The European associations representing manufacturers of medicinal products, parallel distributors, pharmaceutical wholesalers and pharmacists have announced a series of recommendations on the provision of information, designed to help tackle medicines shortages.
Focusing on the transparency and the availability of medicine shortage data, the Associations’ statement is part of their wider commitment to tackling the issue. Evidence suggests it is an increasing problem across the European Union, having a significant impact on patients, on health professionals, on healthcare systems and suppliers.
The recommendations call for greater transparency and availability of medicines shortage data, early detection and assessment of potential shortages, consistency of reporting, increased access to the information available across all parts of the supply chain, improved data infrastructure, and collaborative governance processes.
The recommendations aim to mitigate the impact of shortages on patients, provide patients and health professionals with up-to-date, meaningful information and improve the ability of health systems to diagnose and solve supply issues as they arise.
This statement builds on existing good practices and recommends some specific features of ideal medicines shortages information systems. The European associations representing manufacturers of medicinal products, parallel distributors, pharmaceutical wholesalers and pharmacists hope that, taking into consideration the national specificities of each country, these recommendations can help enhance information systems at a national level, and potentially form the basis of future European level action.
The number of reports of medicine shortages in the EU is increasing(1.;2.). Shortages are occurring across the supply chain and all classes of medicines are affected, from complex chemotherapy agents and anaesthetics to diabetes, hypertension, and asthma medication.
There are a number of reasons why some medicines are sometimes unavailable. The medicines supply chain is highly complex and its efficiency relies on the performance of each individual supply chain actor including raw material suppliers, manufacturers, wholesalers, community pharmacies and intermediaries. If there is a disruption at any point of the supply chain, shortages can occur. However, there is still very little reliable EU wide data available and therefore there is no clear understanding of the scope and extent of the problem.
Patients, who have been traditionally accustomed to a highly reliable medicines supply in Europe, find it difficult to understand why a medicine is unavailable, and often become distressed. If a prescribed medicine is not available, the patient is prescribed an alternative, which in some cases is not adequate and may be more expensive. Where there are no alternatives available, and the patient does not receive his/her treatment, the outcome may be fatal. Ultimately, not only it can affect treatment outcomes of individual patients, but also patients lose confidence in the health system.
In order to better understand the extent of medicine shortages in the EU, PGEU conducted a survey among its members, national community pharmacy associations at the beginning of 2012. According to the survey results, although some countries are more affected than others, all respondents to the survey have reported medicine shortages. According to the survey, a broad range of medicines is affected, including even basic medication such as aspirin (3.). The survey suggests that the prevalence of medicine shortages has increased in the past year- just in the UK over 1 million branded medicine supply failures occur each year (4.).
Shortages are of great concern to community pharmacists, and in some countries already affect their daily practice. In the UK, pharmacy staff spends an average of three hours each week sourcing medicines, which they are not able to order from their usual wholesaler (5.). This equates to 156 hours per UK pharmacy per year. Community pharmacists often turn to the national or regional community pharmacy network to source medicines.
This is a growing problem not only in the EU, but globally too, and it affects both richer and poorer EU Members. The causes are diverse, but the dangers are clear: patients have to wait for medicines or even have to go without them altogether. We need to tackle the multiple causes of shortages, it’s time for governments to recognise that the problem is real, and to develop policy accordingly.
Please find here bellow PGEU Statement on Medicine Shortages and its press release: