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PHM1000 De More3
PHM1000 - Pharmacy Technician, Chapter 3, De More
| Question | Answer |
|---|---|
| Food and Drug Act 1906 | Prohibited interstate commerce in adulterated or misbranded food, drink & drugs. Governmental pre-approval of drugs required. |
| Harrison Tax Act 1914 | required that manufacturers, importers, pharmacists and physicians prescribing narcotics be licensed and pay a tax |
| Food Drug and Cosmetic Act 1938 | Requires new drugs to be shown as safe before distributing. |
| Durham-Humphrey Amendment 1951 | Defines what drugs require a prescription by a licensed practitioner, and requires a legend on the label, such as 'RX Only' |
| Kefauver-Harris Amendment 1962 | Requires drug manufacturers to provide proof of safety and effectiveness before marketing the drug |
| Poison Prevention Packaging Act 1970 | Requires child proof packaging on all controlled and most RX drugs dispensed by pharmacies. Non-child proof can only be used when patient requests. |
| Controlled Substances Act | classifies the levels of drugs (controlled substances) that have potential for abuse. Enforced by the DEA. |
| Orphan Drug Act 1983 | Provides incentives to promote research, approval and marketing of drugs needed for treatment of rare diseases. |
| Hatch-Waxman Act 1984 | allowed for the extension of drug patent ters and quicker introduction of lower-cost generic drugs |
| Omnibus Budget Reconciliation Act (OBRA) 1990 | Requires pharmacists to offer counseling to Medicaid patients regarding medication |
| Health Insurance Portability and Accountability Act (HIPPA) 1996 | Defined the scope of health information that may and may not be shared among health providers without patient consent and provided for broad and stringent regulations to protect patients' right to privacy. |
| Placebos | inactive substances administered to patients to give the impression they are receiving potentially effective medication |
| Phase 1 Testing | 20-100 patients; several months; purpose is mainly safety |
| Phase 2 Testing | up to several hundred patients; several months to two years; purpose is short term safety, but mainly effectiveness |
| Phase 3 Testing | several hundred to several thousand patients; 1 to 4 years; purpose is safety, dosage and effectiveness |
| pharmaceutically equivalent | drug products that contain identical amounts of the same active ingredients in the same dosage form |
| therapeutically equivalent | pharmaceutical equivalents that produce the same effects in patients |
| OTC labels | contain the following: product name; name and address of manufacturer or distributor; list of all active and other ingredients; amount of contents; adequate warnings; adequate directions for use |
| RX Label | name and address of dispenser; prescription serial number; date of Rx filling; expiration date; name of prescriber; name of patient; directions for use; Cautionary statements |
| DEA Form 222 | Used to order controlled substance I and II |
| DEA Numbers | Are assigned to prescribers for controlled drugs. EX: AR4342793; add 1st +3rd +5th number = X; add 2nd+4th +6th number = Y; multiply by 2 = Z; then add X+Y=__ __; The total should be a number whose last digit is the same as the last digit of the DEA #. |
| Schedule I | Have a high potential for abuse. Have no currently accepted medical use in treatment in the United States. Lack of accepted safety for use under medical supervision. (Ex: Heroin, PCP) |
| Recalls | Class I: serious adverse effects or death; Class II: cause temporary but reversible effects; Class III: not likely to cause adverse effects |
| Schedule II | High potential for abuse. Currently accepted medical use in treatment in the US or a currently accepted medical use with severe restrictions. (Ritalin, Duragesic Patches)Abuse may lead to severe psychological or physical dependence. |
| Schedule III | Have potential for abuse less than schedules I and II. Currently accepted medical use in treatment in US. Abuse of the drug or other substance may lead to moderate or low physical dependence or high psychological dependence. (Vicodin, Anabolic Steroids) |
| Schedule IV | Low potential for abuse relative to schedule 3. Currently accepted for medical use in treatment in US. Abuse may lead to limited physical dependence or psychological dependence relative to the drugs or other substances in schedule 3. (Xanax, Soma, Valium) |
| Schedule V | Low potential for abuse relative to schedule IV. Currently accepted for medical use in treatment in the US. Abuse may lead to limited physical dependence or psychological dependence relative to those in schedule 4. (Robitussin AC) |
| Controlled RX Requirements | Patient’s full name and address. Practitioner’s name, address, & DEA#.Drug name, strength, dosage form, quantity, directions, and refills. Ink or typewritten and signed by prescriberControlled substance must be dated on the date of issuance |
Created by:
MrsAFlaherty
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