Pharmacy Law Review 2010

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Pharmacy Law Review 2010 Powered By Docstoc
					Michigan Pharmacy Law Review
       for 2011 MPJE
              Jesse C. Vivian , RPh, JD
           Professor of Pharmacy Practice



                  (313) 577-5389
     jessevivian@wayne.edu: 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.      Misbranded
    II.     Adulterated
    III.    Made with contaminated materials
    IV.     Not effective for intended purpose
           a.   I only
           b.   II only
           c.   All of the above
           d.   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”                             and
   Grandpa
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 child-
 resistant 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.   R.Ph. (Registered Pharmacist
2.   Chemist
3.   Apothecary
4.   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-the-
    art 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                       Wanna FeelGood, M.D.,
                                     Dr. Doyou American Board of Surgical Diplomats F.A.C.S.

 prescription...                                          C.S. Pain Clinic
                                             DiscountAve., Detroit, Mich. 48201
                                                1234 Cass

                                     Patient's Name:      George Fuller
    looks like a prescription       Address:             1234 Rivard, Detroit, Mich.
                                                          Demerol 100mg
    has all the right information                        #100
                                                          2-4 tablets every 4-6
    correct form                            SIG:
                                                          hours as needed for
    not a “forgery”                                      pain.
                                     No refills
    from a licensed prescriber                          Dr. Doyou FeelGood
    for a “patient                                      DEA No. 1234563



not issued in the usual
 course of professional
 treatment.
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

          Right Decision--   Wrong Decision--
Good
          Everybody’s        Patient Harm
Script
          Happy!


          DEA Says, “Very    “Good Job, R.Ph.-
 Bad
          Bad Decision-Bad   -Keep Bad Drugs
 Script
          Pharmacist”        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   Oh Sure!

“Out of Stock”
               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   30 days before or 60 days after
May 1
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, non-
  controlled 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.

				
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