SmPC and PIL databases in national languages in enlarged Europe

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SmPC and PIL databases in national languages in
enlarged Europe

• Nada Tran-Herman, Lek d.d., Ljubljana
• Milan Pukic, JJZ - Pharmacy of Maribor
• Slovenia

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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.

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(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
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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).

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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/Fin
  al).
• 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

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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.

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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.

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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

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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.

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

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