Drug shortages, such as those involving saline solution and the antibiotic piperacillin/tazobactam that are currently challenging hospitals, represent a complex problem that affects the ability of hospitals and other healthcare providers to treat their most vulnerable patients. Though recent actions by government and industry stakeholders have led to reductions in new drug shortages, many ongoing shortages persist and represent a real public health threat.
The U.S. Food and Drug Administration (PDF) and the Government Accountability Office (PDF) both recently conducted analyses and found that the root causes of drug shortages are manufacturing problems, quality issues and barriers to getting new suppliers online when supply is disrupted.
Recent disruptions in the supply of saline, for example, can be attributed to limited production capacity, as well as compliance with existing FDA inspection requirements. The agency continues to use regulatory discretion to allow the importation of saline from two manufacturing sites in Europe, but supplies remain tight and on allocation by all U.S. suppliers. Further complicating an already difficult supply situation, quality issues have led to several voluntary recalls, including one that involved 600,000 bags of saline.
The FDA identified several actions in its strategic plan (PDF) in fall 2013 that could help mitigate drug shortages like these, including a rule requiring drug and biotechnology companies to notify the FDA when potential disruptions to the medical supply of important drugs arise. Similarly, the 2014 GAO report (PDF) suggested the FDA develop policies to certify accuracy of data in the existing drug shortages database and also recommended that they agency conduct periodic analyses of the database to help discover risk factors for potential shortages.
By virtue of their unique position in the supply chain, healthcare group purchasing organizations have been able to help hospitals and other long-term providers anticipate and mitigate the impact of drug shortages.
For example, GPOs have tracked data on drug shortages. When a possible area for supply-chain disruption has been pinpointed, they have strategized with their hospital members on solutions. GPOs subsequently communicated with manufacturers and distributors to inform them of these gaps and worked with all sides to mitigate them. The companies also have helped hospitals and healthcare providers source and safely migrate to alternate products when shortages arise.
For the saline shortage, GPOs have recommended that their hospital partners use alternative IV solutions or smaller volume containers where patient situations allow. As for the short supply of piperacillin/tazobactam, GPOs have provided supportive drug information to their members advising therapeutic alternatives as they do with all drug shortages. GPOs have employed these and other strategies as long as drug shortages have affected hospitals and patients.
Also, GPOs have offered flexible contracting. This means all hospitals are free to purchase products either through their GPO or off-contract through a wholesaler or manufacturer, as they frequently do. This gives healthcare providers multiple options in sourcing prescription drugs and other materials.
Still, more needs to be done to limit drug shortages. In addition to the FDA's proposed plan and the GAO's recommendations, the FDA should enact several other policies to counteract product shortages.
First, it should standardize manufacturing metrics across the country and provide clear guidance on what the agency will be reviewing during manufacturer inspections. The FDA should also publish trends on a quarterly basis of how manufacturers are faring based upon these standardized metrics.
Another step the FDA should take is fast-tracking potential generic drugs into markets experiencing shortages or price spikes. To further enhance its practices in this area, the FDA needs to improve its communication across its various divisions, which will make the agency more responsive to drug shortages.
Clearly there is no quick fix to this complex problem, yet all stakeholders in the supply chain are committed to reducing and isolating future drug shortages and maintaining a safe and reliable supply of products.
Curtis Rooney is president of the Healthcare Supply Chain Association, a trade group representing healthcare group purchasing organizations.