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Reflections on the NECC Compounding Tragedy

Nov 05, 2012

Paul W. Abramowitz, Pharm.D., Sc.D. (Hon.), FASHP

I, LIKE MOST OF YOU, CONTINUE TO FOLLOW the news out of Framingham, Mass., as more is learned about the operations at the New England Compounding Center (NECC).

What investigators are finding—unsatisfactory conditions, shipping of product before the results of sterility testing were known, and inattention to other known safeguards—deeply upsets me. These types of practices are totally unacceptable anywhere, at any time. The patients who relied on these medications deserved much better, and our sympathies go out to all of the affected patients and their families. But condolences cannot begin to replace their losses. Enhanced safeguards must be put into place so that this does not happen again.

Having said this, however, it’s important to note that I am also concerned that compounding by pharmacists—a practice that is essential to patient care—may be broadly called into question. Compounding and pharmacy are inextricably linked.

From preparing a topical cream to the complex processes involved in preparing sterile products, compounding happens every day in every hospital and health system. What happened at NECC does not reflect the professionalism and commitment to patients provided by pharmacists throughout the country. We cannot allow what happened there to shape the public perception of a critical element of patient care.

ASHP has a long history of pushing for the highest standards for compounding and sterile product preparation in hospitals. In the early 1990s, we began publishing practice recommendations in AJHP. We published the “ASHP Technical Assistance Bulletin on Quality Assurance for Pharmacy-Prepared Sterile Products (TAB)” in 1993. The TAB established the three-tier risk assessment structure that was later adapted by USP for use in the <797> standards for sterile compounding. Our guidelines on outsourcing sterile compounding services urge pharmacy departments to conduct due diligence when outsourcing compounding services.

It is essential for the safety of all patients that all pharmacies that compound medications, regardless of the setting, adhere to the very highest standards. In addition, state boards of pharmacy will need additional resources to provide strict oversight of compounding pharmacies and provide more transparency.  And when companies cross the line from compounding to manufacturing, there needs to be enhanced coordination between state boards and the U.S. Food and Drug Administration (FDA) to ensure that the necessary regulatory scrutiny is applied.

We know the important role that compounding plays in patient care, but we have a fair amount of work to do to restore the public’s trust after this tragic event. As hospital and health-system pharmacists, we have always taken the lead in medication safety in our practice settings, ensuring that our patients can always depend upon us. ASHP pledges to work diligently to restore that trust and to help prevent a tragic and unfortunate event like this from ever happening again.

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  • More regulation is not needed. Better regation is. Compounding is not manufacturing, or at least it should not be. This distinction is at the crux of the current tragedy.

  • Therese Staublin

    I think as the smoke clears that it will be important to take a step back and ask the question “Why are pharmacies buying from compounding companies and from sterile compounding centers?”
    My first thoughts are:
    1. Better dating on 797 high risk sterile products. Few hospitals have class 7 clean rooms.
    2. Shortages (repackaging minimizes waste, compounding pharmacy is another source of scarce resources). How did we get to the point where we have to ration furosemide and sodium bicarbonate or buy from a compounder? How many FTEs should a hospital devote to managing shortages?
    3. Manufacturer doesn’t supply the drug in the appropriate packaging (because it’s a non-approved use or because the old NDA was for a MDV or some other inappropriate size. A new drug given once a week, Makena, was released in a multidose vial. Fentanyl and HYDROmorphone PCA’s have to be prepared on site with short dating)
    4. Manufacturer doesn’t supply the drug because it’s not approved. (GA cardioplegia solutions)

    Some pharmacies purchased sterile combination products from a compounder because it was considered safer than having caregivers prepare the combination at the bedside in non-sterile conditions and with chance for calculation or preparation error. Purchasing product with extended dating allowed medication dispensing to be controlled by automated dispensing machine and allowed individual doses to be bar coded for bar code administration.

    Pharmacies receive requests/demands from prescribers to supply products mentioned in the literature and expect the hospital pharmacy to be able to supply the product mentioned in the study.

    Obviously, pharmacies will buy from manufacturers rather than compounding companies if they can.

    What are the factors that were not only driving the development of compounding pharmacies but also making it profitable?

    To stop at asking how we make compounding pharmacies safer is not enough. We need to dig deeper and ask why, why, why.

  • Johanne Andersen

    Compounding and pharmacy are inextricably linked!
    I am encouraged by your statement, and your willingness to argue that compounding should continue to exist — and thrive.
    I am writing to you because I am a pharmacist working in the Center for Clinical and Translational Sciences (CCTS) at Rockefeller University. I do regular compounding, as well as some high risk compounding, but only high-risk compounding that is used right away. I outsource when the compounded material can be stored for a longer period of time. While regulation and oversight of some aspect of compounding no doubt need an overhaul, I fear that it could go too far and would hurt small (research) pharmacies like ours, who strictly compound for research purposes. I find that our current regulations with respect to the compounding process suffice; the problems in Massachusetts did not happen because there were no regulations, rather the regulations were not enforced. Yet, with the development of mega-compounding pharmacies that advertise and sell drugs over the internet, there clearly need to be a clearer definition of what constitutes compounding and when it becomes manufacturing.
    What happened at NECC was not due to lack of regulations but rather a lack of following these regulations by the pharmacy and a lack of oversight by the State Board of Pharmacy and a Federal Government that hesitated to exert its right to inspect. Many people share the blame, but nobody can argue that the regulations were inadequate.

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  • David Goedde

    I see two issues that no one wants to address. First, the FDA impact on creating significant drug shortages. Next, hospitals that refuse to provide 797 compliant areas and regulatory agencies that overlook this issue. The tragic event that has taken 35 lives is only a symtom of the bigger problem.

  • Joseph Lam

    I totally agree with the comments of Therese Staublin. I am a clinical pharmacist working in the government hospital. There are many rationing and shortages of crucial medications like sodium bicarbonate, furosemide, magnesium sulfate, calcium gluconate, etc. It is ironically that oral forms of these meds are fine. Obviously, this is not the problems of availability of raw materials. Since meds like sodium bicarbonate has not acceptable alternative, the only resort we can use is to order it from compounding pharmacy.
    1. How come compounding pharmacy can compound these meds and generic manufacturers cannot? I don’t know. Money? Regulations?

    2. How come those clinics need to order methylprednisolone from these compounding pharmacies instead of ordering the commercially available preparations? Is it again due to the shortage problem? Again, how come it is acceptable for compounding pharmacies to prepare med from raw materials but not the manufacturers? Regulation? Money?

    3. When I follow the news about fungal meningitis cases on the other websites, like Yahoo, Google for general public, nobody has ever raised these questions. Again, thanks to Therese Staublin, she was the very first one having this perspective on this issue.

    4. All the pharmacy associations stay to far back behind the scene. ASHP, CSHP, and other pharmacy associations, I don’t know what you guys have done. Please speak up. This is the time the pharmacists need to speak up, express our professional opinions. Let our voices be heard. I’m so upset that none of the pharmacy associations has expressed the professional opinions to the general public. We should know the most. Look at this website here, nothing except this small column talks about this very very very important issue to pharmacy. Please compare this website with the website of New England Journal of Medicine. They have been following the issue all along. They have detailed analysis of this issue. What about here? What about other pharmacists’ websites?

    4. Please have a detailed and formal analysis of this issue. I honestly don’t understand what are the regulations are there for these compounding pharmacies. When doctors or nurses ask me what guides I use when choosing the compounding pharmacies, I have nothing to say. Please help,.