Intensive pharmacovigilance of high-risk patients on hospital surgical wards.

An open intervention, assessment blinded, before/after study in two community hospitals to reduce events (death, disability, increased hospital stay or readmission) due to prescription errors on surgical wards. In this study intensive pharmacovigilance in high risk patients, much less intensive pharmacovigilance in low risk patients and an education program for prescribers. The primary end point of this study is death, disability, increased hospital stay or readmission due to presciption errors. Secundary endpoints are rate of prescription errors, guideline adherence and a pharmaco economic evaluation. Two groups of minimal 5300 patients will be analysed to detect a 50% reduction of events.

Intensive pharmacovigilance in high-risk patients, much less intensive pharmacovigilance in low-risk patients and an education program for prescribers will lead to a reduction of medication related events (death, disability, increased hospital stay or readmission) due to prescription errors on (orthopaedic) surgical wards.

Time schedule of the study:

1. 4 months of preparation of the study;

2. 6 months of usual care period;

3. 3 months of implementation of the intervention;

4. 6 months of intervention period;

5. 5 months of analyzing data and writing of the manuscript.

1. A team of hospital pharmacists-clinical pharmacologists and internists-clinical pharmacologist will train participating hospital pharmacists to perform intensive pharmacovigilance in high-risk patients;

2. Selection of high risk patients by a screening method;

3. Intensive pharmacovigilance in high risk patients: Structured medication review will be performed combining clinical data and the list of current medication of the patient;

4. Less intensive pharmacovigilance of low risk patients: Automatically finishing of alerts, which are known to be without harm for low risk patients (90%), without intervention of the hospital pharmacist;

5. Education program for physicians and physician assistants: The most important pharmacologic items will be discussed and national and hospital guidelines, related to these subjects will be explained.