EUROmediCAT

WP8 - Dissemination Workshop

Work Undertaken (Deliverables)

Dissemination workshop (Deliverable 32)
Recommendations for pharmacovigilance for drug safety in presgnancy (Deliverable 33)

WP8 Results and Foreground

The main objective of WP8 was to organise the EUROmediCAT dissemination workshop. WP8 was also responsible for drafting recommendations for pharmacovigilance for drug safety in pregnancy. WP8 supplemented the scientific dissemination being undertaken in other workpackages and co-ordinated by WP1 and took charge of organising a final dissemination workshop and creating national dissemination plans.

EUROmediCAT workshop "Safety of mediction use in pregnancy"

The final workshop European Conference “Safety of Medication Use in Pregnancy” was organized in Poznan February 2-4, 2015. Recommendations and further dissemination strategy was agreed. In order to reach the widest range of possible stakeholders with the information of the planned conference a total of 2000 leaflets, 300 invitations and 45 posters have been send to more than 1100 Polish wards, 140 national and regional Polish consultants, 95 Polish departments and clinics, 50 patients societies and association of physicians, EUROmediCAT partners and subcontractors, a total of 1000 emails with conference communique were sent to Polish Universities, hospitals, health care professionals, statement of the conference was published on many websites and in Polish journal “Prenatal Cardiology”. Europe and worldwide dissemination was conducted via mailing lists and newsletters relevant to reproductive pharmacovigilance. The conference website (http://euromedicatconference2015.eu/)

The conference was very well attended, with 620 participants registered from 24 countries. Among the invited speakers, panel members and chairs were experts in the field of pharmacoepidemiology, teratology, genetics, gynecology, neurology and psychiatry. The Conference was held under the patronage of Polish Minister of Health Bartosz Arłukowicz, Polish Chairman of the Polish Parliamentary Health Committee Tomasz Latos, Marshal of Wielkopolska Province Marek Woźniak, Mayor of the City of Poznań Jacek Jaśkowiak, and Rector of the Poznan University of Medical Sciences Prof. Jacek Wysocki.

During the first day of the Conference there was a Satellite Conference "Prevention of congenital malformations - pregnant women therapy safe for the fetus" in Polish, addressed to Polish health care professionals, medical, midwifery and nursing students, giving the opportunity to educate and raise awareness among clinicians and policymakers in Poland regarding medication safety in pregnancy, congenital anomaly prevention, and the important work of the Polish Registry of Congenital Malformations as a part of EUROCAT. Polish participants were presented lectures concerning inter alia recommendations for treatment of pregnant women with diabetes, epilepsy and asthma, and proceedings in pregnant women with ovarian tumors and with breast cancer.

Fifty abstracts for poster presentation were submitted. Thirty three of the abstracts were selected for poster session of “Safety of Medication Use in Pregnancy” Conference (classified in seven categories: epilepsy, mental health, depression, asthma, prevention and public health, natural and herbal products, methodology, other) and thirteen for Satellite Conference. Twenty four posters and eighteen oral presentation abstracts from the Conference will be published in the journal “Pharmacoepidemiology and Drug Safety”.

All EUROmediCAT workpackages results were presented during the Conference in each of the session. After the session the panel discussion were held, giving the opportunity to discuss the results with all the key stakeholders from across Europe and regional stakeholders from Poland. Session 7 “Recommendations for reproductive pharmacovigilance in Europe” of the Conference was specifically devoted to Recommendations for reproductive pharmacovigilance in Europe (Deliverable 33).

Sustainability in terms of the continuation and development of the EUROmediCAT system was considered.

Conference organizers received a letter from the Member of the European Parliament Boleslaw Piecha, in which he stressed the importance of research undertaken by EUROmediCAT and offered assistance in organizing a similar conference in the forum of the European Parliament. It is assumed to take action in order to organize such a conference in the near future.

Attention shall be given on the fact that in the Conference participated representatives of patient organizations and people born with physical and visual impairments as a consequence of thalidomide use by their mothers during pregnancy. One of invited speakers was Geoff Adams-Spink, Trustee of the Disability Rights in United Kingdom and Chairman of the European Dysmelia Reference Information Centre. During the Conference representatives of patient organizations and other patients, took part in the meeting with Geoff Adams-Spink and medical geneticist. The meeting gave the opportunity for patients to exchange experiences and got help and advice from people involved in the fight for real improvement in people's quality of life and helping them to retain independence and dignity. The Conference was the occasion for a press, radio and TV release in Poland.

PUMS stimulated the other partners to widen the scope of their dissemination activities and helped WP1 to collect together information about dissemination by all partners. The Polish National Dissemination Plan has been developed and implemented. The plan assumed education and dissemination of knowledge about EUROmediCAT, European Conference and recommendation agreed during the Conference, through four groups of people: students, healthcare professionals (e.g. physicians, midwifes and nurses), policy makers and the general public. The Polish National Dissemination Plan was fully implemented.

A list of scientific publications relating to the foreground of EUROmediCAT and dissemination activities (lectures, workshops, conference lectures, leaflets, Bachelor’s dissertation, recruitment of EUROmediCAT volunteers, interviews, website, newsletters, posters, presentations, articles, publications, article in press, brochure on EU projects, letters to politicians) was compiled. A new website in Polish (http://mamapodopieka.pl/) dedicated to the project has been designed. It provides information on the project, maternal diseases and medication during pregnancy. It is planned to update and supplement information on this website, even after the end of the EUROmediCAT project.

EUROmediCAT Recommendations: European Pharmacovigilance concerning Safety of Medication use in Pregnancy

The Recommendations for European and national medicines regulatory agencies, public health authorities and professional clinical bodies are:

To improve future pharmacovigilance
To inform future drug safety measures

The recommendations are designed to help make better use of current data, networks and infrastructures in Europe, to achieve a more integrated system and better dissemination of knowledge and to raise the level of reproductive pharmacovigilance to meet women’s reasonable expectations.

These recommendations concentrate particularly on safety in early pregnancy in relation to the risk of congenital anomalies. Wider perspectives should also be taken with respect to other adverse pregnancy outcomes (such as miscarriages, preterm birth or intrauterine growth retardation) and particularly neurobehavioural effects of medication exposure in pregnancy, with respect to the effects of the diseases/conditions themselves on pregnancy outcome, with respect to herbal medications, and with respect to the period of lactation, but these are not the specific focus of these recommendations.

Near the end of the EUROmediCAT project in January, 2015, all EUROmediCAT Workpackage Leaders were asked to contribute recommendations arising from their workpackage. A draft set of the full project recommendations was circulated to the EUROmediCAT Steering Group for comment and approval. The second draft of recommendations was presented for discussion at the final EUROmediCAT conference in Poznan February 2-4. All External Chairs and Panel Members were invited to endorse the recommendations (still in progress at time of drafting of this Report) before scientific journal and website publication.

The 27 Recommendations were grouped under three subheadings as follows:

General Regulatory and Public Health Considerations (9)
Improving Safety of use of antidiabetics, antiepileptics, antidepressant, antiasthmatics (7)
Methodology and Infrastructure for Reproductive Pharmacovigilance (11)

Members of the EUROmediCAT Steering Group and EUROCAT registries have offered to translate the Recommendations into national languages, and will send the Recommendations to their national medicines regulatory authorities and public health authorities. As WHO Collaborating Centre for Surveillance of Congenital Anomalies, the Centre for Maternal, Fetal and Infant Research at Ulster University (Co-ordinator of EUROmediCAT) will seek to engage the WHO with regard to the Recommendations (Deliverable 33).

Other Dissemination Materials & Activities

As Advised by Dr Anna Pierini of Institute of Clinical Physiology-National Research Council, Italy:

At the Pharmocovigilance Congress on Antiasthmatic Medicines held in Bologna, Italy on 23 November 2018, a presentation titled, "The EUROmediCAT Project for the evaluation of the safety of medicines during pregnancy." [Presentation in Italian]

Presentation of the EUROmediCAT results in Florence, Italy on 30 September 2016 "Health and Gender Medicine: from training to services. Good practices" within the project "Women and Health" organised by the regional commission for Equal Opportunities of Tuscany [Presentation]

"Graph of the Month" published on homepage of Epidemiologia & Prevenzione website (the journal of the Italian Association of Epidemiology). The graph refers to the results on antidiabetics in pregnancy published on PLos One.

http://www.epiprev.it/antidiabetici-gravidanza-pi%C3%B9-si-controlla-pi%C3%B9-si-prescrive

The news was also published as spotlight on the Institute of Clinical Physiology-National Research Council's website

https://www.ifc.cnr.it/index.php/it/spotlight/438-importanti-risultati-da-euromedicat

At the following link on the National Center of Rare Diseases website, section folic Acid, you can find the news on the EUROmediCAT Recommendations

http://www.iss.it/acid/?lang=1&id=274&tipo=5

The results on Antiepileptic Drugs published on Pharmacoepidemiology and Drug Safety can be found at

http://www.iss.it/acid/index.php?lang=1&id=273&tipo=5

Links to the news published on the websites of Epicentro and National center of Rare Diseases (section folic Acid) respectively regarding the antidiabetic study published on PlosOne

http://www.epicentro.iss.it/farmaci/aggiornamenti.asp

http://www.iss.it/acid/

On Recommendations

https://www.ifc.cnr.it/index.php/it/arhivio-news/377-ifc-e-le-raccomandazioni-euromedicat

On Antiepildeptic Study

https://www.ifc.cnr.it/index.php/it/arhivio-news/366-pubblicati-i-risultati-del-progetto-euromedicat

On Conference in Poznan

https://www.ifc.cnr.it/index.php/it/arhivio-news/300-conferenza-euromedicat-safety-of-medication-use-in-pregnancy

As advised by Dr Sue Jordan:

SSRI Antidepressants in Pregnancy and Congenital Anomalies press release

http://www.swansea.ac.uk/media-centre/latest-research/researchersfindlinkbetweenantidepressantuseandcongenitalanomaliesorstillbirths.php

SSRI Antidepressants in Pregnancy and Congenital Anomalies local coverage