Raising awareness to combat antimicrobial resistance: European Antibiotic Awareness Day

European Antibiotic Awareness Day EAAD was held on 18 November 2020 with activities taking place during that week. As in previous years, the European Medicines Agency (EMA) actively contributed to raising awareness about Antimicrobial Resistance (AMR) and how to limit it by publishing a set of infocards, developed to reinforce global cooperation to combat AMR.

EAAD is an annual European Union initiative to raise awareness of antimicrobial resistance as an increasing global public health threat and to promote the prudent use of antibiotics.

‘Tackling antimicrobial resistance is a global challenge and a high priority for EMA and the European medicines regulatory network. We all have a role to play in addressing this challenge: regulators, governments, companies through development of new innovative antibiotics, but also healthcare professionals and patients by making sure they prescribe and use antibiotics wisely and responsibly’ said Emer Cooke, EMA’s Executive Director.

To mark EAAD, the EMA launched a social media campaign to highlight the importance of using antibiotics prudently.

A set of info-cards focuses on what patients, healthcare professionals, veterinarians, health-leaders, journalists and the pharmaceutical industry in their respective roles can do on a daily basis to make sure that these important medicines are used wisely.

Antimicrobial resistance occurs when bacteria and other microorganisms change over time and develop resistance to medicines. As a result, antibiotics and other antimicrobial medicines become less effective. This makes infections harder and harder to treat. A prudent use of antibiotics helps slow the process and ensure that treatments continue to be available to treat common and emerging infectious diseases.

For more information on the EMA’s role in the global response to antimicrobial resistance, see Antimicrobial resistance.

You can see examples of the cards below. The full set of these infocards is downloadable on this link. 

 

 

European Medicines Agency to hold a public update on COVID-19 vaccines on 11 December

EMA will organise a public meeting on 11 December 2020 to inform European citizens about the EU regulatory processes for the approval of COVID-19 vaccines and the Agency’s role in their development, evaluation, approval and safety monitoring.

The COVID-19 pandemic is an unprecedented global crisis, with devastating health, social and economic impact. Safe and effective vaccines for COVID-19 are urgently needed to respond to this crisis and reduce its effects.

Together with the European medicines regulatory network, EMA is supporting the development of COVID-19 vaccines and has taken steps to speed up the evaluation processes for these vaccines. The Agency and its partners are doing so while ensuring that the same high regulatory standards for quality, safety and efficacy are being applied to COVID-19 vaccines.

The public meeting will inform citizens about EMA’s role in the pandemic and of EU regulatory procedures. It will also give the opportunity to the public and stakeholder groups to speak and share their needs, expectations and any concerns, that will be considered by EMA and the European medicines regulatory network in the decision-making process.

The EMA will publish the list of speakers who will make an intervention in advance of the event.

The public meeting will be broadcast live and will be open to all citizens. In addition to the selected list of speakers, during the meeting there will be a mailbox open via EMA’s website for the public to make comments.

The agenda and all information related to the event are available on the EMA website event page.

Please check EMA’s dedicated webpage on COVID-19 for the latest updates.

Updates on the EACPT from Athens

Parthenon, Athens

The EACPT Executive Committee is meeting in Athens from 5^th – 6^th April 2019 to plan for future activities of the EACPT.

Main topics for discussion include

-       final details for the upcoming 2019 EACPT Congress to be held in Stockholm from 29th June - 2nd July in 2019

-       early planning for the next EACPT Congress, to be held in Athens in 2021, from 26^th – 29^th June

-       updates from EACPT Research, Regulatory and Education working groups

-       EACPT awards

The next EACPT Congress will be held from 29th June to 2nd July in 2019 in Stockholm as a partnership between the EACPT and the Swedish Society for Pharmacology, Clinical Pharmacology and Therapeutics. 

Early bird registration deadline - 10th April 2019.  Register online for the 2019 EACPT Congress in Stockholm

The Congress will address Tomorrow's Healthcare Challenges and will be held at the City Conference Centre - 5 minutes from Stockholm Central Station.

EACPT committee in Athens by Hippocrates statue. 

Back row: Per Ankaer, MCI (Denmark), Pierre Marquet (France), Vangelis Manolopoulos (Greece), Markus Zeitlinger (Austria), Janne Backman (Finland), Caroline Samer (Switzerland)  Donald Singer (UK),  Michial van Agtmael (Netherlands), Achim Schmidtko (Germany). Front row:  Jamie Coleman (UK), Tabassome Simon (France), Ylva Böttiger (Sweden), Arantxa Sancho Lopez (Spain), Gerard Rongen (Netherlands).

The Congress Reception on the evening of Saturday 29th June, will be held at Stockholm City Hall, the venue of the Nobel Prize banquet.

The Keynote Opening Lecture will be given by the President at the Karolinska Institute, Professor Ole Petter Ottersen, on global health and clinical pharmacology.

Professor Urs Meyer from Switzerland will give the 2019 EACPT Lifetime Achievement Award Lecture based on his work on individual variation in drug response.

Further awards will be presented, including Scientific Awards, including Young Investigator, and EACPT Education Awards.

Around 60 invited speakers are expected from throughout Europe and beyond. Congress keynote lectures, sessions and themes will include:

• Advanced therapies
• Ageing populations
• Anti-coagulation
• Anti-microbial resistance
• Beating cancer
• Chronic disease
• Clinical drug research of tomorrow
• Clinical pharmacologists versus computers
• Clinical use of pharmacokinetics
• Closing the money gap  
• Computers vs. clinical pharmacologists
• Deprescribing
• Drug-drug interaction
• Drug regulation in the 2020s
• Drug utilisation
• EACPT meets Asian Societies      
• Ethics in clinical research
• Global Health
• How to become a clinical pharmacologist
• How to make an oral presentation
• How to measure drug exposure
• How to measure drug use
• How to perform a health economic study
• Inter-professional exchange for better drug treatment
• Mental health
• Misuse of medicines
• Patient empowerment
• Polypharmacy: joint symposium with the Korean Society (KSCPT)
•  medicine: EPHAR-EACPT joint symposium
• Preparing tomorrow's prescribers
• Prescribing and deprescribing
• Publish or perish
• Rare diseases
• Targeting small populations  
• The critically ill patient
• Treating ageing populations 
• Treating disease in children

Major awards to be presented at the Stockholm Congress include the EACPT Lifetime Achievement Award, the biennial EACPT Scientific Award for best publication on a clinical pharmacology or therapeutic theme, Young Investigator awards jointly with EPHAR, and the EACPT Education Award.

Opportunities for EACPT Associate Members include
* discounted registration fees for EACPT meetings
* networking with colleagues worldwide through the global EACPT network of Associate Members
* active involvement in EACPT Working Parties and other activities 

Find out how to become an Associate Member of the EACPT 

Future EACPT Congresses will be held in:
- 2021 Athens
- 2023 Rotterdam

The EACPT was founded in 1993 and now includes as members all national organisations for clinical pharmacology in Europe, as well as organisations from further afield internationally. The EACPT aims to provide educational and scientific support for the more than 4000 individual professionals interested in clinical pharmacology and therapeutics throughout the European region, with its congresses attended by a global audience. The EACPT also advises policy makers on how the specialty can contribute to human health and wealth.

Updates on digital media and health at the European Medicines Agency

Safe and effective healthcare matters for society as a whole.

Digital media and health is the key theme of the latest joint meeting of the European Medicines Agency (EMA) Human Scientific Committees' Working Parties with Patients’ and Consumers’ Organisations (PCWP) and Healthcare Professionals’ Organisations (HCPWP) being held in London on 17^th and 18^th April 2018. Digital media and health topics are being discussed, including recent learning and trends with regard to mHealth, social media, real-word evidence and electronic product information.

Katja Neubauer from the European Commission opened the session with an update on EU initiatives with regard to digital health. She considered 3 priority areas on digitizing health and care: access of the citizen to his or her data for example in electronic medical records and electronic prescribing; access to big data to improve health policy and regulatory decisions; and using digital health make policy decisions more patient-centred.

She discussed clinical use studies, including development of European Reference rare diseases, applying digital health to anticipating epidemics and EU-wide infectious threats and applying Real World Data in medicines development.

An EC report on Digital Single Market strategy is due to be published on 25^th April.

Hans-Georg Eichler from the EMA went on to discuss the relevance of real world evidence to regulation of medicines, including understanding efficacy and monitoring for unexpected risk and for long-term risk. In particular, he considered use of real world evidence to match the speed of science progress with timely integration of innovations into clinical practice.

He considered case studies on accelerating drug development, contrasting findings from real world evidence with those from classical randomized clinical trials; applying real world evidence to monitoring potential long term adverse effects of medicines – for example from risks of insertional mutagenesis following gene therapy for thalassaemia which needs surveillance for decades; and applying real world evidence to understanding therapeutic complexity – for example deciphering combinatorial complexity in oncology treatment with regard to differences in therapeutic impact from treatment order, dose and washout duration between treatments.

He also discussed applying learning for health care from other sectors (aviation, automotive …), including data-driven innovation from rapid feedback loops.

Alison Cave from the EMA discussed key points from recent workshops hosted by the Agency. She stressed the need for a common data model for Europe. A key theme arising from discussion of EMA registries had been the need for common core data elements, checks on data quality (consistency, accuracy and completeness), long-term curation, availability and governance.

Jane Mosely discussed how real-world evidence and patient registries can be used to support early access to medicines, risk-benefit analysis and provide rapid replication within different populations of initial findings. She noted that there are currently limited requests for data from real-world evidence to support pre-authorisation decisions and post-authorisation questions about safety and efficacy. Some aspects which need to be considered include eligibility of participants, outcome definition, patient safety, and extrapolation of findings throughout the EU.

Alexios Skarlatos (EMA) and Dr. César Hernández García (Spanish Agency of Medicines and Medical Devices) discussed Electronic Product Information. Steps include consultation on revising Patient Leaflet content and adding agreed new content, including targeted messages for relevant subgroups of patients. There are already case studies from the Netherlands (Watchyourmeds), quick guides for patients in Norway and in Spain structured product information accessible e.g. by scanned quick response (QR) codes. International standards are needed and transition to a Digital first model.  There will be a European Commission-EMA-HMA multistakeholder workshop on the use of electronic Summary of medical Product Characteristics (SmPC)/Patient Leaflets (PL) on 28^th – 29^th November 2018.

Further speakers will discuss from health professional, regulator, patient, consumer perspectives Real World Evidence (Kieran Breen, Patient Representative on the EMA Committee for Advanced Therapies), mHealth (Kathi Apostolidis, European Cancer Patient Coalition) and Social Media (Caroline Morton, International Bureau for Epilepsy).

More about the meeting and the presentations can be found on the EMA website.

EACPT - 2018 Updates from Stockholm

EACPT Executive Committee meeting in Stockholm

The EACPT Executive Committee is meeting in early April 2018 in Stockholm to plan for future activities.

Key matters for discussion include

1. Future EACPT Congresses - the next is due to be held in 2019 in Stockholm as a partnership between the EACPT and the Swedish Society for Pharmacology, Clinical Pharmacology and Therapeutics. The Congress will address Tomorrow's Healthcare Challenges and will be held at the City Conference Centre - 5 minutes from Stockholm Central Station.
2. The next EACPT Focus meeting: Innovations in CPT Education - to be held at the University of Birmingham 7-8 September 2018.
3. New EACPT Awards for Best Scientific Paper in the previous 12 months. These awards will be launched on 1st June 2018 and awarded initially every 2 months (6 times a year) from August 2018. Award winners will receive a free one year Individual Associate Membership (IAM) of the EACPT. Winners who are already EACPT IAMs will receive a 100€ prize. Papers which receive a EACPT Scientific Paper Award will be eligible to be considered for the biennial EACPT Scientific Award.
4. EACPT working groups on Education, Research, Young Professionals, and Regulation and Ethics.
5. New EACPT web series on Meet the Clinical Pharmacologists
6. Opportunities from links with international organisations such as the European Medicines Agency, IUPHAR, EPHAR and UEM
7. Opportunities for Individual Associate Members including:
* discounted registration fees for EACPT meetings
* online access to the official EACPT Journal - Clinical Therapeutics
* networking with colleagues worldwide through the global EACPT network of Associate Members
* active involvement in EACPT Working Parties and other activities  

Find out how to become an Associate Member of the EACPT  

The EACPT Executive Committee meets 6 monthly, with regular additional discussions by teleconference on key EACPT strategy and activities.

Future EACPT Congresses will be held in:
- 2019 Stockholm
- 2021 Athens
- 2023 Rotterdam

The EACPT was founded in 1993 - 25 years ago - and now includes as members all national organisations for clinical pharmacology in Europe, as well as organisations from further afield internationally. The EACPT aims to provide educational and scientific support for the more than 4000 individual professionals interested in clinical pharmacology and therapeutics throughout the European region, with its congresses attended by a global audience. The EACPT also advises policy makers on how the specialty can contribute to human health and wealth.

European Medicines Agency to move from London to Amsterdam

After a final round dead-heat vote by member states on Monday 20th November, following the drawing of lots, Amsterdam has been confirmed as the new home for the European Medicines Agency. On current plans, the EMA will be operating in Amsterdam from April 2019.

The EMA's Patients and Consumers Working Party annual meeting

Meantime the EMA's Patients and Consumers Working Party (PCWP) is holding its annual meeting with all EMA eligible patient/consumer consumer organisations to consider relocation preparedness, patient and consumer involvement in EMA activities, highlights from major EMA committees and updates on pharmacovigilance, information on medicines and future work programmes in 2018 and 2019 for the PCWP and the EMA's Healthcare Professionals Working Party.

The European Medicines Agency is concerned with regulation of medicines and other advanced therapies for humans and animals for 28 countries across the European Union.

The EMA has established mechanisms for involving patients in regulatory assessment: patients’ value perception and value systems. The EMA also has an increasing remit to engage with stakeholder organisations and to improve transparency in its activities for the ~510 million citizens of the European Union. Furthermore the EMA has a major role in educating patients, carers and health care professionals about medicines.  

There remain many decisions and actions for the coming months needed to ensure the smooth relocation of the EMA to Amsterdam and either to develop systems to retain UK expertise for the EMA or replace that expertise. For the EMA, these include:

• maximising staff retention
• maintaining capacity to continue the work of the EMA 
• continuing productive engagement with stakeholder groups: patients, carers, healthcare professionals ...
• maintaining the capacity of the EMA to engage with the public

For the UK, there are pressing questions regarding the future regulation of medicines in the UK post-Brexit, the impact of loss of international influence of UK regulators and other experts on medicines and the impact of loss of biotech and pharmaceutical companies from London to Amsterdam.

Global threat of antibiotic resistance

WHO estimates of impact on mortality from AMR

The European Medicines agency, in partnership with the ECDC (European Centre for Disease Prevention and Control), is holding a workshop on global challenges from antimicrobial resistance (AMR). 

There are 3 major current approaches to tackling AMR: 
1. reducing selection pressure on microbes to reduce the chance of their developing AMR. This needs strategies to reduce overuse of antimicrobial medicines. 
2. reducing human/human and animal/human transmission microbes. This needs effective infection control measures
3. increasing the availability of new antibiotics through more R & D combined with limiting their use within evidence-based guidelines - ie effective antibiotic stewardship.

There needs to be an integrated approach combining a pipeline of effective new antimicrobial and careful stewardship of existing antimicrobials through their effective use. However from a recent international survey, 20% of the public who took part were unaware that overuse of antibiotics leads to antimicrobial resistance to treatment. Furthermore 44% were unaware that antibiotics are ineffective against colds and 'flu'.

The WHO has estimated that, without major global action, by 2050 there may be ~400,000 preventable deaths annualy in the European region alone, as a result of lack of effective antiobiotics for serious infections.

Martial Plantady from the European Commission opened the day by discussing the EU Action plan launched in 2011 and running until 2016 against the threats from antimicrobial resistance. He noted that many solutions were described within the plan however there remain major challenges to effective implementation of the Plan, including:
- widespread and worldwide antibiotic use for growth promotion in livestock
- resulting need to push strategy to ban antibiotic use in livestock beyond the EU
- availability of animal and human data across member states
- effective surveillance on appropriate and prudent use of antimicrobials in humans
Some solutions include 
- effective dissemination of guidelines on prudent use of antibiotics in animals and humans
- Antibiotic Awareness Days
- more effective coordination of R & D across industry and academic sectors on new antimicrobials, alternatives, vaccines and rapid diagnostic tests
- engagement with key health professional and patient stakeholder organisations
The new EU Action Plan on antibiotic resistance was published in June 2017, with 3 pillars supported by strengthened measures for infection prevention and control:
- making the EU Region a best practice region on AMR
- improving research and innovation
- shaping the global agenda on AMR

At the 68th World Health Assembly in May 2015, the World Health Assembly endorsed a global action plan to tackle antimicrobial resistance, including antibiotic resistance, the most urgent drug resistance trend. Carmen Pessoa da Silva from the WHO underlined the key point that if AMR remains unresolved, the global threat would be enormous both for human health as well as for the world economy. She summarised 5 key elements of WHO strategy against AMR.
1. improved awareness and understanding (annual WHO awareness week)
2. strengthen knowledge through surveillance and research 9WHO Global AMR Surveillance System - GLASS - further report due in Jan 2018 - 47 countries are fully enrolled - 25% of member states)
3. reduce incidence of infection
4. optimise use of anti-microbial medicines
5. ensure sustainable investment for R & D

The Pharmaceutical Group of the European Union represents the ~400,000 community pharmacists who dispense medicines for the ~500 million population of the European Union. Around 46 million people visit a community pharmacist every day in Europe.
James Wilkinson discussed efforts of the PGEU to educate community pharmacists and the public in rational use of antimicrobial medicines.

Report on the 2017 EACPT Congress in Prague

The EACPT 2017 Congress was held in Prague from 24th-27th June with 566 participants from all 5 continents - 28% from beyond the European Region, from Australia to China, Japan and South Korea to the USA. 487 abstracts were presented as 171 oral communications and 316 e-poster presentations were given by delegates from the European Region and around the world.

Delegates by global region

The Congress included 2 plenary sessions, 22 parallel sessions with Keynote Lectures, 5 Oral Communications sessions and 3 Guided Poster Sessions on current issues for research, education and clinical practice on safe and effective use of medicines.  The programme provided an international scientific and educational forum for discussion of clinical pharmacology and therapeutics, including personalised pharmacotherapy.

Countries with 5 or more delegates

Themes included the latest developments on effectiveness and safety of medicines, clinical pharmacology in clinical practice, pharmacokinetics/systems pharmacology, including in special populations, innovative techniques, eHealth, biomarkers, education, advanced practices in topics such as drug discovery, drug development, biological therapies, global health with a focus on access to safe medicines, new pharmacology and pharmacotherapy, safety in prescribing and updates on personalised medicines, as well as updates on specific therapeutic areas, including cardiovascular disease, infectious disease, nephrology, oncology, neurology and psychiatry.

Future EACPT Congresses:
- 2019 Stockholm
- 2021 Athens
- 2023 Rotterdam

Number of delegates by region

The EACPT was founded 25 years ago and now includes as members all national organisations for clinical pharmacology in Europe, as well as organisations from further afield internationally. The EACPT aims to provide educational and scientific support for the more than 4000 individual professionals interested in clinical pharmacology and therapeutics throughout the European region, with its congresses attended by a global audience. The EACPT also advises policy makers on how the specialty can contribute to human health and wealth.

Clinical Therapeutics, the Official Journal of EACPT.