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Regulation 31 (formerly 32) on the use of controlled substances in the treatment of pain by the Board of Medical Licensure and Discipline (BMLD) has been published December 1, 2012 with an effective date of December 11, 2012. In order to continue to prescribe controlled substances for your patients, you need to update yourself and your practice.

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In February 2012, the Board of Medical Licensure and Discipline (BMLD) promulgated Regulation 31 (formerly 32) on the use of controlled substances in the treatment of pain. This new rule was based on a model policy from the Federation of State Medical Boards (FSMB) on the use of controlled substances in the treatment of chronic pain.  In its adoption, the Board made unique changes to the policy that significantly raised angst among physicians and threatened patient access to care (a MSD survey showed that if Reg 31 remained unchanged, 20-45% of physicians planned to stop prescribing all controlled substances for their patients).

Immediately, your Medical Society began discussions with the Board to explain the concerns of physicians:

• The unlimited inclusion of all disease conditions (versus pain) in the scope of rule.
• The unlimited definition of controlled substances.
• The absence of recommendations for Board use of guidelines of expert review.
• Absolute requirements for specific physical exam elements (versus those clinically relevant).

MSD leadership and staff pressed the case for amendments before the Board’s Rules and Regulations Committee, the Division of Professional Regulation and also the entire Board.  MSD’s goal was, and remains, to balance appropriate patient care (already done by supermajority of physicians) with the need for public safety (the prescription drug abuse epidemic is real).  The Board agreed with MSD recommendations and initiated rule-making procedures to incorporate the amendments.  The Final Rule was published on December 1, 2012 and becomes effective 10 days thereafter. (To see the actual amended language, click this link and scroll down to Reg 31, http://regulations.delaware.gov/register/september2012/proposed/16%20DE%20Reg%20260%2009-01-12.htm) 

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1. Review Regulation 31.  In addition, the Guidelines for Use of Controlled Substances for the Treatment of Pain authored by the Physicians Advisory Committee for Controlled Substances (PACCS) of the Medical Society of Delaware (MSD) specifically address the Acute, Sub-acute, Hospice and Emergency Department settings.
2. Incorporate risk assessment, examination and documentation strategies from Reg 31.

a.   If you are treating chronic pain, you need to institute basic best practices (if you have not already) and these are listed as elements of Reg 31. 

b.   If you are treating acute pain, you need to perform basic risk assessment and be aware of elements relative to chronic pain (because any patient may cross over to chronic pain).  For those acute pain patients who are either high risk or have a history of substance/medication abuse, you need to consider (1) chronic pain elements (i.e. Agreement for Treatment, drug testing, etc) and/or (2) pain management consultation.  Therefore, you should maintain a basic knowledge of risk assessment and the elements of chronic pain treatment as outlined in Reg 31 and the Guidelines mentioned above. 

If you have questions about specific requirements, please contact the BMLD at (302) 744-4500.