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| URL: | https://www.deadiversion.usdoj.gov/...19/dec_2019/hunter.pdf |
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| Title: | Preventing Unlawful Prescribing & Controlled Substance Diversion & Abuse, A Perspective from the ALBME |
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| Description: | -None- |
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| Body: | Preventing Unlawful Prescribing and Controlled
Substance Diversion and Abuse
A Perspective from the ALBME
E.
Wilson Hunter
General Counsel
Alabama Board of Medical Examiners
www.albme.org
Purpose and mission
The Alabama Board of Medical Examiners and the Medical
Licensure Commission of Alabama are charged with
protecting the health and safety of the citizens of the state
of Alabama.
Defining the problem
Defining the Problem
Rx
Count
Total Quantity
(Pills)
Days Supply
1
31131
2477387
830231
2
30819
2398679
852734
3
37224
2316444
1140761
4
34543
2202004
921976
5
23989
2147714
714428
6
29814
2126940
766265
7
39725
2084043
1132050
8
25629
1908321
734974
9
28648
1887241
819695
10
22648
1878007
608554
Alabama had the highest opioid prescribing
rate in the nation in 2017
2017 CDC Map
ALBME Initiatives
Alabama Pain Management Act (2013)
Risk and Abuse Mitigation Strategies for Prescribing
Physicians (2017)
Enforcement
Alabama Pain Management Act
Ala. Code §
34-24-600, et seq.,
Ala. Admin. Code 540-X-19
Provisions:
-
Pain management providers must register with the Board
-
Limits ownership and operation
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Requires oversight by a medical director
-
Authorizes Board to conduct investigations and
inspections
-
All ACSC and PM holders must register with the PDMP
Alabama Pain Management Act
Current number of registrations in Alabama:
-
Approximately 600 registrations
Who has to register:
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Anyone who intends to run a "pain clinic"
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Anyone who dispenses opioids
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A practice where any physician is ranked in the top three
percent of controlled substance prescribers in the state
2019 revisions to rules include limiting medical directors to physicians
without significant disciplinary history within the preceding 5 years
Alabama Pain Management Act
Enforcement tools:
-
The Board can initiate investigations
-
The Board can inspect a pain management clinic at any
time (Rule 540-X-19-.06)
-
Practicing pain management without a registration can be
punished with a $10,000 fine (per violation) and/or with
revocation of the ACSC (Rule 540-X-19-.08(3)(a))
-
Medical Director can be held accountable (540-X-19-
.08(3)(b))
Alabama Pain Management Act
Successes:
-
Identification of pain management providers
-
Enhanced enforcement tools
-
Medical director requirement prevents underqualified
physicians from setting up a pain clinic
Weaknesses:
-
Non-physician ownership of facilities
-
No one to report to/No one to shut down repeat, non-
physician offenders
Risk and Abuse Mitigation Rule
Board rule made effective March 9, 2017
Requires:
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Use of CDC-based Morphine Milligram Equivalency
("MME") standard to measure opioid dosing
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Use of risk and abuse mitigation strategies when
prescribing opioids and other controlled substances
-
Use of PDMP when prescribing certain amounts of opioids
-
Continuing medical education in controlled substances
prescribing every two years
Risk and Abuse Mitigation Rule
Emulation of this rule is recommended to all health
care licensing boards that regulate controlled
substances per the Alabama Opioid Overdose and
Addiction Council's 2018 Annual Report
Successes:
-
Heightened awareness of opioid overprescribing problem
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Required PDMP use
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Education of prescribers
Weakness: only applies to prescribers
Risk and Abuse Mitigation Rule
2019 Revision
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All controlled substances have a risk of use, misuse, and
diversion.
-
Today, we are focused on opioids. Historically, widespread opioid
misuse has been followed by widespread amphetamine misuse
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Education is needed to help prescribers understand that all
controlled substances carry some risk
-
The Board has recalibrated the Risk and Abuse Mitigation rule to
make it generally applicable to all controlled substances
-
Adoption of Lorazepam Milligram Equivalence standard and
required PDMP use for benzodiazepine prescriptions
Enforcement: Sources of
Information
Complaints from other physicians
-
"any person making any report or rendering any opinion or supplying any
evidence or information or offering any testimony to the board or to the
commission in connection with an investigation or hearing conducted by the
board or the commission as authorized in this article shall be immune from
suit..." Ala. Code §
34-24-361(i).
Complaints from pharmacists
Patient Complaints
Other state and federal agencies
Board-initiated investigations
Enforcement
Tools for disciplining and educating licensees:
-
Voluntary Agreements
-
Board-ordered Continuing Medical Education
Up to 50 hours per year
Ala. Code §
34-24-61
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Restriction, Suspension, or Revocation of ACSC
Ala. Code §
20-2-54
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Restriction, Suspension, or Revocation of medical license
Ala. Code §§
34-24-360 and -361
Case Studies -
Example 1
Example 1: Investigation resulting in a voluntary
agreement
-
Facts: Pain management physician ranked in top 150 of
Alabama prescribers; reported by local physician;
climbing in the rankings year over year; no specialty
training
-
Numerous patients being prescribed cocktail of opioid,
benzodiazepine, and carisoprodol
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Many patients being prescribed chronic opioid regimens
in excess of 200 MME/day
Case Studies -
Example 1
10 patient charts subpoenaed and reviewed by the
Board
Board concerns:
-
Primary concern is failure to maintain a medical record which
meets the minimum standards for prescribing controlled
substances.
-
In some cases practicing medicine in such a manner as to
endanger the health of the patients of the practitioner by excessive
prescribing of controlled substances and amount of controlled
substance not reasonably related to proper medical management of
patient's illnesses or conditions.
Case Studies -
Example 1
Board concerns (continued)
-
Limited use of risk mitigation strategies.
No PDMP check documented.
No Pill count documented.
No discussion of presence or absence of aberrant behavior.
Board action: Invite
Board conclusion: Unsafe prescribing is a product of
knowledge and training deficit
Case Studies -
Example 1
Board Action
-
Board-ordered to CME (Intensive Prescribing Course and
Medical Records Keeping Course)
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Voluntary agreement signed by physician
Example Terms of the Agreement:
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MME cap for prescribing controlled substances to treat chronic pain
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Referral to pain specialist for patients needing more than 90 MME/day
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Mandatory use of certain risk and abuse mitigation strategies
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Restriction on co-prescribing of opioids and central nervous system
depressing medications
Violation of terms may result in discipline
Case Studies -
Example 2
Example 2 -
Investigation resulting in Probation
Facts: Complaint from pharmacist; pain clinic with
physician ranked in top 850 prescribers; numerous
patients with prescriptions for opioids in excess of
200 MME/day; physician NOT registered to do pain
management; no specialty training
Physician interviewed by investigator; a month later,
he still has not registered
Physician has not accessed the PDMP
Case Studies -
Example 2
10 patient charts subpoenaed and reviewed by the
Board
Board action: Invite
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Fails to articulate medical decision-making
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No objective data in medical records
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States the norm for chronic pain is 200 MME/day
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Claims to be titrating patients down but no evidence to support
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Practicing weight-loss with use of controlled substances but
expresses ignorance that Board has any rules regulating this
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Obtained zero hours of CME the previous year
Case Studies -
Example 2
Board action: Summary Suspension of ACSC
Independent Expert review obtained
-
Conclusions:
Excessive dosages and amounts of opioids and controlled
substances
Inadequate documentation
Inadequate use of risk/abuse/diversion mitigation strategies
Lack of attention or use of non-pharmacologic modalities
Inadequate attention to co-prescribing of highly addictive and
CNS-depressing medications
Case Studies -
Example 2
Result: Joint Stipulation and Consent Order
Physician admitted to violations
ACSC Revoked; Revocation Suspended; ACSC placed
on Probation for 24 months, with conditions;
$10,000 fine
Probation terms restrict prescribing with MME cap,
required use of risk/abuse mitigation strategies, co-
prescribing restrictions and use of protocols
Compliance monitored by the Board
Case Studies -
Example 3
Example 3 -
Investigation resulting in surrender of
license
Facts: Non-physician owned pain management
clinic; prior medical director's ACSC summarily
suspended and revoked; target physician replaces
soon thereafter
Target physician applies for pain management
registration but is not registered with PDMP; pays
$2000 fine
Case Studies -
Example 3
Facts: Physician practices pain management at
location without a registration for 6 months
Investigation: 10 charts subpoenaed; interviews of
non-physician owners and staff
Board Findings:
-
Physician practiced pain management for 6 months without a
registration
-
Clinic is cash only and does not have a medical director
-
Physician has been dispensing phentermine without a registration
-
Physician denied dispensing phentermine; PDMP and staff contradict
Case Studies -
Example 3
Board findings:
-
Insufficient or no objective data in medical records
-
Patients prescribed high doses of narcotics with other
commonly diverted drugs
-
Husband and Wife team of patients receiving 870 pills a
month with daily MME (if they were taking them) of 1275
MME/day and 1425 MME/day, respectively
-
Clinic ownership is straw man because real owner is a
convicted felon
Board conclusion: Pill Mill
Case Studies -
Example 3
Board Action: Summary Suspension of ACSC and Pain
Management Registration
Independent Expert Review obtained (Supports Board
findings)
Result: Physician surrendered his Alabama Medical
License, his Pain Management Registration, and his
ACSC
Location reported by Board to law enforcement
Enforcement
Enforcement
Enforcement
Enforcement
Enforcement
A physician who loses his ACSC or medical license is, in most cases,
going to lose it for a minimum of two years because both the Board
and MLC can summarily deny petitions for reinstatement for up to 24
months before they are required to either grant the petition or set a
hearing at which the reinstatement petition will be contested
-
Ala. Code §
34-24-61(b) (Authority for Board to deny ACSC
reinstatement petitions)
-
Ala. Code §
34-24-361(h)(9) (Authority for MLC to deny license
reinstatement petition)
After five years, a revoked or surrendered license is gone forever (Ala.
Code §
34-24-361(h)(9))
Enforcement
A physician who loses his ACSC or medical license
can be required to pay a fine (up to $10,000 per
violation) AND he/she can be required to pay the
administrative costs of the Board, including:
-
The costs of the Board's expert witnesses
-
Attorney's fees
-
Deposition costs
-
Other actual expenses
-
(Source: Ala. Code §
34-24-380 and -381)
Enforcement
A physician who is assessed an administrative fine or
who is ordered to pay the Board's administrative
costs CANNOT renew his/her medical license until
those fines/costs are paid in full (Ala. Code §
34-24-
383)
Appeals of Board or MLC actions must be filed,
commenced, and maintained in the Alabama Court
of Civil Appeals (Ala. Code §
34-24-380 and Ala.
Code §
34-24-367)
Enforcement
PDMP use and access
-
All physicians who have an ACSC must be registered with the
state's Prescription Drug Monitoring Program
-
Board Rule 540-X-4-.09 REQUIRES physicians to access the PDMP
in certain circumstances
Physicians should not only access the PDMP, but they should
make treatment decisions based on what they find there
Example 1: they might find that a patient is receiving a CNS-depressing drug
from another physician that complicates the physician's planned therapy
Example 2: the "low-risk" elderly patient is doctor-shopping
Example 3: a physician should periodically run himself through the PDMP.
Many physicians have found a staff member who has stolen a prescription
pad that way
Looking Ahead
Areas of misuse, abuse, and diversion identified by the ALBME:
-
The deadly combination of benzodiazepines and opioids
Alprazolam is a major culprit, but the combination of opioids and any other
central nervous system depressing substance creates an even greater risk of
overdose and death than opioids alone
-
Buprenorphine
Treating an addict is not easy; buprenorphine is frequently abused, misused,
and diverted
A buprenorphine "pill mill" is not any better than an opioid pill mill
Looking Ahead
Rule changes
-
Amendment to Board Rule 540-X-19-.03
Added grounds for denial of a pain management registration
Can deny registration at locations with multiple offenders
-
Amendment to Board Rule 540-X-19-.05
Closing enforcement gaps by tightening requirements for a
physician to serve as medical director at a pain clinic
MAT Act of 2019
Resources
Board Website: www.albme.org
-
Rules page: https://www.albme.org/rules.html
-
FAQs for Physicians:
https://www.albme.org/practicematterslnks.html#prescr
Twitter: Follow @AlaMedBd
-
Receive alerts for new rules, public actions, agendas,
newsletters, etc.
Contact Information
Edwin Rogers, Chief Investigator
Direct: (334) 833-0179
E-mail: erogers@albme.org
Robert Steelman, Investigator
Direct: (334) 833-0198
E-mail: bsteelman@albme.org
Wilson Hunter, General Counsel
Direct: (334) 833-0188
E-mail: whunter@albme.org
Matt Hart, Associate General Counsel
Direct: (334) 833-0192
E-mail: mhart@albme.org
Virginia Reeves, Associate General Counsel
Direct: (334) 833-0167
E-mail: vreeves@albme.org
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