Adverse Event Reporting
Terms in this set (...)
adverse drug rxn associated with medications
adverse drug rxn
an unexpected, undesired, unintended excessive response to a med
a preventable event
Adverse drug experience characteristics (4)
occurring in during the use of a drug under a professional practice, occurs from drug overdose (accidental or not), occurs from drug abuse/withdrawing, failure of expected pharmacological action
(1) pharmacovigilance definition, (2) safety signals come from what??,
(1) monitoring, detecting and evaluation to drug safety issues both premarketing and postmarketing, (2) Comes from clinical trials, spontaneous rxns...ect...
Organizations involved in preventing adverse drug events (6)
FDA, Joint commission of on accred of healthcare orgs, world health organization, institute for safe medication practices, united states pharmacopeia, american society of health systems pharmacists
3 ways of assessing causality of ADR
expert judgement, algorithm, probabilistic
based on a healthcare providers experience
specific questions that can give you a quantifiable score
uses bayesian (probability strategy) approach and epidemiological data.
discontinue drug and see what happens
discontinue drug, wait for adverse rxn to stop, then use the drug again and wait for response
does the ADR occur during a certain time period, check the insert..does it make sense?
FDA 3500A form
Form a pharm company needs to fill out if there is a reported ADR
Are health care providers responsible for reports ADR??
What website can someone check for these reports that are from FDA
Can you report adverse events for vet drugs or vaccines on form 3500?
FDA, Adverse, events, reporting, system
promotes safe use of drugs by rapidly disseminating new safety info (internet/email), 78 drug alerts in 2010
How does a medwatch first appear, can lead to...(4), can it lead to market withdrawal?
as a safety signal, change in labeling (1) Adverse RXN, Warning and precautions, Block Box warnings, Drug interactions, yep
Where to report adverse drug events, where to report vaccine adverse rxn
FDA medwatch, VAERS
Drug Consumer Protection Act 2006
Let consumers know we are on top of safety issues, requires mandatory adverse drug event reporting for supplements, any manu or distributor of a supplement see a ADE they are required to report dat.
Serious adverse event (5)
death, life-threatening experience, inpatient hospitalization, incapacity, some issue at birth
Risk management on drugs (6)
labeling, communicating, advertising, packaging, restricting the use, withdrawal
Long-acting beta agonists (LABAS)
requires risk management strategy, single ingredient should only be used with asthma controller med, should only be used in long term pats, use a combo of inhaled corticoid steroid and LABA
2011 LABA requirement
requires manufacturers to conduct 5 double blind studies comparing the addition of LABAs to inhaled corticosteroids
FDA methods for giving patients info on drug safety
medication guide, patient package insert, OTC "drug facts" label, patient information sheet (concise and very important info like safety)
Food and Drug Admin Act '07 - Primary Goal?
To enhance medical product safety
Comes from results from clinical trials..adverse event reports.. post approval studies, may be initiated before or after approvals, REMS allows the approval of a drug.
FDAs enforcement authority (3)
Failure to implement, fda can find the drug misbranded, follow up to REMS must be 18months, 3 (can be stopped here) years than again at 7 years
Content of a REMs (optional)
medication guide, patient package insert, communication plan to hcp,
Goals of REMs
SMART goal, give the serious risk to pats and HCP
what are medication guides
handout issued with some prescriptions that saying that there are risks with dis ish.
Therapeutics Quiz 1
Chapters 10 & 11 - PI in Healthcare
BOOK TERMS Pharmacology- Drug development and Ethical Considerations (Pharm Ch 1 Test 1)
Contracts & Medicare
Drug Information Resources
Formulating a Drug Info Question
Pharmaceutical Industry and Regulatory Issues
Introduction to Clinical Trials