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pht 101 c1p6

chapter 1 part 6

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
Created by: moekah



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