Pharmacology Chapter 6

Front 1

Pharmacology

Back 1

The study of the effects of chemical substances on living tissues.

Front 2

Apothecary System

Back 2

Formed in 1240 A.D. by Arabic doctors. First set of drug standards and measurements (grains, drams, minims). Being phased out to the metric system.

Front 3

The United States Pharmacopeia National Formulary (USP-NF)

Back 3

The current three volume authoritative source for drug standards. Drugs included in the USP-NF have met high standards for therapeutic use, client safety, quality, purity, strength, packaging safety, and dosage form.

Front 4

1938 Food, Drug, & Cosmetic Act

Back 4

Empowered the FDA to monitor and regulate the manufacture and marketing of drugs.

Front 5

1952 Durham-Humphrey Amendment to the 1938 Act

Back 5

Amendment to the 1938 Food, Drug, & Cosmetic Act distinguished between drugs that can be sold with or without prescription and those that should not be refilled without a new prescription (narcotics, hypnotics, or tranquilizers).

Front 6

1962 Kefauver-Harris Amendment to the 1938 Act

Back 6

Amendment to the 1938 Food, Drug, & Cosmetic Act resulted from the widely publicized thalidomide tragedy of the 1950s. Tightened controls on drug safety, and required that adverse reactions and contraindications must be labeled and included in the literature. Also included were provisions for the evaluation and testing methods, withdrawal process of approved drugs when safety and effectiveness were in doubt, and establishing effectiveness of new drugs before marketing.

Front 7

1970 The Controlled Substances Act

Back 7

Designed to remedy the escalating problem of drug abuse using several provisions:
1) promotion of drug education and research into the prevention and treatment of dependence
2) strengthening of enforcement authority
3) the establishment of treatment and rehabilitation facilities
4) designation of schedules/categories for controlled substances according to abuse liability

Front 8

Controlled Substances are:

Back 8

described in five schedules or categories. Some drugs may be listed in more than one schedule category.
EXAMPLE: Codeine is a schedule II drug, but when added to acetaminophen, it becomes a schedule III drug, and when used in combination as a cough preparation it becomes a schedule V drug.

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Schedule I

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High potential for drug abuse. No accepted medical used. Labeled C-1

EXAMPLES: Heroin, hallucinogens (LSD, marijuana [except when prescribed as treatment] mescaline, psilocybin)

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Schedule II

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High potential for drug abuse. Accepted medical use. Can lead to strong physical and psychological dependency. Labeled C-2

EXAMPLES: meperidine (Demerol), morphine, hydrocodone, hydromorphone, methadone, oxycodone, codeine, amphetamines, secobarbital, pentobarbital

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Schedule III

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Medically accepted drugs. Potential abuse is less than for Schedules I and II. May cause dependence. Labeled C-III
EXAMPLES: codeine preparations, paregoric, nonnarcotic drugs (pentazocine, propoxyphene)

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Schedule IV

Back 12

Medically accepted drugs. May cause dependence. Labeled C-IV
EXAMPLES: phenobarbital, benzodiazepines (diazepam, oxazepam, lorazepam, chlorodiazepoxide), chloral hydrate, meprobamate

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Schedule V

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Medically accepted drugs. Very limited potential for dependence. Labeled C-V
EXAMPLES: opioid-controlled substances for diarrhea and cough (e.g. codeine in cough preparations)

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Nursing Interventions: Controlled Substances

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1) Account for all controlled drugs.
2) Keep a controlled-substance record for required information.
3) Countersign all discarded or wasted medication.
4) Ensure that documentation and drugs on hand match.
5) Keep all controlled drugs in a locked storage area; narcotics must be kept under double lock.
6) Be certain that only authorized persons have acces to the keys.

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1978 Drug Regulation Reform Act

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Shortened the time in which new drugs could be developed and marketed. This protect's patients' rights and promotes research.

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1992 Drug Relations Act

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To increase the approval rate of drugs used to treat AIDS and cancer, the regulations were changed. The pharmaceutic companies pay a user fee at the time of application for the new drug.

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1997 Food and Drug Administration Modernization Act

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Five provisions
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 use for serious or life-threatening health conditions
4) Drug companies are required to give information on "off-label" drugs (non FDA approved drugs) and their uses and costs
5) drug companies that plan to discontinue drugs must inform health professionals and clients at least 6 months before stopping production

Front 18

2003 Health Insurance Portability and Accountability Act

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HIPPA sets the standards for the privacy of individually identifiable health information as of 2003. Gives clients more control over their health information, including boundaries on the use and release of records. Example: the client history can only be released to the client and the pharmacist must provide a private area for consultation.

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2003 Pediatric Research Equity Act

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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.

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2003 Medicare Prescription drug Improvement and Modernization Act

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Provides financial assistance to seniors to purchase needed prescription medications. The client is responsible for a monthly premium of $35 and a $250 annual deductible. This benefit will pay 75% of the total cost of the prescription drugs up to $2250. No coverage between $2250-$5100. After $5100, 95% of costs are covered. Double (supplemental) coverage is not allowed.