According to the 2019 Medicines Shortages Report by European Association of Hospital Pharmacists (EAHP) the problems with shortages have continued to worsen. Most hospital pharmacists (95%, N=1806) reported that shortages create issues in delivering the best care to patients. In 2014 the figure was 86%. Furthermore, 81% of hospital pharmacists stated that they have experienced more than three shortages for medicines provided only by a single pharmaceutical company.2
Medicines shortages can occur for several reasons, and they may be unexpected. Depending on the product, expected duration of the shortage and alternatives available can be frustrating and difficult to manage. It’s all very unpredictable, but overall, there seems to be more and more supply issues.1
An example of the unpredictable nature of medicines shortages happened early in the COVID-19 pandemic, when the public was panic buying paracetamol. This led to stock shortages for many weeks. Before the pandemic, this would have been impossible to predict.1
And for the last year or so, COVID-driven issues in demand have directly affected rheumatology patients. There have been problems with some medicines due to their success in treating patients with severe COVID-19 symptoms. This has caused issues in the supply chain, affecting rheumatology patients who use these products to manage their conditions, such as rheumatoid arthritis. As above, before the pandemic this would have been entirely impossible to predict.1
Medicines shortages arise for many reasons, which can occur due to a range of often unforeseen events and even a combination of factors. Sometimes the reason is unknown.1
When asked by the EAHP what hospital pharmacists believed to be the possible reasons for medicines shortages, the top three answers were: the global shortage of an active pharmaceutical ingredient (API), issues in manufacturing process, and supply chain problems.2
Pharmaceutical companies forecast production based on expected demand, and they usually don’t have significant reserves.3
Adapted from NHSE&I, 2019, A Guide to Managing Medicines Supply and Shortages3; EAHP, 2019, Medicines shortages report2, and S. Butler’s clinical experience1
Medicines shortages arise for many reasons, which can occur due to a range of often unforeseen events and even a combination of factors. Sometimes the reason is unknown.1
When asked by the EAHP what hospital pharmacists believed to be the possible reasons for medicines shortages, the top three answers were: the global shortage of an active pharmaceutical ingredient (API), issues in manufacturing process, and supply chain problems.2
Pharmaceutical companies forecast production based on expected demand, and they usually don’t have significant reserves.3
Regardless of the reasons for shortages, patients will either have to go without treatment, accept an alternative treatment, suffer a delay in treatment, or incur some difficulty by trying to obtain treatment via another source.1
The determining factor of the impact on the patient is often the availability of a suitable alternative medicine. However, the outcome depends on many patient and disease related factors, such as the condition, half-life of the drug, treatment withdrawal effects, and potential for loss of disease control. Other potential consequences include stress and anxiety to the patient and additional workload for the pharmacist and prescriber.1
In the 2019 Medicines Shortages Report by EAHP, hospital pharmacists identified the main consequences of medicines shortages. The top three were delays in care or therapy (42%), suboptimal treatment including inferior efficacy (28%) and cancellation of care (27%). Other issues listed were increased length of stay in hospital, increased monitoring of patient, medication error, adverse events/greater toxicity, transfer of patient to a facility where a medicine can be provided, treatment failure, readmission due to treatment failure, and in unfortunate circumstances, death.2 In the UK, patient safety incidents have occurred when medicine doses have been omitted or delayed because of shortages. Problems have also occurred from misidentification or misuse of alternative medicines.4
Indeed, supplying alternative medicines comes with risks, such as alternative product not being so easily recognisable because of infrequent use, and therefore being mis-selected for another medicine at the point of dispensing. There may also be errors in dosing, preparation or administration. Yet another point for additional risks occurs when the original medicine is back in stock and reintroduced to the patient.4
Unfamiliar packaging, or for example the use of parallel imports can lead to dispensing errors due to unfamiliarity or for example, occasional mis-supply of a patient information leaflet in a different language. Using alternative medicines may also mean patients are prescribed a medication that proves less effective for them or is associated with more adverse events than the original treatment. Patients may respond to treatments in an unpredictable manner, and this could happen for example if a brand was switched.1
Indeed, swapping to alternatives isn’t always straightforward. Some patients on certain medications should not swap between brands at all, as this could be detrimental to their treatment.1 A list of medicines that should be prescribed by brand can be found on the SPS website.5
Economic implications for the pharmacy can also arise from the extra time spent managing shortages. For example, trying to source the product or alternatives, contacting the patient and prescriber to make alternative arrangements, and applying additional monitoring or training. Alternative medicines might also be considerably more expensive than the originally prescribed medicine.1
Delays are still better than patients having to stop treatments altogether. In those instances, effects could include withdrawal symptoms, loss of disease control and relapse.1
Given all the possible issues that come with medicines shortages, it is clear that emphasis must be put on the contingency arrangements, as have been put in place by all Trusts around the UK.1
Each supply issue has specific characteristics and should be managed individually. Guidelines by NHS England cover general processes. DHSC Medicine Supply Team, consisting of pharmacists and pharmacy technicians, is responsible for the day-to-day management of medicine supply issues.3
Local management of supply disruptions in secondary care is led by the Pharmacy Teams in NHS Trusts and Collaborative Purchasing Organisations. The Chief Pharmacists of NHS Trusts are responsible for overseeing the local management.3
Clinical pharmacists can help at a local and national level. For example, if your patients are affected, you can contact local specialists as well as colleagues nationally to raise awareness, explain likely duration, and discuss alternative treatments and strategies.1
Once notified of an issue, the DHSC Medicines Supply Team and/or the NHSE&I Commercial Medicines Unit carry out a risk assessment. This is done to evaluate the nature and duration of the problem, determine the potential impact on patients, and decide what type of management options should be considered. The Medicines Shortage Response Group supports the management of supply issues categorised as high impact (Tier 3) or critical (Tier 4), and provides advice on issues categorised as Tier 1 or 2 only when requested to do so.3 Risk assessment Tiers and their management options are shown in Table 1.
Risk assessment tiers and their management options3
| Tier | Potential impact on patient | Management options |
| 1 | Low impact | Management options should result in patients being maintained on the same licensed medicine |
| 2 | Medium impact | Management options are more intense and may carry a greater risk to patients/health providers than Tier 1 issues. Options include using e.g. low risk therapeutic alternatives or alternative strengths or formulations. Local implementation without further escalation. |
| 3 | High impact | The response is nationally coordinated and guided and the NHS may invoke the Emergency Preparedness Resilience and Response (EPRR) function. |
| 4 | Critical | Use of additional support from outside the health system and dedicated national NHS EPRR incident processes and procedures, which provide support |
Table 1. As part of the assessment an initial decision is made about the severity of the issue and Tier allocation.
Adapted from NHSE&I, 2019, A Guide to Managing Medicines Supply and Shortages3
Management options can vary greatly according to situation, and one way to manage shortages can be by supporting the redistribution of stock between NHS Trusts.3 There have also been examples of priority being given to certain indications during a shortage. Furthermore, existing patients’ supplies may be prioritised over new starters, because the new patients can start treatment with an alternative product.1
It is always useful to understand the nature of the supply issue, because it will help you make a judgement about the reliability of the given resupply date. The knowledge of the estimated duration of the issue and the date for resupply will also be useful in conversations with patients.1
Patients are kept informed when there is information around a solution or likely duration of the issue. It is important to give your patients an explanation of the situation and suggested resolution. Patients really appreciate an open, honest, truthful approach, even if that means explaining that we simply do not know when resolution will be. It’s also good to acknowledge patients’ possible fears and worries.1
The DHSC Medicines Supply Team and NHSE&I Commercial Medicines Unit can also advise on how to communicate the supply problem where needed. This includes working with relevant patient groups to develop tailored patient communication.3 Patients are usually fairly accepting, and they understand that these situations are beyond clinicians’ control. The important thing is to work together to find a solution.1
The DHSC Medicines Supply Team and the NHSE&I Commercial Medicines Unit work with manufacturers and other relevant stakeholders and consider a range of options which might include:
It is always useful to understand the nature of the supply issue, because it will help you make a judgement about the reliability of the given resupply date. The knowledge of the estimated duration of the issue and the date for resupply will also be useful in conversations with patients.1
Patients are kept informed when there is information around a solution or likely duration of the issue. It is important to give your patients an explanation of the situation and suggested resolution. Patients really appreciate an open, honest, truthful approach, even if that means explaining that we simply do not know when resolution will be. It’s also good to acknowledge patients’ possible fears and worries.1
The DHSC Medicines Supply Team and NHSE&I Commercial Medicines Unit can also advise on how to communicate the supply problem where needed. This includes working with relevant patient groups to develop tailored patient communication.3 Patients are usually fairly accepting, and they understand that these situations are beyond clinicians’ control. The important thing is to work together to find a solution.1
Local capacity to investigate and manage shortages varies, yet it is important to take action to avoid premature escalation and to resolve most supply issues locally. This would include all shortages in Tier 1 and Tier 2.3
If you can’t source original medicine from alternative routes, and different strengths or formulations are not available or suitable, consider alternative treatments. To do that, you can discuss with local procurement team and with local specialists, such as pharmacists and other medical professionals. In principle, you should first look at alternatives with a UK product licence for the same indication. Remember to also consider the supply chain of any alternative treatment, it may become fragile and create yet another shortage.1
If you can’t find a UK licensed product, continue consultations with the clinician and the local procurement team.1 More information can also be found in the guidance by the General Medical Council: Good practice in prescribing and managing medicines and devices.6
If the shortage cannot be managed locally, the Regional Pharmacy Procurement Specialist is responsible for escalating the issue to the DHSC Medicines Supply Team and/or the NHSE&I Commercial Medicines Unit for advice.3
It’s difficult to predict possible shortages even with the knowledge of supply capacity and expected demand. But pharmacists can prepare for medicines shortages and even help prevent them. In secondary care, pharmacists have a national list of critical medicines and share information about where medicines are stocked. Also, pharmacists often share information regarding alternative suppliers via networks, such as the UK Rheumatology Pharmacists group.1
Critical medicines can pose a major risk, if they are only available from a single manufacturer. Risks can be reduced by contingency plans, including actions such as gathering information about alternatives, and deciding whether to increase the Trust’s stock of the product.4
It would be helpful to see pharmacists given more flexibility when there is a serious ongoing shortage especially in the community sector, to make substitutions without having to refer back to the prescriber. Going back and forth can cause delays to patient treatment. This has been seen for example with the recent shortage of some types of HRT therapy.1
Further improvements in managing medicines shortages could include taking advantage of digital capabilities. But the most important practice a pharmacist can promote to help minimise the impact of medicines shortages is communication. It really is key.1
To learn more about medicines shortages, see the reference list below and download the accompanying infographic on how to manage medicines shortages at local level.
References and further reading: 1. Lead Rheumatology Specialist Pharmacist, Stephanie Butler’s clinical experience and insights from her practice at University Hospitals Sussex. 2. EAHP, 2020. 2019 Medicines shortages report. Available at: https://www.eahp.eu/sites/default/files/eahp_2019_medicines_shortages_report.pdf [Accessed July 2022]. 3. NHSE&I, 2019. A Guide to Managing Medicines Supply and Shortages. 000920. Available at: https://www.england.nhs.uk/wp-content/uploads/2019/11/a-guide-to-managing-medicines-supply-and-shortages-2.pdf [Accessed July 2022]. 4. Cousins D. et al. Managing risks arising from medicine shortages in NHS hospitals. Pharmaceutical Journal, August 2012. Available at: https://pharmaceutical journal.com/article/research/managing-risks-arising-from-medicine-shortages-in-nhs-hospitals [Accessed July 2022]. 5. SPS, 2022. Example medicines to prescribe by brand name in primary care. Available at: https://www.sps.nhs.uk/articles/example-medicines-to-prescribe-by-brand-name-in-primary-care/ [Accessed July 2022]. 6. GMC, 2021. Good practice in prescribing and managing medicines and devices. Available at: https://www.gmc-uk.org/-/media/documents/prescribing-guidance-updated-english-20210405_pdf-85260533.pdf [Accessed July 2022].
GB-RA-NA-202207-00001 | Date of preparation: December 2022
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Date of preparation: October 2023
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© 2022 Galapagos NV. All rights reserved.
GB-IBD-FIL-202208-00005 |
Date of preparation: October 2023
Contact Us
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