Press release no. 689 - The Italian Medicines Agency (AIFA) and the Italian Association of Hospital Pharmacists (SIFO) signed a memorandum of understanding (MoU) on 9 March 2022. The MoU establishes the collaboration between the two bodies that will be valid until 31 December 2024.

The collaboration covers important areas of activity, starting from the analysis of medicines procurement and distribution policies, with particular reference to tenders and the revision of the list of medicines for ensuring inpatient-outpatient continuity of care. The goal is to simplify administrative procedures and ensure uniform therapeutic access within the healthcare process. Therefore, the scientific community will have new tools available for monitoring the value of therapies, ensuring easier access to treatments, analysing the degree of adherence and managing any potential side effects of medicinal products in a safe way.

The agreement also covers the trend in consumption and expenditure of off-label medicines, AIFA monitoring registers and prescriptive appropriateness. The aim is to activate a national computerised monitoring system as part of OsMed activities on the use of off-label medicines, according to Laws 648/96 and 94/98, and to promote the timely and correct population of monitoring registers by authorized specialists and hospital pharmacists, in order for the scientific community to benefit from the relevance of such data.

As SIFO President, Arturo Cavaliere, stated: "We are proud of the MoU signed with AIFA”. “This close relationship between SIFO and AIFA, the national competent authority, confirms once more  the cross-cutting nature of our role, the independence of our work as well as the quality and capillarity of our observation of trends in the therapeutic product flow  in our country. We are confident that we will be able to pursue the objectives of this agreement in the best possible way, in order to ensure that citizens and the NHS receive the best support in managing the pharmaceutical asset".

Training is a core element of the Memorandum, since it is considered a fundamental tool and crucial asset to guarantee the highest possible quality of pharmaceutical assistance, to be developed through professional internships at AIFA intended for pharmacists of Hospital Pharmacy Specialization Schools. In addition, training modules and projects are envisaged on the critical assessment of evidence, the optimal use of medicines (also using current data), on the regulatory context, on clinical trials and on the role of pharmacists in research activities.

"Signing the Memorandum of Understanding with SIFO ensures AIFA an additional, valuable and direct on-site feedback on many issues that are among the priorities of the Agency" underlined AIFA Director General, Nicola Magrini. "We believe that, in light of the  relaunching the National Health Service, and the implementation of many projects within the National Recovery and Resilience Plan, the governance of medicines should be based on the correct observation of the areas that are at the heart of this Memorandum ".

Finally, the AIFA-SIFO collaboration covers unavailability and shortages of medicines, issues already addressed in a tangible and shared way in the context of the Technical Table on Unavailability. The aim is to prevent and solve all problems related to shortages of medicines, quota for wholesalers’ orders,  prevention and traceability of thefts of medicines, and management of emergencies caused by the COVID-19 pandemic.