President's Message - Doing the Right Thing

by Mike Fotis, ICHP President
April 3, 2014

Pharmacists are particularly adept when it comes to figuring out the most efficient ways to do things. It seems like whenever I introduced a new policy or practice to my pharmacy department colleagues, there would be dozen of suggestions for a very efficient way to get this new job done. Most of these suggestions were offered before I was even close to finishing the introduction! It is so easy to start out with the intention to do the right thing and end up instead doing the most efficient thing. I think as pharmacists we need to be alert to this tendency and always keep our guard up. 

One way to protect against the tendency to do the most efficient thing is to build in a bias in favor of pushing the envelope rather than in favor of maintaining the status quo. After all, how safe is the status quo? Can we best secure our future by protecting the status quo, or instead by having a focus on protecting our patients? If our focus was to push the envelope to protect patients, would we have looked differently at recent healthcare initiatives such as the Risk Evaluation and Mitigation Strategies (REMS) developed by the FDA; at Medication Reconciliation Strategies promoted by The Joint Commission (TJC); or even medication teaching? The REMS program proposed by FDA was an opportunity for pharmacists to take the initiative to enhance medication safety and not intended to be just another bureaucratic obstacle to efficiency. Asking a patient to sign a register to verify they don’t want to speak to a pharmacist doesn’t achieve any goals to educate patients about their medications. Of course, time is often used to justify why certain processes were put into place. However, did we stop to consider the risk we were taking by not enhancing our responsibilities instead of substituting with processes aimed only at increasing efficiency? What did it cost us in terms of our future by maintaining the status quo? 

ASHP based the recent Pharmacy Practice Model Initiative (PPMI) around 7 basic goals. The first goal is “Every Patient Deserves a Pharmacist”, and the 7th and final goal is “The Pharmacist is First Responsible to the Patient”. Keeping these two goals in mind can go a long way toward guiding us to Do the Right Thing. 

Let’s apply this discussion to sterile manufacturing, which I define as using non-sterile products in the preparation of a medication to be delivered by injection. Our first question is often, “What is the stability of this preparation?” However, determining whether the preparation is stable or not does not mean we are doing the right thing. Using a medication that is intended for oral or topical patient administration to prepare a product for parenteral patient administration is about as far “off-label” as a medication use can be…unless we include a chemical in this compounded parenteral preparation that is not even approved for human consumption. In this case, the issue is far beyond that of simple off-label use. I think a REMS strategy that all of us should insist on is a process that begins with the assumption that all such medications are NOT on our formulary, whether we have determined if they can be used to compound a stable preparation or not. I believe that any proponent of adding a preparation for injection that starts with non-sterile compounds needs to present his/her rationale including evidence of efficacy and safety to the Pharmacy and Therapeutics (P&T) Committee. The P&T Committee should determine if there is sufficient evidence to support adding this preparation to the formulary. As a final step, before we dispense such a product, we need to determine if the intended patient has a compelling indication to use this preparation. That is, have conservative measures and FDA approved treatments been tried and failed or are there contraindications for using FDA approved treatments in this patient before using the newly compounded preparation? After all, a pharmacist is first responsible to the patient, and I think any of the families of patients who developed central nervous system infections from contaminated compounded IV preparations would prefer that we take these measures very seriously. 

My final thought: What can students and pharmacy residents do? My suggestions: 1) Support ICHP in our efforts to push the envelope and to Do the Right Thing. 2) Choose your first job very carefully. It is so important to work at a site that is dedicated to pushing the envelope and believes that we are first responsible to our patients. It is true that these jobs are more demanding, but the cost of maintaining the status quo is too high. 3) Finally, learn about Practice Based Learning (PBL). Because after completing school or your residency, that is exactly what you should be doing. Work out your own plan for continuous professional development in conjunction with ICHP to be successful. 

Pushing the envelope involves risk, which is scary. Maintaining the status quo for the rest of your career is even scarier.

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