I participated in a conference call with FDA today about their recent ban on non-FDA approved opioids, which included highly concentrated oral morphine solution commonly used in palliative care and hospice. The FDA admitted that they "didn't fully understand the needs of the palliative care population" and have amended their ban. As of now, all formulations of 20mg per milliliter oral morphine solution can be manufactured and distributed to patients in need.
This is great news for hospices and their patients, who are already feeling the effects of the ban with severe shortages of morphine in some areas. The FDA has contacted the manufacturers of the morphine solutions and informed them of the amendment so we should be seeing some relief soon.
This amendment allows manufacturers more time to prove to the FDA the safety, quality, and effectiveness of the morphine solution. This amendment only covers the liquid concentration of the drug and not the tablets that were included. For more information, visit the FDA's website.
This is indeed fantastic news. All of us in the hospice and palliative care fields are breathing a collective sigh of relief!
Great news. I am very happy for you and all the palliative care pts.
What wonderful news – not so much about the drug – although that is great, but about the fact that the FDA “admits” that little is known about palliative care. What a long road of “education” we all have before us!
James C. Williamson, Ph.D.
Regional President, Agape Senior of the Pee Dee and Grand Strand, Executive Director of Agape Community Hospice of the Pee Dee
Cheraw, SC