DRUG APPROVAL PROCESS Flashcards
Who approves new drugs for human use?
FDA
Compounds are consider as _____and _____.
- DRUGS - prozac, loft
- BIOLOGICS - comes from a natural source such as proteins or sugar from human or animals
- Humira, vaccines
Animal trials to determine if it is safe and effective
Preclinical Testing
Investigational New Drug (IND) applications filed w/ FDA
-Once application is approved, human trials begin to determine if it is safe and effective
Clinical Testing
application submitted for naturally sourced compounds seeking FDA approvals
Biologic License Application (BLA)
a drug compound undergoing clinical testing in humans
Investigational drugs
First time given to human subjects
Goal - focus on safety and minimal adverse effects
SUBJECTS - health volunteers, don’t have the disease, less than 100 subjects
Phase 1
- generic name instead of alphanumeric format
- Goal : Effective dose, drug delivery method, dosing internals, continue safety evaluation
SUBJECTS - ppl who has the disease, 50-300, if phase 1 is proven to be safe.
- Goal : Effective dose, drug delivery method, dosing internals, continue safety evaluation
Phase 2
- Goal - establish acceptable uses of the drug, monitor safety and efficacy
- SUBJECTS - 3000 subjects w/ condition
- Documentation - dosages, timing of administration, adverse effects, and outcomes
- If approved, drug companies can manufacture and sell the product.
- Market brand name along w/ its generic.
Phase 3
- FDA still monitors the safety and efficacy data after the drugs goes to market.
Requires to report adverse effect after drugs goes to market.
Phase 4 (Postmarketing Testing)
committee or board
- Purpose is to review/approve research w/ human subjects - Approve documents: protocols, consent forms, brochures
Institutional Review Board (IRB)
makes ethical decisions to protect the health and welfare of research volunteers
- Free of bias and conflict of interest - Represent diverse opinions and point of view
Composition of the IRB
- 5 or more ppl of different professions
- Diverse
- Consideration of race, gender, and cultural backgrounds
- At least one scientist
- At least one non-specialist
- At least one person NOT affiliated w/ the institution
RULES OF IRB
- person who wants to conduct the study, name listed on all paperwork
Responsible and accountable for study implementation
Principal investigator
may be an individual, pharmaceutical company, device manufacturer, governmental agency, academic institution or other.
- Provides funding to support the research
Drug Sponsor
Makes and provides the study drug
Pharmaceutical Manufacturer
consists of specially trained pharmacists and technicians
- Help investigators accomplish goals - Maintain compliance w/ standards and regulations
Investigations Drug Services (IDS)
Cause or potential to cause serious adverse events
Drug Recalls
Who does drug recalls?
drug companies
Usually voluntary unless request/require from FDA (TRUE OR FALSE)
True
Class __Recall
most severe
Likely to cause serious adverse events or death
Class I Recall
Class __Recall
Likely to cause temporary but reversible side effects
- Most common
Class II Recall
Class __Recall
(least severe) : Unlikely to cause adverse effects
- - Usually from packaging issues or labeling mix up, not from a problem w/ the actual meds
Class III Recall
- Drug withdrawals are permanent
- Cannot return to market w/o FDA approval
- Drug is harmful, not due to manufacturing issues
- Drug is unapproved
Market Withdrawals
- New drug -comes under protected brand name, brand name is patent product, exclusive rights for 20 yrs
(T OR F)
True
Generic is given in the place of brand name med
generic substitution
identical in active ingredients, strength, dosage form, and route of admin
Pharmaceutical equivalence
identical in active ingredients, strength, dosage form, and route of admin AND absorb and release the same in the body
Therapeutic equivalence - Bioequivalent
- generic meds that looks identical to the brand
- Repackaged brand name products - relabeled as generic, markets as generic
Authorized Generics
- Same active ingredients, extended - release version
- Different dosage form
Different strength
- Different dosage form
Pharmacologic Alternatives
- Different active ingredients, diff drug Similar product : same drug class, different drug class that’s used to treat same condition
Therapeutic Alternative
Does Therapeutic Alternatives = Therapeutic Equivalence?
no
Substituting Alternatives Required the pharmacist to contact the prescriber for a change. (T or F)
True
between pharmacist and prescriber
- Pharmacist can automatically substitute w/ alternatives
Collaborative Agreements
Nationally recognized code set that’s transmitted w/ a pharmacy claim to the insurance or third party provider.
DISPENSE AS WRITTEN CODES
DAW
DISPENSE AS WRITTEN CODES
Also known as product selection codes
Common DAW Codes
DAW 0, 1, 2, 7
(default code) : no product selection preferred, okay to substitute
DAW 0
substitution NOT allowed, prescriber request, state law dictates specific wording
- "Brand medically necessary" - "Do not substitute" - "Dispense as written" - "Brand only"
DAW 1
substitution is allowed, patient requested BRAND, may be more expensive
DAW 2
substitution NOT allowed, Brand name drug mandated by state law+
DAW 7
pharmacist decides the brand-name is to be dispensed, product available from multiple sources
DAW 3
generic is NOT in stock, based on pharmacy’s buying habits not due to product availability in the market
DAW 4
brand is dispensed as the generic, substitution allowed by prescriber
DAW 5
override is required by insurance, rarely used
DAW 6
substitution allowed by prescriber, generic drug is not available in the marketplace/manufacturer
DAW 8
Other, reserved and not in use
DAW 9
