INTRO Flashcards
How are Nonprescription Drugs defined?
-Benefits outweigh risks
-Low potential for abuse/misuse
-Appropriate for use with self-diagnosed conditions
-Can be adequately labeled
-Can be used safely and effectively without a HC provider
What was the first law about drugs published in 1938?
-Provided regulations to ensure safety -> have to provide the FDA with safety data on how to use the medication
Further regulation laws:
1951: Durham-Humphrey Amendment -> 2 classes: prescription and nonprescription (OTC)
1962: Kefauver-Harris Amendment -> Manufactures must prove safety and efficacy -> proof that the drug works
1972: OTC drug review: a scientific review of the 700 active ingredients in OTC products for safety and efficacy
1991: Division of Nonprescription Drug Products -> guidance documents on OTC
1997: Food and Drug Modernization Act -> inactive
ingredient label requirements (f.e. for people with allergies)
What are the options to get a new drug approved?
-Through NDA: starting with data from animal studies and human clinical trials -> prescription to OTC switch or direct to OTC
-OTC Monograph: recipe book with ingredients
What is the DHSEA about?
Herbal supplements, vitamins, and minerals are considered dietary supplements, not drugs
-have to meet standards of food products
-Labeling: they are limited to health, nutrient, or body function claim -> they can’t make claims if not approved by the FDA
Ca product strengthens the bones but they can’t say it helps with bone cancer bc it is not approved -> no therapeutic claim
Explain the Dietary Supplement and Nonprescription Drug Consumer Protection Act (2006)
-manufacturer is required to record serious adverse events of products + dietary products
What is GMP?
Safety Standards for the production of drug products
How are Homeopathic Products regulated?
Homeopathic
Pharmacopoeia Convention of the United States (HPCUS)
What are the Pseudoephedrine Restrictions?
-Recordkeeping (show ID, NPLEx in Tennessee) and purchase limits for Pseudoephedrine-containing products
How are non-prescription drug products labeled?
-patient-friendly, able to use without medical consultation
-Standardized Drug facts Label format required
-Expiration label required
+ they have TAMPER EVIDENT PACKAGING
What are the two types of labels on OTC products?
-Drug Facts Labeling with API
-Dietary Supplement Labeling
Claims with the disclaimer, serving size, the scientific name of the plant
Why may drugs be shifted from Rx to OTC?
-economic: insurance, seeing the doc
Able to use without medical guidance
-Dual regulatory status (DRS): Rx and OTC exist
What is the Third drug class?
Dont need a prescription but may need safeguards (by a pharmacist)
Examples: Insulin, Syringes, and needles, Pseudoephedrine
What is NSURE?
Make prescription drugs more accessible
-need to pharmacists but easy to monitor by pharmacists
f.e.: Hypertension, asthma, oral contraceptives
