A Breakdown in Quality: Fungal Meningitis and Pharmaceutical Compounding

For the past few weeks, there have been numerous headlines discussing the rising death toll from Fungal Meningitis due to products provided by New England Compounding Center (NECC), a compounding pharmacy.  Legislators and the public are demanding that the FDA respond to how this could happen, how to control the outbreak and how to keep this from happening again.  The FDA and CDC are leading the federal investigation, yet neither has regulatory authority over pharmacies – that authority falls to the Board of Pharmacy departments within each state. Historically, pharmacists have been compounders of active and inert ingredients under the direction of physicians to assist individual patients.  NECC seemingly took advantage of the lack of regulatory oversight, and they mass-produced and sold compounded copies of existing licensed drugs across state lines at a discounted price over the approved branded pharmaceutical products.

This was a “perfect storm” of events that ended with deadly results.  Because of current cost pressures, hospitals and healthcare providers jumped at the chance to pay less for drugs to be administered.  A pharmaceutical company that went through their due diligence to have a drug approved, with all the required quality procedures in manufacturing in place, declared bankruptcy because they could not compete with the compounder.  Allegedly, a group of opportunists took advantage of the lack of oversight of pharmaceutical compounders.  They looked less like a pharmacy and more like a pharmaceutical manufacturer but without the oversight of a quality unit or quality system that would have assured the sterility, efficacy and safety required of licensed pharmaceutical companies.  The result is that there are over 20 known dead and hundreds seriously ill due to the lack of quality in what was essentially a manufacturing process.  NECC has recalled all of their products sold and closed their doors.  To date, no arrests have been made.

There are tens of thousands of legitimate pharmacists who occasionally compound a pharmaceutical product not available as a commercially approved product; this is not an indictment of their practices.  However, there are still scores of “pharmaceutical compounders” that are mass-producing and selling copies of approved products and/or products that have not gone through any New Drug Approval (NDA) process.  These companies need to be identified and regulated the same as the pharmaceutical companies they attempt to simulate.

While this should be a wake-up call to hospitals and healthcare providers to avoid cutting corners and looking for ways not to pay for approved products, it should also be a call to the pharmaceutical industry.  Today, more than 80% of the ingredients used to make pharmaceuticals used in the U.S. originated someplace offshore.  Pharmaceutical companies are outsourcing clinical trials, manufacturing and distribution where they used to control such processes within their four walls.  If their label is on the product, they are ultimately responsible for the quality of the product provided to market.  Companies need to make sure they have quality processes and testing in place before product is released to market.  They need to assure that their suppliers and contractors are following the same Good Laboratory Practices (GLP), Good Clinical Practices (GCP) and Good Manufacturing Practices (GMP) that they themselves follow within their organization.  They need to trust, yet verify, that their suppliers are following these practices as well as document and correct any issues that may be found.

While some pharmaceutical companies may have implemented internal quality management systems that have provided quality and trustworthy products for years, there is inherent danger in the changing ways of a supplier-based business.  Communication and recording of quality issues has reverted to manual modes of communication.  Instead of following a prescribed, repeatable and verifiable process within an automated, electronic quality system, quality issues with suppliers are often performed via phone calls, faxes and correspondence.  Serious quality issues can fall between the cracks in this decentralized and personalized way of communicating. 

In order to provide safe, quality products to consumers, pharmaceutical companies and those that act like pharma companies,  need to plan for the future and build systems that provide the same visibility and transparency with their suppliers that they have built within their own organizations.

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