The bitter taste of overregulation: Pass Assembly Bill 782 to keep flavored medicines available in California.
Infections remain the most common reason parents see a pediatrician or visit an emergency room. The standard course of action is to send the child home for rest and antibiotics, which has saved countless children from discomfort and even death since their discovery.
But as any doctor, parent, or caregiver knows, the medicine is only effective if the patient takes it successfully.
Many times, that is a “BIG IF.”
Convincing suffering, irritable toddlers and children to swallow their pills or liquid medication can be a battle, often resembling more of a wrestling bout than a loving, nurturing moment. But thanks to flavored medicines – especially for critical antibiotics – these battles have become less frequent over the past few decades. In fact, 180 million medications have been flavored across the country, again, with no reported adverse events or incidents of harm.
Flavored medicines have zero downside. Using specialized equipment, the act of medication flavoring takes place at more than 3,000 community pharmacies in California and nearly 40,000 pharmacies nationwide each year as a point-of-care service to help facilitate children’s liquid medication. For a child struggling to take their medicine, flavoring it literally helps make it easier.
Curiously, the California Board of Pharmacy is heading down a dangerous path concerning the regulatory language related to flavoring. Simply put: the board wants to mandate that flavoring medicine be considered a “compounding” process, which necessitates different regulatory requirements than standard pharmacies.
There is a role for compounding pharmacies to make custom medications for people with highly specific medication needs and requirements. But flavoring isn’t one of them. For over 10 years, California’s state regulators have determined that the act of medication flavoring does not rise to the level of traditional compounding in any practical way. And in that time, millions of medications have been flavored without causing any harm to a child.
While the board claims it is not technically banning flavored medicine, this is misleading to the public. Its position will put a chokehold on the supply of flavored medication because your neighborhood pharmacy will not adopt these unnecessary and onerous requirements. Instead, they will cease providing flavored medications. This will not only leave a bitter taste in the mouths of California pediatricians, pharmacists, and parents, but it may also undermine the health and welfare of millions of children.
Currently, 49 out of 50 State Boards of Pharmacy do not regulate flavoring as compounding or to the extent California is about to. In fact, 98% of children 11 or younger live in a state that does not consider the flavoring of medications to be compounding. That includes the 6 million children under the age of 11 living in California.
California’s pharmacies will likely begin phasing out their flavoring services without an exemption to avoid unnecessary, time-consuming, and expensive regulations. This will impact the health and well-being of California’s youngest patients.
This is why I have co-authored Assembly Bill 782, which ensures that pharmacies throughout California can continue to offer flavoring of medications prescribed for toddlers and children.
Being a parent is tough enough. California’s absurd regulations should not make caring for a sick child more difficult than it already is.
Tom Lackey from Palmdale currently represents areas of Kern, San Bernardino, and Los Angeles Counties in the California Assembly.