E-DRUG: E-DRUG Amateur assessment of GMP cont.

[Tim Dodd <timdodd@brain.net.pk>]

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E-DRUG Amateur assessment of GMP cont.

Kirsten Myhr makes some good and valid points and there is little I
would disagree with in terms of the ideal situation.

Reality is of course different and while striving towards a safe and
secure national scheme we still have aduty of care to our patients to
provide them with drugs of appropriate quality.  That respnsibility
rests with me the pharmacist and cannot be avoided or transferred
elsewhere.

In many cases i do not have the facilities to thoroughly test each
medicine we buy let alone the range of medicines that we could buy and,
frankly, nor does the govt. agency in Pakistan.  I recently visited the
premises of a manufacturer that had supplied medicines to which our
patients had exhibited classical reactions to pyrogens.  The
manufacturer was genuinely trying to make a quality product and was,
indeed, GMP approved by the National Authorities.  They had even tested
the fnished product to ensure freedom from pyrogens and done sterility
testing also.  On the surface it looked good.  However, it quickly
became apparent where the deficiencies in the control of the processes
were and how it was possible for a pyrogen containing product to get
through the process and how the pyrogens might get there in the first
place.  The checks and balances neede to control the process simply were
not there.  This I should emphasise was not an attempt to defraud, but
simply one of lack of knowledge and experience.

The point of this tale is to make the point that I do not have the
resources to test the products that I purchase and have to rely on a
system of information gathering and inspection. The tools used by Daniel
and others in this are useful and should not be decried, but their
limitations must also be recognised.   In many cases a good relationship
with a supplier or manufacturer can be educational and help to promote
the improvement of quality.  It does not have to be either
confrontational or punative, but of course can be with recalitrant or
fraudulent suppliers.

As Kirsten implies there is not an easy answer to this.  Rather we must
continiue to develop both National and International systems and be able
to share the information across boundaries.  Meanwhile we must also
contue our best efforts on behalf of our patients even at local level.

Tim Dodd
Director of Pharmacy
Shaukat Khanum Memorial Cancer Hospital. Lahore, Pakistan.





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