Transcript Abstract Presentation

SmPC 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
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.: 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.
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.
Internet access of SmPCs 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 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.
SmPCs database development Assessment of drug interactions (an example)
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.