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ORIGINAL ARTICLE
Year : 2019  |  Volume : 56  |  Issue : 2  |  Page : 146-150
 

Financial audit of wastage of anticancer drugs: Pilot study from a tertiary care center in India


1 Department of Pharmacology, Mangalore Institute of Oncology, Mangalore, Karnataka, India
2 Department of Father Muller Medical College Hospital, Mangalore Institute of Oncology, Mangalore, Karnataka, India
3 Department of Radiation Oncology, Mangalore Institute of Oncology, Mangalore, Karnataka, India
4 Father Muller Research Centre, Mangalore Institute of Oncology, Mangalore, Karnataka, India

Date of Web Publication2-May-2019

Correspondence Address:
Manjeshwar Shrinath Baliga
Father Muller Research Centre, Mangalore Institute of Oncology, Mangalore, Karnataka
India
Princy Louis Palatty
Department of Pharmacology, Mangalore Institute of Oncology, Mangalore, Karnataka
India
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Source of Support: None, Conflict of Interest: None


DOI: 10.4103/ijc.IJC_169_18

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 » Abstract 


PURPOSE: Drug wastage is a major concern in oncology where costs of antineoplastic drugs are exorbitant, and the disposal of toxic drugs increases the chances of occupational hazards to healthcare and sanitary workers and environmental pollution at the site of disposal. The principal objective of this study was to ascertain the extent of drug wastage and calculate its financial costs.
MATERIALS AND METHODS: This was a prospective pilot study conducted to ascertain the quantity of drug wastage in a tertiary care hospital. This pilot study was conducted in day care and inpatient facilities in February 2016. The prescription of cytotoxic drugs, recommended dose, the quantity used, and remainder (waste) left were recorded from the nurses and pharmacy files of the hospital. Cost evaluation of the actual use and the waste was undertaken and an audit was conducted to understand in which anticancer drug the maximum wastage was generated.
RESULTS: The results of this study indicated that 6.1% of the total amount of reconstituted drugs was wasted. The highest drug wastage was observed in trastuzumab (29.55%), followed by etoposide (20.4%), dacarbazine (17.14%), daunorubicin (16.67%), and carboplatin (11.29%). Cost analysis showed that the total cost of the drug issued during the study period was Rs. 1,294,975 and the cost of drug wastage amounted to Rs. 143,820 (11.1%).
CONCLUSION: To the best of authors' knowledge, this is the first study from India and the results indicate that the financial impact of anticancer drug wastage was substantial. Attempts should be directed at minimizing the wastage and cost savings without risking patients' treatment regimen and administering effective dose schedule.


Keywords: Anticancer, antineoplastic drugs, reconstitution, wastage


How to cite this article:
D'Souza VR, Palatty PL, George T, Adnan M, Rao S, Baliga MS. Financial audit of wastage of anticancer drugs: Pilot study from a tertiary care center in India. Indian J Cancer 2019;56:146-50

How to cite this URL:
D'Souza VR, Palatty PL, George T, Adnan M, Rao S, Baliga MS. Financial audit of wastage of anticancer drugs: Pilot study from a tertiary care center in India. Indian J Cancer [serial online] 2019 [cited 2019 May 25];56:146-50. Available from: http://www.indianjcancer.com/text.asp?2019/56/2/146/257544





 » Introduction Top


Global data indicate that cancer is the second leading cause of death and caused 8.8 million deaths in 2015.[1] The most disturbing aspect of cancer is that, in addition to significant mortality, the treatment is extremely expensive and significantly affects the patients and their family's savings/earnings.[2] Projections are that the incidence of cancer is going to increase and that by 2020 the cost would reach 173 billion dollars.[3] Depending on the cancer stage and general health condition of the patient, surgery, chemotherapy, and radiotherapy are used, either as a single modality or in combination to achieve the possible cure and/or control of tumor growth.[4]

Cancer chemotherapy is one of the major therapeutic approaches to combat cancer.[4] It is the main treatment of choice for some cancers and is used in low doses along with radiation (chemoradiation) to achieve optimal radiation cell kill and possible complete tumor remission. Chemotherapy is also useful in reducing the size of tumors before surgery and is termed as neoadjuvant treatment.[4] From a therapeutic view point, anticancer drugs are known to have “double effect” because their optimal pharmacological activity is in a very small range.[4] When administered at lower concentrations than required, the tumor cell kill will be below optimal, while at doses above the optimal range, it can cause severe toxic effects and may even lead to death. Considering this conscious efforts are always in delivering the correct amount of drug while preventing the cytotoxic effects on normal cells.[5] Conventionally, treatment plan and the drug/s to be administered are decided by the medical oncologist, and the regimen consists of more than one cycle with repeats after a stipulated time gap.[4]

From a toxicological perspective, chemotherapy drugs are highly toxic and are always prepared using stringent guidelines by well-trained nurses/pharmacist adopting safety precautions.[4],[5] The dose to be administered is decided by the oncologist and is based on the type of cancer, stage, recommended treatment protocol, weight or body surface area of the patient, age, comorbidities and general health, and hematological, cardiac, pulmonary, liver, and renal function status of the patient.[4],[5],[6] When considering these aspects, it is observed that chemotherapy dose is not fixed and may vary among patients using the same protocol for the treatment of the same cancer.[4],[5],[6]

Cancer drugs are marketed in standard vials and may be available in multiple- or single-quantity designate depending on the company manufacturing them. As final usage of the drug depends on the patient's weight and physician's prescription, in some cases, part of the drug ends up being discarded. Cancer chemotherapy drugs are expensive, and when considered from an economic perspective, the value lost as waste is high. Handful studies around the world[6–9] have addressed the issue on drug wastage in cancer chemotherapy. However, a detailed literature study using the key terms “drug wastage” and “cancer” using Google Scholar and PubMed search engines indicates that there have been no studies from India on this aspect. In lieu of all these observations, this study was conducted to ascertain the proportion of drug wastage and its cost at a tertiary care hospital in India.


 » Materials and Methods Top


This was a prospective, observational pilot study carried out in medical oncology wards and day care center of Father Muller Medical College Hospital, Mangalore. The objective of this study was to assess the quantity of drugs issued to the patient, their actual consumption, and wastage for each drug. As this study did not focus on the nature of the illness or require any patient details/or medical information, a waiver of consent was obtained from IEC. Data were collected from oncology wards and day care unit over a 1-month period (February 2016) during normal daily sessions from Monday to Saturday (Sunday was a weekly day off for these units for maintenance and chemotherapy is not administered). The prescription of cytotoxic drugs, recommended dose, and actual consumption were recorded by the investigator with the help of nursing in-charge in their respective oncology units. Data were tabulated in a data record form and the wastage of drugs was estimated in percentages. Retail price of the drugs for the consumed brand was noted from the pharmacy inventory and cost evaluation was undertaken for the actual use and waste.


 » Results Top


A total of 120 cases were analyzed during the study period, 60 cases each from the wards and day care areas. There were 22 anticancer drugs used in the treatment in the medical oncology department. The waste proportion for all these drugs equalled 6.1% of the total amount of reconstituted drugs. The wastage of various drugs varied from 1.32% to 29.55% [Table 1] and [Figure 1]. Cost analysis revealed that the total cost of the drug issued during the study period was Rs. 1,294,975. Of this, drugs amounting to Rs. 143,820 (11.1%) were wasted. Among the six commonly used drugs in cancer chemotherapy, the prescribed drugs for the patients were Paclitax (paclitaxel), Posid (etoposide), Dabaz (dacarbazine), Kemocarb (carboplatin), Endoxan (cyclophosphamide), and Cisplat (Cisplatin) priced at Rs. 10,850, Rs. 220, Rs. 1030, Rs. 759, Rs. 75, and Rs. 126, respectively. Cost analysis revealed that the total cost of the drug issued during the study period was Rs. 1,294,975. Of this, drugs amounting to Rs. 143,820 (11.1%) were wasted [Table 2]. The cost of wastage of trastuzumab was the maximum, 29.5% (Rs. 110,795) [Figure 2]; [Table 2]. The details of other drugs are listed in [Table 2]. With respect to individual drugs, wastage was more with trastuzumab (29.55%), followed by etoposide (20.4%), dacarbazine (17.14%), daunorubicin (16.67%), and carboplatin (11.29%) [Table 1]. Paclitaxel was the most commonly used drug and wastage of 180 mg (2.52%) from a total of 7140 mg of the issued drug was noted. Cisplatin was administered in 39 patients and the wastage was 1.91%. With regard to other drugs, etoposide caused 20.4% and oxaliplatin 10% wastage. Analysis of average drug wastage with the type of neoplasia indicated that high leftovers were seen in breast cancer [Table 3].
Table 1: Details on the amount of waste generated in an oncology unit in a cancer centre

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Figure 1: Waste proportion of the chemotherapy drug (bleomycin, epirubicin, ifosfamide, irinotecan, rituximab no wastage)

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Table 2: Cost evaluation of Cancer chemotherapy drugs remained as waste in a cancer centre

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Figure 2: Proportion of the cost of five important leftover anticancer drug in this study

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Table 3: Average cost of left over drugs in the treatment of various cancers

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 » Discussion Top


Globally, in the current situation, treatment of cancer is costly and delivering affordable care is a challenge. The problem is especially of high magnitude in developing countries like India where patients are many, treatment facilities less, and resources scarce. In some cancers, medical costs of anticancer drugs and its administration make up more than half of the total economic costs and may also affect the psychosocial well-being of patients and their caregivers. What is of concern is that a part of the drug results as wastage in some cases due to patient-related factors and/or fixed drug vial size.

In our study, drug wastage among cancer chemotherapeutic agents was high and resulted in a substantial economic burden. A total of 6.1% of the reconstituted drugs ended as waste and cost analysis amounted to Rs. 143,820.36. Previous studies carried out in Italy,[6],[7] Japan,[8] and the United States[9] have shown that the impact of drug wastage is a major problem which affects the patient as they pay for it even when the drug is discarded. In a study conducted in Italy, cetuximab and oxaliplatin were found to be the most wasted, while in a Japanese audit, bevacizumab, bortezomib, and rituximab were predominant.[8] In our study, the highest wastage was observed for trastuzumab (29.55%) which amounted to Rs. 110,795. Being an inherently costly drug, the total financial loss was high and in agreement with a previous study.[6],[7] The study also showed that high leftover of drug was seen in breast cancer and this could possibly be due to the range of expensive drugs used in its management depending on the hormonal status and the stage of the cancer.

The most important observation in this study was that the wastage was the least in drugs that were available in multiple denominator quantities like that with paclitaxel (30, 100, 250, 260, 300 mg vials) and cisplatin (10 and 50 mg vials). However, from a financial perspective, when compared with other drugs, although wastage was less in paclitaxel (2.5%), the cost of the waste contributed to a financial loss of INR Rs. 10,910.97 [Table 2]. This is principally because paclitaxel is one of the high-end anticancer drugs with proven efficacy in diverse cancers. Greater wastage was observed in etoposide (20.4%) as it is available only in single strength and the leftover drug from the vial attributed to the maximum wastage. However, from a costloss perspective, financial calculations due to drug wastage were very minimal for etoposide [(5504 cost vs 1122.82 waste (20.4%)] and dacarbazine [cost 1555 vs waste 315 (20.3%)], as the costs of the drugs are comparatively less when compared with trastuzumab or paclitaxel [Table 2]. The other important observation was that oxaliplatin, a new generation platinum-based anticancer drug, caused 10% wastage [Table 1] and the economic loss was Rs. 9,001 [Table 2]. This finding is comparable to a previous study which reported a higher drug waste cost from oxaliplatin.[7]

In cancer, the problem of wastage is principally because the drugs are available in fixed quantities in vials, and once reconstituted they have to be used preferably within 6 h.[9],[10] The main issue here is that the denomination of the marketed drug is principally decided by pharmaceutical companies.[9],[10] The other issue is that healthcare professionals are apprehensive in reusing the reconstituted drug due to apprehensions that storing will lead to loss of drug stability/potency and increase the chances of microbial growth.[9] The most effective way of reducing the wastage would be to have multiple denomination vials of the drug so that an effective drug dose can easily be arrived at.[9],[10] To achieve this, pharmaceutical companies will have to manufacture multiple denominations. The other possibility is to use vial sharing options where a large vial of drug is shared by more than one patient appropriately as per the clinical requirements.[11],[12] The third is to develop and use multidose vials that retain a longer antimicrobial and chemical stability and can be possibly reused in other needy patients as a wastage reduction measure.[7],[8],[9]


 » Conclusion and Recommendation Top


The limitations of this study are the small sample size, short data collection period, and audit from a single center. But we also feel that the observation will be almost the same in all other hospitals in India as increasing the sample size may not have a significant bearing on the observations. On a positive note, the results indicate that wastage does occur in an oncology setup with anticancer drug. Attempts are underway in undertaking methods that will effectively reduce wastage. This is very important in developing countries like India, where the burden of cancer treatment is very high and every molecule of drug is precious. Drug wastage reduction and cost minimization strategies without compromising the quality of care and treatment should be a priority and adhered to by all centers.

Financial support and sponsorship

Nil.

Conflicts of interest

There are no conflicts of interest.



 
 » References Top

1.
WHO Cancer Fact Sheet. World Health Organization; 2017. Available from: http://www.who.int/news-room/fact-sheets/detail/cancer.  Back to cited text no. 1
    
2.
Reeder CE, Gordon D. Managing oncology costs. Am J Manag Care 2006;12:S3-16.  Back to cited text no. 2
    
3.
Mariotto AB, Yabroff KR, Shao Y, Feuer EJ, Brown ML. Projections of the cost of cancer care in the united states: 2010-2020. J Natl Cancer Inst 2011;103:117-28.  Back to cited text no. 3
    
4.
WHO | Cancer Diagnosis and Treatment. World Health Organization; 2017. Available from: http://www.who.int/cancer/treatment/en/.  Back to cited text no. 4
    
5.
Kakde D, Jain D, Shrivastava V, Kakde R, Patil AT. Cancer therapeutics-opportunities, challenges and advances in drug delivery. J Appl Pharm Sci 2011;1:1-10.  Back to cited text no. 5
    
6.
Fasola G, Aprile G, Marini L, Follador A, Mansutti M, Miscoria M, et al. Drug waste minimization as an effective strategy of cost-containment in oncology. BMC Health Serv Res 2014;14:57.  Back to cited text no. 6
    
7.
Fasola G, Aita M, Marini L, Follador A, Tosolini M, Mattioni L, et al. Drug waste minimisation and cost-containment in medical oncology: Two-year results of a feasibility study. BMC Health Serv Res 2008;8:70.  Back to cited text no. 7
    
8.
Usami E, Kimura M, Fukuoka T, Okada K, Yoshimura T. Economic loss of remaining contents in molecular target drug preparation and the simulation for cost saving. Gan To Kagaku Ryoho 2016;43:743-7.  Back to cited text no. 8
    
9.
Leung CY, Cheung MC, Charbonneau LF, Prica A, Ng P, Chan KKW, et al. Financial impact of cancer drug wastage and potential cost savings from mitigation strategies. J Oncol Pract 2017;13:e646-e652.  Back to cited text no. 9
    
10.
Bach PB, Conti RM, Muller RJ, Schnorr GC, Saltz LB. Overspending driven by oversized single dose vials of cancer drugs. BMJ 2016;352:i788.  Back to cited text no. 10
    
11.
Smith RS. A 2-year retrospective review of vial sharing options for the compounding of cytotoxics. Eur J Hosp Pharm 2015;22:161-4.  Back to cited text no. 11
    
12.
Ibrahim N. Impact of dose rounding of cancer therapy on cost avoidance: A pilot study. Farmeconomia Health Econ Ther Pathways 2013;14:169-72.  Back to cited text no. 12
    


    Figures

  [Figure 1], [Figure 2]
 
 
    Tables

  [Table 1], [Table 2], [Table 3]



 

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