Pharmacoepidemiology in Finland – Quo vadis?

Hannes Enlund, DSc, MPharm

Head of Research

Assessment of Pharmacotherapies

Finnish Medicines Agency, Fimea

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

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?)

Who needs pharmacoepidemiology?

Regulator Physician

Drug user

Policy maker

University

Pharmaco-epidemiologist

Payer

Goals of Finnish pharmacoepidemiological research?

Science for manipulation

or

Science for understanding

or

Both?

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)

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?

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

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)

State of pharmacoepidemiological research in Finland

Are we doing the right things?

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.

Emerging themes and collaboration

• Elderly

• Cancer risk

• Statins

• Psychotropics

• Pregnancy

• Pharmacoeconomics

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

Future of pharmacoepidemiology in Finland

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

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

Educational Goals

Knowledge/epi&drugs

Skills/methods Attitudes/motivation

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

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

Measuring the impact of pharmacoepidemiology

• Impact factors

• Numbers of publications

• Amount of research money

• Influence on education

• Influence on health policy and decision making

• Helping customers/patients

• Service to society

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.