Chapter 2: Drug Approval and Regulation Flashcards
Role of FDA
-role in drug approval process
-how drugs get approved and regulated
GOAL: safe and effective drugs
To be approved for marketing, a drug must pass through animal testing, testing on healthy humans, selected testing on people with disease being treated, and then broad testing in people with disease being treated
Why do you need drug regulations?
protect the public from drug misuse and ensure continuous evaluation of safety and effectiveness
FDA was established when and a part of which agency currently
officially established in 1988 and a part of the Unites States Department of Health and Human Services (HHS)
Branches of FDA
CDER: Center for Drug Evaluation and Research
CBER: Center for Biologics Evaluation and Research
CFSAN: Center for Food Safety and Applied Nutrition
CDER
Center of Drug Evaluation and Research
Mission: availability of safe and effective drugs, keeping ineffective and unsafe drugs off the market, improving the health of Americans, clear and easy drug info
-exercises control if OTC or prescription drugs can be used for drug therapy
CBER
Center of Biologics Evaluation and Research
-regulates use of biologics (drugs derived from living sources) including serums, vaccines and blood products
CFSAN
Center for Food Safety and Applied Nutrition
-oversees administration of herbal products and dietary supplements
- can enter the market with prior approval from FDA but all package inserts and info will be monitored after it reaches the market
Black Box Warnings
-primary alert for extreme adverse drug reaction that was discovered during and after review process
-strongest safety warning that a drug can carry and can still be on the market
NCCIH
National Center for Complementary and Integrative Health
-scientific research and info on CAM (Complementary and Alternative Medicine therapies)
Name the Four phases of approval for therapeutic and biological drugs
1) Preclinical investigation
2)Clinical investigation
3) Review of New Drug Application (NDA)
4) Post-Marketing Surveillance
Pre clinical investigation
2-5 YEARS basic science research
1-2 years pre-clinical testing
-extensive research for need for development of drug; target certain disease or illnesses?
-test on animals
-if looks promising, submit Investigational New Drug Application (IND)
Clinical investigation
9 YEARS
3 phases
1) testing on healthy humans
2)selected testing on individuals with disease being treated
3)broad testing on individuals with disease being treated
Review of New Drug Application (NDA)
17 to 24 MONTHS
application for FDA approval: submit NDA New Drug Application
Drug name finalized
NDA approval= final phase
NDA rejection= suspended until concerns addressed
Post-Marketing Surveillance
Survey harmful drug effects in larger population;
FDA holds annual public meetings to receive feedback on new drug therapies (safe and effective?)
Nurse’s Role in Drug Approval Process and in maintaining safety practices
we administer the drugs
monitor therapeutic effectiveness and adverse reactions (POST-MARKETING SURVEILLANCE)
- responsible staying up to date on new drugs
-inform pharmacist or provider to report to FDA
