November-December 2016 Indian Journal of Pharmaceutical Sciences 741 Research Paper Pharmacovigilance Study on Platinum-based Chemotherapeutic Regimens in Oral Cancer Patients: A Prospective Cohort Study K. MURTI*, K. PANDEY 1 , R. K. KRISHNA, M. K. RASTOGI, M. ALI 2 , V. V. GAHLOT 2 , C. S. LAL 3 AND P. DAS 4 Department of Pharmacy Practice, National Institute of Pharmaceutical Education and Research, Hajipur-844102, 1 Department of Clinical Medicine, Rajendra Memorial research institute of Medical Sciences, Patna-800 007, 2 Department of Oncology, Mahavir Cancer Sansthan and Research Centre, 3 Department of Biochemistry, 4 Department of Microbiology, Rajendra Memorial research institute of Medical Sciences, Patna-800 007, India Murti, et al.: Pharmacovigilance Study on Platinum-based Chemotherapeutic Regimens Platinum-based chemotherapy is one of the most common therapies employed in oral cancer treatment. This is a prospective cohort study to analyse the pattern and incidence of adverse drug reactions to platinum-based chemotherapeutic regimens in oral cancer patients. Pharmacovigilance studies are still unexplored in oral cancer patients in Bihar, India. Oral cancer patients who received platinum-based cancer chemotherapy were monitored for adverse drug reactions. The collected reports analysed for demographic, causality, preventability and severity of adverse drug reactions. Causality was assessed by the World Health Organization causality assessment scale. Preventability and severity of adverse drug reactions assessed by modifed Schumock and Thornton scale, modifed Hartwig and Siegel scale, respectively. Incidence rate, relative risk and attributable risk were evaluated among the regimens. Out of 120 patients, 108 (90%) patients were males. One hundred and fve patients (87.5%) developed a total of 247 adverse drug reactions. World Health Organization Uppsala Monitoring Centre causality scale showed 82% of adverse drug reactions were “certain”, 15% were “probable” and 3% were “possible”. Modifed Hartwig and Siegel severity scale showed 89% of adverse drug reactions were of “mild” and 11% were of “moderate” type. Schumock and Thornton preventability scale showed 93% of adverse drug reactions were “not preventable” and 20% were “probably preventable”. Paclitaxel+carboplatin regimen showed lowest values in terms of adverse drug reactions. Platinum-based chemotherapy was used in the treatment of oral cancer. From this study it is evident that paclitaxel+carboplatin regimen reported least incidence rate of adverse drug reactions among platinum regimens. Incidence rate was more reported in cisplatin regimen. Key words: Adverse drug reactions, platinum-based chemotherapy, oral cancer, pharmacovigilance Adverse drug reaction is a common phenomenon associated with cancer chemotherapy. According to World Health Organization (WHO) an adverse drug reaction (ADR) is defned as a response to a drug which is noxious and unintended, which occurs at doses normally used in man for prophylaxis, diagnosis or therapy of disease or for modifcation of physiological function excluding failure to accomplish the intended purpose [ 1] . ADRs cause serious disability and mortality to patients besides being a burden to the healthcare system [2,3] . Pharmacovigilance is a branch of science, which deals with monitoring, detection, assessment, understanding and prevention of ADRs [4] . Oral cancer is a head and neck cancer with cancer growth located in the oral cavity [5] . Ninety percent of all oral cancers are squamous cell carcinomas [6] . About 135 000 deaths are reported in the world every year due to oral cancer [7] . Amongst the top three types of cancers in the Indian subcontinent, oral cancer accounts for 30% of all cancers and is a major medical problem [8] . National cancer registry programme of the Indian Council of Medical Research reported highest number of oral cancers worldwide with up to 80 000 new cases annually [9] . Tobacco and alcohol are regarded as the major risk factors for oral cancer [10] . Different studies suggest that smokeless tobacco or chewing of tobacco *Address for correspondence E-mail: krishnamurti74@yahoo.co.in This is an open access article distributed under the terms of the Creative Commons Attribution-NonCommercial-ShareAlike 3.0 License, which allows others to remix, tweak, and build upon the work non-commercially, as long as the author is credited and the new creations are licensed under the identical terms Accepted 05 November 2016 Revised 14 October 2016 Received 06 June 2016 Indian J Pharm Sci 2016;78(6):741-747