Currently submitted to: JMIR Research Protocols
Date Submitted: Apr 28, 2026
Open Peer Review Period: Apr 28, 2026 - Jun 23, 2026
(currently open for review)
Warning: This is an author submission that is not peer-reviewed or edited. Preprints - unless they show as "accepted" - should not be relied on to guide clinical practice or health-related behavior and should not be reported in news media as established information.
Pharmacovigilance and pharmacoeconomics of cancer chemotherapy medications in a tertiary care hospital: Study Protocol of Observational Study
ABSTRACT
Background:
Despite being a major burden in low- and middle-income countries in India, the understanding of cancer and its treatment remains limited. Adverse drug reactions (ADRs) from chemotherapy, polypharmacy, drug interactions and the cost of care also pose challenges for patient safety and health economics.
Objective:
This protocol describes the design of a prospective, observational, cross-sectional study that will evaluate chemotherapy drugs based on their usage, ADRs, and drug interactions, as well as undertake pharmacoeconomic analyses, including cost-effectiveness analysis, cost-utility analysis, and budget impact analysis to guide safe and cost-effective cancer treatment.
Methods:
The research will involve 67 adult cancer patients on chemotherapy in the oncology department of a tertiary care hospital in India for eight months. The Case Record Form will be used for data collection. Pharmacovigilance estimates will be done using standardised instruments (WHO-UMC scale, Naranjo algorithm, Hartwig and Siegel scale, Schumock and Thornton criteria). Economic analyses will include cost analysis, cost-effectiveness analysis (ICER), cost-utility analysis (ICUR) and budget impact analysis. Polypharmacy (use of >=5 drugs) and drug-drug interactions will also be assessed.
Results:
The study will confirm a high burden of ADRs, polypharmacy, and financial toxicity with chemotherapy. Results will demonstrate the link between prescription complexity, safety and cost.
Conclusions:
Linking pharmacovigilance with pharmacoeconomics will support rational prescribing, encourage generic and biosimilar uptake, and ultimately improve safety, affordability, and access to cancer treatment. Clinical Trial: CTRI/2025/10/096700 (Registered on: 31/10/2025)
Citation
Request queued. Please wait while the file is being generated. It may take some time.
Copyright
© The authors. All rights reserved. This is a privileged document currently under peer-review/community review (or an accepted/rejected manuscript). Authors have provided JMIR Publications with an exclusive license to publish this preprint on it's website for review and ahead-of-print citation purposes only. While the final peer-reviewed paper may be licensed under a cc-by license on publication, at this stage authors and publisher expressively prohibit redistribution of this draft paper other than for review purposes.