Drug shortages can leave patients and those who care for them scrambling.
The Food and Drug Administration’s most recent proposal to help keep a lid on nationwide drug shortages is a move in the right direction but no cure.
It refines a 2012 rule change, adding definitions of what must be reported and how.
I don’t see how they could further regulate it beyond that, said Trent Towne, an infectious disease specialist and assistant professor of pharmacy practice at the Manchester University College of Pharmacy who has lectured on drug shortages.
Towne said he understands where the FDA is coming from, but said there is a sort of Catch-22 involved.
Under the FDA plan made public last week, manufacturers of many medications or biological products – including blood or blood components for transfusion – would be required to notify the FDA of a permanent discontinuance or an interruption that is likely to lead to a meaningful disruption in the supply. It wants six months’ notice whenever possible.
Towne said most supply breakdowns are caused by unforeseen circumstances.
Some supply stoppages occur because the business chooses to do so, but most happen because it needs to retool, a component of the medication is not available or the FDA finds something wrong in the production process and orders a shutdown.
Companies, he said, can’t rub a crystal ball and know what they’ll have in six months, or even tomorrow.
If retooling is required in a sterile facility, the process can be lengthy. Even if another manufacturer takes up the slack, it might not be able meet the demand immediately.
As of Monday, FDA’s drug shortage list shows scores of drugs in short supply. Those numbers have decreased dramatically since the 2012 rule change, but that is cold comfort if your medication is on the list now.
Towne said in recent years they have seen shortages in injectable drugs – including generic painkillers and antibiotics – that are made by just a few companies that run on pretty tight margins.
The latest proposal from the FDA has recommended more fully engaging the entire supply chain, all the way from the manufacturer to the patient.
Christopher Topoleski, director of federal regulatory affairs at the American Society of Health-System Pharmacists, said his group is encouraged by the FDA’s reaching out to other stakeholders – including pharmacists, doctors and hospitals.
Although his group has worked with the FDA on shortages for more than a decade, he said this is the first time the agency has included more than manufacturers in a proposed rule.
He said the FDA’s plan is straightforward, spelling out what is covered and making the process of who must report what very clear.
The best weapon we have against shortages is notification in a timely manner, and he said consistent requirements will help.