Evaluation of contraindicated drug-drug interaction alerts in a hospital setting.

BACKGROUND: Risks associated with contraindicated drug-drug interaction alerts (CDDIAs) should always outweigh benefits. Misclassified CDDIAs should be eliminated. OBJECTIVE: To review CDDIAs and determine if they are contraindicated according to Food and Drug Administration-approved product labeling and if there are circumstances in which contraindicated interactions are acceptable. METHODS: A cross-sectional observational and quality improvement study was conducted over two 1-year periods. The 20 most common CDDIAs from May 2007 to May 2008 and all CDDIAs from April 2008 to April 2009 were collected at a large teaching hospital. Horizon Meds Manager used First DataBank as the knowledge base for decision support. Interactions were deemed truly contraindicated if listed in the contraindications section of the labeling of at least one of the interacting drugs. Alerts were grouped by drug and pharmacologic class to evaluate the evidence supporting the relevance of these interactions. An expert panel determined when an alert was misclassified. A medical advisory committee determined whether a contraindicated drug-drug combination was acceptable. RESULTS: Twelve (60%) of the most common 20 contraindicated interaction pairs from 2007 to 2008 were inappropriately classified. Half of the alerts were not truly contraindicated. The 8 truly contraindicated drug-drug pairs were ketorolac and other nonsteroidal antiinflammatory drugs or oral solid potassium products and anticholinergics. Half of these interactions were subsequently deemed acceptable under specific circumstances. Similar results were found in the second year, with only 55.1% of all CDDIAs being truly contraindicated despite eliminating some of the alerts that were misclassified in the first year. Nearly three fourths of legitimate CDDIAs were deemed acceptable under specific circumstances. CONCLUSIONS: Most contraindicated drug-drug interaction alerts from a commercial knowledge base were inappropriately categorized and could be downgraded. Some contraindicated drug combinations are permissible under specific circumstances. Alerts suggesting that certain drugs should never be used together, but their use together is sometimes acceptable, contribute to alert fatigue.

Pharmacy resident project publication rates and study designs from 1981, 1991, and 2001.

PURPOSE: The publication rates and characteristics of residency projects presented at the Southeastern Residency Conference (SERC) in 1981, 1991, and 2001 are described. METHODS: SERC abstracts from 1981, 1991, and 2001 were searched in MEDLINE and International Pharmaceutical Abstracts with a time limit of six years after the conference. All potential positive publications were reviewed and validated by a second investigator. Publication rates and other secondary variables, including study design, authors' degrees, reporting of results, time to publication, and journal of publication, were compared, with differences noted. RESULTS: A total of 272 abstracts were evaluated. Publication in a journal was achieved for 18 (20%) of 90 projects presented in 1981, 11 (16%) of 70 projects presented in 1991, and 14 (13%) of 112 projects presented in 2001. The median time to publication for all abstracts was 22.8 months. Publications rates decreased at each subsequent time period. Projects published in journals with high impact factors had a longer median time to publication compared with other projects. Abstracts that reported results were published more often than those that did not (43% versus 23%), as were those that included a physician coauthor compared with those that did not (32% versus 19%). Observational studies were the most common study designs and were most published. CONCLUSION: Approximately 16% of pharmacy residents' research projects presented at SERC in 1981, 1991, and 2001 were published. Projects with observational study designs were the most common study type and were the most commonly published.

Efficacy and safety of oral phenylephrine: systematic review and meta-analysis.

BACKGROUND: Oral phenylephrine is used as a decongestant, yet there has been no previously published systematic review supporting its efficacy and safety. OBJECTIVE: To assess the efficacy and safety of oral phenylephrine as a nonprescription decongestant. METHODS: MEDLINE, the Cochrane Central Registry of Controlled Trials, EMBASE, International Pharmaceutical Abstracts, and the Federal Register were searched for English and non-English-language studies published through January 2007 that measured the effects of oral phenylephrine on nasal airway resistance (NAR) in patients with nasal congestion. The retrieved studies were supplemented with information from our personal files and by hand searches of the references in any of the studies. Additionally, a Web of Science Search was conducted using the Cited Reference function for all published clinical trials identified. Studies included in the analysis were randomized, placebo-controlled trials; studies of combination products were excluded. Two investigators independently extracted data on NAR, self-reported decongestant effects, and cardiovascular effects (ie, heart rate, blood pressure) from each of the included studies. Meta-analyses were performed for NAR and cardiovascular effects using a random effects model. Subjective decongestant effects were summarized. RESULTS: Based on 8 unpublished studies that included 138 patients, phenylephrine 10 mg did not affect NAR more than placebo; the mean maximal difference in relative change from baseline between phenylephrine and placebo was 10.1% (95% CI -3.8% to 23.9%). Eight unpublished studies on phenylephrine 25 mg showed a significant reduction of maximal NAR compared with placebo of 27.6% (95% CI 17.5% to 37.7%). There was significant heterogeneity among the studies included in this analysis, which was partially attributable to different laboratories and methods used. Patient-reported decongestion was not consistently better for any phenylephrine dose compared with placebo, and NAR was a more sensitive measurement of efficacy. Phenylephrine showed no consistent effect on heart rate or blood pressure for doses of 25 mg or less. CONCLUSIONS: There is insufficient evidence that oral phenylephrine is effective for nonprescription use as a decongestant. The Food and Drug Administration should require additional studies to show the safety and efficacy of phenylephrine.