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DH reveals 'shortage protocol' for pharmacists to supply alternatives

Health secretary Matt Hancock: This protocol is not just for Brexit
Health secretary Matt Hancock: This protocol is not just for Brexit

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

15 Comments
Question: 
What do you make of the DH's "serious shortage protocol" proposals?

Mr CAUSTIC, Community pharmacist

Could we substitute a branded product if the generic was not available ? Would we be paid ?  NCSO was there for that and that could have solved quite a few problems in the last few months.!

What happens if one uses the protocol for say a drug for hypertension  and the patient is unusually sensitive to it ,falls over from hypotension resulting in an injury ?  Who will the patient hold responsible ?

 

 

 

 

Mitesh Patel, Community pharmacist

Not gonna work for EPS. Plan is already a failure. 

Adam Hall, Community pharmacist

Firstly, finally we can make use of our extensive knowledge in order to supply the most appropriate substitute without having to refer it to those demi-gods (GPs) (being as we are mere mortals)

Secondly, does this spell the demise of concessionary pricing?

Thirdly, reimbursement?

Z Z, Pharmacy Asistant/ Medicine Counter Assistant

Last month we had a shortage of epipens. Last month, really? This last year more like. And many of the alternatives. And those alternatives for much of this year.

It's a sensibly motivated idea, but probably doesn't realise as politicians don't, how incredibly fragile the supply chain is in pharmacy and how shortages are common. Surgeries already have rants about pharmacies not being able to accept faxes, rants about pharmacies not able to send a dispenser to 'pop up' to get a script, rants about their 'stamp budget' to post prescriptions for emergency supplies out and rants about out of stocks. The patient will be happier but I suspect there'll be a lot more mealy mouthed surgery telephone calls as outlined about like with naproxen above.

Paul Dishman, Student

What’s the betting that the PSNC have offered to let us work for free?

Ghengis Pharm, Locum pharmacist

I wonder if we will fall foul of the Medicines Act (" Prescription only medicines can only be given in accordance with the directions of an appropriate practitioner" ).

Richard MacLeavy, Non Pharmacist Branch Manager

I think reimbursement will be a big issue. If you take the current situation with Naproxen being very short in the market, pharmacists could use these new powers to issue Naproxen Gastro resistent tablets as an alternative for the non gastro resisitent naproxen usually prescribed. However pharmacies wouldn't want to issue GR against a reimbursement for non GR, but if we are given the ability to claim for what we have dispensed GP's and CCG's will have a headache with their drug budgets. Then its only a matter of time before vertically intergrated pharmacy businesses start manipulating the drugs market to ensure shortages of medicines to which there is a more expensive alternative (such as naproxen) in order to boost profit.

Crazy Hayz, Community pharmacist

i welcome the move though but also agree that time should be taken into consideration plus it appears as though there will be a list of requirements for stock  to qualify.....let’s hope someone who actually understands the current process gets involved.....who am I kidding LOL!

 

If prescribers did what they were supposed to do and prescribe generically rather than with brand generics then we could supply a lot more consistently anyway.  It comes down again, to GPs trying to make their books look good (on paper only), and eroding our agreed purchasing profits as part of our overall funding contract and actively prescribing against the government model and agreed DT reimbursements.

 

 

Dellesa Robinson, Hospital pharmacist

About time. Pharmacists are more than capable of making these judgements

 

Daniel McNulty, Superintendent Pharmacist

How much good will does anyone have left to help the Department of Health out?

What would French pharmacists do?

Ghengis Pharm, Locum pharmacist

Bit Brexist ...

Richard MacLeavy, Non Pharmacist Branch Manager

French pharmacists would dispense an alternative form, most likely a suppository

N patel , Non Pharmacist Branch Manager

Go on strike they would
Dont help the government out at all
This is not a problem of our making and they WONT pay us for any extra work we will do to ensure continuity
Psnc should agree an extra fee in excess of 5quid per item we have to sort out before we agree to do anything

Locum Pharmacist, Locum pharmacist

we will be forced into it as per usual.

Jim L, Locum pharmacist

Will be interesting to see how this could be reimbursed appropriately, particularly on EPS

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