Both sides weigh in on plan to loosen radiopharma rules

2018 12 11 00 02 7009 Atom Nuclear Lab 400

The U.S. Nuclear Regulatory Commission's (NRC) proposal to create a way for physicians with little or no background in nuclear medicine to become "limited authorized users" and dispense radiopharmaceuticals is drawing both opposition and support from across the healthcare spectrum.

On one side of the debate are members of the nuclear medicine community, who believe that the NRC's existing requirement of 700 hours of clinical experience to become an authorized user of radionuclides already falls far short of the expertise needed.

On the other side is a range of supporters who believe that flexibility in the requirements would make lifesaving radiopharmaceuticals more accessible to patients, especially in rural areas where nuclear medicine physicians have to travel long distances to treat patients.

NRC contemplations

The NRC began soliciting comments on whether to change its training standards to create the limited authorized user category in the October 29 issue of the Federal Register. The fourth and final public forum is scheduled as a webinar on January 22. The deadline for all comments is January 29.

An editorial published in the January issue of the Journal of Nuclear Medicine expressed strong objections to possible NRC amendments to the current requirements. The authors criticized the education period as inadequate, comparing it to allowing nonphysicians in other fields to perform the jobs of highly trained doctors after only minimal training periods.

On the other hand, supporters of the plan would welcome some leeway from the NRC in allowing limited authorized users to dispense therapeutic radiopharmaceuticals. One of these supporters is United Pharmacy Partners (UPPI), which represents 83 independent commercial nuclear pharmacies and nonprofit academic medical center radiopharmacies in the U.S. that provide more than 8,000 unit-dose prescriptions daily for diagnostic imaging and radiotherapy, according to the organization.

"If you look at the NRC regulations to become an authorized user as a nuclear pharmacist, they have to have up to 4,000 hours of clinical experience, plus 200 hours of didactic training," said John Witkowski, president of UPPI.

UPPI believes that having a nuclear pharmacist monitoring and working alongside a limited trained specialist, perhaps in a chemotherapy suite, might satisfy NRC patient and safety concerns and open an avenue for better patient access to treatment.

"The doctor would take care of injecting the patient and would know about handling this material," Witkowski said. "Then the nuclear pharmacist, as a dual authorized user, is able to take care of the radiation safety concerns and has the training and background the NRC is interested in."

Witkowski also maintained that there is a precedent for a team approach in interventional radiology with limited authorized users, whereby interventional radiologists can be trained to perform studies with yttrium-90 (Y-90) microspheres.

"These [procedures] are done under fluoroscopy with injections made into the liver for hepatic cancer, sometimes as a split dose," he said. "As involved as this is, it is still possible to have a limited trained interventional radiologist working with nuclear medicine to deliver this type of therapy."

Supply and demand

One question also posed by the NRC is whether there is -- or will be -- a shortage of authorized users to handle radionuclides.

The JNM editorial authors cited data from the American Board of Nuclear Medicine (ABNM), which estimates there are currently 1,200 board-certified nuclear medicine physicians in the U.S. Based on a forecast that some 150 new theranostic centers will open over the next several years, only 50 to 60 ABNM-trained people will be needed to fill those positions, the authors projected.

On the other hand, radiopharmaceutical companies are developing combination diagnostic and therapeutic drugs with the hope of advancing theranostic care for a variety of cancers and other diseases.

"What happens if we go from a few patients to 1,000 candidates having the ability to access this therapy? Who will be able to handle all of these patients?" Witkowski asked. "That is why we're looking outside the box with the NRC to look at another way to approach the limited authorized user."

Rural challenges

The greatest paucity of healthcare access is in rural areas. That's why the National Rural Health Association (NRHA) is also encouraging the NRC to create a way for nuclear pharmacists with the appropriate training to combine with local physicians to treat patients. In some cases, nuclear pharmacists have to drive within a 100- to 120-mile radius to deliver their products to remote locations. Having a limited authorized user onsite could benefit patient care, the NRHA believes.

"The patient-to-primary care physician ratio in rural areas is only 39.8 physicians per 100,000 people, compared with 53.3 physicians per 100,000 in urban areas," wrote Brock Slabach, senior vice president of the NRHA, in a letter to the NRC. "In an emergency, rural patients must travel twice as far as urban residents to the closest hospital. As a result, 60% of trauma deaths occur in rural America, even though only 20% of Americans live in rural areas."

While the NRHA does not have specific figures on the number of authorized users in rural areas, the organization "assume[s] that the distribution of physician authorized users and specialists is at best equal to this overall physician distribution. This means that there is likely a critical shortage of authorized users in rural areas," Slabach added.

In addition, travel time can be an "impediment to adequate healthcare coverage," he wrote. With healthcare options located several hours away, a patient is forced to take at least one day off from work -- and even more if multiple treatments are necessary.

These challenges may also prompt rural patients to look for less-effective tests and treatments that may be available locally, causing additional harm with a missed diagnosis and no treatment.

"We would hope that the NRC would use this opportunity to revisit this issue as a clarion call to find alternate pathways for rural patients to obtain treatment ... rather than a leisurely investigation with too few resources allocated to it," Slabach concluded.

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