RISK COMMUNICATION Post Graduate Course in Pharmaceutical Medicine

1. RISK COMMUNICATIONPost Graduate Course in Pharmaceutical Medicine Dr Peter Arlett April 2013 Pharmacovigilance and Risk Management, EMA

2. IN THIS TALK… • Health burden • Stakeholders • Key principles • Distribution and tools • Crisis management and urgent communications Risk Communication

3. HEALTH BURDEN Public health burden of Adverse Drug Reactions (European Commission data): • 5% of all hospital admissions are due to an ADR • 5% of all hospital patients suffer an ADR • ADRs are the 5th most common cause of hospital death • It is estimated that 197,000 deaths per year in the EU are caused by ADRs • The total cost to society of ADRs in the EU is €79 billion • Even small improvements in the pharmacovigilance system will have a major impact on public health and society. • Risk communication: - Allows users of medicines a choice - Can reduce risk and increase benefit of medicines thereby promoting public health Risk Communication

4. RISK COMMUNICATION Stakeholders for the benefits and risks of medicines Key stakeholders include: • Patients • Healthcare professionals • Industry • Regulators (EMA + National Agencies + international partners) EU and international coordination role for the EMA • Others (media, academics, payers) We need to consider communication at each step of the pharmacovigilance process and to each of the key stakeholder groups Risk Communication

5. RISK COMMUNICATION Communicating about risks is difficult: • Risk is a difficult concept • Balancing risk and benefit difficult to explain • Number of stakeholders • Urgency required • (Relatively) poor distribution networks Risk Communication

6. KEY PRINCIPLALS (1) • Be open - make clear what the issue is, be honest about the hazard, do not hide or minimise it • Be targeted - first consider your audience and its specific information needs • Understandable - keep it as straight forward as possible, the reader is more likely to respond appropriately if the message is simple and clear • Be tailored to the specific issue • Make clear why communications are being sent at this time Risk Communication

7. KEY PRINCIPLALS (2) • Make clear what healthcare professionals should do next - simple instructions will help to prevent unnecessary consultations and minimise further enquiries • Balance risks with benefits where appropriate - the final test - is it clear that you have considered both risks and benefits: is the overall message right? • Include contact points including web-site address, telephone lines and an address to write to for further information Risk Communication

8. Key principles on distribution For healthcare professionals it might include: The SPC Educational materials Websites Regulatory bulletins Letter via fax, e-mail, post Journals Via professional bodies Media Key principles on distribution For patientsit might include: Patient information leaflet and label Educational materials Websites Via press/media Via letter to health professionals Patient organisations Telephone help-lines RISK COMMUNICATION Distribution mechanism depends on the audience Risk Communication

9. SUMMARY OF PRODUCTCHARACTERISTICS • 4. Clinical particulars: • 4.1. therapeutic indications, • 4.2. posology and method of administration for adults and, where necessary for children, • 4.3. contra-indications, • 4.4. special warnings and precautions for use and, in the case of immunological medicinal products, any special precautions to be taken by persons handling such products and administering them to patients, together with any precautions to be taken by the patient, • 4.5. interaction with other medicinal products and other forms of interactions, • 4.6. use during pregnancy and lactation, • 4.7. effects on ability to drive and to use machines, • 4.8. undesirable effects, • 4.9. overdose (symptoms, emergency procedures, antidotes). Risk Communication

10. PATIENT INFORMATION LEAFLET • Required for all products (Article 59 of Directive 2001/83/EC) • Follows the information in the SPC but in lay-language • Legal obligation for ‘consultations with target patient groups to ensure legible, clear and easy to use’. Risk Communication

11. OUTER PACKAGING OR IMMEDIATE PACKAGING • Information dictated by law (Article 54 of Directive 2001/83/EC) • Information includes: • Name (also in Braille), strength and form INN or common name • Active substances dose • Important excipients • Method of administration • Special warnings • Expiry date • Storage conditions • Disposal • Company name and address • Product authorisation number, batch number • Instructions for use for OTC Risk Communication

12. DRUG SAFETY CONCERN • Action needs to be taken? – yes • Is it urgent or not? Size of threat to public health • All actions need to be communicated • Urgency will determine methods of communication Risk Communication

13. CRISIS MANAGEMENT AND URGENT COMMUNICATION Risk Communication

14. A CRISIS: • Considering suspending a licence due to safety concerns • Withdrawal of a marketed medicine due to safety concerns (even if voluntary) • Identification of hazard of life threatening ADR • Media perceive drug to be unsafe • Major action (e.g. withdrawal) in another country Risk Communication

15. ACTION PLAN • define key activities with target dates • define resource needs • allocate staff to handle the activities • define possible implications of the hazard and likely options Risk Communication

16. start early have a planning meeting define the team members key message target audiences key professional and patient organisations PLANNING COMMUNICATION methods of distribution who writes reviews, signs off dates and times for drafts date to start distribution receive date contingency plan Risk Communication

17. DOCUMENTS • Dear Healthcare Professional (DHPC) letter • information sheet for patients • question and answer document • information for the website • press briefing • Ministerial Submission • infofax etc • agree author, review and sign off at planning meeting Risk Communication

18. Conclusions • The health burden of adverse reactions to medicines is major • Risk communication is key to minimising the risks of medicines • Good communications can be difficult • Good communications - most likely if stakeholders work together • Improvements in our communications will have a major positive impact on public health • GVP: http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2013/01/WC500137666.pdf Risk Communication