Background: Preventable adverse drug events (pADEs) are widely known to be a health care issue for hospitalized\npatients. Surgical patients are especially at risk, but prevention of pADEs in this population is not demonstrated\nbefore. Ward-based pharmacy interventions seem effective in reducing pADEs in medical patients. The costeffectiveness\nof these preventive efforts still needs to be assessed in a comparative study of high methodological\nstandard and also in the surgical population. For these aims the SUREPILL (Surgery & Pharmacy in Liaison) study is\ninitiated.\nMethods/Design: A multi-centre controlled trial, with randomisation at ward-level and preceding baseline\nassessments is designed. Patients admitted to the surgical study wards for elective surgery with an expected\nlength of stay of more than 48 hours will be included. Patients admitted to the intervention ward, will receive\nward-based pharmacy care from the clinical pharmacy team, i.e. pharmacy practitioners and hospital pharmacists.\nThis ward-based pharmacy intervention includes medication reconciliation in consultation with the patient at\nadmission, daily medication review with face-to-face contact with the ward doctor, and patient counselling at\ndischarge. Patients admitted in the control ward, will receive standard pharmaceutical care.\nThe primary clinical outcome measure is the number of pADEs per 100 elective admissions. These pADEs will be\nmeasured by systematic patient record evaluation using a trigger tool. Patient records positive for a trigger will be\nevaluated on causality, severity and preventability by an independent expert panel. In addition, an economic\nevaluation will be performed from a societal perspective with the costs per preventable ADE as the primary\neconomic outcome. Other outcomes of this study are: severity of pADEs, number of patients with pADEs per total\nnumber of admissions, direct (non-)medical costs and indirect non-medical costs, extra costs per prevented ADE,\nnumber and type of pharmacy interventions, length of hospital stay, complications registered in a national\ncomplication registration system for surgery, number of readmissions within three months after initial admission\n(follow-up), quality of life and number of non-institutionalized days during follow-up.\nDiscussion: This study will assess the cost-effectiveness of ward-based pharmacy care on preventable adverse drug\nevents in surgical patients from a societal perspective, using a comparative study design.\nTrial registration: Netherlands Trial Register (NTR): NTR2258
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