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ADR and Drug Interaction Literature


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WHO __________ of causality describe the likelihood that the drug caused the ADR in that particular patient: definite, probable, psooible, unlikely; scoring for Kramer scale
limitations a score of 1-4 on the Naranjo is considered ________
voluntary a score of 5-8 on the Naranjo is considered ________
three the ADR ___________ strategy involves assessing the patient - get pt data needed, perform literature search - tertiary (PI), primary, online/text search, check w/manufacturer - may have unpublished data
probable voluntary ADR reporting in the US is done through the FDA ________ program
primary in ____-_______ studies, it's hard to control for confounders; useful since patients aren't being intentionally exposed to harm; can only assess ASSOCIATION, NOT cause and effect
orginizations ________ literature is used to assess DIs and need to look at: type of patients, how drug was administered, how long study lasted, when outcome was measured
casecontrol this type of primary literature aren't typically designed to assess ADRs; may not have appropriate study endpoints; may not be conducted long enough; population studied may not be at risk for ADR
market drugs make it to ______ if they're unsafe b/c drug approval process becoming shorter
FDA ADR _______ in the FDA MEDWatch program are about experiences w/medications, nutritional supplements, medical devices, and other FDA regulated products; can be e-mailed, phoned in, or faxed; can also ______ product problems
suspected phase ____ of CTs is called post-marketing surveillance; it identifies ADRs that weren't picked up before drug came to market; may be mandated by FDA by submitting quarterly reports for first 3 years on market; used to investigate safety and efficacy
clinical ADR reporting in the US is _________ b/c: lack of socialized medicine, multiple practice sites
interaction pre-_________ trial patient selection based on criteria that may not represent all patients w/comorbid diseases
strengths ADR __________ of patient involves obtaining background information such as age, organ fxn, allergy hist, suspect drug, description of suspected ADR, other medications or recent dose changes
two a score of >9 on the Naranjo is considered ________
case the __ __ __ definition of ADRs is a response to a drug which is noxious and unintended and occurs in doses used for prophylaxis, diagnosis or therapy
MEDWatch phase _____ of pre-marketing CTs is when the drug or treatment is given to a large group of people to confirm its effectiveness,comapre it to commonly used treatments, and collect information that will allow drug or treatment to be used safely
doubtful ________ literature isn't used for drug interaction information b/c there's so much info on-line; specialty texts are still available tho which provide the MOA, significance and managemnt of DIs
one this causality assessment tool was published in 1979 in JAMA; has 56 yes or no questions; has 6 sections: pts previous experience w/drug, alternative causes, timing, drug concentrations, rechallenge and dechallenge; responses weighted and values totaled
clinicaltrials _________ of FDA MEDWatch is that it's a large-scale program, country-wide, cost effective, early warning for rare ADRs
narrow ____ reports are just a DESCRIPTION of a case; NOT intended to esplore the answer to a specific queston; circumstantial evidence of ADR but considered "newsworthy"
reports ________ literature includes animal studies, cohort studies, case-control studies, meta analysis, CTs, and case reports
observational phase ___ of pre-marketing CTs is when researchers test a new drug in a small group of people for the first time to evaluate its safety, determine safe dosage range, and identify SEs
assessing _________ assessment tools like Kramer, Naranjo, and Jonesare usually used in case reports published in pharmacy journals to help determine probability of ADR occurring
next the _____ steps the FDA can take if there's a severe ADR are: mandate addition of ADR information to the drug's label or package insert, require manufacturer to distribute letters to all registered healthcare providers, require manufacturer to develop formal surveillance program (uncommon), or removal of drug from market (if risks outweigh the benefits)
four considerations in assessing ______________ studies include characteristics of study sample, dose and frequency of drug prescribed, harm assessment, duration of study/exposure, potential confounders
kramer in ______ studies, it's hard to control for confounders; useful since patients aren't being intentionally exposed to harm; can only assess ASSOCIATION, NOT cause and effect
assessment _____________ that target ADRs are JHACO, FDA, ISMP
causality b/c of ADR reporting being voluntary, the US has the ______ ADR reporting in the world
possible phase ___ of a pre-marketing CT is when a drug or treatment is given to larger group of people to see if treatment is effective and to further ensure its safety
tertiary this causality assessment tool was published in 1982; even more simplified; any negative response ends assessment; categorial vs. numerical assessment
primary criteria for _________ causality are temporal relationship, dose relationship, parameters which define event, dechallenge information, information on potential other causes of event and rechallenge information
Jones a score of <1 in the Naranjo is considered ________
naranjo phase three studies represent a ______ population, small sample size, and short duration of exposure
metaanalysis _________ literature is information generally based on pre-marketing data; editors may periodically update data based on post-marketing studies; ADRs occurring in frequency > 1% considered "clinically significant"
cohort this causality assessment tool was is an alternative to Kramer; published in 1981; 10 yes, no, do not know questions; compares favorably w/Kramer and is less time consuming; used clinically
tertiary this type of primary literature are systematic reviews in which multiple studies have been pooled together; need to consider study duration to detect an ADR and the study endpoints designed to detect specific ADRs
evaluation the __ __ __ definition of an ADR is any adverse event associated w/the use of drugs in humans including overdose, drug abuse, withdrawal and failure of expected pharmacological action
lowest ___________ of FDA MEDWatch are underreporting, can be subjective, bias, incomplete data or poor quality data
categories ADRs should be reported even if only _________
definate drug ___________ questions can be about problems giving these 2 drugs together or was this reaction caused by a drug ___________

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