University of Minnesota researchers who work with controlled substances now face one less obstacle in the process.
After 13 years without an incident of substance diversion — a theft from a research lab, for example — the University of Minnesota Senate approved a policy change earlier this month that eliminates the requirement for researchers to register with the Minnesota Board of Pharmacy.
Researchers still must register with the Drug Enforcement Administration, but it’s now one registration per building rather than one per researcher.
Controlled substances include both legal and illegal drugs that can be
addictive.
The University policy change affects research on both humans and animals.
The change is part of the University’s risk recalibration initiative, said Sarah Waldemar, director of Research Education and Oversight at the University.
The initiative was established in January 2011 by the Office of the Vice President for Research, and it establishes a “high tolerance for risks in the pursuit of innovative research.”
Cleared at all levels
Various groups like the Council of Research Associate Deans at the University discussed the policy change.
The only opponent was someone concerned about substance misuse, Waldemar said.
The pharmacies at Boynton Health Service and the College of Veterinary Medicine were both involved because they typically dispense the drugs used for research.
Officials at the College of Veterinary Medicine were asked about the process of drug acquisition and their verification process for researchers, said Scott Wood, director of the
pharmacy.
“We cleared it all the way through to make sure the change was acceptable and made sense to everyone,” Waldemar said.
The change is mostly a matter of clarification and showing the University is in compliance with federal guidelines, said Sally Gregory Kohlstedt, Senate Consultative Committee chair.
“The world is becoming more complicated, and we are trying as a nation to both be very international and security-conscious, and this reflects that,” she said.
A streamlining effort
Overall, the policy change streamlines the registration process without decreasing oversight, Wood said.
The University’s administrative policy on using controlled substances for research was established in July 1997 following an incident of substance misuse that caused a death.
Though registration with the state was not a legal requirement, it was included in the policy to prevent diversion in the
future.
License holders at the unit level — pulmonary medicine or radiology, for example — are responsible for holding a DEA license.
The license holders are chosen by the administrative head of each unit, Waldemar said. They are responsible for determining who is authorized to conduct research with controlled substances, submitting inventories and enforcing regulations.
Researchers use a copy of the unit DEA license to obtain controlled substances from pharmacies or wholesalers. Other ordering requirements, such as filling out an order sheet and showing identification, remain the same.
Policy requirements for documentation, registration and keeping inventories of substances are also unchanged.
Varying requirements
There is federal oversight for research with controlled substances, but policies vary at the state level.
The 1970 Controlled Substances Act — which created the DEA — established federal jurisdiction of controlled substances including use by
researchers.
At the University of Michigan, state policy requires researchers using controlled substances to register with the state and the DEA.
Researchers can’t obtain a DEA registration until they have satisfied all state requirements.
“In general, it’s problematic just because, once you get the license, you really can’t do anything with it,” said Patrick Lester, a clinical professor at the University of Michigan. “You can’t order drugs, you can’t store drugs.”
Lester said he’s unsure whether the two levels of registration prevent diversion from occurring, but he said it does allow for a higher level of sanctions.
Diversion can be tracked more easily, he said, and anyone caught diverting substances is subject to both state and federal prosecution.
Examination of how the policy change has affected research will begin in the spring, Waldemar said. Oversight will include inspections, inventory reviews and registration checks with the DEA.
Ultimately, Waldemar said, there is only so much that oversight can do.
“The bottom line is, if a person wants to do it, they’re going to do it,” Waldemar said. “It doesn’t matter how many registrations we make them fill out.”
