Steps That Industry Is Taking To Protect Patients Against Counterfeit Medicines

Friday, February 15, 2013
Room 306 (Hynes Convention Center)
John Clark , Pfizer Global Security, Groton, CT
An Overview of the Counterfeiting Problem:  A Pfizer Perspective

Threat to Patient Health and Safety

For Pfizer, counterfeit medicines are, first and foremost, a matter of patient health and safety. 

Counterfeit medicines pose a threat to patients because of the conditions under which they are manufactured, in unlicensed, unregulated, uninspected and often unsanitary sites.  We have seen life-saving medicines being manufactured in rodent and pest infested labs, with mold growing on the walls, peeling paint and dirty equipment.  We have also seen supposedly “sterile” injectables filled with ordinary tap water in filthy bathrooms.

The “medicines” themselves pose a threat to patient health and safety because their contents are not regulated and they may contain none of the active pharmaceutical ingredient (API) to deliver the therapeutic benefit for which they were prescribed, the incorrect dosage or the wrong API, or even ingredients that are themselves harmful such as heavy metals or pesticides.

Our labs have confirmed the presence of pesticides (boric acid), rat poison, brick dust, leaded highway paint, commercial grade paint, floor polish, cartridge ink, plaster and wallboard.  There have also been reports of heavy metals, arsenic and even anti-freeze.

The danger posed by counterfeits is not limited to toxic ingredients, but extends to those that contain no active ingredient, the wrong active ingredient or the incorrect dosage of an active ingredient, thereby depriving patients of the therapeutic benefit of the medicine that their doctors have prescribed.

 Pfizer’s Aggressive, Focused Anti-Counterfeiting Program

It is precisely because of that risk that Pfizer has implemented an aggressive and focused anti-counterfeiting campaign to detect, disrupt and deter major manufacturers and distributors of counterfeit Pfizer medicines.

The key to the success of our program is the effective partnerships we have built with enforcement authorities around the world. As part of those partnerships, we initiate investigations and refer the results to enforcement authorities for their action, as well as provide training to authorities from at least 122 countries to raise awareness to the counterfeiting problem and enhance their ability to distinguish counterfeit from authentic Pfizer medicines.

A measure of the success of those efforts is that, since 2004, we have prevented almost 148 million doses of counterfeit Pfizer medicines from reaching patients.  By attacking counterfeits at their source, we disrupt their flow to the global market.