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State of Ohio Board of Pharmacy 2 nd Annual Dispensary Informational Session Friday, June 7, 2019
State of Ohio Board of Pharmacy 2nd Annual Dispensary Informational Session
Friday, June 7, 2019
PROGRAM REVIEW AND UPDATE
Dispensary Operations Statistics
Form Product IDs Assigned
Tier I plant material 1,092
Tier II plant material 106
Edible for oral administration 19
Metered oil or solid for vaporization 5
Oil for oral administration 1
Tinctures for oral administration 10
Patients & Caregivers
4
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 Age
Registered patients (Under 18)0%
Registered patients (18-29)10%
Registered patients (30-39)20%
Registered patients (40-49)21%
Registered patients (50-59)22%
Registered patients (60-69)20%
Registered patients (Over 70)7%
Medical Marijuana Patients by Condition
Some patients are registered with multiple conditions.
Aids 45
Alzheimer’s disease 88
Cancer 2337
Chronic traumatic
encephalopathy 70
Crohn’s disease 804
Epilepsy or another seizure
disorder 1182
Fibromyalgia 4043
Glaucoma 587
Hepatitis C 726
Inflammatory bowel disease 470
Multiple sclerosis 839
Pain that is either chronic and
severe or intractable 22611
Parkinson’s disease 327
Amyotrophic lateral sclerosis 40
Positive status for HIV 233
Post-traumatic stress disorder 5434
Sickle cell anemia 48
Spinal cord disease or injury 1897
Tourette’s syndrome 141
Traumatic brain injury 677
Ulcerative colitis. 406
Medical Marijuana Patients by
Condition
8
Some patients are registered with multiple conditions.
45 88
2337
804
1182
4043
587 726 470839
327 40 233
5434
48
1897
141 677 406 70
Compliant Product Labeling
9
Verifying Product Labels
• Labels require in relevant part
• Target cannabinoid content (found in Product ID
name)
• Lab-tested cannabinoid content
• Target content and lab-tested content cannot be
more than + 5% apart
Calculating Actual Cannabinoid
Content
• “Lab-reported cannabinoid content * net weight
of product” should appear on label (Net
Cannabinoid; 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% target
values in Product ID name
Dispensing Low THC Products
12
Whole Day Increment Enforcement
Form Min. Increment Under
Original Interpretation
Min. Increment Under
New Interpretation
Oils for vaporizing 590 mg THC Up to 590 mg THC
Patch, lotion, cream or
ointment
295 mg THC Up to 295 mg THC
Edibles, oils, and
tinctures for oral
administration
110 mg THC Up to 110 mg THC
• “Up to” language only applies to products containing less than the
minimum 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 12th
STATE MEDICAL BOARD of OHIO
State Medical Boardof Ohio
June 2019 Update
16
•484 active Certificates To Recommend
•263 physicians have issued recommendations for patients
18
AIDS Fibromyalgia Positive status for HIV
Amyotrophic lateral sclerosis
GlaucomaPost-traumatic stress
disorder
Alzheimer’s disease Hepatitis C Sickle cell anemia
CancerInflammatory bowel
diseaseSpinal cord disease or
injury
Chronic traumatic encephalopathy
Multiple sclerosis Tourette’s syndrome
Crohn’s diseasePain that is either chronic and severe or intractable
Traumatic brain injury
Epilepsy or another seizure disorder
Parkinson’s disease Ulcerative colitis
Qualifying Conditions
Qualifying Conditions
Medical Marijuana Expert Review Committee suggests:
The full board will consider the additional conditions on June 12, 2019. The next window to petition for additional qualifying conditions will take place Nov. 1- Dec. 31, 2019.
✓Autism spectrum disorder X Depression
✓Anxiety disorder X Opioid use disorder
X Insomnia
Frequently Asked Questions1) How can I be notified when other dispensaries
receive a certificate of operation?
2) Can a caregiver purchase medical marijuana if they are not tied to a patient?
3) Can physicians with an active CTR invest in or have ownership in dispensaries?
4) Is medical marijuana available to minors?
5) May a licensee of the Medical Board use products containing CBD oil?
•484 active Certificates To Recommend
•263 physicians have issued recommendations for patients
Qualifying Conditions
Medical Marijuana Expert Review Committee suggests:
The board will vote on adding the additional conditions on June 12, 2019. The next window to petition for additional qualifying conditions will take place Nov. 1- Dec. 31, 2019.
✓Autism spectrum disorder X Depression
✓Anxiety disorder X Opioid use disorder
X Insomnia
Frequently Asked Questions1) How can I be notified when other dispensaries
receive a certificate of operation?
2) Can a caregiver purchase medical marijuana if they are not tied to a patient?
3) Can physicians with an active CTR invest in or have ownership in dispensaries?
4) Is medical marijuana available to minors?
5) May a licensee of the Medical Board use products containing CBD oil?
AJ Groeber, Executive DirectorState of Ohio Medical Board
DEPARTMENT OF COMMERCE
MMCP Program Updates Licensees
Cultivator
Level I 18 Provision Licenses / 8 Certificates of Operation
Level II 13 Provision Licenses / 8 Certificates of Operation
Processor
36 Provisional Licenses / 3 Certificates of Operation
Testing Lab
5 Provisional Licenses / 3 Certificates of Operation
Product 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
Moisture Content/Water Activity
Contamination
Microbials
Heavy Metals
Mycotoxins
Pesticides
27
Compliance
28
Administrative Holds
Recall Communication
Labeling and Packaging
Transportation
Product Issues
29
Quality control
Incorrect quantity or product
Complaints
Questions
30
OARRS
What is OARRS?
• The Ohio Automated Rx Reporting System
•Public health tool that monitors all prescriptions of controlled substances
• It also monitors all dispensations and help both prescribers and dispensaries ensure that patients are being treated safely
Using OARRS
•Dispensaries are required to report dispensing information to the Ohio Automated Rx Reporting System in real-time (within 5 minutes of dispensing) to prevent medical marijuana diversion
•Dispensaries must verify that the purchaser has not purchased more than a ninety-day supply of medical marijuana in the last ninety days.
Reporting to OARRS
• Dispensary must provide the DEA number of the recommending physician• 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 of operation
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 first name 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: James LN: Coleman
• FN: James LN: T. Coleman
• FN: James T LN: II
• Solution: have your software vendors fix their programs to provide you with a separate field 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 selling product to an infant who is less than 6 months old. Mixing up date of birth with date of sale?
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 wrong information, it submits wrong information.
• 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, separate profile to be established in OARRS, and when you go to look up the patient in the registry, you get the message of “multiple patients found, 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 is some 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 [email protected] [email protected] and [email protected] (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 that patient)
• MM ID number. We can’t find a patient by their MM number, but we’d like to have it anyhow.
• IF we are able to find the groups, we will merge them. After we do our part, it still takes Appriss a couple of hours for the merge to actually process and be translated to the registry for 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 ticket (https://apprisspmp.zendesk.com/hc/en-us/requests/new)
• Description of inquiry: Patient <<full name and date of birth>>. Medical marijuana patient with multiple profiles. Please provide specific search criteria (ex: first name=John, Last name=Smith and DOB for each of the groups to the state admin for them to be able to locate and consolidate all pertinent records. State admin email is [email protected] and [email protected]
• Preferred method of contact: EMAIL
• Reason for inquiry: State admin assistance
• CC list: [email protected], [email protected], [email protected]
• The state does NOT have a way to look up the status of a ticket number.
BREAK
DISPENSARY OPERATIONS OVERVIEW
Requesting a User Account for the Advertising Approval SystemPlease send an email to [email protected] to request a User Account. Include the following information in the email:
• First Name• Last Name• Title• Phone• Email• List relevant dispensary license numbers with which the User will be associated
After the User Account is created, the user will receive an email containing a link to the Log In page (https://medicalmarijuana.ohio.gov/Account/SignIn) and a temporary password. The user’s email address will serve as the username.
Submitting Advertising / Marketing Materials for Review
• Select all relevant license(s) to which the advertising / marketing materials are applicable
• Upload the advertising / marketing materials in acceptable format and size (click on the link on the Web Portal to see the acceptable formats).
• Complete the related questions about the advertising / marketing materials being submitted for review
• Click “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 TO PAYMENT”.
• The following message appears when a payment has been submitted successfully. 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 with
guidance on how to remediate.
• Click on the “View” link to see details on remediation including an explanation of why the 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 – Overview
No advertisement related to the safety or efficacy of marijuana is authorized unless supported by substantial evidence or substantial clinical data. When a health claim is proposed, the Board may require a specific disclosure, make a recommendation or prohibit the use of the material.
Definitive Health Claims – Overview
1) All evidence purporting to support a definitive health claim must be advanced to the Board’s Advertising and Marketing Review Committee.
2) All surveys purporting to support summarized results must be advanced to the Board’s Advertising and Marketing Review Committee.
3) If a specific disclaimer is included it must be included immediately after the statement in question and not at the end of the advertisement.
4) Disclaimers cannot be in small print but must be in the same size and font as the statement itself.
Definitive Health Claims – Review Process
• Initial review of submission
• If a submission includes a health claim the dispensary employee may do either:
o Remove / revise the health claim
o Submit supported by substantial evidence or substantial clinical data for the Board to Review
• The Board’s Advertising and Marketing Review Committee
Definitive Health Claims - Examples
Claim:
Medical marijuana is a remedy for sleep disorders and can be used in treating psychosis, depression, and anxiety.
Issues and Response:
• Statement may not be made in reference to conditions that are not qualifying conditions.
• Statement may not be made without substantial evidence or clinical data. Statement may be modified as follows: Talk to your recommending physicians about whether medical marijuana can be used to treat symptoms of your qualifying condition.
Definitive Health Claims - Examples
Claim:
CBG may help treat symptoms of many qualifying medical conditions
Issue and Response:
• Statement may not be made without substantial evidence or clinical data. Statement may be modified as follows: Talk to your recommending physicians about whether CBG can help treat symptoms of your qualifying condition.
Definitive Health Claims - Examples
Claim:
CBG may help treat symptoms of many qualifying medical conditions
Issue and Response:
• Statement may not be made without substantial evidence or clinical data. Statement may be modified as follows: Talk to your recommending physicians about whether CBG can help treat symptoms of your qualifying condition.
Definitive Health Claims - Examples
Claim:
Reports of survey findings including: Patients with psychiatric or mood disorders and patients with diseases of or injuries to the CNS favor CBD-dominant cannabis medicines
Issue and Response:
• Survey must accompany submissions containing statements purporting to summarize survey results. If survey was conducted and summary statements are supported by survey results statement may be made.
Definitive Health Claims - Examples
Claim:
Alternations in memory, movement, mood, perception, and condition all result from the binding of THC to CB1 receptors
Issue
Statement may not be made without substantial evidence or clinical data establishing accuracy.
Definitive Health Claims - Examples
Statements Related to a Specific Strain:
• Sativa: Typically produces a cerebral (head) sensation and is used for daytime medicating.
• Indica: Typically produces a full body sensation and is used for nighttime medicating
General non-health claims may be made. The terms “euphoric” and “happy” should be replaced with “uplifting.” “Sleepy” may be used.
Definitive Health Claims - Examples
Statements Related to a Method of Administration:
• Topicals are often chosen by patients who want therapeutic benefits without cerebral effects
• Vaporizers – allow patients to inhale active ingredients as a vapor and spares them the irritating effects of smoking. Effects can be felt within minutes and wear off within 90 minutes
General non-health claims may be made. Statement may not claim enhanced safety over other methods of administration.
Advertising Resources
• Advertising and Marketing Health Claims Guidelines
• Dispensary Advertising & Marketing Certificate of Translator’s Competence
• Dispensary Advertising & Marketing Review Submission Guidance Document
• Dispensary Advertising & Marketing Submissions Portal
• MMCP Advertising & Marketing Checklist
• MMCP Advertising & Marketing FAQ
Training Providers / Courses Approved for CEsName Developer
Prescription Monitoring
Program Training
State Inventory Tracking
System
Dispensary Confidentiality
Requirements
Maintaining Employee
LicensesToll-free Line Training Qualifying Conditions
Forms & Methods of Medical
Marijuana Use
Adverse Events from Medical
Marijuana
Recognizing Medical
Marijuana Abuse
Security Measures and
Controls
Regulatory Inspections & Law
Enforcement
About Wellness Ohio Dispensary ✓ ✓ ✓ ✓ ✓ ✓ ✓ ✓ ✓
Bloom Medicinals, LLC Dispensary ✓ ✓ ✓ ✓ ✓ ✓ ✓ ✓ ✓
Buckeye Botanicals LLC Dispensary ✓ ✓ ✓ ✓ ✓ ✓ ✓ ✓ ✓
Clubhouse Dispensary Dispensary ✓ ✓ ✓ ✓ ✓ ✓ ✓ ✓ ✓
CY+ Dispensary Dispensary ✓ ✓ ✓ ✓ ✓ ✓ ✓ ✓ ✓
Debbie's Dispensary Dispensary ✓
Eagle Dispensary Dispensary ✓
FRX Health Dispensary ✓ ✓ ✓ ✓ ✓ ✓ ✓ ✓ ✓
gLeaf Medical of Ohio II, LLC Dispensary ✓ ✓ ✓ ✓ ✓ ✓ ✓ ✓
Harvest Dispensary ✓ ✓ ✓ ✓ ✓ ✓ ✓ ✓ ✓
HerbHall Third Party ✓ ✓ ✓ ✓ ✓ ✓ ✓ ✓
Herbology Dispensary ✓ ✓ ✓ ✓ ✓ ✓ ✓
Leaf Medic Third Party ✓ ✓ ✓ ✓ ✓ ✓ ✓ ✓
Leaf Relief Dispensary ✓ ✓ ✓ ✓ ✓ ✓ ✓ ✓
Mad River Remedies Dispensary ✓
Navigate Cannabis/Verdant
CreationsDispensary ✓ ✓ ✓ ✓ ✓ ✓ ✓ ✓ ✓
Ohio Cannabis Company Dispensary ✓ ✓ ✓ ✓ ✓ ✓ ✓ ✓
Ohio Department of Mental
Health and Addiction Services Third Party ✓
Ohio Valley Natural Relief LLC Dispensary ✓ ✓ ✓ ✓ ✓ ✓ ✓ ✓ ✓
PureOhio Wellness Dispensary ✓ ✓ ✓ ✓ ✓
Rise Dispensary ✓ ✓
Sell Smart Third Party ✓ ✓ ✓ ✓
Soothe Dispensary ✓
Strawberry Fields Dispensary ✓ ✓ ✓ ✓ ✓ ✓ ✓ ✓
Terrasana Labs Dispensary ✓ ✓ ✓ ✓ ✓ ✓ ✓ ✓ ✓
The Botanist Dispensary ✓ ✓ ✓ ✓ ✓ ✓ ✓ ✓ ✓
The Forest Sandusky Dispensary ✓ ✓ ✓ ✓ ✓ ✓ ✓ ✓ ✓
Verilife Dispensary ✓ ✓ ✓ ✓ ✓ ✓ ✓ ✓
Disclaimer:
Notes:
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.
2. The State Inventory Tracking System Foundational Training requirements can be met by taking the METRC provided New Business E-course.
1. The Prescription Montoring Program Foundational Training requirements can be met by taking the Foundational Training E- Course for Prescription Monitoring Program.
FAQ’s to Highlight
• Can multiple licensed dispensaries use common training materials and meet the continuing education requirements?
• If a dispensary is utilizing an already approved training materials do they need to submit anything?
Foundational Training and Continuing Education Resources
• Approved Foundational Training Materials
• Dispensary Foundational Training Resource Guide
• Dispensary Foundational Training Webinar
• Dispensary Healthcare Training Attestation
• Dispensary Training & Continuing Education FAQ
• Dispensary Training & Continuing Education Submission Form - CE Attachment
• Dispensary Training & Continuing Education Submission Form - Foundational Training Attachment
• Dispensary Training & Continuing Education Submission Form
• Dispensary Training & Continuing Education Submission Guidance Document
• Foundational Training E- Course for Prescription Monitoring Program
• METRC Training Update
Product ID Background
• All medical marijuana products must have an assigned Product ID to be accepted by a dispensary
• Without a Product ID dispensaries cannot report the dispensation to the Prescription Drug Monitoring Program
• Processors and Cultivators will not be able to transfer product without a Product ID
• This applies to each medical marijuana strain and medical marijuana form and dose
• The assignment of a Product ID is to ensure that only products in compliance with MMCP regulations are available to patients and their caregivers
Reference Tools
• Non-Plant Material Day Supply Reference
• Plant Material Day Supply Reference
• THC and CBD Percent Ranges and THC and CBD Content Ranges
LICENSING OVERVIEW
Review of eLicense
• www.elicense.ohio.gov
• Features:• Manage Employee Licensing information
• Applying for a new license, renewal of a license or reinstatement of a license
Review of eLicense
• eLicense Homepage:• Create
Account/Login
• Verify License
Review of eLicense
• USER DASHBOARD:
Employee Licensing Process
• Employee submits application on eLicense• *License Affiliation
• Pharmacy staff conducts initial review of the application
• Review of Legal
• Badges
EMPLOYEE LICENSING PROCESS
• EMPLOYEE APPLICATION STATUS:• https://www.elicense.ohio.gov/oh_verifylicense
• Status Definitions:• Submitted: Application has been successfully received by the Board but review of the
application has not been conducted
• In Review – Additional Information: Application is missing required information and pharmacy staff has reached out to the applicant requesting that information via e-mail
• In Review: Legal has been identified either by background check result or answering a legal question on the application in the affirmative
• Active: Employee has successfully obtained licensure
Managing Employee / AKE Licenses
• PROMOTING AN EMPLOYEE FROM SUPPORT TO KEY• Employee must apply on eLicense for Key Employee
• Pay applicable fee
• Background Check*
• EMPLOYEE SEPARATION• Employee Separation Form
• Badge Return
Managing Licenses - Forms
• Available forms on the MMCP website under ‘Licensee Resources’• Change in DR
• Temporary Authority Request Form
• Request to Work at More than 1 Dispensary
• Change of Employment
• Duplicate Badge Request
• Major Modification Request
COMPLIANCE OVERVIEW
Applicable Rules and Definitions
Licensees are advised to review and understand Division 3796:6 of the Ohio Administrative Code, which includes the following Chapters:
▪ Definitions Chapter 3796:6-1
▪ Licensing Chapter 3796:6-2
▪ Operations Chapter 3796:6-3
▪ Enforcement Chapter 3796:6-4
▪ Fees Chapter 3796:6-5
PDLs are also advised to understand Division 3796:8 of the Ohio Administrative Code, which sets forth the products that may be accepted from cultivators and processors.
Pre and Final Inspections
Prior to scheduling a pre-inspection, dispensaries need to complete compliance tasks assigned by State Board of Pharmacy personnel and consider the status of the following requirements:
▪ Designated representative is selected, licensed and identified in eLicense.
▪ Marketing and advertising materials, training materials, labels, logos and DBAs have been submitted for review and approved.
▪ All structural and time variances have been submitted and reached resolution.
▪ Surety bond is filed and a copy is on file with the Board.
Pre and Final Inspections
▪ Registration with the Ohio Business Gateway is completed and PDL is registered for employer withholding as well as sales tax.
▪ Foundational training for all requisite staff is completed.
▪ METRC system preparedness (including online training) is completed.
▪ Prepared to complete point-of-sale testing during pre-inspection.
▪ Pre-inspections are intended to identify outstanding issues, the remediation of which may serve as evidence of compliance with applicable statutes and rules. A pre-inspection can be scheduled but will not be executed without completing all the previously referenced tasks. A final inspection will not be scheduled without evidence of compliance with the applicable statutes and rules.
Pre and Final Inspections
▪ Upon successful completion of the Pre-Inspection, a Final Inspection will be scheduled, which is intended to ensure all items requiring remediation if discovered are completed.
▪ After receiving notice of a satisfactory final inspection from the State of Ohio Board of Pharmacy, the PDL is required to remit payment of the two-year certificate of operation fee before the PDL’s certificate of operation will be activated.
▪ A dispensary may begin receiving and dispensing medical marijuana only after receipt of a medical marijuana dispensary certificate of operation issued by the State of Ohio Board of Pharmacy. A Dispensary does not have an active Certificate of Operation until notified in writing by the State of Ohio Board of Pharmacy’s Licensing Department.
Pre and Final Inspections
Does your operation meet the specifications presented with your initial application?
▪ Facility specifications/layout
▪ Operational plans
▪ Organizational chart
Major Modifications
Pursuant to Rule 3796:6-3-02(H) of the Ohio Administrative Code, the State of Ohio Board of Pharmacy requires that no major renovation or modification shall be undertaken without prior approval from the Board and submission of the five thousand-dollar ($5,000) application fee.
▪ The form to request a Major Modification / Renovation, is available via our website at; www.medicalmarijuana.ohio.gov
▪ Requests for structural changes should not be submitted as a major modification unless the licensee has been awarded a Certificate of Operation.
Dispensary Access
Rule 3796:6-3-23 of the Ohio Administrative Code:
▪ No person, except a dispensary employee, or a cultivator or processor employee who is delivering medical marijuana, shall be allowed in the dispensary department without an active qualifying patient or caregiver registration issued by the State of Ohio Board of Pharmacy.
▪ All persons not expressly permitted to be on the premises of a dispensary under this rule, but who have been authorized, in writing, to enter the dispensary by the State of Ohio Board of Pharmacy, shall obtain a visitor identification badge from the dispensary, prior to entering the dispensary.
Requests For Food At DispensariesRule 3796:6-3-22(H) of the Ohio Administrative Code
▪ Requests have been made to allow for food at dispensaries for patients, caregivers and guests. Food or beverages are prohibited from being consumed on the premises of a dispensary. A dispensary is only permitted to provide non-alcoholic, complimentary beverages to registered patients and caregivers who are present at the dispensary.
▪ Licensed dispensary employees may only consume beverages & food within designated employee break rooms.
Physician Partnerships
No dispensary employee may share office space with, compensate, receive compensation from, or refer patients to a physician holding a certificate to recommend issued by the state medical board under section 4731.30 of the Revised Code. A dispensary shall not allow a physician holding a certificate to recommend issued by the state medical board under section 4731.30 of the Revised Code to conduct a physical examination of a patient or any follow up care for purposes of diagnosing or treating a qualifying medical condition at the dispensary.
Dispensary Designated Representative
▪ Each dispensary shall have a designated representative at all times. The designated representative must hold a dispensary associated key or key employee license. Maintaining a designated representative is a continuing requirement for a certificate of operation.
▪ The designated representative shall be physically present at licensed dispensary premises at least twenty hours each week and must be able to be contacted by dispensary employees during a dispensary's hours of operation.
Dispensary Designated Representative
▪ A dispensary key employee shall be the designated representative for no more than one dispensary location. A designated representative for a licensed dispensary shall be responsible for:
▪ Oversight of the delivery and receipt of medical marijuana and medical marijuana products to a dispensary;
▪ The supervision and control of medical marijuana and medical marijuana products under the custody of a dispensary;
▪ Adequate safeguards of medical marijuana and medical marijuana products to assure that the sale or other distribution of medical marijuana and medical marijuana products will occur only by dispensary employees licensed by the Board of Pharmacy.
NW
NE
SW
SE
PATIENT & CAREGIVER
Grant Miller, Medical Marijuana Patient & Caregiver LiaisonState of Ohio Board of PharmacyEmail: [email protected]
Patient and Caregiver Support
• Toll-Free Helpline – 1-833-464-6627
• Helpline answers questions on all facets of the MMCP
• When caller asks for technical assistance with Registry, caller is referred to the Registry Support Line/Email Inbox
• Registry Support Line/Email Inbox
• (614) 569-4439 / [email protected]
• Monitored by BOP Registry Support staff
• Registry Support staff responds to most inquiries, select topics are escalated to Patient & Caregiver Liaison
• Patient & Caregiver Liaison
• Addresses issues with dispensation history, days’ supply
Common Registrant Issues
Multiple profiles in OARRS
• All issues where a patient’s dispensation history does not appear due to multiple OARRS profiles should be sent to the Board’s OARRS department:
Common Registrant Issues
Caregiver status is pending
• Board is required, by rule, to check all caregivers through 7 separate databases to ensure caregiver eligibility
• Caregiver is placed into queue once registration fee is remitted
• Caregiver approval process may take up to 7 business days
• Caregiver will receive email notifying them when their status is approved
Common Registrant Issues
ID number is incorrect
• All registrants must be registered with one of the following forms of government-issued ID:
o Driver’s License
o State-issued ID
o U.S. Passport
• If the number in their profile is wrong, they will not be able to purchase medical marijuana
• For requests to correct Registry profiles, please have registrants contact their recommending physician
Common Registrant Issues
Days’ supply questions
• Patient & Caregiver Liaison explains how days’ supply is calculated
• P&C Liaison explains how much days’ supply the patient has remaining, and if they do not have any remaining, when they will be able to purchase again
• If patient requests, P&C Liaison will work with Compliance Agents to confirm dispensation history is correct
• Compliance Agent will inform dispensary of any changes needed, or to explain the correct days’ supply remaining for the patient
Days’ Supply Calculation
1. Subtract the days' supply purchased on the current fill from 90;
2. Subtract the days that have passed since the first day of the fill from 90;
3. Subtract the days’ supply purchased in the preceding 90 calendar days from 90.
Whichever number is lowest is the days' supply available for purchase.
Days’ Supply – Associated Statutes
• Ohio Revised Code 3796.04(B)(10):
Specify, by form and tetrahydrocannabinol content, a maximum ninety-day supply of medical marijuana that may be possessed
• Ohio Revised Code 3796.22(B):
The amount of medical marijuana possessed by a registered patient shall not exceed a ninety-day supply, as specified in rules adopted under
section 3796.04 of the Revised Code.
Days’ Supply – Associated Regulations
• Ohio Administrative Code 3796:7-2-04(F)
A patient may purchase any portion of their ninety-day supply at any time except that no patient shall receive more than a ninety-day supply
in a ninety-day period.
Days’ Supply Calculation
1. Subtract the days' supply purchased on the current fill from 90;
2. Subtract the days that have passed since the first day of the fill from 90;
3. Subtract the days’ supply purchased in the preceding 90 calendar days from 90.
Whichever number is lowest is the days' supply available for purchase.
Days’ Supply Calculation – Subtraction of Days
Patient visits dispensary on Day 86 of their only fill, having not purchased any product previously. Without subtracting the days they did not purchase, patient would be able to purchase up to the 90-day supply.
With their recommendation ending four days later, patient would need to dispossess themselves of any product in accordance with 3796:7-2-05 & 3796:7-2-06.
86
Days’ Supply Calculation – Subtraction of Days
Patient visits dispensary on Day 86 of their only fill, having not purchased any product previously. Without subtracting the days they did not purchase, patient would be able to purchase up to the 90-day supply.
With their recommendation ending four days later, patient would need to dispossess themselves of any product in accordance with 3796:7-2-05 & 3796:7-2-06.
86
Days’ Supply Calculation – Example 1
Patient A visits dispensary on Day 26 of Fill 1
90 – 25 = 65
Day 26
Days’ Supply Calculation – Example 1
Patient A has purchased 34 days’ supply so far in current fill (Fill 1)
90 – 34 = 56
Day 26
34 Days Purchased
Days’ Supply Calculation – Example 1
Patient A has purchased 34 days’ supply in past 90 calendar days
90 – 34 = 56
Final 64 Days of Fill 1 First 26 Days of Fill 2
34 Days Purchased
Days’ Supply Calculation – Example 1
Patient A’s remaining days’ supply is 56
Day 26
34 Days Purchased
56 days’ supply
Days’ Supply Calculation – Example 2
Patient B visits dispensary on Day 49 of Fill 2
90 – 48 = 42
Day 49
Days’ Supply Calculation – Example 2
Patient B has purchased 35 days’ supply so far in Fill 2
90 – 35 = 55
Day 49
35 Days Purchased
Days’ Supply Calculation – Example 2
Patient B has purchased 90 days’ supply in past 90 days (including today)
(35 purchased in first 48 of Fill 2, plus 55 purchased in final 41 days of Fill 1)
90 – 90 = 0, Patient B has reached limit and has no days’ supply remaining currently
3555
Final 41 Days of Fill 1 First 48 Days of Fill 2
90 Days’ Supply Purchased
Days’ Supply Calculation – Example 2 Cont’d
Patient B visits dispensary on Day 50 of Fill 1 (90 – 49 = 41)
Patient B has purchased 0 days’ supply in Fill 1 (90 – 0 = 90)
Patient B has purchase 0 days’ supply in past 90 days (90 – 0 = 90)
Day 500 Days Purchased
Days’ Supply Calculation – Example 2 Cont’d
On Day 50 of Fill 1, Patient B’s remaining days’ supply is 41
Patient B purchases a 41-day supply
Day 500 Days Purchased
41 Days’ Supply Remaining
Days’ Supply Calculation – Example 2 Cont’d
Patient B visits dispensary on Day 76 of Fill 1 (90 – 76 = 14)
Patient B has purchased 41 days’ supply in Fill 1 (90 – 41 = 49)
Patient B has purchase 0 days’ supply in past 90 days (90 – 41 = 49)
Day 77
41 Days Purchased
Days’ Supply Calculation – Example 2 Cont’d
On Day 75 of Fill 1, Patient B’s remaining days’ supply is 14
Patient B purchases a 14-day supply
Patient B has now purchased a 55-day supply in final 41 days of Fill 1
Day 77
41 Days Purchased
14 Days’ Supply Remaining
Days’ Supply Calculation – Example 2 Cont’d
Patient B purchases a 14-day supply
Patient B has now purchased a 55-day supply in final 41 days of Fill 1
Day 77
55 Days Purchased
• Remaining Days’ Supply Calculator• Located on Licensee Resource
page of MMCP website
Additional Resource
Grant T. Miller, Patient & Caregiver LiaisonState of Ohio Board of Pharmacy [email protected]
QUESTION & ANSWER
