ABSTRACT
Background & objectives: Prokinetics are extensively prescribed leading to several adverse events (AEs). The aim of this study was to assess the prescription pattern in patients receiving prokinetics, and characteristics of adverse drug reactions (ADRs) in an outpatient department set up in a tertiary care hospital in western India. Methods: Patients attending outpatient departments of a tertiary care hospital and who had received prokinetic agent for at least seven days over the last one month were enrolled. Causality assessment of AEs was done and assessed for severity, preventability, seriousness and predictability. Results: A total of 304 patients [161 males (52.96%); 143 females (47.04%)] were enrolled. Most prescriptions (299/304, 98%) included domperidone, most commonly prescribed as fixed-dose combination (FDC) with pantoprazole (274/304, 90%). Prokinetic dose was not mentioned in 251/304 (83%) prescriptions, and 18/304 (6%) did not mention frequency. Of the 378 AEs reported from 179 patients (47.35%), 306 (81%) were mild, all non-serious; 272 (72%) not preventable and 291 (77%) predictable in nature. Decreased appetite (n=31, 8.2%) and fatigue (n=27,7.14%) were most commonly reported. Causality assessment by the World Health Organization-Uppsala Monitoring Centre scale showed that 180 AEs were related to suspected drug (17 probable and 163 possible ADRs). Significant correlation was observed for AEs with increasing number of drugs per prescription (Spearman's R=+0.8, P =0.05) and with increasing therapy duration (Spearman's R=+1.00, P <0.001). Interpretation & conclusions: Our findings showed that prokinetics were often prescribed as FDCs, with incomplete prescriptions. Domperidone was found to be associated with multiple AEs. It is suggested that regular prescription monitoring should be done in hospitals to encourage rational use of drugs.
ABSTRACT
Background & objectives: Standard treatment guidelines (STGs) are the cornerstone to therapeutics. Multiple agencies in India develop STGs. This systematic review was conducted to find out STGs available in India, evaluate if these were as per World Health Organization (WHO) recommendations for STGs and compare these with National Institute for Health and Care Excellence (NICE) guidelines. Information on legal authority and responsibility for formulating STGs was also sought. Methods: PRISMA guidelines were followed. Publications from PubMed and Google Scholar were searched for STGs using terms 'Standard Treatment Guidelines AND India'. Data from STGs were compiled in excel as per the WHO and authors' criteria for STGs and compared with NICE guidelines. Results: PubMed and Google Scholar search provided 56 publications (out of 1695 search results) mentioning 27 STGs. Google search and replies from authors led us 36 STGs, totalling to 63 STGs. No STG mentioned any specific period of revision, eight STGs were not evidence-based, 55 had some Indian references, 48 STGs were for single disease and the remaining multi-disease, three STGs did not include diagnostic criteria, 16 STGs did not give prescribing information of recommended treatment and 16 STGs provide no referral criteria for patients. Fifty five STGs did not mention level of health care. While NICE is a single legal authority in England and guidelines are as per WHO recommendations for STGs, in India although Acts and rules do not vest authority, National Health Systems Resource Center is generally designated responsible for STGs. Interpretation & conclusions: In India, although there are multiple STGs developed by various authorities and professionals for the same conditions, these fulfil WHO recommendations only partially. Authority with statutory duty collaborating with professional organizations, a standard methodology for adopting international guidelines, Indian data for evidence base, attention to local needs will help in developing better STGs and their acceptance.