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Acid-Suppressive Medication Use and the Risk for Nosocomial Gastrointestinal Tract Bleeding
Acid-suppressive medications are increasingly prescribed for the prevention of nosocomial gastrointestinal tract (GI) bleeding in noncritically ill hospitalized patients. Current practice guidelines do not recommend their use in this setting; however, these guidelines are based only on expert consensus. The incidence of nosocomial GI bleeding outside the intensive care unit and the potential benefit from use of acid-suppressive medication for prevention of such bleeding are unknown. In this pharmacoepidemiologic cohort study of 78 394 hospitalized adults, nosocomial GI bleeding outside of the intensive care unit was rare, occurring in 0.29% of admissions. Despite a protective effect of acid-suppressive medication (odds ratio, 0.63), the number needed to treat to prevent 1 case was high at 770. These findings support the recommendation against routine use of prophylactic acid-suppressive medication in noncritically ill hospitalized patients.
Proton Pump Inhibitor Use and the Antifracture Efficacy of Alendronate
Proton pump inhibitors (PPIs) have been linked to fracture risk and are frequently coadministered in users of oral bisphosphonates. Abrahamsen et al used Danish health databases to conduct a national register–based cohort study of 38 088 new alendronate users with a mean follow-up of 3.5 years. Of these new alendronate users, 26% used PPIs in the first 3 years. Use of PPIs was associated with a dose-dependent loss of the protection against hip fracture that was observed with alendronate use. Although a formal proof of causality cannot be made in an observational study, the dose-response relationship—and the lack of impact of H2 blockers or prior use of PPIs—provides grounds for discouraging the use of PPIs to control upper gastrointestinal complaints in patients treated with oral bisphosphonates.
Potentially Inappropriate Medications Defined by STOPP Criteria and the Risk of Adverse Drug Events in Older Hospitalized Patients
Researchers in Ireland studied the prevalence of potentially inappropriate medications (PIMs) using STOPP (Screening Tool of Older Persons' potentially inappropriate Prescriptions) criteria and Beers criteria in 600 consecutive older people hospitalized with acute unselected illnesses. The incidence of significant adverse drug events (ADEs) in this cohort was 26.3%, two-thirds of the ADEs being causal or contributory to admission. Nearly 69% of the ADEs that were causal or contributory to admission were in turn avoidable according to accepted ADE avoidability criteria. Clinically significant ADEs were listed in STOPP criteria 2.54 times more often than in Beers criteria. After adjusting for age, sex, comorbidity, dementia, baseline activities of daily living function, and number of medications, STOPP criteria PIMs were significantly associated with serious, avoidable ADEs that cause hospitalization in older people, whereas Beers criteria PIMs were not.
Medical Device Recalls and the FDA Approval Process
Unlike prescription drugs, most medical devices are reviewed by the US Food and Drug Administration (FDA) using a “510(k) process” that does not require clinical trials, inspections, or postmarket studies. The more stringent premarket approval (PMA) process, which requires clinical trials and inspections and is similar to the approval process for drugs, is intended for all medical devices that the FDA deems high risk. Zuckerman et al analyze the FDA's list of 113 devices that the agency explained were recalled from 2005 through 2009 because of the high risk of serious health problems or death. Most medical devices recalled for life-threatening or very serious hazards were originally cleared for market using the less stringent 510(k) process or were considered so low risk that they were exempt from review (78%). Cardiovascular devices constituted 31% of high-risk recalls, and two-thirds of these were cleared by the 510(k) process. These findings suggest that reform of the regulatory process is needed to ensure the safety of medical devices.
High-risk recalled devices classified by how the FDA reviewed them from 2005 through 2009.
In This Issue of Archives of Internal Medicine. Arch Intern Med. 2011;171(11):971. doi:10.1001/archinternmed.2011.214
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