High frequency of potential phosphodiesterase type 5 inhibitor drug interactions in males with HIV infection and erectile dysfunction.

OBJECTIVES: We sought to determine the prevalence of phosphodiesterase type 5 inhibitor (PDE-5) mediated drug-drug interactions (DDIs) in males with HIV infection receiving antiretroviral therapy (ART) and identify factors associated with PDE-5-mediated DDIs. METHODS: Male US Military HIV Natural History Study participants diagnosed with erectile dysfunction (ED) and having a PDE-5 inhibitor and potentially-interacting ART co-dispensed within 30 days were included. DDIs were defined according to criteria found in published guidelines and drug information resources. The primary outcome of interest was overall PDE-5 inhibitor-mediated DDI prevalence and episode duration. A secondary logistic regression analysis was performed on those with and without DDIs to identify factors associated with initial DDI episode. RESULTS: A total of 235 male participants with ED met inclusion criteria. The majority were White (50.6%) or African American (40.4%). Median age at medication co-dispensing (45 years), duration of HIV infection (14 years), and duration of ED (1 year) did not differ between the two groups (p>0.05 for all). PDE-5 inhibitors included sildenafil (n = 124), vardenafil (n = 99), and tadalafil (n = 14). ART regimens included RTV-boosted protease inhibitors (PIs) atazanavir (n = 83) or darunavir (n = 34), and COBI-boosted elvitegravir (n = 43). Potential DDIs occurred in 181 (77.0%) participants, of whom 122 (67.4%) had multiple DDI episodes. The median DDI duration was 8 (IQR 1-12) months. In multivariate analyses, non-statistically significant higher odds of DDIs were observed with RTV-boosted PIs or PI-based ART (OR 2.13, 95% CI 0.85-5.37) and in those with a diagnosis of major depressive disorder (OR 1.74, 95% CI 0.83-3.64). CONCLUSIONS: PDE-5-mediated DDIs were observed in the majority of males with HIV infection on RTV- or COBI-boosted ART in our cohort. This study highlights the importance of assessing for DDIs among individuals on ART, especially those on boosted regimens.

The VHA New England Medication Error Prevention Initiative as a model for long-term improvement collaboratives.

BACKGROUND: Quality improvement collaboratives (QICs) are a widely applied strategy for implementing change in health care organizations. Alternative collaborative methodologies were compared to gain insight into the elements important for QIC success. METHODS: A modified version of a previously described QIC evaluation tool was used to assess the methods and characteristics of the Medication Error Prevention Initiative (MEPI) and to compare MEPI with two other long-term ongoing QICs--the Vermont-Oxford Network's Neonatal Intensive Care QIC and the Northern New England Cardiovascular Disease Study Group, and the shorter-term Breakthrough Series QICs of the Institute for Healthcare Improvement (IHI). RESULTS: The modified QIC assessment tool was a useful framework for QIC assessment and comparison. The MEPI differed in scope of topic, team members, and the method for learning about and making improvements. CONCLUSIONS: Long-term QIC methods such as those used by MEPI may be particularly applicable when QICs address broad, complex, comprehensive, or organizationwide improvement needs.

Using the ISMP Medication Safety Self-Assessment to improve medication use processes.

BACKGROUND: The 194-item Institute for Safe Medication Practices (ISMP) Medication Safety Self-Assessment for hospitals is being used by a 21-hospital collaborative as a framework for understanding, evaluating, and systematically implementing medication use system safety improvements. METHODS: The results of the self-assessment were used to prioritize and organize the review of medication use processes, in which each self-assessment-defined "representative characteristic" is reviewed in detail, and "best implementation practices" for the characteristic are established. The collaborative concurrently identifies educational needs and develops tools to assist organizations in implementing improvements. RESULTS: By December 2002 participating organizations had implemented a wide variety of medication safety improvements. Collaborative member scores for the self-assessment increased approximately 20% during the initial assessment when the self-assessment was repeated by members in the second quarter of 2002. SUMMARY: Participant progress in improving medication safety practices is supportive of collaborative methods and the value of completing the ISMP self-assessment, expanding on the knowledge gained, developing effective implementation tools, and systematically applying lessons learned.