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Chapt.3 Pharm. Law..
Chapter 3 Pharmacy Law, Ethics, and Regulatory Agencies
| Accessory: | Any individual who helps a person to violate the law either directly or indirectly. |
| Administrative law: | Regulations set forth by governmental agencies, such as the Internal Revenue Service (IRS) and the Social Security Administration (SSA); also called regulatory law. |
| Adulterated: | Tampering with or contaminating a product or substance. |
| Barbiturates: | Drugs derived from barbituric acid, which act as central nervous system depressants. |
| Bioethics: | A discipline dealing with the ethical and moral implications of biological research and applications. |
| Civil law: | Rules and regulations that govern the relationship between individuals within society. |
| Crime: | A violation of the law. |
| Criminal: | An individual who violates the law. |
| Drug Enforcement Administration (DEA): | A federal law enforcement agency that combats illegal drug use and smuggling both within the United States and abroad. |
| Felony: | A serious crime, such as murder, kidnapping, assault, or rape, that is punishable by imprisonment for more than one year. |
| Food and Drug Administration (FDA): | The agency within the U.S. Department of Health and Human Services that is responsible for assurance of the safety, efficacy, and security of drugs used for humans and pets. |
| Law: | A rule or regulation established by a governing body. |
| Malpractice: | Professional misconduct, or the demonstration of an unreasonable lack of skill, resulting in injury, loss, or damage to a patient. |
| Medical ethics: | The discipline in which merits, risks, and social concerns are evaluated concerning the practice of medicine. |
| Misbranding: | Fraudulent labeling or marking. |
| Misdemeanor: | A crime less serious than a felony, punishable by a fine or imprisonment for less than one year. |
| National Drug Code (NDC): | A unique and permanent product code assigned to each new drug as it becomes available in the marketplace; it identifies the manufacturer or distributor, the drug formulation, and the size and type of its packaging. |
| National Formulary (NF): | A database of officially recognized drug names. |
| Negligence: | A type of unintentional tort alleged when a person has performed, or failed to perform, an act that a reasonable person would, or would not, have performed in similar circumstances. |
| Orphan drug: | A drug that is developed for small populations of people in need of the drug. |
| Regulatory law: | Regulations set forth by governmental agencies. It is also called administrative law. |
| Standard code sets: | Under HIPAA, “codes used to encode data elements, tables of terms, medical concepts, diagnostic codes, or medical procedure.” A code set includes the codes and descriptors of the codes. |
| Standards: | Established by authority, custom, or general consent as a model or example; something set up and established by authority as a rule for the measure of quantity, weight, extent, value, or quality. |
| Statutes: | Rules and regulations resulting from decisions by legislatures. |
| Tort: | A civil wrong committed against person or property. |
| Intentional torts: | Person's rights infringed upon purposely. |
| Unintentional torts: | Committed inadvertently against someone (negligence or malpractice) |
| Fraud: | Dishonest and deceitful practices. |
| Libel: | Defamatory writing. |
| Slander: | Defamatory speech. |
| Negligence: | Failure to use reasonable care. |
| Abuse: | Improper use of equipment, a substances, or a service. |
| The Pure Food and Drug Act of 1906: | Enforces accurate labeling, list of ingredients, and Patient Package Insert. |
| The Harrison Narcotics Act of 1914: | Enforces documentation for prescriptions and dispensing opium, cocaine, and derivatives products. |
| The Food, Drug, and Cosmetic Act of 1938: | Addressed adulteration and misbranding of drugs; based on the 1906 Pure Food and Drug Act. |
| The Durham-Humphrey Act of 1951: | Made the distinction between legend drugs (prescriptions) and over-the-counter (OCTs) medications that do not require a prescription. |
| The Kefauver-Harris Amendments of 1962: | Gave the FDA specific authority to approve a manufacturer’s marketing application before a drug could be available for commercial use. |
| The Controlled Substance Act of 1970: | The DEA was formed to enforce the laws concerning controlled substances and their distribution. |
| Controlled substances are returned using: | The DEA Form 222. |
| SDS sheets are: | Are for all dangerous chemicals in a workplace. |
| The Orphan Drug Act of 1983: | Used to help create medication for a certain diseases with assistance given to the companies that do the research. |
| The Omnibus Budget Reconciliation Act of 1990: | Provided better quality care for elderly on Medicare (quality of hospice care went up) and allowed commercial pharmacies to work with customers who had Medicaid. |
| Health Insurance Portability and Accountability Act (HIPAA): | Is in place to make sure that all patient's information is private. |
| DIfferent classes of recalls: | Class 1, Class 2, and Class 3. |
| Class 1: | With irreversible side effects or death. |
| Class 2: | With reversible side effects. |
| Class 3: | The medication has a different color smell than normal. |
| Medmarx: | Is an Internet-accessible database to track medication errors in hospitals. |
| FDA oversees: | MedWatch |
| FDA is responsible for approving: | "Tall-Man" letters. |
| ISMP is responsible for implementing: | The error-prone abbreviation list. |
| ISMP is responsible for: | Responsible for overseeing Medmarx. |
| ISMP made recommendations for: | Verbal prescriptions. |
| MERP: | Has a medication error systems. |
Created by:
Scarlett Emerson
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