Q&A: Adopting New Therapies
Q: A few days ago a colleague of mine asked an interesting question. The physicians in his practice had their regular journal club and reviewed a series of articles on age adjusted d-dimer values and feedback was positive. Most were in agreement that the new scale was clinically appropriate but the group would not unanimously agree to use it. There was concern regarding malpractice risk, and potential risk to patients and they could not reach consensus.
So, he asked an interesting question. How do you create an atmosphere where some physicians may elect to use the age adjusted d-dimer scale and others may use the single value cut off, all with departmental approval. He did not want to push the director to write an ED policy but he was seeking some method to include the new test interpretation in the local standard of care. He wanted each member of the group to have the freedom to use either value scale. So, what’s the necessary approach?
A: There are three categories of potential new therapies : new medications, new diagnostic tests (lab and imaging), and new procedures. Here is a method of adoption for each:
Medication requires evidence and volume of interest from the community. Interest may come from specialists or EM physicians, and typically each have their share of early adopters. However, in this scenario, the pharmacy and therapeutics committee of the hospital is the official gatekeeper. So, if approved by P&T you may elect to use it at your discretion and no policy allowing it is necessary. Malpractice risk is reduced by the committee’s approval of the medication for the intended use.
Procedures also require the same interest and evidence. These are adopted at varying intervals (early, middle, and late) and their use as an early adopter requires some kind of review. A new surgical procedure for example, can not be undertaken without oversight. Typically a hospital credentialling committee approves the procedure for use based on patient outcomes, physician training, and privileging. Early adoption receives malpractice coverage by the nature of a governing body’s review AND patient consent.
Diagnostics are slightly different. In this case the use of a new scale for the d-dimer can be approached one of three ways. 1) A short ED policy, pathway, or guideline could be written stating that age adjusted d-dimer use is acceptable and approved and at the discretion of the physician. 2) Every lab has a medical director (typically a pathologist) who is in charge of signing off on the reported normal range of values based on manufacturer recommendations and evidence. You could ask that direcor to review the evidence and consider adding the age adjusted d-diner scale to the normal values. That would allow each physician to use either scale. 3) You could just let everyone do what they want without anything specific in writing. Options 1+2 make for a good risk management position. Option 3 forces the physician to rely solely on articles without anything to call upon as a local standard or consensus, therefore I don’t recommend it from a risk standpoint.
So, consider a more standardized approach to adopting new therapies. It doesn’t have to be exhaustive, but a little pre-planning goes a long way in giving your physicians some back up.