DD French regulation Flashcards
What are the 3 bigs things the FDA regulates when it comes to drugs?
1.) Categorization 2.) Evaluation for Safety and Efficacy 3.) Equivalence for generic vs brand name drugs
What are the 4 FDA categories of drugs.
1.) Prescription drugs 2.) Controlled Substances 3.) OTC drugs 4.) Dietary supplements
What is the main thing state governments control when it comes to drugs?
Who may prescribe
Which government agency controls the prescription of controlled substances?
DEA
What is the main thing local governments control when it comes to drugs?
Laws regarding drug use within their jurisdiction. (ex. no pot shops near schools)
Define ?drug.?
A drug is a therapeutic agent intended to treat, cure, prevent, or diagnose a disease.
T or F: Dietary supplements must be tested for safety and efficacy before they can be sold.
FALSE
List the phases of drug development and approval.
Animal testing (pre-clinical trials), Phase I, Phase II, Phase III, Phase IV (postmarketing)
T or F: Animal trials involve testing for safety, efficacy, and effect on reproduction.
TRUE. Also look at selectivity and mechanism
How many patients/volunteers usually participate in Phase I trials?
20-100
T or F: Phase I trials look at drug safety.
TRUE
T or F: Phase I trials look at drug pharmacokinetics.
TRUE
T or F: Phase II clinical trials involve volunteers who do not have the disease the drug is intended to treat.
FALSE. Phase II clinical trials test the drug on real patients with the disease the drug is intended to treat.
What is used to compare the a new drug to in Phase II clinical trials?
Placebo - single blind or open label
What is used to compare the a new drug to in Phase III clinical trials?
Placebo or current standard of treatment - double blind and cross-over techniques
T or F: If a drug is going to fail, it is mostly likely to fail out of Phase II clinical trials.
TRUE
If a new drug for a life-threatening condition appears promising in Phase III trials, what can its developers get to move it to market faster?
Accelerated-development review
T or F: It is possible for a generic drug to get FDA approval after demonstrating bioequivalency only.
TRUE. This is called getting an Abbreviated New Drug Application (ANDA). Otherwise they would have to show pharmaceutical equivalence as well.
T or F: The FDA can regulate how a drug is actually used by doctors.
FALSE
T or F: Once a drug reaches Phase IV (post-marketing), it no longer needs to be monitored for safety.
FALSE
T or F: Generic drugs are inferior to brand name drugs.
FALSE
When is it advisable to avoid switching between a generic and a brand name drug?
Narrow therapeutic window, poor bioavailability, non-linear pharmacokinetics. The slight differences in batches can make a difference in some cases.
How is bioequivalency measured for generic versus brand name drugs?
They must have the same extent of absorption (AUC) and rate of absorption (Cp max - same peak drug concentration)
What are the set limits for AUC and Cp max for a generic drug? (was in absorption lectures as well)
Ratio of Generic/Brand mean and 90% confidence interval of AUC and Cp max must be within 80-125%
T or F: Nonprescription drugs are evaluated the exact same way as prescription drugs.
TRUE
T or F: Dietary supplements are evaluated the exact same way as prescription drugs.
FALSE
Define dietary supplement.
A product intended to supplement the diet taken by mouth as pill, capsule, tablet, or liquid that is not considered food.
T or F: Dietary supplement manufacturer must provide reasonable evidence that their product is safe in humans.
TRUE
T or F: If a dietary supplement proves to be unsafe once it is one the market, the FDA can remove it from the market.
TRUE, but only if they can prove that it is unsafe. The burden of proof lies with the FDA.
T or F: A dietary supplement can make claims about effect on organ system function.
TRUE
T or F: A dietary supplement can make claims about effects on a specific disease.
FALSE
Name the information required on a dietary supplement label. (4 things)
Name of product, manufacturer, amount of contents, directions for use (Bonus: FDA has not evaluated this shit nigga)
T or F: Dietary supplement manufacturers must abide by Good Manufacturing Practice (enforce identity, strength, purity of product)
TRUE. Required since 2011
When must a drug be limited to prescription use?
If it is habit forming, cannot be used without professional supervision, if under a new drug application (NDA)
Drug schedule is based on what 3 criteria?
1.) Medical use 2.) Abuse potential 3.) Potential for physical/psychological dependence
T or F: Schedule I drugs have accepted medical use.
FALSE
How many schedules of drugs are there?
5
T or F: In Colorado, all schedule drugs require a prescription.
TRUE. In some states only drugs scheduled II-IV need a prescription.
T or F: A drug scheduled II can be called into the pharmacist.
FALSE. French loves this question and will always ask it on the first test.
How many times can a prescription be refilled before a new prescription is needed?
5 times in 6 months
How many lbs in 1 kg?
2.2 lbs
How many mLs in 1 fluid oz?
29.56 mL
How many mLs in a tablespoon?
15 mL
How many g in 1 oz?
28.35 g
How many mgs in 1 grain?
64.8 mg
Define qod.
Every other day
Define qid.
Four times a day
Define prn.
As needed (pro re nata)
Define ad.
Right ear
Define au.
Both ears
Define ol.
Left eye
Define po.
By mouth
Define pr.
Per rectum
Define Sig.
Label (refers to instruction on use: # of pills per day)
What must a provider have to prescribe controlled substances?
DEA number
Up to how long is a prescription good as specified by a physician?
Up to 1 year
T or F: A prescription requires a prescribers signature.
TRUE
T or F: A prescription does not need to specify a patient?s address.
FALSE
T or F: A prescription does not need to specify drug quantity.
FALSE
T or F: A prescription must specify name and strength of the drug.
TRUE
T or F: A prescription must specify name, address, and phone number of the prescriber.
TRUE
T or F: A prescription must specify the date of the prescription.
TRUE
T or F: A prescription must specify name of the pharmacy of origin.
FALSE
