The Ohio Academy of Family Physicians has joined a number of other medical societies in calling for the State of Ohio Board of Pharmacy (SOBP) to indefinitely suspend the recently adopted regulations governing the use of compounding of non-hazardous and hazardous drugs by prescribers in the office setting, Ohio Administrative Code 4729-16-04 and 4729-16-11.
The joint letter states, “We have significant concerns about the rules’ impact on the ability of physicians to provide high quality patient care in the most efficient and cost effective manner. While adopted with the best intentions, we believe that the rules will negatively affect patients’ access to care, potentially create inconsistency with federal regulations and unnecessarily increase the cost of medical care in some clinical arenas without a significant improvement in patient safety.”
The letter goes on to say, “As you know, the U.S. Pharmacopeial Convention (USP) is the leading scientific body responsible for establishing standards for the safe manufacturing, distribution, and consumption of drugs in the United States and worldwide. The USP Chapter 797 governing pharmaceutical compounding—sterile preparations is currently undergoing a review and expected to release a draft this fall with the potential for additional stakeholder comments. The USP is working with the leading scientists, health care providers and regulators to revise its standards on compounding and sterile protections.”
The OAFP previously registered its concerns with compounding rules in a May 17 letter to the SOBP that reads as follows:
These rules have created great confusion and concern particularly with regard to provision of vaccines in the primary care office. The additional burden of licensure and purchasing expensive equipment is problematic and could drive primary care practices out of the immunization business. I am sure that wasn’t the SOBP’s intent but potential negative consequences should certainly be considered as these rules are revisited. Ohio’s immunization rates are already dismally low.
It is our understanding that while the SOBP aimed to model its rule after USP 797, the Ohio rules are, in fact, more strict. Ohio’s compounding rule only permits use of the immediate use exception in the case of emergency situations (not applying to vaccinations). USP 797 allows the use of the immediate use exemption when compounding is performed within one hour for any reason (would apply to vaccinations). Ohio’s immediate use exemption should align with the USP version and certainly not be more restrictive.
Implementation of these rules and other rules contributes to a larger problem. Regulatory hassles, interference into the practice of medicine, the overwhelming burden of paperwork, and the associated costs of requirements imposed on physicians and their practice teams are causing physician burnout. A recent survey of our members indicated the severity of this problem – physicians are starting to hate what medicine has become because it is so far from why they chose to go into medicine in the first place. The joy they experienced when they actually had the time and energy to interact and care for patients is diminishing – and the burden of regulatory requirements is one of the major contributing factors. We have to start addressing these regulatory hassles in medicine or we are going to have a greater problem in achieving and maintaining a sufficient primary care workforce to provide care to an aging population.
All of these factors – regulatory burdens, cost, paperwork, and burnout – should be considered when these specific rules are revisited and when future rules are contemplated.
The SOBP issued an extension until Thursday, September 1, to all prescribers that are performing drug compounding (including reconstitution) or ordering compounded drugs to their offices from the requirement to obtain a terminal distributor of dangerous drugs license. The SOBP has also indicated that it plans to issue further guidance on the non-hazardous prescriber compounding rule (4729-16-04) following its meeting in July.
To stay up-to-date on the SOBP’s compounding rules on the OAFP website.