Regulation of Controlled Substances · 4/2/2019 · If CS: name, quantity, dosage, (indications...

Regulation ofControlled Substances

Confronting the Opioid Abuse Epidemic

Kate Goldblum, MSN, FNP-BCApril 2, 2019

Disclosures

No financial conflictsNo discussion of off-label use

State Regulations(NM Board of Nursing)

Describe key elements of Rule 9: Management of Chronic Pain With CS

Definitions (e.g., chronic pain)Criteria (“rules”) for prescriptive practices consistent with appropriate pain treatmentRequirements regarding Prescription Monitoring Program (PMP) participationRequirement for non-cancer pain management (NCPM) CERequirements for HCP treated with opiates

State Regulations(NM Board of Pharmacy)

Identify elements of the NM Board of Pharmacy PMP applicable to APRNs who prescribe opioids

PMP account registrationUse of delegates to access PMPControlled Substance Registration (CRS)

Federal Regulations

Discuss federal controlled substance regulations relevant to opioid prescribing

Initial determination & changes to specific drugs’ schedules (I, II, III, IV or V)Administrative & enforcement provisions of the Controlled Substance Act (CSA)Resources for accurate information regarding federal regulations

State RegulationsNew Mexico Board of Nursing

Management of Chronic Pain With Controlled Substances

Rule 9 (16.12.9 NMAC)

Pain Relief Act Amendment

Amended 1999 Act in 2012Affected all boards with jurisdiction over health care providers

Licensed to provide health careWith prescriptive authority

Expanded & clarified evidentiary requirements for disciplinary actionCreated the Advisory CouncilRequired NCPM CE for licensed health care providers with DEA registration & controlled substance licensure

Pain Relief Act Amendment

The Advisory Council

Includes representatives from a number of statewide professional organizations (including NMNPC) & other health care stakeholdersMeets at least quarterly & is administratively attached to the Department of Health (DOH)

Advisory Council Duties

Reviews prescription drug misuse & overdose prevention in NM & at the national levelReviews current pain management practices in NM & pain management standards at the national levelMakes recommendations for pain management & clinical guidelines

https://cdn.ymaws.com/www.nmnpc.org/resource/resmgr/advisory_council_minutes/2018_Advisory_Council_Recomm.pdf

Rules Part 9

Amended to comply with the new requirements in 2012 Pain Relief ActAmended again in 2017 & 2018 –addressed

Requirements of 2016 SB0263Concerns raised by NMNPC re: original CE requirements

https://www.nmnpc.org/page/43

NCPM CE Issues

Redundancy in bi-annual CE1/3 of entire pharmacology CE requirementCouldn’t offer non-pharmacologic content to meet the CE requirement

Goal of NCPM CE is to reduce abuse, addiction & overdoseCurrent CDC guidelines: nonopioid, nonpharmacologic treatments preferred

Part 9

Sections 1-7: housekeepingSection 8: rules regarding Rx practicesSection 9: PMP requirementsSection 10: CE requirementsSection 11: notification requirementsSection 12: requirements for APRNs, RNs& LPNs treated with opiates

Part 9 (16.12.9)Management of Chronic Pain with Controlled Substances

https://s3.amazonaws.com/realFile30f9bb9a-feed-462b-abce-56bd5dd949fa/b273070a-7bab-4401-8cbf-a908a54e8d61?response-content-disposition=filename%3D%22Part+09+Management+of+Chronic+Pain+with+Controlled+Substances.pdf%22&response-content-type=application%2Fpdf&AWSAccessKeyId=AKIAIMZX6TNBAOLKC6MQ&Signature=knwKbW%2FOkVa6aUnmVR5Iv3Vwrhg%3D&Expires=1552856061

Section 8 – The Rules

Criteria used by the BON to determine if prescriptive practices are consistent with appropriate pain treatment

A, B, D, E & F address general prescriptive practicesC addresses CS prescribing for chronic pain management & includes 8 specific compliance items

Part 9 (16.12.9.8)Management of Chronic Pain with Controlled Substances

A: Legitimate Practice

Treatment of pain with various medicines (including CS) is legitimate

In usual course of professional practiceDoes not preclude treatment of legitimate pain if addicted, physically dependent or tolerant but must monitor closely & document precisely


B: NCPM RequirementsPain management should include

Contractual agreementUse of drug screens before & during treatmentReferral for consultation & appropriately timed re-evaluation if provider identifies misuse concerns


C: CS Appropriateness

Appropriate to prescribe, order, administer or dispense CS to manage chronic pain if compliant with 8 specific guidelines


C1 History & Physical

IncludeEvaluation of psychological & pain statusPrior history of significant painPast history of alternate treatment for painPotential for substance abuseComorbiditiesIndication or contraindications for CS use


C2 Tools & Tx Modalities

Be familiar with & use screening tools & a spectrum of treatment modalitiesConsider integrative approach with


AcupuncturistChiropractorDOMExercise physiologistMassage therapist

PharmacistPhysical therapistPsychiatristPsychologistOther APRNs

C3 Written Plan

Tailor to individual needs (consider age, gender, culture & ethnicity)Include stated objectives to evaluate treatment (é’d function, degree of pain relief, etc.)Include statement of need for further testing, consultation, referral, other Tx


C4 Pain Relief Plateaus

If pain relief “plateaus” on CS, treatment plan should include evaluation of continuing or tapering therapy


C5 Education

Discuss risks & benefits of CS use with patient, surrogate or guardianDocument education & discussion in patient’s record


C6 Record Maintenance

Complete & accurate records of care provided & drugs prescribedIf CS: name, quantity, dosage, (indications for use if opioid)If CS for chronic NCP – written agreement outlining pt responsibilities including 1 practitioner 1 pharmacy


C7 Monitoring

Periodically review (at least q 3 months)Course of treatment, state of health, new information on etiology of painConsult as indicated with professional experienced in chronic pain

Drug screening expected when factors suggest é’d risk of misuse or diversion


C8 Rx Not Required

Not required to prescribe CS if (in your opinion) patient is seeking pain meds for non-medically justified indication


D: Basis for Evaluation

BON evaluation of care based onAppropriate dx & evaluationAppropriate medical indication for treatment prescribedDocumented persistence/change of indicationFU evaluation with appropriate continuity of care


D: Judgment of Validity

Validity of prescribing based on treatment & documentation, not on quantity & chronicity of prescribingGoal is to control pain while addressing physical, psychological, social & work-related functioning


E: Over & Under

BON review will include both over-prescribing & under-prescribingGuiding principle: BON review uses same standard of patient protection in both cases


F: Discipline by BON

Practitioner who appropriately prescribes following 16.12.9.8 will be considered compliant & not subject to discipline by the BoardException: some violation of the NPA, BON rules, Pain Relief Act


PMP Requirements

Intent – balance promotion of safe CS use with need to curtail illegal & harmful activities involving CS


APRNs with DEA & CSL

Register with NM Board of Pharmacy PMP & regularly participate in inquiry & reportingMay authorize delegates to access PMP but APRN must still review & document receipt & review of report


Rx of Controlled Substance

Obtain & review 12-month PMP report before prescribing or dispensing a CS (schedules II-V)

For a period > 4 daysWhen there’s a gap in CS prescription of ≥ 30 daysFrom NM PMP & adjacent states when availableNM PMP connects with Military Health System (MHS) PMP



Review PMP report a minimum of every 3 months during continuous use of CS (schedules II-V)Document report review in patient recordNot needed if ≤ 4 days or if patient in nursing facility or hospice



Review PMP report for red flagsMultiple prescribersOpioids & benzos togetherOpioids for > 12 consecutive weeksMore than one CS analgesicOpioids totaling > 90 MME/dayPotential for abuse or misuse


Review → Red Flags?

Take “appropriate steps” to avoid, mitigate or resolve potential problem(s)Use professional judgment based on prevailing standards of practice


Potential Actions

Counsel patient on risks/benefitsRx & train on naloxoneOffer or arrange for treatment for substance use disorderConsult with or refer to pain management specialistDocument actions taken


In Opioid Tx Programs

Review PMP reportOn initial enrollment in Tx programEvery 3 months while on opioid treatment medications in schedules II-VDocument receipt & review of report in patient record


PMP Reports to BON

Compliance with obtaining PMP reports is improvingBUT – providers (including APRNs) have a long way to goQuarterly reports to BoardPrescriber Feedback Reports (PFRs) to practitioners

CE Requirements

DEA & CS registrations → CE requiredCE must address NCPM


NP Requirements

Current requirements (every 2 years)5 contact hours related to APRN’s practice10 contact hours of pharmacology5 contact hours of NCPM

Some of the NCPM CE will necessarily be pharmacology due to specific requirements in Rule 9


Required Content

Review of 16.12.9Understanding of pharmacology & risks of controlled substancesBasic awareness of the problems of abuse, addiction & diversionAwareness of state & federal regulations for prescription of CS


Notification

BON shall notify of the Pain Relief Act & Part 9 of the NM nursing board rule

Health care providers under jurisdiction of NMBONHealth care provider being investigated by BON in relation to provider’s pain management practices


HCP Opiate Treatment

HCPs with chronic pain & being treated with opiates

APRNsRNsLPNsCertified hemodialysis techniciansCertified medication aides


Requirements for HCP

Evaluated at a pain clinic or by a pain specialistCleared by practitioner before returning to or continuing in practiceRemain under care as long as on opiates & continuing to practiceNeuropsychological evaluation prn


What is NMNPC Doing?

Offer NCPM CE every 2 years (live & enduring CE)Maintain representation on the Advisory CouncilMonitor & disseminate Advisory Council recommendationsMonitor & address BON rule develop-ment

Advisory Council – 2018

Boards should adopt the Benzodiazepine Prescribing Guidelines developed & approved by the Council & include appropriate benzodiazepine education in requirements for NCPM education.Increase distribution of naloxone in a variety of settings & circumstances.

https://cdn.ymaws.com/www.nmnpc.org/resource/resmgr/advisory_council_minutes/2018_Advisory_Council_Recomm.pdf

Looking to the Future

Expect more changes (CE on benzodiazepines)

NMNPC courses already included Holy Trinity problem (opioids, benzos and carisoprodol)

NMNPC will monitor rule changes inbenzo CE requirement

State RegulationsNM Board of Pharmacy

Prescription Monitoring Program

Elements Applicable to APRNs

PMP Accounts

NM licensed practitionersNM registered pharmacistsDelegates of practitioner or pharmacistLaw enforcement or regulatory board agents vetted by PMP to warrant accessMandatory for practitioners with CS registration

NM Board of PharmacyPrescription Monitoring Program

PMP Statistics

Decreasing # of practitioners (all types) who aren’t using PMPIncreasing # of practitioners (all types) using the PMP at least 25% of the timeOver 4000 requests/day processed


User Account Registration

NM licensed practitionerDEA registration numberControlled substance license


Registration

Fill out online registration form

Verify email addressUpload required documentsComplete mandatory training

https://newmexico.pmpaware.net

http://nmpmp.org/Training.aspx


https://newmexico.pmpaware.net/login

http://nmpmp.org/Training.aspx

Delegate Registration

Delegate of practitionerRegistration (same process as practitioner)List supervisor(s) email address; supervisor must already have account

Delegates can obtain reports but practitioner must reviewMay have up to 4 delegates


Which Comes First?

To register with the PMP must already have a controlled substance licenseTo renew a controlled substance license must already be registered with the PMP


PMP Accounts

Delegate report requests linked to supervising practitionerMust make sure delegates log in under correct supervisor


PMP Reports

QuarterlyBoard of NursingProvider Feedback Reports

Promote patient safety & best practices


Quarterly ReportsTotal number of patients

Total number of opioid patients

Total opioid MMEs filled

Total number of benzodiazepine (BZD) patients

Total BZD diazepam milligram equivalents (DME) filled

Percent of opioid patients with ≥90 MME/day

Percent of opioid patients with ≥90 days of opioids in 6 months

Percent of BZD patients with prescriptions ≥30 DME/day

Percent of BZD patients with ≥90 days of BZDs in 6 months

Percent of opioid patients with concurrent BZDs ≥30 days

Controlled substance prescriptions per prescribing day, 3 months

Percent of estimated required reports requested

PMP reports required under Board rules (estimated)

PMP reports requested on patients

Percent of patients with a total of 5 or more practitioners or pharmacies in 6 months

Federal Regulations

Controlled Substances Act

Code of Federal Regulation

Drug Schedules

DEA Registration

New &/or renewalOnlinePaper submission

Must have controlled substance license first

Federal RegulationsControlled Substances

https://www.deadiversion.usdoj.gov/drugreg/index.html

https://www.deadiversion.usdoj.gov/drugreg/index.html

Buprenorphine

Waiver course available through AANPFree training partly through unrestricted grant by Indivior to AANP & ASAM


E Prescribing

Legal for II-V but not mandatoryMust use approved software


DEA – Locum Tenens

Within the state generally don’t need to change address of practiceIn a second state, need to change address to locum location then back to primary location


https://www.deadiversion.usdoj.gov/fed_regs/rules/2009/fr1028.htm

https://www.deadiversion.usdoj.gov/fed_regs/rules/2009/fr1028.htm

Schedule l

No accepted medical use in USLack of accepted safety for use under medical supervisionHigh potential for abuseExamples

HeroinLSDMarijuana

PeyoteEcstasy


Schedule ll & llN

High potential for abuseMay lead to severe psychological or physical dependenceExamples (II narcotics)

CodeineFentanylHydrocodoneHydromorphone

MeperidineMethadoneMorphineOxycodone


Schedule ll & llN

Examples (IIN stimulants)

Examples (other II substances)

AmphetamineMethamphetamineMethylphenidate

AmobarbitalGlutethimidePentobarbital


Schedule lll & lllN

Less potential for abuse than I or IIMay lead to moderate/low physical dependence or high psychological dependenceExamples

≤90 mg codeine/doseBuprenorphineNon-narcotics like ketamine & testosterone


Schedule lV

Low potential for abuse relative to IIIExamples

AlprazolamCarisoprodolClonazepamDiazepam

LorazepamMidazolamTemazepamTriazolam


Schedule V

Low potential for abuse relative to IVMainly preparations containing limited quantities of certain narcotics Example

Cough preparations ≤ 200mg codeine/100ml or 100gms


Federal Resources

Current list of CShttps://www.deadiversion.usdoj.gov/schedules/index.html

Title 21 US Code CS Acthttps://www.deadiversion.usdoj.gov/21cfr/21usc/812.htm

Frequently Asked Questionshttps://www.deadiversion.usdoj.gov/faq/index.html

Title 21 Code of Federal Regulationshttps://www.deadiversion.usdoj.gov/21cfr/cfr/index.html


https://www.deadiversion.usdoj.gov/schedules/index.html

https://www.deadiversion.usdoj.gov/21cfr/21usc/812.htm

https://www.deadiversion.usdoj.gov/faq/index.html

https://www.deadiversion.usdoj.gov/21cfr/cfr/index.html

Documenting Required CE

CE verification documentDocument showing content (if not on verification)

SUBMIT DOCUMENTS ON RENEWAL

CE Information

Available at www.NMNPC.org Contact Rachel Bevan

(505) [email protected]

NM Board of Pharmacy

Peter Ryba, [email protected]

mailto:[email protected]

NM DOH Resource

Prescription Opioid Safetyhttps://nmhealth.org/about/erd/ibeb/pos/

https://nmhealth.org/about/erd/ibeb/pos/

CDC Resources

Implementing the CDC Guidelineshttps://www.cdc.gov/drugoverdose/pdf/prescribing/CDC-DUIP-QualityImprovementAndCareCoordination-508.pdf

Guideline Overviewhttps://www.cdc.gov/drugoverdose/pdf/Guidelines_Factsheet-a.pdf

Checklist for Prescribing Opioidshttps://www.cdc.gov/drugoverdose/pdf/PDO_Checklist-a.pdf

Guideline Resources: Clinical Toolshttps://www.cdc.gov/drugoverdose/prescribing/clinical-tools.html

https://www.cdc.gov/drugoverdose/pdf/prescribing/CDC-DUIP-QualityImprovementAndCareCoordination-508.pdf

https://www.cdc.gov/drugoverdose/pdf/Guidelines_Factsheet-a.pdf

https://www.cdc.gov/drugoverdose/pdf/PDO_Checklist-a.pdf

https://www.cdc.gov/drugoverdose/prescribing/clinical-tools.html

Regulation of Controlled Substances · 4/2/2019 · If CS: name, quantity, dosage, (indications...

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