Colorado Senate Health and Human Services Committee advances bill approving off-label prescription protections for providers


Boram Kim


The Colorado Senate Health and Human Services Standing Committee voted seven-to-one to advance Senate Bill 41 on Thursday, a bill that would authorize providers to prescribe off-label use for FDA-approved drugs in certain instances. 


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Those instances would be if the off-label use has longstanding, common practice and medical evidence that supports rather than contradicts the usage in question, and the patient’s signed informed consent form. 

The issue was raised when physicians in the state received a letter to cease and desist from prescribing off-label use for certain drugs or risk losing their license. 

The only dissenting vote was from Sen. Sonya Jaquez Lewis (D – Longmont), a pharmacist herself who had concerns about how the bill would be interpreted in practice.

“I’m afraid that if we’re saying [to] use off-label drugs, we could encourage what is already happening and [what] we know happened, unfortunately, during COVID—because we had hydroxychloroquine HCQ being used off-label. Now many pharmacists were able to intervene but some were not and we had 293 people die in the United States from the use of HCQ to supposedly stop the COVID virus.

And the other big drug is Seroquel and that has many different uses. But according to the Washington Post, thousands have died when Seroquel was being used off-label. So I feel like this bill is sending the message: use drugs off-label and nobody’s going to do anything about it.”

Sen. Jim Smallwood (R – Castle Rock) responded by clarifying that the amended language of the bill does not provide immunity from malpractice or disciplinary charges for pharmacists, but the act of filling a prescription for off-label use would not be subject to discipline by the state board of pharmacy.

“So by no means is this creating any sort of encouragement that off-label drugs should be prescribed,” Smallwood said. “Simply saying that in a vacuum it is not a violation. I don’t think Colorado had a hydroxychloroquine issue or a problem out here. There’s nothing that prevents a pharmacist from intervening still like they did before if they feel that or for any other inappropriately prescribed drugs. There’s certainly no provision in here that says that that could or should happen.”

The committee also unanimously approved SBs 18 and 40. SB 18 would provide ongoing funding for the state’s 911 resource center, which provides support for 911 emergency communications and dispatch authorities throughout Colorado. 

Meanwhile, SB 40 would require employers and staffing agencies when hiring an individual to work in a position that has contact with an at-risk adult to check if the individual has prior substantiated claims of at-risk adult mistreatment to inform the recruitment process. The measure aims to protect older adults in the long-term care setting.