laws Flashcards
the pure food and drug act 1906
bans the sale of misleading information or impure food and drugs, which laid a foundation for the FDA
OSHA
Ensures a safe and healthful workplace for all employees
Requires a reporting system for job-related injuries and illness
Attempts to reduce hazards in the workplace and conduct audits to ensure compliance with the Act
Addresses air contaminants, flammable and combustible liquids, eye and skin protection, and hazard communication standards
OSHA requires use of Safety Data Sheets (SDSs), which are to be provided by the seller of a particular product to the purchaser.
Established universal precautions
durham-humphrey
“Caution: Federal law prohibits dispensing without a prescription.”
Separated drugs into two categories: legend and non legend (OTC). A legendary drug requires a prescription, but an OTC drug does not. Prescription medications require the supervision of a physician.
Kefauver- Harris amendment 1951
Requires all medications in the United States to be pure, safe, and effective
Established procedures for both drug applications and investigational drugs
Drug manufacturers are required to be responsible for Good Manufacturing Process
HIPAA
Requires that health care providers ensure that patient confidentiality be maintained
Establishes conditions on the use and the disclosure of protected health information (PHI) and requires patient notification on how their PHI will be used
Patients are entitled to a complete discussion of health care options from the health care provider.
Congress enacted the Omnibus Budget Reconciliation Act of 1990 (OBRA ‘90) requiring pharmacists to conduct prospective drug use reviews (ProDUR) and to provide patient counseling for all Medicaid patients.
Sample Question: In 1990 U.S. Congress passed the Omnibus Budget Reconciliation Act (OBRA’90). The original purpose of the bill was to provide medication counseling to which of the following groups of patients?
Tricare covered patients
Uninsured patients
Medicaid covered patients
Workers’ compensation patients
Medicaid covered patients
anabolic steroids control act 1990
Enacted harsher penalties for the abuse of anabolic steroids and their misuse by athletes
Comprehensive Drug Abuse Prevention and Control Act of 1970
The Drug Enforcement Agency (DEA) was created and placed under the supervision of the Department of Justice. Controlled substances are placed in one of five schedules (classifications or categories) based on a potential for abuse and accepted medical use in the united states
drug listing act of 1972
Each drug is assigned a specific 11-digit number to identify it. This number is known as an NDC (National Drug Code) number. The first five digits identify the manufacturer, the next four digits identify the drug product, and the final two digits represent the package size and packaging.
poison prevention packaging act of 1970
The Poison Prevention Packaging Act of 1970 was enacted to reduce accidental poisoning in children. The act requires that most OTC and legend drugs be packaged in child-resistant containers. A child-resistant container is one that cannot be opened by 80% of children younger than 5 years but can be opened by 90% of adults.
FDA
FDA regulates over-the-counter drugs,
enforces drug manufacturing laws,
and regulates the advertising of prescription drugs.
FDA Pregnancy Categories,
Recalls,
ANABOLIC STEROID CONTROL ACT OF 1990
Enacted harsher penalties for the abuse of anabolic steroids and their misuse by athletes
FDA Modernization Act 1997
The act amended the Federal Food, Drug, and Cosmetic Act relating to the regulation of food, drugs, devices, and biological products
- It made its goal to speed research, innovation and access to care.
- Ensured safety in medicine in children
- Introduced new regulation framework for over the counter medicines
- Better investments for orphan drugs
MEDICARE PRESCRIPTION DRUG IMPROVEMENT AND MODERNIZATION ACT OF 200
Provides for a voluntary prescription drug benefit to Medicare beneficiaries
Adds preventive medical benefits to senior citizens
Lowers the reimbursement rates for Medicare payment for durable medical equipment.
Provided for Medication Therapy Management (MTM)
