Drug Regulation Flashcards Preview

Summer Pharm (2016) ** > Drug Regulation > Flashcards

Flashcards in Drug Regulation Deck (18)
Loading flashcards...

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?



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:

  1. scientific person,
  2. nonscientific person (usually lawyer), and
  3. 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

  1. chemistry
  2. pharmacology
  3. 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


Folic acid, vitamin B6, levothyroxine


Category B


  1. Acetaminophen
  2. prednisone
  3. insulin
  4. ibuprofen (before 3rd trimester)
  5. amoxicillin


Category C


  1. Many antidepressants
  2. carbamazepine
  3. ciprofloxacin
  4. fluconazole


Category D


  1. Alcohol
  2. lithium
  3. phenytoin
  4. valproic acid
  5. tetracyclines
  6. ACEI
  7. most cancer chemotherapy


Category X


  1. Isotretinoin (Accutane)
  2. thalidomide
  3. misoprostol (Cytotec)