Wholesalers may not automatically reimburse practices for FMD products that “scan bad”, said John Preston, director of wholesale quality at PSUK.
Speaking at yesterday’s PSUK Live conference and exhibition in Newmarket, he said: “We can’t know who will pay for ‘bad’ products until we know what the problem is.”
He said that FMD system alerts that should result in product quarantine at dispensary level include: ‘status error’, ‘data error’, ‘pack locked’ and ‘already used’. He added: “Like it or not, if a product scans bad it is your responsibility to deal with it. ‘Bad’ product can’t be moved back into the supply chain.”
He said that once responsibility could be attributed for the product quarantine, negotiations over reimbursement for quarantined products could begin. These may be with the wholesaler or with the manufacturer. “Processes will be put in place as the system beds down,” he said. In the meantime, practices with FMD quarantined products are asked to fill out a Yellow Card report so an investigation can start.
In his presentation, the first PSUK conference in the South of England, Mr Preston alerted the conference to the future serialisation of medical devices, possibly using a different system, and requiring different equipment, to the FMD.
Reflecting DDA advice, Mr Preston told dispensing GPs to ‘show willing’ with compliance with the FMD, by raising staff awareness of FMD SOPs, implementing training in FMD processes, and registering as a requestor with SecurMed (full registration requires details of the system supplier).
He also reiterated that regulators understood the limitations on full compliance with the FMD. He said: “They are relaxed if they see that you are doing something about compliance, even though [non compliance] is an offence under the Human Medicine Regulations 2012.”
He added that in an event of an ‘any-deal’ Brexit, the UK’s implementation of the FMD will remain a legal requirement.
FMD end user implementation progress (as of March 22) currently stands at 336 dispensing GPs, 249 GPs, 8970 community pharmacies. There are 164 million FMD compliant packs in the system, although many are still at pre-wholesale stage, and 12, 716 different product lines loaded. 167,000 items have been dispensed.