Opioid Regulations Are Widely Misunderstood


SALT LAKE CITY — State laws governing the availability and use of opioid analgesics are becoming less onerous, but confusion and misunderstanding persist among regulators and practitioners, according to David E. Joranson.

“There are some positive aspects of policies being developed over the last several years because [states] are more affirmatively recognizing how valuable opioids are in medical practice,” said Mr. Joranson, director of the University of Wisconsin Pain and Policy Studies Group in Madison.

The group's mission is to “achieve more balanced international, national, and state policies so that patients' access to pain medications is not compromised by efforts to prevent diversion and drug abuse,” he said.

A large number of physicians don't have a clear understanding of federal and state regulations governing pain management and overestimate state and federal restrictions on opioid use, a lapse that can contribute to unreasonable fear of regulatory scrutiny and unnecessary conservatism in prescribing, he said at the annual meeting of the American Academy of Hospice and Palliative Medicine and the Hospice and Palliative Nurses Association.

“The major organizations advocating for improved pain management in palliative care should focus the attention of their members on better understanding how policies can improve patient care, and then work to bring change to those policies that are hindering treatment,” Mr. Joranson said in an interview.

“If a physician knows the laws, he should be perfectly comfortable prescribing opioids for chronic pain. If he doesn't know the law, he might be concerned,” he added.

During a luncheon presentation, attendees participated in an electronic survey that showed significant gaps in knowledge.

For example, more than half of the 300 survey participants, which included physicians and nurses, said that the Drug Enforcement Administration limits prescriptions for schedule II controlled substances such as morphine to a 30-day supply, when in fact the DEA permits an unlimited supply (though the agency is currently finalizing a 90-day supply limit).

Many of the participants in the survey also were unaware that several states recently adopted pain policies and eliminated restrictions on drug quantity, Mr. Joranson said. This same survey drew similar results at the recent annual meeting of the American Academy of Pain Medicine in New Orleans, he added.

The Wisconsin Pain and Policy Studies Group conducted a 6-year evaluation and analysis of each state's policies.

The group's efforts culminated in a “report card,” which was issued in 2006. The overall grade improved over the period of the study in 19 states.

Mr. Joranson said that, unfortunately, 16 states confuse physical dependence and addiction, and at least one state contradicts itself. The Pennsylvania Uniform Controlled Substances Act defines a drug-dependent person as someone “who is using a drug, controlled substance, or alcohol, and who is in a state of psychic or physical dependence, or both. … This definition shall include those persons commonly known as 'drug addicts.'”

Yet the Pennsylvania State Board of Medicine guideline says physicians should recognize that tolerance and physical dependence are normal consequences of sustained use of opioid analgesics and are not synonymous with addiction.

“So if you have a physically dependent pain patient in Pennsylvania, depending on which definition you look at, that person either is an addict or is definitively not an addict,” Mr. Joranson said.

Other states that confuse physical dependence with addiction are Arizona, Colorado, Georgia, Hawaii, Idaho, Indiana, Louisiana, Maryland, Missouri, Nevada, New Jersey, North Carolina, Oklahoma, Tennessee, and Wyoming.

States that have no statutes relating to pain management and no regulations or guidelines from the state medical or pharmacy boards are Alaska, Delaware, Illinois, and Indiana, Mr. Joranson said.

A model policy is available from the Federation of State Medical Boards, summarized as follows:

▸ Controlled substances are necessary for public health.

▸ People should have access to appropriate and effective pain relief.

▸ Pain management is part of quality medical practice for all patients with pain, acute or chronic, and it is especially urgent for patients who experience pain as a result of terminal illness.

▸ Physicians should not fear regulatory sanctions.

▸ Physical dependence is not synonymous with addiction.

“Obviously, some of the laws that have the potential to confuse patients and practitioners need to be changed,” Mr. Joranson said.

“This is an opportunity for physicians to come forward and explain to policy makers the importance of making those changes,” he added.

Mr. Joranson has received honoraria from A.L. Pharma Inc. and Abbott Laboratories, and he has received grant support from Endo Pharmaceuticals and Purdue Pharma L.P.

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