Stakeholders' Understanding of European Medicine Agency's COVID-19 Vaccine Information Materials in EU and Regional Contexts.

The COVID-19 pandemic posed challenges to communicating accurate information about vaccines because of the spread of misinformation. The European Medicines Agency (EMA) tried to reassure the public by communicating early on about the development and approval of COVID-19 vaccines. The EMA surveyed patients/consumers, healthcare professional organizations, and individual stakeholders, both at the EU level and in an Italian regional context. The objectives of the study were to see if the EMA's core information materials were informative and well-understood and which communication channels were preferred by the public. The main findings showed that individual patients/consumers generally prefer to obtain information about COVID-19 vaccines from the internet or mass media, while organizations and individual healthcare professionals prefer to obtain information from national and international health authorities. Both at EU and local levels, participants had a good understanding of the key messages from regulators and found the materials useful and relevant. However, some improvements were recommended to the visual, text, and dissemination formats, including publishing more information on safety and using a more public-friendly language. Also, it was recommended to maintain the EMA's approach of using media, stakeholder engagement, and web-based formats to communicate about COVID-19 vaccines. In conclusion, user-testing of proactive communication materials aimed to prebunk misinformation during a public health crisis helps to ensure that users understand the development and safety of novel vaccine technologies. This information can then be used as a basis for further evidence-based communication activities by regulators and public health bodies in an emergency context.

Public information on shortages in the EU/EEA: improvements made between 2018 and 2020.

BACKGROUND: In July 2019, the Heads of Medicines Agencies/European Medicines Agency (HMA/EMA) Task Force on Availability of Authorised Medicines for Human and Veterinary Use (TFAAM) published good practice guidance which provides key principles for European Union (EU) regulatory authorities for communication on shortages and availability issues. The use of a shortage catalogue was a key recommendation. OBJECTIVES: To assess how EU/European Economic Area (EEA) national competent authorities have implemented the recommendations of the good practice guidance. METHODS: A survey was run in 2020 among EU/EEA national competent authorities to assess communication practices. The results were compared with those of a similar survey carried out 2 years earlier, before publication of the guidance. The survey covered human medicines only and was sent to 31 authorities: one per EU/EEA member state (and two to Germany's two medicines regulatory authorities). RESULTS: In 2020, 81% of authorities (25/31) had a dedicated public shortage catalogue on their website. This was an increase from 74% (23/31) in 2018, when a similar survey was run. In future this is expected to increase to 87% with two more member states making plans to implement catalogues. Although many member states publish information on shortages there is still selection in terms of the details that are being published, and there is further scope to extend the information currently provided. CONCLUSION: Since publication of the EMA/HMA good practice guide in 2019, transparency has increased across the EU/EEA, and public catalogues of shortages are now a routine tool used by many medicines agencies.Further opportunities to improve transparency on supply issues lie ahead with the EMA network strategy to 2025, the revised EU pharmaceutical legislation and the new legal mandate reinforcing the role of the EMA.

Sustaining Meaningful Patient Engagement Across the Lifecycle of Medicines: A Roadmap for Action.

BACKGROUND: There is increased recognition that incorporating patients' perspectives and insights into the medicines development process results in better health outcomes and benefits for all involved stakeholders. Despite the increased interest and the existence of frameworks and practical recommendations, patient engagement (PE) is not yet considered standard practice. The objective of this work was to provide a roadmap to support systematic change in all stakeholder organisations involved in medicines development across Europe, patients and patient organisations, medicines developers, academia, regulatory authorities, Health Technology Assessment bodies, payers, policy-makers and public research funders, to sustain PE practices. METHODS: A mixed-methods approach was used by the EU-funded Innovative Medicines Initiative PARADIGM Consortium to co-develop the sustainability roadmap including background work to identify success factors and scenarios for sustainable PE. The roadmap development was based on the Theory of Change concept and populated with findings from (1) interviews with national/ and international institutions with the potential to increase PE uptake by other stakeholders; (2) multi-stakeholder workshops and webinars; and (3) consultations with specific stakeholder groups, Consortium members and a consultative body formed by international PE initiatives. RESULTS: This roadmap sets strategic goals for the PE community to achieve meaningful and systematic PE through changes in the culture, processes and resources of stakeholder organisations. It brings in key PARADIGM outputs to work in a coordinated fashion with existing frameworks and mechanisms to achieve system-wide sustained PE. CONCLUSIONS: The roadmap provides a framework for all stakeholders to take collective action within their organisations and across Europe to implement PE in a sustainable manner.

Preparing for the incoming wave of biosimilars in oncology.

With the imminent arrival of oncology biosimilars in the therapeutic paradigm, stakeholders including a clinician, specialist nurse, patient advocate, regulator and economist provide their perspective on optimising the uptake of these new agents in the treatment of cancer. A number of key messages emerge, based on the discussion that took place during a session of the European Society for Medical Oncology's Annual Congress, ESMO Madrid 2017. First, for successful integration of biosimilars into the global healthcare paradigm, informing and educating the full scope of stakeholders, including clinicians, nurses, pharmacists and patients, is primordial. Success is dependent on providing solid evidence and ensuring all voices are heard. Second, for oncology medicines, much can be learnt from the growing experience of approved biosimilars in other disease indications, with success stories for patients, their healthcare providers and healthcare budgets alike. Finally, effective sustainability of the impact on healthcare budgets and the redirection of these savings require education and transparency.

Latest clinical recommendations on valproate use for migraine prophylaxis in women of childbearing age: overview from European Medicines Agency and European Headache Federation.

Migraine is a common and burdensome neurological condition which affects mainly female patients during their childbearing years. Valproate has been widely used for the prophylaxis of migraine attacks and is also included in the main European Guidelines. Previous (2014) European recommendations on limiting the use of valproate in women of childbearing age did not achieve their objective in terms of limiting the use of valproate in women of childbearing age and raising awareness regarding the hazardous effect of valproate to children exposed in utero. The teratogenic and foetotoxic effects of valproate are well documented, and more recent studies show that there is an even greater neurodevelopmental risk to children exposed to valproate in the womb. The latest 2018 European review from the European Medicines Agency, with the active participation of the European Headache Federation, concluded that not enough has been done to mitigate the risks associated with in utero exposure to valproate. The review called for more extensive restrictions to the conditions for prescribing, better public awareness, and a more effective education campaign in migrainous women.

Non-vitamin-K oral anticoagulants and laboratory testing: now and in the future: Views from a workshop at the European Medicines Agency (EMA).

In contrast to vitamin K antagonists, no routine coagulation monitoring is required in patients taking non-vitamin-K oral anticoagulants (NOACs). However, dosing must take into account factors such as patient age, renal function, and accompanying haemorrhagic risk. There has been considerable debate about when laboratory measurement might be appropriate and which tests should be used. A workshop at the European Medicines Agency recently discussed the evidence about laboratory measurement from formal studies, clinical experience, and the multiple perspectives on NOAC treatment, and considered how our knowledge might be further enhanced.

[Unusual complications after radical cystectomy]. / Complicaciones inusuales post-cistectomía radical.

OBJECTIVES: To report complications that are very rare in patients undergoing radical cystectomy and Bricker's ileal conduit. In accordance to the literature and our own experience, to remark the importance of a proper preoperative preparation (nutritional, preanesthetic evaluation...), and adequate postoperative controls to avoid this kind of problems. METHODS: We report three cases which are demonstrative of these complications, their main characteristics, as well as their diagnosis, treatment, and outcomes. RESULTS: All three cases were complicated by fistulae, with different outcomes. The diagnostic measures undertook on each one are reviewed in detail. Although it is well shown in the literature that most of these fistulae appear in patients with intestinal inflammatory/infectious diseases, this was not our experience. CONCLUSIONS: After a bibliographic review and study of our cases, we insist on the importance of a good nutritional evaluation before surgery, and that radical cystectomy with Bricker's type urinary diversion, although consolidated as treatment for infiltrative bladder cancer, is not exempt of immediate postoperative complications or even deferred, as in our case.

Complicaciones inusuales post-cistectomíaradical / Rare complications after radical cystectomy

OBJETIVOS: Exponer complicaciones muy poco frecuentes en pacientes a los que se les realizó Cistectomía radical y conducto ileal tipo Bricker. Remarcar la importancia, recogida en la literatura y, en nuestra propia experiencia, de una correcta preparación preoperatoria (nutricional, evaluación pre-anestésica.......), así como de unos controles postoperatorios adecuados, para evitar este tipo de problemas. MÉTODO: Para ello exponemos tres casos clínicos demostrativos de estas complicaciones, sus características principales así como su diagnóstico, tratamiento y posterior evolución. RESULTADO: Existencia de complicaciones de tipo fistuloso en los tres casos, con diferente evolución, así como detallar las medidas de carácter diagnóstico que se llevaron a cabo en cada uno de ellos. Aunque esta bien recogido en la literatura, que la mayoría de estas fístulas se producen en pacientes con patología inflamatorio/infecciosa digestiva, no fue así en nuestra experiencia. CONCLUSIONES: Después de revisada la literatura y estudiados nuestros casos, abundar en la importancia de una buena evaluación nutricional previa a la cirugía, y que la cistectomía radical con derivación urinaria tipo Bricker, aunque ya muy consolidada como tratamiento del cáncer de vejiga infiltrante no esta exenta de complicaciones postoperatorias inmediatas o incluso, como en nuestro caso diferidas (AU)

Incidencia de la neoplasia intraepitelial prostática de alto grado en las biopsias transrectales de la próstata / Incidence of high grade prostatic intraepithelial neoplasia in transrectal prostate biopsies

OBJETIVO: Evaluar la incidencia de la neoplasia intraepitelial prostática de alto grado en la biopsia transrectal de la próstata en pacientes procedentes de consultas de Urología. MÉTODO: Entre los años 1.995 y 1.999 se han sometido a biopsia de próstata 2.018 pacientes con una edad media de 68 ñ 10 (46-92) años, el 36 por ciento presentaba tacto rectal sospechoso y el nivel medio de PSA sérico fue de 31,7 ñ 152,9 ng/ml. Los distintos diagnósticos anatomopatológicos se agruparon en: a) cáncer; b) patología benigna; c) PIN de alto grado, y d) atipia glandular. Se realizó un estudio estadístico (test de la Chi cuadrado y el de Mann-Whitney) comparando las siguientes variables: edad, tacto rectal, PSA, índice de PSAl/PSAt y existencia de nódulo ecográfico sospechoso. RESULTADOS: La incidencia de PIN de alto grado en la serie fue del 8 por ciento con una incidencia de cáncer de próstata del 38,6 por ciento. En 94 pacientes se diagnosticó PIN grado 3 y en 67 se encontró PIN grado 2, en 13 pacientes se asoció atipia glandular. En los pacientes con cáncer de próstata se observó mayor edad, nivel de PSA, porcentaje de tacto rectal sospechoso, porcentaje de nódulos ecográficos y menor índice PSAl/PSAt que en el resto de los diagnósticos de forma significativa (p < 0,001). Al comparar los pacientes con PIN de alto grado con la patología benigna no se observaron diferencias en la edad, el tacto rectal, los niveles de PSA y el índice PSAl/ PSAt, en cambio, presentaron una menor incidencia de forma significativa (p < 0,001) de nódulos ecográficos sospechoso. CONCLUSION: La incidencia de PIN de alto grado fue del 8 por ciento. La PIN de alto grado no produce las suficientes alteraciones en las variables clínicas evaluadas para permitirnos sospecharla antes de la confirmación patológica (AU)

La cistectomía radical en el tratamiento del cáncer de vejiga / Radical cystectomy in the treatment of bladder cancer

OBJETIVO: Evaluar retrospectivamente la eficacia de la cistectomía radical como tratamiento aislado en los pacientes con cáncer transicional de vejiga. MÉTODO: Se evalúan 125 pacientes tratados mediante cistectomía radical. La mediana de seguimiento de la serie fue de 62 meses. En el momento de la revisión 65 pacientes estaban vivos (3 con enfermedad tumoral y 1 con un segundo tumor primario); 60 pacientes habían fallecido (50 por el cáncer de vejiga y 10 por otras causas). Nueve pacientes se consideraron perdidos con una mediana de seguimiento de 31 meses. El análisis de la supervivencia se ha realizado mediante el método de Kaplan-Meier, comparando las variables analizadas mediante el test de long-rank. RESULTADOS: La supervivencia global de la serie a los 5 años fue del 50 por ciento y la cáncer-específica del 56 por ciento. La supervivencia cáncer-específica a los 3 y 5 años por estadios tumorales fue: pT1 - 83 por ciento y 83 por ciento, pT2 - 78 por ciento y 70 por ciento, pT3 - 52 por ciento y 42 por ciento, pT4 - 24 por ciento y 12 por ciento y pN+ - 14 por ciento p < 0,0001). No encontramos diferencias (p=0,2) en la supervivencia entre los estadios pT2a (73 por ciento y 68 por ciento) y los pT2b (71 por ciento y 53 por ciento). Los pacientes sin tumor residual en la pieza de cistectomía (pT0) tuvieron una mayor supervivencia (93 por ciento y 83 por ciento) de forma significativa (p=0,03) que los pacientes con tumor residual (60 por ciento y 53 por ciento).CONCLUSIONES: La cistectomía radical como monoterapia en los pacientes con cáncer transicional de vejiga puede considerarse como: a) un tratamiento efectivo en los pacientes en estadio pT2; b) un tratamiento poco efectivo en los pacientes en estadio avanzado (pT3 o pT4) o diseminado a ganglios linfáticos; c) un sobretratamiento en los pacientes sin tumor residual en la pieza de cistectomía (AU)