George E. MacKinnon

Efficacy, tolerability, and parent reported outcomes for cefdinir vs. high-dose amoxicillin/clavulanate oral suspension for acute otitis media in young children.

ABSTRACT Objectives: To compare efficacy, tolerability, and parental satisfaction of cefdinir and high-dose amoxicillin/clavulanate oral suspensions given to young children with non-refractory acute otitis media (AOM) based on clinical endpoints and outcomes measures. Research design and methods: This was an investigator-blinded, multicenter study in which 318 children 6 months through 6 years of age with a clinical diagnosis of AOM were randomized to receive 10 days of either cefdinir (14 mg/kg divided BID) or high-dose amoxicillin/clavulanate (90/6.4 mg/kg divided BID). Main outcome measures: Investigators evaluated clinical response at an end-of-therapy (EOT) office visit conducted on day 12–15. Outcomes of satisfaction, tolerability, and adherence were also assessed at that visit using an Otitis Parent Questionnaire. Results: The treatment groups were similar at baseline with respect to patient demographics. At the EOT visit, for cefdinir and amoxicillin/clavulanate, respectively, intent-to-treat (ITT) clinical cure rates were 82% (129/158) and 85% (134/158) ( p = 0.547; 95% confidence interval [CI] –11.7 to 5.4) and per-protocol cure rates were 82% (123/150) and 90% (129/143) ( p = 0.045; 95% CI –16.4 to 0.0). This difference was driven primarily by reduced cefdinir response in patients with recurrent AOM (p = 0.010) and those younger than 24 months (p = 0.039). Comparing cefdinir with amoxicillin/clavulanate, parents more often reported significantly better ease of use (89% vs. 57%; p < 0.0001), better taste (85% vs. 39%; p < 0.0001), and better adherence (at least 95% of doses) (82% vs. 61%; p < 0.0001). Diarrhea/loose stools were more common in the amoxicillin/clavulanate group than in the cefdinir group (28% vs. 18%, respectively; p = 0.0341). One patient in the cefdinir group and eight patients in the amoxicillin/clavulanate group withdrew from the study prematurely due to at least one adverse event ( p = 0.0364). Study limitations included assessment of clinical recurrence by telephone call rather than office visit, exclusion of children with refractory AOM, and no assessment of middle ear microbiology. Conclusions: Among young children with non-refractory AOM, cefdinir was as efficacious as high-dose amoxicillin/clavulanate in the ITT group, but somewhat less effective in per-protocol analysis. From the parental perspective, cefdinir was easier to administer, had a better taste, caused less diarrhea, and resulted in higher treatment adherence than high-dose amoxicillin clavulanate.

The Report of the 2016-2017 Professional Affairs Standing Committee: Formally Embracing and Engaging Preceptors in the Academy — The Time Has Come

EXECUTIVE SUMMARY The 2016-2017 AACP Professional Affairs Committee (PAC) was charged to examine strategies to include adjunct/affiliate preceptors as AACP members and to determine the value proposition of AACP membership for this group of educators. The PAC defined adjunct/affiliate preceptors as preceptors who are neither full-time employees nor have a primary employment commitment (≥50% of the preceptor’s work salary) at a school/college of pharmacy. Specific charges to the PAC included: recommend an approach to increase the number of adjunct/affiliate preceptors as AACP members, examine AACP membership from an adjunct/affiliate preceptor value perspective, and prepare a concise summary of available literature describing value-added contributions of student pharmacists and pharmacy preceptors to pharmacy practice models, interprofessional education (IPE) and interprofessional practice (IPP). The summary of the plan developed by the PAC to address the charges is presented in the following report, which includes three sections: the value proposition of AACP membership for adjunct/affiliate preceptors, expansion of the presence of adjunct/affiliate preceptors in AACP, and the value of student pharmacists in experiential education settings. The value proposition of AACP membership for adjunct/affiliate preceptors section describes results of surveys and focus groups conducted by the PAC. The PAC surveyed experiential education directors at schools/colleges of pharmacy, adjunct/affiliate preceptors (from a request via the experiential education directors), and new pharmacy practice faculty members in order to determine current resources available for adjunct/affiliate preceptor development, as well as explore potential resources AACP could provide for adjunct/affiliate preceptor development. Focus groups were held with adjunct/affiliate preceptors and experiential education faculty/staff to explore some of the results and concepts generated from the surveys. The PAC developed three recommendations for AACP as a result of the surveys and focus groups. The report also describes various factors that should be considered by AACP in developing a membership category for adjunct/affiliate preceptors, including potential membership models, establishment of an advisory board, and collaboration with other stakeholder groups. The final section of the report provides an executive summary and detailed table, which summarizes available literature on the value of student pharmacists in experiential education. The brief literature review reinforces that there are many different practice settings where student pharmacists add value to patient care and the practice site. This information is significant for experiential education faculty/staff, as well as adjunct/affiliate preceptors, and serves as an example of best practices which document the value experiential education provides to patient care and practice sites. The final section of the report provides a policy statement that was adopted by the 2017 AACP House of Delegates and one suggestion to schools/colleges of pharmacy. The report concludes with a call to action regarding the formal involvement of adjunct/affiliate preceptors by AACP and the academy.