Welcome to ParagonRx

Optimizing Physician Prescribing Productivity

Gary Slatko, Chief Medical Officer, Paragon Rx, explains how to improve effectiveness, safety and performance in the pharmaceutical and biotech industry.

NGP. What is the main cause of product performance gaps for pharmaceutical and biotech companies?

GS. The safety, efficacy, and benefit of any medication or device are dependent upon the care that is delivered with the product. Optimal product performance requires administering it to the right patient, at the right time, with the right methods. Clinicians know that the care they deliver in their practice may vary significantly from the care delivered within the protocols of clinical trials - they express this when they say: "Clinical trial results don't reflect the 'real' world".

We often find that companies focus on promoting a product's efficacy, safety, and benefits in comparison to those of other products. Although this is necessary, it is insufficient because it fails to address a more fundamental question in the clinician's mind: "How do I use it"? Until this question is answered, the product's benefits may be of secondary importance, and repeating benefit messages about "why" does not overcome the unanswered questions about "how".

NGP. How do you help the industry improve effectiveness, safety, and value of medications?

GS. The key is to get all clinicians to administer products with the same care delivery techniques as the experts.

Every brand manager can identify the small number of practicing clinicians who proficiently and productively use their products. If all clinicians prescribed their product as proficiently as the "experts", more products would be used by more patients in the right way. ParagonRx uses proprietary methods to identify the techniques, tools, and procedures that expert clinicians have innovated to proficiently use a specific medication or product. These techniques make product prescribing less imposing, and by teaching the less experienced doctors the insights of their more experienced mentors, we help them avoid trial and error and instead give them a positive early experience with use.

NGP. What is particularly challenging about pharmaceutical brands that have been associated with serious and/or frequent adverse events? How do you respond to this challenge?

GS. Physicians, who are trained to do no harm, are often already aware of potential product risks. The challenge for the brand is to acknowledge and address the risk in a way that gives physicians confidence that harm will not occur. Speaking about risks is counter-intuitive to the company's "benefit messaging" mindset. This mismatch between a clinician's concern about product risks and a manufacturer's hesitancy to proactively offer a benefit/risk discussion results in a non-productive interaction between sales representatives and physicians. The sales representative attempts to prove to the physician why they should use the product in more patients, meanwhile, a physicians who is dabbling in the use of a product often responds, "I support your product and I am using it in all of my appropriate patients". The term "appropriate" reflects the unspoken position of the physician: "Given the limited experience or confidence that I have using the product in my hands, I'm using all that is appropriate for me." We respond to this challenge by offering the techniques, tools and procedures that minimize the risks of product use. Now sales representatives can engage in benefit/risk discussions confidently because they have solutions to the "do no harm" questions of physicians.

In some cases, physicians need even more intensive interventions to assure they employ safe medication practices. These "risk management programs" need to be carefully designed so that they are both practical and implementable by practioners, instead of interrupting care.

NGP. What are typical risk management issues and how do you help the industry deal with them?

GS. The important issues are either clinical or strategic in nature. Clinically, the real issues relate to how the process of use can fail and lead to serious adverse events. Common failures include:

Improper patient selection

Inadequate counselling

Not getting baseline lab tests

Co-prescribing with interacting medications

Patient non-compliance with instructions

Not monitoring adequately for the occurrence of adverse events

Strategically, the real issues arise from misaligned objectives among various functions within the manufacturer, for example:

Conceding to risk management programs to obtain regulatory agency approval

Avoiding programs that burden the customer and may hinder product adoption

Providing recommendations that guide appropriate use and minimize adverse events

ParagonRx addresses these issues simultaneously by using two parallel methods. This first, failure mode and effects analysis (FMEA), assures the program addresses the underlying clinical causes of adverse events. The second, based on ethnography, identifies field-tested techniques that assure the program is pragmatic and perceived by clinicians to be helpful.

The result is a program that not only minimizes risk but also supports proficient prescribing and use.