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Implementing a clinical pharmacy survey of adverse drug events in a French emergency department

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Abstract

Background The prevalence of adverse drug events (ADEs) occurring in the ambulatory setting is high, requiring the development of a coherent and comprehensive patient-safety policy framework. Former experiences demonstrated that emergency department (ED) surveillance can help characterise the burden of outpatient ADEs. We developed a clinical pharmacy programme called the clinical pharmacy survey of adverse drug events (CPSA) to support interventions and research projects in the area of ADE prevention and management. Objective To design a survey to identify and describe ADEs in patients visiting the medical ED of our tertiary care hospital. We report the results of the first 2 years of CPSA implementation and an assessment of its performance. Setting The medical ED of a French 3,000-bed tertiary care hospital. Method Between January 2008 and December 2009, adult patients visiting our medical ED were included during randomised time slots. Data were collected by pharmacy students. ADEs were documented by a trained physician pharmacist team using the chart review method. Main outcome measure The primary outcome was the number of patients visiting our ED with an ADE. The CPSA attributes were assessed on the basis of the Centers for Disease Control and Prevention’s 2001 updated guidelines for evaluating public health surveillance systems. Results Of the 1,035 included patients, 201 experienced an ADE at the ED visit (19.4 %; 95 % confidence interval 15.8–23.0 %). Forty-seven ADEs (23.4 %) were unrelated to the patient’s chief complaint. An ADE was the leading cause of 154 in the 1,035 admissions (14.9 %). The assessment of our method on the basis of the Centers for Disease Control and Prevention guidelines showed good performances in terms of data quality, stability, flexibility, timeliness, and acceptability, but not in terms of simplicity and representativeness. The profile of patients with an ADE at admission and detected ADEs did not significantly differ between years 2008 and 2009. Conclusion Our experience demonstrates that clinical pharmacists can successfully implement a survey process of ADEs in an ED over time. Our method seems basic enough to suit most health care facilities with pharmacy students.

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References

  1. Bates DW, Cullen DJ, Laird N, Petersen LA, Small SD, Servi D, et al. Incidence of adverse drug events and potential adverse drug events. Implications for prevention. ADE Prevention Study Group. JAMA. 1995;274(1):29–34.

    Article  PubMed  CAS  Google Scholar 

  2. Bates DW, Spell N, Cullen DJ, Burdick E, Laird N, Petersen LA, et al. The costs of adverse drug events in hospitalized patients. Adverse drug events Prevention Study Group. JAMA. 1997;277(4):307–11.

    Article  PubMed  CAS  Google Scholar 

  3. Lazarou J, Pomeranz BH, Corey PN. Incidence of adverse drug reactions in hospitalized patients: a meta-analysis of prospective studies. JAMA. 1998;279(15):1200–5.

    Article  PubMed  CAS  Google Scholar 

  4. Gandhi TK, Burstin HR, Cook EF, Puopolo AL, Haas JS, Brennan TA, et al. Drug complications in outpatients. J Gen Intern Med. 2000;15(3):149–54.

    Article  PubMed  CAS  Google Scholar 

  5. Pirmohamed M, James S, Meakin S, Green C, Scott AK, Walley TJ, et al. Adverse drug reactions as cause of admission to hospital: prospective analysis of 18,820 patients. BMJ. 2004;329(7456):15–9.

    Article  PubMed  Google Scholar 

  6. Krähenbühl-Melcher A, Schlienger R, Lampert M, Haschke M, Drewe J, Krähenbühl S. Drug-related problems in hospitals: a review of the recent literature. Drug Saf. 2007;30(5):379–407.

    Article  PubMed  Google Scholar 

  7. Kongkaew C, Noyce PR, Ashcroft DM. Hospital admissions associated with adverse drug reactions: a systematic review of prospective observational studies. Ann Pharmacother. 2008;42(7):1017–25.

    Article  PubMed  Google Scholar 

  8. Hohl CM, Nosyk B, Kuramoto L, Zed PJ, Brubacher JR, Abu-Laban RB, et al. Outcomes of emergency department patients presenting with adverse drug events. Ann Emerg Med. 2011;58(3):270–9.

    Article  PubMed  Google Scholar 

  9. Queneau P, Bannwarth B, Carpentier F, Guliana JM, Bouget J, Trombert B, Association Pédagogique Nationale pour l’Enseignement de la Thérapeutique (APNET), et al. Emergency department visits caused by adverse drug events: results of a French survey. Drug Saf. 2007;30(1):81–8.

    Article  PubMed  Google Scholar 

  10. Taché SV, Sönnichsen A, Ashcroft DM. Prevalence of adverse drug events in ambulatory care: a systematic review. Ann Pharmacother. 2011;45(7–8):977–89.

    Article  PubMed  Google Scholar 

  11. Budnitz DS, Layde PM. Outpatient drug safety: new steps in an old direction. Pharmacoepidemiol Drug Saf. 2007;16(2):160–5.

    Article  PubMed  Google Scholar 

  12. Bourgeois FT, Shannon MW, Valim C, Mandl KD. Adverse drug events in the outpatient setting: an 11-year national analysis. Pharmacoepidemiol Drug Saf. 2010;19(9):901–10.

    Article  PubMed  Google Scholar 

  13. Kohn LT, Corrigan JM, Donaldson MS, editors. Committee on Quality of Health Care in America, Institute of Medicine. To err is human: building a safer health system. Washington, DC: National Academy Press; 2000. ISBN: 9780309068376.

  14. Hazell L, Shakir SA. Under-reporting of adverse drug reactions: a systematic review. Drug Saf. 2006;29(5):385–96.

    Article  PubMed  Google Scholar 

  15. Johansson S, Wallander MA, de Abajo FJ, García Rodríguez LA. Prospective drug safety monitoring using the UK primary-care general practice research database: theoretical framework, feasibility analysis and extrapolation to future scenarios. Drug Saf. 2010;33(3):223–32.

    Article  PubMed  Google Scholar 

  16. Hafner JW Jr, Belknap SM, Squillante MD, Bucheit KA. Adverse drug events in emergency department patients. Ann Emerg Med. 2002;39(3):258–67.

    Article  PubMed  Google Scholar 

  17. Gurwitz JH, Field TS, Harrold LR, Rothschild J, Debellis K, Seger AC, et al. Incidence and preventability of adverse drug events among older persons in the ambulatory setting. JAMA. 2003;289(9):1107–16.

    Article  PubMed  Google Scholar 

  18. Budnitz DS, Pollock DA, Mendelsohn AB, Weidenbach KN, McDonald AK, Annest JL. Emergency department visits for outpatient adverse drug events: demonstration for a national surveillance system. Ann Emerg Med. 2005;45(2):197–206.

    Article  PubMed  Google Scholar 

  19. Budnitz DS, Pollock DA, Weidenbach KN, Mendelsohn AB, Schroeder TJ, Annest JL. National surveillance of emergency department visits for outpatient adverse drug events. JAMA. 2006;296(15):1858–66.

    Article  PubMed  CAS  Google Scholar 

  20. Stone DH, Morrison A, Ohn TT. Developing injury surveillance in accident and emergency departments. Arch Dis Child. 1998;78(2):108–10.

    Article  PubMed  CAS  Google Scholar 

  21. Council of Europe, Committee of Ministers. Resolution ResAP (2001)2 concerning the pharmacist’s role in the framework of health security. 2001. https://wcd.coe.int/ViewDoc.jsp?id=193721&Site=CM&BackColorInternet=C3C3C3&BackColorIntranet=EDB021&BackColorLogged=F5D383, 30 June 2012.

  22. Council of Europe, Committee of Ministers. Recommendation Rec(2006)7 on management of patient safety and prevention of adverse events in health care. 2006. https://wcd.coe.int/ViewDoc.jsp?id=1005439&Site=CM&BackColorInternet=C3C3C3&BackColorIntranet=EDB021&BackColorLogged=F5D383, 30 June 2012.

  23. Stone DH, Morrison A, Smith GS. Emergency department injury surveillance systems: the best use of limited resources? Inj Prev. 1999;5(3):166–7.

    Article  PubMed  CAS  Google Scholar 

  24. Bourdon O, Ekeland C, Brion F. Pharmacy education in France. Am J Pharm Educ. 2008;72(6):132.

    Article  PubMed  Google Scholar 

  25. Jhung MA, Budnitz DS, Mendelsohn AB, Weidenbach KN, Nelson TD, Pollock DA. Evaluation and overview of the national electronic injury surveillance system–cooperative adverse drug event surveillance project (NEISS–CADES). Med Care. 2007;45(10 Suppl 2):S96–102.

    Article  PubMed  Google Scholar 

  26. Trotti A, Colevas AD, Setser A, Rusch V, Jaques D, Budach V, et al. CTCAE v3.0: development of a comprehensive grading system for the adverse effects of cancer treatment. Semin Radiat Oncol. 2003;13(3):176–81.

    Article  PubMed  Google Scholar 

  27. Naranjo CA, Busto U, Sellers EM, Sandor P, Ruiz I, Roberts EA, et al. A method for estimating the probability of adverse drug reactions. Clin Pharmacol Ther. 1981;30(2):239–45.

    Article  PubMed  CAS  Google Scholar 

  28. German RR, Lee LM, Horan JM, Milstein RL, Pertowski CA, Waller MN, Guidelines Working Group Centers for Disease Control and Prevention (CDC). Updated guidelines for evaluating public health surveillance systems: recommendations from the Guidelines Working Group. MMWR Recomm Rep. 2001;50(RR-13):1–35.

    PubMed  CAS  Google Scholar 

  29. Bates DW, Evans RS, Murff H, Stetson PD, Pizziferri L, Hripcsak G. Detecting adverse events using information technology. J Am Med Inf Assoc. 2003;10(2):115–28.

    Article  Google Scholar 

  30. Kendrick D, Lyons R, Christie N, Towner E, Benger J, Groom L, et al; UK Burden of Injury Study Group. Recruiting participants for injury studies in emergency departments. Inj Prev. 2007;13(2):75–7.

    Article  PubMed  Google Scholar 

  31. Capuano A, Motola G, Russo F, Avolio A, Filippelli A, Rossi F, et al. Adverse drug events in two emergency departments in Naples, Italy: an observational study. Pharmacol Res. 2004;50(6):631–6.

    Article  PubMed  Google Scholar 

  32. Trifirò G, Calogero G, Ippolito FM, Cosentino M, Giuliani R, Conforti A, et al. Adverse drug events in emergency department population: a prospective Italian study. Pharmacoepidemiol Drug Saf. 2005;14(5):333–40.

    Article  PubMed  Google Scholar 

  33. Patel KJ, Kedia MS, Bajpai D, Mehta SS, Kshirsagar NA, Gogtay NJ. Evaluation of the prevalence and economic burden of adverse drug reactions presenting to the medical emergency department of a tertiary referral centre: a prospective study. BMC Clin Pharmacol. 2007;7:8.

    Article  PubMed  CAS  Google Scholar 

  34. Zed PJ, Abu-Laban RB, Balen RM, Loewen PS, Hohl CM, Brubacher JR, et al. Incidence, severity and preventability of medication-related visits to the emergency department: a prospective study. CMAJ. 2008;178(12):1563–9.

    Article  PubMed  Google Scholar 

  35. Hohl CM, Zed PJ, Brubacher JR, Abu-Laban RB, Loewen PS, Purssell RA. Do emergency physicians attribute drug-related emergency department visits to medication-related problems? Ann Emerg Med. 2010;55(6):493–502.

    Article  PubMed  Google Scholar 

  36. Dean B. Adverse drug events: what’s the truth? Qual Saf Health Care. 2003;12(3):165–6.

    Article  PubMed  CAS  Google Scholar 

  37. Cohen V, Jellinek SP, Hatch A, Motov S. Effect of clinical pharmacists on care in the emergency department: a systematic review. Am J Health Syst Pharm. 2009;66(15):1353–61.

    Article  PubMed  Google Scholar 

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Acknowledgments

The authors thank Guillaume Brément, Sébastien Ruaud, Claire Denis, Laura Bloino, Claire Delville, Marion Cruveilhier, Romain Goument, Pierre-Yves Joubi, Emilie Peron, Thibaut Grare, Emilie Simon, Florence Renaudineau, Julie Lambert, Xavier Guy, Charlotte Bronsard, Alice Bozec, Emilie Bouju, Cyrille Puel and Mélanie Bonal for carrying out data collection.

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Correspondence to Lucien Roulet.

Appendix

Appendix

Definitions of the nine attributes of a surveillance system (excerpt from the Centers for Disease Control and Prevention’s 2001 updated guidelines for evaluating public health surveillance systems [28])

  1. 1.

    Simplicity

The simplicity of a public health surveillance system refers to both its structure and ease of operation. Surveillance systems should be as simple as possible while still meeting their objectives.

  1. 2.

    Flexibility

A flexible public health surveillance system can adapt to changing information needs or operating conditions with little additional time, personnel, or allocated funds.

  1. 3.

    Data quality

Data quality reflects the completeness and validity of the data recorded in the public health surveillance system.

  1. 4.

    Acceptability

Acceptability reflects the willingness of persons and organizations to participate in the surveillance system.

  1. 5.

    Sensitivity

The sensitivity of a surveillance system refers to the proportion of cases of a disease (or other health-related event) detected by the surveillance system.

  1. 6.

    Predictive value positive

Predictive value positive (PVP) is the proportion of reported cases that actually have the health-related event under surveillance.

  1. 7.

    Representativeness

A public health surveillance system that is representative accurately describes the occurrence of a health-related event over time and its distribution in the population by place and person.

  1. 8.

    Timeliness

Timeliness reflects the speed between steps in a public health surveillance system.

  1. 9.

    Stability

Stability refers to the reliability (i.e., the ability to collect, manage, and provide data properly without failure) and availability (the ability to be operational when it is needed) of the public health surveillance system.

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Roulet, L., Asseray, N., Dary, M. et al. Implementing a clinical pharmacy survey of adverse drug events in a French emergency department. Int J Clin Pharm 34, 902–910 (2012). https://doi.org/10.1007/s11096-012-9691-6

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  • DOI: https://doi.org/10.1007/s11096-012-9691-6

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