Code of Maine Rules › 02 - DEPARTMENT OF PROFESSIONAL AND FINANCIAL REGULATION › 396 - BOARD OF LICENSURE OF PODIATRIC MEDICINE › Chapter 21 - USE OF CONTROLLED SUBSTANCES FOR TREATMENT OF PAIN › Section 396-21-1 - PURPOSE

Current through 2024-29, July 17, 2024
The Boards are obligated under the laws of the State of Maine
				  to protect the public health and safety. The Boards recognize that medical and
				  advanced nursing practice dictate that the people of the State of Maine have
				  access to appropriate, empatheticand effective pain management. The application
				  of up-to-date knowledge and treatment modalities can help restore function and
				  thus improve the quality of life of patients who suffer from pain, especially
				  chronic pain.
The Boards recognize that controlled substances, including
				  opioid analgesics, may be essential in the treatment of acute and chronic pain,
				  whether due to cancer or non-cancer origins. However, the Boards are also aware
				  that the inappropriate prescribing of controlled substances poses a threat to
				  the patient and society, and may lead to drug diversion and abuse by
				  individuals who seek them for other than legitimate medical uses. Controlled
				  substanceabuse and overdoses have become very serious public health problems in
				  the United States and Maine.In October 2015, the Maine State Epidemiological
				  Outcomes Workgroup (SEOW) issued a special report on heroin, opioids, and other
				  drugs in Maine. 
				  1The executive summary of that report
				  included:
Prescription drugs continue to represent a serious
					 public health concern.
									Prescription drug misuse continues to have a large
					 impact on treatment, mortality/morbidity, and crime in Maine.
									Pharmaceutical drugs contribute to the majority of drug
					 overdose deaths.
									As the availability of prescription narcotics has
					 leveled off, heroin use and the consequences thereof have been on the
					 rise.
									 Availability and accessibility of opioids continues to
					 be a problem.
According to the SEOW report, from 2009 to 2014 drug-related
				  overdose deaths went up each year. In 2014, there were 208 drug-related
				  overdose deaths compared to 131 motor vehicle related deaths. Of the 208
				  drug-related deaths, 186(89%) involved pharmaceutical drugs. According to the
				  Maine Attorney General's Office, in 2015 there were 272 drug-related overdose
				  deaths in Maine - an increase of 31% over 2014. 
				  2The increase was attributed to heroin
				  or fentanyl or a combination of the two drugs. In addition, overdose deaths
				  (157) caused by illegal drugs like heroin exceeded overdose deaths (111) caused
				  by pharmaceutical opioids. In December 2015, the CDC issued a new report 
				  3 on opioid overdose deaths in the
				  U.S., which included the following observations:
There is an epidemic of drug overdose (poisoning)
					 deaths in the United States.
									Since 2000, the rate of deaths from drug overdoses has
					 increased 137%, including a 200% increase in the rate of overdose deaths
					 involving opioids (opioid pain relievers and heroin).
									In 2014 there were 47,055 drug overdose deaths in the
					 United States.
									The opioid epidemic is worsening.
									Maine was one of 14 states with statistically
					 significant increases in the rate of drug overdose deaths from
					 2013-2014.
									Opioids - primarily prescription pain relievers and
					 heroin - are the main drugs associated with overdose deaths.
									Natural and semisynthetic opioids - which include the
					 most commonly prescribed opioid pain relievers oxycodone and hydrocodone -
					 continue to be involved in more overdose deaths than any other opioid
					 type.
									Heroin drug overdoses tripled in 4 years - and are
					 closely tied to opioid pain reliever misuse and dependence.
									Reversing this epidemic of opioid drug overdose deaths
					 requires intensive efforts to improve safer prescribing of opioids.
In 2016, on a national level prescriptions for narcotic
				  medications were down 16% from their peak in 2011. 
				  4 However, in 2016, there were 376
				  opiate-related overdoses in Maine (representing a 38% increase over 2015). The
				  vast majority (84%) were caused by at least one opioid, including
				  pharmaceutical and illicit opioid drugs. Pharmaceutical opioid deaths (33%)
				  remained mostly stable; however, the number of deaths caused by hydrocodone
				  increased substantially from 2 in 2015 to 18 in 2016. 
				  5Accordingly, the purpose of this rule
				  is to require that clinicians, consistent with the "CDC Guideline for
				  Prescribing Opioids for Chronic Pain - United States, 2016," 
				  6first consider the use of
				  non-pharmacologic modalities and non-controlled drugs in the treatment of pain
				  prior to prescribing controlled substances. Clinicians shall also be required
				  to use and document Universal Precautions when prescribing controlled
				  substances for the treatment of pain, including conducting a risk assessment to
				  minimize the potential for adverse effects, abuse, misuse, diversion, addiction
				  and overdose from controlled substances.Diversion and "doctor shopping" account
				  for 40% of drug overdose deaths in the United States. 
				  7To address this issue, clinicians
				  have an obligation to utilize the PMP.While appropriate pain management is the
				  clinician's responsibility, inappropriate treatment of pain may result from a
				  clinician's lack of knowledge about pain management. Therefore, clinicians who
				  prescribe controlled substances are required to maintain current clinical
				  knowledge by complying with continuing education requirements set forth in this
				  rule. In addition, clinicians shall comply with all applicable state and/or
				  federal laws regarding prescribing of controlled substances.
The Boards also recognize that tolerance and physical and
				  psychological dependence are normal consequences of the sustained use of opioid
				  analgesics and are not the same as addiction, but addiction is a definite risk
				  of such treatment. Clinicians shall offer or arrange evidence-based treatment
				  (usually medication-assisted treatment with buprenorphine or methadone in
				  combination with behavioral therapies) for patients with opioid use
				  disorder.
The Boards will evaluate allegations of inappropriate
				  prescribing of controlled substances by referring to current clinical practice
				  guidelines, including the "CDC Guideline for Prescribing Opioids for Chronic
				  Pain - United States, 2016. "In addition, the Boards will review compliance
				  with this rule, and when necessary, employ expert review in evaluating
				  clinician prescribing of controlled substances. Clinicians should not fear
				  disciplinary action from the Boards for prescribing controlled substances,
				  including opioid analgesics, for a legitimate medical purpose and in the course
				  of professional practice if they are following standards of care, established
				  guidelines and the requirements of this rule. Judgment regarding the propriety
				  of any specific course of action must be made based on all of the circumstances
				  presented, and thoroughly documented in the patient's medical record.
1 Maine Department of Health and
				  Human Services, Office of Substance Abuse. SEOW Special Report: Heroin,
				  Opioids, and Other Drugs in Maine. October 2015.
http://www.maine.gov/dhhs/samhs/osa/data/cesn/Mental_Health_in_Maine_SEOW.pdf
.
2 Gagnon, Dawn. "Overdose Deaths
				  Hit Record High in Maine." Bangor Daily News. Mar. 8, 2016, p. A1.
3 "Increases in Drug and Opioid
				  Overdose Deaths - United States 2000-2014." U.S. Centers for Disease Control
				  and Prevention Morbidity and Mortality Weekly Report, Early Release/Vol. 64,
				  December 18, 2015.
4 Doug Long (IMS Health), "The
				  U.S. Pharmaceutical Market: Trends and Outlook," August 7, 2016.
5 Marcella H. Sorg, PhD (2016)
				  "Expanded Maine Drug Death Report for 2016," Margaret Chase Smith Policy
				  Center, University of Maine.
6 "CDC Guideline for Prescribing
				  Opioids for Chronic Pain - United States, 2016," U.S. Department of Health and
				  Human Services Centers for Disease Control and Prevention Morbidity and
				  Mortality Weekly Report, Early Release/Vol. 65, March 15, 2016.
http://www.cdc.gov/mmwr/volumes/65/rr/rr6501e1.htm
.
7 Paulozzi, L. Baldwin, G.,
				  Franklin, G., Ghiya, N., & Popovic, T. (2012). CDC Grand Rounds:
				  Prescription Drug Overdoses - a U.S. epidemic. Center for Disease Control and
				  Prevention, Morbidity and Mortality Weekly Report (MMWR), 61(01), 10-13.
http://www.cdc.gov/mmwr/preview/mmwrhtml/mm6101a3.htm
.