XV.B.5. Means of safety communication

Communication tools and channels2 have become more numerous and varied over time, offering the public more information than was previously possible. Relevant communication tools and channels should be considered when issuing a safety communication in order to reach the target audiences and meet their growing expectations. Different communication tools and channels are discussed below in XV.B.5.1. to XV.B.5.9.

XV.B.5.1. Direct healthcare professional communication (DHPC)

A direct healthcare professional communication (DHPC) is a communication intervention by which important safety information is delivered directly to individual healthcare professionals by a marketing authorisation holder or a competent authority, to inform them of the need to take certain actions or adapt their practices in relation to a medicinal product. DHPCs are not replies to enquiries from healthcare professionals.

The preparation of DHPCs involves cooperation between the marketing authorisation holder and the competent authority. Agreement between these two parties should be reached before a DHPC is issued by the marketing authorisation holder. The agreement will cover both the content of the DHPC (see XV.B.4.) and the communication plan (see GVP Annex II), including the intended recipients, the timetable and the channels for disseminating the DHPC.

Where there are several marketing authorisation holders of the same active substance and/or a class of products for which a DHPC is to be issued, a single consistent message should be delivered (see XV.C.2.1.).

Whenever possible and appropriate, it is advised that healthcare professionals’ organisations or learned societies are involved during the preparation of DHPCs to ensure that the information delivered by the DHPCs is useful and adapted to the target audience.

A DHPC should be complemented by other communication tools and channels and the principle of providing consistent information should apply (XV.B.2.).

A DHPC should be included as an additional risk minimisation measure as part of a risk management plan (see GVP Modules V and XVI).

A DHPC should be disseminated in the following situations when there is a need to take immediate action or change current practice in relation to a medicinal product:

• suspension, withdrawal or revocation of a marketing authorisation for safety reasons;
• an important change to the use of a medicine due to the restriction of an indication, a new contraindication, or a change in the recommended dose due to safety reasons;
• a restriction in availability or discontinuation of a medicine with potential detrimental effects on patient care.

Other situations where dissemination of a DHPC should be considered are:

• new major warnings or precautions for use in the product information;
• new data identifying a previously unknown risk or a change in the frequency or severity of a known risk;
• new evidence that the medicinal product is not as effective as previously considered;
• new recommendations for preventing or treating adverse reactions or to avoid misuse or medication errors with the medicinal product;
• ongoing assessment of an important potential risk, for which data available at a particular point in time are insufficient to take regulatory action (in this case, the DHPC should encourage close monitoring of the safety concern in clinical practice and encourage reporting, and possibly provide information on how to minimise the potential risk).

A competent authority may disseminate or request the marketing authorisation holder to disseminate a DHPC in any situation where the competent authority considers it necessary for the continued safe and effective use of a medicinal product.

XV.B.5.2. Communication materials from competent authorities targeted at healthcare professionals

Competent authorities can issue safety communications targeting healthcare professionals directly. These are usually published on the website of the competent authority. These communications often complement other means for communicating a safety concern (e.g. a DHPC) and are issued around the same time. They contain the competent authority’s recommendations and advice for risk minimisation for healthcare professionals, and provide relevant background information. Adequate links to further information can be included (e.g. links to the product information of the concerned medicinal product(s) and, whenever possible, prescription and dispensing systems).

Safety communications from competent authorities should follow the principles identified above (see XV.B.2.) and should be issued when there is a need to take immediate action or change current practice in relation to a medicinal product (see XV.B.5.1.).Competent authorities should also consider existing public interest when issuing a safety communication.

Competent authorities should make use of the most appropriate tools and channels described in this Section to maximise dissemination and accessibility of relevant information. This includes interaction with other organisations such as learned societies, local health authorities, patient and other healthcare organisations, as appropriate.

XV.B.5.3. Documents in lay language to patients and the general public

Communication material in lay language (e.g. using a questions & answers format) helps patients and the general public to understand the scientific evidence and regulatory actions relating to a safety concern. It can also be an additional tool that healthcare professionals can use in their communication with patients. Lay language documents should contain the competent authority’s recommendations and advice for risk minimisation for patients, and should be accompanied by relevant background information.

Lay language documents should be useful to members of the public who have an interest in the subject but do not have a scientific or regulatory background. Reference should be made to other communication materials on the topic to direct readers to where they can find further information.

For the dissemination and accessibility of lay language documents, the most appropriate tools and channels described in this Section should be used as appropriate.

Whenever possible and appropriate, it is advised that patients are involved during the preparation of lay language documents to ensure that the information they deliver is useful and adapted to the target audience.

XV.B.5.4. Press communication

Press communication includes press releases and press briefings which are primarily intended for journalists.

Competent authorities may send press releases directly to journalists in addition to publishing them on their websites. This ensures that journalists, in addition to obtaining information from other sources, receive information that is consistent with the authority’s scientific assessment. Interaction with the media is an important way to reach out to a wider audience as well as to build trust in the regulatory system.

Press releases may also be prepared and published by marketing authorisation holders. Their press releases should make reference to the regulatory action taken by the competent authority. Relevant ongoing reviews should be mentioned in any communication by the marketing authorisation holder.

Although aimed at journalists, press releases will be read by other audiences such as healthcare professionals, patients and the general public. Reference should therefore be made to related communication materials on the topic. In cases where a DHPC and/or a communication from a competent authority is also prepared, healthcare professionals should ideally receive it prior to or around the same time of the publication or distribution of a press release so that they are better prepared to respond to patients.

Press briefings with journalists should be considered by competent authorities for safety concerns or other matters relating to the safety of medicinal products that are of high media interest or when complex or public-health-sensitive messages need to be conveyed.

XV.B.5.5. Website

A website is a key tool for members of the public (including patients and healthcare professionals) actively searching the internet for specific information on medicinal products. Competent authorities as well as marketing authorisation holders should ensure that important safety information published on websites under their control is easily accessible and understandable by the public. Information on websites should be kept up-to-date, with any information that is out-of-date marked as such or removed.

The applicable legislation on pharmacovigilance foresees the creation of an EU medicines web portal which will contain information on all medicines authorised in the EU [REG Art 26(1)]. This web portal will become a key tool for communicating up-to-date safety information to EU citizens and will contain information in all EU official languages. Each Member State shall set up and maintain a national medicines web-portal which shall be linked to the EU medicines web-portal [DIR Art 106]. Until the web portal is fully established and into operation, the Agency’s website will be acting as an interim platform to convey this important up-to-date safety information.

XV.B.5.6. Social media and other online communications

Online safety information may also be disseminated via social media and other web tools. When using newer, more rapid communication channels, special attention should be paid to ensure that the accuracy of the information released is not compromised. Communication practices should take into account emerging digital communication tools used by the various target audiences.

XV.B.5.7. Bulletins and newsletters

Bulletins and newsletters provide at regular intervals information about medicines and their safety and effectiveness. These tools may serve as reminders of previous communications. Competent authorities can reach a large audience with these tools by using web-based and other available means.

XV.B.5.8. Inter-authority communication

When one competent authority takes regulatory action on a particular safety concern, other competent authorities may also receive enquiries or may want to communicate on the same issue. The use of inter-authority communication material, such as lines-to-take should be considered. Lines-to-take are documents prepared by a competent authority to assist its staff and those of co-operating authorities in responding consistently to external enquires or communicating a consistent message on a specific issue.

XV.B.5.9. Responding to enquiries from the public

Competent authorities and marketing authorisation holders should have systems in place for responding to enquiries about medicines from individual members of the public. Responses should take into account the information which is in the public domain and should include the relevant recommendations to patients and healthcare professionals issued by competent authorities. Where questions relate to individual treatment advice, the patient should be advised to contact a healthcare professional.

In this respect, DIR Articles 86(2) and 98(1) apply to marketing authorisation holders.

XV.B.5.10. Other means of communication

In addition to those discussed above, there are other tools and channels such as publications in scientific journals and journals of professional bodies.

Some tools and channels may be used in the context of risk management; in addition to the product information, other communication tools can be used to disseminate information about the product. These are considered as additional risk minimisation measures and may include patient alert cards or educational materials. These are outside the scope of this Module and are described in more detail in GVP Module XVI.