Some people swear by compounding pharmacies, which prepare personalized medications for patients, including bioidentical hormones for menopausal women. But they have had a disturbing safety record—the wrong doses in many cases and, in one case, a manufacturing error that killed dozens of people.
Fortunately, there are ways to make sure a compounding pharmacy is safer. If you are planning to use one—or are already using one—read on to learn how to protect yourself.
WHAT DO COMPOUNDING PHARMACIES DO?
These specialized pharmacies can take a nasty-tasting medicine for a kid and make it palatable…provide a customized dose of a medication that you can’t get from a standard pharmacist…and prepare a prescription medication without allergenic ingredients. Most notably, though, they are famous for offering bioidentical hormones that millions of menopausal women rely on, rather than standard prescription hormone therapy such as Premarin. Naturopathic and integrative physicians often prescribe customized bioidentical hormone preparations for their patients that can be produced only by compounding pharmacies.
But compounding pharmacies have had some notorious safety issues. Some organizations such as the North American Menopause Society argue that they are risky and should be avoided for hormone preparations. One way around this dilemma is to simply avoid compounding pharmacies and find other solutions. For menopausal women, for example, there are now many FDA-approved bioidentical hormones that are dispensed by standard pharmacies.
But what about patients—and their doctors—who still want a customized preparation from a compounding pharmacy? Is there a safer way to use them? The answer is “Yes,” if you follow some specific guidelines and cautions.
HOW COMPOUNDING PHARMACIES GOT INTO TROUBLE
Before the 1950s and 1960s, all pharmacies were compounding pharmacies. Then mass-produced prescription medications became much more widely available, so pharmacists no longer needed to know how to manufacture their own prescriptions. Some of these pharmacies hung on, however. Over time, especially with the popularity of bioidentical hormones, they grew.
As they grew, however, so did safety concerns. While the FDA regulates active ingredients in prescriptions, compounders are subject to very little oversight in how they combine them—even though they, too, are providing drugs. Nor do compounders’ manufacturing standards have to comply with the FDA’s strict standards to prevent contamination. Nor do they have to ensure quality and consistency from one pill or teaspoon of medicine to the next.
In 2012, there was a multistate outbreak of fungal meningitis among patients who had received contaminated steroid injections that were produced at the New England Compounding Center in Framingham, Massachusetts, and then distributed to doctors throughout the country. More than 700 patients were sickened and 64 died.
Several studies have also found that there are inconsistencies in compounded medications. One study, conducted by an investigative team at More magazine in 2012, had 12 different compounding pharmacies fill the same prescription for bioidentical hormone therapy and then sent the resulting pills out to a laboratory for testing. The amount of estrogen in some of the pills was as much as 173% greater than had been prescribed, and the amount of progesterone was as much as 40% lower. That affects the ratio of estrogen to progesterone and, for a woman who took these preparations, could increase the risk for endometrial cancer.
NEW REGULATIONS TARGET SAFETY
When it comes to manufacturing issues that led to the fungal meningitis outbreak, there is good news. The tragic episode with the now-defunct New England Compounding Center—the owner is currently serving a nine-year prison sentence—led to new regulations. This kind of pharmacy isn’t an actual drugstore that you can walk into but rather an “outsourcing” compounder, which manufactures drugs and distributes them to physicians. As a result of the tragedy, this kind of pharmacy is much more regulated, thanks to the 2013 FDA Drug Quality and Security Act, a direct response to the deaths. Outsourcing pharmacies must now comply with tougher manufacturing standards—although not as tough as those applied to FDA-approved pharmaceuticals—and report any adverse events to the FDA.
The law also tightens up oversight of regular walk-in compounding pharmacies. There are two kinds. Some regular drugstore pharmacists occasionally do compounding, meaning that it’s not their primary business but they offer some basic compounding services. There also are compounding pharmacies that specialize in compounding. These are the ones that make most of the bioidentical hormones for menopausal women.
WHY ACCREDITATION MATTERS
Some of the new federal regulations are voluntary, however. Compounding pharmacies are licensed and regulated by their states, but states vary widely in the extent of oversight they do. In some states, the compounding standards are minimal. Fortunately, there is a way to further ensure that the compounding pharmacy that you (and your provider) use is safer—voluntary accreditation.
There are an estimated 5,000 compounding pharmacies in the US. But only 652 have received accreditation from the Pharmacy Compounding Accreditation Board (PCAB), which is run by the Accreditation Commission for Health Care (ACHC), a nonprofit agency that accredits Medicare facilities, home-health agencies, hospice facilities—and pharmacies.
To evaluate a compounding pharmacy, PCAB does an onsite survey once every three years, as well as an annual review of documentation to ensure ongoing compliance. The goal is to ensure compliance with standards based on US Pharmacopeia Convention (USP) guidelines on compounding practice. To be accredited, compounders must meet many standards, including that they follow rules and guidelines regarding…
- compounding process standards
- training of staff
- quality control, such as testing of potency of products.
Why is staff training important? In most states, to be a compounder, all you need to do is have a pharmacist license, but it doesn’t mean that you’re trained in compounding, explains Jon Pritchett, PharmD, associate director of pharmacy for ACHC, which oversees PCAB.
Do you wonder whether your compounding pharmacy is accredited? Find out here.
WHAT IF YOUR COMPOUNDING PHARMACY IS NOT ACCREDITED?
Accreditation is not mandatory and costs pharmacies a few thousand dollars a year, which may be prohibitive for some smaller pharmacies. Just because a pharmacy hasn’t received PCAB accreditation doesn’t mean it’s not safe or reliable, according to Dr. Pritchett. Some unaccredited facilities choose to follow USP guidelines.
He recommends that you ask your pharmacy what steps it takes to ensure safety and quality. Most pharmacists will pride themselves on these efforts to set them apart from others. When Dr. Pritchett was in practice, he was so proud of his pharmacy’s practices that he’d bring customers back to the lab and show them what was done. Some specific questions to ask…
- What do you do to make sure the medication is appropriate and safe?
- What kind of staff training do you do that is specific to compounding?
- What kind of quality-control procedures do you have in place? For example, how are records kept to ensure that specific compound formulas are produced consistently?
- Do you buy your ingredients from FDA-registered suppliers?
Also, make sure your medications look uniform from batch to batch. Are the color and consistency the same? If not, that may be a sign of lax standards on consistency.
Of course, someone who wants to cut corners could omit the truth or evade your questions—so actual accreditation is still the safest bet. Don’t be fooled by pharmacies that insist they are “inspected” when you ask if they are “accredited.” There’s a big difference. A pharmacy may claim that it “undergoes inspection by it’s state board,” but that doesn’t mean that it has corrected all deficiencies pointed out in the inspection! It does have to pass the inspection, but the state standards may be minimal. To be accredited, a pharmacy must not only undergo an extensive survey but submit convincing evidence that it has systematically corrected any deficiencies that were found.
Is it worth the trouble to evaluate and use a compounding pharmacy if you don’t have to? That, of course, is something that only you and your doctor can answer. Many naturopathic and integrative health-care providers rely on compounding pharmacies to create bioidentical hormones in customized formulations that are individualized for each patient. On the other hand, it’s entirely reasonable to prefer to take FDA-approved medications—including bioidenticals—that must comply by law with mandatory manufacturing standards.
But one thing is beyond debate—if you choose to use a compounding pharmacy, take the steps above to make sure it’s as safe a facility as possible.