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Emerging issues – April 2019

EAHP Marketing Plan

The Marketing plan has been revised. The latest version is available HERE.

Changing roles of HPs

AS, NM and PP have revised the business case on the changing roles of HPs (see HERE). The document now also contains detailed information on the financial aspects of implementing the different activities.

EAHP data sharing document

JP and KN have developed a first draft position which outlines EAHP’s views on (raw) data sharing and data access. The document is available HERE. (uploaded on 9th April)

Endorsement strategy update

PP and AS have reviewed and updated EAHP’s endorsement strategy. The document is available HERE. (uploaded on 9th April)

Carcinogens and Mutagens Directive (CMD)

Please find HERE an update on the CMD initiative that EAHP is supporting. A press release has been prepared by ECCO which names EAHP as one of the supporters (see HERE).

Relationship of the SDGs with the Statements

The updated SDG document is available HERE.

EAHP Manifesto for the 2019 EU Elections

The Manifesto has been sent to all MEPs of the ENVI committee that are running in the 2019 elections. Also the Finnish Council presidency has been contacted. A follow-up will be started after the elections once it has become clear which MEPs have been elected. A more targeted campaign, including the request for meetings, will be started in July, when the different committees are being set up and the committee chairs are being selected.

Revision of EAHP’s “old” position papers

The following position papers have not been revised in the past 3 years:

  • Statement on Hospital Pharmacy Specialisation (2011) – Misses reference to Statements
  • Statement on Patient Safety (2011) – Misses reference to Statements
  • EAHP Statement on the need for barcoding of the single dose administered in hospitals (2012)
  • EAHP Statement on clinical trials (2012) – Difficult to update since it comments on the revision of the clinical trial legislation
  • EAHP Statement on public spending austerity and its impact upon access to medicines and patient safety (2013)
  • EAHP Statement on medical device regulation (2013) – Difficult to update since it comments on the revision of the medical device legislation
  • EAHP Statement on sustainable and equitable access to medicines (2014) – to be revised for GA 2020

In which order should those that can be reviewed be updated?

Publication of EAHP position papers in EJHP

Phil Wiffen and the editorial Board discussed the publication of EAHP’s position papers during their last meeting. Concerns were expressed due to the fact that EAHP’s position papers do not have an expiry date. SK discussed these concerns with Phil Wiffen. A disclaimer – referring the reader to EAHP’s website and detailing that the position papers are regularly reviewed – could be an option.

Opioid crisis

Jonathan Underhill informed SK that the project is being run by Christian Mallen at the Institute for Primary Care and Health Sciences. It’s an NIHR grant to investigate the overprescribing of opioid painkillers, and to improve care for patients with persistent pain – without the use of long-term opioids. They are looking at training clinical pharmacists in GP practices to offer pain management. Link to Keele news item available HERE

European Society of Anaesthesiology 2020 Patient Safety Policy Summit

The European Society of Anaesthesiology (ESA) has reached out to us to explore if EAHP is interest in participating in the organisation of a Policy Summit on patient safety in perioperative care in 2020 in Brussels (see letter to PH HERE). A concept note (see HERE) was shared together with the request.

ESCO community forum for domain experts

The European Commission reached out to SK with a request to join the ESCO community forum for domain experts. For more information see here the email, the background note and the FAQs. Participation could be beneficial for CTF and potentially for the promotion of the European Statements.

ESOP endorsement request

Klaus Meier recharged out to us with a request about an endorsement for the first activity of ESOP in the Arabian area to start with the specialisation for Oncology Pharmacists. Please find here the letter and the supporting document.

2019 GA – emerging issues policy document

The 2019 emerging issues policy document will be prepared after the Board meeting. It will contain information on CMD, 2019 EU election manifesto, SDGs, opioid crisis and future revision of EAHP position papers. The document will be shared with the PH for review.

SharePoint – inclusion of useful links

RM requested to include useful website links on SharePoint. GML checked this request and it would be feasible to do. GML is however the only person that could do this.

EMA (including consultations)

Teleconference with EMA
A conference call was organised between EMA and EAHP since Ivana Silva could not join us as a President’s guest due to Brexit. A short summary is available HERE. A call between EAHP and the agency should be organised on a yearly basis.

Shelf life inquiry
The EMA has provided us with a response to our shelf life request (see HERE). The answer does not touch fully on the issue. Further clarification will be asked. In case EMA cannot help us, we will reach out to EDQM. The topic was already brought up with Silvia Ravera and Dirk Leutner during the meeting in Barcelona.

EMA/Commission consultations

EAHP is currently preparing input to the following consultations:

  • Concept paper on the revision of the guideline on the evaluation of anticancer medicinal products in man (14/04)
  • EMA – Role of big data for evaluation and supervision of medicines in the EU (15/4)
  • Draft guidelines on excipients in the label and package leaflet of medicinal products for human use (deadline 31/05)
  • Concept paper on the need for revision of the Note for Guidance on Clinical Investigation of Medicinal Products for the Treatment of Peripheral Arterial Occlusive Disease (deadline 30/06)
  • EMA discussion paper: Use of patient disease registries for regulatory purposes – methodological and operational considerations (deadline 30/06)
  • EMA – Paediatric addendum on the guidelines on clinical investigation of medicinal products for the treatment and prophylaxis of venous thromboembolic disease (deadline 30/06)
  • EMA public consultation on a draft guideline on the non-clinical requirements for radiopharmaceuticals (deadline 30/06)
  • EMA – Regulatory Science to 2025 (deadline 30/6)
  • EMA Draft guideline on quality and equivalence of topical products (deadline 30/6)
  • EMA revision of its guideline on the evaluation of human medicines indicated for the treatment of bacterial infections (deadline 31/7)
  • Public consultation a draft guideline onquality, non-clinical and clinical aspects of medicinal products containing genetically modified cells (deadline 31/7)
  • Public consultation – Draft questions and answers on Data Monitoring Committees issues (deadline 31/7)
  • Public consultation on key principles for the electronic product information of EU medicines (31/7)
  • EMA – Public consultation a guideline on clinical investigation of medicinal products for the treatment of gout (8/8)
  • Reflection paper on regulatory requirements for the development of medicinal products for chronic non-infectious liver diseases (PBC, PSC, NASH) (deadline 31/08)

2019 GA – EMA policy document
The 2019 EMA policy document will be prepared after the Board meeting. It will contain information on our EMA activities as well as details on the consultations that EAHP responded to between June 2018 and May 2019. The document will be shared with the EMA Board leads for review.

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EAHP Forum

All the EAHP team is working on providing a Forum that can help connect all the members in Conversations and Groups to talk about important matters for the European Hospital Pharmacist.

The Forum will be accessible for all the EAHP members, you don’t have to create a new account to browse and participate.

Conversations and groups

The Conversations will be moderated by our team to provide documents and relevant topics for the community.

The Groups will connect all members that share a category. Members who work on the same assocation, on the same hospital, that have the same role, etc.

Stay tuned for the realase of the forum. Soon on EAHP.