Analysispedicinih2020

Analysis… Advocating AMR action

EUROPE: Portal speaks to Piernicola Pedicini MEP about his ‘Safer healthcare in Europe: improving patient safety and fighting antimicrobial resistance’ report and what further action Brussels can take to tackle this growing problem.

According to statistics from the European Parliament, an estimated ten million people worldwide will die every year due to antimicrobial resistance (AMR) by 2050, more than the number from cancer. At the moment, 25,000 patients in the EU die annually as a result of infections caused by resistant bacteria, and the costs incurred by AMR amount to around €1.5bn each year due to loss of productivity and an increase in healthcare expenditure costs. However, by improving knowledge of how antibiotics work, the more responsible use of such drugs and developing new medication could help avert such major and devastating losses.

EP debate

In May, members of the European Parliament proposed a blueprint for safer healthcare following a plenary session in Strasbourg. Suggested ways to improve patient safety include tackling growing resistance to human and veterinary antibiotics, using today’s treatments more responsibly, and promoting innovation.
Commenting on the debate, Italian MEP Piernicola Pedicini said: “Austerity measures cannot be imposed in such a way that they affect the safety of patients, staff or experts in hospitals. Every year 25,000 citizens die in Europe owing to the growing resistance to existing antimicrobials, so we must stimulate research into new types of substances. In the veterinary sector, online sales of antimicrobials and their prophylactic use should be prevented.”

Following the publication of his report entitled ‘Safer healthcare in Europe: improving patient safety and fighting antimicrobial resistance’, Pedicini made several recommendations on how to ensure that antibiotics are used more responsibly; suggestions include strictly prohibiting their use without prescription and requiring a microbiological diagnosis before prescribing antibiotics.

Other proposals are implementing marketing practices designed to prevent conflicts of interest between producers and prescribers and improving information on the monitoring of antimicrobial consumption, AMR and infection control. Following a vote by MEPs, the proposals were approved by 637 votes to 32, with ten abstentions.

Parliamentarians are urging pharmaceutical companies to invest in developing new antimicrobial agents and are asking the European Commission to consider proposing a ‘legislative framework’ to encourage the development of new antibiotic drugs.

Piernicola Pedicini MEP

Piernicola Pedicini MEP © European Union 2014 – source: EP

Animal AMR

MEPs are also encouraging the responsible use of antimicrobials in veterinary medicine, including medicated feed, by allowing their use only for treatment after veterinary diagnosis. The use of veterinary antibiotics should gradually be restricted to therapeutic purposes by progressively eliminating their use for prophylactic ones.
Parliamentarians also say that the use of metaphylaxis, i.e. the mass medication of animals to cure sick ones on farms whilst preventing the infection of healthy ones, should also be kept to a minimum. Two pieces of legislation on the matter are under discussion in the Parliament.

Following the plenary debate, Portal spoke to Pedicini to explore his report in further detail and gain further thoughts on the EU’s approach to tackling AMR and how Horizon 2020 can help support research to overcome it.

What are the greatest difficulties facing the EU in making progress to tackle AMR?

In the initiative report, we welcomed the work that has been done so far on such a big challenge for the EU and the entire world; however, more actions are needed at supranational level, such as the continuation of the EU’s Action Plan against AMR post-2017, led by the European Commission.

It is essential to stimulate further research for new antimicrobial drugs, in particular antibiotics with activity against prevalent multidrug-resistant Gram-negative bacteria such as K. pneumoniae and Acinetobacter, as well as for alternative methods aimed at fighting healthcare-associated infections (HAI) without using antibiotics.

Between 2010 and 2013, the percentages of K. pneumoniae resistant to fluoroquinolones, third-generation cephalosporins and aminoglycosides, as well as combined resistance to all three antibiotic groups, significantly increased in many EU member states and at supranational level. Moreover, during the same period, resistance to third-generation cephalosporins also significantly increased in many member states and at EU level for E. coli.

Other important challenges include increasing awareness raising on the importance of the rational use of antimicrobial agents, and antibiotics in particular, in humans – as it affects the development of drug resistance – but also in animals.

What impact are national health budget difficulties having on overcoming AMR?

The austerity measures that some EU member states have indiscriminately applied to the health sector have a negative impact on patient safety. For example, the reduction of medical personnel or of hygiene specialists increases the risk of patients getting HAIs. This eventually leads to higher expenses for the healthcare sector.

What are the key aims and proposals of your ‘Safer healthcare in Europe’ report?

The report aims at increasing patient safety in the healthcare sector and to fight against AMR by any means. The upstream cause of threat to patient safety is political interference in the appointment of managers and other health professionals, which implies lower healthcare quality standards. That is the reason why we stressed in the report that EU member states should “ensure that health managers are appointed on the basis of their merit and not of political affiliation”.

Adverse events, such as medical errors and healthcare infections, affect more than three million people per year – about 10% of the patients admitted to hospitals – with a total annual cost of over €2.7bn for medical expenses. This can and must be avoided through lifelong training and education programmes for health professionals; awareness raising campaigns; a multidisciplinary approach to treatment built on evidence-based medicine; concrete measures to report adverse events and expose them, together with systems for collecting and evaluating data; and telemedicine integrated with healthcare at home to rationalise costs and increase the humanisation of care.

In the report, we called for some urgent measures to be undertaken such as investment by the pharmaceutical industry in the ‘real’ development of new antimicrobial drugs and, at the same time, research into alternative natural methods to fight drug resistance. Other recommendations include an appropriate microbiological diagnosis before prescribing any antibiotics; the prohibition of sales without prescription; awareness raising campaigns targeting all population groups to promote an appropriate and responsible use of antibiotics; and limiting the use of antibiotics in veterinary medicine.

What further efforts can the Commission and EU member states make?

While progress has been made by member states in developing patient safety strategies and reporting and learning systems, we regret that there is still uneven progress among member states on patient safety. The latter should implement the recommendation of the Council of the European Union on patient safety as a matter of urgency. The Commission should continue the work of its Patient Safety and Quality of Care Working Group on comparable indicators to assess patient safety, and member states should implement such indicators.

The Commission and the EU member states should also further explore the possibilities offered by e-health in the area of patient safety in reducing adverse events by tracking information flows and improving the understanding of medical processes, as well as through digital prescriptions and alerts on drug interaction.

The Commission should also ensure the continuation of the EU Action Plan against AMR post-2017. On their side, member states should make sure that antibiotics are used in a rational way, only for the correct indications, at the correct dose, and for the shortest duration possible.

Actions at both EU and national level should also be taken to limit the use of antibiotics in veterinary medicine, including decoupling the veterinarian’s right to both prescribe and sell antibiotics, eliminating the use of prophylactic, and strongly restricting the metaphylactic use of antibiotics in animals.

What contributions can Horizon 2020 make to better supporting research in tackling AMR?

More funds are needed for a real development of new antimicrobials, as well as for the development of other methods to treat infections without necessarily using antibiotics. Horizon 2020 should therefore incentivise research into not only new antibiotics but also alternative natural methods and medicines.

What are the next steps for your report?

DG Health and Food Safety in the European Commission, in co-ordination with the Patient Safety and Quality of Care Working Group, is developing the work programme of the Commission on this topic and will take a final decision on the EU’s next actions at the end of this year.

From bilateral meetings, we understand that the Commission welcomes and shares the main messages of this initiative report, which will be used as a basis to justify further action to increase patient safety and fight AMR.

Piernicola Pedicini MEP

European Parliament

This article first appeared in the seventh edition of Horizon 2020 Projects: Portal, which is now available .