Short Communication IDENTIFICATION AND ANALYSIS OF ADVERSE DRUG REACTIONS ASSOCIATED WITH CANCER CHEMOTHERAPY IN HOSPITALIZED PATIENTS ANEKHA ANTONY 1 , JUNO J JOEL 2 , JAYARAM SHETTY 3 , NEETHU FATHIMA UMAR 4 Department of Pharmacy Practice, NGSM Institute of Pharmaceutical Sciences, Mangalore-575018 1, 2, 4 , Department of Oncology, K S Hegde Medical Academy , Mangalore 3 Email: anekhamariya@gmail.com Received: 09 Mar 2016 Revised and Accepted: 17 May 2016 ABSTRACT Objective: To analyze the incidence of adverse drug reactions (ADRs) associated with chemotherapeutic drugs and study its management. Methods: A prospective observational study was carried out on hospitalized patients undergoing cancer chemotherapy. The identified ADRs were assessed for causality, severity and preventability. Results: Among 120 patients followed 100 patients developed 161 ADRs. Most common ADRs were anemia, leucopenia, mucositis fever, and chills. As per the WHO causality assessment 87(54.0%) ADRs were probable whereas with the Naranjo’s scale 98(60.9%) were probable. Moderate reactions were 59.62%. Majority 122 (75.8%) of the ADRs were not preventable. Most of ADRs were implicated with cisplatin followed by 5-Fluro-uracil and the combination drugs which included FAC (Flurouracil, adriyamycin, cyclophosphamide) regimen, Paclitaxel, and Carboplatin (PC) regimen. Conclusion: Patients undergoing cancer chemotherapy have higher chances to develop ADRs. Those patients on chemotherapy with cisplatin followed by 5-Fu and combination drugs which include FAC and PC regimen should be strictly monitored for the early detection and prompt management of the ADR to prevent morbidity and mortality. Keywords: Adverse drug reactions, Cancer, Chemotherapy, Predictable, Management. © 2016 The Authors. Published by Innovare Academic Sciences Pvt Ltd. This is an open access article under the CC BY license (http://creativecommons.org/licenses/by/4.0/) Drugs are widely used because of their ability to effect the biological systems of the body. The use of these drugs may also carry certain unwanted or unintended effects. Each time a patient is exposed to a drug we cannot be certain about the unwanted effects of the product. However, we can learn from previous experience where patients have been exposed to the similar drug. ADR is recognized as a hazard of drug therapy. It may develop promptly or only after prolonged medication or even after stoppage of the suspected drug. The World Health Organization defines an ADR as “any reaction that is noxious and unintended and occurs at a dose normally used in man for diagnosis, prophylaxis and treatment of diseases or for modification of physiological function”[1]. Cancer has become a global burden because of the aging, increased adoption of cancer-causing behaviors particularly smoking and exposure to triggering factors like chemicals, radiations, unhealthy eating habits and a sedentary lifestyle. Different modalities for treatment of cancer include radiation, surgery, chemotherapy, hormonal therapy, immunotherapy, biologic therapy and cryosurgery [2]. The treatments with cancer chemotherapeutic drugs are often associated with a variety of serious and non-serious ADRs. The most common side effect of chemotherapy administration is nausea with or without vomiting, diarrhea, alopecia, darkening of skin and nails, darkening of the injection site, myelosuppression, mucositis, gonadal dysfunction, hyper-uricemia, neuropathy, cardiomyopathy, hemorrhagic cystitis, impaired renal function, electrolyte imbalance, etc [3]. The objectives of ADR monitoring include detection of unknown drug-related safety problems, identification, and quantification of risk factors associated with the use of drugs and prevention of patients from being affected unnecessarily. The information pertaining to ADRs can be used to formulate therapeutic guidelines, public health policy decision and in pharmacoeconomic research. Based on these facts the regulatory authorities can bring about changes in package inserts and restrict the use of drugs or withdraw drugs from the market [2]. The analysis of ADRs associated with the cancer chemotherapy in a hospital set up gives an insight regarding the causality, severity, and preventability of the identified ADRs. It may also create awareness among the treating physicians. This can prevent future occurrence of similar ADRs in the same patient. Hence, this study was undertaken to analyze the ADRs identified in an oncology unit of a tertiary care teaching hospital. A prospective observational study was carried out in the oncology department of Justice K S Hegde Charitable Hospital at Mangalore over a period of eight months. A total of 120 patients were enrolled in the study. All hospitalized patients of age 18 y and above and who were on cancer chemotherapy were included in the study. Patients using an alternative system of medicine such as ayurveda and homeopathy, subjects being treated as out-patient and mentally challenged subjects were excluded from the study. The study was approved by the central ethics committee of Nitte University Ref No: NU/CEC/P. G.-03/2015. During the study period, the in-patients of the oncology ward diagnosed with all types of cancer and treated with all types of chemotherapeutic drugs were observed on a daily basis. When an ADR was suspected information regarding patients demographics, diagnosis, drug therapy, relevant investigational reports were collected and documented in a suitably designed patient data collection form and ADR reporting form after obtaining the informed consent. It was then discussed with the treating physician for detailed evaluation. Once the ADR is confirmed it was analyzed for causality using WHO probability scale and Narajo’s algorithm. The severity was analyzed by using Hartwigs severity scale, and preventability was assessed by using Modified Shomock and Thoronton scale. The management of the identified ADR was studied. The outcome of the ADR was then documented. Data analysis was carried out using statistical package for social sciences (SPSS) 16.0. Descriptive statistics was applied for analysing the collected data. Among 120 cancer patients followed 58 (48.3%) male and 62 (51.7%) female received chemotherapy for a duration of eight months. A Hundred patients developed a total of 161 ADRs out of which 54(54%) were female, and 46 (46%) were male. This shows that incidence of ADRs was more common in female patients. The prevalence of cancer in the age group of 50-59 was found to be higher 42(35%). Highest distribution pattern of cancer among the International Journal of Pharmacy and Pharmaceutical Sciences ISSN- 0975-1491 Vol 8, Issue 7, 2016