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DH reveals 'shortage protocol' for pharmacists to supply alternatives

The DH intends to amend regulations before March to allow pharmacists to dispense an alternative in cases of “serious, national” medicines shortages.

The Department of Health and Social Care’s (DH) proposed “serious shortage protocol” – which it claims it is currently consulting on – would amend the Human Medicines Regulation 2012 to enable pharmacists to dispense an alternative medicine in accordance with the protocol, rather than the prescription, and without having to contact a GP.

Explaining the proposals on BBC Radio 4’s Today Programme this morning (December 7), health secretary Matt Hancock stressed that they are “not actually just about Brexit.”

“For instance, last month we had a shortage of EpiPens, because of a problem with the supplier in the United States. It is important that as well as making sure we have [a] supply of medicines or medical devices, if trained pharmacists and clinicians need to make judgements like this, then they have the ability to do so,” he added.

The DH confirmed to C+D that the regulations “will come into force before March, regardless of the situation with Brexit”.

The “strict protocol, 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 medicines”.

“In the unlikely event of a shortage of any medicine, it is vital that patients continue to receive the high level of treatment they expect,” it added.

“Ongoing dialogue”

The Pharmaceutical Services Negotiating Committee (PSNC) revealed last week that it has been holding an “ongoing dialogue” with the DH since the summer about “secondary measures” which may be required to maintain the supply of medicines, “particularly in the event of [a] no-deal” Brexit.

One of these measures would be “giving pharmacies the ability to exercise appropriate professional discretion to ensure the continuity of an alternative equivalent medicine to patients in accordance with patient need”, PSNC said at the time.

The Company Chemists’ Association (CCA), which represents the UK’s largest multiples, has also met with the DH to discuss “plans for ensuring the continuity of supply of medicines to patients as the UK leaves the EU”, alongside the Association of Independent Multiple Pharmacies and the National Pharmacy Association, it announced last week.

In October, the Healthcare Distribution Association’s executive director Martin Sawer told MPs that pharmacists need emergency powers to substitute drugs on prescriptions in the event of a no-deal Brexit, in order to prevent shortages.

The House of Commons is scheduled to vote on Tuesday (December 11) on the terms of Theresa May’s deal for the UK’s withdrawal from the EU.

What does the DH’s “serious shortage protocol” entail?

The DH’s proposed “serious shortage protocol” could be issued by ministers in instances of serious national shortages and would enable community pharmacists and other dispensers to dispense in accordance with the protocol – rather than the prescription – without contacting a GP.

In these instances, pharmacists would be allowed to dispense an alternative medicine in a limited number of circumstances and when it is appropriate to be managed at a pharmacy level.

The pharmacist would still use their professional judgement to decide on what medicine to dispense.

The protocol would be developed with clinicians and would clearly indicate what alternative can be dispensed and to which patients it applies. The protocol covers four possibilities:

  • dispensing a reduced quantity
  • dispensing an alternative dosage form
  • dispensing a therapeutic equivalent
  • dispensing a generic equivalent

Source: The Department of Health and Social Care, December 7

What do you make of the DH's "serious shortage protocol" proposals?

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