(293) Time trends of prevalence of drugs with suggested shortages in Europe

Background: Shortage of essential medicines has detrimental effects on patients’ health, leading to elevated risk of death, higher occurrence of negative outcomes, and increased chances of medication errors.

Objectives: To investigate the use of medicines with suggested shortages between 2010 and 2023.

Methods: We performed a descriptive study in all individuals present in CPRD Gold (UK) and IPCI (NL) between 2010 and 2023, and in PharMetrics® Plus for Academics (US) [2017-2022] as a negative control. All databases had been previously mapped to the OMOP Common Data Model. We estimated annual period prevalence (%, [95%CI]) of 24 drugs with suggested shortage according to the European Medicines Agency (EMA). Additionally, we estimated annual period prevalence of possible alternatives to those drugs in shortage.

Results: A total of 11,771,177; 2,781,072 and 34,806,847 individuals in the UK, NL and US, respectively, were included in the analysis. A shortage of the antibiotic amoxicillin alone and in combination with clavulanate was declared in Oct 2022 by the EMA due to an increment in their demand. A decreasing trend in amoxicillin alone was observed in the UK from 2010 (12.8% [12.7-12.8]) to 2019 (9.1% [9.1-9.2]), whilst NL presented a lower yet continuous use during the same period (ranged 4.2% [4.1-4.2] to 5.51% [5.5-5.6]). A drop in use corresponding with the COVID-19 pandemic in 2020 (UK: 6.0% [6.0-6.0], NL: 3.6% [3.5-3.6]), and a peak in use in 2022 (UK: 9.6% [9.6-9.6], NL: 4.3% [4.3-4.4]) were detected in both countries. For amoxicillin combined with clavulanate, there was a continuous decrease in both countries and an increase in 2022. In contrast, data from the US show a decreased use of both amoxicillin alone and in combination throughout the study period (e.g., amoxicillin in 2010 and in 2022: 7.0% [7.0-7.0] and 2.4% [2.4-2.5], respectively). Belatacept, an interleukin inhibitor, was also subject to a shortage of demand exceeding production between 2017 to 2023. Belatacept was insufficiently captured in the data bases but the use of its alternative was: systemic tacrolimus increased between 2010 and 2023 in both the UK and the NL: 0.03% (0.03-0.03) to 0.05% (0.05-0.06) in UK, and from 0.03% (0.02-0.03) to 0.06% (0.06-0.06) in NL. In the US, the use of systemic tacrolimus also increased from 0.08% (0.08-0.08]) to 0.10% (0.09-0.10).

Conclusions: Shortages may present in multiple trends, such as increases in use that will exceed production capacity and subsequent decreases or flattening of the curve. Monitoring the utilization of essential medications by analysing their trends over time can play a crucial role in the worldwide effort to combat the problem of medicine shortages. This analysis will be extended to multiple data partners in EHDEN.