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Table 3

Evaluation of AHRQ's Pharmaceutical Outcomes Portfolio

Table 3: Level 1 Findings: Medication Safety

CERTPopulationTopic or Finding
VanderbiltGeneral populationExamined association between oral erythromycin and sudden cardiac death. Also found that risk of death is greater if erythromycin taken with CYP3A inhibitors.
HMOPrenatalDescribed the extent of prenatal exposure to prescription drugs.
VanderbiltArthritis patientsRofecoxib (Vioxx) prescribed and used at higher than recommended doses
VanderbiltHeart disease patientsRetrospective heart disease study found no protective benefit from NANSAIDs, suggesting that NANSAIDs should not be prescribed to protect against heart disease.
VanderbiltMedicaid & VAIdentified that as many as half of patients receiving NSAIDs are at high risk of ulcer disease because they are not receiving protective therapy for their stomachs.
VanderbiltPsychiatric patientsAmong patients taking antipsychotic medications with severe cardiovascular disease, current moderate dose users had 3.3 fold increased rate relative to comparable nonusers, resulting in 367 additional deaths per 10,000 person-years of follow-up. Data reviewed by FDA prior to thioridazine label change.
VanderbiltPregnant womenMuch press publicity for paper in New England Journal (2006) examining effects of ACE inhibitor medications during pregnancy, early in pregnancy and the development of birth defects in babies whose mothers took those medications. FDA held press conference before paper released indicating that a public advisory would follow.
HMOPediatric15% of the children were prescribed a medication that constituted a potential dosing error.
HMOElderly (>65)High level of inappropriate medication use in the over 65, outpatient population.
ArizonaElderly (>65)Using a national PBM's database to identify inappropriate prescribing. Identified many filled prescriptions for potentially inappropriate drugs; suggests need for careful monitoring of such databases.
AlabamaArthritis patientsAssessed how patients and physicians are communicating about risk, and then completed an intervention. Baseline data show large disparities in risk awareness, risk communication, and risk behavior.
AlabamaPatients with steroid associated bone diseaseFor patients with steroid associated bone disease two studies demonstrated major deficiencies in the monitoring for side effects of glucocorticoids.
ArizonaHispanic women with diabetesSome herbal remedies may affect diabetes control, as well as produce adverse effects or medication interactions.
PENNPenicillin allergic patientsLarge numbers of patients were prescribed penicillin a second time, despite a prior allergic-like event.
ArizonaGeneral populationEvaluated the accessibility and quality of information for dietary supplements promoting "colonic health" ...Manufacturers found to be unwilling/unable to provide clinicians with data on product efficacy or safety. Claimed need for independent research on the safety and efficacy of supplements.
HMOPregnant womenA significant number of women become pregnant while taking drugs for which the risks are unknown or demonstrated.

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Page last reviewed December 2007
Internet Citation: Table 3: Evaluation of AHRQ's Pharmaceutical Outcomes Portfolio. December 2007. Agency for Healthcare Research and Quality, Rockville, MD.