order of MD a single dose to pt. Includes: preparing, verifying, giving to proper pt by proper route at proper time, assuring it was taken and recording time given.
Who can enter hospital pharmacy when closed for emergency doses? What verification do they need to leave?
designated RN record of pt., med, quantity, date, RN sig. If from bulk btl, leave btl by form for verification
What should be done with unused portions of meds in boarding care home left by pt that has been discharged OR died?
destroyed by person in charge of the boarding care home by flushing them into the sewer system and removing/destroying the labels from the containers *Destruction should be witnessed and signed by both persons
When pharmacist reviews med profiles for nursing home pts, who should they report concerns to? When must reports be acted on by?
director of nursing services and attending physician must be acted on by next physician visit (acceptance/rejection and initialing on report by both)
What can happen if anyone tries to block DUR/counseling?
disciplinary action
What needs to be done if a cheaper generic is available and DAW is not on RX?
dispense the cheapest generic and let the pt know
What is a wholesaler?
distributes/ reverse distributes to anyone by the user/pt
Who can prescribe, dispense, admin C 4-5
doctor of optometry
Who is the only entity that can use a DEA # to monitor prescribing practices?
drug enforcement
Each prepackaged container needs what info on the label? (5) What is the exception?
drug name/strength manuf name beyond use date internal control number physical description/imprints on pills (doesn't need to be on unit-dose if info on outer container containing < 72 hr supply)
What does 'emergency medical reasons' include?
drug transfers between health care entities to retail to help alleviate temporary shortages
By Jan. 1, 2010 what does the board need to create?
electronic system for monitoring C's dispensed Board must form a committee
What are some of the PIC responsibilities?
establish policies/procedures supervise all employees assure all are appropriately licensed
How often do laminar hoods need to be inspected?
every 12 months byb qualified individual
How often do those who manuf/compound/process/sell/dipose of any C need to complete a full inventory? How often do the records need to be kept for?
every 2 years Keep records for 2 years
Control inventory must be performed how often?
every 2 years (federal) every month (MN- perpetual inventory)
How often must pharmacy renew DEA registration?
every 3 years
How often does pharmacy need to inspect home health care emergency box for outdates?
every 60 days
If have bound log book for controlled drugs, must be signed off by rph how often?
every day
when does preceptor registration expire
every other year on anniversary of its issuance
How often do: manuf/wholesaler/sellers of drugs, medicines, chemicals, poisons, to those other than consumer, need to licensed?
every year with the BOP Exp June 1 each year must be renewed by May 1
What is the purpose of the ERP?
identify indvls engaging in doctor shopping
Can tech do jobs not listed in regulations?
if RPh ok and don't use professional judgment
Can researchers admin/dispense to humans? Are meds exempt from labeling requirements?
if authorized yes
Can a RPh make a customized medication package?
if consent by pt/caregiver, can put 1+ med together, need to follow ch. 661 standards
What are the two ways a central pharmacy can be licensed?
if out of state sending in = nonresident pharmacy in state are licensed = pharmacy
where do ADS need to be kept?
in a locked med room
How should cytotoxic meds be shipped?
in a manner to minimize rupture
Where does a hopsital PIC need to be licensed?
in state of MN
for accountability, what needs to happen during Rx filling? How long records kept?
initals of all involved at each step keep records 2 years
What needs to be on C if alcohol effects it?
label with warning not to drive
what does a pharmacy need to be to conduct business in MN or outside that comes in?
licensed by the board
If automated dispensing cabinet not located in same building as pharmacy, who can have access?
licensed nurses
What pharmacy employees can sell precursor drugs?
licensed pharmacist pharmacy technician pharmacy clerk
What must be recorded to sell a poison? what's exception?
log book: name/address amount/kind unless Rx from physician
How many hypodermic needles and syringes can pharmacy sell at a time?
max 10 Also, must certify to commissioner of health participation in an activity that supports proper disposal of used needles or syringes
What period of time can be covered by an audit?
max 24 months from date claim submitted to or adjudicated by entity
If pt takes a leave from facility, how are meds handled?(2)
max 72 hr supply and only 1 med per properly labeled container
If attending physician at nursing home does not concur with recommendations or does not provide adequate justification, who must the pharmacist refer it to?
medical director if pharmacist feels QoL is being affected. If attending physician is the medical director, report to QAA committee
commingling of lot numbers would be considered..
misbranded
If you commingle lot numbers of the same drug you can be charged with...
misbranding
Penalty for violation of compounding laws (outside pharmacy, not disp by pharmacist)
misdemeanor when death of human being occurs, is gross misdemeanor this is supplement to laws existing for homicide
How often does an audit of C need to be done?
monthly
how often inventory emergency kit
monthly
How does MD file Rx records?
must reduce all to writing and file numbered. Chart records do not count as Rx.
What must be on label to avoid misbranding?
name and place of business of the manufacturer, packer, or distributor statement of identity accurate statement of net quantity (weight, measure, or numerical count)
What must tech wear at all times?
name badge
What needs to be recorded on the personal care record when administering a drug to a pt living in a boarding care home?
name of drug quantity of drug time distributed initials of person that distributed
What extra component must be on rx label in MN?
name of mfr or distributor of finished dosage form
Can employees of state or subdivision of the state that are on the BOP be reimbursed?
not for activities can be reimbursed for child care needed dt board activities for hours beyond their normal work day
Does preceptor always need to be present?
not for med hx, aducational activities, counseling... but intern needs plan approved first
Does MD need to be physically present with tech?
not if available electronically or by phone
Does RPh need to always be with ADS?
not if continuously, electronically monitored
Is counseling required for I.P/nursing homes..etc.?
not if licensed HCP is admin the drugs or pt/caregivers request not to be counseled.
Who can administer CS?
nurse, intern, assistant under direction of the doctor
What is considered a transfer in pharmacy ownership, requiring reapplication for licensure?
o Sale of substantially all of the assets of the pharmacy o Addition or deletion of one or more partners in a partnership to which pharmacy license has been issued o Change of ownership of 20% or more of the issued voting stock of a corporation pharmacy since the issuance of the license or the last renewal Does not apply to any corporation the voting stock which is actively traded on any securities exchange or in any OTC market o Change in ownership from one form to another- sole proprietor, partnership, or corporation
Who is not eligible to participate in health professionals service program?
o Who have diverted CS for other than self-administration o Who have been terminated from this or any other state professional services program for noncompliance in the program o Currently under a board disciplinary order or corrective action agreement, unless referred by a board o Regulated under sections 214.17 to 214.25 unless referred by a board or by the commissioner of health o Accused of sexual misconduct o Whose continued practice would create a serious risk of harm to the public
Where do Rx files need to be kept? how long?
on location, 2 yrs.
Who is a donor?
one NOT a manuf/distributor
Can techs check other techs?
only by varience request
Which radioactive meds canbe dispensed by nuclear pharmacy?
only those approved by FDA or investigational with IND or NDA
Does the Rph have to counsel refills?
onyl if RPh deems necessary. Then must be in person too.
What cannot be in the emergency kit?
oral C stimulants
What is the min. number hours on-site pharmacy needs to be open for services?
part-time, 5 days a week
What types of pseudoephedrine can be sold OTC?
peds pdts (<12 years) liquid gel caps liquid powder form where pseudoephedrine constitutes less than one percent of its total weight and is not its sole active ingredient *more difficult to make meth from
Who can override computer alerts?
pharmacist or pharmacy intern
Who can retrieve messages from an answering machine
pharmacist or pharmacy intern technician only if approving refills for drug already filled at the pharmacy with no changes
• Use of PTs in performance of delegated tasks not included in written procedures may be considered unprof conduct on part of
pharmacist pic pt
Who can sell a stimulant or depressant drug?
pharmacist, assistant pharmacist, intern under supervision of licensed pharmacist
What needs to be done to do high alert compound?
pharmacy determines which are high alert RPh needs ot verify at each step before finished product
Who has to wear a name badge?
pharmacy technicians while on duty
Who can administer injections in LTCF?
physician, PA, RN, NP, LPN or may be self-admin if allowed
What needs to be available for inspection at a pharmacy that wants to be licensed as a parenteral-enteral home health care pharmacy? How often review?
policy and procedures manual- reviewed and revised annually.
Who can administer drugs?
practitioner, nurse, PA, medical student, resident
What are APNP authorized to do? (4)
prescribe (after 2,080 hrs under collaborative) admin procure dispense -within scope and admin
How can counseling be completed when doing mail order?
providing written info and the availability of the pharmacist to answer question thru provision of toll free phone # for long distance calls
What consent is needed for investigational radioactive?
pt consent
What needs to be on med dispensed to pt by med order? (7)
pt name drug name/strength route aux labels PRN exp date and date dispensed
What info must a reasonable effort be made to obtain? What's the exception?
pt name/address/DOB/telephone/gender significant med. Hx allergies all meds/devices used & rx number if fill RPh comment pertaining to care Except nursing home residents under consultant RPh care
Who can receive medical gases? (4)
pt with RX hospital practitioner licensed pharmacy
What does dispense mean:
pursuant to a lawful order from physician
Min. label info for LTCF: (3)
quantity date original issue or most recent refill expiration
what other C info needs ot be kept for 2 years?
quantity and kind of each C received/sold/delivered/ disposed of and the name/address to whom it went.
How often does BOP have to report to board of optometry any complaints regrding rx or admin of legend drugs?
quarterly
How often does BOP need to report to board of Optometry complaints?
quarterly
How can name of radioactive med be on label?
radioactive name or abbreviation
Are technicians required to be registered? Certified? Licensed?
registered- Yes Certified- Licensed- yes
commingling of mixed lots or returned meds deems them all misbranded, what is exempt?
returned medical devices properly sanitized
IN cases where physical characteristics of container do not permit full labeling must contain
rx number and name
What is not wholesaling ?
samples, hospital to hospital, charitable donations, emergency sale, blood products
What is needed to use emergency kit for home care pt?
signed MD protocol
What form should C2's be stored in when possible?
single unit dose containers
Which med is exempt from labeling rules?
small packages
What form must ephedrine be in?
solid, oral 400 mg guaifenesin + 25 mg ephedrine rectal < 5%
Radioactive drugs: what not include?
spontaneous disintegration of unstable nuclei with emission of protons/particles . Not include carbon containing or K salts with trace natural occuring quantities
Who can use a federal DEA # to monitor the practice of prescriber for drug enforcement purposes?
state govt agency, regulatoy board *NOT health plans, managed care orgs
Can an intern earn hrs in another state?
submit them to BOP to decide
Who needs a copy of the policy?
supplying pharmacy and board
Who can perform non-dispensing functions?
supportive personnel may fill drawers
Who pays for the Tx via the referral?
the program participant
What happens if the appointing authority can't find a successor for a member?
they can serve another 4 years.
A Rph must certifiy all drugs going into ADS except?
those going in via barcode scan.
What type container dispense in?
tight or well closed with child resisitant per PPPA.
What do out of state pharmacy need to have on every RX?
toll free phone number
Pharm tech role
traditional computer data entry and other manipulative tasks in preparing medications
How does pharmacy need to provide meds to LTCF pt if requested?
unit-dose packaging
How many refills can be on a CV or non-control med?
unlimited, they are just good for 12 months
What can a qualified research person do with C?
use them in research, but not admin or dispense to humans unless legally authorized to do so.
Who can initiate a proceeding to suspend/revoke license? (2)
verified compliant by agency/law enforcement board by own motion
How can C2 be delivered to home health care pt?
via courier documented in full chain of possession
How often does RPh need to visit a hospital that has a med room where meds come from off-site pharmacy?
weekly
How do drugs need to be stored in a nurse med room? C's storage?
well lit, locked drug cabinet, clearly labeled bins, with pt names if individually prescribed. C's need to be locked, permanently attached cart/wall
Can drugs from LTCF/nursing homes be returned and reused?
yes if: -consultant RPbh can assure proper storage conditions -facility has 24/7 nursing coverage -returned to same pharmacy in same package as dispensed -package integrity still intact
Can pharmacists charge a fee for counseling?
yes per state
Can MD keep DAW as the default?
no
Can a PIC be a PIC in more than 1 location?
no
When you give a copy of an rx to an allowed individual, what must be on it?
"Copy for information only" on the face of the rx
Can you save or use a drug supply for one resident of a LTCF for another resident?
no
How can the closing pharmacy deal with C's? (3)
- destroy after contacting local DEA for instructions -C 3-5 transfer with duplicate invoices -C 2 transfer with 222
How can a pharmacy alert its pt it's closing and where to find Rx's?
- publish in local newspaper 1 week prior to closing -direct mailing to pt who've filled Rx in prev 6 mo. to arrive no later than 1 day prior to closing -handout to all pt picking up Rx 30 days prior to closing.
What drugs can be donated? Can C's be donated? CAn a dropbox be used?
- single doses, direct from container - taper evident - good for 6 more months - NO C's. -NO dropbox- donor must sign BOP form
When does one need to be an intern?
- student - awating time to examinate -resident not licensed yet
What does the pharmacy receving the Rx need to do?
-"Transfer" or "copy" on face of Rx - All Rx info required by law -date of issuance and date of original fill -original # refills -date of last refill -original rx # -Transferring pharmacy name/address/phone - name RPh/intern -DEA # of transferring pharmacy PRN
What does the transferring RPh need to do? (4)
-"VOID" on face or void all remaining electronic refills -on back: name/address/phone receiving RPh/intern -DEA Number of receiving pharmacy PRN -record date of transfer
A verbal can be taken for C2 rx for which circumstances?
-immed admin needed -No appropriate alternative -not reasonable for MD to provide written
Qualifications of pharmacist applicants
-18 years of age -good moral character -graduate of UMN COP or of a college of pharmacy in good standing of which the board shall be the judge and shall have completed internship requirements as prescribed by the board -US SSN
What must optometrist do in order to prescribe or administer topical ocular drugs?
-60 hours of study in general and clinical optometry related pharmacology approved by board -30/60 hours must be in ocular pharmacology and emphasize systemic effects of and rxns to topical ocular drugs including emergency mgmt. and referral of any adverse rxns that may occur -passing exam
What are the requirements for remote processing of prescriptions?
-A variance must be requested for remote prescription processing -All variance requests related to telepharmacies are reviewed by the full BOP, on a case-by-case basis, at one of its regularly scheduled meetings -the Board may place conditions on any variance request before granting approval, which is also done on a case-by-case basis
What can you do if are pharmacy/physician that never or rarely dispenses CS?
-Can request permission from board to be entirely exempt -Those that dispense occasionally DO need to report, but can submit "zero-claim" reports for periods where they do not dispense any
What min. equipment must a pharmacy have?
-Class A balance w/ 50-100 g metric weights or electronic balance of equal/greater accuracy -measuring devices from 1-500 ml -mortars, pestles, stir rods, funnels, spatulas, hot plate -equipment needed for 797 -fridge for drugs only and temp monitoring device -sink w/ hot and cold running water -toilet w/ hand washing and disposable towels.
Who patrols who is receiving cs that is enrolled in opioid tx program?
-Commissioner of human services must implement system thru which dept of human servies must routinely access data to determine whether any client enrolled in opioid tx program has been prescribed or dispensed CS in addition to that provided by program -When commissioner determines have been multiple prescribers or rxs they must: Inform medical director of opioid tx program only that they determined existence of multiple prescribers or rxs Direct medical director of opioid tx program to access the data directly, review effect, document the review
What are the requirements for storage and accountability for controlled substances in a hospital? (3 ways to account for CS's) (wasting doses) (PHARMACY STORAGE/ACCESS/INVENTORY) (TEMPORARY PT LEAVE)
-Controlled substances must be accounted for by either: (1) a "proof-of-use" sign-out sheet where each dose given is accounted for by the licensed LCP -No CS on floor stock unless accompanied by the sign-out sheet -proof-of-use sheets must include the date & time, patient name, dose administered, and the HCP's signature -there must be a system for reconciling the proof-of-use sheets in the pharmacy (2) the dispensing of a drug to a specific patient after receiving an individual drug order (3) a computer system using electronic distribution records, which has specific requirements (see other flashcard) WASTING: -Wasting of doses must be carried out by two licensed individuals who are authorized to have access to controlled substances ***must be documented and must include signatures*** PHARMACY STORAGE/ACCESS/INVENTORY: -Controlled substances must be stored under lock on the nursing stations or other patient care area -Access to main supply of C2's in the pharmacy must be restricted to a limited number of persons in the pharmacy, and must be kept locked when not being used -Single unit-of-use should be used when possible -A perpetual C2 inventory must be maintained TEMPORARY LEAVE OF PATIENT: -For a patient temporarily leaving the facility when the pharmacy is closed or cannot supply the needed medication in a timely manner, may issue meds to the pt by the RN, not to exceed a 72-hour supply, in paper envelopes or other suitable containers. -Each container may hold only one medication and the label shall include the date, patient name, facility, drug name/strength/dose, time of admin, and the initials of the RN preparing.
What are requirements to be nuclear pharmacist?
-Currently licensed in MN -Certified as nuclear pharmacist by Board of Pharmaceutical Specialties or meet following stds: A. minimum 200 contact hours of instruction in nuclear pharmacy and the safe handling/use of radioactive materials from accredited COP with emphasis in: 1. radiation physics and instrumentation 2. radiation protection 3. mathematics of radioactivity 4. radiation biology 5. radiopharmaceutical chemistry B. attain minimum 500 hours of clinical nuclear pharmacy training under supervision of qualified nuclear pharmacist C. submit affidavit of experience and training to BOP
What reasonable efforts must be made to tx intractable pain?
-Evaluation by attending physician and 1 or more physicians specializing in pain medicine or tx of the area, system, or organ of body perceived to be source when treating nonterminally ill pt -Evaluation by attending physician who does so in accordance w/ level of care, skill, and tx that would be recognized by reasonably prudent physician under similar conditions and circumstances in terminally ill pt
How quickly do records need to be retrieved by?
-immediately if electronic copies -with in 2 days if kept at central location
What can cause a license to be denied/suspended/revoked/refused renewal?
-Fraud or deception in connection w/ the securing of the license/registration -Conviction in any court of felony (pharmacist) -Conviction in any court of an offense involving moral turpitude (pharmacist) -Habitual indulgence in use of narcotics, stimulants, or depressants or habitual indulgence in alcohol in a manner which could cause conduct endangering public health -Unprofessional conduct or conduct endangering public health -Gross immorality -Employing, assisting, or enabling in any manner an unlicensed person to practice pharmacy -Conviction of theft or drugs or unauthorized use, possession, or sale thereof -Violation of any provisions of this chapter or any rules of the State BOP -Pharmacy license- operation of pharmacy w/o pharmacist present and on duty -Pharmacist- physical or mental disability which could cause incompetency in practice of pharmacy -Pharmacist- suspension or revocation of license to practice pharmacy in another state -Pharmacist- aiding suicide or aiding attempted suicide
What kind of funding can the board seek to help finance the database?
-Grants and private funds frmo non-profit, charitable, and the fed govt. -Fees from each medical board
What can an optometrist NOT prescribe/admin?
-IV/IM drugs except to tx anaphylaxis -invasive or laser surgery -C2-3 or oral steroids -Oral antivirals duration of > 10 days -Oral carbonic anhydrase inhibitors for > 7 days
What records must physician keep in order to avoid disciplinary action for tx pt w/ intractable pain?
-Keep accurate records of purpose, use, and disposal of CS -Writes accurate rx -Discuss risks associated w/ schedule 2-5 before prescribe and document this discussion in pt record
Who is a practitioner in MN?
-MD -doctor osteopathy -DDS -doctor optometry -podiatrist -Vet -PA -APNP -dental therapist
WHEN and to WHO must theft/loss of a SIGNIFICANT amount of CS be reported? (1) What must the report include? (4)
-Must report the loss, IN WRITING, to MN BOP and DEA immediately -Report must include: 1. description of how the loss occurred (if known) 2. date the loss occurred (if known) 3. steps being taken to prevent future losses 4. inventory of the missing drugs **this applies to any pharmacy, wholesaler, manufacturer, or researcher detecting a significant loss due anything except inadvertent errors**
Are pharmacists and prescribers required to look up pts in the database?
-No, pharmacists/prescribers/other dispensers are immune from civil, criminal, or administrative liability on the basis that they did not not seek/obtain/use info from the system -Also immune from all liability for requesting/receiving/using info from the program
What do Canadian grads before 1993 or after 2004 need to do?
-Pass FPGEE -Pass English written and spoken exams -1600 hours internship, complete intern manual -submit all required for USA grad student
Who can access the database?
-Prescriber (or agent) -Dispenser (or agent) -Pt who had info entered/parent/guardian/indvl acting under health care directive -Authorized personnel of board (investigations, data collection) -Vendor under contract -local, state, federal law enforcement -personnel of medical assistance program delegated to identify indvls that need to have restrictions to single provider, pharmacy, hospital -personnel of dept human services assigned to access data
How can ephedrine be dispensed? (3)
-Rx -OTC if labeled properly -for legitimate medicinal use
What patients do not have to have their data submitted to the electronic reporting system?
-SNF or LTCF -indvls receiving assisted living services thru medical assistance home and community based waiver -indvls receiving meds IV -hospice/end of life care -indvls receiving services from home care provider
What do foreign pharmacy grads need to do?
-Same as Canadian after 2004.
What needs to be in tech procedures? Where is copy kept?
-details of tasks to perform -certification steps by RPh to verify tech work -each tech gets copy and post in pharmacy
What elements need to be included in the counseling? (9)
-drug name/description -dosage form, route, dose, duration -intended use/expected action -common severe SE/ avoidance/ action to take -self-monitoring -storage -refill info PRN -missed dose -RPh comments they feel important
What 5 requirements need to be done monthly, but not all at once?
-drugs properly stored in correct configurations -outdates removed -only approved drugs in ADS -inventory levels are appropriate -device and drugs are secure
Requirements for those apply for pharmacist licenses from outside US
-good moral character -At least 18 years of age -Completed internship requirements as prescribed by board -provided verification of academic record and graduation -Successfully passed examinations approved by board to establish proficiency in English and equivalency of education w/ graduates of cop which the board has determined to be in good standing
What dosages/dosage forms of ephedrine are allowed?
-guafenesin 400mg/ephedrine 25mg per dosage unit -anorectal preparation that contains 5% or less ephedrine -pdts containing EPHEDRA or MA HUANG marketed as dietary supplements
What qualifications does RPh need to be preceptor?
-have practiced 4000 hrs, 2000 in MN -work at least 20 hr / week -set aside time, at least 3x/mo, just to help interns -to RENEW, have done preceptor training in past 2 yrs.
Can emergency kits contain C's?
-if kept in looked room/cabinet -limited access -max 6 unit doses of any narcotic -facility keeps record of C used for 2 yrs. -used in same situation as an emergency verbal C Rx
When can an MD dispense? how often renew? other pharmacy located where? can supervise tech?
-in designated health prof shortage area -renewed annually -dispense as limited service pharmacy -no other pharmacy within 15 miles -a certified tech can assist them if MD responsible for.
What min. info is needed to apply as wholesale distributor
-name/address/telephone -all trade/business names used by licensee -names/address/telephones/contact people for all facilities used by licensee for storage/handle/distribution. -name owner whether: partnership, corporation, sole proprietorship or individual.
Under what conditions with BOP grant varience? (3) how long to BOP decision?
-no adverse safety to public -alternative is equivalent/better than current -compliance w/o varience would be undue burden 60 days
Rx from pharmacy for animals needs to be labeled:
-non food animal: name of client or animal, vet name only -food animal: owner name, name/address of facility, *drug withdrawal time, name & address of vet* -species - regular Rx info.
What must RPh have completed to be nuclear RPh?
-nuclear pharmacy course &/or board approved experience -board certified nuclear RPh or -200 contact hrs of instruction from accredited college plus 500 hrs under supervisor and submit experience to board.
When can a pharmacy deliver Rx to pt work?
-obtains written consent -delivered directly to pt/caregiver -ensures security of HIPAA
Who can be deemed at fault if anhydrous ammonia is tampered with?
-owner/lawful custodian of the container/equipment -person responsible for installation/maintenance -person lawfully selling or offering for sale
All those preparing radioactive drugs must be licensed as manufactuer unless:
-physically attached to emdical facility -drug is for pt due to med order from MD
What are examples of topical ocular drugs?
-proparacaine 0.5%, tetracaine 0.5%, benoxinate 0.4% -phenylephrine 2.5% or less, hydroxyamphetamine 1% or less -tropicamide 1% or less, cyclopentolate 1% or less
To mail a drug what must one do? (4)
-protective packaging and storage temps -containers with evidence of tampering -have policy for drugs MIA and provisions for replacement -Provide written/elec/telephone to offer counseling
What 2 other requirements need to be met to practice?
-provide Soc Sec number -Pay original licensure fee
What must purchaser do to get pseudoephedrine?
-provide photo ID showing proof of 18 years of age -sign paper/electronically in logbook that contains date and time of sale name and address of purchaser amt sold pdt sold (by name)
Who can you divulge contents of rx or provide copy of rx to?
-pt/agent/another pharmacist acting on behalf of pt/agent -licensed practitioner who issued it -licensed practitioner treating the pt -member, inspector, investigator of board or any other federal, state, county, or municipal officer whose duty it is to enforce laws of MN or US related to drugs and engaged in specific investigation involving designated person or drug -agency of govt charged w/ responsibility of providing care to pt -insurance carrier or attorney on receipt of written authorization signed by pt or pt's legal representative -any person duly authorized by court order
How does a unit dose system need to work?
-separating meds by pt/room number -separate meds by day of admin -organize dose dispensed/admin/returned -means of identifying dosage regimen -RPh verify original drug order -RPh verify med before delivery to pt
What can ephedrine NOT be marketed for: (4)
-stimulation/energy -mental alertness -weight loss/ appetite control -muscle enhancement
What do Canadian grads 1993- 2004 need to do?
-submit letter outlining intern experiences (BOP decides if comparable, or if need to do more) -submit all required for USA grad student
When can the database not be used?
-to see if a prescriber is prescribing excessively -to get info to for prosecuting against a prescriber
Requirements for CS rx
-written in ink -contain name and address of pt -contains handwritten signature, address, federal registry number and *designation of branch of healing art pursued by prescriber
how many cassettes of an ADS can be filled at once?
1
What are the requirements for references in LTCF?
1 current medication reference book (published within previous 2 yeArs)
How many pharmacies per license? need to pass?
1 license / pharmacy need pass inspection unless own state inspected within passed 24 months.
Who needs to be physically present at all times in the pharmacy?
1 licensed pharmacist, except for brief absences due to course of pharmacy practice
Who is is on the 'Health Professionals Services Program' committee in addition to the advidory committee?
1 member from each participating board, each getting 1 vote
Who is on the advisory committee for the health professional services program? How long are their terms
1 member from: -MN Academy of Pas, MN Dental Association, MN Chiropractic Association, MN LPN Association, MN Medical Association, MN Nurses Association, MN Podiatric Medicine Association -1 member appointed by each of the professional associations of the other professions regulated by a participating board not specified in clause 1 -2 public members Terms are 2 years, can be reappointed
If using manuf original package for animals how many labels do you need?
1 on each bottle/package
Who is on the health professional services program committee?
1 person appointed from each board each board has 1 vote
How long are rx for CII valid from date issued?
1 year
How long are rx for CV valid from date issued?
1 year
How long are rx for legend drugs valid from date issued?
1 year
What is the max amount of time the BOP can require intership?
1 yr
Do pharmacy hours have to be posted?
no
Do these rules pertain to OTC items?
no
Under what circumstances may a pharmacist refuse to fill a lawful prescription? (4)
1. -If the pharmacist would be violating a law 2. -Drug or drug product not in stock 3. -Pharmacist believes the drug could be harmful to the patient 4. -Suspected forgery or suspicious prescription
What are the requirements to be pharmacy technician?
1. 18 years of age 2. high school graduate or GED
How long must pharmacy maintain records for: 1. Transfers 2. Originals 3. Refills 4. Pt profiles 5. Sample requests from physicians to mfrs
1. 2 years from date of last refill 2. 2 years 3. 2 years 4. 2 years from date of last entry 5. 3 years *Medicare modernization act requires rx to be kept x 10 years *FDA claims may request records of drug distribution dating back 5 years
What must be done if the computer system goes down? (3)
1. AUX SYSTEM; Pharmacy must have an auxiliary record system for use 2. 2-DAY ENTRY; Must have provisions for entry of info into the system within 2 working days 3. 3-DAY REPORTING; Lost info must be reported to BOP within 72 hours
What items need to be on prepackage?
1. Date 2. Identification of drug (name, dose, manufacturer, lot #, expiration date) 3. Container specification 4. Copy of label 5. Unique identifier of the packager 6. Unique identifier of supervising RPh 7. Internal control number or date
What items need to be on an outpatient IV admixture, in addition to the items mentioned in the Rx label? (5+)
1. Date of compounding 2. Beyond-use date 3. Storage requirements 4. Infusion or administration rate 5. Other cautionary info (***Physical description is not required***)
What is required on the label of an OTC product? (19)
1. Drug Facts - title 2. Active ingredient(s)-including amount in each dosage unit 3. Purpose - pharmacologic class 4. Use(s) - indications 5. Warnings 6. Do not use - absolute contraindications, when the product should not be used under any circumstances 7. Ask a doctor before use if you have - warnings for persons with certain preexisting conditions and for persons experiencing certain symptoms 8. Ask a doctor or pharmacist before use if you are - drug/drug and drug/food interactions 9. When using this product - side effects that could occur and substances or activities to avoid 10. Stop use and ask a doctor if - signs of toxicity and other serious reactions that would require consumers to stop using the product immediately 11. Pregnancy/breast-feeding warning 12. Keep out of reach of children/Accidental overdose warnings 13. Direction - dosage and when, how, or how often to take 14. Other information 15. Inactive ingredients 16. Questions? (Optional) 17. Lot number 18. Expiration date 19. Name and addresses of manufacturer or distributor
Are there any required notices that must be displayed to the public? (5)
1. Generic substitution policy (151.21) 2. Pharmacy and pharmacist licenses (151.19) 3. Controlled substance reporting: must provide to pt a conspicuous notice of the reporting requirements of this section and notice that the info may be used for program admin purposes 4. Privacy policy (???according to flashcard quizlet???) 5. Public notification when closing a pharmacy: distribution of a notice that informs patients that the pharmacy will close on a specified date and that gives the name, address, and telephone number of the pharmacy to which prescription files will be transferred. Notice via: A. local newspaper one week prior B. direct mailing to patients (1+ rx's during six months preceding closing, reaching patients no later than one business day prior to closing C. notice to patients picking up rx at least 30 days prior to closing. *In the case of LTCF, the pharmacy shall provide a written notice to the patient/caregivers/LTCF 30+ days prior to closing
In what cases can the ratio of RPh's to techs be 1:3?
1. IV admixture prep 2. Setting up/preparing patient Rx's in unit dose 3. Prepackaging 4. Compounding
When can pharmacist refuse to fill a lawful prescription?
1. If the pharmacist would be violating a law 2. the drug is not in stock 3. the pharmacist believes the drug could be harmful to the pt 4. suspected of forgery of fictitious rx
What minimum sets of references are required in all community pharmacies?
1. Most recent editions of laws relating to pharmacy 2. The rules of the Board of Pharmacy 3. The current copies of DEA regulations and CFR (title 21, parts 1300 to 1316) 4. At least 1 current reference (electronic or hard copy) from each of the following categories: A. Pharmacotherapy B. Dosage and Toxicology (**HARD COPY**) C. General reference (e.g. Physician's Desk Reference)
What must be documented when administering meds in LTCF?
1. Name 2. date 3. time 4. quantity 5. method of admin of all meds 6. signature of person administering
What items need to be on unit dose packaging? (6+)
1. Name of drug 2. Dosage form 3. Strength 4. Manufacturer's name 5. Lot number 6. Expiration date ((***Must comply with prepackaging label rules when given to a patient***))
What items need to be on a prepackage label when given to the patient? (7+)
1. Name of drug 2. Strength 3. Name of manufacturer/distributor 4. Beyond-use date 5. Internal control number date 6. Physical description 7. Radiopharmaceuticals must follow those rules
What items are required on a patient profile? (3+)
1. Name, address, telephone #, DOB/age, gender 2. Individual hx where significant (allergies, meds, devices, dx states) 3. RPh comments (care needs, services rendered, impression of drug therapy)
What 10 items must an RPh cover when counseling a patient?
1. Name/description of drug 2. Dosage form, route, dose, duration 3. Intended use and expected action 4. Special directions/precautions 5. Common side effects, interactions, contraindications 6. Techniques for self-monitoring 7. Proper storage 8. Prescription refill information 9. Action to be taken if dose is missed 10. Any pharmacist comments/concerns
What items need to be on an Rx label? (11)
1. Pharmacy name/address/telephone 2. Patient's name 3. Rx number 4. Name of prescribing practitioner 5. Directions 6. Name of manufacturer/distributor 7. Auxiliary labels prn 8. Date of original issue/renewal 9. Generic/trade name and strength 10. Central pharmacy information (if applicable) 11. Physical description
When pharmacy is closing, what ways can they provide public notification?
1. Publication in local newspaper for 1 week prior to date on which is to be closed 2. Direct mailing to pts that have had at least 1 rx filled at that pharmacy during the 6 mo preceding the date of closing, with mailing designed to reach pts no later than 1 business day prior to closing 3. Distribution of the notice to pts p/u rxs at least 30 days prior to date on which pharmacy will be closed
Public notification of a pharmacy closing must be done in 1 of 4 ways.
1. Publication of the notice in a local newspaper for 1 week prior to the date of closing 2. Direct mailing to patients who have had at least 1 Rx filled during the past 6 months with the mailing no later than 1 business day prior to closing 3. Distribution to patients picking up Rx's at least 30 days prior to closing date 4. Long-term care residents, provide written notice to patients, caregivers, or the long-term care facilities at least 30 days prior to closing date
What 2 items are required to fill an Rx for an animal?
1. Species 2. Full name of owner and their address
What are special requirements, if any, to be a nuclear pharmacist? (2)
1. competent in the preparation, handling, storage, receiving, dispensing, disposition, and pharmacology of radiopharmaceuticals 2. completed a nuclear pharmacy course and/or acquired experience in programs approved by the board. **Education and experience in nonapproved programs may be accepted if, in the opinion of the board, the programs provide a level of competence substantially the same as approved programs.**
What requirements must be completed for unlicensed personnel to administer meds in LTCF?
1. completed nursing assistant training program approved by the dept 2. completed standardized med admin training program for unlicensed personnel in nursing homes offered thru MN postsecondary educational institution that includes at a minimum instruction on the following: Complete procedure of checking the resident's medication record Preparation of the med for admin Admin of the med to the resident Assisting resident's w/ self-admin as necessary Documentation after admin of date, time, dosage, method of admin, reason for not admin all meds as ordered, sig Type of info regarding med admin reportable to a nurse
Employer is not subject to punishment for an employee incorrectly selling meth precursors if...
1. did not have prior knowledge of, participate in, or direct the employee or agent to commit the violation 2. documents that an employee training program was in place to provide the employee or agent with information on the state and federal laws and regulations regarding methamphetamine precursor drugs
What is considered a med error in nursing homes?
1. discrepancy bw what is prescribed and what is administered 2. the administration of expired meds
10 elements of counseling (MN BOP rules)
1. drug name and description 2. dosage form, dose, route, and duration 3. intended use and expected action 4. special directions & precautions for prep, admin, use 5. common SE (severe and non-severe), interactions, contraindications, how to avoid, what to do if they occur 6. self-monitoring 7. storage 8. refill info 9. what to do in case of MISSED DOSE 10. other relevant comments
When can pharmacies accept drugs back from pts for reuse?
1. in hospital for inpt use only when have not left the span of control of the pharmacy 2. nursing homes and assisted living facilities if -24/7 nursing coverage -returned to pharmacy that dispensed them -integrity of packaging is intact
When is counseling not required?
1. inpts of hospital or other institution where other licensed hcps are authorized to admin drugs 2. pt or pts agent has expressed desire to not receive the consultation
Does BOP do background checks on wholesalers?
no
What services does this committee provide? (3)
1. referral of eligible persons for treatment per illness 2. develop program participation agreements/monitoring 3. compliance monitoring
Influenza vax ages
10yo+
How long are C-II scripts good for?
12 months
How long does a pharmacy application have until it is no longer valid?
12 months
How long is a non-C Rx good for?
12 months
How long is data maintained in the database?
12 months
How long must the data be maintained for?
12 months
How longs are C-V scripts good for?
12 months, no federal limit on refills
What is the max amount of CV drugs in 48 hour period?
120 mL or 24 dosing units
How far in advance must pharmacy be notified of an audit?
14 days
How many days to notify BOP of pharmacy closing?
14 days
How soon must a pharmacy notify the board of closing?
14 days
After transfer of ownership, how long can the new owner operate the pharmacy until they receive a new license?
14 days (whichever is earlier)
When do you need to notify board of closing of a pharmacy?
14 days before closes
How long is an application to become a pharmacist valid?
18 months
How old does a registered technician have to be? What level of education?
18 years old High school diploma or equivalent
How big must the counter be?
18" deep by 24" long
What is the ratio of ASA:Butalbital that is required to be exempt from CS scheduling?
188 mg : 15 mg
Ratio of RPh's to techs?
1:2
RPh : tech ratio
1:2. 3:1 if one tech is board certified PIC can ask for waiver of ratio, if don't hear anything in 90 days, it's approved.
Who can waste C's?
2 licensed individuals. Must be documented
What is the health professional services program?
2 or more health related licensing boards that jointly conduct a health professionals services program to protect the public from persons regulated by the boards who are unable to practice with reasonable skill and safety by reason of illness, use of alcohol, drugs, chemicals, or any other materials, or as a result of any metnal, physical, or psychological condition
222 forms should be kept for how long?
2 years
How long do ADS records need to be kept?
2 years
How long do both sides need to keep transfer Rx info?
2 years
How long do wholesalers need to keep records of drug source, distribution, disposition?
2 years
How long does PIC need to keep copies of weekly work schedules?
2 years
How long must a TRANSFERRING pharmacy keep a record of transferred Rx's?
2 years
How long must a patient profile be kept after the last entry?
2 years
How long must record keeping be kept for wholesalers?
2 years
How long must the PIC keep documentation of tech training?
2 years
How long must the original Rx be kept on file?
2 years
How long should a contract pharmacy maintain records?
2 years
How long to radioactive records need to be kept?
2 years
How long, according to Minnesota, should an Rx be kept on file?
2 years
Unique identifier of each pharmacist, pharmacist-intern, pharm tech who performs any portion of rx filling process must be documented and maintained for how long?
2 years
How long do elec. pt records need to be kept?
2 years from date of last entry
How long do medical gas records need to be kept?
2 yrs
How long do wholesalers need to keep records?
2 yrs
After how many years of not working can BOP ask RPh to retake NAPLEX?
2 yrs immediately preceeding application for reciprocity
How far back can an audit go?
2 yrs.
How long must repackaging records be kept?
2 yrs.
How much CE must technicians do?
20 hours per 2 years
Minimum square feet required to be considered a pharmacy?
250 ft2
If Rx is certified at central pharmacy, does dispensing pharmacy need additional certification?
no
Who is on the CE advisory task force? (4) how often meet?
3 RPh from MN pharmaceutical assoc 3 RPh from MSHP 2 RPh from U of MN college of pharmacy 2 from BOP Shall meet quarterly
A practitioner can administer (but not prescribed) methadone for how long if the pt is waiting for a treatment program?
3 days
CE providers must keep records of attendance, program content, and evaluation summary for how long?
3 years
How long should a CE provider maintain records of hours given?
3 years
How many hours of CE must a pharmacist have in a 2-year period?
30 hours
CE rqrmts? RP
30 hours every 2 years due 9/30 on EVEN YEARS *topics can include legal, psychological, and socioeconomic aspects of health care delivery*
How long are board terms? When do they end?
4 years long (no term limits) Ending the first monday of January.
What is considered a small amount of marijuana
42.5 g or less -water in pipe will not be considered unless in cases where marijuana is mixed with 4 oz or more of fluid
By what time frame should approval for CE presentation credit be submitted to the board?
45 days
How long does pharmacy have to provide documentation for audit after receiving the preliminary report?
45 days
Cancer drug repository records must be kept for how long?
5 years
How long should Cancer Drug Repository donor and recipient forms be maintained for?
5 years
How long do Cx drug donor records need to be kept? How long records of drug destruction be kept?
5 yrs 5 yrs
What is max amt pseudoephedrine that can be sold OTC in given month?
6 g (9g federal) Thru a max of 2 packages
What is max amt pseudoephedrine that can be sold via mail order in given month?
6 g? (7.5 g federal)
How long are rx for CIII-CIV valid from date issued?
6 months or 5 refills
How long are C-III scripts good for?
6 months, 5 refills
How long are C-IV scripts good for?
6 months, 5 refills
How far in advance do audit terms need to be communicated in advance to pharmacy by PBM?
60 days
How long is a DEA 222 form valid?
60 days
How long is the C2 partials valid for?
60 days
How many days must PBM notify pharmacy of contract changes?
60 days
How many days must pharmacy give BOP to set up ADS?
60 days
How many days notice must a pharmacy give the board in order to move location or open a satellite?
60 days
Max number days temp suspend license w/o hearing?
60 days
How much notification does the BOP need to set up an ADS?
60 days. Pharmacy may proceed if doesn't hear from BOP not to
Emergency refill original rx must be received within...
7 days (if don't receive call DEA regional office)
How many members serve on the BOP?
7- 2 public, 5 actively engaged pharmacists that have had at least 5 years consecutive practical experience as pharmacist immediately preceding appointment. Elect president and vice from within; secretary is pharmacist (may or may not be an addtl person)
What is the ratio of APAP:butalbital that is required to be exempt from CS scheduling?
70 mg : 15 mg
When RPh developes policies, how many hours supply of a medication can a resident take when going on a leave? How many meds / container?
72 hour supply Only med / container. Labeled: date, pt name, facility name, med name/strenght/dose, admin time, initials.
Balance for partial fill of CII must be obtained within...
72 hours
If have computer printout for controlled drugs, must be signed off by rph within...
72 hours
How many members serve on the Board of Pharmacy? How many are public members?
9 members (3 public and 6 pharmacists)... -2 public members are defined as: 1. a person who is not, or never was, a member of the profession or occupation 2. nor the spouse of any such person 3. does not have (or has never had) a (1) material financial interest in providing the professional service or (2) an activity directly related to the profession **the public member could not be a former pharmacy tech** -6 pharmacists must be: 1. actively engaged in the practice of pharmacy in MN 2. have at least 5 consecutive years of practical experience as a pharmacist immediately preceding appointment
If pharmacist/PT want CE hours for a program not previously approved, how long do they have to submit the info to the board? What must they submit?
90 days after completing the program title site date type length program outline description of evaluation mechanism used
How much time do you have to submit hours after you attend a CE course?
90 days after the date of the course
If PIC changes, how long varience still good for?
90 days or exp of varience- whichever sooner new PIC can then submit varience renewal
What must the med error rate be in nursing homes?
<5% must be free of significant error
does MN recognize VIPPS?
no
When must the Board of Pharmacy be notified of a change of a technician's address?
Change of technicians address: Within 10 days of change.
Can RPh get CE for preceptor training?
yes, if approved by BOP
Can one submit request to renew varience?
yes, if before expiration
Who approves a CE provider? what need to do as a provider? How soon submit to BOP?
BOP: -they need to provide curriculum, & keep records of evals/program content for 3 yrs. -submit approval 45 days before offering program for CE
Where do C and non C need to be kept?
C in locked cart/area at all times non-C in locked cart/area unless staff always present
Which Rx are not valid w/o documented in-person pt eval? (4)
C's muscle relaxant butalbital PDE5-I for ED
Who can compound/dispense a compounded med order?
RPh, practitioner, intern
What are rules to be a CRNA (nurse anesthetist)?
CRNA msut provide anesthesia services @same hospital, clinic, health care setting as the physician, surgeon, podiatrist, or dentist
What penalties can board place on licensee?
Civil penalty max of $10,000 for each violation Amount of civil penalty to be fixed to deprive licensee of any economic advantage gained by reason of violation, to discourage similar violations by anyone else, or to reimburse board for cost of litigation
Who can mass prescribe meds in emergency situation?
Commissioner of health or person designated by the commissioner that is a licensed practitioner Commissioner may modify state drug labeling requirements, medical screening criteria and documentation where time is critical to reduce morbidity and mortality
What copy is kept by the pharmacy ordering the meds (the purchaser)?
Copy 3 (Copy 1 and Copy 2 go to the supplier)
Is a med adulterated if different strength than NF?
yes, if claims to be a med that is on NF
Can LTCF bulk Rx be repackaged to unit dose?
yes, if have valid Rx to begin with.
Do techs need to post tech registration?
yes, in pharmacy in easy to see place
Can you make a new elec drug order for each change?
yes, instead of changing the original
Can donor charge handling fee?
yes, no more thnan 250 % MA dispensing fee / med
What is required on the label of a parenteral solution dispensed for a patient in a hospital? (required vs optional) (rqrd: 3 things and 2 things each for diluent & additive) (opt: 4 things)
IV admixtures MUST be labeled with the following info: 1. patient name 2. diluent name and volume 3. additive name and quantity (for each additive!) 4. BUD 5. Ancillary precaution labels OPTIONAL THINGS (IF APPROPRIATE): 1. bottle sequence number or control number 2. storage requirements (if not room temp) 3. infusion rate 4. date/time of administration
When can the 2:1 ratio of techs to RPh's be overlooked?
If at least 1 of the techs is board certified
When may you have to take the NAPLEX again?
If have been out of practice for previous 2 years before applying for licensure in MN
Which of the following can prescribe CSA drugs (and which classes): O.D., Nurse Practitioner, Clinical Nurse Specialist, Physician's Assistant, Midwife, Nurse Midwife, Chiropractor, Naturopath, Clinical Psychologist, Physical Therapist, Pharmacist?
In the course of professional practice only: MD, DO DDS, DDM DPM, APRN DVM (not for use by a human being) OD (limited to C4-C5) Research projects: CS's allowed in the course of a bona fide research project but cannot administer or dispense to human beings unless prescribed, dispensed and administered by a person lawfully authorized to do so. Also, shall apply annually for registration by the state Board of Pharmacy and pay any applicable fee (but not required if the person is covered by and has complied with federal laws covering such research projects)
What about meds that are dispensed for an animal?
Must report the following: -First name: animal name -Last name: owner's last name -DOB if known, otherwise estimate -Gender -Owner's address
What are requirements for out of state pharmacy to register in MN?
Must: -Provide location, names, and titles of all principle corporate officers and all pharmacists involved in dispensing drugs to residents of MN -maintains records of dispensed drugs to residents of MN so that readily retrievable from records of other dispensed drugs -agrees to cooperate w/ and provide information to the board concerning matters related to dispensing to MN residents -That toll free telephone service is provided to facilitate communication bw pts in MN and pharmacist at the pharmacy who has access to the pts records during its regular hours of operation (but no less than 6 days/week, minimum 40 hours/week) -Toll free number must be disclosed on label affixed to each container of drugs dispensed to MN residents -That pharmacy will dispense meds prescribed for resident in unit dose packaging upon request of resident of LTC in MN, the resident's authorized representative, or contract pharmacy or licensed health care facility acting on behalf of resident
Is counseling required on new prescriptions, refills, or both?
New Rx? Yes. Pharmacist reviews patient record then personally initiates, in person wherever possible, discussion using professional judgement to optimize drug therapy of pt or pt caregiver. (pharmacist may vary/omit information if he/she believes it serves the pt's best interest, but must document) Refill Rx? Only if pharmacist deems counseling necessary according to pharmacist's professional judgement.
How does a pharmacy transfer ownership?
New owner submits license application can work under previous owner license for max 14 days.
Is counseling required on new rxs, refills, or both?
New= Yes Refills= Must counsel if deemed necessary according to pharmacist's professional judgment.
Can DAW be a default on electronic rxs?
No
Can a contract prohibit pharmacy from giving pt info to the pt.?
No
Can unused LTCF meds be reused for another pt.?
No
Can you refill a C2?
No
Do discharge rxs need to be reported?
No
Do pharmacies sharing realtime computer data base need to transfer Rx?
No
Do pharmacy hours have to be posted? Where?
No
Do the generic substitution rules apply for persons covered under managed health care plan w/ a mandatory or closed drug formulary?
No
Do these rules prevent sale poisons for commercial/home use?
No
Does anything is these regs say an analytical lab cannot conduct an anonymous analysis service?
No
Does pharmacist have to substitute brand for generic if it makes the drug no longer covered by insurance?
No
Does the above on ephedrine apply to ephedra or ma huang marketed as dietary supplements?
No
If a long term care facility properly administers a drug, are they liable for actions taken prior to the drug arriving to the facility?
No
If contract pharmacy correctly repackages drugs, are they liable for issues that occurred before they received the med from the original pharmacy?
No
If mail order certifies an rx, does the dispensing pharmacy have to certify it again before it is given to the pt?
No
Is an NDC required to be on OTC products?
No
Can a mfr or wholesaler offer gifts of any value to a practitioner?
No Gift does not include: o Professional samples of drug provided to prescriber for free distribution to pts o Items w/ total combined retail value ≤$50 in any calendr year o Payment to sponsor of medical conference, professional meeting, or other educational program- provided that payment is not made directly to practitioner and used solely for bona fide educational purposes o Reasonable honoraria + payment of reasonable expenses of practitioner who serves on faculty at professional or educational conference/meeting o Compensation for substantial professional or consulting services or practitioner in connection w/ genuine research project o Publications and educational materials o Salaries or other benefits paid to employees
Does administration of a drug in the clinic/ER/etc need to be reported?
No *pt must have to be taking home for later use
Can a non-custodial parent act on behalf of a minor to authorize disclosure of information in the patient medication record?
No mention in MN laws or rules. However... If State or other applicable law is silent on a parent's right of access in these cases, the licensed health care provider may exercise his or her professional judgment to the extent allowed by law to grant or deny parental access to the minor's medical information. There are three situations when the parent would not be the minor's personal representative under the Privacy Rule. These exceptions are: 1. When the minor is the one who consents to care and the consent of the parent is not required under State or other applicable law; 2. When the minor obtains care at the direction of a court or a person appointed by the court; and 3. When, and to the extent that, the parent agrees that the minor and the health care provider may have a confidential relationship.
Are methadone clinics required to submit data to PMP?
No, disclosure for monitoring programs not authorized federally. *If methadone dispensed for pain, must be reported though *physician or pharmacist working for a outpt treatment clinic can still access the PMP Code of Federal Regulations says this: "Records of the identity, diagnosis, prognosis, or treatment of any patient which are maintained in connection with the performance of any drug abuse prevention function conducted, regulated, or directly or indirectly assisted by any department or agency of the United States shall, except as provided in subsection (e) of this section, be confidential and be disclosed only for the purposes and under the circumstances expressly authorized under subsection (b) of this section."
May a person be pharmacist-in-charge for more than one pharmacy?
No, except for cases of a pharmacist serving a hospital pharmacy on a part-time basis.
Does the above apply to MD? Researchers?
No, not if both are acting in usual business. (Unless the MD regularly dispenses.)
Can the database be accessed in order to initiate or substantiate disciplinary action by a prescriber?
No, only with search warrant or court order
Is counseling required for inpatients of a hospital?
No, personal communication by an RP is not required for (1) inpatients of a hospital or other institutions (e.g., licensed nursing home) where other HCP's are authorized to administer drugs, or (2) where a patient/agent/caregiver has expressed a desire not to receive the consultation
Is there a max number of refills for legend drugs?
No, rx is just good for 12 months after date written
When transferring CS after closing a pharmacy, do you need to submit the inventory of CS to the DEA?
No, unless requested by regional adminstrator
Can PBM require info to be written on rx unless info is required on rx by state or federal law for an audit?
No, unless the info is: • Addtl info required in provider maual • Info is required by FDA • Info required by drug mfr's safety program
Can a PBM require that you also pay them back the dispensing fee as a result of the audit?
No, unless... prescriber denied authorization rx was not actually dispensed prescription dispensed was med error by pharmacy identified overpayment is solely based on an extra dispensing fee
Can someone be a PIC for >1 pharmacy
No- may be waived for pharmacist serving in hospital pharmacy part-time
May a pharmacy transmit a patient's prescription claim information electronically to a third party payor without the patient having provided written consent to the payor or the pharmacy?
No. "The HIPAA "privacy rule" requires that a patient consent to the sharing of private data. Most insurance companies require that clients sign a waiver allowing the company to process and audit medical and prescription claims."
Can an RPh compound a drug of a commercially available product?
No. Compounding a drug product that is commercially available in the marketplace or that is essentially a copy of a commercially available FDA-approved drug product is generally prohibited.
Does hospital need additional license for each satelite pharmacy?
No. PIC needs to inform board of each satelite and is responsible for all.
Is a drug order required for a pharmacy to dispense a research drug?
Not unless study protocol requires pharmacy to receive the order
What information is required on the profile? (3)
Note: This documentation is not required for residents of a licensed nursing home where a consultant pharmacist is performing regular drug regimen reviews. However, for all other pt's, a reasonable effort must be made to obtain, record, and maintain the following: 1. Patient data: name, address, telephone, DOB/age, gender 2. Significant history: A. disease state(s) B. known allergies & drug reactions C. comprehensive list of meds/devices (showing Rx #, name & strength, quantity, date patient received, prescriber name) **if history is obtained by someone other than the pharmacist, the pharmacist must review the information with the patient** 3. Pharmacist comments: A. documentation of following each prescription B. pharmaceutical care needs C. services rendered D. pharmacist's impression of the drug therapy
Whose responsibility is it that tech properly trained?
PIC
When do you need to notify board after deficiencies are noted in the pharmacy?
PIC will submit in 30 days steps that will be taken
Optometrist can prescribe Topical Ocular Meds and PO meds related to practice, except ...... (4)
PO antivirals >10 days PO carbonic anhydrase inhibitors > 7 days PO steroids, IV/IM meds (except Epineprine!)
Under what conditions, if any, is therapeutic substitution allowed?
Pharmacist is required to therapeutically substitute when a brand name is NOT specified -AND- You must have a visible sign in the pharmacy that informs customers of this. A therapeutic substitution is not allowed in 4 situations: 1. Hard copy prescription on which the prescriber has written "dispense as written" or "D.A.W.," 2. A prescription sent by electronic transmission which indicates that the prescription is to be dispensed as transmitted w/ prescriber's e-signature 3. An oral prescription in which the prescriber has expressly indicated that the prescription is to be dispensed as communicated 4. RP's professional judgement is that the generic is not therapeutically equivalent
Can a pharmacist legally repackage another pharmacy's prescription? Under what circumstances? (1o requirements)
Pharmacist/pharmacy may repackage Rx's for LTCF pt into a compatible unit-dose system: 1. Must be dispensed from original bulk prescription containers delivered directly from original dispensing pharmacy to the contract pharmacy 2. Contract pharmacy shall notify the long-term care facility whenever medications have been dispensed 3. Contract pharm verifies drug name, strength, mfr, lot, exp, filling date, and the validity of the prescription order 4. Returned drugs cannot be re-dispensed. 5. Uses board-approved unit-dose packaging 6. Resident receives discounted rate from original pharmacy under a state/federal/private assistance or insurance program 7. Resident signs an informed consent (includes explanation of repackaging and immunities from liability) 8. Maintain a record for 2+ years,following information: (1) drug name, manufacturer, lot/exp, quantity (2) resident name and address (3) prescriber name and address (4) date prescription issued, repackaged, delivered (5) sig & copy of label (6) packager and RP initials (7) original pharmacy name & address 9. Contract pharmacy & LTCF/employees immune from civil liability arising from harm caused by acts/omissions of other persons 10. Monthly Handling fee of no more than 250% of the MA program dispensing fee FOR EACH DRUG REPACKAGED (**no more than $100 per month/resident**)
What is the max ratio of technicians to pharmacists?
Pharmacist: Technician 1:2 may be 1:3 w/ at least 1 certified techs PIC may petition board for authorization to supervise >2 PTs Must include provisions addressing maintenance of pt care and safety Petition filed w/ board deemed approved 90 days after board receives unless board denies w/I 90 days of receipt and notifies the petitioning pharmacist the reason for denial
Does a RPh always need to be in a pharmacy?
Pharmacy area must be under supervision of RPh
Can techs fill IVs? Can techs fill or check drug dispensing machines?
Pharmacy technicians may perform pharmacy tasks not specifically reserved in this chapter to a licensed pharmacist or pharmacist-intern and that do not involve the use of professional judgment. Yes, a tech may fill an automated dispensing machine as long as.... -A pharmacist certifies all packaging, labeling, and stocking -Certification process must utilizes fail-safe bar coding
who can do tasks not requiring prof judgement?
Pharmacy techs
Which of the following must be on the label of an outpatient prescription: Pt address, Quantity, Expiration Date, Lot number, Name of Drug, RPh initials, Technician initials, Pharmacy telephone number? Other items?
Pharmacy: name, addy, tele (**if filled by a central pharmacy then an identifier for that pharmacy must be present**) Patient: name Prescriber: name Manufacturer/distributor: name Rx: original date, Rx number, directions Drug: name, strength, description (**brand OR generic name is fine**) Auxiliary labels (**for CS's: if drug used alone or with alcohol may impair the ability of the user to operate a motor vehicle, notice of this must be prominent on the label or container, unless evidence that the user will not operate a motor vehicle while using the drug)
Which of the following can prescribe legend drugs: O.D., Nurse Practitioner, Clinical Nurse Specialist, Physician's Assistant, Midwife, Nurse Midwife, Chiropractor, Naturopath, Clinical Psychologist, Physical Therapist, Respiratory Therapist, Pharmacist? May any of them purchase legend drugs for use in their practice?
Prescribe: NP, CNS, PA, Nurse Midwife Traditional Midwife (only Vit K, postpartum antihemorrhagic meds, local anesthetics, oxygen, and prophylactic eye agent to newborn) Optometrist (OD) - topical ocular meds and PO meds related to practice, but no oral antivirals >10 days, no oral carbonic anhydrase inhibitors > 7 days, and no oral steroids, no IV or IM meds (except Epi) All may purchase for use in their practice! (O.D., NP, Clinical Nurse Specialist, Physician's Assistant, Nurse Midwife, Traditional Midwife, Optometrist)
How can a prescriber indicate that substitution is or is not permitted?
Prescriber must personally/expressly indicate only the brand should be dispensed ("dispense as written" or "D.A.W"). If this is not indicated, the pharmacist may dispense a generic if it is cheaper than the name brand product. Note: prescribers are not allowed to maintain "dispense as written" or "D.A.W." as a default on all prescriptions. They must add the"dispense as written" or "D.A.W." designation to electronic prescriptions individually, as appropriate.
Can printed materials satisfy the counseling requirement? Under what circumstances?
Printed materials can satisfy the counseling requirement for MAIL/DELIVERY Rx's as long as availability of RP and a toll-free phone # is also provided. For other situations, printed materials can only supplement counseling.
Who only can have access to the hospital pharmacy? Who else can access in an emergency?
RPh hospital administrator
Directions for use can only be changed by who? What about refill directions?
RPh on MD/Md's agent instructions Refills should be labeled for use at that dispensing time (facility personnel can affix labels alerta change in directions )
Who can unit dose package?
RPh or a manufacturer
Who must be involved in and document pt training?
RPh when it deals with med delivery
Who can reconstitute drugs? (4)
RPh, MD, RN, or those under their supervision
compounding and dispensing need to be done by: Vending and selling can be done by:
RPh, intern, practitioner persons supervised by RPh
What information must be placed on the original copy of the transferred prescription by the receiving pharmacy? -extra info added to transfering in a Rx: 3 dates 2 refill info's 3 pharmacy info's 2 more things 1 more thing if C3-C5
The pharmacist or intern receiving the transferred prescription drug order information shall write the word "transfer," "copy," or a word of similar import on the face of the transferred prescription, and shall obtain from the transferring pharmacist or intern all information required by law to be on a prescription, plus: 1. OD & Date of First Fill, date of Last Fill 2. Original number of refills, RR 3. Transferring pharmacy's name, address, and telephone 4. Original Rx# 5. Name of the transferring pharmacist or intern. 6. If C3-C5, must obtain the transferring pharmacies DEA#
How can changes in the "Notice of Privacy Practices" be communicated to patients?
The pharmacy must post its entire "Notice of Privacy Practices" in a prominent location and on its website if one exists. (complete info??)
Who does the BOP need to report to if a rule will increase state costs for public employees?
The senate and house representatives of the HEalth and Human Service finance/budget division
Can a pharmacist substitute a written offer of counseling if he/she deemed it necessary?
Yes, as long as the counseling is offered
Do drugs dispensed from ERs/urgent care clinics need to be reported?
Yes lots of drug seeking occurs here, must even report when meds dispensed as pre-packs or starter packs *this includes InstyMeds! For instymeds, the prescriber who writes the rx is also the dispenser- not the company that sells the machine
Can refills of legend drugs be transferred from 1 pharmacy to another? Can they be transferred back?
Yes and Yes
Can wholesalers keep records at a central location?
Yes as long as can be made available for inspection by board within 2 days
Can the prescribed brand name be placed on the label when a generic is dispensed? If so, what wording is required?
Yes it can be placed on label, but (per FDCA) it must be labeled in such a way as to not be misleading (misbranded)
Can legend drug prescriptions be transferred electronically (ie, by computer)? Under what circumstances and requirements? (2 requirements for shared e-systems) (4 requirements for non-sharing pharmacies)
Yes! Pharmacies sharing a real-time electronic database are not required to "transfer" the prescription as long as: 1. The common file contains complete records of each prescription drug order and refill dispensed, and 2. A hard copy record of each prescription accessed for refilling was generated and maintained at the pharmacy refilling the prescription (**this means that C3-C5 are not subject to the DEA's one-time transfer rule!**) For all other pharmacies doing electronic transfer: 1. Computerized system must invalidate the original prescription drug order 2. Hard copy record must be generated and maintained at the pharmacy refilling the prescription 3. Transfer of the electronic Rx is acceptable only when the QA check has been completed 4. For C3-C5, must record the DEA# of the receiving pharmacy and the names of the receiving/transferring RPs
Can legend drug prescriptions be FAXed? Under what circumstances and requirements?
Yes! (Note: this is for situations that are not internal hospital faxes) Rx's that are transmitted by fax must contain the practitioner's manual signature (An electronic prescription must contain the practitioner's electronic signature) Rx may be transmitted via fax machine. RP must be able to (i.e., responsible for) identify the person sending the prescription drug order. If not generating a hard copy that is readable for 5+ years (e.g., thermal paper), then fax must be followed up within 72 hours with the original Rx -OR- the RP must reduce it to writing. **If C2-C4, follow Federal DEA rules** ***If faxed by patient, can NOT be filled!***
Is counseling required for mailed/delivered prescriptions? (2 requirements)
Yes! When a new or refill prescription for which counseling is required is being mailed or delivered to the patient, the consultation must still be provided but may be accomplished by: 1. providing written information to the patient regarding the medication being dispensed, and 2. providing the availability of the pharmacist to answer questions via a toll-free phone number
Must generic savings be passed on to patients? If so, what proportion, and how determined?
Yes, Any difference between acquisition cost to the pharmacist of the drug dispensed and the brand name drug prescribed shall be passed on to the purchaser. (i.e. you can't charge the brand price and give the generic drug) A pharmacist shall not dispense a drug of a higher retail price than that of the brand name drug prescribed. If more than one safely interchangeable generic drug is available in a pharmacist's stock, the pharmacist shall dispense the least expensive alternative. The pharmacy must post a sign stating: "In order to save you money, this pharmacy will substitute whenever possible an FDA-approved, less expensive, generic drug product, which is thera-peutically equivalent to and safely interchangeable with the one prescribed by your doctor, unless you object to this substitution." Nothing requires a pharmacist to substitute if the substitution will make the transaction ineligible for third-party reimbursement. When dispensing a brand name legend drug while a less expensive generic is in stock, the pharmacist shall disclose to the purchaser that a generic drug is available. None of these rules apply to dispensing to persons covered under a managed health care plan that has a closed drug formulary. Also, the Drug Formulary Committee shall establish a list of drug products that are excluded from this section. (updated annually)
Are patient profiles required for all patients? (2 general things about profiles)
Yes, a patient profile record system must be maintained in all pharmacies for persons for whom filled prescription drug orders are dispensed. The patient profile record system must: 1. be designed for retrieval of information to identify previously dispensed medications at the time a prescription is dispensed 2. One profile record may be maintained for all members of a family living at the same address and possessing the same family name
Can pharmacies under common ownership share a single database? If so, what are the rules for prescription transfers?
Yes, as long as database contains complete records of each drug order and refill dispensed
Can a resident bring in meds to LTCF?
Yes, but they can only be administered if they are written by a practitioner licensed to prescribe in MN
Is there a list of drugs that are excluded from the generic substitution rules?
Yes, created by the Drug Formulary Committee Available annually Provided to board for dissemination to pharmacists
Can RNs implement predetermined protocols?
Yes, for legend drugs and for vaccines
Does pharmacist have to tell pt receiving a brand name drug that a generic equivalent is available?
Yes, if less expensive generic is available in stock
Can pharmacy deliver drugs to pts place of employment?
Yes, if obtains authorization for delivery from pt ensures rx is delivered directly to them security of PHI is maintained
Can a physician be granted the ability to dispense meds by the BOP?
Yes, if pharmaceutical care is not reasonably available (15 miles or more away)
Can a resident of a LTCF self-administer meds?
Yes, if the comprehensive resident assessment and comprehensive plan of care indicate this is safe and there is a written order from attending physician
Can refills of legend drugs be transferred from one pharmacy to another? Can they be transferred back?
Yes, legend drugs can be transfered as long as the transfer is communicated directly between RPs/interns; Rx must be authentic & complete, must be cancelled at the sending pharmacy. There is no explicit limitation to the number of transfers for legend Rxs. C2's may not be transferred. C3-5's may be transferred once for refill purposes only, UNLESS sharing a real-time electronic database (then max is # of refills)
Does the refusal of the offer to counsel need to be documented?
Yes, need to put on rx, pt records, or in specially developed log
Do pharmacist licenses have to be on display? The original or copy? Can you obscure your address on the copy displayed to the public?
Yes, needs to be displayed and a copy is acceptable. No information about obscuring or not obscuring, but license must be "readily visible to public"
Can the store remain open when the pharmacy is closed?
Yes, no access to the pharmacy (continuous, floor to ceiling partition with doors capable of being securely locked to prevent entry when the pharmacy is closed)
Is it possible for pharmacies under a common ownership to share a single patient/prescription database? If so, what are the rules for prescription transfers?
Yes, pharmacies can share a single patient/prescription database and are not required to transfer prescriptions as long as the database contains complete records of each prescription and refill, and a hard copy of each prescription dispensed is generated at the pharmacy refilling the prescription.
Do patients have the option of demanding the brand name when substitution is permitted? How about patients whose prescriptions are paid for by public funds?
Yes, pt's can demand brand even without DAW 1. However, an RP may override a pt's request for brand when the person is covered under a managed health care plan that maintains a mandatory or closed drug formulary, or if it makes the transaction ineligible for third-party payment.
Can the store be open but the pharmacy department closed? Under what requirements?
Yes, the pharmacy can be closed within a store that is open. But there must be no access to the pharmacy, which includes a continuous, floor to ceiling partition with doors capable of being securely locked to prevent entry when the pharmacy is closed.
Do patients need to be notified their info is being submitted to electronic reporting program?
Yes- conspicuous notice of reporting requirements must be given Could be: -sign in patient waiting areas -conspicuous notice on receipt of CS rx -verbally tell pts when they pick up the rxs -put sticker on rx bottle/package -include extra piece of paper as a notice for mailed out rxs
Is a separate patient counseling area required? (6 requirements, 2 exceptions)
Yes. An area of consultation between patient and pharmacist is required. 1. Must provide a reasonable assurance of privacy 2. If using partitions with patient standing, they must be sound-dulling, >=7 ft high, 24 inches deep, and have partitions on each side of the patient. 3. Area must not contain any item for sale apart from the articles needed for counseling sessions. 4. Pharmacist must have access to patient profiles 5. Area must be accessible to the patient from the outside and be open whenever the pharmacy is open 6. Area must be lighted to a level >=75-foot candles measured in the major work areas Note: A. Areas without partitions may be approved if the board deems a reasonable assurance of privacy B. The counseling area requirement may be waived for satellite pharmacies located in hospitals.
Are there any special requirements for mail order pharmacies?
Yes. Must have a toll-free number that patients can call at least 6 days a week, 40 hours a week, during regular hours of operation for patient-pharmacist communication. (??can't find this in the law??)
Are pt profiles required for all pts?
Yes. One profile may be maintained for all members of family w/ same address and name
Who organizes and directs pharmaceutical services in a hospital?
a pharmacist
Who only can aprovide pricing on Rx drugs?
a pharmacy
If the person picking up a *C2-3* is not known to the dispenser, what do they need to provide? What is the exception to this law?
a photo ID It only applies to Rx *NOT* covered by 3rd party.
how big must aisle be behind rx dispensing counter?
at least 36 inches wide and extend the full length of the counter
How often must pharmacist currently licensed by MN BOP review every patients medication profiles at nursing home?
at least monthly
How/When should wholesalers permit BOP/law enforcement to inspect premise/vehicles/records?
at reasonable times in reasonable manner
What words are banned from non-pharmacy businesses?
drugs drug store pharmacy medicine apothecary chemist shop or any abbreviation, translation, extension or variation therof unless the place is a pharmacy Also cannot refer to business by ad, circular, poster, sign, or otherwise
Definition of distressed drugs
drugs or medicines that have been subjected to accident, fire, flood, adverse temperatures, or other physical influences that could affect potency, quality, purity, or efficacy Every person who owns or controls distressed drugs shall immediately notify board of existence of such drugs and location. Board will grant approval when applicant has clearly demonstrated that distressed drugs were inspected on site w/I reasonable period by an agency of the foreign state satisfactory to the board and furnishing a written certificate by the agency indicating there is no reasonable cause to believe the drugs are not adulterated or misbranded (within 30 days). If no probably cause, will furnish with a certificate.
How can samples be given to pt? (2)
hands of adult or via mail
What do elec systems need to be able to print out?
hard copy detail of a C transactions/refills for past 2 years
When do you need to report sig loss of CS to BOP in writing?
immediately
What needs to be on label from manufacture? On pill?
name/address imprinted symbol/number/letter...
What type of exams must be taken by prospective licensees? What is the exception?
national standardized tests When the material relates to MN law of the profession
When can CIIs be refilled?
never
Are pharmacy licenses transferrable?
no
Is it lawful to use the name 'pharmacy' or any implication of?
no, not if not a licensed pharmacy with license displayed
Can a pharmacy give Rx blanks to a MD to use with the pharmacy logo/name on them?
no. Nor make agreement refering to one specific RPh or pharmacy
What records (info) must contract pharmacy keep for meds they have repackaged for LTC pts?
o Name, mfr, lot #, exp date, quantity o Name and address of resident for whom drug was repackaged o Date rx was issued and date was repackaged o Date repackaged drug was delivered to LTC facility o Directions for use o Copy of label affixed to repackaged drug o Initials of packager o Initials of supervising pharmacist o Name and business address of original dispensing pharmacy Original pharmacy must give the contract pharmacy the original bulk container! Resident or representative must sign consent indicating they understand the repackaging process.
What is the role of the pharmacist in the nursing home?
o Provides consultation on all aspects of provision of pharmacy services in the nursing home o Establishes system of records and receipt/disposition of all CS in sufficient detail to enable an accurate reconciliation o Determines that records are accurately maintained and that account of all CS is maintained
manufacturing is:
packing, prepacking, tableting, encapsulating, lebeling, relabeling, filling
What type of inventory is needed for C2's?
perpetual
How often does C 2 need to be inventoried? how often reconciled? How long keep documents?
perpetually reconciled monthly documents kept for 2 years
Can original Rx/ pt specific records be stored outside pharmacy?
yes, if locked and only accessable to pharmacy staff/ those trained in HIPAA
Can one get CE credit for presenting an inservice?
yes, if pharmacy topic, Once during a reporting period (2 yrs)
How should Md who dispense drugs store them?
separate locked storage area, limited access to those who can legally dispense
If the RPh feels it's best to omit info, can they?
yes, if they log it in pt record or a log for that purpose.
The Dept of Human Services shall routinely access the data and inform who if they see multiple Rx/prescribers?
the medical director of the opioid tx program
What is the "original dispensing pharmacy' for LTCF?
the one that dispenses bulk Rx to nursing home residents
What needs to be verified of a compound?
the original Rx drug order. not the rewritten, verbal, or electronic copy
What must be compared for all new Rx? In what time frame? What is the exception?
the original, or image of, to the Rx entered into the computer no sooner than 2 hrs after, no later than 72 hrs after. (unless done by 2 RPh consecutively)
Do preceptors need to register?
yes, every other year on anniversary of registration
How soon must a new PIC form be sent to the BOP?
within 10 days
Within what time period must audit preliminary report be delivered?
within 60 days of conclusion of the audit
How can a RPh counsel if the med is mailed?
written info is acceptable must provide toll free phone number to call with questions
harmacy may provide limited supplies of drugs for use in emergency kit if the have...
written or oral request from QA committee
Does one need to self-report?
yes
Does pharmacy who received Rx need to alert pt that the Rx at the previois pharmacy is now invalid?
yes
Does pt need to be notified if use central fill pharmacy?
yes
Does refusing to compound or dispense a Rx beyond reasonable expectations count as misconduct?
yes
Does the BOP have an advisory committee for intership?
yes
Does the board of optometry need to notify the board of pharmacy who has the certificate?
yes
Does there need to be a policy for drug waste?
yes
If the board fails to respond is this an approval?
yes
Is it misconduct to refuse to transfer a Rx that the pt wants?
yes
Is it the law to 'distinctly label the container of a C w/ directions from the Rx?'
yes
Is there a law saying if a drug is not controlled than the Rx doesn't need a DEA number?
yes
Must every pharmacy have a PIC?
yes
Does BOP have tech training & CE requirements?
yes & yes
Can the partials be done through computer system?
yes if: can printout all Rx info., has real time updating, retrieves info like C3-4 refill list.
Do all meds need to be in unit dose form in the system?
yes when practical
Can contract pharmacy charge monthly fee?
yes, -no more than 250% of MA dispensing fee per repackage med -no more than $100/mo per pt.
Do board members get compensation?
yes, $75 a day spent on board activities, plus childcare if applicable.
Can RPh wanting to transfer substitute worked hrs for missing intern hours?
yes, 1 full time week for every week needed of intern hrs
Do pharmacies need a separate counseling area?
yes, all built after 2011. Those built before have two yrs to add one. Partitions must be sound dulling, 7 ft high and 24 in deep. Nothing else can be in area except counseling supplies RPh must have access to pt profile in counseling area.
Can a license that wasn't renewed in time still be renewed?
yes, and a fine up to $1000
Does pharmacy outside MN need license to give Rx to MN pt?
yes, and need to agree to operate pre MN BOP rules.
Can an RPh use a program/alerts to help with DUR?
yes, as long as all meds dispensed for prev 6 mo is in it.
Can a wholesalers keep records centrally? How many days if requested?
yes, available in 2 days of request
Can MD delegate dispensing functions?
yes, but must follow all rules RPh follows with dispensing
Can clinical nurse specialist/ nurse midwife prescribe?
yes, but not plain midwife
Can Rx be taken from a voice mail?
yes, but only by RPh or intern - tech can take onyl if adding refills to Rx w/o changes
If the rx has never been dispensed and the QA verification has not been completed, can you transfer the rx?
yes, but only from the hard copy
Can a verbal order be sent by a LTCF on behalf of MD? What does RPh need to get?
yes, but want a fax/elec whenever possible as a direct copy of the chart order that MD will sign later. -must get name of person sending order.
Does each location, in state and out of, need license?
yes, each location here and that ships drugs in
Can physicians dispense CS?
yes, even vets
