[e-drug] SMS texting and drug quality in West Africa (3)

e-drug
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E-DRUG: SMS texting and drug quality in West Africa (3)
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I think that Bright's posting gives us an important message: a proper
database of all medicines brought unto the market legitimately may be useful
to fight counterfeit and sub-standard medicines. However, I have some
remarks on the plan Bright described:

1. A database with data of all medicines legally imported (in the
ports) or produced should be maintained by the Medicines Regulatory
Authority (MRA) of a country. It becomes rather easy to establish if any
medicine found in the market is legitimate (or not) by checking the data on
the label (name, batch number, manufacturer) against the data in the
database. The public may be educated what to look for and legitimate
pharmacists may be involved to assist.

2. Proper follow-up on any counterfeit found can only be done by the
local authorities, i.e. MRA and police. It is frustrating for the public
when nothing is being done after counterfeits are found and no actions taken
against the culprits.

3. No extra code is needed and is, in my opinion, even
counter-productive. Apart that an extra code will involve extra costs, I
think that a proper label contains enough data against which a legitimate
medicine can be checked, also with involvement of the consumer. But more
importantly, it should be avoided that legitimate medicines that do not
carry the extra code will be regarded as counterfeit.

So yes, the idea on itself is sound, but I would advise a re-think on the
implementation.

Rob Verhage
HERA Pharmaceutical Consultant
PO Box 4002
Tawajakoerastraat 4
Paramaribo
Suriname
+597 438966
"rob verhage" <verhager@cq-link.sr>

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E-DRUG: SMS texting and drug quality in West Africa (4)
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Thanks, Rob, for your comments.

1. The scheme actually does work with regulators by providing a
complementary system that produces real-time intelligence to help
resource-burdened regulatory agencies to cut costs and target their efforts.

2. The beauty of the system is that it automates, facilitates and therefore
accelerates the follow-up process through its capacity to provide electronic
alerts and other real-time notification services for regulators and brand
owners as well.

3. Extra coding is required. One that is non-duplicable and
security-protected. Otherwise, as we have seen time and again, fraudsters,
criminal rings, counterfeiters, supply chain cheats, and a host of other
anti-social elements will simply duplicate, tamper, or outrightly ignore the
certification process. That is the whole point. Nearly in every country on
the globe, certification information, including registration numbers, are
either a requirement or a best-practice directive, but that has not stopped
anti-social elements from pushing out uncertified, unregistered,
counterfeit, or otherwise unregulated products onto the market, many of
which are also substandard.

4. It is the role of regulators to determine which products in the market
are most at risk of such abuse and to work with brand owners to secure them
against such abuse. It is then the role of the various stakeholders to
effectively communicate the need for additional regulatory protection to
consumers and patients with respect to such at-risk products. In no way does
such a process work to the detriment of legitimate drugs not so protected.
In the same way that existing security measures adopted and in use for many
years by regulators and brand owners such as holography, RFID, EMID and
optical features, do not necessarily render legitimate medicines not bearing
such features illegitimate, there is no basis to suppose that the situation
shall be different for SMS-based authentication.

Much obliged,

Bright Simons

Coordinator, mPedigree Network
"Bright Simons" <bbsimons@mpedigree.net>