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Which law made label requirements for OTC products?
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When a drug is in the process of being made or discovered, this application must be filed with the FDA to prove efficacy and safety before becoming commercially available.
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Pharmacy Laws
Laws and Amendments
| Question | Answer |
|---|---|
| Which law made label requirements for OTC products? | FDA-Food, Drug, and Cosmetic Act |
| When a drug is in the process of being made or discovered, this application must be filed with the FDA to prove efficacy and safety before becoming commercially available. | NDA- New Drug Application |
| product contains decomposed substance | adulterated |
| the label may be false or misleading | mis-branding |
| The Durham-Humphrey Amendment is also called the | prescription drug amendment |
| proper warning and directions are absent | mis-branding |
| manufacturer name and place of business absent | mis-branding |
| stock label fails to say "warning-may be habit forming" if med is habit forming | mis-branding |
| product has been packaged under unsanitary conditions | adulterated |
| product has different strength or purity than whats indicated on label | adulterated |
| What is the amendment that requires manufacturers to dispense medications with labels to the patient? | Kefauver-Harris Amendment |
| What are requirements for manufacturers as outlined by the Kefauver-Harris Amendment? | 1. requires manufacturers to register annually 2. be inspected every 2 years 3. report any drug interactions |
| requires all medication on the U.S market to be pure, safe, and effective | Kefauver-Harris Amendment |
| PPI's are regulated by the FDA. What are these? | Patient Package Inserts |
| PPI's MUST be supplied to patients receiving what medications? | oral contraceptives estrogen progestin isotetinoin (accutane) intrauterine devices ( IUD's) inhalers |
| Information on the PPI MUST include: | product description indications for use contraindications (when/ and what it interacts with) warnings (extreme side-effects) precautions (less sever side-effects) Dose (how much and how often) |
| The Occupational and Safety Act of 1970 gave rise to | OSHA- Occupational Safety and Health Administration |
| What does OSHA do? | ensures job safety and an injury reporting system for job related injuries or illnesses |
| OSHA requires the pharmacy to | post the number to poison control have a reference guide for toxicities must have Material Safety Data Sheets (MSDS) for any "hazardous materials" in pharmacy |
| The Poison Prevention Packaging Act was enacted to | reduce accidental poisonings in children |
| The Poison Prevention Act requires pharmacies to | use child resistant containers |
| Exceptions to the PPA | medical emergency meds written requests from DRs or patients |
| According to the PPA, OTC meds must | be labeled "package not child resistant" of the package is not child-resistant. |
| Examples of medication exempt from the PPA include: | nitroglycerin sublingual (for chest pain) betamethasone, mebendazole, methylprednisolone (<85 mg), oral contraceptives, pancrelipase, cholestyramine |
| A Poison Log must include: | date of sale name and address of purchaser name and quantity of poison dispensed full name of dispenser |
| Poisonous substances must be labeled with: | complete name of poison the word "POISON" boldly imprinted on label place of business of the seller proper directions of use |
| What is Syrup of Ipecac and how much should be ingested? | used in the emergency treatment of certain kinds of poisoning 15ml or 1 tablespoon |
| What does activated Charcoal do? | absorbs and eliminates poison in the body (not to be taking with Syrup of Ipecac as this will either not work or make the person vomit) |
| Who enforces the Controlled Substances Act of 1970? And what do they do? | The DEA- regulates use and distributes drugs with high abuse potential and/or addiction into one of the five schedules |
| Every pharmacy must make a complete inventory of controlled substances every ___ years and kept on record for ___ years. | two, two |
| A DEA number contains how many letter and numbers? | Two letters, seven numbers |
| DEA letters usually | start with A, B or M for residents 2nd letter is Drs initial to last name |
| Is this DEA number valid? Why? BB10066123 | Do math and answer. |
| Can CII medications be refilled? | No, new prescription is required with every fill |
| CIII and CIV scripts cannot be filled more than ___ times in a ____ month period. | Five, Six (also CVs) |
| CII and CIV scripts can be filled verbally with what exception? | A written script follows verbal. |
| CV meds can be dispensed without script is state allows but this must | be recorded in the CV log. |
| Schedule I medications are | not accepted for medical use in the U.S lack of accepted safety use under medical supervision, and a high potential for abuse |
| Some examples of CI meds include: | crack heroin lysergic acid (LSD) marijuana peyote methaqualone (Ecstasy) |
| Schedule II medications | have a high potential for abuse which may lead to sever psychological or physical dependence. |
| Some examples of CII meds include: | hydromorphone methadone meperidone oxycodone fentanyl morphine opium codeine hydrocodone |
| Schedule III medications | has a potential for abuse, less than CI and CII. May lead to moderate or low physical dependence or high psychological dependence. |
| Some examples of CIII meds include: | products containing not more than 90 milligrams of codeine per dosage unit --Tylenol 3 & 4, Suboxone |
| Schedule IV medications | low potential for abuse |
| Some examples of CIV meds include: | Xanax, Klonopin, Valium, Ativan, Restoril |
| Schedule V medications | have a low potential for abuse, contain limited quantities of certain narcotics |
| Some examples of CV meds include: | Robitussin AC Phenergan w/ codeine Ezogabine cough preparations containing note more than 200 mg of codeine per 100 ml or per 100 grams |
| Limitations of Pharmacy Technician duties: | -varies by state cannot take verbal scripts cannot give consultations cannot take or transfer prescriptions |
| Drugs are recalled if | it was improperly made or labeled and causes severe adverse reactions |
| Class I drug recall: | exposure will cause extreme health hazards or death |
| Class II drug recall: | exposure may cause temporary health hazards |
| Class III drug recall: | not likely to cause health hazards |
| OBRA is also known as the | Omnibus Reconciliation Act of 1990 |
| The function of OBRA: | directed toward pharmacists but require technician assistance improves quality of drug therapy and saves healthcare costs (requires pharmacists to give consultations) |
| OBRA requires counseling that must include: | name and description of medication dosage form, dose, route of administration, and duration of therapy special directions, precautions side effects and ways to prevent techniques for self-monitoring storage refill info action to take if missed dose |
Created by:
braswell1994
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