Transcript Pharmacy Law Review 2010

Michigan Pharmacy Law Review
for 2011 MPJE
Jesse C. Vivian , RPh, JD
Professor of Pharmacy Practice
(313) 577-5389
[email protected]: http://jessevivian.net
Greg Baran
Michigan Pharmacists Association
(517) 377-0224
http://michiganpharmacists.org
Today’s Agenda:
Prepare for MPJE




Discus MPJE, Study Materials and Resources
Reflections by Dr. Kathryn Hurren
Basic Constitutional Law
Review Statutes and Regulations:
Where to find statutes and Regulations
FDA
Michigan
Controlled Substances
• DEA
• Michigan
 Food
 Evaluation
 Open Discussion
MPJE
Computer Adaptive Test
Answer Question
Can’t go back to prior questions
90 Questions
75 questions counted
No way to know which 15 questions don’t
count
Assume every question counts
MPJE Study Materials
 Michigan Pharmacy Law, 6th ed.
January 2011
New: cover new e-script CS Rule
 ASHP’s PharmPrep 3rd ed., Federal Pharmacy Law (online or book; Good
for NAPLEX)
Mock Questions
 Reiss and Hall, Guide to Federal Pharmacy Law, 7th ed.
Several example questions: mediocre
 Feinberg, Pharmacy Law
Practice Test: Pretty Good
 Abood, Pharmacy Practice and the Law, 6th ed.
Very Detailed, Class Textbook, Example Questions Okay.
MPJE
http://nabp.net
Click on PROGRAMS
NABP
Click on MPJE
NABP MPJE
 Read entire page and links
Constitutional Law
Not on Exam, per se
Need to know for background
 Clauses
Supremacy
• Duel Jurisdiction
Due Process
Interstate Commerce
• Intrastate commerce
Ex Post Facto
• Grandfathering
 If conflict between Federal and State law exists,
Stricter Law Applies
Online Legal Resources
 Federal Food Drug and Cosmetic Act
http://www4.law.cornell.edu/uscode/21/ch9.html
• Learn to navigate this site to find specific statutes
• http://www.law.cornell.edu/topics/food_drugs.html
– search database
Do your own search with words like:
“food drug and cosmetic act laws and regulations
administration”
 Federal Regulations
http://vm.cfsan.fda.gov/~dms/reg-2.html
Online Resources
Statutes:
http://www.lib.umich.edu/libhome/
Documents.center/michlaw.html
Regulations: http://michigan.gov
First Section
Federal Regulation of Drugs Generally
Adulteration
Misbranding
Labeling
Antitrust
Medicare
PPPA
USPS
History of Drug Regulation
MPJE Questions don’t usually refer to the
Names of Acts but focus in on what the Act
did at the time.
Pay attention to year law was enacted and
effect the law had.
Pure Food and Drug Act of 1906
Prohibited the introduction of adulterated or
misbranded drugs and foods into interstate
commerce.
Ingredients did not have to be listed
Did not regulate cosmetics of medical devices
Example Question

After 1906, it was illegal to introduce drugs
into interstate commerce which were:
I.
II.
III.
IV.
Misbranded
Adulterated
Made with contaminated materials
Not effective for intended purpose
a.
b.
c.
d.
I only
II only
All of the above
I, II and III only
Food Drug and Cosmetic Act of 1938
 1938: 107 deaths from sulfanilamide elixir mixed with
diethylene glycol (anti-freeze)
 No “new drug” could be introduced into interstate commerce
unless first proven ‘safe’ for labeled indication.
Established New Drug Application/Approval Process (NDA)
Required ‘adequate directions for use’
• Unless dispensed pursuant to prescription from state-authorized
prescriber
Required labeling for habit-forming drugs
 Applies to Cosmetics and medical devices as well as food
and drugs
 Established Food and Drug Administration
 Labels, labeling, manufacturers label, pharmacy label, patient
information label
Prohibitions
Its is unlawful to introduce into interstate
commerce and article that is
Adulterated or
Misbranded
Adulteration
Adulterated drugs and devices A drug or
device shall be deemed to be adulterated:
(1) If it consists in whole or in part of any filthy,
putrid, or decomposed substance; or (2)(A) if
it has been prepared, packed, or held under
insanitary conditions whereby it may have
been contaminated with filth, or whereby it
may have been rendered injurious to health.
Adulteration
 or (B) if it is a drug and the methods used in, or the
facilities or controls used for, its manufacture,
processing, packing, or holding do not conform to or
are not operated or administered in conformity with
current good manufacturing practice to assure
that such drug meets the requirements of this
chapter as to safety and has the identity and
strength, and meets the quality and purity
characteristics, which it purports or is represented to
possess
Adulteration
or (4) if (A) it bears or contains, for purposes
of coloring only, a color additive which is
unsafe within the meaning of section 379e(a)
of this title, or (B) it is a color additive the
intended use of which in or on drugs or
devices is for purposes of coloring only and is
unsafe within the meaning of section 379e(a)
of this title.
Adulteration
(b) Strength, quality, or purity differing from
official compendium If it purports to be or is
represented as a drug the name of which is
recognized in an official compendium, and its
strength differs from, or its quality or purity
falls below, the standard set forth in such
compendium.
Misbranding
If an article is alleged to be misbranded because the labeling or
advertising is misleading, then in determining whether the
labeling or advertising is misleading there shall be taken into
account (among other things) not only representations made or
suggested by statement, word, design, device, or any
combination thereof, but also the extent to which the labeling or
advertising fails to reveal facts material in the light of such
representations or material with respect to consequences which
may result from the use of the article to which the labeling or
advertising relates under the conditions of use prescribed in the
labeling or advertising thereof or under such conditions of use as
are customary or usual.
Label
The term ''label'' means a display of written, printed, or
graphic matter upon the immediate container of any
article; and a requirement made by or under authority
of this chapter that any word, statement, or other
information appear on the label shall not be
considered to be complied with unless such word,
statement, or other information also appears on the
outside container or wrapper, if any there be, of the
retail package of such article, or is easily legible
through the outside container or wrapper.
Labeling
The term ''immediate container'' does not
include package liners.
The term ''labeling'' means all labels and
other written, printed, or graphic matter (1)
upon any article or any of its containers or
wrappers, or (2) accompanying such article.
Generally
If a drug is mislabeled—
It is Misbranded
If drug not manufactured according to CGMPs
It is adulterated
If Drug does not conform to compendial
standards and is labeled “USP”
It is adulterated
Drugs can be both misbranded and
adulterated at the same time
Solid Oral Drugs
Must be marketed with an imprint that permits
identification
Applies to Rx-only and OTC drugs
Exceptions where ‘impracticable’
• Sublingual Nitroglycerin tablets
Drug is misbranded without required
identification
FDCA of 1938
 Grandfather Clause
Drugs on market before 1938 were not subject to
review and NDA requirements
• Avoided ex post facto clause
 Did NOT establish prescription-only/OTC status of
drugs
Some drugs were considered ‘safe’ only when used
under medical supervision
 Did not required drugs to be ‘effective’ for intended
purposes
Distinguish “drug” and “new drug”
Grandpa
and
The term ''new drug'' means (1) Any drug (except a new animal drug or an animal feed bearing or
containing a new animal drug) the composition of which is such that
such drug is not generally recognized, among experts qualified by
scientific training and experience to evaluate the safety and
effectiveness of drugs, as safe and effective for use under the
conditions prescribed, recommended, or suggested in the labeling
thereof, except that such a drug not so recognized shall not be
deemed to be a ''new drug'' if at any time prior to June 25, 1938, it was
subject to the Food and Drugs Act of June 30, 1906, as amended, and
if at such time its labeling contained the same representations
concerning the conditions of its use.
FDCA of 1938
Recognized “Official Compendia,” privately
published, that standardized drug quality
USP/NF Monographs
• Chemical characteristics and quality standards of
listed drugs
• USP/NF merged
Homeopathic Pharmacopoeia of the United
States
Anything published in official compendia is a
drug
Articles in the FDCA
Food
Drug
Cosmetic
Dietary Supplements
Soap
An Article may be a food, a drug, a
cosmetic and/or a dietary supplement
• Depends on distributor’s CLAIMS
Foods and Cosmetics
 The term ''food'' means (1) articles used for food or
drink for man or other animals, (2) chewing gum, and
(3) articles used for components of any such article.
 The term ''cosmetic'' means (1) articles intended to
be rubbed, poured, sprinkled, or sprayed on,
introduced into, or otherwise applied to the human
body or any part thereof for cleansing, beautifying,
promoting attractiveness, or altering the appearance,
and (2) articles intended for use as a component of
any such articles; except that such term shall not
include soap.
Drug
The term ''drug'' means (A) articles recognized in the
official United States Pharmacopoeia, official
Homoeopathic Pharmacopoeia of the United States,
or official National Formulary, or any supplement to
any of them; and (B) articles intended for use in the
diagnosis, cure, mitigation, treatment, or prevention
of disease in man or other animals; and (C) articles
(other than food) intended to affect the structure or
any function of the body of man or other animals;
and (D) articles intended for use as a component of
any article specified in clause (A), (B), or (C).
Dietary Supplement
 A food or dietary supplement for which a claim,
subject to sections 343(r)(1)(B) and 343(r)(3) of this
title or sections 343(r)(1)(B) and 343(r)(5)(D) of this
title, is made in accordance with the requirements of
section 343(r) of this title is not a drug solely
because the label or the labeling contains such a
claim. A food, dietary ingredient, or dietary
supplement for which a truthful and not misleading
statement is made in accordance with section
343(r)(6) of this title is not a drug under clause (C)
solely because the label or the labeling contains
such a statement.
Dietary Supplements
 The term ''dietary supplement'' - (1) means a product
(other than tobacco) intended to supplement the diet that
bears or contains one or more of the following dietary
ingredients:
(A) a vitamin;
(B) a mineral;
(C) an herb or other botanical;
(D) an amino acid;
(E) a dietary substance for use by man to supplement the diet by
increasing the total dietary intake; or
(F) a concentrate, metabolite, constituent, extract, or combination of
any ingredient described here.
 Except for purposes of paragraph (g), a dietary
supplement shall be deemed to be a food within the
meaning of this chapter.
Important Amendments to FDCA
 Durham-Humphrey Act of 1951
Created 2 Classes of Drugs
• Prescription-only (Rx only, prescription legend)
– Rx-only legend must appear on manufacturer label
– Safe only when used under medical supervision
– ‘adequate directions for use not required if dispensed pursuant to
prescription using a pharmacy label in its place
• OTC
– Safe to use without medical supervision and when accompanied by
‘adequate directions for use’
Allowed oral transmission of prescriptions
Allowed prescription refills
Durham-Humphrey
Created § 503(b)(1) drugs
(b)(1) A drug intended for use by man which—
(A) because of its toxicity or other potentiality for harmful effect, or the method of its use, or the
collateral measures necessary to its use, is not safe for use except under the supervision of a
practitioner licensed by law to administer such drug; or
(B) is limited by an approved application under section 505 {New Drug} to use under the
professional supervision of a practitioner licensed by law to administer such drug; shall be
dispensed only (i) upon a written prescription of a practitioner licensed by law to administer
such drug, or (ii) upon an oral prescription of such practitioner which is reduced promptly to
writing and filed by the pharmacist, or (iii) by refilling any such written or oral prescription if
such refilling is authorized by the prescriber either in the original prescription or by oral order
which is reduced promptly to writing and filed by the pharmacist. The act of dispensing a drug
contrary to the provisions of this paragraph shall be deemed to be an act which results in the
drug being misbranded while held for sale.
Kefauver-Harris Act of 1962
 a/ka/ ‘Drug Efficacy Amendment’
Thalidomide in Europe caused birth defects in children
of pregnant mothers
All new drugs put on market after 1962 must be proven
‘effective’ for intended purposes
• Now ‘new drugs’ must be safe and effective before given an
NDA
• Applied to drugs marketed between 1938 and 1962
– Established Drug Efficacy Study Initiative (DESI)
– Burden on FDA to prove 1938-1962 drugs not effective
Established Informed Consent for Human Research
Subjects
Implemented Good Manufacturing Practices
• GMPs, CGMPs
Kefauver-Harris
 Established DESI class of drugs for those marketed
between 1938 and 1962.
 Drug Efficacy Study Implementation
 The DESI program was intended to classify all pre-1962 drugs that were already
on the market as either effective, ineffective, or needing further study. The Drug
Efficacy Study Implementation (DESI) evaluated over 3000 separate products and
over 16,000 therapeutic claims. By 1984, final action had been completed on 3,443
products; of these, 2,225 were found to be effective, 1,051 were found not
effective, and 167 were pending.
http://en.wikipedia.org/wiki/Drug_Efficacy_Study_Implementation
One of the early effects of the DESI study was the development of the Abbreviated New Drug
Application (ANDA). More about this later
Kefauver-Harris Act
Another aspect of this act is that it gave
authority to regulate Advertising and
Marketing of:
Rx-Only and OTC drugs to the FDA
Dietary Supplements to the FTC
• Federal Trade Commission
– The Federal Trade Commission is the nation's consumer protection agency.
The FTC's Bureau of Consumer Protection works For The Consumer to
prevent fraud, deception, and unfair business practices in the marketplace.
– http://www.ftc.gov/bcp/index.shtml
Points to Remember
 Not all drugs on US market have an NDA
Pre-1938 drugs grandfathered
• Examples:
– digoxin, nitroglycerin, levothyroxine (thyroid products), phenobarbital
Important because not all drugs have an Orange Book rating even
though there may be equivalents available
 All drugs on US market must be manufactured according to
GMPs (CGMPs)
 Drugs put on market in US between 1938 and 1962 are safe
and effective for labeled indications
 “Adequate Directions for Use” applies to ALL drugs
Can remove and replace by prescription labeling on pharmacy
label
Poison Prevention Packaging Act of
1970
 Not Part of FDCA
 Administered by Consumer Product Safety
Commission (CPSC) since 1973
 Purpose to prevent accidental poisoning of children
under age five
 Requires “Hazardous Household Products” to be
marketed in child-resistant packaging
Immediate container or wrapping
With exceptions, ALL DRUGS are ‘hazardous
household products’ subject to special packaging
requirements
PPPA
 Know drugs to which Act applies
Examples:
• All oral dosage forms of
– Aspirin
– Controlled substances
– Prescription drugs
 Know drugs that have limited application:
Examples
• Packages with more than 250 mg of non-injectable iron
• Packages with more than 50 mg elemental fluoride or 0.5%
• fluoride
PPPA
Know ALL Exceptions for drugs not required
to be in child-resistant packaging
Examples:
• Packages of less than 8 grams of erythromycin
ethylsuccinate
• Sublingual nitroglycerin tablets
• Oral contraceptives dispensed in manufacturer’s
mnemonic packaging
• Packages of less than 105 mg prednisone tablets
• One size of OTC line with label indicating package
is not child-resistant
PPPA
Failure to Comply with PPPA is an act of
misbranding
Patient may ASK for blanket waiver of childresistant packaging for all dispensed
prescription medication
Physician may ASK for non-child-resistant
packaging only for single prescriptions
Request does NOT have to be in writing
• BUT: “if its not documented, it didn’t happen’
Federal Anti-Tampering Act of 1982
 Not part of FDCA
 Somewhat related to, but independent of PPPA
 Enacted after intentional cyanide contamination of
OTC products on drugstore shelves
Tylenol (TYMURS), Chicago
http://en.wikipedia.org/wiki/Chicago_Tylenol_murders
 Most ORAL OTC drug products and many dietary
supplements must have tamper-proof indicator or
barrier that shows if package has been opened or
tampered with
Medical Device Act of 1976
Pre-Market Approval
GMP manufacturing standards
Performance Standards
Classified according to intended Use
Records and Reporting Requirements
Not a major focus of exam
Orphan Drug Act of 1983
Limited reasons for manufacturers to invest in
research and development because potential
for return on investment limited or non-existent
Rare Disease < 20,000 persons in US
Tax incentives to manufactures
Not a major focus of exam
Drug Price Competition and Patent
Term Restoration Act of 1984
 a/k/a “Hatch-Waxman Act”
 Established Standards for marketing of ‘generic’
drugs without necessity of NDA process
 Replaced with Abbreviated New Drug
Application/Approval (ANDA)
 Generics have to be ‘therapeutically equivalent’ to
pioneer drugs
 Generally, adds about 5 years of exclusivity (patent)
rights to pioneer (innovator) company
Hatch-Waxman Act
 FDA published “Orange Book”
“Approved Drug Products with Therapeutic Equivalence
Evaluations.”
 Is Guideline Only
Some States Require Following it
• Positive Formularies
• Negative Formularies
Michigan is NOT and Orange Book State
• If generic is chemically/pharmaceutically equivalent to Brand name
prescribed generic interchange is permitted
• DO NOT use term ‘generic substitution’ for DPS
– Substitution is illegal in Michigan
» Means to dispense a drug other than the drug prescribed
» i.e., a different chemical entity
» erythromycin vs. erythromycin ethylsuccinate
» E-Par vs. EES
Prescription Drug Marketing Act of
1987
PDMA—Very Important
 Prohibits re-importation of drugs produced in the US after they have left
the US
 Wholesalers must be licensed under state law according to federal
standards
 Bans the sale, trade or purchase of ‘drug samples
In Michigan, term is “complimentary starter doses”
Hospital pharmacies may ‘hold’ samples and ‘dispense’ them at request
of a staff physician
Community pharmacies can NEVER have samples on premises or face
large fine.
Distribution of samples are strictly regulated
• Record-keeping and storage mandates
 Institutions (hospitals) cannot sell drugs to community pharmacies unless
there is a ‘bone fide’ emergency
Hospitals usually get special discount pricing
Robinson-Patman Act of 1936
 NOT an amendment to FDCA
 Is part of the Antitrust Laws
 a/k/a/ ‘Anti-Price Discrimination Act’
 Prohibits institutions (hospitals) that buy drugs at
favorable discounted rates from selling drugs at cost
to others—primarily community pharmacies
 “Own Use” Doctrine
 ‘Bone fide emergency’ exception
 http://uwacadweb.uwyo.edu/PHARMACYNOTES/Ca
sey%20Wood/unit%205%20core%20ctw.pdf
OBRA ‘90
Applied originally only to Medicaid
prescriptions
Most states enacted regulations making OBRA
standards applicable to all prescriptions
Drug Utilization Review
Necessary and Appropriate
Offer to Counsel
Counseling only by RPh or intern
Record-keeping
Prescription Drug User Fee
Act of 1992
Transformed FDA from a public watchdog
agency funded by taxpayer money that
should be protecting the interests off the
population of the USA.
PHRMA now funds most of FDA activities
FDA Modernization Act of 1997
Established ‘fast track’ NDA process for drugs
intended to treat life-threatening diseases
Established guidelines to allow pharmacy
compounding of drugs without adhering to
GMPs or NDAs
Changed ‘prescription-legend’ to ‘Rx only’
Eliminated Habit-forming warning labeling
Provides incentives for SNDAs
Mandates pediatric testing of pediatric drugs
Medicare Prescription Drug
Improvement and Modernization
Act of 2003
 NOT part of FDCA
 Medicare Modernization Act or MMA) produced
the largest overhaul of Medicare in the public health
program's 38-year history.
Medicare Part D
Its most touted change is the introduction of an entitlement benefit for
prescription drugs, through tax breaks and subsidies.
In the years since Medicare's creation in 1965, the role of prescription
drugs in U.S. patient care has significantly increased. As new and
expensive drugs have come into use, patients, particularly senior
citizens for whom Medicare was designed, have found prescriptions
harder to afford. The MMA, is meant to address this problem.
Related Federal Issues
Off-label Prescribing
Off-Label Marketing
Labeling
Package Inserts
Patient Package Inserts
Drug Recalls
I, II, III
Who initiates
FDA limitations
Postal Regulations
New Drug Issues
NDA
ANDA
SNDA
IND
Clinical Trials, Phase 1, 2, 3
Post-Marketing Surveillance
Second Section
Michigan Pharmacy Law
The “Practice of Pharmacy”
Know This:
A person shall not engage
in the practice of
pharmacy unless licensed
or otherwise authorized
by this article.
What does “engage” mean?
No Public Health Code Definition, therefore, use
ordinary meaning.
http://www.dictionary.com/search?q=engage
1. To obtain or contract for the services of;
employ: engage a carpenter.
2. To arrange for the use of; reserve: engage a
room. To pledge or promise, especially to
marry.
3. To attract and hold the attention of; engross: a
hobby that engaged her for hours at a time.
4. To win over or attract: His smile engages
everyone he meets.
Practice of Pharmacy
"Practice of pharmacy" means a health
service, the clinical application of which
includes the encouragement of safety and
efficacy in the prescribing, dispensing,
administering, and use of drugs and
related articles for the prevention of
illness, and the maintenance and
management of health.
Practice of Pharmacy
Professional functions associated with the practice of
pharmacy include:
(a) The interpretation and evaluation of the prescription.
(b) Drug product selection.
(c) The compounding, dispensing, safe storage, and
distribution of drugs and devices.
(d) The maintenance of legally required records.
(e) Advising the prescriber and the patient as required
as to contents, therapeutic action, utilization, and
possible adverse reactions or interactions of drugs.
License
"License," except as otherwise
provided in this subsection,
means an authorization issued
under this article to practice
where practice would otherwise
be unlawful.
License
License includes an authorization to use
a designated title which use would
otherwise be prohibited under this article
and may be used to refer to a health
profession subfield license, limited
license, or a temporary license.
Titles
1.
2.
3.
4.
R.Ph. (Registered Pharmacist
Chemist
Apothecary
Doctor
License
For purposes of the definition of “prescriber”
contained in section 17708(2) only, license
includes an authorization issued under the
laws of another state, or the country of
Canada, to practice in that state, or the
country of Canada, where practice would
otherwise be unlawful, and is limited to a
licensed doctor of medicine, a licensed doctor
of osteopathic medicine and surgery, or
another licensed health professional acting
under the delegation and using, recording, or
otherwise indicating the name of the
delegating licensed doctor of medicine or
licensed doctor of osteopathic medicine and
surgery.
“this article”
Article 15
Occupations
“otherwise authorized”
Under the circumstances and subject to the
limitations stated in each case, the following
individuals are not required to have a license issued
under this article for practice of a health profession in
this state:
(a) 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.
“otherwise authorized”
(c) An individual who by education, training, or experience substantially
meets the requirements of this article for licensure while rendering medical
care in a time of disaster or to an ill or injured individual at the scene of an
emergency.
(d) An individual who provides non-medical nursing or similar services in
the care of the ill or suffering or an individual who in good faith ministers to
the ill or suffering by spiritual means alone, through prayer, in the exercise
of a religious freedom, and who does not hold himself or herself out to be a
health professional.
(e) An individual residing in another state or country and authorized to
practice a health profession in that state or country who, in an exceptional
circumstance, is called in for consultation or treatment by a health
professional in this state.
(f) An individual residing in another state or country and authorized to
practice a health profession in that state or country, when attending
meetings or conducting lectures, seminars, or demonstrations under the
auspices of professional associations or training institutions in this state, if
the individual does not maintain an office or designate a place to meet
patients or receive calls in this state.
Sec. 17711
A person shall not engage in the practice of
pharmacy unless licensed or otherwise authorized
by this article.
Professional Conduct
Rule 20
Professional responsibility
A pharmacist has a professional
responsibility for the strength, quality, purity,
and the labeling of all drugs and devices
dispensed under a prescription. In
discharging this responsibility, a pharmacist
shall utilize only those drugs and devices
that are obtained from manufacturers and
wholesale distributors licensed under section
17748 of the code or from other lawful
channels of distribution.
The “Long-Arm” Statute
A pharmacy, manufacturer, or wholesale distributor of
prescription drugs, whether or not located in this state
but doing business in this state, shall be licensed by
the board in accordance with this part. Licenses shall
be renewed biennially. A pharmacy, manufacturer, or
wholesale distributor may designate an individual to
be the licensee for the pharmacy, manufacturer, or
wholesale distributor and the licensee is responsible
for compliance with this part.
Rule 20 (2)
A pharmacist shall not fill a prescription order
if, in the pharmacist's professional judgment,
any of the following provisions apply:
(a) The prescription appears to be
improperly written.
(b) The prescription is susceptible to more
than 1 interpretation.
(c) The pharmacist has reason to believe
that the prescription could cause harm to the
patient.
(d) The pharmacist has reason to believe
that the prescription will be used for other than
legitimate medical purposes.
Logic: for a statement to be true,
the opposite must also be true.
1. Does that mean that if those 4 conditions
are not present, the pharmacist SHALL fill
all other prescriptions? Can a pharmacist
refuse to fill a prescription for any reason or
even for no reason?
2. Is Professional Judgment subjective or
objective?
Rule 20 (3)
A prescription drug shall only be dispensed
when the pharmacy is open and under the
personal charge of a pharmacist.
Sec. 17763. In addition to the grounds set forth in part 161, the
disciplinary subcommittee may fine, reprimand, or place a
pharmacist licensee on probation, or deny, limit, suspend, or
revoke the license of a pharmacist or order restitution or
community service for a violation or abetting in a violation of this
part or rules promulgated under this part, or for 1 or more of the
following grounds:
(d) Permitting the dispensing of prescriptions by a pharmacist
intern, except in the presence and under the personal charge of a
pharmacist.
Personal Charge
"Personal charge" means the
immediate physical presence of a
pharmacist or dispensing
prescriber.
Rule 20 (4)
To encourage intended, positive patient outcomes,
a pharmacist shall communicate, to the patient or
the patient's caregiver, necessary and appropriate
information regarding safe and effective medication
use at the time a prescription is dispensed. As
used in this subrule, "caregiver" means the parent,
guardian, or other individual who has assumed
responsibility for providing a patient's care. All of
the following provisions apply to communicating
medication safety and effectiveness information:
Shall Communicate
(a) The information shall be communicated orally and in person, except when
the patient or patient's caregiver is not at the pharmacy or when a specific
communication barrier prohibits oral communication. In either situation,
providing printed material designed to help the patient use the medication
safely and effectively satisfies the requirements of this subrule.
(b) The information shall be provided with each prescription for a drug not
previously prescribed for the patient.
(c) If the pharmacist deems it appropriate, the information shall be provided
with prescription refills.
(d) The information shall be provided if requested by the patient or patient's
caregiver or agent for any prescription dispensed by the pharmacy. This
subrule does not require that a pharmacist provide consultation if a patient or a
patient's caregiver refuses consultation. This subrule does not apply to
prescriptions dispensed for administration to a patient while the patient is in a
medical institution.
Important Distinctions
Personal Charge §17707 (1)
Supervision §16109(2)
Delegation §16215 and Rule 20(5)
Supervision §16109(2)
“the overseeing of or participation in the work of another individual
by a health professional licensed under this article in circumstances
where at least all of the following conditions exist:
(a) The continuous availability of direct communication in person or
by radio, telephone, or telecommunication between the supervised
individual and a licensed health professional.
(b) The availability of a licensed health professional on a regularly
scheduled basis to review the practice of the supervised individual,
to provide consultation to the supervised individual, to review
records, and to further educate the supervised individual in the
performance of the individual’s functions.
(c) The provision by the licensed supervising health professional of
predetermined procedures and drug protocol.”
Delegation Rule 20 (5)
Pharmacist delegation of acts,
tasks, or functions shall be in
compliance with section 16215 of
the code and under the personal
charge of the delegating
pharmacist, except as provided in
R 338.486(3).
§16215
(1) A licensee who holds a license other than a health
profession subfield license may delegate to a licensed
or unlicensed individual who is otherwise qualified by
education, training, or experience the performance of
selected acts, tasks, or functions where the acts,
tasks, or functions fall within the scope of practice of
the licensee's profession and will be performed under
the licensee's supervision. An act, task, or function
shall not be delegated under this section which, under
standards of acceptable and prevailing practice,
requires the level of education, skill, and judgment
required of a licensee under this article.
§16215
Except as otherwise provided in this subsection, a licensee under
part 170 or 175 shall delegate an act, task, or function that
involves the performance of a procedure that requires the use of
surgical instrumentation only to an individual who is licensed
under article 15. This subsection does not apply if the unlicensed
individual is 1 or more of the following and if the procedure is
directly supervised by a licensed physician or osteopathic physician
who is physically present during the performance of the procedure
or if the unlicensed individual is performing acupuncture:
(a) A student enrolled in a school of medicine or osteopathic
medicine approved by the Michigan board of medicine or the
Michigan board of osteopathic medicine and surgery.
(b) A student enrolled in a physician's assistant training program
approved by the joint physician's assistant task force created
under part 170.
§16215
(3)
A board may promulgate rules to further prohibit or
otherwise restrict delegation of specific acts, tasks, or
functions to a licensed or unlicensed individual where the
board determines that the delegation constitutes or may
constitute a danger to the health, safety, or welfare of the
patient or public.
(4) To promote safe and competent practice, a board may
promulgate rules to specify conditions under which, and
categories and types of licensed and unlicensed individuals
for whom, closer supervision may be required.
(5) An individual who performs acts, tasks, or functions
delegated pursuant to this section does not violate the part
which regulates the scope of practice of that health
profession.
…under personal charge.. except as provided
in R 338.486(3)
R 338.486 "Medical institution" and
"pharmacy services" defined; pharmacy
services in medical institutions.
Rule 16(3) Pharmacy personnel who assist the
pharmacist by performing delegated functions
in the care of inpatients shall be supervised by
a pharmacist who is on the premises of the
medical institution.
Delegation Rule 20(5)
A pharmacist who delegates acts, tasks, or functions to a licensed or
unlicensed person shall do all of the following:
(a) Determine the knowledge and skill required to safely and
competently complete the specific act, task, or function to be
delegated.
(b) Before delegating an act, task, or function, make a
determination that the delegatee has the necessary knowledge and
skills to safely and competently complete the act, task, or function.
(c) Provide written procedures or protocols, or both, to be
followed by the delegatee in the performance of the delegated act, task,
or function.
(d) Supervise and evaluate the performance of the delegatee.
(e) Provide remediation of the performance of the delegatee if
indicated.
Note: Inclusive, all 5 requirements
Rule 20 (6)
A delegating pharmacist shall bear the
ultimate responsibility for the
performance of delegated acts, tasks, and
functions performed by the delegatee
within the scope of the delegation.
“While a task may be delegable, the
responsibility associated with the proper
performance of it is never delegable.”
The Practice of Pharmacy
The pharmacists on duty are responsible for
compliance with federal and state laws
regulating the distribution of drugs and the
practice of pharmacy.
The pharmacist “in charge” has ultimate
responsibility.
Are there any special rules for
“institutional” pharmacy practice?
Institution
hospital
skilled nursing facilities
 county medical care facilities,
nursing homes
other health facilities licensed or approved by the
state that:
directly or indirectly provide or
include pharmacy services.
Not “Institutions”
assisted living homes,
adult foster care facilities,
group homes for the physically or mentally
impaired,
other unique settings
Governed under the standard community
pharmacy rules
Many community-based retail pharmacies may
also contract with a nursing home or other
medical institution to provide pharmacy services
the retail portion of the business would be
governed by the typical community pharmacy
rules
the institutional part of the practice is governed
by the institutional rules.
The director of pharmacy services in an
institutional practice has unique
responsibilities.
 develop, implement, supervise and coordinate all
pharmacy services
minimizes additional preparation before administration
to the patient, including the admixture of parenterals
adopt a process that will permit the pharmacy to
obtain the prescriber’s original medication order, a
direct carbonized copy or an electromechanical
facsimile
• an order for a drug or device in the patient’s chart constitutes
the original prescription
monitoring medication orders to evaluate clinically
significant chemical and therapeutic incompatibilities
Institutional Director of Pharmacy
providing educational programs for the
medical institution’s personnel and patients
regarding medications and their safe use
establishing the specifications for the
procurement of all pharmaceuticals,
biologicals and chemicals approved for use in
the medical institution.
Institutional Director of Pharmacy
 institutions are required to establish an interdisciplinary practitioners’
committee (usually called the Pharmacy & Therapeutics or P&T
Committee) that makes recommendations for formulary or approved drugs
 the pharmacist director is required to adopt written policies and
procedures that promote safe medication practices, to conduct medication
utilization reviews and to approve medications for the medical institution’s
formulary or medication list
 director also is required to meet with the committee at least quarterly to
address these responsibilities
 make the policies, procedures and written reports required under these
provisions available to the Board of Pharmacy, if requested
Institutional Director of Pharmacy
 devising methods of interpreting and reviewing the
prescriber’s medication orders and communicating
this interpretation before administration of the first
dose
 however, if communicating this interpretation will
cause a medically unacceptable delay, a limited
number of medications and their doses, ordinarily
called “floor stock,” may be kept in the patient care
areas
Institutional Floor Stock
stored in a manner that ensures immediate
availability
Secured
sealed or secured medication kits, carts or
treatment trays
a pharmacist routinely inspects the
medications
Non-24 hour Institutional
Pharmacies
 establish a method by which medications can be obtained during the absence of a
pharmacist that minimizes the potential for medication errors.
 the services of a pharmacist are available on an on-call basis
 a limited number of medications that are packaged in “unit of use” (or unit-dose
packaging) may be made available in a securely locked, substantially constructed
cabinet in an area of limited access in a centralized area outside the pharmacy
 list of medications kept in this “after hours” lock box has to be approved and
reviewed at least quarterly by the P&T Committee
 Each medication kept in the after hours box has to be labeled to include the name
of the medication, the strength, the expiration date (if dated) and the lot number
 A written order and a proof of removal and use document have to be obtained for
each medication unit removed.
 order has to be reviewed by a pharmacist within 48 hours of the removal of the
medication from the cabinet.
 director is required to designate which practitioners will be permitted to remove
the medications from the box.
 an audit of the box as often as needed to guarantee control, but not less than
once every 30 days.
Central Fill Pharmacies
 processing by a pharmacy of a request from another
pharmacy to fill or refill a prescription drug order or to
perform processing functions such as dispensing,
performing drug utilization review, completing claims
adjudication, obtaining refill authorizations, initiating
therapeutic interventions, and other functions related
to the practice of pharmacy
Central Fill Pharmacies Records
(a) the date the request for centralized prescription processing
services was received from the originating pharmacy;
(b) the name and address of the originating pharmacy from
which the request for centralized prescription processing
services was received;
(c) the date the prescription was processed, verified, or filled;
(d) the identification of any pharmacist who was responsible
for processing the prescription and shipping a filled
prescription to an originating pharmacy or delivering a filled
prescription to a patient or a patient's agent;
(e) the date the filled prescription was shipped to the originating
pharmacy or was shipped or delivered to the patient or the
patient's agent;
(f) if shipped, the name and address of the patient to whom the
filled prescription was shipped; and
(g) the method of delivery, such as private, common, or contract
carrier, if shipped.
Pharmacy Ownership
 25% rule unenforceable
 any legal entity that is not disqualified from
ownership may own a pharmacy
Sole proprietorship
Corporation
• Public
• Private
 Designation of “licensee” required
Changes in Ownership
 A partnership, corporation or entity operating under
an assumed name must provide the Board with
written notification of a change in any of the
partners, stockholders, officers or members of the
board of directors.
 The reporting requirement does not apply to
publicly held corporations.
 A change in the individual pharmacist who is
designated as the pharmacy licensee of a licensed
pharmacy must be reported.
 30 days.
 Pharmacy licenses are not transferable between
owners
Pharmacy Licenses
 The application for a new pharmacy license must
describe the premises and include pictures of both
the interior and exterior of the pharmacy.
 A Self-Inspection Form must be obtained, completed
and sent in with the application. If an existing
licensed pharmacy moves to a new location, it also
must apply and be approved for a new license before
moving.
DEA Notification
Licenses
Pharmacy
Pharmacist
Intern
Generally Valid 2 Years
• Sometimes only 1 year initially
Renew on July 1
DEA Registration
Generally Valid 3 Years
Pharmacist License
 At least 18
 “Good Moral Character”
propensity to serve the public in a fair,
open, and honest manner
Moral turpitude
 Education: Accredited College
 Working Knowledge of English Language
 Fingerprints, Criminal Background Check
Reciprocity:
“Licensure by Endorsement”
Transfer of license between states (or Canada
until 2012)
Other state must reciprocate with state to
which transfer is sought.
• Assumes pass NAPLEX in one state
Must take MPJE for transfer state (75%)
• Six Tries or Go To Back to Jail (School)
Drug Control License
Prescribers (other than Vets) that dispense
drugs directly to own patients must apply for
license from Board of Pharmacy.
Not required for emergency hospital/trauma
center
Not required for “complimentary starter dose”
(samples-PDMA)
Labeling, recordkeeping, storage
CE Requirements
 30 accredited hours during two year license
period (Not 15o/yr)
 Theory only: “proficiency exam”
 One CE: pain and symptom management
 10 hours “live”
 May 12o/24o
 Must receive Date Earned Certification
before Renewal Date
 Waivers
CE Requirements: Topics
 (a) social, psychological, economic and legal aspects of
healthcare delivery;
 (b) properties and actions of drugs and dosage forms;
 (c) etiology, characteristics and therapeutics of the disease
state;
 (d) emergency skills;
 (e) specialized professional services; and
 (f) other areas of study that the board finds are designed to
maintain or enhance a pharmacist’s ability to deliver
competent pharmacy services
Preceptors
 A pharmacist who is approved by the Board of
Pharmacy to direct the training of a pharmacy intern
in a pharmacy that is Board-approved to provide
such training
 One year license as RPh required
 Intern Responsible to Make Sure Preceptor License
is Current at Time of Certifying Internship Hours and
Affidavit of Qualification to Become Pharmacist
Preceptors
 Responsible for the overall internship
training program in a pharmacy
 Internship training and hours only need by
under personal charge of a pharmacist
does not have to be the preceptor (who
supervises)
no more than two interns per pharmacist may
be on duty in a pharmacy at any given time
• Tech ratio repealed
Preceptor must Train Intern”
 pharmacy administration and management;
 drug distribution, use and control;
 legal requirements; provision of health
information services,
 consultations with patients;
 pharmacists’ ethical and professional
responsibilities; and
 knowledge of drug and product information
Preceptor Signature Required
annual internship training affidavits
certify the number of hours an intern has
worked over a given period of time and that
the intern is receiving training and experience
in the required areas of practice
required to issue an opinion on the ability of
the intern to practice pharmacy without
supervision at end of internship
Internship Requirements
an educational program of professional and
practical experience
licensed by the Board for the purpose of
obtaining instruction in the practice of
pharmacy from a preceptor
“limited pharmacist license”
educational pharmacist license
Internship Requirements
 when eligible, a student must apply for licensure as an intern
eligible at the beginning of the first professional year
(requirement for this course)
 Must submit application and pay fee
 Prove Enrolled in Pharmacy School
we do dat
 License NUMBER good until become RPh or up to one year
after graduation
Pay renewal fee annually
Lapses: leave of absence for 1 year
 See Text for other requirements
Michigan Pharmacy Law
Part E: Drugs
Compare how drugs are regulated in
Michigan with Federal law
Adulteration
Misbranding
• Especially Note Labeling Differences
– Community
– Institution
Do drugs sold in Michigan have to be
marked with special numbers or symbols?
 All solid oral dosage forms of prescription-only
drugs manufactured or distributed in Michigan
must be prominently marked or imprinted with an
individual symbol, number, company name,
words, letters, marking, national drug code or a
combination of any of these that identifies the
prescription drug and the manufacturer or
distributor of the drug
 Distributor must give key to MDCH
 $25,000 penalty
 Same sort of federal law
“Harmful Drug” = §503(b)(1)
 Intended to be used by “human beings”
 Is harmful because of its toxicity, habit-forming nature, or other
potential adverse effect, the method of its use, or the collateral
measures necessary to its safe and effective use, and which is
designated as harmful by the board
 A “harmful drug” may be dispensed only as a “prescription
drug”
drug dispensed pursuant to a prescription, a drug
bearing the federal legend “CAUTION: federal law
prohibits dispensing without a prescription,” or a drug
designated by the board as a drug that may only be
dispensed pursuant to a prescription. Caution: Rx
only
Deleterious Drug
a drug, other than a proprietary medicine, that
is likely to be destructive to adult human life in
quantities of 3.88 grams or less.
Importance ?????
Michigan Version of PPPA
Identical
PPPA “preempts” inconsistent state law
Request for Non-Safety Caps
Law: Does not have to be in writing
LAWYER: MUST BE IN WRITING
Michigan Pharmacy Law
Chapter 4
Dispensing and Prescribing
Part A
The Prescription
What is a Prescription?
 An order
for drugs (both Rx-only and OTC) or devices written
and signed or transmitted by other means of
communication, including oral telephone orders and
those received electronically
for drugs or devices written and signed or transmitted
by other means of communication, including oral
telephone orders and those received electronically
What is a Prescription?
Do not be confused about whether a drug is
Rx-only or OTCWith whether a third-party will pay for it or not
Don’t confuse regulatory laws with—
Contract laws
Third Class of Drugs
Behind the Counter (BTC)
Emergency Contraceptives
• Plan B for women over 17 y/o
Pseudoephedrine
OTC Schedule V
• Cough Syrups
• Anti-diarrheals
Communication of an Order
traditional handwritten or typed piece of paper
telephone
fax (facsimile)
“electronic prescribing”
e-prescribing
e-script
Communication of an Order
Information on order depends on:
How communicated
What Kind of drug is ordered
• Controlled
• Non-controlled
Where order comes from
Type of pharmacy order goes to
Distinguish Communication and
Prescribing
Prescribing is act of ordering
Communication of a prescription is not
prescribing
Uniform
Requirements




name of the patient,
name of the drug being ordered,
dosage of the drug,
date the prescription is being originated (also called the date the
prescription was “issued”) and
 directions for use of the drug,
number of times a day the drug is to be administered to or by the patient
over a 24-hour day.
 The name, address and phone number of the prescriber must appear on
the vast majority of prescriptions;
this is not always required for prescriptions that originate in an
institutional setting, such as a hospital, if there have been arrangements
for recording the prescriber’s name differently.
 Don’t confuse this information with “labeling”
Unique Prescribing Situations
Electronic prescribing
encouraged because many of the prescription
drug errors made in the healthcare spectrum
are caused by poor communication
But: “Junk in-Junk out” problem
• Especially dangerous with refills
Electronic Signatures in Global and
National Commerce Act of 2000
 ESIG
 PL 106-229 enacted June 30, 1999, (SB 761) and
(HB 1714 IH); 15 USC 7001 and effective October 1,
2000
 See Vivian, JC, “E Signatures in Pharmacy Practice,”
U.S. Pharmacist, Vol. 26: 02, February 2001
E-SIG
 A signature cannot be denied legal effect solely because it is
in electronic form
 DEA developed standards for electronic transmission of
prescriptions using digital security technology in June, 2010.
Applies to ALL CS Scripts including Schedule II
 Centers for Medicare and Medicaid Services (CMS) has
adopted standards for electronically transmitted prescriptions
that are subject to Medicare Part D benefits
Other Prescribing Requirements
 Noncontrolled substances federal legend electronic
prescriptions in community (retail) pharmacies
 Controlled substance federal legend electronic
prescriptions
 Handwritten, noncontrolled substances
prescriptions in the community setting
PA or NP name and delegating physician
name. PA or NP DEA number
 Handwritten, controlled substances prescriptions in
the community setting
 Oral nonemergency federal legend controlled
substances prescriptions in community pharmacy
Other Prescribing Requirements
 Nonemergency federal legend prescriptions in
medical institutions (both controlled substance and
noncontrolled substance drugs)
 Delegated prescribing in medical institutions
 Emergency controlled substance prescriptions in
medical institutions
 Emergency controlled substance prescriptions in
medical institutions
 Federal legend controlled substances prescriptions
for terminally ill patients
Refills
Refills for federal legend controlled substance
prescriptions
No C-II Refills
• Partial Fills
– Out-of-stock:72 hours
– Terminally Ill: 60 days
C-III and C-IV: 5x in 6 months
C-V: as written (up to 1 year
90 days for C-IIs with date of next fill
Don’t confuse 60 day rule for terminal
patients
Pre-Printed Rx Blanks-Rule 9b
 (3) A prescriber shall not prescribe more than the following on
a single prescription form as applicable: (a) For a prescription
prescribed in handwritten form, up to 4 prescription drug
orders.
 (b) For a prescription prescribed on a computer-generated
form or a preprinted list or produced on a personal computer
or typewriter, up to 6 prescription drug orders.
 (4) A prescriber shall not add handwritten drugs to a
preprinted form and shall clearly designate which drugs are to
be dispensed.
 (5) A prescriber shall not prescribe a controlled and
noncontrolled substance on the same prescription form
What if Prescriber Deviates from
Rule 9b Requirements?
 Fix it.
 The rule was adopted to avoid pharmacy errors
caused by messy handwriting and attempts by
prescribers to cram the most amount of information
into the smallest area.
 If there are any doubts about the accuracy of any
prescription order caused by these kinds of issues,
the prescriber should be consulted before
dispensing.
Can controlled substance and noncontrolled substance
prescription drugs appear on the same written
prescription form?
No
Fix it.
Mail-Order Rx
Old Law: Can’t dispense by mail if Rx received
by mail
Current Law: Whatever
Federal Post Office Regulations
Locum Tenens
Why you can’t find this in the statutes or
regulations
Vending Machines
http://www.instymeds.com/
“The Future of Physician Dispensing is Here!”
The safety and security of an ATM with the simplicity of a
soda machine! InstyMeds is the solution for providing
outpatient prescription medication services 24 hours a day,
7 days a week, at the point-of-care.
The InstyMeds Prescription Medication Dispenser is the
health care industry's first fully-automated, ATM-style
dispenser of acute prescription medications. State-of-theart InstyMeds technology ensures safe and secure
dispensing of prescription medications directly to patients
at the point-of-care
Vending Machines
 The use of any mechanical device that is designed for the
specific purpose of selling, dispensing or otherwise
disposing of any drug or device ordered by a prescription is
regulated by the Board in two different ways. There is one
General Rule that applies to all automated drug vending
devices. There are separate provisions in the Controlled
Substance Rules applying to vending devices used to
dispense controlled substances in medical institutions, as
well as nursing homes, county medical care facilities,
hospices and the office of a dispensing prescriber.[1] The
rule expressly prohibits a pharmacy from owning,
controlling or operating a device used to dispense federal
legend drugs located within a prescriber’s office
[1] General Rule 19; R 338.489 and Controlled Substance Rules
32; R 3383132 and 54 (4); R 338.3154
Prescription Copies
 Transfer Between Pharmacies
Independents
Chains linked by on-time real-time databases
 Controlled vs. Rx-only
CS: 1x only
 Procedures and Record-Keeping
 Non-Transfer: “For informational or reference
purposes only”
Rx Record-Keeping
 Michigan
Rx: 5 years minimum from date of last fill or refill ALL
PRESCRIPTIONS
• Could be 6 years
• Don’t confuse 3rd party contracts
– Medicaid, Blue Cross: 7-8 years
 Federal
2 years CS scripts
2 years CS Invoices
2 Years C-II Form 222 orders
 Record Retention Policy
Confidentiality of Rx Records
 “not public”
Patient permission
Another pharmacist assisting patient
Government (inspectors, police
Court order
Approved research
 HIPAA
No PHI except for TPO
 Beware “confidentiality” vs. “privilege”
Prescribing
Who can Prescribe §503(b) drugs in Michigan?
“Prescribing is limited to a Prescriber”
Distinguish prescribing and dispensing
Depends on
Location of prescriber’s license
–Michigan
–Other state
–Canada
Which kind of prescriber
–Independent: MD, DO, DP, DDS, DV, “special” OD
–Dependant: MD or DO’s: PA or NP
Prescriber’s scope of practice
Kind of drug being prescribed
–Non-Controlled
–Controlled
Prescribing Terminology
 qd
 hs
 bid
 tid
 Qid
 au, as, ad
 ou, os, od
 http://en.wikipedia.org/wiki/List_of_abbreviations
_used_in_medical_prescriptions
Vivian’s Commandment
Thou shalt not dispense
without prescriptive
authority.
Prescriptive authority dies with the
prescriber
 No rule is a good rule unless there
are exceptions to the rule
• unless you need to
Independent Prescribing
vs.
Dependent Prescribing
 Independent---Because of Scope of Practice
“Physician”
• RDs: State and Canada MDs, DOs,
• FDs: DDSs, DPMs ,some ODs (special license), DVMs
• DCs: can’t prescribe anything in Michigan
– “Is a Chiropractor a Real Doctor?”
– http://ezinearticles.com/?Is-a-Chiropractor-a-Real-Doctor?&id=1911538
 Dependent—Delegated to Prescribe by MD or DO only
Pas: Max 4 PAs supervised @ 2locations; 2 @ 1 location
NPs (dx: LPN, RN, NP), NMs (Nurse Midwife): No ratio
• Name of delegator (physician) AND name of prescriber (NP, NM, PA)
on Rx
MAYBE: PharmD (BTC drugs); delegatee?
Written protocol (Pharmacy get copy)
 All must be “licensed,” not just Degreed
Dispensing
 Drug Product Selection (DPS)
Generic Interchange
Substitution---illegal
Brand exchange
 Brand Name Drugs
Patent medicines
Proprietary medicines
Ethical medicines
 Generic Drugs
ANDA
Brand Name Prescribed
 When a pharmacist receives a prescription for a “brand name” drug
product, the “pharmacist may, or when a purchaser requests a lower
cost, generically equivalent drug product, the pharmacist shall,
dispense a lower cost but not higher cost generically equivalent drug
product if available in the pharmacy” unless the prescriber has
prevented a generic interchange----DAW—in own handwriting
Don’t confuse 3rd party’s that mandate generic interchange

The term “brand name” is defined to mean “the registered trademark
name given to a drug product by its manufacturer,” §17702(1)
 The term “generically equivalent drug product” is not defined in the
statutes or rules. However, based on the definitions of “drug” and
“generic name” as used in the statutes, it is understood that the term
is referring to a drug that is the exact same chemical entity in the
same dosage form and strength as the prescribed drug.
Generic Interchange
 Notice
if and when drug product selection or generic interchange has
occurred:
• the statute and rule state that the purchaser shall be notified and the
prescription label shall indicate both the name of the brand
prescribed and the name of the brand dispensed.
Two levels
• the “purchaser” (i.e., the patient or caregiver) be notified that a
generic alternative has been dispensed. Neither the statute nor the
rule addresses the issue of whether this particular notice should be
oral or in writing.
• Label needs to indicate the “name of the brand [drug] prescribed
and the name of the brand dispensed.” UNLESS DO NOT LABEL
• Generics don’t have Brand names; therefore manufacturer name
 Confusion about “GEq”
Only applies to multi-ingredient drugs
Generic Interchange
Post Policy
display a written notice concerning pricing and
generic interchange policies in a
“conspicuous” place where it can be read by
patients and consumers.
State standards on size and wording
Not apply to institutions
Generic Interchange
Michigan is NOT an Orange Book state
Some states are:
• Positive or negative Orange Book authorized
There is no MI STATE authorized
formulary
Some states: negative or positive
formulary
Don’t confuse 3rd party contracts that do
have formularies
Don’t confuse Medical Institutions or
Health Facilities that may have formularies
Generic Interchange
Cost savings must be passed on to
“purchaser”
Who is “purchaser?”
• Cash customer
• Beneficiary of cost savings—3rd party payor
Cost Savings
Difference between cost of generic drug
and cost of brand name drug
• Problem: What is “cost” and how to
determine it?
Labeling
Recall dx bw “label” and “labeling”
Discussed in Federal Law Section
Know difs here
• ‘label” means “a display of written, printed,
or graphic matter on the immediate
container of a drug or device, but does not
include package liners
• “labeling” means the labels and other
written, printed or graphic matter on a drug
or device or its container or wrapper, or
accompanying the drug or device
Labeling
Drug is “misbranded” if not properly labeled
 Manufacturer's label
Michigan and Federal law consistent
 Community Pharmacy Labeling
Vial or Format dispensed to the patient
• name of the medication in the container, unless the prescriber
writes ‘do not label’ on the prescription
• “Discard this medication one year after the date it is
dispensed,” unless the medication expires on another date
under applicable state or federal law or rules or regulations or
other state or federal standards. If the medication expires on
another date, the pharmacist dispensing the prescription has
to strike or omit the statement and, instead, specify on the
label the actual expiration date of the medication.
Community Pharmacy Labeling
 (a) Pharmacy name and address
 (b) Prescription number
 (c) Patient’s name
 (d) Date the prescription was most recently
dispensed
 (e) Prescriber’s name
 (f) Directions for use
 (g) The name of the medication, unless the
prescriber indicates “do not label”
 Remember the altered labeling requirements
if DPS occurs
Community Pharmacy Labeling
If C-2, C-3 or C-4 Controlled Drug:
Transfer Warning:
• “Caution: Federal law prohibits the transfer of this
drug to any person other than the patient for whom
it was prescribed.”
Not Required for C-5
Standard of practice: many pharmacies
include warning on all dispensed labels
Is not required except as above
Community “Labeling:” Receipts
 all prescriptions dispensed in community
pharmacies must be accompanied by prescription
drug receipts
 may appear on the prescription label, on the receipt
or on a combination of the receipt and the label
 Name of drug unless “do not label”
Remember generic interchange labeling
 Date most recently dispensed
 Price paid by patient (not insurer)
 Retain copy of receipt for 90 days
Other Labeling
C-5 OTCs
Vending Machines
Hospice Boxes
Institutional Labeling
Multidose vials
Unit of Use Packaging
• “Unit Dose”
Refills Documentation
Three options
Select one and use only one
Back of script
Hardcopy log
Electronic (Computer) recording
Remember different records needed if DPS
occurs
Complimentary Starter Doses
 “prescription drugs packaged, dispensed and distributed in
accordance with state and federal law that are provided to a
dispensing prescriber free of charge by a manufacturer or
distributor and dispensed free of charge by the dispensing
prescriber to his or her patients.”
 Called “samples” under federal law
Remember PDMA
 Recall limitations on what kind of pharmacies can have
samples and under what conditions and what the penalties
are for illegal possession
Customized Patient
Medication Packages
 For “gray area” Unique Living Situations that do not
clearly fit “community” or “institutional” practice.
 Applies only to solid oral dosage forms
 Must have consent of patient (or caregiver) and
prescriber
 Follow special labeling, restocking, recordkeeping
rules
Hospice Dispensing
For “gray area” btw community and
institutional practice.
See Text for Special Rules
Miscellaneous Provisions
Returns of drugs to pharmacies
Max 5% distribution and compounding
Section Three
Controlled Substances Statutes and Regulations
Federal Law
and
Michigan Law
Federal CS Laws
 DEA implements the Comprehensive Drug
Abuse Prevention and Control Act of
1970, often referred to as the Controlled
Substances Act (CSA) and the Controlled
Substances Import and Export Act (21 U.S.C.
801-971).
DEA publishes the implementing regulations
for these statutes in Title 21 of the Code of
Federal Regulations (CFR), Parts 1300 to
1399.
Federal CS Laws
 These regulations are designed to ensure an adequate supply
of controlled substances for legitimate medical, scientific,
research, and industrial purposes, and to deter the diversion
of controlled substances to illegal purposes.
 The CSA mandates that DEA establish a closed system of
control for manufacturing, distributing, and dispensing
controlled substances.
 Any person who manufactures, distributes, dispenses,
imports, exports, or conducts research or chemical analysis
with controlled substances must register with DEA (unless
exempt) and comply with the applicable requirements for the
activity.
Controlled Substances
Drugs and other substances that have a
potential for abuse and psychological and
physical dependence;
These include
opioids, stimulants, depressants,
hallucinogens, anabolic steroids, and drugs
that are immediate precursors of these classes
of substances.
• Notice word “narcotic” is not present
Five Schedules
 Schedule I substances have a high potential for abuse and
have no currently accepted medical use in treatment in the
United States. These substances may only be used for
research, chemical analysis, or manufacture of other drugs.
 Schedule II – V substances have currently accepted medical
uses in the United States, but also have potential for abuse
and psychological and physical dependence that necessitate
control of the substances under the CSA. The vast majority of
Schedule II, III, IV, and V controlled substances are available
only pursuant to a prescription issued by a practitioner
licensed by the State and registered with DEA to dispense the
substances.
 Overall, controlled substances constitute between 10 percent
and 11 percent of all prescriptions written in the United
States.
Written and Oral Prescriptions
 The CSA used to provide that a controlled substance in
Schedule II may be dispensed by a pharmacy pursuant to a
“written prescription,” or “electronically communicated” to a
pharmacy
 Electronically transmitted prescription for Schedule II CS
drugs allowed after June 1, 2010
 For controlled substances in Schedules III and IV, the CSA
provides that a pharmacy may dispense pursuant to a
“written, electronic, or oral prescription.” (21 U.S.C. 829(b)).
 Where an oral prescription is permitted by the CSA, the DEA
regulations further provide that a practitioner may transmit to
the pharmacy a facsimile of a written, manually signed
prescription in lieu of an oral prescription (21 CFR
1306.21(a)). Not apply to C-IIs
Legitimacy of a CS Rx
For a prescription for a controlled substance to
be valid, it must be issued for a legitimate
medical purpose by a practitioner acting in the
usual course of professional practice (United
States v. Moore, 423 U.S. 122 (1975); 21 CFR
1306.04(a)).
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.”
(21 CFR 1306.04(a)).
 It is the individual practitioner (e.g., physician, dentist, veterinarian, nurse
practitioner) who issues the prescription authorizing the dispensing of the
controlled substance.
 This prescription must be issued for a legitimate medical purpose and
must be issued in the usual course of professional practice.
 The individual practitioner is responsible for ensuring that the prescription
conforms to all legal requirements.
 The pharmacist, acting under the authority of the DEA-registered
pharmacy, has a corresponding responsibility to ensure that the
prescription is valid and meets all legal requirements.
The Prescription
 A prescription is much more than the mere method of
transmitting dispensing information from a practitioner to a
pharmacy.
 The prescription serves both as a record of the practitioner’s
determination of the legitimate medical need for the drug to be
dispensed, and as a record of the dispensing, providing the
pharmacy with the legal justification and authority to dispense
the medication prescribed by the practitioner.
 The prescription also provides a record of the actual
dispensing of the controlled substance to the ultimate user
(the patient) and, therefore, is critical to documenting that
controlled substances held by a pharmacy have been
dispensed legally.
 The maintenance by pharmacies of complete and accurate
prescription records is an essential part of the overall CSA
regulatory scheme.
Unique Law
The Controlled Substances Act is unique
among criminal laws in that it stipulates acts
pertaining to controlled substances that are
permissible. That is, if the CSA does not
explicitly permit an action pertaining to a
controlled substance, then by its lack of
explicit permissibility the act is prohibited.
Punishment
Violations of the Act can be civil or criminal in
nature, which may result in administrative,
civil, or criminal proceedings.
Remedies under the Act can range from
modification or revocation of DEA registration,
to civil monetary penalties or imprisonment,
depending on the nature, scope, and extent of
the violation.
Violations
 It is unlawful for any person knowingly or intentionally to
manufacture, distribute, or dispense, a controlled substance
or to possess a controlled substance with the intent of
manufacturing, distributing, or dispensing that controlled
substance, except as authorized by the Controlled
Substances Act (21 U.S.C. 841(a)(1)).
 It is unlawful for any person knowingly or intentionally to
possess a controlled substance unless such substance was
obtained directly, or pursuant to a valid prescription or
order, issued for a legitimate medical purpose, from a
practitioner, while acting in the course of the practitioner’s
professional practice, or except as otherwise authorized by
the CSA (21 U.S.C. 844(a)).
 It is unlawful for any person to knowingly or intentionally
acquire or obtain possession of a controlled substance by
misrepresentation, fraud, forgery, deception, or subterfuge
Violations
 It is unlawful for any person knowingly or intentionally to use a
DEA registration number that is fictitious, revoked,
suspended, expired, or issued to another person in the course
of dispensing a controlled substance, or for the purpose of
acquiring or obtaining a controlled substance (21 U.S.C.
843(a)(2)).
 It is unlawful for any person to refuse or negligently fail to
make, keep, or furnish any record (including any record of
dispensing) that is required by the CSA (21 U.S.C. 842(a)(5)).
 It is unlawful to furnish any false or fraudulent material
information in, or omit any information from, any record
required to be made or kept (21 U.S.C. 843(a)(4)(A)).
DEA Regulations and
Pharmacy Practice
The Providers
Dilemma:
Balancing Good Care
and Gatekeeper Duties
Drug Laws
 Food and Drug Administration (FDA)
Determines if “drug” is “safe” and “effective”
and if “prescription” is required for access
 Drug Enforcement Agency (DEA)/St. Bd. of
Pharmacy
Determines if a “substance” has “abuse”
potential and assigns “controlled substance”
to a “schedule” (I through V)
 FDA and DEA/Bd. Rx jurisdiction is concurrent
and independent
“prescription,” “drug” and “controlled
substance” status are independent
Policy Goal
Find way to Maximize Legitimate Medical
Use of Abusable Drugs
• minimal intrusion on those with need to
access these drugs
While Minimizing Ability of Abusers to
Obtain These Drugs
• keep the “bad guys” off drugs
Controlled Substance Access
“Closed” Distribution System
from Manufacturer to “Ultimate User”
total accountability
Access determined by Licensees
Prescriber at first level
Pharmacist at last level
• (Caregiver intervention)
The Federal Controlled Substances Act
(CSA):
21 USC § 829:
Written, Electronic, Fax
or oral “prescription”
required to dispense
controlled substances.
Can’t fax C-IIs
“Prescription” Defined:
21 CFR § 1306.02(f):
An order for medication
which is dispensed to or
for an ultimate user
(non-institutional).
Issuance of a CS Prescription
21 CFR § 1306.03:
A CS prescription may be
issued only by an
individual practitioner who
is authorized by state license
to prescribe and is registered
or exempted from registration
with the DEA
“Corresponding Responsibility”
21 CFR § 1306.04: The purpose of a
prescription:
To be effective, the CS Rx must be issued
for a legitimate medical purpose by a
practitioner acting in the usual course of
professional practice.
The pharmacist has a “corresponding
responsibility” with the prescriber for
proper prescribing and dispensing.
An order purporting to be a “prescription”
is not a “prescription”(21 USC §829) if
not issued in the usual course of
professional treatment.
“Corresponding Responsibility”
21 CFR § 1306.05: The “form” of a prescription:
CS prescriptions must be dated and
signed that day, have patient’s name
and address, prescriber's DEA
number and written in ink, indelible
pencil or typewritten.
The pharmacist has a corresponding
responsibility to determine that
prescriptions are issued in this form.
What Does it All Mean
?????????????
A Prescription is NOT a
duck !
Dr. Doyou Wanna FeelGood, M.D., F.A.C.S.
American Board of Surgical Diplomats
Discount C.S. Pain Clinic
1234 Cass Ave., Detroit, Mich.. 48201
Patient's Name:
George Fuller
Address:
1234 Rivard, Detroit, Mich..
Demerol 100mg
#100
SIG:
2-4 tablets every 4-6
hours as needed for
pain.
No refills
Dr. Doyou FeelGood
DEA No. 1234563
What is a Duck?
The “see, hear and feel” approach to
defining a thing:
If it looks like a duck...
If it waddles like a duck...
If it quacks like a duck...
..Its A Duck!
What is a CS “Prescription?”
A “Process” Definition
an order for a CS drug
issued by an individual state
licensed prescriber
who is registered with the DEA
for a “patient”
for a legitimate medical purpose
in the usual course of professional
treatment
in the right “form”
What is NOT A CS Prescription?
an order for a CS drug...
that “purports” to BE a
prescription...
looks like a prescription
has all the right information
correct form
not a “forgery”
from a licensed prescriber
for a “patient
not issued in the usual
course of professional
treatment.
Dr. Doyou American
Wanna
FeelGood, M.D., F.A.C.S.
Board of Surgical Diplomats
Discount
C.S. Pain Clinic
1234 Cass Ave., Detroit, Mich. 48201
Patient's Name:
Address:
SIG:
George Fuller
1234 Rivard, Detroit, Mich.
Demerol 100mg
#100
2-4 tablets every 4-6
hours as needed for
pain.
No refills
Dr. Doyou FeelGood
DEA No. 1234563
The Policy Question:
Drawing The Line
Between Patients With
Legitimate Pain and
Drug Seekers
If Life is not Perfect, On
Which Side Do We Err?
DEA Orientation:
Drug Cops
Health Care Providers are “gatekeepers”
who should keep bad people from getting
addictive drugs.
All CS prescriptions are “suspect” and
should be scrutinized carefully.
Providers should “Just Say No” to drugs.
Turn away CS prescriptions.
Healthcare is a secondary concern to
keeping bad drugs off the street
DEA/St. Bd. Actions Against
Health Care Providers
The “Too Much” Prosecution
Prescription/Prescribing Volume
The “Corresponding Responsibility”
Quagmire
Pit Dr. against R.Ph.
The “Never-ending” Prosecution
Criminal, DEA, State Adman. (License)
Malpractice (Orzel v. Scott Drugs),
Mi. S. Ct, 8/15/95
Health and Human Services
Perspective:
U.S. is NOT aggressive in
pain control management.
Fear of patient addiction
and legal entanglement
prevents practitioners from
good pain control
HHS Policy Manual
February, 1992
Health Care Providers’
Orientation:
Health Care:
taking care of patient needs to maximize
“outcomes”
recognizing CS Drugs have therapeutic
value, pain is a legitimate disease and its
treatment is necessary and appropriate
“Gatekeeper” Function:
keep “bad” people from getting
“bad” drugs
The Dilemma of Decision
Analysis: Consequences
Dispense Script
Refuse Script
Good
Script
Right Decision-Everybody’s
Happy!
Wrong Decision-Patient Harm
Bad
Script
DEA Says, “Very
Bad Decision-Bad
Pharmacist”
“Good Job, R.Ph.-Keep Bad Drugs
Off Street
The Policy Dilemma:
Government Agencies in Conflict
What are Health
Care Providers
supposed to
do?
“ Is it Legitimate?
Strategies for Assessing
Questionable Prescriptions and
DEA Considerations”
Most Commonly Forged
Prescriptions
Hydrocodone Products
Vicodin, Lortab, Lorcet, Anexsia
Oxycodone
Percodan, Percocet, OxyContin
Methylphenidate
Ritalin
Benzodiazepines
alprazolam, diazepam, lorazepam
Characteristics of Forged
Prescriptions
 Prescription looks “too good”
 Quantities, directions or dosages differ from usual
medical usage
 Prescription does not comply with acceptable
standard abbreviations
 Prescription appears to be photocopied
 Directions for use written in full with no abbreviations
 Prescription written in different-color inks or written in
different handwriting
Pharmacist’s 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.
21 CFR Sec. 1306.04(a)
Prevention Techniques
Know the prescriber and his signature
Know the prescriber’s DEA registration
number
Know the patient
Check the date on the prescription order.
When there is a question about any aspect of the prescription
order, call the prescriber for verification or clarification.
Proper Controls
Common Sense
Sound Professional Practice
Using Proper Dispensing Procedures and
Controls
Electronic Prescriptions
Advantages
reduce forgeries
reduce mistakes
improve healthcare efficiency
Digital Signature
authenticity
non-repudiation
message integrity
Allowance, not a mandate
Supporting documents are published on DEA’s Internet Web Site
o Application Forms
new and renewal
o Laws and Regulations
o List of Controlled Substances
o Frequently Asked Questions
o Federal Register Notices
o List of Local DEA offices
The Pharmacists Manual
Your Responsibilities
 The abuse of prescription drugs—especially controlled
substances—is a serious social and health problem in the
United States today. As a healthcare professional, you share
responsibility for solving the prescription drug abuse and
diversion problem.
 You have a legal responsibility to acquaint yourself with the
state and Federal requirements for dispensing controlled
substances. You also have a legal and ethical responsibility
to uphold these laws and to help protect society from drug
abuse.
 You have a personal responsibility to protect your practice
from becoming an easy target for drug diversion. You must
become aware of the potential situations where drug
diversion can occur and safeguards that can be enacted to
prevent this diversion.
The Pharmacists Manual
The dispensing pharmacist must maintain a
constant vigilance against forged or altered
prescriptions. The law holds the pharmacist
responsible for knowingly dispensing a
prescription that was not issued in the usual
course of professional treatment.
The Pharmacists Manual
Types of Fraudulent Prescriptions
• The practiced forger of prescriptions is usually very adept at the
job. The forger knows what information is needed on the
prescription to make it appear authentic. Pharmacists should be
aware of the various kinds of forged prescriptions that may be
presented for dispensing.
• Some patients, in an effort to obtain additional amounts of
legitimately prescribed drugs, alter the physician’s prescription.
They will also have prescription pads printed using a legitimate
doctor’s name, but with a different call back number that is
answered by an accomplice to verify the prescription. Also, drug
seeking individuals will call in their own prescriptions and give
their own telephone number as a call back confirmation.
• Legitimate prescription pads are stolen from physicians’ offices
and hospitals and prescriptions are written using fictitious
patients names and addresses. In addition, individuals will go to
emergency rooms complaining of pain in the hopes of receiving
a controlled substance prescription. The prescription can then be
altered or copied to be used again. Computers are often used to
create prescriptions for nonexistent doctors or to copy
legitimate doctors’ prescriptions.
The Pharmacists Manual
Note: The quantity of drugs prescribed and
frequency of prescriptions filled are not alone
indications of fraud or improper prescribing
especially if the patient is being treated with
opioids for pain management. Pharmacists
should also recognize that drug tolerance and
physical dependence may develop as a
consequence of the patient’s sustained use of
opioid analgesics for the legitimate treatment
of chronic pain.
The Pharmacists Manual
 The following criteria may indicate that a prescription
was not issued for a legitimate medical purpose.
The prescriber writes significantly more prescriptions (or in larger
quantities) compared to other practitioners in your area.
The patient appears to be returning too frequently. Prescription
which should last for a month in legitimate use, is being refilled on
a biweekly, weekly or even a daily basis.
The prescriber writes prescriptions for antagonistic drugs, such as
depressants and stimulants, at the same time. Drug abusers often
request prescriptions for "uppers and downers" at the same time.
Patient appears presenting prescriptions written in the names of
other people.
A number of people appear simultaneously, or within a short time,
all bearing similar prescriptions from the same physician.
Numerous "strangers," people who are not regular patrons or residents of
your community, suddenly show up with prescriptions from the same
physician.
The Pharmacists Manual
Characteristics of Forged Prescriptions
1. Prescription looks "too good"; the prescriber’s
handwriting is too legible;
2. Quantities, directions or dosages differ from usual
medical usage;
3. Prescription does not comply with the acceptable
standard abbreviations or appear to be textbook
presentations;
4. Prescription appears to be photocopied;
5. Directions written in full with no abbreviations;
6. Prescription written in different-color inks or written
in different handwriting.
7. Apparent erasure marks
The Pharmacists Manual
Prevention Techniques








Know the prescriber and his/her signature;
Know the prescriber’s DEA registration number;
Know the patient;
Check the date on the prescription order. Has it been presented to
you in a reasonable length of time since the prescriber wrote it?
When there is a question about any aspect of the prescription order,
call the prescriber for verification or clarification. Should there be a
discrepancy, the patient must have a plausible reason before the
prescription medication is dispensed.
Any time you are in doubt, require proper identification. Although this
procedure isn’t foolproof (identification papers can also be
stolen/forged), it does increase the drug abuser’s risk.
If you believe that you have a forged, altered, or bogus prescription-don’t dispense it--call your local police.
If you believe that you have discovered a pattern of prescription
abuses, contact your State Board of Pharmacy or your local DEA
office. Both DEA and state authorities consider retail-level diversion a
priority issue.
The Pharmacists Manual
Proper Controls
Dispensing procedures, without control and professional
caution, are an invitation to the drug abuser. Proper controls
against bogus prescriptions can best be accomplished by
following common sense, sound professional practice, and
proper dispensing procedures and controls.
Have your pharmacy staff help protect your practice from
becoming a source of prescription drug diversion. Become
familiar with which drugs are popular for abuse and resale on
the streets in your area. Drug abuse prevention must be an
ongoing staff activity.
Encourage local pharmacists and physicians to develop a
network, or at least a working relationship, which promotes
teamwork and camaraderie. Discuss abuse problems with other
pharmacists and physicians in the community. Most drug
abusers seek out areas where communication and cooperation
between health professionals are minimal because it makes
their work so much easier.
Message from the Administrator
Dear Pharmacist:
Your role in the proper dispensing of controlled
substances is critical to the health of the patient
and to safeguard society against drug abuse and
diversion. Your adherence to the Controlled
Substances Act, together with your voluntary
compliance with its objectives, are a powerful
resource for protecting the public health, assuring
patient safety, and preventing the diversion of
controlled substances and drug products
containing listed chemicals.
Sincerely,
Donnie R. Marshall
Administrator
Drug Enforcement Administration
DEA Check Digit Algorithm
AB1234563
Digits 1, 3, and 5 are added together
1+3+5=9
Digits 2, 4, and 6 are added together and multiplied by two
2 + 4 + 6 = 12 x 2 = 24
The sums of the two calculations are added together
9 + 24 = 33
The last digit of the DEA registration number should be
the same as the last digit of the sum
3
If you believe that you have a
forged, altered, or counterfeited
prescription
Do not dispense it
Call your local police
“Out of Stock”
Oh Sure!
Problem?
• If you believe that you have
discovered a pattern of prescription
abuses
• Contact
• State Board of Pharmacy or
• Local DEA office.
MAPS
Michigan Automated Prescription System
Replaces the OPP (Official Prescription
Program)
January 1, 2003
 Dx: “form” and “format”
No Form
Just formal
MAPS applies to all CS dispensed drugs
Patient Identifiers
Required by Statute
Sec. 7333a
Defined in Regulation
BP CS Rule 2(1)(f)
Required with other information set forth in BP
CS Rule 62b.
"Patient identifier" includes the
following information about a patient:
(i) Full name.
(ii) Address, including zip code.
(iii) Date of birth.
(iv) Any of the following:
(A) Social security number.
(B) Driver's license number.
(C) State-issued identification number.
(v) If a patient is an animal, any of the
following:
(A) The owner's social security number.
(B) The owner's driver's license number.
(C) The owner's state-issued identification
number.
What if the Patient or the Animal
Does not have a ‘patient identifier?’
Newborns, pediatric patients
Seniors without driver’s licenses or state
identification number
Immigrants or aliens
Adopted animals
Adopted children
Alternatives?
Reporting Alternatives
BP CS Rule 62c
Data required in BP CS Rule 62b
Electronic format, state approved
• Computer disk, tape or cartridge
Waiver if no electronic communication is
available
Requires waiver in writing.
When to report
Minimum of ever 30 days
No later than the 15th of the month following
the month in which the prescription was
dispensed.
Subject to discipline if fail to report timely
Reporting Exceptions
A pharmacist, a dispensing prescriber (i.e.,
one who had a BP Drug Control License and a
veterinarian
Who administers a C-2 to C-5 drug directly to a
patient.
When the C-2 to C-5 drug is dispensed in a
health facility or agency by a dispensing
prescriber in an amount needed to treat a
patient for 48 hours or less.
Reporting Alternatives
BP CS Rule 62c
Data required in BP CS Rule 62b
Electronic format, state approved
• Computer disk, tape or cartridge
Waiver if no electronic communication is
available
Requires waiver in writing.
Reporting Alternatives
BP CS Rule 62c
Data required in BP CS Rule 62b
Electronic format, state approved
• Computer disk, tape or cartridge
Waiver if no electronic communication is
available
Requires waiver in writing.
When to report
Minimum of ever 30 days
No later than the 15th of the month following
the month in which the prescription was
dispensed.
Subject to discipline if fail to report timely
How to Determine
if an Rx is valid?
The
Good Faith
Standard
Good Faith
Sec. 7333.
(1) As used in this section, “good faith” means the
prescribing or dispensing of a controlled
substance by a practitioner licensed under
section 7303 in the regular course of
professional treatment to or for an individual
who is under treatment by the practitioner for a
pathology or condition other than that
individual's physical or psychological
dependence upon or addiction to a controlled
substance, except as provided in this article.
Good Faith
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.
Good Faith
The pharmacist shall be guided by nationally
accepted professional standards including, but not
limited to, all of the following, in making the
judgment:
 (a) Lack of consistency in the doctor-patient
relationship.
 (b) Frequency of prescriptions for the same drug
by 1 prescriber for larger numbers of patients.
 (c) Quantities beyond those normally prescribed
for the same drug.
 (d) Unusual dosages.
 (e) Unusual geographic distances between
patient, pharmacist, and prescriber
§ 7333(2)
Except as otherwise provided in this section, a
practitioner, in good faith, may dispense a controlled
substance included in schedule 2 upon receipt of a
prescription of a practitioner licensed under section
7303 on a prescription form. A practitioner shall not
issue more than 1 prescription for a controlled
substance included in schedule 2 on a single
prescription form.
§ 7333 (4)
A practitioner, in good faith, may dispense a controlled
substance included in schedule 3, 4, or 5 that is a
prescription drug as determined under section 503(b)
of the FD&CA upon receipt of a prescription on a
prescription form or an oral prescription of a
practitioner. A prescription for a controlled substance
included in schedule 3 or 4 shall not be filled or refilled
without specific refill instructions noted by the
prescriber. A prescription for a controlled substance
included in schedule 3 or 4 shall not be filled or refilled
later than 6 months after the date of the prescription or
be refilled more than 5 times, unless renewed by the
prescriber in accordance with rules promulgated by
the administrator.
Emergency C-II Drugs
Except for a terminally ill patient whose terminal illness the
pharmacist documents pursuant to rules promulgated by the
administrator, a prescription for a controlled substance
included in schedule 2 shall not be filled more than 60 days
after the date on which the prescription was issued. A
prescription for a controlled substance included in schedule 2
for a terminally ill patient whose terminal illness the
pharmacist documents pursuant to rules promulgated by the
administrator may be partially filled in increments for not more
than 60 days after the date on which the prescription was
issued.
Emergency Conditions
(c) If the prescriber is not known to the
pharmacist, then the pharmacist shall make a
reasonable effort to determine that the oral or
electronically transmitted authorization came
from a prescriber by returning the prescriber's
call, using the telephone number listed in the
telephone directory and other good faith
efforts to assure the prescriber's identity.
More Conditions:
BP CS Rule 65
Within 7 days after authorizing an emergency
oral prescription of a controlled substance listed
in schedule 2, the prescriber shall reduce the
prescription to writing and have recorded on the
prescription's face "Authorization for Emergency
Dispensing" and the date of the oral order.
Could avoid this rule if prescription is
electronically prescribed
More Conditions:
BP CS Rule 65
The written prescription shall be delivered to the
pharmacist in person or by mail within 7 days after
the oral prescription is issued. Upon receipt, the
dispensing pharmacist shall attach this prescription
to the oral order which earlier had been reduced to
writing. The pharmacist shall notify the department of
consumer and industry services if the prescriber fails
to deliver a written prescription to him or her.
BP CS Rule 65
The failure of a pharmacist to notify
the department if the prescriber
fails to deliver a written
prescription voids the authority
conferred by this rule to dispense
without a written prescription of a
prescriber.
If no Prescriptive authority:
Dispensing to Addicts
BP CS Rule 63
No dispensing to continue addiction except:
• If prescriber is licensed to run a drug dependency
program
• The individual is enrolled in a treatment facility
• The individual who is hospitalized
Cf: Federal Law: 3 days grace
CS Drug Inventories
• Federal Law: Every 2 years
• Keep copy in pharmacy
• Michigan Law:
• every year
• Copy kept in pharmacy and copy
sent to Board of Pharmacy
• Federal Law
--inventory
on same date each year
Michigan Law
--inventory
May 1
30 days before or 60 days after
TIMING
90 days
6 months
1 year
2 years
5 years
TIMING
a. 30 days
b. 7 days
c. 72 hours
d. 60 days
e. 48 hours
What Factors are important?
 Valium 5mg tablets (a non-narcotic Schedule
IV 503(b) drug)
 Demerol 50mg tablets (a narcotic Schedule II
503(b) drug)
 Dyazide capsules (a non-narcotic, noncontrolled substance 503(b) drug)
 All of the above
 None of the above
Discussion
Questions
THE END
• Best wishes for a successful result
on first test!
• Remember: Not everything was
covered on this Review Session
• Read the books and NABP MPJE
documents.