Friday, February 6, 2009

Does our Drug Supply Chain Have a False Sense of Security?

When it comes to Pharmaceutical Quality -What you see is not always what you get.

It is time for our security measures to move beyond pedigree and taggants that document where our drug supply has been and concentrate on authentication to ensure that the contents are genuine and of standard quality.

As you can see from the recent stories below, pedigrees did nothing to protect consumers from fraudulent and substandard medicines. The sad fact is pedigrees can themselves be counterfeited. Also medicines have become a huge commodity providing those individuals with questionable intentions a lucrative income. Even when false paperwork is finally detected, it can take years to retract the questionable product and bring the criminal to justice.

Thousands 'have taken fake drugs'
Thirty-thousand packs of fake life-saving drugs may have been consumed by NHS patients, the BBC has learned.

Three medicines, Casodex (bicalutamide) for prostate cancer, Plavix (clopidogrel) which treats strokes and heart conditions and Zyprexa (olanzapine) to control schizophrenia, had to be removed from pharmacies and warehouses across the UK in the recall 18 months ago.

How fake drugs got into the NHS
It was the highest state of alert the United Kingdom's medicines watchdog can issue.

A UK wholesaler spotted discrepancies in packaging of stock bought from in Europe.
According to former industry investigator Graham Satchwell reputable companies were duped by sophisticated counterfeits.

Woman faces prison time in drug scheme
A Milford, NH woman has pleaded guilty for her role in a two-year scheme to sell more than $2 million worth of AIDS drugs that were bought from patients around the U.S. and resold under falsified paperwork.


Paul Fowler said...

While it is clear that paper-based drug pedigrees and shipment documentation provides no assurance that a product is genuine, there are significant issues with a strategy of full-contents authentication as well. There are currently tens of thousands of individual drugs, and more are released each day. Can authentication tests be developed and distributed for each one? Given the continuing economic pressures on healthcare systems worldwide, the cost alone would seem prohibitive.

Organizations like EPCglobal and the U.S. FDA think the answer is a secured electronic exchange of drug movement data that tracks and traces all products from the point of manufacturing to the point of dispensing. Any suspicious product would be authenticated electronically with the manufacturer’s original database. This one method could authenticate all existing drugs and any future drugs.

Drug safety is a must, but it has to be provided as cost effectively as possible. Any extra money spent on the supply chain is money not going to patient care.

Paul Fowler
VP, Healthcare Innovation, Office of the CTO
Axway Inc

Alan Clock said...

XStream has always taken the position much like the FDA that a variety of solutions must be utilized to adequately protect the pharmaceutical supply chain however Mr. Fowler’s statement questioning the cost as a reason to dismiss authentication shows a lack of understanding as to its process and efficiency.
Clearly he does understand and admits readily that pedigrees and transaction documentation “provides no assurance that a product is genuine”.
That is why I find it hard to understand his commentary, the cost to consumers, brands and healthcare in general for substandard or harmful healthcare far outstrips any technology that can properly verify the efficacy.
Isn’t shipment documentation a given in any intelligent business process, why should an entire supply chain be forced to spend billions on a solution that does not provide assurance that the healthcare being delivered is not genuine?
The cost of authentication, which can be quickly and easily deployed at all points among the chain and operate autonomously, is relatively minor compared to the cost of pedigree and tracing solutions that require standardization and all members to comply or it is information is useless as a safety tool.
When you authenticate a product on-site you in fact are producing a real time pedigree of the product.
Authentication goes beyond anti-counterfeiting it also detects formulation errors, provides quality control and can prevent medication administration errors.
We realize that there is no one single solution but just remember, all of the Heparin that killed hundreds of people in the United States had perfect pedigrees. I am sure that all of their victims and families would not share your opinion that the cost of authentication was not going to patient care.

Anonymous said...

Response to Paul Fowler, V.P. Healthcare Innovations, Office of the CTO, Axway, Inc.

Written by Charles Earl, M.A., ABD, CEO Communication Connections

The growing awareness of the necessity for pharmaceutical and patient safety is a good thing.

Patients are well served when their ultimate health and safety are areas of concern. It should be noted, however, that patients and providers rely on the product…not the packaging.

While earlier technologies have provided some level of safety in times past, new issues (and artful counterfeiters) require higher standards and greater reliability.

Is cost a consideration? Certainly, but one could argue that doing nothing is the most cost-effective method, but that remedy is unacceptable for providers’ and patients’ peace of mind. Does a Blackberry cost more than a simple cell phone? Which is the most versatile and useful?
Nearly every technology that has been developed to insure patient safety has been more effective and, in the beginning, more costly than its predecessor. It is not good enough to remark: “Sorry, Ms. or Mr. Patient, your package was good, but your medicine was deadly.” Progress and patient safety must march forward. Standing still, anchored to the past is unacceptable.