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Research Concept Draft

This research concept aims to assess stock-outs and affordability of oncology drugs for childhood hematologic cancers at Moi Teaching and Referral Hospital (MTRH) in Kenya, where drug shortages affect treatment access. The study will employ a mixed-methods approach to analyze drug availability, costs, and the impact on patient outcomes, focusing on key oncology drugs listed as essential. Findings are expected to inform policy and improve access to cancer medications for children in resource-limited settings.

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0% found this document useful (0 votes)
4 views6 pages

Research Concept Draft

This research concept aims to assess stock-outs and affordability of oncology drugs for childhood hematologic cancers at Moi Teaching and Referral Hospital (MTRH) in Kenya, where drug shortages affect treatment access. The study will employ a mixed-methods approach to analyze drug availability, costs, and the impact on patient outcomes, focusing on key oncology drugs listed as essential. Findings are expected to inform policy and improve access to cancer medications for children in resource-limited settings.

Uploaded by

Ongondi Timothy
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Research Concept:

Assessment of Stock-outs and Affordability of Oncology drugs Used in


Childhood Hematologic Cancers at MTRH, Kenya.

Background and Rationale


The fight against childhood cancer in Kenya faces a formidable obstacle - the struggle to
maintain consistent access to life-saving cancer medications. At Moi Teaching and Referral
Hospital (MTRH), one of East Africa's premier pediatric cancer centers, young patients and their
families frequently encounter the harsh reality of empty pharmacy shelves and prohibitively
expensive treatments. The situation is particularly dire when it comes to crucial chemotherapy
drugs like methotrexate and etoposide. In fact, Kenya's healthcare system experiences drug
shortages nearly half the time, topping the unavailability rates in East Africa at 48.5%.
Behind these shortages lies a complex web of challenges in how hospitals manage their drug
supplies. While several Kenyan public hospitals have been studied, MTRH's unique
circumstances - including its role as a major regional cancer center - demand closer examination.
The economic burden of childhood cancer treatment varies dramatically worldwide, but we lack
detailed understanding of how these costs impact families seeking care at MTRH. Research from
rural Western Kenya reveals a troubling cascade effect: when medications run out, treatments are
postponed, children's health deteriorates, and healthcare expenses spiral upward.
Previous investigations at prominent Kenyan institutions like Kenyatta National Hospital and
Defence Forces Memorial Hospital have shed light on how hospital policies, systems, and staff
expertise affect drug availability. However, these studies only scratch the surface of what causes
medication shortages. Some hospitals have experimented with innovative approaches like Vendor
Managed Inventory (VMI), where suppliers take a more active role in managing hospital stock
levels, but the effectiveness of such solutions needs further evaluation.
Our research seeks to fill critical knowledge gaps by conducting a comprehensive analysis at
MTRH. We will document the frequency and duration of drug shortages, evaluate the cost-
effectiveness of cancer medications, and identify key factors that influence both availability and
affordability. By building upon existing research from Kenyan healthcare settings, we aim to
uncover the root causes of supply chain difficulties and develop practical solutions to ensure
children have reliable access to essential cancer medicines.
This work comes at a crucial time, as the burden of childhood cancer continues to grow in
resource-limited settings. Our findings will provide valuable insights to help strengthen Kenya's
healthcare system and could serve as a model for other low- and middle-income countries facing
similar challenges in pediatric cancer care.
Research Objectives
o Broad Objective:
o To assess the frequency and duration of stock-outs of essential oncology drugs used
in childhood cancers at MTRH.
2. Specific Objectives:
o To analyze the affordability of oncology drugs used in treating childhood cancers at
MTRH.
o To.

Research Questions
1. What is the frequency and duration of stock-outs of essential oncology drug at MTRH?
2. How affordable are the standard hematologic oncology regimen drugs used in treating
childhood cancers at MTRH?
3. ?

Methodology
Study Design:
A mixed-methods approach combining quantitative and qualitative data collection.
Quantitative Component:
A retrospective analysis of drug procurement and stock-out data from MTRH’s pharmacy records
in 2024. A ten-drug list will be selected of relevance to stock-outs, essential and standard, wide
coverage and cost-effective to ensure validity and reliability. Cost-effectiveness analysis will be
conducted using the incremental cost-effectiveness ratio (ICER) per quality-adjusted life year
(QALY) for key drugs.
Qualitative Component:
Structured interviews with key stakeholders, including pharmacists, oncologists, procurement
officers, and hospital administrators, to explore determinants of drug availability and
affordability. Structured format questionnaires and mixed question types combining Likert
scales, multiple-choice, and open-ended questions will be used for depth and flexibility.

Study Population:
Quantitative: Pharmacy records of oncology drugs used in childhood cancers at MTRH.
Qualitative: Key stakeholders involved in drug procurement and administration at MTRH.

Rationale for selection:


1. Relevance to Childhood Cancers: These drugs are crucial in the treatment of Acute
Lymphoblastic Leukemia (ALL), Wilms Tumor, Burkitt Lymphoma, Retinoblastoma, and
Rhabdomyosarcoma.
2. Essential Medicines Lists: All drugs are included in both the Kenya 2019 Essential Drugs
List and the WHO Pediatric Essential Drugs List, ensuring their recognition as essential
medications.
3. Frequency of Stock-Outs: Priority has been given to drugs that are frequently out of stock
at MTRH, based on available data and regional trends.
4. Data Availability: The study will focus on drugs for which complete and accurate data is
available to ensure feasibility and reliability of the findings.

Inclusion Criteria
 Patient Population: Children (aged 0–18 years) diagnosed with one of the five most
common childhood cancers in Western and Central Kenya (regional scope)
o Acute Lymphoblastic Leukemia (ALL)
o Wilms Tumor (Nephroblastoma)
o Burkitt Lymphoma
o Retinoblastoma
o Rhabdomyosarcoma

 Drugs: Only include the top 10 oncology drugs used in the study that are listed in both
the Kenya 2019 Essential Drugs List and the WHO Pediatric Essential Drugs List and the
frequency of the stock-outs.

 Time Frame: Pharmacy records and patient data from the past 12 or 6 months (to ensure
relevance and feasibility).

 Data Availability: Only include drugs and patients with complete records (e.g., drug
dispensation, stock levels, and patient outcomes).
Exclusion Criteria
 Patient Population: Children with cancers not among the five most common in the region
(e.g., brain tumors, osteosarcoma). Patients receiving palliative care only (as their
treatment regimens may differ significantly).

 Drugs: Exclude drugs not listed in both the Kenya 2019 Essential Drugs List and the
WHO Pediatric Essential Drugs List. Exclude drugs used off-label or as part of
experimental therapies.

 Time Frame: Exclude pharmacy records or patient data older than 12 or 6 months to
ensure relevance and accuracy.

 Data Availability: Exclude drugs or patients with incomplete records (e.g., missing stock
levels, unclear dispensation data).

 Cost-Effectiveness: Focus on drugs with high cost variability or frequent Stock-outs to


provide actionable insights for policymakers.

Data Collection:
Quantitative: Extraction of stock-out data, drug prices, and treatment outcomes from MTRH’s
electronic health records and pharmacy databases.
Qualitative: Conducting interviews with 15–20 stakeholders using a purposive sampling
approach.

Data Analysis:
Quantitative: Descriptive statistics to summarize stock-out frequency and duration. Cost-
effectiveness analysis using ICER per QALY.
Qualitative: Thematic analysis to identify key determinants of drug availability and affordability.

Expected Outcomes
1. A detailed assessment of stock-out patterns and their impact on treatment outcomes at
MTRH.
2. Cost-effectiveness estimates for key oncology drugs used in childhood cancers.
3. Identification of health system determinants influencing drug availability and
affordability.

Significance of the Study


This study will provide critical evidence to inform policy and practice at MTRH and similar
institutions. By identifying predictors of stock-outs and cost-effectiveness, the findings will
support the development of targeted interventions to improve drug availability and affordability,
ultimately enhancing childhood cancer outcomes.

Conclusion
This research concept addresses a critical gap in the literature by focusing on stock-outs and
costs of oncology drugs at MTRH. The findings will contribute to evidence-based strategies for
improving access to essential cancer medicines for children in Kenya and beyond.

References
1. Bukachi, S. A., Tuju, J., & Wamae, W. (2021). Access to essential cancer medicines for
children: A comparative mixed-methods analysis of availability, price, and health-system
determinants in East Africa. BMC Health Services Research, 21(1), 1-12.
https://doi.org/10.1186/s12913-021-06322-6

2. Cherny, N. I., Sullivan, R., Torode, J., Saar, M., & Eniu, A. (2017). ESMO International
Consortium Study on the availability, out-of-pocket costs, and accessibility of
antineoplastic medicines in countries outside of Europe. Annals of Oncology, 28(11),
2633-2647. https://doi.org/10.1093/annonc/mdx521

3. Goldstein, D. A., Chen, Q., Ayer, T., Howard, D. H., Lipscomb, J., El-Rayes, B. F., & Flowers,
C. R. (2016). Cost-effectiveness analysis of regorafenib for metastatic colorectal cancer.
Journal of Clinical Oncology, 34(6), 654-660. https://doi.org/10.1200/JCO.2015.64.5647
4. World Health Organization. (2019). Shortages and price variability of essential cytotoxic
medicines for treating children with cancers. WHO Technical Report Series, 1021, 1-50.

2. Kariuki, J., & Waiganjo, E. (2017). Determinants of effective drugs inventory management in
public health institutions: A case of Kenyatta National Hospital. International Journal of
Supply Chain and Logistics, 1(1), 1-15.

3. Mwangi, J., & Ngugi, P. (2018). Factors influencing inventory management performance in
public hospitals: A case of Defence Forces Memorial Hospital. Journal of Procurement &
Supply Chain, 2(1), 1-10.

4. Nyaberi, D., & Okibo, W. (2019). Vendor Managed Inventory (VMI) as a strategy for
mitigating drug stock-outs in public healthcare facilities in Kenya. International Journal
of Healthcare Management, 12(3), 234-241.
https://doi.org/10.1080/20479700.2018.1503867

5. Omondi, L., & Atieno, M. (2020). Impact of drug stock-outs on patient outcomes in rural
Western Kenya: A case study of pediatric oncology care. Journal of Health Systems and
Policy, 8(2), 45-58.

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