President's Message - A Better Formulary

Often it is easy to predict that a newly approved drug will end up a best seller. Sometimes the new medication fills a vacant niche in the marketplace, or is easier to use, or safer, or, once in a while, has better efficacy. Deep pockets in the marketing department can help as well! Aren't there times though that you wonder, “How in the world did THAT medication ever get on the formulary?” There are a couple of simple rules you can apply, so that those “how in the world” statements don't end up applying to your formulary. The best part of these rules is that I believe your Formulary Committee will be very agreeable to adopting these measures. 

Don't you think that if a new product costs significantly more money it should provide a clinical benefit over the more established product? If a new medication costs significantly more money, we should require the advocate of this medication to provide high-level evidence of meaningful improvements in safety, administration, or efficacy. By meaningful I mean benefits that are both clinically and statistically significant. Simply put, if a new medication is more costly, it should be better! Can anyone really argue against this rule? 

Keep in mind those terms like novel compound, unique mechanism of action, higher Anti Xa-Anti IIa ratios are NOT examples of clinical benefits. Novel compound only really establishes a new drug as a possible alternative for patients who are intolerant to, or have failed to respond to, established and proven therapies. Findings based on animal models, human cell cultures, laboratory analyses, observational studies and even expert opinions may not provide evidence of meaningful benefit. 

Be Wary of Placebo Trials 

If the evidence of meaningful benefit is provided only by placebo controlled clinical trials, it is time to take a closer look at the patients in these studies. Keep in mind there is a very good chance that patients in this trial are much healthier and very unlike the patients who you intend to treat with medications. After all, there would be a MAJOR ethical problem if all patients in a placebo trial are in need of active treatment. In order to qualify for a placebo study, it is very likely the patients would not meet your criteria as a clinician to initiate treatment. As a result, it is unlikely these studies can be applied to your patients. 

Restrict by Indication rather than Service 

Restrictions by service are very common in pharmacy, particularly for antimicrobials. For example, a new super antibiotic may end up added to the restricted formulary – restricted to infectious diseases. Restriction by service has worked out very well, especially if your goal is to limit use. However, restricting by service can mean that you and your colleagues have to reject medications ordered by the primary care team (which often includes pharmacists), who know the patient the best. When the time comes to defend a formulary decision, and I have had to do this a lot in my career, defending by indication provides a much stronger argument than defending by service. It also fits in better with the goal of your formulary, which is to promote the use of superior medications, and limit the use of inferior medications to specified situations. Restrictions by indication also support an evidence-based practice, as off-label uses that also lack high-level evidence for efficacy and safety will not survive the formulary process. 

By applying these four simple rules, you could end up with a Better Formulary and never have to ask, “How in the world did THAT medication ever get on the formulary?”