Pharmacy Laws, Regulations & Ethics Flashcards
This law defines what drugs require a prescription by a licensed practitioner and requires them to include this legend on the label: “Caution: Federal Law prohibits dispensing without a prescription.”
1951 Durham-Humphrey Amendment
The leading enforcement agency at the federal level for regulations concerning drug products.
Food and Drug Administration (FDA)
The agency which controls the distribution of drugs that may be easily abused.
Drug Enforcement Administration (DEA)
Prohibited interstate commerce in adulterated or misbranded food, drinks, and drugs. Government pre-approval of drugs is required.
Food and Drug Act of 1906
In response to the fatal poisoning of 107 people, primarily children, by an untested sulfanilamide concoction, this comprehensive law requires new drugs be shown to be safe before marketing.
1938 Dood, Drug and Cosmetic (FDC) Act
This law defines what drugs require a prescription by a licensed practitioner and requires them to include this legend on the label: “Caution: Federal Law prohibits dispensing without a prescription.”
1951 Durham-Humphrey Amendment
Requires drug manufacturers to provide proof of both safety and effectiveness before marketing the drug.
1962 Kefauver-Harris
Requires child-proof packaging on all controlled and most prescription drugs dispensed by pharmacies.
1970 Poison Prevention Packaging Act
The CSA classifies drugs that may be easily abused and restricts their distribution. It is enforced by the Drug Enforcement Administration (DEA) within the Justice Department.
1970 Controlled Substances Act
Among other things, this act required pharmacists to offer counseling to Medicaid patients regarding medications, effectively putting the common practice into law.
1990 Omnibus Budget Reconciliation Act (OBRA)
Provided broad and stringent regulations to protect patients’ privacy.
1996 Health Insurance Portability and Accountability Act (HIPAA)
Inactive substances, not real medications, that are used to test the effectiveness of drugs.
All new drugs, whether made domestically or imported, require FDA approval before they can be marketed in the United States.
Tests on proposed new drugs (investigational drugs) are “controlled” by comparing the effect of a proposed drug on one group of patients with the effect of a different treatment on other patients.
clinical tests
prescription drug labels
The minimum requirements on prescription labels for most drugs are as follows: name and address of dispenser, prescription serial number, date of prescription or filling, name of prescriber, name of patient, directions for use, and cautionary statements.
NDC (National Drug Code) number
The number assigned by the manufacturer. Each number has three parts or sets of numbers: The first set indicates the manufacturer; the next set indicates the medication, its strength, and dosage form; the last set indicates the package size.
A drug which has the potential to be abused and for which distribution is controlled by one of five “schedules.”
controlled substances
The number all prescribers of controlled substances are assigned and which must be used on all controlled drug prescriptions. It has two letters followed by seven single-digit numbers, e.g. AB1234563.
DEA number
DEA formula
If the sum of the first, third and fifth digits is added to twice the sum of the second, forth and sixth digits, the totalk should be a number whose last digit is the same as the last digit of the DEA number
For the most part, voluntary on the part of the manufacturer. Three classes: I. where there is a strong likelihood that the product will cause serious adverse effects of death; II. where a product may cause temporary but reversible adverse effects, or in which there is little likelihood or serious adverse effects; III. where a product is not likely to cause adverse effects
recalls
MedWatch
FDA reporting program for health care professionals to report adverse effects that occur from the use of an approved drug or other medical product.
Used for FDA-regulated drugs, biologics, medical devices, and special nutritional products and cosmetics.
MedWatch Online Voluntary Reporting Form 3500
state regulations
State boards of pharmacy are responsible for licensing all prescibers and dispensers and administering regulations for the practice of pharmacy in the state.
Schedule I
Each drug has a high potential for abuse and no accepted medical use in the United States. It may not be prescribed. Heroin, various opium derivatives, and hallucinogenic substances are included on this schedule.
Schedule II
Each drug has a high potential for abuse and may lead to physical or psychological dependence, but also has a currently accepted medical use in the United States. Amphetamines, opium, cocaine, methadone, and various opiates are included on this schedule.
Schedule III
Each drug’s potential for abuse is less than those in Schedules I and II and there is a currently accepted medical use in the U.S., but may lead to moderate or low physical dependence or high psychological dependence. Anabolic steroids and various compounds containing limited quantities of narcotic substances such as codeine are included on this schedule.
Schedule IV
Each drug has a low potential for abuse relative to Schedule III drugs and there is a current accepted medical use in the U.S., but abuse may lead to limited physical dependence or psychological dependence. Phenobarbital, the sedative chloral hydrate, and the anesthetic methohexital are included in this group.
