|Year : 2019 | Volume
| Issue : 2 | Page : 99-100
“Financial audit of wastage of anticancer drugs: Pilot study from a tertiary care center of India”: A commentary
Fatih Safa Erenay1, Susan Horton2
1 Department of Management Sciences, University of Waterloo, Waterloo, Canada
2 School of Public Health and Health Systems, University of Waterloo, Waterloo, Canada
|Date of Web Publication||2-May-2019|
Fatih Safa Erenay
Department of Management Sciences, University of Waterloo, Waterloo
Source of Support: None, Conflict of Interest: None
|How to cite this article:|
Erenay FS, Horton S. “Financial audit of wastage of anticancer drugs: Pilot study from a tertiary care center of India”: A commentary. Indian J Cancer 2019;56:99-100
|How to cite this URL:|
Erenay FS, Horton S. “Financial audit of wastage of anticancer drugs: Pilot study from a tertiary care center of India”: A commentary. Indian J Cancer [serial online] 2019 [cited 2019 Aug 26];56:99-100. Available from: http://www.indianjcancer.com/text.asp?2019/56/2/99/257541
This article provides a discussion on the wastage of cancer drugs in one- or multidose vials from the hospital/public-health perspective and assesses the contribution of the article by D'Souza et al. to the existing literature. Worldwide cancer incidence is expected to reach 18.1 million new cases per year in 2018, leading to a fast-growing economic burden, for example, annual cancer care expenditure is estimated to reach $170–200 billion in the United States by 2020 assuming 2%–5% annual increase in costs. The high burden of cancer care may be mitigated by developing effective and cost-efficient cancer treatment plans, which are hindered by combined adverse effects of issues such as long drug approval processes, increasing cancer drug costs, drug shortages, and drug wastage., Cancer drug wastage is mainly caused by administering cancer drugs from vials containing larger amounts than required and not using (and thus disposing) the remaining portion of the vial before the beyond-use date. Although cancer drugs are stocked in various standard vial sizes, the prescribed drug amount is based on patient's body surface area (BSA), which varies significantly and may not match the available vial sizes. Cancer drug wastage may also result from several other causes including human errors (e.g., errors in dispensing or dosage/BSA calculations,), issues around drug supply chain (e.g., inadequate package sizes, suboptimal drug stock management), and unused drugs expired in stock or at houses (e.g., due to early treatment termination, changes in guidelines, poor demand prediction). The reported cancer drug wastage could be high depending on the drug type and institution setting, for example, the proportion of wasted carfilzomib (Kyprolis) in 2012 is estimated as 33% based on 2016 US values.
Cancer drug wastage may have several adverse effects including increasing the spending on cancer drugs and increasing the overall burden of cancer care. It may even potentially reduce the availability of cancer drugs and delay treatments in settings such as pediatric cancer drugs in low-income countries, where cancer drug availability is already low due to low volume and long drug stock replenishment times. For instance, Cancer Care Ontario reported that drug wastage due to expiration of beyond-use date of the remaining doses in single-dose vials may result in $13–26 million additional cost per year in Ontario, Canada, while a study on 17 cancer drugs reported that drug wastage may increase the cost per life-year saved by 24% on average. Cancer drug wastage can be significantly reduced by various mitigation approaches such as vial sharing (e.g., using a single vial to cover the doses of two or more patients),, dose rounding (reducing the dose to the lower margins in the prescription to prevent opening a new vial),, keeping cancer drugs in optimal/smaller size vials,,, and batch drug administration (i.e., patient pooling)., Bach et al. estimated that vial sharing and including smaller size vials in the cancer drug stocks may decrease the amount of wasted drugs by 75%.
The literature on cancer drug wastage has been growing especially in the last decade; however, it is not yet extensive enough to address all the controversies around the best practice for mitigating the wastage. Most studies focus on quantifying cancer drug wastage and their economic impacts for particular cancer drugs as well as assessing the benefits of selected wastage mitigation approaches. However, most of these studies use hypothetical approaches to estimate wastage rather than using real data, due to lack of records on actual wastage amounts., As a result, the marginal effects of different sources of drug wastage on the cumulative wastage rate are unknown. In addition, most studies only measure the benefits of one (at most two) mitigation approaches in reducing cancer drug wastage. Thus, the following questions are yet to be answered: (i) In what combination should the mitigation techniques be applied given the considered region/institution settings; (ii) What should be the specifications of each approach (e.g., what size of smaller vials should be made available, how batch drug administration sessions should be scheduled, or which patients should be matched for vial sharing); and (iii) How much may these cumulative mitigation efforts reduce wastage? In addition, existing studies do not consider the effects of future changes in healthcare delivery, such as recent updates in sterilization guidelines and the move toward personalized cancer treatment, which may increase cancer drug wastage. Moreover, there is limited research on cancer drug wastage in developing countries, where the dynamics of the wastage process and mitigation approaches may be different; for example, issues including restrictions on budget and drug variety, and reliance on out-of-pocket payment may need to be incorporated into the analyses. Furthermore, although mitigating cancer drug wastage, either in vial or solid form (i.e., oral drugs that entail different mitigation mechanisms such as redistribution of unused drugs), requires involvement of several stakeholders in medical supply and service chain including manufacturers, oncologists, pharmacists, and patients. This multistake holder perspective is considered in only a few studies.,
In this context, a recent article titled as “Financial audit of wastage of anticancer drugs: Pilot study from a tertiary care centre of India” is noteworthy. This study estimates the wastage proportions and their economic impacts for 22 cytotoxic cancer drugs using records from a tertiary care clinic in India. The work is important because they track down the actual wastage amounts rather than hypothetically calculated values and provide a new developing country perspective as this is the first study analyzing cancer drug wastage in India. The study estimates the average drug wastage as 6% (with a range of 0%–30% based on drug type), which specifies the room for improvement for wastage mitigation efforts. Mitigation of cancer drug wastage is especially important in India where many patients self-finance their cancer care; thus, wastage mitigation focusing on critical drugs may directly increase accessibility to care. The article has several striking results. First, their results imply that the cost associated with wasted drugs is dominated by the five most expensive drugs. Second, the drugs with various dose denominators (e.g., vial sizes) and those that can be used for variety of cancers (e.g., paclitaxel) have lower wastage. On the other hand, drugs that are not commonly used (e.g., those for treating a particular cancer at specific stages and conditions) are associated with higher wastage proportions. These findings imply that the efforts for wastage mitigation (e.g., encouraging/matching patients for vial sharing, batch-scheduled drug administration, using closed-system drug-transfer devices to extend the current beyond-use date), may focus on (i) high-cost and less commonly used drugs (e.g., trastuzumab) to reduce cost of wastage and (ii) commonly used drugs with fewer dose denominators to reduce the total amount of drugs wasted and the risk of drug shortage. Finally, the study showed that the drugs associated with the highest wastage proportions or wastage costs in India may not match to those from Western countries such as the United States, Italy, and Japan,,, which implies that recommendations on mitigation of cancer drug wastage should be tailored for developing countries.
More detailed insights could be drawn from the article, if the available dose denominators for each drug and the contributions of different causes of drug wastage into the cumulative wastage rates were specified. Hopefully, a follow-up of this pilot study would clarify these details and may take other relevant cost components (e.g., cost of disposing wasted drugs) into account for a more realistic analysis. In addition, the overall proportion of wasted drugs (i.e., 6%) reported in the article is lower than those in the literature (e.g., 10% wastage in Bach et al.). This may imply that particular wastage mitigation techniques may already be applied in this particular health institution. Reporting these mitigation measures would help better interpret the results. In addition, the last table in the article indicates that standard deviations of the wastage costs are higher than their means for almost all drug types, possibly due to varying BSA in the patient cohort and small sample size. Therefore, we advise caution when interpreting these results and hope that a follow-up study may validate the reliability of the estimations in the current article. Although the mitigation techniques suggested by the authors in the discussion section sound reasonable given the results summarized above, increasing vial size options for each drug may further complicate the inventory system and may increase associated costs in the short term. Thus, introducing additional vial size option may require more efficient drug stock management.
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