The Government is consulting on granting pharmacists emergency powers to amend GP prescriptions in the event of medicines shortages, it has been revealed.
The “serious shortage protocols” described in a memo leaked to the Times are designed to “support the continuity of supply of medicines in a ‘no-deal’ scenario”, says the Department of Health and Social Care. They outline powers for pharmacists to dispense a “reduced quantity”, “alternative dosage form”, “therapeutic equivalent” or “generic equivalent” to that stated on the prescription.
The DHSC is seeking views of relevant stakeholder representative bodies on the proposed changes by December 12. The Department's 'informal consultation' document says: "Normally, we would consult publicly for 12 weeks before making any changes to the Human Medicines Regulations 2012. However, you will understand that any legislative changes in relation to the UK’s exit from the EU need to be progressed quickly so that they are in force before the day that the UK leaves the EU."
The plans, which would require changes to current legislation, “could be issued in case of a serious national shortage and would enable community pharmacists and other dispensers to dispense in accordance with the protocol rather than the prescription without contacting the GP”.
There are also plans to fast-track lorries carrying medicines at ferry ports and to charter planes to fly medicines into the UK if needed.
Speaking to BBC Radio 4’s Today programme, Mr Hancock said the plans were aimed at “making sure that the rules are aligned to what is best practice, to make sure that if there is, on any individual area – whether it is to do with Brexit or not – if there is a shortage of an individual drug, that pharmacists can make their clinical and professional judgements.”
Putting into place contingency plans for medicines shortages is not just about Brexit, Mr Hancock said, though he claimed these concerns were a reason to support Theresa May’s Brexit deal.
The Healthcare Distribution Association’s Martin Sawer told the Commons health select committee in October that emergency measures such as allowing pharmacists to substitute medicines they have in stock for those prescribed may be necessary in the event of a no-deal Brexit.
A DHSC spokesperson said in a statement that in the “unlikely event” of shortages it is “vital that patients continue to receive the high level of treatment they expect”.
They commented: “We are consulting on the introduction of a strict protocol, which would be developed in collaboration with doctors, to allow our highly trained pharmacists to provide an appropriate alternative should there be a shortage of certain types of medicine.
“This is a sensible approach that should reduce the time taken for alternatives to be provided to patients.”
The Royal Pharmaceutical Society said: "Making sure pharmacists are able to provide patients with the medicines they need is our priority. Pharmacists are already helping patients to get hold of medicines in short supply every day.
"We are working with the Department of Health and pharmacy to make sure pharmacists are supported to provide an appropriate alternative should there be a shortage of certain types of medicines.
"This ‘serious shortage protocol’ will enable community pharmacists to dispense in accordance a protocol rather than contacting the GP. We support pharmacists using their professional judgment to decide on what medicine to dispense. Pharmacists will work with doctors to make sure any communication about changes to medicines is clear.
PSNC says it “broadly supports the proposals”. In cases of branded medicine shortages, PSNC’s “preferred option would be to allow pharmacies to generically substitute certain medicines,” though it says the “feasibility of enabling generic substitution within a short space of time may make this option difficult to implement”.
PSNC says: “In the short term, as well as working towards giving pharmacists appropriate professional discretion to dispense an alternative equivalent medicine to patients, it makes sense to relax the NHS Terms of Service obligation on pharmacists to allow pharmacists to refuse supply if necessary.
“This would allow pharmacies to avoid dispensing drugs at a significant loss and incurring costs that their business could not survive, but it would also allow pharmacies to refuse to dispense complete prescriptions where, for example, patients were seeking several months’ worth of a medicine at once, or where they already had sufficient stock from a previous prescription.
“Again, this would allow pharmacists to use their professional discretion to manage the demand for medicines better and to prioritise stock for patients who need it most in a shortage situation.”
PSNC says it is “continuing to work closely” with DHSC officials and with the other pharmacy organisations via the Brexit Forum “to try to minimise the impact of Brexit on the medicines supply chain”, including looking at what measures may be required in addition to the six-week stockpile of medicines the Government has requested manufacturers to set aside.
The possibility of medicine price hikes post-Brexit is a concern, the PSNC says. The Committee says it “would like to continue to work with DHSC” to implement measures that would ensure quicker and clearer reimbursement and stock availability information, a more responsive concession pricing system and reimbursement of any additional costs incurred by pharmacists.