I am hearing this phrase with greater frequency from nurses in conversations and on various discussion forums. I have recently heard about a specific practice recommendation from a manufacturer that could increase patient risk. Although the “recommendation” was made in an effort to improve patient safety, the outcome of the recommended practice would increase product sales and could cause harm, in my opinion, and is not evidence-based. When I hear about these conversation or recommendations, my question is always, “Have you seen the same information in the printed literature supplied by the manufacturer?” This printed information is considered product labeling and must meet the guidelines from the FDA.
Most sales representatives are working to help solve your problems, but we must keep in mind that they also have other motivations for various statements – specifically their personal annual income. They have a built-in motivation for making the statements that you hear. There are sales training classes using role-playing exercises to learn key phrases and ways to explain specific aspects of a product, along with financial incentives to sell certain products. Most manufacturers have training departments that work hard to educate sales staff about what they can and cannot say, but the individual may not always adhere to their training when trying to sell a product to your facility. For anyone making a decision about any aspect of clinical practice, it is our responsibility to base product decisions on solid evidence. Where is this evidence found? First, look at published standards of practice (e.g., Infusion Nurses Society, Oncology Nursing Society, etc.) and guidelines (e.g., Centers for Disease Control, Society for Healthcare Epidemiology of America, etc.). Look at the date of publication on those documents. If those documents are aging, then you will need to go to more recent studies published in peer-reviewed journals to see if there is new information. Literature from a manufacturer is a valuable resource as well, especially the instructions or directions for use that accompanies all devices. Do the verbal statements from the sales representative match this literature? The claims allowed by the company are addressed in this literature along with other supporting white papers and sales materials. Look at the references on these pieces. How old are the quoted studies? Also, remember that a white paper is written for marketing purposes and has not been through any blinded peer-reviewed process. Do these resources quote presentations or posters from conferences? These are also lacking any type of blinded peer-review process. Relying exclusively on verbal information from a local sales representative is not adequate for product decisions or practice questions about a specific product. The sales representatives job is to sell product. While most are concerned about clinical outcomes, they do not have the same perspective as clinical decision-makers. All claims made in a conversation must be supported by sound clinical evidence. There can easily be a situation with new devices where this evidence from clinical studies is not yet available. I would recommend benchmarking your practice against what is being done in other healthcare facilities or posting a question to colleagues on an online discussion forum instead of total reliance on this verbal information from a sales situation.
Rita Spano
7/22/2015 11:37:17 am
In cases where evidence is not yet available, Clinicians can choose to become independent investigators for data generation purposes related to a particular product or technology they are considering. Many medical device and pharmaceutical manufacturers have Investigator-Sponsored Study (ISS) programs in place to support independent research aimed at studying their products or disease processes of interest to them. Independent research funding opportunities may be available by contacting the manufacturers Clinical Affairs Department or Research Review Boards. The research proposal submission process is independent of the sales function of the organization. 7/30/2015 12:09:13 am
Thanks Rita. I am not in the research world so often forget about these valuable resources for clinical research made available by the manufacturer. The research proposal would still go thru the hospital IRB and the manufacturer has not input into the process or its outcomes. Thanks for posting this reminder.
Brenda Howe, MSN-NE, RN
7/24/2015 10:35:43 am
Lynn - this article is so "right on." For years I worked in multispecialty clinics. The sales representatives were multitudinous to the point the doctors put a cap on how many would be allowed into the department per day. 7/30/2015 12:08:39 am
Thanks Brenda. This is not only about sales reps talking to prescribers. Most devices are sold through communication with nurses making product decisions. One example was years ago when one brand of needleless connectors was placed inside a CVAD insertion kit and those sales reps were instructing inserters that this needleless connector never had to be changed! As you mentioned, it applies to drugs and device sales reps. Comments are closed.
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Author: Lynn HadawayLynn Hadaway is an international thought leader in infusion therapy and vascular access, having been in this practice for more than 40 years. Her experience comes from hospital-based infusion teams, device manufacturers, and continuing education services. Her journal and textbook publications are extensive. She also maintains board certification in infusion nursing (CRNI) and nursing professional development (RN-BC). Categories
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