E-DRUG: Industry Control over Information (3)
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There have been several studies which have looked at the quality of
information in drug compendia. Some of the classic "consciousness
raising" studies were based on comparison of the information in drug
compendia in developing and industrialised countries. (e.g. J S Yudkin
compared African MIMS with British MIMS in the late 70s; in 1978
Socail Audit compared British MIMS with African, Caribbean and Middle
Easter MIMS, in 1974 Silverman, Lydecker and Lee compared the
information in the Physicians' Desk Reference (PDR) with information in
Latin American commercial compendia.). All of these studies confirmed that
there were, in general, fewer contraindications and warnings, larger
recommended doses and wider indications in developing country compendia.
There have been more recent studies. The US Congress Office of
Technology Assessment study "Drug Labelling in Developing Countries"
(1993) included prescribing guides in their review which confirmed that
information on US products marketed in developing countries was inferior
to in the US. A M Pleil and D S Pathak (1988) compared info from four
third world compendia with info in the PDR, the ABPI Compendium, the
Rote List. Information from industrialised countries was not always
consistent but was generally more comprehensive than from developing
countries. It is interesting that this study didn't find major
differences between local and multinational companies. This study was
entitled "commercial drug compendium information: a first world/third
world comparison" and was published in the International Journal of
Health Services Vol 18 nr 4.
There is a major difference between compendia which contain approved
product info such as the Physicians' Desk Reference which is available
free of charge to doctors in the United States and contains the official
labeling information for each product. The ABPI data sheet compendium in
the UK works on the same principle. These books contain the complete
approved product information. They do not give comparative information
and give no information on cost (in contrast to publications such as the
British National Formulary) so they are not particularly helpful in
choosing between drugs but they do give the complete approved product
information.
IMS and other commercial prescribing guides do not give complete
approved product information. They are published privately and financed
by advertising. The entries are based on the product info but are
generally incomplete and the summaries are done by IMS. I do not know
how much quality control IMS exerts or whether the companies review the
data before it is published. In the past they did not but after
publication of all the critical studies in the late 70s and 80s there was
a move towards more control and review. I do not know if much has changed
but I would welcome information on this.
It should also be remembered that in some countries there is remarkably
little control on the quality of the product information - so even if
the product info has been "approved" it may still include far wider
indications and less info on contraindications than the info for the same
product in a country with stricter regulatory control.
NB: For imported drugs the WHO Certification Scheme, if properly used,
gives importing countries information about whether the product
information provided is consistent with that in the country of
manufacture.
I am interested in more information in this area, especially in more
recent comparisons of information in compendia or in regulatory actions
to improve quality and consistency of information.
Regards
Catherine Hodgkin MPH
Public Health Consultant
Linnaeusparkweg 35
1098CP Amsterdam
The Netherlands
Phone/Fax 6949365
Email: e-drug@usa.healthnet.org
[Notes from the co-moderator: (1.) PDR in the U.S. generally contains
FDA-approved labeling of those drugs which make money for the drug
company. In other words, drugs which dont generate money may not have
their approved labeling in PDR. I think it costs several thousand
dollars to buy space in PDR.
(2.) A major unbiased and authoritative source of drug information in
the U.S. which is not controlled by the industry is the United States
Pharmacopeia's USP DIs. By the way, I am still in need of funder(s) to
help distribute 1997 edition of USP DIs to many folks who requested it
following my posting in E-DRUG earlier this year. There were several
reasons for not getting back to most people who expressed their
interest to receive USP DIs including delay in receipt of the books from
the distributors, it turned out that the only mode of payment that can be
accepted was check in U.S. dollars, and no funding agency offered to help
in the distribution. My apologies to all.
Syed Rizwanuddin Ahmad, Email: srahmad@essential.org].
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