By Terri Lewis, PhD.

Dr. Lewis is well known to the National Pain Report. She will write a series of articles in September that address the big issues facing chronic pain and chronic illness patients. Here is her first installment.

Who Are the People We Are Concerned About?

Marlene is a single 42 year old woman who resides in public housing in southern Indiana. She has a history of substance abuse but has been free of its’ effects for four years. She also has a blood clotting disorder that caused a major abdominal bleed, requiring her to present to her local emergency room for pain related symptoms. Her history of substance abuse resulted in ER personnel turning her away from the department after she was labeled as drug seeking. Moreover, the abdominal bleed resulted in blood clots that formed in her legs, with amputation of both lower limbs the result. After Marlene’s amputations, she was discharged to her home with a 7 day prescription for opiates which her insurer, Humana, refused to authorize because opiates are no longer covered on her dual Medicare, Medicaid policy. The recommended substitutions were contraindicated for her rare blood clotting disorder. Marlene was able to borrow $400.00 from her family members to obtain 7 days of minimum relief. Her next appointment is on September 26 where she will be evaluated for possible changes to the medication that controls her blood clotting factors.

David, 38, is a young father of four, a five year survivor of the fungal meningitis outbreak. He still suffers from the effects of his exposure to contaminated epidural injections with headaches, vision disturbances, tinnitus, adhesive arachnoiditis and fibromyalgia. The state that he lives in has battled opiate addiction aggressively causing most physicians to drop patients who require complex coordinated health supports. His neurosurgeon recommended and installed a pain pump which resulted in 3 unsuccessful surgeries for pump repositioning and a blood patch. The CSF leak remains. The daily morphine equivalent dose has been reduced to 40 MME, insufficient to reduce his pain levels. David is denied oral medications for breakthrough pain support. He spends 20 of 24 hours per day in a reclining position in a dark room. Parenting is difficult. Suicidal ideation is real.

September is Pain Awareness Month

As we advance into the month of September, I will be taking a close look at the systems issues that surround current pain policy across the United States. Our interactions with the care system are built on a scaffold of law, regulation, policy, professional practices, insurance regulations, guidelines, and personal resources. This scaffold is destabilizing across the system as new guidelines and reactive public responses to the increasing numbers of opioid associated overdoses seizes the public imagination. Some might say it is collapsing under its own weight. In any case it is important that we understand how consumers and practitioners are affected within the structures that currently ration our resources. First, to open this discussion, let’s begin with laws, regulation, and policy. Second, I will address how these are implemented by federal and state organizational structures. Third, I will address how these structures influence the care that consumers are able to access.

Even prior to the publication of both the CDC’s and VA’s Guidelines for Treatment of Chronic Pain, a number of states were advancing opioid prescribing legislation designed to limit, or reduce the number of prescriptions written for controlled narcotics. The promulgation of such legislation became a method for assuring that state departments of health programs received their full allotment of federal health dollars much in the same way that highway dollars are distributed based on the passage of seat belt, car seat, and driving under the influence legislation.

Federal laws that affect persons impacted by pain are largely regulated by the departments of Justice (Drug Enforcement Administration), and Health and Human Services (Food and Drug Administration, Centers for Disease Control, SAMHSA, NIDA, and National Institute of Health). These subdivisions handle various justice and public health functions in coordination with the states. Tracking of federal legislation can be found here:

https://www.dea.gov/index.shtml

https://www.deadiversion.usdoj.gov/21cfr/21usc/index.html

The prohibition against opiates has a long history that continues to exert a strong social and cultural influence even today. The Harrison Act (1914) required sellers of opiates and cocaine to get a license, which set a legal precedent that any prescription for a narcotic given by a physician or pharmacist – even in the course of medical treatment for addiction – constituted conspiracy to violate the Harrison Act. The Supreme Court ruled in Doremus (1919) that the Harrison Act was constitutional and in Webb that physicians could not prescribe narcotics solely for maintenance. In Jin Fuey Moy v. United States, the court upheld that it was a violation of the Harrison Act even if a physician provided prescription of a narcotic for an addict, and thus subject to criminal prosecution.

The Harrison Act promulgated the initial federal governmental structures and cultural beliefs that continue to exert an influence on the government’s regulation of drug policy which is enforced at the (intra)state level, except where it affects interstate activities – pharmacy sales and commerce, illegal trafficking, and federal justice system activities.

Prescribing and pharmaceutical actions are regulated by each state through Departments of Health, acting through their authorities to regulate the practice of medicine within their states. Each state has something akin to a Board of Medicine, a Board of Pharmacy, a Board of Dentistry, and other licensing entities. Some states separate these functions, and sometimes a single entity regulates all licensing activities in the state. Functions are prescribed by a system of state laws and regulations. The design of policy may be influenced by professional practice groups.

Insurance regulation acts in much the same way. Each state has a regulating insurance entity that looks to federal policy to consolidate laws across systems and manage regulations promulgated by the states. State resources vary, taxation structures vary, and cultural influences have an effect on priorities as demonstrated by laws that are engendered by state legislatures.

From state to state, these differences create wide variation in the design of laws, regulations, and policies that affect health care. The federal government allows for this under the concept of state’s rights, requiring that states meet minimum, not maximum requirements. This results in a patchwork of regulation and policy that fosters very different results across states, making it difficult for us to compare efforts or interpret the effectiveness of regulatory activity at either the state or the federal level.

These differences make us vulnerable to a truncated interpretation of results that tend to be explained based on a standardized or average effect on the population as a whole. In turn, these averages are applied to individual subgroups as a standard for comparison – this leads to very large errors of interpretation and meaning due to the differences that underlie the standardized data. This ‘best fit’ approach is often adopted by individual states in their approach to legislation, and design, and regulation of policies. It is quite evident in our national approach to pain policy legislation.

Standards

With their permission, I have changed the names of Marlene and David to protect their identities, but their experiences are quite real. They both experience very real intractable pain that will require complex care and pain support for the rest of their lives. Both have run into problems with the way their care protocol is being implemented and addressed within their state and with state resources. Why this is occurring is a matter of some concern and should cause us to question how this is possible in the current system of care. So let’s examine the system and look closely at the factors that influence their respective experiences.

The Federation of State Medical Boards has developed a model pain policy with recommended definitions and features to guide physicians who practice and state regulatory functions. Certainly states are not bound to adopt these recommendations but the majority of states have adopted policies that have incorporated the following definitions and criteria into their model language (sic) –

Definitions.

Acute Pain—Acute pain is the normal, predicted physiological response to a noxious chemical, thermal or mechanical stimulus and typically is associated with invasive procedures, trauma and disease. It is generally time-limited.

Addiction—Addiction is a primary, chronic, neurobiologic disease, with genetic, psychosocial, and environmental factors influencing its development and manifestations. It is characterized by behaviors that include the following: impaired control over drug use, craving, compulsive use, and continued use despite harm. Physical dependence and tolerance are normal physiological consequences of extended opioid therapy for pain and are not the same as addiction.

Chronic Pain—Chronic pain is a state in which pain persists beyond the usual course of an acute disease or healing of an injury, or that may or may not be associated with an acute or chronic pathologic process that causes continuous or intermittent pain over months or years.

Pain—An unpleasant sensory and emotional experience associated with actual or potential tissue damage or described in terms of such damage.

Physical Dependence—Physical dependence is a state of adaptation that is manifested by drug class specific

signs and symptoms that can be produced by abrupt cessation, rapid dose reduction, decreasing blood level of the drug, and/or administration of an antagonist. Physical dependence, by itself, does not equate with addiction.

Pseudo addiction—The iatrogenic syndrome resulting from the misinterpretation of relief seeking behaviors as though they are drug-seeking behaviors that are commonly seen with addiction. The relief seeking behaviors resolve upon institution of effective analgesic therapy.

Substance Abuse—Substance abuse is the use of any substance(s) for non-therapeutic purposes or use of medication for purposes other than those for which it is prescribed.

Tolerance—Tolerance is a physiologic state resulting from regular use of a drug in which an increased dosage is needed to produce a specific effect, or a reduced effect is observed with a constant dose over time. Tolerance may or may not be evident during opioid treatment and does not equate with addiction.

Evaluation of the Patient. A medical history and physical examination must be obtained, evaluated, and documented in the medical record. The medical record should document the nature and intensity of the pain, current and past treatments for pain, underlying or coexisting diseases or conditions, the effect of the pain on physical and psychological function, and history of substance abuse. The medical record also should document the presence of one or more recognized medical indications for the use of a controlled substance.

Treatment Plan. The written treatment plan should state objectives that will be used to determine treatment success, such as pain relief and improved physical and psychosocial function, and should indicate if any further diagnostic evaluations or other treatments are planned. After treatment begins, the physician should adjust drug therapy to the individual medical needs of each patient. Other treatment modalities or a rehabilitation program may be necessary depending on the etiology of the pain and the extent to which the pain is associated with physical and psychosocial impairment.

Informed Consent and Agreement for Treatment. The physician should discuss the risks and benefits of the use of controlled substances with the patient, persons designated by the patient or with the patient’s surrogate or guardian if the patient is without medical decision-making capacity. The patient should receive prescriptions from one physician and one pharmacy whenever possible. If the patient is at high risk for medication abuse or has a history of substance abuse, the physician should consider the use of a written agreement between physician and patient outlining patient responsibilities, including o urine/serum medication levels screening when requested; number and frequency of all prescription refills; and reasons for which drug therapy may be discontinued (e.g., violation of agreement).

Periodic Review. The physician should periodically review the course of pain treatment and any new information about the etiology of the pain or the patient’s state of health. Continuation or modification of controlled substances for pain management therapy depends on the physician’s evaluation of progress toward treatment objectives. Satisfactory response to treatment may be indicated by the patient’s decreased pain, increased level of function, or improved quality of life. Objective evidence of improved or diminished function should be monitored and information from family members or other caregivers should be considered in determining the patient’s response to treatment. If the patient’s progress is unsatisfactory, the physician should assess the appropriateness of continued use of the current treatment plan and consider the use of other therapeutic modalities.

Consultation. The physician should be willing to refer the patient as necessary for additional evaluation and treatment in order to achieve treatment objectives. Special attention should be given to those patients with pain who are at risk for medication misuse, abuse or diversion. The management of pain in patients with a history of substance abuse or with a comorbid psychiatric disorder may require extra care, monitoring, documentation and consultation with or referral to an expert in the management of such patients.

Medical Records. The physician should keep accurate and complete records to include

the medical history and physical examination, 2) diagnostic, therapeutic and laboratory results, 3) evaluations and consultations, 4) treatment objectives, 5) discussion of risks and benefits, 6) informed consent, 7) treatments, 8) medications (including date, type, dosage and quantity prescribed), 9) instructions, and agreements and 10) periodic reviews. Records should remain current and be maintained in an accessible manner and readily available for review.

Compliance with Controlled Substances Laws and Regulations. To prescribe, dispense or administer controlled substances, the physician must be licensed in the state and comply with applicable federal and state regulations. Physicians are referred to the Physicians Manual of the U.S. Drug Enforcement Administration and (any relevant documents issued by the state medical board) for specific rules governing controlled substances as well as applicable state regulations.

The specific methodology by which states have crafted their laws and regulations include these criteria and interpretive guidance for implementation. That will become the topic of our next conversation as I begin to examine Marlene and David’s experience in relationship to the locations in which they live. As we will learn, they are each having very different experiences.

This Federation of State Boards Model Policy for the Use of Controlled Substances for the Treatment of Pain is located at this link-

Model Policy for the Use of Controlled Substances for the Treatment of Pain https://www.ihs.gov/painmanagement/includes/themes/newihstheme/display_objects/documents/modelpolicytreatmentpain.pdf

A number of entities track laws associated with drug control policy and use of controlled substances for pain management legislation at the state level-

Database of Statutes, Regulations, & Other Policies for Pain Management

http://www.painpolicy.wisc.edu/database-statutes-regulations-other-policies-pain-management

National Alliance for Model State Drug Laws

http://www.namsdl.org/library/7C4DC653-1C23-D4F9-7411227356D4CFE3/

Academy of Integrative Pain Management

http://blog.aapainmanage.org/state-state-laws-regulations-guidelines-pain-management/

Source. National Drug Control Budget: FY 2018 Funding Highlights. Washington, DC: Executive Office of the President, Office of National Drug Control Policy

Subscribe to our blog via email