6 Fall 2014 | IACPRx.org THE NEW REALITY by Pat Stephens, Pharm.D., IACP President Think about the continuum of care. That’s been all the rage in the pharmacy literature in the past few years. A patient is admitted to a hospital where their medications are changed to match the formulary of the institution. New treatments are added; old ones discontinued; doses are modified. When it comes time to be discharged, the patient is sent home with a stack of paper containing instructions, what to do and not do, and, of course, a sheaf of prescriptions. Sometimes a discharge planner or nurse explains the medications, sometimes not. Then the patient arrives at their local pharmacy and depends upon the pharmacist to help sort out their new, old, changed, revised drug therapy regimen with their regular doctor. At any point along that continuum, things can and do break down. Information isn’t conveyed correctly. A new medication is added without clearly discontinuing a previous therapy. The hospital formulary product isn’t covered by the patient’s prescription benefit plan, and yet another change in product selection is made. Specialists and hospitalists don’t coordinate care with the generalist. Poor communication, disconnect between care settings, and a lack of understanding all contribute to the one thing that should never happen: a patient suffers. How does that apply to compounding? Quite simply, our continuum has been disrupted. And both patients and compounders are suffering. Starting with the NECC tragedy in October 2012, compounding has been in a state of uncertainty and upheaval. In the past two years, there have been more than 138 pieces of state legislation offered to regulate compounding with an even greater number of new regulations and rules developed by Boards of Pharmacy grappling to prevent an NECC in their own state. At the federal level, the Food and Drug Administration began inspecting pharmacy practices using manufacturing standards and publicizing those inspections to show Congress and the media “we’re doing something.” And, of course, Congress enacted the Drug Quality and Security Act which reaffirmed the 17-year old and judicially contested section 503A while at the same time adding an entirely new entity into the marketplace, the 503B outsourcing facility. Things we used to do as compounders, things we took for granted, things we understood… all of that has changed. Information has been conflicting – a state says one thing, the federal government says another. Something as simple as the selection of an API as the basis of a compound is even in question… Does it have a monograph? Is it on a list? Where is the list? Providing care to patients, something that is second-nature to all pharmacists, is fraught with uncertainty… can I provide an office-use medication to their doctor? What if they’re located in another state? What does the MOU allow me to do? What is an MOU? The new reality of compounding is that nothing is clear any longer. Just like a patient being discharged from a hospital, we have to step back, look at what happened before, look at what happened while we were in the midst of the change, and then think carefully “what should our future look like?”
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