Background and Importance Various clinical trials, especially in oncology and haematology, involve chemiotherapic drugs compounding. These preparations require standard working procedures for which hospital pharmacist is responsible. Oncological drugs used in clinical trials are characterised by: low therapeutic index; unknown toxicity; dosage to be personalised on patient; assignment of number kit/placebo to specific patient; associations with other drugs not known in consolidated clinical practice. All these elements can contribute to the occurrence of potential errors.
Aim and Objectives The aim of this study is to used Hazard Vulnerability Analysis in order to classify, into high, medium, low risk, experimental protocols that provide for chemiotherapic drugs compounding and which are currently active our hospital. For protocols classified as high risk, standard procedures will be outlined to minimise risks.
Material and Methods In order to determine the percentage risk(R%), is calculated: probability(P) that an error will occur, by calculating the number of preparation-phases; magnitude(MA) by calculating carcinogenicity, storage time of preparation and chemical incompatibility between drugs and medical devices; mitigation(MI) by calculating drug dosage, chemical-physical preparation stability, possible use of safety-devices. By applying the formula R%=(P/3)*[(MA+MI)/18]*100, protocols are defined low-risk if R%<30%, moderate-risk if 30%≤R%≤60%, High-risk if R%>60%.
Results Among 35 active clinical-trials analysed, 18 require chemiotherapic drugs compounding. For 33%(6/18) of protocols the probability is low; 50%(9/18) is moderate; 17%(3/18) is high. For 44%(8/18) of protocols the magnitude is low; 50%(9/18) is moderate; 6%(1/18) is high. Finally, for 6%(1/18) of protocols the mitigation is low; 88%(16/18) is moderate; 6%(1/18) is high. By applying the formula to calculate percentage risk it was found that 5/18 protocols are low risk, 10/18 moderate risk, 3/18 high risk.
Conclusion and Relevance HVA provides a systematic approach to analysing hazards that may affect hospital service. Clinical protocols classified as ‘high risk’ have been monitored, and standard procedures have been outlined to minimise the risks (e.g. procedures for managing vial accidental breaking, cold chain control for prepared drugs, use of software to calculate drug dosage based on body surface). These procedures are aimed at all personnel involved in preparation phase, including the hospital pharmacist. Hospital pharmacist is coordinates whole process, deals with risk management and ensures personnel/patients safety.
Conflict of Interest No conflict of interest.
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