Product information (II) – aspects relevant for ACTs

1. Product information (II) – aspects relevant for ACTs Regine Lehnert Training workshop: Regulatory requirements for registration of Artemisinin based combined medicines and assessment of data which are submitted to regulatory authorities, Kampala, February 2009

2. Synopsis • A „good“ medicinal product • Product information • Patient Information Leaflet (PIL) • Structure • Format • Style • Conclusion

3. A “Good” Medicinal Product Efficacy and Safety (Bioequivalence) Pharmaceutical Quality Product information

4. Required Documents → Prequalification Programme:format according to European standards (http://www.who.int/prequal/Guidance note to Applicants (Manufacturers) on the compilationof the WHO Public Assessment Report (WHOPAR) ) • Summary of Product Characteristics (SPCorSmPC):Main scientific information on the safe use of the product for the health care professional. • Package Leaflet /Patient Information Leaflet (PL or PIL) : Relevant information on the safe use of the product in a patient-friendly language for the user. • Labelling on outer and immediate packaging materials.

5. Patient information leaflet (I) Relevant European Guidelines: • on packaging information of medicinal products: http://ec.europa.eu/enterprise/pharmaceuticals/eudralex/vol-2/c/bluebox_02_2008.pdf • on readability of the label and package leaflet http://ec.europa.eu/enterprise/pharmaceuticals/eudralex/vol-2/c/gl981002.pdf (currently under revision)

6. Patient information leaflet (II) • Legislation • Contents in accordance with the Summary of product characteristics (SPC) • One leaflet per product • Approval by competent authority • Clear and understandable • Clearly legible • Language of where the product is placed on the market • Contents of all language versions identical • Optional: local representative (for enabling patients to address queries in the local language).

7. Patient information leaflet (III) • Structure - 6sections: • 1. What {product name} is and what it is used for • 2. Before you take {product name} • 3. How to take {product name} • 4. Possible side effects • 5. How to store {product name} • 6. Further information

8. Patient information leaflet (IV) • Readability • Format • Print size and type • At least 8 points Didot • space between lines at least 3 mm • Print colour (to highlight headings), red colour only for very important warnings • Not more than two levels of headings (numbered) • Use of capitals to be avoided • Capitals for emphasis only • Paper size: preferably A4/A5, since user-friendly • Paper weight: not less than 40g/m2

9. Patient information leaflet (V) • Readability (cont.) • Style • Consumer understandable language • Explanation for specific/specialized terms • Active/direct style, e.g. „Take 1 tablet once daily“ • Pictograms only in addition to clarify • Instructions prior to explanations, e.g. „take care with X when you have asthma – it may bring you on an attack.“

10. Patient information leaflet (VI) • Readability (cont.) • Style (cont.) • Syntax • Sentences not longer than 20 words • Avoid subordinate clauses • Bullet points • Not more than one sentence per bullet point • Whenever possible, „it“ instead of product name • Prominence to the most crucial information for thesafe use of the product. • Use of Braille encouraged.

11. Patient information leaflet (VII) Use of pictograms - difficulties

12. Patient information leaflet (VIII) • In conclusion: • concise/comprehensible information • In a well defined/reproducible structure with • clear format and • cross-referencing between sections → allows fast access to the relevant information → safe/effective use of the medicinal product