mPEDIGREE
WHO data suggests that 25% of drugs sold in developing nations are counterfeit, contain few or no active ingredients, and that these pose alarming health consequences for those who use them.1
Concerns of a related nature led to the proposal of the ePedigree system by the federal agency responsible for Food & Drugs Administration in the United States of America.2
But even in affluent USA, the implementation of an integrated public pharmacovigilance and drug supply chain integrity system has been dogged by the high costs of new, dedicated infrastructure to handle the requirements of specialized technologies such as RFID (Radio Frequency Identification Devices). It is estimated that for a mid-size pharmaceutical firm, the costs of enrolment into the ePedigree scheme through the adoption of RFID-supported supply chain practices can run upwards of $25 million.3
Needless to say, the prospects of establishing ePedigree-type programs in the developing world to safeguard patient safety, notwithstanding the urgent need for such patient protection, considering that in China alone nearly 200,000 drug users die annually from the effects of counterfeit medication, is nil for reasons of cost and infrastructure deficiency.4
The proposed public pharmacovigilance system dubbed mPedigree, which relies on GSM infrastructure to deliver drug-user protection as well as satisfy regulatory documentation directives, is in our view the only solution capable of addressing the urgent problem of counterfeit and substandard drugs in the developing world.
We are proud to be part of the mPedigree program.
1. WHO, "Substandard and Counterfeit Medicines," Fact Sheet No. 275, November 2003.
2. The Prescription Drug Marketing Act, Report to Congress, Department of Health and Human Services, U.S. Food and Drug Administration, June 2001.
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