Maryland Oncologists Faced With Navigating the Maze of Chemotherapy Safety Regulations
We’re all wrestling with the same issues…. Now we need to make decisions on how to address these issues. I do feel that the solution will evolve over time.
—Paul Celano, MD, FACP
In March 2013, 60 Minutes aired a devastating piece about a Massachusetts compounding center that shipped an injectable steroid contaminated with fungus. One of the many ripple effects from this story of horrendous patient suffering was felt in Maryland, where it sparked legislative action in the Annapolis State House.
“Maryland passed a compounding bill, which at first we didn’t think had anything to do with oncology,” recalled Paul Celano, MD, FACP, Chief of the Division of Medical Oncology at the Greater Baltimore Medical Center. “But as the law was being implemented, it was clear that it applied to any medication that was being ordered, mixed, and given to patients anywhere.” Dr. Celano is President of the Maryland/DC Society of Clinical Oncology and a member of both ASCO’s State Affiliate Council Executive Subcommittee and ASCO’s Task Force on Safe Handling of Chemotherapy.
At the time, said Dr. Celano, there were no oncology-based standards or recommendations to help guide physicians. “Everything defaulted back to USP [U.S. Pharmacopeial Convention] standards, which are very broad-based and apply to anything and everything. No one would argue with the principle of safety for patients and employees, but it has been the application of these standards that is the point of contention.”
If oncology practices were compelled to follow the proposed Chapter <797> or Chapter <800> recommendations (designed to protect patients and health-care workers, respectively), it would have major implications, particularly for those in rural areas or freestanding practices, Dr. Celano asserted.
USP is a scientific nonprofit organization that sets standards for the quality and purity of medicines, food ingredients, and dietary supplements worldwide. The organization works with experts in a number of countries to develop and revise standards that help protect public health. Enforced by the U.S. Food and Drug Administration, USP standards help secure the quality of the American drug supply.
That’s the view from 30,000 feet. At ground level, the picture looks quite different.
“There’s a patient access issue,” said Dr. Celano. “With these rules in place, [many] patients could not even receive therapy. And there are issues around physical changes: The regulations would require external venting of chemotherapy hoods in all situations. In some places—for instance, where practices lease office space—that isn’t practical. They could not make those kinds of alterations.”
Challenges to States
What has been happening in Maryland in part inspired ASCO to form the Task Force on Safe Handling of Chemotherapy, said Dr. Celano. Robin Zon, MD, FACP, FASCO, head of the Task Force on Safe Handling of Chemotherapy and Chair of ASCO’s Clinical Practice Committee, credits Dr. Celano with shining a bright light on the safety compliance struggles of practices in states such as Maryland. “He has brought to our attention first-hand knowledge of the challenges states are facing when it comes to the maze of regulations,” Dr. Zon said. “He has helped guide us as we continue to develop safe handling recommendations.” Dr. Zon is Vice President and one of the Senior Partners at Michiana Hematology Oncology, PC, in Northern Indiana.
“It was ASCO’s State Affiliate Council that served as a sounding board for Dr. Celano’s concerns,” said James N. Frame, MD, FACP, Chair of the Council and Medical Director of the David Lee Cancer Center in Charleston, West Virginia. During a February 2014 Council meeting, Dr. Celano expressed his concerns, and “it galvanized ASCO’s review and action on the potential loss of cancer treatment access in Maryland’s community oncology practices,” said Dr. Frame. That rapid response, he notes, also “engendered a broader discussion on core chemotherapy safety standards that are practicable and implementable.”
Working with the Maryland Department of Health and Mental Hygiene, Dr. Celano and his colleagues were able to, at least partially, put the brakes on a compounding bill in 2013 and 2014. “We were able to exempt oncology,” he said. “In return, we said we would help develop safety regulations in the state. The standards we developed are for the proper administration of chemotherapy and infectious issues—which USP doesn’t address directly—and hazardous drug administration. In the absence of any national regulations, we needed to do something.”
However, he said ruefully, when dealing with bureaucracies, the path is rarely smooth. “There is never just one agency we had to deal with. MOSH [Maryland Occupational Safety and Health] had its own set of regulations. That is still the loose end in Maryland. There was a change of administration. We went from having a Democratic governor to a Republican governor and a change in the Secretary of Health. They put everything on hold. The Republicans want to get rid of the regulations, but that’s not going to happen. It’s not realistic.”
Unified Standard Needed
What is happening in Maryland is a warning sign of what is happening throughout the country, Dr. Celano said. “The USP <800> regulations have added another level to this. If we could have one unified standard that we can all live with that is proper, safe, and doable, we can use that as our reference so we don’t have to fight 50 individual battles in 50 states.”
Aside from Quality Oncology Practice Initiative (QOPI®) standards, ASCO, working with the Oncology Nursing Society, has also adopted recommendations from the Centers for Disease Control and Prevention for proper infection control procedures and hazardous drug handling issues.
“We’re all wrestling with the same issues,” said Dr. Celano. “What are the proper precautions on taking the drugs in, unpacking them, preparing them, and handling the drugs? What happens if the drug spills on the floor? If someone is exposed, is it necessary to have medical surveillance? We have outlined the issues. Now we need to make decisions on how to address these issues. I do feel that the solution will evolve over time.” ■
Disclosure: Drs. Celano, Zon, and Frame reported no potential conflicts of interest.
In July 2014, ASCO President Peter Paul Yu, MD, FACP, FASCO, wrote a lengthy letter to the CEO of the U.S. Pharmacopeial Convention (USP), commenting on the proposal for Chapter <800> regulations, saying “it is not evidence-based and is fundamentally flawed” and urging USP to “engage with...