Background The European Resolution CM/ResAP(2011)1, by affirming the importance of medicinal products prepared in the pharmacy, states that before setting up a preparation, the clinical needs of the patient should be evaluated in relation to the risk associated. The resolution states that it is necessary to adopt strict protocols of preparation to ensure the quality of the product, in addition to pharmacopoeial requirements.
Purpose To assign a numerical risk value to each preparation in order to assess the risk/benefit ratio and then to apply an adequate system of quality assurance.
Material and methods After the recent drafting by our National Society of Compounding Pharmacists of a position paper on risk assessment, based on the resolution, pharmacists and technicians in our hospital pharmacy collaborated to classify preparations as low, medium-low, medium-high and high risk, by assigning values, as tabulated in the document, for pharmacological risk, preparation process risk and risk depending on number of preparations per year. By entering the values obtained and using a defined formula, on a specific Excel worksheet, we calculated the overall risk value.
Results 10 preparations (non-sterile, sterile, oncology IV, intrathecal, TPN) were analysed and classified using this method, resulting in different values. It was also noted that different formulations, with the same active molecule and therapeutic use, can generate different values. For example, spironolactone obtained a value of 34.6 (low risk) as an oral suspension versus 325 (high risk) as a unit dose oral powder. This instrument can be used to support the choice between different options of formulations, as well as a stimulus for development and improvement in quality, safety and effectiveness of drugs prepared in the pharmacy.
Conclusion The method of risk assessment proposed was very useful for the activities performed in our laboratory; however, there are some aspects which require further reflection, such as how much computerisation and automation of the processes or specialisation of operators, related to the annual amount of products prepared, affect the overall risk value related to pharmacy preparations.
References and/or Acknowledgements
Resolution CM/ResAP(2011)1 on quality and safety assurance requirements for medicinal products prepared in pharmacies for the special needs of patients
References and/or AcknowledgementsNo conflict of interest.
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