Regulation Flashcards
Where natl hospital quality measures for anesthesia are
Specifications manual for natl hospital in pt quality measures
Website for quality measures
Www.qualitynet.org
Where to compare clinical sites
Www.medicare.gov
Website for med safety
Institute for safe med practices. Www.ismp.org
Safe syringe technique: never do which 6 things
Same syringe to mult pts even if needle changed, reuse a needle (even if same pt), regular syringe once used (even if same pt), use iv admin sets mult pts, reuse syringe/needle for multi dose vial, reenter single use vial
IRB board must be composed of who
5 or more experts with varying backgrounds
Phases of IRB
1- 20-100 subjects, months, safety. 2- several hundred, months-2 yrs, effectiveness/safety. 3- hundreds-thousands, 1-4 yrs, safety/dose/effectiveness
Program where HCPs can report serious med events after drug approval
MEDwatch program
Phase I trials are often what
Non blinded
Phase 2 trials are often what
Often w pts w medical condition of interest. Dosing ranges, toxicity info. Single or double blind. Drug vs placebo or existing therapy
Phase 3 trials are often what
Randomized, controlled, double blind, w multiple arms.
Rx writing: inpatient requirements
Pt ID, date and time written, allergy status
Rx writing: what goes on all
Full name of med (generic preferable), dose units, frequency of admin, duration of therapy when indication, reason for admin on PRN orders
Outpt rx writing includes what
Name/office address/phone number, pts name/address/date, directions for pt/pharmacist, name of drug and quantity, refills
Out pt controlled substances also require what
DEA number and C3-5 5 refills or valid 6 months, C2 no refills/hard copy required, signature required
Class 1 drugs
High abuse potential, not in US, lack of safety. Heroin, marijuana
Class 2 drugs
High abuse potential. In US w restrictions. Psych/phys dependence. Morphine, fentanyl, methadone
Class 3 drugs
Less abuse then 1+2. In US. Moderate/low phys dep, high psych dep. buprenorphine, hydrocodone/APAP (lortab), tyelenol 3, Marinol, testosterone
Class 4 drugs
Less abuse than 3, in us. Ltd phys and psych dep. benzos, ambien, phenobarb, darvocet
Class 5 drugs
Ltd phys and psych dep. cough syrup w codein, promethazine, lyrica
Pregnancy categories
Based on animal or human studies. Many up to discretion of practitioner/pt in terms of risk/benefit. 1st tri vs 3rd tri risks. A-D, X. A- 100% safe. X never ok. B-D up to doctor
Category A drugs
Well controlled, not shown inc risk fetal abn in any trimester. Folic acid, B6, levothyroxine
Category B
Animal studies no harm to fetus. But not enough studies in preg women OR animal studies have adverse effect but no risk in human studies to fetus. Tyelenol, prednisone, insulin, ibuprofen before 3rd tri, amoxicillin
Category C drugs
Animal studies adverse fx and none in humans. OR no animal studies done/not enough studies in preg women. Anti depressant, carbamazepine, Cipro, fluconazole
Category d drugs
Risk to fetus in trials. Benefits of therapy may outweigh risk, life threat situation. Alcohol, lithium, phenytoin, valproic acid, tetracyclines, ACEI, cancer chemo
Category X
Fetal abnormalities or risks. Contraindicated in women who are/may become pregnant. Accurate, thaliomide, misoprostil
