Glossary of Pharmacy Tech: Chapter 2 Law and Ethics of Pharmacy
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- What year was the Federal Food and Drug Act? What is it?
Law to stop inaccurately (truthful info)labled drugs.
- What year was the Harrison Narcotic Act? What is it?
Law passed because of opium abuse. Need prescription. (Got harder to get)
- What year was the Food, Drug and Cosmetic Act? What is it?
Law made adulteration and misbranding illegal. Need to include package inserts with direction and info on drug. Need "Warning: May be habit forming" for narcotics (controlled substance.
- What year was the Durham-Humphrey Amendment? What is it?
Amendment separated OCT and Legend drugs. Need label: "Caution: Federal law prohibits dispensing without a prescription."
- What year was the Kehauver-Harris Amendment? What is it?
Attempted to ensure safety and effectiveness (by testing for safety and effectiveness) of all new drugs introduced to market (sold).
- What year was the Comprehansive Drug Abuse and Prevention and Control Act?
What is it?
Formed DEA to enforce laws on controlled substance and req. for distributions on them. Also schedule of sub. was introduced.
- What year was the Orphan Drug Act? What is it?
Incentive to drug companies allowing them to waive restrictions on long testing and cost of a new drug and provide it to person with rare disease. (Disease < 200,000 person)
- What year was the Prescription Drug Marketing Act? What is it?
Controlled use of drugs on animal. Need on label: "Caution: Federal law restricts this drug to use by or on the order of a licensed veterinarian."
- What year was the Anabolic Steroids Control Act? What is it?
Stifened regulations on abuse/misuse of anabolic steroids for athletes.
- What year was the Omnibus Budget Reconciliation Act (OBRA)? What is it?
States that pharmacist must counsel all patients who recieve new prescriptions at the time of purchase. (info on drugs: name, when to take it, how long, side effects, adverse reatction.)Need to ensure meds taken checked for problems, interactions, allergies, etc.
- What year was the Health Insurance Portability and Accountability Act? What is it?
Patient's right to continue health insurance even changing employers.
- Who is in charge of advertising?
- What should employers follow? Strickest law or other (Federal vs State)
- Demeral is what schedule of drug?
- C-III drug can be refilled how many times?
- 5 times in 6 months
- When does a prescription for C-IV drug expire?
- 6 months.
- What is a drug monograph?
- Literature on drug.
- Who can recieve phone order prescription?
- Pharmacy interns and pharmacist.
- Where is the prescription for controlled substances are designed with "C" be?
- In red in the lower right corner of the prescription.
- Whick medication does not require a childproof cap?
- Nitrostat SL tablets.
- What is the highest level or manufacture recall?
- Class 1 recall.
- What is a tort?
- Causing injury to a person intentionally or because of negligence.
- For a pharmacy to obtain schedule II controlled substances from a distributor, which DEA form must be filled out?
- Which controlled substance schedule drugs can be obtained OTC?
- Which reference text do physicians use to access drug information?
- Recommended dosing is usually specified by _____ and _______.
- Age and weight.
- What are the two major components needed on a prescription lable?
- Pharmacy info and patient info.
- What is the FDA? (Food and Drug Administration)
- Federal agency. (Deparment of health services.) Enforce guidelines for manufacture for safety and effectiveness of medication.
- What is the DEA? (Drug enforcement agency)
- Federal Agency. (Department of Justice) Prevent illegal distribution and misuse of narcotics. Also issue licenses to distribute narcotics.
- How do you report to the FDA for defect found in OTC or drug problem?
- 800 toll free #
- If you find problems with adverse effect (hospitalization, death, disability, fainting,etc that is not reported on the monograph should be reported by (to?)
- FDA, Poison control center.
Medwatch from FDA.
- What is a Medwatch?
- Allows healthcare professionals and consumers to report discrepancies or adverse reactions with medication. Can be found in PDR/Facts and Comparison.
- What is a controlled substance/narcotics?
- Substances that are addictive and can be abused.
- What type of registration required for maintaining narcotics?
- FORM 225 (Manufacture or distribute C sub.)
FORM 363 (Running C sub. treatment program/compound controlled sub)
FORM 224 (Dispence controlled sub)
- What is FORM 224 used for?
- Registration with DEA (permission) to dispense controlled substance.
- What is FORM 225 used for?
- Registration with the DEA (permission) to manufacture and distribute C sub.
- What is FORM 363 used for?
- Registration with the DEA (permission) to run a controlled substance treatment program / compound controlled sub.
- Which form do you use to order C-II substance? What do you fill out with? How long is invoice kept?
- DEA form 222. Pen typewriter, indelible pencil. Retain for 7 years.
- How do you order C-III to V?
How long do you retain invoice?
- By regular invoice. 2 years.
- What are the 3 record keeping method (filing) controlled substance and legend drugs in pharmacy?
- 1. C-II separate (drawer 1)
C-III though V (drawer 2)
All others (drawer 3)
2. C-II separtate (drawer 1)
C-III to V and all legend. (Drawer 2)
3. C-II to C-V (Drawer 1)
All other pres (Drawer 2)
C-II to C-V when Mixed- stamped with "C" easy iD. or
- What is Schedule I for controlled substance? Give examples.
- No medicinal value. High potential of abuse. Heroin, LSD, MJ, PCP etc. (Street drugs)
- What is Schedule II for controlled substance? Give examples.
- Medicinal use. High potential for abuse. (Psych/physio dependence)
- What is Schedule III for controlled substance? Give examples.
- Medicinal use. Potential for abuse less than II/I. Moderate/low phys/psych dep.
Vicodin, Percodan, Tylenol w/coedine.
- What is Schedule IV for controlled substance? Give examples.
- Medicinal use. low potential of abuse than III. Limited phys/psycho dependence than III. Valium, Barbital.
- What is Schedule V for controlled substance? Give examples.
- Medicainal use. Low potential for abuse in rel. to IV. Limited dep. comp to IV. Robutussin/Coedine, Lomotil.
- How are C-III to C-V refilled (How often can U?)
- 5 times or within 6 months from original order whichever. Amt. should not excede original order.
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