The Serious Shortage Protocol

Published: March 28 2019
Last updated: September 28 2022

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.

It 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?

Since 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.