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Pharmacists due to get promised medicine shortages powers next month

The order containing the regulatory changes was laid before parliament last Friday
The order containing the regulatory changes was laid before parliament last Friday

Pharmacists may be able to dispense an alternative in cases of “serious” medicines shortages from February 9, as a change in law comes one step closer.

The Human Medicines (Amendment) Regulations 2019 order – which was laid before parliament last Friday (January 18) – includes provisions to allow pharmacists to dispense an alternative in accordance with a “serious shortage protocol”, rather than the prescription, without contacting the GP, in the event of a national medicines shortage.

The amendments would also allow pharmacists to dispense less medicine or a different strength or form to that prescribed.

The Department of Health and Social Care (DH) stressed this would be the more likely solution to medicines shortages, rather than instructing pharmacies to substitute a generic or therapeutic alternative, “which would only be used in very exceptional circumstances”.

In its explanatory note published alongside the order, the DH said the new powers “do not relate to withdrawal from the European Union”. However, if Brexit does affect medicines supplies, a “serious shortage protocol” could be implemented.

The amendments are scheduled to come into force on February 9, but pharmacies will have to wait for ministers to publish a protocol “when they consider that a medicine is or may become in serious shortage” before they can make use of the regulatory change, the DH explained.

Concerns over protocol time lag

Speaking in her personal capacity as a locum pharmacist, Royal Pharmaceutical Society English board member Thorrun Govind told C+D that while the regulation amendments would give community pharmacists the “professional autonomy” they have so far been lacking, she is concerned of a possible time lag from when a shortage is recognised to when a protocol is implemented.

“From our professional training and clinical skills, pharmacists are very capable of managing incidences where there are serious shortages, so overall, I am positive about the [new powers],” she said.

“However, I don't think it goes far enough, because it is the minister who is going to say, ‘You can make that decision’ and we will have to act against a strict protocol. How long is it going to take for the messages to get to the minister that there is a shortage of [a] medicine?”

David Reissner, a consultant at law firm Charles Russell Speechlys, said: “Ministers aren’t keen on admitting there is a problem and they aren’t the first to know, because they aren’t the ones having to spend time on the phone to suppliers to source medicines.”

Risk to pharmacists remains

In their responses to the DH’s informal consultation on the amendments, pharmacy bodies warned that pharmacists could be at risk of prosecution when acting in accordance with the DH’s protocols, as they would be breaching section 64 of the Medicines Act 1968, which prevents the sale of “any medicinal product which is not of the nature or quality demanded by the purchaser”.

Mr Reissner said that while the DH is “aware of the points raised” through the consultation, “they don’t appear to agree that an offence would be committed” (see Mr Reissner's explanation of the legislative changes).

“It is a pity that, even though the [DH’s explanation of the amendments] isn’t legally binding, they didn’t take the opportunity to say something in it about the risk of prosecution,” he told C+D.

The Pharmaceutical Services Negotiating Committee (PSNC) said the practical issues in implementing these new powers are “considerable”, including the costs involved and “implications for community pharmacy contractors’ terms of service”.

“Work to address the practical issues with any [shortages protocol] introduction must now begin,” PSNC stressed.

Contingency planning

In a letter to “NHS pharmacy leaders, system-wide” last week (January 17), England’s chief pharmaceutical officer Keith Ridge said the “serious shortage protocols” form part of the government’s contingency planning in case of a no-deal Brexit.

He also used the letter to reiterate that “it is not helpful or appropriate for anyone to stockpile medicines locally”.

“Any incidence involving the over-ordering of medicines will be investigated,” Dr Ridge said.

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

Reeyah H, Community pharmacist

No thanks. I just want powers to pay my bills! 

Bob Dunkley, Locum pharmacist

If I’d wanted to play at doctors, I would have studied harder and GONE TO MEDICAL SCHOOL.!! No doubt those pharmacists who are frustrated doctors are rubbing their hands in glee. I’m sorry for the poor patients who will be the recipients of this wildly misplaced largesse.

anti-depressed Pharmacist, Manager

 

You want us to randomly pick an alternative medication without seeing a patient's GP records?

 

Funny how in one article Community Pharmacists are not seen as Clinical Pharmacist as stated by Bruce Warner and this is used as an excuse to cut funding to the community sector but all of a sudden when it suits them they want us to become Pseudo Doctors dishing out drugs willy-nilly.

Leon The Apothecary, Student

You may dispense less. What the hell is an Owing?

Richard MacLeavy, Non Pharmacist Branch Manager

That is something that Keith Ridge has come up with, and proposes putting into use on 9th February. Having spent many years on the front line he came up with this idea to be used when there arn't enough tablets in stock to match the prescribed quantity. What didn't anyone else think of this? Its these sorts of outside the box ideas that justify's his position

Interleukin -2, Community pharmacist

Ha ha ha ha ! Damn! I was just about to say that !.....

C A, Community pharmacist

I think what they mean is - The pharmacist may dispense less and finish the script (for example during the AAI protocol, where you were limited to dispensing 2 and then refering the patient back to the GP if they needed more, and processing the script for payment with the reduced instalment).

It would be handy for naproxen, I'm getting tired of seeing scripts for 224 naproxen 250mg "because the patient used to get 112 x 500mg"... there is a shortage, how about you don't prescribe a single patient large quantities!

Leon The Apothecary, Student

I've been obtaining it from Numark, no shortages at all there.

Watto 59, Community pharmacist

You might be wise to check the price you have paid compared to what the NHS will pay you.
 

Leon The Apothecary, Student

The joys of being a locum! I saw the price difference. That's shocking how everyone is essentially forced to loss-lead.

Lucky Ex-Locum, Superintendent Pharmacist

Sorry, but I won't be flexing these particular muscles at all. I'll still be referring everything back to the GP. If we don't tell the GPs there is a shortage, they just keep churning the prescriptions out. By referring back you might just irritate them into prescribing an alternative right at the beginning of the process.

V K P, Community pharmacist

an thrown into the mix is the FMD. say we do make a substitution and the GP tells the patient not to take it and bring the prescription back to him, what happens to the cost of the subsitituted medicines. we cant take it back whether it is within the 10 day rule or not. that is a patient return which belongs in the doop bin and not on the shelf for re-dispensing. more waste at our detriment. this non-sense can be carried out by dr Ridge himself.

 

C A, Community pharmacist

The problem is the patients that get it on repeats that the GP barely looks at -

Oh Mrs Smith wants her monthly order - OK...issued

Leon The Apothecary, Student

Are you referring to eRDs? Cause that's something I've yet to see administered comprehensively and effectively yet. 

C A, Community pharmacist

I was referring to the current situation, where GPs keep prescribing items that are out of stock, because they don't have time to look at them.

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