Pharmacy Law and Ethics

according to the code of ethics for pharmacists, telling the truth fro the benefit of patients and for the correct reporting of medication errors is ..

according to the code of ethics for pharmacists, telling the truth fro the benefit of patients and for the correct reporting of medication errors is ..

Veracity

What was the disaster that led to the Food, Drug, and Cosmetics Act of 1939?

Sulfanilamide

-enacted to ensure patient confidentiality and privacy;adulterated drugs

altered and causing an undesirable effect;misbranded drugs

-detailed document pertaining to a specific drug;

Pure Food & Drug Act of 1906

passed for fed. inspection of meat and forbade the manufacture, sale or transport of adulterated food products. Was inadequate because it did not: -cover cosmetics -grant gov't authority to ban unsafe drugs -prohibit mfg from making false statements -require labeling to identify contents

Food, Drug and Cosmetic Act of 1938 (FDCA)

-req. to prove drugs were safe -had to have warnings and directions for use -new drugs req to be tested -req 'labeling' -regulated who could prescribe legend drugs

legend drugs

drugs available by prescription only

Durham-Humphrey Amendment of 1951

AKA - Prescription Drug Amendment -required that prescription drugs bear the legend, 'Caution: Federal law prohibits dispensing without a prescription.' -Later substituted 'Rx only'

Kefauver-Harris Amendment of 1962

AKA - Drug Efficacy Amendment -focused on drug manuf. accountability for the efficacy, or effectiveness of drugs -Good manuf. practices (GMP) established -Req to supply proof of effectiveness -Advertising placed under FDA -Procedure for drugs established

Comprehensive Drug Abuse Prevention and Control Act of 1970

AKA - Controlled Substance Act of 1970 -est. the Drug Enforcement Admin (DEA) -est. five classes (schedules) of controlled substance by potential for abuse

Schedule I (C-I)

-high potential for abuse -no currently accepted medical use -illegal drugs -heroin, LSD, marijuana

Schedule II (C-II)

-high potential for abuse -accepted medical use -may lead to severe dependence -cocaine, morphine, Ritalin

Schedule III (C-III)

-less potential for abuse -accepted medical use -moderate physical dependence -Vicodin, Lortab, Tylenol 3, anabolic steroids -5 refills within 6 months

Schedule IV (C-IV)

-low potential for abuse -accepted medical use -limited dependence -Valium, Librium -5 refills within 6 months

Schedule V (C-V)

-low potential for abuse -accepted medical use -limited dependence -Lomotil -can be refilled for up to one year

Poison Prevention Packaging Act of 1970 (PPPA)

all legend and controlled substances must be dispensed in a childproof container

Occupational Safety and Health Act of 1970 (OSHA)

created to ensure worker and workplace safety

Drug Listing Act of 1972

-amended the Food, Drug & Cosmetic Act to require manufactures, etc to register their products with the FDA -each drug assigned a unique and permanent product code known as National Drug Code (NDC)

Orphan Drug Act of 1983

-to stimulate development of drugs for rare diseases -7 year market exclusivity -tax credit of 50% of cost of conducting human trials -fed research grants for clinical testing -exemption from drug application or user fees

Prescription Drug Marketing Act of 1987

marketing practices including distribution of free sample, coupons for drugs at no cost or low cost, etc

Anabolic Steroid Control Act of 1990

placed steroids on Schedule III list

Omnibus Budget Reconciliation Act of 1990

AKA OBRA -focused on federal funding of Medicare and Medicaid programs -created increased need for pharmacy techs -mandated that pharmacists perform drug utilization reviews (DURs) -offer counseling to patients

Dietary Supplement Health and Education Act of 1994

-define dietary supplements & ingredients -literature displayed where sold -req ingredient & nutrition labeling

Health Insurance Portability and Accountability Act of 1996

AKA - HIPAA -enacted to ensure patient confidentiality and privacy

adulterated drugs

altered and causing an undesirable effect

misbranded drugs

a drug that has been misleadingly or fraudulently labeled.

medical device

any instrument or apparatus used in the diagnosis, prevention, monitoring, treatment or alleviation of disease

monograph

-commonly referred to as 'package inserts' -detailed document pertaining to a specific drug