Pharmacy Law and Ethics

• Meet the Instructors• Overview of schedule• Blackboard – please use it!• Exams and Grading• Attendance• Respect for everybody’s opinions

Instructors

• Me (Joe Schnabel)• Dell Alexander – R.Ph., J.D.• Board of Pharmacy – members and

staff• Karen Peterson – R.Ph., J.D.• DEA Agents(?)

Course Overview

• Federal Laws (Joe Schnabel)– FDA and DEA

• Civil/Criminal Law (Dell Alexander)• State Law (Joe Schnabel)• Ethics (Joe Schnabel)

Major Federal Drug Laws

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

Sources of Federal Law

• Constitution• U.S. Congress (House of

Representatives and Senate)• Federal Agencies (FDA, DEA, CMS,

FTC…)• Courts (Common Law)

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

Federal vs. State Law

• State can regulate where Federal doesn’t

• 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– “State’s rights” issues (See: Civil War)

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)

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

Legal Illegal

Ethical

Unethical

1 2

3 4

Four Categories of Professional Activity

You will want to spendmost of your time in thisbox.

You will have to makedifficult decisions thatare in this box. Do whatis best for the patient!

You might get away withthings in this box, butyou should avoid them!

Stay away! People in this box can and do lose their licenses.

11 years old

14 years old

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

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

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

Sinclair’s Novel “The Jungle”, which exposed substandard (and disgusting!) meat packing conditions (see Blackboard for excerpt)

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

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

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”

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

1951 Durham-Humphrey Amendment

• Established the category of “prescription” or “legend” drugs

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

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

Thalidomide

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

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

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

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

“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). 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.

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.

Drug Definition

• Established by FDCA• Articles recognized as official by

USP, Homeopathic Pharmacopoeia, NF

• To treat disease

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

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

Foods vs. Drugs

• Natural products--Health Foods• i.e.., St. John’s Wort to treat

depression• Sometimes called “Nutraceuticals”

if neither food or drug• Often lacking evidence of efficacy

“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.

Labels and Labeling

• Label: Display of written material on the product’s 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)

Official Compendia

• United States Pharmacopoeia/ National Formulary (USP/NF)

• Homeopathic Pharmacopoeia of the United States

Enforcement

• FDA can enforce FDCA via civil or criminal charges

• FDA works with other agencies i.e...., State Boards of Pharmacy, DEA, Customs Service…

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

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

Product Recalls

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

Source: FDA

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

Adulterated Drugs

• Most provisions apply to manufacturers• A pharmacy is considered a

manufacturer if it repackages or compounds for resale

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

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

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

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

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