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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.