Term
| The Food and Drug Administration |
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Definition
| A branch of the Department of Health and Human Services, is the regulatory agency for the field of pharmacy. Controls all drugs for legal use. |
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| Deals with interpretation and implementation of the U.S. Constitution |
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| Enacted by a legislative body with the power to make laws, such as Congress |
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| Established by agencies of the federal government. Establish controls system Control I, II, III, IV, V |
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| Created by judges based on previous court decisions; includes “torts,” which are civil wrongs committed against a person or property |
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| Based on treaties and agreements between two or more countries |
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Term
| The Pure Food and Drug Act of 1906 |
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Definition
| prohibited interstate distribution or sale of adulterated or misbranded food and drugs |
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Term
| The Food, Drug, and Cosmetic Act of 1938 |
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Definition
| Amended the previous act; created the FDA, and required manufacturers to file a New Drug Application with the FDA |
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Term
| The Durham-Humphrey Amendment of 1951 |
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Definition
| Prohibited dispensing of legend drugs without a prescription |
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| The Kefauver-Har Amendment of 1962 |
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Definition
| Extended the Food, Drug, and Cosmetic Act to require that all drug products must be effective and safe |
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| Medical Device Amendments of 1976 |
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Definition
| Required manufacturers to register and list products, follow good practices, and report device failures |
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Term
| Comprehensive Drug Abuse Prevention and Control Act of 1970 |
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Definition
| Controlled manufacture, distribution, and dispensing of controlled substances that have potential for addiction and abuse; outlined the various drug schedules |
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Term
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Definition
| high abuse potential not accepted for medical use in the US; DEA # of Pharmacy on Prescription; Verify DEA #; no refills; Heroin, LSD, marijuana, mescaline, and peyote |
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Definition
| high abuse potential accepted for medical use in the United States; no refills; Cocaine, codeine, methamphetamine (Desoxyn), methadone hydrochloride (Methadose), morphine (Astramorph), opium (deodorized), methylphenidate (Ritalin), and secobarbital(Seconal) |
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Term
| Schedule III or Group III |
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Definition
| lower abuse potential accepted for medical use in the US; contain limited quantities of narcotics and non-narcotics; refills 6 months; Certain drugs compounded with small quantities of narcotics; drugs with high potential for abuse and certin barbiturates |
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Definition
| low abuse potential; include long-acting barbiturates, certain hypnotics, and minor tranquilizers; refills 6 months; Barbital, chloral hydreate (Noctec), diazepam, (Valium), chlordiazepoxide (Librium), and pentazone hydrochloride (Talwin) |
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Term
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Definition
| lowest abuse potential; over-the-counter (OTC) preparations except for a few exceptions; refill 18 months or older; Cough syrups with codeine, diphenoxylate hydrochloride with atrophine sulfate (Lomotil), and kaolin/pectin/opium (Parepectolin) |
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Term
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Definition
- Controlled-drug manufacturers, dispensers, or distributors must provide a registration unless they are exempted
- Most pharmacy registrations are issued for a 3-year period
- A Drug Enforcement Agency (DEA) number must be assigned to them
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Term
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Definition
- Any pharmacy handling controlled substances must keep complete, accurate records of all transactions, and maintain them for 2 to 5 years, depending on which state they are located in
- Schedule II drug records must be kept separate from all other records
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Definition
- The Controlled Substances Act (CSA) requires each registrant to make a complete and accurate record of all controlled substances in stock, every 2 years
- Schedule II drugs require that an exact count or measure be made
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Term
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Definition
- A prescription for a controlled substance must be issued by a practitioner for a valid medical purpose
- No prescription for a Schedule II controlled substance may be refilled
- Pharmacies must keep Schedule II – V controlled substances in a locked cabinet
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Term
| Poison Prevention Packaging Act of 1970 |
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Definition
- Authorized the Consumer Product Safety Commission (CPSC) to create standards for child-resistant packaging
- Most OTC and legend drugs must be packaged in these types of containers
- Containers cannot be opened by 80% of children under 5 years of age
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Definition
- Each new drug is assigned a National Drug Code (NDC) number which identifies the manufacturer or distributor, drug formulation, and the size and type of its packaging
- The NDC for one product may not be used for another if any changes occur in product characteristics
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Definition
- Offers federal financial incentives to commercial and nonprofit organizations to produce drugs previously unavailable
Orphan drugs are used to treat diseases that affect fewer than 200,000 people in the country- Drugs that have been approved under this act include those used to treat AIDS, cystic fibrosis, blepharospasm, and snakebite
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| Drug Price Competition and Patent-Term Restoration Act of 1984 |
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Definition
| Designed to lower drug prices by providing methods to increase competition in the drug industry |
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| Prescription Drug Marketing Act of 1987 |
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Definition
- Addresses the safety and competition in secondary markets
- Prohibits reimportation of a drug into the United States by anyone except the manufacturer
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Term
| Anabolic Steroids Control Act of 1990 |
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Definition
- Places anabolic steroids under the regulation of the CSA
- Anabolic steroids promote muscle growth and are used by athletes to increase performance
- Some believe this act reflects an essential change of direction for drug abuse control
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Term
| Omnibus Budget Reconciliation Act of 1990 |
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Definition
OBRA-90 requires pharmacists to offer to discuss information about new and refill prescriptions with Medicare/Medicaid patients including:- Medication name, description, dosage form, route of administration, and duration of therapy
- Severe side or adverse effects, interactions, contraindications
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Term
| Occupational Safety and Health Act(OSHA) 1970 |
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Definition
| This 1970 Act created OSHA, whose mission is to ensure workplace safety, and a healthy workplace environment |
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Term
| Health Insurance Portability and Accountability Act of 1996 (HIPAA) |
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Definition
Common OSHA violations include:- no eyewash facilities available
- lack of proper labeling of hazardous chemicals
- no employee training documentation
- no Emergency Action Plan
- Security and Electronic Signature Standards must be in place for physical storage, maintenance, transmission, and access to individual health information
Privacy and Confidentiality Standards are raised to further protect private health information
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Term
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Definition
Food and Drug Administration
Oversees food, bottled water, wine beverages with less than 7% alcohol, cosmetics, medicines, medical devices, radiation products, and farm animal products; set standards and requirement for subtance formulation, ingredients, and dosage form |
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Definition
| Center for Disease Control, Oversees all foodborne diseases |
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| Drug Enforcement Agents, Oversees controlled substances, including investigation and prosecution |
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Definition
FDA’s medical staff determines health hazards and manages drug recalls:- Class I: use or exposure to products will cause severe adverse reactions or death
- Class II: use or exposure to products may cause temporary or medically reversible adverse health hazards
- Class III use or exposure to products is not likely to cause adverse health hazards
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Term
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Definition
- The set of requirements for formulation of drug substances, ingredients, and dosage forms
- A drug formulary (or list of drugs) must be maintained
Pharmacist must supervise:
- drug handling
- administration
- patient drug regimens
- and report any irregularities to administrators or medical directors
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Term
| Ethical Foundation of Pharmacy |
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Definition
- Patients must be made aware of the benefits and risks of drugs they are taking
- Bioethics is a discipline dealing with ethical and moral implications of biological research and applications, especially relating to life and death
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Term
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Definition
Drugs may have several different names assigned to them:- Chemical name
- Generic
(nonproprietary) name
- Official name
- Trade or brand name
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