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What does the Serious Shortage Protocol mean for people with epilepsy?

28 Mar 2019

What is the serious shortage protocol?

The serious shortage protocol (SSP) gives pharmacists additional powers to alter prescriptions in the event of a serious shortage of a particular medicine.

The purpose of this change is to reduce the impact of medicine shortages on patients.

chemist speaking with clientIt was bought in by the UK government as a change to the Human Medicines Regulations 2012 and became law in February 2019.

What does this mean?

If the government, in this case the Department of Health and Social Care, decide that there is a serious shortage of a particular drug they would issue a serious shortage protocol.

When an SSP is issued, pharmacists will be given additional powers to respond to a shortage of a particular medicine. Pharmacists will be asked to take one or more of the following actions:

  • Dispense an alternative dosage form of the drug – for example if you are normally prescribed 10 milligram tablets you might be prescribed 5 milligram tablets and told to take two
  • Dispense a reduced quantity of the drug – for example if you are normally prescribed a six-week supply of a drug you might be prescribed a four-week supply
  • Prescribe a therapeutic equivalent of the drug – a different drug that has the same effect as the one originally prescribed
  • Prescribe a generic equivalent of the drug – a non-branded version of the drug originally prescribed

Each SSP would clearly set out what actions of the above four pharmacists should take. When making any decisions around these protocols, the government would consult with specialist doctors and relevant drugs companies.

A protocol would only be used in ‘exceptional circumstances’ and would only be in place until adequate supplies of the drug have been restored.

What does this mean for people with epilepsy?

In response to concerns raised by a coalition of epilepsy voices, including Epilepsy Action, the government set out that anti-epilepsy drugs (AEDs) would have additional protections under any protocols.

This is because there are additional regulations around switching or changing prescriptions of AEDs.

The additional information that was published by the government when this change became law sets out that:

‘Protocols for therapeutic or generic equivalents will not be suitable for all medicines and patients. For example, those types of protocols would not be suitable for treatments for epilepsy ... In these cases, patients would always be referred back to the prescriber for any decision about their treatment before any therapeutic or generic alternative is supplied.

This means that if there was an SSP was issued for an anti-epilepsy drug the protocol would not recommend prescribing a therapeutic equivalent or prescribing a generic equivalent.

Instead, patients affected by the shortage would be referred back to their prescribing doctor. This advice was repeated by a junior health minister, Jackie Doyle-Price MP, in a recent debate in Parliament:

‘In the event of a shortage of these epilepsy drugs, the clear guidance would be for the pharmacist to refer the patient back to their prescriber’

There are currently no serious shortage protocols in place and these protocols have not been used since they became law in February 2019.

Why do we need a serious shortage protocol?

chemist selecting tabletsSince 2017 shortages of particular medicines have become more common. This can cause problems for patients, particularly for people with long-term health conditions, who need a constant supply of medicines.

Before the serious shortage protocol was introduced, any changes to a patient’s prescription would have to be approved by a prescribing doctor. This is still the case in most situations but after these changes, if it is decided by the government that there is a serious shortage of a particular medicine, the government can issue a SSP.

The government have said that while this change has happened quickly as part of changes to the law around Brexit, it is not explicitly linked to preparing for a no-deal Brexit. Since 2017, for a number of reasons unrelated to Brexit, the number of drug shortages in the UK have increased.

What next?

There are currently no serious shortage protocols in place and these protocols have not been used since they became law in February 2019.

If one was to be introduced this would be communicated by the government and Epilepsy Action will be sure to let you know if it relates to epilepsy medicines. There is a need for more clarity around how a ‘serious shortage’ would be measured and when an SSP would be used.

Epilepsy Action will continue to monitor this area closely and request more information around the protocol and what it means for people with epilepsy.

Comments: read the 18 comments or add yours

Comments

Thank you for putting my mind at rest about my medication. I have been concerned about my specific medication being replaced by a generic, as there is only one that works without issues. When I was put on a different companies, it didn't go too well! Thanks again for the reassurance that epilepsy medications have more measures in place to prevent this.

Submitted by Robert Slater on

I could not get my normal Epilim Crono 500 in March of this year. The chemist contacted my doctor who authorised the issue of Epilim Crono 200 PLUS Epilim Crono 300. I wrote to Sanofi (copy of their reply already sent to you). My April prescription for Epilim Crono 500 was obtained only after my chemist had read the rees;ponse from Sanofi and rung the wholesalers.

Submitted by Ann Stanyer on

Hi I have tried many different generic drugs for Keppra in the past and I was getting the most violent headaches. I mentioned it to my Consultant who said that I had to stay on the branded Keppra only Levetiracetam. How do I stand if they try to change them to a different Keppra?

Submitted by Julie White on

If go to a large Boots they only stock Keppra, so you get Keppra regardless of what brand is written on your prescription. All the best, Nigel

Submitted by Nigel on

I have been having an increased difficulty in getting my epilim 500 controlled release tabs. There have been cited reasons ranging from factory problems to Brexit, which hasn't even happened. Does anyone else have this problem?

Submitted by Linda Powdrill on

I am quite happy about the first two suggestions (eg. 2x200mg, instead of 1x400) and eg. 4wks supply, instead of 6wks I am unsure about taking 'therapeutic equivalents' or (with some AEDs) the generic equivalent. But as far as all this Brexit stuff is going on, I have been wondering about things like meds. (of all type)

Submitted by Sue Carpenter on

Since January I have been having difficulties in obtaining Epilim500. My doctor has been great and issued me an extra prescription which I eventually was able to get filled. This has given me some peace of mind for the short term. It is very worrying that the shortages of this particular drug are occurring.

Submitted by Ann Jones on

Chemist referred to Dr as they cannot get the controlled release Epilim 500. Some Dr who I have never dealt with before on the phone said it will have to be made up of lower dosages. BIG concerns as he said lower formulas cannot be controlled release. Basically said if we changed the medication then you would need monitoring as you may have seizures again, also you would have to notify the DVLA of a change in your medication. I said dont' you dare change my prescription, this could affect my life. The seizures have been controlled for many years now after having years of problems finding the best combination of medication. He didnt seem to give a damn and said this is happening with many people. What in the hell are they playing at? This could affect our livlihood, ability to drive, our careers and keeping a roof over our heads! I told him dont you dare change that prescription we will get and appointment to see our usual Dr and discuss this. Im seriously worried. I think he was either a locum stand in Dr or a new one. Totally unrealistic and had no empathy whatsover. Many epileptics do drive and hold down jobs!!!

Submitted by Margaret Jones on

My husband is prescribed Novartis UK 400 Tegretol. In January he recieved a generic version with serious adverse effects on control. I , and the pharmacy both found a number to call Novartis, in case of urgent problems they would deliver direct next day. After many attempts the pharmacy got through and the tablets were delivered. However attempts fulfil the latest prescription of two weeks ago have failed so far. The pharmacy has not been able to get through to Novartis.

Submitted by June Jepson on

In recent months I have experienced some problems in obtaining Oxcarbazepine 300mg (Novartis) for my younger daughter. On a number of occasions the pharmacy to which her electronic prescription is sent has provided some, but not the whole amount of her prescription and has put the remainder on order for collection a few days later. However, last week the pharmacist said me he had none in stock at all. He did have a limited amount of 150mg tablets in stock but told me he was unable to dispense those because pharmacists are unable to alter an electronic prescription. He gave me a paper copy of the electronic prescription to take to another pharmacy but I was unable to get 300mg tablets from any other pharmacy in the local area. I was eventually able to track some down at a large Boots the Chemists store a few miles away. They dispensed what they had available, put in an order, and then I collected the remainder a couple of days later. Following this I spoke with the pharmacist at my daughter's GP practice who advised next time to request a 'green' prescription, rather an electronic one, so that any pharmacy would then be able dispense her prescription in 150mg and/or 300mg tablets.
All the pharmacists I spoke with said that here have generally been some problems with supplies of medication, not necessarily to do with Brexit, but that part of the problem is that Oxcarbazepine is not widely prescribed and therefore tends not to be held in stock.
I live in London and have the time and resources to track down medication for my daughter but others may not be so fortunate.

Submitted by Gillian Edwards on

Thank you for the opportunity to comment.
Like a number of people I've been feeling very anxious about my Son's epilepsy medication.
He takes Lamotrigine Lamictal and Pregabalin.
Suddenly Pregabalin has been made a controlled drug restricting the amount you can have. This causes a lot of problems with day services and respite.
This is the first time my Son's medication has worked well and I've bad many sleepless nights worrying about shortages. I just hope and pray that things will not deteriorate.

Submitted by Juliet Gregory on

I was diagnosed with the above type of Epilepsy after I was found in bed having violent seizures by my husband who heard me above him.

I was unconscious and was rushed to our nearest A & E. I was in intensive care for about five days with Phenytoin drips. After having an MRI they discovered a Cavernous Hemangioma, blood clot on my brain which had bled so badly I was thrown into Epilepsy. Twelve Tonic Clonic seizures later I awoke with my family around the bed. I had lost my memory, speech and had no idea who my family were.

My benign tumour is in the left frontal lobe so is too dangerous to remove. I had another four seizures in November 14 and after trying a variety of drugs am now controlled by Keppra.

After time my speech came back, short term memory is still affected but I have some life back, thanks to this amazing drug.

This only started in May 12 and my Neurologists believe that I was born with a type of birthmark in this position. It took over 50 years to bleed so much that the above happened.

I had many “migraines “ which were unknown symptoms most of my life like my mother but no medication helped.

My life changed after this and I can no longer do swimming etc on my own as I get no warning.

Without Keppra I know I would not have a decent quality of life and anyone with Epilepsy understands the importance of controlling this condition.

I will help to camp as much as I am able as I realise how many people this condition affects.

Hopefully my story will give some hope to newly diagnosed people.

Regards

Gill Brady

Submitted by Gillian Brady on

I have been lucky so far and am still receiving Tegretol (same brand name). My Pharmacist has assured me that should any problems occur, he will certainly advise me and consult my Doctor first.

Submitted by Lesley Gay Donnelly on

I've recently been having difficulty in getting my 500mg of chrono as my doctor surgery has been saying there's a shortage the last time I went to get my tablets the 500mg has been replaced by 300mg however I feel that I don't have enough for my months supply why do these manufactures blame Brexit when it hasn't happened yet.

Submitted by Carl Wass on

On the last 2 occasions I’ve tried to get Epilim chrono 500 there has been difficulty and I’ve had to get more prescriptions and shop around to other pharmacies. I get told it’s to do with the changed packaging too!

Submitted by Freebies on

This is not as straight forward as many people seem to think.

Whilst I have every respect for Pharmacists sometimes they do not look to carefully at the prescription and although a non-branded drug may do the same thing, their are some times subtle differences, in particular the difference between "coated" and "non coated" (often known as UCB).

I have a friend who is a serious epileptic on several drugs to control the condition (although still taking frequent attacks); and he noted that sometimes that the prescription he is given may be coated when in fact that the should be uncoated. As most people will know the coating changes the speed of the breakdown of the drug and uptake in to the blood stream. In my friends case that can be critical and the difference between him taking a seizure or not.

What concerns me is that in his case if this alternative drug (one he takes indeed Epilim as well as the very dated drug Phenobarbitone) does not have the coating or indeed breaks down in a different way irrespective of the coating or not could put him at risk.

He has had to take prescriptions back before because the wrong type was issued and if this business of what are in effect "substitute drugs" how will even a well trained chemist know whether the cheaper, more available medication may cause an issue, particularly as in the case of my friend has been on some of the medications, for literally decades.

Submitted by Christopher Richards on

My son has been having difficulty getting Novartis 200mg Tegretol Retard tablets. We were very worried when we were only given a few days supply (1 strip of 10 tablets!) and then after almost running out (9 days after first order) we got only 2 boxes. The rest of the order is still owing, now 2 weeks after first ordering.

Submitted by JOHN SIMPSON on

I live Wales and Epilim Chrono controlled release seems to be harder to obtain than in other parts of G.B. I was prescribed another drug without my consultants knowledge and after 3 does started having really bad seizures again ending up in hospital. Pharmacist do not understand the stress and what it is like to suffer with this condition and the fear of not being able to obtain your drugs. Personally I think it is all about money, people are selling these drugs at higher prices because the pound is so low, my opinion only.

Submitted by Mrs G. Marshall on
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