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Across 3. ____ 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" 7. phase three studies represent a ______ population, small sample size, and short duration of exposure 9. 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 12. ADRs should be reported even if only _________ 15. ________ 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 17. a score of <1 in the Naranjo is considered ________ 18. 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 19. voluntary ADR reporting in the US is done through the FDA ________ program 21. ADR reporting in the US is _________ b/c: lack of socialized medicine, multiple practice sites 22. _____________ that target ADRs are JHACO, FDA, ISMP 29. 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 31. pre-_________ trial patient selection based on criteria that may not represent all patients w/comorbid diseases 32. _________ of FDA MEDWatch is that it's a large-scale program, country-wide, cost effective, early warning for rare ADRs 33. 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 34. 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 35. 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 36. ___________ of FDA MEDWatch are underreporting, can be subjective, bias, incomplete data or poor quality data 38. drug ___________ questions can be about problems giving these 2 drugs together or was this reaction caused by a drug ___________ 39. b/c of ADR reporting being voluntary, the US has the ______ ADR reporting in the world 40. 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

Down 1. a score of >9 on the Naranjo is considered ________ 2. 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 4. 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 5. this causality assessment tool was published in 1982; even more simplified; any negative response ends assessment; categorial vs. numerical assessment 6. drugs make it to ______ if they're unsafe b/c drug approval process becoming shorter 8. 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 9. 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 10. a score of 1-4 on the Naranjo is considered ________ 11. 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 13. _________ assessment tools like Kramer, Naranjo, and Jonesare usually used in case reports published in pharmacy journals to help determine probability of ADR occurring 14. _________ 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" 16. ________ literature includes animal studies, cohort studies, case-control studies, meta analysis, CTs, and case reports 20. 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 23. considerations in assessing ______________ studies include characteristics of study sample, dose and frequency of drug prescribed, harm assessment, duration of study/exposure, potential confounders 24. a score of 5-8 on the Naranjo is considered ________ 25. 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 26. ________ 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 27. __________ of causality describe the likelihood that the drug caused the ADR in that particular patient: definite, probable, psooible, unlikely; scoring for Kramer scale 28. 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) 30. criteria for _________ causality are temporal relationship, dose relationship, parameters which define event, dechallenge information, information on potential other causes of event and rechallenge information 37. 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