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.
Schedule V
Each drug has a low potential for abuse relative to Schedule IV drugs and there is a current accepted medical use in the U.S., but abuse may lead to limited physical dependence or psychological dependence. Compounds containing limited amounts of a narcotic such as codeine are included in this group.
“A” drug products
Drug products are those the FDA considers to be therapeutically equivalent to other pharmaceutically equivalent products. There are (1) no known or suspected bioequivalence problems or (2) the actual or potential bioequivalence problems have been resolved with adequate in vivo and/or in vitro evidence supporting bioequivalence.
“B” drug products
Drug products are those the FDA considers not to be therapeutically equivalent to other pharmaceutically equivalent products. Often, the problem is with specific dosage forms rather than with the active ingredient.
Approved Drug Products With Therapeutic Equivalence Evaluations (“Orange Book”)
Provides a two letter evaulation code to allow users to determine whether the FDA has evaluated a particular product as therapeutically equivalent to other pharmaceutically equivalent products (first letter) and to provide additional information on the basis of FDA’s evaluations (second letter).
AA
Products in conventional dosage forms not presenting bioequivalent problems
AB
Products meeting bioequivalence requirements
AN
Solutions and powders for aerosolization
AO
Injectable oil solutions
AP
Injectable aqueous solutions
AT
Topical Products
BC
Extended-release tablets, extended-release capsules, and extended-release injectables
BD
Active ingredients and dosage forms with documented bioequivalence problems
BE
Delayed-release oral dosage forms
BN
Products in aerosol-nebulizer drug delivery systems
BP
Active ingredients and dosage forms with potential bioequivalence problems
BR
Suppositories or enemas for systemic use
BS
Products with drug standard deficiencies
BT
Topical products with bioequivalence issues
BX
Insufficient data
A court order preventing a specific action, such as the distribution of a potentially dangerous drug.
injunction
adverse effect
An unintended side effect of a medication that is negative or in some way injurious to a patients’ health.
legend drug
Any drug which requires a prescription and this “legend” on the label: Rx only.
product labeling
Important associated information that is not on the label of a drug product itself.
“look-alike” regulation
Federal laws require that a drug and/or its container not be imitative of another drug so that the consumer will be misled.
controlled substance mark
The mark (CII-CV) which indicates the control category of a drug with a potential for abuse.
exempt narcotics
Medications with habit-forming ingredients that could be dispensed by a pharmacist without a prescription
True of false: Child-proof packaging was required by the Fair Packaging and Labeling Act.
false-it was required by the 1970 Poison Prevention Packaging Act
True of false:The CMEA sets daily and monthly restrictions on the sale of pseudoephedrine.
True
Why is blind testing used in drug approval processes?
This prevents patients and/or their physicians from imagining effects one way or the other. Medical results alone determine the drugs’s effectiveness and its safety.
Why are some drug patents extended past the original 17 year period?
According to the Hatch-Waxman Act of 1984, up to five years extension can be added to a patent to make up for time lost while products went through the FDA approval process.
Why would a manufacturer want to recall a drug product?
The negative publicity from not recalling would significantly damage a company’s reputation, and the FDA would probably take the manufacturer to court, where criminal penalties could be imposed.
Class III Recall
When a product is not likely to cause adverse effects.
Schedule V Drugs
Compounds containing limited amounts of a narcotic such as codeine are included in this group.
Class II Recall
Compounds containing limited amounts of a narcotic such as codeine are included in this group.
Schedule V Drugs
When a product may cause temporary but reversible adverse effects, or in which there is little likelihood of serious adverse effects.
Class I Recall
When there is a strong likelihood that the product will cause serious adverse effects or death.
A need for tighter drug regulations from the thalidomide lesson led to the
a. Kefauver-Harris Amendment.
b. Durham-Humphrey Amendment.
c. Food and Drug Act of 1906.
d. Food Drug and Cosmetic Act.
a. Kefauver-Harris Amendment.
Legend drugs should have the legend _____ on the manufacturer’s label.
a. “Federal law prohibits transfer of this prescription”
b. “Store at room temperature”
c. “For external use only”
d. “RX only”
d. “RX only”
The main purpose of phase I clinical trials is
a. efficacy.
b. dosage.
c. safety.
d. economics.
c. safety.
The daily sales limit of pseudoephedrine base is
a. 3.6g per household.
b. 3.6g per purchaser.
c. 3.6g per transaction.
b. 3.6g per purchaser.
The national drug code (NDC) is assigned by the
a. FDA.
b. DEA.
c. CDER.
d. manufacturer.
d. manufacturer.
