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14th April 2018

1) CTF

WG1
Rahul would like to organise a face-to-face meeting with his WG. When should we do this ideally? During the short phone conversation I had with him he seemed eager to start as soon as possible.

WG4
What are we doing with WG4? Technically this group was set up on a short term basis.

2) Shortages survey

The shortages survey has been promoted via social media, via EAHP presidents/delegates and the Statement ambassadors. In addition, I gave a short presentation on the survey during the last COST action meeting. We will continue with promotion via social media and send a follow-up request for circulation to presidents and delegates in late April/early May.

If possibility Board members should contact their board countries. This is especially important for those countries from which we have received few responses. Aida and Nenad are already working on this for their own countries.

Overall, we have received 323 responses (status on April 11). They come from the following countries: Austria (2), Belgium (35), Bosnia and Herzegovina (9), Croatia (2), Cyprus (1), Denmark (2), Estonia (1), Finland (6), FYROM (1), France (3), Germany (52), Greece (5), Iceland (6), Ireland (13), Italy (11), Latvia (3), Malta (2), Montenegro (2), Netherlands (7), Norway (19), Poland (1), Portugal (57), Romania (4), Russia (1), Serbia (14), Slovakia (9), Slovenia (15), Spain (15), Sweden (3), Switzerland (2), Turkey (10) and the UK (10).

3) Position papers for GA

AMR
Steffen will share the final draft on Friday with me.

Procurement
We had a conference call on 30th of March during with the following division of tasks was decided in terms of research contributions:
Rob – the involvement of hospital pharmacists in hospital level procurement and preparation of the first draft
Aida – quality assurance and monitoring
Despoina – why should HPs be involved in procurement on a national level
Stephanie – background information (types of procurement)
The first draft version is available here.

4) Consultations – state of play

EMA released this week new consultations on GMPs as well as on the Draft European herbal monographs and a call for scientic data for use in HMPC assessment work. I don’t think any of these are relevant to us, unless you see that differently.

30/04/18 EMA – draft guideline on the clinical evaluation of medicinal products indicated for the prophylaxis or treatment of respiratory syncytial virus (RSV) disease  feedback  from Inese; consultation reply submitted to EMA in January
30/04/18 EMA – Concept paper on the development of a reflection paper on new analytical methods/technologies in the quality  request sent to Steffen
30/04/18 EMA – draft guideline on safety and efficacy follow-up and risk management of advanced therapy medicinal products – Revision 1 request sent to Antonio and Marc Dooms
31/07/18 EMA – questions and answers document on Bovine Spongiform Encephalopathies (BSE) and vaccines – Revision 1 Joan will look at it; reminder to be sent in May 
31/07/18 EMA – a draft guideline on quality aspects included in the product information for vaccines for human use Joan will look at it; reminder to be sent in May 
31/07/18 EMA – reflection paper on investigation of pharmacokinetics and pharmacodynamics in the obese population request sent to Branislava Miljkovic
30/08/2018 EMA – draft addendum to the guideline on the evaluation of medicinal products indicated for treatment of bacterial infections to address paediatric-specific clinical data requirements – First version should we ask Inese?
18/12/18 Draft ICH guideline Q12 on technical and regulatory considerations for pharmaceutical product lifecycle management – Step 2b  on hold until summer 2018

The Netherlands is so far the only country that has nominated 3 persons as EMA experts (see here). I plan to share again the request when I send around the minutes from the members meeting to all participants as well as presidents and delegates that were not present at the meeting.

5) SDGs

Since a number of president’s guests brought up SDGs, I would like to include it in the policy part of the board meeting under emerging issues.

6) Hazardous Drugs

ESOP
I met with Klaus and Richard to discuss the observatory of the European Biosafety Network. Klaus is opposed to the idea of getting involved due to the close connection to BD. Report HERE

European Biosafety Network
attended the meeting at European Parliament 10th April on the Madrid model. The meeting was attended by the speakers (see agenda here), RPP, Spanish nurses and Spanish trade union representatives, representatives of BD, representatives of the European Agency for Safety and Health at Work (EU-OSHA), the Bulgarian Drug Agency, a Dutch hospital pharmacist and another hospital pharmacist that represented the interests of ESOP. Apart from me only 2 other EU organisations were present (Richard and Patrick (ECCO) and Melina Raso (Health First Europe)).

Ian used this meeting largely to push is own agenda – i.e. getting the Commission to commit to including hazardous drugs in Annex 1 of the Carcinogen and Mutagen Directive. His speakers (a chemist from Exposure Control Sweden, a representative of the regional government of Madrid, a nurse and a labour law expert that supported the nurse in her legal battle) as well as the MEP (Sion Simon) that chaired the meeting were all in favour of including hazardous drugs in the Carcinogen and Mutagen Directive. In addition, they heavily advocated for the use of closed system transfer devices.

The Commission representative was very cautious with her remarks and also pointed out that not all hazardous drugs cause cancer but also other illness wherefore the Carcinogen and Mutagen Directive might not be the right place to include all of them. The Dutch hospital pharmacists commented on the of closed system transfer devices and stated that the Netherlands is doing very well without them. He asked the Commission to keep their recommendations on devices broad in order to prevent the mandatory use of closed system transfer devices. The lady from ESOP (I think she was Polish and the chair of ESOP’s MASHA Project) raised the same issue. I could not speak to her and the Dutch HP, because they left rather quickly and I was tied up in a conversation with Ian and Richard.

Ian approached Richard and me after the meeting to tell us about his dissatisfaction with the attitude of EAHP and ECCO. He and European Biosafety Network (EBN) are doers that would like to work with us but our processes and politics are stalling the actions he wants to take, wherefore he went ahead without us. ECCO (from what I learned from Richard after the meeting) had expressed the need of transparency and the inclusion of the organisation in decisions taken by EBN in previous conversations with Ian. This was dismissed by Ian, because he cannot be more transparent then he already is and working relations (i.e. who is doing what and contributing how much too the project) grow in his opinion organically once somebody has signed up to the project. Richard disagreed with him on that point and that is where their conversations stopped. Ian has never talked to ESOP, wherefore Richard suggest to him to get in contact with Klaus.

Report HERE

BPP project proposal
Feedback on the proposal (HERE) is requested

7) Miscellaneous

Request from RPP
See minutes of March Board meeting.

FIP Call for Nominations for Hospital Pharmacy Section Executive Committee
Inese has expressed interest in joining the Hospital Pharmacy Section Executive Committee of FIP as European Vice-President.

ASHP mid-year international session (December 2018)
ASHP is planning to include a session at the 2018 ASHP Midyear Clinical Meeting & Exposition that will feature short, 20 minute presentations on pharmacy practices from around the world. Abstracts should be submitted by 27th April (COB).

EDQM – Committee of experts on falsified medicines (CMED)
EDQMs Committee of experts on falsified medicines sent me an invitation to present EAHP and activities at their next Committee meeting. External stakeholders – such as EAHP – will get the opportunity to present on 17th May. I send this request to the FMD board leads (you were in CC) but I have not received any feedback, apart from Despoina who told me in person that she cannot attend.

HCPWG meeting EMA
EMA will be speaking about the EMA-HMA collaboration on shortages and availability of medicines to collect stakeholder input for the November 2018 workshop. This is interesting to us.

Healthcare cooperation
Non-Brussels based health professionals associations (podiatrists, dieticians, speech therapists/ logopedists and occupational therapists) are trying to further get in contact with policy officers of Brussels based associations (CPME, CED, PGEU, EAHP). The dieticians are holding their annual meeting in Rotterdam in September. They have suggested to organise a meeting on 27th September to speak about further collaboration. Are we interested?

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