Last month, eight people in Florida were charged in a massive insurance fraud scheme that ran into the hundreds of millions of dollars.
A number of
compounding pharmacies in the Tampa Bay and Miami areas were found to be
submitting fraudulent reimbursement claims and covering them up with
bribes and kickbacks; experts believe that thousands of consumers had
their personal information misused in the scheme. All of this comes as a
key federal agency is considering stricter oversight of the growing—and
dangerously under-regulated—field of compounding pharmacies in the
United States.
Compounding is a practice in which a pharmacist or physician
combines, mixes, or alters ingredients of a drug to create a medication
tailored to the needs of an individual patient, according to the Food and Drug Administration (FDA).
Compounding allows changes in medications to avoid allergies or other
adverse reactions, or to convert dosage (such as from a pill to a
liquid) one patient at a time. Or at least it used to be. Large-scale
compounding pharmacies today are acting as quasi drug manufacturers, and
the industry has grown in recent years. With that growth, problems of
health and safety for consumers have increased as well. These aren’t
corner drug stores any more, where trusted neighborhood pharmacists
prepare individualized compounds for regular customers. Compounding has
been taken over by behemoth facilities churning out thousands of
compound medications. And as we’ve found out in recent years, these
compounders need far greater oversight.
In 2012, this
captured national attention when contaminated steroid injections
prepared by a major compounding pharmacy in Massachusetts caused a
multi-state outbreak of fungal meningitis. Sixty-four patients died, 800
were sickened, and the 14,000+ patients who had received the injections
lived in a state of fear. Following the outbreak, consumers and
legislators called for stricter regulations. The National Consumers
League (NCL), which has spent more than 100 years defending the rights
of consumers to safe and effective medications, was a vocal advocate of
strengthened oversight and safeguards for patients using compounding
medications. While some of the regulations were tightened up,
compounding pharmacies still lack adequate oversight, and the explosion
of these pharmacies has left regulators playing catch-up.
In May, more
than 7,300 patients at a San Diego-area hospital “may have been exposed
to infection from contaminated medications last year,” which was “traced
to the compounding pharmacy lab at Paradise Valley Hospital in National
City, California,” according to Kaiser Health News. In 2012, 43 patients developed fungal eye infections
linked to contaminated sterile ophthalmic drug products shipped from a
compounding pharmacy in Ocala, Florida; at least 29 of these patients
suffered partial-to-severe vision loss. Unfortunately, the list goes on
and on.
One of the
primary concerns is that compounded drugs are not FDA-approved. The FDA
does not verify the safety or effectiveness of compounded drugs, which
also lack an FDA finding of manufacturing quality before they are
marketed. It is state boards of pharmacy that have primary
responsibility for the day-to-day oversight of state-licensed pharmacies
that compound drugs, and state boards often have limited resources to
regulate their licensees. A recent study by the Pew Charitable Trusts
found an alarming disparity in how states regulate compounding
pharmacies, including that only half of the states require the
compounding pharmacies that make sterile medications (those that are
injected or ingested into the body) to fully comply with recognized
quality standards. Meanwhile, 60 percent of states do not even require
compounding pharmacies to report serious adverse drug events and
reactions related to sterile compounding.
The FDA has the
authority to act when compounding pharmacies break the law, and the
agency typically responds when it receives reports of problems or
adverse events, but consumers shouldn’t be expected to wait for bad
actors to injure or kill people before their right to safe,
uncompromised medications are enforced. The FDA and state boards of
pharmacy must have the ability to inspect pharmacy records, ensure that
quality standards are upheld, and track facilities as they engage in
drug compounding. As with all things, this takes money, and the FDA and
state agencies have too long been underfunded in many of their oversight
roles.
The FDA has
issued draft guidance to address some of these issues and, while that
guidance is encouraging, I believe we need to do far more to protect
consumers who depend on the integrity of the medications they are
prescribed. One immediate and significant step forward would be
compulsory reporting of adverse events as they happen for compounding
pharmacies. Oversight and enforcement lead to better safety and security
for patients and their families. We don’t have that right now, and,
without it, we remain in the untenable position of putting patients at
unreasonable risk.
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