Medicines shortages – from assumptions to evidence to action

It is hard to image the frustration and worry for patients, their families and clinicians when shortages of essential medicines they depend on occur. Unfortunately this has been the reality for many patients across Europe over recent months.
Addressing the issue of shortages is a priority for the research-based industry in Europe as well as for supply chain stakeholders and national competent authorities. The situation requires more than empathy or ‘lip-service’ – it requires serious engagement and action. 
For patients, any single medicine shortage means a disruption in their treatment. Such a disruption can take many forms, for example, a patient may: 
  • Have to visit multiple pharmacies until he/she finds the treatment (waste of time and additional frustration), 
  • Be substituted on to a different medicine by the pharmacist (causing additional un-ease about managing his/her condition),
  • Be required to go back to the doctor to have a change in treatment plan altogether (leading to uncertainty about treatment effects, adherence, side-effects etc.),
  • In the worse-case scenario, be forced to simply forego treatment (leading to a worsening of the condition, with all the implications thereafter).
We are acutely aware of the impact a medicine shortage can have on an individual patient, but we are insufficiently equipped to measure and foresee how many individual patients are (or will be) affected by a medicine shortage in any given country or region, or to accurately predict the seriousness of the disruption.
The starting point to address medicines shortages is to utilise all the available evidence to understand the extent and root causes of the problem. In recent years industry, academics, supply chain stakeholders, policy makers and patient representatives have increased their attention on defining and developing such metrics. But measurement and analysis is only as good as the data that underpins it. Despite living in an increasing digitalized and data-driven world, we are a long way from making use of all possible information sources at our disposal. Our collective understanding is limited and we risk knee-jerk policy responses based on assumption rather than evidence.  Patients deserve more.
Understanding the causes, addressing the issues. 
In our position paper, published today, we look more closely at the causes and main drivers of medicine shortages. Despite the multiple individual country reports, EFPIA believes that there is still a lack of sound evidence and knowledge about the key drivers and extent of medicine shortages. That lack of understanding prevents us getting quickly to solutions for patients.
One source of information, currently under-utilised, that can make a real difference is the data captured by the national repositories set up in the context of the EU Falsified Medicines Directive. These repositories record the number of prescription medicines supplied by manufacturers in each country as well as the number of packs dispensed in national pharmacies, the number of packs exported (or imported) and, by simple mathematics, allow for the interrogation of the overall level of stock remaining in the supply chain at country level. All this data is recorded in real time and should be accessible to National Competent Authorities for analysis at a very granular level (per day, per week, per month as well as per region, postal code or individual supply chain actor).
EFPIA is committed to working with other supply chain stakeholders in order to ensure that the data stored in the interoperable network of national repositories being set up in the context of the EU Falsified Medicines Directive be used to help to monitor, analyse and understand the causes of shortages.
We are looking to our supply chain colleagues from all sectors to support our efforts to bring additional evidence and transparency to the drug shortage issue to help find solutions that prevent the disruption of patients’ treatment.  
Given the impact on patients, we must use everything we have at our disposal including any data that can help us move from assumptions to evidence and to action.

Nathalie Moll

Nathalie Moll joined the European Federation of Pharmaceutical Industries and Associations (EFPIA) as Director...
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