The California State Board of Pharmacy is considering regulatory changes that could make it more difficult for pharmacies to add flavoring to medicine, a generally safe and increasingly sophisticated practice that helps children take medication.
I encounter dozens of parents daily who enter my pharmacy with a desperate look when their child is sick. All parents, including myself, have been there at one point, and know that helpless and concerned feeling.
One of the more comforting aspects of this profession is knowing that we can respond in a way that offers parents personalized solutions that provide relief to their children. But the medicine pharmacists provide only works if children take it.
Historically, this problem would result in battles between parents and their children which can sometimes lead to non-adherence and shortened therapy, or drug resistant infections. To establish peace, for decades, pharmacists in California have been able to add flavoring – bubble-gum flavored clindamycin, for example – to prescription medicines.
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 the medication literally helps make the medicine go down.
But recently, the California Board of Pharmacy has created some ambiguity in the regulatory language related to flavoring. This is raising concerns for many pharmacists.
Flavoring has been uncontroversial for a long time. For decades, there have been no reported incidents of patient harm or death from using medication flavoring. The practice and science of flavoring have also become more sophisticated over the years.
Today, typical flavoring agents are independently tested, manufactured in FDA-registered facilities and chemically inert. And flavoring medication can now be automated by flavoring machines.
In pharmacies with this specialized equipment, the pharmacist is no longer required to add the various sweeteners and flavoring agents physically. Instead, the flavoring process is fully automated and accomplished by scanning a barcode and confirming information on a screen.
Flavoring has, for the most part, never been regulated as part of a “compounding” process. A compounding pharmacy is a specific type that makes custom medications for people with highly specific medication needs and requirements.
Compounding pharmacies must adhere to different regulatory requirements than standard pharmacies. For over 10 years, California’s state regulators have determined that the act of 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.
Late last year, United States Pharmacopoeia, an independent, non-governmental organization establishing pharmaceutical compounding standards, updated its definition of compounding and the requirements to perform compounding. They also took the opportunity to reiterate their long-held belief that flavoring should be subjected to compounding standards.
Right now, 48 out of 50 State Boards of Pharmacy do not regulate flavoring as compounding. In fact, 98% of children 11 or younger live in a state that does not consider flavoring of medications to be compounding. That includes the 6 million children under the age of 11 living in California.
Without this exemption, California’s pharmacies will likely begin phasing out their flavoring services to avoid unnecessary, time-consuming and expensive regulations. This will have an effect on our business and, more importantly, the health and wellbeing of our youngest patients.
California’s community pharmacies provide a simple and safe service to flavor medications for our customers. This new regulation the California State Board of Pharmacy is considering will take away this service that pharmacists can offer to sick children and worried parents alike.