|Ahead of print publication
Impact of educational interventions on utilization patterns of anticancer agents in patients with breast cancer at the specialty oncology care setting in South India
Aakanksha Sharma, Himanshu Patel, Gurumurthy Parthasarathi
Department of Pharmacy Practice, JSS College of Pharmacy, JSS Academy of Higher Education and Research, Mysore, Karnataka, India
|Date of Submission||08-Jan-2020|
|Date of Decision||07-Apr-2020|
|Date of Acceptance||18-Apr-2020|
|Date of Web Publication||09-Dec-2020|
Department of Pharmacy Practice, JSS College of Pharmacy, JSS Academy of Higher Education and Research, Mysore - 570015, Karnataka
Source of Support: None, Conflict of Interest: None
| Abstract|| |
Aims/Objectives: This study was conducted to assess the utilization patterns of anticancer agents in patients with breast cancer and to provide practice recommendations/educational interventions to optimize medication use in patients with breast cancer.
Materials and Methods: This was an ambispective study conducted for a period of 3 years at a private, specialty oncology care hospital in South India. In the initial phase, the selection of anticancer agents, dosage of anticancer agents, and management of chemotherapy-induced nausea and vomiting (CINV) were reviewed retrospectively (using paper medical records) with respect to the National Cancer Comprehensive Network guidelines. The administration of anticancer agents and anti-emetics were reviewed with respect to the hospital drug administration policies. The deviations from the standards were reported, and practice recommendations/educational interventions were developed. Treatment patterns were reevaluated prospectively after providing educational interventions. Descriptive statistics were used to report and compare the results from both phases.
Results: During retrospective phase, we observed 80% compliance in the selection of anticancer drugs, 74% compliance in drug dosing, and 63.5% compliance in the administration of anti-cancer agents. After the implementation of educational interventions, we observed 85% compliance in the selection of anticancer agents, 82.3% in their dosing, and 86.9% compliance in the administration of anticancer agents. For the management of CINV, we observed 75% compliance in the selection of drugs (vs. 53% during preintervention), 92% compliance in their dosing (vs. 90% during preintervention), 85.1% compliance in the administration of anti-emetics (vs. 50% during preintervention), and 80% compliance in the management of delayed CINV (vs. 60% during preintervention).
Conclusions: Treatment patterns of breast cancer were improved with respect to treatment standards after educational interventions to oncology care team.
Keywords: Breast cancer, chemotherapy-induced nausea and vomiting, drug utilization evaluation, practice recommendations, quality use of anticancer agents
|How to cite this URL:|
Sharma A, Patel H, Parthasarathi G. Impact of educational interventions on utilization patterns of anticancer agents in patients with breast cancer at the specialty oncology care setting in South India. Perspect Clin Res [Epub ahead of print] [cited 2021 Jul 31]. Available from: https://www.picronline.org/preprintarticle.asp?id=302577
| Introduction|| |
Cancer management has remained a challenge due to the complex nature of disease and high medical expenditure., Management strategies of cancer may vary based on different health-care settings and resources available for medical care in a respective practice setting (s). It depends on various factors such as availability of medication (s), affordability to patient, physicians' discretion and traditional practices, and most importantly, behavior of local patient population with respect to available treatments. Usually, most oncology physicians follow standard practice guidelines and recommendations (like National Comprehensive Cancer Network (NCCN), European Society For Medical Oncology, American Society of Clinical Oncology guidelines) developed based on available clinical evidences and expert opinions.,, However, in some settings, the feasibility to strictly adhere to evidence-based guidelines is beyond the control due to the factors such as limited financial resources, limited specificity of local patients to existing evidence (s), and shortage of qualified health-care professionals (HCPs) to deliver optimum cancer care. Despite of diversity in health-care practice and differences in management strategies, it is essential to periodically review the treatment patterns in respective setting (s) to understand the potential areas of improvements in patient care. This further guides a need for education and training of HCPs and to propose administrative changes in the health-care system.,
Breast cancer is the most common cancer reported in women in India and accounts for 14% of the new cancers diagnosed in Indian women., This study was conducted to understand the utilization patterns of anticancer agents in patients with breast cancer. We also aimed to provide practice recommendations/educational interventions to oncology treatment team to optimize the medication use in patients with breast cancer.
| Materials and Methods|| |
This was an ambispective study carried out over a period of 3 years.
The study site is oncology specialty hospital in South India (Mysore), having 86 beds for inpatients with specialized facilities of medical, radiation, and surgical oncology. It also has an ambulatory chemotherapy unit, with a capacity of 20 chairs/beds.
All breast cancer patients aged above 18 years treated in the hospital and prescribed with at least one anticancer agent were included in the study. Terminally ill breast cancer patients were excluded from the study.
The present study was conducted in four steps: (1) retrospective observational phase, (2) analysis of retrospective data and development of practice recommendations/educational interventions, (3) implementation of treatment recommendations/educational interventions, and (4) prospective observational phase. Ethics committee approval (candidate number-15PPM001, approval date: 29-April 2015) was obtained to conduct the study, and administrative approval was obtained to access the medical records [Figure 1].
|Figure 1: Process flow of drug utilization evaluation and implementation of practice recommendations/educational interventions|
Click here to view
Retrospective observational phase - relevant data collection form and informed consent form were designed. The aim of the study during this phase was to understand the utilization patterns of the anticancer agents and antiemetics in breast cancer patients with respect to the NCCN guidelines version 2015. It was carried out for a period of 6 months (May 2015-October 2015). Paper-based medical records for patients treated for breast cancer in past 1 year at the study site were reviewed.
Analysis of retrospective data and development of practice recommendations (November 2015-January 2016) - each patient record was reviewed by the research pharmacist for: (1) selection of anticancer agents (includes cancer chemotherapy, endocrine therapy, and anti-HER2 therapy as applicable), (2) dosing of selected agents, (3) administration technique/process, and (4) antiemetics prescribed specific to given chemotherapy agent (s), and administration of antiemetics. Selection of anticancer agents, dosing of these agents, and prescribed antiemetics was reviewed with respect to the NCCN guidelines version 2015. The administration of the anticancer agents and antiemetics was reviewed with respect to the “in house” (hospital) drug administration policies. Standards to review prescribing/utilization patterns were adapted in mutual consultation and agreement among the prescribers and research panel. The observations were compiled and presented to the research panel, including one medical oncologist, one radiation oncologist, two senior clinical pharmacists, nursing superintendent, and one research pharmacist. Based on observations from retrospective data, practice recommendations/educational interventions were developed considering local health-care system and hospital policies. Differences in opinion among the panel members were sorted out with discussions and mutual consensus method.
Implementation of treatment recommendations/educational interventions (February 2016-April 2016): the drafted recommendations were presented to the research panel for final review and further implementation at the study site. The draft was then presented to the Medical Superintendent of the hospital (radiation oncologist independent from the research panel) and hospital administration for approval and implementation of these recommendations. All the HCPs of the study hospital (oncology treatment team) involved in patient care were provided with a copy of the recommendations during the presentation for future ready reference. Recommendations/interventions specific to the nursing staff were presented again to the nurses in smaller groups in consultation with nursing superintendent to ensure that nurses understand the importance and need for the implementation of these recommendations/interventions.
Prospective observational phase: it was conducted for a period of 18 months (May 2016-October 2017). The objective of this phase was to study utilization patterns and to understand the compliance of the treatment patterns to standards after providing practice recommendations/educational interventions by research panel. In this phase, breast cancer patients were enrolled prospectively as per the study criteria after obtaining informed consent. Enrolled patients were followed, and utilization patterns were reviewed in the similar fashion as in the retrospective phase.
Analysis of results (completed in December 2017) - descriptive statistics was used to report results obtained from both, retrospective and prospective phases. Observations from both phases were reported as the percentage compliance among the total prescriptions reviewed, intended to understand extent of improvement/changes noted in the practice after educational interventions.
| Results|| |
A total of 400 medication orders from 100 different patients were reviewed. Majority of patients had the diagnosis of Stage 3 breast cancer (54%). A total of 34 patients had endocrine responsive tumors (ER positive: n = 18, PR positive: n = 16). A total of 6/100 patients were HER 2 positive. The demographic details of the study population are presented in [Table 1].
Utilization patterns with respect to standards
The most commonly prescribed therapy in the study population was anthracycline-based chemotherapy without radiation therapy (n = 53, 61%) followed by anthracycline-based chemotherapy with radiation therapy (n = 34, 39%). Most commonly used endocrine therapy was tamoxifen and anastrazole. The selection of cancer chemotherapy agents was well (80%) in compliance with standards. Selection of endocrine therapy was in compliant in 88.8% cases. Management of HER positive tumors was in compliance in only 16.6% cases. Furthermore, selection of antiemetics was compliant only in 53% cases. The dosing of anticancer agents and antiemetics were in compliance with standards in 74% cases and 90% cases, respectively. The administration of anticancer agents and antiemetics was in compliance (with respect to hospital drug administration policies) in 63.5% and 50% cases, respectively [Table 2]. [Table 3] provides the examples of some of the deviations from standards, and recommendations provided by research panel to optimize medication use.
|Table 2: Assessment of treatment patterns in study patients during retrospective and prospective phase|
Click here to view
|Table 3: Examples of deviations from treatment standards and practice recommendations/interventions provided by research panel|
Click here to view
A total of 725 medication orders were reviewed which corresponded to 91 patients. Majority of the patients were diagnosed in Stage 2 and 3 breast cancer (around 80%). A total of 36 patients had endocrine-positive tumors (ER positive: n = 21 and PR positive: n = 15). A total of 13/91 patients were HER 2 positive. The demographic details of the study population are given in [Table 1].
Utilization patterns with respect to standards
The most commonly prescribed cancer chemotherapy in the study population was anthracycline-based chemotherapy with radiation therapy (n = 53; 71%), followed by anthracycline-based chemotherapy without radiation therapy (n = 22; 29%). Most commonly used endocrine therapy was tamoxifen and anastrazole. The selection of cancer chemotherapy agents was well (85.1%) in compliance with standards. Selection of endocrine therapy was in compliance in 95.2% cases. Management of HER-positive tumors was in compliance in 50% cases. Furthermore, selection of antiemetics was compliant only in 75% cases. The dosing of anti-cancer agents and anti-emetics were in compliance with standards in 82.3% cases and 92% cases, respectively. Administration of anticancer agents and antiemetics was in compliance (with respect to hospital drug administration policies) in 86.9% and 85.1% cases, respectively [Table 2].
| Discussion|| |
Drug utilization studies in oncology practice have been useful to identify the areas of improvement related to use of chemotherapy, biologicals, and supportive care in cancer patients. These studies could be explored at institutional, regional, or at national level based on aims, anticipated benefits, and implications of the study. We aimed to review the usage of anticancer agents at institutional level to understand the usage pattern and to provide need based therapeutic and educational interventions to HCPs to optimize overall medication use in patients with breast cancer. We considered to follow NCCN guidelines as standards to compare our practice because physicians usually consider NCCN guidelines as primary reference for their clinical practice at the study site. However, the administration of drugs was reviewed with respect to hospital-drug administration policies to allow realistic comparison between standards and clinical practice.
During retrospective review, we observed that the selection of anticancer agents (including cancer chemotherapy and endocrine therapy) was fairly in compliance with standards. However, dosing of prescribed drugs and its administration were relatively less compliant with standards. The most common reason for noncompliance in dosing (anti-cancer drugs) was body-surface area of first cycle being used for dose calculations during all subsequent cycles. This was primarily due to physicians facing a high number of patient load which do not allow them to follow step-by-step approach to write medication orders for each patient. Moreover, paper-based medical records and drug orders in our practice setting further add workload to physicians. Administration of anticancer agents was not in compliant in some patients due to the administration errors such as excess dilution of drugs, faster infusion rates (than recommended in drug orders) due to patient pressure, and to accommodate more patients in a given time.
Usage pattern of antiemetics drew a serious attention during our review. We observed majority patients were prescribed suboptimal antiemetics regimen due to traditional prescribing, limited insurance coverage, and higher out of pocket expenses, mainly noticed in patients treated under the government schemes. In some cases, patient paying their medical expenses themselves had limited affordability and insurance coverage which ultimately did not provide flexibility to physicians for prescribing quality supportive care. Usually, the administration of antiemetics should be done at least 30-60 min before the administration of chemotherapy depending on oral or intravenous formulation used. We noticed many patients at study site were administered antiemetics 5-10 min before initiating chemotherapy which caused/increased risk of chemotherapy-induced nausea and vomiting (CINV). A multicentric cross-sectional study was conducted by Zeitoun AA to study an extent of inappropriateness of antiemetics for prophylaxis of CINV in patients receiving cancer chemotherapy in Lebanese hospitals. They reported that around 211 (42.8%) patients received inappropriate antiemetic regimen, and only 17 (6%) patients of those receiving appropriate regimen received the appropriate dose, and just 55 (19.5%) patients were treated for the appropriate duration. Thus, similar to our study, this study also showed areas for improvement in antiemetics use and suggested recommendations to minimize patient risk and optimize safe and effective CINV management. However, our study was interventional in nature and also studied an impact of practice recommendations provided by the study team. Management of HER-2-positive patients was not in compliant in many patients solely due to financial constraints. Many patients in low-to-middle income countries face similar challenges to have access to anti-HER 2 therapy for patients with HER-2-positive breast cancer.,
Observations reported during retrospective review informed the immediate need for educational interventions to HCPs, mainly nurses. Practice recommendations/educational interventions were proposed by research panel after considering several factors such as local health-care system, qualification and training of nurses, and patient load. Most nurses in our practice setting have not undergone specialized training to provide patient care in oncology setting. Hence, period training and education are highly recommended for nursing staff to ensure continued quality of their services. An interview-based ethnographic study conducted by LeBaron et al. had aimed to explore challenges encountered by nurses in India and offer recommendations to improve the delivery of oncology and palliative care. Major challenges reported by the study team were safety related to chemotherapy administration, workload and clerical responsibilities, patients who died on the wards, monitoring family attendants, lack of supplies, and lack of formal oncology training. Our study also echoes similar challenges informing a need of quality and structured oncology training of nurses. An interventional study by Patel H conducted at the specialty cancer hospital in South India reported most common medication-related problems in the oncology care setting in India, which noted higher administration errors by nurses due to shortage of skills and had recommended structured educational interventions for nurses. There is a great opportunity to work for nurses in coordination with pharmacists to optimize the medication use process. At the same time, there is a need to review nurse to patient ratio which is high in our practice. Nurses in our oncology setting are expected to deliver many additional patient care services (such as coordinate transition of care, support reimbursement, coordinates internal referral, and complete paper records), leading to high workload. A survey-based multicentric study was conducted by Ulas A to investigate unintentional medication errors and underlying factors during chemotherapy preparation and administration in academic cancer hospitals in Turkey by oncology nurses. They also reported a heavy workload (49.7%) and insufficient number of nursing staff (36.5%) as the most common reasons for higher medication and administration errors (50.5%).
The number of medication orders reviewed was relatively higher in prospective phase because it was longer in duration than retrospective phase, and hence, allowed patients' follow-up for more number of treatment cycles. After educational interventions were provided to HCPs, during prospective evaluation, we noticed compliance to dosing of anticancer agents and administration of drugs were relatively improved. With regard to the selection of antiemetics for prophylaxis and delayed prevention was greatly improved (by 32% and 20%, respectively). This improvement indicates that educational interventions provided by research team were well followed and had the impact on improving medication use pattern. We realized that interventions provided to nursing staff regarding safe and effective administration of anticancer agents and antiemetics helped to strengthen their medication handling practice. This study also highlighted need and importance of enhancing team work among physicians, nurses, and pharmacists to ensure the quality medication use process. This was a single-center study. Hence, the results cannot be generalized and may not be representative of all other cancer care settings in the region. As per our knowledge, we have captured all necessary data during retrospective review. However, if any information which was not documented on patient file will remain beyond the scope of study.
| Conclusions|| |
This study had emphasized on the great need for improvements in the administration of anticancer agents, and safe and effective use of antiemetics in the study population. Pattern of medication use improved after educational interventions by research team to HCPs involved in cancer care.
The authors would like to thank JSS Academy of Higher Education and Research, Mysore, India, for constant support and encouragement.
Financial support and sponsorship
This study was supported by JSS College of Pharmacy, Mysore, India.
Conflicts of interest
There are no conflicts of interest.
| References|| |
Peppercorn J. Financial toxicity and societal costs of cancer care: Distinct problems require distinct solutions. Oncologist 2017;22:123-5.
Lapeyre-Mestre M, Gary J, Machelard-Roumagnac M, Bonhomme C, Bugat R, Montastruc JL. Incidence and cost of adverse drug reactions in a French cancer institute. Eur J Clin Pharmacol 1997;53:19-22.
Langton JM, Drew AK, Mellish L, Olivier J, Ward RL, Pearson SA. The quality of web-based oncology guidelines and protocols: How do international sites stack up? Br J Cancer 2011;105:1166-72.
von Dincklage JJ, Ball D, Silvestri GA. A review of clinical practice guidelines for lung cancer. J Thorac Dis 2013;5 Suppl 5:S607-22.
Dittrich C, Kosty M, Jezdic S, Pyle D, Berardi R, Bergh J, et al
. ESMO/ASCO recommendations for a global curriculum in medical oncology edition 2016. ESMO Open 2016;1:e000097.
Ketkaew C, Kiatying-Angsulee N. Drug use evaluation of letrozole in breast cancer patients at regional cancer hospitals in Thailand. Asian Pac J Cancer Prev 2015;16:6055-9.
Zeitoun AA, Nassif JG. Evaluation of anti-emetic use in chemotherapy-induced nausea and vomiting in a third-world country (Lebanon). J Eval Clin Pract 2013;19:68-75.
Malvia S, Bagadi SA, Dubey US, Saxena S. Epidemiology of breast cancer in Indian women. Asia Pac J Clin Oncol 2017;13:289-95.
National Comprehensive Cancer Network. NCCN Clinical Practice Guidelines in Oncology- Anti-Emesis (Version 1.2015). Available from: http://www.nccn.org/patients
. [Last accessed on 2015 Jul 16].
El Saghir NS, Adebamowo CA, Anderson BO, Carlson RW, Bird PA, Corbex M, et al
. Breast cancer management in low resource countries (LRCs): Consensus statement from the breast health global initiative. Breast 2011;20 Suppl 2:S3-11.
Garrison LP Jr., Lubeck D, Lalla D, Paton V, Dueck A, Perez EA. Cost-effectiveness analysis of trastuzumab in the adjuvant setting for treatment of HER2-positive breast cancer. Cancer 2007;110:489-98.
LeBaron VT, Palat G, Sinha S, Chinta SK, Jamima BJB, Pilla UL, et al
. Recommendations to support nurses and improve the delivery of oncology and palliative care in India. Indian J Palliat Care 2017;23:188-98.
] [Full text]
Patel H, Gurumurthy P. Implementation of clinical pharmacy services in an academic oncology practice in India. Journal of Oncology Pharmacy Practice 2019;25:369-81.
Ulas A, Silay K, Akinci S, Dede DS, Akinci MB, Sendur MA, et al
. Medication errors in chemotherapy preparation and administration: A survey conducted among oncology nurses in Turkey. Asian Pac J Cancer Prev 2015;16:1699-705.
[Table 1], [Table 2], [Table 3]