ATrain Education

 

Continuing Education for Health Professionals

Pain: Healthcare’s Persistent Challenge

Module 3

Regulatory Issues re Pain Management

Patients, providers, communities, and health systems have struggled to achieve balance between access to opioid treatment for chronic pain and potential harmful consequences of long-term opioid therapy—especially misuse, addiction, and overdose. Regulatory agencies and expert groups have published prescriber guidelines aimed at improving evidence-based practices, including:

  1. Use of opioid treatment agreements
  2. Regular monitoring for efficacy, safety, and misuse using tools such urine drug testing and querying prescription monitoring databases
  3. Provision of, or referral to, addiction treatment if recurrent misuse or opioid use disorder is identified.

These practices are becoming the standard of care for individuals on long-term opioid therapy (Becker et al., 2016).

In 2016 the U.S. Centers for Disease Control and Prevention (CDC) issued Guideline for Prescribing Opioids for Chronic Pain. The guideline calls for a drastic reduction in the use of opioids for the treatment of chronic, noncancer pain. Dosage recommendations for exercising caution are lower than older opioid prescribing guidelines and recognize that even relatively low doses (20–50 morphine milligram equivalents per day) increase risk (CDC, 2016a).

Additionally, the CDC Guideline cautions that opioids pose risk to all patients, and currently available tools cannot rule out risk for abuse or other serious harm. It provides recommendations on providing safer care for all patients. The Guideline also encourages use of recent technological advances, such as state prescription drug monitoring programs. The Guideline provides more specific recommendations than previous guidelines on monitoring and discontinuing opioids when risks and harms outweigh benefits (CDC, 2016a).

The Joint Commission

In recent years, the Joint Commission’s requirement for assessment and reassessment of pain has transformed how healthcare providers approach pain management. The Joint Commission, in collaboration with the University of Wisconsin, Madison, has developed pain management standards for accredited ambulatory care facilities, behavioral healthcare organizations, critical access hospitals, home care providers, hospitals, office-based surgery practices, and long-term care providers. The standards require organizations to:

  • Recognize the right of patients to appropriate assessment and management of pain.
  • Screen patients for pain during their initial assessment and, when clinically required, during ongoing periodic re-assessments.
  • Educate patients suffering from pain and their families about pain management as a part of care. (The Joint Commission, 2013)

The Joint Commission’s pain guidelines further state that:

  • Clinicians must be competent in the assessment and management of pain.
  • Pain should not interfere with optimal level of function or rehabilitation.
  • Pain and symptom management must be included in discharge planning. (The Joint Commission, 2013)

Choice of a pain assessment tool is left to the discretion of an individual healthcare facility, but the Joint Commission encourages a simple 0 to 10 pain scale. Healthcare providers are required to address the needs of non-communicative patients—including those with dementia—by using an alternative means of assessment.

Despite widespread belief to the contrary, the Joint Commission does not require healthcare organizations to assess pain as a fifth vital sign (The Joint Commission, 2016), although the Commission does require that patients be screened for pain during the initial assessment. Some large organizations, including the Veteran’s Administration (VA), in an effort to make pain a more visible part of patient assessment, decided to describe pain as the “fifth vital sign”, to be assessed along with temperature, pulse, respiration, and blood pressure. Acknowledging that assessing pain as a fifth vital sign may have contributed to the overprescribing of opioids, in June 2016 the American Medical Association recommended that pain be removed as one of the vital signs for which patients are assessed.

Controlled Substances Act

The Controlled Substances Act (CSA) established in 1970 is a system that regulates the manufacture and distribution of certain substances with a potential for abuse. The CSA groups or classifies drugs into five “schedules,” based on whether they have a currently accepted medical use in treatment in the United States, their relative abuse potential, and the likelihood of causing dependence when abused (DEA, 2016).

 

The Five Schedules of the Controlled Substances Act

  • Substances in Schedule I have (1) no currently accepted medical use in the United States, (2) a lack of accepted safety for use under medical supervision, and (3) a high potential for abuse. Examples include heroin, marijuana, LSD, peyote, and ecstasy (DEA, 2016).
  • Substances in Schedule II have a high potential for abuse, which may lead to severe psychological or physical dependence. Examples include Dilaudid, methadone, Demerol, oxycodone, and fentanyl (DEA, 2016).
  • Substances in Schedule III have a potential for abuse less than substances in Schedules I or II. Abuse may lead to moderate or low physical dependence or high psychological dependence. Examples include Tylenol with codeine, Suboxone, substances containing not more than 90 mg of codeine per dosage, ketamine, and anabolic steroids (DEA, 2016).
  • Substances in Schedule IV have a low potential for abuse relative to substances in Schedule III. They consist primarily of preparations containing limited quantities of certain narcotics such as Xanax, Soma, Klonopin, Tranxene, Valium, Ativan, Versed, Restoril, and Halcion (DEA, 2016).
  • Substances in Schedule V include cough preparations containing not more than 200 milligrams of codeine per 100 milliliters or per 100 grams (Robitussin AC, Phenergan with Codeine), and ezogabine (DEA, 2016).

 

The CSA also establishes a national drug control system to distribute approved medications to patients. The drug control system is a closed system—that is, all enterprises and individuals involved in production, distribution, prescribing, dispensing, possession, research, and disposal of prescription-only controlled substances must be registered with the Drug Enforcement Administration (DEA) and also the state, if required. Conditions of DEA registration include:

  • Adhering to laws and regulations that limit medication availability to legitimate medical uses and patients
  • Implementing safeguards against diversion
  • Reporting to the DEA amounts distributed to all registrants at the retail level, as well as amounts that are lost or stolen (PPSG, 2014a)

Federal controlled substances laws do not supersede FDA-approved uses of medications, and states have the jurisdiction to regulate healthcare professionals and their practice (PPSG, 2014a).

Physicians can lose their DEA registration and be subject to criminal or civil penalties if they issue prescriptions for non-medical purposes or outside the usual course of medical practice. Many states have policies that acknowledge a practitioner’s need to understand and comply with relevant federal and state laws when prescribing controlled substances (PPSG, 2014a).

Intractable Pain Treatment Acts

Intractable pain is commonly defined as “a pain state. . . which in the generally accepted course of medical practice no relief or cure of the cause of the pain is possible. . .” (PPSG, 2014b).

Intractable Pain Treatment Acts (IPTA) are statutes originally intended to improve access to pain management by providing physicians immunity from regulatory sanctions for prescribing opioids to patients with intractable pain. The first IPTA was adopted by Texas in 1989 (PPSG, 2014b).

IPTAs are a product of the time in which they were first created, typically the late 1980s and 1990s. At that time, many physicians felt that their regulatory authorities viewed opioid use for chronic pain as being outside legitimate medical practice, and they worked with legislators to develop IPTAs to protect their practice from disciplinary action by placing it squarely within legitimate medical practice (PPSG, 2014b).

A potential consequence of such a policy is that prescribing controlled substances, if viewed as outside the IPTA, could be considered a violation of federal and state controlled substances law or regulatory policy. In addition, IPTAs were probably not intended to formalize the use of opioids for pain as being within medical practice only when meeting the IPTA standards. The IPTA language was often ambiguous and was not consistent with the recognition that pain management, including the use of opioid medications, is part of general medicine and is a legitimate professional practice (PPSG, 2014b).

A number of states have recognized these contradictions and have worked to remove confusing language from their IPTAs. For example, in 2001 Michigan became the first state to delete the term intractable pain from its statute, thus making its provisions applicable to pain in general. More recently, both California (the state with the second-oldest IPTA) and Rhode Island repealed a number of restrictive provisions from their IPTAs, including removing the term and definition of intractable pain (PPSG, 2014b).

In states where IPTAs still exist, state policies can require (without exception) the physician to obtain a consultation from a specialist for every patient with intractable pain as a means to qualify for immunity from discipline before prescribing opioids to that patient, regardless of the clinical situation or practitioner qualifications. Such a requirement may be inappropriate if the practitioner is knowledgeable or has relevant expertise, and appears to regulate pain management excessively as well as the entire class of patients who have “intractable” pain (PPSG, 2014b).

Although IPTAs are intended to improve access to pain relief, such policies may instead discourage pain management or limit patient access because of the increased time and administrative burden for the physician, a lack of available consultation resources, as well as the possibility of increased cost for the patient. Also, when a state policy requires a consultation, the liability is unclear for a physician who prescribes an opioid in the course of treating a patient with pain and who does not obtain the consultation (PPSG, 2014b).

The Central Principle of Balance

The Central Principle of Balance represents a government’s dual obligation to establish a system of drug controls that prevent abuse, trafficking, and diversion of narcotic drugs while ensuring the adequate medical availability of needed medications. Opioids, including those in the therapeutic group of morphine, should be accessible to patients who need opioids for the relief of pain (PPSG, 2014b).

The Central Principle of Balance encourages governments to ensure the adequate availability of opioids for medical and scientific purposes. This includes empowering medical professionals to provide opioids in the course of professional practice, allowing them to prescribe, dispense, and administer according to the individual medical needs of the patient, and ensuring that a sufficient supply of opioids is available to meet medical demand (PPSG, 2014b).

The evaluation of state pain policies by the University of Wisconsin Pain and Policies Study Group has shown continual improvement in state policies. A state’s grade represents the quality of its policies affecting pain treatment, based on the Central Principle of Balance, and is calculated from the total number of provisions in a state fulfilling the evaluation criteria; higher grades mean more balanced state policies influencing pain management, including the medical use of opioid analgesics. In 2013, Alabama, Georgia, Idaho, Iowa, Kansas, Maine, Massachusetts, Michigan, Montana, Oregon, Rhode Island, Vermont, Virginia, Washington, and Wisconsin received an “A” rating, meaning these states have the most balanced pain policies in the country. The 15 states achieving an A comprise 22% of the total U.S. population (PPSG, 2014a).

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