Pharmacy Law and Ethics

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Pharmacy Law and Ethics

• Meet the Instructors
• Overview of schedule
• Blackboard please use it!
• Exams and Grading
• Attendance
• Respect for everybodys opinions

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Instructors

• Me (Joe Schnabel)
• Dell Alexander R.Ph., J.D.
• Board of Pharmacy members and staff
• Karen Peterson R.Ph., J.D.
• DEA Agents(?)

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Course Overview

• Federal Laws (Joe Schnabel)
• FDA and DEA
• Civil/Criminal Law (Dell Alexander)
• State Law (Joe Schnabel)
• Ethics (Joe Schnabel)

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Major Federal Drug Laws

• Food Drug and Cosmetic Act
• Federal Alcohol Tax
• Poison Prevention Packaging Act
• OBRA 90
• Controlled Substances Act

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Sources of Federal Law

• Constitution
• U.S. Congress (House of Representatives and
  Senate)
• Federal Agencies (FDA, DEA, CMS, FTC)
• Courts (Common Law)

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Where to Find Federal Laws

• Federal Register
• Published daily
• On the internet
• Code of Federal Regulations (CFR)
• A compilation of Federal Law
• Updated more slowly than Federal Register

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Federal vs. State Law

• State can regulate where Federal doesnt
• If there is a Federal regulation, State can only
  make more restrictive
• State can not permit activities that are illegal
  under Federal Law
• Conflicts? Feds win! Usually
• See Oregon Medical Marijuana, Death With Dignity
  Acts
• States rights issues (See Civil War)

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Regulatory Agencies

• Oregon Board of Pharmacy
• Drug Enforcement Administration (DEA)
• Food and Drug Administration (FDA)
• Oregon Public Health Services
• Centers for Medicare and Medicaid Services (CMS)
• Federal Trade Commission (FTC)
• Joint Commission on Accreditation of Healthcare
  Organizations (JCAHO)

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Pharmacy Laws

• Statutes (ORS) - from the Oregon Leglslature
• Administrative Rules (OAR) - from the Board of
  Pharmacy
• Federal Laws (CFR)
• From US Congress
• From FDA and DEA

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Four Categories of Professional Activity
Legal
Illegal
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2
You will have to make difficult decisions
that are in this box. Do what is best for the
patient!
You will want to spend most of your time in
this box.
Ethical
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4
Stay away! People in this box can and do lose
their licenses.
You might get away with things in this box,
but you should avoid them!
Unethical
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11 years old
14 years old
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History of Food and Drug Law

• 1906 Pure Food and Drug Act
• 1938 Food, Drug, and Cosmetic Act
• 1951 Durham-Humphrey Amendment
• 1958 Food Additives Amendment
• 1960 Color Additives Amendment
• 1962 Kefauver-Harris Amendment
• 1976 Medical Device Amendments

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History of Food and Drug Law

• 1983 Orphan Drug Act
• 1984 Drug Price Competition/Patent Term
  Restoration Act
• 1987 Prescription Drug Marketing Act
• 1990 Nutrition Labeling and Education Act
• 1992 Prescription Drug User Fee Act
• 1994 Dietary Supplement Health and Education Act
• 1997 Food and Drug Modernization Act

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1906 Pure Food and Drug Act

• Inspired by widespread sales of ineffective
  and/or unsafe remedies
• No provision to test drugs prior to sale
• Action taken only after harmful effects occurred
• 1906 law was preceded by 103 bills dating to 1848
• Opposition to 1906 law was overcome by Upton
  Sinclairs Novel The Jungle, which exposed
  substandard (and disgusting!) meat packing
  conditions (see Blackboard for excerpt)

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1906 Pure Food and Drug Act

• 1. Protect public from adulterated and misbranded
  food and drugs
• 2. States took limited action to solve problem of
  interstate commerce
• 3. Secure a uniform law throughout the U.S.

?The Food and Drug Administration, 1862
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1906 Pure Food and Drug Act

• Needed Strengthening and six amendments were
  added over the years
• Amendments were inadequate to monitor growing
  technology
• Did not require premarket testing for safety
• 1938 Elixir of Sulfanilamide Case
• prepared with diethylene glycol, a poison

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1938 Food Drug and Cosmetic Act

• Is current law of the land, as amended.
• Gave the Federal Gvt power to establish product
  safety, but did not mention efficacy
• Regulates Drug quality
• No new drug can be marketed until proven safe
  under conditions described on the label
• required all drugs to be labeled with adequate
  directions for use

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1951 Durham-Humphrey Amendment

• Many drugs on market were not safe for use,
  except under medical supervision
• These drugs could not meet adequate directions
  for use requirement
• Drugs labeled by manuf. with Caution Federal
  law prohibits dispensing without a prescription
  are exempt from labeling requirement directing
  adequate directions for use
• Labels on Rx drugs do not contain directions on
  how to use the product

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1951 Durham-Humphrey Amendment

• Established the category of prescription or
  legend drugs
• Established the OTC (non-prescription) category
  of drugs

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Kefauver-Harris Amendment 1962

• Required proof of efficacy and strengthened
  safety requirements
• Thalidomide tragedy occurred at this time
• Manufacturers had to evaluate pre-1962 drugs for
  efficacy
• Led to DESI - Drug Efficacy Study implementation
• National Academy of Sciences reviewed 50,000
  Rx/OTC Products
• Established Good Manufacturing Practices (GMP)
• Strengthened clinical trial safeguards/adverse
  reaction reporting

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Thalidomide
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Medical Device Amendment 1976

• Gave FDA much more oversight of medical devices
• Similar safety and efficacy issues
• Classification of devices according to function
• premarket approval required
• establishment of performance standards
• Good Manufacturing Practices (GMP) required
• record keeping and reporting of problems

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Orphan Drug Act 1983

• Orphan drug - drugs that have little or no
  commercial value (rare diseases)
• Drug development costs exceed any possible return
  on investment
• Provides pharmaceutical manufacturers tax and
  licensing incentives to develop them

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Drug Price Competition and Patent-Term
Restoration Act 1984

• Also called Waxman-Hatch Amendment
• Streamlined generic drug approval process to make
  them more readily available
• Brand-name manufacturers have become increasingly
  creative at delaying generics
• Bush limits automatic 30-month patent extensions
  to one in 2002

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Prescription Drug Marketing Act of 1987

• Established sales restrictions and recordkeeping
  requirements for prescription drug samples
• Prohibits hospitals and other non-profit
  organizations from reselling Rx items to other
  businesses
• Requires state licensing of drug wholesalers

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Drug means

• 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).
  A food or dietary supplement for which a claim,
  subject to sections 403(r)(1)(B) and 403(r)(3) of
  this title or sections 403(r)(1)(B) and
  403(r)(5)(D) of this title, is made in accordance
  with the requirements of section 403(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 403(r)(6) of this
  title is not a drug under clause (C) solely
  because the label or the labeling contains such a
  statement.

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Definition of Drug in English

• It is listed in the United States Pharmacopoeia/
  National Formulary (USP/NF), or the official
  Homoeopathic Pharmacopoeia of the United States,
  or any supplement to them.
• It is intended for use in the diagnosis, cure,
  mitigation, treatment, or prevention of disease.
• It is intended to affect the structure or any
  function of the body.
• It is a component of any article specified above.

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Drug Definition

• Established by FDCA
• Articles recognized as official by USP,
  Homeopathic Pharmacopoeia, NF
• To treat disease

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Counterfeit Drug

• A drug whose container or label bears trademark,
  trade name or other identifying mark, imprint or
  device, likeness
• Without legal authorization
• Recent increase in counterfeiting of high cost
  drugs

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Device

• instrument, apparatus, implement, machine,
  contrivance, implant, in vitro reagent, or other
  similar or related article, including any
  component, part, or accessory
• Intended to diagnose or treat diseases
• Similar wording to drug definition

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Foods vs. Drugs

• Natural products--Health Foods
• i.e.., St. Johns Wort to treat depression
• Sometimes called Nutraceuticals if neither food
  or drug
• Often lacking evidence of efficacy

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Nutritional Supplement Regulation

• Nutrition Labeling and Education Act of 1990
• Dietary Supplement Health Education Act of 1994
• both prohibit disease prevention claims of
  dietary supplements
• regulates allowable claims
• nutrient deficiency, how it affects the body,
  mech of action etc.

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Labels and Labeling

• Label Display of written material on the
  products container and on the outside container
  or wrapper, if any.
• Labeling All labels and other written, printed,
  or graphic matter on any container or wrapper or
  material accompanying the product (package
  insert, advertising)

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Official Compendia

• United States Pharmacopoeia/ National Formulary
  (USP/NF)
• Homeopathic Pharmacopoeia of the United States

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Enforcement

• FDA can enforce FDCA via civil or criminal
  charges
• FDA works with other agencies i.e...., State
  Boards of Pharmacy, DEA, Customs Service

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Product Recalls

• FDA can remove adulterated or misbranded products
  from the market via a recall
• Usually a manufacturer informs the FDA of a
  problem and initiates a voluntary recall

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Product Recalls

• Recalls are divided into three classes I, II, III
• Class I
• reasonable probability that the use of or
  exposure to the product will cause serious
  adverse consequences or death.
• Class II
• may cause temporary or medically reversible
  adverse consequences or the probability of
  serious adverse health consequences is remote.
• Class III
• not likely to cause adverse health consequences

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Product Recalls

• 1994
• Two Class I Recalls
• 120 Class II Recalls
• 145 Class III Recalls

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Source FDA
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Adulterated Drugs

• If it consists in whole or in part of any filthy,
  putrid or decomposed substance
• If it has been prepared, packed or held under
  unsanitary conditions whereby it may have been
  contaminated with filth, or whereby it may have
  been rendered injurious to health
• If the strength differs, or quality or purity
  fall below label standards

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Adulterated Drugs

• Most provisions apply to manufacturers
• A pharmacy is considered a manufacturer if it
  repackages or compounds for resale

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Current Good Manufacturing Practice (GMP)

• A drug is adulterated unless it is manufactured
  in accordance with GMP
• GMP establishes minimum requirements for
  facilities, manufacturing controls, processing ,
  packaging.
• Pharmacies are not subject to GMP unless they are
  manufacturing Rx products for resale to other
  pharmacies, physicians or retail outlets

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Product Tampering

• Congress passed the Federal Anti-Tampering Act
  1982
• Gave authority to FBI, USDA and FDA to
  investigate tampering
• Due to Tylenol capsule tampering

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Misbranded Drugs (Definition)

• If the label is false or misleading
• Label must contain name/place of business
• Accurate statement of contents
• If required information is not displayed as
  required
• Label must warn of habit forming drugs

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Counterfeit Drugs

• Misbranding occurs if one drug is an imitation of
  another drug
• Neupogen, Epogen in 2002
• Viagra
• More likely with high cost drugs
• See Dangerous Doses, by Katherine Eban

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Batch Certification

• 1941 Amendment to FDCA mandated insulin batch
  certification for efficacy and safety
• 1945 Amendment to FDCA mandated antibiotic batch
  certification for efficacy and safety
• D/Cd in 1982