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    NECC and Future of Compounding Pharmacy

    Compounding pharmacist's case hinged on whether he was "willfully indifferent."

     

    NECC and the Future of Compounding Pharmacy

    In the five years since the outbreak, compounding pharmacists have had to brace for a new normal of greater public scrutiny by government and the media.

    In response to the case, the FDA has stepped up regulations and inspections of pharmacies, especially in light of embarrassment in its handling of the NECC case. It was later shown, through both media and Congressional investigation, that FDA was aware of the problems at the NECC, and many argued that it did not act strongly enough on those accusations.

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    John Voliva, RPh, Executive Vice President of the International Academy of Compounding Pharmacists (IACP), told Drug Topics that “The tragic results of the NECC situation undermined the fundamentals of pharmacy.”

    John VolivaJohn VolivaThe FDA and Massachusetts Board of Pharmacy, according to Voliva and many other members of the media, “had clear authority to investigate and take action that would have stopped the operations at New England Compounding Center, and both had been informed of problems there. Neither did.”

    “The NECC tragedy provided more evidence that an increase in the communication and coordination between the FDA and the State Boards of Pharmacy was vital,” said Voliva.

    This extra scrutiny and regulation came at a cost, however. The Drug Quality and Security Act (DQSA), enacted in 2013, uses language that shows, according to Voliva, “Congressional intent to increase communication between the State Boards of Pharmacy and FDA.” However, Voliva and the IACP believe that the DQSA “does not square with Congressional intent.” “In addition, the IACP believes some elements of DQSA have restricted compounding pharmacists’ ability to serve patients and prescribers.”

    Related article: FDA temporarily shutters ‘filthy’ compounding pharmacy

    Voliva stressed that the IACP is working with lawmakers on several issues, including office-use compoundng and FDA inspections. It is important, he said, to remember that, while patient safety is of utmost importance, regulations also need to be respectful of patients’ ability to access medications. “With drug shortages continuing to increase and skyrocketing prescription drug prices,” said Voliva, “compounding of medications preserves access to vital medications that patients often cannot get elsewhere.”

    It is hoped that the increased regulation and scrutiny will win back public trust by making compounding pharmacies and pharmacists safer. Hasson argues that in the future, there will likely be fewer of these kinds of cases, because stricter regulations are removing “bad actors,” since the risks of neglecting safety protocols will outweigh the rewards.

    Additionally, pharmacists will now have a better defense against these kinds of cases, because increased regulation means an increased chance for pharmacists to demonstrate compliance or “good faith.”

    “Our profession continues to work with leaders from across the federal and state governments to make sure that what happened at NECC never happens again,” Voliva said.

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