Tennessee Physician Ebook Continuing Education

This interactive Tennessee Physician Ebook contains 10 hours of continuing education. To complete click the Complete Your CE button at the top right of the screen.

Tennessee Continuing Medical Education

2024 Tennessee Medical Licensure Program

DEA REQUIREMENT (NEW) 8 HOURS SATISFIES THE DEA’S NEW ONE-TIME MATE REQUIREMENT Substance Use Disorders

2 HOURS

SATISFIES 2 HOURS ON CONTROLLED SUBSTANCE PRESCRIBING Controlled Substances

10 TOTAL AMA PRA CATEGORY 1 CREDITS TM

INCLUDES: DEA’s new one-time MATE requirement

CME FOR:

AMA PRA CATEGORY 1 CREDITS ™ MIPS MOC STATE LICENSURE

TN.CME.EDU

InforMed is Accredited by the Accreditation Council for Continuing Medical Education (ACCME) to provide continuing medical education for physicians.

2024 TENNESSEE

*Completion of this course satisfies the mandatory CME requirement in controlled substance prescribing which must include instruction in the Department’s Chronic Pain Guidelines. COURSE ONE | 2 CREDITS* TENNESSEE GUIDELINES FOR MANAGING CHRONIC PAIN

COURSE TWO | 8 CREDITS** SUBSTANCE USE DISORDERS: A DEA REQUIREMENT **Satisfies the DEA’s new one-time MATE Requirement

LEARNER RECORDS: ANSWER SHEET & EVALUATION 56 REQUIRED TO RECEIVE CREDIT

Program Options

Price

Option

Code

Credits

ENTIRE PROGRAM • Tennessee Guidelines for Managing Chronic Pain • Substance Use Disorders: A DEA Requirement • Tennessee Guidelines for Managing Chronic Pain • Substance Use Disorders: A DEA Requirement

$110

10 Credits

TN24CME

$50 $80

TN24CME-50 TN24CME-80

2 Credits 8 Credits

CME that counts for MOC Participants can earn MOC points equivalent to the amount of CME credits claimed for designated activities (see page iii for further details). InforMed currently reports to the following specialty boards: the American Board of Internal Medicine (ABIM), the American Board of Anesthesiology (ABA), the American Board of Pediatrics (ABP), the American Board of Otolaryngology–Head and Neck Surgery (ABOHNS), and the American Board of Pathology (ABPath). To be awarded MOC points, you must obtain a passing score, complete the corresponding activity evaluation, and provide required information necessary for reporting. DATA REPORTING: Federal, State, and Regulatory Agencies require disclosure of data reporting to all course participants. InforMed abides by each entity’s requirements for data reporting to attest compliance on your behalf. Reported data is governed by each entity’s confidentiality policy. To report compliance on your behalf, it’s mandatory that you must achieve a passing score and accurately fill out the learner information, activity and program evaluation, and the 90-day follow up survey. Failure to accurately provide this information may result in your data being non-reportable and subject to actions by these entities.

InforMed has joined the Elite Learning family Two of the nation’s top healthcare education providers have joined forces with one goal in mind: to offer physicians a state-of-the-art learning experience that fulfills your state requirements and empowers you with the knowledge you need to provide the best patient care. Here’s what you can expect from our new partnership: • COURSES: In addition to the mandatory courses you need to renew your state license, you’ll now have access to dozens of hours of elective courses and an expanded content library. • ACCOUNTS: You’ll also have access to a personalized learner account. In your account you can add, organize, and track your ongoing and completed courses. For instructions on how to set up your account, email us at office@elitelearning.com. • BOOK CODES: You may notice a book code on the back cover of the latest InforMed program you’ve received in the mail. When entered on our new site, this code will take you directly to the corresponding self-assessment. See more information below. How to complete Please read these instructions before proceeding.

Read and study the enclosed courses and answer the self-assessment questions. To receive credit for your courses, you must provide your customer information and complete the mandatory evaluation. We offer two ways for you to complete. Choose an option below to receive credit and your certificate of completion. Scan this QR code to complete your CE now !

• Go to BOOK.CME.EDU . Locate the book code TN24CME found on the back of your book and enter it in the box then click GO . • If you already have an account created, sign in to your account with your username and password. If you do not have an account already created, you will need to create one now. • Follow the online instructions to complete your self- assessment. Complete the purchase process to receive course credit and your certificate of completion. Please remember to complete the online evaluation. • To find more elective hours, please visit TN .CME.EDU ONLINE FASTEST AND EASIEST!

Enter book code

TN24CME

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• Fill out the answer sheet and evaluation found in the back of this booklet. Please include a check or credit card information and e-mail address. Mail to InforMed, PO Box 2595, Ormond Beach, FL 32175-2595 . • Completions will be processed within 2 business days from the date it is received and certificates will be e-mailed to the address provided. • Submissions without a valid e-mail will be mailed to the address provided. BY MAIL

1-800-237-6999

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BOOK CODE: TN24CME

INFORMED TRACKS WHAT YOU NEED, WHEN YOU NEED IT

Tennessee Professional License Requirements

MANDATORY CONTINUING MEDICAL EDUCATION REQUIREMENT FOR LICENSE RENEWAL PHYSICIANS By Board Rule, all licensees are required to complete forty (40) hours of continuing medical education courses within twenty-four (24) months preceding their license renewal. All licensees (unless exempt under TENN. CODE ANN. § 63-1-402(c)) shall complete at least two (2) of the forty (40) required hours of continuing education on controlled substance prescribing, which must include instruction in the Department’s Chronic Pain Guidelines on opioids, benzodiazepines, barbiturates and carisoprodol and may include topics such as medicine addiction, risk management tools and other topics approved by the Board. OSTEOPATHIC PHYSICIANS During the two (2) calendar years that precede licensure renewal, all osteopathic licensees must complete forty (40) hours of courses approved by the Board in Category I-A, II-A and/or I-B continuing medical education. All licensees (unless exempt under TENN. CODE ANN. § 63-1-402(c)) shall complete at least two (2) of the forty (40) required hours of continuing education on controlled substance prescribing, which must include instruction in the Department’s Chronic Pain Guidelines on opioids, benzodiazepines, barbiturates and carisoprodol and may include topics such as medicine addiction, risk management tools and other topics All physician assistants must, within a two (2) year period prior to the application for license renewal, complete one hundred (100) hours of continuing medical education satisfactory to the Committee. At least fifty (50) hours shall be obtained in certified medical education Category I. At least two (2) Category I hours of the required continuing education hours shall address controlled substance prescribing, which must include instruction in the Department’s treatment guidelines. Licensees without a DEA registration must complete one (1) hour in prescribing practices. approved by the Board. PHYSICIAN ASSISTANTS NEW CHANGE TO CME CYCLE FOR TENNESSEE PHYSICIANS Due to recently enacted regulations, physicians licensed by the Tennessee Board of Medical Examiners may now complete their CME requirements in the twenty-four (24) months preceding their license renewal. DEA ONE-TIME MATE REQUIREMENT (NEW) Effective June 27, 2023 , renewing DEA-registered practitioners must complete eight (8) hours of one-time training on the treatment and management of patients with opioid or substance use disorders.

Tennessee Board of Medical Examiners 665 Mainstream Drive, 2nd Floor We are a nationally accredited CME provider. For all board-related inquiries please contact:

CME DEADLINE: Prior to your upcoming license renewal

LICENSE TYPES: Physicians and Physician Assistants

Nashville, TN 37243 615-532-3202 local or 1-800-778-4123 nationwide

Disclaimer: The above information is provided by InforMed and is intended to summarize state CE/CME license requirements for informational purposes only. This is not intended as a comprehensive statement of the law on this topic, nor to be relied upon as authoritative. All information should be verified independently.

MOC/MIPS CREDIT INFORMATION

In addition to awarding AMA PRA Category 1 Credits TM , the successful completion of enclosed activities may award the following MOC points and credit types. To be awarded MOC points, you must obtain a passing score and complete the corresponding activity evaluation.

Table 1. MOC Recognition Statements Successful completion of certain enclosed CME activities, which includes participation in the evaluation component, enables the participant to earn up to the amounts and credit types shown in Table 2 below. It is the CME activity provider’s responsibility to submit participant completion information to ACCME for the purpose of granting MOC credit. Board Programs ABA American Board of Anesthesiology’s redesigned Maintenance of Certification in Anesthesiology TM (MOCA®) program, known as MOCA 2.0®

ABIM

American Board of Internal Medicine’s Maintenance of Certification (MOC) program

American Board of Otolaryngology – Head and Neck Surgery’s Continuing Certification program (formerly known as MOC)

ABOHNS

ABPath

American Board of Pathology’s Continuing Certification Program

ABP

American Board of Pediatrics’ Maintenance of Certification (MOC) program.

Table 2. Credits and Type Awarded

AMA PRA Category 1 Credits TM 2 AMA PRA Category 1 Credits TM 8 AMA PRA Category 1 Credits TM

Activity Title

ABA ABIM ABOHNS ABPath ABP

Tennessee Guidelines for Managing Chronic Pain

2 Credits LL 8 Credits LL

2 Credits MK 8 Credits MK

2 Credits SA 8 Credits SA

2 Credits LL 8 Credits LL

2 Credits LL + SA

Substance Use Disorders: A DEA Requirement 8 Credits LL+SA Legend: LL = Lifelong Learning, MK = Medical Knowledge, SA = Self-Assessment, , LL+SA = Lifelong Learning & Self-Assessment, PS = Patient Safety

Table 3. CME for MIPS Statement Completion of each accredited CME activity meets the expectations of an Accredited Safety or Quality Improvement Program (IA PSPA_28) for the Merit-based Incentive Payment Program (MIPS). Participation in this Clinical Practice Improvement Activity (CPIA) is optional for eligible providers.

iii

COURSE DATES:

MAXIMUM CREDITS:

FORMAT:

TENNESSEE GUIDELINES FOR MANAGING CHRONIC PAIN

Release Date: 5/2022 Exp. Date: 4/2025

2 AMA PRA Category 1 Credits ™

Enduring Material (Self Study)

TARGET AUDIENCE

HOW TO RECEIVE CREDIT:

All health care professionals who participate in the management of patients with pain.

• Read the course materials.

•

Complete the self-assessment questions at the end. A score of 70% is required.

COURSE OBJECTIVE This course is designed to increase physician knowledge and skills regarding Tennessee guideline-recommended principles of pain management. An overview of controlled substances and addiction complications, with an emphasis on the Tennessee Chronic Pain Guidelines will be presented.

• R eturn your customer information/ answer sheet, evaluation, and payment to InforMed by mail or complete online at BOOK.CME.EDU .

LEARNING OBJECTIVES

Completion of this course will better enable the course participant to: 1. Describe the different Schedules of Controlled Substances.

2. Understand terminology regarding medications in the different groups, their uses and risks. 3. Discuss recommended guidelines for use of opioids in the treatment of chronic, non-malignant pain. 4. Describe factors that contribute to risk of substance use disorder.

ACCREDITATION STATEMENT InforMed is accredited by the Accreditation Council for Continuing Medical Education (ACCME) to provide continuing medical education for physicians. DESIGNATION STATEMENT InforMed designates this enduring material for a maximum of 2 AMA PRA Category 1 Credits ™. Physicians should claim only the credit commensurate with the extent of their participation in the activity. IMPLICIT BIAS IN HEALTHCARE Implicit bias significantly affects how healthcare professionals perceive and make treatment decisions, ultimately resulting in disparities in health outcomes. These biases, often unconscious and unintentional, can shape behavior and produce differences in medical care along various lines, including race, ethnicity, gender identity, sexual orientation, age, and socioeconomic status. Healthcare disparities stemming from implicit bias can manifest in several ways. For example, a healthcare provider might unconsciously give less attention to a patient or make assumptions about their medical needs based on race, gender, or age. The unconscious assumptions can lead to delayed or inadequate care, misdiagnoses, or inappropriate treatments, all of which can adversely impact health outcomes. Addressing implicit bias in healthcare is crucial for achieving equity in medical treatment. Strategies to combat these biases involve education and awareness programs for healthcare professionals. These programs help individuals recognize and acknowledge their biases, fostering a more empathetic and unbiased approach to patient care. Additionally, implementing policies and procedures prioritizing equitable treatment for all patients can play a pivotal role in reducing healthcare disparities. Ultimately, confronting implicit bias in healthcare is essential to creating a more just and equitable healthcare system where everyone receives fair and equal treatment regardless of their background or characteristics.

ACTIVITY PLANNER Michael Brooks CME Director InforMed Dove Medical Communications Dawn Demangone-Yoon, MD Medical Writer Colibri Healthcare FACULTY Russell Yoon, MD Emergency Medicine Department Cooper University Health Care Beth Dove Medical Writer

COURSE SATISFIES

Prescribing Controlled Substances 2

Completion of this course satisfies the Tennessee Board of Medical Examiner’s requirement in controlled substance prescribing which must include instruction in the Department’s Chronic Pain Guidelines on opioids, benzodiazepines, barbiturates and carisoprodol. SPECIAL DESIGNATION Tennessee Licensees must complete at least two hours of controlled substance prescribing CME as a condition of renewal (unless they are exempt under TENN.CODE ANN. § 63-1-402(c)).

DISCLOSURE OF INTEREST In accordance with the ACCME Standards for Integrity and Independence in Accredited Continuing Education, InforMed implemented mechanisms, prior to the planning and implementation of this CME activity, to identify and resolve conflicts of interest for all individuals in a position to control content of this CME activity.

FACULTY/PLANNING COMMITTEE DISCLOSURE The following faculty and/or planning committee members have indicated they have no relevant financial relationship(s) to disclose with ineligible companies whose primary business is producing, marketing, selling, re-selling, or distributing healthcare products used by or on patients: • Russel Yoon, MD • Beth Dove • Dawn Demangone-Yoon, MD • Michael Brooks

STAFF AND CONTENT REVIEWERS

InforMed staff, input committee and all content validation reviewers involved with this activity have reported no relevant financial relationships with commercial interests.

DISCLAIMER *2023. All rights reserved. These materials, except those in the public domain, may not be reproduced without permission from InforMed. This publication is designed to provide general information prepared by professionals in regard to the subject matter covered. It is provided with the understanding that InforMed, Inc is not engaged in rendering legal, medical or other professional services. Although prepared by professionals, this publication should not be utilized as a substitute for professional services in specific situations. If legal advice, medical advice or other expert assistance is required, the service of a professional should be sought.

To appropriately manage patients while minimizing diversion and misuse, HCPs must stay abreast of the existing and evolving laws, regulations, and policies that govern CS prescribing and to comply with all requirements. 17 To improve patient outcomes and minimize misuse, HCPs should aim to recognize the signs and symptoms of appropriate medical indications for prescribed CS. 5,17 This activity is designed to educate HCPs about select controlled substances as required by the State of Tennessee. Introduction to Controlled Substances Drugs or medications with the potential for misuse and a high risk of resulting in substance- use disorder (SUD) are strictly controlled by the federal government. The aim is to protect access to drugs with a legitimate medical purpose while preventing the detrimental effects of illegal importation, manufacture, distribution, possession, and improper use. The Drug Enforcement Administration (DEA) enforces federal CS laws in all states and territories. In recent decades, the agency’s approach to curtailing drug misuse and diversion of pharmaceutical opioids has been to focus on traffickers and doctors who prescribe inappropriately rather than on individuals who illegally obtain opioids. 18 Drug Schedules The Controlled Substance Act (CSA), which took effect in 1971 regulates manufacture, distribution, and dispensing of CS with specifics laid out in the Code of Federal Regulations (CFR) Title 21, §§1300- 1316. Under the CSA, illegal and prescription drugs are classified into 5 schedules according to: 18,19 • Actual or relative potential for misuse • Known scientific evidence of pharmacological effects

Introduction Controlled substances (CS) are used to treat many medical conditions but are associated with risks to patients and society. 1-4 Research suggests that the potential for misuse of non-opioid medications is under appreciated by heath care providers (HCPs). 5-8 Although most overdose deaths still involve opioids, 9 polysubstance involvement is on the rise and includes prescription stimulants, benzodiazepines, and sedative-hypnotics. 6-8 Misuse of any prescription drug is a serious problem, and that includes opioid and non-opioid CS. 1-4,10 Actions aimed at containing the societal opioid crisis have paralleled increased prescription rates for non-opioid CS, 11,12 some of which are recommended as first-line agents for pain treatment. 13 Despite these efforts, reductions in opioid prescriptions 14 have not seen a corresponding drop in overdose drug deaths in the United States. 9 At the same time, interest in non-opioid CS has grown: prescriptions for stimulants have risen sharply, and benzodiazepines are among the most commonly prescribed CS (Figure 1). 4 An analysis based on a single commercial insurance provider found a “concerning” 5-fold rise in stimulant use over 15 years (2004-2019). 4 Opioid-use disorder (OUD) can develop with opioid medication use, significantly affecting quality of life. Yet, significant barriers prevent broad access to treatment for OUD, despite strong evidence that treatment with medications approved by the US Food and Drug Administration (FDA) for OUD reduces morbidity and mortality. 15 Fewer than a third of people with OUD receive treatment, and those who do often wait years to begin. 15,16 Additional barriers include stigma, lack of professional education and training related to the evidence base for using medication to treat OUD, and a fragmentary health care system that does not incentivize best care. 15

• Current scientific knowledge of the substance • History and current pattern of misuse • Scope, duration, and significance of misuse • Risk to public health • Psychic or physiological dependence liability • Whether the substance is an immediate precursor of an already-scheduled substance Two federal agencies, the DEA and the Food and Drug Administration (FDA), determine which substances are added to or removed from Schedules I-V. 12 Each schedule is defined as shown in Table 1. Schedule I drugs have the highest risk for substance use disorder (SUD) and misuse and no accepted medical uses. Cannabis, although legal in some states, is still a Schedule I drug at the federal level. It is the only Schedule I drug that is legal at the state level for medicinal and recreational uses. The DEA does allow research to be conducted with Schedule I drugs when an investigator is deemed to be qualified and the protocol is found to have merit. Schedule II medications do have accepted medical uses (some with restrictions), including opioids for acute or chronic pain severe enough to warrant an opioid prescription and stimulants used to treat attention deficit hyperactivity disorder (ADHD). Use of Schedule II drugs may lead to severe psychological or physical dependence. The medications in Schedule III may lead to a moderate or low degree of physical dependence or “high.” Schedule III opioids include products containing not more than 90 mgs of codeine per dosage unit. This is also the schedule that contains stimulants and anabolic steroids. Although Schedule IV drugs are considered to have low potential for SUD and misuse relative to Schedule III, cautions do apply. This schedule contains medications that are frequently prescribed for insomnia and anxiety disorders.

Figure 1. Trends for Most Commonly Dispensed Controlled Substances in US Commercially- Insured Adults (January 2004 to June 2019)*

Figure 1. Trends for Most Commonly Dispensed Controlled Substances in US Commercially-Insured Adults (January 2004 to June 2019)

*Based on de-idenIfied longitudinal claims data on beneficiaries of a large US employer-sponsored commercial health insurance provider and covers approximately 9 million individuals ages 19 to 64 years in any given month across all 50 states. *Based on de-identified longitudinal claims data on beneficiaries of a large US employer-sponsored commercial health insurance provider and covers approximately 9 million individuals ages 19 to 64 years in any given month across all 50 states.

Table 1. Drug Schedules I-V Established by the Controlled Substances Act

Schedule

Risk Level

Medical Use Status

Prescriptions

Refills allowed

Examples

Highest risk for SUD and misuse

No currently accepted medical use

N/A

Heroin LSD Mescaline MDMA Methaqualone Marijuana Amphetamine

Lack of accepted safety for medical use

High potential for SUD and misuse (less than Schedule I)

Currently accepted medical use

Paper

No*

Electronically transmitted with strict requirements Phone only in emergencies with written prescription to follow within 7 days

Opioids: Codeine Fentanyl Hydrocodone Hydromorphone Meperidine Morphine Methadone Opium Oxycodone

Methylphenidate Pentobarbital ACET with codeine

III

Less potential for SUD and misuse than Schedules I or II

Currently accepted medical use

Paper

Up to 5 refills within 6 months

Electronically transmitted

Anabolic steroids

Phone, fax

Buprenorphine

Ketamine

Low potential for SUD and misuse relative to Schedule III**

Currently accepted medical use

Paper

Up to 5 refills within 6 months

Benzodiazepines: Alprazolam Clonazepam Diazepam

Electronically transmitted

Phone, fax

Lorazepam Midazolam Temazepam Triazolam

Carisoprodol

Low potential for SUD and misuse relative to Schedule IV

Currently accepted medical use

Paper

No limits, except partial refills must occur within 6 months of issue date

Cough preparations with codeine

Electronically transmitted

Ezogabine

Phone, fax

SUD = Substance-use disorder LSD = Lysergic acid diethylamide MDMA = Methylenedioxymethamphetamine ACET = Acetaminophen *See exceptions under “Federal Restrictions Regarding Refills” **Benzodiazepines carry risks of substance dependence and respiratory depression, particularly in combination with other substances that also depress respiration. 21,22

These drugs, which include alprazolam, diazepam, and lorazepam, are frequently mentioned in overdose statistics involving opioids, and expert guidance urges caution in their use and taper and particularly discourages the combination with opioids unless deemed necessary. 13,20,21 Schedule V contains drugs with limited quantities of opioids that include cough preparations, containing no more than 200 milligrams of codeine per 100 milliliters or per 100 grams. Although this lower schedule has less misuse danger relative to other schedules, patients prescribed any CS still must be managed with care.

Part of the role of the DEA is to ensure medications are not diverted for misuse. Table 2 contains common terms associated with the use and misuse of opioids and other prescription drugs that are categorized under CS schedules. 5 The DEA provides manuals for HCPs and other practitioners to keep abreast of federal requirements in implementing the CSA. 22 As of this writing, the DEA Diversion Control Division is currently updating all manuals but did issue an updated pharmacist’s manual as of 2020.

The Purpose of a Prescription in Legitimate Medical Practice The DEA tracks the flow of CS from manufacture to ultimate use and enforces the CSA, including the tenets of lawful prescribing. 12 In order to be legal, a CS prescription must be issued for a legitimate medical purpose in the course of professional practice. 23 In general, this means HCPs must practice in accordance with medical standards recognized and accepted in the United States. 22 The totality of circumstances particular to each HCP and patient must be evaluated on its own merits.

Table 2. Definitions Related to Prescription Drug Use and Misuse

Term

Definition

Physical dependence • Not the same as addiction

• Occurs because of physiological adaptations to chronic exposure to a drug • Withdrawal symptoms occur when medicine is suddenly reduced or stopped or when antagonist is administered • Symptoms can be mild or severe and can usually be managed medically or avoided through slow drug taper

Tolerance

• Same dose of drug given repeatedly produces reduced biological response • Higher dose of drug is necessary to achieve initial level of response • Taking medication in a manner or dose other than prescribed • Taking someone else’s prescription, even if for a medical complaint like pain • Taking medication to feel euphoria (i.e., to get high) • Nonmedical use of prescription drugs refers to misuse

Misuse

Addiction

• Primary, chronic disease of brain reward, motivation, memory, and related circuitry • Dysfunction in circuits leads to characteristic biological, psychological, social, and spiritual manifestations as individual pathologically pursues reward and/or relief by substance use and other behaviors • Characterized by inability to consistently abstain, impairment in behavioral control, craving, diminished recognition of significant problems with one’s behaviors and interpersonal relationships, and dysfunctional emotional response • Involves cycles of relapse and remission • Without treatment or recovery activities, is progressive and results in disability or premature death

Opioid-use disorder

• A problematic pattern of opioid use leading to clinically significant impairment or distress • Defined in DSM-5* • Previously classified as “opioid abuse” or “opioid dependence” in DSM-4 • Also referred to as “opioid addiction”

*DSM-5 = Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition; diagnostic criteria given later in this activity

Registration Requirements to Prescribe Controlled Substances The cornerstone of CS regulation is that all handlers of CS must register with the DEA. The registration requirement extends to HCPs, drug manufacturers, wholesale distributors, hospitals, pharmacies, and scientific researchers. 24 One person or the institution itself (for example, a hospital) may serve as the registrant, and nonregistered agents may write prescriptions under that registration. 22 If an HCP has more than one practice, each location must have its own DEA registration to prescribe CS. 22 This applies to a business location and not to HCPs who practice at multiple locations within the same state. The DEA may act to suspend or revoke a prescriber’s registration, for example, if the prescriber has: 22 • Falsified any application • Been convicted of a felony related to a CS • Had a state license or registration suspended, revoked, or denied • Committed an act that would render DEA registration inconsistent with public interest • Been excluded from participation in a Medicaid or Medicare program Considerations in determining the public interest include recommendations of state licensing boards, compliance with CS law at the state, federal, or local level, conviction record pertaining to CS, experience with respect to CS, and “such other conduct” that may threaten public health and safety. 22 The registrant takes responsibility for compliance with the CSA and for ensuring CS are distributed only to those authorized to receive them. 22

A registrant must notify the local DEA Diversion Field Office in writing within a business day of discovery of a theft or significant loss of a CS. 19 The DEA may also move to investigate a prescriber for alleged criminal acts. The agency assures HCPs that investigation and prosecution are reserved for instances where “conduct is not merely of questionable legality, but instead is a glaring example of illegal activity,” and that cases “typically involve facts that demonstrate blatant criminal conduct;” however, the agency does not set a clear standard or signify a basis for prosecution. 24 The DEA does provide some examples of prescribing in violation of the CSA (i.e., for other than a legitimate medical purpose or outside the usual course of professional practice). 24 While there are no set criteria, some recurring patterns cited by the DEA that might indicate inappropriate prescribing include: 22 • An inordinately large quantity of CS or numbers of prescriptions in comparison to other area HCPs (while also recognizing that some practitioners, for example, those who treat cancer, may prescribe more than others) • Lack of physical exam • Warnings to the patient to fill prescriptions at different pharmacies • Prescriptions issued that are known to be delivered to others • Prescriptions issued in exchange for sex or money • Prescribing intervals inconsistent with legitimate medical treatment • Use of street slang for medical drugs • No logical relationship between prescribed drugs and alleged medical condition

The DEA further clarifies that the existence of any of the foregoing factors does not automatically mean a prescriber has acted improperly. For example, some patients require doses that would be considered large for other patients, and the DEA asserts that each case is individually considered. 24 Information on Prescriptions CS prescriptions must be dated and signed on the day when issued and include the patient’s full name and address as well as the registrant’s full name, address, and registration number. 22 In addition, the prescription must include: 22 • Drug name • Quantity prescribed • Directions for use • Number of refills (may be 0) CS prescriptions must be written in indelible ink or pencil or else be typewritten. 22 Federal Restrictions Regarding Refills Schedule II prescription orders must be written and signed by the HCP and may not be phoned into the pharmacy except in an emergency. If phoned in under emergency circumstances, the HCP must present the written and signed prescription to the pharmacy within 7 days. 19,22 One further exception is that a fax may serve as the written prescription for residents of long-term care facilities, hospice patients, or compounded IV opioids. 22 Prescriptions for Schedule III-IV drugs may be written or phoned in and may be refilled up to 5 times within 6 months of issue. 19 Schedule V drugs have no refill limits but are restricted in that the patient must be at least 18 years old and must offer some form of identification to fill a prescription. 19 • Drug strength • Dosage form

However, the danger from the opioid crisis is ongoing, and HCPs are called on to prescribe judiciously, reserving opioids for pain that does not respond to other treatments. Despite some recent progress on several fronts, the situation in Tennessee remains dire as illustrated by the following statistics: • In 2019, 1,543 Tennesseans died from an opioid-related overdose, an average of more than 4 deaths every day, a 49% increase compared to 1,034 deaths in 2015. 26 • Tennessee had the nation’s third-highest rate of opioid prescriptions (68.5 for every 100 persons) in 2020, which was almost one-and- a-half times higher than the national average of 45.9 prescriptions per 100 persons. 27 • The number of cases of Neonatal Abstinence Syndrome increased slightly from 810 in 2019 to 824 in 2020. 28 Opioids are classified according to their action at mu receptors as full agonists, mixed agonist- antagonists, or antagonists (Table 3). 29-32 Most clinically prescribed opioids are full mu agonists. Buprenorphine has a reduced potential for respiratory depression and acts as an antagonist at the kappa receptor, which is shown to reduce anxiety, depression, and the unpleasantness of opioid withdrawal. 5 Tapentadol and tramadol have dual modes of action as agonists at the mu receptor and SNRIs. 5 Considerations with dual-mechanism opioids include lowering of the seizure threshold in susceptible patients and the risk of serotonin syndrome. 33

Formulations may be extended-release (ER) or immediate-release (IR), and delivery systems for outpatients include oral, transmucosal, and transdermal routes of administration. Combination products contain products such as acetaminophen (ACET) together with an opioid, necessitating careful tracking of daily dose limits so as not to incur risk for liver and GI toxic effects. 34 All transdermal and transmucosal fentanyl and hydromorphone ER products are for use only in opioid-tolerant patients and never for acute or short-term pain. 35 ER/LA opioids are primarily intended to be taken once or twice a day, are not indicated for acute pain, and are for use only in patients who are already tolerant to opioids. 13,35 The primary risk with opioids is respiratory depression leading to death. Some opioids (e.g., methadone) can prolong the QTc interval. ER/LA opioid tablets should be swallowed whole, never crushed, chewed, broken, cut, or dissolved, which may result in rapid release and absorption of a potentially fatal dose. 35,36 Transdermal systems and buccal films should not be cut, torn, or damaged before use nor chewed, swallowed, or patches exposed to heat, which may lead to fatal overdose. Possible opioid side effects include but are not limited to: 5,13 • Lightheadedness

Commonly Prescribed Controlled Substances The 5 drug classes regulated by the CSA are opioids (called “narcotics” by the DEA), sedative- hypnotics, stimulants, hallucinogens, and anabolic steroids. Each class produces its own effects in the body, but all share the commonality that they have the potential for being misused by patients and non-patients. They are also among the most highly sought-after drugs for diversion. 25 Many CS drugs are commonly prescribed for indicated medical conditions. Others, such as cocaine, have very limited medical indications. Non- opioid medications can minimize opioid exposure, and different medications can complement one another; however, each has unique risks and benefits as well as mechanisms of action, 5 and their effects can be synergistic when used in combination. 5 A risk-benefit analysis is always recommended based on the individual patient’s medical, clinical, and biopsychosocial circumstances. 5 Specific categories and medications will be described as required by the State of Tennessee. Opioids As Schedule II medications, opioid prescriptions are not limited by quantity or treatment by the CSA; however, many states and insurance carriers do set limits on quantity, frequency, and duration of prescriptions as well as other facets of treatment and monitoring. Remember that the more restrictive law trumps the less restrictive in regard to prescribing CS. Prescribing for pain has dropped off in recent years after peaking in 2011. 17

• Dizziness • Sedation • Nausea and vomiting • Drowsiness • Mental clouding • Constipation

Table 3. Opioid Analgesic Classifications

Type

Generic Name

Notes/Cautions

Pure agonists

Codeine Dihydrocodeine Fentanyl Hydrocodone Hydromorphone Levorphanol Meperidine* Methadone Morphine Oxycodone Oxymorphone Propoxyphene Partial agonist: Buprenorphine

*Meperidine not recommended for long-term treatment or in patients with renal compromise due to toxicity risks

Agonist-antagonists

May produce withdrawal with physical dependence

Mixed agonist-antagonists: Butorphanol Dezocine

Nalbuphine Pentazocine Naloxone Naltrexone

Pure antagonists

Administered to reverse opioid effects

Other

Tramadol

Dual action mu-agonist and serotonin–norepinephrine reuptake inhibitor

Tapentadol

Dual action mu-agonist and norepinephrine reuptake inhibitor

• Hormonal deficiencies • Pruritis • Myoclonus • Irritability • Respiratory depression

In 2020 the Tennessee Department of Health issued the latest edition of its clinical practice guidelines for the outpatient management of chronic non-malignant pain. 41 The guidelines can serve as a resource for any prescriber who may be utilizing opioid medications in the treatment of patients with chronic pain, with an emphasis on the avoidance of adverse outcomes or addiction. The guidelines provide detailed recommendations when considering, initiating and continuing the use of opioid medications in the treatment of chronic, non-malignant pain. Many useful resources are available to the prescriber within the guidelines including assessment tools, special population concerns, examples of informed consent/ patient agreements, as well as information of Emergency Department opioid prescribing guidelines and acute pain management. The guidelines may be found at: https://www. tn.gov/content/dam/tn/health/healthprofboards/ pain-management-clinic/ChronicPainGuidelines.pdf The following represents a summary of some of the key principles included in the Tennessee Chronic Pain Guidelines. Considerations for the Prescriber: Prior to the Initiation of Opioid Therapy 1. Prior treatment of pain with opioids, provided by a previous provider, does not obligate, or necessitate continued opioid treatment. 2. Non-opioid treatment modalities should be attempted prior to initiating treatment with opioid medications. 3. Telemedicine is not an appropriate modality for treatment of chronic pain with opioids (or other controlled substances). 4. Birth control methods should be discussed to avoid unintended pregnancy in women of childbearing age. 5. A thorough history, physical examination and review of a patient’s prior medical records should be completed and documented. 6. A thorough history of the patient’s painful condition should be pursued, including prior diagnostic testing and treatment attempts. 7. Risks for abuse, misuse, addiction, and diversion must be assessed. 8. A current diagnosis must be established to justify opioid medications. 9. The prescriber and patient must identify a plan that includes treatment modalities beyond opioids. 10. Goals of treatment should be established and emphasize reduction of pain for improved daily function, not necessarily complete elimination of pain. Functional goals could include improved activities of daily living, increase social participation or returning to work. To be effective, functional treatment goals should be realistic and tailored to each patient. A helpful strategy is to help the patient define SMART goals (specific, measurable, action-oriented, realistic, and time-sensitive). 42

11. Informed consent regarding the potential risks of opioid medications such as physical dependence, physical impairment, over- sedation, addiction, and death must be obtained. The guidelines include an example of an Informed Consent document. The patient should be counseled that the goal of chronic opioid therapy is to increase function and reduce pain, not to eliminate pain. Most randomized controlled trials have shown modest reductions in pain with opioids averaging 30%. A recent systematic review found that only 44.3% of patients had 50% pain relief with opioids in the short term. 43 Documentation of this discussion should be included in the medical record. The possible presence of co-occurring mental health disorders should be considered, and screening tests should be used if depression, anxiety, PTSD, current or past substance use disorder, or any other mental health conditions are suspected. Prescribers should obtain a Urine Drug Test (UDT) (or a comparable test on oral fluids) prior to initiating opioid therapy and they should access the Tennessee Controlled Substances Monitoring Database (CSMD) to obtain data about a patient’s risk of misuse, abuse or diversion of medications. 41 Considerations for the Prescriber: Initiation of Opioid Therapy 1. Written agreements/ treatment plans between patient and prescriber should define reasons for discontinuance of opioids, refill policies, lost prescription/ medication policies, safe storage of medications, intermittent drug testing and use of one pharmacy for obtaining medications. The guidelines offer an example of a patient agreement. 2. The patient must acknowledge that initiation of treatment with opioids is a therapeutic trial. 3. Treatment should begin with the lowest dose of opioids and titrate to effect. 4. Patients should be monitored closely for any evidence of abuse, misuse, or diversion. 5. Patients must acknowledge that unannounced urine drug testing is required at least twice yearly. 41 Patients initiated on a trial of opioids for chronic pain should be initiated at the lowest effective dose and titrated slowly to analgesic effect. 44 Short- acting (SA) opioids are preferred and considered safer when initiating a therapeutic trial of opioids and are often prescribed for use as needed, every 4 to 6 hours. 44,45 If patients require long-term treatment and pain is severe enough to require around-the-clock, long-acting (LA) analgesia that is not adequately relieved by IR/SA opioids or other therapies, consider a transition to ER/LA opioids with scheduled dosing. 46 Methadone for pain presents special clinical challenges due to properties that include a long and variable half-life and pain relief that wanes even though the concentration in the body remains and depresses breathing. 24

Signs of an opioid overdose include: 37,38 • Small, constricted “pinpoint pupils” • Falling asleep or loss of consciousness • Slow, shallow breathing • Choking or gurgling sounds • Limp body • Pale, blue, or cold skin • Snoring heavily and cannot be awakened • Periods of ataxic (irregular) or other sleep- disordered breathing • Trouble breathing • Dizziness, confusion, or heart palpitations Acute Pain Opioids in acute pain settings should only be prescribed for the duration of the pain at the lowest effective therapeutic dose. 13,39 Prescriptions beyond 3 days are rarely necessary, 13 while more severe episodes rarely need more than 7-14 days, although there are exceptions, and each patient should be treated as an individual. 13,40 Be aware also that localities and states may have strict regulations governing maximum duration of prescriptions for acute pain. Acute pain should not be treated with ER/LA formulations of opioids, and opioids typically are not recommended for nonspecific back pain, headaches, or fibromyalgia, if the HCP should see a patient experiencing acute pain flares with these conditions. 33 HCPs should check the PDMP ahead of prescribing opioids for acute pain whenever possible 5 and reevaluate the pain diagnosis and treatment plan if pain persists beyond the expected healing period. Chronic Pain Patients need access to appropriate and effective pain relief with a commitment to avoiding or managing adverse effects arising from treatment with CS. Some 50 million U.S. adults live with chronic daily pain, and 19.6 million experience high-impact pain that interferes with daily life and work. 5 Patients who suffer pain long term have reduced quality of life and are at risk for morbidity when pain goes untreated or is managed inappropriately. Effective pain management skills are part of quality medical practice. Effective treatment for pain does not usually involve ongoing opioid therapy, which should be reserved for patients with pain severe enough to warrant an opioid and for whom more conservative therapies would not be effective or have previously failed to be effective. 13 Numerous non-opioid pharmacologic therapies are available for pain, and these should be tried or considered, alone or in combination, before initiating long-term opioid therapy. 5 A trial of opioids, when indicated, should be part of a comprehensive treatment approach, typically in combination with one or more treatment modalities. 33

Only HCPs with experience and knowledge of methadone should prescribe it (only for severe pain unrelieved by other opioids) or else seek expert consultation. 38 Dual-mechanism opioids may control pain with less opioid, and opioid-sparing techniques, such as combining therapeutics should be considered. Certain cautions are necessary for special populations. Women should be informed of the risks of long-term opioid therapy during pregnancy to the developing fetus, including neonatal opioid withdrawal syndrome (NOWS), 13,46 birth defects, preterm delivery, poor fetal growth, and stillbirth. 13 Adults older than 65 years need cautious opioid dosing and consideration of risks that include falls, cognitive effects, interaction with other medications,

and increased sensitivity to analgesic effects. 44 Initial doses should be 25–50% lower than in those who are younger. 40 Caution is necessary when initiating and titrating opioid doses in people with renal and hepatic impairment. 47 Naloxone co-prescription is recommended with patients at higher risk of opioid overdose. This includes those with a history of overdose, history of SUD, clinical depression, opioid dosages ≥50 MME/day, concurrent benzodiazepine use, 13 or with evidence of increased risk by other measures. Clear rationale for prescribing or increasing dosages of opioids should be documented in the medical record, particularly if dosages exceed current recommended guidelines. 48 (Table 4)

The CDC guideline identified a dose limit of 90 morphine milligram equivalents (MMEs) daily after which caution is advised. 13 However, no dose is completely safe, 49 and much of the risk at higher doses appears to be associated with co-prescribed benzodiazepines. 50 Evidence is strong that prescribing opioids together with benzodiazepines increases risk for overdose, 33,51 and evidence also suggests that co-prescription of opioids and gabapentinoids may increase overdose risk. 33 Considerations for the Prescriber: Ongoing Opioid Therapy 1. Opioid medication prescriptions should be obtained from a single provider/ practice and filled by a single pharmacy.

Table 4. Items to Perform and Document in the Patient Record When Prescribing Opioid Therapy for Chronic Pain 18,32,38,52,53 1. Signed informed consent 2. Signed opioid treatment agreement(s) 3. Pain and medical history Chief complaint Treatments tried and patient response Past laboratory, diagnostic, and imaging results

Comorbid conditions (e.g., medical, substance-use, psychiatric, mood, sleep) Social history (e.g., employment, marital, family status, substance use) Pregnancy status or intent, contraceptive use

4. Results of physical exam and new diagnostic and imaging tests Review of systems Pain intensity and level of functioning One or more indications for opioid treatment Objective disease/diagnostic markers 5. Results of opioid risk assessment prior to prescribing opioids

Clinical interview or any screening instruments Personal history of SUD, mental health disorder Family history of SUD, mental health disorder Co-management or treatment referral for patients at risk for SUD Treatment or referral for patients with active OUD Treatment or referral for patients with undiagnosed depression, anxiety, other mental health disorders 6. Treatment goals for pain relief, function, quality of life 7. Treatments provided With risk-benefit analysis after considering available nonpharmacologic and non-opioid pharmacologic options All medications prescribed (including the date, type, dose, and quantity) All prescription orders for opioids and other controlled substances whether written or telephoned 8. Prescription of naloxone, if provided, and rationale 9. Results of ongoing monitoring toward pain management and functional goals

10. Presence and treatment of adverse events 11. Results of initial and ongoing PDMP checks

Consider risk for dangerous drug-drug interactions Consider risk for misuse with opioids Collaborate on transition with primary prescriber if opioids previously prescribed

12. Results of initial and ongoing UDT 13. Counseling and instructions to the patient and significant others Directions for medication use Ongoing discussions of risks and benefits

Adherence to prescribed therapies, including results of UDT and PDMP checks Actions taken regarding aberrant medication use (e.g., document results, collaborate with multidisciplinary team, institute taper)

14. Referrals given and notes on consultations for specialists in pain, SUD, mental-health, and medical comorbidities 15. Notes on continuing, revising, or discontinuing opioid therapy (e.g., titrate, rotate, taper, OUD management) 16. Authorization for release of information to other treatment practitioners SUD = substance-use disorder OUD = opioid-use disorder; PDMP = prescription drug-monitoring programs; UDT = urine drug testing

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