Controlled Substance Prescribing: What to do?

James V. McDonald MD MPHChief Administrative Officer, Rhode Island Board of Medical Licensure and Discipline

Disclosure

Speakers Report - Dr McDonald – No disclosures

Objectives:1. Discuss changes with the PDMP2. Describe Controlled Substance Prescribing &

current regulations3. Describe co-prescribing of Benzodiazepines &

Opioids – where are we going?4. Summarize: Governor’s Task Force Strategic Plan5. The Physicians Health Committee

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……

2013 2014 20150

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

1,189,243

1,449,627

1,792,407

Annual Buprenorphine, Dispensed_x000d_

Buprenorphine doses per year• What is Medication

Assisted Treatment?• Who can

provide/prescribe MAT?• Patient limits?• What about Physician

Assistants?

Medication Assisted Treatment

*Doses of OpioidsPer month (millions)

*Doses of Stimulants Per month (millions)

*Schedule 2 Prescriptions per Month

*PDMP reports Per month

•Why is the PDMP changing?

Physician APRN Physician Assistant Residents Dentist Podiatrist Veterinarian Midwife Optometrist*0

5000

10000

15000

20000

25000

30000

35000

4000037679

8492

41822615 2167

551 77 29 0

12475

2948 3488

627 124015 0 0 0

Schedule 2 Prescriptions and PDMP Reports January 2016

Schedule 2 Prescriptions Written PDMP Reports Run

Could we do better on checking the PDMP?

Dentist Midwife Nurse Optometrist Physician Physician Assistant Podiatrist Veterinarian

75%

58%

50%

79%

46%

71%

81%

64%

87%

70%68%

89%

81%85%

89%

78%

% by Profession Registered for the PMPSeptember March

Who is registered for the PDMP as of March 2016 ?

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 Request Screen

• Search for a Patient

• Search other PMP Interconnect States

• View Results

• Access Patient Requests History

Log in to begin

Patient Rx Request

2 of 6 • To request prescription history on a patient, on the main menu go to: RxSearch / Patient Request.

• Required fields are indicated by a Red Asterisks *.

• At a minimum, First Name, Last Name, and Date of Birth, as well as Prescription Fill Dates are required.

• 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 be changed.

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 Search section.

• Once all patient information has been entered, simply agree to the terms if required, and click Search.

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 accuracy or enter additional information, like a ZIP code to enhance the 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 Date Range to a different time frame.

Patient Rx Request

5 of 6Other Messages you may encounter during search:

• Multiple Patients Found – This message indicates that 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 Criteria button.

Patient Rx Request

6 of 6 • You can view the results of anypreviously 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 when viewed.

• Select a patient’s row to display their corresponding information card at the bottom of the screen.

• To view the saved Patient Rx History Report, click the View button.

Prescriber-Oriented “Dashboard”

• Patient Centered Alerts

• Recent Request history

• Delegate Activity• Prescriber Specific

Announcements

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

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?

….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

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

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

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

3.8 Pain Medicine/Addiction Medicine PhysicianDocument 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

contact3.11 Transmissions of Controlled Substance Prescriptions

• No unlicensed staff member to telephone or otherwise transmit

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

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

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?

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:

•(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

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).

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:

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

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

Recovery Strategy: Expand Recovery Supports

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

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%

• 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

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