Physicians order, dispense, and administer medications under the scope of their medical license, approved by the Board of Medicine in the state where they practice. In oncology, this drug management usually involves the acquisition, transport, storage, handling, reconstitution, mixing, and administration of nonhazardous and hazardous drugs in their offices. Many physicians also dispense drugs that patients take home; this may be under the scope of a medical license or a pharmacy license, depending upon state laws.
In any given state, the Board of Pharmacy is empowered by state laws, as well as their own regulatory policies to oversee and enforce the practice of pharmacy, which generally is defined as the provision of pharmacy care, including the acquisition, transport, storage, handling, reconstitution, compounding, and dispensing of nonhazardous and hazardous drugs, in any setting. Historically, there has been a clear separation between the auspices of the Board of Medicine and the Board of Pharmacy. However, the line is blurring, which is creating a ticking time bomb for the practice of oncology.
Why Medical Practices Need to be Concerned
Similar to the way in which groups such as the National Comprehensive Cancer Network, the American Society of Clinical Oncology, and the Oncology Nursing Society develop clinical practice guidelines and standards in oncology, the US Pharmacopeia (USP) publishes pharmacy compounding and handling standards, including Sterile Compounding (USP 797) and Safe Handling of Hazardous Drugs (USP 800), which are used by many Boards of Pharmacy, state regulators, and legislators to determine which regulations they will enforce. USP 797 is currently in effect, and a comment period for a revision of this chapter ended in November 2018. The USP plans to issue final versions of USP 797 and USP 800 in June 2019 before both chapters become “official” in December 2019.
Why is this a ticking time bomb for oncology groups? Because these pharmacy standards are now being applied—or will be applied—at some point in the future to medical practices, including private or hospital-based oncology groups that handle drugs, regardless of whether they have a pharmacy licensed with their state Board of Pharmacy. At this point, the impact varies greatly from state to state, but the momentum is inevitable.
There has been a lot of discussion about the looming impact of USP 800. There have also been many challenges to the proposed 2018 revision of USP 797 and to USP 800. The number of comments received for an earlier proposed version of USP 800 vastly exceeded historic norms for the USP, and there is speculation that a record-breaking number of comments were also received before the November 2018 deadline for the revision of USP 797. The USP included several standards in both chapters for which there is less than compelling scientific evidence and which were the result of a very limited number of opinions. Typically, these opinions are expressed by “experts” outside of the practicing medical community.
It should be noted, however, there are many components of USP 797 and USP 800 that, although not the standards to which medical practices may directly comply, are difficult to challenge as reasonable. The USP Compounding Compendium, which some pharmacy boards have entirely adopted (or have at least used) as the basis for regulation, purport to set minimum requirements for:
- Personnel responsibilities, training and evaluation, competency testing, and documentation of such
- Aseptic manipulation skills and verification of accuracy and sterility
- Handling of hazardous drugs
- Environmental quality and control, storage, and beyond use dating
- Standard operating procedures, monitoring, and elements of quality control.
Although the revised version of USP 797 separates out the language related to safe handling of hazardous drugs which would, in the future, be covered under USP 800, the medical community needs to realize that there is significant potential for some entity—be it state, local, competitive, or even market-driven, such as specialty pharmacy, pharmacy benefit managers, payers, or employers managing provider networks—to require a degree of accountability related to the current version of USP 797.
Strategies and Interventions
Willis Triplett, PharmD, Principal, Comply797, Indianapolis, IN, and Partner, USP Compliance Division, DGH Consulting, South Windsor, CT, has years of experience working with pharmacies and Boards of Pharmacy in several states. I am currently working with him to monitor the blurring of lines between Boards of Medicine and Boards of Pharmacy. Most Boards of Medicine are not equipped to inspect and oversee the medical practice of sterile compounding under the auspices of the physician medical license. There is increasing pressure on Boards of Medicine to address the presence of standards and drug handling safety performance in the wake of a 2012 tragedy in which a compounding pharmacy in Massachusetts shipped contaminated drugs across the country, resulting in dozens of deaths and hundreds of injured patients.
In November 2017, we were called to New Hampshire by medical practices that needed our assistance. New Hampshire law allows broad rule-making authority for its Board of Pharmacy to govern sterile compounding wherever it takes place. The New Hampshire Board of Pharmacy had cited these practices for USP 797 noncompliance, fined them, and imposed a ban that prevented them from infusing patients until compliance was achieved. In the ensuing months, there was a flurry of hearings and legislative action, and we were able to have the fines and bans lifted from the practices. The board heard our concerns about the application of USP 797 as a regulation and decided to replace USP 797 with more realistic sterile compounding regulations they are writing themselves. They even asked Mr Triplett to join the task force that is developing those regulations. However, these physician practices are about to be subjected to oversight in some form, particularly around aseptic technique. This is an ongoing journey.
In some states, the Boards of Medicine have already ceded inspection and oversight of sterile admixtures to the Boards of Pharmacy. In one Midwestern state, a practice with an infusion suite and a licensed retail pharmacy housed in a separate building was visited by the board of pharmacy inspector at the infusion suite. When directed to the retail pharmacy, the inspector noted that he knew where he was and proceeded to inspect the infusion mixing area according to their pharmacy regulation compounding standards, noting several areas of noncompliance.
More Challenges to Come
Practices that are trying to get ahead of the curve and prepare for these standards are caught between a rock and a hard place, because the future revised USP 797 and USP 800 are in flux, and will not be “official” until December 2019; even this is subject to change because of the increasing pressure and challenges from the pharmacy and medical communities. In the meantime, the current version of USP 797 already exists as a standard for pharmacy compliance.
Consultants, architects, and contractors offering compliance support to the medical community must be carefully vetted for their understanding of the details of current USP 797 as well as the future, but not yet official, revised USP 797 and USP 800. We have seen hundreds of thousands of dollars of conversions already proposed (and, in some instances, completed) that are not ultimately compliant. Some practices are wisely considering a stepped approach: addressing the operational, personnel, and standards development first, while moving cautiously to create physical solutions that can be expanded to meet more aggressive standards and enforcement when and if they materialize.
Many early compliance projects focus exclusively on the facilities’ questions and ignore the many other components to compliance that are just as important. One major challenge for medical practices is that the whole premise for pharmacy standards assumes an operations model where the mixing process uses dedicated staff, whereas in medical practice, mixing is usually conducted by multifunctional staff (often nurses) who have other responsibilities pertaining to patient care and treatment administration. The logistics of the 2 models are completely different.
Despite these challenges, the ticking time bomb for medical practices continues, especially in oncology. When and where will compliance be enforced? How will pharmacy standards be held up to scrutinize medical practices, and which ones will be used—the current USP 797, which includes hazardous and nonhazardous drug standards, or the revised USP 797 and USP 800, both of which are not finalized and remain under aggressive challenges?
Most practices hesitate to openly ask about compliance in their state, adopting the theory that they should “let sleeping dogs lie.” An outside expert can explore the landscape by proxy without risking exposure to practices. Mr Triplett has found several avenues in different states where these issues could have already been addressed, may be percolating, or even have pending action, not just at the Board of Pharmacy or Board of Medicine levels.
To assist practices in their planning, we have developed a simple self-assessment for practices seeking to prepare for this imminent challenge. This self-assessment may be requested by e-mail at