Term
Food and Drug Administration
FDA |
|
Definition
| federal agency that supervises the development, testing, purity, safety, and effectiveness of prescription and OTC medications |
|
|
Term
Comprehensive Drug Abuse Prevention and Control Act
AKA
Controlled Substance Act (CSA) |
|
Definition
| regulates manufacturing, distribution, prescribing, and dispensing of controlled substances through the Drug Enforcement Administration (DEA) |
|
|
Term
| Consumer Product Safety Commission (CPSC) |
|
Definition
| requires most prescriptions for oral use to be dispensed in child-resistant containers unless patients or prescriber's request otherwise |
|
|
Term
Omnibus Budget Reconciliation Act of 1990
(OBRA '90) |
|
Definition
increases pharmacist professional responsibility
1. requires records to be kept for medications used by Medicaid patients.
2. required counselling to be offered to all Medicaid patients about proper drug usage |
|
|
Term
Joint Commission on Accreditation of Healthcare Organization
(JCAHO) |
|
Definition
| organization sets forth standards for organizations such as hospitals |
|
|
Term
United States Pharmacopeia-National Formulary
(USP-NF) |
|
Definition
defines the standards for medications
1) official titles of medications
2) standards
3) purity
4) packaging and labeling
5) proper handling and storage
6)preparation |
|
|
Term
United States Pharmacopeia Drug Information
(USP-DI) |
|
Definition
1)Patient and 2) Professional Versions
1) easy to understand information about prescription medication for non-medical personal
2) more detailed technical information
|
|
|
Term
Drug Facts and Comparisons
(DFC) |
|
Definition
| encyclopedia of medications that contains facts about the medications... *contains much of the same information as the USP-DI as well as relative price comparisons for drug products. |
|
|
Term
American Hospital Formulary Services Drug Information
(AHFS-DI) |
|
Definition
| cornerstone in pharmacy ... most widely used source of complete drug information. |
|
|
Term
| Physicians Desk Reference (PDR) |
|
Definition
listing of over 4,000 current brand and generic drugs with descriptions and information on usage, warnings, drug interactions, category, and color photos.
annually updated and considered standard amongst physicians |
|
|
Term
| Approved Drug Products with Therapeutic Equivalence Evaluation |
|
Definition
ORANGE BOOK
list of all FDA-approved prescriptions and OTC drugs rated for safety and effectiveness as well as bioequivalence. (Generic production evaluation) |
|
|
Term
| Handbook on Injectable Drugs |
|
Definition
| key reference for hospital or home-infusion settings |
|
|
Term
|
Definition
1) Brand Name
2) Generic Name
3) Medication Strength
4) Legend Statement
5) Storage Requirements
6) Package Quantity
7) Medication dosage form
8) manufacturers Name
9) controlled substance mark
10) Lot #
11) Expiration Date
12) NDC # |
|
|
Term
|
Definition
| Manufacturer- name, strength, and dosage- package size |
|
|
Term
|
Definition
|
|
Term
|
Definition
| drug product is being recalled because there is a strong chance of serious adverse effects or death to the patient |
|
|
Term
|
Definition
| drug product is being recalled because there is a temporary but reversible chance of adverse effect or little chance of serious adverse effect |
|
|
Term
|
Definition
| drug product is being recalled because of some problem that is not likely to cause adverse effects |
|
|
Term
|
Definition
| Studies in pregnant women failed to show a risk to the fetus; fetal harm appears remote |
|
|
Term
|
Definition
| Either animal studies have shown no risk, but controlled studies in pregnant women are not done, or animal studies have shown an adverse effect that was not confirmed in women |
|
|
Term
|
Definition
| Either animal studies have shown an effect on the fetus & there are no controlled trails in women, or there are not studies in either animals or women; should be given only if the risk to the fetus outweighs the benefits |
|
|
Term
|
Definition
| positive evidence of risk to a human fetus, must weigh the risks versus the benefits |
|
|
Term
|
Definition
| Studies show fetal abnormalities; the drug is contraindicated in women who may be pregnant |
|
|
Term
Drug Enforcement Administration
(DEA)
|
|
Definition
| regulates controlled substances-- drugs that have potential for abuse or physical or psychological dependence |
|
|
Term
| Schedule II Scripts must have |
|
Definition
1) typed of hand-written
2) full name and address of patient
3) date of issue
4) medication information |
|
|
