Regulatory Issues & Addiction

Because opioid analgesics have the potential to be abused, their medical use is subject to special laws and regulations. It is incumbent upon the physician to be familiar with both federal and state requirements and the elements that are essential to responsible opioid prescribing. This session provides links to relevant resources and also emphasizes the need to understand the meaning of the terms: tolerance, physical dependence and addiction.

Licensed physicians who wish to prescribe opioids must

  1. Register with the Drug Enforcement Administration (DEA)
  2. Comply with the requirements in the Controlled Substances Act (CSA) http://www.usdoj.gov/dea/pubs/csa.html
  3. Comply with the laws and regulations of the state in which they practice.

Responsible Opioid Prescribing

To reduce concerns about the use of these drugs, The Federation of State Medical Boards (FSMB) has developed a Model Policy that distills safe opioid prescribing into seven basic elements:

  1. Evaluation of the patient
  2. Development of a treatment plan
  3. Informed consent and agreement for treatment
  4. Periodic review
  5. Consultation
  6. Maintenance of comprehensive medical records
  7. Compliance with controlled substances laws and regulations

Table 6 summarizes the FSMB criteria for evaluating the physicians' treatment of pain. Consult the Federation's web site for more details http://www.fsmb.org.

Under all circumstances, the following 4 outcomes of therapy should be regularly assessed and documented:

  • Analgesia: pain relief
  • Activities of Daily Living: physical and psychosocial functioning
  • Adverse effects: side effects (these are common and can affect function and adherence)
  • Aberrant behaviors: may indicate addiction or inadequate treatment