SIX DAYS UNTIL INDIANA’S PAIN REGULATIONS GO INTO EFFECT

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December 10, 2013 – Counting today there are six days until Indiana’s Emergency Pain Regulations go into effect (on December 15, 2013).

The Painful Truth (my opinion) examines section FIVE.

SECTION FIVE

Although the term “Informed Consent” (IC) is not mentioned, this section clearly deals with elements of informed consent in discussing the requirement for a treatment agreement (TA).

Both the PATIENT and the PHYSICIAN must sign the “agreement.” A copy must be kept in the patient’s chart.

The document(s) must attest to a “simple and clear” explanation of:

  1. Risks and benefits (IC)
  2. Alternatives to opioid treatment (IC)
  3. Consent to drug monitoring and random pill counts (TA)
  4. The requirement to take the drugs as prescribed (TA)
  5. Prohibition of the sharing of drugs (TA)
  6. “That the patient inform the physician about any other controlled substances prescribed or taken” (TA)
  7. Treatment goals (TA)
  8. Reasons opioid therapy may be changed or discontinued (TA)
  9. COUNSELING FOR WOMEN: Particular attention must be given to “women between the ages of 14 and 55 with child bearing potential” (e.g., has not had a hysterectomy). They must be counseled regarding RISKS TO THE FETUS, specifically including the risks of “fetal opioid dependency and neonatal abstinence syndrome.” (IC)

 

The Painful Truth recommends combining the treatment agreement and the informed consent into one document.

SEVEN DAYS UNTIL INDIANA’S “DRAMATIC” PAIN REGS GO INTO EFFECT

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December 9, 2013 – Counting today there are seven days until Indiana’s Emergency Pain Regulations go into effect (on December 15, 2013).

The Painful Truth (my opinion) today examines section FOUR:

SECTION FOUR

This section deals with the Physician’s responsibility for performing the initial evaluation, including determination of level of risk.

It is clearly stated that the physician shall do the physician’s OWN evaluation and risk stratification of the patient by doing the following:

  1. Perform an APPROPRIATELY focused history and physical exam
  2. Obtain or order APPROPRIATE tests “as indicated”
  3. Make a DILIGENT effort to obtain and review records & document the effort.
  4. ASK the patient to complete an OBJECTIVE pain assessment tool
  5. Use a VALIDATED screening tool for mental health and substance abuse
  6. Establish a “working diagnosis”
  7. Tailor a plan with MEANINGFUL and FUNCTIONAL goals (to be reviewed “from time to time”)
  8. WHERE MEDICALLY APPROPRIATE use non-opioid options instead of or IN ADDITION TO prescribing opioids.

The Painful Truth believes the requirements of Section Four lend themselves to creating a checklist. Therefore, at the initial evaluation a Hoosier physician must be DRAMATIC.

o          D         diagnosis made (“working diagnosis”)

o          R         records obtained (a diligent effort made to obtain & review)

o          A          assessment of pain

o          M         mental health (and substance abuse) screen

o          A          activity goals established

o          T          tests ordered if indicated

o          I           instead of opioids, use non-opioid options

o          C         conduct focused history and physical

The Painful Truth notes that the terms “appropriate,” “as indicated,” “diligent,” “meaningful,” and “from time to time” are subjective. Physicians are advised to be able to defend his or her interpretation of these terms.

The Painful Truth believes it is acceptable for a prescribing physician use historical information obtained by sources other than the prescribing physician (i.e., office staff) as long as the physician personally verifies the information with the patient.

The Painful Truth points out that the initial physical exam must be done by the prescribing physician and cannot be delegated.

The Painful Truth notes that a truly “objective pain assessment tool” does not exist, as pain is personal and subjective. Nevertheless, at minimum, a visual analog scale (i.e., 0 to 10) or similar documentation aid should be employed in order to satisfy the regulatory requirement.

The Painful Truth believes that only in rare circumstances would a non-opioid treatment option fail to exist.

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INDIANA’S PAIN REGULATIONS GO INTO EFFECT IN TEN DAYS

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December 5, 2013 – In ten days Indiana’s Emergency Pain Regulations go into effect (on December 15, 2013).

Let’s look at section THREE (By the way “The Painful Truth” is my opinion):

SECTION 3

This section explains which patients are exempt from the regulations.

(1) with a terminal condition

(2) living in a licensed health facility

(3) enrolled in a licensed hospice program

(4) enrolled in a palliative care program of a licensed hospital

Note: If a non-terminal patient eventually leaves the health, hospice, or palliative facility the opioid use during that time still counts in the threshold calculation (see below).

Section 3 also establishes thresholds that trigger the requirements of the Emergency Regulations.

(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 Painful Truth: With a little creativity and a literal interpretation, these thresholds allow a wide range of unintended prescribing options.

For example: You could prescribe 60 pills for the month and tell the patient to break each pill in half – effectively offering FOUR doses per day without exceeding the 60 pill per month threshold.

You could even prescribe a drug as potent as Oxycontin twice per day for 89 consecutive days and avoid the THREE CONSECUTIVE MONTH threshold.

In contrast, prescribing a relatively benign sixty-one codeine pills for the month exceeds the threshold and triggers all of the requirements spelled out in the regulations.

This should not encourage anyone to “game the system.” It only illustrates how difficult it is to establish dosing thresholds that are clinically relevant and enforceable.

I addressed dosing thresholds in a letter (and blog post) from October of this year. Hopefully there will be some changes to the thresholds when the final regulations are enacted in 2014.

Be advised that the Attorney General’s “First Do No Harm” provider Toolkit does not explore these initial thresholds or the concept of exempted patients in any detail.  The Toolkit seems to imply that any use of opioids carries enough danger to warrant risk stratification, surveillance, and a cautious approach when prescribing.

The Painful Truth advises prescribers to conservatively interpret the measures outlined in the Emergency Regulations.

And stay tuned, because a 60 mgm morphine equivalent dose threshold becomes an important issue in Section NINE (to be discussed later by The Painful Truth).

Reference:

RECOMMENDED CHANGES TO INDIANA’S EMERGENCY PAIN REGULATIONS
https://jamespmurphymd.com/2013/10/16/recommended-changes-to-indianas-emergency-pain-regulations

TWELVE DAYS UNTIL INDIANA’S PAIN REGULATIONS GO INTO EFFECT

December 4, 2013 – Counting today there are twelve days until Indiana’s Emergency Pain Regulations go into effect …on December 15, 2013.

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Let’s look at the first two sections (By the way “The Painful Truth” is my opinion):

SECTION 1

These REGULATIONS are from the Medical Licensing Board of Indiana and are applicable to PHYSICIANS only; and specifically with regards to OPIOIDS for CHRONIC PAIN.

The Painful Truth: In my opinion, every provider (i.e. dentists, podiatrists, nurse practitioners, physicians, etc.) should understand that the Attorney General’s Office supports the “First Do No Harm” guidelines for every provider.

SECTION 2

This section offers definitions, some of which I examine below:

* Chronic Painmeans 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.”

The Painful Truth: I take this as meaning any type of pain, for whatever reason, regardless of the severity, that is a problem for two months or longer; even if it is intermittent pain. This encompasses a generous range of chronic pain scenarios.

* Morphine Equivalent Dose “means a conversion of various opioids to a standardized dose of morphine by the use of accepted conversion tables.”

The “First Do No Harm” Toolkit gives some examples of equianalgesic doses to SIXTY MGM of MORPHINE (i.e. hydrocodone 50 mg; oxycodone 40 mg; fentanyl patch 25 mcg/hr), and notes “Equianalgesic tables should only serve as a general guideline to estimate equivalent opioid doses.”

The Painful Truth: This is an inexact science, and there are many “accepted” morphine equivalent conversion tables from which to choose – none of which are perfect. The Toolkit references an online calculator from GlobalRPH. I also like the one from Practical Pain Management. The state of Washington has a nice one as well. When making these conversions try to err on the low side. Better to underestimate than overestimate (i.e. Once someone takes a medicine it is impossible to get it back). Murphy’s laws:  (1) Start low and go slow; (2) Every dose is a test dose.

 * “Outset of an opioid treatment plan” refers only to a patient who has been prescribed: (1) more than sixty opioid-containing pills a month; or (2) a morphine equivalent dose of more than fifteen (15) milligrams per day; for more than three consecutive months.

The Painful Truth: This is very important, somewhat confusing, and will be discussed later. For now, just realize that there is definitely a threshold where these regulations become relevant.

Disclaimer: This is not legal advice. This is not medical advice. I represent no organization. All opinions, unless specifically referenced, are my own. If you have a medical condition please seek advice from your personal physician. Every patient, practitioner, and facility should consult its own counsel for advice and guidance. If you rely upon information from this website, you do so at your own risk.

FIFTEEN DAYS UNTIL INDIANA’S PAIN REGULATIONS GO INTO EFFECT

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December 1, 2013 – counting today there are fifteen days until Indiana’s Emergency Pain Regulations go into effect. On December 15th the way physicians prescribe pain medications in the Hoosier State will change.

Between now and December 15th I will regularly be posting this pain specialist’s take on the Indiana situation.  Having said that, it is time for a disclaimer:

This is not legal advice. This is not medical advice. I represent no organization. All opinions, unless specifically referenced, are my own. If you have a medical condition please seek advice from your personal physician. Every patient, practitioner, and facility should consult its own counsel for advice and guidance. If you rely upon information from this website, you do so at your own risk.

Here we go…

One should begin this journey by understanding the difference between a law, a regulation, and a guideline.

A law is a rule that has been passed by elected officials. Violation of a law may be viewed as a criminal act.

Indiana’s new pain law (a.k.a. additions to Senate Bill 246) is fairly concise and does not directly apply to physicians. Instead, it says the medical board must come up with regulations – which they did.

A regulation is a rule that is usually created by a government agency (i.e. a “bureaucracy”) as opposed to the legislature. Regulation determines how laws will be enforced. Violation of a regulation may not be a criminal act but can incur a wide-range of penalties.

As previously stated, Indiana’s Emergency Pain Regulations go into effect on December 15, 2013 and are subject to revision until November 1, 2014, at which time the permanent regulations are due.

A guideline, especially when endorsed by a governing body, is a set of opinions that offer insight into the manner in which regulations and laws can be properly followed. Violating a guideline may or may not be considered a wrong move, but generally will require a legitimate explanation as to the decision-making process.

The Indiana State Attorney General’s Office has published a detailed set of guidelines, called “First Do No Harm,” which offer insight as to what regulators will consider as proper medical practice, should they be called upon to investigate a controlled substances related issue.

In summary, Indiana physicians who prescribe controlled substances do not need to know details of the new law, as it does not apply directly to them.

However, physicians should clearly understand the Emergency Pain Regulations and how these regulations will affect their practice after December 15, 2013.

Also, physicians are strongly urged to become familiar with the “First Do No Harm” guidelines and to start incorporating as many of the recommended practices as possible.

Stay tuned.  It’s only December 1st.

There’s more painful truth in the days to come.