Compounding pharmacies started as small mom-and-pop stores that mixed hard-to-find medications for local doctors and their patients who had allergies, difficulty swallowing, or otherwise could not take mass-produced drugs.
But amid growing drug shortages in the pharmaceutical industry, some large compounders such as the New England Compounding Center stepped in and expanded their business far beyond the industry’s homespun roots.
The Framingham company, whose products are implicated in a nationwide outbreak of fungal meningitis that sickened more people Friday, listed dozens of products online and apparently took thousands of orders from doctors, clinics, and hospitals in at least 23 states, a transformation that regulators have not kept pace with, critics and even some industry executives said.
“A question still has to be answered: Who the heck at the government level was asleep at the switch?’’ said David G. Miller, executive vice president of the International Academy of Compounding Pharmacists.
The outbreak starkly illustrates the yawning gap in oversight, said Allen Vaida, executive vice president of the Institute for Safe Medication Practices, a Pennsylvania-based advocacy and research organization. The US Food and Drug Administration is supposed to regulate compounding companies that ship their products to many providers, a practice known as outsourcing, while state pharmacy boards monitor the small mom-and-pop operations. But the rules are too vague to delineate when a compounder crosses that line, he said.
“The state boards of pharmacies are not equipped financially or with the knowledge to really inspect these types of operations,” Vaida said.
Federal and state health officials are investigating the outbreak of a rare and severe type of meningitis caused by fungus known as aspergillus and exserohilum. The number of people sickened Friday grew to 47 in seven states, including five who died from the infection, which attacks the brain and spinal cord, the US Centers for Disease Control and Prevention reported. Patients with lower back pain received injections of a steroid made by New England Compounding Center. Contaminants injected into the spine can easily travel to the brain.
The CDC and FDA said Friday that the investigation into the cause of the outbreak is ongoing. But the FDA found a sealed vial of the injectable steroid, called methylprednisolone acetate, contaminated with fungus at New England Compounding. The agency is testing the sample further to determine the species of the fungus. Foreign material could easily be seen floating in other vials found at the company, FDA officials said.
Infected patients received drugs from three lots of methylprednisolone acetate, containing 17,676 one-dose vials that the company shipped to providers in 23 states. The CDC listed those 75 providers on its website Friday.
New England Compounding has recalled about 35 products it prepares for injection in and around the spine, according to a list on the FDA website. Federal and state health officials have also urged doctors, clinics, and hospitals to stop using all products made by the company.
Health agencies are imploring caregivers to immediately track down patients who received injections from the three potentially contaminated lots and monitor them for symptoms, including fever, new or worsening headache, nausea, and numbness and slurred speech similar to a stroke.
This is hardly the first time that problems with compounding companies have resulted in widespread infections. At least 33 patients in seven states contracted fungal eye infections from products mixed at a Florida pharmacy, federal officials said in May. And there have been numerous other instances of compounding-related illnesses.
According to Miller, the number of pharmacies that specialize in compounding has grown from 5,000 three years ago to more than 7,500. Of those, 3,000 provide compounding for drugs that need to remain sterile, such as those that are inhaled and injected.
Patient safety advocates have long urged officials to strengthen federal oversight of compounding companies. In testimony before a congressional committee nine years ago, Sarah Sellers, executive director of the Center for Pharmaceutical Safety, said it was ironic that officials were so focused on regulating imported drugs while the country had “within our own borders a flourishing, unregulated [compounding] industry that manufactures, markets, and sells substandard products throughout the US.”Continued...