Assessing the quality of drug information provided by hospital pharmacies using a fictitious enquiry and simulated real-life conditions.

OBJECTIVES: Guidelines for drug information (DI) provided by hospital pharmacists call for quality assurance procedures; however, no method of evaluation is internationally agreed on. The procedure should be feasible, reproducible and representative for real-life quality. We tested a new approach using a fictitious enquiry under simulated real-life conditions for quality assessment of DI by German hospital pharmacists. METHODS: A fictitious enquiry was submitted under simulated real-life conditions (study part I; test week announced, but not exact day; response time given). An expert panel determined content-related (three essential, and up to seven additional items of useful information) and structural requirements for answers and performed blinded evaluations. To compare quality of routine DI answers (study part II), five recently answered routine enquiries could retrospectively be evaluated for plausibility (binary scale 0/1) and structural requirements. RESULTS: Of 62 hospital pharmacies opting to participate, 45 (71%) entered study part I and 18 (40%) entered study part II. In study part I, 28 participants (62%) presented three essential contents, 11 (24%) two, five (11%) one, and one none. Additional useful information was given in 44-80%. Structural requirements achieved mixed results with low scores for logical conclusion deduction and reference presentation. In study part II, plausibility for the 90 recently answered routine enquiries was rated good (median 0.91, range 0.53-1). Concerning structural requirements, overall comparable results were achieved with minor variations compared with study part I. Thus, the quality of DI was judged to be comparable between study parts I and II. CONCLUSIONS: An open quality assessment procedure with a fictitious enquiry under simulated real-life conditions can successfully be used for quality measurement of DI of hospital pharmacists and identifies areas for improvement.

Multiplex and functional detection of antigen-specific human T cells by ITRA--indirect T cell recognition assay.

The identification and functional characterization of pathogen-specific T cells plays a critical role in immunological research and diagnostics. In addition to the present standard technologies such as intracellular cytokine staining (ICS), enzyme-linked immunospot (ELISPOT) and peptide-major-histocompatibility-complex (MHC) multimer staining, we aimed to develop a multiplex detection assay, which provides fast in vitro functional data for both human CD4 and CD8 T cells with different antigen specificities in one sample. In this study, we have exploited the expression of CD83 on B cells to develop the cell array-based indirect T cell recognition assay (ITRA). In detail, B cells are pulsed with different pathogen peptide pools and fluorescently barcoded. Thereafter the B cells are pooled and co-cultured with autologous T cells. Subsequently each B cell population is analyzed via flow cytometry for CD83 expression, which indicates antigen-specific interaction with CD4 T cells. Moreover, we revealed donor dependent variations of cytotoxic activity of pathogen-specific CD4 T cells and CD8 T cells, evidenced by specific lysis of peptide-pulsed B cells. Taken together, ITRA is a novel antigen presenting cell (APC) array based method to analyze the presence and function of various antigen-specific T cells in one sample. It has the potential to be used in the future for epitope/antigen screening in research and for analysis of anti-tumor, anti-pathogen or autoimmune T cell responses in patient samples.