UK GPs advised not to buy ‘expensive’ kit pre-FMD

GP practices in three UK counties have been advised not spend money on ‘expensive kit’ to comply with the Falsified Medicines Directive, until the government provides further guidance.

A letter sent to practices from Richard Wood, chief executive of Berkshire, Buckinghamshire & Oxfordshire Local medical Committee (LMC), says that there will be “very few products” carrying the FMD safety feature codes after the FMD comes into effect on 9 February.

Wood also tells GPs that “it is likely that it will be several months for old medicine stocks to be used up [and] we, therefore, expect that there will be a gradual impact from these requirements.” The LMC is recommending against purchasing equipment that “might be redundant until we have clear national guidance.”

“It is not the responsibility of practices to provide if it is for the delivery of the contract,” he adds. That chimes with advice from the British Medical Association (BMA) which argues that “the cost of providing connectivity to the database, or for the IT hardware and software that will be required in every pharmacy” should be provided by the NHS “so that the impact on the workload of GPs and their employees is kept to a minimum.”

The LMC letter comes in the wake of new guidance from the General Pharmaceutical Council (GPhC) and the Medicines and Healthcare products Regulatory Agency (MHRA) on the implementation of the FMD when it comes to inspections and enforcement, as well as MHRA advice on the potential impact of Brexit.

The latter guidance notes that in the event that no deal is agreed “we expect the UK would not have access to the EU central data hub, and therefore stakeholders would be unable to upload, verify and decommission the unique identifier on packs of medicines in the UK.”

In that case, the legal obligations for actors in the UK supply chain would be removed, but packs containing the FMD safety features would still be accepted in the UK, provided that they are in line with other UK packaging requirements.

GP surgeries are defined as healthcare institutions under the EU directive, so the FMD affects all practices, notes the LMC letter, with the greatest impact on pharmacies and dispensing doctors.

“The minimum that every practice will need is a scanner to read the barcodes so that they can decommission the medicine,” says Wood. “For non-dispensing practices, this is likely to affect vaccines and personally administered items. For dispensing doctors, this will add an extra step to the dispensing of every drug pack.”

An article in the Pharmaceutical Journal says that Wood “was unable to suggest what GP pharmacists should do when dispensing in a practice with no FMD hardware.”