Regulatory Flashcards
National quality measures for anesthesia
Abx received within one hour prior to surgical incision
Peri-op temperature management
Pts on BBs who received their BB during the peri-op period
Important charting items that are looked at for national quality standards
Anesthesia start/end time and date Surgical incision time Abx name, dose, route, time, allergies BB current med, last dose, peri-op admin if needed Reasons for not giving BB peri-op Temp
Med errors injure…
1.3 million people annually and cause at least 1 death per day in the US
Can occur during prescribing, repackaging, dispensing, administering, monitoring
Common meds errors invlovle
poor communication
Similar med names, abbreviations, poor instructions, poor handwriting
Poor procedures/techniques
Pt misuse door to poorly understood instructions
Job stress, lack of training, similar/confusing labelling
Institute for safe medication practices
Lists high risk meds List dangerous abbreviations Can search recent med safety info Report med errors and ADRs Link to FDA's medwatch
AANA needle safety
Never use same needle/syringe for more than one pt
Never reuse any needle for any reason
Never refill a syringe, even for the same pt
Never reuse infusion sets
Never reuse a syringe/needle to draw from a multi-dose vial
Never reenter a single use medication vial/amp/solution
AANA statement on propofol
Should be kept in a secure environment and kept track of
FDA approval process
Pre-clinical IRB Clinical OTC Generic Post-approval
Major FDA legislation
1906 Pure food and drugs act- requires truthful labeling of all drugs
1912 Amendment prohibits fraudulent advertising
1938 Food, drug, cosmetic act- requires proof of safety and purity
1951 Durham-Humphrey Amendment- gives FDA authority to determine which meds can be sold without a prescription
1962 Kefauver-Harris Amendment- requires proof of efficacy, puts forth guidelines for ADR reporting, testing, and advertising
1983 Orphan drug act
1984 Drug price competition and patent restoration act- shorter approval time for generics, extends patents caused by FDA delay
1992 Expedited drug approval act- special drugs can be approved faster, but need more postmarketing studies
The CDER assures safe and effective drugs for the US and is in charge of what three major areas
New drug development process
IND review process
NDA review process
Ethics in drug development
Balance of risk and benefit for the subject. 4 major principles-
Trial must minimize risks
Provisions must be made for care of the subjects
Must terminate trial when risks become incompatible with goals
Adverse events must be reported immediately to ethics/safety committee
Informed consent
Pt must be aware of B/R/A- if terminal they must realize this will not benefit them, but likely future patients
Well informed of the entire process before making a voluntary choice to participate
IRB
Located within hospitals and research centers- Mandated by the FDA. Review ethical/legal issues related to research.
Ensure subjects are fully informed and protected
IRB composition
5 experts and lay people with varying backgrounds
Must be able to evaluate proposals with law, institutional regulations/commitments, professional standards, and community attitudes in mind
Specific IRB criteria
Minimizes risks to human subjects Risks are reasonable relative to possible benefits and scientific gain Equitable selection of subjects Informed consent Safeguards vulnerable populations
Preclinical
Show drug is reasonable and safe in small scale studies
In vitro, animal studies
Previous clinical testing results
Proposed protocol
Info is submitted in form of IND- 30 day review of chemistry, pharm/toxicology, medical potential
Preclinical goals
Establish potential efficacy and safety Determine biological actions Chemical properties Kinetics Synthesis/purification
Preclinical research
Animals- used as little as possible. Two or more species. Used for kinetics, safety testing
Short term testing- 2 weeks to 3 months
Long term- Several weeks to years, can continue after human testing for long term AE searches
Clinical studies can proceed when
IND is active following FDA review
IRB approves the study protocol
Phase I
20-100 subjects, several months, purpose is SAFETY
Phase II
Several hundred subjects, severals months to 2 years, purpose is EFFECTIVENESS AND SHORT TERM SAFETY
Phase III
Several hundred to thousands, 1-4 years, SAFETY, DOSAGE, EFFECTIVENESS
NDA
Formal proposal for the FDA to approve a new drug. Includes- non clinical, clinical, drug, and manufacturing information from all previously completed studies
Must provide enough info to answer- Is it safe/effective with benefits that outweigh risks
Is the labeling appropriate
Is the manufacturing adequate
Compassionate use protocols
Drugs must show preliminary efficacy
Pt must be likely to die or suffer rapid progression within several months or die prematurely without treatment
Must be no comparable approved therapy to treat the disease at that stage
Generic drug review
Abbreviated NDA must-
Contain same active ingredient as original drug
Be identical in strength, dosage form, and ROA
Have the same indications
Be bioequivalent
Meet same batch requirements
Meet the same manufacturing requirements
OTC review
6 out of 10 meds are OTC
>80 classes of OTC drugs, >100,000 products
Phase IV (post approval)
More information about SE and safety when used in the general population
Long term risk/benefit analysis
Efficacy in the general population
FDA may require these studies
How does CDER monitor safety and efficacy
Pharmacovigilance and Epidemiology division
MEDWatch
Pharmacoepidemiology
Contracts/Coop agreements
MEDWatch
Started in 1993, 4 goals:
Make it easier the report serious events
Make it clear what type of ADEs are being reported to the FDA
Widely disseminate information about FDA action regarding ADEs
Increase provider awareness of drug/device-induced disease
Inpatient Rx
Patient ID
Date and time the Rx is written
Allergy Status
Rx writing
Full med name (generic prefered) Dose must be written Frequency (PRN must specify as well) Duration when indicated (Abx) Include reason for all PRN orders
Include special parameters for titration, monitoring, or administration
If weight based, must include pt weight AND the calculated dose based on that weight
Round to nearest dosing increment
Sign with full name, title, and pager #
For verbal/telephone, receiver must read back the order
For outpatient Rx
Have name, office address, and phone #
Pts name, address, date
Directions for pt/pharmacist
Name of drug and quantity
Refills if needed
Outpatient controlled Rx
Must include DEA # and
CIII-V- only 5 refills or 6 months, whichever comes first
C-II- no refills, hard copy only, signature required
State Laws vary widely in addition to these requirements
DEA Class I
High abuse potential
No currently accepted medical use in the US
Lack accepted safety for use
Heroin, marijuana
Class II
High abuse potential
Currently accepted medical use in the US or accepted with severe restrictions
Abuse may lead to severe dependence
Morphine, fentanyl, mathadone
Class III
Less abuse potential than I and II
Accepted medical use in the US
Low/moderate dependence potential
Buprenorphine, Lortab, Tylenol 3, Dronabinol, Testosterone
Class IV
Low abuse potential
Accepted medical use
Limited dependence potential
Class V
Low abuse potential
Accepted medical use
Limited dependence potential
Codeine/Promethazine syrup, pregabalin
Pregnancy A
Well controlled human studies showing no increased risk of fetal abnormalities in any trimester
Folic acid, B6, levothyroxine
Pregnancy B
Animal studies showing no harm, but no human studies OR
Human studies say its ok, animal studies suggest some risk
APAP, prednisone, insulin, ibuprofen (before 3rd trimester), amoxicillin
Pregnancy C
Animal studies have shown adverse effect and no human studies OR
No animal studies and no adequate human studies
Many antidepressants, carbamazepine, cipro, fluconazole
Pregnancy D
Human studies have shown risk, however potential benefits may still outweigh risks
ETOH, lithium, phenytoin, valproic acid, tetracyclines, ACEI, most chemo
Pregnancy X
Animal or human studies have demonstrated increased risk of fetal problems
No use in pregnant women
Isotretinoin, thalidomide, misoprostil
