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BMJ Open: first published as 10.1136/bmjopen-2017-019186 on 20 March 2019. Downloaded from BMJ Open is committed to open peer review. As part of this commitment we make the peer review history of every article we publish publicly available. When an article is published we post the peer reviewers’ comments and the authors’ responses online. We also post the versions of the paper that were used during peer review. These are the versions that the peer review comments apply to. The versions of the paper that follow are the versions that were submitted during the peer review process. They are not the versions of record or the final published versions. They should not be cited or distributed as the published version of this manuscript. BMJ Open is an open access journal and the full, final, typeset and author-corrected version of record of the manuscript is available on our site with no access controls, subscription charges or pay-per-view fees (http://bmjopen.bmj.com). If you have any questions on BMJ Open’s open peer review process please email [email protected] http://bmjopen.bmj.com/ on September 29, 2021 by guest. Protected copyright. BMJ Open BMJ Open: first published as 10.1136/bmjopen-2017-019186 on 20 March 2019. Downloaded from Potentially inappropriate prescriptions and omissions in pediatrics: detection by POPI (Pediatrics: Omission of Prescription and Inappropriate prescription) in the emergency unit and in the ambulatory setting. ForJournal: peerBMJ Open review only Manuscript ID bmjopen-2017-019186 Article Type: Research Date Submitted by the Author: 16-Aug-2017 Complete List of Authors: Berthe-Aucejo, Aurore; Hopital Universitaire Robert Debre, Pharmacy department Nguyen, Phuong Khanh Hoang; Hopital Universitaire Robert Debre, Department of Pharmacy Angoulvant, François; Hopital universitaire Necker-Enfants malades, Emergency unit; INSERM, U1123 Bellettre, Xavier; Hopital Universitaire Robert Debre, Emergency unit Albaret, Patrick; Albaret Pharmacy Weil, Thomas; Hopital Universitaire Robert Debre, Department of Pharmacy Boulkedid, Rym; Hopital Universitaire Robert Debre, Clinical Epidemiology unit; INSERM, U1123 Bourdon, Olivier; Hopital Universitaire Robert Debre, Department of http://bmjopen.bmj.com/ pharmacy; Universite Paris Descartes, Clinical Pharmacy Prot-Labarthe, Sonia; Hopital Universitaire Robert Debre, Department of Pharmacy; INSERM, U1123 <b>Primary Subject Paediatrics Heading</b>: Secondary Subject Heading: General practice / Family practice Keywords: inappropriate prescription, omission, tool, detection on September 29, 2021 by guest. Protected copyright. For peer review only - http://bmjopen.bmj.com/site/about/guidelines.xhtml Page 1 of 27 BMJ Open BMJ Open: first published as 10.1136/bmjopen-2017-019186 on 20 March 2019. Downloaded from 1 2 3 Potentially inappropriate prescriptions and omissions in pediatrics: detection by POPI 4 (Pediatrics: Omission of Prescription and Inappropriate prescription) in the emergency 5 unit and in the ambulatory setting. 6 7 8 A. Berthe-Aucejo1, H.P.K Nguyen1, F. Angoulvant2,3, X. Bellettre4, P. Albaret5,6, T. Weil1, R. 9 10 3,7 1,6,8,9 1,3,9 11 Boulkedid , O. Bourdon , S.Prot-Labarthe 12 13 14 15 1 16 Department of ForPharmacy, peer Robert-Debré review Hospital, Paris, France only 17 18 2 19 Emergency unit, Necker Hospital, Paris, France 20 21 3 U1123, INSERM ECEVE, Paris, France 22 23 4 24 Emergency unit AP-HP, Robert-Debré Hospital, Paris, France 25 26 5 Albaret Pharmacy, Cesson, France 27 28 29 6 Clinical Pharmacy, Paris Descartes University, Paris, France 30 31 7 32 Clinical Epidemiology Unit, Robert-Debré Hospital, Paris, France http://bmjopen.bmj.com/ 33 34 8 Laboratoire Educations et Pratiques de Santé, Paris XIII University, Bobigny, France 35 36 37 9 Groupe Pédiatrie de la Société Française de Pharmacie Clinique, Paris, France 38 39 40 on September 29, 2021 by guest. Protected copyright. 41 Word count : 2628 42 43 44 Corresponding author 45 46 47 Dr Aurore Berthe-Aucejo, Service Pharmacie, AP-HP Hôpital Robert-Debré, 48 Boulevard 48 49 Sérurier, 75019 Paris, Fax: 01-40-03-24-81, Tel: 0140-03-57-41, Email: 50 [email protected] 51 52 53 Keywords 54 55 56 Inappropriate prescription, omission, tool, detection 57 58 59 60 For peer review only - http://bmjopen.bmj.com/site/about/guidelines.xhtml BMJ Open Page 2 of 27 BMJ Open: first published as 10.1136/bmjopen-2017-019186 on 20 March 2019. Downloaded from 1 2 3 ABSTRACT 4 5 6 Background and Objective: POPI (Pediatrics: Omission of Prescription and Inappropriate 7 prescription) is the first tool of detection for potentially inappropriate medicines (PIM) and 8 9 potentially prescribing omissions (PPO) in pediatrics. The aim of this study was to evaluate 10 11 the prevalence of PIM and PPO detected by POPI regarding issuing of prescription in hospital 12 and outpatient car. The second objective is to determine the risk factors related to PIM. 13 14 Design: A retrospective and descriptive study was conducted in the emergency department 15 16 (ED) and communityFor pharmacy peer (CP) from review 1 October 2014 only and 31 March 2015. POPI was 17 18 used to identify inappropriate prescriptions and omissions. 19 20 Setting: Robert-Debré Hospital (AP-HP, France) and Albaret community pharmacy (Seine 21 and Marne 22 23 Participants: Inclusion criteria included patients who were under 18 years old and who had 24 25 one medicine prescription between 1st October 2014 and 31st March 2015. Exclusion criteria 26 27 consisted of inaccessible medical records for patients consulted in ED and prescription 28 without drugs for outpatients. 29 30 Primary and secondary outcome measures: PIM and PPO rate, PIM risk factors 31 32 Results: A total of 18.562 prescriptions for 15.973 patients at the ED and 4.780 prescriptions http://bmjopen.bmj.com/ 33 34 for 2.225 patients at the CP were analyzed. The PIM rate and PPO rate were respectively 35 36 3.3% and 2.6% at the ED and 26.4% and 13.2% at the CP. Respiratory and digestive diseases 37 had the highest rate of PIM in hospital and community pharmacy. Multivariate analysis 38 39 showed that children aged between 2 and 6 years (OR=2.4; IC 1.9-2.9; p<0,001) and 40 on September 29, 2021 by guest. Protected copyright. 41 prescriptions issued from outpatient care (OR=5.2, 95% confidence interval (CI) 5.0-6.5, 42 p<0.001) correlated with a higher risk of PIM. 43 44 Conclusion: This study is the first to observe the prevalence of PIM and PPO detecting by 45 46 POPI in a pediatric population. A prospective and multicenter study should be conducted to 47 evaluate its impact and benefit in clinical practice. 48 49 50 51 52 53 54 55 56 57 58 59 60 For peer review only - http://bmjopen.bmj.com/site/about/guidelines.xhtml Page 3 of 27 BMJ Open BMJ Open: first published as 10.1136/bmjopen-2017-019186 on 20 March 2019. Downloaded from 1 2 3 Strengths and limitations of this study 4 5 6 - This study is the first to observe the prevalence of PIM and PPO in a pediatric population. 7 8 The inappropriate prescription rate and omission rate were respectively 3.3% and 2.6% at the 9 10 emergency unit and 26.4% and 13.2% at the community pharmacy. 11 12 13 - It is a retrospective and monocentric study. Our result in the hospital could be 14 15 underestimated. 16 For peer review only 17 18 19 - Ambulatory prescription and the group age between two and six years were associated with 20 21 a higher risk of inappropriate prescribing. 22 23 24 - Our study showed that there are many criteria which could be detected without access to 25 26 27 clinical information and that they are easy to identify. 28 29 30 31 32 http://bmjopen.bmj.com/ 33 34 35 36 37 38 39 40 on September 29, 2021 by guest. Protected copyright. 41 42 43 44 45 46 47 48 49 50 51 52 53 54 55 56 57 58 59 60 For peer review only - http://bmjopen.bmj.com/site/about/guidelines.xhtml BMJ Open Page 4 of 27 BMJ Open: first published as 10.1136/bmjopen-2017-019186 on 20 March 2019. Downloaded from 1 2 3 INTRODUCTION 4 5 6 Inappropriate prescribing is a known preventable cause of adverse drug events (ADE) and has 7 8 an important impact on public health and cost of care.[1,2] Incidence of hospitalization due to 9 10 ADE was 42.8% according to a French survey in 2009.[3] The World Health Organization 11 12 estimated that 50% of medications are prescribed and utilized inappropriately.[4] The most 13 14 recent definition of inappropriate prescription (IP) encompasses potentially inappropriate 15 16 For peer review only 17 medicines (PIM) and prescribing omissions (PPO).[5] In a report from the French National 18 19 Authority for Health, PIMs are defined as “drugs being used in a situation in which the risks 20 21 involved in treatment potentially outweigh the benefits, lack of indication demonstrated, high 22 23 risk of ADE, and an unfavorable cost-effect or risk-benefit ratio exists”. PPO or underuse of 24 25 appropriate medication is defined as the absence of initiation of an effective treatment in 26 27 subjects with a condition for which one or several drug classes have demonstrated their 28 29 30 efficacy [6]. In an elderly population, which presents with age-related physiological changes 31 32 and high prevalence of polypharmacy, various measures have been developed to detect PIM http://bmjopen.bmj.com/ 33 34 such as: Beers’ criteria, the Inappropriate Prescribing in the Elderly Tool, The Medication 35 36 Appropriate Index, and STOPP/START (Screening Tool of Older Person’s 37 38 prescriptions/Screening Tool to Alert doctor to Right Treatment).[7–11] Only the 39 40 STOPP/START enables us to detect under-prescribing.[5] Using these tools, many studies on September 29, 2021 by guest.
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