OPINION:
Contrary to what most Americans think, the drugs they’re prescribed at doctors’ offices and in hospitals are not all made in a carefully regulated, scrupulously maintained factory that meets the highest standards of drug safety.
A lot of the drugs are made in compounding pharmacies. Two or more drugs are bound together with various agents and prescribed to an often-unknowing public. Mixing drugs could create their own problems for patients, the ingredients used to mix them could create problems of their own, and although the Food and Drug Administration (FDA) certifies the individual drugs that go into the compounded formulas, it does not require these mixed drugs be tested for safety, effectiveness or quality.
To keep us safe, the FDA relies on a law that few understand and fewer observe and on market forces — news that drugs failed in one location curtailing sales in others. The FDA rarely inspects compounding pharmacies, and it when it does, years can pass before it penalizes or shuts down compounders that make and sell potentially dangerous products.
In short, the system doesn’t work. Every year, patients suffer unnecessary injuries or death that can be traced to the use in medical procedures of unsanitary, super-potent, or inappropriately prepared products made by compounding pharmacies — many of which are administered without patients’ knowledge or consent.
In 2012, 64 people died and 751 fell ill from meningitis from compounded steroids made at the New England Compounding Center in Framingham, Mass. From 2013 to 2017, a compounding pharmacy in Indiana mislabeled the dosage of drugs, exposing infants to “super potent” doses of morphine and midazolam.
In the Indiana case, two executives were charged with, among other things, sending their compound drugs out to be tested but distributing them for use before the results came back. The company also was accused of providing morphine sulfate that was 25 times stronger than its label indicated. One baby who received these drugs had to be transported to a children’s hospital for care after the incident.
In Dallas in 2017, nearly 70 patients went partially or completely blind after cataract surgery during which their eyes were injected with a compounded steroid–antibiotic liquid that was contaminated.
The companies sometimes are punished. Executives in the Massachusetts and Indiana cases were charged with second-degree murder after patients died, and other compounders have faced multimillion-dollar lawsuits against the physicians and facilities, some resulting in financial penalties and loss of physicians’ medical licenses.
But the lax enforcement remains a problem. The hospital in Indiana alerted Pharmakon Pharmaceuticals, the compounding company that produced the dangerous drugs, after an employee noticed syringes with conflicting labels. But for two months, the complaint against the firm stated, Pharmakon knew about the flawed drugs but did nothing to correct the problem.
The liability problem is not insignificant. Not only do drug manufacturers face problems if their products don’t work properly, but hospitals, doctors and other providers find themselves in trouble as well.
Given the dangers to patients and providers, lax enforcement and, in most cases, availability of safer alternatives, why is compounding so widely used? In short, because federal health policy, especially Medicare policy, encourages it.
In the Dallas case, for instance, patients were blinded because providers chose a cost-saving substitute for FDA-approved drugs. Cataract surgery patients are largely Medicare beneficiaries, and, when it comes to reimbursement, the Centers for Medicare and Medicaid Services (CMS) puts drugs administered to patients during surgeries as surgical supplies, such as gloves, gauze or sutures.
This means hospitals sometimes can save big by going with compounded drugs rather than FDA-approved drugs that are proven to work.
The FDA could fix this by ensuring physicians and patients have ready access to solutions they can have confidence in. CMS should pay for at least one member of a class of drugs with any distinct FDA-approved indication — instead of relegating patients to less safe and often less effective compounded products.
Compounded products have a role, but the reasons they are used should be medical and not financial. That’s not what’s happening now, and Americans are suffering needlessly as a result.
• Brian McNicoll, a freelance writer based in Alexandria, Va., is a former senior writer for The Heritage Foundation and former director of communications for the House Committee on Oversight and Government Reform.
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