Telehealth industry leaders are urging the Drug Enforcement Administration to provide guidance to pharmacists on safely dispensing controlled substances without restricting access for patients in need.
In a letter released Wednesday, a coalition of online health-care companies, trade groups, and policy organizations called on the DEA to explicitly inform pharmacies that the location of a prescriber in relation to the patient or pharmacy should not be a concern when a prescription is from a telehealth visit.
Currently, pharmacists have the discretion under the Controlled Substances Act to refuse to fulfill treatments they deem too risky when prescribed by out-of-state telehealth providers.
Although red flags are not explicitly defined in statute or regulations, pharmacists have been directed to identify red flags as part of their due diligence since the widespread over-dispensing that contributed to the opioid crisis, the letter said.
These red flags often include behaviors such as writing significantly more prescriptions than other practitioners in a particular area, returning too frequently for refills, or presenting prescriptions in the name of other people.
“If pharmacists are hesitant to fulfill these prescriptions of controlled substances because the provider isn’t physically geographically close to the patient, the patient is out of luck,” said Kyle Zebley, senior vice president of public policy at the American Telemedicine Association.
The organizations’ letter comes as they anticipate the first-quarter release of the agency’s controlled substance special registration pathway—a licensure program that would allow vetted providers to prescribe controlled substances without worrying about violating the Controlled Substances Act.
Libby Baney, an attorney at Faegre Drinker who supported drafting of the letter, said the proposed rule will be the perfect opportunity to clarify what constitutes “proper dispensing” for pharmacists.
“Right now, the red flags tell a pharmacist, ‘Yikes, I’m nervous, and the DEA’s guidance says I should be nervous, and the DEA hasn’t told me how to stop being nervous,’” Baney said.
“The DEA has a unique opportunity in this rulemaking to clarify that we do want you to dispense pursuant to legitimate prescriptions, and legitimate prescriptions can be issued via telemedicine when a doctor is at a distance,” she said.