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July 17, 2008

The New PhRMA “Code on Interactions with Health Care Professionals”: What will it mean?

This analysis is solely the work of the author. It has not been edited or endorsed by GLG.
Analysis By:
Joseph Bertino, Pharm.D., Independent ConsultantJoseph Bertino, Pharm.D.
Independent Consultant, Bertino Consulting
Implications: -The new code will limit all gifts and meals to healthcare professionals, thus reducing pharmaceutical representative contact time. -Medical education programs will follow guidelines established by professional education groups -The guidelines do not go far enough for sales representative-healthcare professional interactions

Analysis:  As of January 2009, a new guideline for interactions of pharmaceutical companies with health care professionals will go into effect (http://www.thepinksheet.com/nr/FDC/SupportingDocs/Pink/2008/PhRMA_2008_Code_on_interaction_with_healthcare_professionals.pdf).  This code is not mandatory, pharmaceutical companies can opt in or opt out.  

The Good:   Support for continuing medical education will be required to follow accreditation body standards. In this context, meals can be provided to health care professionals and their staff, however attendance by spouses, friends, etc. is still prohibited. No outside meals can be provided.  In addition, executives of publically traded companies will be required to assure that their financial records are accurate.  This was put into place to avoid Congressional action.  For P&T committees, the guidelines suggest that consultants to companies who are members of P&T committees disclose their relationships to the committee. Isn’t this under the auspices of the individual P&T committee and not PhRMA?  

The Bad:   There is no provision to stop pharmaceutical representatives, many of whom have no healthcare background or even scientific experience from presenting topics on their products in these lunch sessions in providers offices, etc. In fact, the new guidelines tout the usefulness of these non-medically trained personnel.  Many companies have established a scientific liaison workforce made up of physicians, nurses, pharmacists and other healthcare professionals. These individuals are generally better trained than sales representatives to present data on new products, answer questions and refer other questions to medical information departments in companies. Perhaps the guidelines should have recommended establishment of these scientific liaison workforces for all companies to do correct and accurate education. The lack of this provision maintains the “dine and dash” mentality, providers and their staff come into a room, grab something to eat while the sales representatives attempts to “educate” them.  Additionally, no mention of sampling is made in the document.  While samples can help individuals with limited resources, their primary purpose is to get the prescriber to “try” the medication, oftentimes when other less expensive, equally effective medications are available. Finally, there is no method to sanction companies who violate the code.  How about an independent group that reviews the data yearly and publishes on a web site the violations and the violators?  

The Silly:   Banning of “reminder gifts” to healthcare professionals. These include pens, sticky pads, and the like. Does PhRMA really believe (or does Congress believe) that these things influence prescribers? Additionally, PhRMA will no longer be able to provide tools that are very useful in the clinical setting, such as stethoscopes to students, etc.  

Overall, the new guidelines are an improvement, but don’t go far enough.  If PhRMA really wants to get serious then implementing some additional restrictions would be a large step. However, these things should be done, not to avoid Congressional legislation or media hype, but to truly help providers and patients while keeping their investors happy.


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