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Pharmacy law 2011
Pharmacy law
| Question | Answer |
|---|---|
| Medicare Part A | Covers inpatient hospital services, skilled nursing facilities (not custodial or long |
| Medicare Part B | Helps pay doctors, outpatient hospital services, medical equipment, physical & occupational therapy, some home health care. Pay premium & deductible. |
| Medicare Part C | "Medicare Advantage". Combines A & B. Has an HMO, POS, PPO, PSQ. |
| Medicare Part D | Voluntary drug policy. Monthly premium, annual deductible. |
| "A" rating | generic drug considered therapeutically equivalent to brand. |
| AAPT | American Association of Pharmacy Technicians |
| adulterated | contaminated or not manufactured appropriately |
| Abbreviated New Drug Approval (ANDA) | When patent expires on name brand. Generics must have exact same active chemical ingredients. Does not have to submit andy safety & efficacy data. |
| APhA | American Pharmacists Association |
| "B" rating | generic drug not therapeutically equivalent to brand. |
| Class I drug recall | Reasonable probability will cause serious adverse health consequences or death. |
| CMS | Federal agency, Centers for Medicare & Medicaid Services |
| CPhT | Certified Pharmacy Technician |
| CPT | Current Procedural Terminology. Codes to bill a payor for services |
| Controlled Substances Act | Covers buying, inventorying, prescribing, dispensing, storing, using, and destroying controlled substances. The DEA administers the CSA; frequently requires coordination with the FDA |
| Drug Enforcement Administration (DEA) | Has jurisdiction to determine which drugs should be controlled substances. |
| dietary supplement | vitamins, minerals, herbs, nutritional supplements. Regulated as a special class of food. Supplements cannot make health claims for treating a specific disease without prior review by FDA |
| "drug" legal definition | substance used in diagnosis, cure, mitigation treatment or prevention of disease in man or animals |
| FDA | Food and Drug Administration. Created in 1938 by the FDCA. Drugs created after 1938 must meet guidelines. Drugs before 1938 were grandfathered in. |
| Hippa fines for violations | $100 for each violation up to $25,000 in a calendar year. Purposeful violations $50,000 to $250,000 and/or 1 |
| Investigational New Drugs | Drugs used for experimental or investigational use. Or if being used in new way or new method of administration than what was approved for in original NDA process. |
| Institute for Safe Medication Practices (ISMP) | Nonprofit healthcare agency of pharmacists, nurses, & physicians dedicated to learn about med errors, system |
| misbranded | mislabeled |
| NDA | New Drug Application. Manufactures must prove new drug to be safe and effective before FDA will grant an NDA. |
| OBRA | Omnibus Budget Reconciliation Act of 1990. Pharmacist must preform DUR for all Medicaid patients. Patient counseling cannot be delegated or assumed by technician. |
| Orange Book | Approved Drug Products with Therapeutic Equivalence Evaluations. Lists generic drugs that have been compared to brand drugs marketed with NDA. |
| Prescription Benefits Manager (PBM) | Company contracts with this org, which contracts with pharmacy. Provides formularies, drug utilization reviews, disease management services, mail services |
| Phase I for investigational drugs | Clinical investigation in small number of patients. Determine preferred administration route & safe dosing. |
| Phase II for investigational drugs | Clinical investigation on limited number of patients. Specifice disease treatment or prevention. Further determine drug safety. |
| Phase III for investigational drugs | Clinical trials expanded. Further testing of safety and efficacy. |
| PHI | protected health information. Oral, written, or electronic info created or received by healthcare provider. |
| Phase IV for investigational drugs | Post |
| Poison Prevention Packaging Act 1970 | Requires safety caps. Covers prescritptions and most OTC. Also furniture polish, turpentine, ethylene, etc. |
| PPO | Preferred Provider Organization. Similar to HMO but homogenous group of providers collectively offer single type of service |
| SND | Supplemental New Drug application. If manufacturer seeks new labeling or deviation from routes of administration does not have to resubmit original data proving drug is safe & effective. |
| Class II drug recall | May cause temporary or medically reversible health consequences. Remote chance of serious consequences. |
| Class III drug recall | Product not likely to cause adverse health consequences |
| USP | NF |
| Defines quality assurance procedures. | |
| Controlled Substances | DEA regulates whether drug is classified as controlled or not. States also regulate. The stricter law is the law followed. Classified by abuse potential. |
| Refill restrictions | Schedule II -- no refills Schedule III & IV--up to 5 times within 6 months Schedule II -- no refills Schedule III & IV--up to 5 times within 6 mo Schedule V- as directed by prescriber,up to 5 refills |
| Schedule I (C1) | No accepted medical use in US, and high abuse potiential. ex: heroin, marijuana |
| Schedule II (CII0 | Have accepted medical use and high abuse potential with severe psychic or dependence liability |
| Schedule III (CIII) | have accepted medical use and abuse potential less than C-II |
| Schedule IV (CIV) | Have accepted medical use and abuse potential less than C-III. |
| Schedule V (CV) | have accepted medical use and abuse potential less than C-IV |
| Tamper resistant packaging | FDA required. Established after tampering led to 7 deaths. Exemptions: dermatological, nitroglycerin, insulin, throat lozenge produc ts |
| Federal Hazardous Substance Act | Hazardous substance is one that my cause injury or illness and potential danger, esp to children. Covers items besides drugs such as cleaners, antifreeze, etc. May only be sold in original containters. |
| Malpractice (definition) | Categorized as tort law (civil liability). Injury or damage thru negligence or intentional action. Courts have ruled only liable in cases of dispensing error. Failure to do DUR checks constitute pharmacist malpractice. |
| Malpractice elements (4) | 1) duty owed the patient 2) breech of duty by professional 3) patient has to be injured 4) injury caused by breach of |
| Professional judgement | laws protect pharmacist when making a discretionary judgment to protect the best interest of the patient. |
| "C" must be place on | Class I, II, III, IV, & V drugs |
| Joint Commission of Accreditation of Healthcare Organizations | grant hospitals accreditation |
| Licensure | Government agency grants permission to individual to practice in occupation |
| P & T Committee | group that develops drug policies, educates professionals on med use, develops & revises list of approved drugs in a hospital |
| Formulary | list of drugs approved for use in a specific hospital or other organization |
| Code of Ethics | standards of conduct to which member of a profession are held |
| DEA confirmation | first letter = prescriber classification last letter = first letter prescriber's last name add numbers: (1st + 3rd +5th ) + [(2nd + 4th + 6th) *2] =? last digit of answer = last digit of DEA number |
| National drug code, (NDC) | A 10-digit,3-segment,unique number assigned by the FDA when the drug 1'st becomes available in the US Segments: Seg 1 - Labeler Code - Manufacturer/Distributer Seg 2 - Product Code - Dose, form, strength, formula #3 Package Code - size of drug pack |
| Nonfeasance | The failure to act when one should. |
| Occupational Safety and Health Administration (OSHA ) | A division of the US deartment of labor |
| The Harrison Narcotic Tax Act of 1914 | Implemented to regulate and tax the distribution, importation, andproduction of opiates. |
| Kefauver | Harris Amendment of 1963 |
| Durham Humphrey Amendment of 1951 | Prohibits dispensing of legend drugs without a prescription. |
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