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pharmacy tech chap1
| Question | Answer |
|---|---|
| when was pure food and drug enacted? | enacted in 1906 |
| When was the Food, drug, and cosmetic act created and What does it require? | created under FDCA 1938, which required that all new drug applications be filed with the FDA |
| what does the FDCA 1938 define? | the adulteration and misbranding of drugs and food products |
| When was Durham-Humphrey Act established? | was established in 1951. |
| Durham-Humphrey act seperated drugs into two categories:.. | legend and nonlegend (over the counter [OTC]) |
| Legend drugs | requires a prescription |
| OTC drug | does not require the supervision of a physician |
| what does Durham-Humphrey Act allow? | verbal prescriptions over the telephone. refills to be called in from a physician's office |
| When was Kefauver-Harris Amendment established? | in 1962 |
| what year was Comprehensive drug abuse prevention and control act established? | 1970 |
| What does the pure food and drug act do? | prohibit the interstate transportation or sale of adulterated and misbranded food or drugs |
| What is Durham-Humphrey Act about? | An amendment to FDCA 1938 requiring all products to have adequate directions for use unless they contain the federal legend "Caution: Federal law prohibits dispensing without a prescription". |
| How was the Drug Enforcement Agency (DEA) created? | It 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 US |
| How many schedules are controlled substances placed in? | 5 |
| What is schedule I about? | No accepted medical use in the US and possesses an extremely high potential for abuse |
| What is schedule II about? | Has a medical use but has a high abuse potential with severe psychological or physical dependency |
| Schedule III? | Has accepted medical use, and the abuse potential is less than with Schedule I and II drugs |
| Schedule Iv? | abuse potential is less, but administration may lead to limited physical or psychological dependence |
| Schedule V? | Abuse potential is less. Schedule includes exempt narcotics. |
| What is drug enforcement agency registration about? | every facility that dispenses controlled substances must be registered with the DEA |
| how can the pharmacy registers with the DEA? | by submitting a DEA form 224 |
| How often must the pharmacy renew the drug enforcement agency registration? | every 3 years |
| What form should be used to order schedule II drugs? | a DEA Form 222 (a triplicate order form). |
| How long is a DEA Form 222 valid for? | 60 days |
| how many items can be ordered in a DEA Form 222? | 10 different items per form. |
| The inoice or packing slip, in addition to the completed DEA Form 222, must be retained in a secure location of the pharmacy for a minimum of 4 years. T/F? | False. it must be retained in a secure location of the pharmacy for a minimum of 2 years. |
| How to order Drugs in Schedules III to V? | Drugs in schedules III to V may be ordered by any method (written, faxed, verbal). |
| How long should a DEA record be maintained for? | minimum of 2 years. It must be kept seperately from other invoices, and kept readily retrievable. |
| What should a pharmacy do with defective forms? | must be kept for a minimum of 2 years and be readily retrievable |
| What should be done for a biennial inventory? | an exact count for Schedule II and an estimated count for Schedule III to V drugs must be performed every 2 years. Records must be kept for a minimum of 2 years |
| What does a perpetual inventory do? | it will show the actual number of units of a drug at a particular moment in time. |
| Return of controlled substances? | can only be returned between DEA registrants |
| How to return schedule II drugs? | Using The DEA form 222 |
| Can controlled subsatnces be returned from long term care facilities? | no. Because these facilities do not have a DEA number |
| Destruction of outdated or damaged controlled substances | A DEA form 41 must be submitted to the DEA, indicating the name, strength, quantities of controlled substances, date & method & witnesses present for the destruction |
| What does form DEA 41 do and how many can a retail pharmacy submit each year? | a retail pharmacy uses this form when there is a destruction of outdated or damaged controlled substances. It may submit one DEA form 41 each year. |
| How many DEA Form 41 can a hospital submit each year? | Hospital may have "blanket authorization" which is direct authority to act without having to gain approval for each action. For example: |
| What form must a pharmacy complete if there is theft of controlled substances? | DEA Forms 106 |
| Exempt narcotic | is a term used to generally describe those Over-the-Counter (OTC) medications, that contain low-level dosages of narcotic and narcotic-type drugs. |
| When was the federal National All Schedules Prescription Electronic Reporting Act introduced? | in 2005 |
| What is the federal national All Schedules Prescription Electronic Reporting Act about? | the Act established an electronic system for practitioner monitoring of the dispensing of controlled substances in Schedules II, III, and IV |
| When was the poison prevention packaging act established? | 1970 |
| What is the poison prevention packaging act about? | it was enacted to reduce accidental poisoning in children. |
| When was the occupational safety and health act (OSHA) established? | 1970 |
| What does OSHA require? | the use of material Safety Data Sheets (MSDSs), which are to be provided by the seller of a particular product to the purchaser. |
| When was drug listing act established? | 1972 |
| What is a drug listing act about? | Each drug is assigned a specific 11-digit number to identify it. This number is known as an NDC (National Drug Code) number |
| How does an NDC (national Drug Code) number work? | 1st five digits identify the manufacturer, next four digits identify the drug product, and the final two digits represent the package size and packaging |
| When was orphan drug act established? | 1983 |
| What is orphan drug act about? | for treatment of diseases or conditions of which there are fewer than 200,000 cases in the world. these product manufacturers receive tax incentives and exclusive licensing of products |
| What does Kefauver-Harris Amendment do? | it required all medications in the US to be pure, safe, and effective (p.10) |
| When was drug price competition and patent term restoration act established? | 1984 |
| What is the drug price competition and patent term restoration act about? | It encourages the creation of both generic and new medications. |
| When was the prescription drug marketing act established? | 1987 |
| What is the prescription drug marketing act about? | It prohibits the reimportation of a drug into the US by anyone except the manufacturer. Prohibit the sale or distribution of samples to anyone other than those licensed to prescribe them |
| Which act requires the label:"Caution: Federal law restricts this drug to use by or on an order of a licensed veterinarian" to appear on all medications to be administered to animals? | The prescription drug marketing act (p. 19) |
| Define medicare? /ˈmediˌke(ə)r/ | A federal system of health insurance for people over 65 years of age and for certain younger people with disabilities |
| Define medicaid? /ˈmediˌkād/ | A federal system of health insurance for those requiring financial assistance |
| Define regimen? /ˈrejəmən/ | A prescribed course of medical treatment |
| Define antipsychotic drugs? æntɪsaɪˈkɒtɪk | Used to treat psychotic disorders |
| What does anabolic steroid do? /ˌænəbɑlɪk ˈsteˌrɔɪd/ | increase protein synthesis within cells, which results in the buildup of cellular tissue (anabolism), especially in muscles. growth of the vocal cords, testicles, and body hair |
| When was the omnibus budget reconciliation act occurred? | 1987 and 1990 |
| When was the FDA Safe medical devices act established? | 1990 |
| When was the Americans with disabilities act (ADA) established? | 1990 |
| What is the ADA about? | prevents discrimination against potential employees who may possess a disability |
| What does EPA stand for? | Environmental Protection Agency (p.20) |
| What is FDA modernization act about? | The federal drug legend:"Federal law prohibits the dispensing of this medication without a prescription" is now represented by the abbreviation "RX" on the container under this act |
| What does DSHEA stand for? | Dietary supplement Health and Education Act |
| When was the DSHEA established? | 1994 |
| What does HIPAA stand for? | Health insurance Portability and Accountability Act. |
| When was the HIPAA established? | 1996 |
| What is the HIPAA about? | It ensures that patient confidentiality be maintained. It sets boundaries on the use and the disclosure of protected health information |
| When was the Isotretinoin safety and risk management act established? | 2004 |
| define isotretinoin | Isotretinoin (Accutane) is a very powerful medication used to treat acne. It might cause birth defects, induce abortions, produce adverse psychiatric effects, including depression, psychosis, suicidal ideation, suicide attempts, and suicide. |
| What is MPDIMA? | Medicare Drug, Improvement, And Modernization Act |
| When was the MPDIMA established? | 2003 |
| When was combat methamphetamine epidemic Act established? | 2005 |
| What is combat methamphetamine epidemic Act about | It is a federal law that placed ephedrine, pseudoephedrin, and phenylpropanolamine in the Controlled Substances Act category "scheduled listed chemical products. Products containing those medication are subject to sales restrictions...(P.22) |
| What is USP <797>? | It is designed to cut down on infections transmitted to patients through pharmaceutical products n to better protect staff working in pharmacies in the course of their exposure to pharmaceuticals. (p.22) |
| What does ATF stand for? | Bureau of alcohol, tobacco, and firearms |
| What does CMS stand for? | centers for medicare and medicaid services |
| What does DEA stand for? | Drug Enforcement agency |
| What does EPA stand for? | Environmental Protection Agency |
| What does FDA stand for? | Food and drug administration |
| What does TJC stand for? | The joint commission (p. 23) |
| What does TJC do? | It addresses quality of patient care and patient safety, establishes standards and accredits health care providers. |
| What does NABP stand for? | National association of the boards of pharmacy (p.23) |
| What does BOP stand for? | state boards of pharmacy (p. 23) |
| What does USP stand for? | United states pharmacopeia |
| What does NABP do? | composed of all State Boards of Pharmacy. Has no regulatory authority but meets to discuss current trends and issues in pharmacy that affect the practice of pharmacy |
| What is USP? | it is an official public standards-setting authority for all prescription and OTC medicines and other health care products manufactured or sold in the US |
| What is therapeutic equivalence? | 2 drugs are therapeutically equivalent if they contain the same active ingredients and have the same strength or concentration, some dosage form, route of administration, clinical effect n safety profile |
| what is therapeutic interchange? | it is a substitution of one medication for another medication that is not generically equivalent but would provide the same therapeutic effct |
| Epidemiology p.25 | is defined as a medical science that deals with the incidence, distribution, and control of a disease in a population. Khoa nghiên cứu bệnh dịch, dịch tễ học |
| Nomenclature /ˈnōmənˌklāCHər/ | danh pháp, hệ ký hiệu |
| Antibiotic | thuốc kháng sinh |
| Nomenclature | danh pháp, ký hiệu |
| Prefix | tiền tố |
| suffix | hậu tố |
| sulfonamides | hợp chất dùng để giết các vi khuẩn |
Created by:
jenniferdnguyen1
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