It’s no secret that the United States is battling an opioid epidemic. As relevant for our Phoenix practice, in Arizona, Governor Ducey declared a State of Emergency on June 5, 2017 which led to the passing of emergency regulations, effective March 6, 2018, and the Opioid Epidemic Act of 2018, most of the provisions of which were effective beginning April 26, 2018.
These regulations require that medical facilities implement policies to help address and rectify the opioid crisis. Here’s what you should know before you start drafting.
How to write an effective opioid policy:
- Review both federal and state statutes and regulations. Because the Arizona laws are currently stricter than their federal counterparts, you can focus mainly on the Arizona laws. Some of the most relevant regulatory provisions are: A.A.C. R9-10-120 (regulations for prescribing, ordering, and administering opioids), and A.A.C. R9-4-602 (opioid poisoning-related reporting regulations). Some of the most relevant statutory provisions are: A.R.S. §§ 13-3424, 32-1401, 32-1491, 32-1501, 32-1606, 32-1854, 32-1871, 32-2501, 32-3248, 32-3248.01, 36-109, 36-123, 36-192, 36-407, 36-448.01, 36-448.02, 36-2229, 36-2525, 36-2606, and 36-2930.06.
- Understand how an opioid policy ties into other related policies. Creating an opioid policy provides a good opportunity to review the facility’s other policies related to pharmaceuticals (e.g. storage, disposal, and acquisition), and to create tracking sheets for each narcotic used in the facility. Depending on the policies that already exist, you may want to combine or separate out the opioid-specific mandates.
- Pay close attention to definitions. Ironically, several key words in the statutes and regulations have more than one meaning, or may not be defined at all. Look in particular at definitions for “dispense,” which changes depending on the specific medical profession. Also note the difference between “ordering” as in medical ordering (a variation of prescribing) versus “ordering” as in purchase ordering (or inventory ordering). When you draft your own definitions, be conscious of the fact that the medical terminology your readers know does not always match up with (and indeed sometimes has a different meaning altogether from) the legal terminology.
- Read the regulations in full. Many of the new laws have major exceptions, e.g. reduced reporting requirements for physician-administered opioids.
- Be prepared to update these policies quickly. This area of the law is constantly changing at both the state and national level. When you draft your opioid policy the first time, organize it in a way that is easily amendable so it is clear to your readers when new information and requirements are added.
- Information to gather beforehand: Know every type of medical professional that you or your client employs. Also be sure to know and ask about every type of narcotic used in your or your client’s facility. Learn the common names of the drugs as well as the scientific names. Different laws apply to pharmaceuticals depending on their schedule.
- Explain why these laws were created. Your readers will be more likely to strictly follow policies when they understand the reasoning behind them. What goal does the legislature have for the particular medical profession or facility at issue? In other words, why is the policy necessary?
- Communicate with your medical/legal counterpart. Medical providers – If you don’t understand the laws (remember that legal terms and medical terms often don’t have the same meaning), call a qualified attorney who can help guide you. Attorneys – If you don’t understand the medical realities implicated by these laws (remember that legal ideals and medical realities often do not mesh without tweaking), call your clients and ask. To write effective policies, you need bifocals – with both legal and medical vision. Without sufficient knowledge of each, you will not be able to draft effective and comprehensible policies, particularly in this complicated area of the law.