[e-drug] Tracing counterfeit medicines (2)

e-drug
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E-DRUG: Tracing counterfeit medicines (2)
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Dear E-druggers,

Even if technology-based solutions can have a role in some other contexts, in
our opinion they may play only a very limited role in resource-poor
countries, not simply because they may be technically too demanding, but
mostly because they cannot identify sub-standard medicines.

Actually, the very large majority of the poor-quality medicines that are
circulating in developing countries are genuine products, manufactured by
companies that are not controlled by stringent authorities: as pointed out by
the WHO and many other actors, these substandard products are not compliant
with the WHO specifications for pharmaceutical products, despite being
legitimate. These products originate from a multitude of possible
manufacturers operating in various countries (= multi source products).
Beyond the issue of the feasibility of a global database of multi source
products, a bar code identification is not likely to offer consistent
guarantees on their quality.

The fight against poor-quality medicines in developing countries should not
primarily rely on post-marketing, technology-based solutions. It should
rather be conducted by strenghtening national regulatory systems, by
enforcing regulatory supervision on the international market (including
brokers and intermediate supply chains) and by improving procurement policies
and practices.

Raffaella Ravinetto, pharmacist, Institute of Tropical Medicine Antwerp
Jean-Michel Caudron, pharmacist
Daniel Vandenbergh, pharmacist, AEDES
Jacques Pinel, pharmacist
Sophie-Marie Scouflaire-Mallet, pharmacist
Corinne Pouget, pharmacist
Sandrine Cloez, pharmacist
[Pharmahook]
"Raffaella Ravinetto" <rravinetto@itg.be>

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Tracing counterfeit medicines (4)
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Dear E-Druggers,

Modern technologies offer excellent ways of guaranteeing the identity of
products for patients. I agree with Paul Lobb that barcode
serialisation appears one of the most promising, and such systems are
already being used successfully in countries like Belgium and Greece.

Notably, these use regular barcodes, which can be cheaply read by
pharmacists' existing barcode-reading equipment. It's important that
authorities don't lumber pharmacists with high costs by enforcing
unnecessarily complex technological requirements. Too often
protectionist measures are taken in the name of 'safety', which damage
competition.

Serialisation systems also help to stop medicines being sold beyond
their use-by dates, a primary cause of drugs becoming substandard. They
also allow for recalls when a batch is suspected of being substandard;
and in tracing the history of drugs they can provide evidence as to why
some drugs will degrade (potentially in transit, for example).

I think it's a tad defeatist to assume technologies cannot help in
resource-poor countries. I'm not sure exactly what countries count as
resource-poor, but places in SSA like Nigeria, which suffer from
extremely high levels of fakes, can benefit from cheaper, more flexible
technologies - like the SMS system that Paul Lobb refers to.

Reliable regulation would of course be beneficial, yet extra layers of
regulation often make the problem worse through being more corrupt than
reliable. In Argentina at the moment a counterfeit medicines ring
appears to involve the local health ministry, trade unionist heads and
supporters of the president. In Sri Lanka and Uganda drug regulators are
being accused of importing substandard drugs. In China, infamously,
corruption made it to the very top of the SFDA. One could go on. Alas
we can't assume that government officials will be benevolent and
efficient, especially where corruption is rife; and of course no
regulator checks a large proportion of medicines in any given market
(the FDA checks far less than one percent, I believe).

In lieu of an all-encompassing, efficient, well-meaning government body,
patients and companies should have the chance to defend themselves from
fake medicines-and new technologies are offering just that.

Julian Harris

International Policy Network
"Julian Harris" <jharris@policynetwork.net>

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E-DRUG: Tracing counterfeit medicines (3)
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Dear E-druggers:

Please allow me to add a comment to message [2] in this regard:

Huge proportions of Donor money is presently spent in approval, procurement, sampling, and testing of generic sources for essential medicines. Entire systems (eg, the WHO PreQualification effort) are in place to do this. These efforts are intended to be temporary - just until National authorities are able to handle these efforts themselves. And, these efforts have the unintended result of negatively impacting the growth of regional industries and National Regulatory Authorities who are able to assure Quality.

We, as E-druggers need to find the means to articulate to the agencies who are funding making the world better, that a sound investment in building National Regulatory Authorities and in promoting Regional capability (not capacity) for producing quality-assured medicines is a long term goal that MUST be pursued. In doing so, the ultimate benefits are to greatly, greatly reduce the cost of essential medicines. They are probably also the best way of expanding access to many medicines for cardiovascular, cancer and diabetest indications that otherwise simply will not be available in African (for instance) national markets.

thank you

Joseph M. Fortunak
Associate Professor, Chemistry and Pharmaceutical Sciences
Howard University
525 College Street NW
Washington, DC 20069 USA
+1 202 806 6880 (office)
+1 301 928 7568 (mobile)
jfortunak@comcast.net (preferred)

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E-DRUG: Tracing counterfeit medicines (5)
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Dear All,

the issue of electronic monitoring of pharmaceutical supply chains are no
longer an academic, abstract, matter.

Our organisation is already, actively, involved in implementing such systems
in 4 African countries, with more to follow hopefully.

Through ingenious backend engineering, the frontend - which interfaces with
ordinary consumers/general public - can be reduced to a single, free, text
message. Resource issues scarcely arise in such a context.

The debate has moved to evidence, I presume; which of course is not to say
at all that academic discourse about the pros and cons of electronic
transparency initiatives in the pharmaceutical sector do not advance the
cause of patient safety, but just to emphasise the importance of drawing
upon feedback from the field as well.

Thanks all.

Regards,

Bright Simons

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

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E-DRUG: Tracing counterfeit medicines (6)
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Dear colleagues,

What Julian and Bright present is exactly what is needed in the application or enforcement of regulations and rules within the pharmaceutical sector. To suggest that newer and better regulations or recruitment of armies of field- based regulators/inspectors, is of course an option for some countries, but I bet not the case for the majority of developing countries, like Zambia. In any case, newer, simpler, affordable and cost-effective technological innovations that are coming from this sector of pharmaceutical/regulatory research and industry offers, in many cases, the best option for developing countries.

Regards,

Bonnie

Bonface Fundafunda PhD., MBA., B.Pharm
Manager, Drug Supply Budget Line
Ministry of Health,
P.O. Box 30205,
Ndeke House,
Lusaka,
Zambia
Tel: +260 211 25 41 83
Fax: +260 211 25 33 44
Mobile: + 260 979 25 29 00
Email: bcfunda@hotmail.com

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E-DRUG: Tracing counterfeit medicines (7)
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Dear e-druggers,

Professor Fortunak is quite correct about donor funds spent on ensuring quality of medicines because national systems are somehow inadequate to do so. Part of the solution to this problem is the process of procurement, the contract and its implementation. Even in the absence of national regulatory capacity the contract and steps taken within it to ensure quality and performance can go a long way to solving this issue immediatly while we wait for national regulatory systems to mature. The basic business skills to do this are not within the skill set of health authorities but can be so if time is taken to learn these.

Second local regulatory capacity needs to be developed. There is no reason why some aspects of drug regulation cannot be managed jointly by countries. There are efficiencies to be had and it is time to demand these. The same is true for manufacturing but for manufacturing to result in good quality - good regulation such as GMP must be in place as a legal requirement. Moreover, the requirement to and cost of registering drugs in every country is needlessly expensive and time consuming. This national requirement is an impediment to access even for donor funded drugs. This is a technical barrier to trade and should be vehemently opposed by public health.

The WHO can only do so much. While it has set the standard for prequalification we cannot expect it to manage this for all of the drugs and manufacturers that are needed to produce the drugs we want. It is time for some efficiencies in drug regulation and donors should insist on this otherwise funds are spent that might be used for the health of people.

Michele Forzley JD, MPH
Lawyer, Consultant and Professor
Silver Spring, Maryland US
Widener School of Law
301 -565-0680
michele@micheleforzley.com