Opioid Regulations Often Misunderstood by Practitioners

SALT LAKE CITY – State laws governing the availability and use of opioid analgesics are becoming less onerous, but confusion persists among regulators and practitioners, David E. Joranson said at the annual meeting of the American Academy of Hospice and Palliative Medicine and the Hospice and Palliative Nurses Association.

“There are some positive aspects of policies being developed over the last several years because [states] are 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.”

Many physicians do not have a clear understanding of federal and state regulations governing pain management and overestimate state and federal restrictions on opioid use. This disconnect can contribute to unreasonable fear of regulatory scrutiny and unnecessary conservatism in prescribing, he said.

In an interview, Mr. Joranson urged the major organizations advocating for improved pain management in palliative care to focus their members' attention on better understanding how policies can improve patient care–and then work to change those that hinder treatment.

“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, those who attended the meeting 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 survey participants 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, culminating in a “report card” issued in 2006. The overall grade improved over the period 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 the addiction issue are Arizona, Colorado, Georgia, Hawaii, Idaho, Indiana, Louisiana, Maryland, Missouri, Nevada, New Jersey, North Carolina, Oklahoma, Tennessee, and Wyoming.

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.

This is an opportunity for physicians to come forward and explain to policy makers the importance of making those changes that are needed, Mr. Joranson said.

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

For more information on state policies and guidelines on pain and links to other resources, go to www.painpolicy.wisc.edu/index.htm

The Pennsylvania Uniform Control Substances Act's definition of addiction is confusing. MR. JORANSON

SALT LAKE CITY – State laws governing the availability and use of opioid analgesics are becoming less onerous, but confusion persists among regulators and practitioners, David E. Joranson said at the annual meeting of the American Academy of Hospice and Palliative Medicine and the Hospice and Palliative Nurses Association.

“There are some positive aspects of policies being developed over the last several years because [states] are 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.”

Many physicians do not have a clear understanding of federal and state regulations governing pain management and overestimate state and federal restrictions on opioid use. This disconnect can contribute to unreasonable fear of regulatory scrutiny and unnecessary conservatism in prescribing, he said.

In an interview, Mr. Joranson urged the major organizations advocating for improved pain management in palliative care to focus their members' attention on better understanding how policies can improve patient care–and then work to change those that hinder treatment.

“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, those who attended the meeting 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 survey participants 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, culminating in a “report card” issued in 2006. The overall grade improved over the period 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 the addiction issue are Arizona, Colorado, Georgia, Hawaii, Idaho, Indiana, Louisiana, Maryland, Missouri, Nevada, New Jersey, North Carolina, Oklahoma, Tennessee, and Wyoming.

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.

This is an opportunity for physicians to come forward and explain to policy makers the importance of making those changes that are needed, Mr. Joranson said.

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

For more information on state policies and guidelines on pain and links to other resources, go to www.painpolicy.wisc.edu/index.htm

The Pennsylvania Uniform Control Substances Act's definition of addiction is confusing. MR. JORANSON

SALT LAKE CITY – State laws governing the availability and use of opioid analgesics are becoming less onerous, but confusion persists among regulators and practitioners, David E. Joranson said at the annual meeting of the American Academy of Hospice and Palliative Medicine and the Hospice and Palliative Nurses Association.

“There are some positive aspects of policies being developed over the last several years because [states] are 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.”

Many physicians do not have a clear understanding of federal and state regulations governing pain management and overestimate state and federal restrictions on opioid use. This disconnect can contribute to unreasonable fear of regulatory scrutiny and unnecessary conservatism in prescribing, he said.

In an interview, Mr. Joranson urged the major organizations advocating for improved pain management in palliative care to focus their members' attention on better understanding how policies can improve patient care–and then work to change those that hinder treatment.

“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, those who attended the meeting 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 survey participants 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, culminating in a “report card” issued in 2006. The overall grade improved over the period 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 the addiction issue are Arizona, Colorado, Georgia, Hawaii, Idaho, Indiana, Louisiana, Maryland, Missouri, Nevada, New Jersey, North Carolina, Oklahoma, Tennessee, and Wyoming.

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.

This is an opportunity for physicians to come forward and explain to policy makers the importance of making those changes that are needed, Mr. Joranson said.

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

For more information on state policies and guidelines on pain and links to other resources, go to www.painpolicy.wisc.edu/index.htm

The Pennsylvania Uniform Control Substances Act's definition of addiction is confusing. MR. JORANSON