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Regulation Issues in Pain Management
Jean B. Lazarus, EdD, RN
Alabama Board of Nursing
February 2002

Pain, inextricably linked to health care delivery, erupted as a major regulatory issue in the last decade of the 20th century. Social issues of compassion for end-of-life care, stigma associated with chronic pain management as well as issues of substance abuse have collided with political intrigue and regulatory authority.

Pain management is directed by federal and state health policy. At the federal level, the Controlled Substances Act of 1970 as amended contains the primary regulations that establish limitations on medical prescribing. State laws and regulations or policies set parameters for prescribing in matters of pain control. Regulatory agencies are held accountable for implementing the laws and regulations. Professionals who work for regulatory compliance may be highly sensitive to issues of pain management, but assuring compliance is their responsibility and the caveat for the regulatory agency.

In the current world of state regulations, enforcement is primarily complaint driven, retrospectively, rather than proactively driven through quality control measures. Seventeen states have formal monitoring programs for determining adherence to prescribing practices, the majority of which are directed to medical practice. Of these, only three include joint statements that involve nurses and pharmacists. Reasons for this are built in the traditions of medical control over prescribing practices. Today with other professions authorized for prescriptive practice, there is need to assure compliance with prescriptive authority as established by the law. Concerns center on illegal dispensing of drugs and substance abuse, as well as qualifications of licensees to prescribe.

Manpower issues and lack of formal monitoring systems for adherence to pain policies deter effective monitoring so that regulatory agencies relent to investigation simply to take care of the worse case scenarios. As one medical Board investigator put it, "This pain management thing caught us off guard. We're doing all we can to educate ourselves on the model laws and resultant rules, as well as proposed legislation so we can help educate the doctors about their responsibilities. Today only one in ten have any idea of our pain relief guidelines." Another investigator, this one from a Board of Nursing, said that they are just starting a proactive monitoring system, but it is necessarily random and limited due to manpower shortages and cost. Additionally, investigators encountered resistance from physicians, nurses, and organizations' attorneys when seeking access to records.

Moving any public policy into regulations at the state and local levels requires considerable finesse. Pain management policy is still in development and implementation infancy. From a regulatory perspective, there is need to establish a balance in assuring compliance with rules that offer protection to the public from unscrupulous practices, while allowing the latitude for autonomy in decision making for compassionate care. There is need for proactive monitoring to assure compliance with regulations, and there is need to assure that the regulations are not unreasonably cumbersome so that health care practice is not impeded. There is need for regulatory agencies to support education for pain management and substance abuse to assist providers in decision-making about pain management. Finally there is need for research to advance pain management to more exacting practice so that evidence can be applied to sound changes in regulations.

When negligence or failure to meet professional standards is evidenced, regulatory agencies must consider hard decisions about licensure. The goal, however, would be for regulatory agencies to become proactive in the interest public safety and welfare and focus on prevention through education and monitoring for compliance with pain policies before public harm is caused.