Pharmocology Chapter 6
____ is a schedule II drug but when it is added to acetaminophen, it becomes a schedule III drug, and when it is used in combination as a cough preparation, it becomes a schedule V drug.
The _________ shortened the time in which new drugs could be developed and marketed. This act protects patient's rights and at the same time facilitates the investigational process and promotes research.
1978 Drug Regulation Reform Act
The _______ increases the approval rate of drugs used to treat AIDS, and cancer. The pharmaceutic companies pay a user fee at the time of application for the new drug. The fee is for the FDA drug-approval process.
1992 Drug Regulations Act
The five provisions in __________ include: 1) Review and use of new drugs is accelerated; 2) Drugs can be tested in children before marketing; 3) Clinical trial data are necessary for experimental drug us for serious or life-threatening health conditions; 4) Drug companies are required to give information on "off-label" drugs (non-FDA approved drugs); 5) Drug companies that plan to discontinue drugs must inform health professionals and clients at least 6 months before stopping drug production.
1997 Food and Drug Administration Modernization Act
The _____ sets the standards for the privacy of individually identifiable health information. Rules include the use and release of health records, and limitation on access to information from the pharmacy. Pharmacist must provide a private area for consultation.
2003 Health Insurance Portability and Accountability Act (HIPAA)
The FDA is authorized to require testing by drug manufacturers of drugs and biologic products for their safety and effectiveness in children. One must not assume that children are small adults.
2003 Pediatric Research Equity Act
The _______ provides financial assistance to seniors to purchase needed prescription medications. Drug costs up to $2250 is 75% covered. Drug costs between $2250-$5100 is not covered. Drug costs above $5100 is 95% covered. The client is responsible for a monthly premium of $35 and a $250 annual deductible.
2003 Medicare Prescription Drug Improvement and Modernization Act (MMA)
Negligence; giving the wrong drug or drug dose that results in the clients death.
Omission; omitting a drug dose that results in the clients death.
Giving the correct drug but by the wrong route that results in the clients death.
America's first law to regulate drugs was the ______, which did not include drug effectiveness and drug safety.
Federal Pure Food and Drug Act of 1906
The Food, Drug, and Cosmetic Act of 1938 empowered a governing body, _______, to monitor and regulate the manufacture and marketing of drugs.
U.S. Food and Drug Administration (FDA)
The ______ to the Food, Drug, and Cosmetic Act of 1938 distinguished between drugs that can be sold without prescription and those that can not be refilled with a new prescription.
1952 Durham-Humphrey Amendment
The _________ to the Food, Drug, and Cosmetic Act of 1938 resulted from the widely publicized thalidomide tragedy of the 1950's in which pregnant European women who took the sedative-hypnotic thalidomide during the first trimester of pregnancy gave birth to infants with extreme limb deformities.
1962 Kefauver-Harris Amendment
In 1970 the _________ of the Comprehensive Drug Abuse Prevention and Control Act, Title II, was passed by congress. Designed to remedy the escalating drug problem through education, research, enforcement, rehab centers and creating categories for controlled substances according to abuse liability.
Controlled Substance Act (CSA)
High potential for drug abuse. No accepted medical use. Includes heroin, hallucinogens, LSD, marijuana, mescaline, peyote, psilocybin.
High potential for drug abuse. Accepted medical use. Can lead to strong physical and psychological dependency. Includes meperidine, demerol, morphine, hydrocodone, hydromorphone, methadone, oxycodone, codeine, amphetamines, secobarbital, penobarbital.
Medically accepted drug use. Potential abuse is less than some other schedules. May cause dependence. Includes codeine preparations, paregoric, nonnarcotic drugs, pentozocine, propoxyphene.
Medically accepted drug use. May cause dependence. Includes phenobarbital, benzodiasepines, diazepam, oxazepam, lorazepam, chlordiazepoxide, chloral hydrate, meprobamate.
Medically accepted drug use. Very limited potential for dependence. Includes Opioid-controlled substances for diarrhea and cough, codeine in cough preparations.