Drug Development and Ethical Considerations (OBJECTIVES 5-9) Flashcards
the authoritative source for drug standards (dosage, forms, drug subtansces, excipients, biologics, compounded preparations, and dietary supplements), is published annually.
United States Pharmacopeia and the National Formulary (USP-NF)
Drugs that meet these standards have the initials “___” following their official name, denoting global recognition of high quality.
USP
first published in 1951 by the World Health Organization (WHO), provides a basis for standards in strength and composition of drugs for use throughout the world. The book is published in English, Spanish, and French.
The International Pharmacopeia
The International Pharmacopeia first published in ___ by the _______. The book is published in ___, ___, and ___.
first published in 1951 by the World Health Organization (WHO); English, Spanish, and French.
attempts to protect the public from drugs that are impure, toxic, ineffective, or not tested before public sale.
Federal Legislation
The primary purpose of the federal legislation is to ______.
ensure safety
America’s first law to regulate drugs was the __________, which prohibited the sale of misbranded and adulterated drugs but did not address drug effectiveness and safety.
Food and Drug Act of 1906
prohibited false therapeutic claims on drug labels.
Under the ______, the government had to prove intent to defraud a drug could be removed from the market.
1912: The Sherley Amendment
a product advertised to treat teething and colic, which contained morphine and led to the death of many infants.
Mrs. Winslow’s Soothing Syrup
required prescriptions for drugs that exceeded set narcotic limits.
It also mandated increased record keeping by physicians and pharmacists.
1914: The Harrison Narcotic Tax Act
empowered the FDA to ensure a drug was safe before marketing.
The Federal, Food, Drug, and Cosmetic Act of 1938
It was the ___’s responsibility to ensure that all drugs are tested for harmful effects; it also required that drugs be labeled with accurate information and have detailed literature in the drug packaging that explains adverse effects.
FDA’s
The FDA can prevent the marketing of any drug it judges to be incompletely tested or dangerous.
When are the drugs approved for marketing?
Only drugs considered safe by the FDA are approved for marketing.
distinguished between drugs that could be sold with or without prescription by a licensed health care provider.
1951: Durham-Humphrey Amendment
resulted from the widely publicized thalidomide tragedy of the 1950s in which European patients who took the sedative-hypnotic thalidomide during the first trimester of pregnancy gave birth to infants with extreme limb deformities.
1962: Kefauver-Harris Amendment Act to the 1938 Act
tightened controls on drug safety, especially experimental drugs, and required that adverse reactions must be labeled and included in the literature.
The Kefauver-Harris amendment
The amendment also included provisions for the evaluation of testing methods used by manufacturers, the process for withdrawal of approved drugs when safety and effectiveness were in doubt, and the establishment of effectiveness of new drugs before marketing.
The Kefauver-Harris amendment
This medication is used to treat or prevent certain skin conditions related to Hansen’s disease, once known as leprosy (erythema nodosum leprosum).
is also used to treat a certain type of cancer (multiple myeloma). It works in Hansen’s disease by reducing swelling and redness (inflammation).
thalidomide
Enacted in 1965, the _______ attempted to control the abuse of depressants, stimulants, and hallucinogens.
1965: Drug Abuse Control Amendments
This act, designed to remedy the escalating problem of drug abuse, included several provisions: (1) promotion of drug education and research into the prevention and treatment of drug dependence; (2) strengthening of enforcement authority; (3) establishment of treatment and rehabilitation facilities; and (4) designation shedules, or categories, for controlled substances according to abuse liability.
1970: The Comprehensive Drug Abuse Prevention and Control Act
Based on their abuse potential and acceptable medical use practices, controlled substances are categorized into five schedules.
Schedule 1
Schedule 2
Schedule 3
Schedule 4
Schedule 5
Identify which schedule are the drugs classified as.
Drugs with no currently accepted medical use and a
high potential for abuse. They are the most dangerous
drugs of all the drug schedules with potentially severe
psychological or physical dependence.
Schedule 1
Identify which schedule are the drugs classified as.
Drugs with a high potential for abuse, with use potentially leading to severe psychological or physical dependence. These drugs are also considered dangerous.
Schedule 2
Identify which schedule are the drugs classified as.
Drugs with a moderate to low potential for physical and psychological dependence. Schedule _ drugs abuse
potential is less than Schedule 1 and Schedule 2 drugs but more than Schedule 4.
Schedule 3
Identify which schedule are the drugs classified as.
Drugs with a low potential for abuse and low risk of dependence.
Schedule 4
Identify which schedule are the drugs classified as.
Drugs with lower potential for abuse than Schedule 4 and consist of preparations containing limited
quantities of certain narcotics. Schedule _ drugs are generally used for antidiarrheal, antitussive, and analgesic purposes.
Schedule 5
Identify which schedule are the drugs classified as.
- Heroin
- Lysergic acid diethylamide (LSD)
- Marijuana (Cannabis)
- Methylenedioxymethamphetamine (Ecstasy)
- Methaqualone
- Peyote
Schedule 1
Identify which schedule are the drugs classified as.
- Combination products with less than 15mg of hydrocodone per dosage unit (Vicodin)
- Cocaine
- methamphetamine
- Methadone
- Hydromorphone (Dilaudid)
- Meperidine (Demerol)
- Oxycodone (OxyContin)
- Fentanyl
- Dexedrine
- Adderall
- Ritalin
Schedule 2
