E-drug: Expiry-date tampering
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[Reports of counterfeit are depressing reading, here is a report if
extending expiry date on a diagnostic kit described in a letter to this
week's Lancet. The 'original' which can be accessed free, has a picture
included. Copied as fair use. KM, moderator]
Lancet 2004; 363(9403) (10 January)
Expiry-date tampering
Sir--Counterfeit drugs are causing increasing problems in the delivery of
quality health care, especially in southeast Asia, where up to 38% of
samples of artesunate contain no active drug, and in Peru where up to 80% of
drugs are estimated to be fake.(1,2) The relative lack of central control
and regulation over the quality of drug supply, and the fact that relatives
rather than the hospitals or physicians are responsible for obtaining
sources of medication for the patient from a vast number of different
outlets, generates a situation that counterfeiters can easily exploit.(3)
Pharmaceutical companies have responded by developing increasingly
sophisticated tablet and packaging design (eg, the use of holograms).
However, despite increasing the technical difficulties and costs involved in
counterfeiting, these methods are already beginning to be matched by the
fraudsters, and fakes can be difficult to spot even with detailed
examination.(4)
We recently discovered evidence of a simpler, yet equally effective, method
of fraud that could have serious consequences for patients. We have found
that measurement of lactate concentrations in blood and cerebrospinal fluid
is very useful in aiding diagnosis (causes of meningitis), and assessing
prognosis and response to treatment in severe malaria and sepsis.5 Out of
normal working hours, we use a handheld BM meter (Boehringer Mannheim
Accusport 1488767) with BM-Lactate test strips (Roche Diagnostics, Mannheim,
Germany) for this purpose. Recently we noticed a discrepancy between the
clinical picture, the readings obtained with this meter, and those obtained
from our internal quality control. Close inspection of the BM-Lactate test
strips revealed that the expiry dates on the strips themselves, the package
inserts, and the boxes had been tampered with, such that they appeared to
expire in 2004, when in fact they had expired in 2002 (figure, Tampered
expiry dates on insert and foil-strip packaging of BM-Lactate strip test).
After thorough discussions with all parties involved, this expiry date
alteration clearly arose when the product was distributed via loose networks
out of the control of the parent companies or licensing authorities. This
finding could have implications for how companies distribute and sell their
products in certain markets. Compared with drug counterfeiting, this method
of fraud is cheap and technically simple, yet at least as difficult to spot
and potentially dangerous, particularly if applied to drugs as well as to
consumables. The quality of the changes suggests that this fraud is well
organised and potentially widespread. Pharmacists, nurses, and physicians,
as well as companies and their distributors, need to remain vigilant to this
threatening new version of counterfeit products.
*Jeremy N Day, Tran Tinh Hien, Jeremy Farrar
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Oxford University Clinical Research Unit, Hospital for Tropical Diseases,
190 Ben Ham Tu, Quan 5, Ho Chi Minh City, Vietnam
(e-mail:jeremyday@doctors.org.uk)
1 Kapp C. Counterfeit drug problem "underestimated", says conference. Lancet
2002; 360: 1080.
2 Newton P, Proux S, Green M, et al. Fake artesunate in southeast Asia.
Lancet 2001; 357: 1948-50. [Text]
3 Chatterjee P. India's trade in fake drugs--bringing the counterfeiters to
book. Lancet 2001; 357: 1776.
4 Newton PN, Dondorp A, Green M, Mayxay M, White NJ. Counterfeit artesunate
antimalarials in southeast Asia. Lancet 2003; 362: 169.
5 Day NP, Phu NH, Mai NT, et al. The pathophysiologic and prognostic
significance of acidosis in severe adult malaria. Crit Care Med 2000; 28:
1833-40. [PubMed]
Reply from Roche Diagnostic
Sir--Roche Diagnostics is extremely concerned about the discovery of fraud
involving one of our products in Vietnam. We have been in communication with
Jeremy Day and colleagues, and share their alarm at the discovery of product
tampering.
Counterfeiting and package tampering are issues that health-care suppliers
in Asia are grappling with now. Thanks to the vigilance of the staff at the
Hospital for Tropical Diseases, the removal of expiry dates and replacement
with new, false dates was discovered.
Roche Diagnostics views the fraudulent alteration of expiry dates on
diagnostic kits extremely seriously. As a result of local investigations in
Vietnam, we believe we have identified the external party responsible for
the expiry alteration and are working with local authorities and regulators
to address the problem. We have also redefined local logistical processes to
minimise the risk of similar fraudulent alterations in the future.
Although we hope that no other health-care supplier or medical professional
will face the situation that we and the staff at the Hospital for Tropical
Diseases in Vietnam have encountered, we feel it is vital to ensure that
other members of the industry are informed of incidents such as this and are
able to heighten their own vigilance to ensure that patients are not harmed
by these fraudulent tactics.
Graham Watt
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Roche Diagnostics Asia Pacific, 15 Rakino Way, Mt Wellington, Auckland, New
Zealand (e-mail:graham.watt@roche.com)
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