Medicines Shortages Policy: Solutions for empty shelves (Royal Pharmaceutical Society, 26 November 2024)

Summary

The three national pharmacy boards at the Royal Pharmaceutical Society (RPS) identified medicines shortages as a key policy area that is impacting patients, pharmacy teams, clinicians and wider groups throughout the NHS. As a result, in January 2024, RPS commissioned a report into medicines shortages.

This report is the culmination of extensive engagement and collaboration with patients, the pharmacy profession, wider healthcare professionals and the key local, regional and national stakeholders integral to ensure the continuity of medicines supply.

The report concludes by setting out 19 recommendations.

Content

Recommendations

UK National Policy

Recommendation 1: Publish a UK-wide strategy for shortages

The UK government should develop a cohesive cross-government and NHS strategy to improve medicines supply chain resilience and medicines security in the context of changing pharmaceutical market dynamics and the ongoing increases in medicines shortages globally. The strategy should incorporate current national policy, ongoing work and existing measures, and create greater alignment in managing shortages across primary and secondary care.

Recommendation 2: Recommendation 2. Support UK manufacturing infrastructure for medicines

The Government should boost UK medicines manufacturing infrastructure, in both commercial and NHS manufacturing units –particularly generic manufacturing, which accounts for 80% of medicines prescribed in the NHS. UK manufacturing infrastructure offers the potential for a more rapid response from manufacturers to help mitigate acute national medicines shortages.

Recommendation 3: Flexibility in existing medicines regulations to speed up access

Building on the learning applied during the COVID-19 pandemic, existing and potential regulatory flexibilities should be explored with the MHRA. Recognising that nothing should be done to undermine the purpose of regulation, timely opportunities to flexibly use existing regulations in acute supply challenges associated with national shortages should be identified. For example, enabling medicines manufacturers to reactivate dormant market authorisations more rapidly so they could potentially supply medicines in acute shortage.

Recommendation 4: Make better use of pharmacists’ skills

The Government should enact legislation to enable community pharmacists to make minor amendments to prescriptions in line with existing hospital practice, RPS policy and the recommendation of the Health and Social Care Select Committee report into pharmacy. Organisations, professional bodies and regulators should identify where pharmacist prescribers can use their prescribing qualification to help manage the impact of medicines shortages on patients and develop pathways to enable this role.

Recommendation 5: Reiterate the legal and ethical responsibilities of the supply chain

Organisations and professionals in all parts of the supply chain, from manufacturers to wholesalers, pharmacists and prescribers, should understand their responsibilities to patients to enable appropriate, equitable and ethical access to medicines. The 2013 guidance published by the Department of Health Supply Chain Forum – Best practice for ensuring the efficient supply and distribution of medicines across the supply chain (2013) – should be refreshed (or an equivalent developed) and re-promoted to reinforce the behaviours expected in all parts of the supply chain.

Recommendation 6: Review the community pharmacy contractual framework

The community pharmacy contract in each of the UK nations should be reviewed to ensure that, while acknowledging a pharmacists professional and contractual responsibilities, it minimises the risk of individual contractors incurring a potential loss on the purchase of medicines and supports a stable supply of medicines to patients.

Predicting, reporting and responding to shortages

Recommendation 7: Earlier reporting of shortages by Marketing Authorisation Holders

Timely and accurate information on supply disruptions and shortages should be provided by medicines manufacturers. Marketing Authorisation Holders should work with DHSC to find ways to improve the reporting of medicines shortages and the provision of ongoing information to help mitigate shortages, with a focus on early and consistent information sharing. Developing a more meaningful performance management approach to reporting that promotes good practice, distinguishes between planned and unexpected shortages and actively penalises repeated poor performance would facilitate this.

Recommendation 8: Enable greater data sharing to support planning and predict demand

The NHS and manufacturers/wholesalers should proactively collaborate to share data, for example, NHS data that enable manufacturers/wholesalers to better predict demand for their products and manufacturer/wholesaler supply chain data that enable the NHS/DHSC to proactively manage the medicines supply chain to minimise disruption and increase resilience of supply.

Information flows

Recommendation 9: Expand and develop information cascades

Information cascades about medicines shortages from DHSC and relevant NHS national medicines supply teams to the wider healthcare system should be reviewed to ensure that they are reaching the right people at the right time. All organisations that cascade or need to act upon information about national shortages should review and develop systems to ensure that information is cascaded to and accessed by those that need it. Equally, healthcare professionals should be aware of their responsibility to access this information and act promptly.

Recommendation 10: Further Involve patient groups to support information sharing

Patient groups should be a fundamental part of information cascades to facilitate the appropriate sharing of consistent and accurate information to patients. This will enable patient groups to provide support for patients experiencing acute national shortages of their medicines.

Recommendation 11: Fund, promote and develop the DHSC/NHS Medicines Supply Tool

The DHSC/NHS medicines supply tool hosted on the SPS website (sps.nhs.uk). should be the single source of accessible, consistent, accurate and rapidly updated information about medicines shortages for healthcare teams across the UK. As well as promoting the current tool more widely to healthcare teams, its utility should be increased. There should be funding for the integration of the tool into prescribing systems to alert prescribers to shortages and enable alternatives to be prescribed in real time to provide proactive updates, for example, when medicines are no longer in shortage, and to developing an app-based format to enable easier access to the information.

Recommendation 12: Improve systems that provide timely information at the point of dispensing

Wholesaler and community pharmacy IT systems should be developed to provide resupply dates for medicines out of stock to enable more meaningful communication with patients and help pharmacists to more rapidly distinguish short-term supply disruptions from national shortages. This is only possible with the provision of accurate and timely information from medicines manufacturers.

Local systems

Recommendation 13: Develop patient-centred pathways to manage shortages in local systems

Continuity planning in local systems should account for the resources required for healthcare teams to manage medicines shortages. Local systems should have protocols for the management of a medicines shortage that works across a locality, particularly between GP surgeries and community pharmacies, to ensure that they continue to minimise the impact of shortages on patients and do not exacerbate health inequalities.

Recommendation 14: Invest in the resources needed to manage medicines shortages

NHS organisations should review whether they have sufficient resources in pharmacy teams to mitigate and manage medicines shortages. Any investment required needs to be weighed against the opportunity costs of healthcare teams managing a shortage and the impact on patients’ health outcomes and quality of life, not just the cost of alternative medicines.

Recommendation 15: Develop cross-sector protocols for shortages of life-critical medicines

Cross-sector emergency protocols for life-critical medicines where patients have no alternative treatment should be developed. This will require collaborative working across local systems and the use of regulatory flexibility to allow medicines to flow between primary and secondary care. There should be national/regional oversight to ensure this happens.

Recommendation 16: Fund and recruit regional procurement specialists to work across sectors

In England, NHS specialist pharmacy services’ regional network of procurement specialists should be funded to work with ICBs to facilitate the development of cross-sector approaches to acute medicines shortages. In Wales, Scotland and Northern Ireland, equivalent arrangement should be established.

Recommendation 17: Prioritise supply chain resilience within secondary care contracts

Supply chain resilience measures and management of lead times should be further developed and incentivised in awarding secondary care and homecare contracts, which should be proactively managed with suppliers to minimise avoidable causes of supply disruptions.

Education, training and research

Recommendation 18: Educate healthcare professionals, patients and the public on shortages

Joint education programmes for healthcare professionals should be developed to support wider understanding of how UK systems operate end-to-end to mitigate and manage medicines shortages, and highlight common misconceptions about their causes and how to manage them. This will improve transparency and understanding across the supply chain and improve opportunities for shared education and training. All pharmacy teams and students should be trained in where to find accurate information about medicines shortages, and in how to have proactive, informed and supportive conversations with individual patients and the wider public regarding medicines shortages.

Recommendation 19: Understand the economic cost of shortages to healthcare organisations and systems

The research base on the costs of medicines shortages should be developed to inform resourcing decisions and underpin investment in resources and the implementation of quality improvement programmes. This should include not just the cost of alternative medicines but the wider costs to the healthcare systems and the clinical impact on patients in terms of their health outcomes and quality of life.

Recommendation 20: Understand the impact of speculation and digital purchasing systems on the supply chain

Further work needs to be done to understand the extent to which speculation exists within wholesale and medicines brokering activities and the extent to which the use of automated purchasing platforms is disrupting demand prediction and purchasing patterns. These factors have the potential to confuse the issue of medicines shortages locally.

Read the full report on the Royal Pharmaceutical Society's website via the link below.