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Balancing State Opioid Policies With Need for Access to Pain Therapies

States are increasingly playing a regulatory role when it comes to certain pain medications. To follow is a discussion with Dr. Ziegler on the impact of drug regulation and enforcement on the treatment of pain.
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Q : What research are you currently engaged in?

Dr. Ziegler: I am examining the proliferation of opioid dosage thresholds in various state prescribing policies. Once a chronic pain patient’s daily opioid dosage reaches a predetermined threshold—for example, 120 mg/d morphine equivalent dose (MED)—it triggers an action by the prescriber. The thresholds and the actions that prescribers must take once this threshold is reached differ by state. For example, in Washington State, a 120 mg/d MED threshold will trigger the prescribing physician to conduct, or refer the patient for, a pain consultation (exceptions and exemptions do exist).1

In some states, these thresholds appear in regulations, making the actions required actions, while in other states the thresholds appear in guidelines, making the actions merely recommended.

One goal of my research is to understand the impact of dosage threshold models across the United States and to examine their potential to create unintended consequences, specifically increased pain and increased opioid-related mortality—the very thing that policymakers are trying to prevent. Dr. Tennant and colleagues recently discussed rationale medical management in pain care.

Many policymakers are looking for the panacea or silver bullet solution to prevent unintended overdose, but it is complex problem and finding a solution will be extremely difficult. Preventing prescription drug abuse is complicated, and there are no easy answers. Many unintentional opioid overdoses stem from polypharmacy and/or polysubstance abuse; all solutions should keep this in mind.

Another goal of my research is to advance balanced policies and approaches. We hear a lot about opioid overdose rates, but we don’t hear a lot about undertreated pain. It is not appropriate for policies to focus solely on one issue and ignore the other.

Q: What advice would you give to primary care physicians and pain specialists who struggle with decisions about whether or not to prescribe opioids to patients with noncancer pain?

Dr. Ziegler: Prescribers certainly are concerned about prescribing opioids to patients with noncancer pain, but they also are concerned about prescribing opioids to those who are terminally ill. What is best for their patient? The Institute of Medicine and others recognize that pain is individualized; its treatment should be individualized as well.

I would also recommend that prescribers read Responsible Opioid Prescribing: A Clinician’s Guide by Scott Fishman, MD.2 The book covers patient evaluation, treatment plans, informed consent, periodic review, documentation, compliance, etc. Dr. Fishman offers good advice that is straight to the point. As he notes, clinicians should be familiar with state and federal prescribing rules and regulations. State medical or osteopathic associations might be helpful in locating these resources.

Q: Do you think that the reclassification of all hydrocodone combination agents from Schedule III to Schedule II under the federal Controlled Substances Act will help curb opioid abuse?

Dr. Ziegler:No, I do not (of course it depends on how one defines and measures abuse). I recently wrote an article about this topic for Pain View.3< The reason is that drug abuse is a moving target and is an extremely complex social and medical phenomenon. Politically, it may look like the Drug Enforcement Agency (DEA) did something by playing a significant role in the change from Schedule III, but the move will create access problems. This was a broad sweeping reform that has both positive and negative consequences. The action is positive in that it creates a barrier to abuse via more restrictive scheduling, but it is negative because it creates barriers to adequate treatment of pain by reducing legitimate access. The DEA is a law enforcement agency, not a public health agency. Drug abuse and undertreated pain are public health problems, not law enforcement problems.

Q: Can you give an example of a balanced policy on opioid prescribing?

Dr. Ziegler: Yes, New Mexico has decided not to establish a dosage threshold because of concern that such a policy would interfere with the patient-provider relationship. Instead, the state requires a mandatory continuing medical education course covering both prescription drug abuse prevention and the treatment of pain.4-7 Thus, the program is balanced and does not fixate on one problem at the expense of the other. The program was created by several stakeholders—regulators, practitioners, and the public—to ensure balance.

Another example of a balanced approach is Project Lazarus (—a public health model that not only focuses on overdose but also provides educational opportunities related to pain treatment.

Q: How did you become interested in prescription drug policy and pain treatment?

Dr. Ziegler: I come from a medical family; thus, I had an interest in medicine already. However, I also was interested in the social sciences and politics, because I am a reformer.

In college, I took a course on bioethics and it merged my interest in medicine, politics, and reform. I was particularly interested in end-of-life decision making, because my overarching goal in research always has been a desire to reduce unnecessary human suffering.

When I was in law school, Jack Kevorkian was assisting the death of terminally ill people. It was at this time that pain treatment became intertwined with the topic of assisted death. Physicians became concerned that if they overmedicated a patient during end-of-life care and the patient expired, they might be accused of assisting death. I went on to practice law for a couple of years and then decided that what I really love to do is work in the health care and research fields.

When I was in my PhD program, my dissertation focused on the likelihood of prosecution stemming from opioid and non-opioid administrations. Coincidentally, the Mayday Fund had a request for proposal out on a similar topic, and I received a grant from the Fund to study pain management and the risk of criminal prosecution in Connecticut, Oregon, Maryland, and Washington. The research showed that the risk of investigation or prosecution was less when terminally ill patients were involved. This research led to publication of my research in several peer-reviewed outlets,8 and the opportunity to present my research at the National Press Club in Washington, D.C.

In 2005, with a grant from the Greenwall Foundation, I worked as a research fellow at the Institute of Legal Medicine in Zurich, Switzerland, where I studied the Swiss model of assisted suicide to explore its potential to inform the regulation of assisted death in the United States.

Last updated on: May 12, 2015
First published on: March 1, 2015