Pharmacy-Made Premature Birth Drug Faces Scrutiny
The meningitis outbreak is forcing a rethink by regulators, policy makers, and insurers about the decision to allow pharmacies to make an unapproved version of a brand-name drug that is meant to prevent premature births.
No injuries related to the pharmacy-produced version of the pregnancy drug Makena have been reported to date. But Kaiser Health News writes that the story of Makena highlights how the tradeoff between cost and patient safety is an issue that needs greater federal attention.
The FDA-approved Makena costs $1,500 per dose whereas the drug produced by pharmacies costs just $20-40 per dose and has wider acceptance by state and private sector insurers because of its affordability, writes Kaiser Health News. The FDA allows production of the pharmacy-compounded versions of Makena.
Some have questioned the potency of the pharmacy-made version of the drug and its effectiveness in preventing a premature birth. The FDA investigated complaints by the maker of Makena about the quality of the pharmacy versions earlier this year but found no significant safety concerns, according to Kaiser Health News.
However, the role of pharmacies needs to be better understood and regulated as some have begun to manufacture unapproved drugs for asthma and menopause, as well as some pain relievers.
A compounded injectable pregnancy drug was among the many products recalled by the New England Compounding Center (NECC)—the pharmacy responsible for the deadly meningitis outbreak that killed at least 28 people and sickened nearly 400 people.
Though healthcare experts assure that meningitis cannot be contracted from the pregnancy drug as it is administered into muscle and not the spine, a contaminated dose “could cause a local infection,” writes Kaiser Health News.