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Perspectives and Achievements with
Rational Pharmacotherapy
The role of the authorities
Gunnar Alvan
MD, Ph D, Prof
Director General
Medical Products Agency (MPA)
Gunnar Alvan November 2002
Rational pharmacotherapy
Rational or based on reason
would mean
science or evidence based
Gunnar Alvan November 2002
Science
The gold standard for regulatory work
T. Sjöstrand 1907-1987
"Science is a social process through which man, by making
observations and experiments is providing factual data to
found a system of concepts which will approximately
describe reality as we experience it and which should be
tested by further observations and experiments."
(translation by G.A.)
Gunnar Alvan November 2002
What is rational pharmacotherapy?
An ideal situation
1. Indication for drug therapy in relation to all prevailing
circumstances: age, disease, abuse, pregnancy, sex,
nutrition, concomitant drug use or other strategy….
2. Choice of drug according to factual criteria:
pathophysiology, mechanism of action, the above
conditions, characteristics of drug product….
Gunnar Alvan November 2002
What is rational pharmacotherapy?
An ideal situation
3. Drug treatment should be carried out according to
knowledge based principles: choice of dose, evaluation
of effect, dose adjustment, therapy and adverse effect
monitoring.
4. Therapy should be withdrawn when a defined and
preset endpoint has been reached.
Gunnar Alvan November 2002
Pharmacotherapy
The role of authorities
• Great mission to fulfil
• Goal given in the official instruction
• Contribute on many levels
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The emphasis for authorities has shifted
Scientific evaluation of
documents
Post approval
laboratory
control
Information (SPC, PIL)
Pharmacovigilance
Therapeutic advice
Media
Environment
Gunnar Alvan November 2002
The role of the authorities
• Preregistration
– Clinical trials, compassionate use
• Registration
– Evaluation and approvals
• Post registration
–
–
–
–
–
Information, follow-up studies
ADR monitoring, evaluation, actions
Control laboratories
Inspections
Legal actions (advertisements, illegal claims etc)
Gunnar Alvan November 2002
Role of guidelines
• Rationality - scientifically based work
• The guidelines are continuously developed and
reflect the movement of the research front.
Gunnar Alvan November 2002
Scientific domain
Observation
Description
Analysis
Cause-effect relationship
Statistical perspective: reality/uncertainty
Objectivity
Reproducibility
Hypothesis: confirmation/rejection
Consistence
Evolution
Gunnar Alvan November 2002
Adopted Guidelines 2002
(Efficacy, Safety and Quality)
Note For Guidance on:
•
Clinical Investigation of Medicinal Products in the Treatment of Diabetes
Mellitus
•
Clinical Investigation of Medicinal Products in the Treatment of Depression
•
Clinical Investigation of Medicinal Products in the Treatment of Peripheral
Arterial Occlusive Disease
•
Carcinogenic potential
•
Photosafety Testing
•
Quality of Water for Pharmaceutical Use
•
Requirements for Pharmaceutical Documentation for Pressurised Metered Dose
Inhalation Products
Gunnar Alvan November 2002
Abbreviations
• SPC:
Summary of Product Characteristics
• PIL:
Package Insert Leaflet
• EPAR: European Public Assessment Report
Gunnar Alvan November 2002
SPC and PIL
• Products description documents with
instructions for use
• Founded on evaluated facts presented in
registration file
• Anyone can view
• Problems: update, translation,
disharmony, no reference list
Gunnar Alvan November 2002
Aim of PIL
• Patients can be aware of and
correctly use the product
• Communication task, should be easy
to read
• Problem: neglected? negativity?
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At the time of approval….
• Is it possible for the professionals in the health care
system to evaluate new drugs?
• To which extent is it possible to find clinical studies in
PubMed at the time of approval of new drugs?
Gunnar Alvan November 2002
Number of published studies vs
total number of clinical studies
Cipralex
Zyban
Vioxx
Synagis
Subutex
Sonata
Reminyl
Relenza
Nexium
Celebra
Avandia
0
10
20
30
40
50
Number
Published studies
Clinical studies
Gunnar Alvan November 2002
Treatment guidelines
Expert meetings (6-8/year) together with the
Norwegian drug authority
. with reviews as basis
Internet
Guidelines
WS-books
Information
pharmacists
Drug committees
Information from
the MPA bulletin
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Continuous drug communication is
the basis for rational drug use
• New drugs
• New knowledge about old
drugs
• How to use the drug-
treatment guidelines
Gunnar Alvan November 2002
Non commercial drug information actors
• Drug committees and Public drug information centres
• Drug regulatory agencies
• Pharmacies
• Independant drug bulletins i.e. La Revue Prescrire and
The International Prescriber
• Medical technology assessment and research
Gunnar Alvan November 2002
organisations
From darkness into light
• Drug monographs on
NCE:s and new
indications
– Presentation of all, including
unpublished, clinical trials
– Safety assessment
– Comments on the value of
the drug
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Distribution of the information
• Information from the
MPA ”Bulletin”
• Internet - www.mpa.se
• A workshop book series
• Drug committees
• Information propagated
from doctors and
pharmacists
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Is the drug information role hampered
by legal requirements?
• NO!
• However, the file is under business secrecy.
• The approval, SPC and monographs is the outcome of
the total file submitted.
• There is no crucial information ”hidden” in the files,
but there will be bias in publication and citation.
Gunnar Alvan November 2002
DTC - direct to consumer advertising
• The European Parliament voted against the Commissions
proposal to allow companies to communicate directly with
consumers about some prescription medicines.
A personal view:
• No inhibition of Internet sites that discuss drug treatment.
• Advertising in public media for Rx is not in the interest of
public health. The public sector will have to pay for the
advertising and also receive information without tools to
evaluate its reliability.
Gunnar Alvan November 2002
Made up DTC examples
Slogans we will not see in the underground
• Got cystitis? Get Uricure®!
• No more morning anxiety with Gloomy®!
• When it comes to high blood pressure use A-stop®, turns
off your A-II receptors better than any other drug!
• Erected on Niagara®!
• Get high on Himalaya®!
Gunnar Alvan November 2002