Chapter 3: Drug Regulation and Control Flashcards
Established that manufacturers, pharmacists, importers, and physicians prescribing narcotics should be licensed and required to pay a tax.
1914 Harrison Tax Act
Prohibited interstate commerce in adulterated or misbranded food, drinks, and drugs. Government preapproval of drugs is required.
Food and Drug Act of 1906
this came into effect because of fatal poisoning from liquid sulfanilamide, it required new drugs to be shown to be safe before marketing
1938 Food, Drug and Cosmetic (FDC) Act
This law defines what drugs require a prescription by a licensed practitioner and requires them to include “RX only” on the label
Also known as legend drugs
1951 Durham- Humphrey Amendment
Requires drug manufacturers to provide proof of both safety AND effectiveness before marketing the drug.
1962 Kefauver-Harris Amendment
Requires all consumer-products in interstate commerce to be honestly and informatively labeled.
1966 Fair Packaging and Labeling Act
Requires childproof packaging on all controlled and most prescription drugs dispensed by pharmacies.
1970 Poison Prevention Packaging Act
The act that classifies five levels of drugs, controlled substances, that have potential for abuse and therefore we restricts their distribution.
Completely replaced Harrison Act
1970 Controlled Substances Act (CSA)
The drug enforcement agency was created and placed under the supervision of the Department of Justice. Control substances are placed in one of five schedules based on a potential for abuse and accepted medical use in the United States.
Comprehensive Drug Abuse Prevention and Control Act of 1970
Requires premarket approval for safety and effectiveness of life-sustaining and life-supporting medical devices.
1976 Medical Device Amendment
Provides incentives to promote research, approval, and marketing of drugs needed for the treatment of rare diseases
1983 Orphan Drug Act
This act allowed for both the extension of drug patent terms and quicker introduction of lower-cost generic drugs.
1984 Drug Price Competition and Patent Term Restoration Act (Hatch-Waxman)
Requires pharmacists to offer counseling to Medicaid patients regarding medications.
1990 Omnibus Budget Reconciliation Act (OBRA 90)
Restricts distribution of PRESCRIPTION DRUGS to legitimate commercial channels and requires drug wholesalers to be licensed by the states.
1987 Prescription Drug Marketing Act
This act was passed to “address the abuse of steroids by athletes, and, especially, youngsters and teenagers.”
1990 Anabolic Steroid Control Act
The scope of health information that may and may not be shared among healthcare providers without patient consent and provided for a broad and stringent regulations to protect patients right to privacy.
1996 Health Insurance Portability and Accountability Act (HIPAA)
All drugs have pediatric dosing and safety information on their labels if the drug has potential use for pediatric patients.
The pediatric labeling rule established 1994
What is the purpose of phase 1 testing
Safety
What is the purpose of phase 2 testing
Short-term safety but mainly effectiveness
What is the purpose of phase 3 testing
Safety, dosage, and effectiveness
During the trial phase, what is a proposed new drug called
Investigational New Drug (IND)
How long is a drug patent in effect for
17 years from the date of the drug’s discovery
What does OTC stand for
Over-the-counter
What are OTC drugs
Drugs which do not require a prescription
Sets daily and monthly restrictions on the amount of ephedrine or pseudoephedrine that can be sold to an individual
Combat Methamphetamine Epidemic Act
What is the restriction for the combat methamphetamine epidemic act
3.6 g per day and 7.5 g per month
What is required of a patient before purchasing ephedrine or pseudoephedrine
What is required of retailers
Present photo identification
To keep personal information about the purchasers for at least two years after each purchase
How many control schedules are there for controlled substances
Five
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 the schedule.
Schedule I
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 the schedule.
Schedule II
is a currently accepted medical use in the US, but abuse 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 the schedule.
Schedule III
Low potential for abuse, there is a current accepted medical use in the US, but abuse may lead to limited physical dependence or psychological dependence. Compounds containing limited amount of narcotic such as codeine are included in this group.
Schedule V
Low potential for abuse. there is a current accepted medical use in the US, but abuse may lead to limited physical dependence or high psychological dependence. Phenobarbital, the sedative chloral hydrate, and the anesthetic methohexital are included in this group.
Schedule IV
How long are schedule II records kept
Seven years
How long are schedules III, IV, & V kept
Two years
Where are schedule II drugs stored
In a locked, tamper-proof narcotics cabinet
Where are schedule III, IV, & V drugs stored
storage shelves
What is an injunction
When the FDA prevents the manufacturer from distributing the drug
How many classes of recalls are there
Three
Where there is a strong likelihood that the product will cause serious adverse effects or death.
Class I Recall
Where a product may cause temporary but reversible adverse effects, or in which there is little likelihood of serious adverse effects.
Class II Recall
Where a product is not likely to cause adverse effects
Class III Recall
Who is the leading enforcement agency at the federal level for regulations concerning drug products
Food and drug administration
FDA
Who controls the distribution of drugs
Drug Enforcement Administration (DEA)
Which OTC medications are kept behind the counter even if they do not require a prescription
Medications containing ephedrine and pseudoephedrine; exempt narcotics; and emergency contraceptives.
What is ASHP stand for and who do the represent
American Society of Health-System Pharmacists
The 30,000 member Association for pharmacist practicing in hospitals, HMOs, long-term care facilities, home care agencies, and other healthcare systems. It is an accrediting organization for pharmacy residency and pharmacy technician training Program.
What does USP stand for and who do they set standards for
United States Pharmacopoeia
A voluntary non-for profit organization that set standards for the manufacture and distribution of drugs related products in the United States. These standards are directly referred to by federal and state laws.
What does TJC (JCAHO) stand for And who are they.
The Joint Commission (Joint commission on accreditation of healthcare organizations)
A non-profit independent organization that establishes standards and monitors compliance for nearly 20,000 healthcare programs in the United States, Including hospitals, healthcare networks,HMOs, and nursing homes, among others.
What does ASCP stand for And what do they do
The American Society for consultant pharmacists
Set standards for practice for pharmacists who provide medication distribution and consulting services to nursing homes.
