The issue of medicine supply shortages has been highlighted by EPHA and its members throughout 2013, and it once again took centre stage at a recent workshop organised by the European Association of Hospital Pharmacists (EAHP). Already in winter, a common position on the issue has been drafted by members of the European Medicine Agency’s Patients’ and Consumers’ / Healthcare Professionals Working Party.
2014 EAHP Congress, Barcelona
The 19th annual EAHP Congresshighlighted the profound consequences of medicine supply shortages for hospital pharmacists whose activities can be easily disrupted by uncertain supplies of life-saving medicines (e.g., oncology, cardiovascular, emergency meds) but also of vaccines, aneasthetics, antimicrobials, CNS agents, pain medicines, etc. As a result of such shortages, they spend a significant amount of time every week trying to source products and manage shortages, e.g. by formulating/compounding and advising on alternatives and ensuring that no potential errors occur.
This in turn also has a big impact on hospitals, which are faced with increased medicine expenditure, potential public health problems such as antimicrobial resistance, as well as delays and cancellations of treatments and operations. Moreover, lack of medicines can exert a negative impact on the operation of clinical trials and requires altering protocols and formularies in order to continue with ’business as usual’.
The impact on patients is clear and most worrying:
It is important to be aware that shortages have been reported in all EU countries and they appear to occur on a regular basis, whether in hospitals or in community pharmacies. These problems are currently addressed in many ways, e.g. by following standardised protocols, reallocating existing staff and/or recruiting new staff, allocating existing stock in ethical ways, and by following guidelines that have been created at European, national and institutional level. In any case, for hospital pharmacists it will be important to have contingency plans for dealing with procurement problems reated to medicines and other healthcare products.
Moreover, a number of websites in Europe and North America track shortages and expected shortages, encouraged by legislation that is aiming to tackle the problem.
Common Position on Medicine Shortages by PCWP/HCPW
The common position between patients’, consumers, and healthcare professionals’ organisations involved in the activities of the European Medicines Agency (EMA) was developed under the lead of EURORDIS, Rare Diseases Europe in collaboration with EPHA. Our members the European AIDS Treatment Group (EATG), the European Association of Hospital Pharmacists (EAHP) and the Pharmaceutical Group in the European Union (PGEU), as well as two other external partners were also involved as co-contributors. The findings of the revealing surveys on the extent of supply shortages conducted by PGEU and EAHP informed parts of the statement.
It highlights that avoidable shortages such as those related to supply chain problems can cause a patient’s conditions to deteriorate - in the worst case, it might lead to death - and analyses the various causes and consequences of medicine shortages. These include manufacturing problems, medial, regulatory, economic and marketplace issues.
The common position takes a balanced view and describes the impact of medicine shortages not only on patients, but also on health professionals and health system managers, the latter groups forced to rapidly adapt and reallocate capacities and resources in order to cope with the situation.
A number of comprehensive recommendations underline the importance of putting patients first and they are separated into recommendations aimed at the European Medicines Agency (EMA), public authorities, industry, as well as more general short- and long-term measures which also encourage a change of the regulatory framework to better prevent and monitor supply shortages.
EMA workshop on supply shortages
Already in October 2013, the EMA held a workshop on the issue of medicine supply shortages following a Reflection Paper of November 2012. It served as a forum to exchange views and learn what regulators have done so far and what industry can do to tackle the problem. The outcome will be a more comprehensive Concept Paper that will discuss how the impacts of supply shortages can be mitigated for patients.
The stakeholders present (regulators, industry, civil society) agreed that the next steps must first of all include a high level of understanding of what the problems are so that shortages will not occur in the first place, e.g. via improved risk assessment, supply chain resilience, combined with an appropriate system of decision-making and communication. It is important to note that there are many different kinds of shortages and that their reasons are multifaceted. While it is an EU-wide issue that requires increased coordination, national level independent management will also be crucial to manage the situation. In particular there is a need for integrated Action Plans outlining who is responsible for what. The issue of lack of quality data also came up a few times as it is crucial to be aware of triggers where shortages are waiting to happen; Moreover, a clear definition of medicines shortages needs to be elaborated, and the role of wholesalers in the communication process needs to be worked out. The question of how to ensure equity of access to the remaining supply was also identified as a delicate issue that needed to remain on the EMA work plan.
While industry representatives mainly related the problem to global supply chain aspects and competition, they expressed that they would welcome EMA involvement in finding and coordinating flexible regulation processes in the quest for more transparency. EMA stated it would welcome a united industry position on medicines shortages.
There could be many root causes for supply shortages, e.g. decisions on production plants having to be updated and uncertainties related to the length of time it takes to upgrade parts of the manufacturing chain, which leads to further delays. There needed to be more opportunities for companies to sit with authorities to remove uncertainties and increase the likelihood of investment occurring and, potentially, faster approvals. They also called for improved metrics to be sure about the performance of a facility and the possibility to transfer production to other facilities when needed. It was recognised as important for industry to engage with authorities at the earliest possible opportunity so that decisions could be expedited.
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