Tom Wilson, owner of Cape Apothecary in Annapolis, works in… (Lloyd Fox, Baltimore Sun )
Technicians at the Cape Apothecary compounding pharmacy in Annapolis spend their days mixing drugs that are no longer sold commercially or creating specialized batches of medicine for patients such as children who can't handle the normal dose.
Federal officials have linked a compounding pharmacy in New England to a multistate outbreak of meningitis that has infected 119 people, including eight in Maryland. The owner of Cape Apothecary said there is a big difference between his storefront drugstore and the New England Compounding Center in Framingham, Mass.: size.
"What bothers me about the whole situation up there is volume," said owner Tom Wilson, who has run his pharmacy for more than two decades. "You are talking thousands and thousands of vials that were made and that is huge. We make 20 at a time here."
Wilson and others said that as the compounding pharmacy industry has evolved from mom-and-pop businesses into large facilities that act more like drug manufacturers, it has created an environment ripe for contaminations such as the one that has sickened people across 10 states with the rare fungal meningitis. Eleven people have died, including one in Maryland.
The outbreak has spurred calls for stronger regulation of the pharmacies, which are monitored and licensed by state boards, unlike drug manufacturers, who are under the jurisdiction of the Food and Drug Administration.
"They serve a need. They do good work," said Allen Vaida, executive vice president at the Institute For Safe Medication Practices, of compounding pharmacies. "But many of them are getting outside the traditional realm and serving more as a manufacturer and there is no real oversight."
Two members of Congress from Connecticut, where the outbreak was first detected, have sent letters to the FDA asking for stronger federal oversight of large compounding pharmacies that sell large batches of medicines for use in clinics and other medical facilities.
"I believe this outbreak and corresponding recall make clear that strong federal authority is needed over these large-scale compounding pharmacies to ensure that patients receive safe and effective drugs," wrote Rep. Rosa DeLauro, a Democrat, who said she plans to introduce legislation on the issue.
Others agree that if the pharmacies are going to act like drug manufacturers they should be regulated the same way. Under federal jurisdiction, compounding pharmacies would have to follow good manufacturing practices and be subject to stricter inspections, said Linda D. Bentley, an attorney with Mintz Levin in Boston who specializes in FDA regulatory issues.
"The line between what would qualify as a compounding pharmacy and what is large-scale commercial manufacturing is not clear," Bentley said. "There is no clear regulation of these kinds of entities and they kind of fall into a crack."
The FDA passed regulations in 1997 to give the agency better oversight of compounding, but a 2002 Supreme Court decision invalidated those rules.
Vaida, Bentley and others worry that the state boards do not have the resources to properly monitor these pharmacies as they become bigger, leaving room for missteps. Different states have different standards.
In Maryland, a pharmacy board licenses facilities and inspects them once a year, like any other pharmacy. State law also requires the facilities to meet some of the guidelines under the U.S. Pharmacopeial Convention, a voluntary group that sets drug safety standards.
Compounding centers make drugs that cannot be found commercially. Drug shortages have added to the demand for and growth of these facilities as doctors seek commonly used, but unavailable drugs.
Traditional compound pharmacies work on a small scale, filling prescription requests for individuals.
Larger facilities like New England Compounding Center have grown in recent years. These companies make doses in large batches, sending them to outpatient centers and clinics where patients don't need a prescription.
New England Compounding Center sent boxes of the steroid-filled vials to clinics around the country where doctors injected them into the spinal cords of patients looking to ease back pain. Federal officials ordered a recall of the steroid drugs. The pharmacy voluntarily recalled every other drug it made and closed.
The type of methylprednisolone acetate steroid at the center of the meningitis outbreak was preservative-free, unlike what is sold commercially and typically used by doctors. Clinicians injected the steroid directly into patients' spinal cords, which cannot metabolize preservatives.
Cape Apothecary's Wilson said he has many safety precautions in place to prevent drug contamination. Sterile drugs are made in a clean room that is blocked off from the rest of the facility. Within the clean room drugs are made inside a sterile area called a laminar flow hood.