E-drug: Evaluation of generic drugs
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For quite sometime now, the private sector drug market in Kenya has been a
free for all. In the public sector, decisions on what drugs to stock have
been largely driven by the actual cost of the drug (Budgetary constraints)
with the quality assessment being done through "Technical Evaluation
Committees". What is done is a physical look at the product and a quick read
through available literature in a meeting set up as a basic
assessment. A number of Private hospitals have in the recent years
either set up or
reactivated their Drugs and Therapeutics committees.
One major set back that has occurred is "How does one evaluate a
generic drug for inclusion in a formulary?" . The straight forward
answer from the text books is to check for quality, safety, efficacy
and cost. But how do you translate this to
reality? How does one evaluate quality, i.e.how can one guarantee that a
product is of acceptable quality without laboratory support? (This in vitro
testing does not always translate to desired in vivo results).
In my hospital, we started by requesting generic producers to provide
independent bioequivalence studies against the originator brand for
antibiotics but this has only been possible for high profile generic
companies which are invariably close to the originator brand in price
as well. I have not received any bioequivalence studies for local
generic manufacturers or those from India and the middle East. Any
one out there with any suggestions of what has been proven to work
anywhere?
The other plague is the usual inference by respected consultants (opinion
leaders) that a particular product works for their patients and is better
than XYZ. Other Doctors in the DTC would normally side with them and shut
down any other concerns. How does one get round this?
One last question; should members of the DTC vote regarding
inclusion/exclusion of a product into a formulary? I am asking this
because a majority vote has been used to include a product when there
is evidence against its safety profile and cost effectiveness?
NB:What is the new name that refers to generic drugs?
Dr Atieno Ojoo
Gertrude's Garden Childrens' Hospital
P O Box 42325-00100
GPO, Nairobi
Kenya
Tel; 254 2 763474-7
Fax; 254 2 763281
Email; mojoo@gerties.org
[There is a chapter in Managing Drug Supply from MSH (JULIE MCFADYEN"
<JMCFADYEN@msh.org>) that could be very helpful for you. BS]
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