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Sangameshwar Mahangaonkar

Sangameshwar Mahangaonkar

IMS Health, Dubai, United Arab Emirates

Title: Drug safety assessment using Dubai Real World Claims Database (DRWD)

Biography

With over 16 years of experience spanning clinical practice, medical education, public health research and pharmaceutical consulting, Sangameshwar currently leads the practice of Real World Evidence Solutions at IMS Health based in Dubai. At IMS Health, in addition to outcomes research, his work interests include post-authorization safety and effectiveness studies. A trained physician with specialization in epidemiology and public health, Sangameshwar obtained his MBBS from Bangalore Univesrity, his MD in public health. He is also an adjunt professor of Public Health in the Department of Community Medicine at PES Institute of Medical Sciences & Research, Kuppam, India.

Abstract

The large databases of health insurance claims often contain information on potential adverse events (AE). If investigated further, this information could complement other methods of drug safety assessments. The Dubai Real World Claims Database (DRWD) is an anonymized longitudinal patient level database of all insurance claims generated from private healthcare sector in the Emirate of Dubai. Covering over 1.9 million lives, the DRWD currently represents about 15% of the total UAE national population and is available since January 2014. Major data fields available are: patient demographics, physician specialty, provider, details of prescriptions, clinical diagnosis (ICD10), few lab test results, procedures and hospitalizations, which ultimately generate an insurance claim. DRWD is a rich source of healthcare data in UAE that may be valuable for epidemiological and outcomes research. We are conducting a retrospective observational study to evaluate the suitability of using the DRWD adverse event reporting. We have considered all categories of lipid-modifying drugs for this exercise, given that these drugs are amongst the 5 most prescribed drugs in the United Arab Emirates. We are thereby confident of securing a robust sample of patient records with lipid modifying therapy. Those patient records currently existing within the database, aged 18 years or above and receiving 2 or more prescriptions for lipidmodifying drugs between January 1, 2014 and September 30, 2015 will be included in the study. Hospitalizations with diagnosis codes (ICD-10) related to common and known adverse drug reactions of lipid modifying therapy such as muscle, kidney, and liver affections will be determined for patients receiving statins, fibrates, cholesterol absorption inhibitors, or combination therapy. The key criteria to be considered for suitability of DRWD for this exercise, would be two fold. First would be an attribute of the DRWD itself – the availability of actual data on the four elements of adverse event reporting – suspected drug, actual adverse event, identifiable patient and an identifiable physician. The second criterion is the consistency of findings from DRWD with reported rate of adverse events in real world clinical practice. The latter will be confirmed through a survey among clinical experts.

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