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Monday, October 21, 2019

PTCB - Chapter 3 - Drug Regulation and Control - Definitions

Legend drug
- any drug that requires a prescription and either of these legends on the label: "Caution: Federal law prohibits dispensing without a prescription" or "Rx only"

Pediatric
- having to do with the treatment of children

Placebo
- an inactive substance given in place of a medication

Pharmaceutical equivalent
- drug products that contain identical amounts of the same active ingredients in the dosage form

Product labeling
- important associated information that is not on the label of a drug product itself, but is provided with the product in the form of an insert, brochure, or other document

Therapeutic equivalent
- pharmaceutical equivalents that produce the same effects in patients

Combat Methamphetamine Epidemic Act (CMEA)
- federal law that sets daily and monthly limits on OTC sale of pseudoephedrine and ephedrine

Dual marketing
- status of medications like Plan B that are classified as both prescription drugs and OTC drugs

Exempt narcotics
- medications with habit forming ingredients that could be dispensed by a pharmacist without a prescription to persons at least 18 years of age

CMEA
 - sets daily and monthly restrictions on the amount of ephedrine or pseudoephedrine that can be sold to an individual (3.6 grams per day and 9 grams per month, of which not more than 7.5 grams may be imported by means of a common or contract  carrier or U.S. Postal Service). The law requires purchasers to present  photo identification and retailers to keep personal information about the purchasers for at least 2 years after each purchase

Controlled substance mark
- the mark (CII - CV) that indicates the control category of a drug with a potential for abuse

NDC (National Drug Code) Numbers
 - an NDC number is an identification number assigned by the manufacturer to a drug product. Each NDC number has 3 sets of numbers: the first set indicates the manufacturer; the second set indicates the medication, its strength, and dosage form; and third set indicates the package size. Last set of numbers has 2 digits

Controlled substances
- five groups of drugs identified by the 1970 Controlled Substances Act (CSA) as having the potential for abuse and whose distribution is therefore strictly controlled by five control schedules set forth in the CSA

DEA Form 222
- used to order CI and CII substances. Copy 1 is retained by the supplier, Copy 2 is forwarded to the DEA, and Copy 3 is retained by the purchaser. All forms must be kept on hand for 2 years, even if they are filled out incorrectly. CIII to CV don't require federal order forms because of their lower potential for abuse

CSA
- requires manufacturers, distributors, or dispensers of controlled substances to register with the Drug Enforcement Administration (DEA) of the Justice Department

Adverse effect
- an unintended side effect of a medication that is negative or in some way injurious to a patient's health

Injunction
- a court order preventing a specific action, such as the distribution of a potentially dangerous drug

Recall
- the action taken to remove a drug from the market and have it returned to the manufacturer

Voluntary Med Watch
- reports for adverse reactions to drugs may be submitted online

Vaccine Adverse Event Reporting System (VAERS)
- adverse reactions to vaccines are reported through the VAERS maintained by the Centers for Disease Control (CDC) and the FDA

Compliance
- doing what is required

Protocol
- specific guideline for practice

Liability
- legal responsibility for costs or damages arising from misconduct or negligence

Negligence
- failing to do something that should or must be done

American Society of Health System Pharmacists
- The ASHP is a 30,000 member association for pharmacists practicing in hospitals, HMOs, long term care facilities, home care agencies, and other health care systems. It is an accrediting organizations for pharmacy residency and pharmacy technician training programs

United States Pharmacopeia Convention
- the USP is a voluntary not for profit organization that sets standards for the manufacture and distribution of drugs and related products in the U.S. These standards are directly referred to by federal and state laws and are published in the United States Pharmacopeia and the National Formulary

The Joint Commission
- TJC is an independent nonprofit organization that establishes standards and monitors compliance for nearly 20,000 health care programs in the U.S. TJC-accredited programs include hospitals, health care networks, HMOs, and nursing homes, among others

The American Society for Consultant Pharmacists
- the ASCP sets standards for practice for pharmacists who provide medication distribution and consultant services to nursing homes

Ethics
- a branch of philosophy that helps determine what should be done in a principled sense

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