In response to lawmakers' objections, a state board has temporarily withdrawn a proposed rule that would have allowed pharmacists to substitute lower-cost versions of biotechnology drugs at the drugstore counter without consulting a patient's doctor.
The Board of Pharmacy's move came after state Rep. Stephen Magie, D-Conway, accused the board earlier this week of trying to do an "end run" around the Legislature.
He said he sponsored a bill during this year's legislative session that would have allowed such substitutions but withdrew it to allow legislators more time to study the matter.
"We want to get this right," Magie said Thursday.
In an email Thursday, Pharmacy Board Director John Kirtley said he hopes to resubmit the regulations next month after helping Magie with an inquiry on how other states have handled the issue.
When a doctor prescribes a conventional brand-name drug, state law and Pharmacy Board rules allow a pharmacist to substitute a cheaper generic drug without consulting a patient's doctor.
Biotechnology drugs, which are made from natural sources such as viruses or human cells, don't have exact generic equivalents.
But the proposed regulations would allow substitutions when a drug has been approved by the U.S. Food and Drug Administration as "interchangeable," meaning that it is expected to produce the same clinical result without any additional risk of harm to the patient.
That's a step beyond "biosimilar" drugs, which have been approved by the FDA as producing the same clinical result as a higher-priced drug.
Kirtley has said the board decided to move forward after the FDA announced that it plans to approve the first interchangeable biologics within two years.
"For health plans and for patients, it can be a huge cost savings," Kirtley said Thursday.
Magie said he wants to ensure that patients and physicians are notified of the substitutions and that any drugs that are substituted come at a lower cost to the patient.
The rules would require a pharmacist to notify the prescribing physician of the substitution through a notation in electronic medical or pharmacy records.
Pharmacists and major retailers have told the board that requiring other methods of notification, such as making a phone call or sending a fax would "be vehemently opposed as it could represent a significant financial impact and regulatory burden as well as an increased risk of audit issues if the pharmacy cannot prove that notification was received," Kirtley said in a letter to lawmakers.
At a meeting of the House and Senate Public Health Committees on Monday, Sen. Missy Irvin, R-Mountain View, proposed giving the regulations a negative recommendation, but the committees adjourned without voting after Sen. Stephanie Flowers, D-Pine Bluff, asked for a check to see if enough members were present to constitute a quorum.
The committees had been scheduled to discuss the rules again Thursday, but the meeting was canceled after Kirtley agreed to the temporary withdrawal.
Magie said he will attempt to reach an agreement with the Pharmacy Board on revised wording for the regulations and introduce legislation addressing the issue in the 2019 regular legislative session.
Metro on 12/08/2017