Ohio Medical Marijuana Control Program

Transcription

Ohio Medical MarijuanaControl Programhttp://medicalmarijuana.ohio.govPresented atNADDI Tri-State TrainingAugust 8, 2019

SpeakerJesse L. Wimberly, Regional Agent in Charge, Medical MarijuanaState of Ohio Board of Pharmacywww.pharmacy.ohio.govMobile: 937-603-4111Office: 614-466-4143Email: Jesse.Wimberly@pharmacy.ohio.gov

Ohio’s Path to Medical MarijuanaFall 2015 Issue3 ballotinitiative tolegalizemedical andrecreationalmarijuanaMarijuanaPolicy Project(MPP) beginsnew ballotinitiativecampaignHB 523 signedJune 8, 2016,establishingOhio’s MedicalMarijuanaControlProgramMPP withdrawsits ballotinitiativeHB 523effectiveSeptember 8,2016

Who is Responsible?Department of Commerce Cultivators Processors Testing laboratoriesPharmacy Board Dispensaries Patients/Caregivers New forms and methods of medical marijuanaMedical Board Certified physicians New qualifying conditions

Timeline and Key DatesEventBeginning DatesCultivators Provisionally LicensedNovember 30, 2017CTR Applications AcceptedMarch 19, 2018Dispensaries ProvisionallyLicensedJune 4, 2018Testing Labs Provisionally LicensedJuly 2, 2018Processors Provisionally Licensed August 17, 2018Patient & Caregiver Registry Opens December 4, 2018First Sale of Medical MarijuanaJanuary 16, 2019

DispensaryLicensing

License Distribution First Request for Applications (RFA) September 2017 60 available licenses 31 dispensary districts After scoring Board could award up to 56 licenses in 28 dispensarydistricts

Allocation Guiding Principles Applicants awarded up to 5 licenses No more than 66% (2/3) of licenses for any district awarded to asingle applicant Foster competition Widen product choice Protect enforcement interestsNo less than 15% (9 licenses) allocated to applicants fromeconomically disadvantaged groups

Dispensary Certificates of Operation Now available online Only dispensariesawarded a certificateof operation Available at:www.medicalmarijuana.ohio.gov

PMPReporting toOARRS

90-Day supply of medical marijuana based onTHC contentForm90-Day SupplyTier I plant material(up to 23% THC)8 ounces of plant material;10 ounces for terminal exception5.3 ounces of plant material;6.6 ounces for terminal exceptionTier II plant material(over 23% THC)Oils for vaporizing53.1 grams of THC;65.7 grams for terminal exceptionPatches for transdermal administration 26.6 grams of THC;33.3 grams for terminal exceptionEdibles, oils, and tinctures for oraladministration9.9 grams of THC;11.7 grams for terminal exception

Product ID Background All medical marijuana products must have an assigned Product ID to beaccepted by a dispensary Without a Product ID dispensaries cannot report to OARRS Processors and Cultivators cannot transfer product in seed-to-salewithout a Product ID This applies to each medical marijuana strain and medical marijuanaform and dose The assignment of a Product ID is to ensure that only products incompliance with MMCP regulations are available to patients and theircaregivers

Forms and Methods Types DefinitionsForms and Methods TypesItem Name ConventionUnit ofMeasureMaxDoseTier 1 (less than 23% THC content) Tier 1 Vap – [Strain] – [% THC] – [%CBD] - [# of grams]Plant Material for VaporizationWeight (Grams) N/ATier 2 (23-35% THC content)Plant Material for VaporizationOil for Oral AdministrationWeight (Grams) N/ATincture for Oral AdministrationCapsule for Oral AdministrationEdible for Oral AdministrationMetered Oil or Solid forVaporizationPatch for TransdermalAdministrationLotion for Topical AdministrationTier 2 Vap – [Strain] – [%THC– [%CBD] - [# of grams]Volume (Fluid 50 mgOil Oral Admin – [THC Content (mg) per dose] – [CBDOunces)Content (mg) per dose] – [# of doses]Volume (Fluid 50 mgTin Oral Admin – [THC Content (mg) per dose] – [CBDOunces)Content (mg) per dose] – [# of doses]Count (Each)50 mgCap Oral Admin – [THC Content (mg) per dose] – [CBDContent (mg) per dose] – [# of doses]Count (Each)50 mgEdb Oral Admin – [THC Content (mg) per dose] – [CBDContent (mg) per dose] – [# of doses]Oil or Sol Vap – [THC Content (mg) per dose] – [CBD Content Weight (Ounces)N/A(mg) per dose] – [# of doses]50 mgPat TD Admin – [THC Content (mg) per dose] – [CBD Content Count (Each)(mg) per dose] – [# of doses]Volume (Fluid N/ALot Top Admin – [THC Content(mg)] – [CBD Content(mg)]Ounces)

Patients andCaregivers

540 active CertificatesTo Recommend (CTR) Interactive map nowavailable

Qualifying Conditions AIDSAmyotrophic Lateral SclerosisAlzheimer’s DiseaseCancerChronic Traumatic EncephalopathyCrohn’s DiseaseEpilepsy / Seizure DisorderFibromyalgiaGlaucomaHepatitis C Inflammatory Bowel DiseaseMultiple SclerosisPain: Chronic/Severe or IntractableParkinson’s DiseasePositive Status for HIVPost-traumatic Stress DisorderSickle Cell AnemiaSpinal Cord Disease or InjuryTourette’s SyndromeTraumatic Brain InjuryUlcerative Colitis

Qualifying Conditions Under Review Anxiety Disorder Autism Spectrum Disorder Petitions Rejected by the Medical Board Depression Insomnia Opioid Use Disorder

Procedure for patient registrationPhysician examines patient and determines that patient has a qualifying conditionPhysician or delegate uses OARRS credentials to log into registry and begin registration processMakes requisite attestationsSpecifies number of 90-day refills authorizedNotes instruction for use, if anyRecommendation is generated in the patient registryPatient and/or caregiver emailed link to access registryPatients will be able to modify home address, email address, and payment information

Patient access to the patient registry Patient or caregiver receives email containing link and accesses linkWebpage contains patient information including recommendationPatient or caregiver has ability to modify only certain fieldsPatient or caregiver establishes passwordPatient card is generated and sent electronically to patientValid for 1 yearCan be accessed by patient at anytime

Patients and caregivers -- generally Patients and caregivers may not cultivate or extractmedical marijuana Samples may not be accepted Medical marijuana must be securely stored to preventtheft and unauthorized access and be kept in a dispensarycontainer with original label Caregivers may not receive payment exclusively forserving as a caregiver Must dispossess selves of marijuana within 7 days ofexpiration, suspension, or revocation of registration

Patient andCaregiverRegistry Total Patient Recommendations: 45,663 Registered Patients: 48,248 Patients with Veteran Status: 3,083 Patients with Indigent Status: 1,752 Patients with a Terminal Diagnosis: 238Total Caregivers: 3,417*All patient data through June 2019

RegisteredMedicalMarijuanaPatients byAgeRegistered patients(Over 70)8%Registered patients(Under 18)0%Registered patients(60-69)20%Registered patients(50-59)22%Registeredpatients (18-29)10%Registered patients(30-39)19%Registered patients(40-49)21%Total Registered - 48,248

AIDSMedicalMarijuanaPatients byConditionAlzheimer’s diseaseCancerCrohn’s diseaseEpilepsy or another seizuredisorderFibromyalgiaGlaucomaHepatitis CInflammatory bowel diseaseChronic traumaticencephalopathy58Pain that is either chronic andsevere or intractable29,7543,152Amyotrophic lateral ��s diseasePositive status for HIV444308PTSD7,122Spinal cord disease or injury2,259Sickle cell anemiaTourette’s syndromeTraumatic brain injuryUlcerative colitisMultiple sclerosisSome patients are registered with multiple conditions.591818675151,079

7122MedicalMarijuanaPatients 94444830859Some patients are registered with multiple conditions.181867515

House Bill 523Approved FormsOilsTincturesEdiblesPlantmaterialPatches

Tinctures: What Are They?Tinctures are alcoholbased cannabis extractsto be consumed drop bydrop not as a beverage.

House Bill 523 Prohibitions onForm and Method of AdministrationForms and methodsconsideredattractive tochildrenForms that requiresmoking orcombustion

90-Day supply of medical marijuanabased on THC contentFormTier I plant material(up to 23% THC)90-Day Supply8 ounces of plant material;10 ounces for terminal exceptionTier II plant material(over 23% THC)5.3 ounces of plant material;6.6 ounces for terminal exceptionOils for vaporizing53.1 grams of THC; 65.7 grams forterminal exceptionPatches for transdermaladministration26.6 grams of THC; 33.3 grams forterminal exceptionEdibles, oils, and tinctures for oral 9.9 grams of THC; 11.7 grams foradministrationterminal exception

Relevant LawEnforcementRules & Law

Duty to report Fraudulent use of registration identification cards and knownunauthorized access to the medical marijuana registry Patients or caregivers must report to the board within 7 days if thepatient no longer is diagnosed with a qualifying condition Caregivers must report any arrest, charges pending, or conviction forany felony or misdemeanor except non-DUI-related trafficmisdemeanors Affords 7 days or more to report in many cases where licensedprofessionals must report immediately

Ohio Cultivator Packaging Samples

Ohio Cultivator Packaging Samples

Sample Ohio Dispensary Label

Dispensary AncillaryDevices Ohio medicalmarijuanadispensaries arepermitted to sellmedical marijuanaaccessory devices,which assist a patientwith theadministration of theirmedical marijuana. Grinders Vaporizer Devices Scales

Relevant Law Enforcement Rules & Law3796.06With respect to the methods of using medical marijuana, smoking or combustionof medical marijuana is prohibited.3796.22The amount of medical marijuana possessed by a registered patient shall notexceed a ninety-day supply, as specified in rules adopted under section 3796.04of the Revised Code.3796:7-2-05Medical marijuana shall be maintained in on one of the following containers atall times until administered to or by a patient: The original dispensing package with an unaltered dispensary label inaccordance with rule 3796:6-3-09 of the Administrative Code; or The container provided by a dispensary in accordance with paragraph (G)of rule 3796:6-3-01 of the Administrative Code.

Relevant Law Enforcement Rules & Law3796:7-2-05If a patient's registration is suspended or revoked, or if a patient's registration lapses, the patient orcaregiver shall dispose of all medical marijuana dispensed for the benefit of that patient within sevencalendar days of the expiration of their registration.3796:7-2-07A patient shall report to the state board of pharmacy a conviction of any offense and/or any arrest orcharges pending of a felony or misdemeanor offense under Chapter 2925., 3715., 3719., or 4729. ofthe Revised Code, or of an arrest or conviction in another jurisdiction that is substantially the same asa felony or misdemeanor offense under Chapter 2925., 3715., or 4729. of the Revised Code, withinfourteen calendar days of the conviction or arrest.3796:6-3-22No dispensary shall transport medical marijuana or medical marijuana products to residences ofpatients or caregivers.3796:6-3-23No medical marijuana shall be sold, dispensed, or distributed to a patient or caregiver via a deliveryservice or any other manner outside of a dispensary, except that a caregiver may deliver medicalmarijuana to the caregiver's qualified patient.

Relevant Law Enforcement Rules & LawHow should an officer proceed if an individual has a patient ID card but the marijuanaproducts in their possession are not appropriately labeled? Patients are required to store medical marijuana in the dispensary container with theoriginal label. Marijuana not contained in the appropriately labeled packaging would NOT beconsidered medical marijuana and therefore subject to control and regulation underChapter 2925 of the Ohio Revised Code.Are individuals allowed to grow medical marijuana for personal use under the medicalmarijuana control program? No. The law limits the cultivation of medical marijuana only to cultivators licensed by theDepartment of Commerce.Are individuals allowed to operate a motor vehicle under the influence of medicalmarijuana? No. Patients are not allowed to operate a vehicle, streetcar, trackless trolley, watercraft oraircraft under the influence of medical marijuana.

Relevant Law Enforcement Rules & Law3796:7-2-05 Grounds for discipline(A) The state board of pharmacy, after notice and hearing in accordance withChapter 119. of the Revised Code, may revoke or impose any one or more of thefollowing sanctions on a patient or caregiver if the board finds the individualengaged in any of the conduct set forth in paragraph (B) of this rule: (1) Revoke, suspend, restrict, limit, or refuse to grant or renew a registration;or (2) Reprimand or place the registrant on probation, or refuse to grant anidentification card.(B) The board may impose the sanctions listed in paragraph (A) of this rule if theboard finds:

Investigations Caregiver Background Investigations. Employee Background Investigations; Disqualifying Convictions – Proposal to Deny pending.Patient Trafficking and Possession Investigations;Employee Investigation; Trafficking/Possession –

Investigations

Ohio Dispensary Photos

Ohio Cultivator Photos

Ohio Cultivator Photos

Transportation(E) A registered employee transportingmedical marijuana shall do the following:(1) Display his or her department issuedemployee identification card at all timeswhen transporting or delivering medicalmarijuana and shall produce it for thedepartment or department's authorizedrepresentative or law enforcement officialupon request;

Northeast Region

Northwest Region

Southeast Region

Southwest Region

ProductsDerived fromHemp/CBD

Products Derived from Hemp SB 57 change the definition of marijuana No longer includes products with less than 0.3% THC content Hemp-derived CBD (cannabidiol) can now be sold outside of a licensed medicalmarijuana dispensary. Ohio Department of Agriculture to establish a Hemp Cultivation and ProcessingProgram Includes licensing of hemp cultivators and processors Requires the Department to adopt rules governing the operation of the programThe Board published a FAQ on hemp derived products, which can be found at:www.pharmacy.ohio.gov/hemp

MedicalMarijuana.ohio.gov Designed to keep Ohioans informed about the developmentof Ohio’s Medical Marijuana Control Program Important program milestones Announcement of opportunities for public input

ContactsOhio Medical Marijuana Control ProgramToll-Free Helpline1-833-4OH-MMCP

Physician or delegate uses OARRS credentials to log into registry and begin registration process. Makes requisite attestations. Specifies number of 90 -day refills authorized. Notes instruction for use, if any. Physician examines patie