The shuttering of Teva’s long troubled manufacturing facility in Irvine, California, may create shortages of up to 24 generic sterile injectable drugs, including five essential medications of which the company supplied more than 15% of the market last year, according to an industry group.
The End Drug Shortages Alliance (EDSA), which launched in November, recently concluded (PDF) that medicines made at the plant to treat cancer, adult and pediatric diabetes and pancreatic neuroendocrine tumors are susceptible to shortages.
Of the drugs made at the facility—which Teva shuttered in October—EDSA said the most vulnerable to shortages are likely to be the vasodilator alprostadil, antibiotic amikacin and chemotherapy drugs bleomycin, dacarbazine, idarubicin, ifosfamide, mitoxantrone, streptozocin and topotecan along with the hormone octreotide used to treat the symptoms of intestinal tumors.
Other injectables made at the facility but less likely to face shortages are adenosine, daunorubicin, desmopressin, epoprostenol and more.
“We are surfacing the information and amplifying it so that all industry stakeholders are aware and can prepare for an unanticipated disruption,” Terri Lyle Wilson, director of pharmacy, supply chain services for Children’s Hospital Association and vice chair for the EDSA, said in a statement. “Information shared in this report highlights the level of transparency that is required across the supply chain to successfully navigate drug shortages.”
The group urges drug manufactures to look at boosting production of the affected drugs. It advises wholesalers keep enough supplies in storage to ensure the medications are available.
Additionally, the EDSA is calling on the FDA to expedite approval of all applications for drugs affected by the plant closure or allow for the importation of those drugs, especially in the case of treatments without an alternative, such as streptozocin to treat pancreatic cancer.
Teva halted operations at the facility in response to FDA concerns about contamination issues at the facility that triggered the recall earlier in the year of 2.5 million vials of drugs used to treat cancer, arthritis, schizophrenia and a muscle relaxer used during intubation.
An FDA inspection in July last year found the company hadn't repaired water damage at the site and failed to maintain procedures to keep factory workers from spreading mold and bacteria. The regulatory agency also said Teva failed to make sure equipment it installed more than two decades ago to test for sterility and harmful organisms worked properly.
Issues with the Irvine facility go as far back as 2009 when the company issued a voluntary plant shutdown in the wake of a large recall of the anesthetic drug propofol after the FDA found problems with raw material testing, batch failure investigations, equipment cleaning and sanitizing and record keeping.