Regulatory Flashcards
(43 cards)
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
