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Development of a new method for risk assessment related to management of clinical trials in hospital pharmacy: classification of protocols by risk index (ρ) and development of strategies for errors’ minimization

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European Statement

Patient Safety and Quality Assurance

Author(s)

Giulia CANCELLIERI, Piera POLIDORI

Why was it done?

Hospital pharmacist provides all management of investigational medical product(IMP), i.e. its conservation, distribution, return and destruction. However, each clinical trial involves different methods of managing the drug: this can mislead the pharmacist who has to manage multiple trials at the same time. With the aim of minimizing errors that may arise from the simultaneous management of different clinical trials, we have developed a method to classify clinical protocols by “risk index”.

What was done?

With the aim of minimizing errors resulting from management of clinical trials in hospital pharmacy, we have developed a method to classify experimental protocols into low-moderate-high risk(risk index). For each of these categories, standard procedures were then outlined in order to minimize the occurrence of any errors.

How was it done?

In order to determine risk index(ρ) we have identified all risks related to IMP’s management: pharmacological risk(φ), dependent on pharmacological characteristics of IMP; technological risk(α), if drug should be compounding; risk related to number of patients enrolled(np); risk inherent to the protocol(π), i.e. whether protocol involves placebo, or randomization, etc. These risks were then related through the formula created by us, ρ=φ+(α*np)+π: protocols are defined low-risk if ρ<50, moderate-risk if 51<ρ151. For each risk index, standard procedures were outlined in order to minimize risks, i.e.(for high-risk) inclusion of at least four pharmacists in “Delegation of Responsibilities Log”; scheduling monthly meetings with trial’s Monitor; dispensing of IMP with supervision by at least two pharmacists; etc.

What has been achieved?

We applied this method to 45 active trials in our hospital. For 3/45(6,7%) protocols, φ>75 because IMPs are carcinogenic; instead, 26/45(57,8%) protocols, involve IMP’s compounding; finally 29/45(64,4%) protocols are randomized and 14/29(48,3%) of these involve use of placebo. By applying aforementioned formula, we found that 3/45(6,7%) protocols are low-risk, 32/45(71,1%) moderate-risk, 10/45(22,2%) high-risk. For these 10, standard procedures were applied, to improve the safety of patients enrolled in a clinical trial.

What next?

We promote use of this method in other clinical centers, because we believe it can be a valid tool for risk minimization. Finally, we hope that we will receive numerous feedback from these centers to further improve the proposed method.

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