Action in the supply chain

To minimise patient impact, all supply chain actors, including hospital pharmacists, wholesalers, manufacturers and national competent authorities, have the obligation and responsibility to collaborate more closely in terms of resolving the shortages problem. When it comes to medicines availability, hospital pharmacists are the key information holder inside the hospital. They are responsible for sharing relevant notices on forthcoming shortages with colleagues, including the hospital management and with hospital pharmacies about likely and current shortages. Such communication should be carried out in a timely manner and contain insights on how imminent the issue is, the expected duration of the shortage and whether alternatives are available. Communication between supply chain actors should be facilitated by national competent authorities to make sure that each entity works diligently and with urgency on bringing to an end the shortage difficulties that are currently experienced throughout Europe. The overarching objective of these collaborative actions must be that the entire supply chain works together in minimising the detrimental effects on patients.

Managing medicines shortages and ensuring continuity of supply can cause the diversion of significant amounts of time4 and attention from other important tasks that a hospital pharmacist must perform in the provision of high quality, safe and efficacious care. It can also add to already high levels of stress experienced at the workplace. As shown in the results of the 2018 EAHP Medicines Shortages Survey, medicines shortages have the potential to result in increased medication error rates and lead to the delay or even the cancellation of therapies. Furthermore, efforts to reduce costs in health systems are very often undermined by having to opt for either a more costly or a less effective alternative that, in the long term, augments the use of financial resources by increasing the likelihood of hospital stay or readmission. Consequently, EAHP urges national governments and healthcare organisations to evoke appropriate staffing levels in order to lower the impact that medicines shortages currently have on the overall patient services provided by hospital pharmacists.

Hospital pharmacists in particular should remain vigilant and alert to the issue of medicines shortages as well as fully engage with prescribers and managers. To this end, they should raise awareness about the issue at local level and ensure the development and implementation of appropriate contingency plans. To better address the impact caused by shortages on patients and their therapy, hospital pharmacists should use and keep up to date their pharmacy skills in order to identify other solutions which can include small scale production of a medicine without a marketing authorisation.

Action at the national level

The results of the 2018 EAHP Medicines Shortages Survey showed that many European countries have reporting systems in place. However, the views on their effectiveness were mixed with only 56% of participants judging their systems to be functional. Given the high degree of divergency throughout Europe, efforts should be made to strengthen the robustness and functionality of these reporting systems.5 Consequently, EAHP appeals for improved information exchange between authorities and supply chain actors as well as best practice sharing and implementation support on shortage management strategies between relevant national regulatory bodies to support patient safety. Ideally, it should be an expectation in each country that medicines are available to pharmacies within 24 hours of having ordered them.

The demand by hospital pharmacists for more timely and accurate information is increasing.2 To achieve higher quality of information, authorities and pharmacy practices should invest in combining their sourced shortages data. Such a measure would safeguard the timely detection of both temporary and permanent shortages since different signals on potential medicines shortages are being picked up by authorities and hospital pharmacists.6 In addition, national regulatory bodies should ensure action is taken against elements of the supply chain found to be in breach of legal and ethical obligations in relation to supply.7 Consideration should also be given to putting in place more rigorous rules on issuing timely alerts about shortage problems. EAHP advises national governments to evaluate if their shortages measures and management systems are fit for purpose and to rectify shortcomings where and when needed. This includes the removal of legal barriers that prevent compounding by hospital pharmacists in case of a medicine shortage.

Action at pan-European level

The problems created by medicines shortages have been widely reported by healthcare professionals6 8 as well as patients9 and acknowledged at the European level by the European Medicines Agency (EMA), the European Commission and the Heads of Medicines Agencies (HMA). This acknowledgement manifested itself on the one hand in the creation of a dedicated task force on the availability of authorised medicines for human and veterinary use,10 and on the other hand through dedicated research funding in the field of medicines shortages from the European Cooperation in Science and Technology (eCOST). Despite the efforts of the European Medicines Shortages Research Network,11 funded by eCOST, the problem of medicines shortages continues to persist. The issues caused by medicines shortages are understood to be multifactorial. However, robust data on the causes are missing. To fill this information gap, EAHP calls on the European Commission to urgently commence an investigation on the medicines shortage problem by focusing on the causal factors and proposing solutions that will help alleviate or solve shortages.

Closer collaboration between member states is crucial for the pan-European solution finding process. The EMA and the European Commission are the most suitable actors to coordinate such action since they can build on their previous work, experience, expertise and involvement to date in this area. Further efforts should, however, be invested in the development of a comprehensive communication strategy, including the introduction of a unified European medicines identification system. Only a comprehensive communication strategy on shortages targeting all European states will ensure that all supply chain actors, including hospital pharmacists, receive adequate information on the shortage of medicines in their countries. National early reporting systems that exist in a number of countries should be complemented by a European-wide database that lists reasons and estimated durations of shortages. In addition, this system should include advice on alternatives which includes the expertise is provided by hospital pharmacists.

EAHP urges the EMA and the HMA to consider the development of a comprehensive communication strategy on medicines shortages.

The position paper on medicines shortages was adopted in June 2019. EAHP’s position papers are reviewed regularly. For information on the latest update of the position paper on medicines shortages please visit http://www.eahp.eu/practice-and-policy/medicines-shortages