71 terms

Pharmacy Law

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What is a law?
- A rule or regulation.
- Laws offer minimum levels of acceptable standards.
- At the state or federal level, the most stringent law prevails.
Regulation
Written rule or procedure that assures laws are carried out.
What are standards?
Criteria that measure product quality or professional performances.
Organizations setting and assuring standards.
-United States Pharmacopeia (USP)
-State boards of pharmacy
-Institutions
Types of Law (4)
Constitutional
Statutes and Regulations
State Law
Legislative Intent
Constitutional Law
- Conform to the constitution
- 10 amendments the Bill of Rights
Statutes and Regulations Law
- Statutes: passed by federal, state, local legislatures
- Regulations: clarify and explain statutes
- Regulatory agency: enforce regulations
State Law
- Established by the organization of state government
- Must meet federal and state constitutions
- United States Code (U.S.C.), Code of Federal Regulations (C.F.R)
Legislative Intent
- Legal interpretation of the law
- Judges determine legislative intent (case law)
State Law and Regulations
-Each state has its own set of laws that must be followed
- Whenever federal and state law cover the same issues, the more stringent of the two always applies ****
- States may not take away rights that are provided by federal law, but may provide additional rights
Criminal Law
- Dealing with crime or punishment
- Homicide, illegal drugs, theft
- Enforced by State agents
- Protect society as whole
Crime: violation of law
- Misdemeanor: less serious
- Felonies: serious (jail time > 1 year)
Civil Law
- Deals with the rights of citizens
- Personal injuries, business disputes
- Medical Malpractice: professional errors (negligence)
Administrative Law
- Centers for Medicare and Medicaid Services (CMS)
- IRS, SSA, State Board of Pharmacy
- Refine laws and regulations
Regulatory Agencies
- CMS: regulates administration of Medicaid and Medicare
- HIPAA: Health Insurance Portability and Accountability Act
- CLIA: Clinical Laboratory Improvement Amendment
- FDA: Food and Drug Administration
Safety, security, and efficacy of drugs, medical devices, cosmetics, and food
Drug Enforcement Administration
-Regulates legal trade in narcotic and dangerous drugs
-Administrator of the DEA reports to the director of the FBI
-Inspections of pharmacies and healthcare facilities suspicious activity
-Maintains Controlled Substance Schedules II-V audit trails
-Requires DEA Registration
Regulatory Agencies
Joint Commission: accredits (safety and quality) healthcare organizations

OSHA: Occupational Safety and Health Administration
- Ensure safety and health of American workers

SBOP: State Boards of Pharmacy
- Registers and Regulates pharmacies, pharmacists, and
-pharmacy technicians (Professional Degree)
National Association of Boards of Pharmacy
-Develops North American Pharmacist Licensure
-Examination (NAPLEX)
-Pharmacy inspections
-Coordinates and guides state pharmacy boards-standards
****National Commission on Certification of Physician Assistants
What is not a type of law in the United States?
Government Policy
FDA Jurisdiction
Therapeutic agents
biological origin
medical devices
radiation-emitting products for medical, and occupational use
cosmetics
animal feed
United States Pharmacopeia (USP)
Standards for manufacturing and distribution of drugs and related products
National Formulary (NF)
National database of officially recognized drug names
Food, Drug, and Cosmetic Act of 1938
Very important act: known as the "Safety Act"
Prompted by the sulfanilamide disaster of 1937
Regulated labeling of drugs
Authorized factory inspections
Durham-Humphrey Amendment of 1951 (Rx Drug Amendment)
Required prescription drugs to bear the legend, "Caution: Federal law prohibits dispensing without a prescription."

Later amendments approved a substitute legend that reads "RX only."
1962 - Thalidomide
Thalidomide, a new sleeping pill prevented morning sickness. Caused birth defects in 1000s of children. Short limbs. FDA kept it off shelves in US.
Kefauver-Harris Amendment of 1962
-Prompted by the thalidomide disaster of 1962
Also known as the Drug Efficacy Amendments
-Focused on accountability from drug manufacturers for the effectiveness of drugs
Kefauver-Harris Amendment of 1962
-Manufacturers required to supply proof of effectiveness and safety.
-Burden put on manufacturing companies to have good manufacturing practices (GMP
Drug development and approval process (Phase 1)
20-100 patients
several months
mainly safety as the purpose
Drug development and approval process (phase 2)
Up to several hundred patients
Several months to two years
Purpose is short-term safety but mainly effectiveness
Drug development and approval process (phase 3)
Several hundred to several thousand patients
One to four years
Purpose is safety, dosage, and effectiveness
Drug development and approval process (phase 4)
Post marketing surveillance
Drug Recall: Class I
strong likelihood product will cause serious adverse effects or death
most serious recall
Drug Recall: Class II
product may cause temporary but reversible adverse effects
Drug Recall: Class III
not likely to cause adverse effects
FDA Reporting Process and Adverse Reactions
Program under the FDA that allows consumers and health care professionals to report any discrepancies in medication or adverse reactions to medications
Comprehensive Drug Abuse Prevention and Control Act of 1970
-Also known as the Controlled Substances Act of 1970
-The Drug Enforcement Agency (DEA) was formed
-Established five "classes" or schedules for controlled substances
Controlled Substances
-In the language of federal regulation, the word narcotics refers to all controlled substances
-Narcotics are derived from opium or opium-like substances
Controlled Substances
-Opiates, such as codeine and morphine, are substances created from opium
-Opioids are narcotics that are produced synthetically in the laboratory
-Each type of narcotic is assigned a rating that depends on its addiction potential
Ratings of Scheduled (Controlled) Substances
Letter "C," meaning controlled substances, is used in addition to Roman numerals to indicate the addictiveness or abuse potential of narcotics
The Warning
Caution: Federal law prohibits the transfer of this drug to any person other than the patient for whom it was prescribed
-Must appear on the label of every controlled prescription dispensed
SCHEDULE I
-Has a high potential for abuse
-Has no currently accepted medical use in treatment in the United States
SCHEDULE I (examples)
gamma-hydroxybutyric acid (GHB), heroin, LSD, mescaline, peyote
SCHEDULE II
-Has a high potential for abuse
-Has a currently accepted but severely restricted medical use in treatment in the United States
-Abuse of the substance may lead to severe psychological or physical dependence
-No Refills permitted
SCHEDULE II (examples)
amphetamine, cocaine, fentanyl, hydrocodone, hydromorphone, meperidine, methadone, methylphenidate, morphine, opium, oxycodone
SCHEDULE III
- Has a potential for abuse less than the substances contained in Schedules I and II
- Has a currently accepted medical use in treatment in the United States
- Abuse of the substance may lead to moderate or low physical dependence or high psychological dependence or may lead to physical damage
Ratings of Schedules (Controlled) Substances (Schedule 3)
-5 refills or within 6 months
-less potential for abuse
-opiate combinations (Percocet, Lortab,)
-analgesic/acetaminophen combinations = lower abuse
-Anabolic Steroids
SCHEDULE IV
-Has a low potential for abuse relative to the substances in Schedule III
-Has a currently accepted medical use in treatment in the United States
-Abuse of the substance may lead to limited physical or psychological dependence relative to the substances in Schedule III
SCHEDULE IV (examples)
Benzodiazepines, Chlordiazepoxide, Diazepam, Lorazepam, Sedative/hypnotics, zolpidem
Ratings of Schedules (Controlled) Substances IV
-5 refills or within 6 months
-less potential for abuse
-"Benzodiazepines": Lorazepam, Diazepam
SCHEDULE V
A substance, compound, mixture, or preparation of a substance which has a low potential for abuse relative to the substances in Schedule IV
SCHEDULE V examples
diphenoxylate, pregabalin
Ratings of Schedules (Controlled) Substances V
-5 refills or within 6 months
-low potential for abuse
-Lomotil: diphenoxylate-Atropine added to discourage abuse
DEA Verification
All prescribers must be registered with the DEA to write prescriptions for controlled substances
DEA Verification
Prescribers are given a nine-character identification code, which is different for each prescriber
DEA Verification
-The last digit in the calculated sum is 5, which matches the last digit of the DEA number
-The second letter of the DEA number is U matching the first letter of the prescriber's last name, Umberger
-This appears to be a valid number. (AU3284065)
Child-Resistant Caps Poison Prevention Packaging Act: 1970
-The Poison Prevention Act addresses the issue of accidental poisoning in children, especially 81 mg flavored, chewable "baby aspirin"
-"Childproof"caps were created
OSHA Act of 1970
Requires employers to provide a workplace free from hazards such as: Exposure to toxic chemicals, Excessive noise levels, Mechanical dangers, Heat or cold stress, Unsanitary conditions.
Medical Device Amendment of 1976
Requires life-sustaining and life-supporting devices to have premarket approval from the FDA.
Orphan Drug Act of 1983
Intended to stimulate the development of drugs for rare diseases. (rare=200,000 or less people)
Drug Price Competition and Patent Term Restoration Act of 1984 (Hatch-Waxman Act)
-Established modern system of generic drugs
-Abbreviated new drug application (ANDA)
Drug Price Competition and Patent Term Restoration Act of 1984
Bioequivalence:
FDA definition- the comparison of bioavailability between two dosage forms
Drug Price Competition and Patent Term Restoration Act of 1984
Bioavailability:
The amount of an administered dose that reaches the general circulation and the rate at which this occurs
Drug Price Competition and Patent Term Restoration Act of 1984
-Ratings-bioequivalence-Orange Book
-Orange Book AB rating indicative of full bioequivalence
-AA Drugs which are considered NOT to have potential bioavailability
-AB Drugs that have been shown to be bioequivalent through testing
Prescription Drug Marketing Act of 1987
-Enacted to address certain prescription drug marketing practices
-Distribution of free samples
-Use of coupons redeemable for drugs at no cost or low cost
-Sale of deeply discounted drugs to hospitals and healthcare entities
Anabolic Steroid Control Act of 1990
-Placed anabolic steroids into Schedule III of the Controlled Substances Act (CSA)
-CSA defines anabolic steroid as:
"any drug or hormonal substance chemically and pharmacologically related to testosterone (other than estrogens, progestins, and corticosteroids) that promotes muscle growth"
Omnibus Budget Reconciliation Act of 1990 (OBRA '90)
-Focused on federal funding of Medicare and Medicaid
-Mandated that pharmacists perform drug utilization reviews (DURs) and offer counseling to Medicaid patients-now extended to ALL patients
Dietary Supplement Health and Education Act of 1994 (DSHEA)
-Defined dietary supplement and dietary ingredient
-Required ingredient and nutrition labeling
-Granted the FDA authority to establish good manufacturing practice (GMP) regulations
-Strictly speaking, dietary supplements are not considered "drugs" -oversight function of FDA much less than OTC Drugs.
Health Insurance Portability and Accountability Act of 1996 (HIPAA)
-Enacted to ensure patient confidentiality and privacy
-Gave patients the right to review their medical records
-Established the requirement of patient consent for the transfer of medical records
Combat Methamphetamine Epidemic Act of 2005 (CMEA)
Regulates retail over-the-counter sales of ephedrine, pseudoephedrine: Daily sales limits, 30-day purchase limits, Placement of product out of direct customer access, Sales logbooks, Customer ID verification, Employee training
Most laws pertaining to pharmacy were enacted to:
Protect the public interest
Which agency / administration is responsible for protecting the privacy of patients?
HIPAA