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):
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.”
(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).
RECOMMENDED CHANGES TO INDIANA’S EMERGENCY PAIN REGULATIONS