Wolf Carolin, Pauly Anne, Mayr Andreas, Grömer Teja, Lenz Bernd, Kornhuber Johannes, Friedland Kristina
Molecular & Clinical Pharmacy, Friedrich-Alexander University Erlangen-Nürnberg (FAU), Erlangen, Germany.
Department of Medical Informatics, Biometry and Epidemiology, Friedrich-Alexander-University Erlangen-Nürnberg (FAU), Erlangen, Germany.
PLoS One. 2015 Nov 6;10(11):e0142011. doi: 10.1371/journal.pone.0142011. eCollection 2015.
This prospective, controlled trial aimed to assess the effect of pharmacist-led medication reviews on the medication safety of psychiatric inpatients by the resolution of Drug-Related Problems (DRP). Both the therapy appropriateness measured with the Medication Appropriateness Index (MAI) and the number of unsolved DRP per patient were chosen as primary outcome measures.
Depending on their time of admission, 269 psychiatric patients that were admitted to a psychiatric university hospital were allocated in control (09/2012-03/2013) or intervention group (05/2013-12/2013). In both groups, DRP were identified by comprehensive medication reviews by clinical pharmacists at admission, during the hospital stay, and at discharge. In the intervention group, recommendations for identified DRP were compiled by the pharmacists and discussed with the therapeutic team. In the control group, recommendations were not provided except for serious or life threatening DRP. As a primary outcome measure, the changes in therapy appropriateness from admission to discharge as well as from admission to three months after discharge (follow-up) assessed with the MAI were compared between both groups. The second primary outcome was the number of unsolved DRP per patient after completing the study protocol. The DRP type, the relevance and the potential of drugs to cause DRP were also evaluated.
The intervention led to a reduced MAI score by 1.4 points per patient (95% confidence interval [CI]: 0.8-2.0) at discharge and 1.3 points (95% CI: 0.7-1.9) at follow-up compared with controls. The number of unsolved DRP in the intervention group was 1.8 (95% CI: 1.5-2.1) less than in control.
The pharmaceutical medication reviews with interdisciplinary discussion of identified DRP appears to be a worthy strategy to improve medication safety in psychiatry as reflected by less unsolved DRP per patient and an enhanced appropriateness of therapy. The promising results of this trial likely warrant further research that evaluates direct clinical outcomes and health-related costs.
Deutsches Register Klinischer Studien (DRKS), DRKS00006358.
这项前瞻性对照试验旨在通过解决药物相关问题（DRP）来评估药剂师主导的药物评估对精神科住院患者用药安全的影响。选用用药适宜性指数（MAI）衡量的治疗适宜性以及每位患者未解决的DRP数量作为主要结局指标。
根据入院时间，将269名入住某精神科大学医院的精神科患者分为对照组（2012年9月 - 2013年3月）或干预组（2013年5月 - 2013年12月）。两组中，临床药师在入院时、住院期间及出院时通过全面的药物评估来识别DRP。在干预组中，药剂师针对识别出的DRP编写建议并与治疗团队进行讨论。在对照组中，除了严重或危及生命的DRP外，不提供建议。作为主要结局指标，比较两组之间从入院到出院以及从入院到出院后三个月（随访）时用MAI评估的治疗适宜性变化。第二个主要结局是完成研究方案后每位患者未解决的DRP数量。还对DRP类型、药物导致DRP的相关性和可能性进行了评估。
与对照组相比，干预组在出院时每位患者的MAI评分降低了1.4分（95%置信区间[CI]：0.8 - 2.0），随访时降低了1.3分（95%CI：0.7 - 1.9）。干预组未解决的DRP数量比对照组少1.8个（95%CI：1.5 - 2.1）。
对识别出的DRP进行跨学科讨论的药物评估似乎是提高精神科用药安全的一项有价值的策略，这体现在每位患者未解决的DRP减少以及治疗适宜性增强。该试验的良好结果可能值得进一步开展研究，以评估直接临床结局和与健康相关的成本。
德国临床研究注册中心（DRKS），DRKS00006358。
