Sm PC and PIL databases in national languages

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

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 required. practice • Drug Information Centres. • Information specialists - trained in health related subjects and promoting e-health.

(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

Sm. PCs and PILs - information on medicinal products - issued by pharmaceutical industry • Sm. PC (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 Sm. PC but it must be understandable to patients. • Regulatory requirements in Europe enforce Sm. PCs and PILs to be written in national languages. • PILs: important for better patient compliance (e. g. : twothirds of patients are not fully compliant with prescribed medical therapies).

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

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.

Sm. PCs 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 Sm. PCs and PILs databases - but they are not available via Internet in all countries.

Internet access of Sm. PCs in PILs databases in national languages A survey result (September 2004): Cyprus No Czech R. Yes Estonia Yes Hungary No * Latvia Yes Lithuania Yes Malta No Poland No Slovakia Yes Slovenia Yes * in Hungary via Internet only a short description about medicinal products

Future developments • Development of internet access of Sm. PCs 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 Sm. PCs 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.

Sm. PCs database development Assessment of drug interactions (an example)

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