Gunnar Alvan November 2002 Perspectives and Achievements with Rational Pharmacotherapy - Gunnar...

Gunnar Alvan November 2002

Perspectives and Achievements with Rational Pharmacotherapy

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Gunnar Alvan MD, Ph D, Prof

Director General

Medical Products Agency (MPA)

The role of the authorities


Rational pharmacotherapy

Rational or based on reason

would mean

science or evidence based


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.)


What is rational pharmacotherapy?

An ideal situation1. 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….


An ideal situation3. 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 Therapy should be withdrawn when a defined and preset endpoint has been reached.

What is rational pharmacotherapy?


• Great mission to fulfil

• Goal given in the official instruction

• Contribute on many levels

Pharmacotherapy The role of authorities


Post approval laboratory control

Scientific evaluation of documents

Information (SPC, PIL)

Pharmacovigilance

Therapeutic advice

Media

Environment

The emphasis for authorities has shifted


• 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)

The role of the authorities


• Rationality - scientifically based work

• The guidelines are continuously developed and reflect the movement of the research front.

Role of guidelines


Scientific domain

Observation

Description

Analysis

Cause-effect relationship

Statistical perspective: reality/uncertainty

Objectivity

Reproducibility

Hypothesis: confirmation/rejection

Consistence

Evolution


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


Abbreviations

• SPC:Summary of Product Characteristics

• PIL: Package Insert Leaflet

• EPAR: European Public Assessment Report


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


Aim of PIL

• Patients can be aware of and correctly use the product

• Communication task, should be easy to read

• Problem: neglected? negativity?


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?


Number of published studies vs total number of clinical studies

0 10 20 30 40 50

Avandia

Celebra

Nexium

Relenza

Reminyl

Sonata

Subutex

Synagis

Vioxx

Zyban

Cipralex

Number

Published studies Clinical studies


.

Treatment guidelines

Expert meetings (6-8/year) together with the Norwegian drug authority with reviews as basis

InternetInternet

WS-booksWS-books

Information from Information from the MPA bulletinthe MPA bulletin

GuidelinesGuidelines

Information Information pharmacistspharmacists

Drug committeesDrug committees


• New drugs

• New knowledge about old

drugs

• How to use the drug-

treatment guidelines

Continuous drug communication is the basis for rational drug use


• 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 organisations

Non commercial drug information actors


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


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


• 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.

Is the drug information role hampered by legal requirements?


• 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.

DTC - direct to consumer advertising


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®!

Made up DTC examples

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