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‘No deal’ Brexit could see pharmacists take lead amid drug shortages

Government steps up preparations as Brexit day nears


Community pharmacists in the UK will be able to dispense alternative medicines without consulting a doctor if drug shortages arise from a ‘no deal’ Brexit.

The plans were floated last week by the UK government, which has held a lightning 7-day consultation with pharmacy groups and other stakeholders, so that the plans can be put rapidly in place, should the UK exit Europe without a deal.

Should it occur, a no deal Brexit is widely predicted to cause some drug shortages, even though UK pharmaceutical companies are currently stockpiling a minimum of six weeks’ supplies of medicines.

The need for further measures became clear late last week, when the government admitted on Friday that the key ports of Dover and Folkestone could see delays and disruption of up to six months if there is a no deal Brexit.

The proposals means the Human Medicines Regulation 2012 would be amended to allow a ‘serious shortage protocol’ (SSP) to be issued in the event of a major medicines supply problem.

This would allow community pharmacists and other dispensers, to dispense in accordance with the protocol rather than the prescription without contacting the GP. Pharmacist would “use their professional judgment to decide on what medicine to dispense”. The SSP is to  be developed with clinicians, and would  cover four possibilities:

* Dispensing a reduced quantity
* Dispensing an alternative dosage form
* Dispensing a therapeutic equivalent
* Dispensing a generic equivalent

The government says it would be a reserve power, allowing ministers to use it in response to any serious national shortage, such as the ‘no deal’ scenario.

This amendment will be progressed as part of the ‘Human Medicines (FMD) (Amendment) Regulations 2019’ which is expected to be laid in Parliament in January 2019.

The Company Chemists’ Association (CCA) said it welcomed the opportunity for community pharmacy to help maintain medicines supplies to the public in the event of shortages.

Malcolm Harrison, Chief Executive of the CCA, said his organisation supported the move, but said there would be work to be done to ensure the plans could be carried out in the most safe and effective way for patients.

He added also that the workload and cost impact to pharmacies of making supplies against SSPs would be considerable, and that this would need to be taken into account.

Daniel Lee chief Pharmacist of Pharmacy2U, the UK’s largest NHS online pharmacy, also welcomed the proposal – and said such changes to current practices were a good idea,  Brexit or no Brexit.

“This is action Pharmacy2U has supported for a number of years as a means to prevent delays and blockages in patient access to their medication. We therefore welcome the government’s position regardless of the outcome of the Brexit negotiations."

Lee said the government should also consider extending pharmacy’s powers to cover other scenarios saying the NHS “must respond to societal change.”    

“The future of healthcare in the UK is technology working in tandem with healthcare professionals for smarter repeat-prescriptions delivery, enhancing the patient experience and freeing up pharmacists to supply more front-line care, and we welcome affirmation of the role pharmacists can have in delivering smarter patient services,” he added.

Fears of a no deal Brexit have risen after the Prime Minister Theresa May decided to postpone the Commons’ ‘meaningful vote’ on the deal agreed with the EU, after it became clear it would be defeated.

The Commons must vote on the deal by 21 January, but this leaves very little room for manoeuvre before 'Brexit day', 29 March 2019, if no deal is agreed, although many MPs have pledged to avert a ‘no deal’ scenario, come what may.

Article by
Andrew McConaghie

13th December 2018

From: Regulatory



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