Development of indicators for identifying adverse drug events in an indian tertiary care teaching hospital

R. Thiyagu, S.R. Mallayasamy, V. Rajesh, V. Muralidhar, P. Smitha, V. Sudha, B.K. Laxminarayana

Research output: Contribution to journalArticle

3 Citations (Scopus)

Abstract

Objective: Adverse drug events (ADEs) are drug-related events which continue to pose serious challenges to the safety of patients. There are a number of ways to monitor ADEs, and the use of indictors to screen them provides an alternative method for detecting them. This method helps to assess the safety of drugs by the manual record review technique. The aim of this work was to develop a list of indicators to use in medical units of the study hospital to identify ADEs. Setting: Tertiary care teaching hospital in India. Method: An initial list of ADE indicators based on published literature was developed by a panel of three experts. The list of indicators was subjected to review by a Delphi panel of five members. The Delphi panel reviewed the list of valid indicators and also suggested an addition of new indicators. The final list of indicators was used to review 100 previously documented ADE case reports. The case reports were screened for the presence of any of the indicators from the list. Parameters studied included number of indicators per case report and the most used indicators. Results: From the literature, a 72 item indicator list was initially prepared which was further narrowed down to a list of 63 items. The Delphi panel conducted a review with these 63 items. At the end of review, and after addition and deletion of indicators, a 49 item indicator list was finalized. When this list of indicators was used for the review of ADE case reports, 42 indicators were identified. On average, three indicators were present in the reviewed case reports. Conclusion: An indicator list was developed for identification of ADEs in the study setup. The relevance of this indicator list was demonstrated by the presence of these indicators in the previously documented ADE reports. This is the first study from India to report on the development of ADE indicators, which might provide an alternative method to detecting ADEs in the setup of future studies. © 2010 Thiyagu et al.
Original languageEnglish
Pages (from-to)95-100
Number of pages6
JournalDrug, Healthcare and Patient Safety
Volume2
Issue number1
Publication statusPublished - 2010

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Tertiary Healthcare
Drug-Related Side Effects and Adverse Reactions
Teaching Hospitals
India
Hospital Units
Patient Safety
Pharmaceutical Preparations
Safety

Cite this

@article{a2a544de4e7b444e999d2225d3e99ba2,
title = "Development of indicators for identifying adverse drug events in an indian tertiary care teaching hospital",
abstract = "Objective: Adverse drug events (ADEs) are drug-related events which continue to pose serious challenges to the safety of patients. There are a number of ways to monitor ADEs, and the use of indictors to screen them provides an alternative method for detecting them. This method helps to assess the safety of drugs by the manual record review technique. The aim of this work was to develop a list of indicators to use in medical units of the study hospital to identify ADEs. Setting: Tertiary care teaching hospital in India. Method: An initial list of ADE indicators based on published literature was developed by a panel of three experts. The list of indicators was subjected to review by a Delphi panel of five members. The Delphi panel reviewed the list of valid indicators and also suggested an addition of new indicators. The final list of indicators was used to review 100 previously documented ADE case reports. The case reports were screened for the presence of any of the indicators from the list. Parameters studied included number of indicators per case report and the most used indicators. Results: From the literature, a 72 item indicator list was initially prepared which was further narrowed down to a list of 63 items. The Delphi panel conducted a review with these 63 items. At the end of review, and after addition and deletion of indicators, a 49 item indicator list was finalized. When this list of indicators was used for the review of ADE case reports, 42 indicators were identified. On average, three indicators were present in the reviewed case reports. Conclusion: An indicator list was developed for identification of ADEs in the study setup. The relevance of this indicator list was demonstrated by the presence of these indicators in the previously documented ADE reports. This is the first study from India to report on the development of ADE indicators, which might provide an alternative method to detecting ADEs in the setup of future studies. {\circledC} 2010 Thiyagu et al.",
author = "R. Thiyagu and S.R. Mallayasamy and V. Rajesh and V. Muralidhar and P. Smitha and V. Sudha and B.K. Laxminarayana",
note = "Cited By :3 Export Date: 10 November 2017 Correspondence Address: Thiyagu, R.; Department of Pharmacy Practice, Manipal College of Pharmaceutical Sciences, Manipal University, Manipal-576104, India; email: thiyagur@hotmail.com Chemicals/CAS: amiodarone, 1951-25-3, 19774-82-4, 62067-87-2; amlodipine, 88150-42-9; captopril, 62571-86-2; enalapril, 75847-73-3; ferrous sulfate, 10028-21-4, 10124-49-9, 13463-43-9, 7720-78-7, 7782-63-0; imipramine, 113-52-0, 50-49-7; insulin, 9004-10-8; levothyroxine, 51-48-9; lithium, 7439-93-2; methenamine, 100-97-0, 24360-05-2; nalidixic acid, 389-08-2; nitrofurantoin, 54-87-5, 67-20-9; propylthiouracil, 51-52-5; tetracycline, 23843-90-5, 60-54-8, 64-75-5, 8021-86-1; warfarin, 129-06-6, 2610-86-8, 3324-63-8, 5543-58-8, 81-81-2 References: Bates, D.W., Cullen, D., Laird, N., Incidence of adverse drug events and potential adverse drug events: Implications for prevention (1995) JAMA, 274, pp. 29-34; Bates, D.W., Spell, N., Cullen, D.J., The costs of adverse drug events in hospitalized patients (1997) JAMA, 227, pp. 307-311; Brennan, T.A., Leape, L.L., Laird, N., Incidence of adverse events and negligence in hospitalized patients: Results from the Harvard Medical Practice Study I (1991) N Engl J Med, 324, pp. 370-376; Edwards, I.R., Biriell, C., Harmonization in pharmacovigilance (1994) Drug Saf, 10, pp. 93-102; Brewer, T., Colditz, G.A., Post marketing surveillance and adverse drug reactions: Current perspectives and future needs (1999) JAMA, 281, pp. 824-829; Palaian, S., Mishra, P., Shankar, P.R., Dubey, A.K., Bista, D., Almeida, R., Safety monitoring of drugs - where do we stand? (2006) Kathmandu Univ Med J, 4 (13), pp. 119-127; (2005) Global Trigger Tool Kit - Version 6, , http://www.ihi.org/NR/rdonlyres/E44B4920-3E5B-4739-97618E3A7168AA0E/2438 /GlobalTriggerToolKit6.pdf, Institute for Healthcare Improvement, Available from, Accessed May 13, 2005; Suzanne, C.B., Using trigger tools to enhance patient safety (2005) AORN J, 82 (1), pp. 115-116; Jick, H., Drugs - remarkably toxic (1974) N Engl J Med, 291, pp. 824-828; Resar, R.K., Rozich, J.D., Classen, D., Methodology and rationale for the measurement of harm with trigger tools (2003) Qual Saf Health Care, 12 (SUPPL. 2), pp. ii39-ii45; Classen, D.C., Pestotnik, S.L., Evans, R.S., Description of a computerized adverse drug event monitor using a hospital information system (1992) Hosp Pharm, 27, pp. 774-783; Szekendi, M.K., Sullivan, C., Bobb, A., Active surveillance using electronic triggers to detect adverse events in hospitalized patients (2006) Qual Saf Health Care, 15, pp. 184-190; Regal, B., Finally a pharmacovigilant India (2004) Uppsala Rep, 25, pp. 7-8; Hazell Lorna, S., Saad, A.W., Under-reporting of adverse drug reactions: A systematic review (2006) Drug Saf, 29 (5), pp. 385-396; Ramesh, M., Pandit, J., Parthasarathi, G., Adverse drug reactions in a South Indian hospital - their severity and cost involved (2003) Pharmacoepidemiol Drug Saf, 12 (8), pp. 687-692; Arulmani, R., Rajendran, S.D., Suresh, B., Adverse drug reaction monitoring in a secondary care hospital in South India (2008) Br J Clin Pharmacol, 65 (2), pp. 210-216; Jose, J., Rao, P.G., Pattern of adverse drug reactions notified by spontaneous reporting in an Indian tertiary care teaching hospital (2006) Pharmacol Res, 54 (3), pp. 226-233; Takata, G.S., Mason, W., Taketomo, C., Logsdon, T., Sharek, P.J., Develop ment, testing and findings of a pediatric-focused trigger tool to iden tify medication-related harm in US children's hospitals (2008) Pediatrics, 121 (4), pp. e927-e935; Matlow, A., Flintoft, V., Orrbine, E., The development of the Canadian paediatric trigger tool for identifying potential adverse events (2005) Healthc Q, 8, pp. 90-93; Wet, D.C., Bowie, P., The preliminary development and testing of a global trigger tool to detect error and patient harm in primary care records (2009) Postgrad Med J, 85 (1002), pp. 176-180; Szekendi, M.K., Sullivan, C., Bobb, A., Active surveillance using electronic triggers to detect adverse events in hospitalized patients (2006) Qual Saf Health Care, 15 (3), pp. 184-190; Caroline, M., Judy, C., Preventable drug-related morbidity indicators in the U.S. and U.K (2002) J Managed Care Pharm, 5 (8), pp. 372-377; Morris, C.J., Cantrill, J.A., Hepler, C.D., Noyce, P.R., Preventing drug-related morbidity - determining valid indicators (2002) Int J Qual Health Care, 14 (3), pp. 183-198; Steven, M.H., Joseph, T.H., Subashan, P., Yazan, F.R., Consensus list of signals to detect potential adverse drug reactions in nursing homes (2008) J Am Geriatr Soc, 56 (5), pp. 808-815",
year = "2010",
language = "English",
volume = "2",
pages = "95--100",
journal = "Drug, Healthcare and Patient Safety",
issn = "1179-1365",
publisher = "Dove Medical Press Limited",
number = "1",

}

TY - JOUR

T1 - Development of indicators for identifying adverse drug events in an indian tertiary care teaching hospital

AU - Thiyagu, R.

AU - Mallayasamy, S.R.

AU - Rajesh, V.

AU - Muralidhar, V.

AU - Smitha, P.

AU - Sudha, V.

AU - Laxminarayana, B.K.

N1 - Cited By :3 Export Date: 10 November 2017 Correspondence Address: Thiyagu, R.; Department of Pharmacy Practice, Manipal College of Pharmaceutical Sciences, Manipal University, Manipal-576104, India; email: thiyagur@hotmail.com Chemicals/CAS: amiodarone, 1951-25-3, 19774-82-4, 62067-87-2; amlodipine, 88150-42-9; captopril, 62571-86-2; enalapril, 75847-73-3; ferrous sulfate, 10028-21-4, 10124-49-9, 13463-43-9, 7720-78-7, 7782-63-0; imipramine, 113-52-0, 50-49-7; insulin, 9004-10-8; levothyroxine, 51-48-9; lithium, 7439-93-2; methenamine, 100-97-0, 24360-05-2; nalidixic acid, 389-08-2; nitrofurantoin, 54-87-5, 67-20-9; propylthiouracil, 51-52-5; tetracycline, 23843-90-5, 60-54-8, 64-75-5, 8021-86-1; warfarin, 129-06-6, 2610-86-8, 3324-63-8, 5543-58-8, 81-81-2 References: Bates, D.W., Cullen, D., Laird, N., Incidence of adverse drug events and potential adverse drug events: Implications for prevention (1995) JAMA, 274, pp. 29-34; Bates, D.W., Spell, N., Cullen, D.J., The costs of adverse drug events in hospitalized patients (1997) JAMA, 227, pp. 307-311; Brennan, T.A., Leape, L.L., Laird, N., Incidence of adverse events and negligence in hospitalized patients: Results from the Harvard Medical Practice Study I (1991) N Engl J Med, 324, pp. 370-376; Edwards, I.R., Biriell, C., Harmonization in pharmacovigilance (1994) Drug Saf, 10, pp. 93-102; Brewer, T., Colditz, G.A., Post marketing surveillance and adverse drug reactions: Current perspectives and future needs (1999) JAMA, 281, pp. 824-829; Palaian, S., Mishra, P., Shankar, P.R., Dubey, A.K., Bista, D., Almeida, R., Safety monitoring of drugs - where do we stand? (2006) Kathmandu Univ Med J, 4 (13), pp. 119-127; (2005) Global Trigger Tool Kit - Version 6, , http://www.ihi.org/NR/rdonlyres/E44B4920-3E5B-4739-97618E3A7168AA0E/2438 /GlobalTriggerToolKit6.pdf, Institute for Healthcare Improvement, Available from, Accessed May 13, 2005; Suzanne, C.B., Using trigger tools to enhance patient safety (2005) AORN J, 82 (1), pp. 115-116; Jick, H., Drugs - remarkably toxic (1974) N Engl J Med, 291, pp. 824-828; Resar, R.K., Rozich, J.D., Classen, D., Methodology and rationale for the measurement of harm with trigger tools (2003) Qual Saf Health Care, 12 (SUPPL. 2), pp. ii39-ii45; Classen, D.C., Pestotnik, S.L., Evans, R.S., Description of a computerized adverse drug event monitor using a hospital information system (1992) Hosp Pharm, 27, pp. 774-783; Szekendi, M.K., Sullivan, C., Bobb, A., Active surveillance using electronic triggers to detect adverse events in hospitalized patients (2006) Qual Saf Health Care, 15, pp. 184-190; Regal, B., Finally a pharmacovigilant India (2004) Uppsala Rep, 25, pp. 7-8; Hazell Lorna, S., Saad, A.W., Under-reporting of adverse drug reactions: A systematic review (2006) Drug Saf, 29 (5), pp. 385-396; Ramesh, M., Pandit, J., Parthasarathi, G., Adverse drug reactions in a South Indian hospital - their severity and cost involved (2003) Pharmacoepidemiol Drug Saf, 12 (8), pp. 687-692; Arulmani, R., Rajendran, S.D., Suresh, B., Adverse drug reaction monitoring in a secondary care hospital in South India (2008) Br J Clin Pharmacol, 65 (2), pp. 210-216; Jose, J., Rao, P.G., Pattern of adverse drug reactions notified by spontaneous reporting in an Indian tertiary care teaching hospital (2006) Pharmacol Res, 54 (3), pp. 226-233; Takata, G.S., Mason, W., Taketomo, C., Logsdon, T., Sharek, P.J., Develop ment, testing and findings of a pediatric-focused trigger tool to iden tify medication-related harm in US children's hospitals (2008) Pediatrics, 121 (4), pp. e927-e935; Matlow, A., Flintoft, V., Orrbine, E., The development of the Canadian paediatric trigger tool for identifying potential adverse events (2005) Healthc Q, 8, pp. 90-93; Wet, D.C., Bowie, P., The preliminary development and testing of a global trigger tool to detect error and patient harm in primary care records (2009) Postgrad Med J, 85 (1002), pp. 176-180; Szekendi, M.K., Sullivan, C., Bobb, A., Active surveillance using electronic triggers to detect adverse events in hospitalized patients (2006) Qual Saf Health Care, 15 (3), pp. 184-190; Caroline, M., Judy, C., Preventable drug-related morbidity indicators in the U.S. and U.K (2002) J Managed Care Pharm, 5 (8), pp. 372-377; Morris, C.J., Cantrill, J.A., Hepler, C.D., Noyce, P.R., Preventing drug-related morbidity - determining valid indicators (2002) Int J Qual Health Care, 14 (3), pp. 183-198; Steven, M.H., Joseph, T.H., Subashan, P., Yazan, F.R., Consensus list of signals to detect potential adverse drug reactions in nursing homes (2008) J Am Geriatr Soc, 56 (5), pp. 808-815

PY - 2010

Y1 - 2010

N2 - Objective: Adverse drug events (ADEs) are drug-related events which continue to pose serious challenges to the safety of patients. There are a number of ways to monitor ADEs, and the use of indictors to screen them provides an alternative method for detecting them. This method helps to assess the safety of drugs by the manual record review technique. The aim of this work was to develop a list of indicators to use in medical units of the study hospital to identify ADEs. Setting: Tertiary care teaching hospital in India. Method: An initial list of ADE indicators based on published literature was developed by a panel of three experts. The list of indicators was subjected to review by a Delphi panel of five members. The Delphi panel reviewed the list of valid indicators and also suggested an addition of new indicators. The final list of indicators was used to review 100 previously documented ADE case reports. The case reports were screened for the presence of any of the indicators from the list. Parameters studied included number of indicators per case report and the most used indicators. Results: From the literature, a 72 item indicator list was initially prepared which was further narrowed down to a list of 63 items. The Delphi panel conducted a review with these 63 items. At the end of review, and after addition and deletion of indicators, a 49 item indicator list was finalized. When this list of indicators was used for the review of ADE case reports, 42 indicators were identified. On average, three indicators were present in the reviewed case reports. Conclusion: An indicator list was developed for identification of ADEs in the study setup. The relevance of this indicator list was demonstrated by the presence of these indicators in the previously documented ADE reports. This is the first study from India to report on the development of ADE indicators, which might provide an alternative method to detecting ADEs in the setup of future studies. © 2010 Thiyagu et al.

AB - Objective: Adverse drug events (ADEs) are drug-related events which continue to pose serious challenges to the safety of patients. There are a number of ways to monitor ADEs, and the use of indictors to screen them provides an alternative method for detecting them. This method helps to assess the safety of drugs by the manual record review technique. The aim of this work was to develop a list of indicators to use in medical units of the study hospital to identify ADEs. Setting: Tertiary care teaching hospital in India. Method: An initial list of ADE indicators based on published literature was developed by a panel of three experts. The list of indicators was subjected to review by a Delphi panel of five members. The Delphi panel reviewed the list of valid indicators and also suggested an addition of new indicators. The final list of indicators was used to review 100 previously documented ADE case reports. The case reports were screened for the presence of any of the indicators from the list. Parameters studied included number of indicators per case report and the most used indicators. Results: From the literature, a 72 item indicator list was initially prepared which was further narrowed down to a list of 63 items. The Delphi panel conducted a review with these 63 items. At the end of review, and after addition and deletion of indicators, a 49 item indicator list was finalized. When this list of indicators was used for the review of ADE case reports, 42 indicators were identified. On average, three indicators were present in the reviewed case reports. Conclusion: An indicator list was developed for identification of ADEs in the study setup. The relevance of this indicator list was demonstrated by the presence of these indicators in the previously documented ADE reports. This is the first study from India to report on the development of ADE indicators, which might provide an alternative method to detecting ADEs in the setup of future studies. © 2010 Thiyagu et al.

M3 - Article

VL - 2

SP - 95

EP - 100

JO - Drug, Healthcare and Patient Safety

JF - Drug, Healthcare and Patient Safety

SN - 1179-1365

IS - 1

ER -