Medicine shortages: what is DHSC's proposal to improve the pharmaceutical supply chain?

The Department of Health and Social Care (DHSC) recently published an in depth paper 'Managing a Robust and Resilient Supply of Medicines', outlining the challenges, current systems, and future strategies to address this issue. With nearly 2,000 incidents of supply shortages in 2024 - the highest figure since recording began in 2020, this article looks at the key points of the DHSC paper, including the impact of shortages, their causes, existing measures, and proposed improvements.

Why has the paper been published?

The paper sets the scene - 14,000 licensed medicines in the UK that rely on complex global supply chains in a highly regulated environment to ensure patient safety. Supply chains are generally in good supply, but this is not always the case. The UK faces issues, but is not alone in this, with other countries also experiencing problems from time to time.

The paper seeks to provide transparency around the issues, showing what is already happening, looking for resilience around future steps, and seeking partnership from everyone involved with the health system and medicines supply chain to meet the challenges - from product licence holders to distributors and wholesalers and pharmacies.

The impact of medicine shortages

The impact can be felt on the following:

Patients: Shortages can mean patients do not get the treatment they need or face delays to receiving their treatments, as well as anxiety particularly at a time they least want it. This is especially the case for those relying on critical medicines.
Healthcare Professionals: For professionals already under massive pressure, further time and resources are diverted to sourcing alternative medicines, managing patient concerns, and adapting treatment plans.
Systemic Challenges: Supply disruptions can strain the NHS, creating inefficiencies and additional costs.

Causes of medicine shortages

Medicine shortages arise from a combination of global and local factors, often interconnected. Key causes include:

Manufacturing issues - This was the most common cause. There is a complex supply chain. Disruptions can arise from various factors, including raw material or packaging availability (20%), production failures or relocation of manufacturing facilities (15%). There can be geopolitical, environmental, societal and cyber shocks - whether wars, travel disruption or cyber attacks. This is in an industry where there are regulatory requirements in order to be able to continue to be authorised to supply active pharmaceutical ingredients as well as other essential items that make up a medicine manufacture and supply. The paper highlighted one example when the UK faced a severe shortage of the radioisotope molybdenum-99 in 2024 due to a sudden disruption in manufacturing capacity after several nuclear reactors had gone out of service, impacting patients globally.
Demand surges - Sudden increases in demand, often due to behavioural changes or media influence. For example, there was increased demand for HRT products in 2022, which led to unexpected requirements. It can take months or even years to scale up production to meet the demand. Consumer demand account for 20% of all notifications.
Regulatory and licensing delays - It is essential that medicines are regulated to ensure patient safety, but compliance requirements can slow down production or distribution, particularly if any of the supply chains fails a regulatory inspection or delays meeting their compliance requirements. This accounted for 10% of notifications of issues.
Logistical challenges - Transportation delays (such as in the Red Sea causing ships to go a different route) or geopolitical events (Russia-Ukraine war) can disrupt supply chains. This accounted for 5% of notification.

Current measures in place

The DHSC and NHS England already has several ways it is monitoring and managing medicine shortages:

Identifying potential disruption:

Relationships with other Government departments and with UK embassies overseas, participating in the Global Regulatory Working Group, where information on medicines supply shortages with a global impact is shared.
Health Service Products (Provision and Information) Regulations 2018 - licence holders have to provide the DHSC with information about the availability of their medicines for at least six months in advance. This is reported through the Discontinuations and Shortages (DaSH) Portal - a reporting tool for pharmaceutical suppliers to notify DHSC of potential supply issues.
Global risk register - the DHSC developed a global risk register to map manufacturing touchpoints within the supply chain to help understand medicines supply chains vulnerability and risk.
Targeted seasonal supply monitoring - for example, when there are particular pressures during winter, so the DHSC and NHS England have a winter monitoring group.
Use of Medicine Supply Notifications (MSNs) to inform healthcare professionals of shortages.

Risk assessment and management:

Cross-cutting disruption - working with a range of internal and external partners to understand the scale of risk posed by large events, feeding into departments and the Cabinet Office.
Undertaking risk assessments at Government level, to understand issues, whether there are alternative suppliers, current stock levels, and ability to expedite deliveries and increased production.
Risk management - High and critical impact issues are overseen by a Medicine Shortages Response Group - a clinically led group of senior clinicians, regulators and professionals. They can look at measures such as:

- Using alternative strengths of the same medicine, such as 2 x 125mg solutions instead of 1 x 250mg solution, or a tablet instead of a capsule.

- Advice on use of appropriate clinical alternatives based on advice from Specialist Pharmacy Service.

- Working with the MHRA to expedite regulatory reviews.

- Sourcing parallel imports from the European Economic Area.

- Sourcing unlicensed medicines - where there is a medicine that may or may not have a marketing authorisation in another territory.

- Using a UK licensed medicine outside of the terms of its licence.

- Proactive monitoring of supply and demand.

- Working with wholesalers to manage the situation.

- Adding to a list of medicines that are prohibited to be exported.

- Working with pharmacies to allow the use of SSPs (Serious Shortage Protocols), to allow them to supply alternative products without returning to the prescriber.

- National Supply Disruption Response (NSDR) - involves an Express Freight Service to expedite the delivery of critical medicines.

Buffer stocks - Since 2022, NHS England has mandated the holding of an eight week buffer stock for secondary care medicines to absorb short-term disruptions. This is to allow for the ebb and flow of demand fluctuations and short-term supply issues.
Communications - When there is a supply issue, the Government provides information through MSNs, National Patient Safety Alerts and SSPs. From 2021, the DHSC and NHS England launched the Medicines Supply Tool to enable healthcare professionals to find out more about shortages.

DHSC's proposals for improvement

The paper highlights that other countries have introduced various measures. The DHSC is proposing several forward-looking strategies to enhance the resilience and reliability of the UK's medicine supply chain:

Earlier identification of disruptions:

Not all suppliers report disruptions in a timely manner. There will be a consultation on how to improve this including looking at the penalties for failure to do so.
Enhanced Data Visibility - leveraging digital tools and commercial datasets to identify early warning signals across supply chains.
Demand Forecasting - collaborating with manufacturers to better anticipate demand fluctuations and prevent stockouts.

Improving reliability and timeliness of supply:

Working to ensure there are enough finished product suppliers in the UK.
Exploring the role of pharmacies in facilitating consistent supply of medicines to patients.
Being mindful of unintended incentives from pharmacy buying systems.
Consulting on pharmacist flexibilities so they can dispense alternative strengths or formulations to improve patient access.
Increasing levels of compliance with eight week buffer stock requirements.
Reactivating dormant licences for critical medicines with limited suppliers in the market, working with the MHRA and Medicines UK (formerly known as the British Generics Manufacturers Association) to identify molecules that could be activated.
Enhancing domestic manufacturing, through strengthening UK-based production to reduce reliance on imports and shorten lead times.
Supporting the new Department of Business and Trade Supply Chain Centre, which is working in conjunction with business to build resilient supply chains. Health supply chains including medicines are a priority sector within that.

Improved communication and guidance:

Updating 2013 medicines supply best practice guidance - to give suppliers information about how to ensure efficient supply of medicines to patients.
Information for patients, pharmacies and GPs - publishing guides to help patients, pharmacies and GPs with an understanding about shortages and where to seek support. Also, giving better shortage information to GPs through prescribing software integration, that enables them to have better live information on shortages to prevent unnecessary prescriptions for unavailable medicines.

Stronger international partnerships - This can come about through enhancing relations with other countries and groups of countries including the G7, G20, and WTO to harmonise regulations and share intelligence. There is also an intention to increase the number of trade agreements, and therefore stronger relationships with key pharmaceutical exporters, such as India and the US, will secure supply chains.

Comment

Supply shortages have been an issue for a long time and seem to have been worsening. This has a massive impact on the pharma supply chain, but - even more importantly - patients. The DHSC's paper provides clear explanations of the causes and current actions. By setting out proposals, it underscores the importance of a number of measures to look to address shortages, given that they can come from several directions. This will probably not eliminate shortages altogether, but hopefully the measures will alleviate some of the problems, for the good of everyone including patients.

What are your thoughts on shortages in the pharma supply chain? Please contact Paul Gershlick in our Pharmaceuticals and Life Sciences team to let me know.