The New England Compounding Center (NECC) is tied up in a federal investigation with the Federal Drug Administration (FDA) and the Center of Disease Control (CDC) because authorities believe a steroid solution prepared by the compounding pharmacy was contaminated with fungus and injected into as many as 14,000 people nationwide.
An injection that was originally intended to relieve pain infected more than 460 people, primarily with fungal meningitis, and resulted in more than 30 fatalities to date. Legislators wasted no time around the election demanding the FDA respond to and control the outbreak, freeing the supplies from the contaminated ingredients.
The FDA and CDC are leading the federal investigation, yet neither have regulatory authority over the pharmacies involved. The Board of Pharmacy departments within each state are charged with creating a task force to study the issue and make recommendations.
There are thousands of legitimate pharmacists who compound pharmaceutical products that are not available as a standalone, approved product. This is not an indictment of their practice, however, there are still scores of ‘pharmaceutical compounders’ that are mass-producing and selling copies of approved products that have not gone through any New Drug Approval (NDA) processes. These companies need to be identified and regulated the same way as the pharmaceutical companies they attempt to mimic.
While this should be a wake-up call to hospitals and healthcare providers to avoid cutting corners by purchasing products that are not approved by the FDA, it should also be a call to the pharmaceutical industry. Pharmaceutical companies are outsourcing clinical trials, manufacturing and distribution where they used to control such processes within their four walls.
With more than 80 percent of the ingredients used to make pharmaceuticals in the U.S. originating offshore, pharmaceutical companies 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). Name brand or generic, if their label is on the product, the pharmaceutical company is responsible for the quality and effectiveness that label promises to consumers, and compounded drugs should be held to the same standards.
The pharmaceutical industry must align its business processes with the world of quality. Extended supply chains create serious lags and risks when reporting product issues, consumer complaints and discrepancies in performance. The more diverse the supply chain, the greater the chance for inconsistencies.
Although pharmaceutical companies have relied on internal quality management systems to provide safe and trustworthy products for years, there is an inherent danger in the changing ways of a supplier-based business.
Instead of following a prescribed, repeatable and verifiable process within an automated, electronic quality system, reported issues with suppliers are often performed over the phone, or via fax and email. These outdated methods and siloed ways of communicating do not provide the data needed to meet regulations.
How can pharmaceutical companies work better with suppliers? Pharmaceutical companies can extend their enterprise and enforce processes to track and manage the qualification and approval process for new potential suppliers. This approach will help avoid redundant evaluations by maintaining complete records of all previous suppliers.
The globalized supply chain and the inability to recall unsafe drugs is a result of the lack of transparency between pharmaceutical companies and their supply chains.
How do we know exactly what’s in the medicine prescribed to us?
In order to provide safe, quality products to consumers, pharmaceutical 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. The FDA and EMA expect that companies have proof of the quality systems approach within their supply chain.
The FDA holds pharmaceutical companies to the highest standards, and the same practices need to be adopted by suppliers. This approach also needs to be enforced by compounding pharmacies that are mirroring pharmaceutical companies’ efforts, and Congress is looking to give FDA the authority to regulate compounders.
Enforcing quality management practices within the pharmaceutical industry and their suppliers can reduce the risk of product deviations and other quality incidents by ensuring supplier non-conformances are addressed before using the materials in the product. Quality management software can increase supplier selection efficiency by eliminating redundant evaluations across departments using a standardized, centralized supplier evaluation process. The ultimate goal is for the industry to have systems in place that allow them to trust their supply chain, assure the safety of products brought to market as well as creating efficiencies.
KR Karu is the industry solution director for Sparta Systems’ product management group. In this role, Karu manages the relationships with some of the company’s largest pharmaceutical customers, helping them track and better understand ongoing regulatory changes and trends in the industry. He can be reached at firstname.lastname@example.org.