Candidate metrics for evaluating the impact of prescriber education on the safe use of extended-release/long-acting (ER/LA) opioid analgesics.

OBJECTIVE: The objective of this study was to develop metrics to assess opioid prescribing behavior as part of the evaluation of the Extended-Release/Long-Acting (ER/LA) Opioid Analgesic Risk Evaluation and Mitigation Strategies (REMS). DESIGN: Candidate metrics were selected using published guidelines, examined using sensitivity analyses, and applied to cross-sectional rolling cohorts of Medicare patients prescribed with extended-release oxycodone (ERO) between July 2, 2006 and July 1, 2011. Potential metrics included prescribing opioid-tolerant-only ER/LA opioid analgesics to non-opioid-tolerant patients, prescribing early fills to patients, and ordering drug screens. RESULTS: Proposed definitions for opioid tolerance were seven continuous days of opioid usage of at least 30 mg oxycodone equivalents, within the 7 days (primary) or 30 days (secondary) prior to first opioid-tolerant-only ERO prescription. Forty-four percent of opioid-tolerant-only ERO episodes met the primary opioid tolerance definition; 56% met the secondary definition. Fills were deemed "early" if a prescription was filled before 70% (primary) or 50% (secondary) of the prior prescription's days' supply was to be consumed. Five percent (primary) and 2% (secondary) of episodes had more than or equal to two early fills during treatment. At least one drug screen was billed in 14% of episodes. Stratified analyses indicated that older patients were less likely to be opioid tolerant at the time of the first opioid-tolerant-only ERO prescription. CONCLUSIONS: Investigators propose three metrics to monitor changes in prescribing behaviors for opioid analgesics that might be used to evaluate the ER/LA Opioid Analgesics REMS. Low frequencies of patients, particularly those >85 years, were likely to be opioid tolerant prior to receiving prescriptions for opioid-tolerant-only ERO.

Chart-confirmed guillain-barre syndrome after 2009 H1N1 influenza vaccination among the Medicare population, 2009-2010.

Given the increased risk of Guillain-Barré Syndrome (GBS) found with the 1976 swine influenza vaccine, both active surveillance and end-of-season analyses on chart-confirmed cases were performed across multiple US vaccine safety monitoring systems, including the Medicare system, to evaluate the association of GBS after 2009 monovalent H1N1 influenza vaccination. Medically reviewed cases consisted of H1N1-vaccinated Medicare beneficiaries who were hospitalized for GBS. These cases were then classified by using Brighton Collaboration diagnostic criteria. Thirty-one persons had Brighton level 1, 2, or 3 GBS or Fisher Syndrome, with symptom onset 1-119 days after vaccination. Self-controlled risk interval analyses estimated GBS risk within the 6-week period immediately following H1N1 vaccination compared with a later control period, with additional adjustment for seasonality. Our results showed an elevated risk of GBS with 2009 monovalent H1N1 vaccination (incidence rate ratio = 2.41, 95% confidence interval: 1.14, 5.11; attributable risk = 2.84 per million doses administered, 95% confidence interval: 0.21, 5.48). This observed risk was slightly higher than that seen with previous seasonal influenza vaccines; however, additional results that used a stricter case definition (Brighton level 1 or 2) were not statistically significant, and our ability to account for preceding respiratory/gastrointestinal illness was limited. Furthermore, the observed risk was substantially lower than that seen with the 1976 swine influenza vaccine.

Babesiosis among elderly Medicare beneficiaries, United States, 2006-2008.

We used administrative databases to assess babesiosis among elderly persons in the United States by year, sex, age, race, state of residence, and diagnosis months during 2006-2008. The highest babesiosis rates were in Connecticut, Rhode Island, New York, and Massachusetts, and findings suggested babesiosis expansion to other states.

Outpatient transfusions and occurrence of serious noninfectious transfusion-related complications among US elderly, 2007-2008: utility of large administrative databases in blood safety research.

BACKGROUND: Transfusion-related acute lung injury (TRALI) and hemolytic transfusion reactions account for significant transfusion-related morbidity and mortality in the United States. Our study evaluated types and quantities of transfused components as well as occurrence of TRALI, ABO, and Rh incompatibilities among the US elderly in the institutional outpatient setting during 2007 to 2008. STUDY DESIGN AND METHODS: This retrospective claims-based study utilized the Centers for Medicare & Medicaid Services' large administrative databases. Transfusions were identified by recorded procedure and revenue center codes, while complications were ascertained via ICD-9-CM diagnosis codes. The study quantified blood use based on revenue center units. RESULTS: Among 26,054,242 and 25,662,864 Medicare elderly in 2007 and 2008, a total of 241,055 (0.9%) and 251,284 (1.0%) had outpatient transfusions. Leukoreduced red blood cells (LR-RBCs) was the most frequently transfused single blood component (60.1 and 61.3%, respectively) each year. Likewise, LR-RBCs and LR pheresis platelets (LR-PLTs) was the most frequent component combination (2.4 and 2.6%, respectively). TRALI rate comparison for RBCs and PLTs versus RBCs only showed higher rate for RBCs and PLTs (p = 0.033). In 2007 and 2008, ABO incompatibility rate comparison for irradiated (IR) LR-RBCs versus LR-RBCs showed higher rates for IR LR-RBCs (rate ratio [RR] 37.4, 95% confidence interval [CI] 10.6-132.6; and RR 31.3, 95% CI 11.6-84.4, respectively). CONCLUSION: This study shows potential usefulness of Medicare databases in assessment of blood utilization, transfusion-related complications, and risk factors among US elderly in the outpatient setting. It suggests limitations (e.g., need for several years of data to better assess rare complications) and importance of databases as hypothesis-generating tool to supplement blood safety research.