Indiana Medical Licensing Board
Emergency Pain Management
Prescribing Rule
1
OBJECTIVES At the end of live activity, participants should be able to: (1) List Indiana’s new prescribing laws (2) Identify patient compliance tools
appropriate for controlled substance prescribing (3) Discuss ways to comply with Indiana’s new prescribing laws.
CME CREDIT INFORMATION Credit Designation Information: The Indiana State Medical Association (ISMA) designates this live seminar for a
maximum of 1.0 AMA PRA Category 1 Credits™. Physicians should claim only the credit commensurate with the extent of their participation in the
activity. Accreditation Information: The ISMA is accredited by the Accreditation Council for Continuing Medical Education (ACCME) to provide
continuing medical education for physicians. Disclosure Information: To comply with ACCME accreditation requirements, the ISMA is including the
Speaker and Committee Financial Relationship Disclosure Grid for this program (see following pages for grid). In accordance with the ACCME
Standards for Commercial Support, educational programs sponsored by the ISMA must demonstrate balance, independence, objectivity and scientific
rigor. Financial disclosure or relationships with a commercial product or manufacturer of commercial services that might be discussed or referred to in
the educational activity must be made to the audience prior to the activity. To receive CME credit, you must complete the evaluation at the close of
this seminar, providing name and attestation of hours. The CME certificate will be e-mailed.
PLANNING CMTE.
SPEAKERS
FINANCIAL DISCLOSURE CONFLICT OF INTEREST GRID
The ISMA has implemented a process where everyone who is in a position to control the content of an education activity has disclosed to us all
relevant financial relationships with any commercial interest. In addition, should it be determined that a conflict of interest exists as a result of a
financial relationship this will need to be resolved prior to the activity.
Name
Commercial Interest
What I received
My Role
Conflict/Resolved
Julie Reed JD
I do not have any relevant financial relationships with any commercial interests.
N/A
N/A
None
Mike Rinebold
I do not have any relevant financial relationships with any commercial interests.
N/A
N/A
None
Name
Commercial Interest
What I received
My Role
Conflict/Resolved
Jill Bruce
I do not have any relevant financial relationships with any commercial interests.
N/A
N/A
None
Sandy Miller
I do not have any relevant financial relationships with any commercial interests.
N/A
N/A
None
Julie Reed JD
I do not have any relevant financial relationships with any commercial interests.
N/A
N/A
None
Mike Rinebold
I do not have any relevant financial relationships with any commercial interests.
N/A
N/A
None
2
Background and Context
• Every 25 minutes someone dies from a
prescription drug overdose.
• 1:20 people in the United States have used
prescription painkillers for non-medical
reasons.
• Approx. 560 to 700 Hoosiers die every
year from overdoses from prescribed
narcotics (rank: 16th per capita).(Source:
http://www.in.gov/bitterpill/)
3
Physician Disciplinary Cases
Since January 2012, the Office of the
Indiana Attorney General has taken action
against more than 15 doctors for their
controlled substance prescribing habits.
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Physician Disciplinary Cases
• Multiple Patient Deaths Due to Multiple
Drug Toxicity
• Pre-signing Prescription Pads
• High Pill Counts & Dangerous
Pharmacological Mixes:
– opiates/benzodiazepines + muscle relaxers
– opiates/benzodiazepines + stimulants
– butrans + hydrocodone
5
National Landscape
• Rise of the pain management clinics –
Florida
• Kentucky and Ohio - comprehensive “pill
mill” laws
• Kentucky clinic  Jeffersonville, IN
– Regulators immediately frustrated by their
inability to take prompt action against the
clinic/physician.
– Senator Ron Grooms
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SEA 246
1. Clinic owners (who are not otherwise already
licensed/registered) must register pain management
clinics.
2. MLB adopt emergency rules by November 1, 2013
creating an investigation authorization procedure for
AG’s office to examine a physician’s records and
controlled substances inventory and materials relating
to controlled substance prescribing practices.
3. MLB adopt emergency rules by Nov. 1, 2013, to
establish standards and protocols for the prescribing
of controlled substances for pain management.
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Lots of Existing Prescribing Laws!
8
The Federal Standard
A prescription that is issued for a legitimate
medical purpose in the usual course of
professional practice by: (i) a practitioner who
has conducted at least one in-person medical
evaluation of the patient; or (ii) a covering
practitioner.
(21 U.S.C. § 829(e)(2)(A))
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Indiana Law:
Prescribing to Patients Not Seen
Except in limited circumstances,* a physician cannot
prescribe, dispense, or otherwise provide any
prescription medication to a person the physician has
never personally physically examined and diagnosed.
*Limited circumstances:
–
–
–
–
Inpatients/residents of Institutional facilities
On-call coverage
Cross-coverage
Advanced practice nurses with prescriptive authority under
collaborative arrangement
(844 IAC 5-4-1)
10
Indiana Law:
Assisting an Addict
A physician is subject to disciplinary sanctions
if the physician “knowingly prescribed, sold, or
administered any drug classified as a narcotic,
addicting, or dangerous drug to a habitue or
addict.”
(Ind. Code § 25-1-9-4(a)(9))
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Indiana Law:
Prescription Formalities
• Must be dated as of the day when issued.
• Must be signed the day when issued.
• Non-electronically prescribed prescriptions
may be prepared by a secretary or agent
for the signature of a practitioner, but the
prescribing practitioner is responsible in
case the prescription does not conform in
all essential respects to the law and
regulations.
(856 IAC 2-6-4)
12
Drug Refills
• Prohibited for Schedule II’s
• DEA – Revised regulations (2007)
• A prescribing practitioner may issue multiple
prescriptions authorizing the patient to
receive a total of up to a 90-day supply of a
schedule II controlled substance provided the
mandatory conditions are met.
13
Federal Law: Multiple Prescriptions
1.
2.
3.
4.
5.
Each separate prescription is issued for a legitimate medical
purpose by an individual practitioner acting in the usual course
of professional practice;
The individual practitioner provides written instructions on each
prescription indicating the earliest date on which a pharmacy
may fill each prescription;
The individual practitioner concludes that providing the patient
with multiple prescriptions in this manner does not create an
undue risk of diversion or abuse;
The issuance of multiple prescriptions is permissible under state
laws (Indiana law defers to federal regulations regarding this
issue);
The individual practitioner complies fully with all other
applicable requirements under state and federal laws.
14
Indiana Law: Diet Drugs
Physicians may not prescribe any amphetamine, sympathomimetic amine drug
or a schedule II controlled substance for weight reduction or control.
Only a physician may treat a patient for weight reduction or control with a
schedule III or IV controlled substance. In those circumstances, it is permissible
only if the physician:
•
•
Determines through review of either the physician's records of prior treatment or
records of prior treatment from a previous treating physician or weight-loss
program that the patient made a reasonable effort to lose weight using a weightreduction regimen based on caloric restriction, nutritional counseling, behavior
modification and exercise – without controlled substances. And the physician
must determine the treatment described in those records was ineffective,
documenting thoroughly.
Obtains a thorough history and performs a thorough physical examination of the
patient before initiating a treatment plan using a schedule III or schedule IV
controlled substance for weight reduction or to control obesity. Again, document
thoroughly.
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Diet Drugs (cont.)
A physician may not begin and shall discontinue using a schedule
III or schedule IV controlled substance for weight reduction or
obesity control after determining by professional judgment:
• The patient failed to lose weight using a treatment plan
involving the controlled substance;
• The controlled substance has offered decreasing contributions
toward further weight loss for the patient, unless continuing to
take the controlled substance is medically necessary or
appropriate as maintenance therapy;
• The patient has a history of or shows a propensity for alcohol
or drug abuse, or has consumed or disposed of a controlled
substance in a manner not strictly in compliance with a treating
physician's direction.” (Ind. Code 35-48-3-11)
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Federal Guidance
Use of Staff
• Agent may not make medical
determinations for the prescribing physician
(i.e., medical need determination may not
be delegated).
• Physician must personally sign (e- or
manual) (i.e., signature authority cannot be
delegated).
(U.S. Dept. of Justice, Drug Enforcement Administration, 21 CFR Part 1306, “Role
of Authorized Agents in Communicating Controlled Substance Prescriptions to
Pharmacies,” Policy Statement, 75 Fed. Reg. 193, p. 61613, Oct. 6, 2010)
17
Indiana Law
Staff – Nurse Practitioners
• NPs can prescribe once granted prescriptive
authority, consistent with the terms of a physician
collaborative agreement.
• NPs must submit prescribing practices to physician
within 7 days and physician must review 5%
random sampling of charts and medications.
18
Indiana Law
Staff – Physician Assistants
• Can prescribe under a supervision agreement with a
physician (limit 2 at any moment).
• Can prescribe a controlled substance, in an aggregate
amount, that does not exceed a thirty (30) day supply.
Any refills or subsequent prescriptions beyond the thirty
(30) day supply must be authorized by the supervising
physician and recorded in the medical record.
• If the supervising physician/designee is not present in the
same facility as the PA, the supervising
physician/designee must be within reasonable travel
distance from the facility.
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Indiana Law
Staff – Physician Assistants
• Review of patient encounters within 72 hours for the
following:
o 100% for the 1st year of employment
o 50% for the 2nd year of employment
o 25% for the 3rd year of employment
• PAs are now required to submit a list of all locations
where the PA and the supervising physician may
practice.
20
The Three Rules of
Responsible Prescribing
1. Consider whether it is responsible to
prescribe - i.e., consider alternatives
2. If you do prescribe, do it responsibly i.e., monitor your patients
3. If your patient is noncompliant or the
treatment isn’t working, take action.
21
Indiana’s New
Pain Management
Prescribing Emergency Rule
Adopted by the MLB on October 24, 2013
22
The Rulemaking Process (2013)
May 31
MLB solicited stakeholder proposals (IN RULE
FORMAT) by June 20, 2013.
June 17
ISMA and AG Task Force met to discuss rule language.
June 27
MLB discussed process at monthly meeting.
July 16
Rule stakeholder meeting including ISMA and AG Task Force.
July 24
MLB special public forum for input on rules.
Aug. 22
MLB discussed proposals at monthly meeting.
Sept. 25 MLB held 2nd public forum for input on rules.
Sept. 26 MLB discussed rule at monthly mtg.
Oct. 24
MLB adopted Rule
23
Applicability
Only applies to the use of opioidcontaining controlled substances for
chronic pain management.
24
Definition – Chronic Pain
“Chronic Pain” – 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.
25
Exclusions
The rule does not apply to:
1. Patients who are terminal.
2. Residents of a licensed* health facility.
3. Patients enrolled in a licensed* hospice program.
4. Patients enrolled in inpatient or outpatient
palliative care program of a licensed* hospital or
licensed* hospice.
(*Indiana licensed)
26
Definition - Terminal
“Terminal” – A condition caused by injury,
disease or illness from which, to a reasonable
degree of medical certainty:
1) there can be no recovery; and
2) progression to death can be anticipated as
an eventual consequence of that condition.
27
Dosing Thresholds
The rules only apply if the patient has been
prescribed, for more than 3 consecutive
months:
1) >60 opioid-containing pills per month;
OR
2) morphine equivalent dose >15 mg/day
28
Patient Assessment
Physician must perform own evaluation and
risk stratification of the patient in initial
evaluation:
1) Appropriately focused H&P exam &
appropriate tests, as indicated
2) Documented attempt to obtain and review
records from prior providers
3) Patient complete pain assessment tool
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Patient Assessment
4) Assess patient’s MH status and risk for
substance abuse w/ valid screening tools
5) After initial evaluation, establish working
DX and tailor treatment plan to meaningful and
functional goals (review w/ patient
occasionally)
30
Consider Alternatives
Where medically appropriate, the
physician shall utilize non-opioid options
instead of prescribing opioids.
31
Patient Informed Consent
Discuss with the patient:
– Potential risks and benefits of opioid
treatment for chronic pain
– Expectations related to prescription
requests
– Proper medication use
32
Patient Informed Consent
Discuss with patient:
– Alternative modalities to opioids for managing
pain
– Provide a simple and clear explanation to help
patients understand the key elements of their
treatment plan
– Counsel women 14-55, of child bearing potential,
about risk to fetus when mother has taken
chronic opioids during pregnancy (including risk
of fetal opioid dependency and neonatal
abstinence syndrome)
33
Face-to-Face Patient Visits
No prescribing without periodic
scheduled face-to-face visits.
– Stable meds & treatment plan  every 4
months
– More frequent if still optimizing.
– Changes to meds & treatment plan  every 2
months until stabilized
34
Patient Visits
During visits, evaluate progress and
compliance with treatment plan
regularly and set clear expectations
along the way (e.g., PT, counseling,
other treatment).
35
INSPECT Reports
At outset of treatment plan, and at least annually
thereafter, prescribing physician must run an
INSPECT report and document in patient’s chart
whether it is consistent with the physician’s
knowledge of the patient’s controlled substance
use history.
*Initial report – grandfathering as of 12/15/13
*Annual report – postponing to 11/1/14
36
Drug Monitoring Tests
• At outset, and at least annually thereafter,
prescribing physician must perform a drug
monitoring test, which must include
confirmatory test.
• If test is inconsistent with medication use
patterns or shows illicits, review treatment
plan. Document the discussion and any
changes in patient chart.
37
Drug Monitoring Tests
• Initial test – Grandfathering as of 1/1/15
• Annual test – Postponing to 1/1/15
38
The Prescribing Rule
“Think Twice”
When opioid dose reaches morphine equivalent
dose of >60mg/day:
1. Schedule a face-to-face review of treatment
plan and patient evaluation
2. Consider referral to a specialist
Think twice…and then…
39
After Thinking Twice….
If physician elects to continue treating at that
level, physician must:
– Develop a revised assessment and plan for
ongoing treatment.
– Document in chart, including assessment of
increased risk for adverse outcomes, including
death.
40
Treatment Agreements
Together with patient, review and sign a
“Treatment Agreement,” which must include
(minimum):
1) Goals of the treatment
2) Patient’s consent to drug monitoring testing
3) Your prescribing policies, including
a) Rule that patient take meds as prescribed
b) Prohibition on sharing meds
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Treatment Agreements
4) Requirement that the patient inform the physician
about any other controlled substances prescribed or
taken.
5) Reasons the opioid therapy may be changed or
discontinued by the physician.
6) Grant physician permission to conduct random pill
counts.
*A copy of the agreement stays in patient’s chart*
42
Supervising PAs
- A Reminder
The prescribing of opioids for chronic pain
management falls within the requirements on
supervising physicians (or their designees),
including appropriate delegating of duties and
responsibilities and appropriate supervision.
43
Collaborating with NPs
– A Reminder
The prescribing of opioids for chronic pain
management falls within the requirements on
collaborating physicians regarding the
prescriptive authority for advanced practice
nurses.
44
Rule Enforcement Date
December 15, 2013
45
ISMA Prescribing Resources
• Newsletter articles
• Website (www.ismanet.org)
– New prescribing resources webpage
– Pain Management Rule Webinar (30 min.)
– 2-page rule summary
• CME programs (December, May, September, November)
• Hospital talks around the state
• Phone and email inquiries
46
Additional Resources
• www.bitterpill.in.gov – Prescribers Toolkit
• Book, Responsible Opioid Prescribing (2nd
ed.), Scott Fishman, MD
• Drug Disposal www.in.gov/idem/recycle/2343.htm
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We want to hear from you!!
• Questions about the rule?
• Concerns about implementation?
• What changes should be made to the rule?
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