Flavored Medication Debate for Children in California | Forward Valley

If you’re a parent, you know how hard it is to get kids to take bad-tasting drugs.

Parents can remedy this by asking that their children’s prescription drugs be flavored at 3,000 California pharmacies where possible. But the unintended consequence of the 2019 law could bring this longstanding practice into conflict not just with the national standard, but with the federal government as well.

A new bill in this session seeks to remedy this by codifying that the preparation of a medicinal product “does not include … the addition of flavoring to improve palatability.”

But the California Pharmaceutical Board is preparing to oppose the bill despite a social media campaign (#MomsforFlavor) in favor of the measure and supporters who warn the change will exacerbate regulatory bureaucracy.

The table was scheduled for Tuesday and today, but was canceled due to lack of a quorum to continue the debate.

Let’s go back: In 2019, the state passed a law requiring California pharmacists to prepare drugs according to the rules set forth by the USP, a non-profit organization that sets standards for drug preparation. This includes drug preparation, where pharmacists combine, mix, or modify ingredients to meet the needs of individual patients.

At the time, Assemblyman Jackie Irvine, a Thousand Oaks Democrat and author of the legislation, said the goal was to ensure Californians get drugs that meet national health and safety standards, citing a multi-state outbreak of fungal meningitis in 2012. which resulted in the death of 64 people. to an unsafe steroid formulation. The board approached his office seeking to establish minimum drug composition standards and identifying the USP as the basis for compliance.

The status quo in California held up relatively well until November, when the United States Pharmacopoeia updated its guidelines to clarify that flavors are covered under prescription drugs. And since California is required by law to comply with its drug preparation standards, this would further regulate how pharmacists flavor drugs and could prevent them from offering full service.

So the bill, which was approved by the Assembly in March and after some ups and downs in the Senate, is now before the Appropriations Committee.

Irvine, a co-sponsor of the bill, says he wants the board and key lawmakers to come up with a solution that protects consumer safety and ensures access to flavored medicines.

In a statement to CalMatters, Assemblyman Tom Lackey, R-Palmdale, and another co-sponsor with Assemblyman Tina McKinnor, D-Inglewood, said flavored drugs “do not cause problems” and described the council’s opposition to the bill as “curious.”

The position of the council “will make it difficult to supply flavored medicines because your local pharmacy will not accept these unnecessary and burdensome requirements…. Being a parent is hard enough. Absurd California regulations should not make it harder to care for a sick child, as it already is,” said Lackey.

While the board denied my request for further comment, it has reason to play it safe and dismiss the action. The United States Pharmacopoeia establishes rules that can be enforced by government agencies as well as the Federal Food and Drug Administration. If the proposal is passed, analysis of the bill warns of “potential conflict” with federal requirements.

CalMatters.org is a non-profit, non-partisan media organization that explains public policy and political issues in California.

The article was originally published at https://calmatters.org/newsletters/whatmatters/2023/08/california-children-flavored-medicine/.

Read more at https://www.facebook.com/calmatters and www.calmatters.org.