Europe still stuck in drug shortages

According to the latest annual survey by the Pharmaceutical Group of the European Union (PGEU), which represents pharmacists in European Union countries as well as the United Kingdom, drug shortages across Europe worsened in 2020.

Cardiovascular, vaccines, respiratory and nervous system among worst affected

According to the survey - which included responses from 26 countries - 65% of respondents believed that the situation had deteriorated compared with the previous year. The therapeutic areas worst affected by shortages, according to the survey, were:

• cardiovascular medicines,
• vaccines,
• respiratory disease medicines, and
• medicines to treat nervous system disorders.

Approximately 65% of the respondents (representing individual countries) reported shortages of more than 200 medicines during 2020, up from 58% in 2019.

As many as 96.15% of respondents stated that shortages caused stress and inconvenience to patients, and 80.77% said that they led to treatment interruptions; 57.69% of respondents stated that co-payments were increased due to shortages. Furthermore, 92.31% of participants claimed that shortages led to financial losses due to additional time invested in mitigating the problem.

The average amount of time per week spent by pharmacy staff on mitigating drug shortages in 2020 was 6.3 hours. In 21 out of the 26 countries surveyed, generic substitution was permitted as a mitigation mechanism, although in only 13 was it possible to import medicines from another country - and in only six out of the 26 countries was it possible to revert to therapeutic substitution.

Pharmacists ''twinning'' to tackle drug shortages

The national associations of pharmacists in France, Italy, Portugal, and Spain have recently completed a project - originally initiated in November 2019 - to improve medicine shortage detection. The year-long project sought to inform the design of a future pan-European shortage notification system. It was developed within the Digital Health Europe framework, funded by the European Commission, and referenced the real-time supply notification system (CisMED) implemented by the General Council of Pharmaceutical Associations of Spain (CGCOP).

According to a report in Spanish source Portalfarma, the project was able to detect cross-country patterns as well as differences in drug shortage trends that have emerged during the coronavirus disease 2019 (COVID-19) virus pandemic. All four countries experienced supply issues affecting drugs for the central nervous system (CNS) in 2020, with Spain and Portugal in particular reporting shortages of antidepressants and anxiolytics. There were notable differences in the evolution of supply issues affecting respiratory system drugs, which were attributed to variations in the progression of the COVID-19 virus pandemic between the countries.

The initiative culminated in recommendations for the design of a pan-European drug shortage notification system, with key recommendations including the need for national-level reporting systems collecting information at the pharmacy level based on automatic reporting, and international co-operation.

Outlook

The project paves the way for the development of future collaborative solutions in this area in Europe, at a time when drug shortages remain a highly topical issue across the region. With the COVID-19 pandemic, supply issues have been exacerbated by factory closures and lockdowns affecting major Asian drug exporters, exposing the need to reinforce the European Union's domestic manufacturing capabilities. Debates on the importance of strengthening self-sufficiency in pharmaceutical supply will continue as many regard Europe as being excessively dependent on China and India for drug supply, leaving pharmacists and patients vulnerable to future exacerbations in shortages. According to a recent study carried out on behalf of German generics association Pro Generika, two-thirds of compliance certificates for APIs for EU-approved products are held by producers in Asian countries, compared with around one-third in 2000.

Notably, however, the stabilization of supply from China and India in the second half of 2020 that followed the significant supply bottlenecks in the first half of the year, meant that API reshoring has moved off the top of the EU's agenda, while other issues - including vaccines - have come to dominate the health agenda. One major boost to Europe's pharma self-sufficiency was the announcement in July last year that thanks to a joint project with the Austrian government, Novartis subsidiary Sandoz would continue to manufacture key antibiotics in Europe - including the API penicillin.

In the meantime, the ''twinning'' project is aiming at implementing a European information-sharing mechanism for pharmacists, but more specific follow-up plans have yet to be formulated. And for the foreseeable future, regular shortages and outages of medicines will be a challenge that pharmacists will have to manage, while the structural imbalances in the market and the insufficient financial incentives continue to deter manufacturers from investing in high-volume, low-price products.

Posted 10 March 2021 by Anne Charlotte Ackermann, M.A, Principal Analyst, Life Sciences and

Brendan Melck, Senior Research Analyst, Life Sciences, IHS Markit and

Ewa Oliveira da Silva, Senior Analyst, Life Sciences