The U.S. must address the lax rules and oversight over compounding pharmacies, one of which has been linked to a deadly meningitis outbreak.
You get what you pay for. This maxim is proving true all over again when it comes to steroid injections used to alleviateback pain. Making safe and effective versions of such drugs involves manufacturing steps that aren't trivial. The cost of the medicine has to match the care that goes into creating it and the oversight required to ensure that the standards are maintained.
Since September, about 250 people have been sickened and 19 have died after getting steroid injections for back pain. They came down with a rare form of fungal meningitis that has been traced to tainted vials of the steroid shots. The injections have been linked to a compounding pharmacy in Massachusetts.
Compounding pharmacies are licensed by states, typically with little oversight by the federal Food and Drug Administration. They are supposed to exist to create customized drugs to fit the unique needs of individual patients. They are called upon to fill a prescription for a specialized dose of a drug or to provide patients with a customized medicine that is not produced by the big drug companies. Compounding pharmacies that do their job well fill an important role in clinical medicine.
The Food and Drug Administration has "guidance" in place regarding compounding pharmacies: These businesses cannot mass produce drugs or widely distribute them across state lines unless the shipments are fulfilling prescriptions doctors wrote for individual patients. But the agency doesn't have the funds or personnel to enforce the rules. The compounding pharmacy implicated in the meningitis outbreak has recalled more than 17,000 individual vials of injectable steroid that were sent to 23 states, and it had been warned about unsafe manufacturing conditions in the past.
Lax rules and oversight mean that ...
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