The DDA has today published an SOP covering the ‘Falsified Medicines Directive (FMD) process’, as well as updated eight SOPs to support practices in demonstrating compliance with and, eventually, implementation of the FMD.
The updated SOPs, which have been added to the DDA member only SOP library, are:
- Assembling and labelling prescriptions (FMD)
- CD orders, storage and dispensing (FMD)
- Transferring items to patients (FMD)
- Home deliveries (FMD)
- Split packs (FMD)
- MDS initiation and supply (FMD)
- Prescription retrieval (FMD)
- Dispensing insulin (FMD)
Scottish practices are able to start implementation with the FMD once they have received payment from their health board. Practices are advised to check exit clauses before signing up to long-term contracts.
All practices are reminded that the transition to FMD-compliant packaging will be gradual, and that only a small proportion of packs in the supply chain will be FMD compliant in the immediate aftermath of the Directive coming into force on Saturday 9 February.
Registering with SecurMed (at least as a requestor) is recommended as a good step towards demonstrating full FMD compliance. Practices are advised to ensure that the principles of the updated FMD SOPs are understood, and modified as necessary to suit a practice’s individual circumstances, and that staff are fully trained on FMD compliant equipment before workflows are changed to incorporate FMD processes.
There is also more information (for developers, but also useful background information) on implementation from the Health Developer Network.
Practices may also want to read this letter from DDA CEO Matthew Isom.
The DDA Board is very grateful to DDA Board Member Mark Stone for producing the SOPs.