PHA 338 - Federal Acts and Amendments L1

Law

A rule established by government that must be followed and is enforceable by penalties

Rule or Regulation

Detailed requirement created by administrative agencies to explain how laws should be followed

Policy

A workplace or organizational guideline that directs procedures or behavior

Which law should pharmacists follow if state and federal laws conflict?

Follow whichever law is stricter

Why is pharmacy law important?

Guides daily practice, protects patients, keeps pharmacists out of jail, protects pharmacist licenses, and allows pharmacists to practice

Negligence

An unintentional civil wrong that deviates from the standard of care and harms a patient

Criminal law

Law involving crimes or violations against society

Civil law

Law involving personal harm or injury to another person

Administrative law

Rules and regulations created by administrative agencies that guide pharmacy practice

Examples of administrative agencies

State Board of Pharmacy, FDA, DEA, FTC, CMS

Duty to care

Pharmacist’s responsibility to care for the patient’s health

Breach of duty

Failure to perform the accepted standard of care

Injury/actual damages

Harm suffered by the patient due to pharmacist actions

Causation/Proximate cause

The pharmacist’s action directly caused the patient’s injury

Can a pharmacist face multiple types of legal action for one incident?

Yes, pharmacists may face criminal, civil, and administrative actions simultaneously

What are the sources of law?

U.S. Constitution and statutory law

Statutory law

Laws passed by legislatures such as Congress or state legislatures

What do administrative agencies do?

Create and enforce rules and regulations

What is an example of pharmacist liability?

Loaning medication without a prescription that later causes patient harm

Pure Food and Drug Act (Wiley Act)

Main purpose was to prevent adulterated and misbranded drugs

What did the Wiley Act require?

Labeling and ingredients meeting USP/NF standards for strength, quality, and purity

What dangerous ingredients had to be listed under the Wiley Act?

Alcohol, heroin, cocaine, and other dangerous ingredients

Adulterated drug

Something is wrong with the drug itself such as contamination or improper storage

Misbranded drug

Something is wrong with the label such as wrong expiration date or incorrect dose

Food, Drug, and Cosmetic Act of 1938

Required proof that drugs are safe before marketing

Did the 1938 FDCA require proof of efficacy?

No, only proof of safety

What labeling requirements were added by the 1938 FDCA?

Adequate directions and habit-forming warnings on manufacturer labels

What products did the 1938 FDCA apply to?

Drugs, cosmetics, and medical devices

Durham-Humphrey Amendment of 1951

Established OTC and prescription drug classes

What did the Durham-Humphrey Amendment authorize?

Oral prescriptions and prescription refills

Federal legend

Statement identifying a prescription-only medication

Kefauver-Harris Amendment of 1962

Required proof of both drug safety and efficacy

What are Good Manufacturing Practices (GMP)?

Standardized manufacturing processes to ensure drug quality and safety

Who regulates prescription drug advertising?

FDA

Who regulates OTC advertising?

FTC

What research protections were required by Kefauver-Harris?

Informed consent and adverse event reporting

Controlled Substance Act of 1970

Created schedules for controlled substances and established DEA authority

Schedule I controlled substances

Drugs with no accepted medical use and high abuse potential

Examples of Schedule I drugs

LSD, heroin, MDMA

Schedule II controlled substances

Drugs with accepted medical use but high abuse potential

Example of a Schedule II drug

Cocaine

What did the Controlled Substance Act require?

Recordkeeping, inventory, and penalties for violations

What agency was formed under the Controlled Substance Act?

DEA

Poison Prevention Packaging Act of 1970

Required child-resistant packaging

Failure to comply with Poison Prevention Packaging Act results in what?

Misbranding

Examples of drugs exempt from child-resistant packaging

Nitroglycerin sublingual tablets and oral contraceptives

If a physician requests an easy-open cap, how long does it apply?

One prescription only

If a patient requests an easy-open cap, how long does it apply?

All future prescriptions until changed

Drug Listing Act of 1972

Required manufacturers and processors to register with FDA and use NDC numbers

NDC number

Unique National Drug Code assigned to medications

Medical Device Amendment of 1976

Regulated medical devices and required pre-market approval

Examples of medical devices

Pacemakers, hearing aids, artificial hips

Federal Anti-Tampering Act of 1983

Required tamper-resistant packaging for OTC products

Why was the Anti-Tampering Act passed?

Because of the 1982 Tylenol poisoning deaths

Tamper-resistant

Means packaging shows evidence of tampering but is not tamper-proof

Examples exempt from tamper-resistant packaging

Toothpaste, lozenges, OTC insulin, skin products

Orphan Drug Act of 1983

Encouraged development of drugs for rare diseases

Rare disease definition under Orphan Drug Act

A disease affecting fewer than 200,000 Americans

What incentives did the Orphan Drug Act provide?

Tax incentives and exclusive licensing

Waxman-Hatch Amendment

Streamlined approval of generic drugs

Requirements for generic drug approval

Bioequivalent and same dosage form as brand product

What can the Waxman-Hatch Act extend?

Patent terms

Prescription Drug Marketing Act of 1987

Controlled drug samples and prescription drug distribution

Who may distribute prescription drug samples?

Prescribing physicians only

What did the Prescription Drug Marketing Act ban?

Reimportation and resale of certain prescription drugs

Omnibus Reconciliation Act of 1990 (OBRA-90)

Established pharmacist counseling and DUR requirements

Who did OBRA-90 originally apply to?

Medicaid patients

Primary goal of OBRA-90

Improve therapeutic outcomes and reduce healthcare costs

Prospective Drug Utilization Review (Pro-DUR)

Reviewing a patient’s medication profile before dispensing

Dietary Supplement Health and Education Act of 1994

Allowed supplements to promote health but not claim to cure disease

Can dietary supplements claim to treat diseases?

No

HIPAA

Protects patient health information and privacy

Protected Health Information (PHI)

Patient information that must remain confidential

Food and Drug Modernization Act of 1997

Created fast-track approval process for certain drugs

What information system was created by the FDAMA?

Clinical trial databank

Medicare Modernization Act of 2003

Established Medicare Part D and MTM services

Medicare Part A

Hospital insurance

Medicare Part B

Supplemental medical insurance

Medicare Part C

Medicare Advantage plans

Medicare Part D

Prescription drug coverage

Medication Therapy Management (MTM)

Pharmacist services focused on improving medication outcomes

Combat Methamphetamine Epidemic Act of 2005

Regulated sales of pseudoephedrine and related products

Daily pseudoephedrine sales limit under CMEA

3.6 grams per 24 hours

30-day pseudoephedrine sales limit under CMEA

9 grams per 30 days

What products are regulated under the CMEA?

Ephedrine, pseudoephedrine, and phenylpropanolamine

FDA Amendments Act of 2007

Created REMS programs

REMS

Risk Evaluation and Mitigation Strategy used to ensure drug benefits outweigh risks

Example of a REMS program

iPledge for Accutane

Biologics Price Competition and Innovation Act of 2009

Created approval pathway for biosimilars

Biosimilar

A biologic product highly similar to an approved biologic

What must biosimilars have in common with the original biologic?

Same mechanism, route, dosage form, and strength

Purple Book

FDA reference for biologics and biosimilars

Affordable Care Act of 2010

Expanded health insurance coverage and generic competition

What age can patients remain on parents’ insurance under ACA?

26 years old

Drug Quality and Security Act of 2013

Improved oversight of compounding and drug distribution tracking

503A pharmacy

Traditional community compounding pharmacy regulated mainly by state BOP

503B facility

Outsourcing facility regulated by FDA that compounds large quantities

Track and trace

System to monitor drug distribution through the supply chain

Pregnancy and Lactation Labeling Rule of 2014

Created new pregnancy and lactation labeling categories

Three PLLR categories

Pregnancy, lactation, and reproductive potential