Drug Regulatory Process - Part II Flashcards
1
Q
Generic Drug Review Process:
- Abbreviated new drug application (ANDA) is filed
- To gain FDA approval, a generic drug must:
- contain the same active ingredient as the _________ drug
- be identical in _____, _____ form and _____ of administration
- have the same use _______
- be bioequivalent
- meet the same batch requirement for identity, _____, _____ & quality
- be manufactured under the same strict standards of FDAs good manufacturing regulations
A
- innovator
- strength, dosage, route
- indications
- strength, purity
2
Q
OTC drug review process:
- 6 out of 10 medication purchased
- available without a ________ - easy access
- > 80 classes of OTC drugs, > 100, 0000 products marketed
- FDA - evaluates the ingredients and labels these products as part of the “ _____ _____ ______ ______ ______”
- The _____ ________ _______ Board assists the FDA with this evaluation process
A
- prescription
- “The OTC Drug Review Program”
- Nonprescription Drug Advisory Board
3
Q
Post Drug Approval:
Phase 4:
- more information about the ____ _____ and safety of the drug when used in the general population
- long term risks and benefits
- efficacy when used in the general population
- may be required by the _____
A
- side effects
2. FDA
4
Q
Post Drug Approval:
- a vital part of the CDER’s mission is to monitor the safety and effectiveness of drugs that are currently available
- this is done via CDER’s :
- division of ___________ and epidemiology
- MEDWatch/spontaneous reporting system
- ______________
- contracts/ coopertaive agreements
A
- pharmacovigilance
2. pharmacoepidiemiology
5
Q
Post Drug Approval
- to capture serious adverse event data, CDER recieves expeditied and periodic reports from drug manufacturers
- MEDWatch Program - has 4 goals:
- make it easier for healthcare provider (HCP) to report serious events
- make it clearer to HCP’s what types of adverse events FDA is interested in
- more widely disseminate info on the FDA’s actions that have resulted from adverse event and product problem reporting
- increase HCP’s understanding and awareness of _____ and ______ - induced disease
A
- drug and device
6
Q
Post Drug Approval
- ______ ________ system contains adverse drug reaction reports from hospitals, HCP’s and lay person that are sent either directly to the Agency (via MEDwatch) or first to the _____ ________ and the by regulation to the Agency by the drug manufacturer.
A
- spontaneous reporting
- drug manufacturer
7
Q
Prescription Writing
- divided into 2 main categories:
A
- inpatient (institution)
2. outpatient
8
Q
Prescription Writing
- Inpatient Requirements:
1. ______ _______
2. date and _____ the script was written
3. _______ status
4. full name of _______ (generic name preferred)
5. _____ must be written (mg, micrograms, units)
6. ________ of administration (1 tab q4hrs prn)
7. _____ of therapy (IV antibiotics)
8. _______ for administration on all PRN medication orders (ie: prn pain)
9. include any special parameters for medication titration, monitoring or admin (ie: clonidine 0.2mg PO TID, hold for SBP
A
- patient identification
- time
- allergy
- medication
- dose
- frequency
- duration
- reason
- weight, dose
9
Q
Prescription writing (things to keep in mind)
- round to the nearest _____ increment
- sign order with _____ name, title and _____ number
- for verbal or telephone orders, all the receiver to ____ back the order
A
- dosing
- full name, pager #
- read
10
Q
Prescription Writing: Outpatient
- prescription must have your name, office _____ and _____ number
- there should be a section for pt’s name and address and date
- there should be a section for ________ for the pt or the pharmacist
- there should be a name of the drug (generic or brand name) and _______.
- ____ if required
A
- address and telephone
- directions
- quantity
- refills
11
Q
Prescription Writing
- Outpatient controlled Substances
- same requirement as other prescriptions PLUS ______ # AND:
* CIII-V: (allowed ____ refills or valid for ___ months -
whichever comes first)
* C-II: (NO _____ allowed, _____ copy required, ______
required)
* Laws can vary from state to state
A
- DEA
- CIII-V: 5 refills, 6 months
- C-II: No refills, hard copy, signature
12
Q
Prescription Writing (this slide is informational - no answer)
- DEA numbers
- Class I, Class II, Class III, Class IV, Class V drugs
A
😊
13
Q
Schedules of Controlled Drugs: ?
- high potential for abuse
- Not currently accepted use in treatment in the in the US
- lack of accepted safety for use of the drug or other substance under medical supervision
- Drug examples: 2?
A
- Class I
* heroin, marijuana
14
Q
Schedules of Controlled Drugs: ?
- high abuse potential
- currently ACCEPTED medical use in treatment in the US or a currently accepted medical use with severe restrictions
- abuse may lead to severe psychological or physical _________
- Drug examples: 3?
A
- Class II
- dependence
- morphine, fentanyl, methadone
15
Q
Schedules of Controlled Drugs: ?
- potential for abuse LESS than the classes that precede
- currently accepted medical use in treatment in the US
- abuse may lead to moderate or low ______ dependence or high _______ dependent
- Drug examples: Buprenorphine, Hydrocodone/APAP (______), Codeine/APAP (________) Marinol, Testosterone products
A
- Class III
- (low) physical, (high) psychological
- Lortab, Tylenol 3
16
Q
Schedules of Controlled Drugs: ?
- low potential for abuse
- currently accepted medical use in treatment in the US
- abuse of the drug may lead to _______ physical or psychological dependence
- Drug Examples: ________, Zolpidem (Ambien), __________, Propoxyphene/APAP (Darvocet-N)
A
- Class IV
- limited
- Benzodiazepines, Phenobarbital
17
Q
Schedules of Controlled Drugs: ?
- Low potential for abuse
- currently accepted medical use in the US
- abuse may lead to limited physical dependence or psychological dependence
- Drug Examples: ______ ______ containing small amounts of codeine (codeine/promethazine), pregabalin (Lyrica)
A
- Class V
* cough syrup
18
Q
Pregnancy Categories
- based on ______ studies and/or _______ studies
- many categories leave drugs up to the discretion of the practitioner/pt in terms of risk/benefit
- _____ trimester risks VS. _____ trimester risks
- Categories: A, B, C, D, X
A
- animal, human
* 1st, 3rd
19
Q
Pregnancy Categories: ??
- studies show NO increased risk of fetal abnormalities to the fetus in any trimester of pregnancy
- Drug Examples: folic acid, vit B 6, levothyroxine
A
- Category A
