Spanning the Treatment Gap

While education is a cornerstone of any clinical practice, sales teams often fall short of informing doctors and other healthcare professionals how to successfully integrate new therapies into patient care.

As early as the 1960s, Upjohn began to use other field-based medical personnel to fill in the gaps. Historically, these programs have been characterized by small groups of technically oriented sales reps, and have leveraged relationships with thought leaders, ultimately influencing prescribing. As a result, many physicians see these field-based medical personnel as an extension of the sales force.

The pharma industry still employs medical experts to call on professionals. Today, however, the background and medical expertise of these medical liaisons is very different from the original concept. A recent survey found that 66 percent of pharma companies require medical liaisons to hold an MD, PhD, or Pharm.D degree. With that knowledge base, field-based medical support programs can play a more powerful role in bridging the education gap between drug information and appropriate clinical use. We found this to be particularly true in diabetes, where many practices fail to incorporate new, effective treatments into patient care.

Diabetes Educators

In 1917, Elliott Joslin, the first US diabetes physician-specialist, noted that, "A well trained nurse was of more value than the patient's doctors." Joslin recognized that for patients with diabetes to make the behavioral changes to manage their condition, they needed information from healthcare professionals who were specially trained to teach them.

In the early 1980s, following NIH funding for diabetes research and training centers, and the adoption of national standards for diabetes education, a professional subspecialty emerged. The goal of these diabetes educators was to inform patients about the disease process, train them in self-care, and to support patients in lifestyle modifications and behavioral changes. Diabetes educators may be nurses, dietitians, pharmacists, or other health professionals, and very often function within a larger, multidisciplinary team. The educator assesses patient needs, communicates treatment recommendations to prescribers, and serves as an advocate for patients. They may also adjust medication and carry out other disease management activities, depending on licensure guidelines and other clinical practice protocols.

Patients that receive this disease education have lower costs of care, fewer emergency room visits, and an improved quality of life. According to a 2002 study published in Diabetes Care, for every 23.6 hours of contact with a diabetes educator, A1C (hemoglobin A1C, a measure of glucose control over the preceding 2–3 months) decreased 1 percent, which corresponds to a decrease in average blood glucose of 35 mg/dl.

DCLs and the Translation Gap

The pharma industry should appreciate the influence of diabetes educators when it comes to the uptake of novel therapeutics. They are a particularly important target to help translate research findings regarding novel therapies into safe and effective clinical care practices.

To help in the translation and support the launch of an injectable adjunct therapy to insulin for patients with type 1 and type 2 diabetes, Amylin created its Diabetes Clinical Liaison (DCL) program in 2001. The initial team was comprised of seven registered nurses or dietitians, all of whom were Certified Diabetes Educators. (The team was later expanded to 15 field members.) With an average of 15 years of diabetes-specific experience as well as additional expertise in clinical management, clinical research, and education, these DCLs were able to discuss the science, clinical impact, and use of the drug with healthcare professionals.

Amylin deployed DCLs to complement the medical science liaison team, with whom they worked in tandem. While MSLs focused on educating and cultivating KOL advocacy among physicians, DCLs focused on providing scientific and medical education to members of multidisciplinary diabetes care teams, with particular focus on diabetes educators and diabetes center staff. The primary objectives of DCLs were to ensure that these healthcare professionals gained clinical understanding of the therapy and understood how to integrate it into patients' regimens. They educated clinicians about when and how to use the drug, how to interpret therapeutic results, and what information to give patients—which promoted a better understanding of the drug and skills patients needed to safely employ this unique therapeutic. DCLs also supported KOL efforts among diabetes educators, and provided local, broad-based education to the clinical care community.

Evolving Role

Today, Amylin employs these field-based medical professionals in a much broader way. For example, DCLs now work not just with diabetes educators, but with primary care physicians, who play a major role in handling the growing burden of diabetes. The strong clinical background of DCLs qualifies them to address ongoing educational needs and thus enhance patient care in the primary care setting.

Additionally, as the corporate business has expanded, the DCL team has been tasked with expanding its reach beyond diabetes. Diabetes Clinical Liaisons are now called Clinical Management Liaisons, emphasizing the team's experience in direct patient care and reflecting the team's expanded role.

Positive Evaluation

Evaluating the objective impact of the DCL team—and indeed any field-based medical team—is challenging. Unlike the traditional sales force, there are no standard metrics, such as prescriptions, office calls, or dinner programs, to analyze. Indeed, for this team, the "customers" have been largely non-prescribers.

Instead, the success of medical teams is generally defined by their ability to appropriately educate thought leaders—their customers—on the science and support their efforts to educate their peers and patients. However, certain evaluation strategies can still be employed. For example, Amylin conducted surveys to evaluate three key measures of the DCL team's success, including 1) the transfer of information, 2) the reach of the KOL in educating others, and 3) feedback from the KOL and internal corporate customers regarding the effectiveness of the services provided. Based on these measurements, DCLs proved that they provided positive impact.

While clearly distinct from their commercial colleagues in the field, the synergy between the medical teams' activities is critical to the successful integration of a new therapy. After all, for novel therapies to be prescribed, clinicians must understand the science behind the compound, as well as the practical considerations of utilizing such a therapy.

Gayle Lorenzi is a director of medical affairs, Amylin Pharmaceuticals. She can be reached at gayle.lorenzi@amylin.com

Barbara Schreiner is the senior clinical education specialist, Amylin Pharmaceuticals. She can be reached at barb.schreiner@amylin.com

Jimmy Black, Pharm.D, is the senior regional director, Field Medical Team, Amylin Pharmaceuticals. He can be reached at Jimmy.Black@amylin.com>