How risky are compounding pharmacies?

A national meningitis outbreak that’s caused 12 deaths so far and sickened more than 100 patients—who were treated for back pain with a possibly-contaminated steroid drug made in a Framingham compounding pharmacy—has raised concerns about the safety of any drug mixed by individual pharmacists rather than produced in a giant manufacturing facility.

The injectable steroid was produced in the New England Compounding Center, shipped to 75 medical practices and clinics in 23 states, and administered to 13,000 patients.

Representative Edward Markey, a Massachusetts Democrat who represents the district in Framingham, announced Tuesday that he plans to introduce federal legislation requiring certain compounding pharmacies that send products across state lines to register with the US Food and Drug Administration and comply with minimum safety standards including a ban on producing bulk quantities.

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While that may eventually prevent widespread outbreaks, thousands of Americans continue to receive compounded drugs to get cheaper prescriptions or medications that aren’t available from big pharmaceutical firms. A progesterone drug that halts preterm births, for example, is often produced for pregnant women from compounding pharmacies because a new mass-produced version called Makena costs $1,500 a dose instead of the $25 charged by the pharmacies.

Compounding pharmacies also make suspensions of capsule medications—for kids and elderly folks who can’t swallow pills—ointments for nursing mothers with sore nipples, and hormonal creams for women experiencing hot flashes and other symptoms of menopause.

If you’re using a compounding pharmacy for one of these, do you need to stop?

I posed the question to Andrew Stein, a pharmacist and manager of Bird’s Hill Pharmacy in Needham. “We’ve gotten dozens of calls from patients about this ever since the outbreak,” he said. “I tell them the New England Compounding Center used the term compounding as a guise. They were really a drug manufacturer” operating outside the bounds of a compounding pharmacy.

(I was unable to reach folks at New England Compounding Center for a comment, and their website has been replaced with a single page announcing a recall of all their products. A company spokesman issued a previous statement that company officials are focused on cooperating with the investigation and has shut down operations.)

Compounding pharmacies are designed to make a single prescription at a time for an individual patient, not hundreds of vials of a substance to be shipped all over the country. When drugs are made in this manner using proper procedures, Stein said, they’re just as safe as those made in large plants.

Mass production in compounding pharmacies, however, can be a major hazard. “The autoclaves and filters we use to sterilize a medication and tests we perform to see if it’s potent aren’t meant to be used on bulk manufacturing,” said Stein.

While the chance of error and contamination increases greatly when pharmacies produce more than a single prescription at a time, even a single dose, according to the FDA, can be contaminated because there aren’t mandatory standards in place to regulate compounding pharmacies.

“Consumers need to be aware that compounded drugs are not FDA-approved,” FDA deputy director Kathleen Anderson said in a statement on the agency’s website. “This means that FDA has not verified their safety and effectiveness.” In fact, the FDA doesn’t consider compounded drugs to be as safe as those manufactured in large plants that have to meet standards for quality assurance and urges consumers to use FDA-approved drugs whenever possible.

Stein said his pharmacy has taken the precaution of getting accredited by the Pharmacy Compounding Accreditation Board, which requires inspections every three years to ensure that safety procedures are in place. But the accreditation is voluntary, and only five compounding pharmacies in the state have it. New England Compounding isn’t on the list and never received accreditation, according to Stein.

It’s also difficult to say whether the accreditation process is rigorous enough to prevent lax standards that might increase the chances of contamination or dosing mistakes.

The state Pharmacy Board—which regulates compounding pharmacies via infrequent inspections—announced on Wednesday that it was now requiring all compounding pharmacies in Massachusetts to sign affidavits swearing they are complying with state regulations requiring compounders to mix medications for specific patients, according to an article published in today’s Globe.

The FDA recommends the following tips for consumers:

Ask your doctor if an FDA-approved drug is available and appropriate for your treatment. Check with the pharmacist to see if he or she is familiar with compounding the product in your prescription. Get information from your doctor or pharmacist about proper use and storage of the compounded product. If you receive a compounded product, ask the pharmacist if the doctor asked for it to be compounded. If you experience any problems or adverse events, contact your doctor or pharmacist immediately and stop using the product. Report any adverse events experienced while using the product to FDA's MedWatch program.

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