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TITLE:

PRESCRIPTION PATTERN & ADVERSE DRUG REACTIONS OF PROKINETICS

AUTHORS:

Dr Fouzia Iqbal, Dr Sana Abbas, Dr Salman Tahir

ABSTRACT:

Background & objectives: Prokinetics lead to several adverse events (AEs) when prescribed in huge amounts. We wanted 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 Services hospital Lahore. Methods: We included patients from outpatient department, who had received prokinetic agents for at least seven days in the over the period of a 30 days. Causality assessment of AEs was done and assessed for severity, preventability, seriousness and predictability. Results: A total of 304 patients of which 161 were male that is (52.96%); 143 patients were female that is (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: The results of this study 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. Key words Domperidone - gastric acid suppression - hypomotility - levosulpiride - prescription audit - proton pump inhibitor

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