Drug Regulation Flashcards
What role does the federal government play in drug regulation?
They control what drugs can be prescribed or directly sold to the public. The organization that oversees this is the food and drug administration (FDA)
What does the FDA regulate?
- Evaluation process for determining safety and efficacy of new drugs prior to public availability. and removal of dietary supplements deemed unsafe after availability
- Equivalency of brand vs. generic
- Placement of drug in prescription vs. nonprescription and controlled substances
What is the role of the state government in drug regulation?
They control who may prescribe drugs through licensing This does not include controlled substances in which a prescriber must register with the DEA
What is the role of the local government in drug regulation?
may pass laws that concern drug use in their jurisdiction
Prescription drugs:
Evaluated?
Prescription Only?
Abuse potential?
Yes
Yes
Very Low
Controlled Substances:
Evaluated?
Prescription Only?
Abuse potential?
Yes
Yes
Yes
Over-the-Counter
Evaluated?
Prescription Only?
Abuse potential?
Yes
No
No
Dietary Supplements
Evaluated?
Prescription Only?
Abuse potential?
No
No
No
What did the Food, Drug, and Cosmetic Act of 1938 do?
Requires for new drugs and drugs since 1938 manufacturers must demonstrate proof of efficacy and safety prior to release to the public
Describe animal studies
Attempts to determine safe dosage range for humans. Highly predicitive but not totally reliable
After what successful study is the Investigational New Drug Application submitted? Does the application have to be specific for a particular indication?
After successful animal studies
Yes
Describe Phase I
Testing the pharmokinetics. Is it safe? Using less than 100 healthy male volunteers
Describe: Phase II.
Does it work in patients?
Select patient pool of 200-300 with no other medical problems.
Safety and Efficacy evaluated
Comparison of placebo or existing treatment
Describe: Phase III
Does it work, double blinded?
1000-6000 patients
What is a accelerated or conditional approval?
Approval for drugs with the greatest potential benefit for serious, life-threatening disease
When is a NDA approved?
After positive results from phase III
What is the abbreviated New Drug Application?
Application for generic drugs to skip clinical trials. Only approved if bioequivalence standards are met
Describe: Phase IV
Post-marketing surveillance where manufacturers are required to submit reports to the FDA about adverse effects of their drugs. Used to study groups omitted in clinical trials practitioners must play active role in reporting adverse reactions
Name some similarities of generic and brand name drugs
- Same active ingredient
- exact same dosage, intended use, therapeutic effects, SIDE EFFECTS, ROA, risk, safety, and efficacy
3, Pharmacologically the same
Are generic drugs cheaper because they are inferior to the brand name?
No. they didn’t have to pay for clinical trials
Most generic brands are bioequivalents and have a mean bioavailability variation of less than what percent?
4%
What two drugs is it advised to use one or the other formulation?
- Levothyroxine
2. Anti-epipleptic drugs
What is a pharmaceutical alternative?
same therapeutic moiety but different salts or esters, different dosage forms, or strengths
Name four dietary supplements.
Vitamins
Botanicals/ Herbs
Amino acids
Minerals
What is the Dietary Supplement Health and Education Act of 1994 (DSHEA)
Products intended to SUPPLEMENT THE DIET to be TAKEN BY MOUTH that CONTAINS ONE OR MORE DIETARY INGREDIENTS
Which of the four dietary supplements has a molecular entity imparting pharmacologic activity is known?
Vitamins
Amino Acids
Minerals
Which of the four dietary supplements does not have a molecular entity imparting pharmacologic activity that is known?
Herbal medications
What are the regulations on dietary supplements before ‘94?
After 94?
Who is the burden of evidence on to prove a dietary supplement is unsafe?
Not required to be reviewed by FDA for safety before marketing
After must provide reasonable evidence, but manufacturer does not have to probide the FDA with evidence of safety and effectiveness
FDA
Does a health claim on a dietary supplement require evaluation by FDA?
Yes
Does a structure/function claim on a dietary supplement require evaluation by FDA?
No, but the label must contain a disclaimer
Does the law require identification of active principle or data regarding bioavailability, pharmacokinetics, or potential interactions
No, not even on prescription or OTC
What does the Good Manufacturing Practice do?
Who enforces it?
When was it implemented?
Rules that describe conditions under which dietary supplements must be prepared, packed, and stored
FDA
2011
