Researchers highlight steps to be taken in the European Union to manage the challenge of ongoing drug shortages.
When it comes to mitigation and prevention of drug shortages, notifying the affected parties regarding potential threats is crucial. The need for proactive action has been amplified in light of ongoing drug shortages that continue to impact many regions beyond the United States.
In Europe, there have been requirements in place since 2019 requiring pharmaceutical companies in both in the European Union (EU) and European Economic Area (EEA) to notify authorities of drug shortages a minimum of two months in advance. A study published by the Journal of Pharmaceutical Policy and Practice1explores how the notification process in the region works, while diving into facts that could affect notification times.
The study gathered data from eight European nations—Belgium, Croatia, Finland, Germany, Norway, Slovakia, Slovenia, and Sweden—with a total of 18,897 notifications. Investigations determined that 5.2% of all shortage notifications were made at least two months (60 days) in advance as required, while 56.2% of total notifications were made on the start of, or even while the shortage was taking place. In regard to production-related shortages, statistics out of Belgium, Croatia, Germany, and Norway (n = 2097) illustrated that 3.9% of those shortages were notified at least 60 days in advance, but 74.3% were made on the starting day or later.
Out of the eight participating countries, during the 12-month period from June 2021–May 2022, Finland had the highest percentage of shortage notifications at least two months in advance (10.0%) and the lowest percentage of notification on the day of the shortage or after that timeframe (37.7%).
On the other hand, informing nations in advance of these impending shortages can cause repercussions, including medication hoarding by hospitals, pharmacies, and patients, which can further worsen the shortage. Yet, federal governments can dampen these negatives by controlling excessive buying at the wholesaler and pharmacy level, a tactic commonly used by Finland over the years, according to the study.
Simply put, advance notification of potential threats provides national authorities, wholesalers, and manufacturers with additional time to seek alternatives by finding other products to fit specific needs. After all, one could argue that drug shortages are are a national, rather than a global type of disruption.2,3
Overall, investigators found the early notification program to be unsuccessful, noting that “ … implementation of an early notification system for drug shortages is yet to be seen in the EU. Early notification as a routine was not realized in any of the EU/EEA countries that had published data on notification times. The similarity of results across the eight countries studied implies that these results might be generalized to the EU area.”
However, beyond the EU, the United Kingdom is also feeling the effects of drug shortages like many other countries worldwide. To assess this issue, the authors of a study published by Pharmacy conducted a survey4 from September to December 2021 exploring how pharmacists in the region are coping with these challenges.
According to the report, the UK introduced Serious Shortage Protocols (SSPs) as a way to reduce the impact of drug shortages, including in February 2019, when the Human Medicines Regulations (2012) were updated to feature SSPs. By July 2019, there were new changes as per the NHS (Amendments Relating to Serious Shortage Protocols) 2019 regulations.5 In essence, similar to what has been done in Finland, SSPs give community pharmacists the authority to substitute a prescribed drug as set out in the protocol without needing to check with the prescribing practitioner; this is an exception, being that the drug is in short supply. Pharmacists are expected to use their best judgement in terms of figuring out whether it is necessary to supply a drug under the protocol, which could arguably point to a need for additional transparency among pharma companies and healthcare providers.
The data showed that 83% of total respondents (n = 100, from 11 regions in the UK) felt that drug shortages affected them three or more times per week, and over 70% of these pharmacies reportedly spend a range of 1–3 hours each week trying to combat these supply issues. Generally speaking, 93% expressed that drug shortages is in fact an issue, while 61% say it has gotten worse since the start of the pandemic in 2020. The pharma supply chain is centered around the patient, and keeping this in mind, 65% of respondents feel that drug shortages had had an impact on patient care. Via these data, there is a correlation between drug shortages affecting pharmacists’ workloads and the impending case for this impacting quality of patient care, according to the study authors.
Drug shortages are an ongoing issue that will need to be addressed moving forward, so the challenge remains: what is the most efficient way to do so?
1. Ravela, R.; Airaksinen, M. & Lyles, A. State of the European Union’s early notification obligation for drug shortages: enforcement and compliance in eight European countries (2020–2022). J of Pharm Policy and Pract 16, 135 (2023). https://doi.org/10.1186/s40545-023-00646-w
2. European Commission, Directorate-General for Health and Food Safety, Jongh T, Becker D, Boulestreau M, Davé A, et al. Future-proofing pharmaceutical legislation : study on medicine shortages : final report (revised). 2021.
3. Ravela R, Lyles A, Airaksinen M. National and transnational drug shortages: a quantitative descriptive study of public registers in Europe and the USA. BMC Health Serv Res. 2022;22:940.
4. Pharmacy 2023, 11(5), 166; https://doi.org/10.3390/pharmacy11050166
5. Dowden, A. Will Serious Shortage Protocols help ease drug shortages? Prescriber 2020, 31, 29–31.
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