EURO DURG bulletin

No. 1 April 1997

IN THIS ISSUE

Notes from the Chair
Plan of action of EURO DURG
Balaton meeting report
Next meeting in Berlin
Working groups
National DURGs - individual members
EURO DURG resolution on confidentiality

Notes from the Chair:

• Dear colleagues,

  we are pleased to send you information about the EURO DURG. It is our mission to contribute to rational drug use by drug utilization research. Communication between scientists in this field is of primary importance to develop the field further.

  Since the constituting meeting at the shore of lake Balaton, Hungary, the Executive Committee has been busy with organizing the workshop in Berlin Sept. 1997, in collaboration with dr. M Schaefer. I hope you have received information about this meeting; if not there is also some information in this bulletin. Do not hesitate to contact us for more information. In the workshop, working groups will meet with the intent to develop resolutions, joint research or joint publications. All members are invited to contribute actively. The working groups will form the backbone of EURO DURG. The workshop is organized in conjunction with the EACPT meeting (European Association of Clinical Pharmacology and Therapeutics). We would like to invite you to come to the joint symposium, and urgently invite you to send abstracts to that meeting (deadline May 10, 1997). If we want to get our message across to the European clinical pharmacologists, here is our chance! The more abstracts of high quality we send in, the better our message will be heard!

  The Executive Committee has developed plans for the future. In any plan, member DURG groups in the different countries, their members and individual members play a central role. You find the first information in this bulletin. The plans will be discussed more in detail during the workshop in Berlin.

  We hope to see you in Berlin in September.

  For the Executive Committee

  Prof. Dr. Flora M Haaijer-Ruskamp
  chair EURO DURG

Plan of action of EURO DURG

• EURO DURG, the European Drug Utilization Research Group is a multidisciplinary society bringing together scientists from different disciplines, which aims to implement evidencebased information on rational drug use in daily practice in order to optimize the quality of drug use by understanding the determinants of prescribing behavior

  EURO DURG is mostly an association of national Drug Utilization Research Groups, but also individual members from countries where a national DURG has not yet been established are accepted.

  A basic mission of EURO DURG is to facilitate and strengthen collaborative research among national DURGs and individual researchers. This will be done by building-up of an "inventory" of ongoing research projects of the members.

  A more active role of EURO DURG is that of promoting and developing research projects, by setting-up Working Groups, coordinated by members of the Executive Committee and open to all the interested DURGers.

  For Working Groups identified for the period 1996/1998, see the corresponding page.

Report from EURO DURG 1st meeting

• EURO DURG held its first meeting in June 27-30 1996 at Club Aliga at the border of Lake Balaton in Hungary. The theme of the meeting was "Rational Drug Use in Europe - challenges for the 21st century". Some 250 participants from 35 countries attended. EURO DURG is in fact the formalization of the WHO Drug Utilization Research Group, which functioned for over 20 years as an informal group of scientists advising WHO Europe on drug policy.

  The meeting was organized by the interim committee, elected in 1994, together with the local committee, chaired by professor Paal from the Hungarian National Pharmacy Institute, a WHO Collaborating Centre on Drug Information and Quality Assurance.

  A detailed report from the Meeting as well as the abstracts of the oral presentations and selected posters will be published in Eur J Clin Pharmacol no. 52/3 May 1997.

  The meeting ended with the business meeting, where the EURO DURG constitution was accepted and the Executive Committee for the period 1996-1998 was elected. See the main page of EURO-DURG.

NEXT MEETING

• The next scientific meeting of EURO DURG will be organized in September in Berlin (Germany). The meeting will be organized in two parts:

  EURO DURG Workshop:

  September 16 (whole day) and 17 (morning) 1997, at the

  Humboldt University,
  Institute for Pharmacy
  Local organizer: Dr. Marion Schaefer,
  fax +49-30-9348-280.

  Joint SymposiumÝ EURO DURG - EACPT:

  September 17 (afternoon)
  as an event of the 2nd EACPT Congress
  (Sept. 18-20, 1997, Hotel Inter Continental Berlin)

  Secretariat fax: +49-30-21-29-5-420

Working groups

• DURGers interested to join the working groups may contact the respective coordinators (for tel/fax/e-mail, see this page)

• Mapping Europe

  Coordinator: Nicola Montanaro

  Aims of the step of the project are:

  1. to agree on a common methodology of data collection and data analysis (ATC/DDD);
  2. to compare the quality of available data, i.e., source of drug prescription data, information on reference population (national vs. local data), time period covered, completeness of the data set available (all drugs vs. specific groups), record media used;
  3. to agree on a common protocol for a cross-national report consisting of an overall comparison of the participating countries by main ATC Groups and by specific aspects.

     ---

  Drug utilization and quality assurance

  Coordinators: Ulf Bergman, Hugh McGavock

  In general practice, the quality of therapeutic choice by individual doctors varies from excellent to terrible, and the average could not be described as acceptable. The working group will face the problem how to use pharmaceutical pricing databases, which are available in many countries, to analyze individual doctors´ prescribing patterns and identify areas of economically or scientifically inappropriate prescribing, producing reports that doctors can use to modify their prescribing.

  ---

  Patient Perspectives

  Coordinators: Ebba Holme Hansen, Emilio Sanz

  Use of mood-modifying drugs for certain indications varies greatly across countries and between regions. Research that tries to uncover the reasons for such disparity needs refocusing to include the user of such drugs. The objective of this working group is to plan and conduct a study of cultural differences in the use of mood-modifying drugs for certain indications.

  ---

  ATC/DDD methodology

  Coordinator: Kåre Øydvin

  One of the major goals for the work of the ATC/DDD Working group within DURG Europe will be to work for the establishment of formal national centres for the ATC/DDD methodology in all European countries and to assure that basic information on the use of drugs based on this methodology will be available for all European countries.

• Confidentiality of data

  Coordinator: Liselotte von Ferber

  See the corresponding section.

ÝNational DURGs in Europe

Welcometo new individual EURO DURG members!

• According to the Constitution, EURO DURG is an association of national DURGs. In the case a national DURG has not yet been established in a country, Europeans (as well as non-Europeans) with an active or developing involvement in drug utilization research may be accepted as members on individual basis.

  On April 7th, 1997, the Executive Committee accepted 28 applications for individual membership from the following 10 countries: Croatia (1), Estonia (3), Finland (1), France (2), Hungary (6), Israel (2), Poland (1), Romania (2), Slovakia (3), Yugoslavia (7).

  These new members will now receive individual letters with instructions about payment etc., but also how to set up a national Group in their home countries.

  The EURO DURG Executive Committee is preparing guidelines for establishing national DURGs (goals/functions) and for the formal procedure of acceptance of a new Group by EURO DURG. Groups interested in receiving further information may contact:

  Dr. Robert Vander Stichele (Member of the Executive Committee)
  Heymans Institute of Pharmacology, University of Gent
  De Pintelaan 185, B-9000 Gent (Belgium)
  Tel: +32 9 240 33 36
  Fax: +32 9 240 49 88
  e-mail: Robert.VanderStichele@rug.ac.be

  Individuals from countries where a national DURG is not yet established and wishing to join to EURO DURG may send their application to:

  Secretariat EURO DURG
  WHO Collaborating Centre for Drug Utilization Research and Clinical Pharmacological Services
  Karolinska Institute
  Huddinge University Hospital
  S-14186 Huddinge, Sweden
  Phone +46 8 58 58 11 96
  Fax: +46 8 58 58 10 70
  E-mail: Ulf.Bergman@pharmlab.hs.sll.se

  Alternatively, on behalf of the Executive Committee, to:
  Prof. Nicola Montanaro
  Department of Pharmacology, University of Bologna
  Via Irnerio 48 - I-40126 Bologna (Italy)
  Phone +39 51 24 05 63
  Fax: +39 51 24 88 62
  E-mail: itadurg@biocfarm.unibo.it

Confidentiality of data

Coordinator: Liselotte von Ferber

• EURO DURG will seek by means of a Working Group on Confidentiality to work with other European and national organizations to draw up a Code of practice relating to the use of personal data in health research in order to protect the privacy of the individual while supporting improvements in public health arising from high quality research. The working Party on Confidentifality should be constituted by as many national associations of EURO DURG as possible. The Working Group on Confidentiality will be one of the themes of EURO DURG Workshop in Berlin meeting.

  News from Confidentiality Working Group

  A questionnaire will be sent out to all national chairs and contact persons of the national EURO DURGs with the demand to distribute it to their nominee for confidentiality.
  In March 1997 at the ISPE meeting a workshop on Confidentiality was held (Chair Annekarin Bertelsmann, Ronald Mann). The EURO DURG resolution was discussed together with the proposal for an ISPE memorandum on confidentiality. It was. proposed to approximate ISPE memorandum to the EURO DURG resolution especially with respect to the implications for the use of health data for public health research.

Resolution of the European Drug Utilisation Research Group on

Confidentiality of Personal Health Data (5 July 1996)

The European Drug Utilisation Research Group (EURO DURG) considering:

• the Directive 95/46/EC of 24 October 1995 on the protection of individuals with regard to the processing of personal data and on the free movement of such data
• the need to conduct research, to protect the public health and to ensure the efficient use of medicines in the healthcare systems of Member States
• the need to access personal health data in order to conduct an appropriate spectrum of research which fully addresses the clinical, social and economic circumstances of patients

urges European Union Member States to take into account the importance to the public health of drug utilisation and pharmacoepidemiology research when implementing the Directive 95/46/EC into national legislations. In particular Member States are urged to recognise that drug utilisation and pharmacoepidemiology research is an activity îof substantial public interestî and to ensure that an exemption to the prohibition in paragraph 1 of Article 8 of the Directive, as provided for in paragraph 4 of article 4, is included in national implementation for the Directive. In the absence of such an exemption, EURO DURG believes that public health research in the European Union will be inappropriately restricted with adverse consequences on the public health.

Drug utilisation research is an important branch of public health research. It performs several functions, including

• the monitoring of medicines safety after marketing
• ensuring and improving quality in drug therapy by the doctor and pharmacist
• monitoring and control of medicament costs in welfare statefinanced health systems.

EURO DURG defines drug utilisation and pharmacoepidemiology research as research on the quantitative and qualitative aspects of drug use, the determinants and the effects on patients specifically and the population in general. Drug utilisation research is an in-terdisciplinary research area which employs the methodology of epidemiology, pharmacology, health services research, empirical social research and cultural anthropology.

Drug utilisation research investigates medicines usage in the population, the prescription habits of doctors, the market strategies of pharmaceutical companies and the effects of political interventions in the use of medicines.

Drug utilisation research relies on access to documents, paper and electronic, containing personal health data such as diagnoses and prescriptions. Primary surveys of medicines usage are comparatively expensive and time consuming.

The use of documents from welfare statefinanced health systems is an important and efficient source of data to be used to protect the public health.

EURO DURG recognises both the importance of protecting the privacy of personal health data and the importance of protecting and improving the public health by means of appropriate research. EURO DURG will seek, by means of a Working Party on Confidentiality, to work with other European and national organisations to draw up a Code of Practice relating to the use of personal health data in health research in order to protect the privacy of individuals while supporting continuing improvements in public health arising from high quality research.

European Journal of Clinical Pharmacology 52/3, May 1997