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Tuesday, 17 April 2018

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 17th and 18th 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 25th 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 28th – 29th 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.

Thursday, 5 April 2018

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  
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.

Tuesday, 12 December 2017

Developing a Common Health Data Model for Europe

The European Medicines Agency has been holding a 2 day international workshop in London [11th -12th December 2017] to define  opportunities and challenges for a common health data model in Europe. The expected outcome of the workshop was agreeing guiding principles for the development of such a Common Data Model (CDM) in Europe, including key criteria for validation in the context of regulatory decision-making.

See more about the workshop

 
A common data model could help harmonise healthcare data across multiple data sets and provide a mechanism to conduct pan-European studies in a timely manner to address regulatory questions. At the same time, applying a common model to European data has multiple challenges. The meeting brought together regulators with academia, data holders and the pharmaceutical industry.

Sessions included talks from experts from North America and the European region discussing lessons learned and current challenges in very large current clinical data resources, regulatory verification and related issues. Common data model case studies  included Sentinel – the Harvard-based FDA system for accessing patient data from health data partners across the USA and CNODES (the Canadian Network for Operational Drug Effect Studies) which can access data on 100 million patients – a similar scale to Sentinel.


The U.S. Food and Drug Administration's (FDA) Sentinel Initiative uses a common health data model to improve the FDA’s ability to identify safety issues for medical products. Sentinel actively surveys pre-existing electronic healthcare data from multiple sources.

Themes at the workshop included ensuring the relevance of CDMs to health policy, keeping timelines short, inter-operability, consent and related ethical issues, and careful internal and external validation of clinical definitions, data, software and analytical models.

From the perspective of health professionals, policy makers, regulators and the public, key future questions include whether clinical outcomes from common data models will be generalisable or only relevant to specific sub-populations based on geography, genetics, demographics and/or complex co-morbidity.  In the era of precision medicine there is the clear need is to avoid “right” answers from the wrong clinical populations and “wrong” answers from the right populations.
Further key points to consider include the cost of CDMs and who should pay; and whether updating existing databases will be sufficient or will new, more robust databases be needed.

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

The EACPT was founded in 1993 - 24 years ago - and now includes as members all major 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


Wednesday, 22 November 2017

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.

Friday, 10 November 2017

EACPT 2017 Updates from Vienna


Votive Church, Vienna
The EACPT Executive Committee is meeting in Vienna from 10th - 11th November 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. EACPT working groups on Education, Research, Young Professionals, and Regulation and Ethics.

3. Opportunities from links with international organisations such as the European Medicines Agency, IUPHAR, EPHAR and UEMS

4. 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



Back row: Caroline Samer, Switzerland; Donald Singer, UK; Michiel van Agtmael, Netherlands; Ylva Böttiger, Sweden; Jamie Coleman, UK; Pierre Marquet, France; Emilio Clemente, Italy; Markus Zeitlinger, Austria.
Front row: Janne Backman, Finland; Jolanta Gulbinovič, Lithuania; Arantxa Sancho López, Spain; Achim Schmidtko, Germany.
The EACPT Executive Committee meets 6 monthly, with regular interim 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 - 24 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

The 2017 EACPT Scientific Award

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. The Congress included 22 sessions with Keynote Lectures on current issues for research, education and clinical practice on safe and effective use of medicines. Almost 500 oral and poster presentations will be presented by delegates from the European Region and around the world.

Prof. Simon, Prof Webb and Prof. Böttiger

The EACPT Scientific Award was presented to Professor David Webb, President of the British Pharmacological Society for his 2015 Lancet paper on PATHWAY 2.  This study
reported a significant improvement in blood pressure control in older, overweight patients with poorly controlled hypertension despite combination medical therapy when the mineralocorticoid antagonist spironolactone was added, treatment supported by directly observed therapy.

Future EACPT Congresses
- 2019 Stockholm
- 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.


Clinical Therapeutics, the Official Journal of EACPT.

Tuesday, 19 September 2017

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.