Policy paper

Serious shortage protocols: one-year policy review

Published 27 May 2021

Introduction

Over 2 million prescription items are dispensed in England every day and the vast majority of these are not subject to supply problems. The government receives regular reports from the pharmaceutical industry about impending medicine supply issues that may affect patients in the United Kingdom. It has well-established processes in place to manage and mitigate the small number of supply problems that may arise at any one time due to manufacturing or distribution issues. Not all issues that are notified will result in a shortage that has an impact on patients, as work will often be undertaken to alleviate a supply problem before it becomes a shortage.

Background to the policy

Serious shortage protocols (SSPs) under the Human Medicines Regulations 2012 (HMRs) are an additional tool to manage and mitigate medicines shortages. An SSP enables community pharmacists to supply a specified medicine in accordance with a protocol rather than a prescription, without needing to seek authorisation from the prescriber, saving time for patients, pharmacists and prescribers. They are only used in the case of a serious shortage, where a medicine would be likely to be out of stock for some time, and if, in the opinion of ministers, it would help manage the supply situation.

Subsequent to amending the HMRs, supplying in accordance with an SSP was introduced into NHS pharmaceutical services. Prior to this, if community pharmacy staff were unable to dispense medicines on prescriptions due to serious shortages, the only options available to ensure patients continued their treatment were:

• support the patient to identify another local pharmacy that had stock (if any)
• refer the patient back to the prescriber
• contact the prescriber requesting an alternative medicine be prescribed

Stakeholder consultation

Before the introduction of the policy, the Department of Health and Social Care (DHSC) engaged with a range of stakeholder representative bodies about the proposals. As part of that engagement, a written consultation took place between 5 and 12 December 2018. 47 responses to the consultation were received from across the NHS, industry, and pharmacist, doctor and patient representative bodies.

Consultation responses were broadly supportive of the proposal. However, patient groups and doctors’ representative bodies raised concern about automatic therapeutic or generic substitution of medicines for high-risk patients – for example, patients with epilepsy or transplant patients, without consulting the prescriber. Separate from the consultation, correspondence was received from further patient representative groups raising identical concerns.

Similar concerns were raised more generally about therapeutic or generic substitution where the Medicines and Healthcare products Regulatory Agency (MHRA) requires prescribing by brand, including anti-epilepsy medicines or biological products.

Industry representative bodies queried the role of the manufacturer or supplier and expressed concern about the need for the provisions and the protocols to be time-limited or linked to a ‘no deal’ exit from the EU. They also asked for a serious shortage to be defined.

Addressing stakeholder concerns

To address concerns about the short public consultation and the provisions not being time-limited, the regulations were amended post-consultation to include a clause committing to this review which looks at, specifically, any adverse consequences for either the market in prescription-only medicines or patient safety. The regulations also required a stakeholder consultation to be carried out as part of the review. Please see below for further information on the consultation.

Legislation on SSPs was laid before Parliament in early 2019. On 1 July 2019, amendments were made to the National Health Service (Pharmaceutical and Local Pharmaceutical Services) Regulations 2013 which introduced SSPs into the terms of service for NHS community pharmacies for England. Similar changes were made by the devolved administrations to their equivalent NHS legislation with effect from 1 October 2019.

Overview of SSPs issued to date

To date, 12 SSPs have been issued. Seven of these have been for fluoxetine, a type of antidepressant known as a selective serotonin reuptake inhibitor (SSRI). It is often used to treat depression in adults and children, and sometimes to treat obsessive-compulsive disorder and bulimia in adults. The non-fluoxetine SSPs were for:

• haloperidol (Serenace®), an antipsychotic medicine
• Salazopyrin®, a medicine used in the treatment of rheumatoid arthritis, Crohn’s disease and colitis
• levothyroxine, which is used to treat hypothyroidism (under-active thyroid gland)

More recently, SSPs have also been issued for:

• Competact 15mg/850mg tablets, an anti-diabetic medicine used to treat type 2 diabetes
• Estradot® 75 microgram patches, a hormone replacement therapy (HRT) patch

Full details of the SSPs issued to date can be found in the table at annex A. Examples of published SSPs are in annexes C and D.

The effect of SSPs on the medicines market

Medicines shortages are an ongoing issue that DHSC has been managing for many years. The production of medicines is complex and highly regulated, and materials and processes must meet rigorous safety and quality standards. Supply problems can arise for various reasons such as manufacturing issues, problems with the raw ingredients and batch failures.

DHSC has well-established processes to manage and mitigate the small number of supply problems that may arise at any one time due to manufacturing or distribution issues.

The department receives regular reports from the pharmaceutical industry about issues which may potentially interrupt the supply of medicines that may affect UK patients. As a result, not all medicine supply issues will result in a shortage.

Since January 2019 it has been a mandatory requirement for the pharmaceutical industry to report issues that could potentially disrupt the supply of medicines and affect UK patients.

These requirements aim to address the ongoing concerns about medicine supply issues and to ensure that DHSC has relevant information at the earliest point possible to help manage supply shortages and mitigate any potential impacts on patients.

The medicines market is never static. So when considering whether an SSP is needed, or once one is in place, DHSC constantly monitors the market and stays in contact with suppliers. This enables SSPs to be introduced, withdrawn, amended or extended in a timely manner to take account of changes in the supply situation.

An example of this is flexibility can be seen with the first 3 SSPs which were introduced in October 2019 for fluoxetine 10mg, 30mg and 40mg capsules. Because the supply situation for the 10mg capsules improved, DHSC was able to end the SSP early. Similarly, ongoing supply problems with the 30mg and 40mg capsules meant that the SSPs were extended beyond their original end dates.

There have also been instances where proposed SSPs were shelved after an improvement in the supply situation meant that they were no longer required. In addition, SSPs have not been used in situations because there were inadequate supplies of the alternative medicine that would be supplied in accordance with the SSP and it would have led to a shortage of another product.

At no point in the operation of the SSP policy to date have DHSC officials received or been made aware of any concerns or negative effects on the market for prescription-only medicines as a result of an SSP being in place.

The effect of SSPs on patient safety

Patient safety is a key factor in deciding whether to use an SSP to manage a shortage. As well as being agreed upon by clinical experts, every draft SSP is reviewed by NHS England’s National Medical Director and Chief Pharmaceutical Officer, who can suggest amendments and exclusions and raise any potential safety concerns about the SSP.

All SSPs include a section on those patients who are excluded from being supplied in accordance with the SSP. Pharmacists must also use their professional judgement to decide whether it is appropriate for any patient to be supplied in accordance with an SSP. In addition, patients must consent to be supplied in accordance with an SSP. In the event that either the pharmacist or patient has any concerns, the pharmacist must refer the patient back to their prescriber, as would happen if an SSP was not in place.

DHSC has always been clear that SSPs will not be suitable for all medicines and patients. For example, they would not be suitable for patients with complex medicine regimes, and protocols for generic or therapeutic alternative medicines would not be suitable for patients who need to be prescribed medicines by brand for clinical reasons, such as patients with epilepsy. In these cases, patients would be referred to the prescriber for any decision about their treatment. To date, the requirement to notify the prescriber has only been included for the SSP for Estradot® 75 microgram patches, as swapping HRT treatments can cause side effects, even if the substitute has the same active pharmaceutical ingredient.

At no point in the operation of the SSP policy has DHSC yet received or been made aware of any concerns or negative effects on patient safety as a result of an SSP being in place.

Stakeholder consultation

As part of this review, a stakeholder consultation was held between 3 November and 24 November 2020.

The consultation was conducted by email and sent to 16 organisations representing the medicines industry, pharmacy groups, medical groups and patient organisations. A full list of the organisations consulted, along with the text that was sent to them, can be found at annex B.

Stakeholder views were sought on the following questions:

Have you had, or been made aware of by colleagues or stakeholders, any concerns about the impact of the SSPs issued over the past year on the prescription-only medicines market?

Have you had, or been made aware of by colleagues or stakeholders, any concerns about the impact of the SSPs issued over the past year on patient safety?

Eight responses were received. Of these, none had, or had been made aware of, any concerns about the impact of the SSP on either the prescription-only medicines market or on patient safety.

Conclusion

In the 12 months that the SSP policy has been in effect, DHSC is not aware of any concerns being raised about the effect on the medicines market or on patient safety for any of the SSPs that have been issued to date. None of the responses to the stakeholder consultation held as part of this review indicated any concerns about the policy.

Engagement with stakeholders has, rather, shown that SSPs have received a largely positive reception and are viewed as being beneficial, both in managing medicines shortages and in saving time.

DHSC continues to closely monitor the SSP policy to ensure that patients, pharmacists and prescribers continue to benefit from the use of SSPs, and that SSPs are safe for patients and do not distort the medicines market.