Aaron M. Gilson, MS, MSSW, Ph.D., has pursued a career addressing policy and system initiatives. He is the Director of the U.S. Program at the Pain and Policies Study Group, a World Health Organization Collaborating Center for Policy and Communications in Cancer Care, at the University of Wisconsin Carbone Comprehensive Cancer Center.

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Questions

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Evelyn Corsini, MSW:

The American Pain Society and the American Academy of Pain Medicine published suggested clinical guidelines for the use of chronic opioid therapy (COT), in chronic noncancer pain (CNP), in early 2009. One guideline states “clinicians should be aware of current federal and state laws, regulatory guidelines, and policy statements that govern the medical use of COT for CNP.”

From your experience with prescribing clinicians across the US, how would you assess this knowledge?

Aaron M. Gilson, MS, MSSW, Ph.D.: I was a panel member and co-author of this policy, and I contributed this particular guideline recommendation because I believe that there is a great variability in clinicians’ knowledge in this area. Over the past decade especially, clinicians have become more aware of the importance of understanding these policies, but I believe that their actual knowledge is generally still lacking. For example, many clinicians still believe that the policies in their state do not condone chronic opioid therapy for non-cancer pain, even though most states have some type of policy promoting such practice.

I believe that for many, the problem relates back to their educational experience. We know that, even now, there is very little teaching about chronic pain in medical schools. Consequently, there are not many opportunities to acquire this knowledge in medical school, as well as in schools for other healthcare professionals.

EC: In your opinion, what impact does the lack of knowledge of these policies have on clinician practice and patient care?

AG: Unfortunately, there is both misinformation and a lack of knowledge. I just touched on an example of misinformation, when clinicians mistakenly believe that their state’s regulatory policy does not condone using controlled substances for treating pain. Such beliefs can then contribute to the high prevalence of concern that clinicians’ report about being investigated by a regulatory agency if controlled substances are prescribed. In addition, it is fair to say that practitioners who are unaware of their state’s regulatory policy supporting the treatment of chronic pain may be less likely to conform to those specific practice recommendations. In such a situation, clinicians would be more vulnerable to regulatory investigation or discipline if they fail to comply with such fundamental practice tenets – and, if such tenets appear in statute or regulation, they would be in violation of law.

If you feel that your state policy inhibits your ability to use your clinical judgment to provide the best patient care, then you can actively engage in activities to help improve the policy and to remove the barriers. Historically, organizations like the Alliance of State Pain Initiatives and the American Pain Foundation have mobilized clinicians to work with their state legislators to overcome these barriers. And it is these kinds of activities that have contributed to the substantial state-level policy progress that we have seen in recent years.

EC: What policy changes have occurred in recent years that clinicians should understand?

AG: I am especially heartened by the recent activity of healthcare regulatory agencies to promote the safe and effective treatment of pain, not just medical boards but also boards of pharmacy and nursing, and even dentistry in some states. Most of this policy change is a function of the availability of a series of model policy templates for the use of controlled substances for the treatment of pain developed by the Federation of State Medical Boards, which is the national umbrella organization for all state medical boards. To date, 37 state medical or osteopathic boards have adopted the Federation’s models to help guide health care practitioners in the safe and effective use of controlled substances, and multiple regulatory boards (such as medicine, pharmacy, and nursing) in a number of states have developed joint policy statements for pain management. In addition, some states have adopted statutes, such as “intractable pain” acts or a “pain patient bill of rights”. Only two states (Illinois and Indiana) do not have some type of state pain policy.

While guidelines do not have force of law, they do allow for treatment flexibility, outline a number of treatment steps (such as patient selection, informed consent, periodic patient monitoring, and documentation), and urge clinicians to be compliant with relevant federal and state laws and regulations.

EC: What is the goal of state prescription drug monitoring programs?

AG: Prescription drug monitoring programs are a state-level strategy to reduce the abuse and diversion of prescription medications, including pain medications. The program can be a useful clinical practice tool to help guide treatment by permitting prescribers access to information about other medications being prescribed to their patients, and thus potentially identify doctor- or pharmacy-shoppers. Currently, 34 states have an operational prescription drug monitoring program, and several other states are developing implementation plans to do so. Better communication about these programs is warranted, however, because surveys in many states show that only around 20% of prescribers are even aware that the program exists, let alone know how to access or interpret the data.

Each state prescription drug monitoring program is unique, and they vary in the way that clinicians can access information. Most states’ programs cannot share data, and this is something that needs rectifying to enhance their utility. Unfortunately, shrinking state budgets have the potential to limit the advance of these programs.

EC: What resources are available to clinicians to learn about current controlled substances laws and policies that affect them, and to help them stay current with changes?

AG: The Pain and Policy Studies Group at the University of Wisconsin (www.painpolicy.wisc.edu) maintains a database of state statutes, regulations, and other official governmental policies. From the site it is very easy to access the full text of the policies in each state. On the home page we also have available an “Evaluation Guide,” which contains our criteria-based analysis of all states’ policies that are relevant to this issue, so that people can understand the extent that the policies in their state can either promote or impede effective pain care. And this is the principal resource that people use to justify changing the policies in their state.

I also would recommend that practitioners visit the website of their regulatory licensing board, since most boards offer links to current relevant laws and regulations.

In addition, the US Department of Justice, Drug Enforcement Administration, Office of Diversion Control (www.deadiversion.usdoj.gov) now has separate manuals for physicians and pharmacists to aid their understanding of the Federal Controlled Substances Act and its implementing regulations as they pertain to the two healthcare disciplines.

EC: What advice do you have for those clinicians who fear that they are vulnerable to regulatory investigation or discipline?

AG: It is most important to understand and adhere to your state’s statutes, regulations, and regulatory guidelines, and to set up your practice in a way that you can demonstrate that you follow the parameters established by these policies. Having the knowledge, and then showing that your practice conforms to the policies in your state, is an important strategy.