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State of Ohio Board of Pharmacy2nd Annual Dispensary Informational SessionFriday, June 7, 2019
PROGRAM REVIEW AND UPDATE
Dispensary Operations StatisticsFormProduct IDs AssignedTier I plant material1,092Tier II plant material106Edible for oral administration19Metered oil or solid for vaporization5Oil for oral administration1Tinctures for oral administration10
Patients &Caregivers4
Patient & Caregiver Registry Total Patient Recommendations: 34,225 Registered Patients: 31,075 Patients with Veteran Status: 2,386 Patients with Indigent Status: 1,216 Patients with a Terminal Diagnosis: 171 Total Caregivers: 2,109*All patient data through April 2019
Registered Medical Marijuana Patients by AgeRegistered patients (Over70)7%Registered patients (18-29)10%Registered patients (Under18)0%Registered patients (60-69)20%Registered patients (50-59)22%Registered patients (30-39)20%Registered patients (40-49)21%
Medical Marijuana Patients by ConditionAids45Alzheimer’s disease88Multiple sclerosisPain that is either chronic andsevere or intractable83922611CancerChronic traumaticencephalopathy2337Crohn’s diseaseEpilepsy or another seizuredisorder1182Fibromyalgia4043Spinal cord disease or injury1897Glaucoma587Tourette’s syndrome141Hepatitis C726Traumatic brain injury677Inflammatory bowel disease470Ulcerative colitis.406Parkinson’s disease32770Amyotrophic lateral sclerosis40804Positive status for HIV233Post-traumatic stress disorder5434Sickle cell anemiaSome patients are registered with multiple conditions.48
Medical Marijuana Patients 32740233481416774068Some patients are registered with multiple conditions.70
CompliantProductLabeling9
Verifying Product Labels Labels require in relevant part Target cannabinoid content (found in Product IDname) Lab-tested cannabinoid content Target content and lab-tested content cannot bemore than 5% apart
Calculating Actual CannabinoidContent “Lab-reported cannabinoid content * net weightof product” should appear on label (NetCannabinoid; e.g. Total THC or Total CBD) Total THC Net THC (Net THCA * 0.877) Same formula to calculate CBD Total THC and Total CBD must be within 5% targetvalues in Product ID name
DispensingLow THCProducts12
Whole Day Increment EnforcementFormOils for vaporizingPatch, lotion, cream orointmentEdibles, oils, andtinctures for oraladministrationMin. Increment UnderOriginal Interpretation590 mg THCMin. Increment UnderNew InterpretationUp to 590 mg THC295 mg THCUp to 295 mg THC110 mg THCUp to 110 mg THC “Up to” language only applies to products containing less than theminimum increment of processed products Plant material is not impacted Actual dose must still fall within 5% of target
METRC Webinars June 27, 2019 11:00am – 12:00pm ET July 11, 2019 11:00am – 12:00pm ET Registration will be available at www.metrc.com/ohio Advanced training available beginning June 12 th
STATE MEDICAL BOARD ofOHIO
State MedicalBoard of OhioJune 2019 Update16
484 activeCertificates ToRecommend 263 physicianshave issuedrecommendationsfor patients
Qualifying ConditionsAIDSAmyotrophic lateralsclerosisAlzheimer’s diseaseHepatitis CInflammatory boweldiseasePositive status for HIVPost-traumatic stressdisorderSickle cell anemiaSpinal cord disease orinjuryChronic traumaticencephalopathyMultiple sclerosisTourette’s syndromeCrohn’s diseasePain that is either chronicand severe or intractableTraumatic brain injuryEpilepsy or anotherseizure disorderParkinson’s diseaseUlcerative colitisCancerFibromyalgiaGlaucoma18
Qualifying ConditionsMedical Marijuana Expert Review Committeesuggests: Autism spectrum disorder X Depression Anxiety disorderX Opioid use disorderX InsomniaThe full board will consider the additionalconditions on June 12, 2019. The next window topetition for additional qualifying conditions willtake place Nov. 1- Dec. 31, 2019.
Frequently Asked Questions1) How can I be notified when other dispensariesreceive a certificate of operation?2) Can a caregiver purchase medical marijuana ifthey are not tied to a patient?3) Can physicians with an active CTR invest in orhave ownership in dispensaries?4) Is medical marijuana available to minors?5) May a licensee of the Medical Board useproducts containing CBD oil?
484 activeCertificates ToRecommend 263 physicianshave issuedrecommendationsfor patients
Qualifying ConditionsMedical Marijuana Expert Review Committeesuggests: Autism spectrum disorder X Depression Anxiety disorderX Opioid use disorderX InsomniaThe board will vote on adding the additionalconditions on June 12, 2019. The next window topetition for additional qualifying conditions willtake place Nov. 1- Dec. 31, 2019.
Frequently Asked Questions1) How can I be notified when other dispensariesreceive a certificate of operation?2) Can a caregiver purchase medical marijuana ifthey are not tied to a patient?3) Can physicians with an active CTR invest in orhave ownership in dispensaries?4) Is medical marijuana available to minors?5) May a licensee of the Medical Board useproducts containing CBD oil?
AJ Groeber, Executive DirectorState of Ohio Medical Board
DEPARTMENT OF COMMERCE
MMCP Program Updates Licensees Cultivator LevelI 18 Provision Licenses / 8 Certificates of Operation LevelII 13 Provision Licenses / 8 Certificates of OperationProcessor 36 Testing Lab 5 Provisional Licenses / 3 Certificates of OperationProvisional Licenses / 3 Certificates of OperationProduct Sales (through June 2, 2019) 1075 lbs. of plant material 9,604 units of manufactured product 8.7 million in product sales 63,241 total receipts26
Testing Laboratory What is tested? Potency MoistureContent/Water Activity Contamination Microbials HeavyMetals Mycotoxins Pesticides27
Compliance Administrative Holds RecallCommunication Labelingand Packaging Transportation28
Product Issues Qualitycontrol Incorrect quantity or product Complaints29
Questions mmcpcompliance@com.ohio.gov mmcplicensing@com.ohio.gov mmcp@com.ohio.gov30
Mark Nye, Director of ComplianceDepartment of Commercemark.nye@commerce.ohio.gov
OARRS
What is OARRS? The Ohio Automated Rx Reporting System Public health tool that monitors all prescriptions ofcontrolled substances It also monitors all dispensations and help bothprescribers and dispensaries ensure that patients arebeing treated safely
Using OARRS Dispensaries are required to report dispensinginformation to the Ohio Automated Rx ReportingSystem in real-time (within 5 minutes of dispensing) toprevent medical marijuana diversion Dispensaries must verify that the purchaser has notpurchased more than a ninety-day supply of medicalmarijuana in the last ninety days.
Reporting to OARRS Dispensary must provide the DEA number of the recommendingphysician Not a test DEA number (OH1111119) Physician DEA number can be found in recommendation history A DEA number is also required for each dispensary Not a test DEA number (MM1234567) Generated by Appriss and provided by agent after award of certificate ofoperation
Dispensary Feedback It can sometimes be challenging to find a patient’s history in the registry Your software has one field to enter the name. Then your software parses that full name into firstname and last name fields. HOW it parses may vary from day to day. Example: James T Coleman II is entered into your single field. What we may get: FN: JamesLN: Coleman FN: JamesLN: T. Coleman FN: James TLN: II Solution: have your software vendors fix their programs to provide you with a separatefield for the first name and a separate field for the last name. Example: misspelled names, wrong dates of birth. Many lines of dispensing where the patient has a date of birth suggesting you are sellingproduct to an infant who is less than 6 months old. Mixing up date of birth with date ofsale?
Dispensary Feedback It can sometimes be challenging to find a patient’s history in the registry Example: AUTOCOMPLETE may save you some time/data entry, but if your system pulls wronginformation, it submits wrong information. Manual entry of data for reporting to OARRS helps get the first name into the first name field andthe last name into the last name field, but manual entry also increases opportunities formisspelled names, finger fumbles. Each of these examples/variations causes a new, separate profile to be established in OARRS, andwhen you go to look up the patient in the registry, you get the message of “multiple patientsfound, please go to your PMP site and search for the patient.” Even if you do go to the PMP site,you’re only going to get one group, not all. The search criteria is the name you entered. The“linked records” all belong to ONE group, and are not the groups that we need to merge. There issome separate group, hiding somewhere, that needs to be located and merged with the existing,known group. ACCURACY in data entry matters. Every inaccurate entry is another profile.
Merging Records When you get “patients needing to be merged”: EMAIL Terri.ghitman@pharmacy.ohio.gov Ashley.hood@pharmacy.ohio.gov andGrant.miller@pharmacy.ohio.gov (yes, all three) Subject line: MM merge Patient name and date of birth Content of email: Patient FN , LN full name (and any variations of it that you know of) Date of birth (and any other date of birth that you know of that are wrong, but still thatpatient) MM ID number. We can’t find a patient by their MM number, but we’d like to have itanyhow. IF we are able to find the groups, we will merge them. After we do our part, it still takesAppriss a couple of hours for the merge to actually process and be translated to the registryfor you to look up that patient and get their true report. Finding these groups can take time. It will not be done with a “simple phone call.”
Merging Records If we aren’t able to find the groups, you need to escalate the request to Appriss via a uests/new) Description of inquiry: Patient full name and date of birth . Medical marijuanapatient with multiple profiles. Please provide specific search criteria (ex: firstname John, Last name Smith and DOB for each of the groups to the state admin forthem to be able to locate and consolidate all pertinent records. State admin email isTerri.ghitman@pharmacy.ohio.gov and Ashley.Hood@pharmacy.ohio.gov Preferred method of contact: EMAIL Reason for inquiry: State admin assistance CC list: Terri.ghitman@pharmacy.ohio.gov, y.ohio.gov The state does NOT have a way to look up the status of a ticket number.
Blair Cathcart, Director of Information ServicesState of Ohio Board of Pharmacyblair.cathcart@pharmacy.ohio.gov
BREAK
DISPENSARY OPERATIONSOVERVIEW
Requesting a User Account for the AdvertisingApproval SystemPlease send an email to MMCP@pharmacy.ohio.gov to request a UserAccount. Include the following information in the email: First NameLast NameTitlePhoneEmailList relevant dispensary license numbers with which the User will be associatedAfter the User Account is created, the user will receive an email containing alink to the Log In page and a temporary password. The user’s email address will serve as theusername.
Submitting Advertising / Marketing Materials forReview Select all relevant license(s) to which the advertising / marketing materials areapplicableUpload the advertising / marketing materials in acceptable format and size (click on thelink on the Web Portal to see the acceptable formats).Complete the related questions about the advertising / marketing materials beingsubmitted for reviewClick “CONTINUE” after electronically signing (check box).
How to Modify a Pending Submission
Payment for Marketing and Advertising Submission Following successful submission, users are prompted to click on “PROCEED TOPAYMENT”. The following message appears when a payment has been submittedsuccessfully. Please note receipts are not emailed. For full submission details,including receipts, users should click on “VIEW SUBMISSION HISTORY”.
Remediating and Uploading Revised Advertising /Marketing Materials for Review If a submission has been returned for remediation, users will receive an email withguidance on how to remediate. Click on the “View” link to see details on remediation including an explanation of whythe submission is not compliant with Rule 3796:6-3-24. Attach the remediated advertising / marketing materials.
FAQ’s to Highlight What materials are required to be submitted via the Advertising /Marketing Materials Portal? Newsletters Swag Third party websites Images of marijuana leaves / plant product Social media
Definitive Health Claims – OverviewNo advertisement related to the safety or efficacy of marijuana isauthorized unless supported by substantial evidence or substantialclinical data. When a health claim is proposed, the Board may require aspecific disclosure, make a recommendation or prohibit the use of thematerial.
Definitive Health Claims – Overview1) All evidence purporting to support a definitive health claim must beadvanced to the Board’s Advertising and Marketing ReviewCommittee.2) All surveys purporting to support summarized results must beadvanced to the Board’s Advertising and Marketing ReviewCommittee.3) If a specific disclaimer is included it must be included immediatelyafter the statement in question and not at the end of theadvertisement.4) Disclaimers cannot be in small print but must be in the same sizeand font as the statement itself.
Definitive Health Claims – Review Process Initial review of submission If a submission includes a health claim the dispensary employeemay do either:o Remove / revise the health claimo Submit supported by substantial evidence or substantial clinicaldata for the Board to Review The Board’s Advertising and Marketing Review Committee
Definitive Health Claims - ExamplesClaim:Medical marijuana is a remedy for sleep disorders and can be used intreating psychosis, depression, and anxiety.Issues and Response: Statement may not be made in reference to conditions that are notqualifying conditions. Statement may not be made without substantial evidence or clinical data.Statement may be modified as follows: Talk to your recommendingphysicians about whether medical marijuana can be used to treatsymptoms of your qualifying condition.
Definitive Health Claims - ExamplesClaim:CBG may help treat symptoms of many qualifying medical conditionsIssue and Response: Statement may not be made without substantial evidence or clinicaldata. Statement may be modified as follows: Talk to yourrecommending physicians about whether CBG can help treatsymptoms of your qualifying condition.
Definitive Health Claims - ExamplesClaim:CBG may help treat symptoms of many qualifying medical conditionsIssue and Response: Statement may not be made without substantial evidence or clinicaldata. Statement may be modified as follows: Talk to yourrecommending physicians about whether CBG can help treatsymptoms of your qualifying condition.
Definitive Health Claims - ExamplesClaim:Reports of survey findings including: Patients with psychiatric or mooddisorders and patients with diseases of or injuries to the CNS favorCBD-dominant cannabis medicinesIssue and Response: Survey must accompany submissions containing statementspurporting to summarize survey results. If survey was conducted andsummary statements are supported by survey results statement maybe made.
Definitive Health Claims - ExamplesClaim:Alternations in memory, movement, mood, perception, and conditionall result from the binding of THC to CB1 receptorsIssueStatement may not be made without substantial evidence or clinicaldata establishing accuracy.
Definitive Health Claims - ExamplesStatements Related to a Specific Strain: Sativa: Typically produces a cerebral (head) sensation and is usedfor daytime medicating. Indica: Typically produces a full body sensation and is used fornighttime medicatingGeneral non-health claims may be made. The terms “euphoric” and“happy” should be replaced with “uplifting.” “Sleepy” may be used.
Definitive Health Claims - ExamplesStatements Related to a Method of Administration: Topicals are often chosen by patients who want therapeutic benefitswithout cerebral effects Vaporizers – allow patients to inhale active ingredients as a vaporand spares them the irritating effects of smoking. Effects can be feltwithin minutes and wear off within 90 minutesGeneral non-health claims may be made. Statement may not claimenhanced safety over other methods of administration.
Advertising Resources Advertising and Marketing Health Claims Guidelines Dispensary Advertising & Marketing Certificate of Translator’sCompetence Dispensary Advertising & Marketing Review Submission GuidanceDocument Dispensary Advertising & Marketing Submissions Portal MMCP Advertising & Marketing Checklist MMCP Advertising & Marketing FAQ
Training Providers / Courses Approved for CEsNameDeveloperPrescription MonitoringProgram TrainingState Inventory TrackingSystemDispensary ConfidentialityRequirementsMaintaining EmployeeLicensesToll-free Line TrainingQualifying ConditionsForms & Methods of Medical Adverse Events from MedicalMarijuana UseMarijuanaRecognizing MedicalMarijuana AbuseSecurity Measures andControlsRegulatory Inspections & LawEnforcementAbout Wellness OhioDispensary Bloom Medicinals, LLCDispensary Buckeye Botanicals LLCDispensary Clubhouse DispensaryDispensary CY DispensaryDispensary Debbie's DispensaryDispensaryEagle DispensaryDispensaryFRX HealthDispensary gLeaf Medical of Ohio II, LLCDispensary HarvestDispensary HerbHallThird Party HerbologyDispensary Leaf MedicThird Party Leaf ReliefDispensary Mad River RemediesDispensaryNavigate Cannabis/VerdantCreationsDispensary Ohio Cannabis CompanyDispensary Ohio Department of MentalHealth and Addiction ServicesThird PartyOhio Valley Natural Relief LLCDispensaryPureOhio WellnessDispensaryRiseDispensary Sell SmartThird Party SootheDispensaryStrawberry FieldsDispensary Terrasana LabsDispensary The BotanistDispensary The Forest SanduskyDispensary VerilifeDispensary Disclaimer: Trainings identified on this list are not substantively approved. These courses may be taken to meet Foundational Training requirements for all employee dispensary employees. Representations made during any of the courses referenced above are expected to be in compliance with Chapter 3796 of the Ohio Revised Code and the MMCP rules.Notes: 1. The Prescription Montoring Program Foundational Training requirements can be met by taking the Foundational Training E- Course for Prescription Monitoring Program.2. The State Inventory Tracking System Foundational Training requirements can be met by taking the METRC provided New Business E-course.
FAQ’s to Highlight Can multiple licensed dispensaries use common training materialsand meet the continuing education requirements? If a dispensary is utilizing an already approved training materials dothey need to submit anything?
Foundational Training and Continuing EducationResources Approved Foundational Training MaterialsDispensary Foundational Training Resource GuideDispensary Foundational Training WebinarDispensary Healthcare Training AttestationDispensary Training & Continuing Education FAQDispensary Training & Continuing Education Submission Form - CE AttachmentDispensary Training & Continuing Education Submission Form - FoundationalTraining AttachmentDispensa
Manual entry of data for reporting to OARRS helps get the first name into the first name field and the last name into the last name field, but manual entry also increases opportunities for misspelled names, finger fumbles. Each of these examples/variations causes a new, sepa
