Two years ago, Gates Healthcare Associates initiated a pioneering program aimed at helping compounding pharmacies bridge the gap between an important patient need and stricter federal oversight of the profession. We partnered with the maker of Makena (17-hydroxyprogesterone caproate) to allow larger, sterile compounding pharmacies to dispense the FDA-approved, commercially available formulation of the injectable drug, in place of the compounded version known as "17P."

 

Compounders have a long, proud history with 17P, a drug that has been compounded in pharmacies since positive clinical results were published in the "New England Journal of Medicine" in 2003. The compounded version provided patients with a personalized and much-lower-cost alternative to the commercially manufactured Makena (first manufactured by KV Pharmaceuticals in 2011 and currently by AMAG Pharmaceuticals).

 

But in the wake of the New England Compounding Center tragedy, compounding pharmacies, especially those with larger operations and specializing in sterile drug products, faced a much stricter regulatory environment. In this atmosphere, there was an increased chance of enforcement action related to 17P -- even as healthcare providers and patients continued to turn to compounders for a customized formulation of the drug used to lower the risk of preterm birth in women with a history of preterm delivery.

 

AMAG created a direct purchase program for qualifying compounders to gain access to Makena, and we at Gates Healthcare built a Makena network to help qualifying compounders avoid problems in an era of evolving regulatory guidance, while still maintaining healthy relationships with obstetrics providers and their high-risk pregnant patients. Two years on, we are pleased to report that many former large compounders of 17P have successfully transitioned their business to dispensing Makena.

 

We know first-hand that compounders have been able to continue their positive relationships with prescribing obstetricians and patients. Moreover, the legal cloud has dissipated.

 

Another favorable development involves Makena itself: the product is now available in a single-dose, preservative-free formulation. Having the single-dose, preservative-free option provides flexibility to prescribers and pharmacists, as well as improved access to the drug for patients .

 

The direct purchase program for Makena has now evolved to become more available to compounders large and small, sterile and non-sterile.

 

Here at Gates Healthcare, we are pleased to have played a role in creating a smoother path for providers, prescribers and, most important, patients. If you'd like more information about the benefits of the direct purchase program, please contact Dan Parisi, our Business Development Manager, via email at [email protected] or by phone at 978-646-0091.

Ernest P. Gates Jr., RPh, FASCP, FIACP, FACA