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Pharmacists granted power to supply different fluoxetine strengths

The legal groundwork for a serious shortage protocol was set out in February
The legal groundwork for a serious shortage protocol was set out in February

The government has granted pharmacists the ability to supply an alternative strength or form of fluoxetine without contacting the patient’s GP, in an effort to cope with shortages.

This is the first time pharmacists can dispense an alternative to a medicine suffering a shortage, rather than the prescription and without contacting a GP, under a “serious shortage protocol” (SSP). The legal framework for a protocol was put in place in February, but it required a government directive for pharmacists to act on it – one was issued today.

The Department of Health and Social Care (DH) has issued the protocols (see below) for fluoxetine 10mg, 30mg and 40mg capsules, as they are currently out of stock, it announced this morning (October 3).

As there are sufficient supplies of 20mg capsules, as well as tablets and oral solutions, pharmacists have been granted the power to switch to these strengths or forms, it said.

“The protocol will remain in place while manufacturing issues mean the drug is temporarily in short supply,” the DH explained.

Dispensers would only be able to make this switch during the time in which the [protocol] is valid, with the patient’s consent and where appropriate, it stressed.

Pharmacists must always use their professional judgement to decide whether it is appropriate to supply against a protocol, the DH continued. Patients can always refuse the alternative and instead go to their GP to discuss alternative treatments.

The DH told C+D that the shortages powers currently only apply to England. However, the devolved administrations have said that they are content for Scottish, Welsh and Northern Irish patients presenting prescriptions in England to be served under the terms of the SSPs.

What alternatives can pharmacists supply under the fluoxetine SSPs?

SSP
Alternative supply instructions
1 x fluoxetine 10mg tablet or fluoxetine 20mg/5ml solution or fluoxetine 20mg/5ml sugar-free oral solution
1 x fluoxetine 10mg tablet and 1 x fluoxetine 20mg capsule
2 x fluoxetine 20mg capsules

Source: NHS Business Services Authority, October 2019

 

Read each of the protocols in full and the accompanying operational guidance on the NHS Business Services Authority's website.

HRT importing restrictions

To help “tackle” shortages of hormone replacement therapy (HRT) products, the DH simultaneously announced it has restricted wholesalers from exporting 19 HRT drugs out of the country.

The DH has written to wholesalers to explain the restrictions on parallel exporting, which it said are similar to measures already in place in other European countries.

Further products are also subject to restrictions – including: adrenaline auto-injectors; emergency hormonal contraception levonorgestrel; and hepatitis B vaccines – “to safeguard patients”, it said.

Companies found to flout the rules could face “stringent action”, including having their licence suspended immediately.

Health secretary Matt Hancock said he recognises “how distressing medicine shortages can be for those who rely on drugs like HRT”.

“The new measures we’re introducing today will help us ensure patients get the medicines they need and the high quality care they deserve.”

C+D’s reader survey of the extent of shortages – which has since been reported in the Daily Mail, The Sun, the Daily Mirror and the Telegraph – revealed on Monday that 84% of respondents have struggled to obtain HRT products in the past six months, making it the most common medicine in short supply.

Dr Rick Greville, director of supply chain at the Association of the British Pharmaceutical Industry, said the DH’s decision will be “very much welcomed by our members”.

“It means that these stockpiles of medicines, which companies have built over previous months, are better protected and available for use only by the NHS patients for which they were intended.”

The DH added that it is aware of ongoing issues affecting some HRT preparations, due to manufacturing issues.

The DH has been working closely with the affected suppliers to resolve the supply issues and [is] working with other suppliers of the available products to see if they are in a position to help with current shortages, it said.

C+D is exploring the impact of medicine shortages on community pharmacy staff all week. Read the coverage so far and join the conversation by tweeting #MedicineShortagesWeek

25 Comments
Question: 
What do you think of the DH's announcements?

Susan M Shepherd, Community pharmacist

I suspect this is the trial batch, as these are only prescribed rarely anyway in these strengths. If successful, then a whole load more will follow, eg memantine.

N O, Pharmaceutical Adviser

Slightly off topic but may be relevant.

Received 2 emails from Gov.UK/ MHRA --

1. Advisory to inform all patients to carry atleast 2 emerade 500 autoinjectors at all time.

2. MHRA Class 4 recall for Emerade -- The MHRA cas cancelled the recall due to defective devices and has mention that there won't be sufficient devices avalable for a long time now.

What and why do they give such contradicting statements?? First of all there is no stock for people to even fulfill their Rx for 2 devices and on top they are not recalling the faulty devices and still warn that the devices may not work!!!

Margaret O'doherty, Community pharmacist

Emerade has been recalled in the Republic of Ireland. Our lives must be more valuable than yours!

 

Alexander The Great, Community pharmacist

How do you endorse an electronic script when the NHS ignore endorsements and just pay whats prescribed????

Richard Judge, Manager

Where is the Protocol Document?

Career Miss Take, Locum pharmacist

Exactley

Tas Bhatti, Community pharmacist

Surely this should be a standard approach.... as well as stopping branded generic prescribing..

Alexander The Great, Community pharmacist

they really do need to stop branded generic prescribing, it kills off any profits we can make and also makes it a pain when items are out of stock. eg zapain, venlablue, bunov coming in and out of stock.
 

Lucky Ex-Locum, Superintendent Pharmacist

Trouble is that the GPs get a kickback for branded generic prescribing, so it takes money out of our pockets and puts it into theirs. It doesn't save the NHS much because they (via the QOF scheme or whatever it's called these days) give the difference direct to the GP but it profits the GPs even if they are non-dispensing. That's why stopping it will never happen. Their wheel is WAY squeakier than ours, therefore they get the grease.

Richard Binns, Primary care pharmacist

Qof pays Gps based on clinical indicators, it has nothing to do with prescribing practices.

Branded generic prescribing is normally the result of medicine managment teams at the CCG, who are given a prescribing budget to manage and are held accountable for overspend in relation to this.

Branded generic prescribing is a often seen a quick win with regards to cutting the drugs spend for a CCG in the face of fiscal pressures.

I cant see where the GPs are getting a kickback in the process as you have suggested , from the evidience ive seen its just a means for CCGs to try balance the books. 

Farmer Cyst, Community pharmacist

Lots of CCGs will operate a scheme where GPs get paid for either coming under budget, or even a 'gain share' where the more they save the more the GPs earn.

 

I have experience working for three CCGs and in each the GP surgeries could make money for themselves by prescribing branded generics (they could also save money in other ways, but branded generics was definitely where the majority of effort was focused)

Richard Binns, Primary care pharmacist

Thanks, perhaps Ive been lucky to avoid such schemes, my GP colleagues are not the biggest fans of branded-generic prescribing for the record, especially the time spent changing them back when they go out of stock , I think theres bigger fish to fry with regards to NHS savings

Lucky Ex-Locum, Superintendent Pharmacist

Yes, you're right about QoF. The scheme I'm thinking of used to be called the GPSIPP but I can't remember what it is called now, but I work closely with GPs. Provided they meet targets on branded generics, they get a  payment. I don't know the precise mechanics of how it works but they get a financial incentive to prescribe branded generics. There has to be a kickback or there is no way on this earth that a dispensing GP would ever go along with it.

Richard Binns, Primary care pharmacist

Theres prescribing incentive schemes where the practice recieves a payment for meeting prescribing targets, (in our area I believe its is £3k for 100% compliance, probably not enough to offset the loss to a dispensing practice). our CCG is focusing on areas which are patient focused i.e. safe DOAC prescribing (trying to save money via preventing patient harm), Opiate prescribing and I believe appropriate nutritional supplement prescribing (so preventing meds wastage)

If other CCGs are focusing on branded-generic prescribing through these schemes then all I can say its not exactly what you would consider as a patient focused service.

 

Lucky Ex-Locum, Superintendent Pharmacist

I definitely agree with you there. However, I can assure you that the financial incentive is more than enough to entice dispensing GPs to comply.

If your CCG is looking at nutritional supplements, I really hope they are concentrating on care homes. We deal with seven or so and the level of wastage on those is utterly horrendous.

Richard Binns, Primary care pharmacist

Theyre doing a lot with care home wastage in general, their technicians are quite involved.

Same with waste from the comapnies which request catheters etc, your looking at £100s saved rather than pennies from simvador

guess it just highlights the differences depending on which post code you work in

Career Miss Take, Locum pharmacist

There is a brain cell operating somewhere. ******* common sense.

Kevin Western, Community pharmacist

And wont it be fascinating if the listed products suddenly become freely available...food for the discussion with the wholesalers when they turn up to explain themselves :-)

John Cleese, Production & Technical

So C&D and PJ are reporting this, but where is the official link / statement? Shouldn't you tell the pharmacists at the same time as the media outlets?

Daniel McNulty, Superintendent Pharmacist

Abso-f******-lutely.

While I'm on - can anyone show me where to claim for my efforts please?

 

edit: Endorse as NCSO to claim product.

Still fuzzy about our fee payment, though. We need to make sure we get our share of the 'up to £10m'  that's been topsliced off our global sum before giving us it back for additional service. 
 

 

A B, Community pharmacist

£5.35 per item. It's all detailed on the PSNC site; how to endorse etc.

Lucky Ex-Locum, Superintendent Pharmacist

But that's a payment to the contractor not the pharmacist, so once again, the person who does the work and takes the responsibility gets precisely bugger all out of the deal unless they are a one man band.

Farmer Cyst, Community pharmacist

That was always going to be the way -  if you want more money for providing this service speak to your employer.

Benie I, Locum pharmacist

Is it me or is the announcement being made as if a breakthrough in curing cancer has been found?!

Interleukin -2, Community pharmacist

This happens all over the world btw..dont get all the drama around it

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