SmPC and PIL databases in national languages in enlarged Europe

1. SmPC and PIL databases in national languages in enlarged Europe Nada Tržan-Herman, Lek d.d., Ljubljana Milan Pukšič, JJZ - Pharmacy of Maribor Slovenia

2. EC - information society and e-health • e-health: a plan to improve patients’ access to health information online (e.g.: Healthgate - The EU Health Portal. • Pharmaceutical care - good information practice required. • Drug Information Centres. • Information specialists - trained in health related subjects and promoting e-health.

3. (BMJ, 29 May 1997, p. 1496 -modified) Information age health care - the role of “the informed consumer” Individual self care Self help networks, Patient groups, Friends and family Professionals as facilitators and partners Disease management: - Nursing care - Pharmaceutical care - Hospital care - Physicians’ care - Other Professionals as authorities Increasing role of consumers, patients

4. SmPCs and PILs - information on medicinal products - issued by pharmaceutical industry • SmPC (Summary of product characteristics):This is information about medicinal product for professionals (Physicians, Pharmacists, Nurses...). • PIL (Patient Information Leaflet): This is information for patients; it must be written in accordance with SmPC but it must be understandable to patients. • Regulatory requirements in Europe enforce SmPCs and PILs to be written in national languages. • PILs: important for better patient compliance (e.g.: two-thirds of patients are not fully compliant with prescribed medical therapies).

5. PIL - important for better patients compliance • PIL (written in official language) is enclosed in each package of medicinal product and accessed via Internet, too. Co-operation between regulatory bodies and patients’ groups: EMEA/CPMP Working group with Patients Organisations (Ref: EMEA/CPMP/5819/04/Final). • PILs are tested by public before Marketing Authorisation (MA): surveys on readability tests. EC Guideline on readability test - three groups of languages (Ref: EMEA/88/00, Dec. 1999): Group A: French, Italian, Portuguese, Spanish Group B: Dutch, English, German Group C: Danish, Finish, Greek, Swedish

6. EFPIA (European Federation of Pharmaceutical Industries and associations) and its view about information on medicines for patients (Ref: EFPIA-June 2004) • Enhanced access to health information for all patients and citizens in Europe. • High quality medicines information from multiple sources (not sensible to exclude pharmaceutical industry information sources !). • Internet access to medicines information. • Regulatory developments on drug information access. • Development of Information strategy that benefit patients. • Public Private Partnerships as a part of this strategy.

7. SmPCs and PILs in national languages in 10 new EC countries - a general view • EC Regulatory requirements for medicinal products are adopted and implemented. • Implementation has started years before the May 2004. • National Drug Regulatory Agencies (DRAs) build SmPCs and PILs databases - but they are not available via Internet in all countries.

8. Internet access of SmPCs in PILs databases in national languages - A survey result (September 2004): Cyprus No Czech R.Yes EstoniaYes Hungary No * Latvia Yes LithuaniaYes Malta No Poland No Slovakia Yes SloveniaYes * in Hungary via Internet only a short description about medicinal products

9. Future developments • Development of internet access of SmPCs and PILs in national languages in Hungary, Poland, Malta and Cyprus. • In Slovenia there is a plan to expand the national medicinal registry (which includes SmPCs and PILs) with additional recording of information on contraindications, adverse affects, warnings and drug interactions. It can become a tool for assessment of wrong medicinal products combinations and adverse affects.

10. SmPCs database development - Assessment of drug interactions (an example)

11. Future potential projects for Health information specialists regarding SmPCs and PILs databases • Promotion of e-health. • Performing readability tests of PILs in Slavic languages. • Performing readability tests - an assessment of health literacy. • SmPc and PIL databases use as a basic information source on medicinal products.