Ukens, Carol, Drug Topics
The Food & Drug Administration's revived plans to bring some stand-alone medical software under its regulatory umbrella poses some interesting questions for pharmacists.
The FDA is in the midst of discussions in-house and with the healthcare software industry and health-care professionals to arrive at some consensus about whether some software should be regulated as medical devices, said spokeswoman Sharon Snider. While software used in conjunction with medical devices is already regulated, the agency is now taking a hard look at stand-alone software. Possible pharmacy-related targets for regulation include software for prescription ordering, drug interactions, and automated dosing calculations.
"The reason is that technology has advanced a lot since we first started looking at software," said FDA's Snider. "We are looking at the whole world of [health-care] stand-alone software. We're trying to decide what needs to be regulated and what doesn't."
Pharmacists will feel the impact if FDA regulates software, said Carmen Catizone, executive director, National Association of Boards of Pharmacy. In the first place, the necessity for agency approval could slow down development of software, which has a short shelf life. In addition, it raises other questions, such as whether pharmacists could deviate from the information provided by the software.
"Drug interaction software would fall in the new regulatory area, which has tremendous implications for pharmacists," said Catizone. "What if, for example, the information is outdated or is for an off-label use? If the pharmacist dispenses the drug, what happens then?"
State pharmacy boards don't want the FDA poaching on their turf because the software proposal would give the agency authority over regulation of pharmacy practice, said Catizone, who feels the FDA is serious about the proposal. "That is a function of state boards, not the FDA," he added.
The National Association of Chain Drug Stores voiced its opposition at an FDA workshop held in September, said Roy Bussewitz, managed care/telecommunications v. …