Taking back your turf: Understanding the role of law in medical decision making in opioid management (Part II—Putting legal/regulatory materials to work for you)
DOI:
https://doi.org/10.5055/jom.2005.0040Keywords:
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I do not intend for this section to cover every question relevant to compliance for controlled-substance prescribing.
You may obtain a copy of the Model Policy on the Federation’s Web site: http://www.fsmb.org.
To determine where your state stands, visit http://www.fsmb.org.
It is important to remember that as a “policy,” the Federation’s Model Policy does not have the force of law in a state unless the state incorporates the document into a licensing board regulation or rule. Likewise, a “policy” does not itself set a standard of care. Instead, a “policy” typically sets forth minimum standards of medical practice as defined by a state licensing board, meaning that you should follow them or have a good and well-documented reason for not doing so.
This is commonly referred to as “verification.” A good way to do this is to get records directly from prior providers instead of simply relying on the patient’s self-report or delivery of his/her own medical records.
Remember, these are only my recommendations based on my experience. Your state’s position on these issues is in control. If you have a specific legal question in this area, make sure to ask your attorney or expert counsel.
In some states this is a “must,” and I believe personally that it is best to use a written treatment plan.
I am not attacking the Federation’s efforts here. I was privileged to participate in the drafting of the Model Policy, and I think that the Federation’s work product has had a very positive effect on furthering pain management policy in the United States. However, I also believe that it is important to emphasize the difference between pain policy and legal/regulatory standards, especially when it comes to educating physicians about compliance and risk-management issues. Not only do I look at documents like the Model Policy from the “how are we balancing pain care and legal/regulatory interests” perspective, but also from a “what can and does happen when legal and regulatory suits are filed in civil and criminal courts, or before licensing boards” perspective. I mean only for my comments here to help physicians think about the different approaches to these matters as they make decisions about their approaches to compliance and risk management.
I actually believe that informed consent is required any time you prescribe any medication to a patient. Take, for example, the anticoagulation drug, Coumadin. If you had to prescribe this to a patient, no doubt you would talk to the patient about the risks of not taking the drug at all, the risks of taking too much or too little, the risks of taking certain other medications in addition (e.g., aspirin), the effects of alcohol, etc. You would also discuss the benefits of using the drug, especially when the patient has a history of a Factor V Leiden mutation, as I do. And, finally, you would discuss the treatment alternatives to using Coumadin. I will discuss extended informed consent issues, including informed consent for off-label use of medications for pain management, in a future article.
As of August 22, 2005, the Web site for the Patient Rights handbook is http://www.calpatientguide.org. The American Medical Association Code of Ethics describes informed consent as a process, whereby the physician covers the elements described above with the patient and then allows the patient to ask him/her directly questions about these matters. If, at any time, your treatment recommendations involve the use of different drugs or drugs in off-label ways, then a new informed consent process is in order.
http://www.legalsideofpain.com.
New Jersey Administrative Code Title 13, Chapter 35, Subchapter 7, section 7.6, available online at: http://www.state.nj.us/lps/ca/bme/statreg/bmeregulations2.doc.
Louisiana Administrative Code Title 46, Vol. 45, Chapter 69, Subchapter B, Section B-6921, available online at: http://www.lsbme.org/documents/laws_rules/rules/46V45069PrescriptionDi spensationandAdministrationofMedicatio.pdf.
In April 2005, the California Medical Board issued a statement about the DEA’s Interim Policy Statement that suggested to some that the statement itself required physicians to see their patients every month, prior to issuing a new Schedule II prescription. In July 2005, the California Medical Board issued a “clarifying” statement about this matter, stating that the board did not mean to suggest that physicians must personally see their patients each month and referred CA physicians back to the CA guideline on using controlled substances to treat pain. To read these two items, go to the board’s Web site at http://www.medbdca.gov and look under Controlled Substances in the April and July Action Reports.
Of course, doing everything I mention in this paper does not guarantee that you will be problem free when it comes to issues surrounding the abuse and diversion of controlled substances. Nonetheless, you will be able to show that you understand the legal/regulatory boundaries and use them to guide your documentation process.
Federation of State Medical Boards’ Model Policy for the Use of Controlled Substances for the Treatment of Pain, May 2004.
To obtain the DEA’s Pharmacist’s Manual, go to http://www.deadiversion.usdoj.gov and click on “Publications” and then “Manuals.”
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