Help
Options
Didn't know it?
click below
click below
Knew it?
click below
click below
Don't Know
Remaining cards (0)
Know
retry
shuffle
restart
0:00
Embed Code - If you would like this activity on your web page, copy the script below and paste it into your web page.
Normal Size Small Size show me how
Normal Size Small Size show me how
Cert Ch 2 Laws
Cert Exam CH02 Flash Cards--Laws
| Term | Definition |
|---|---|
| Occupational Safety and Health Act (1970) | Created the Occupational Safety and Health Administration (OSHA), which attempts to reduce hazards in the workplace and create a safe and healthy workplace for all employees; required reporting of job-related injuries and illnesses. |
| Poison Prevention Packaging Act (1970) | Required child-resistant containers for most prescription and OTC drugs to prevent accidental ingestion and poisoning. |
| Omnibus Budget Reconciliation Act (OBRA-90) (1990) | Required pharmacists to engage in drug utilization reviews (DUR) and offer Medicaid patients the option of free prescription counseling. |
| Dietary Supplement Health and Education Act (DSHEA) (1994) | Classified herbal supplements as food products rather than drugs; prohibited manufacturers of herbs and dietary supplements from making claims that their products treat or cure any specific disease or illness. |
| Durham-Humphrey Amendments to FDCA (1951) | Distinguished between prescription and nonprescription drugs; required amendments to FDCA that all drug products have adequate usage directions or bear the legend “Caution: Federal Law Prohibits without Prescription” and that all OTC drugs that includes a list of active ingredients; allowed verbal prescription and refill requests to pharmacies by telephone. |
| Prescription Drug Marketing Act (PDMA) (1987) | Prohibited the reimportation of drugs to the United States, except by the manufacturer. |
| Pure Food and Drug Act (1906) | First law to regulate the development, compounding, distribution, storage and dispensing of drugs; prohibited false or misleading labeling about drug strength or purity, and interstate transport or sale of adulterated or misbranded drugs. |
| Patient Protection and Affordable Care Act (ACA) (2010) | Comprehensive health care reform law; established health insurance exchanges; provided catastrophic coverage for high-cost illness; prohibited insurers from refusing coverage to those with preexisting conditions. |
| Combat Methamphetamine Epidemic Act (CMEA) (2005) | Restricted sales of OTC drugs used in making methamphetamines (pseudoephedrine, ephedrine, and phenylpropanolamine) to limited amounts; stored behind the counter with sales monitored (in some states, only by the pharmacist). |
| Comprehensive Methamphetamine Control Act (1996) | Established methamphetamine as a dangerous addictive drug requiring legislative oversight and control of the exportation, importation, and manufacturing of methamphetamine substances and its ingredient chemicals. |
| Comprehensive Drug Abuse Prevention and Control Act (Controlled Substances Act/CSA) (1970) | Established the federal Drug Enforcement Administration (DEA); created a schedule of drugs that have the potential for abuse and/or addiction and categorized them into five classes. |
| Patient Safety and Quality Improvement Act (PSQI) (2005) | Promoted mechanisms for patient safety and continuous quality improvement; encouraged creation of Patient Safety Organizations (PSOs) to collect confidential information on medical errors to detect systematic changes for safety. |
| Anabolic Steroids Control Act 1990 | Redefined anabolic steroids as Schedule III controlled substances. |
| Resource Conservation and Recovery Act (1976) | Governs the disposal of solid waste and hazardous waste; established “cradle-to-grave” standards for the generation, transportation, treatment, storage, and disposal of hazardous waste. |
| Orphan Drug Act (1983) | Provided tax incentives for developing and marketing drugs used to treat rare conditions; established longer exclusive licensing and tax incentives for manufacturers that develop orphan drugs. |
| Medicare Modernization Act (2003) | Provided a voluntary prescription drug plan (Part D) for Medicare patients for additional cost; created the health savings account (HSA); allowed pharmacists to get reimbursed for medication counseling and therapy management. |
| Biologics Price Competition and Innovation Act (BCPI) (2009) | Created an abbreviated pathway for the approval of biological products that are proven to be biosimilar or interchangeable with an FDA-approved reference biological product. |
| Drug Quality and Security Act (DQSA) (2013) | Title I (Compounding Quality Act) established regulations for compounding pharmacies and outsourcing facilities; encouraged regulation of all outsourcing facilities. Title II (Drug Supply Chain Security Act) established a national database to “track and trace” drug products through the supply chain from the manufacturer to the dispensing pharmacy |
| Drug Price Competition and Patent Term Restoration Act (1984) | Streamlined the FDA approval process for marketing generic drugs; extended the terms of patents for companies that develop new drugs. |
| Food, Drug and Cosmetic Act (FDCA) (1938) | Created the US Food and Drug Administration (FDA); required that products be safe for human use and that manufacturers include product inserts. |
| Kefauver-Harris Amendment to FDCA (1962) | Required that drugs be safe and effective, and that pharmaceutical manufacturers file an Investigational New Drug Application (INDA) before starting clinical trials on human subjects to win FDA approval |
| Drug Listing Act (1972) | Required National Drug Code (NDC) numbers be assigned to every marketed drug. |
| Health Insurance Portability and Accountability Act (HIPAA) (1996) | Addressed patient privacy concerns by requiring signing of a confidential annual HIPAA form outlining who has access to patient information; allowed employees to easily move their health insurance from one job to another; resulted in privacy protection practices for the communicating, collecting, storing, disclosing, and disposing of patient data. |
Created by:
alavance
Popular Pharmacology sets