Dr. James MacDonald, Chief Administrative Officer or the RI Board of Medical Licensure and Discipline presents to the RIAPA on controlled substance prescribing in RI.

1. Controlled Substance Prescribing: What
to do?
James V. McDonald MD MPH
Chief Administrative Officer, Rhode Island Board of Medical Licensure
and Discipline

2. Disclosure
Speakers Report - Dr
McDonald – No disclosures

3. Objectives:
1. Discuss changes with the PDMP
2. Describe Controlled Substance Prescribing &
current regulations
3. Describe co-prescribing of Benzodiazepines &
Opioids – where are we going?
4. Summarize: Governor’s Task Force Strategic
Plan
5. The Physicians Health Committee

4. What is the issue and what is your
perspective……
• Pain: we all
experience it, yet
what is it?
• Opioids: effective
yet addictive
• First Do no
harm……

5. 1,189,243
1,449,627
1,792,407
0
200,000
400,000
600,000
800,000
1,000,000
1,200,000
1,400,000
1,600,000
1,800,000
2,000,000
2013 2014 2015
Annual Buprenorphine, Dispensed
Buprenorphine doses per year
• What is Medication
Assisted Treatment?
• Who can
provide/prescribe MAT?
• Patient limits?
• What about Physician
Assistants?
Medication Assisted Treatment

6. *Doses of Opioids
Per month (millions)
*Doses of Stimulants
Per month (millions)
*Schedule 2
Prescriptions per
Month
*PDMP reports
Per month

8. •Why is the PDMP
changing?

9. 37679
8492
4182
2615 2167
551 77 29 0
12475
2948
3488
627
1240
15 0 0 0
0
5000
10000
15000
20000
25000
30000
35000
40000
Physician APRN Physician Assistant Residents Dentist Podiatrist Veterinarian Midwife Optometrist*
Schedule 2 Prescriptions and PDMP Reports January 2016
Schedule 2 Prescriptions Written PDMP Reports Run
Could we do better on checking the
PDMP?

11. 75%
58%
50%
79%
46%
71%
81%
64%
87%
70%
68%
89%
81%
85%
89%
78%
Dentist Midwife Nurse Optometrist Physician Physician Assistant Podiatrist Veterinarian
% by Profession Registered for the PMP
September March
Who is registered for the PDMP as
of March 2016 ?

12. Patient Rx Request
1 of 6 This tutorial steps through how
to request a patient’s Rx report
and how to access your
previous patient requests.
Learn How To
• Access the Patient RequestScreen
• Search for a Patient
• Search other PMP InterconnectStates
• ViewResults
• Access Patient Requests History
Log in to begin

13. Patient Rx Request
2 of 6 • To request prescription history on a
patient, on the main menu go to:
RxSearch / PatientRequest.
• Required fields are indicated by a Red
Asterisks*.
• At a minimum, First Name, LastName,
and Date of Birth, as well as
Prescription Fill Dates arerequired.
• Including additional information, such
as ZIP code, can improve your search.
• Prescription Fill Dates default to a one
year search range from the current
date, but can bechanged.

14. Patient Rx Request
3 of 6 • Accessing Other PMP Interconnect
States – If you wish to search other
states for information about this
patient, check the corresponding box
next to any state available under the
PMP Interconnect Searchsection.
• Once all patient information has been
entered, simply agree to the terms if
required, and click Search.

15. Patient Rx Request
4 of 6 • When a match is found,the Patient Report
is automatically displayed as shownhere.
• Getting Results – Depending on your
role, requests may require review and
approval by the state PMP Administrator.
If this is the case,a message will appear
with further instructions.
Other messages you may encounter during
search:
• No Matching Patient Identified – This
message indicates that no patient was
found matchingthe criteria entered.
– Possible Solutions: Check the
patient information entered to
ensure accuracyor enter additional
information, like a ZIP code to
enhancethe search.
• No Prescriptions within the listed date
range – This message indicates the
patient was found, but had no
prescriptions within the fill dates selected.
– Possible Solution: Change the
Prescription Fill DateRange to a
different time frame.

16. Patient Rx Request
5 of 6 Other Messages you may encounter during
search:
• Multiple Patients Found – This
message indicatesthat more than one
patient matched the search criteria
provided.
• A special pop-up window displays
each patient and instructions about
how to proceed.
• Select one or more patients, then click
Run Report to continue to the Patient
Rx Report or change your search
information by clicking the Refine
Search Criteriabutton.

17. Patient Rx Request
6 of 6 • You can view the results of any
previously run Patient Rx Request
by going to: RxSearch / Requests
History
• Patient Rx Reports viewed from
Requests History are saved reports
showing the same information as the
day they were prepared. They do not
automatically refresh whenviewed.
• Select a patient’s row to display their
corresponding information card at the
bottom of thescreen.
• To view the saved Patient Rx History
Report, click the Viewbutton.

18. Prescriber-Oriented “Dashboard”
• Patient Centered Alerts
• Recent Request history
• Delegate Activity
• Prescriber Specific
Announcements

21. Rules, regulations, guidelines….what
should I do, What is the difference?
Rules and Regulations
• Force of Law
• Minimum standard
• Exceeding this is good
• Promulgated by
Department of Health
Guidelines
• Good ideas, yet need
judgement
• Represent what you should
do all the time
• Exceeding these are hard
and following is good
• Promulgated by anyone

23. Rules and Regulations for Pain Management, Opioid use and the
Registration of Distributors of Controlled Substances in Rhode Island
March 2015
Introduction
• ….principles of quality medical
practice dictate that the people of
the State of Rhode Island have
access to appropriate and effective
pain relief
• Practitioners should always consider
the many facets of pain and strongly
consider an interdisciplinary …to
management of pain, (acute,
episodic or chronic)
• ….view pain management as part of
quality medical practice for all
patients with pain, acute or chronic,
and it is especially urgent for
patients who experience pain as a
result of terminal illness Who? Do you
have a CSR?

24. …
.Patient evaluation
• History and physical
• documentation
Document treatment plan
• (a) Any change in pain
relief;
• (b) Any change in physical
and psychosocial function;
and
• (c) Additional diagnostic
evaluations or other
planned treatments.
Rules and
Regulations: 3.2

25. Duration of Prescription
Proportionate Prescribing
• Acute injury – reasonable
duration
• Community standard
Patient Education/Consent
• Risk of alcohol,
psychoactive medications,
tolerance, dependence,
addiction, overdose, death
• Safeguard medication
• Safe disposal
Need to Review the PMP prior to
starting an opioid

26. Written, part of medical record,
started at any point…..no later than
90 days
• Patient agrees to take
meds at the dose and
frequency
prescribed…specific
protocol for early refills
• Reasons why meds could
be discontinued
• Single practitioner
• Not to abuse alcohol or
other unauthorized
medications
• Violation-change in
treatment plan or referral to
addiction program
• Tox screens at prescriber
discretion
Sample at
www.health.ri.gov/saferx
Written Patient Treatment
Agreement 3.6

27. 3.7 Periodic Review
• See patient at least every
12 months
• Determine adherence with
any medication treatment
plan
• If pain, function, quality of
life have improved
• Continuation of medication
needed for progress
towards tx objectives
Consider Taper or discontinue
• Function or pain does not
improve after trial period
• Misuse, addiction or
diversion
• Must review PMP if
patient on chronic
opioids for > 6 months at
least once every 12
months

28. 3.8 Pain Medicine/Addiction
Medicine Physician
Document it was considered
>120mg MED
Multidisciplinary Approach to
Treatment of Chronic Pain
3.10 Transitions of Care
• Patient goes from one
practitioner to another
• Provider to provider
contact
3.11 Transmissions of
Controlled Substance
Prescriptions
• No unlicensed staff
member to telephone or
otherwise transmit

29. One time CME REMS by 15 January
2017
Document:
(1) Serious life-threatening or even
fatal respiratory depression
(2) Methadone treatment may
initially not provide immediate pain
relief, and patient needs to be
aware of overdose potential if taken
in excess of dose, as prescribed
(3) Accidental consumption of long-
acting opioids especially in children,
can result in fatal overdose;
(4) Long-term opioid use can result
in physical addiction to opiates and
abrupt stopping of medication may
cause withdrawal

30. Intrathecal Pump and
Chronic opioids
• Review PMP before
starting opioids
• Risks/benefits as well as
risk of withdrawal
• Only refilled by licensed
professional
• Pain agreement

31. RECORD KEEPING
• KEEP A RECORD OF
CONTROLLED SUBSTANCES
RECEIVED
• KEEP A RECORD OF
CONTROLLED SUBSTANCES
ADMINISTERED, DISPENSED,
OR PROFESSIONALLY USED,
OTHER THAN BY
PRESCRIPTION
• RECORD DATE OF RECEIPT
• RECORD NAME AND
ADDRESS OF WHERE YOU
RECEIVED CONTROLLED
SUBSTANCES (I.E.
WHOLESALER)
• RECORD THE NAME AND
QUANTITY OF
CONTROLLED SUBSTANCE
RECEIVED
• RECORD ALL CONTROLLED
SUBSTANCES SOLD,
ADMINISTERED,
DISPENSED, OR DISPOSED
Do you keep controlled
substances in your office?

32. Controlled substances listed in Schedules II, III,
IV, and V shall be stored in a securely locked,
substantially constructed cabinet.
Obligation to notify if there is theft - DEA
 The registrant shall notify the Field Division
Office of the Administration in his area, in
writing, of the theft or significant loss of any
controlled substances within one business
day of discovery of such loss or theft.
 Complete form DEA Form 106 regarding the
loss or theft. When determining whether a
loss is significant, a registrant should
consider, among others, the following factors:
-Quantity lost
-Name of what was lost;
-Circumstances around the
loss
-Is there a pattern of loss
-how likely it will be diverted
--Practitioners should refer to
CFR Title 21 sections
1301.75 and 1301.76 for
more information
Physical Security & Storage:

33. •(1) Promptly destroy that controlled
substance in accordance with
subpart C (witnessed) of this part
using an on-site method of
destruction; (DOCUMENT WASTE)
•(2) Promptly deliver that controlled
substance to a reverse distributor's
•(3) For the purpose of return or recall, promptly deliver
that controlled substance by common or contract carrier
pick-up or pick-up by other registrants at the registrant's
registered location to: The registered person from whom
it was obtained, the registered manufacturer of the
substance, or another registrant authorized by the
manufacturer to accept returns or recalls on the
manufacturer's behalf; or
(4) Request assistance from the Special Agent in
Charge of the Administration in the area in which the
practitioner is located.
• Have A
Reverse
Distributor
• Know how to
document
waste
§1317.05 Registrant disposal

34. Summary of Governors Strategic
Plan 4 Main Strategies
Prevention Strategy:
main focus of this strategy is to use prescriber,
Prescription Monitoring Program (PMP) and system-
level efforts to reduce co-prescription of
benzodiazepines with opioids (for pain or opioid use
disorder).

35. Goal/ Strategy: The core of this initiative recommends
the development of a system of medication-assisted
treatment at every location where opioid users are found,
primarily: the medical system, the justice system,
substance use treatment programs, and in the
community.
Every door is the right door:
Medication Assisted Treatment:

36. Goal/ Strategy: This initiative seeks to
ensure a sustainable source of naloxone
for community and first responder
distribution, and a high coverage of
naloxone among populations at risk of
overdose.
Overdose Rescue: Naloxone as the
Standard of Care

37. Goal/ Strategy: This initiative
recommends the large-scale
expansion of recovery coach reach
and capacity.
Recovery Strategy: Expand Recovery
Supports

38. Individuals under the age of 19 only 2013 2014 2015
Individuals with a Benzodiazepine prescription
filled
1,867 3,302 3,436
Individuals with an Opioid prescription filled 7,586 8,136 7,743
Individuals in which a benzodiazepine and an
opioid pain reliever were filled within the same
month
245 506 561
Monthly average, number of individuals in which a
benzodiazepine and an opioid pain reliever were
filled within the same month
20 42 47
% dispensed both as a % of benzos 13% 15% 16%
% dispensed both as % of opioids 3% 6% 7%
Co-Prescribing Opioids &
Benzodiazepine in individuals < 19
years old

39. Benzodiazepine & Opioid use all ages
All ages 2013 2014 2015
Individuals with a Benzodiazepine prescription filled 68,896 104,324 103,968
Individuals with an Opioid prescription filled 198,869 222,339 224,493
Individuals in which a benzodiazepine and an opioid pain reliever were filled within the
same month
28,217 60,609 60,991
Monthly average, number of individuals in which a benzodiazepine and an opioid pain
reliever were filled within the same month
2,351 5,051 5,083
% dispensed both as a % of benzos 41% 58% 59%
% dispensed both as % of opioids 14% 27% 27%

40. • Prescription Drug Overdose deaths,
combinations are more common
• Reviewing literature on co-prescribing
• What is the evidence base
• Develop a clinical practice guideline
• Come to Benzodiazepines: Pharmacology
to Co-prescribing Risks and Concerns
CME May 12th and May 19th at Brown
Where are we going with Benzodiazepine
and Opioid co-prescribing

41. Physicians Health Committee
• Kathleen Boyd, MSW,
LICSW
• Director, Physician Health
Program
• Rhode Island Medical
Society
• 405 Promenade Street,
Suite A
• Providence, RI 02908
• Phone: (401) 443-2383
• Fax: (401) 273-4001
• Email: kboyd@rimed.org