Economic impact of the preparation of cytotoxics
Recent research in Belgium shows that careful planning of the preparation of cytotoxic injections and the avoidance of wastage can result in significant cost- savings with no loss of product integrity
Johan Vandenbroucke PharmD Central Pharmacy, Ghent University Hospital, Ghent, Belgium
When cost-savings are sought, inevitably questions arise about the way in which expensive medicines such as cytotoxic agents are prepared and whether more economical approaches might be possible. Cytotoxic injections need to be prepared in response to demand so that the doses can be tailored to individual requirements. However, when planning a cytotoxic reconstitution service a number of factors need to be taken into account. Some of the reconstituted products do not have long shelf lives. In some centres, good aseptic practice demands that vials and ampoules are not shared between patients. As a result of working within these constraints, there is often a significant amount of wastage of cytotoxic drugs.
Economical provision One approach to more economical provision of cytotoxic injections is dose-banding which is associated with quality and safety benefits and reduces wastage. An alternative approach might be to design a scheme that allows use of surplus reconstituted cytotoxic injections for other patients, instead of discarding these amounts. Clearly, this could only be done if the shelf lives of the reconstituted products are long enough, if the processes and equipment can guarantee sterility during the requisite period and if national laws and local guidelines permit such a procedure.
26 In defining the shelf-life/expiry time www.hospitalpharmacyeurope.com
Table 1: Scenarios and calculations Scenario
Scenario 1: Discard surplus after each individual preparation
Scenario 2: Discard the rest of the vial at the end of the day
Scenario 3: Use the vials until the expiry time of the product
The optimum number of vials needed to prepare each dose individually + transfer devices
The number of different vials needed to prepare the prescribed doses for all patients attending the oncology unit each day + transfer devices
The number of vials needed, based on the highest volume and/or concentration available on the market for the total period, paying attention to the time that the next preparation was required and the maximum time before expiry found in the literature + transfer devices. When the internal expiry date set by the department was shorter than the interval between two consecutive preparations of that product, the remaining volume of the vial was discarded and a new vial was used to starts the second preparation.
for a reconstituted cytotoxic injection the following factors must be taken into account: ● The shelf life/expiry time of the (reconstituted) drug regarding its physical and chemical properties.
● The internal procedures of the hospital and hospital pharmacy.
Box 1: Central pharmacy of Ghent University Hospital
The central pharmacy of Ghent University Hospital prepares approximately 28,500 cytotoxic doses per year in a centralised preparation unit. This unit is equipped with biological safety cabinets located in a controlled zone (which includes, for example, negative pressure, high efficiency particulate air (HEPA) filtered air and limited access). The unit and procedures comply with ISO 9001 of the International Organisation or Standardisation as part of the hospital pharmacy certification.
● The level of safety/quality assurance for the sterility of the product because of the ‘hardware’ such as the location, equipment, air quality of the clean room and use of special devices.
● The level of safety/quality assurance for the sterility of the product because of the ‘software’ such as the training, education and skills of personnel.
● National laws or guidelines. Given that cytotoxic doses are individually tailored, on many occasions there will be a quantity of surplus material in the vial after the dose has been prepared. The pharmacist then has three options: ● Discard the rest of the vial after each individual preparation.
● Discard the rest of the vial at the end of the day.
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