Speakers - cdn.ymaws.com · Acute Pain CS/CS/HB 21 #FSHP2018 Regulatory Compliant Prescriptions...
Transcript of Speakers - cdn.ymaws.com · Acute Pain CS/CS/HB 21 #FSHP2018 Regulatory Compliant Prescriptions...
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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
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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
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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
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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
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"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
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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
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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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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
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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
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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
#FSHP2018FL PDMP AWARxE user guide (https://d1b1sdx6nwlphm.cloudfront.net/aware/flaws_prod/aware_user_guide.pdf)
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
#FSHP2018FL PDMP AWARxE user guide (https://d1b1sdx6nwlphm.cloudfront.net/aware/flaws_prod/aware_user_guide.pdf)
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
#FSHP2018FL PDMP AWARxE user guide (https://d1b1sdx6nwlphm.cloudfront.net/aware/flaws_prod/aware_user_guide.pdf)
Select a patient listed OR
FL PDMP Partial SearchFL PDMP Partial Search
#FSHP2018FL PDMP AWARxE user guide (https://d1b1sdx6nwlphm.cloudfront.net/aware/flaws_prod/aware_user_guide.pdf)
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
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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”
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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
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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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OPIOID Addiction Treatment Resources
https://goo.gl/images/vfchHJ
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TheChallengingDrive‐thruPharmacy Case
Recite HB 21 to this guy
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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