How to create better Patient Information Leaflets for patients?

The EC will soon report about the shortcomings of the current Product Information leaflets and make recommendations for improvement. A EuroDia Meeting session on 3-4 March 2013 in Amsterdam took the opportunity to look at how to create Product Information that meets the needs of the customer -patient, carer or healthcare professional.“Reliable and accessible information on medicinal products is a fundamental right of patients. Information is a key pillar of patient safety, patient empowerment and meaningful patient involvement in healthcare” reiterated Nicola Bedlington at the session.

She also highlighted the four principles for providing information to patients: the evidence base, factual correctness, the ability to verify source and content of the information, and the relevance.

However more than 15 years after publication of the first EU readability guidelines we are still not visibly producing leaflets that meet the needs of those for whom they are meant. And it is not from a lack of trying.

The session participants pointed to the need for the information to be available electronically. It would allow for providing the information in a timely manner. It could also help with the need for more personalised information and could allow greater tailoring of the information to the individual.

The magic word that also emerged in the debate was multi-stakeholder. Patients’ organisations, caregivers, physicians, pharmacists, regulators and industry want to work together. Patients’ groups and healthcare professional organisations can play an important role in helping define useful content and how the product information can best support and synergise with health literacy initiatives.

It emerged from the discussions that the current regulatory framework is adapted to allow for the necessary changes. There is sufficient trust to encourage an open discussion and feedback on what is available, from the perspective of ethical and transparent communication in the patients’ space.

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