Design, Develop and Validate a Tool for Assessing Drug Related Problems in Cancer Patients within The Indian Healthcare Context

Abstract

The objective of the study was to design, develop and validate a tool for assessing drug related problems in cancer patients within the Indian healthcare context. A six-month prospective observational study was conducted on inpatients receiving chemotherapy in the Medical Oncology Department and Daycare Unit at Geetanjali Medical College and Hospital, Udaipur, Rajasthan. Patient selection was guided by retrospective records considering factors like age, gender, complaints, comorbidities, past medications, cancer type, stage, chemotherapy intent, cycle count and potential adverse drug reactions. Information was gathered using a structured patient data collection form and consent form, then analyzed with MS Excel and statistical software. The study included 100 patients (mean age: 51.22 years; 56% male, 44?male; mean body mass index: 21.67 kg/m²). Comorbidities included diabetes (7%), hypertension (3%), and others. Bone/soft tissue cancer (22%) and lung/thoracic cancer (18%) were prevalent diagnoses, with 61% at stage 3. Chemotherapy was adjuvant (79%), palliative (12%), or neoadjuvant (9%). Common drugs included carboplatin (35%) and paclitaxel (28%). Common adverse drug reactions included anemia (92%) and weakness (77%), totaling 510 events. An assessment tool was developed, piloted, adjusted, and validated, identifying 318 drug related problems linked to adverse drug reactions, dose changes, allergies, lab shifts, and omitted supportive drugs, yielding a moderate risk score of 6.4. The study successfully developed and validated a reliable tool (Cronbach alpha: 0.736) to assess DRPs enhancing clinical decision-making and enhancing patient safety.

Keywords

Introduction

Cancer is a complex disease marked by the uncontrolled growth and division of abnormal cells in the body that leads to tumor formation which are classified as benign or malignant. Benign tumors are generally localized and non-invasive while malignant tumors can invade nearby tissues and metastasize to distant organs. The rise in cancer incidence worldwide has placed immense pressure on healthcare systems, especially in developing countries like India. According to the National Cancer Registry Programme (NCRP), over 1.46 million new cancer cases were projected in 2022, with a 12.8% increase anticipated by 2025. The most common cancers include lung in men, breast in women, and lymphoid leukemia in children. Cancer-related deaths account for 18.1% of all non-communicable disease mortality. Despite government initiatives like Ayushman Bharat, the unequal distribution of diagnostic and treatment services continues to hinder cancer care, particularly in rural areas. Chemotherapy remains a cornerstone in cancer treatment, aiming for cure, disease control, or palliation. Chemotherapy drugs, however, are non-selective and can affect rapidly dividing healthy cells, resulting in adverse effects such as nausea, fatigue, hair loss, immune suppression, and organ toxicity. Proper planning and monitoring are critical to maximizing therapeutic benefit while minimizing harm. Adverse drug reactions (ADRs) and Drug-Related Problems (DRPs) are significant challenges in chemotherapy. The Pharmaceutical Care Network Europe (PCNE) defines DRPs as events or circumstances involving drug therapy that interfere with desired health outcomes. These include incorrect drug selection, drug interactions, suboptimal dosing, and patient non-adherence. Drug related problems can lead to treatment failure, increased hospitalizations, and higher healthcare costs. Various tools exist to detect and manage drug related problems, such as the Pharmaceutical Care Network Europe (PCNE classification), Naranjo scale, ECOG Performance Status, Karnofsky Performance Scale, Chemotherapy risk assessment scale for high age patients (CRASH score) and the NCC MERP (National coordinating council for medication error reporting and prevention) index. Quality of life and symptom burden are often assessed using tools like the EORTC (European organization for research and treatment of cancer), and Functional Living Index Cancer (FLIC). Despite the availability of these tools, India lacks a standardized, context-specific drug related problem assessment scale, leading to underreporting and inconsistent management. India’s diverse healthcare landscape—with high rates of polypharmacy, limited pharmacist involvement, rural-urban disparities, and common self-medication—poses unique challenges for drug related problem identification and prevention. Global tools may not adequately capture these local nuances. Therefore, the development of an indigenous DRP assessment framework is imperative. A tailored tool would help standardize clinical monitoring, support early detection and prevention of drug related problems, and enhance treatment outcomes. It would also aid policymakers and clinicians in improving pharmacovigilance and guiding effective healthcare interventions. In conclusion, addressing chemotherapy-related drug related problems in India requires not only improved infrastructure and awareness but also a reliable, India-specific tool to assess, manage, and prevent drug related problems systematically. This could significantly enhance patient safety and the overall effectiveness of cancer therapy.

METHODOLOGY:

Study Design: A prospective observational study.

Study setting: The study was conducted in Medical Oncology Department of Geetanjali Medical College and Hospital, Udaipur.

Study duration: The study was conducted over a period of six months.

Study criteria

Inclusion criteria

Patients of age > 18 years who were diagnosed with cancer and undergoing chemotherapy admitted in Medical Oncology Ward and Daycare center.

Exclusion criteria

• Pregnant and Lactating women.
• Patients undergoing radiation and immunotherapy.
• Patients admitted to Surgical Oncology ward.

Sample size: Based on the retrospective data from January to July 2024, approximately 2000 chemotherapy patients were identified in two months. Using the ASQA- Validation sample size calculator (95% confidence, 10% margin), 100 patients were recruited.

Sources of data: Medical records of in-patients maintained by Geetanjali Medical College and Hospital.

Study protocol: Patients meeting the inclusion criteria were enrolled, and data was collected using a structured form from case reports, treatment charts, and lab findings. A pilot study guided the development of a DRP assessment tool, with initial questions reviewed by a multidisciplinary team. The tool was validated using SPSS (Cronbach’s alpha >0.7), ensuring reliability in identifying DRPs in oncology settings.

Statistical analysis: Demographic data were presented as percentages, and tool reliability was assessed using SPSS v30, yielding a Cronbach’s alpha of 0.736. This indicates acceptable internal consistency, confirming the tool’s reliability and suitability for identifying and evaluating DRPs.

RESULTS:

In the recruitment process, 100 patients fulfilled the inclusion criteria and were enrolled in the study by using the purposive sampling method. The age distribution mean of the study participants was found to be 51.222 with a standard deviation of 12.981, out of which 44 (44%) were female and 56 (56%) were male participants.

Figure 1: The description of genders of the participants in the study

The study population had a mean weight of 57.533 and the mean height of the participants was found to be 162.615 with a mean BMI of 21.676.

Out of the 100 patients enrolled, 7 were present with type 2 diabetes mellitus (7%), 3 were present with Hypertension (3%), 1 was present with COPD (1%), 1 was present with AIDS (1%) and 1 with hyperthyroidism, remaining participants did not have any co- morbid condition.

Out of the 100 participants, 70 participants (70%) were non- smokers, while 30 participants (30%) had a history of smoking.

Out of the 100 participants, 76 participants (76%) did not consume alcohol, while 24 participants (24%) participants had a history of alcohol consumption.

Out of 100 participants, 64 participants (64%) belonged to rural population, while 36 participants (36%) belonged to urban population.

Out of 100 participants, 22 (22%) patients were diagnosed with bone and soft tissue cancer, 18 (18%) were diagnosed with lung and thoracic cancer, 16 (16%) with gynaecologic cancer, 10 (10%)with breast cancer, 7 (7%) with buccal cancer, 7 (7%) with gastrointestinal cancer, 6 (6%) with non-Hodgkin’s lymphoma, 5 (5%)with genitourinary cancer, 3 (3%) with head and neck cancer, 2 (2% )with skin cancer, 2 (2%) with, 2 (2%) with hematologic cancer and 2 (2%) with germ cell tumor.

Amongst 100 respondents, majority, 61 participants (61%), were in Stage 3, making it the most common stage. This is followed by 30 participants (30%) who were in Stage 2. A smaller percentage, 8 participants (8%), were found to be in Stage 4, while the least number of cases, 1 participant (1%), was in Stage 1.

Out of the 100 participants the majority, 79 participants (79%), received chemotherapy for adjuvant purposes, indicating treatment given after primary surgery to eliminate residual cancer cells. 12 participants (12%) underwent palliative chemotherapy, aimed at symptom relief and improving the quality of life rather than curing the disease. The remaining 9 participants (9%) received neo-adjuvant chemotherapy, which is administered before the primary treatment to shrink tumors.

Out of 100 participants, 15 (15%) were undergoing cycle 1 of chemotherapy regimen followed by 23 (23%) for cycle 2, 20 (20%) for cycle 3, 11 (11%) for cycle 4, 8 (8%) for cycle 5, 2 (2%) for cycle 6, 3 (3%) for cycle 7, 15 (15%) for cycle 10, 2 (2%) for cycle 19 and 1 (1%) for cycle number 23.

CHEMOTHERAPY REGIMEN-

Figure 2: Frequency patterns of chemotherapy drug regimens

Figure 3: Incidence and types of potential adverse drug reactions (ADRs) during chemotherapy

Patient responses to the 10-question C- MADS TOOL (Chemotherapy Medication Associated DRP Scale V.1) assessment tool highlighted various clinical concerns. Among 100 participants, 67% had abnormal lab results indicating ADRs or toxicities from previous chemotherapy cycles, and 8% required dosage adjustments due to age, weight, or organ function. Allergic reactions were reported by 18%, while 67% experienced injection site reactions or discomfort. Significant lab changes due to ongoing chemotherapy were observed in 72%, and 17% had omissions in supportive medications. Evidence of drug toxicity, interactions, or contraindications was found in 36% of patients. Additionally, 25% had acute conditions that could have been managed with proper treatment, and 8% lacked sufficient vigilance in monitoring chemotherapy-related complications. No dosing protocol deviations were reported.

PATIENT RESPONSES TO DRP TOOL BY RISK LEVEL:

Table 4: Result of the tool according to risk scores

41 patients (41%) exhibited low risk (0-5 score) indicating minimal or no significant DRP’s requiring only routine monitoring followed by 44 patients (44%) exhibiting a moderate risk (6-10 score), suggesting mild ADR’s which may require regular follow- ups and therapy adjustments. 11 patients (11%) indicated high risk category (11-15 score) exhibiting significant DRP’s that require interventions, medication review, and adherence support. 4 patients (4%) exhibited high risk category, suggesting significant DRP’s requiring immediate necessary urgent medical interventions, supportive care, patient education, proactive monitoring and patient counselling for medication optimization. The average risk score was found to be 6.4 which indicated moderate to intermediate risk.

DISCUSSION:

This study was compared with previous research by Ying-Jie Su et al., who identified 47 DRPs in 33 cancer patients through medication reviews, interviews, and ward rounds. Most DRPs were related to treatment effectiveness (68.3%) and safety (36.2%), largely due to suboptimal regimens (90%), drug selection (40.9%), and dosing issues (24.2%). In contrast, our study identified 318 DRPs and 510 ADRs, mainly from prior chemotherapy-induced side effects, required dose adjustments, allergic reactions, injection site complications, lab abnormalities, and omission of supportive medications. Similarly, a study by Eskinder Ayalew Sisay et al. reported a 74.7% prevalence of DRPs among 367 patients in Ethiopia, with ADRs and dosing issues being prominent, influenced by polypharmacy, comorbidities, and hospital stay duration. Additionally, Carole P. Kaufmann et al. developed the DART tool, demonstrating high reliability and feasibility in identifying DRP risks. Our validated tool (Cronbach’s alpha: 0.736) proved effective in identifying DRPs and facilitating timely clinical interventions, thereby enhancing patient safety and therapeutic outcomes.

CONCLUSION:

The objective of this study was to design, develop, and validate a tool for assessing drug-related problems (DRPs) in cancer patients undergoing chemotherapy in Indian clinical settings, facilitating targeted pharmaceutical interventions in a tertiary care hospital. The most common diagnoses were bone and soft tissue cancer (22%), lung/thoracic (18%), and gynecologic cancers (16%). Frequently prescribed drugs included carboplatin, paclitaxel, cisplatin, gemcitabine, and others. A total of 510 potential adverse drug reactions (ADRs) were identified, primarily anemia, GIT toxicities, fatigue, neutropenia, hepatotoxicity, and mucositis. The tool, developed and tested using SPSS version 30, showed acceptable reliability with a Cronbach’s alpha of 0.736. It identified 318 DRPs, enabling interventions to enhance patient safety and treatment effectiveness. Key DRP contributors included ADRs from previous cycles, organ-function-based dose adjustments, allergies, injection site reactions, lab abnormalities, and omission of supportive care. These factors negatively impacted patients’ quality of life and therapeutic outcomes, underscoring the tool’s clinical value.

ACKNOWLEDGEMENTS:

The authors would like to thank all the respondents who took part in answering, analysing and validating the tool and the following for their contribution in evaluation and assistance of the tool: Dr. Insaaf Mansury, Geetanjali Medical College and Hospital, Udaipur, Rajasthan, India and Dr. Ayush Giri, Pharm D., India.

AUTHOR CONTRIBUTIONS:

The authors agree to be addressed accountable of the work to ensure that the questions related to the accuracy or integrity of the work are appropriate. Deepanmita Wakalwar- Contribution to the concept and design of the work, data collection, data analysis and interpretation, drafting work and revising manuscript, development and validation of the tool. Edward Hector Williams- Contribution to the concept and design of the work, data collection, data analysis and interpretation, development and validation of the tool. Dr. Narendra Bheemraj Parihar- Contribution to the concept and design of the work, analysis, development and validation of the tool, revising the manuscript for final approval of the version to be published. Dr. Ankit Agarwal- Contribution to the concept and design of the work, analysis, development and validation of the tool. Dr. Mahendra Singh Rathore- review and analysis of project work and review of manuscript for publication.

CONFLICT OF INTREST:

The authors declare no conflict of interest related to the design, conduct, or publication of this study. No financial, personal or professional relationships influenced the outcomes or interpretations of the data presented.

FUNDING:

This research work is not sponsored by any public, private, commercial or non- profit organization and did not receive any funding from any agencies.

ETHICAL APPROVAL: Geetanjali University, Udaipur, Rajasthan, India. (Ref: GU/HREC/2024/2626), dated 9^th September,2025.

DATA ACCESS STATEMENT: The authors have full access to the study data.

DATA AVAILABILITY: The data supporting the findings of this study are available from the corresponding author upon reasonable request.

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