E-DRUG: Differences in Drug Datasheets (What has not been said)
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The most important point in this discussion has been what has NOT been
said.
All those who have participated in the discussion are from the developed
world. The only glancing reference is to a study that involved Thailand.
This clearly and sadly illustrates the status of Drug Information as a
whole in the developing world.
Data Sheets are a function of Drug Registration. This in turn is
approval for the quality of the product as well as the approval of the
official information of the product. Such information is official and
has legal validity.
To make a crude analogy, the Data Sheet is the "Birth Certificate" of
the Product. The Data Sheet specifies what can be said about the product
(Indications), what must also be then said, with what can be said
(Contraindications, Adverse effects etc). After all you cant claim you
are a Prince (or Princess) if your Birth Certificate simply says you
were born to plain old Mr and Mrs!
A good Data Sheet is then a very good opportunity for providing
officially approved unbiased information to prescribers, pharmacists and
other health care personnel.
What is the situation in developing countries? Drug Registration focuses
on the quality of the product and only in a very few instances has a
sideways glance at the information that is provided. So the majority of
approvals simply have no officially approved information. Take a look -
how many of the Drug Regulatory Authorities in the developing world have
approved Data Sheets? A few may - how many then put it on their
websites? A Data Sheet is official information and should be publicly
available.
Are Data Sheets a minor regulatory matter that is unimportant to the
overall use of medicines in the developing world? Yes, at present. No,
they can be a very powerful tool to encourage proper, correct use of
medicines.
First it is a no-cost method of providing good drug information (again
for those in the developing world, quick, how many Drug Information
Centers does your country have?); the Data Sheet must accompany the
product and therefore is available for those who want the information at
the point of use. The cost is borne by the manufacturer.
Secondly, it provides the framework for assessing what is said during
promotion. Prescribers can ask for a copy of the Data Sheet along with
the Advertisements and other glossy brochures the Drug Representative
leaves on the desk.
Thirdly it is a very good method of educating those dealing with
medicines - check the Data Sheet and you can get most of the
information. Tell the medical, pharmacy and nursing students that they
should look at Data Sheets when they want good drug information.
In the developing world the need for Drug Information is not on the
latest medicine and it's indications, adverse effects etc but on
essential medicines (does furosemide cause hypocalcaemia?). Can a
developing world Drug Regulatory Authority (which has limited resource)
provide such good information? Yes, it Can.
Just accept the "cut and paste" of the Indications, Adverse Effects etc
of a good independent drug information source (the British National
Formulary comes to mind, the WHO Model Formulary will be available soon)
as the Data Sheet for the Product. Tell the industry any indications
outside these will require clinical trials and separate justification,
which also means lengthy evaluation of the dossier.
So in conclusion, good Data Sheets have the potential to be powerful
sources of good independent drug information regulated by the Drug
Regulatory Authorities and provided by the Industry. The framework
exists (Drug Registration), the data for the tool (i.e. the Data Sheet)
exists - what then is lacking? That answer I leave to those involved in
Drug Regulation in the Developing World which is 80% of the population
of the world.
As for the title "Differences in Drug Datasheets" - in the developing
world they must exist before we can look for differences.
Krisantha Weerasuriya
Essential Medicines
WHO South-East Asia Region
WeerasuriyaK@searo.who.int
(Institutional affiliation given for information - the views expressed
are personal)