They wanted to know the types and quantity of medications that compounding pharmacies prepared and dispensed, and how many such pharmacies existed across the country.
There was limited data about the industry then.
While much has changed in six years, including a federal law, strengthened state regulations, and far greater standards, one thing remains absolutely the same: a dearth of data about this practice, which prepares customized medications when patients have a need that cannot be met by an off-the-shelf medication or when their medication is not commercially available.
When Congress first looked at the industry, right after NECC and before enacting the Drug Quality and Security Act (DQSA), trade groups said that between 1 percent and 3 percent of all prescriptions dispensed in the U.S. were compounded medications. Those trade groups say the same thing today.
Similarly, no entity – federal or state government, trade association or industry monitor – knows how many compounded pharmacies exist in the U.S. today, or, of those, how many produce sterile medications (those that are generally injected into the body), or how many are non-sterile, meaning they produce capsules, gels and creams.
This data gap will narrow over time as state boards of pharmacy increasingly require compounding pharmacies to be identified and certified or licensed. But we should not have to wait for the states to finish this process.
Why Does Nobody Know the Numbers?
It is actually not hard to understand why there is little collective data on the industry. For one thing, the regulatory landscape is fractured.
When Congress passed the DQSA in November 2013, it created two categories of compounders. The first group, called 503A compounders (after the section of the Federal Food, Drug and Cosmetic Act), were the traditional compounding pharmacies regulated by state boards of pharmacy. Some are sterile and others are non-sterile, but all fill patient-specific prescriptions.
The 503B “outsourcers” are large-scale sterile compounders that are regulated by the Food and Drug Administration and must comply with current Good Manufacturing Practices or cGMP. They are, in essence, manufacturers of compounded medications.
The active ingredients that compounders use are FDA-approved, just like commercially manufactured drugs. The finished compounded product, however, does not get individual FDA approval; for that reason, the same coding and tracking process used by manufacturers is not used by compounders. There is, therefore, no centralized database that tracks compounded medications and their use.
Manufactured, FDA-approved drugs have National Drug Code – or NDC – numbers that enable meticulous tracking, such as the quantity of drugs dispensed by pharmacy or prescribed by a practitioner. For instance, Pfizer manufactures the cholesterol-lowering drug Lipitor, and it knows exactly how many units are dispensed, the pharmacies dispensing them and, of course, the prescribers writing the prescriptions. Yes, it uses this data to guide its marketing efforts, but the data also provides vital information for population health.
That level of detail does not exist with compounded medications.
Why Does it Even Matter?
This substantial gap in data is affecting our health care system. Scientists developing cures for serious diseases must contend with this gap in data and it impairs their abilities. For example, for some rare diseases, compounded medications are the only option. As researchers look at eliminating these diseases, they need to understand the compounds that have been dispensed for those suffering from these illnesses and, even more important, their efficacy. They could learn more that might enable them to develop cures if they had the data.
Compounders create myriad formulations by prescribers seeking an individualized medication and/or dosage to treat a disease or condition. It would be useful to know what formulations have been used to treat which conditions and, of course, how effective they have been. Physicians prescribing a particular compounded medication often have read in medical journals of its successful use in other cases; if a database existed, more uses could be shared and more patients helped.
In addition to potential patients, the lack of data also does a disservice to the compounding pharmacy community, because the public never sees the full benefit provided by this profession.
The federal government could help solve the problem by allocating the funds to study the industry and, once and for all, empowering an agency – the National Institutes of Health is perfectly suited for this task – to create a meaningful and relevant database of compounded medications.
Such a move would have a near-term benefit for Americans, particularly those fighting a disease, and it would bring this vital and important profession into the mainstream.
Ernest P. Gates, Jr., R.Ph, is president and CEO of Gates Healthcare Associates, a national pharmaceutical and healthcare consulting firm based in Massachusetts.
