BMJ Open BMJ Open: first published as 10.1136/bmjopen-2016-013658 on 26 July 2017. Downloaded from BMJ Open: first published as 10.1136/bmjopen-2016-013658 on 26 July 2017. Downloaded from Medication Incidents in Primary Care Medicine: a Prospective Study in the Swiss Sentinel Surveillance Network (Sentinella) For peer review only Journal: BMJ Open Manuscript ID bmjopen-2016-013658 Article Type: Research Date Submitted by the Author: 29-Jul-2016 Complete List of Authors: Gnädinger, Markus; University of Zurich, Institute for General Medicine Conen, Dieter; Swiss Patient Safety, Herzig, Lilli; University of Lausanne, Institute of General Medicine Puhan, Milo; University of Zurich, Institute of Epidemiology, Biostatistics & Prevention Staehelin, Alfred; Sentinel Surveillance Network, Swiss Federal Office of Public Health, Zoller, Marco; Zurich University Hospital, Instiute for General Medicine Ceschi, Alessandro; National Poisons Centre, Tox Info Suisse, Associated Institute of the University of Zurich, Division of Science, Head of ; University Hospital Zurich , Dept. Clinical Pharmacology & Toxicology http://bmjopen.bmj.com/ <b>Primary Subject http://bmjopen.bmj.com/ General practice / Family practice Heading</b>: Secondary Subject Heading: Pharmacology and therapeutics, Paediatrics CLINICAL PHARMACOLOGY, Health & safety < HEALTH SERVICES Keywords: ADMINISTRATION & MANAGEMENT, Adverse events < THERAPEUTICS on September 28, 2021 by guest. Protected copyright. on September 28, 2021 by guest. Protected copyright. For peer review only - http://bmjopen.bmj.com/site/about/guidelines.xhtml Page 1 of 69 BMJ Open BMJ Open: first published as 10.1136/bmjopen-2016-013658 on 26 July 2017. Downloaded from 1 2 3 4 Medication Incidents in Primary Care Medicine 5 6 7 8 A Prospective Study in the Swiss Sentinel Surveil- 9 10 lance Network (Sentinella) 11 12 1Markus Gnädinger (corresponding author, [email protected]), 2Dieter Conen, 3,4Lilli 13 5 1,4 1 6 14 Herzig, Milo Puhan, Alfred Staehelin, Marco Zoller, Alessandro Ceschi 15 For peer review only 16 1Institute of Primary Care, University of Zurich, 2Patientensicherheit Schweiz, Zurich 3Policlinique 17 4 18 Médicale, University of Lausanne, Sentinel Surveillance Network, Swiss Federal Office of Public 19 Health, Bern (Sentinella), 5Epidemiology, Biostatistics, and Prevention Institute, University of Zur- 20 6 21 ich, Division of Clinical Pharmacology and Toxicology, Department of Internal Medicine, Ente 22 Ospedaliero Cantonale, Lugano, Switzerland and Department of Clinical Pharmacology and Toxi- 23 24 cology, University Hospital Zurich, Zurich, Switzerland and National Poisons Centre, Tox Info 25 Suisse, Associated Institute of the University of Zurich, Zurich, Switzerland 26 27 28 (Correspondence: Markus Gnädinger, Dr. med. Facharzt für Innere Medizin, Birkenweg 8, 9323 Steinach, 29 0041 71 446 04 64) 30 31 32 33 Objectives: To describe the type, frequency, seasonal and regional distribution of medication http://bmjopen.bmj.com/ 34 incidents in primary care in Switzerland and to elucidate possible risk factors for medication inci- 35 36 dents. 37 38 Design: Prospective surveillance study. 39 40 41 Setting: Swiss primary health care, Swiss Sentinel Surveillance Network. on September 28, 2021 by guest. Protected copyright. 42 43 Participants: Patients with drug treatment who experienced any erroneous event related to the 44 45 medication process and interfering with normal treatment course, as judged by their physician. 46 The 180 physicians in the study were general practitioners or pediatricians participating in the 47 48 Swiss Federal Sentinel reporting system in 2015. 49 50 Outcomes: Primary: medication incidents; secondary: potential risk factors like age, gender, 51 52 poly-medication, morbidity, care-dependency, previous hospitalization. 53 54 55 Results: The mean rates of detected medication incidents were 2.07 per general practitioner and 56 year (46.5 per 100,000 contacts) and 0.15 per pediatrician and year (2.8 per 100,000 contacts), 57 58 1 59 60 For peer review only - http://bmjopen.bmj.com/site/about/guidelines.xhtml BMJ Open Page 2 of 69 BMJ Open: first published as 10.1136/bmjopen-2016-013658 on 26 July 2017. Downloaded from 1 2 3 respectively. The following factors were associated with medication incidents (OR, 95% CI): high 4 er age 1.004 per year (1.001;1.006), care-dependency 1.458 (1.025;2.073) for care by community 5 6 nurse, and 1.802 (1.399;2.323) for care by an institution, chronic conditions 1.052 per condition 7 (1.029;1.075), medications 1.052 per medication (1.030;1.074), as well as Thurgau Morbidity In 8 9 dex for stage 4 1.292 (1.004;1.662), 5 1.420 (1.078;1.868), and 6 1.680 (1.178;2.396), respective 10 11 ly. Most cases were linked to an incorrect dosage for a given patient, while prescription of an er- 12 roneous medication was the second most common error. 13 14 15 Conclusions:For Medication peer incidents are commonreview in general medicine only whereas they rarely occur in 16 pediatrics. Reasons for medication incidents are diverse but often seem to be linked to communi- 17 18 cation problems. Older and multimorbid patients are at a particularly high risk for medication inci- 19 dents. 20 21 22 Trial registration: www.clinicaltrials.gov, NCT0229537 23 24 Keywords: Patient safety, pharmaceutical preparations, medication errors. 25 26 27 Strength and limitations 28 This is the first Swiss prospective and systematic collection of incident data in primary care. 29 30 It covers three linguistic regions and two drug distribution systems. 31 It was conducted by experienced physicians and with high response rates. 32 33 http://bmjopen.bmj.com/ 34 There was – as expected – bias from selective and underreporting or non-detection of medication 35 incidents. 36 37 38 39 40 Proposed reviewers: 41 on September 28, 2021 by guest. Protected copyright. 42 - Prof. Tobias Dreischulte, Population Health Sciences, School of Medicine 43 44 The Mackenzie Building, Kirsty Semple Way, Dundee DD2 4BF, 45 46 [email protected] 47 - Prof. Meredith A B Makeham, MPH(Hons), FRACGP, Lecturer and NHMRC Scholar, Dis- 48 49 cipline of General Practice, The University of Sydney, Sydney, NSW. make 50 [email protected] 51 52 53 54 55 56 57 58 2 59 60 For peer review only - http://bmjopen.bmj.com/site/about/guidelines.xhtml Page 3 of 69 BMJ Open BMJ Open: first published as 10.1136/bmjopen-2016-013658 on 26 July 2017. Downloaded from 1 2 3 Introduction 4 5 6 Patient safety is a major concern in healthcare systems worldwide. Although most safety research 7 has been conducted in the in-patient setting [1], evidence indicates that medical errors and ad- 8 9 verse events pose a serious threat for patients in the primary care setting as well, since most pa- 10 tients receive ambulatory care [2-4]. The rationale of this project has been published in our study 11 12 protocol [5]. The aim of the project was to describe the type, incidence, seasonal and regional dis- 13 tribution of medication incidents in primary care in Switzerland and to elucidate risk factors for 14 15 medication incident.For peer review only 16 17 18 19 20 Method 21 22 Study design 23 24 25 We conducted a prospective surveillance study among primary care patients during 2015 to identi- 26 27 fy cases of medication incidents. 28 29 Study population 30 31 32 The study population was any person undergoing drug treatment in general internal or pediatric 33 practices participating the Sentinella network. The latter covers a representative sample of patients http://bmjopen.bmj.com/ 34 35 in primary care for Switzerland [6, included to this manuscript]. Founded in 1986, it was mainly 36 designed to survey transmissible diseases. Later, it also assessed other health problems of public 37 38 interest. It generates daily to weekly current data and covers the entire geographic and linguistic 39 regions of our country. Children, the mentally handicapped or the elderly were also included, all of 40 whom might be at increased risk for medication errors. 41 on September 28, 2021 by guest. Protected copyright. 42 43 Medication incidents 44 45 We defined medication incidents as any erroneous event (as defined by the physician) related to 46 47 the medication process and interfering with normal treatment course (e.g. administration of an er- 48 roneous medication). We did not include lack of treatment effect, adverse drug reactions or drug- 49 50 drug or drug-disease interactions without detectable treatment error. Nor did we consider medica 51 tion incidents if patients refused to have them reported to the Sentinella system. 52 53 54 55 56 57 58 3 59 60 For peer review only - http://bmjopen.bmj.com/site/about/guidelines.xhtml BMJ Open Page 4 of 69 BMJ Open: first published as 10.1136/bmjopen-2016-013658 on 26 July 2017. Downloaded from 1 2 3 Data sources 4 5 6 The study physicians recorded the patient’s year of birth and gender on their weekly reporting 7 form. After a maximum of four weeks they had to fill in a detailed incident questionnaire (Appendix 8 9 A). It was comprised of their Sentinella number and the calendar week of notification. Concerning 10 the patients, they reported the living situation, several supposed risk factors for an incident, as well 11 12 as the following variables: hospitalization during the previous year, care-dependency, number of 13 14 drugs used chronically, number of chronic conditions, and the Thurgau-Morbidity-Index (TMI), to be 15 compared withFor a denominator peer analysis (below)review [6]. We further receivedonly a detailed description of the 16 17 incident and proposals to avoid future incidents. 18 19 We got the annual number of patient-to-physician contacts (PPC) per practice from the Sentinella 20 21 administration, as well as morbidity data from a fortnight cross-sectional denominator analysis of all 22 patients consulting a Sentinella practice during weeks 11 or 12 [6].