Drug Regulation Flashcards
What Carrie said to focus on:
- Know Barash Table
- Know pregnancy categories
- Know DEA classifications
- EXACTLY what is on inpatient order writing
- Who is responsible for what measures
- Needle slide Don’t worry about history stuff
- Know role of IRB
- Purpose of 3 phases, how many people in each
…
Position statement 2.13 of safe practices for needle and syringe use..
Can you reuse a needle to draw up a med on the same pt?
Can you refill a syringe of the same med for the same pt?
Reuse syringe/needle on multidose medication vial?
NO
Position statement 2.14 of securing propofol says what?
Propofol must me kept in a secure environment, draw up med for the case you’re on only
To lessen access leading to abuse, addiction, and death
List some ethical principles in clinical drug research process?
Trial must minimize risk for subjects
Provisions must be made for overall care of pt
Investigator must terminate trial when data shows the drug is way better/worse than current drug (HIV drug trial)
Adverse events reported immediately to ethics committee
This is all a balance of risk and benefit
What does the IRB do?
Make sure participants are fully informed
Oversee that rights and welfare of people participating in trials are protected
Located at hospitals/research institution, mandated/monitored by FDA
Approve, modify, or disapprove research proposals
Safeguards human subjects, vulnerable populations
IRB composition?
At least 5 people 3 that must be on the board:
- scientific person,
- nonscientific person (usually lawyer), and
- someone with no ties to the institution
This variety is to evaluate regulations, law, standards of conduct, and community attitudes
What is included in preclinical research?
FDA requires data compiled from animals/in-vitro or previous studies, then
make a proposed protocol IND submitted (application) giving info on
- chemistry
- pharmacology
- toxicology
Compare phases 1-3 of clinical trials.
Phase 1: 20-100 subjects over months, non-blinded
Phase 2: 100s of subjects over a year, single/double-blind
Phase 3: 1000s of subjects of a few years, randomized, double-blind
Now that we know what it takes for a new drug to get through the process, what are anesthetic considerations of giving a new drug?
It may react differently in your patient, so be cautious and report any adverse effects
the drug may not be safe in certain populations
What is CDER’s mission regarding generic drugs?
Assure the generic drugs are safe and effective, as well as available to public
Generic drugs must gain FDA approval, strict standards
Note: other missions involve monitoring marketing/labeling
In the post drug approval phase (phase 4), which is sometimes required by the FDA
what did the MEDwatch Program do to help with this phase?
Make it easier to report events
Make it clear what should be reported
Disseminate information Increase understanding of drug
Inpatient requirements on prescription writing?
Patient identification
Date and time the Rx written
Allergy status
Full name of med, dose, frequency, duration
Reason for administration on PRN meds
Parameters for titration/monitoring If med is weight based, include pt weight and actual dose (round to nearest increment)
Sign with full name, title, and pager number
The order is invalid if any of this is missing
DEA classes of drugs 1-5
1: not accepted treatment d/t high potential for abuse (heroin, marijuana)
2: high potential for abuse (morphine, fentanyl, methadone)
3: less potential for abuse (Buprenorphine, Hydrocodone/APAP (Lortab), Codeine/APAP (Tylenol 3), Dronabinol (Marinol), Testosterone products)
4: low potential for abuse (Benzodiazepines, Zolpidem (Ambien), Phenobarbital, Propoxyphene/APAP (Darvocet-N))
5: least potential for abuse (Cough syrups containing small amounts of codeine (codeine/promethazine), pregabalin (Lyrica)
Pregnancy categories: A, B, C, D, X
A: studies show no risk in any trimester
B: no evidence of harm in animals but no human studies OR adverse effect in animals but no risk to human fetus in any trimester
C: animal has adverse effect but no human studies OR no animal/human studies
D: human studies show risk to fetus, but benefits may outweigh risk (withdrawal)
X: human/animal studies show risk to fetus, absolutely contraindicated
Category A
pregnancy
Folic acid, vitamin B6, levothyroxine
