The Korean journal of internal medicine

The Korean Association of Internal Medicine (대한내과학회)
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A Comparison of Active Surveillance Programs Including a Spontaneous Reporting Model for Phamacovigilance of Adverse Drug Events in a Hospital

  • Yun, Il Seon (Severance Hospital Regional Pharmacovigilance Center) ;
  • Koo, Myung Jin (Severance Hospital Regional Pharmacovigilance Center) ;
  • Park, Eun Hye (Severance Hospital Regional Pharmacovigilance Center) ;
  • Kim, Sung-Eun (Severance Hospital Regional Pharmacovigilance Center) ;
  • Lee, Jae-Hyun (Severance Hospital Regional Pharmacovigilance Center) ;
  • Park, Jung-Won (Severance Hospital Regional Pharmacovigilance Center) ;
  • Hong, Chein-Soo (Severance Hospital Regional Pharmacovigilance Center)
  • Published : 2012.12.01
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Abstract

Background/Aims: Spontaneous reporting systems have several weak points, such as low reporting rates and insufficient clinical information. Active surveillance programs, such as ward rounds and a clinical data repository (CDR), may supplement the weak points of such systems. We developed active surveillance programs and compared them with existing spontaneous reporting. Methods: We collected adverse drug event (ADE) cases, which comprised 1,055 cases of spontaneous reporting, 309 reported by ward rounds, and 229 found using a CDR. The clinical features and causative drugs were evaluated. Results: Active surveillance programs detected additional serious ADEs compared to those of spontaneous reporting programs. The ADEs identified by CDR (22.9%) were more likely to be classified as "serious" than those reported spontaneously (5.2%) or identified during ward rounds (10.3%). Causative drugs also differed. Opioids, antibiotics, and contrast media were the most common drugs causing ADEs in the spontaneous reporting system, whereas the active surveillance programs identified antibiotics as the most common causative drug. Clinical features also differed. ADEs with gastrointestinal manifestations were reported most frequently by spontaneous reporting programs. ADEs reported from active surveillance more reliably identified events associated with changes in laboratory values, such as hepatobiliary toxicity, hematologic manifestations, and nephrologic manifestations, compared with spontaneous reporting programs. Conclusions: Our findings suggest that active surveillance programs can supplement spontaneous reporting systems in hospitals. ADEs related to laboratory abnormalities were monitored more closely by active surveillance programs and may be useful for identification of serious ADEs.

Keywords

References

  1. Forster AJ, Halil RB, Tierney MG. Pharmacist surveillance of adverse drug events. Am J Health Syst Pharm 2004;61:1466-1472.
  2. Leape LL, Brennan TA, Laird N, et al. The nature of adverse events in hospitalized patients: results of the Harvard Medical Practice Study II. N Engl J Med 1991;324:377-384. https://doi.org/10.1056/NEJM199102073240605
  3. Thomas EJ, Studdert DM, Burstin HR, et al. Incidence and types of adverse events and negligent care in Utah and Colorado. Med Care 2000;38:261-271. https://doi.org/10.1097/00005650-200003000-00003
  4. Classen DC, Pestotnik SL, Evans RS, Lloyd JF, Burke JP. Adverse drug events in hospitalized patients: excess length of stay, extra costs, and attributable mortality. JAMA 1997;277:301-306. https://doi.org/10.1001/jama.1997.03540280039031
  5. Senst BL, Achusim LE, Genest RP, et al. Practical approach to determining costs and frequency of adverse drug events in a health care network. Am J Health Syst Pharm 2001;58:1126-1132.
  6. 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;274:29-34. https://doi.org/10.1001/jama.1995.03530010043033
  7. Nebeker JR, Hoffman JM, Weir CR, Bennett CL, Hurdle JF. High rates of adverse drug events in a highly computerized hospital. Arch Intern Med 2005;165:1111-1116. https://doi.org/10.1001/archinte.165.10.1111
  8. Bates DW, Spell N, Cullen DJ, et al. The costs of adverse drug events in hospitalized patients: Adverse Drug Events Prevention Study Group. JAMA 1997;277:307-311. https://doi.org/10.1001/jama.1997.03540280045032
  9. Leape LL, Bates DW, Cullen DJ, et al. Systems analysis of adverse drug events: ADE Prevention Study Group. JAMA 1995;274:35-43. https://doi.org/10.1001/jama.1995.03530010049034
  10. Raschke RA, Gollihare B, Wunderlich TA, et al. A computer alert system to prevent injury from adverse drug events: development and evaluation in a community teaching hospital. JAMA 1998;280:1317-1320. https://doi.org/10.1001/jama.280.15.1317
  11. Weaver J, Willy M, Avigan M. Informatic tools and approaches in postmarketing pharmacovigilance used by FDA. AAPS J 2008;10:35-41. https://doi.org/10.1208/s12248-007-9004-5
  12. Zancan A, Locatelli C, Ramella F, et al. A new model of pharmacovigilance? A pilot study. Biomed Pharmacother 2009;63:451-455. https://doi.org/10.1016/j.biopha.2008.07.091
  13. Bates DW, Leape LL, Petrycki S. Incidence and preventability of adverse drug events in hospitalized adults. J Gen Intern Med 1993;8:289-294. https://doi.org/10.1007/BF02600138
  14. Keith MR, Bellanger-McCleery RA, Fuchs JE Jr. Multidisciplinary program for detecting and evaluating adverse drug reactions. Am J Hosp Pharm 1989;46:1809-1812.
  15. Jha AK, Kuperman GJ, Teich JM, et al. Identifying adverse drug events: development of a computer-based monitor and comparison with chart review and stimulated voluntary report. J Am Med Inform Assoc 1998;5:305-314. https://doi.org/10.1136/jamia.1998.0050305
  16. Gandhi TK, Seger DL, Bates DW. Identifying drug safety issues: from research to practice. Int J Qual Health Care 2000;12:69-76. https://doi.org/10.1093/intqhc/12.1.69
  17. Hwang SH, Lee S, Koo HK, Kim Y. Evaluation of a computer-based adverse-drug-event monitor. Am J Health Syst Pharm 2008;65:2265-2272. https://doi.org/10.2146/ajhp080122
  18. Faich GA. National adverse drug reaction reporting: 1984-1989. Arch Intern Med 1991;151:1645-1647. https://doi.org/10.1001/archinte.1991.00400080129025
  19. Berry LL, Segal R, Sherrin TP, Fudge KA. Sensitivity and specificity of three methods of detecting adverse drug reactions. Am J Hosp Pharm 1988;45:1534-1539.
  20. Rogers AS, Israel E, Smith CR, et al. Physician knowledge, attitudes, and behavior related to reporting adverse drug events. Arch Intern Med 1988;148:1596-1600. https://doi.org/10.1001/archinte.1988.00380070090021
  21. Schiff GD. Using a computerized discharge summary data base check box for adverse drug reaction monitoring. QRB Qual Rev Bull 1990;16:149-155. https://doi.org/10.1016/S0097-5990(16)30357-8
  22. Cullen DJ, Bates DW, Small SD, Cooper JB, Nemeskal AR, Leape LL. The incident reporting system does not detect adverse drug events: a problem for quality improvement. Jt Comm J Qual Improv 1995;21:541-548.
  23. The Uppsala Monitoring Centre. The WHO-ART Adverse Reaction Terminology. Uppsala: The Uppsala Monitoring Centre, 1992.
  24. Edwards IR, Aronson JK. Adverse drug reactions: definitions, diagnosis, and management. Lancet 2000;356:1255-1259. https://doi.org/10.1016/S0140-6736(00)02799-9
  25. Vallano A, Cereza G, Pedros C, et al. Obstacles and solutions for spontaneous reporting of adverse drug reactions in the hospital. Br J Clin Pharmacol 2005;60:653-658. https://doi.org/10.1111/j.1365-2125.2005.02504.x
  26. Miwa LJ, Randall RJ. Adverse drug reaction program using pharmacist and nurse monitors. Hosp Formul 1986;21:1140-1146.
  27. Marcondes RA. Dental care of the cardiac patient. Ars Curandi Odontol 1976;2:3-8.
  28. Hunziker T, Kunzi UP, Braunschweig S, Zehnder D, Hoigne R. Comprehensive hospital drug monitoring (CHDM): adverse skin reactions, a 20-year survey. Allergy 1997;52:388-393. https://doi.org/10.1111/j.1398-9995.1997.tb01017.x
  29. Choi JH, Shin YS, Suh CH, Nahm DH, Park HS. The frequency of adverse drug reactions in a tertiary care hostpital in Korea. Korean J Med 2004;67:290-296.
  30. Classen DC, Pestotnik SL, Evans RS, Burke JP. Computerized surveillance of adverse drug events in hospital patients. JAMA 1991;266:2847-2851. https://doi.org/10.1001/jama.1991.03470200059035
  31. Kunac DL, Kennedy J, Austin N, Reith D. Incidence, preventability, and impact of Adverse Drug Events (ADEs) and potential ADEs in hospitalized children in New Zealand: a prospective observational cohort study. Paediatr Drugs 2009;11:153-160. https://doi.org/10.2165/00148581-200911020-00005
  32. Kaushal R, Bates DW, Landrigan C, et al. Medication errors and adverse drug events in pediatric inpatients. JAMA 2001;285:2114-2120. https://doi.org/10.1001/jama.285.16.2114
  33. Holdsworth MT, Fichtl RE, Behta M, et al. Incidence and impact of adverse drug events in pediatric inpatients. Arch Pediatr Adolesc Med 2003;157:60-65. https://doi.org/10.1001/archpedi.157.1.60

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