Medication incidents in primary care medicine: protocol of a study by the Swiss Federal Sentinel Reporting System.

BACKGROUND/RATIONALE: Patient safety is a major concern in healthcare systems worldwide. Although most safety research has been conducted in the inpatient setting, evidence indicates that medical errors and adverse events are a threat to patients in the primary care setting as well. Since information about the frequency and outcomes of safety incidents in primary care is required, the goals of this study are to describe the type, frequency, seasonal and regional distribution of medication incidents in primary care in Switzerland and to elucidate possible risk factors for medication incidents.

STUDY DESIGN AND SETTING

We will conduct a prospective surveillance study to identify cases of medication incidents among primary care patients in Switzerland over the course of the year 2015.

PARTICIPANTS

Patients undergoing drug treatment by 167 general practitioners or paediatricians reporting to the Swiss Federal Sentinel Reporting System.

INCLUSION CRITERIA

Any erroneous event, as defined by the physician, related to the medication process and interfering with normal treatment course.

EXCLUSION CRITERIA

Lack of treatment effect, adverse drug reactions or drug-drug or drug-disease interactions without detectable treatment error.

PRIMARY OUTCOME

Medication incidents.

RISK FACTORS

Age, gender, polymedication, morbidity, care dependency, hospitalisation.

STATISTICAL ANALYSIS

Descriptive statistics to assess type, frequency, seasonal and regional distribution of medication incidents and logistic regression to assess their association with potential risk factors. Estimated sample size: 500 medication incidents.

LIMITATIONS

We will take into account under-reporting and selective reporting among others as potential sources of bias or imprecision when interpreting the results.

ETHICS AND DISSEMINATION

No formal request was necessary because of fully anonymised data. The results will be published in a peer-reviewed journal.

TRIAL REGISTRATION NUMBER

NCT0229537.