FDA Tackles Drug Shortages
October 30, 2011
Posted by chcablogadmin in : Cost Reduction, Group Purchasing, Industry Trends, Quality
by John VanEeckhout, Pharm.D., Vice President, Clinical Services, CHCA
On Sept. 26, I participated as part of a panel discussion for the Drug Shortage Workshop presented by the FDA Center for Drug Evaluation and Research. The objectives of the workshop were to update the status of drug shortages in the U.S. including trends over time and a discussion of the impact on patients and the health care system; describe the FDA’s role in and regulatory authority related to drug shortages; hear perspectives from the health care sector, patient representatives and the industry, and seek perspectives on solutions to alleviate or prevent drug shortages.
As part of the professional group panel offering recommendations, I shared the particular vulnerability of our children’s hospital patients — pediatric dose substitutions and different strengths; severity of medication errors on vulnerable patient population, and higher use of injectables to name a few. In addition, I outlined our specific drug shortages — hematology and oncology, electrolytes and trace elements used in TPNs for neonates and nutritionally at risk patients; specialized agents for diagnostic procedures such as intravenous Arginine, and controlled substances such as Morphine and Fentanyl in small dose forms to avoid overdoses. I shared our efforts to date to diminish the effects of the shortages such as close contact among pharmacy personnel, vendors, buyer groups and directors. We’ve also worked with Premier on education about the risks and costs associated with gray marketers.
Among our CHCA recommendations:
- Improve communications to end users and distributors of pending and existing drug shortages;
- Allocate remaining supplies by drug wholesalers or directly by the manufacturer;
- Create CDC-like, federally controlled repositories of critically needed drugs similar to pandemic and disaster supplies now in place;
- Review the effects of Regulatory Action by FDA with drug manufacturers; and
- Provide an incentive/stimulus to drug manufacturers by federal, state or local entities to maintain and improve or build new factories for manufacturing critical drugs in the U.S.
The FDA stated they would take more accountability and vowed to be much more effective in the future. They cited 100 drug shortages prevented by FDA intervention. For several of the drugs in limited supply, five vendors are expanding their plants in the next three to four years. Three tactics outlined are as follows:
- Better communication among vendors, distributors, hospitals and the FDA about shortages;
- Asking vendors to know who they are selling to, to avoid gray marketers or problems with drug pedigree; and
- Protecting the supply chain particularly for the most vulnerable patients, e.g. oncology, small unit production, low volume and high expense drugs.
Children’s hospitals were also represented as part of a ASHP Drug Shortages Summit Regulatory-Legislative Work Group by Michael P. Link, M.D., President-elect of the American Society of Clinical Oncology and a pediatric oncologist at Lucile Packard Children’s Hospital at Stanford.
The CHCA Pharmacy Team is working on multiple fronts to counter drug shortage issues including legislative efforts, advance warnings and connecting available supplies to Owner Hospitals with an acute shortage of a drug product or unusually high demand. Specifically, we are working with partners on the following efforts:
- Premier Pharmacy Drug Shortage group for latest updates on their activities on supply availability and failure to supply refunds;
- Contracted Pharma vendors who can supply small quantities of short supply drugs for critical needs of patients e.g. chemotherapy treatments or other treatment regimens;
- CHCA Pharmacy Buyers and CHCA Pharmacy Directors who through networking and utilization of various legitimate drug wholesalers, expedite supplies of drug to their colleagues location in need of the drug in short supply; and
- Advocacy efforts through Healthcare Supply Chain Association (HSCA), HSCA Pharmacy Committee and Premier, and by talking directly to key decision makers on Capitol Hill.
Recently, I discussed drug shortages and their impact on children’s hospitals with Sen. Herb Kohl’s (D-WI) legislative aides and the Chief Investigator of the Special Committee on Aging. They are very interested in the gray market issues that have become a source of concern in our industry. I am supplying them information on gray market sources and examples of solicitation of our Owner Hospitals.
We are also in discussions with our current vendors to determine if we have any looming shortage issues we may not be aware of at this time. This is especially vital concerning drugs for special needs that are truly small market products.
Please contact me with any questions. (john.vaneeckhout@chca.com).
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