FIP Congress 2005
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A joint session of the Pharmacy Information Section
and Young Pharmacists' Group was organised on 5 September to address
the issue of combating counterfeit and substandard medicines. Jane
Nicholson reports
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 The World
Congress of Pharmacy and Pharmaceutical Sciences was
organised by the International
Pharmaceutical Federation in association with the Syndicate
of Pharmacists of the Arab Republic of Egypt.
It took place in
Cairo from September 2 to 8, 2005 |
Information sharing to address counterfeit and substandard drugs
Counterfeiting medicines is a lucrative business affecting both developing
and developed countries. The real magnitude of the problem is unknown.
In part, this is due to a reluctance by all parties to report because
the data could prejudice ongoing court cases, or disclosures in relation
to past cases might compromise future methods of investigation. Counterfeiters
use “spoke and wheel” organisations so that anyone involved
during one step of the chain of manufacture and distribution is not familiar
with the next. Therefore most prosecutions are of individuals involved
with unlawfully distributing, smuggling, dispensing or, in the case of
internet sales, money laundering. Only rarely is the manufacturing source
identified.
In her presentation on collecting information, Sabine Kopp, of the World
Health Organization, Switzerland, indicated that the WHO has been notified
of cases of counterfeit medicines since 1982. Most reports do not distinguish
between substandard and counterfeit products and the WHO was not in a
position to validate the bulk of the cases. Counterfeiters have copied
the industry’s sophisticated security devices such as holograms
and reference codes. Indeed, counterfeits have been found to include
holograms where there was none on the originator’s product.
Dr Kopp emphasised the importance of accurate reporting on counterfeits
and gave a detailed explanation of the steps involved in completing the
WHO form. She explained that because of personal threats to some of those
reporting, information supplied in confidence to the WHO will not be
disclosed without the consent of the provider. In addition, she discussed
the FIP text for an A5-sized reporting form for counterfeits detected
in pharmacies designed to be sent to the pharmaceutical societies of
the respective countries. It was noted that the Western Pacific Region
of the WHO had launched a rapid alert system earlier this year and that
web-based networks were under consideration in other regions.
The enforcement of an effective licensing system with penalties severe
enough to be a deterrent would be a major step in combating counterfeits.
At present, one third of WHO member states have well developed regulatory
systems; about a third have none.
The importance of strict national regulatory controls on exported pharmaceuticals,
such as those of Australia’s Therapeutic Goods Administration,
was also discussed. The medicines laws in many countries, including those
in Europe, do not apply regulatory controls to medicinal products imported
solely for re-export. This could be exploited by counterfeiters and suppliers
of substandard medicines who are working on a global basis.
Prosecutions of counterfeit offences are often taken under trademark acts or
general theft and forgery acts and not under medicines acts because the latter
are not designed to deter organised crime. In an attempt to harmonise legislation,
the WHO has an ongoing project moving towards an “international convention” against
counterfeits with a framework similar to that of the International Convention
on Narcotics.
Taking action
When analysing the reports on counterfeits, Jane Nicholson, of Bristol-Myers
Squibb, UK, had contacted members of the Permanent Forum on International
Pharmaceutical Crime — a group of government intelligence and
enforcement staff. She described the action taken by the European and
US authorities once a potential counterfeit is reported. The laboratory
of the regulatory authority will liaise with the pharmaceutical industry
laboratory of the marketing authorisation holder to verify the report.
A medical risk assessment will be made by the regulatory authority
and a rapid alert then issued. These would be Class 1 (life-threatening,
action to be taken within 24 hours), Class 2 (serious but not life
threatening, action within 48 hours) or Class 3 (product not compliant
but no major risk, action within five days). In the UK, these alerts
will be taken to wholesale and pharmacy level but if there is a serious
problem, a press release to patients will be issued by the Medicines
and Healthcare products Regulatory Agency. The information will be
shared among other regulatory agencies of the EU, the European Economic
Area, the Australian, US and Malaysian inspectorates and the WHO.
She described the activities of the Pharmaceutical Security Institute,
whose members are 21 major pharmaceutical companies. The PSI uses spider
technology software to trawl websites, researches reports from regulatory
authorities, evaluates newspaper articles, tracks counterfeits and looks
for trends in the diversion or theft of products in order to advise member
companies.
Mrs Nicholson showed a bar chart indicating a 15-fold increase in the
number of cases of counterfeits under investigation by the US Federal
Drug Administration in the four years to 2004. The lack of control of
secondary wholesaling and, in some countries, the established practice
of mailing pharmaceuticals to the patient through the post rather than
collection from a local pharmacy, must be helping the distribution of
counterfeit medicines, said Mrs Nicholson.
Addressing the problem in Ghana
Worryingly, counterfeits of life-saving products
such as antibiotics and insulin are hitting some of the poorest
nations that are least
able to cope. Although there are numerous reports of counterfeits
in developing countries, their dissemination to health professionals
in a timely manner is “patchy”, said Naana Frempong,
from the Ghanaian Ministry of Health.
She had conducted a survey and concluded that pharmacists can play a significant
role in curbing the menace of counterfeits. Because of the close network of professionals
in the national pharmaceutical association, she had found that using a cascade
of e-mails or text messaging to colleagues was successful in disseminating information.
She favoured the use of a combination of communication channels to advise on
counterfeits, namely, mass media with a follow up of more detailed information
to the professions through journals, newsletters, flyers, the use of professional
group meetings and networking.
The core subjects taught in most pharmacy schools contain the necessary elements
for addressing counterfeit and substandard medicines, commented Alexander Dodoo,
of the University of Ghana Medical School. However, these subjects are taught
in a compartmentalised manner and prevent a holistic approach to pharmacy education.
Thus, pharmacy students do not realise the scientific knowledge taught in pharmaceutics
and pharmacognosy lectures provides a background to detecting counterfeits. Drawing
on the principles imparted earlier in the curriculum, Dr Dodoo thought that a
formal course on the cycle of medicines management to include the subjects of
counterfeit and substandard medicines could be delivered in the final year.
A format of tutorials and discussion periods with problem-based practical examples
should be used to allow students to “put it all in context”. Academic,
regulatory and law enforcement staff and practitioners should be involved to
bring real life examples to the student. |
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The
Pharmaceutical Journal