EMA meeting PCWP/HCPWP 8th March 2016
Session on communication and information on medicines
Different types of information prepared by the EMA which are a relevant resource for patients and healthcare professionals:
1. EPAR – European public assessment report: This is a collection of information on a centrally authorised medicine, which can be downloaded and viewed on the EMA website. The function of the EPAR is to give the scientific conclusion for approval of the medicine to be marketed. The following documents are included in the EPAR: EPAR summary, Product information, Summaries of product characteristics (SmPC), Package Leaflet, Labelling, Public Assessment Report.
Other product specific publications:
2. Summaries of orphan designations, information in lay language on the opinions of the COMP (committee for orphan medicinal products) about the medicines under development for rare diseases that have applied for orphan designation.
3. Summaries of paediatric investigation plans (PIP): These summaries describe the evaluation of the PIP by the PDCO (paediatric committee) and waiver applications, including the potential use of the applicant’s medicine in children.
4. Press releases on new medicines: issued by the EMA and published on the website highlighting those medicines considered of significant public interest.
5. Summaries of opinions (SMOPs): are published at the time of a committee’s opinion and contains key technical and regulatory information on the medicine involved. These summaries are first discussed during the CHMP meeting and after that made available on the specific medicine webpage after EU commission’s decision.
6. Withdrawals and refusals Q & As: are summaries of the evaluation at the time of the withdrawal/refusal of the application for marketing authorisation. This document contains in lay language the scientific assessment of the product and is then published on the EMA website in English and after that in all official EU languages.
7. Post- authorisation: the EMA publishes information on non-safety referrals, imposed safety and efficacy post-authorisation studies and periodic safety updates for national authorised medicines, containing the same active substance or combination of active substances also known as PSUSAs – periodic safety update report single assessment.
8. Safety communication – or Public Health communication: these safety communications relate to withdrawal/suspension or new contra-indications, warnings, restrictions of use or defects. A referral procedure, which tries to resolve concerns about safety or benefit-risk balance of a medicine or a class of medicines would require a scientific assessment by the EMA. There would then be an assessment by the PRAC – Pharmacovigilance Risk Assessment Committee.
9. Information on shortages of medicines: for centrally authorised medicines is published on the EMA website where shortages affect or are likely to affect more than one EU Member State.
10. Newsletter – Human medicines highlights: provides a monthly update on key information on human medicines published by the EMA.
11. New Product information wording: extracts from PRAC recommendations on signals, this publication captures the proposed changes to the product information following the assessment of a safety signal. The PRAC assesses safety signals for centrally and non-centrally authorised medicines. Their recommendations are published every month.
12. Opinions on safety variations/Periodic Safety Update reports (PSURs): deals with changes related to safety of the SmPC.
13. Opinions on annual re-assessments, renewals of marketing authorisations and accelerated assessment procedures: these are published after the CHMP meeting where the opinion was discussed.
14. Summaries of herbal medicines: include information on the herbal substances assessed, the conclusions from the HMPC (committee on herbal products), data supporting the recommendations and potential side effects. The summaries are published by the EMA on the dedicated herbal medicine webpage.
15. EU Clinical trial Register website: provides the public with information about EU clinical trials database, EudraCT, this is used by NCA to support supervision of clinical trials. All aspect of the clinical trial are available.
16. European database of suspected adverse drug reaction reports provides the public with information generated by EudraVigilance: is the EU network system for managing information on suspected adverse reactions. This public website allows access to view the reported cases of suspected serious side-effects for each centrally authorised medicine.
17. Clinical data publication website: will publish clinical reports related to all marketing authorisation applications as soon as a decision on the application has been made.
In view of the large amount of information available it was decided to have a workshop session on “Producing, Disseminating and Using Information”.
A survey conducted in 2015 wanted to find out how EMA’s communication to the public was perceived, understand how EMA’s communications are valued and finally assess and measure the levels of satisfaction with the services provided by the Agency. Over 1000 stakeholders, partners and specific individuals were contacted and over 40% responded. The outcome was that the EMA communication was widely used by all stakeholders, there was a high level of trust and confidence in the EMA, but greater effort should be made to simply the language used .Increased use of social media would create a better awareness of EMA and its work. With regard to specific information, the press releases are very important as well as safety communications. News items and meeting highlights are less known. Transparency was highly rated with the EMA being compared very favourably with other regulatory authorities.
The amount of information on medicines in general is overwhelming and it was highlighted that the internet generated information often lacks quality and does not actually address the needs of physicians, patients and public at large. Some standard of quality or accreditation should be introduced. The main source of drug information is provided by the NCA (national competent agency) and some countries have an advanced framework of evidence-based drug information for HCPs and the general public. Other agencies such as EUNetHTA have adopted clear guidelines in the assessment of added therapeutic value (ATV) measures to see the effectiveness of a drug. The role of patient and doctor groups is essential for effective transparency of medicines.
The outcome of the various workshops was that information should be regularly updated (with date shown of update). Information should be more patient friendly and in lay language. Social Media should be used more and differently to convey information. The website should be designed so that ii is easier to access the relevant information. EMA has launched a dedicated page to Patients and Consumers and one for Health Care Professionals.