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Chapter 2
Pharmacy Law , Ethics , and Regulatory Agencies
| Term | Definition |
|---|---|
| Act | a statutory plan passed by congress or any legislature that is a bill until it is enacted and becomes law |
| Adulteration | the mishandling of medication that can lead to contamination or impurity , falsification of contents , or loss of drug quality or potency. |
| Amendment | a change in an original act or law |
| barbiturate | a drug derived from barbituric acid; a barbiturate acts as a central nervous system depressant. often used in the tx of seizures and as a sedative and hypnotic agents. |
| Board of Pharmacy BOP | state board that regulates the practice of pharmacy within the state |
| boxed warning | drug warning that is placed in the prescribing information or package insert of the product and indicates a significant risk for potentially dangerous side effects. ---strongest warning the US Food and Drug Administration FDA can give. |
| Controlled substance | any drug or other substance that is scheduled' I through V ' and regulated by the US DRUG Enforcement Administration ' DEA ' |
| Drug diversion | The intentional misuse of a drug intended for medical purposes ; The DEA usually defines diversion as the recreational use of a prescription or scheduled drug |
| Drug Enforcement Administration DEA | Federal agency within the U.S Department of Justice that enforces US Laws and regulations related to controlled substances |
| Drug Utilization Evaluation DUE | A process that ensures that prescribed drugs are used appropriately . The main desired outcome of any DUE program is an increase in medication-related efficacy and safety |
| Ethics | the values and morals used within a profession |
| Health Insurance Portability and Accountability Act of 1996 HIPPA | Federal Act that protects patients rights , establishes national standards for electronic health care communication, and ensures the security and privacy of health data. |
| Legend Drug | Drug that requires a prescription for dispensing ; these drugs carry the federal legend; ' Federal Law prohibits the dispensing of this medication without a prescription ' . |
| Medicaid | Federal and state operated insurance program that covers health care costs and prescription drugs for low income children, adults and elderly and those with disabilities |
| medicare | Federal- and state - managed insurance program that covers health care costs and prescription drugs for individuals older than 65 , persons younger than 65 with long term disabilities and individuals with end stage renal disease |
| misbranding | labeling of a product that is false or misleading ; label information must include dirrections for use ; safe and/or unsafe dosages; manufacturer, packer, or distrubutor ; quantity ; and weight |
| monograph | Comprehensive information on a medications actions within that class of drugs . Also list generic and trade names , ingredients , dosages, side effects, adverse effects , how the patient should take the med, and foods or other drugs ( OTC, MEDS,HERBALS) |
| morals | standard concering or relating to what is right or wrong in human behavior |
| narcotic | a nonspecific term used to describe a drug (such as opium) that in moderate doses dulls the senses , relieves pain, and induces profound sleep but in excessive doses causes stupor , coma, or convulsions and may lead to addiction . |
| National Drug Code NDC 12 NUMBERS | a 12 digit number that indicates specifics of a prescription drug or an insulin product . The NDC specifies the drug manaufacture, the drug product ( drug strength, dosage from, and formulation) and the package size. |
| National Formulary NF | a book of standards for certain pharmaceuticals and preparations not included in the USP; revised every 5 years , and recognized as a book of official standards by the Pure Food and Drug Act of 1906. |
| Negligence | a legal concept that describes an action taken without the forethought that should have been taken by a reasonable person of similar competency. |
| Occupational Safety and Health Administration OSHA | US government managed agency that oversees safety in the workplace ; created by Safety Data Sheet SDS requirements |
| Omnibus Budget Reconciliation Act of 1990 OBRA'90 | Congressional act that changed reimbursement limits and mandated drug use evaluation, pharmacy patient consultation and educational outreach programs |
| Over-The-Counter OTC | describes medication that can be purchased w/o a prescription ; nonlegend medications |
| Physicians Desk Reference PDR | one of the many reference books on medications; it compiles and publishes select manufacturer-provided package inserts and prescribing information useful for health professionals. |
| Pregnancy Categories | a system used by the FDA to describe five levels of assessment of fetal effects caused by a drug; a required section of current prescription drug labeling ; first introduced in 1979 |
| Protected Health Information PHI | a term used to describe a patients personal health data. Under hippa , this information is protected from being shared or distributed without permission. |
| Pure Food and Drug Act of 1906 | Act which led to the creation of the FDA and was enacted to prevent mislabeling or misbranding of medicines |
| Safety Data Sheet SDS Formerly known as MSDS Sheets | a document providing chemical product information. An SDS includes the product name , composition( chemicals in the product) , hazards , toxicology , and other info. |
| The joint commission TJC | and independent , nonprofit organization that accredits hospitals and other health care organizations in the united states. Accreditation is required to be eligible for medicare and medicaid payments |
| tort | an act that causes harm or injury to a person intentionally or because of negligence |
| United States Pharmacopeia USP | an independent , nonprofit organization that establishes documentation on product quality standards , drug quality and information , and health care info. on meds, otc products, dietary supplements , and food ingredients |
| United states pharmacopeia-national formulary USP-NF | a publication of the usp that contains standards for medications , dosage forms , drug substances, excipiets, and medical devices , and dietary supplements |
| US Drug Enforcement Administration DEA | federal agency within the US Department of Justice that enforces US laws and regulations related to controlled substances |
| US Food and Drug Administration FDA | The agency within the US Department of Health and Human Services that is responsible for ensuring the safety,efficacy & security of human and veterinary drugs,biological products, medical devices, the national food supply,cosmetics,and radioactive product |
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dmattaRx
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