E-DRUG: Counterfeit Drug Reporting
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[A counterfeit medicine is one which is deliberately and fraudulently mislabelled with respect to identity and/or source (WHO definition). Counterfeit medicines should be stopped - I am sure everyone agrees. But how? A duty for every health worker: CDR like ADR?
Below a posting from PSI, a non-profit organisation supported by big farma, requesting that counterfeits be notified to them.
E-druggers might like to know whether the PSI database is also publicly accessible, or only for members? And what action is PSI taking to remove counterfeits from the market? Are the drug regulators always informed by PSI? And is WHO informed about counterfeits reported to PSI as well?
In my view, counterfeits should, in the interest of protection of public health, first be reported to the national Drug Regulatory Authority and the local original company concerned. If a counterfeit is dangerous but hard to distinguish, and therefore dangerous for public health, the DRA then could take the drastic action by temporarily recalling the original + counterfeit from the market. This is obviously tough on the original manufacturer, but might be needed (remember Tylenol with cyanide in USA?).
If the counterfeit is not dangerous (ie a good quality, but illegal copy), the DRA might allow the company to use under cover techniques to try and stop the counterfeit trade, and inform pharmacists how to discover the counterfeit.
If that is not working (no or weak DRA or no action), one could report suspected counterfeits to WHO (cft@who.int) or PSI. There is a standard procedure for reporting counterfeits to WHO at www.who.int/medicines/organization/qsm/activities/qualityassurance/cft/CounterfeitReporting.htm
The PSI and WHO procedures are described below.
Wilbert Bannenberg, E-drug moderator. wilbertb@wanadoo.nl]
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Dear E-drug Subscribers,
The Pharmaceutical Security Institute (PSI) is a Washington, DC metro
area not-for-profit trade association with additional offices in
London, England. PSI's members are the Security Directors of
eighteen major research-based international pharmaceutical
manufacturers. PSI works in tandem with its member companies,
international organizations, and other concerned parties to collect
and disseminate information on incidents of counterfeiting,
diversion, and theft of pharmaceuticals worldwide. PSI's mission is
to protect public health, share information, and initiate law
enforcement action through the appropriate authorities. PSI also
assists with contacting pharmaceutical manufacturers for quick
product analysis.
PSI manages a special database, the Counterfeiting Incident System,
which captures counterfeiting incidents reported anywhere in the
world. Open source reports of counterfeiting, diversion and theft
comprise a major portion of the database entries. Therefore, PSI is
always striving to locate new information sources.
Since many incidents go unreported, PSI would like to request that
e-drug subscribers notify us of any incidents that may occur in your
respective country or locality. Please send incident reports to PSI
at pyork@psi-inc.org.
Thank you for your time and assistance.
Sincerely,
Peter York
Pharmaceutical Security Institute
USA
pyork@psi-inc.org
http://psi-inc.org/index.cfm
Counterfeit medicines � Reporting counterfeit cases
There is no simple solution or remedy that can be applied to eliminate counterfeit medicines nor can the problem be solved by an individual company or government. Given the global dimension of the problems, WHO promotes a global approach to combat the problem of counterfeit medicines and addresses the shared responsibility of all concerned parties to participate in this process.
The importance of reporting counterfeit cases to WHO
WHO is inviting all stakeholders to enhance cooperation and collaboration in the fight against counterfeiting of medicines.
This in turn requires, among others,
access to reliable information on the nature and extent of the problem as well as
availability of an effective information exchange system between all the concerned parties.
WHO has now simplified the process and tools for reporting on counterfeit and substandard medicines.
Who should report cases of counterfeit medicines to WHO?
National Medicine Regulatory Authorities, anti-counterfeiting Liaison Officers, pharmaceutical manufacturers and distributors, health professionals and others who detect counterfeit medicines are encouraged to report a case of counterfeit medicines to WHO.
How to report cases of counterfeit medicines to WHO?
Use our Counterfeit data base (MS Access 2000 or higher)
Step 1: Download the database;
Step 2: Enter the relevant counterfeit medicine case information; you may enter as many case records* as appropriate
Step 3: Compress the database using a ZIP program (download WINZIP)
Step 4: Send your database by email to WHO.
OR
Use our CFT Reporting Form (MS Word: EN FR SP or Rich text format RTF: EN FR SP or PDF: EN FR SP)
Step 1: Download the document;
Step 2: Fill out the form; please note that one separate form has to be filled out for each case*
Step 3:Send the completed form(s) by email to WHO.
*Note: . A case is defined by the stated active ingredient(s), dosage form, the trade name on the label and batch number. If any one of these is different, then the case will be considered to be different.
News & events
Overview
Activities
Reporting counterfeit cases
Factsheets
FAQ
Publications
How will the WHO report:
Information supplied to WHO as "confidential" will not be disclosed without the consent of the information provider.
WHO will consolidate and screen the reports received and post relevant information on this web site.
For enquiries please contact:
Mr Eshetu Wondemagegnehu
Quality Assurance and Safety of medicines (QSM)
Department of Essential Medicines and Policy (EDM)
World Health Organization CH-1211 Geneva 27
Switzerland
Tel: +41 22 791 37 43
Fax: +41 22 791 47 30
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