Micronized progesterone shortage update

SOGC has been in contact with the Drug Shortages Unit at Health Canada regarding the serious shortage of micronized progesterone that is expected to occur in the next coming months.

As you are all aware, the medication is used widely for a variety of both on-label and off-label uses in the patients we treat. Even if we recommend it mostly for menopause hormonal therapy, it is also widely used for IVF, luteal phase defect, and preterm labour with shortened cervix. The cause of this shortage is a very low supply of raw materials available in Canada now, and so it is not possible to simply increase production to alleviate the issue.

Health Canada has informed us that they have ensured adequate production coverage between different companies until approximately the end of January, but perhaps February. There is a significant replenishment expected in February as well. While they are not expecting a complete stock-out, they are dependant on Organon to bring in a replenishment in February to avoid a more serious shortage.

We were asked whether alternatives were available to use in place of micronized progesterone, or if patient populations could be prioritized by need. After urgent consultations held with our clinical advisory committee members, the SOGC responded to Health Canada with a request for Health Canada to seek out a foreign-authorized supply to help alleviate the possible shortage. SOGC does not support prioritizing one patient population over another in this regard, and there are no suitable alternatives available.

Until the supply has been replenished in February, it is possible that there may be regional shortages. Our colleagues at Health Canada are working with pharmaceutical companies to stay informed about stock levels, and looking into companies that may be able to provide compounding services, in addition to seeking out foreign-authorized supply.

We recommend the following actions:

  • Tell your patients about it, so that they do not wait until the last day to renew their prescriptions.
  • Suggest that your patients inquire about their pharmacy’s stock so they are aware if they may need to look at another pharmacy to get their medication.
  • SOGC has suggested that pharmacies do not provide more than a month supply at a time.

SOGC will continue to monitor the situation, and we are committed to working with Health Canada to seek innovative solutions. We will continue to communicate any updates that become available. See guidelines where we recommend the use of micronized progesterone.