Implementation and evaluation of adverse drug reaction monitoring system in a tertiary care teaching hospital in Mumbai, India

Abstract

Adverse drug reactions (ADR) are a significant cause of morbidity and mortality, often identified only post-marketingly. Improvement in current ADR reporting, including utility of underused or innovative methods, is crucial to improve patient safety and public health. Hospital-based monitoring is one of the methods used to collect data about drug prescriptions and adverse events. The aims of this study were to identify the most frequent ADRs recognized by the attending physicians, study their nature, and to target these ADRs in order to take future preventive measures. A prospective study was conducted over a 7-month period in an internal medicine department using stimulated spontaneous reporting for identifying ADRs. Out of the 254 admissions, 32 ADRs in 37 patients (14.56%) were validated from the total of 36 suspected ADRs in 41 patients. Female predominance was noted over males in case of ADRs. Fifty percent of total ADRs occurred due to multiple drug therapy. Dermatological ADRs were found to be the most frequent (68.75%), followed by respiratory, central nervous system and gastrointestinal ADRs. The drugs most frequently involved were antibiotics, anti-tubercular agents, antigout agents, and NSAIDs. The most commonly reported reactions were itching and rashes. Out of the 32 reported ADRs, 50% of the reactions were probable, 46.87% of the reactions were possible and 3.12% of the reactions were definite. The severity assessment done by using the Hartwig and Seigel scale indicated that the majority of ADRs were ‘Mild’ followed by ‘Moderate’ and ‘Severe’ reactions, respectively. Out of all, 75% of ADRs were recovered. The most potent management of ADRs was found to be drug withdrawal. Our study indicated that hospital based monitoring was a good method to detect links between drug exposure and adverse drug reactions. Adequate training regarding pharmacology and optimization of drug therapy might be helpful to reduce ADR morbidity and mortality.

Development, implementation, and analysis of adverse drug reaction monitoring system in a rural tertiary care teaching hospital in Narketpally, Telangana

“…This was in accordance with the previous studies by Patidar et al, 12 Murphy and Frigo, 14 and Lobo et al, 15 but differed from studies carried out by Lin and Lin. 16 The reason may be higher number of adults visiting the hospital outpatients department or being hospitalized and dose adjustments made in pediatric or geriatric groups.…”

“…In India also ADRs have emerged as leading killers. 12 The foremost objective of PvPI was to facilitate and improve the reporting of ADRs in India and to promote patients' safety. 13 Establishment of Pharmacovigilance units in the Medical College and hospitals has facilitated the spontaneous reporting of ADRs to a great extent.…”

A retrospective analysis of adverse drug reaction reported in a tertiary care hospital

“…The reason for the high morbidity in adult population may be because of multi drug therapy or other disease like hypertension, diabetes, asthma or other chronic diseases. Our finding similar with the finding of Patidar et al, Murphy et al 6,8 The most common category associated with ADRs was skin (46.55%). This finding is consistent with the study by Coelho et al, Fredy et al, Rajesh et al, but it differs from reports of Suh et al where gastrointestinal manifestations had the highest rate, which was second highest in our study (30.45%).…”

“…5 Patidar et al observed that the occurrence of ADRs was (45.94%) in men and (54.05%) in women. 6 Other studies by Sriram et al, Richa, VR Tandon et al reported that males have greater risk of ADR than females. 12,15 There are various factors like age of patients, gender, number of drug taken, duration of hospital admission, genetic factors, ethnicity, dietary, and environmental factors affecting the ADR incidence.…”

Retrospective analysis of adverse drug reactions reported at ADR monitoring centre under PvPI in a tertiary care hospital

“…A similar trend has been reported in other studies. 14,15 The common ADRs shown by patients were rashes, itching, respiratory distress, diarrhoea and fever. This pattern has been reported in other study also.…”