While relationships are changing between physicians and pharmaceutical companies, doctors still need pharma to provide direction with comparative drug efficacy, among other things. Kristine Rapp, vice president of global ethics and compliance at Hospira, Inc., speaks about the need for continuing medical education and other learning tools to be presented with impartiality and fairness. Dr. Maurice Pickard hosts.
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Our presidential election is only days away. 48 million people in America are uninsured and healthcare costs are rising 2 to3 times faster than our nation’s GDP. Where will America’s healthcare system be in 5 years? Welcome to ReachMD’s monthly series focused on public health policy. This month we explore the many questions facing healthcare today.
EXPERT HIGHLIGHTS IN PUBLIC HEALTH POLICY
HOST:
Dr. Morris Pickard.
Dr. MORRIS PICKARD:
Much has been written about the tension that exists between the pharmaceutical industry and their interaction with physicians. Is it time for a change. You are listening to ReachMD XM157, the channel for medical professionals. Welcome to the clinicians’ roundtable. I am your host, Dr. Morris Pickard and joining me today is Kristine Rapp, Vice President of Global Ethics & Compliance at Hospira Inc. Thank you very much for joining us.
Dr. KRISTINE RAPP:
It is my pleasure to be here, Dr. Pickard.
Dr. MORRIS PICKARD:
The popular presses filled with information about the <_____> that exist between the pharmaceutical industry and physicians and what can be done about it. How do you view this particular situation at the present time?
Dr. KRISTINE RAPP:
The relationship between industry and healthcare professionals is one that is in need of change. I am a strong proponent of seeing some changes take place and actually have been working; Hospira works and other companies in the industry work to change the codes of ethics about interactions between industry and healthcare professionals. We are engaged in one of those changes right now.
Dr. MORRIS PICKARD:
What are the changes that are taking place? Are you referring to the recent change in the code?
Dr. KRISTINE RAPP:
Well, the Pharma code is one that came out. It will represent some profound changes, but Hospira is not a member of Pharma. We are manufacturer of generic injectable drugs and also medication delivery devices where a number of trade association called AdvoMed that is a medical technology trade association and AdvoMed is also engaged in changing its code of ethics to derive some changes of similar sort to the Pharma code between industry and healthcare professionals.
Dr. MORRIS PICKARD:
For much is made about gifts, whether it is a mug, a pen, it is very hard to see how these things and the cost of these things should be passed on to third party pairs or Medicare whomever. Is this what we are talking about today?
Dr. KRISTINE RAPP:
In part, the AdvoMed code and companies that are part of AdvoMed and companies that are part of Pharma are moving away from the provision of gifts to healthcare professionals and I think it is about time. At the end of the day, healthcare is costly and one of the costs that is indirect and very difficult to quantify is the cost of the items that have been provided to healthcare professionals at conventions or at meetings, the little calculators or the sponge balls, or pens, or note pads or cups, all at the end do cost money and if we can eliminate those, I do not think the exchange between industry and healthcare professionals will be diminished in any substance with respect.
Dr. MORRIS PICKARD:
Well, having all of these gifts or meals has been a way for the pharmaceutical industry to access physicians and get their particular message across.
Dr. KRISTINE RAPP:
They have, but I think industry is recognizing that it needs to change the approach and become more creative, but also more scientific or clinical in its approaches to healthcare professionals as you know the time of healthcare professionals is very limited. We want to make sure that these changes that take place between companies and healthcare professionals is really focused on the science and not on the type of meal that is being served or the type of gift that might be provided at a convention booth.
Dr. MORRIS PICKARD:
I do not particularly understand how am I to get this information, what are the creative ways that I can get information that I can evaluate and use, where is this interchange going to take place?
Dr. KRISTINE RAPP:
Some of the exchanges are in continuing medical education sessions and some of those sessions in the past have been build on provision of a dinner, often healthcare professionals do not have time during their busy days, so industry has established sort of a tradition if you will of having continued medical education dinners for healthcare professionals. I do not really know if the meals will go away altogether, but one of the things that these trade associations, Pharma, AdvoMed, and others are driving to make sure that the exchange is much more based on the science or the clinical or the instruction and less based on the meal.
Dr. MORRIS PICKARD:
Well, when we have looked at seeing the education, when it is sponsored by the pharmaceutical industry, it also seems to be self-serving. Again, coming back to, how do we change this?
Dr. KRISTINE RAPP:
Making it more objective, making it less focused on the products and actually continuing medical education really should be less focused on specific products and more focused on general therapy or on a scientific principle.
Dr. MORRIS PICKARD:
Is this where compliance your particular office and career is taking you?
Dr. KRISTINE RAPP:
The area of compliance in healthcare companies, healthcare industry is really a burgeoning field and I have been engaged in it for many years, but functions like mine at Hospira are really focused on making sure that the employees are educated about what the laws and the industry codes and other requirements are and making sure that our employees are following those.
Dr. MORRIS PICKARD:
How do you go about doing this on a day-to-day basis?
Dr. KRISTINE RAPP:
Training everyday, answering phone calls everyday from sales reps, or medical science liaisons, or executives who want to know “What am I supposed to do, what is the requirement, what are the procedures that apply to me and my interactions with my customers.”
Dr. MORRIS PICKARD:
The recent code that Pharma has come up with has left it to the industry to self-police. Is this going to be the job of the compliance officer?
Dr. KRISTINE RAPP:
At this point, the responsibility at least within Hospira is placed on the employees to adhere to the requirements, the code of conduct, and our own procedures, but we are engaged in my office and the office of Ethics and Compliance in monitoring that activity and making sure that the employees are adhering to the requirements.
Dr. MORRIS PICKARD:
A great deal has been made out of the AMA’s physician data restrictive program and I know this is not your particular area of expertise, but this particular data could and does get through the pharmaceutical industry and it is supposed to be used for research and recalls, but it is conceivable that a hospital representative, a pharmaceutical hospital representative might use this information, is it therefore the industry’s position that we have to police our representative so that this information is not misused?
Dr. KRISTINE RAPP:
It is the responsibility of companies in the industry to make sure that the sales reps and other representatives from the company know the facts and only use facts, not misrepresent that information, so yes it is our responsibility and my office does get engaged in that from time to time.
Dr. MORRIS PICKARD:
Educational institutions have become very restrictive on their contact that they allow pharmaceutical industries to see interns and residents. Do you think this is the way we have to go to accomplish our goals?
Dr. KRISTINE RAPP:
Some of what has happened among the academic institutions is perhaps overreaction to these exchanges that have been taking place between industry and healthcare professionals that have gone too far. Some institutions have put in place some very restrictive provisions about the contact that can be had between industry sales representatives and the healthcare professionals within the institutions. I think they have gone too far and the concern I have is that industry has an obligation, actually it is driven by FDA in part to train healthcare professionals who are going to be using medical technology. If the sales reps can reach the new healthcare professionals, the newly graduated doctors for instance, how do we train, how do we make sure that those devices are being used safely on patients?
Dr. MORRIS PICKARD:
The Institute of Medicine is also looking at this. Could you tell me what direction they are going?
Dr. KRISTINE RAPP:
The Institute of Medicine decided in 2007, I believe, that it needed to focus on the topic of conflict of interest between industry and healthcare professionals. They conducted a series of hearings and I believe their intent is to issue a white paper later this year or early next year on how industry and healthcare professionals should interact in order to mitigate conflict of interest.
Dr. MORRIS PICKARD:
Everybody seems to be involved. The Federal Government has the Sunshine Bill that is coming up. Could you explain how that is taking place and what role that is going to have?
Dr. KRISTINE RAPP:
In the senate, in particular the US senate, there was a bill proposed earlier this year or perhaps late last year called the Physician Payment Sunshine Act and that will actually require that industry post on a public website, the dollar amounts of exchanges that are had between industry and healthcare professionals, so by company that data would be very transparent.
Dr. MORRIS PICKARD:
In fact they have even talked about having a data online where patients can go to and find out what their particular doctors may have received in gifts. It seems unfair because what you are doing is seeing about a particular doctor and you do not know whether he really provided fair value for his compensation. Does this seem too restrictive and a bad thing?
Dr. KRISTINE RAPP:
I do not think transparency is bad, Dr. Pickard. In fact I am a strong proponent of it. What I do think is somewhat problematic in requirements that this bill would place on industry is that it is not specific enough, so a general dollar amount does not tell a patient or someone from the public what actually has happened in the exchange between the healthcare professional and the company.
Dr. MORRIS PICKARD:
So we have talked about the company, the industries involved. We have talked about the Federal Government. We have talked about the Institute of Medicine. Are the States doing anything?
Dr. KRISTINE RAPP:
Actually there are about 9 states that have laws on books right now and probably another several, I think the number is up to about 13 or 14 states that are considering laws that have either a restriction on the interactions that take place between a company and healthcare professionals in that state or a reporting responsibility, much like the Federal Sunshine Bill.
Dr. MORRIS PICKARD:
How is this going to be better for our patients?
Dr. KRISTINE RAPP:
That is a great question because at some point all of us will be patients. From my vantage point, I want to make sure that the interactions that take place between company such as my own Hospira and the healthcare professional is based on scientific information and I think the efforts that AdvoMed and Pharma and States and Congress are about is to derive a more substance of scientific exchange rather than something that is based on money.
Dr. MORRIS PICKARD:
Do you present us with data that in some way helps educate us in a positive way so that ultimately our patients are being benefited?
Dr. KRISTINE RAPP:
Yes, we do. Our sales reps are trained on that data and provide a data that would help a healthcare professional to understand better the efficacy of the medical technology; that is actually something that is rigorously imposed upon the sales reps when they go through their new higher training or when they come in for training on a new technology.
Dr. MORRIS PICKARD:
In your field, are there certain specialists who are targeted to get the message out. Even in CME education, are there certain specialists who carry the load so to speak to get the message across?
Dr. KRISTINE RAPP:
With one of the products that Hospira has, which is an anesthesia product, we would focus on anesthesiologists, but for the most part, our technology and our generic drugs are really directed at all healthcare professionals. So there is not a targeting of particular practices.
Dr. MORRIS PICKARD:
Well, today, we have been discussing a very difficult problem, how to help the pharmaceutical industry help actually their partners, the physician to bring better care to their patients and ultimately again to cut cost in this rising medical area that now represents some 16% to 17% of our gross domestic product. I want to thank Kristine Rapp who is Vice President of Global Ethics & Compliance at Hospira. This has certainly been educational at something that the whole medical profession has to deal with and improve on. I am Dr. Morris Pickard and you have been listening to the clinicians’ roundtable on ReachMD XM157, the channel for medical professionals. So listen to our on demand library, visit us at ReachMD.com. If you have comments or suggestions, call us at 888MD XM157. Thank you for listening.
You have been listening to public health policy in America, a special ReachMD XM157 interview series with our nation’s top thought leaders in public health. This month ReachMD XM157 will be discussing the many issues challenging public health policy in America. For a complete scheduled guests and programming information, visit us at ReachMD.com.
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While relationships are changing between physicians and pharmaceutical companies, doctors still need pharma to provide direction with comparative drug efficacy, among other things. Kristine Rapp, vice president of global ethics and compliance at Hospira, Inc., speaks about the need for continuing medical education and other learning tools to be presented with impartiality and fairness. Dr. Maurice Pickard hosts.
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