Recommended Changes to Indiana’s Emergency Pain Regulations

courthouse corydon

Old Capitol Building – Corydon, IN

 

From Emails Sent to the Medical Licensing Board of Indiana

Re: recommended changes to:

TITLE 844 MEDICAL LICENSING BOARD OF INDIANA Emergency Rule

LSA Document #13-XXX(E)Temporarily adds provisions under P.L. 185-2013 (SEA 246) regarding physicians prescribing opioids for chronic pain.  (Effective December 15, 2013)

Email message sent October 15, 2103

Dear Medical Licensing Board of Indiana:

On September 25th I had the privilege of representing the American Academy of Pain Management, testifying at the Board’s public hearing concerning proposed Emergency Regulations regarding physicians prescribing opioids for chronic pain.

I am now sending two documents with recommendations. The first attached document pertains to the utilization of laboratory analysis (e.g. urine drug screens).  The second attachment pertains to facilitation of physician-led team based care. Note: On October 9, 2013 I sent an email with my recommendations regarding the threshold morphine equivalent dose.

I would appreciate a notification from the Board, indicating the Board’s receipt of all three of my recommendations (i.e. drug screens, team based care, and morphine equivalent dose thresholds).

If at any time the Board wishes to contact me for discussion, I will go to whatever lengths necessary to make myself available.

Sincerely,

James Patrick Murphy, MD, MMM

Jeffersonville, Indiana

 

 

Submitted October 15, 2013:

These recommendations pertain to drug monitoring by laboratory analysis.

Currently Section 8 (a) reads:

(a) At the outset of an opioid treatment plan, and at least annually thereafter, a physician prescribing controlled substances for a patient shall perform a urine or saliva monitoring test, which must include a confirmatory test, on the patient.

The recommended change reads:

(c) During the first 30 days of initiation of an opioid treatment regimen for chronic pain as outlined in Section 3, and at least annually thereafter, a physician prescribing controlled substances for a patient shall utilize a laboratory analysis to aid in determining compliance with the prescribed plan of care.  A confirmatory quantitative laboratory analysis shall be utilized if in the physician’s clinical judgment, such a test is necessary to adequately manage the patient’s opioid treatment regimen.

Discussion:

Analysis of body substances (e.g. urine, saliva, hair, blood) is an important aspect of managing a patient on chronic opioid therapy. These tests are not only useful in establishing boundaries of acceptable behavior, but can alert the physician to signs of addiction, dependence, and drug diversion. There are at least four tissue / body fluid tests that are currently utilized by pain specialists.  More testing options will likely be available to the future.

The drug testing should be a routine part of the treatment plan of a patient using opioids on a chronic basis. These tests are not only useful at the onset of a treatment regimen, but regularly, randomly, and when there is a significant change in the patient’s clinical status.

To encourage and allow adequate use of drug tests, they must be accessible and affordable, else access to care will be hindered. Confirmatory “quantitative” tests are only necessary when the physician in formulating the plan of care requires this information.

Also, the accuracy of expensive confirmatory tests is dependent upon the chain of custody and the manner in which the specimen was obtained (i.e. observing the patient urinate in the cup).

Most times, using a less expensive and readily available “screening” test will be sufficient when coupled with other available data, most important of which is a direct interview of the patient.  Drug screens should build bonds of trust between the physician and the patient. Theses tests should considered “therapeutic” as opposed to “punitive” or “forensic.”

Optimally, a drug screen can be done at the first visit. But if a physician feels it is clinically appropriate to treat the patient at the initial visit, treatment should be allowed as long as early in the course of treatment a drug screen is performed.

References:

  1. 2010 Washington State Agency Medical Directors’ Group Interagency Guideline on Opioid Dosing for Chronic Non-cancer Pain http://www.agencymeddirectors.wa.gov/Files/OpioidGdline.pdf
  1. Gourlay DL, Heit HA, Almahrezi A.
    Universal Precautions in Pain Medicine: A Rational Approach to the Treatment of Chronic Pain
    Pain Med. 2005;6(2):107-12.
  2. http://onlinelibrary.wiley.com/doi/10.1111/j.1526-4637.2005.05031.x/pdf
  3. Murphy, JP. The Compliance Documentation Aid. Pain Medicine. 2005:6(4):329-330  http://www.readcube.com/articles/10.1111/j.1526-4637.2005.00051.x?locale=en
  4. Murphy, JP. Tumblin’ Dice–Why Does Random Matter? Practical Pain Management. May 2006:6(4) http://www.practicalpainmanagement.com/treatments/pharmacological/opioids/tumblin-dice-why-does-random-matter

 

Submitted October 15, 2013:

These recommendations pertain to the requirement that the prescribing physician must perform the physician’s own specific functions (e.g. initial evaluation, drug screens, INSPECT, patient education).

The current draft language in Section 4 is presented below:

Section 4 (a) The physician shall do the physician’s own evaluation and risk stratification of the patient by doing the following in the initial evaluation of the patient:

Most physicians are in group practices and share the same medical records. Also, cross-coverage and on-call duties are the norm. If each physician in the group is required to do his or her own initial evaluation, then access to care will likely be hindered. Also, healthcare costs would rise as initial evaluations are generally more complex (and usually less available) than follow-up or acute care evaluations.

Additionally, the fact that Advanced Practice Registered Nurses can obtain DEA certification and legally prescribe the entire spectrum of available opioids must be taken into consideration.  Physician Assistants can also obtain certification to prescribe Schedule III through IV controlled substances. Therefore, it is very important that the supervising physician remain responsible for defining the prescriptive parameters for APRNs and PAs with whom the physician is collaborating.

The American Medical Association has taken a stand on Physician-Led Team Based Care:

New health care delivery system reforms hinge on a team-based approach to care. In the physician-led team approach, each member of the team plays a critical role in delivering efficient, accurate, and cost-effective care to patients.

Finally, qualified members of prescribing clinician’s staff should be allowed to perform duties within their scope of care (e.g., request INSPECT reports, administer assessment “tools,” educate regarding risks and responsibilities). This concept is echoed in the Federation of State Medical Boards’ text Responsible Opioid Prescribing:

Note that some parts or all of this task might be handled by trained “physician helpers in the office – nurses, physician assistants, or other personnel.

Requiring physicians to perform an abundance of administrative tasks will discourage them from treating chronic pain patients, further limiting access to care.

Recommendation 1:

The first recommendation is to change “physician” to “prescribing clinician.”  “Prescribing clinician” should be defined as:an individual engaged in the care of a patient who is a physician, advanced practice nurse practitioner, or physician’s assistant and whose scope of practice includes prescribing controlled substances and who is legally authorized to prescribe controlled substances.

Recommendation 2:

The second recommendation is to permit prescribing clinicians who are formal members of the same care team to share the responsibilities outlined in these regulations when caring for a patient of their care team. This will allow collaboration and facilitate team-based care.  It should improve access, control costs, and lead to improved clinical outcomes.

Recommendation 3:

Qualified members of the prescribing clinician’s staff should be allowed to perform certain tasks on behalf of the prescribing clinician (e.g. requesting INSPECT reports, educating the patient on risks and responsibilities, processing treatment agreements, administering risk assessment “tools.”). 

Thus, an additional definition in Section 2 (a) would be:

(g) “Prescribing clinician” means an individual engaged in the care of a patient who is a physician, advanced practice registered nurse, or physician’s assistant and whose scope of practice includes prescribing controlled substances and who is legally authorized to prescribe controlled substances.

The recommended language in Section 4 (a) would become:

Section 4 (a) The prescribing clinician shall do his or her own evaluation and risk stratification of the patient by doing the following in the initial evaluation of the patient: …

(With the additional corresponding changes from “physician” to “prescribing clinician” throughout the document as necessary)

In addition, this language is recommended:

It is the prescribing clinician’s responsibility to personally examine the patient, review the available data, assess the level of risk, establish the working diagnosis, and formulate the treatment plan. Other tasks may be delegated to auxiliary members of the care team in accordance with their level of training and responsibility.

References:

  1. Fishman, S.  Responsible Opioid Prescribing, 2nd ed. The Federation of State Medical Boards, Published by Waterford Life Sciences, Washington, D.C. 2012.
  2. American Medical Association: Physician-Led Team Based Care. Available on their website as of 10/14/2013 http://www.ama-assn.org/ama/pub/advocacy/state-advocacy-arc/state-advocacy-campaigns/physician-team-based-care.page

 

 

Submitted October 9, 2013:

These recommendations pertain to thresholds that trigger the measures in the Emergency Rule (i.e. Sections 3 and 9).

Currently Section 3 (c) reads:

(c) The requirements in the SECTIONS identified in subsection (a) only apply if a patient has been prescribed: (1) More than sixty (60) opioid-containing pills a month; or (2) A morphine equivalent dose of more than fifteen (15) milligrams per day; for more than three (3) consecutive months.

The recommended change reads:

(c) The requirements in the SECTIONS identified in subsection (a) only apply if a patient has been prescribed: a morphine equivalent dose of more than 60 milligrams per day at any time during any three consecutive months.

Discussion:

There must be reasonable parameters (e.g. opioid dose) that lawful prescribers can clearly understand and unlawful prescribers (and “doctor-shopping patients”) will not easily be able to circumvent.

MED (Morphine-equivalent dose)

There is no national consensus regarding the most appropriate parameters for increased risk mitigation measures. Likewise, while the physiology of opioid tolerance is well understood, there exists no morphine-equivalent-dose (MED) that defines tolerance.

However, most experts would agree that when a patient’s daily MED reaches 60 milligrams the patient is likely physically tolerant to the opioid (Ref 1).

Furthermore, opioid tolerant patients generally receive opioids on a regular basis.

They are also more susceptible to a withdrawal syndrome than non-tolerant patients. Therefore 60 mg MED would be a logical (and physiological) threshold for requiring increased risk mitigation strategies.

Setting the threshold at a lower level (e.g. 15 MED) has the potential to:

  1. Make physicians wary of treating mild to moderate pain, leading to undertreament; and
  2. Focus a disproportionate amount of attention on patients at lower risk of adverse events, diverting resources needed in treating the higher risk groups.

Temporal parameters:

By convention, three months has been an important interval in the treatment of chronic pain. Some definitions of chronic pain require three months duration. Many prescription plans allow for up to three months supply, usually with a substantial monetary discount for the patient.  Some state controlled substance regulations (e.g. Section 6 of Indiana’s draft) point to three months as a proper interval for surveillance measures and re-evaluation.

If the milligram threshold limit is raised to 60 mg, then the Emergency rules should be triggered if at any time in any three consecutive month interval, a daily MED exceeds 60 mg.

This would be a clear parameter. The requirement to keep track of multiple days with variable dosages not only is cumbersome for the prescriber, but creates opportunity for “gaming the system” by inappropriate prescribers and would-be drug abusers (i.e. “doctor-shoppers”).

The number of pills:

The number of pills (units) dispensed has not been shown to be a significant risk factor in addiction or abuse of opioids. Ever-changing manufacture of potent dosage units allows for a wide range of milligrams per unit, further minimizing the importance of regulating the number of units dispensed. Also many therapeutic regimens require multiples of units for effective titration. Restricting the number of units prescribed would be an impediment to this therapeutic process.

Currently Section 9 reads:

SECTION 9. When a patient’s opioid dose reaches a morphine equivalent dose of more than fifty (50) milligrams per day, a face-to-face review of the treatment plan and patient evaluation must be scheduled, including consideration of referral to a specialist.  If the physician elects to continue providing opioid therapy at a morphine equivalent dose of more than fifty (50) milligrams per day, the physician must develop a revised assessment and plan for ongoing treatment.

The recommendation is to raise the threshold of 50 mg MED, to 120 mg MED.

Discussion:

In this excerpt from his August 27, 2013 letter to the Indiana members of the American Academy of Pain Management, AAPM Director of Policy and Advocacy, Robert Twillman, Ph.D., FAPM explains:

“The concept of setting a threshold to trigger a review of the course of, and plan for, treatment is not new, and seems to me to be entirely reasonable. However, a 50 mg MED threshold is FAR lower than any other existing threshold. The next-lowest threshold is 80 mg MED, in Ohio; other guidelines use thresholds ranging from 90 mg MED to 120 mg MED. I believe that a 50 mg MED threshold is far too low to be practical, and that using such a threshold will result in a substantial chilling effect with respect to prescribing opioids, as prescribers take steps to avoid reaching this dose, avoiding the extra work that results from doing so. Additionally, there is no research supporting the use of a 50 mg MED threshold; in fact, while there is evidence suggesting that 90-120 mg MED might be a reasonable range for a threshold, that research is flawed and thus less than totally convincing.”

Setting this threshold at 120 mg would make Indiana’s parameter consistent with the widely acclaimed 2010 Washington State Agency Medical Directors’ Group’s Interagency Guideline on Opioid Dosing for Chronic Non-cancer Pain (Ref 2). Prescribers and regulators alike could then draw upon the research and experience of this successful program.

A threshold of 120 mg would logically be twice the recommended 60 mg threshold from Section 3, allowing prescribers to more easily remember the dosage parameters.

References:

  1. Duragesic “Boxed Warning” http://www.duragesic.com
  1. 2010 Washington State Agency Medical Directors’ Group Interagency Guideline on Opioid Dosing for Chronic Non-cancer Pain http://www.agencymeddirectors.wa.gov/Files/OpioidGdline.pdf
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