Table 3: Level 1 Findings: Medication Safety

CERT Population Topic or Finding
Vanderbilt General population Examined association between oral erythromycin and sudden cardiac death. Also found that risk of death is greater if erythromycin taken with CYP3A inhibitors.
HMO Prenatal Described the extent of prenatal exposure to prescription drugs.
Vanderbilt Arthritis patients Rofecoxib (Vioxx) prescribed and used at higher than recommended doses
Vanderbilt Heart disease patients Retrospective heart disease study found no protective benefit from NANSAIDs, suggesting that NANSAIDs should not be prescribed to protect against heart disease.
Vanderbilt Medicaid & VA Identified 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.
Vanderbilt Psychiatric patients Among 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.
Vanderbilt Pregnant women Much 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.
HMO Pediatric 15% of the children were prescribed a medication that constituted a potential dosing error.
HMO Elderly (>65) High level of inappropriate medication use in the over 65, outpatient population.
Arizona Elderly (>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.
Alabama Arthritis patients Assessed 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.
Alabama Patients with steroid associated bone disease For patients with steroid associated bone disease two studies demonstrated major deficiencies in the monitoring for side effects of glucocorticoids.
Arizona Hispanic women with diabetes Some herbal remedies may affect diabetes control, as well as produce adverse effects or medication interactions.
PENN Penicillin allergic patients Large numbers of patients were prescribed penicillin a second time, despite a prior allergic-like event.
Arizona General population Evaluated 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.
HMO Pregnant women A significant number of women become pregnant while taking drugs for which the risks are unknown or demonstrated.

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