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Pharmacology intro 1
intro to pharmacology ch.1
| Question | Answer |
|---|---|
| Biotechnology | process of manipulating deoxyribonucleic acid (DNA) and ribonucleic acid (RNA) and recombining genes into hybrid molecules that are inserted into living organisms and reproduced. increasing % of drugs in development. |
| Brand or trade name of drugs vs generic name | brand/trade designated & patented by manufacturer - capitalized in literature. generic name related to chemical or official name independent of the manufacturer. - in lower case. indicates the drug group. Drugs prescribed/dispensed by both. |
| controlled substances | narcotics, stimulants, depressants, hallucinogens and anabolic steroids that are categorized according to therapeutic usefulness and potential for abuse. |
| The Food, Drug and cosmetic act of 1938 | regulate manufacture, distribution, advertising and labeling of drugs. meets standards of purity/strength as determined by chemical analysis or by animal response to specified doses (bioassay) |
| Pharmacology | study of drugs (chemicals) that alter function of living organisms. |
| over-the-counter (OTC) drugs | No prescription required. |
| Pharmacoeconomics | costs of drug therapy, including costs of purchasing, dispensing, storage, administration, laboratory and other tests used to monitor patient responses and losses due to expiration. Length of illness/hospitalization considered. research goal lower cost |
| Pharmacotherapy | drug therapy - use of drugs to prevent, diagnose, treat signs/symptoms and disease processes. |
| local vs systemic effects of drugs | local effects act mainly at site of application. Systemic effects taken into body, circulated in blood to site of action in tissue and eliminiated from body. |
| Benefits of using synthetic drugs | more standardized in chemical characteristics, consistent in effects, less likely to produce allergic reactions. |
| Semisynthetic drugs | many antibiotics --naturally occurring substances that have been chemically modified |
| Drug classification | classified based on effects on particular body system their therapeutic uses and their chemical characteristics. therapeutic reflect conditions used for - drug groups reflect chemical characteristics. Fit in multiple groups bc range of effects on body |
| prototypes | individual drugs that represent groups of drugs, often first drug of group to be developed, usually standard that similar drugs compared to. |
| official drugs | those listed in the US pharmacopeia and designated usp |
| Durham-Humphrey amendment | designates drugs that must be prescribed |
| regulator of vaccines and other biologic products | Public Health service |
| federal trade commission role in drug safety | can suppress misleading advertisements of non-prescription drugs |
| Food and drug administrations role in drug safety | enforce drug laws |
| comprehensive drug abuse prevention and control act title II (1970) | called the controlled substances act, regulates manufacture and distribution of narcotics, stimulants, depressants, halucinogens and anabolic steroids. |
| Pure food and drug act (1906) | standards/requirements for accurate labeling of drug products |
| Sherley amendment (1912) | prohibited fraudulent claims of drug effectiveness |
| Harrison Narcotic act (1914) | restricted importation, manufacture, sale and use of opium, cocaine, marijuana and other drugs that the act defined as narcotics |
| food, drug and cosmetic act (1938) | revised/broadened fda power over drug safety, req. proof of safety from manufacturer before new drug marketed, factory inspections, penalties for fraudulent claims |
| amendment (1945) | req'd governmental certification of biologic products (such as insulin and antibiotics) |
| Kefauver-Harris amendment (1962) | manufacturer to provide evidence that drug effective for claims and conditions on label, federal government can standardize drug names |
| Drug regulation reform act (1978) | guidelines for research studies and data to be submitted to fda by manufacturers. shortened development and marketing time for new drugs. |
| orphan drug act (1983) | decreased taxes and competition for manufacturers who would roduce drugs to treat selected serious disorders affecting relatively few people |
| prescription drug user fee act (1992) | fda collect user fees from pharmaceutical companies w/ each new drug application, shortens review time (bc more staff). review time set at 12 months for standard drugs and 6 months for priority drugs |
| NIH revitalization act (1993) | requires inclusion of women and minorities in NIH funded research studies, including phase III clinical drug trials |
| FDA modernization act (1997) | updated regulation of biologic products. inc patient access to experimental drugs and devices. faster review of important drugs, companies can disseminate info about of label (non fda approved) uses and costs of drugs. extended fees. |
| best pharmaceuticals for children act (2002) | encouraged studies and label drugs for use by children. funds for 5 years for pediatric drug studies. |
| Drug enforcement administration and drug safety | enforces controlled substances act. individuals and companies working with controlled substances need to be registered with dea. |
| nurses role in drug safety of controlled substances | storing controlled substances in locked containers, administering only to whom they are prescribed, recording each dose given on narcotic sheets and on patient mar, maintaining accurate inventory and reporting discrepancies to proper authorities. |
| Categories of controlled substances | Schedule I, no approve for med use high abuse pot'l. II, used med high abuse pot'l. III less potential for abuse than I&II, may lead to psychoogical/physical dependence. IV, some potential for abuse. V, mod. amts ctrl'd substances. no Rx but restricted. |
| Drug testing | done in studies - phases - progresses if continuing evidence of safety and effectiveness. |
| Phase I drug testing | Phase I, few doses given to certain # healthy volunteers to determine safe dosages, routes OF Admin, Absorption, Metabolism, Excretion and toxicity |
| Phase II drug testing | few doses to certain number of subjects w/ disease/symptom for which drug being studied, responses are compared to healthy subjects. |
| Phase III drug testing | drug given to larger more representative group. double-blind, placebo-controlled designs, half receive drug half placebo with neither subjects nor researchers knowing who receives which formula. determine if benefits outweigh risks |
| Crossover studies - drug testing | subjects receive drug half of study and placebo other half. |
| Phase IV drug testing | FDA evaluates data from first thre phases for safety ad effectiveness, allows drug to be marketed for general use and requires manufacturers to continue monitoring effects. |
| 1P | state indicating new drug reviewed on priority (accelerated) basis and w/ some therapeutic advantages over drugs already available. |
| 1S | status indicating standard review and drugs w/ few if any therapeutic advantages. Most drugs fall into this category. |
Created by:
FSclafani
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