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pht 101 c1p6
chapter 1 part 6
| Question | Answer |
|---|---|
| pharmacist | one who is licensed to prepare and dispense medications, counsel patients, and monitor outcomes pursuant to a prescription from a licensed health professional |
| pharmacy technician | an individual working in a pharmacy who, under the supervision of a licensed pharmacist, assists in activities not requiring the professional judgment of a pharmacist; also called the pharmacy tech or tech |
| Pharmacy Technician Certification Board (PTCB) | a national organization that develops pharmacy technician standards and serves as a credentialing agency for pharmacy technicians |
| drug | a medicinal substance or remedy used to change the way a living organism functions; also called a medication |
| pharmacologic effect | drug actions on a living system |
| therapeutic drug | the desired pharmacological action of a drug in the treatment of a particular disease state or symptom |
| prophylactic drug | a drug used to prevent disease |
| pharmacognosy | the study of medicinal functions of natural products of animal, plant, or mineral origins |
| biopharmaceutical | bioengineered drugs that are produced by recombinant DNA technology |
| chemical name | a name that describes a drug's chemical makeup |
| generic name | a common name that is given to a drug regardless of brand name; sometimes denotes a drug that is not protected by a trademark; also referred to as a USAN (United States Adopted Name); for example, acetaminophen is the generic drug name for Tylenol |
| brand name | the name under which the manufacturer markets a drug; a registered trademark of the manufacturer; also known as the trade name |
| alternative medicine | herbs, supplements, and homeopathic remedies for medicinial purposes |
| homeopathy | a system of therapeutics in which diseases are treated by administering minute doses of drugs that are capable of producing in healthy patients symptoms like those of the disease being treated |
| “Safe” does not mean | “harmless”—every drug has risks |
| The FDA evaluates significant adverse effects to determine | the seriousness and likelihood that they were drug related |
| If the risk outweighs the benefits, the FDA will ask manufacturer to | withdraw a drug from the market voluntarily |
| Drugs on the market are found to be problematic, but | still provide therapy for specific conditions |
| Black Box warnings are | on package insert |
| Black Box Alerts prescribers to | known problems |
| Thousands of drugs on the market have | Black Box warnings |
| The Controlled Substances Act of 1970 was | to combat escalating drug abuse |
| In 1973, the establishment of the DEA, was the branch of | U.S. Justice Department |
| Controlled Substances levels are | CI highest abuse potential, CII can lead to severe dependency, CIII less potential, CIV low potential, & CV lowest potential |
| Patent grants the sponsor the sole right to manufacture a drug while | the patent is in effect |
| Under a patent, the generic and brand name of a drug belong to | the drug sponsor |
| Once the patent expires, other companies can | produce this drug as a generic |
| Generic Drugs must be equivalent to | the brand-name drugs |
| The FDA has an A/B rating system to establish | therapeutic equivalence of generic drugs |
| The FDA has identified generics as | not therapeutically equivalent in the Orange Book |
| Many drugs used in treating a disease | are OTCs |
| Pharmacy technicians can play an important role in helping patients | identify ingredients in OTC medications |
| It's particularly important when the ingredients of | a previously purchased OTC medication has changed |
| Food and Drug Administration (FDA) | the agency of the federal government that is responsible for ensuring the safety of and efficacy of drugs and food prepared for the market |
| New Drug Application (NDA) | the process through which drug sponsors formally propose that the FDA approve a new pharmaceutical for sale and marketing in the United States |
| drug sponsor | the entity responsible for testing a drug's efficacy and safety, usually a pharmaceutical company |
| legend drug | a drug sold only by prescription and labeled "Caution: Federal law prohibits dispensing without prescription" or "Rx only" |
| over-the-counter (OTC) drug | a drug sold without a prescription |
| medication guide | specific info about certain drug types required by the FDA to be made available to patients |
| clinical trial | drug testing on humans, used to determine drug safety and efficacy |
| double blind study | clinical trials in which neither the trial participants nor the study staff know whether a particular participant is in the control group or the experimental group |
| Black Box warning | info printed on a drug package to alert prescribers of the potential problems with a drug |
| controlled substance | drugs with potential for abuse; organized into five categories or schedules that specify the way the drug must be stored, dispensed, recorded, and inventoried |
| Drug Enforcement Administration (DEA) | the branch of the U.S. Justice Department that is responsible for regulating the sale and use of specified drugs |
| patent | a government grant that gives a drug company the sole right to manufacture a drug for a certain number of years; protects the company's investment in the drug's development |
| The Primary objectives of FDA are weighing risks against | benefits & to protect consumers |
| In 1999, the FDA authorized food companies to | promote disease-fighting and cancer-fighting benefits of whole grains in breakfast cereals |
| In 1999, the FDA authorized use of health claims about the role of | soy protein in reducing risk of coronary heart disease |
| These products are not substitutes for prescribed medications, they are | used in conjunction with drug therapy |