title: Medication incidents in primary care medicine: protocol of a study by the Swiss Federal Sentinel Reporting System.
abstract: BACKGROUND
  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.
  
  
  METHODS
  
  
  
  METHODS
  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.
  
  
  METHODS
  Patients undergoing drug treatment by 167 general practitioners or paediatricians reporting to the Swiss Federal Sentinel Reporting System.
  
  
  METHODS
  Any erroneous event, as defined by the physician, related to the medication process and interfering with normal treatment course.
  
  
  METHODS
  Lack of treatment effect, adverse drug reactions or drug-drug or drug-disease interactions without detectable treatment error.
  
  
  METHODS
  Medication incidents.
  
  
  METHODS
  Age, gender, polymedication, morbidity, care dependency, hospitalisation.
  
  
  METHODS
  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.
  
  
  CONCLUSIONS
  We will take into account under-reporting and selective reporting among others as potential sources of bias or imprecision when interpreting the results.
  
  
  BACKGROUND
  No formal request was necessary because of fully anonymised data. The results will be published in a peer-reviewed journal.
  
  
  BACKGROUND
  NCT0229537.
authors.affiliation: Institute of Primary Care, University of Zurich, Zurich, Switzerland.
authors.forename: Markus
authors.initials: M
authors.lastname: Gnädinger
authors.affiliation: Department of Clinical Pharmacology and Toxicology, University Hospital Zurich, Zürich, Switzerland National Poisons Centre, Tox Info Suisse, Associated Institute of the University of Zurich, University Hospital Zurich, Zürich, Switzerland.
authors.forename: Alessandro
authors.initials: A
authors.lastname: Ceschi
authors.affiliation: Patientensicherheit Schweiz, Zürich, UK.
authors.forename: Dieter
authors.initials: D
authors.lastname: Conen
authors.affiliation: Policlinique Médicale, University of Lausanne, Lausanne, UK.
authors.forename: Lilli
authors.initials: L
authors.lastname: Herzig
authors.affiliation: Epidemiology, Biostatistics, and Prevention Institute, University of Zurich, Zürich, Switzerland.
authors.forename: Milo
authors.initials: M
authors.lastname: Puhan
authors.affiliation: Institute of Primary Care, University of Zurich, Zurich, Switzerland Sentinel Surveillance Network, Swiss Federal Office of Public Health, Bern, Switzerland.
authors.forename: Alfred
authors.initials: A
authors.lastname: Staehelin
authors.affiliation: Institute of Primary Care, University of Zurich, Zurich, Switzerland.
authors.forename: Marco
authors.initials: M
authors.lastname: Zoller
mesh_terms: D005260:Female; D058006:General Practice; D006801:Humans; D016015:Logistic Models; D008297:Male; D008508:Medication Errors / Q000706:statistics & numerical data*; D061214:Patient Safety / Q000706:statistics & numerical data*; D010372:Pediatrics; D011159:Population Surveillance; D011320:Primary Health Care / Q000706:statistics & numerical data*; D011446:Prospective Studies; D012307:Risk Factors; D011795:Surveys and Questionnaires; D013557:Switzerland
keywords: CLINICAL PHARMACOLOGY; EPIDEMIOLOGY; PUBLIC HEALTH