DECEMBER 7, 2012 BY LEAVE A COMMENT
As an owner of a compounding pharmacy I have been closely monitoring the media coverage about the meningitis outbreak from medications prepared at the New England Compounding Center (NECC) in Massachusetts. While my heart goes out to the families affected, I implore you to not lump all compounders together. We are not like NECC.
Our compounding pharmacy is PCAB accredited, and we take great care to ensure the quality of every compound we prepare, as do many other pharmacies across the nation. Compounders fill an important void in our healthcare system; if we were not able to prepare customized medications for our patients it would jeopardize the health of millions of people.
Because of the severity of the issue, I understand the need for lawmakers to “fix” the problem, but it is imperative that we avoid knee jerk reactions. A familiar old saying comes to mind, ‘don’t throw the baby out with the bathwater’. In other words, it is imperative that we fully assess the situation to gain an understanding of what went wrong and why. Once all the issues are identified, we must then address them to prevent another tragedy like this from occurring.
Federal regulators are offering up all kinds of suggestions to fix the problem. We’ve heard they may create a pre-approval process for any pharmacy that prepares medication in anticipation of an order. In other words, they don’t want us to have anything pre-made and ready for the patient. Any idea how long it would take the federal government to respond to a pharmacy’s pre-approval application? There have been major drug shortages this year, I hate to think how many patients would have been adversely affected if compounders were not able to quickly respond and help fill in the supply gaps.
We have adequate regulations in place, we just need to assess where the current system failed and fix that. Each State Board of Pharmacy is the most appropriate body to regulate compounding pharmacies. They are capable and willing to handle routine pharmacy inspections and disciplinary actions if needed. However, we must guarantee that the budgets for the State Boards remain intact in order for them to meet the demands of regulating all pharmacies. We cannot allow their budgets to be cut, and then accuse them of not doing their job.
Additionally, we already have excellent Standard Operating Procedures. They are the same procedures we use every day in our practice. All compounding pharmacies should be operating according to the United States Pharmacopeia standards outlined in Chapters 795 and 797 and/or abiding by the Pharmacy Compounding Accreditation Board (PCAB) standards. These should be used for the basis of all inspections of compounding pharmacies.
In VA we have knowledgeable and helpful inspectors who do visit us regularly. If that is not happening in every state then let’s start there. Every Board of Pharmacy should have representation of a compounding pharmacist either on their Board or on a sub-committee to tap when compounding issues arise. All State Boards should be inspecting routinely using USP and/or PCAB standards. Set expectations for the Boards of Pharmacy, provide the necessary resources, determine appropriate accountability measures for the Boards, and let them do their jobs.
In desperate times it seems we always look to place blame and point fingers, but that does not take care of the problem. Yes, I agree people or agencies should be held accountable, but wouldn’t it be more productive to work together towards a solution instead of complaining and blaming each other?
About Cheri Garvin
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