A bill recently passed by the U.S. Senate and on its way to the House has an amendment tucked deep down inside that would make all hydrocodone products a Schedule II controlled substance.
Vicodin schedule II? Lortab schedule II? Really? This is a bad idea. I mean REALLY bad.
The primary bill (designated S.3187) was passed by the Senate on May 24 nearly unanimously.
The main bill’s purpose reads “A bill to amend the Federal Food, Drug, and Cosmetic Act to revise and extend the user-fee programs for prescription drugs and medical devices, to establish user-fee programs for generic drugs and biosimilars, and for other purposes”
Attached to this bill are MANY amendments (as usual). One of which is amendment AMDT.2151 which read “To amend the Controlled Substances Act to make any substance containing hydrocodone as schedule II drug.”
This amendment was sponsored by Senator Joe Manchin (D) of West Virginia, and claims to be a proposal aimed at reducing the abuse of hydrocodone in our nation. Senator Manchin said “That bipartisan amendment was submitted on behalf of the countless West Virginians and Americans whose lives have been cut short by drug abuse and the families who are picking up the pieces, and it is on their behalf that I thank my colleagues in the Senate for passing it unanimously.”
This amendment, attached to this bill, is (in my HONEST opinion) BAD news for pain patients, pharmacists and physicians alike. It will create burdensome obstacles in the way of legitimate pain patients to receive needed medication, as well as promoting more illegal drug trafficking for those who use it improperly. It hurts the legal prescribers and users, and ultimately funnels more business toward black market and back alley sales.
Since this amendment is now attached, like a leech, to S.3187, the only hope is that the amendment will get struck or the bill gets defeated.
Adam Kaye, PharmD, Clinical Professor of Pharmacy puts it well in his article “It is my opinion and that of many others that no assurance of a reduction in diversion and abuse would be expected with this monumental change to the hydrocodone controlled substance classification. For certain the change would have a profound impact on patient care as well as the pharmacy’s cost of dispensing these products.”
Here are some of my own arguments against this amendment to the bill:
1) It punishes lawful users for the abuse of others. Yes, mis-use is a problem. But far more people use this medication legally and appropriately than those who do not.
2) The burden this would place upon health care delivery would be immense. Physicians would be subjected to more time-consuming paperwork. Pharmacies would be subjected to a significant increase in the number of time-consuming schedule II prescriptions. These burdens ultimately must result in greater costs (added personnel) or decreased time per patient and per prescription.
3) It undermines efforts already underway to reduce the amount of acetaminophen in prescription drugs so as to improve their safety
4) As a Schedule III product, hydrocodone prescription already have far stricter regulations than other medications, including limited refills and quantities.
5) The illegal trafficking of hydrocodone products will be encouraged, as access is restricted through legitimate channels
6) Pain patients will suffer more due to access challenges being imposed. This includes people from all walks of life. U.S. veterans wounded in battle, patients with debilitating chronic conditions for whom even transportation is challenging, and all other ordinary law-abiding patients who need some form of chronic pain control.
7) Hydrocodone is safe when used appropriately. Unlike propoxyphene which had some (albeit small) evidence that it was harmful even in normal dosages, such has never been the case for Hydrocodone and acetaminophen.
Hopefully the House will shoot down this bill for the sake of patients everywhere.
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Last modified: April 17, 2023