Drug shortages loom from hurricane-impaired manufacturing in Puerto Rico
Damaged Baxter plants on the island make large portion of saline products, already in short supply
Small, fluid-filled bags known as “minibags” have been in short supply for years. Now, hospitals are feeling even more compromised from the shortage ever since production at Baxter facilities in Puerto Rico was hampered in September by hurricane Maria.
“Clearly this has a huge impact on hospitals as well as home infusion pharmacies and infusion centers since many medications given by the I.V. route are mixed into these bags and given by infusion,” said Matthew Grissinger, RPh, from the Institute for Safe Medication Practices (ISMP).
Baxter International makes a significant portion of I.V. solution products for the U.S. market. The most severe shortages are being felt with small-volume parenteral solutions, such as the 50 and 100 milliliter minibags of sodium chloride 0.9%, dextrose 5%, and I.V. nutritional products made by Baxter, according to the American Hospital Association (AHA).
As this article went to press, the American Society of Health-System Pharmacists (ASHP) had been hearing from both large and small hospitals alike that they only had a 1- to 2-week supply of small-volume parenteral solutions left. ASHP has been working around the clock to identify solutions and strategies for facilities.
FDA has also been actively involved, and is monitoring a list of about 30 critical drug products that are either manufactured solely or primarily in Puerto Rico. Of those 30 drugs, 14 are sole-source products, meaning there are no alternatives available. FDA was not able to provide the exact list of medications it’s monitoring.
According to written testimony made by FDA commissioner Scott Gottlieb during an October Congressional hearing, about 8% of the medications Americans consume (based on the dollar value of pharmaceuticals) are manufactured in Puerto Rico, including blood fraction products, cardiovascular drugs, and treatments for cancer and HIV. More than 80 pharmaceutical companies have facilities on the island.
To mitigate the shortage of I.V. solution products, FDA is doing something that it rarely does: import products from overseas plants. In this case, FDA is allowing temporary importation of an alternative supply of sodium chloride 0.9% injection bags, dextrose 5% injection bags, and metronidazole injection into the U.S. from Baxter facilities in Ireland, Australia, Mexico, and Canada.
Deborah Pasko, PharmD, ASHP’s director of medication safety and quality, said there has been no release date or date of delivery for these shipments, however.
“At this point, everyone is running short, so the importation will not alleviate the issue until the products can actually be delivered to hospitals—and this time frame remains elusive,” she said.
FDA said it undergoes a complex process of review when it imports drugs from overseas. This includes evaluating the overseas formulation, labeling, and other attributes as well as the quality of the manufacturing sites. Any differences from the approved version are outlined in a letter shipped with the drug and posted on FDA’s website.
In instances where U.S. approved firms don’t have supplies from additional sites to redirect to the U.S. market, FDA said it is able to work with regulatory counterparts in countries such as Canada, Australia, and the European Union on potential, temporary drug sources. In fact, the agency has done this on 37 different occasions in the past 7 years.
In addition, FDA said it is working with other U.S. companies who make I.V. saline solution products, and the agency will also expedite review of any new product applications that will assist with the shortage.
Baxter has sent multiple “Dear Customer” letters indicating what drugs are manufactured in Puerto Rico and may be running low soon. However, drug manufacturers are under no mandate to notify FDA, although they are encouraged to do so. In a recent letter to a Congressional subcommittee, ASHP, AHA and other organizations urged Congress to examine how the pharmaceutical industry communicates information about what drugs are manufactured at which plants and where those plants are located.
For the full article, please visit www.pharmacytoday.org for the December 2017 issue of Pharmacy Today.
Where can pharmacists go to get updates and guidance on a current drug shortage?
ASHP has posted all known information from the manufacturers, Utah’s Drug Information Center, and FDA: www.ashp.org/shortages
ASHP has guidance documents: “Small-Volume Parenteral Solutions Shortages, Suggestions for Management and Conservation guidance. It’s also available on FDA’s main drug shortage page: www.fda.gov/Drugs/DrugSafety/DrugShortages
Pharmacists can contact ASHP’s Center for Medication Safety and Quality at firstname.lastname@example.org with questions.