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Pharmacology 123
chap 1
| Question | Answer |
|---|---|
| Pharmacology | the study of drugs and their actions on living organisms. |
| Drugs | chemical substances that have an effect on living organisms. |
| Therapeutic drugs | those used in the prevention or treatment of diseases. |
| Drug names must have three basic names | Chemical name, Generic name, and trade name (proprietary name, product name, brand name) |
| Drug classified by | body systems, therapeutic use or clinical indications, physiologic or chemical action, prescription or OTC (over the counter) |
| Over the counter drugs (OTC) | Margin of safety, advantages, and disadvantages |
| Drug regulations | needed to protect the public form drug misuse, The FDA of the department of Health and Human Services has been given this responsibility. |
| Federal Food, Drug, and Cosmetic ACT of 1906 | Required that drugs meet standards of strength and purity Required that the type and amount of opioid be listed on the label of opiate mixtures Was amended in 1912 (Sherley Amendment) to prohibit drug companies from using fraudulent therapeutic claims |
| Food Drug and Cosmetic Act – Amendment of 1938 | Four stages of clinical trials Mandates for drug labels |
| Food, Drug, and Cosmetic Act – Durham-Humphrey Amendment of 1952 | Distinguishes between prescription and OTC medications Requirements for opioid prescriptions |
| Controlled Substances Act or Comprehensive Drug Abuse Prevention Act of 1970 | Groups controlled substances into five categories (schedules) Limits the number of prescription refills for controlled substances and requires specific guidelines and procedures Enforced by the DEA |
| Scheduled Drugs | Drugs with a potential for abuse are categorized into schedules Five categories (schedules) according to their potential for abuse Schedule 1 is the most restrictive category Schedule V is the least restrictive category |
| Schedules 1 | Highest abuse potential -High physical dep -High psychological dep -Limited or no therapeutic use |
| Schedules 11 | High abuse potential High physical dep High psychological dep Used therapeutically with prescription – some no longer used |
| Schedules 111 | Moderate abuse potential Moderate phys dep High psychological dependence Used therapeutically with prescription |
| Schedules 1V | Lower abuse potential Lower physical dep Lower psychological dep used therapeutically with prescription |
| Schedules V | - lowest abuse potential Lowest physical dep Lowest psychological dep Used theapeutically WITHOUT prescription |
| Preclinical Investigation | Basic science research Tests on cells and animals Drug dose range Adverse effects Results are inconclusive |
| Clinical Investigation | Involves clinical pharmacology Evaluation of human benefit Longest part of the approval process Submission of the NDA |
| Review of NDA | Approved or rejected after review Approved = it goes on the market Rejected = all testing stops |
| Postmarketing Surveillance | After NDA review completed and approved New drug placed on the market Check for new harmful effects in larger group of humans Drug removed from the market if serious problems occur |
| Medicines are most commonly classified by: A. Brand or generic name B. Chemical name C. Proprietary name D. Body systems, clinical use, or physiology | the answer is D |
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