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Preventability of Drug-Related Harms — Part I

A Systematic Review

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Abstract

‘Preventability’ is a crucial concept in the literature on adverse drug reactions (ADRs). We have carried out a systematic review in order to identify and analyse the approaches used to define ‘preventability’ in relation to ADRs. We have restricted this investigation to definitions of preventability and have not dealt with other aspects. We searched MEDLINE (1963–April 2009) and EMBASE (1980–April 2009), without language restriction, for papers in which preventability of ADRs was likely to be defined.

We found 234 papers, of which we retrieved 231. Of these, 172 either contained original definitions of preventability or referred to other papers in which preventability was defined. Forty contained no definition, and 19 were not relevant. In the 172 papers selected, we identified eight different general approaches to defining the preventability of ADRs: (1) analysis without explicit criteria; (2) assessment by consensus; (3) preventability linked to error; (4) preventability linked to standards of care; (5) preventability linked to medication-related factors; (6) preventability linked to information technology; (7) categorization of harmful treatments in explicit lists; and (8) a combination of more than one approach.

These approaches rely on two general methods: the judgement of one or more investigators or the use of pre-defined explicit criteria; neither is satisfactory. Specific problems include the weakness of consensus as a method (since experts can agree and yet be wrong), inadequacy of definition of standards of care, and circularity in several definitions of preventability. Furthermore, attempts to list all preventable effects are bound to be incomplete and will not always apply to an individual case.

We conclude that an approach based on analysis of the mechanisms of adverse reactions and their clinical features could be preferable; such an approach is described in a companion paper (Part II) in this issue of Drug Safety.

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References

  1. Aronson JK, Ferner RE. Preventability of drug-related harms — part II: proposed criteria, based on frameworks that classify adverse drug reactions. Drug Saf 2010; 33(11): 995–1002

    Article  PubMed  Google Scholar 

  2. Goettler M, Schneeweiss S, Hasford J. Adverse drug reaction monitoring: cost and benefit considerations. Part II: cost and preventability of adverse drug reactions leading to hospital admission. Pharmacoepidemiol Drug Saf 1997; 6 Suppl. 3: S79–90

    Article  PubMed  Google Scholar 

  3. Melmon KL. Preventable drug reactions: causes and cures. N Engl J Med 1971; 284(24): 1361–8

    Article  PubMed  CAS  Google Scholar 

  4. Burnum JF. Preventability of adverse drug reactions. Ann Intern Med 1976; 85(1): 80–1

    Article  PubMed  CAS  Google Scholar 

  5. Takata GS, Mason W, Taketomo C, et al. Development, testing, and findings of a pediatric-focused trigger tool to identify medication-related harm in US children’s hospitals. Pediatrics 2008; 121: e927–35

    Article  PubMed  Google Scholar 

  6. Bigby J, Dunn J, Goldman L, et al. Assessing the preventability of emergency hospital admissions. Am J Med 1987; 3: 1031–6

    Article  Google Scholar 

  7. Dubois RW, Brook RH. Preventable deaths: who, how often, and why? Ann Intern Med 1988; 109(7): 582–9

    Article  PubMed  CAS  Google Scholar 

  8. Baker GR, Norton PG, Flintoft V, et al. The Canadian Adverse Events Study: the incidence of adverse events among hospital patients in Canada. CMAJ 2004; 170(11): 1678–86

    Article  PubMed  Google Scholar 

  9. Baker GR. e-Appendix 3: brief description of clinical details of adverse events occurring in 255 patients, by corresponding maximum degree of preventability [online]. Available from URL: http://www.cmaj.ca/cgi/data/170/11/1678/DC3/1 [Accessed 2009 Jun 21]

  10. Morris CJ, Cantrill JA. Preventing drug-related morbidity: the development of quality indicators. J Clin Pharm Ther 2003; 28(4): 295–305

    Article  PubMed  CAS  Google Scholar 

  11. Buetow SA, Sibbald B, Cantrill JA, et al. Appropriateness in health care: application to prescribing. Soc Sci Med 1997; 45(2): 261–71

    Article  PubMed  CAS  Google Scholar 

  12. McDowell SE, Ferner HS, Ferner RE. The pathophysiology of medication errors: how and where they arise. Br J Clin Pharmacol 2009; 67(6): 605–13

    Article  PubMed  Google Scholar 

  13. Nebeker JR, Barach P, Samore MH. Clarifying adverse drug events: a clinician’s guide to terminology, documentation, and reporting. Ann Intern Med 2004; 140(10): 795–801

    Article  PubMed  Google Scholar 

  14. Kanjanarat P, Winterstein AG, Johns TE, et al. Nature of preventable adverse drug events in hospitals: a literature review. Am J Health Syst Pharm 2003; 60(17): 1750–9

    PubMed  Google Scholar 

  15. Hallas J, Harvald B, Gram LF, et al. Drug related hospital admissions: the role of definitions and intensity of data collection, and the possibility of prevention. J Intern Med 1990; 228(2): 83–90

    Article  PubMed  CAS  Google Scholar 

  16. Ho PM, Maddox TM, Wang L, et al. Risk of adverse outcomes associated with concomitant use of clopidogrel and proton pump inhibitors following acute coronary syndrome. JAMA 2009; 301(9): 937–44

    Article  PubMed  CAS  Google Scholar 

  17. Bates DW, Cullen DJ, Laird N, 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 

  18. Gurwitz JH, Field TS, Avorn J, et al. Incidence and preventability of adverse drug events in nursing homes. Am J Med 2000; 109(2): 87–94

    Article  PubMed  CAS  Google Scholar 

  19. Gurwitz JH, Field TS, Harrold LR, 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 

  20. Ferner RE. The epidemiology of medication errors: the methodological difficulties. Br J Clin Pharmacol 2009; 67(6): 614–20

    Article  PubMed  Google Scholar 

  21. Karch FE, Lasagna L. Adverse drug reactions: a critical review. JAMA 1975; 234: 1236–41

    Article  PubMed  CAS  Google Scholar 

  22. Pirmohamed M, James S, Meakin S, 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 

  23. van der Hooft CS, Dieleman JP, Siemes C, et al. Adverse drug reaction-related hospitalisations: a population-based cohort study. Pharmacoepidemiol Drug Saf 2008; 17: 365–71

    Article  PubMed  Google Scholar 

  24. Franceschi M, Scarcelli C, Niro V, et al. Prevalence, clinical features and avoidability of adverse drug reactions as cause of admission to a geriatric unit: a prospective study of 1756 patients. Drug Saf 2008; 31(6): 545–56

    Article  PubMed  Google Scholar 

  25. Raschetti R, Morgutti M, Menniti-Ippolito F, et al. Suspected adverse drug events requiring emergency department visits or hospital admissions. Eur J Clin Pharmacol 1999; 54(12): 959–63

    Article  PubMed  CAS  Google Scholar 

  26. Darchy B, Le Mière E, Figuérédo B, et al. Iatrogenic diseases as a reason for admission to the intensive care unit: incidence, causes, and consequences. Arch Intern Med 1999; 159(1): 71–8

    Article  PubMed  CAS  Google Scholar 

  27. Thomas EJ, Brennan TA. Incidence and types of preventable adverse events in elderly patients: population based review of medical records. BMJ 2000; 320: 741–4

    Article  PubMed  CAS  Google Scholar 

  28. Zed PJ, Abu-Laban RB, Balen RM, 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 

  29. Sari AB, Cracknell A, Sheldon TA. Incidence, preventability and consequences of adverse events in older people: results of a retrospective case-note review. Age Ageing 2008; 37(3): 265–9

    Article  PubMed  Google Scholar 

  30. Hayward RA, Hofer TP. Estimating hospital deaths due to medical errors: preventability is in the eye of the reviewer. JAMA 2001; 286(4): 415–20

    Article  PubMed  CAS  Google Scholar 

  31. Brennan TA, Leape LL, Laird NM, et al. Incidence of adverse events and negligence in hospitalized patients: results of the Harvard Medical Practice Study I. N Engl J Med 1991; 324(6): 370–6

    Article  PubMed  CAS  Google Scholar 

  32. Brennan TA, Hebert LE, Laird NM, et al. Hospital characteristics associated with adverse events and substandard care. JAMA 1991; 265(24): 3265–9

    Article  PubMed  CAS  Google Scholar 

  33. Gosney M, Tallis R. Prescription of contraindicated and interacting drugs in elderly patients admitted to hospital. Lancet 1984; 2(8402): 564–7

    Article  PubMed  CAS  Google Scholar 

  34. Hartwig SC, Siegel J, Schneider PJ. Preventability and severity assessment in reporting adverse drug reactions. Am J Hosp Pharm 1992; 49(9): 2229–32

    PubMed  CAS  Google Scholar 

  35. Kelly WN. Potential risks and prevention: part 1. Fatal adverse drug events. Am J Health SystPharm 2001; 58(14): 1317–24

    CAS  Google Scholar 

  36. Kelly WN. Potential risks and prevention: part 2. Drug-induced permanent disabilities. Am J Health Syst Pharm 2001; 58(14): 1325–9

    PubMed  CAS  Google Scholar 

  37. Marcellino K, Kelly WN. Potential risks and prevention: part 3. Drug-induced threats to life. Am J Health Syst Pharm 2001; 58(15): 1399–405

    PubMed  CAS  Google Scholar 

  38. Kelly WN. Potential risks and prevention: part 4. Reports of significant adverse drug events. Am J Health Syst Pharm 2001; 58(15): 1406–12

    PubMed  CAS  Google Scholar 

  39. Schumock GT, Thornton JP. Focusing on the preventability of adverse drug reactions. Hosp Pharm 1992; 27(6): 538

    PubMed  CAS  Google Scholar 

  40. Gholami K, Shalviri G. Factors associated with preventability, predictability, and severity of adverse drug reactions. Ann Pharmacother 1999; 33(2): 236–40

    Article  PubMed  CAS  Google Scholar 

  41. Ruiz B, García M, Aguirre U, et al. Factors predicting hospital readmissions related to adverse drug reactions. Eur J Clin Pharmacol 2008; 64(7): 715–22

    Article  PubMed  Google Scholar 

  42. Leendertse AJ, Egberts ACG, Stoker LJ, et al., the HARM Study Group. Frequency of and risk factors for preventable medication-related hospital admissions in the Netherlands. Arch Intern Med 2008; 168(17): 1890–6

    Article  PubMed  Google Scholar 

  43. Kunac DL, Reith DM. Preventable medication-related events in hospitalised children in New Zealand. N Z Med J 2008; 121: 17–32

    PubMed  Google Scholar 

  44. Ducharme MM, Boothby LA. Analysis of adverse drug reactions for preventability. Int J Clin Pract 2007; 61(1): 157–61

    Article  PubMed  CAS  Google Scholar 

  45. Dormann H, Neubert A, Criegee-Rieck M, et al. Readmissions and adverse drug reactions in internal medicine: the economic impact. J Intern Med 2004; 255: 653–63

    Article  PubMed  CAS  Google Scholar 

  46. Snyder RA, Abarca J, Meza JL, et al. Reliability evaluation of the adapted national coordinating council medication error reporting and prevention (NCC MERP) index. Pharmacoepidemiol Drug Saf 2007; 16: 1006–13

    Article  PubMed  Google Scholar 

  47. Rawlins MD. Clinical pharmacology: adverse reactions to drugs. BMJ (Clin Res Ed) 1981; 282: 974–6

    Article  CAS  Google Scholar 

  48. Aronson JK, Ferner RE. Clarification of terminology in drug safety. Drug Saf 2005; 28(10): 851–70

    Article  PubMed  Google Scholar 

  49. Jonville-Béra AP, Saissi H, Bensouda-Grimaldi L, et al. Avoidability of adverse drug reactions spontaneously reported to a French regional drug monitoring centre. Drug Saf 2009; 32(5): 429–40

    Article  PubMed  Google Scholar 

  50. Anonymous. Failings in treatment advice, SPCs and black triangles. Drug Ther Bull 2001; 39(4): 25–7

    Article  Google Scholar 

  51. Bates DW, O’Neil AC, Boyle D, et al. Potential identifiability and preventability of adverse events using information systems. J Am Med Inform Assoc 1994; 1(5): 404–11

    Article  PubMed  CAS  Google Scholar 

  52. Bobb A, Gleason K, Husch M, et al. The epidemiology of prescribing errors: the potential impact of computerized prescriber order entry. Arch Intern Med 2004; 164(7): 785–92

    Article  PubMed  Google Scholar 

  53. Kuo GM, Phillips RL, Graham D, et al. Medication errors reported by US family physicians and their office staff. Qual Saf Health Care 2008; 17: 286–90

    Article  PubMed  CAS  Google Scholar 

  54. van der Sijs H, Vulto A, Berg M. Overriding of drug safety alerts in Computerized Physician Order Entry. J Am Med Inform Assoc 2006; 13: 138–47

    Article  PubMed  Google Scholar 

  55. Silverman JB, Stapinski CD, Churchill WW, et al. Multi-faceted approach to reducing preventable adverse drug events. Am J Health Syst Pharm 2003; 60(6): 582–6

    PubMed  Google Scholar 

  56. Aronson JK. Medication errors: definitions and classification. Br J Clin Pharmacol 2009; 67(6): 599–604

    Article  PubMed  Google Scholar 

  57. Beers MH, Ouslander JG, Rollingher I, et al. Explicit criteria for determining inappropriate medication use in nursing home residents. UCLA Division of Geriatric Medicine. Arch Intern Med 1991; 151(9): 1825–32

    Article  PubMed  CAS  Google Scholar 

  58. Beers MH. Explicit criteria for determining potentially inappropriate medication use by the elderly: an update. Arch Intern Med 1997; 157(14): 1531–6

    Article  PubMed  CAS  Google Scholar 

  59. Fick DM, Cooper JW, Wade WE, et al. Updating the Beers criteria for potentially inappropriate medication use in older adults: results of a US consensus panel of experts. Arch Intern Med 2003; 163(22): 2716–24

    Article  PubMed  Google Scholar 

  60. Budnitz DS, Shehab N, Kegler SR, et al. Medication use leading to emergency department visits for adverse drug events in older adults. Ann Intern Med 2007; 147(11): 755–65

    Article  PubMed  Google Scholar 

  61. Robertson HA, MacKinnon NJ. Development of a list of consensus-approved clinical indicators of preventable drug-related morbidity in older adults. Clin Ther 2002; 24(10): 1595–613

    Article  PubMed  Google Scholar 

  62. Hepler CD, Strand LM. Opportunities and responsibilities in pharmaceutical care. Am J Health Syst Pharm 1990; 47: 533–43

    CAS  Google Scholar 

  63. MacKinnon NJ, Hepler CD. Indicators of preventable drug-related morbidity in older adults: 2. Use within a managed care organization. J Manag Care Pharm 2003; 9(2): 134–41

    PubMed  Google Scholar 

  64. Howard RL, Avery AJ, Howard PD, et al. Investigation into the reasons for preventable drug related admissions to a medical admissions unit: observational study. Qual Saf Health Care 2003; 12(4): 280–5

    Article  PubMed  CAS  Google Scholar 

  65. Baena MI, Marin R, Martinez Olmos J, et al. Nuevos criterios para determiner la evidabilidad de los problemas relacionados con los medicamentos. Una revisión actualizada a partir de la experiencia con 2558 personas. Pharm Care Esp 2002; 4: 393–6

    Google Scholar 

  66. Olivier P, Caron J, Haramburu F, et al. Validation d’une éhelle de mesure: exemple de l’échelle française d’évitabilité des effets indésirables médicamenteux. Thérapie 2005; 60(1): 39–45

    Article  PubMed  Google Scholar 

  67. Winterstein AG, Sauer BC, Hepler CD, et al. Preventable drug-related hospital admissions. Ann Pharmacother 2002; 36(7–8): 1238–48

    Article  PubMed  Google Scholar 

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Acknowledgements

No sources of funding were used to prepare this review. The authors have no conflicts of interest that are directly relevant to the contents of this review.

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Authors and Affiliations

  1. West Midlands Centre for Adverse Drug Reactions, City Hospital, Dudley Road, Birmingham, B18 7QH, UK

    Robin E. Ferner

  2. School of Clinical and Experimental Medicine, University of Birmingham, Birmingham, UK

    Robin E. Ferner

  3. Department of Primary Health Care, University of Oxford, Headington, Oxford, UK

    Jeffrey K. Aronson

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Ferner, R.E., Aronson, J.K. Preventability of Drug-Related Harms — Part I. Drug-Safety 33, 985–994 (2010). https://doi.org/10.2165/11538270-000000000-00000

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