compounding pharmacies

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Pregnancy Woes: Why Did The Price Of My Progesterone Skyrocket?

(Photo: Rekha Murthy)

(Photo: Rekha Murthy)

By Rekha Murthy
Guest Contributor

Update: KV Pharmaceutical changed its name to Lumara Health, two days after this post was published.

I’m 34 weeks pregnant and working hard to keep this baby inside me for as long as possible. As with my last pregnancy, there’s a real risk that the baby could come too early. But we’re both holding on so far, thanks to a combination of luck, modified bed rest and medical science.

The science is my biggest concern right now. I will spare you much of it because, man or woman, you will instinctively cringe and close your legs. However, one critical medical intervention that has been proven to work for countless women and babies is again under threat, and I must speak up.

Every week, my husband injects me with 250 mg (1 ml) of 17 alpha-hydroxyprogesterone caproate (“progesterone” for short). Leaving aside what this does to an otherwise tender and loving marriage, these injections have been found to significantly lower the risk of preterm birth.

Two weeks ago, my insurance co-pay for progesterone went from $5.50 per dose to $70 per dose. Just like that. For those without insurance (or with a deductible), the medication went from $32.50 per dose, according to my local compounding pharmacy, to…wait for it…$833 per dose, according to the new pharmacy my insurer is now requiring me to use.

$833. Per. Dose.

Pricing varies somewhat across pharmacies and insurers, but not enough to make this price change any less breathtaking. In fact, the drug’s list price is $690 per dose.

The 12-fold leap in my co-pay sent an epic shock through my (natural and synthetic) hormone-laden system. I immediately called both pharmacies, my insurer, and my doctor, and started digging around online. I soon learned that the price increase came from a new requirement to buy expensive brand-name progesterone, instead of the affordable compounded version I had been getting. A disturbing picture came into focus. Continue reading

Budget Victim: Inspections For Compounding Pharmacies. Really?

Remember all that outrage last year when we learned that a Framingham compounding pharmacy, the New England Compounding Center, was at the heart of national meningitis outbreak? And remember what followed: a flurry of new government oversight measures, tough public health safeguards, pledges of “Never again.”

So what happened?

Kevin Outterson, a professor at the Boston University School of Law and co-director of the Health Law Program, reports today that additional money that was supposed to be used to inspect compounding pharmacies around the state was cut to zero. At least for now.

(WBUR)

(WBUR)

Blogging for The Incidental Economist, he reminds us why the inspections are important: “fungal meningitis from improperly compounded products killed 55 people and infected more that 600.” But apparently, in the latest state budget proposal, money for inspections has been cut, Outterson writes:

All of these products originated in Massachusetts, but all of the injuries occurred in other states. But Massachusetts felt some responsibility for the failures at NECC, as acknowledged by both Gov. Patrick and the Interim Commissioner of Public Health. The DPH enacted emergency regulations on Nov. 1, 2012 and the Governor’s special commission delivered a comprehensive set of recommendations. Both efforts informed the Governor’s proposed legislation in January 2013 and several bills pending in the Massachusetts House and Senate. Continue reading

Troubled Compounding Pharmacy ‘Clean’ Room Not Clean, Inspectors Say

WBUR’s Martha Bebinger reports:

(WBUR)

State investigators have found numerous health and safety problems at the Framingham pharmacy allegedly tied to 23 meningitis deaths, but still don’t know how fungus got into steroid vials.

Inspectors with the Department of Public Health say they found black particles in vials of steroid returned to New England Compounding Center…the steroid that has caused 23 deaths and made 304 patients in 16 states sick.

The “clean room” where the steroids were produced did not meet basic standards including untested sterilizing equipment, dirty floor entrance mats and protective hoods that weren’t cleaned.

Governor Deval Patrick, speaking at a news conference today, extended condolences to all those affected by this outbreak. He says the state will begin unannounced visits of the other 25 pharmacies that mix drugs in Massachusetts and require more specific reporting.

The state’s preliminary report is here. Continue reading

Probe Of Pharmacy Linked To Tainted Steroids Widens; 14 Now Reported Dead

(multimediaimpre/flickr)

As of today, 14 people have died in a national meningitis outbreak linked to a Framingham compounding pharmacy.

WBUR’s Martha Bebinger reports:

Federal officials say as many as 14,000 people may have been exposed to tainted medication from the New England Compounding Center.

State and federal regulators say they are still investigating the exact cause of the outbreak. But the FDA’s Deborah Autor says regulators would like more clarity about state and federal authority over such pharmacies.

State regulators say it appears that the New England Compounding Center violated state law by supplying large amounts of medicines without an individual prescription.

Sources close to the investigation says NECC followed state laws.

The Massachusetts Department of Public Health says New England Compounding Center was licensed to mix specialized medications based on individual prescriptions. So selling vials of steriods in bulk to hospitals across the country, where 169 patients are now ill from tainted injections, was not allowed, says Madeleine Biondolillo, with the DPH. Continue reading