Pattern of adverse drug reactions notified by spontaneous reporting in an Indian tertiary care teaching hospital

J. Jose, P.G.M. Rao

Research output: Contribution to journalArticle

87 Citations (Scopus)

Abstract

Hospital-based adverse drug reaction (ADR) monitoring and reporting programs aims to identify and quantify the risks associated with the use of drugs. The present study was undertaken to characterize the pattern of ADRs reported in a tertiary care teaching hospital (Kasturba Hospital, Manipal) in South India. The study was conducted based on the ADRs reported between March 2004 and February 2005 (12 months) to the ADR reporting unit of the hospital. Evaluation of the data was done for various parameters which included patient demographics, drug and reaction characteristics, and outcome of the reactions. Assessment was also done for causality, severity, preventability, and predisposing factors. A total of 408 ADRs which were reported during the 12 months period were evaluated. The overall incidence of ADR calculated from the patient population was 0.15%. At least one ADR was reported in 1.14% of the hospitalised patients and in 0.012% of the outpatients. No significant difference was seen in the overall incidence of ADRs observed in males and females. Incidence of ADRs among elderly adults and older adults (0.23%) were significantly higher than other age groups. Type A reactions (72.5%) accounted for majority of the reports and a greater share of the ADRs were described to be very common (43.4%) in the literature. Dermatological system (23.5%) was the most commonly affected organ system with skin rash (10.5%) as the most frequently reported reaction. Antineoplastic agents (21.8%) was the drug class most commonly involved, while phenytoin (7.8%) was the individual drug most frequently reported. The suspected drug was withdrawn for the management of the ADR in majority (56.6%) of the reports. In 74.8% of the reports the patient recovered from the reaction at the time of evaluation. Upon causality assessment, majority of the reports were rated as probable (53.7%). Mild and moderate reactions accounted for 50.5 and 43.9%, respectively. In 28.7% of the reports, the reaction was considered to be preventable. At least one predisposing factor was present in 79.9% of the reports and the most common predisposing factors associated were polypharmacy and multiple disease state. Evaluating the relationship between patient characteristics and reaction characteristics, type A reactions were more common among elderly adults (85.92%) and type B reactions more common in adults (35.01%) compared to other age groups. In conclusion, the pattern of ADRs reported in our hospital is comparable with the results of studies conducted in hospital set up elsewhere. Our evaluations revealed opportunities for interventions especially for the preventable ADRs to ensure safer drug use. © 2006 Elsevier Ltd. All rights reserved.
Original languageEnglish
Pages (from-to)226-233
Number of pages8
JournalPharmacological Research
Volume54
Issue number3
DOIs
Publication statusPublished - 2006
Externally publishedYes

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Tertiary Healthcare
Drug-Related Side Effects and Adverse Reactions
Teaching Hospitals
Causality
Pharmaceutical Preparations
Incidence
Age Groups
Polypharmacy
Hospital Units
Drug Monitoring
Phenytoin
Exanthema
Antineoplastic Agents
India
Outpatients
Demography
Population

Cite this

@article{d281defacb5b405dbdb4aec3850e8082,
title = "Pattern of adverse drug reactions notified by spontaneous reporting in an Indian tertiary care teaching hospital",
abstract = "Hospital-based adverse drug reaction (ADR) monitoring and reporting programs aims to identify and quantify the risks associated with the use of drugs. The present study was undertaken to characterize the pattern of ADRs reported in a tertiary care teaching hospital (Kasturba Hospital, Manipal) in South India. The study was conducted based on the ADRs reported between March 2004 and February 2005 (12 months) to the ADR reporting unit of the hospital. Evaluation of the data was done for various parameters which included patient demographics, drug and reaction characteristics, and outcome of the reactions. Assessment was also done for causality, severity, preventability, and predisposing factors. A total of 408 ADRs which were reported during the 12 months period were evaluated. The overall incidence of ADR calculated from the patient population was 0.15{\%}. At least one ADR was reported in 1.14{\%} of the hospitalised patients and in 0.012{\%} of the outpatients. No significant difference was seen in the overall incidence of ADRs observed in males and females. Incidence of ADRs among elderly adults and older adults (0.23{\%}) were significantly higher than other age groups. Type A reactions (72.5{\%}) accounted for majority of the reports and a greater share of the ADRs were described to be very common (43.4{\%}) in the literature. Dermatological system (23.5{\%}) was the most commonly affected organ system with skin rash (10.5{\%}) as the most frequently reported reaction. Antineoplastic agents (21.8{\%}) was the drug class most commonly involved, while phenytoin (7.8{\%}) was the individual drug most frequently reported. The suspected drug was withdrawn for the management of the ADR in majority (56.6{\%}) of the reports. In 74.8{\%} of the reports the patient recovered from the reaction at the time of evaluation. Upon causality assessment, majority of the reports were rated as probable (53.7{\%}). Mild and moderate reactions accounted for 50.5 and 43.9{\%}, respectively. In 28.7{\%} of the reports, the reaction was considered to be preventable. At least one predisposing factor was present in 79.9{\%} of the reports and the most common predisposing factors associated were polypharmacy and multiple disease state. Evaluating the relationship between patient characteristics and reaction characteristics, type A reactions were more common among elderly adults (85.92{\%}) and type B reactions more common in adults (35.01{\%}) compared to other age groups. In conclusion, the pattern of ADRs reported in our hospital is comparable with the results of studies conducted in hospital set up elsewhere. Our evaluations revealed opportunities for interventions especially for the preventable ADRs to ensure safer drug use. {\circledC} 2006 Elsevier Ltd. All rights reserved.",
author = "J. Jose and P.G.M. Rao",
note = "Cited By :75 Export Date: 10 November 2017 CODEN: PHMRE Correspondence Address: Jose, J.; Department of Pharmacy Practice, Manipal College of Pharmaceutical Sciences, Manipal Academy of Higher Education, Manipal, 576 104 Karnataka, India; email: jimmy_jose2001@yahoo.com Chemicals/CAS: acetylsalicylic acid, 493-53-8, 50-78-2, 53663-74-4, 53664-49-6, 63781-77-1; amlodipine, 88150-42-9; amoxicillin, 26787-78-0, 34642-77-8, 61336-70-7; cyclophosphamide, 50-18-0; doxorubicin, 23214-92-8, 25316-40-9; gabapentin, 60142-96-3; heparin, 37187-54-5, 8057-48-5, 8065-01-8, 9005-48-5; ibuprofen, 15687-27-1; isoniazid, 54-85-3, 62229-51-0, 65979-32-0; levofloxacin, 100986-85-4, 138199-71-0; lorazepam, 846-49-1; methotrexate, 15475-56-6, 59-05-2, 7413-34-5; phenytoin, 57-41-0, 630-93-3; prednisone, 53-03-2; salbutamol, 18559-94-9; theophylline, 58-55-9, 5967-84-0, 8055-07-0, 8061-56-1, 99007-19-9; warfarin, 129-06-6, 2610-86-8, 3324-63-8, 5543-58-8, 81-81-2; Antineoplastic Agents; Pharmaceutical Preparations; Phenytoin, 57-41-0 References: Ditto, A.M., Drug allergy (2002) Patterson's allergic diseases. 6th ed., p. 295. , Grammer L.C., and Greenberger P.A. (Eds), Lippincott Williams & Wilkins, Philadelphia; Jick, H., Adverse drug reactions: the magnitude of the problem (1984) J Allergy Clin Immunol, 74, pp. 555-557; Lazarou, J., Pomeranz, B.H., Corey, P.N., Incidence of adverse drug reactions in hospitalized patients: a meta-analysis of prospective studies (1998) JAMA, 279, pp. 1200-1205; Hartwig, S.C., Siegel, J., Schneider, P.J., Preventability and severity assessment in reporting adverse drug reactions (1992) Am J Hosp Pharm, 49, pp. 2229-2232; American Society of Health System Pharmacists, ASHP guidelines on adverse drug reaction monitoring and reporting (1989) Am J Hosp Pharm, 46, pp. 336-337; Murphy, B.M., Frigo, L.C., Development, implementation, and results of a successful multidisciplinary adverse drug reaction reporting program in a university teaching hospital (1993) Hosp Pharm, 28 (12), pp. 1199-1204. , 1240; Moride, Y., Haramburu, F., Requeyo, A.A., Begaud, B., Underreporting of adverse drug reactions in general practice (1997) Br J Clin Pharmacol, 43 (2), pp. 177-181; Alvarez-Requejo, A., Carvajal, A., Begaud, B., Moride, Y., Vega, T., Martin Arias, L.H., Under reporting of adverse drug reactions. Estimate based on a spontaneous reporting scheme and a sentinel system (1998) Eur J Clin Pharmacol, 54, pp. 483-488; Gallelli, L., Ferreri, G., Colosimo, M., Pirritano, D., Flocco, M.A., Pelaia, G., Retrospective analysis of adverse drug reactions to bronchodilators observed in two pulmonary divisions of Catanzaro, Italy (2003) Pharmacol Res, 47 (6), pp. 493-499; Wu, W.K., Evaluation of outpatient adverse drug reactions leading to hospitalization (2003) Am J Health-Syst Pharm, 60 (3), pp. 253-259; Regal, B., Finally a pharmacovigilant India (2004) Uppsala Rep, 25, pp. 7-8; Adithan, C., National pharmacovigilance program (2005) Indian J Pharmacol, 37, p. 347; Gallelli, L., Ferreri, G., Colosimo, M., Pirritano, D., Guadagnino, L., Pelaia, G., Adverse drug reactions to antibiotics observed in two pulmonology divisions of Catanzaro, Italy: a six year retrospective study (2002) Pharmacol Res, 46 (5), pp. 395-400; Rawlins, M.D., Thompson, J.W., Pathogenesis of adverse drug reactions (1977) Textbook of adverse drug reactions. 1st ed., p. 44. , Davies D.M. (Ed), Oxford University Press, Oxford; Naranjo, C.A., Busto, U., Sellers, E.M., Sandor, P., Ruiz, I., Roberts, E.A., A method for estimating the probability of adverse drug reactions (1981) Clin Pharmacol Ther, 30, pp. 239-245; Lau, P.M., Stewart, K., Dooley, M.J., Comment: hospital admissions resulting from preventable adverse drug reactions (2003) Ann Pharmacother, 37, pp. 303-312; Edwards, I.R., Pharmacological basis of adverse drug reactions (1997) Avery's drug treatment. 4th ed., pp. 261-299. , Speight T.M., and Holford N.H.G. (Eds), Adis International, Auckland, New Zealand; Parthasarathi, G., Sten, O., Adverse drug reactions (2004) A text book of clinical pharmacy practice-essential concepts and skills. 1st ed., pp. 86-102. , Parthasarathi G., Nyfort-Hansen K., and Nahata M.C. (Eds), Orient Longman Private Limited, Chennai; Veehof, L.J.G., Stewart, R.E., Haaijer-Ruskamp, F.M., Meyboom-de Jong, B., The development of polypharmacy. A longitudinal study (2000) Family Practice, 17 (3), pp. 261-267; Bates, D.W., Spell, N., Cullen, D.J., Burdick, E., Laird, N., Petersen, L.A., The cost of adverse drug events in hospitalized patients (1997) JAMA, 277, pp. 307-311; Gonzalez-Martin, G., Caroca, C.M., Paris, E., Adverse drug reactions (ADRs) in hospitalized pediatric patients-a prospective study (1998) Int J Clin Pharmacol Ther, 36 (10), pp. 530-533; Impicciatore, P., Choonara, I., Clarkson, A., Provasi, D., Pandolfini, C., Bonati, M., Incidence of adverse drug reactions in paediatric in/out-patients: a systematic review and meta-analysis of prospective studies (2001) Br J Clin Pharmacol, 52 (1), pp. 77-83; Gholami, K., Shalviri, G., Factors associated with preventability, predictability, and severity of adverse drug reactions (1999) Ann Pharmacother, 33 (2), pp. 236-240; Bates, D.W., Cullen, D.J., Laird, N., Petersen, L.A., Small, S.D., Servi, D., Incidence of adverse drug events and potential adverse drug events-implications for prevention (1995) JAMA, 274 (1), pp. 29-34; Bennett, B.S., Lipman, A.G., Comparative study of prospective surveillance and voluntary reporting in determining the incidence of adverse drug reactions (1977) Am J Hosp Pharm, 34, pp. 931-936; 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 (2002) Fundam Clin Pharmacol, 16 (5), pp. 343-346; 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 (2000) Ann Pharmacother, 34, pp. 1373-1379; Prosser, T.R., Kamysz, P.L., Multidisciplinary adverse drug reaction surveillance program (1990) Am J Hosp Pharm, 47 (6), pp. 1334-1339; 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 (2003) Am J Health Syst Pharm, 60, pp. 1750-1759; Bates, D.W., Leape, L.L., Petrycki, S., Incidence and preventability of adverse drug events in hospitalized adults (1993) J Gen Intern Med, 8, pp. 289-294; Gandhi, T.K., Weingart, S.N., Borus, J., Seger, A.C., Peterson, J., Burdick, E., Adverse drug events in ambulatory care (2003) N Eng J Med, 348, pp. 1156-1164; 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 (2005) Ann Pharmacother, 39, pp. 1161-1168; Fonescue, E.B., Kausbal, R., Landrigan, C.P., McKenna, K.J., Clapp, M.D., Federico, F., Prioritizing strategies for preventing medication errors and adverse drug events in pediatric inpatients (2003) Pediatrics, 111 (4 PART 1), pp. 722-729; Field, T.S., Gurwitz, J.H., Avorn, J., McCormick, D., Jain, S., Eckier, M., Risk factors for adverse drug events among nursing home residents (2001) Arch Intern Med, 161, pp. 1629-1634; Bates, D.W., Miller, E.B., Cullen, D.J., Burdick, L., Williams, L., Laird, N., Patient risk factors for adverse drug events in hospitalized patients (1999) Arch Intern Med, 159, pp. 2553-2559",
year = "2006",
doi = "10.1016/j.phrs.2006.05.003",
language = "English",
volume = "54",
pages = "226--233",
journal = "Pharmacological Research",
issn = "1043-6618",
publisher = "Academic Press Inc.",
number = "3",

}

Pattern of adverse drug reactions notified by spontaneous reporting in an Indian tertiary care teaching hospital. / Jose, J.; Rao, P.G.M.

In: Pharmacological Research, Vol. 54, No. 3, 2006, p. 226-233.

Research output: Contribution to journalArticle

TY - JOUR

T1 - Pattern of adverse drug reactions notified by spontaneous reporting in an Indian tertiary care teaching hospital

AU - Jose, J.

AU - Rao, P.G.M.

N1 - Cited By :75 Export Date: 10 November 2017 CODEN: PHMRE Correspondence Address: Jose, J.; Department of Pharmacy Practice, Manipal College of Pharmaceutical Sciences, Manipal Academy of Higher Education, Manipal, 576 104 Karnataka, India; email: jimmy_jose2001@yahoo.com Chemicals/CAS: acetylsalicylic acid, 493-53-8, 50-78-2, 53663-74-4, 53664-49-6, 63781-77-1; amlodipine, 88150-42-9; amoxicillin, 26787-78-0, 34642-77-8, 61336-70-7; cyclophosphamide, 50-18-0; doxorubicin, 23214-92-8, 25316-40-9; gabapentin, 60142-96-3; heparin, 37187-54-5, 8057-48-5, 8065-01-8, 9005-48-5; ibuprofen, 15687-27-1; isoniazid, 54-85-3, 62229-51-0, 65979-32-0; levofloxacin, 100986-85-4, 138199-71-0; lorazepam, 846-49-1; methotrexate, 15475-56-6, 59-05-2, 7413-34-5; phenytoin, 57-41-0, 630-93-3; prednisone, 53-03-2; salbutamol, 18559-94-9; theophylline, 58-55-9, 5967-84-0, 8055-07-0, 8061-56-1, 99007-19-9; warfarin, 129-06-6, 2610-86-8, 3324-63-8, 5543-58-8, 81-81-2; Antineoplastic Agents; Pharmaceutical Preparations; Phenytoin, 57-41-0 References: Ditto, A.M., Drug allergy (2002) Patterson's allergic diseases. 6th ed., p. 295. , Grammer L.C., and Greenberger P.A. (Eds), Lippincott Williams & Wilkins, Philadelphia; Jick, H., Adverse drug reactions: the magnitude of the problem (1984) J Allergy Clin Immunol, 74, pp. 555-557; Lazarou, J., Pomeranz, B.H., Corey, P.N., Incidence of adverse drug reactions in hospitalized patients: a meta-analysis of prospective studies (1998) JAMA, 279, pp. 1200-1205; Hartwig, S.C., Siegel, J., Schneider, P.J., Preventability and severity assessment in reporting adverse drug reactions (1992) Am J Hosp Pharm, 49, pp. 2229-2232; American Society of Health System Pharmacists, ASHP guidelines on adverse drug reaction monitoring and reporting (1989) Am J Hosp Pharm, 46, pp. 336-337; Murphy, B.M., Frigo, L.C., Development, implementation, and results of a successful multidisciplinary adverse drug reaction reporting program in a university teaching hospital (1993) Hosp Pharm, 28 (12), pp. 1199-1204. , 1240; Moride, Y., Haramburu, F., Requeyo, A.A., Begaud, B., Underreporting of adverse drug reactions in general practice (1997) Br J Clin Pharmacol, 43 (2), pp. 177-181; Alvarez-Requejo, A., Carvajal, A., Begaud, B., Moride, Y., Vega, T., Martin Arias, L.H., Under reporting of adverse drug reactions. Estimate based on a spontaneous reporting scheme and a sentinel system (1998) Eur J Clin Pharmacol, 54, pp. 483-488; Gallelli, L., Ferreri, G., Colosimo, M., Pirritano, D., Flocco, M.A., Pelaia, G., Retrospective analysis of adverse drug reactions to bronchodilators observed in two pulmonary divisions of Catanzaro, Italy (2003) Pharmacol Res, 47 (6), pp. 493-499; Wu, W.K., Evaluation of outpatient adverse drug reactions leading to hospitalization (2003) Am J Health-Syst Pharm, 60 (3), pp. 253-259; Regal, B., Finally a pharmacovigilant India (2004) Uppsala Rep, 25, pp. 7-8; Adithan, C., National pharmacovigilance program (2005) Indian J Pharmacol, 37, p. 347; Gallelli, L., Ferreri, G., Colosimo, M., Pirritano, D., Guadagnino, L., Pelaia, G., Adverse drug reactions to antibiotics observed in two pulmonology divisions of Catanzaro, Italy: a six year retrospective study (2002) Pharmacol Res, 46 (5), pp. 395-400; Rawlins, M.D., Thompson, J.W., Pathogenesis of adverse drug reactions (1977) Textbook of adverse drug reactions. 1st ed., p. 44. , Davies D.M. (Ed), Oxford University Press, Oxford; Naranjo, C.A., Busto, U., Sellers, E.M., Sandor, P., Ruiz, I., Roberts, E.A., A method for estimating the probability of adverse drug reactions (1981) Clin Pharmacol Ther, 30, pp. 239-245; Lau, P.M., Stewart, K., Dooley, M.J., Comment: hospital admissions resulting from preventable adverse drug reactions (2003) Ann Pharmacother, 37, pp. 303-312; Edwards, I.R., Pharmacological basis of adverse drug reactions (1997) Avery's drug treatment. 4th ed., pp. 261-299. , Speight T.M., and Holford N.H.G. (Eds), Adis International, Auckland, New Zealand; Parthasarathi, G., Sten, O., Adverse drug reactions (2004) A text book of clinical pharmacy practice-essential concepts and skills. 1st ed., pp. 86-102. , Parthasarathi G., Nyfort-Hansen K., and Nahata M.C. (Eds), Orient Longman Private Limited, Chennai; Veehof, L.J.G., Stewart, R.E., Haaijer-Ruskamp, F.M., Meyboom-de Jong, B., The development of polypharmacy. A longitudinal study (2000) Family Practice, 17 (3), pp. 261-267; Bates, D.W., Spell, N., Cullen, D.J., Burdick, E., Laird, N., Petersen, L.A., The cost of adverse drug events in hospitalized patients (1997) JAMA, 277, pp. 307-311; Gonzalez-Martin, G., Caroca, C.M., Paris, E., Adverse drug reactions (ADRs) in hospitalized pediatric patients-a prospective study (1998) Int J Clin Pharmacol Ther, 36 (10), pp. 530-533; Impicciatore, P., Choonara, I., Clarkson, A., Provasi, D., Pandolfini, C., Bonati, M., Incidence of adverse drug reactions in paediatric in/out-patients: a systematic review and meta-analysis of prospective studies (2001) Br J Clin Pharmacol, 52 (1), pp. 77-83; Gholami, K., Shalviri, G., Factors associated with preventability, predictability, and severity of adverse drug reactions (1999) Ann Pharmacother, 33 (2), pp. 236-240; Bates, D.W., Cullen, D.J., Laird, N., Petersen, L.A., Small, S.D., Servi, D., Incidence of adverse drug events and potential adverse drug events-implications for prevention (1995) JAMA, 274 (1), pp. 29-34; Bennett, B.S., Lipman, A.G., Comparative study of prospective surveillance and voluntary reporting in determining the incidence of adverse drug reactions (1977) Am J Hosp Pharm, 34, pp. 931-936; 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 (2002) Fundam Clin Pharmacol, 16 (5), pp. 343-346; 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 (2000) Ann Pharmacother, 34, pp. 1373-1379; Prosser, T.R., Kamysz, P.L., Multidisciplinary adverse drug reaction surveillance program (1990) Am J Hosp Pharm, 47 (6), pp. 1334-1339; 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 (2003) Am J Health Syst Pharm, 60, pp. 1750-1759; Bates, D.W., Leape, L.L., Petrycki, S., Incidence and preventability of adverse drug events in hospitalized adults (1993) J Gen Intern Med, 8, pp. 289-294; Gandhi, T.K., Weingart, S.N., Borus, J., Seger, A.C., Peterson, J., Burdick, E., Adverse drug events in ambulatory care (2003) N Eng J Med, 348, pp. 1156-1164; 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 (2005) Ann Pharmacother, 39, pp. 1161-1168; Fonescue, E.B., Kausbal, R., Landrigan, C.P., McKenna, K.J., Clapp, M.D., Federico, F., Prioritizing strategies for preventing medication errors and adverse drug events in pediatric inpatients (2003) Pediatrics, 111 (4 PART 1), pp. 722-729; Field, T.S., Gurwitz, J.H., Avorn, J., McCormick, D., Jain, S., Eckier, M., Risk factors for adverse drug events among nursing home residents (2001) Arch Intern Med, 161, pp. 1629-1634; Bates, D.W., Miller, E.B., Cullen, D.J., Burdick, L., Williams, L., Laird, N., Patient risk factors for adverse drug events in hospitalized patients (1999) Arch Intern Med, 159, pp. 2553-2559

PY - 2006

Y1 - 2006

N2 - Hospital-based adverse drug reaction (ADR) monitoring and reporting programs aims to identify and quantify the risks associated with the use of drugs. The present study was undertaken to characterize the pattern of ADRs reported in a tertiary care teaching hospital (Kasturba Hospital, Manipal) in South India. The study was conducted based on the ADRs reported between March 2004 and February 2005 (12 months) to the ADR reporting unit of the hospital. Evaluation of the data was done for various parameters which included patient demographics, drug and reaction characteristics, and outcome of the reactions. Assessment was also done for causality, severity, preventability, and predisposing factors. A total of 408 ADRs which were reported during the 12 months period were evaluated. The overall incidence of ADR calculated from the patient population was 0.15%. At least one ADR was reported in 1.14% of the hospitalised patients and in 0.012% of the outpatients. No significant difference was seen in the overall incidence of ADRs observed in males and females. Incidence of ADRs among elderly adults and older adults (0.23%) were significantly higher than other age groups. Type A reactions (72.5%) accounted for majority of the reports and a greater share of the ADRs were described to be very common (43.4%) in the literature. Dermatological system (23.5%) was the most commonly affected organ system with skin rash (10.5%) as the most frequently reported reaction. Antineoplastic agents (21.8%) was the drug class most commonly involved, while phenytoin (7.8%) was the individual drug most frequently reported. The suspected drug was withdrawn for the management of the ADR in majority (56.6%) of the reports. In 74.8% of the reports the patient recovered from the reaction at the time of evaluation. Upon causality assessment, majority of the reports were rated as probable (53.7%). Mild and moderate reactions accounted for 50.5 and 43.9%, respectively. In 28.7% of the reports, the reaction was considered to be preventable. At least one predisposing factor was present in 79.9% of the reports and the most common predisposing factors associated were polypharmacy and multiple disease state. Evaluating the relationship between patient characteristics and reaction characteristics, type A reactions were more common among elderly adults (85.92%) and type B reactions more common in adults (35.01%) compared to other age groups. In conclusion, the pattern of ADRs reported in our hospital is comparable with the results of studies conducted in hospital set up elsewhere. Our evaluations revealed opportunities for interventions especially for the preventable ADRs to ensure safer drug use. © 2006 Elsevier Ltd. All rights reserved.

AB - Hospital-based adverse drug reaction (ADR) monitoring and reporting programs aims to identify and quantify the risks associated with the use of drugs. The present study was undertaken to characterize the pattern of ADRs reported in a tertiary care teaching hospital (Kasturba Hospital, Manipal) in South India. The study was conducted based on the ADRs reported between March 2004 and February 2005 (12 months) to the ADR reporting unit of the hospital. Evaluation of the data was done for various parameters which included patient demographics, drug and reaction characteristics, and outcome of the reactions. Assessment was also done for causality, severity, preventability, and predisposing factors. A total of 408 ADRs which were reported during the 12 months period were evaluated. The overall incidence of ADR calculated from the patient population was 0.15%. At least one ADR was reported in 1.14% of the hospitalised patients and in 0.012% of the outpatients. No significant difference was seen in the overall incidence of ADRs observed in males and females. Incidence of ADRs among elderly adults and older adults (0.23%) were significantly higher than other age groups. Type A reactions (72.5%) accounted for majority of the reports and a greater share of the ADRs were described to be very common (43.4%) in the literature. Dermatological system (23.5%) was the most commonly affected organ system with skin rash (10.5%) as the most frequently reported reaction. Antineoplastic agents (21.8%) was the drug class most commonly involved, while phenytoin (7.8%) was the individual drug most frequently reported. The suspected drug was withdrawn for the management of the ADR in majority (56.6%) of the reports. In 74.8% of the reports the patient recovered from the reaction at the time of evaluation. Upon causality assessment, majority of the reports were rated as probable (53.7%). Mild and moderate reactions accounted for 50.5 and 43.9%, respectively. In 28.7% of the reports, the reaction was considered to be preventable. At least one predisposing factor was present in 79.9% of the reports and the most common predisposing factors associated were polypharmacy and multiple disease state. Evaluating the relationship between patient characteristics and reaction characteristics, type A reactions were more common among elderly adults (85.92%) and type B reactions more common in adults (35.01%) compared to other age groups. In conclusion, the pattern of ADRs reported in our hospital is comparable with the results of studies conducted in hospital set up elsewhere. Our evaluations revealed opportunities for interventions especially for the preventable ADRs to ensure safer drug use. © 2006 Elsevier Ltd. All rights reserved.

U2 - 10.1016/j.phrs.2006.05.003

DO - 10.1016/j.phrs.2006.05.003

M3 - Article

VL - 54

SP - 226

EP - 233

JO - Pharmacological Research

JF - Pharmacological Research

SN - 1043-6618

IS - 3

ER -