SUPPLY CHAIN SECURITY: The PADLOck Project
In recent years, medicine thefts have become a European challenge. In Italy, the number of thefts, from hospitals, has increased exponentially since 2011. The major drivers were the introduction of life-saving expensive medicines, the price differentials between countries and the different reimbursement regimes adopted in the European Union.
This situation resulted in the AIFA (Italian Medicines Agency) Counterfeiting Prevention Unit setting up a number of preventive strategies that have minimized and in some cases eradicated the problem. In this review, we briefly describe trends and impacts of medicine thefts in Italy, the ‘Herceptin Case’, a major criminal effort that has been dismantled, and some of the preliminary results of PADLOck (Progetto di Adeguamento Dei Livelli di sicurezza delle farmacie Ospedaliere contro il rischio di furti e definizione di standard tecnici), a study aimed at evaluating the safety of hospital pharmacists and made sure that preventive and corrective measures against medicine thefts are put in place.
The implementation of some of the tools developed by AIFA is under evaluation and/or implementation by other European Authorities, leading to a more effective approach in tackling one of the most relevant challenges in access to medicines in the European Union.
There are countermeasures to be implemented to combat the phenomenon of crime and reduce insurance costs to cover the residual risks. The achievement of high levels of protection presuppose the design coordination of multidisciplinary aspects: operating procedures, information systems, technological installations, intelligence, ...
LOGPLUS +, with his strong and unique experiences in the field is the ideal partner to manage this type of increasing risks.
Audit - risk analysis and identification of priority areas of intervention
Protection of warehouses and production facilities
Product protection in procurement and sales processes (e.g. counterfeiting, contamination, ...)
ISO, TAPA certifications
The project has now been expanded with a second phase - once again thanks to the unrestricted grant of Roche –
named PADLOck 2.0.
The SIFO project indeed has attracted the attention of other major stakeholders, in the world of healthcare and beyond, which have decided to join and par- ticipate in this new phase of the project. PADLOck 2.0 now includes FIASO (Italian Federation of Health and Hospital Companies), AIFA, NAS, ANIA (National Association of Insurance Companies) and AIBA (Italian Association of Insurance and Reinsurance Brokers). The new guidelines from PADLOck 2.0 will be developed and finalized by all the stakeholders, under the scientific coordination of the Institute of Management of the Scuola Superiore Sant’Anna of Pisa (partner of the PADLOck project since its start).
To implement the analysis in these new pharmacies, SIFO will appoint a multidisciplinary scientific committee, having the task to draw up a formal document covering the require- ments for excellence against thefts in hospitals; those security criteria will be agreed by all PADLOck 2.0 Partners. The idea is that adopting these security standards will allow qualified hospitals (through specific assessments) to obtain the ‘Qualify for Excellence’, recognized by ANIA and AIBA, hopefully enabling the renegotiation of insurance terms thanks to reduced risk of thefts. Also, the PADLOck 2.0 project will provide 10 of the 50 HPs audited during the project with an advanced consultancy/audit to achieve the PADLOck Qualify for Excellence.
Finally, the three pharmacies found to have the greatest exposure to risk of thefts will be admitted to a personalized study to improve prevention, including a compliance programme. The PADLOck 2.0 project has been presented and launched during the 37th National SIFO Congress (Milan, 1–4 December 2016) in the session, ‘Innovation in the logistics of medicines and medical devices: traceability, security and sustainability’.