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2010 | 5 | 3 | 338-346

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Spontaneous reporting of adverse drug reactions at a department of Internal Medicine


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The aim of the present study was to characterize the pattern of adverse drug reactions (ADRs) reported in a university teaching hospital in south-east Serbia. The study was conducted based on ADRs reported during a six-month period to the ADR reporting unit of the university clinical center. Evaluation of data was done for various parameters, such as patient demographics, drug and reaction characteristics, and outcome of reactions. Assessment was also done for causality, severity and predisposing factors. During the 6-month study period, 44 ADRs were reported, with an overall incidence of 0.33%. No significant difference was seen in the overall incidence of ADRs observed in males and females. Incidence of ADRs among elderly (43.2%) and older (25%) adults was significantly higher than in other age groups. Type A reactions (66.7%) accounted for majority of the reports. The most commonly affected organ system was the renal system, (22.7%) with hyperkalemia as the only reported reaction. ACE inhibitors (48.6%) were the drug class most commonly involved, where fosinopril (25.7%) was the individual drug most frequently reported. Additional treatment was pursued for management of ADRs in majority (52.3%) of the reports. In 52.3 % of the reports, the patient had recovered from the reaction by the time of evaluation. Upon causality assessment, the majority of the reports were rated as probable (43.2%). Mild and moderate reactions accounted for 43.2% and 54.6%, respectively. In 36.3% of the reports, the reaction was considered to be preventable. The most common predisposing factors were polypharmacy and multiple disease state. The pattern of ADRs reported in our hospital is comparable to the results of studies conducted in hospital set up elsewhere. Our evaluations revealed opportunities for intervention to ensure safer drug use.










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1 - 6 - 2010
9 - 4 - 2010


  • Department of Pharmacology and Toxicology, Medical Faculty, University of Nis, 18000, Nis, Serbia
  • Department of Internal Medicine, University Clinical Center, 18000, Nis, Serbia
  • Department of Pharmacology and Toxicology, Medical Faculty, University of Nis, 18000, Nis, Serbia
  • Clinic for Children’s Internal Diseases, University Clinical Center, 18000, Nis, Serbia


  • [1] Davies E.C., Green C.F., Mottram D.R., Pirmohamed M., Adverse drug reactions in hospital in-patients: a pilot study, Journal of Clinical Pharmacy and Therapeutics, 2006, 31, 335–341 http://dx.doi.org/10.1111/j.1365-2710.2006.00744.x[Crossref]
  • [2] Somers A., Petrovic M., Robays H., Bogaert M., Reporting adverse drug reactions on a geriatric ward: a pilot project, Eur J Clin Pharmacol, 2003, 58, 707–714
  • [3] Classen D.C., Pestotnik S.L., Evans R.S., Lloyd J.F., Burke J.P., Adverse drug events in hospitalized patients, Excess length of stay, extra costs, and attributable mortality, JAMA, 1997, 277, 301–306 http://dx.doi.org/10.1001/jama.277.4.301[Crossref]
  • [4] Lagnaoui R., Moore N., Fach J., Longy-Boursier M., Begaud B., Adverse drug reactions in a department of systemic diseases-oriented internal medicine: prevalence, incidence, direct costs and avoidability, Eur J Clin Pharmacol, 2000, 56, 181–186 http://dx.doi.org/10.1007/s002280050738[Crossref]
  • [5] Dormann H., Muth-Selbach U., Krebs B., Criegee-Rieck M., Tegeder I., Schneider H.T., et al., Incidence and costs of adverse drug reactions during hospital stay, Drug Saf, 2000, 22, 161–168 http://dx.doi.org/10.2165/00002018-200022020-00007[Crossref]
  • [6] Moore N., Lecointre D., Nobelt C., Mabille M., Frequency and cost of serious adverse drug reactions in a department of general medicine, Br J Clin Pharmacol, 1998, 45, 301–308 http://dx.doi.org/10.1046/j.1365-2125.1998.00667.x[Crossref]
  • [7] Levy M., Azaz-Livshits T., Sadan B., Shalit M., Geisslinger G., Brune K., Computerized surveillance of adverse drug reactions in hospital: implementation, Eur J Clin Pharmacol, 1999, 54, 887–892 http://dx.doi.org/10.1007/s002280050571[Crossref]
  • [8] Ditto A.M., Drug allergy, In, Grammer L.C., Greenberger P.A., editors. Patterson’s allergic diseases. 6th ed. Philadelphia: Lippincott Williams & Wilkins, 2002. p.295
  • [9] Jick H., Adverse drug reactions: the magnitude of the problem, J Allergy Clin Immunol, 1984, 74, 555–557 http://dx.doi.org/10.1016/0091-6749(84)90106-4[Crossref]
  • [10] Lazarou J., Pomeranz B.H., Corey P.N., Incidence of adverse drug reactions in hospitalized patients: a meta-analysis of prospective studies, JAMA, 1998, 279, 1200–1205 http://dx.doi.org/10.1001/jama.279.15.1200[Crossref]
  • [11] Hartwig S.C., Siegel J., Schneider P.J., Preventability and severity assessment in reporting adverse drug reactions, Am J Hosp Pharm, 1992, 49, 2229–2232
  • [12] American Society of Health System Pharmacists, ASHP guidelines on adverse drug reaction monitoring and reporting, Am J Hosp Pharm, 1989, 46, 336–337
  • [13] Moride Y., Haramburu F., Requeyo A.A., Begaud B., Underreporting of adverse drug reactions in general practice, Br J Clin Pharmacol, 1997, 43(2), 177–181 http://dx.doi.org/10.1046/j.1365-2125.1997.05417.x[Crossref]
  • [14] Alvarez-Requejo A., Carvajal A., Begaud B., Moride Y., Vega T., Martin Arias L.H., Underreporting of adverse drug reactions. Estimate based on a spontaneous reporting scheme and a sentinel system, Eur J Clin Pharmacol, 1998, 54, 483–488 http://dx.doi.org/10.1007/s002280050498[Crossref]
  • [15] Gallelli L., Ferreri M., Colosimo M., Pirritano D., Flocco M.A., Pelaia G., et al., Retrospective analysis of adverse drug reactions to bronchodilators observed in two pulmonary divisions of Catanzaro, Italy, Pharmacol Res, 2003, 47(6), 493–499 http://dx.doi.org/10.1016/S1043-6618(03)00003-3[Crossref]
  • [16] Rawlins M.D., Thompson J.W., Pathogenesis of adverse drug reactions, In: Davies DM, editor Textbook of adverse drug reactions. 1st ed.Oxford: Oxford University Press; 1977. p.44
  • [17] WHO Collaborating Centre for Drug Statistics Methodology. Completed ATC Index 2005
  • [18] Naranjo C.A., Busto U., Sellers E.M., Sandor P., Ruiz I., Roberts E.A., et al., A method for estimating the probability of adverse drug reactions, Clin Pharmacol Ther, 1981, 30, 239–245 [Crossref]
  • [19] Lau P.M., Stewart K., Dooley M.J., Comment: hospital admissions resulting from preventable adverse drug reactions, Ann Pharmacother 2003, 37, 303–312 http://dx.doi.org/10.1345/aph.1A333a[Crossref]
  • [20] Edwards I.R., Pharmacological basis of adverse drug reactions, In: Speight TM, Holford NHG, editors. Avery’s drug treatment. 4th ed. Auckland, New Zealand: Adis International; 1997. p. 261–299
  • [21] Parthasarathi G., Olsson S., Adverse Drug Reactions, In: Parthasarathi G., Nyfort-Hansen K., Nahata M.C., editors. A textbook of clinical pharmacy practice-essential concepts and skills 1st ed. place: Orient Longmann; 2005. p. 85–102
  • [22] Veehof L.J.G., Stewart R.E., Haaijer-Ruskamp F.M., Meyboom-de Jong B., The development of polypharmacy: A longitudinal study, Family Practice, 2000, 17(3), 261–267 http://dx.doi.org/10.1093/fampra/17.3.261[Crossref]
  • [23] Bennett B.S., Lipman A.G., Comparative study of prospective surveillance and voluntary reporting in determining the incidence of adverse drug reactions, Am J Hosp Pharm, 1977, 34, 931–936
  • [24] Impicciatore P., Choonara I., Clarkson A., Provasi D., Pandolfini C., Bonati M., Incidence of adverse drug reactions in pediatric in/out-patients: a systematic review and meta-analysis of prospective studies, Br J Clin Pharmacol, 2001, 52(1), 77–83 http://dx.doi.org/10.1046/j.0306-5251.2001.01407.x[Crossref]
  • [25] Montastruc J.L., Lapeyre-Mestre M., Bagheri H., Fooladi A., Gender differences in adverse drug reactions: analysis of spontaneous reports to a Regional Pharmacovigilance Centre in France, Fundam Clin Pharmacol, 2002, 16(5), 343–346 http://dx.doi.org/10.1046/j.1472-8206.2002.00100.x[Crossref]
  • [26] Bates D.W., Cullen D.J., Laird N., Petersen L.A., Small S.D., Servi D., et al., Incidence of adverse drug events and potential adverse drug eventsimplications for prevention, JAMA, 1995, 55(1), 29–34 http://dx.doi.org/10.1001/jama.274.1.29[Crossref]
  • [27] Murphy B.M., Frigo LC., Development, implementation and results of a successful multidisciplinary adverse drug reaction reporting program in a university teaching hospital. Hosp Pharm, 1993, 28(12), 1199–1204
  • [28] Suh D.C., Woodall B.S., Shin S.K., Hermes-De-Santis E.R., Clinical and economic impact of adverse drug reactions in hospitalized patients, Ann Pharmacother, 2000, 34, 1373–1379 [Crossref]
  • [29] Prosser T.R., Kamysz P.L., Multidisciplinary adverse drug reaction surveillance program. Am J Hosp Pharm, 1990, 47(6), 1334–1339
  • [30] Acker C.G., Johnson J.P., Palevsky P.M., Greenberg A., Hyperkalemia in hospitalized patients: causes, adequacy of treatment, and results of an attempt to improve physician compliance with published therapy guidelines, Arch Intern Med, 1998, 158, 917–924 http://dx.doi.org/10.1001/archinte.158.8.917[Crossref]
  • [31] Rimmer J.M., Horn J.F., Gennari F.J., Hyperkalemia as a complication of drug therapy, Arch Intern Med, 1987, 147, 867–869 http://dx.doi.org/10.1001/archinte.147.5.867[Crossref]
  • [32] Perazella M.A., Drug-induced hyperkalemia: old culprits and new offenders, Am J Med, 2000, 109, 307–314 http://dx.doi.org/10.1016/S0002-9343(00)00496-4[Crossref]
  • [33] Ahuja T., Freeman D. Jr., Mahnken J.D., Agraharkar M., Siddiqui M., Memon A., Predictors of the development of hyperkalemia in patients using angiotensin-converting enzyme inhibitors, Am J Nephrol, 2000, 20, 268–272 http://dx.doi.org/10.1159/000013599[Crossref]
  • [34] Reardon L.C., Macpherson D.S., Hyperkalemia in outpatients using angiotensin-converting enzyme inhibitors, Arch Intern Med, 1998, 158, 26–32 http://dx.doi.org/10.1001/archinte.158.1.26[Crossref]
  • [35] Gholami K., Shalviri G., Factors associated with preventability, predictability and severity of adverse drug reactions, Ann Pharmacother, 1999, 33(2), 236–240 http://dx.doi.org/10.1345/aph.17440[Crossref]
  • [36] Gonzalez-Martin G., Caroca C.M., Paris E., Adverse drug reactions /ADRs/ in hospitalized pediatric patients-a prospective study, Int J Clin Pharmacol Ther, 1998, 36(10), 530–533
  • [37] Jose J., Rao P.G.M., Pattern of adverse drug reactions notified by spontaneous reporting in an Indian tertiary care teaching hospital, Pharmacological Research, 2006, 54(3), 226–233 http://dx.doi.org/10.1016/j.phrs.2006.05.003[Crossref]
  • [38] Kanjanarat P., Winterstein A.G., Johns T.E., Hatton R.C., Gonzalez-Rothi R., Segal R., Nature of preventable adverse drug events in hospitals: a literature review, Am J Health Syst Pharm, 2003, 60, 1750–1759
  • [39] Bates D.W., Leape L.L., Petrycki S., Incidence and preventability of adverse drug events in hospitalized adults, J Gen Intern Med, 1993, 8, 289–294 http://dx.doi.org/10.1007/BF02600138[Crossref]
  • [40] Gandhi T.K., Weingart S.N., Borus J., Seger A.C., Peterson J., Burdick E., et al., Adverse drug events in ambulatory care, N Eng J Med, 2003, 348, 1156–1164 http://dx.doi.org/10.1056/NEJMsa020703[Crossref]
  • [41] Evans R.S., Lloyd J.F., Stoddard G.J., Neberker J.R., Samore M.H., Risk factors for adverse drug events: a 10 year analysis, Ann Pharmacother, 2005, 39, 1161–1168 http://dx.doi.org/10.1345/aph.1E642[Crossref]
  • [42] Fonescue E.B., Kausbal R., Landrigan C.P., McKenna K.J., Clapp M.D., Federico F., et al., Prioritizing strategies for preventing medication errors and adverse drug events in pediatric inpatients, Pediatrics, 2003, 111(4 Pt 1), 722–729
  • [43] Field T.S., Gurwitz J.H., Avorn J., McCormick D., Jain S., Eckier M., et al., Risk factors for adverse drug events among nursing home residents, Arch Intern Med, 2001, 161, 1629–1634 http://dx.doi.org/10.1001/archinte.161.13.1629[Crossref]
  • [44] Bates D.W., Miller E.B., Cullen, Burdick L., Williams L., Laird N., et al., Patient risk factors for adverse drug events in hospitalized patients, Arch Intern Med, 1999, 159, 2553–2559 http://dx.doi.org/10.1001/archinte.159.21.2553[Crossref]

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