Chapter 3 -- Drug Regulation and Control Flashcards
Food and Drug Administration
leading enforcement agency at federal leval for regulations involving drug products
Drug Enforcement Administration
agency which controls distribution of drugs that can be easily abused
Food and Drug Act of 1906
Prohibits interstate commerce in adulterated or misbranded food, drinks,and drugs. Government pre-aproval of drugs is required.
1938 Food, Drug, and Cosmetic (FDC) Act
Comprehensive law requires new drugs be shown to be safe before marketing
1951 Durham-Humphrey Amendment
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.”
1962 Kefauver-Harris Amendments
Requires drug manufacturers to provide proof of both safety and effectiveness before marketing the drug
1970 Poison Prevention Packaging Act
Requires child-proof packaging on all controlled and most prescription drugs dispensed by pharmacists
1970 Controlled Substances Act (CSA)
The CSA classifies drugs that may be easily abused and restrict their distribution. It is enforced by the Drug Enforecement Adminsitration (DEA) within the Justice Department
1990 Omnibus Budget Reconciliation Act (OBRA)
Requires pharmacists to offer counseling to Medicaid patients regarding medications, effectively putting common practice into law
1996 Health Insurance Portability and Accountability Act (HIPAA)
Provided broad and stringent regulations to protect patients’ privacy
placebos
inactive substances, not real meds, used to test effectiveness of drugs
prescription drug labels (minimum requirements)
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
number assigned by manufacturer Three parts: 1. MANUFACTURER 2. MEDICATION, STRENGTH, DOSAGE FORM 3. PACKAGE SIZE
DEA number/formula
number all prescribers of controlled substances are assigned which must be used on all controlled drug prescriptions.
Two letters folowed by seven single-digit numbers.
EXAMPLE: AB1234563
Formula for checking a DEA number on a prescription form is:
- Sum of first, third, and fifth digit added to..
- Twice the sum of second, forth, sixth digit
- The total should be a number whose last digit is the same as the last digit of the DEA number.
recalls
recalls are voluntary on the part of manufacturer. three classes of recalls.
1) where there is a strong likelihood that the product will cause serious adverse effects or death
2) where a product may cause temporary but reversible adverse effects, or in which there is little likelihood of serious adverse effects
3) where a product is not likely to cause adverse effects
state regulation
state boards of pharmacy are responsible for licensing all prescribers and dispensers and administering regulations for the practice of pharmacy in the state
liability
legal liability means you can be prosecuted for misconduct
Schedule I
each drug has a high potential for abuse;
no accepted medical use in the U.S;
may not be prescribed;
Heroin
Opium derivatives
Hallucinogenic substances
Schedule II
each drug has a high potential for abuse;
may lead to physical or psychological dependence;
has a currently accepted medical use in the U.S.
amphetamines opium cocaine methadone various opiates
Schedule III
each drug’s potential for abuse is less than those in Schedules I and II;
may lead to moderate/low physical dependence or high psychological dependence;
anabolic steroids
various compounds containing lmited 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;
abuse may lead to limited physical dependnce or psychological dependence
phenoarbital
sedative chloral hydrate
anesthetic methonexital
Schedule V
each drug has low potential for abuse;
limited physical dependence or psychological dependence
compounds containing limited amounts of narcotic such as codeine
