Medicines shortages have been a problem in pharmacy for years, but with the potential of Brexit to exacerbate the situation, the issue has become more prominent.
In 2012, the World Health Organisation warned that medicine shortages represented a complex global challenge and in 2013 the first-ever International Summit on Medicine Shortages was held in Toronto. The Toronto Summit agreed that: “A medicine shortage can be defined [as] a drug supply issue requiring a change. It impacts patient care and requires the use of an alternative agent.”
Why do medicine shortages occur?
The European Medicines Agency (EMA) offers three main reasons for unavailability:
- Medicinal products are not authorised. Member States may determine that the availability of a medicinal product is important for patients, but the marketing authorisation application hasn’t been presented for that Member State or the previous valid registration has been withdrawn.
- Medicinal products are authorised but are not marketed.
- Disrupted supply chains directly prevent the availability of authorised and marketed products. These stem from good manufacturing practice difficulties; good clinical practice difficulties; safety concerns; other problems affecting the quality of medicinal products or derived from parallel trade; and lack of continuity within the supply chain of medicinal products.
The EMA notes that the temporary or permanent unavailability of authorised medicinal products is acknowledged as a significant issue in the EU Medicines Agencies Network Strategy to 2020. The EMA further recognises that the global nature of the pharmaceutical industry means that the problem has also to be confronted from a global perspective.
In the UK, independent contractors have had a torrid time in recent years due to generic medicine shortages and turbulent prices. Pharmacists have spent a considerable amount of extra time and effort sourcing stock and, according to the NPA, have “displayed professionalism and put patients first by continuing to supply medicines to patients promptly in good faith, despite knowing that they may be doing so at a loss.” With prices of generic medicines often varying widely, the shortfalls can be significant.
Many independent pharmacies cannot buy bulk stock in advance, therefore they are particularly vulnerable to price instabilities.
Medicine shortages and Brexit
There have been concerns that the UK’s departure from the European Union could create supply bottlenecks. In such circumstances, says the NPA, it is imperative that wholesalers take an equitable approach to distribution, meeting the needs of independents in terms of availability of stock and promptness of supply. It is also important that quota systems are flexible to meet any changes in demand and that they do not cause any unnecessary delays to patients receiving their medicines.
NHS England Chief Pharmaceutical Officer, Dr Keith Ridge, addressed the continuity of supply of medicines as part of the Government’s contingency preparations for a “no deal” EU exit. Commenting that it is “not helpful or appropriate for anyone to be stockpiling medicines locally,” he said: “The government has undertaken a comprehensive assessment of medicines supply to identify products that have a manufacturing touch point in the EU or wider European Economic Area countries.”
The Department of Health & Social Care (DHSC) has been engaged with industry on developing a six-week stockpile of prescription-only medicines and pharmacy medicines to ensure supply for patients is maintained across the NHS. DHSC has also secured contract agreements for additional warehouse space for stockpiled medicines, including ambient, refrigerated and controlled drug storage.
The DHSC asked all key unlicensed and specials suppliers to ensure that by March 2019 they had a minimum of six weeks additional supply in the UK in the event of a “no deal” scenario.
Other mitigations include a system for Serious Shortage Protocols (SSPs). SSPs will give community pharmacies the ability to dispense less, give a different strength or pharmaceutical form or provide an alternative product. It is envisaged that where serious shortages occur, each medicine would have its own SSP that will need to be developed carefully to ensure that it can be implemented in practice.
Waiting longer than usual leaflet
How many times recently have you had to apologise to a patient because they have waited longer than usual for their medicines? When it happens again, a new NPA leaflet might help you to explain the situation and reassure them you are doing all you can.
The leaflet – part of the NPA’s Medicines Supply Chain Toolkit (see box, left) – explains that supply problems with medicines are almost always completely beyond the control of the individual pharmacy team. It explains that it may be necessary for the pharmacist to supply a limited initial quantity of the medicine, whilst they try to obtain the rest. It goes on: “If the supply problem is likely to continue, your pharmacist may need to discuss with your GP whether it might be appropriate to give you an alternative medicine. If this is the case, then your pharmacist can help to arrange for you to receive a new prescription from your GP. In these circumstances, please be assured that your pharmacist will do their best to get the medicines you need as soon as possible. Your pharmacist and GP will work together to make sure that you get the most appropriate treatment and that there are no gaps in your care and treatment”.
Image credit: iStock
The DHSC has been working to develop a six-week stockpile of prescription-only medicines and pharmacy medicines