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Dear ESOP Members,

We say hello with ESOP May Newsletter before entering summer. This issue has included the articles under the title of ESOP conference for quality in oncology and ESOP delegate meeting, ESOP e-mail service, 6th National conference of oncology pharmacy in Sofia, Pharmacovigilance Studies in Slovenia and A Letter from EMA.

We wish you enjoyable readings.

Best regards,

Eda Gedikoglu

Chair of Publication

ESOP Conference for Quality in Oncology and ESOP Delegate Meeting

ESOP conference for Quality in Oncology and ESOP Delegate meeting was held on 16-17th March in Brussels with the partipication of 11 non- and 20 EU countries. ESOP conference for Quality in Oncology were included presentations of Cancer biology and therapy: pharmacological lessons learned and lessons to learn by Prof. Alain Astier, Decision Making to Inform Resource Allocation in Cancer Treatment by Dr. Elena Pizzo, Minimal standards for a multiprofessional treatment by Prof. Riccardo Audisio.

Starting to the delegate meeting President Klaus Meier made introduction to Delegate Meeting speech and introduced of new delegates to other participiants. Presentation of activities were made by QuapoS 6 core team members Christoph Bardin, Sherif Kamal , Carien Van der Merwe, Kristjan Kongi and Stavroula Theophanous-Kitiri, for EPIC Project by Andreja Eberl about current status in Estonia and Slovenia, for MASHA Project by Ewelina Korczowska, for publication by Eda Gedikoglu about Newsletter and Alain Astier about EJOP, for education Ahmet Bosnak , for ECOP by Petra Janssen and Wendy Trempler, for ERQCC- Role of the pharmacist by Marko Skelin, for CODE by Robert Terkola.

At the end of the meeting, with the votes of all the delegates related projects and works decisions were made. All participants left the meeting to meet at ECOP 4 in Nantes on 25-27 October…

ESOP Email Forum

ESOP e-mail service creates a communication platform for you and a platform for information exchange for all oncology pharmacists. After your data has been activated and you will automatically receive all incoming contributions via e-mail and will be able to send contributions to a discussion to all registered members easily through answering to the received email. You find information how to use the ESOP email forum here.
Download the info sheet(PDF)»


Best Regards,
Eda Gedikoglu

EMA Recommendation

EMA has recommended contraindicating the use of the prostate cancer medicine Xofigo (radium-223 dichloride) with Zytiga (abiraterone acetate) and prednisone/prednisolone, due to an increased risk of death and fractures with this combination.

EMA’s Pharmacovigilance Risk Assessment Committee (PRAC) has reviewed the preliminary data from an ongoing clinical study in metastatic prostate cancer patients. In this study 34.7% of patients treated with Xofigo, Zytiga and prednisone/prednisolone have died so far, compared with 28.2% of patients given placebo, Zytiga and prednisone/prednisolone. Fractures have also occurred more frequently with the Xofigo combination than the placebo combination (26% versus 8.1%).
In view of the seriousness of the events reported, the PRAC has taken action by introducing a contraindication as a temporary measure to protect patients’ safety while an in-depth review of the benefits and risks of Xofigo is ongoing.
These are temporary measures until the ongoing in-depth review of the benefits and risks of Xofigo is complete. EMA will communicate further at the conclusion of the review.
The press release is available by clicking below
http://www.ema.europa.eu/ema/index.jsp?curl=pages/news_and_events/news/2018/03/news_detail_002922.jsp&mid=WC0b01ac058004d5c1
For more information on the European regulatory system for medicines, please click below (brochure available in alllanguages)
http://www.ema.europa.eu/ema/index.jsp?curl=pages/about_us/general/general_content_000671.jsp&mid=WC0b01ac05809f8ed0

Aisling Murphy
Public Engagement Department
Stakeholders and Communication Division

Importance of Pharmacovigilance and Pharmacist Role

Pharmacovigilance Studies in Slovenia

In last March 400 brochures were distributed in Slovenia to inform the colleagues about the importance of pharmacovigilance and the role of the pharmacist. Reporting suspected adverse reactions (ADR) is an important source of data for detecting safety signals and monitoring the risk/benefit balance. Changes may be reflected in the updating of the summary of product characteristics and the package leaflet. Where risk, in spite implementation of the preventive measures, prevails over the benefit, the marketing authorization withdrawal colud take place for the medicinal product. Each ADR report thus contributes significantly to safer use, and it is important that pharmacists actively take their role and obligation in the process of phamacovigilance. For the purpose of raising awareness of the phamacists´ role 400 brochures were printed and distributed to the community pharmacists.

VIth National Conference of Oncology Pharmacy in Sofia

VIth National conference of oncology pharmacy was held on 23-25.02.2018 in Sofia. More than 70 oncology pharmacists and students took part in. Dr Andrea Eberl was a guest of the event and she presented EPIC project. We had lectures about new oncology products, some close systems, "yellow hand" and EU commission, pharmacists as a part of multidisciplinary team, discussion about central preparation of cytostatics.

Velina Grigorova,Sofia,Bulgaria

European Society of Oncology Pharmacy
Veritaskai 6, D 21079 Hamburg
Tel: 0049 - 40 466 500 300
Mail: membershipservice@esop.li



Fax: 0049 - 40 466 500 100
Web: www.esop.li

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