Washington State’s Approach to Opioid Dosing Guidelines
Melissa Burke-Cain, JD, Senior Counsel
Agriculture and Health Division
Office of the Attorney General of Washington
The need addressed by Washington policies
Like many states, Washington faces a growing public health problem of morbidity and mortality associated with the misuse of prescription opiates. Washington’s most recent health risk assessment report, The Health of Washington 2007, found that more than 90% of Washington’s poisoning deaths are drug overdoses, the majority involving multiple drugs. The 2007 Health Report also found that an increasing number of poisoning deaths could be attributed to prescription opiate overdoses. In Washington, in 2004, about 60% of prescription opiate deaths involved more than one drug; opiates were most commonly accompanied by anti-anxiety agents and anti-depressants. [1]
Washington’s Department of Health Injury and Violence Prevention Program reviewed the volume of prescription opiates distributed in Washington’s pharmacies and hospitals [1997-2005] and compared it with vital records data in which unintentional opiate overdose was identified as a contributing cause of death. According to that analysis, Washington has experienced an increase in unintended opiate deaths that mirrors an increase in the volume of prescription opiates distributed in hospitals and pharmacies. [2] The analysis also found that methadone had the most dramatic increase in involvement in overdose deaths from 1995–2004. Based on DEA ARCOS data, Washington is in the top 1/3 of states in its volume of methadone prescribing. This may be due, in part, to policy changes in the state’s regulatory framework for prescription opiates used to treat chronic pain.
Prior to the late 1990’s, Washington strictly regulated use of opiates in pain management due to concerns about risks of narcotic misuse and patient addiction. In the late 1990’s, the state’s policy approach began to change in light of growing beliefs among some physicians that the state’s policies were too restrictive and caused physicians to undertreat chronic pain when the potential for addiction was low. These concerns came to the attention of Washington’s Department of Health, Medical Quality Assurance Commission (physician licensing program), Department of Social and Health Services (Medicaid program) and Department of Labor and Industries (worker injury program)¾three state agencies responsible for regulating and paying for a large portion of the prescription opiates used to treat chronic pain. As a result, the state agencies modified their policies to allow more discretion for providers to prescribe opiates to treat chronic pain. Since then, opioid prescribing patterns in Washington have also changed.
The volume of prescription opiates distributed by hospitals and pharmacies in Washington has significantly increased. From 1997–2004, sale of methadone (as a painkiller) and oxycodone in Washington increased 974% and 580%, respectively. [3] As a result of the changes in physician use of such drugs from 1996–2002, injured workers in Washington were increasingly likely to be prescribed more potent opiates and higher doses per prescription. [4]
As opiate usage increased in Washington, the state’s poisoning mortality rate also rose; from 9/100,000 in 1996 to 14/100,000 in 2005. Males ages 45-54 were at the highest risk. Washington is also seeing a growing trend in adolescents who divert prescription drugs for non-medical use. Estimates show that 4% of 8th graders, 10% of 10th graders, and 12% of 12th graders reported using a painkiller such as oxycodone or Percocet™ to get high in the previous month.[5]
As might be expected, these data were troubling to many state policymakers. In response, Washington’s policy focus is evolving, but the policy efforts employed have not always been well-coordinated within state government. For example, convinced that immediate action was needed, state agency medical directors developed and published a set of interagency guidelines on opioid dosing for chronic non-cancer pain.[6] Only limited internal and external stakeholdering occurred before the guidelines were published. The 2007 Opioid Guidelines, published in March 2007, and the medical directors who developed them are now entangled in a class action challenge filed in the federal district court for the Eastern District of Washington in July 2008.
The most recent policy development is the formation within the last 6 months of a new Washington Department of Health workgroup, The Prescription Opiate Morbidity and Mortality Prevention Workgroup, to provide a neutral forum and expand internal and external stakeholder input on the public health problem of death and injuries associated with prescription opiate use.[7] At present there are about 50 workgroup participants representing the following organizations: state licensing boards and commissions for nursing, pharmacy, dentistry, medicine, osteopathy, DOH, local public health departments, Group Health Cooperative (HMO), hospital emergency departments (public and private), Choice Regional Health Network, Labor and Industries, Health Care Authority, Washington Poison Control Center, University of Washington academic medical centers, county Medical Examiners, DSHS (Medicaid and alcohol and substance abuse programs), state association of sheriffs and police chiefs, University of Washington Alcohol and Drug Abuse Institute, Attorney General’s Office, Seattle Police Dept. Narcotics Division, state Department of Community Trade and Economic Development, Safeway (retail pharmacy), Sacred Heart Consistent Care ( hospital-based care emergency department chronic care management program), and Together for Drug Free Youth.
Legal Authority and Justification
There is no specific legal authority for the Opiate Dosage Guidelines or for the collaboration of agency medical directors to direct specific policy efforts such as developing opioid dosing guidelines; however each agency whose medical director participates in the agency medical directors group has broad organic legislation authorizing quality improvement activities for the programs under their jurisdiction and the general power to delegate authority to administer its programs among its agency staff. The guidelines have not been adopted as administrative rules under Washington’s Administrative Procedures Act, chapter 34.05 RCW, or as interpretive or policy statements as authorized under RCW 34.05.230. The lack of specific legal authority has, in part, formed the basis for the pending legal challenge to the guidelines discussed below.
The policy as implemented
The 2007 Opioid Dosing Guidelines have two parts. In Part I, the guidelines make recommendations for three aspects of clinical practice regarding opioid treatment for chronic non-cancer pain—initiating or transitioning from acute to chronic pain care; assessing or monitoring on-going opioid treatment; and weaning from opioids if an opioid trial fails to yield improvements in function and pain. Part II makes specific recommendations, including referral for evaluation by specialists in pain management, when primary care providers are treating patients whose morphine equivalent dose (MED) already exceeds 120 mg. per day. [8] In addition to the guidelines, the agency medical directors have developed Continuing Medical Education activities for practitioners about the guidelines, and have created a series of links for providers including an opioid dosing calculator, a list of pain management specialists in the state, and a set of FAQs about the guidelines and other opioid resources.[9]
The agency medical directors developed an independent website for outreach and have prepared, but not distributed, a mass mailing to all practitioners authorized in Washington to prescribe opiates regarding the guidelines. The guidelines were presented at the annual meeting of the Washington State Medical Association in September 2008.
Early experience with the policy—pending litigation
The Opioid Dosing Guidelines have been controversial from their inception as to the substance of the recommendations, the process through which they were developed, and as to their potential use as a de facto standard of care for opioid prescribers. The guidelines have never been adopted or approved by the Medical Quality Assurance Commission or the Osteopathic Board, the state physician and physician assistant licensing boards. Prescribers have expressed concern about the science behind the guidelines, whether they are based on a robust, evidence-based review, and whether physicians employed by the state agencies that pay for prescription drugs are motivated by the need to cut program costs and should not be responsible for defining guidelines for the larger medical community. The guidelines recommend criteria for referral to pain management specialists. As a practical matter, Washington practitioners are concerned that there are not enough pain management specialists available for referral, especially in rural and underserved parts of the state, to meet the needs of practitioners who are trying to comply with the guidelines in treating their chronic pain patients.
The pending class action lawsuit challenging the 2007 Opioid Dosing Guidelines was filed by Dr. Merle Janes, a board-certified pain specialist, claiming to represent the interests of a number of “John Does” and “Jane Does” who are patients with chronic non-cancer pain symptoms. Dr. Janes also includes claims for himself and purportedly other physicians. [10] The suit is funded and coordinated by the Pain Relief Network (PRN), a national non-profit organization that defends physicians facing criminal and civil sanctions in connection with opiate prescription practices. [11]
The PRN claims that the 2007 Opioid Dosing Guidelines have become de facto regulations and are being used by other jurisdictions and insurers as a foundation to regulate opiate use in pain treatment. The PRN claims physicians are afraid to prescribe opiates in amounts larger than the guidelines recommend out of fear that they will face disciplinary action or other sanctions.[12] As a result, patients needing pain management care for chronic non-cancer pain in excess of the guidelines’ recommendation may not be able to obtain care. The Defendants are Washington state agencies, officers, and employees at all levels of government from the Governor, Christine Gregoire, to the line administrative staff of the Medical Quality Assurance Commission. State employees and officers are named individually and in their official capacities.
The 2007 Opioid Dosing Guidelines are the core of the suit, and the medical directors who developed the guidelines are parties, but named Defendants also include individuals and agencies having no role in developing or implementing the Opioid Dosing guidelines. Another notable feature of the suit is the effort to tie the actions of the physician licensing board with the agency medical directors’ development of the Opioid Dosing Guidelines to demonstrate government agency action that amounts to conspiracy to discriminate against patients with chronic non-cancer pain symptoms.
Procedurally, the suit is in its earliest stages. After the Complaint was filed, Defendants filed FRCP 12(b)(6) [dismissal] and 12(e) [more definite statement] motions. The Court granted the motion for a more definite statement, given the Complaint’s length (202 pages) and confusing format. An Amended Complaint was filed on November 3. The Amended Complaint is reduced to 149 pages, and contains similar claims to the original in addition to state law tort claims. No class has been certified, and no case schedule or trial date is set. The State Defendants have reserved their rights to challenge class certification and assert jurisdictional challenges (standing, ripeness) as well as other affirmative defenses. Both parties are likely to bring dispositive motion(s) forward in fairly short order.
An important point in defense of the 2007 Opioid Dosing Guidelines is that they are only advisory; i.e., the guidelines impose no legal duty or restriction upon physicians or patients and, therefore, do not deprive anyone of fundamental liberty interests or civil rights. Plaintiffs’ claims are based solely on anticipatory fear of future state action and speculation about damages that may be associated with future state action.
Briefly summarized, the Complaint (which sets forth 19 separate counts) alleges that the Dosing Guidelines:
· are preempted by federal drug labeling laws;
· impermissibly regulate the practice of medicine in violation of Washington’s Constitution;
· conflict with state law authorizing the Department of Health to coordinate development of opiate dosing guidelines for licensing boards, thus depriving prescribing physicians of due process;
· threaten prescribing physicians with sanctions under the state’s medical licensing laws, thereby depriving patients of their due process liberty interests in choosing particular health care providers or pain treatment;
· deprive patients with non-cancer chronic pain of equal protection by treating them differently than cancer patients with chronic pain;
· discriminate on the basis of age by creating an exemption for children and elderly persons
· violate federal and state laws protecting the rights of disabled persons by interfering with physician treatment decisions in a way that prevents a class of chronic pain patients from “mitigating the effects of their disabilities” through adequate use of opiate drugs;
· constitute a conspiracy on the part of the state defendants, thereby harming plaintiffs and entitling them to damages for tortious interference with their rights under state and federal law.
Evaluation of the policy
In hindsight, some of the challenges Washington is facing over its Opioid Dosing Guidelines could be mitigated with advance planning. First, if practicable, try to get specific legislative direction either in substantive law, like Utah’s recently enacted House Bill 137, a two-year program to create practice guidelines on chronic pain management with a measurable goal of reducing deaths from prescription opioids by 15% at the end of the program. Another option is to incorporate into the budget proviso language demonstrating legislative intent for agencies to act under existing organic laws. If appropriate, consider developing a record in legislative floor debate as an option for reducing claims that legislative intent is contrary or existing statutes are ambiguous.
Recognizing that legislation is not always an option, I have three other practical recommendations for a state that may be considering using existing administrative authority to take action on the problem of morbidity and mortality associated with prescription opioid use. First, develop an internal stakeholdering plan and try to align the state or local agencies that have administrative authority to coordinate their efforts before taking action; try to keep the internal stakeholdering process moving so that one or more stakeholders won’t feel compelled to act alone because of slow or stalled progress.
Second, work through potential legal authority issues under your applicable state laws with legal counsel and agency staff before action is taken. Consider all the options you have to formalize and validate the collaborative process you plan to use. For example, establish express delegation of authority within agencies, develop interagency memoranda or memoranda of understanding to validate collaboration among agencies, negotiate and formalize interlocal cooperative agreements to bring local public health or other public health resources to the table, or consider seeking an executive order to authorize action among executive branch agencies. Use the forms and requirements that track your state’s unique administrative legal authority.