Last month, C+D exclusively revealed detailed proposals for pharmacy technicians to be handed legal responsibility for supervising the supply of prescription-only medicines (POMs), which had been submitted to a Department of Health (DH) programme board.
In order for this to happen, a working group established by the UK’s four chief pharmaceutical officers has suggested amending the wording of regulation 220 of the Human Medicines Regulations 2012 so that references to “pharmacist supervision” of a pharmacy are replaced with a broader requirement for a “registered pharmacy professional” to supervise a pharmacy.
Responding to the revelations, David Reissner, senior healthcare partner at law firm Charles Russell Speechlys, said while "in theory it is easier to change" the Human Medicines Regulations 2012 than the Medicines Act 1968 – where the requirement for pharmacies to be supervised was contained until 2012 – “experience suggests that even making changes to regulations can be complicated and time-consuming”.
If the DH’s intention is to replace the wording in these regulations, “then a definition of ‘registered pharmacy professional’ will have to be created”, and “even a definition of ‘supervision’ – something that legislators have avoided doing” so far, Mr Reissner told C+D earlier this month (October 13).
But if the DH instead decides to amend legislation to allow pharmacy technicians to supervise “some” transactions – such as repeat prescriptions and the sale of “family packs of analgesics” – “complicated drafting may be required”, he said.
“The DH might find that anything more than a simple change to allow all pharmacy technicians to supervise all transactions…would involve biting off more than it can chew,” Mr Reissner added.
It could also "bring a different law into play – the law of unintended consequences”.
Proposals must be considered publically
While the conversations around supervision changes have so far remained “secret”, “changes to the law cannot be made without the proposals being considered in the public arena through proper consultation”, Mr Reissner said.
“Quite apart from publishing the proposals and inviting comments from pharmacy representatives, the DH [programme board] would also have to seek comments in particular from patient representatives and bodies concerned with patient safety,” he stressed.
Last month, the DH said that only after a public consultation has been held “will proposals be submitted to ministers for consideration”.
Catch up on all of C+D's supervision coverage here.