speakers - cdn.ymaws.com · acute pain cs/cs/hb 21 #fshp2018 regulatory compliant prescriptions...

7/3/2018

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Management of Controlled Substances Dispensing 2018: FOCUS on Health QualityManagement of Controlled Substances Dispensing 2018: FOCUS on Health Quality

Mark W. Mikhael Pharm.D. Norman P. Tomaka, BS. Pharm., MS

ProHealth Pharmacy Solutions Clinical Consultant Pharmacist

Vice President of Operations Healthcare Risk Manager

Florida Board of Pharmacy

#FSHP2018

SpeakersSpeakers

#FSHP2018

Norman P. TomakaPharmacist, Consultant Pharmacist BS Pharmacy- Duquesne UniversityMS Pharmacy- University of Florida

Health Care Risk Manager

AffiliationsFSHP and Treasure Coast SocietyConsultant Pharmacy ServicesClinical Consultant Pharmacist Outpatient - Ambulatory Facilities

Mark W. MikhaelPharmacistPharm.D, Florida A&M University College of Pharmacy

Past ChairmanFlorida Board of Pharmacy

AffiliationsFSHP and Central Florida Society Vice-President of Operations, Prohealth Pharmacy Solutions

• Dr. Mikhael and Mr. Tomaka do not have a vested interest or an affiliation with any corporation or organization offering financial support or grant monies for this seminar

• Dr. Mikhael and Mr. Tomaka do not have an affiliation with any organization whose philosophy could potentially bias this presentation

Speakers Disclosure

#FSHP2018

The information here is solely for educational purposesThe content of this presentation provides a general overview of the regulatory requirements.

Pharmacists and Technicians should review state and federal regulatory statutes for a complete description of compliance requirements.

Our discussion does not constitute legal, risk, or accreditation advice. No warranty is made, expressed or implied, with respect to this presentation and any liability resulting from any use or reliance on this event is disclaimed.

Management of Controlled Substances Dispensing 2018: FOCUS on Health Quality

SPECIAL ACKNOWLEDGEMENT

Douglas J. Tam, Pharm.D. Candidate 2019University of Florida College of Pharmacy

StudentsRxOCK!

SPECIAL ACKNOWLEDGEMENT

#FSHP2018

ObjectivesObjectivesSummarize compliant pharmacist licensure requirements as per

64B16‐27.831 of the Florida Administrative Code and other

regulations governing the dispensing of controlled substances

Differentiate a “valid” vs. “invalid” prescription order for a controlled

substance drug ‐including the appropriate therapeutic doses for

prescribed controlled substances

Describe processes that foster regulatory compliance when validating

a prescription order

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ObjectivesObjectives

Recall processes for evaluating the legitimate medical purposes for the controlled substance prescriptions

Recognize and describe the appropriate use of the Florida Prescription Drug Monitoring Program Database E‐FORSCE at the presentation’s

conclusion

Identify proper disposal of unused controlled substances

#FSHP2018

ObjectivesObjectivesEvaluate methods for properly addressing and resolving problems

recognized during Drug Utilization review including, interactions, side effects, dosing concerns

Explain resources for opioid physical dependence, addiction, misuse, and abuse

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Opioid Regulatory Madness?

H.R. 4275 Empowering Pharmacists in the Fight Against Opioid Abuse Act

H.R. 5197 Alternatives to Opioids (ALTO) Act

H.R. 5327 Comprehensive Opioid Recovery Centers Act

H.R. 5041 Safe Disposal of Unused Medication Act

H.R. 5473 Better Pain Management Through Better Data Act

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June 2018: US House Passes 12 BillsCombating Opioid Crisis https://goo.gl/images/8m8zay

Opioid Regulatory Madness?

H.R. 5009 Jessie’s Law

H.R. 5812 Creating Opportunities that Necessitate New& Enhanced Connections that Improve Opioid Navigation Strategies Act

H.R. 4284 Indexing Narcotics, Fentanyl and Opioids (INFO) Act

H.R. 5483 Special Registration for Telemedicine Clarification Act

H.R. 5353 Eliminating Opioid Related Infectious Diseases Act

H.R. 5582 Abuse Deterrent Access Act of 2018

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June 2018: US House Passes 12 Bills Combating Opioid Crisis

https://goo.gl/images/uhXTej

FL Controlled SubstancesWhat’s New?

FL Controlled SubstancesWhat’s New?

CHAPTER 2018‐13

Committee Substitute for House Bill No. 21

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Signed by the FL Governor on March 19, 2018 Effective July 1, 2018

Addresses opioid abuse in FL Supplements forthcoming Federal mandates

https://goo.gl/images/AztR8w

https://goo.gl/images/1hkuyt CS/CS/HB 21CS/CS/HB 21

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Establishes prescribing limits Requires continuing education on controlled substance prescribing Maintains current CE requirement for pharmacists Expands required use of Florida’s Prescription Drug Monitoring Program, EFORCSE

Prescribing Limits

PDMPResource

RegulatoryEducation

https://goo.gl/images/vt3brw

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http://www.flhealthsource.gov/FloridaTakeControl/?/floridatakecontrol/

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RegulatoryCompliance

FL CS/CS/HB21

RESOURCE

http://www.flhealthsource.gov/FloridaTakeControl/?/floridatakecontrol/

REFERENCE

HB 21: Prescribing LimitsHB 21: Prescribing Limits

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Acute Pain‐prescribing practitioner may prescribe or dispense up to a 3‐day supply of a Schedule II opioid to alleviate acute painException: a prescribing practitioner may prescribe or dispense up to a 7‐day supply for acute pain if the physician determines more than a three‐day supply is needed based on

professional judgement indicates "acute pain exception" on the prescription documents the justification for deviating from the 3‐day supply limit in the patient's

medical record

3DAYS

7DAYS

HB 21: Acute PainHB 21: Acute Pain

#FSHP2018

"Acute pain" is the normal, predicted, physiological, and time-limited response to an adverse chemical, thermal, or mechanical stimulus associated with surgery, trauma, or acute illness

3 DAYS

7 DAYS

HB 21: Acute or not…HB 21: Acute or not…

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"Acute pain" does not include pain related to cancer, terminal conditions, pain treated with palliative care, or traumatic injuries with an Injury Severity Score of 9 or greater

NonAcutePain

An Injury Severity Score ranges from 1 to 75The “score” is a method for describing trauma patientswith multiple injuries and evaluating emergency care

http://www.trauma.org/archive/scores/iss.html

HB 21: Traumatic PainHB 21: Traumatic Pain

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Injury Severity Score (ISS) Anatomical scoring system that provides an overall

score for patients with multiple injuries Each injury is assigned an “Abbreviated Injury

Scale” (AIS) score allocated to one of six body regions Head, Face, Chest, Abdomen, Extremities

(including Pelvis), External

NonAcutePain

http://www.trauma.org/archive/scores/iss.html

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SampleInjury Severity

ScoreCalculation

Krongdai Unhasuta, RN. Ed. D.Trauma Specialist.”Trauma Scoring”https://www.slideshare.net/krongdai/trauma-scoring

Injury Score of 9 or greater is Traumatic

Krongdai Unhasuta, RN. Ed. D.Trauma Specialist.”Trauma Scoring”https://www.slideshare.net/krongdai/trauma-scoring

Krongdai Unhasuta, Trauma Specialist

Injury Severity Calculator: http://www.trauma.org/index.php/main/article/383/

CS/CS/HB 21CS/CS/HB 21

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Prescriptions for Non‐acute PainIf a Schedule II opioid is prescribed for the treatment of pain other than acute pain, the prescriber must indicate "Non‐acute Pain" on the prescription

Non‐acute pain Cancer Terminal condition Palliative care pain Traumatic injury with an Injury Severity Score of 9 or greater

NonAcutePain

CS/CS/HB 21CS/CS/HB 21

#FSHP2018

Regulatory Compliant Prescriptions must contain Pain Condition “notation” otherwise Rx is for “Acute Pain” with 3 day supply limitation

NonAcutePain

AcutePain

Exception

AcutePain

Concurrent Opioid AntagonistFor the treatment of pain related to a traumatic injury with an injury severity score of 9 or greater, a prescriber issuing a schedule II controlled substance must concurrently prescribe an emergency opioid antagonist

https://goo.gl/images/7ECn5h

http://mediad.publicbroadcasting.net/p/wvpn/files/styles/x_large/public/201610/adapt_pharma_pic.jpg https://goo.gl/images/hWPbZy

HB 21 Rx summary Impacting the Pharmacist Prescriptions for Schedule II Opioids for the

treatment of Acute Pain may not exceed a 3

day supply.

A 7 day supply for acute pain may be

prescribed if all of the following conditions

are met: More than a 3 day supply is needed

based on the professional judgement of

the prescriber

The prescriber indicates “ACUTE PAIN

EXCEPTION” on the prescription.

The prescriber documents in the medical

records the acute medical condition and

lack of alternative treatment options that

justify deviation from the day supply

limit

• Chronic Non‐Acute Pain Prescribing*

• Adds to existing prescriber requirements for patient chart documentation when treating chronic non‐acute pain

• Prescriptions for schedule II opioid for the treatment of pain other than acute pain (ex: chronic pain, or pain that is excluded from the definition of acute pain), must indicate “NON‐ACUTE PAIN” on the prescription

*Florida Statute456.44 Controlled substance prescribinghttp://www.leg.state.fl.us/Statutes/index.cfm?App_mode=Display_Statute&Search_Stri

ng=&URL=0400‐0499/0456/Sections/0456.44.html

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http://www.floridahealth.gov/licensing‐and‐regulation/counterfeit‐proof‐prescription‐pad‐vendors/_documents/rx‐pad‐sample.pdf

CS/CS/HB 21 Pharmacist are….Required to become familiar with changes to certain prescribing limits on controlled substances

Required to become familiar with emerging rules adopted by prescribing practitioners that establish guidelines for use of controlled substances for treatment of acute pain

Required to report to the Prescription Drug Monitoring Program (PDMP) system when dispensing any controlled substances Schedules II, III, IV, and V drug to a patient.

Exceptions ‐ schedule V controlled substances that are non‐opioids‐ prescriptions dispensed to patients under the age of 16

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Pharmacist CorrespondingResponsibilityPharmacist CorrespondingResponsibility

The DEA spells out a "corresponding responsibility" of prescribers and pharmacists. The responsibility for the proper prescribing and dispensing of controlled substances is upon the prescribing practitioner, but a corresponding responsibility rests with the pharmacist who fills the prescription.

PDMP

AcutePain

Days Supply

RXIndication

RegulatoryJustification

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https://www.deadiversion.usdoj.gov/21cfr/cfr/1306/1306_04.htm

Appropriate Pain ManagementAppropriate Pain Management

• Rationale for therapeutic selection

• Documented medical condition

• Regulatory compliant

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ValidPrescription

What Makes A Controlled Substances Prescription Valid?

• Valid Prescription• Based on a practitioner‐patient relationship• Issued for a legitimate medical purpose

What Makes A Controlled Substances Prescription Valid?

TrustHonestyAppropriateness Green Flags

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#FSHP2018

ValidPrescription

?

Prescribers from distant locations

Drug cocktailsHydrocodone, alprazolam, carisoprodolOxycodone, alprazolam, carisoprodol

Paying cash

Unusual behaviors

Early refills

Multiple prescribers

Multiple prescriptions for same controlled substances regardless of patient factors

Prescriber isn’t associated with pain management

Use of street slang

Large quantities

Red Flag Behaviors Red Flags• Circumstances that cause suspicion about the validity of the prescription

• We must act upon the red flags we observe

#FSHP2018

If pharmacist is convinced that providing the controlled substances Rx to the patient is NOT in the best interest of the patient, document the process and file at the pharmacy!

If the pharmacist is convinced that the controlled substances Rx is not valid or illegal,There may be a requirement to report the issue to regulatory authorities

Kenneth R. Baker, BS Pharm, JD “Refusal To Fill Prescriptions” Drug Topics, June 22, 2018

Valid CS PrescriptionValid CS Prescription Date prescription was issued

Prescriber’s signature

Patient’s full name and address

Medication name & strength

Dosage form

Quantity prescribed

Directions for use

Prescriber’s name, address, and DEA registration number

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Boards of pharmacy. NABP website. https://nabp.pharmacy/boards‐of‐pharmacy/ Accessed May 22, 2018.

Valid CS PrescriptionValid CS PrescriptionPharmacist communication with prescriber

Bona‐fide medical condition, diagnosis

Pain management contract with prescriber

Established provider patient relationship

Pharmacist‐Patient relationship

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Johnson,Brittany, PharmD (1/24/18). Pharmacists' Role in the Management of Perioperative Analgesia. Pharmacy Times https://www.pharmacytimes.com/publications/health‐

system‐edition/2018/january2018/pharmacists‐role‐in‐the‐management‐of‐perioperative‐analgesia (accessed 5/23/18)

www.ashpintersections.org

Validate CS PrescriptionValidate CS PrescriptionConsult the Prescription Drug Monitoring Program (PDMP) FL E‐FORCSE

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FL PDMP AWARxE user guide (https://d1b1sdx6nwlphm.cloudfront.net/aware/fl_aws_prod/aware_user_guide.pdf)

E‐FORCSE®, Florida Prescription Drug Monitoring Program4052 Bald Cypress WayBin C‐16Tallahassee, FL 32399(877) 719‐3120

E‐FORCSE = Electronic Florida Online Reporting of Controlled Substances Evaluation Program

Now known as: AWARxE

NEW E‐FORCSE PMP AWARxEplatform is now available at: https://florida.pmpaware.net

FL PDMPFL PDMP E‐FORCSE® AWARxE requires: Every individual register as a separate user, using

their email address as their username within the system

A user can register as a designee (referred to as a “Prescriber Delegate ‐ Unlicensed” or “Pharmacist Delegate ‐ Unlicensed” in PDMP AWARxE

Delegate role is designed to allow the user to generate reports on the behalf of another, current user

#FSHP2018

FL PDMP AWARxE user guide (https://d1b1sdx6nwlphm.cloudfront.net/aware/fl_aws_prod/aware_user_guide.pdf)

https://florida.pmpaware.net/login

AWARxE

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How Do I Register for E‐FORCSE?

• Open a browser window https://Florida.pmpaware.net

• Click “Create and Account”.

• Enter an email address and password.

• Select User Role

• Enter personal and employer information.

• Click “Submit your Registration”

E‐FORSCE™ Delegate/Designee• Pharmacists designating a “delegate” have E‐Forsce subscription and rights

• Pharmacists can delegate access rights to Registered Pharmacy Technicians

• Delegate must be directly supervised

• Appointed to act as an agent of a prescriber or dispenser for the purposes of requesting or receiving information from E‐FORCSE

• Delegate must complete education and additional requirements as specified on the E‐FORCSE site: http://www.floridahealth.gov/statistics‐and‐data/e‐forcse

FL PDMP Log OnFL PDMP Log On

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FL PDMP AWARxE user guide (https://d1b1sdx6nwlphm.cloudfront.net/aware/flaws_prod/aware_user_guide.pdf)

Delegate Assignment

• Begin reporting dispensing of schedule V controlled substances

• Report patient’s telephone number

• The name of the individual picking up the controlled substance prescription and type and issuer of the ID provided

Include Florida Department of Health pharmacy permit/license number for the entity that dispensed the medication

E‐FORCSE – New Pharmacy Data Requirements

FL PDMP AWARxE™ templateFL PDMP AWARxE™ template

#FSHP2018FL PDMP AWARxE user guide (https://d1b1sdx6nwlphm.cloudfront.net/aware/flaws_prod/aware_user_guide.pdf)

FL PDMP Patient RequestFL PDMP Patient Request


Clicking the Partial Spelling boxes for either first or last name allows the option to use only part of a patient’s name to perform a search

Use when searching hyphenated names

or names that are abbreviated

“Will” vs. “William”

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FL PDMP Patient RequestFL PDMP Patient Request


Patient searches may include a zip code BUTit is recommended that searches be made without zip code

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Four main sections: Patient Information, Prescriptions Prescribers, and Dispensers

Patient AdvisoryReport

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FL PDMP Patient PrescriptionsFL PDMP Patient PrescriptionsPatient AdvisoryReport

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FL PDMP Patient PrescriptionsFL PDMP Patient Prescriptions

MME (Milligram Morphine Equivalents)

#FSHP2018 #FSHP2018

FL PDMP Prescribers and DispensersFL PDMP Prescribers and DispensersPrescribers table displays the information for all prescribers who issued a prescription to thepatient within the search period used

Dispensers table displays the information for all Dispensers who filled a prescription to thepatient within the search period used

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FL PDMP “Multiple” PatientsFL PDMP “Multiple” Patients


Select a patient listed OR

FL PDMP Partial SearchFL PDMP Partial Search


IF entered search criteria cannotidentify a single patient record, the user receives a message that multiple patients have beenidentified

Refine their search criteria and rerun the report‐or‐

select one or more of the patient records identified and run the report

Drug Diversion Prevention ToolProactive Utilization Review

Evaluates appropriate drug dosing

Reviews excessive utilization

Evaluates drug‐drug interactions

Addresses potential side effects

Maintains active communication with patient and prescriber

The Pharmacist is the health care provider who….

Drug Diversion Prevention ToolProactive Utilization Review

Fosters a system that provides consistent, people‐centered language when addressing drugs

The Pharmacist is the health care provider who….

https://goo.gl/images/LVr3qi

http://www.globalcommissionondrugs.org/

Diversion PreventionDiversion Prevention

In 2015, 3.8 million Americans reported misusing prescription drugs within the last month, and deaths from prescription opioids have more than quadrupled since 1999

About half of the people who reported misusing prescription drugs in 2015 received them from a friend or relative

#FSHP2018

GAO Highlights October 2017 United States Government Accountability Office https://www.gao.gov/assets/690/687719.pdf

Diversion PreventionDiversion PreventionSafe Disposal of Unused Medication Act of 2018 (proposed)

• “Ensuring that unused prescription opioids are properly disposed of is critical to saving lives and combating the opioid crisis“ Senator Maggie Hassan (NH)

• Senator Susan Collins (ME) “The disposal of unused prescription drugs is key to making sure they do not fall into the wrong hands”

#FSHP2018

An important step in preventing drug diversion includes educating consumers about the dangers of leaving unused controlled prescription medication in the homeJeanie E. Jaramillo‐Stametz, Heather Stewart, Leslie Ochs & Kenna Payne (2017) Multi‐state medication take back initiative: Controlled substances collected from 2011 to 2015, Journal of Substance Use, 23:1, 36‐42, DOI: 10.1080/14659891.2017.1337821

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rexburgpolice.org www.Tricare.mil.drugtakeback

Viable CommunityDrug Disposal Initiatives

Sharpsinc.com

http://www.clackamasproviders.org/drug-take-back-boxes/https://goo.gl/images/CyQSHX

#FSHP2018

OPIOID RISK MITIGATION

Provider Mandate

Patients with signs or symptoms of abuse must be immediately referred to a board‐certified pain management physician, an addiction medicine specialist, or a mental health addiction facility

https://www.flsenate.gov/Session/Bill/2018/21/BillText/Filed/PDFhttps://goo.gl/images/TGWXbd

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OPIOID RISK MITIGATION

Pharmacist Corresponding Responsibility

Communication with other providers

Evidence/behavioral indications of diversion shall be followed by discontinuation of controlled substance therapy, patient shall be discharge, all testing and actions documented in the medical record

https://www.flsenate.gov/Session/Bill/2018/21/BillText/Filed/PDFhttps://goo.gl/images/ipSkFx

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OPIOID Addiction Treatment Resources

US government resource

Substance Abuse and Mental Health Services Administration

Guidelines for program and facilities certification

Directory of local treatment facilitieshttps://dpt2.samhsa.gov

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OPIOID Addiction Treatment Resourceshttps://dpt2.samhsa.gov/treatment/directory.aspx

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#FSHP2018

OPIOID Addiction Treatment Resources

https://goo.gl/images/vfchHJ

https://goo.gl/images/6h51wp

https://goo.gl/images/kPDUCY

https://goo.gl/images/8QiRqe

TheChallengingDrive‐thruPharmacy Case

Recite HB 21 to this guy

#FSHP2018

References• Department of Health and Human Services: Substances Abuse and Mental Health Services Administration 5600 Fishers Ln, Rockville, MD 20857

https://www.samhsa.gov/ (Accessed 5/25/18)

• United States Government Accountability Office, “GAO Highlights” Oct. 2017 edition. https://www.gao.gov/assets/690/687719.pdf

• Jeanie E. Jaramillo‐Stametz, Heather Stewart, Leslie Ochs & Kenna Payne (2017) Multi‐state medication take back initiative: Controlled substances collectedfrom 2011 to 2015, Journal of Substance Use, 23:1, 36‐42, DOI: 10.1080/14659891.2017.1337821 (Accessed 5/23/18)

• H.R.5041 ‐ Safe Disposal of Unused Medication Act United States115th Congress (2017‐2018) Sponsor: Rep. Walberg, Tim [R‐MI‐7] https://www.congress.gov/115/bills/hr5041/BILLS‐115hr5041ih.pdf

• Lenchus, Joshua, DO, RPh. “Controlled Substances Prescribing”. Florida Medical Association Continuing Education Program. https://flmedical.inreachce.com/Details?groupId=c64bbce1‐c037‐4008‐b6bd‐1204fd149224 (Viewed 5/21‐5/22/18)

• Global Commission on Drug Policy. http://www.globalcommissionondrugs.org/wp‐content/uploads/2018/01/GCDP‐Report‐2017_Perceptions‐ENGLISH.pdf(Accessed 5/23/18)

• Florida Prescription Drug Monitoring Program E‐FORSCE. https://florida.pmpaware.net (Accessed 5/20‐5/21/18)

• Florida Department of Health “Take Control of Controlled Substances” http://www.flhealthsource.gov/FloridaTakeControl/ (Accessed 5/18/18)

• Department of Health, Florida Board of Pharmacy “New Legislation Impacting Your Profession” http://floridaspharmacy.gov/latest‐news/new‐legislation‐impacting‐your‐profession‐3/ (accessed 5/6‐5/22/18)

• Florida Statutes Chapter No. 2018‐13 CS/CS/HB21 https://www.flsenate.gov/Session/Bill/2018/21/BillText/er/PDF. (Accessed 5/6/18)

• US Drug Enforcement, Title 21, Part 1306 Prescriptions: §1306.04 Purpose of issue of prescription. “Corresponding Responsibility of the Pharmacist” https://www.deadiversion.usdoj.gov/21cfr/cfr/1306/1306_04.htm (Accessed 5/4/18)

Management of Controlled Substances Dispensing 2018: FOCUS on Health Quality

Management of Controlled Substances Dispensing 2018: FOCUS on Health QualityManagement of Controlled Substances Dispensing 2018: FOCUS on Health QualityMark W. Mikhael Pharm.D. Norman P. Tomaka, BS. Pharm., MS

ProHealth Pharmacy Solutions Clinical Consultant Pharmacist

Vice President of Operations Healthcare Risk Manager

Florida Board of Pharmacy

#FSHP2018

Questions duringPanel Discussion

#FSHP2018

speakers - cdn.ymaws.com · acute pain cs/cs/hb 21 #fshp2018 regulatory compliant prescriptions...

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