Key Terms
State board that regulates the practice of pharmacy within the state
Board of Pharmacy (BOP)
Required that medication manufacturers have to prove a drug's purity, strength, and safety BEFORE it can be sold
1938 Federal Food, Drug, and Cosmetic Act
A medication that has the same ingredients, same dosage form, same routes of administration, and strength is considered:
Pharmaceutically Equivalent
No product selection indicated
0
Medication part of the REMS iPledge program
isotretinoin
Strongest warning in the FDA often enclosed in a black outlined box to draw attention
Black Box Warning
Created schedule classes I-V
1970 Comprehensive Drug Abuse Prevention and Control Act
Patient Package Inserts are required for medications containing_____ and _________
Estrogen, Oral Contraceptives
Override
6
First set of NDC numbers represents the:
Manufacturer
Drug/substance that is scheduled I-V and regulated by the DEA
Controlled Substance
Amendment in place to ensure safety and effectiveness of all new drugs. Reponse to Thalidone tragedy
1962 Kefauver - Harris Amendment
Medications like NSAIDs (Ibuprofen, naproxen) and Antidepressants (fluoxetine, sertraline) must provide ________ when dispensed.
MedGuides
Substitution allowed - Pharmacist selected product dispensed
3
Medications that are exempt from the 1970 Poison Prevention Packaging Act include:
1
2
3
4
Angina Meds, Birth Control, Meds dispensed in a hospital setting, patient/physician request
10 digit number that indicates specifics of a prescription drug.
National Drug Code (NDC)
FDA tracking system for bulk compounding supplies - response to Massachusetts meningitis incident
2013 Quality and Security Act
Who oversees recalls?
FDA
Substitution allowed -Brand dispensed as generic
5
Pregnancy category where studies have shown fetal abnormalities - risk does not outweigh benefit
Category X
Labeling of a product that is false or misleading
Misbranding
Made initial distinction between legend and OTC drugs
1951 Durham-Humphrey Amendment
CII medications can be refilled a max of ______ times.
Zero
Other
9
Process of taking medication from bulk packaging and placing them into blister packs or unit-dose devices
Repackaging
Intentional misuse of a drug intended for medical purposes
Drug Diversion
Required all pharmacies to use a DUE (Drug utilization evaluation)
1990 Omnibus Budget Reconciliation Act
This DEA form is used to authorize the destruction of damaged, outdated, or unwanted controlled substances
Form 41
Substitution is NOT allowed - Brand drug mandated by law
7
Organization that enforces that the workplace must be safe for employees
Occupation Safety and Health Administration (OSHA)
Medications that can be purchased without a prescription
Over-the-counter (OTC)
Made preventative health care more accessible and affordable
2010 Patient Protection and Affordable Care Act
Products that could cause serious harm or prove fatal is what recall class?
Class 1
Substitution allowed - generic not in stock
4
Amount of pseudoephedrine that can legally be sold per day
3.6 grams
Term used to describe a patient's personal health data.
Protected Health Information (PHI)
Required manufacturers and pharmacies to place all medications in containers with childproof caps or packaging
1970 Poison Prevention Packaging Act
CV controlled substances that can be sold OTC to persons over 18 are also referred to as:
Exempt Narcotics
Substitution not allowed per prescriber
1
Medication part of the REMS program that may cause agranulocytosis
Clozapine
Document providing chemical product information (composition, hazards, toxicology, etc)
Safety Data Sheet (SDS)
Restricted the sales of pseudoephedrine
2005 Combat Methamphetamine Epidemic Act
Form that is utilized to report loss or theft of a controlled substance
Form 106
Substitution allowed - patient wants the brand and not generic
2
Government agency that prevents illegal distribution and misuse of controlled substances
Drug Enforcement Administration (DEA)
Publication of the USP that contains standards for medication, dosage forms, drug substances, excipients, medical devices, and dietary supplements
USP-NF (United States Pharmacopeia National Formulary)
Requries that pharmacists offer counseling to patients recieveing new prescriptions
1990 Omnibus Budget Reconciliation Act
Type of inventory that once is started, does not end until medication is no longer in stock. All incoming and outgoing transactions are documented.
Perpetual Inventory
substitution allowed - generic drug not available in marketplace
8
FDA program that allows consumers and health care professionals to report any discrepancies or adverse reactions to medication
MedWatch