|Year : 2020 | Volume
| Issue : 1 | Page : 67-73
Utilization evaluation of anti-cancer agents in patients with head and neck cancer in a South Indian specialty cancer hospital
Aakanksha Sharma, Gurumurthy Parthasarathi, Himanshu Patel
Department of Pharmacy Practice, JSS College of Pharmacy, JSS Academy of Higher Education and Research, Mysore, Karnataka, India
|Date of Submission||03-Sep-2019|
|Date of Decision||03-Oct-2019|
|Date of Acceptance||04-Oct-2019|
|Date of Web Publication||13-Jan-2020|
Dr. Gurumurthy Parthasarathi
Department of Pharmacy Practice, JSS College of Pharmacy, JSS Academy of Higher Education and Research, Mysore - 570 015, Karnataka
Source of Support: None, Conflict of Interest: None
BACKGROUND: This study was aimed to understand prescribing patterns of anti-cancer agents in patients with head and neck cancer, and to provide practice recommendations/educational interventions to optimize medication use in patients with head and neck cancer.
MATERIALS AND METHODS: This study was carried out in an oncology specialty hospital for 3 years. The retrospective data were collected for 6 months for head and neck cancer patients treated in a last one year, and the prescribing pattern was studied. The selection of anticancer drug(s), dosage of the anticancer drugs, and emesis management were reviewed with respect to the National Cancer Comprehensive Network guidelines, whereas the administration was reviewed with respect to the hospital policies. The deviations were observed, and practice recommendations were developed. Health care professionals (oncology treatment team) were updated/educated on these recommendations. This was followed by a prospective phase for 18 months wherein the prescribing pattern was reviewed in a similar manner as retrospective phase. Compliance to treatment standards was assessed in both phases and reviewed to study an impact of educational interventions provided.
RESULTS: One hundred and four retrospective prescriptions were reviewed and showed a compliance of 88% in selection of anticancer drug, 71% in its dosing, and 75% in its administration whereas antiemetics prescription showed 55% compliance in selection, 53% in dosing, and 88% in administration. Two hundred and eighty-eight prescriptions were reviewed prospectively and showed 92% compliance in selection of anticancer drug, 80% in its dosing, and 85% in its administration, whereas antiemetics prescription showed 87% compliance in selection, 75% in dosing, and 92% in administration.
CONCLUSION: This study demonstrated that practice recommendations provided by research panel, in form of educational interventions were useful in improving use of medications in study population. It was evident from relatively higher compliance rate to treatment standards after interventions.
Keywords: Cancer, drug utilization evaluation, head and neck cancer, National Cancer Comprehensive Network guidelines
|How to cite this article:|
Sharma A, Parthasarathi G, Patel H. Utilization evaluation of anti-cancer agents in patients with head and neck cancer in a South Indian specialty cancer hospital. Int J Health Allied Sci 2020;9:67-73
|How to cite this URL:|
Sharma A, Parthasarathi G, Patel H. Utilization evaluation of anti-cancer agents in patients with head and neck cancer in a South Indian specialty cancer hospital. Int J Health Allied Sci [serial online] 2020 [cited 2020 Jul 15];9:67-73. Available from: http://www.ijhas.in/text.asp?2020/9/1/67/275653
| Introduction|| |
Cancer is widely spreading in the modern-day world. According to the Global Cancer Observatory (GLOBOCAN 2018), a total of 17 million new cancer cases and 9.6 million deaths were reported worldwide, which included 8.8 million males (52%) and 8.2 million females (48%). The most common types of cancer were lung, breast, gastrointestinal, and prostate, and they accounted for almost 43% of the new cancer cases reported. The cancer prevalence in the developing countries is increasing at high rate. Literature suggests 57% of the newly detected cases in 2012 were reported from developing countries. India reported 2.25 million existing patients with 1.15 million newly diagnosed cases and 784,821 deaths in 2018.
The management of cancer is often a challenge due to various factors such as complexity of disease, complex treatment regimens, concurrent diseases, adverse reactions to anticancer agents, higher treatment costs and impaired quality of life. Management strategies of cancer vary based on difference in health-care settings and depending on various factors such as availability of medication(s), affordability to patient, physicians' clinical acumen, and traditional practices and behavior of local patient population with respect to available treatments. Usually, most oncology physicians follow practice guidelines and recommendations developed based on available clinical evidence (such as the National Comprehensive Cancer Network, European Society For Medical Oncology, and American Society of Clinical Oncology guidelines); however, in some settings, it may not be feasible to strictly adhere to evidence-based guidelines due to factors such as limited financial resources, limited specificity of local patients to exist evidence and shortage of qualified health-care professionals (HCPs) to deliver optimum cancer care. Despite diversity in health-care practice and differences in management strategies, it is essential to periodically review treatment patterns in a respective setting to understand the area of improvements in patient care.
Conventionally, drug utilization studies have been found useful in understanding treatment patterns which help to identify areas of improvement in practice, to identify the need of education and training of HCPs, and to propose administrative changes in health-care system. A study conducted in Thailand observed inappropriate use in breast cancer patients because of noncompliance with duration, menopausal status, and hormone receptor requirements. A study conducted to study prescribing patterns of antiemetics in patients receiving cancer chemotherapy, in a Lebanese hospital, showed 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. Such findings help to develop interventions and recommendations for HCPs with the aim to optimize medication use in oncology practice.
There are limited evidence published from India which describes the utilization evaluation of anticancer agents in the local population. Head and neck cancer is one of the most commonly prevailing cancers in India and accounts for approximately 30% of the total cancer cases. Furthermore, India accounts for one-third of the total head and neck cancer cases reported worldwide. Hence, the present study was aimed to understand drug utilization patterns in head and neck cancer patients.
Aim of the study
This study was conducted to understand the prescribing pattern of cancer chemotherapeutic agents in patients with head and neck cancers and to provide recommendations/educational interventions to optimize/rationalize medication use in head and neck cancer therapy.
| Materials and Methods|| |
The ethics approval was obtained from the Institutional Ethical Committee, JSS Medical College, Mysore. Additionally, an administrative approval was obtained from a concerned authority to conduct study at specialty cancer hospital.
The study hospital has the in-patient facility of 86 beds with medical, surgical, and radiation oncology units. It has a dedicated daycare chemotherapy center with 20 beds/chairs.
Study population and criteria
The sample size was decided by nonprobability convenience sampling technique so as to attain the maximum possible sample size.
The study population comprised of all the head and neck cancer patients aged above 18 years irrespective of gender and treated with at least one anti-cancer agent.
This study was ambispective in nature and was conducted for 24 months. The study was conducted in the following phases: (1) Phase 1 – retrospective observations,(2) Phase 2 – analysis of retrospective data and development of practice recommendations, (3) implementation of recommendations, and (4) prospective observations. Process flow adapted for this study is provided in [Figure 1].
|Figure 1: The process flow of drug utilization evaluation and implementation of interventions|
Click here to view
Phase 1: Retrospective observations
It was aimed to study the prescribing pattern of anticancer agents to understand if changes in practice are essential to optimize medication use in the study population. Paper-based medical records were reviewed for 6 months to collect data of patients treated from the past 1 year at the study site. Each patient's medical record was reviewed by research pharmacist for the following criteria: (1) selection of anticancer drug/s, (2) dosing of selected drug/s, (3) administration technique/process, and (4) antiemetics prescribed specifically to given chemotherapy agent. The selection of chemotherapy drugs, its dosing, and prescribed antiemetics were reviewed with respect to the National Comprehensive Cancer Network (NCCN) guidelines version 2015. Administration of anti-cancer agents was reviewed with respect to “in house” drug administration policies of the study site. Standards to review prescribing patterns were adapted in mutual consultation and agreement among the prescribers and research panel.
Phase 2: Analysis of retrospective data and development of treatment recommendations
The study findings were compiled and presented before the research panel. Research panel included one medical oncologist, one radiation oncologist, two senior clinical pharmacists, nursing superintendent, and one research pharmacist. The data were analyzed for appropriateness in prescribing with respect to selection, dosing, and administration of anticancer medications and antiemetics. A draft of practicing recommendations was prepared by analysis of the data obtained from the retrospective study and information from different other sources taking into consideration the local factors. Differences in opinion among the panel members were sorted out with discussion and mutual consensus.
Phase 3: Implementation of treatment recommendations
The draft guidelines were presented among panel members for the final review and were accepted for implementation. Medical superintendent (radiation oncologist independent from the research panel), nursing superintendent, and hospital administration had approved the implementation of these recommendations. All the HCPs of the study hospital involved in patient care were provided with a copy of the recommendations during the presentation for ready future reference. Recommendations specific to the nursing staff were presented again to the nurses in small groups in consultation with nursing superintendent to ensure that nurses understand the importance and need for the implementation of these recommendations.
Phase 4: Prospective observations
It was conducted for 18 months to understand compliance to developed practicing recommendations. All the newly diagnosed head and neck cancer patients were enrolled as per the study criteria. Enrolled patients were followed throughout treatment, and their prescribing patterns were reviewed for the same criteria as in retrospective phase.
Analysis of results
Descriptive statistics were used to report results obtained from both retrospective and prospective phases. Observations from both phases were presented as the percentage compliance amongst the total prescriptions reviewed to understand the extent of improvement/changes noted in the practice.
| Results|| |
A total of 104 prescriptions corresponding to 68 patients were reviewed. It was observed that 72% of study populations were males and 28% were females. Smoking tobacco (cigarettes/beedies) was the major social habit seen amongst the enrolled population (67%). Majority of the patients had Stage IV disease (52%) and only one patient had Stage I disease (2%). The most common study patients were receiving cisplatin-based therapy concurrently with radiotherapy (n = 41, 60%); other regimens were cisplatin with or without 5-fluorouracil, taxane based and only one patient was prescribed gemcitabine. The demographic details of the patients enrolled for the study are presented in [Table 1].
It was observed that the selection of chemotherapeutic drugs was well in compliance with the standards (88%), whereas dosing of the anticancer agents was noncompliant in 29% of the total prescriptions reviewed (n = 92, 30, respectively). The administration of anticancer drugs was done as recommended in 75% of cases. It was noted that the selection of antiemetics and its dosing were in a compliant by only 55% and 53%, respectively, whereas the administration of the antiemetic was compliant in 88% of chemotherapy orders followed. The prophylactic treatment given for the management of delayed emesis was also compliant (60%) with the standard followed for the study [Table 2].
|Table 2: The evaluation of treatment patterns of study patients during retrospective and prospective phase|
Click here to view
Providing recommendations to oncology treatment team
Based on the findings of the retrospective data, research team developed recommendations/interventions to improve safe and effective use of anticancer agents. The developed recommendations were presented to the hospital management and the entire oncology treatment team. These interventions were also circulated as a handbook in the hospital as a readily available reference material so as to disseminate among the all health-care providers as reference and associated caretaking staff.
A total of 288 prescriptions corresponding to sixty patients were enrolled during this phase. The demographics of the enrolled patients are presented in [Table 1]. The majority of enrolled study patients were male (73%) and 27% were females. Smoking tobacco was the major social habit seen among the enrolled population (67%). Majority (60%) of the enrolled patients were in Stage IV disease. The most commonly followed treatment protocol was Cisplatin-based chemotherapy concurrent to radiotherapy (47%), other being Cisplatin with 5-Fluorouracil and Taxane-based regimen. [Table 2] compares compliance to treatment standards during both phases. [Table 3] provides examples of commonly observed noncompliance and interventions made to improve the practice.
|Table 3: Examples of observed deviations from the standards adopted for the study|
Click here to view
| Discussion|| |
The burden of cancer is increasing in India, which ultimately demands higher medical expenditure, standard oncology care facilities, and well-coordinated multidisciplinary patient care. Most Indian cancer patients do not have access to well-regulated and well-organized cancer care system. A diagnosis of cancer leads to catastrophic consequences on family due to either lack of personal health insurance or limited coverage of health insurance for cancer care. Benefits of government cancer schemes are available to limited patients, mainly those who are economically poor as defined by the Government of India.
Although the concept of multi-disciplinary care exists in many settings, it is still in evolving phase. Indian health-care system also faces challenges with regard to the shortage of qualified and trained HCPs such as nurses and pharmacists. Hence, the overall burden of cancer care remains on physician in most settings. The patient to oncology physicians' ratio also remains high. These factors may influence the overall quality of care provided to cancer patients, especially medication use.
According to the Indian Council of Medical Research, the National Cancer Registry Programme report released in 2001, 16.1% of all cancer cases in men and 10.4% in women are head and neck cancers in India., This trend is due to higher consumption of tobacco-based products. According to a case–control study conducted in 2008 by Jha et al., in India and a meta-analysis by Sinha et al., in 2014, smoking was a major contributing factor for increased mortality in cancer. We also observed that most of our study patients were also following habits such as chewing tobacco (paan, gutka), smoking (beedi, cigarettes), and alcohol which are known risk factors of head and neck cancers.,, Longer exposure to such risk factors increases the risk of disease; hence, it is likely that the onset of these cancers during middle age. There was a retrospective study published by Shenoi et al., in 2012, explaining the demographic and clinical profile of oral squamous cell carcinoma patients published in 2012 which concluded that head and neck cancer is more common in elderly patients. Our study also observed a similar observation with majority patients aged above 50 years.,
Drug utilization studies in oncology practice have been useful to identify areas of improvement related to use of chemotherapy, biological agents, and supportive care. These studies could be explored at institutional, regional, or at the 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 provide therapeutic and educational interventions to HCPs involved in cancer care. We considered NCCN guidelines as standards to compare our practice because physicians usually considered NCCN guidelines as a primary reference at the study site. However, the administration of medicines was reviewed with respect to hospital policies to allow realistic comparison between standards and clinical practice.
During retrospective review, we observed that the selection of anticancer agents was fairly in compliance with standards. However, dosing of prescribed drugs and its administration was relatively less compliant with standards. The most common reason for deviations in dosing was, body surface area of the first cycle being used for dose calculations during all subsequent cycles. According to a study in 2015 by Suhag et al., the oncologist to the patient ratio is 1:1600 in India compared to 1:100 in the United States. High patient burden does not provide physicians to follow step by step approach to prepare medication orders. The drug administration of anticancer agents was not compliant in some patients due to administration errors such as excess dilution of medicines, faster infusion rates (than recommended in medication orders) due to patient pressure, and to accommodate more patients in a given time. Major noncompliance was noted in the selection and administration of antiemetics. Majority patients were prescribed suboptimal antiemetics regimen due to limited insurance coverage and higher out of pocket expenses, mainly noticed in patients treated under government schemes. The administration of antiemetics should be done at least 30–60 min prior to the administration of chemotherapy depending on oral or intravenous formulation used. Many patients in the study were administered antiemetics 5–10 min prior to initiating chemotherapy which may not be effective in reducing the risk of chemotherapy-induced nausea and vomiting. An observational study by Zeitoun and Nassif in Lebanon in 2013, also reported that around 211 (42.8%) patients received inappropriate antiemetic regimen, and only 17 (6%) patients of those receiving appropriate regimen also received the appropriate dose, and just 55 (19.5%) patients were treated for the appropriate duration.
After educational interventions provided to HCPs, during prospective evaluation, we noticed compliance to dosing of anticancer agents and administration of drugs was relatively improved (85% compared to 75% in retrospective phase). With regard to the selection of antiemetics for prophylaxis and delayed prevention was greatly improved (32% and 20%, respectively). This improvement indicates that educational interventions provided by research team were well followed and had an impact on improving medication use pattern.
Most nurses in our practice settings have not undergone specialized training to provide patient care in oncology setting. Hence, periodic training and education are highly recommended for nursing staff to ensure continued quality of their services. LeBaron et al. published a study about challenges faced by nurses practicing in oncology and palliative care in a south Indian hospital in 2017 and recommended similar types of periodic training for nurses to improve patient care. There is a great opportunity to work for nurses in coordination with pharmacists to optimize medication use process. At the same time, there is a need to review nurse to patient ratio which is high in our practice (3:20). Nurses in oncology setting are expected to deliver many additional patient care services such as assistance in the reimbursement process, coordinating the patient's treatment payments, and discharge formalities, leading to high workload. A multicenter study by Ulas et al., in 2015, in academic cancer hospitals in Turkey among oncology nurses, also reported a heavy workload (49.7%) and inadequate number of nursing staff (36.5%) as the most common reasons for higher medication errors (50.5%). Physicians can be provided with additional therapeutic administrative support while dealing with high number of patients to prevent dosing errors. The clinical pharmacists can play an important role in such situations. They are specifically educated and trained in patient care settings. They can efficiently share the burden of the physician in instances of high patient volume by coordinating between the physicians, other health-care professionals, and the patients. They can contribute in obtaining the best possible outcomes from the prescribed medications by working along with the physicians, other HCPs by planning the treatment plan that caters to all the goals for patient care. In general, this drug utilization study raised clinically significant concerns and guided to strengthen medication use process. Further studies on reviewing treatment patterns of patients with other commonly seen cancers at study site can be useful to have a larger snapshot of qualitative utilization of medications at the study site. Further studies on the utilization of supportive care can be useful to propose further interventions to improve the use of supportive care and strengthen medication policies.
| Conclusion|| |
The selection of drugs was observed fairly in compliant with standard recommendations like NCCN guidelines. There was an opportunity to optimize the selection of antiemetics for prevention and delayed prophylaxis of chemotherapy-induced nausea and vomiting. However, there was a great need to improve the administration of anticancer agents and antiemetics. The pattern of medication use improved after educational interventions by research team to HCPs involved in cancer care.
Authors would like to thank JSS Academy of Higher Education and Research, Mysore, for constant support and encouragement.
Financial support and sponsorship
This study was supported by JSS College of Pharmacy, Mysore.
Conflicts of interest
There are no conflicts of interest.
| References|| |
Bray F, Ferlay J, Soerjomataram I, Siegel RL, Torre LA, Jemal A, et al.
Global cancer statistics 2018: GLOBOCAN estimates of incidence and mortality worldwide for 36 cancers in 185 countries. CA Cancer J Clin 2018;68:394-424.
Saini KS, Agarwal G, Jagannathan R, Metzger-Filho O, Saini ML, Mistry K, et al.
Challenges in launching multinational oncology clinical trials in India. South Asian J Cancer 2013;2:44-9.
] [Full text]
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.
Sankaranarayanan R, Ramadas K, Thomas G, Muwonge R, Thara S, Mathew B, et al.
Effect of screening on oral cancer mortality in Kerala, India: A cluster-randomised controlled trial. Lancet 2005;365:1927-33.
Coelho KR. Challenges of the oral cancer burden in India. J Cancer Epidemiol 2012;2012:1-17.
Sarnath D, Khanna A. Current status of cancer burden: global and Indian scenario. Bio Res J 2014;1:1-5.
Jha P, Jacob B, Gajalakshmi V, Gupta PC, Dhingra N, Kumar R, et al.
Anationally representative case-control study of smoking and death in India. N
Engl J Med 2008;358:1137-47.
Sinha DN, Palipudi KM, Gupta PC, Singhal S, Ramasundarahettige C, Jha P, et al.
Smokeless tobacco use: A meta-analysis of risk and attributable mortality estimates for India. Indian J Cancer 2014;51 Suppl 1:S73-7.
Shenoi R, Devrukhkar V, Chaudhuri, Sharma BK, Sapre SB, Chikhale A, et al.
Demographic and clinical profile of oral squamous cell carcinoma patients: A retrospective study. Indian J Cancer 2012;49:21-6.
] [Full text]
Suhag V, Bs S, Singh AK, Dashottar S, Semwal M, Singh S, Lohia N. The oncology scenario in India: Lots of gaps need to be bridged. Global J Med Res 2015;15:1-6.
LeBaron VT, Palat G, Sinha S, Chinta SK, Jamima BJ, 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]
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]