Friday, February 18, 2011

Should State Laws Dictate Pain-Care Practices?

JusticeAlarmed and frustrated by escalating opioid analgesic misuse, abuse, diversion, and overdose, elected officials in certain U.S. states seem determined to take matters into their own hands — even if it means venturing into and shaping medical practice. While the opioid-related problems appear to be real, and the intentions of legislators are sincere, the possible unintended consequences seem clear; a great many patients may suffer due to decreased access to appropriate care and medications for their chronic pain conditions.

Actions of individual state legislatures may supplement or, in some cases, preempt guidelines and regulations coming from federal agencies, such as the FDA, and national medical organizations. The result could be that elected officials will be dictating medical practices and healthcare providers will need to consult their state’s laws before selecting treatment for their patients with pain; whether or not it is the best care for the particular patient may become a secondary concern. Recent reports of initiatives in West Virginia and Washington State may be harbingers of what lies ahead.

Washington State Constrains Opioid Dosing
The Washington State Medical Quality Assurance Commission has for many months been forging new rules for the management of chronic noncancer pain with opioid analgesics. Five professional boards within the state — governing physicians, osteopaths, nurse practitioners, physician assistants, dentists, and podiatrists — are being required to adopt the rules in a consistent fashion as applied to their constituents.

While many, but not all, of the rules seem to make sense from perspectives of sound medical practice, a critical question is whether such practices should be mandated by state legislatures as dogma, rather than being determined independently by medical professional organizations as evidence-based standards of care. For example, the Washington State rules require a thorough patient evaluation and extensive documentation, including a treatment plan, and these elements are specified in some detail. An informed patient-consent for treatment is required, although this component is vaguely described, and a written agreement for treatment — referred to elsewhere as an “Opioid Treatment Agreement” (and, of questionable value [as discussed in UPDATE here]) — also is required. Practitioners prescribing long-acting opioids, including methadone, are required to complete at least 4 hours of continuing education relating to the topic; although, the contents, quality, and source of such training are not specified. There are no rules specifically requiring patient/caregiver education on opioid safety.

During patient visits for “episodic care” (eg, emergency or urgent care), practitioners are discouraged from providing opioids for chronic pain management. Such medication is allowed only if deemed absolutely necessary and then it requires documented justification. Consultations with and referrals to specialists are urged for the management of patients having substance abuse problems or risks, or for patients with comorbid psychiatric disorders; however, this does not take into account barriers, such as limited accessibility to such specialists or financial hurdles.

Perhaps most controversial, consultation with a pain management specialist is mandated by law if a patient requires more than 120 mg per day of morphine or its equivalent (which is poorly defined and can be confusing with some opioids), and this must be thoroughly documented. Such consultations (which may or may not include the patient) are allowed to take place face-to-face, via telephone or videoconference, or electronically (presumably by fax or e-mail). Practitioners who qualify as pain management specialists, or who have completed a minimum of 12 hours of training in chronic pain management, may be exempt from the consultation requirement. The rules for who can be considered a pain management specialist are extensive; however, there have been concerns about whether sufficient numbers of professionals qualifying as such specialists within the state would be available for timely consultations and how their fees will be compensated.

As with most governmental rule-making procedures, the process in Washington State has been long and deliberative; however, the extent, quality, and objectivity of the evidence base guiding many of the rules (eg, the 120 mg/day morphine equivalent limit and others) remains questionable. While, overall, the rules do not at first appear to be Draconian in most of their requirements, they do add layers of medical practice regulations and paperwork onto the already time-starved days of busy healthcare professionals. Plus, the rules do not have the endorsement or approval of national medical organizations or professional boards — they are unique to only one state, at least presently.

Past attempts by groups, such as the now defunct Pain Relief Network, to forestall the Washington State initiatives in the courts — claiming the state’s mandates would endanger the rights and personal welfare of practitioners and patients — were unsuccessful. A concern is that many practitioners, rather than becoming enmeshed in cumbersome (and possibly confusing or untenable) rules requirements, may shift to prescribing lower doses of only short-acting opioids, which are inappropriate for most chronic pain conditions. Others, fearful of running afoul of the rules and jeopardizing their licensure, may opt out of prescribing opioid analgesics altogether. Some healthcare providers may even alter their practices to avoid treating patients with chronic pain conditions, and affected patients may find it necessary to travel out of state, if they have the means, to receive adequate pain care. Such deleterious consequences would be realized only after the rules are fully in effect and, then, reversing the harms by repeal or modification of the rules could take many months or years.
[The various specific documents relating to the above discussion may be accessed at the Washington State Department of Health rulemaking web page at: https://fortress.wa.gov/doh/policyreview/]
West Virginia Proposed Law Trumps Medical Science
While specific reasons have yet to be adequately elaborated, West Virginia citizens comprise one of the most medicated populations in the nation. Consequently, the state has long been plagued by prescription medication abuse and diversion; its rate of fatal prescription-drug overdoses is more than 3 times the national average, with opioid analgesics blamed for most of the problems.

According to news reports, during the current West Virginia legislative session, more than 2 dozen bills have been introduced to address the state’s drug abuse problems. Meanwhile, healthcare providers in the state are already wary of local medical boards and federal regulators (eg, DEA) scrutinizing their prescribing practices, to the extent that patients with legitimate pain are often undertreated or untreated — a fact that may be contributing to the state’s burgeoning “street market” for potent analgesics.

One item of legislation, introduced for approval in mid-February 2011, is of particular concern, since it represents a case where politicians are proposing rules governing the chemical formulation of analgesic products that may be distributed and prescribed within a state's borders. This could become a precedent-setting case of state’s rights superseding medical science; following is the verbatim text of West Virginia House Bill 3139 [as accessed here]:
By Delegates Staggers and Perry
[Introduced February 15, 2011; referred to the Committee on Health and Human Resources then the Judiciary.]

A BILL to amend the Code of West Virginia, 1931, as amended, by adding thereto a new section, designated §60A-3-309, relating to prohibiting the prescription of oxycontin extended release or fentanyl patches unless those items contain naloxone to be released only on alteration of the delivery vehicle; requiring those substances be directly prescribed by a licensed practitioner with Schedule II privileges and directly monitored by a licensed physician or nurse at least monthly; and providing penalties, including being a felony for a third offense.

Be it enacted by the Legislature of West Virginia: That the Code of West Virginia, 1931, as amended, be amended by adding thereto a new section, designated §60A-3-309, to read as follows:

ARTICLE 3. REGULATION OF MANUFACTURE, DISTRIBUTION AND DISPENSING OF CONTROLLED SUBSTANCES.

§60A-3-309. Restrictions on dispensing oxycontin and fentanyl patches; penalties; felony for third conviction.


(a) No person may prescribe, nor may a person possess, oxycontin extended release or fentanyl patches unless those items contain naloxone to be released only on alteration of the delivery vehicle. These two items must be directly prescribed by a licensed practitioner with Schedule II privileges and directly monitored by a licensed physician or nurse at least monthly.

(b) Any person that violates this section is guilty of a misdemeanor and, upon conviction thereof, shall be confined in jail for not less than ten days nor more than sixty days. If a person violates this section for a second offense, the person is guilty of a misdemeanor and, upon conviction thereof, shall be confined in jail for not less than thirty days nor more than six months. Any person violating this section for a subsequent offense, the person is guilty of a felony and, upon conviction thereof, shall be confined in a correctional facility for not less than one year nor more than two years.


NOTE: The purpose of this bill is to prevent the abuse of oxycontin extended release and fentanyl by requiring those substances contain naloxone to be released only on alteration of the delivery vehicle . The bill requires those substances be directly prescribed by a licensed practitioner with Schedule II privileges and directly monitored by a licensed physician or nurse at least monthly. The bill also provides for penalties, including being a felony for third and subsequent convictions. This section is new; therefore, it has been completely underscored.
There are currently no FDA-approved naloxone-containing formulations of extended-release oxycodone (ie, OxyContin) or fentanyl as mandated in the bill, so passage of this legislation would essentially outlaw those two medications in West Virginia, even though they have been scientifically demonstrated as safe and effective when prescribed and used properly for treating chronic pain. It is highly unlikely that any manufacturer would pursue development, testing, and approval of new oxycodone or fentanyl products containing naloxone as an abuse deterrent just to satisfy West Virginia legislators, and even if they did the laboratory-to-market process could take many years.

Two further aspects of the Bill are worth noting: (a) no distinctions are made between use of the two drugs for cancer- or noncancer-related pain, and (b) mere possession of the offending analgesics, by anyone, is considered a punishable offense. In effect, for example, a patient with cancer returning home to West Virginia following treatment in another state where a prescribed supply of fentanyl patches was provided could be jailed for “not less than ten days.”

At the time House Bill 3139 was introduced, it was one of 68 bills pending action in the West Virginia House Health and Human Resources Committee; so, when it might be reviewed and whether it would receive an affirmative vote are unknown. In principle this could be a hazardous path of action: essentially outlawing 2 analgesic products in this fashion would most likely only transfer the problems to other opioid analgesic agents. Repeating the legislative cycle, West Virginia could eventually end up banning ALL opioid analgesics in the state.

Interestingly, while the legislators introducing this bill were clearly familiar with naloxone, they completely overlooked its use as a preventive measure when prescribed for at-home opioid overdose rescue. This has been previously discussed [in an UPDATE here], and it seems like a great lost opportunity for states like West Virginia to ignore this approach that could significantly reduce their soaring opioid overdose fatality rates.

Can Balance Be Achieved by Mandates?
It must be acknowledged that opioid analgesics are not the only class of medications for treating chronic pain, and they are not always optimal therapy for every patient. Opioid analgesics are one component of what should be a multimodal mindset for managing chronic pain conditions of all types. However, they are a vital and essential part of the therapeutic armamentarium of modern pain practice; severely restricting or eliminating their availability also would diminish the ability of patients to receive the most appropriate and adequate individualized care for their disabling pain conditions, which are life-threatening in many cases [discussed in UPDATE here].

Certainly, today’s problems of opioid misuse, abuse, diversion, and overdose are real and cannot be ignored. Whether the majority of problems stem from an over-prescribing of these medications, as some authorities suggest, is highly debatable and unsupported by much of the better evidence. Meanwhile, the misprescribing of these drugs by unscrupulous practitioners at their “pill mills” is deplorable, and few would disagree that swift and forceful legal actions to eliminate those who deliberately operate outside of already-established laws and regulations would be appropriate.

In the process, however, a balance must be achieved between minimizing the problems while ensuring adequate access to effective analgesics for patients in need of them, and legislators and regulators have strongly endorsed this perspective — at least in their public proclamations. At the same time, initiatives such as those in West Virginia and Washington State appear to be focused on actions that at the least will have a “chilling effect” on opioid prescribing and at worst could severely restrict access to those medications.

Those state initiatives also come at a time when the U.S. FDA is soon expected to release their Risk Evaluation and Mitigation Strategies (REMS) program covering opioid analgesics [as previously discussed in UPDATE here]. This federally-mandated opioid-REMS, which has been in development for many months, is expected to include requirements for prescriber and patient education, certain procedures for patient selection and the safe prescribing of opioid analgesics, performance monitoring, and other mandated components. It is unknown whether the Washington State rules and the FDA opioid-REMS would complement each other or be to some extent in conflict, and which might supersede the other. It is not expected that the REMS will ban any specific opioid products, as would the West Virginia legislation.

What seems certain is that select states via legislation and the federal government via regulation are pursuing their separate paths toward managing the prescribing of opioid analgesics and the associated problems. And, while commentary from healthcare providers and their professional organizations have been solicited along the way, the end result will be imposed upon but not truly determined by the expressed opinions and concerns of clinical medical practitioners. Of even greater concern is that, rather than focusing on community-centered mental health and family issues that foster substance misuse, abuse, and diversion in the first place, lawmakers apparently find it easier and more efficient to target and regulate healthcare providers and the drugs they prescribe. Ultimately, of course, those most affected will be the 78 million patients [prevalence data here] with chronic pain.

What do healthcare providers think of this? Comment below.