Pharmacoepidemiology in Finland Quo vadis?

Transcription

1 Pharmacoepidemiology in Finland Quo vadis? Hannes Enlund, DSc, MPharm Head of Research Assessment of Pharmacotherapies Finnish Medicines Agency, Fimea

2 Quo vadis? Wanderer, your footsteps are the road, and nothing more; wanderer, there is no road, the road is made by walking. By walking one makes the road, and upon glancing behind one sees the path that never will be trod again. Wanderer, there is no road Only wakes upon the sea. From Proverbios y cantares in Campos de Castilla (1912) by Antonio Machado

3 Finding and walking the right path Who defines the path? Which kind of compass or GPS to use? Which is more important the journey or reaching utopia or heaven? (i.e. rational use of medicines?)

4 Who needs pharmacoepidemiology? Drug user Regulator Physician Policy maker Pharmacoepidemiologist Payer University

5 Goals of Finnish pharmacoepidemiological research? Science for manipulation or Science for understanding or Both?

6 Pharmacoepidemiology Applying epidemiologic knowledge, methods, and reasoning to the study of the effects (beneficial and adverse) and uses of drugs in human populations (Hartzema and Porta 1991) Describing, explaining, controlling, and predicting the effects and uses of pharmacologic treatments in a defined time, space and population Studying the use of and the effects of drugs in large numbers of people (Strom 1994)

7 Evidence and progress in pharmacoepidemiology Following a reductionistic approach? Isolating, simplifying and holding key conditions constant (i.e. attempting to understand effects by controlling or removing all potential confounds) Following a holistic approach? Studying drug use with descriptive methods in their context gaining understanding?

8 A reductionistic or holistic perspective? Reductionism - Acceptance from scientific circles? Hard sciences, like e.g. physics, have moved towards systems theory, complexity/chaos theory Impact of observer in particle physics - interdependence Rejecting the possibility of understanding by studying things in isolation Focus on interrelationships, importance of starting points and contextual factors

9 Understanding data Understanding does not proceed simply from examining data But From examining data in a particular context The significant problems we face cannot be solved at the same level of thinking we were at when we created them (Einstein)

10 State of pharmacoepidemiological research in Finland Are we doing the right things?

11 Past and present Roots in the seventies and eighties Descriptive drug utilization studies Case-control studies on ADRs of antihypertensives Factors influencing prescribing Patient compliance/adherence studies Last ten years - Increase in number of papers - Increase in register studies - Cancer and hormones, statins, antidepressants etc. - ADRs and statins, NSAIDs, antidepressants etc.

12 Emerging themes and collaboration Elderly Cancer risk Statins Psychotropics Pregnancy Pharmacoeconomics

13 Impact and visibility of current research? Pharmacovigilance Drug safety Patient safety and quality of life Medication process Patient perspective Prescribing behaviors Rational prescribing Health policy The role of medicines in society

14 Future of pharmacoepidemiology in Finland

15 Medicines Policy 2020 Patient centeredness Quality, effectiveness, cost-effectiveness Rational use of medicines Medication safety Supporting medicine users to take responsibility Medicines information to users and professionals HTA of medicines Supporting drug innovations Rational use of veterinary drugs

16 Educational needs Basic education (pharmacy, medicine, public health, health sciences) Basic epidemiological courses Methodological courses Need for specialized courses Graduate programmes Graduate school Specialization in PE Nordic collaboration Continuing education SLY and SES Pharmaceutical continuing education Others

17 Educational Goals Knowledge/epi&drugs Attitudes/motivation Skills/methods

18 Critical aspects influencing the future of research Research infrastructure Data sources, access to data, e-prescribing, prescription register, patient specific drug use data from hospitals Methodological development Focusing research -specialising Institutionalisation of research Research funding go where the money is? Independence and collaboration Graduate education and formation of research groups

19 Collaboration in research National collaboration (research topics, funding) Locally between different subjects medicine, public health, pharmacy, other Nationally between universities Fimea, THL Private companies and drug industry Nordic collaboration National drug agencies Public health institutions Nordiska hälsovårdshögskolan EU and international collaboration EU-programmes Emea and ENCePP

20 Measuring the impact of Impact factors pharmacoepidemiology Numbers of publications Amount of research money Influence on education Influence on health policy and decision making Helping customers/patients Service to society

21 The path There is no path automatically open in the future of Finnish pharmacoepidemiology. The path will be as Antonio Machado envisioned, i.e. the result of choices of ends and means, both scientific and political.