“Protect your Patients - Know your Supplier”:
Rx-360 Cascades Antidiversion Education Through Medical Associations
Article by Lew Kontnik
Rx-360 member companies have been aware for some time that certain internet and “Canadian” pharmaceutical sales organizations were actively promoting foreign, unapproved versions of US medications for use by physicians and clinics. While various companies have initiated different programs to warn physicians about the risks of buying non-FDA approved products from unknown sources, the tragic situation of fake Avastin® being sold through these channels and used on unsuspecting cancer patients (http://www.fda.gov/Drugs/DrugSafety/ucm291960.htm) emphasized the need to do more.
Rx-360 conducted an analysis of the history of diversion cases and held discussions with field sales staff to better understand the situation. This led to the realization that some doctors, and perhaps more importantly, many medical office managers, did not understand the true nature of the risk they would be taking if they used illegally diverted foreign products. Indeed some practices were asking field representatives if they could verify foreign products they had bought from unregistered sellers, but the majority did not question the products.
This gave birth to a new idea: Rx-360 could further our mission to protect patients by arming medical professionals with critical information about unapproved medications - what illegal diversion is, how it is related to counterfeiting and the facts about the safety and legal risks that doctors are taking by administering diverted products.
Taking the idea one step further, Lew Kontnik, Amgen; Tara Steketee, Merck; and others within the Rx-360 leadership realized that medical professional organizations would make an ideal communication channel to deliver this message to a broader audience. As a result, in February, Rx-360 initiated a project to create messaging and line up medical professional organizations willing to cascade the message to their members.
The effort gained almost immediate support with Marv Shepherd, The University of Texas at Austin School of Pharmacy; Carmen Catizone, National Association of Boards of Pharmacy; Brian Donnelly, Pfizer; Bryan Morgan, Genentech; and Megan Cahill, DBR rounding out the team. FDA also provided oversight to the project.
The team reached out to nearly 20 different organizations, including the American Medical Association, American Dental Association, American Association of Medical Practice Administrators, the Partnership for Safe Medicines and others, asking if they would be interested in cascading this safety message to their members. The universal answer was “Yes.”
In June, the team completed work on its message, “Protect your Patients - Know your Supplier,” (Message), and distributed it for the medical professionals to use. The effort worked, and numerous organizations released the message directly to their members; others took different approaches, such as including it in articles in their newsletters.
The Rx-360 team is now following up on the response different organizations received with the message release. FDA has now kicked off a more in-depth analysis of how it can work with a wide array of medical organizations to further educate physicians about safe buying practices. In July, the Brookings Institution hosted a stakeholder conference, sponsored by FDA, to better understand how this can be accomplished. Rx-360 presented at the meeting and will remain an active participant in helping drive understanding of the problem and expand the use of education to prevent the purchase and use of illegally imported, non-FDA approved products.