THERAPEUTIC AND ECONOMIC BENEFITS OF A CENTRALIZED UNIT FOR CYTOSTATIC DRUGS PROCESSING

THERAPEUTIC AND ECONOMIC BENEFITS OF A CENTRALIZED UNIT FOR CYTOSTATIC DRUGS PROCESSING

Artan Shkoza ^*1, Mirlinda Likmeta ², Enida Balla ² and Ledjan Malaj ³

Biomedical and Experimental Department ¹, Hospital Pharmacy ²,  Department of Pharmaceutical Technology and Bio-pharmacy ³, Faculty of Medicine, University of Medicine in Tirana, Albania

ABSTRACT: Cancer is a global problem. However, in low-income and developing countries, the expenditures associated with its treatment are increasing disproportionately with resources available. Hence, reducing the drug wastage and financial burden placed on patients, family and society in general is becoming imperative. Our aim was to calculate therapeutic and economic benefits derived by the use of a centralized unit, which allows residual amounts of unused drugs to be reused by patients whose treatments are elaborated in the same working day. We calculated in a comprehensive manner the number of spared vials (flasks) for seven drugs generated from residual amounts of the same working day and, its consequent therapeutic and/or economic benefits. We did not take into account prescribed drug dosages that fitted exactly with doses contained in a vial. Over a six month period, there were: a total of 1524. 07 saved vials with an approximate consequent therapeutic benefit of 123.57 patients and, considering the price of the centralized unit, a total economic benefit of approximately 134, 348 (€), for a total of 6558 prescriptions and a total of 1180 patients. The economic benefit represents 6.2 percent of the cytostatic drugs budget for 2015. Our analysis confirms that how a relatively simple policy of drug waste reduction, due to a centralized unit of cytostatic drugs processing, gives consequent therapeutic and economic benefits. The centralized unit increases also the drug traceability from preparation to patient

Therapeutic Benefit,

Economic Benefit,

Centralized Unit, Cytostatic Drug Processing, Drug Traceability.

INTRODUCTION: Current knowledge in the field of Medical Oncology is greater than ever before, but the number and cost of new anticancer drugs are higher than the available resources. This financial burden of cancer ¹ represents a moral as well as an economic challenge, especially in developing countries and emerging economies in which health care budget is limited ².

Furthermore, recent date demonstrates that the growing cost of cancer treatment will accelerate in the coming years due to the development of new, more expensive treatments ³, the ageing of the world’s population, the increased life expectancy by improvements in therapeutic outcome, and more effective diagnostic procedures.

The cost of one cycle of chemotherapy may range from 330 euro for doxorubicin 50 milligram (mg) to 13116 euro for trastuzumab 150 mg, both delivered every three weeks. Several strategies have been suggested to contain the increasing expenditures and improving efficiency, such as the use of generic and biosimilar molecules ⁴, the outpatient management of cancer patients, and optimizing treatment selection based on pharmacogenetics.

Some other strategies proposed to reduce cancer treatment expenditures using the rational application of personalized dose principle, dose rounding to the nearest vial size ^{5, 6}, dose standardization ⁷ of anticancer drugs and, selecting the most convenient vial size ⁸.

The Service of Oncology in University Hospital Centre “Mother Teresa” of Tirana is the only public health structure that offers multidisciplinary treatments for cancer patients in Albania.

Cancer is becoming a major priority for health policies in Albania for three major reasons: the increase of mortality and morbidity rates for a number of cancers, the delays in diagnosis and high costs of its treatment.

In this framework, a project of drug waste reduction was designed and launched at the end of 2014. The project aimed at: estimating the resulting therapeutic and economic benefit of reused leftovers of the same working day while respecting drug stability.

MATERIALS AND METHODS:

The material for the study of this topic has been collected, over a period of six months (October 2014 – April 2015), from Day Hospital and the Chemotherapy Ward of Oncology Department, in University Hospital Center "Mother Teresa", Tirana, Albania where data like patient generalities, record number, diagnosis and chemotherapy regimens can be found. In order to protect the patient’s privacy the patient’s name has not been shown. As a study material, charts and medical prescriptions of seven drugs selected by us were used (Table1).

TABLE 1: LIST OF DRUGS INCLUDED IN THE STUDY

The Hospital Pharmacy calculated the number of different vials needed to prepare the prescribed dose if vials are shared by patients whose treatments are elaborated in the same working day. Knowing most commonly used dosage of each drug, we converted the number of spared vials in  approximate number of new patients that would be included in the treatment plan (therapeutic benefit) or its consequent economic benefit for other scenario. Below we show a calculation sample for doxorubicine (Table 2).

TABLE 2: SIX MONTH THERAPEUTIC AND/OR ECONOMIC BENEFIT EVALUATION FOR DOXORUBICINE

In Table 3 we are representing the number of patients, number of vials spared and consequent therapeutic and/or economic benefits for each drug selected over a six months period.

TABLE 3: THE FINAL RESULTS

RESULTS: During the study period, vial consumption data were obtained, number of saved vials (flasks) for each drug and, the consequent therapeutic and/or economic benefits are also indicated using the Doxorubicine sample calculations. The total number of saved vials were 1524.07, which means that the total number of new patients who might be included in treatment plan (therapeutic benefit) was, approximately 123.57. The total savings for seven drugs were 134,348 (€), which represents 6.2 percent of the cytostatic drugs budget for 2015.

DISCUSSION: Our Department of Medical Oncology is a research-oriented academic unit with an admission capacity around 3.500 new patients every year. The Facilities include a ten-bed day-hospital service and a forty-bed- ward. On September 2014 we installed a reconstitution unit for the preparation of intravenous cytotoxic drugs, but the pharmacy is not yet equipped with a computerized physician order entry (CPOE) system.

Before the installation of the centralized unit, the prescriptions of the chemotherapeutic agents were written in mg/kg/m² and number of vials correspondent to the dose needed, respectively in patient’s record and pharmacist’s chart. The remaining residual amounts of each vials were disposed immediately, causing a significant economic loss. On the other hand, the patient or his/her family members followed a path of taking the vials in the pharmacy room according to the physician prescription and following the pharmacist’s orders. The dosage administration took place in the chemotherapy ward, day hospital or in an outpatient settings. Drug traceability was unfavorable in the last option.

It has been previously demonstrated that inefficiency of drug waste minimization may produce a considerable economic loss, though experiences are limited and most studies are dated or focused on other therapeutic areas ^{9, 10, 11}.

The results of our research have confirmed that the use of the residual amounts of the vials while the drug remains stable decreases drug loss and represents a considerable reduction in cancer treatment budget ¹². Therefore, a change in the management process would minimize the overall health expenditure without adversely impacting patient's health outcomes. This is one of the biggest future challenges of health care systems in the current economic environment.

The leftover amount of the used drug depends on the number of patients attended, anthropometric characteristics, the time between patients who receive the same drug and the marketed vials.

In our study, results imply an overall cost savings for seven drugs around 6.2% of the cytostatic drugs budget, almost approximate with those previously described, who estimated potential savings around 7% and 15%. These findings demonstrate that this practice is economically advantageous, especially in large hospital centers. However, this process could be hindered because of the available drug stock in the hospital pharmacy, treatment delays due to adverse effects and the fact that in some patients  a delay in treatment could adversely affect the outcomes.

Finally, we think that after the installation of the centralized unit, new working habits have been developed. The benefits of this change in paradigms into cooperation could be defined as a combination of reaching the goal of giving the right drug, with the right dosage, to the right patient, at the right time, at a more cost-efficient level.

CONCLUSION: Our experience confirms how a relatively simple policy of drug loss reduction due to a centralized unit of cytostatic drugs processing, gives consequent therapeutic and economic benefits, especially when used in large centers. The centralized unit also increases the drug traceability from preparation to patient. We recommend to extend this approach toward Pediatric Onco-Haematologic Service and to initiate a centralization project at least in three other national urban centers.

REFERENCES:

1. Ferlay J, Shin HR, Bray F, Forman D, Mathers C, Parkin DM: Estimates of world- wide burden of cancer in 2008: GLOBOCAN 2008. Int J Cancer 2010; 127(12):2893-917.
2. Lopes Gde L Jr, de Souza JA, Barrios C: Access to cancer medication in low and middle-income countries. Nat Rev Clin Oncol, 2013, 10:22-314.

3. Khayat D: Innovative cancer therapies: putting cost into context. Cancer 2012, 118:2367-2371.
4. Renner L, Nkansah FA, Dodoo AN: The role of generic medicines and biosimilars in oncology in low-income countries. Ann Oncol, 2013, 24 (Suppl 5): v29-v32.
5. Field K: Dose rounding of chemotherapy in colorectal cancer: an analisys of clinicians attitudes and the potential impact on treatment costs. Asia Pac J Clin Oncol 2010, 6: 203-209.
6. Winger BJ, Clements EA, DeYounge JL, et al: Costs saving from dose rounding of biological anticancer agents in adults. J Oncol Pharm Practice 2010, 17:246-251.
7. Poulquen AL, Escalup L, Jourdan N, Cottu P, Faure P, Madelaine-Chambrin I: Dose standardisation of anticancer drugs. Int J Clin Pharm 2011; 33 (2):221-8.
8. Clark L, Castro AP, Fortes AF, Santos F, Clark O, Engel T, et al.: Ideal vial size for bortezomib: real-world data on waste and cost reduction in treatment of multiple myeloma in Brazil. Value Health 2011; 5 (Suppl).
9. Fasola, G. et al. Drug waste minimization as an effective strategy of cost-containment in Oncology. BMC Health Serv. Res. 2014; 14,
10. Hyeda A, Da Costa E: A preliminary analysis of the reduction of chemotherapy waste in the treatment of cancer with centralization of drug preparation. Rev Assoc Med Bras, 2015; 61 (4): 368-374.
11. Rowe, E. C. et al. Economic and Microbiologic Evaluation of Single-Dose Vial Extension for Hazardous Drugs. Oncol. Pract. 2012, 8, e45–e49.
12. Sanchez-Rubio, F. et al. Reduction of cancer expenditures by diminishing drug wastage. Revista de la O.F.I.L. 2013, 23, 4: 145–151.
    

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    How to cite this article:

    Shkoza A, Likmeta M, Balla E and Malaj L: Therapeutic and Economic Benefits of a Centralized Unit for Cytostatic Drugs Processing. Int J Pharm Sci Res 2016; 7(3): 1039-42.doi: 10.13040/IJPSR.0975-8232.7(3).1039-42.

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