A retrospective analysis of reporting of adverse drug reactions to oncology drugs: An experience from a national center of clinical excellence

Abstract

INTRODUCTION:Adverse drug reaction (ADR) is a public health problem which constitutes one of the leading causes of morbidity and mortality worldwide. In India, only a few studies reported cancer chemotherapy-induced ADRs. The objectives of the present study were to assess the organ system involved, frequency, severity, and preventability of the ADRs occurred.MATERIALS AND METHODS:Data on ADRs of retrospective cohorts were extracted from the filled ADR forms received from the department of radiation oncology. Descriptive statistic was used to summarize and analyze the available data, namely patient demography, causality, severity, and preventability of the event.RESULTS:A total of 191 chemotherapy-induced ADR reports were received from 164 patients during the period March 2015 to August 2017. Almost three-fourth of the ADRs occurred in patients who were receiving regimens involving multiple drugs. Taxanes, alkylating agents, and platinum compounds were the common drug groups involved. The skin (n = 90) was the most frequently involved organ with alopecia and hyperpigmentation as most common manifestations. The severity (Hartwig and Siegel) and preventability scales (Modified Schumock and Thornton) indicated that most reactions were mild (54.45%) in nature and the majority of them were preventable. More than two-third (69%) of the reactions were related “possible” to the suspected drug as determined by the World Health Organization causality assessment.CONCLUSION:Chemotherapy-related ADRs among cancer patients are worrisome. It has a negative impact on patient quality of life and in addition increases cost of therapy. It is found that timely reporting of chemotherapy-related ADRs and having an effective ADR monitoring system in place ensure preventability of the ADRs in many cases. Oncologists, Radiotherapists and Onco-surgeons should be actively involved in ADR reporting (Onco-Pharmacovigilance) and exchange constructive information, update and educate each other about appropriate use of anticancer drugs. Onco-pharmacovigilance is the need of the hour and could be of immense value in reducing morbidity and mortality if practiced with utmost importance.

Toxicity profile, adverse drug reactions and drug-drug interactions among geriatric cancer patients under metronomic chemotherapy in a South Indian tertiary care hospital

“…Sharma PK et al 25 study showed that the more than two-thirds of the ADRs were related “possible” to the suspected oncology in causality assessment, mild in severity and the majority of them were preventable, which is consistent with the findings of this study. Out of 129 prescriptions, 13% of interactions were classified as “monitor therapy” (category C), with the majority of interactions being between Capecitabine and proton pump inhibitors (PPIs).…”

Nutritive diet becomes unhealthy if taken in a wrong ratio: Scientific validation of Ayurvedic concept of “incompatible diet” (Virrudh Aahar)

“…Such effects have been reported in patients going under chemotherapy, immune check point inhibitor, program protein inhibitor (PD1) at the latter stage of treatment even after discontinuing the medicine. In these patients the symptoms of Alopecia (hair loss), skin patches, dermatitis eczema are observed (Sharma et al, 2018). The genes like Tnfrs19, Ercc2, Lama5, Ctsl, Per1 are shown to be involved in etiology of skin disorders, these genes regulate various biological process involved in hair follicle development, hair follicle maturation, hair follicle morphogenesis and regulation of hair cycle (Lim, Kim, Lim, & Kim, 2019).…”

Assessment of adverse drug reactions in oral cancer patients receiving chemotherapy treatment at tertiary care centres in North-Western India

“…8 Although few studies pertaining to pharmacovigilance in cancer patients have been undertaken in the past, all were generally designed as snapshot studies with relatively little attention to a particular cancer and its associated risk factors in the target populations. [9][10][11][12] Therefore, the present study was planned among the oral cancer patients with the aim of providing them with tailored pharmacotherapy with fewer adverse effects and complications.…”