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A recent and disturbing policy shift by the US Drug Enforcement Administration (DEA) "may result in a 'chilling effect' on effective pain care," the American Pharmacists Association (APhA) has charged. In testimony before the House Subcommittee on Regulatory Affairs, an APhA official said that, whereas curbing illicit trafficking of prescription drugs is an important goal, "it is imperative that we balance the need to regulate the 'bad actors' with the need to address the health care needs of patients who have legitimate medical conditions that require access to prescription pain medications."
One specific example of the DEA's "going one step too far" in this regard is the agency's recent shift away from a balanced approach to reducing diversion while promoting pain management, the representative from the APhA told Congress. Under the DEA's new interim policy, a single factorsuch as dispensing controlled substances to a large number of patientsmay indicate that a pharmacist or other health care professional is involved in diversion or abuse. An increased fear of DEA prosecution, the APhA official warned, "will have a 'chilling effect' on the prescribing and dispensing of medically necessary controlled substances."
The APhA official also voiced concern over congressional efforts to legislate OxyContin and other abuse-prone drugs off the market, charging that this action would undermine the FDA and interfere with the treatment of patients. In a statement to the subcommittee, the APhA representative warned that "using the legislative process to set clinical policy circumvents the thoughtful, scientific-based dialogue that supports the FDA's decisions." What may appear to be a simple decision to a legislator "is, to [clinicians], an intrusion on their ability to provide their patients necessary and appropriate care," the representative from the association said.
Mr. Rankin is a freelance medical writer.