Background Pharmacists are allowed to prepare medicines for the needs of patients. They have to balance the benefits and risks of the clinical and pharmaceutical qualities. In other words they have to perform a risk assessment for extemporaneous preparation as well as for stock preparation.

To perform a risk assessment the pharmacist should be able to list the benefits and risks and needs a tool to balance them. Some approaches have been published, but they don’t deal with all aspects in one view. We think there is a need for a risk assessment tool that is simple, transparent and conclusive and that deals with all relevant aspects.

Purpose To analyse the pharmaceutical process for decisive steps, levels of evidence and actors. To incorporate these aspects into a practicable form.

Materials and Methods 15 years of feedback from community and hospital pharmacists on former assessment forms, discussions with authorities, 40 years searching for sound reasons for pharmacy preparation, writing an opinion on the Resolution on pharmacy preparation of the Council of Europe, have been used as an input for creating a new form that emphasises the benefit and risk balance.

Results Two forms were developed for the pharmacist: for extemporaneous and for stock preparation. They use the same type of benefit and risk aspects but extemporaneous preparation affects an assignable patient and the request is from an assignable physician. Often two pharmacists are involved, the attending pharmacist and the preparatory pharmacist. All four carry responsibility but the preparatory pharmacist has to decide whether to fulfil the request or not. For stock preparations the preparatory pharmacist will put together the information about benefits and risks. The physician, patient and attending pharmacist have to balance them. Stock preparation requires numerous items per batch and serves a number of patients. This requires a higher level of evidence about the clinical value and a higher quality of design.

Conclusions Forms were developed for the risk assessment of extemporaneous and stock preparations. They show decisions and provide transparency, pointing at responsibility and accountability. Practical experience will provide more information about the roles of pharmacist(s), physician and patient.

No conflict of interest.