[e-drug] Falsified medicines in Africa: all talk, no action (4)

e-drug
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E-DRUG: Falsified medicines in Africa: all talk, no action (4)
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Thank you Bright for your message and the link to your web site.
I would like to know your results. How many falsified medicines have been detected with these tools? Were they reported to the WHO ALERT system? Or does the presence of such a system prevent people putting such falsified medicines into the distribution chain. I assume that the system does not address the problem of substandard or poorly stored medicines?
Thanks
Richard

Richard Laing
Professor International Health
Boston University School of Public Health,
801 Massachusetts Avenue Boston MA 02118
Tel 617 414 1445 (Office) 617 435 7860 (Mobile)
http://www.bu.edu/pharm/the-program/
E mail richardl@bu.edu

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E-DRUG: Falsified medicines in Africa: all talk, no action (5)
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Dear Richard,

The system was launched just a few weeks ago by the pharmaceutical society
of Ghana. I understand that they shall be commissioning periodic reviews.
For more information, please reach out to: info@preventfaking.com, and the
secretariat will respond.

I believe this is the only system capable of providing the broadest
transparency on fake, falsified, counterfeit and substandard medicines.

So long as the competent authorities responsible for managing GMP/GDP
compliance in the territory plug their repositories into the system, then
the patient will only receives a positive alert to a query about each
specific pharmaceutical pack if the batch from which that package comes
from has been cleared in the latest audit (which could have been
accomplished by mobile screening equipment, by the way, and uploaded into
the cloud in real-time).

Like all such systems, that presupposes a minimally functional, and
cooperative, regulatory authority.

But the point is that in the absence of such a system, how can regulators
communicate nearly personalised information to the patient/consumer that a
particular pack of medicine has been compliant with good manufacturing and
distribution practice *to the best of the regulator's capacity and
knowledge*? Or that there is no record of such compliance and therefore
that the patient is better off not taking the medicine? Or that the batch
from which the medicine originates is high risk and therefore that the
patient should get in touch with the authorities (super-useful during
recalls and investigations)?

The way I see it, the system addresses the two main gaps in any system that
relies solely on laboratory analysis and GMP/GDP certification:

1. You can't regulate what you can see (the root cause of both counterfeits
and substandards is 'regulatory evasion'; and

2. Unless the patient has a trusted node of information, they will be
deceived at the point of dispensing regardless whichever other measures are
deployed in the supply chain.

Thanks.

Warm regards

Bright
Bright Simons <bbsimons@mpedigree.net>