Chapter 1&2 Exam Flashcards
Omnibus Budget Reconciliation Act 1990
- Mandates that OTC drugs be documented as part of a medical record
- Mandates that pharmacists provide drug use review and patient counseling
Pure Food and Drug Act 1906
- First attempt to establish consumer protection in drug and food manufacture
- Required drugs to meet minimal standards of strength, purity, and quality
- Demanded labeling for preparations containing dangerous ingredients
- Established United States Pharmacopeia (USP) and National Formulary (NF)
Federal Food, Drug, and Cosmetic Act 1938
-Established more specific regulations for preventing adulteration of (tampering with) drugs, foods, and cosmetics
- Example: “Warning” labels must be present on certain preparations
- “May cause drowsiness,” “may cause nervousness,” “may be habit-forming,” etc.
Orphan Drug Act
• Gives financial incentives to develop medications for diseases that affect a small number of people (orphan drugs that would otherwise be of a low profitability
Controlled Substances Act 1970
- Established the Drug Enforcement Administration (DEA)
- Set tighter controls on depressants, stimulants, psychedelics, narcotics, and anabolic steroids
- Demanded security and accountability of controlled substances
- Set limitations on the use of prescriptions
- Demanded each prescriber of these substances register with the DEA and obtain a DEA registration number
- Isolated the abused and addicting drugs into 5 levels or schedules, according to their medical value, harmfulness, and potential for abuse and addiction
- Refer to Table 1-1, textbook
- C-I, C-II, C-III, C-IV, and C-V
- C on a drug package indicates a controlled substance
- the roman numeral indicates the schedule level
C-I definition
High abuse potential, not approved for medical use in the United States, are illegal
C-I Examples
heroin, LSD, ecstasy,
C-II definition
High abuse potential; may lead to severe dependence, written Rx only, in emergency it can be phoned in by physician, but handwritten Rx must be provided to the pharmacy within 7 days
C-II Examples
morphine, codeine, Oxycontin, Ritalin, Demerol
C-III definition
May lead to moderate dependence, Rx written, faxed, or verbal (phoned in) by physician only, can be refilled up to 5x’s in 6 months
C-III examples
codeine & hydrocodone with Tylenol, anabolic steroids
C-IV definition
Lower abuse potential than the previous schedules, Rx may be written out by health care practitioner, but must be signed by the physician, can be phoned in or faxed, can be refilled up to 5x’s in 6 months
C-IV Examples
Valium, Ativan, Xanax, phenobarbital, Ambien,
C-V definition
Low abuse potential, medication consists primarily of preparations for cough suppressants containing codeine and preparations for diarrhea
C-V examples
promethazine with codeine, Lomotil
FDA stands for …
food and drug administration
FDA responsibilities
- Oversees drug testing before release
- Inspects plants where foods, drugs, medical devices or cosmetics are made
- Reviews new drug applications and petitions for food additives
- Investigates and removes unsafe drugs from the market
- Ensures proper labeling of foods, cosmetics, and drugs
DEA stands for…..
Drug Enforcement Administration
What does the DEA do?
- Oversees drug testing before release
- Inspects plants where foods, drugs, medical devices or cosmetics are made
- Reviews new drug applications and petitions for food additives
- Investigates and removes unsafe drugs from the market
- Ensures proper labeling of foods, cosmetics, and drugs
Generic Name
Common/general name, initial lowercase letter-never capitalized (always begins with a lowercase letter), assigned by USAN
Trade Name
name assigned by the Pharmaceutical company, copyrighted, capitalize the first letter
Chemical Name
Exact molecular formula, usually long and difficult to pronounce, of little concern to the health care practitioner
Official Name
Official name used in USP/NF, generally the same as the generic name
OTC Drug
No purchasing restrictions by the FDA; Medication available without a prescription;
Legend Drug
Prescription drug; determined unsafe for over-the-counter purchase because of possible harmful side effects if taken indiscriminately
Includes birth control pills, antibiotics, cardiac drugs, and hormones
Controlled Substance
Drug controlled by prescription requirement because of the danger of addiction or abuse
Indicated in references by schedule numbers C-I, C-II, C-III, C-IV, or C-V
Therapeutic Use
Most useful way to classify drugs from the standpoint of health care professionals.
Adverse Reactions
List of possible unpleasant or dangerous secondary effects, other than the desired effect
Cautions
Precautions; steps to take to prevent errors
Contraindications
List of conditions for which the drug should not be given
Classifications
Broad subcategory for drugs that affect the body in similar ways
Most helpful grouping: according to therapeutic use
indications
List of conditions for which a drug is meant to be used
actions
A description of the cellular changes that occur as a result of the drug
