Advanced prescription of injectable anticancer drugs: Safety assessment in a European Comprehensive Cancer Centre using the risk matrix approach.

AIMS: The purpose of this work was to assess failures in the advanced prescription of parenteral anticancer agents in an adult day oncology care unit with more than 100 patients per day. METHODS: An a priori descriptive analysis was carried out by using the risk matrix approach. After defining the scope in a multidisciplinary meeting, we determined at each step the failure modes (FMs), their effects (E) and their associated causes (C). A severity score (S) was assigned to all effects and a probability of occurrence (O) to all causes. These S and O indicators, were used to obtain a criticality index (CI) matrix. We assessed the risk control (RC) of each failure in order to define a residual criticality index (rCI) matrix. RESULTS: During risk analysis, 14 FMs were detected, and 61 scenarios were identified considering all possible effects and causes. Nine situations (15%) were highlighted with the maximum CI, 18 (30%) with a medium CI, and 34 (55%) with a negligible CI. Nevertheless, among all these critical situations, only three (5%) had an rCI to process (i.e., missed dose adjustment, multiple prescriptions and abnormal biology data); the others required monitoring only. Clinicians' and pharmacists' knowledge of these critical situations enables them to manage the associated risks. CONCLUSIONS: Advanced prescription of injectable anticancer drugs appears to be a safe practice for patients when combined with risk management. The major risks identified concerned missed dose adjustment, prescription duplication and lack of consideration for abnormal biology data.

Dose standardisation of anticancer drugs.

OBJECTIVE OF THE STUDY: Body size based dosing is often used for prescribing anticancer drugs. However the scientific and the clinical rationales of this historical method have recently been criticized. As a result, alternative dosing strategies have been suggested, as flat-fixed dosing regimens, but not implemented in routine practice. Dose standardisation is a first step in order to rationalise chemotherapy dose calculation. A new method, derived from dose-banding, was developed, taking into account prescription and economic criteria. SETTING: Feasibility and interest of this concept were studied in two French cancer centres Institut Curie and Hôpital Saint-Louis. MAIN OUTCOME MEASURES: The aim of our study was to assess dose standardisation of expensive anticancer drugs in objectives of quality and economy. METHOD: Nine candidate drugs were selected and standardized rounded doses (SRD) were proposed. To determine the specific standard doses of these two centres, two theoretical and practical methods were applied, and then, their results were compared. For each anticancer drug the objective was to fix SRD in order to cover all the doses most frequently prescribed. RESULTS: It has been possible to propose SRD for six of the nine drugs. These SRD have been implemented with the agreement of the medical staff. These doses are, whenever possible, rounded to the nearest vial size, or correspond to a combination of the different strength of the commercial drug. CONCLUSION: Our study shows that dose standardisation is a help to optimise the productivity and improve the organisation of the preparation unit.