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

Rajakannan Thiyagu¹, Surulivel R Mallayasamy¹, Valakkathala Rajesh¹, Varma Muralidhar², Prabhu Smitha³, Vidyasagar Sudha², Bairy K Laxminarayana⁴

¹Department of Pharmacy Practice, Manipal College of Pharmaceutical Sciences, Manipal University, Manipal, India; ²Department of General Medicine, ³Department of Skin & STD, ⁴Department of Pharmacology, Kasturba Medical College, Manipal University, Manipal, India

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.

Keywords: adverse drug events, drug safety indicators, Delphi panel