Pattern, Causality and Preventability of Adverse Drug Reactions in an Oncology Chemotherapy Day-Care Unit

This B.Pharm group project is a prospective observational pharmacovigilance study of adverse drug reactions (ADRs) in patients receiving cancer chemotherapy at the day-care unit of a tertiary-care teaching hospital. Cytotoxic drugs have a narrow therapeutic index, so nausea, vomiting, myelosuppression, mucositis, alopecia, neuropathy and hypersensitivity reactions are common — and many of them are under-reported because they are "expected".

Over twelve weeks the group, working with the hospital's clinical pharmacologist and the ADR Monitoring Centre (AMC) of the Pharmacovigilance Programme of India (PvPI), identifies suspected ADRs through daily visits, patient interviews and case-record review. Each ADR is documented on the PvPI Suspected ADR Reporting Form, graded with CTCAE v5.0, assessed for causality with the WHO-UMC system and the Naranjo scale, for severity with the modified Hartwig and Siegel scale, and for preventability with the modified Schumock and Thornton criteria. Reports are forwarded to the AMC for entry into the national database.

The data are analysed in SPSS with descriptive statistics and chi-square tests of association between ADR occurrence and age group, sex, number of cycles and regimen. The project is built for the PCI BP813PW Project Work slot and is tied directly to the Semester VIII elective BP805ET Pharmacovigilance, which gives students real practice in the ADR reporting and assessment methods they learn in theory.

Abstract

A prospective observational study was conducted over 12 weeks in the chemotherapy day-care unit of a tertiary-care teaching hospital to describe the pattern of ADRs to anticancer drugs. Adult patients receiving at least one cycle of chemotherapy were enrolled after written informed consent. Suspected ADRs were recorded on the PvPI form and assessed for causality (WHO-UMC, Naranjo), severity (modified Hartwig and Siegel) and preventability (modified Schumock and Thornton). Associations with patient and treatment factors were tested by chi-square test in SPSS.

Introduction

Pharmacovigilance is the science of detecting, assessing, understanding and preventing adverse effects of medicines. In India the Pharmacovigilance Programme of India (PvPI), coordinated by the Indian Pharmacopoeia Commission under CDSCO, collects reports through ADR Monitoring Centres in medical colleges. Oncology is a high-risk area: cytotoxic regimens such as CMF, AC-T, FOLFOX and carboplatin–paclitaxel produce ADRs in most patients, and many of these affect quality of life and adherence to the treatment schedule.

Literature gap

Published Indian studies on chemotherapy ADRs often report frequency only, without preventability assessment or grading by CTCAE. Student-level projects rarely apply two causality systems side by side or forward reports to PvPI. This study applies the full assessment set and links the project to the national programme.

Proposed work

• Enrol eligible patients over 12 weeks and follow them through each day-care visit.
• Detect ADRs by interview, observation and record review; document on the PvPI form.
• Apply causality, severity, preventability and CTCAE grading.
• Analyse ADR pattern by organ system, drug class and regimen.

Feasibility

• Technical: assessment scales are published and free; SPSS is available in the college.
• Economic: no cost beyond printing forms.
• Operational: the hospital's AMC supports student participation.
• Ethical: Institutional Ethics Committee approval and written informed consent are obtained before enrolment.

Patients receiving cancer chemotherapy experience adverse drug reactions far more often than most other patient groups, yet in routine practice many of these reactions are treated as an unavoidable part of treatment and are neither systematically documented nor reported to the Pharmacovigilance Programme of India. Without structured data on which drugs and regimens cause which reactions, how severe they are and how many of them could have been prevented — for example through adequate antiemetic premedication or dose adjustment for renal function — hospitals cannot improve supportive care, and the national database remains incomplete.

This project therefore asks: what is the pattern, causality, severity and preventability of ADRs among adult patients receiving chemotherapy in a day-care unit, and are ADRs associated with age, sex, regimen or number of cycles? The study also gives B.Pharm students direct experience of PvPI reporting, as intended by the BP805ET Pharmacovigilance elective.

In scope

• Adult patients (≥ 18 years) receiving intravenous or oral chemotherapy in the day-care unit during 12 weeks.
• Detection, documentation, causality, severity, preventability and CTCAE grading of ADRs.
• Descriptive and chi-square analysis; reporting to PvPI via the AMC.

Out of scope

• Paediatric patients, radiotherapy-only patients and in-patients in wards.
• Changing any patient's treatment — all clinical decisions remain with the treating oncologist.
• Pharmacoeconomic cost of managing ADRs and long-term follow-up after the study period.

Study design: prospective, observational, cross-sectional pharmacovigilance study.

Setting: chemotherapy day-care unit of a tertiary-care teaching hospital with a PvPI ADR Monitoring Centre (the hospital is not named in this bundle).

Duration: 12 weeks of data collection within a 16-week project.

Sample size: using n = Z²p(1 − p)/d² with Z = 1.96, p = 0.5 (most conservative when the local ADR proportion is uncertain) and absolute precision d = 0.10, n ≈ 96; rounded to 100 patients. All eligible patients during the period are approached consecutively until the target is reached.

Inclusion criteria: age ≥ 18 years; confirmed malignancy; receiving at least one cycle of chemotherapy during the study; written informed consent.

Exclusion criteria: patients unable to communicate without a caregiver present, patients participating in an interventional clinical trial, and those receiving only hormonal therapy or radiotherapy.

Instruments: (1) study case record form (demographics, diagnosis, stage, regimen, cycle, premedication, renal and liver function, blood counts); (2) PvPI Suspected ADR Reporting Form; (3) CTCAE v5.0; (4) WHO-UMC causality categories; (5) Naranjo 10-question scale; (6) modified Hartwig and Siegel severity levels 1–7 grouped as mild, moderate and severe; (7) modified Schumock and Thornton preventability criteria.

Procedure: daily visits to the day-care unit; patient interview before and after infusion; review of case notes and lab reports; each suspected ADR discussed with the clinical pharmacologist; forms completed the same day and submitted to the AMC.

Statistical analysis: SPSS — frequencies and percentages for ADR pattern, mean ± SD for age; chi-square (or Fisher's exact test where expected counts < 5) for associations; agreement between WHO-UMC and Naranjo shown in a cross-table; p < 0.05 significant.

Ethics: Institutional Ethics Committee approval before enrolment, in line with the ICMR National Ethical Guidelines (2017) and the New Drugs and Clinical Trials Rules, 2019 registration of the committee with CDSCO; written informed consent in the local language; confidentiality — patient initials never leave the AMC form.