Baran's Law Review
¬¬_____ means an authorization granted by a licensee to a licensed or unlicensed individual to perform selected acts, tasks, or functions that fall within the scope of practice of the delegator and that are not within the scope of practice of the delegatee and that, in the absence of the authorization, would constitute illegal practice of a licensed profession.
"Delegation"
A pharmacy must notify in writing, the local DEA diversion field office within ____ of discovery of a theft or significant loss of a CS.
1 business day
A pharmacy/pharmacist license is good for ____ year(s).
1 year initially, then 2 years after the first year of being licensed
3 ways to violate the FD&C Act
1) Place an unapproved drug into interstate commerce 2) Misbranding 3) Adulteration
What are the requirements for a generic drug to gain FDA approval?
1) contain the same API as the innovator drug (inactive ingredients may vary) 2) be identical in strength, dosage form, and route of administration 3) have the same use indications 4) be bioequivalent 5) meet the same batch requirements for identity, strength, purity, and quality 6) be manufactured under cGMP
Under the Drug Quality and Security Act, a compounder may only use bulk drug substances to compound if (3)....
1) the bulk drug substances comply with the standards of an applicable USP or NF monograph, if one exists 2) if such a monograph does not exist, the drug substance(s) is a component of an FDA-approved human drug product, or 3) if such a monograph doesn't exist and the drug substance is not a component of an FDA-approved human drug product, it appears on a list of bulk drug substances for use in compounding developed by the FDA through regulation
What 2 conditions must be met for CS's to be mailed?
1) the mailer or the addressee is registered with the DEA 2) the mailer or the addressee is exempt from DEA registration as permissible by law (i.e. mailing to a patient)
If you get reprimanded, fined, placed on probation, or ordered to pay restitution, within what amount of time do you have to notify your employer?
10 days
Michigan requires that within ____ of a theft or significant loss of a CS you report it to the DEA using a form 106.
10 days
Medicare Part D requires that all prescription records be kept for ___.
10 years
# of Members, BOP - how many public & professional?
11 members 6 professional 5 public
CE requirements if licensed >1 year but less than 2 years?
15 hours, 1 pain
What are the requirements to be a board member (BOP)?
18+ y/o, good moral character, resident of state for at least 6 months prior and remain resident throughout term, be currently licensed/registered in a health profession, have actively practiced that profession or taught in an approved educational institution that prepares applicants for licensure or registration in that profession (or a combo of both), in any state for NLT 2 years immediately preceding appointment
Phase 1 studies typically involve ___ people.
20-80
Which is the required intern to pharmacist ratio?
2:1
A licensee or registrant shall report to the department a change in name or mailing address no later than ____ after the change occurs.
30 days
CE requirements?
30 hours, 10 live, 1 pain in full license period (q 2 yrs)
Disciplinary subcommittee - how many members, public & professional?
5 members 3 professional 2 public
A prescription, or an equivalent record of the prescription approved by the board, shall be preserved by a licensee or dispensing prescriber for not less than ___.
5 years
All invoices and other acquisition records for each CS acquired by the prescriber must be retained separately from other prescription records for not less than ____ after the date the prescriber acquires the CS.
5 years
Provided there is no readmission, records of HPRP participants are destroyed ___ after successful completion.
5 years
A resident of the US may bring ____ dosage units from a foreign country on their person, and declare it upon entering the US.
50
A prescription in electronic format that is contained within a patient's chart in a health facility may contain more than ___ prescriptions and may contain prescriptions for schedule _____ controlled substances and non-controlled substances on the same form.
6 Rx's, CIII-CV
A substance can be emergency scheduled for ____ and it can be renewed for ____.
6 months, 6 months
The side effects statement which lists the FDA phone # on an OTC product must appear in a minimum _____ letter height or type size.
6-point BOLD
After an NDA is received, the FDA has ____ (how long?) to decided whether to file it so it can be reviewed.
60 days
A delegating physician may not delegate the prescription of a CII issued for the discharge of a patient for a quantity of more than a ____ period by a NP or nurse midwife.
7 day
If an error in MAPS has been found, what time frame do you have to correct the error and re-submit the data?
7 days (formerly 15 days)
Upon verbal consultation with a prescriber, which components of a CII prescription CAN be altered?
A pharmacist may add or change a patient's address, dosage form, drug strength and quantity, directions for use, or issue date with regard to a prescription
When is it ever ok for a pharmacy to obtain drug samples?
A sample may only be distributed by a practitioner licensed to prescribe or to the pharmacy of a hospital or health care entity at the written request of the prescriber.
Drug companies must submit an ________ for approval to market a generic product.
ANDA (abbreviated new drug app)
Misbranding or adulteration? A drug contains unsafe coloring
Adulterated
Misbranding or adulteration? A drug is prepared, packaged, or held under unsanitary conditions where it may have been contaminated
Adulterated
Misbranding or adulteration? A drug's strength, quality, or purity differs from that in the official compendium
Adulterated
Misbranding or adulteration? A tablet has been dropped on the floor
Adulterated
Misbranding or adulteration? If the drug has been substituted in whole or part
Adulterated
Misbranding or adulteration? A drug contains filthy, putrid, or decomposed substances
Adulteration
Misbranding or adulteration? A drug is manufactured under conditions that do not conform to cGMP
Adulteration
Misbranding or adulteration? Dispensing Cytotec not in the unit of use package
Adulteration
Misbranding or adulteration? Dispensing a drug mixed with another drug
Adulteration
Misbranding or adulteration? Dispensing a liquid that has been diluted
Adulteration
Misbranding or adulteration? NTG SL not in the original package
Adulteration
DEA 224b
Affidavit for chain renewal form
CS inventories must be done how often?
Annually between April 1 - June 30
How often does the board/task force elect a chairperson and vice-chairperson?
Annually; "shall hold office for 1 year or until their successors are elected and qualified"
What can an out of state DO prescribe?
Anything
What can an out of state MD prescribe?
Anything
What can an out of state DDS prescribe?
Anything within scope
DEA 224
Application for registration
DEA 224a
Application for registration renewal
What does "good faith" mean?
Application of good faith to a pharmacist means the dispensing of a controlled substance pursuant to a prescriber's order, which, in the professional judgment of the pharmacist, is lawful.
In a medical institution, how often must the areas where medications are stored be inspected?
At least every 6 months
How often does the board/committee need to meet?
At least quarterly
OBRA 90 - Michigan Medicaid Manual: "To encourage intended, positive patient outcomes, a pharmacist shall communicate to the patient (or patient's caregiver), necessary and appropriate information regarding safe and effective medication use at the time ____. Which Rx's does this apply to?
At the time a prescription is dispensed. Applies to each prescription for a drug not previously prescribed to a patient.
A CS that is listed in schedule(s) ____ shall be stored in a secure locked, substantially constructed cabinet that is anchored to a wall or the floor.
C1
Which schedules of CS need an exact count?
CI & CII
Schedule ___ drugs shall be separated on the inventory from all other drugs.
CII
The label of any drug listed as a CS in schedule ____ of the Federal Controlled Substances Act shall, when dispensed to or for a patient, contain the following warning: "Caution: Federal law prohibits the transfer of this drug to any person other than the patient for whom it was prescribed."
CII, III, or IV Note: this statement is not required to appear on the label of a CS dispensed for use in clinical investigations which are "blind".
A physician may delegate the prescription of controlled substances listed in schedules ____ to ____ to a RN who holds specialty certification with the exception of a ____, if the delegating physician establishes a written authorization that contains all of the following information: the name, license #, and signature of the delegating physician and the NP or nurse midwife, limitations or exceptions to the delegation, and the effective date of the delegation.
CIII-CV, exception: nurse anesthetist
When is an exact count of a CIII-V needed?
Can estimate unless the container holds >1000 dosage units, then an accurate account of the contents must be made
Which class of recall? A situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death
Class I
Which class of recall? A situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of a serious adverse health consequence is remote.
Class II recall
Which class of recall? A situation in which the use of or exposure to a violative product is not likely to cause adverse health consequences.
Class III recall
Which form is filed electronically to the DEA to report significant loss or theft of a CS?
DEA form 106
How often does data have to be uploaded to MAPS?
Daily ("By the end of the next business day and shall include the data for all controlled substances dispensed since the previous transmission or report") (formerly twice/month)
DEA 41
Destruction form
MD
Doctor of Medicine
DPM
Doctor of Podiatric Medicine
DVM
Doctor of Veterinary Medicine
DDS (or DDM)
Doctor of dental surgery or doctor of dental medicine (same degrees = dentist!)
DO
Doctor of osteopathic medicine
T/F: a NP, under delegation from an MD or DO, can prescribe CII drugs without limitation, if so delegated by the MD or DO
False
T/F: A prescriber can't write CS and non-CS on the same Rx.
False - they can be combined now, with the exception of CIIs. Those still need to be separate. But you can have >1 CII on one form.
T/F: an NDC code on a drug means it is FDA approved
False!
T/F: a pharmacy may ship controlled substance prescriptions to individuals in other countries.
False, UNLESS registered as an exporter with the DEA
Except as provided in section 16215, an individual who practices or holds himself or herself out as practicing a health profession regulated by this article without a license or registration or under a suspended, revoked, lapsed, void, or fraudulently obtained license or registration, or outside the provisions of a limited license or registration, or who uses as his or her own the license or registration of another person, is guilty of a ____.
Felony
What are the packaging requirements for mailing CS's?
Inner container must be marked and sealed as required by the provisions of the CSA and paced in a plain outer container or securely wrapped in plain paper, the inner container must show the name and address of the pharmacy, practitioner, or other person dispensing the prescription, and the outside wrapper or container must be free of markings that would indicate the nature of the contents
A(n) _____ outlines what the sponsor of a new drug proposes for human testing in clinical trials.
Investigational New Drug App (INDA)
Pharmacist and pharmacy licenses expire ____.
June 30th
DEA 106
Loss report form
A DEA # of a mid-level practitioner will begin with the letter...
M!
Which type of recall? Occurs when a product has a minor violation that would not be subject to FDA legal action. The firm removes the product from the market or corrects the violation. For example, a product removed from the market due to tampering, without evidence of manufacturing or distribution problems, would be this type of recall.
Market withdrawal
How do referrals to the HPRP program work?
May come in the form of a self referral from the individual licensee or from colleagues, partners, hospital administrations, patients, family members, or the state. Any of the health licensing boards may also refer licensees/registrants to the HPRP for similar monitoring as part of a board order.
This is issued in situations where a medical device may present an unreasonable risk of substantial harm. In some cases, these situations are also considered recalls.
Medical device safety alert
The FDA requires that _____ be issued with certain prescribed drugs and biological products when they determine that 1) certain information is necessary to prevent serious adverse effects, 2) patient decision-making should be informed by information about a known serious side effect with a product, or 3) patient adherence to directions for the use of a product are essential to its effectiveness
Medication Guide
What prescriptions require the "Transfer Caution" auxillary label?
Michigan rescinded the rule, but federal legislation still requires it on CII -> CIV (although really it's still seen on all Rx's)
Misbranding or adulteration? Dispensing without a prescription
Misbranded
Misbranding or adulteration? Dispensing PremPro without the patient package insert
Misbranding
Misbranding or adulteration? Dispensing a generic & labeling as the brand name only
Misbranding
Misbranding or adulteration? Dispensing without an authorized refill
Misbranding
Misbranding or adulteration? Dispensing without the PPI
Misbranding
Misbranding or adulteration? Dispensing without the mandated medication guide
Misbranding
Misbranding or adulteration? Drug is an imitation of another drug or is offered for sale under the name of another drug
Misbranding
Misbranding or adulteration? Drug is packaged in violation of the PPP Act
Misbranding
Misbranding or adulteration? Label does not contain "adequate directions for use"
Misbranding
Misbranding or adulteration? Label doesn't identify name and place of manufacturer, packer, or distributor
Misbranding
Misbranding or adulteration? Label is false or misleading
Misbranding
Misbranding or adulteration? Name of drug not on the label
Misbranding
Misbranding or adulteration? Quantity of contents not on the label
Misbranding
What occurs when you do not provide the side effects statement with a refill for a prescription?
Misbranding (it is part of the labeling requirement!)
The Side Effects statement, "Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088" is required on which prescriptions?
Must be included with both new Rx's and refills (may be on the receipt as part of the required labeling)
If a pharmacy can't electronically upload to MAPS, what time frame do they have to report the data?
Must be within 7 days after the controlled substance has been dispensed
If an OTC product does not include the manufacturer or distributor's toll-free number for reporting complaints (SE's), what must be included in the labeling?
Must include "--- report side effects to FDA at 1-800-FDA-1088"
Submission of an ____ is the formal step asking the FDA to consider a drug for marketing approval.
NDA (new drug app)
Which of the following can prescribing be delegated to? a) LPN b) vet tech c) Dental hygienist
NONE
Who are mid-level practitioners?
NPs, nurse midwives, nurse anesthetists, clinical nurse specialists, Pas, optometrists, ambulance services, animal shelters, euthanasia technicians, nursing homes, and homeopathic physicians.
List a few of the classes of drugs that require Medication Guides.
NSAIDs, antidepressants, antipsychotics, ER/LA opioids, etc.
A licensee's printed ______ shall be recorded on the inventory.
Name, address, and DEA number
Can RN's prescribe controlled substances if under delegation?
No
Can drug samples be CS's?
No
Does the counseling rule apply to patients in medical institutions?
No
If a drug has been withdrawn or removed from the market, can you still use it in compounding?
No
If a prescriber designates an agent to act on their behalf, does it have to be in writing to be considered a valid designation?
No
CE requirements if you've been licensed <1 year?
No CE required
Are technicians licensed in MI?
No, also there is no definition for technician in the Michigan Public Health Code
Can a NP, nurse midwife, or PA delegate prescribing?
No; they can have prescribing delegated to them, but they can't delegate what's been delegated to them.
What happens if you don't complete the HPRP program or get kicked out?
Non-compliant participants are reported to the Bureau of Health Professions as required by law, which could result in subsequent disciplinary actions.
What is the required technician (support staff) to pharmacist ratio?
None
Can the chair of the BOP be a member of the disciplinary subcommittee?
Nope
Does the required side effects statement apply to inpatients in a hospital or health care facility under order of a licensed practitioner?
Nope
T/F: A prescriber must indicate the total number of drugs prescribed on each prescription.
Not anymore, rule rescinded.
The HPRP will work with the licensee to develop a written monitoring agreement that defines the requirements of participation and will typically last ____.
One to three years.
Who can delegate prescribing?
Only MD & DO
What can a Canadian MD or DO prescribe?
Only non-controlled substances
OD
Optometrist, doctor of optometry
DEA 222
Order form
Under delegation, who can prescribe CII's without limitation (if so delegated)?
PA's
This is professional information, which may be given to a patient but is NOT required to be given.
Package insert
Upon verbal consultation with a prescriber, what 4 components of a CII prescription can NOT be altered?
Patient, drug prescribed, prescriber (including signature), and do not fill until date
The drug control administrator of the controlled substances advisory commission is a licensed ____.
Pharmacist
Which phase? 20-80 healthy volunteers, emphasize safety.
Phase 1
Which phase? A few dozen to about 300 people, people with the disease or condition emphasizes effectiveness, safety, and short-term SE's.
Phase 2
Which phase? Typically involves several hundred to about 3000 people, studies safety and effectiveness, different populations and dosages.
Phase 3
When is animal testing done? (which phase)
Preclinical
A delegated prescription must bear the name of _____. This applies to the delegated prescribing of controlled and non-controlled substances.
The physician who delegates
What is required as far as expiration dating goes on a rx label?
The prescription shall bear the label "Discard this medication 1 year after the date it is dispensed" unless of course, it expires earlier, then put that date on the label.
Which practitioners are exempt from having a DEA #?
The requirement of registration is waived for any official of the US Army, Navy, Marine Corps, Air Force, Coast Guard, Public Health Service, or Bureau of prisons, who is authorized to administer, dispense, or prescribe, but not to procure or purchase CS's in the course of their official duties
What is "corresponding responsibility"?
The responsibility for the proper prescribing and dispensing of controlled substances is upon the prescribing practitioner, but a corresponding responsibility rests with the pharmacist who fills the prescription.
What authority does the controlled substance advisory commission have?
They have no authority, only make recommendations
T/F: A prescriber can add handwritten drugs to a preprinted form.
True
T/F: If a medical professional participates in the Health Professional Recovery Program (HPRP) it is confidential. Meaning... their name will not be disclosed to state regulatory authorities or to the public.
True
T/F: Michigan law is stricter than the DEA law regarding CS inventories, and requires a copy of the inventory be mailed to the board.
True
T/F: Michigan law states that an electronically transmitted Rx if appropriately sent and if it contains the appropriate information, is the original rx.
True
T/F: a PA, under delegation from an MD or DO, can prescribe CII drugs without limitation, if so delegated by the MD or DO
True
T/F: a student in a health profession training program, which has been approved by the appropriate board, while performing the duties assigned in the course of training, is not required to have a license issued for practice of a health profession.
True
T/F: You can find a list of names and addresses of disciplined health professionals at your local library.
True (bastards!) "Once each calendar year, the department shall transmit to the library of Michigan sufficient copies of a compilation of the lists required under subsection (1) for the immediately preceding 3 calendar years. The library of Michigan shall distribute the compilation to each depository library in this state. The department shall also transmit the compilation to each county clerk in this state once each calendar year."
T/F: an agent of the board may execute and serve search warrants, arrest warrants, administrative inspection warrants, subpoenas, and summonses issued under the authority of the state.
True!
T/F: the side effects statement for OTC drugs is not required if the product's packaging includes a manufacturer's or distributor's toll-free number for reporting complaints.
True!
Can board inspectors seize property?
Yes
Do computer printed prescriptions have to be manually signed?
Yes
If a prescriber designates an agent to act on their behalf, can the agent transmit to a pharmacy a prescription that is contained within a patient's chart in a health facility?
Yes
Do you have to indicate at what time of day the CS inventory was taken?
Yes (as of opening or closing)
The law requires us to have access to reference texts in a pharmacy. Can they be electronic?
Yes - "a current electronic medium version of the pharmacy laws, rules, and pharmacy reference texts, including internet accessible versions, meets the requirements of this subrule."
"A prescription shall be numbered, dated, and initialed by the pharmacist who performs the final verification prior o dispensing at the time of the first filling at the pharmacy." - can the pharmacist electronically initial?
Yes!
After administrative disciplinary action is final, the department shall publish...
a list of the names and addresses of disciplined individuals
Which of the following are true? Outsourcing facilities must: 1) comply with cGMP 2) are inspected by the FDA according to a risk-based schedule 3) Must report AE's and provide FDA with information on the products they compound
all of the above
BOP members are appointed by the ______
governor
The chairperson of the disciplinary subcommittee is a _____ member appointed by the chair of the board.
public
You must submit a copy of the CS inventory to...
the board
A delegating physician may delegate the prescription of CII's to NP's or nurse midwife's if...
the delegating physician and NP or nurse midwife are practicing within a freestanding surgical outpatient facility, hospital, or hospice; the patient is located within one of those facilities, and the delegation is in compliance with the rule.
T/F: a board inspector can inventory CS's and take samples thereof as needed.
true!
