Drug Regulatory Process - Part II Flashcards
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
- innovator
- strength, dosage, route
- indications
- strength, purity
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
- prescription
- “The OTC Drug Review Program”
- Nonprescription Drug Advisory Board
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 _____
- side effects
2. FDA
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
- pharmacovigilance
2. pharmacoepidiemiology
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
- drug and device
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.
- spontaneous reporting
- drug manufacturer
Prescription Writing
- divided into 2 main categories:
- inpatient (institution)
2. outpatient
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
- patient identification
- time
- allergy
- medication
- dose
- frequency
- duration
- reason
- weight, dose
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
- dosing
- full name, pager #
- read
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
- address and telephone
- directions
- quantity
- refills
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
- DEA
- CIII-V: 5 refills, 6 months
- C-II: No refills, hard copy, signature
Prescription Writing (this slide is informational - no answer)
- DEA numbers
- Class I, Class II, Class III, Class IV, Class V drugs
😊
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?
- Class I
* heroin, marijuana
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?
- Class II
- dependence
- morphine, fentanyl, methadone
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
- Class III
- (low) physical, (high) psychological
- Lortab, Tylenol 3
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)
- Class IV
- limited
- Benzodiazepines, Phenobarbital
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)
- Class V
* cough syrup
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
- animal, human
* 1st, 3rd
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
- Category A
Pregnancy Categories: ?
- Animal studies have revealed no evidence of harm to the fetus, however, there are NO adequate/well-controlled studies in preg women OR
- animal studies have shown an adverse effect, but adequate/well-controlled studies in preg women show NO risk to the fetus in any trimester
- Drug Examples: APAP, _________, insulin, Ibuprofen (before ____ trimester), amoxicillin
- Category B
- predinisone
- 3rd
Pregnancy Categories: ?
- animal studies have shown an ADVERSE effect and there are NO adequate/well-controlled studies in preg women OR
- no animal studies have been conducted and there are NO adequate and well-controlled studies in preg women
- Drug Examples: _________, carbamazepine, ciprofloxacin, _________
- Category C
* antidepressants, fluconazole
Pregnancy Categories: ?
- adequate/well controlled studies in pregnant women have shown RISK to the fetus
- however, benefits of therapy may outweigh the potential risk.
- this drug may be acceptable if needed in ____ _______ situation
or serious disease for which safer drugs cannot be effective
*Drug Examples: ______, _______, pheytoin, valproic acid, ACEI, tetracyline, most cancer chemo
- Category D
- life threatening
- Alcohol
- lithium
Pregnancy Categories: ?
- adequate/well-controlled studies in animals and pregnant women have demonstrated POSITIVE evidence of fetal abnormalities or risk.
- the use of the product is ______ in women who are pregnant or may become pregnant
- Drug Examples: Istrotretinoin (_______), thalidomide, misoprostil (cytotec)
- Category X
- contraindicated
- accutane
“the general study of all of the many different genes that determine drug behavior”
- Pharmacogenomics
Defects in the 1st trimester are related to?
- birth defects
Defects in the 3rd trimester are related to?
*disruption of the physiological change from fetus to neonate (giving ibuprofen in the 3rd trimester will close the ductus)
” the study of inherited differences (variation) in drug metabolism and response.”
- Pharmacogenetics
“is the determination of the order of nucleotides (the base sequencse) in DNA molecule.”
- DNA sequencing
Human Genome Project - Goals
- identified approx _____ - ______ genes in the human DNA
- determined the sequences of the __ _____ chemical base pairs in the human DNA
- store this information in databases
- improve tools for data analysis
- transfer related technologies to the _____ sector, and address the ethical, legal and social issues
- 20,000 - 25,000
- 3 billion
- private
Human Genome Project: Outcomes
- human genome = ___ ______ chemical nucleotide bases (A, C. G, T)
- 30,000 genes
- > _____ % of all nucleotide bases is the same in all humans
- 3 billion
* 99%
SNP: Single Nucleotide Polymorphism
- _____ _________ variations that occur when a single nucleotide (A, T, C, G) in the genome sequence is _____
- occurs in > ___ % of the population
- can occur in protein ______ regions
* causes loss of protein ______
* abnormal protein synthesis
- can occur in ____ - ______ regions (regulatory regions)
* abnormal rate of protein synthesis
- DNA sequence, altered
- > 1%
- coding
- synthesis
- non-coding
Pharmacokinetic Consequences of SNPs (ie: genetic variation)
- unexpected _______
- _____ of ______
- lack of ________
- toxicity
- duration of action
- efficacy
Examples of Genetic Influence on Anesthetic Pharmacology:
- ______________ deficiency
- ___________ hyperthermia
- anesthetic requirements and different genetic backgrounds
- pseudocholinesterase
2. malignant
Pharmacokinetic Variability:
Beta Blockers (CYP 450) ?
- enhanced drug effect
Pharmacokinetic Variability:
Codeine, dextromethorphan (CYP2D6) ?
- decrease drug effect
Pharmacokinetic Variability:
Alfentanil (CYP3A4)?
- enhanced drug response
Pharmacokinetic Variability:
Angiotensin II - Receptor Type 1 Blockers (CYP450)?
- enhanced BP response
Pharmacokinetic Variability:
Warfarin (CYP2C9)?
- enhanced anticoagulant effect ( risk of bleeding)
Pharmacokinetic Variability:
ACEI (angiotensin-1 converting enzyme)?
- BP response
Pharmacokinetic Variability:
Procainamide (NAT2)?
- enhanced drug effect
Pharmacokinetic Variability:
Succinycholine (BCHE)?
- enhanced drug effect
Pharmacokinetic Variability:
Digoxin (ABCB1, MDR1)?
- increased bioavailability
Pharmacokinetic Variability:
Beta Blockers
(B1 and B2 adrenergic receptors - ADRB1, ADRB2)?
- BP and HR response
- a/w responsiveness to B2
Pharmacokinetic Variability:
QT prolonging drugs (antiarrythimics, erythromycin, cisapride)
(Na and K ion channels)?
- long QT syndrome
- risk of torsades de pointes
Pharmacokinetic Variability:
Aspirin, glycoprotein IIb/IIa inhibitors?
- variability in antiplatelet effects
Pharmacokinetic Variability:
Phenylephrine (endothelial nitric oxide synthase) ?
- BP repsonse
Pharmacokinetic Variability:
Ca Channel Blockers (CYP450)
- uncertain
Pharmacokinetic Variability:
Phenytoin (CYP2C9)?
- enhanced drug effect
Generic Drug Review Process:
- An important parts of the _______ mission is to assure that safe and effective generic drugs are available to American people
- CDER’s
