Playing Russian roulette with health on the internet
The counterfeiting of medicines is a growing problem. Jane
Nicholson writes
Mrs Nicholson is a committee member of the Society’s Industrial
Pharmacists Group and an expert member of the FIP board of pharmaceutical
practice
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“Purchasing a Rolex watch or a Louis Vuitton handbag on the street
corner for a fraction of its list price is something to show off to your
friends.
So what is the harm in a bit of counterfeiting?
“Talk to your pharmacist — counterfeit medicines can damage
your health. All purchasers of cheap medicines are vulnerable because
they
have no means of knowing whether the product is genuine or contains no
active ingredient or perhaps includes some poisonous heavy metals like
lead or arsenic."
This is the message a working group of the International
Pharmaceutical Federation (FIP) is trying to get across to patients purchasing medicines
over the internet. Global trade arrangements and internet sales are dramatically
changing the worldwide market in medicines. An environment has been established
that favours an increase in counterfeit activities. The counterfeiting
of medicines is attractive because relatively small quantities provide
huge profits for the counterfeiter.
In developing countries limited access to affordable medicines and lack
of enforcement of regulations creates an environment that is conducive
to the distribution of counterfeits. The most frequently counterfeited
medicines are those used to treat life-threatening conditions such as
malaria, tuberculosis and HIV/AIDS. For example, a recent WHO survey
of the quality of antimalarial preparations in seven African countries
revealed up to 38 per cent of chloroquine tablets and up to 90 per cent
of sulphadoxine/pyrimethamine tablets were below standard.
In wealthier countries, the most frequently counterfeited medicines are
those that are new and expensive, such as antihistamines, hormones and
steroids. There are various estimates of the amount of counterfeit Viagra
in circulation but on average you have a one in two chance of receiving
a counterfeit if you order the product via the internet.
So, apart from life-style medicines, do the real problems lie only in
developing countries with weak regulatory systems? Not if you look at
what is happening in the US. A recent headline in FDA News, a bulletin
from the Food and Drug Administration, was “FDA overwhelmed by
volume of illegal prescription drugs sent through the mail”. As
many as 10,000 packages of illegal drugs move through the country’s
mail distribution facilities daily, according to Christopher Knauer,
an investigator for the House Energy and Commerce Committee. The FDA
is required by an exemption to federal law to allow individuals to order
through the mail up to 90 days’ supply of prescription drugs for
personal use. But the amounts moving through the mail facilities and
those carried by couriers such as FedEx and DHL far exceed what could
be accounted for by that exemption. US Customs segregate suspect packages
and, under the law, the FDA must then contact the person who ordered
the drugs and request evidence that they should legally receive them.
The FDA has the responsibility but has neither the time nor the resources
to meet its duties.
Although the pharmaceutical industry is working on sophisticated electronic
bar coding, and governments such as those of Greece and Italy have implemented
sequential numbering and reconciliation processes for individual packs,
everyone recognises there is no single magic bullet against counterfeiters.
A global alliance has been formed by WHO and other international bodies,
such as FIP, the World Medical Association, UNICEF and Interpol.
What can individual pharmacists do to help? WHO’s advice is to
create awareness of the problem among the public, to advise patients
of the dangers of purchasing over
the internet and to report all suspect
counterfeits.
The text of a reporting form for pharmacists (PDF 40K)
has been sent by FIP to national pharmaceutical societies with a recommendation
that it be made available as an A5 preaddressed card, similar to the
yellow card system for reporting adverse reactions, so that pharmacists
can report suspected counterfeit to the regulatory authorities.
An international website comparing photographs of counterfeits alongside
the genuine product is under consideration. Answers to frequently asked
questions, fact sheets and other helpful advice can be found at the WHO
website |
The
Pharmaceutical Journal