Maryland Board Of Pharmacy Public Board Meeting Agenda .

Maryland Board of PharmacyPublic Board MeetingAgendaJanuary 20, 2020NameTitleBouyoukas, EEvans, K.Fink, K.Hardesty, J.Geigher, P.Leikach, N.Morgan, K.Oliver, BRusinko, K.Singal, S.Yankellow, erCommissionerBethman, L.Felter, B.Board CounselBoard CounselSpeights-Napata, D.Fields, E.James, D.Leak, T.Chew, C.Executive DirectorDeputy Director /OperationsLicensing ManagerCompliance DirectorManagement AssociatePresentAbsent

SubjectI. ionAction Due Date(Assigned To)A.) K. Morgan,BoardPresidentMembers of the Board with a conflict of interest relating to any itemon the agenda are advised to notify the Board at this time or whenthe issue is addressed in the agenda.1. Call to Order2. Sign-in Introduction and of meeting attendees – (Pleaseindicate on sign-in sheet if you are requesting CE Units forattendance)3. Distribution of Agenda and packet materialsII. A. ExecutiveDirector ReportB. New BusinessC. OperationsD. LicensingB.)K. Rusinko,SecretaryD. SpeightsNapata,ExecutiveDirectorK. Morgan,BoardPresidentE. Fields,DeputyDirector/OperationsE. Bouyoukas,Commissioner4. Review and approve December 2020 Public MeetingMinutes1. Staffing Update2. Meetings Report3. Legislative Update4. COVID Vaccine Update1. None1. Procurement and Budget Updatesa: December 2020 Financial Statements2. Management Information Systems (MIS) Unit Updatesa: None1. Unit Updates2. Monthly StatisticsLicense TypeNewRenewedReinstatedTotalPage 2

SubjectResponsiblePartyAction Due Date(Assigned cy00058103077983256210,92730059278892233,687Intern GraduatePharmacyIntern TOTALE. ComplianceT. Leak,ComplianceDirector1. Unit Updates2. Monthly StatisticsComplaints & Investigations:New Complaints – 30 Customer Service – 0 Refusal to Fill - 4Page 3

SubjectResponsiblePartyDiscussion Action Due Date(Assigned To)Employee Pilferage – 2Disciplinary Action in Another State – 4Unlicensed Personnel - 1Unprofessional Conduct – 3Dispensing Error – 1Medication Error - 3Invalid/Expired CPR – 0Failure to Report Adverse Event in Compounding - 3Inspection Issues – 6Fraud – 2Arrested for Possession of Firearm - 1Resolved (Including Carryover) – 28Actions within Goal – 23/28Final disciplinary actions taken – 3Summary Actions Taken – 1Average days to complete – 63Inspections:Total - 167Annual Inspections - 142#17 Follow-up Narc AuditsOpening Inspections - 6Closing Inspections - 2Relocation/Change of Ownership Inspections - 0Board Special Investigation Inspections – 0F. Legislation &RegulationsB. Clark,LegislativeLiaisonRegulationsNonePage 4

SubjectResponsiblePartyDiscussionAction Due Date(Assigned To)LegislationNoneIII. CommitteeReportsA. PracticeCommitteeEvans, K.CommissionerJeannie Saylor-Pharmacy Inc.: Pharmacy Incorporated recently obtained apharmacy permit in Maryland. Your law is very specific stating a pharmacycannot provide prescription forms that have the pharmacy name, address, orother identifiers.Pharmacy Incorporated provides only nebulizer medication and almost allof our patients are Medicare part B recipients. Often the prescriptions wereceive from prescribers do not include all the necessary requirements to billMedicare part B, so we generate a prescription form in response to theseprescriptions and fax it back to the doctor to review, sign and fax back to usso we can bill Medicare. If a patient refills regularly we will send this formto the doctor the month before the prescription expires so there is nointerruption in therapy for the patient. This form has the name addressphone and fax of the pharmacy so they know where to send this when it issigned or who to call if there is a question. Is it okay for us to do this inMaryland since it is in response to the prescription the provider has sent tous?Proposed Response: Under Maryland Board of Pharmacy statute Md. CodeAnn., Health Occ. § 12-313(b)(11), pharmacies may not provideprescription forms that provide the name or address of a pharmacist orpharmacy. Therefore, all identifying information about the pharmacy wouldneed to be removed from the form in order to ensure compliance with thestatute.Leila Sasanpour-Midtown Pharmacy: We are trying to be able to sell Covid19 home kit tests in our pharmacy but we want to be sure that we areauthorized to do that because we got different responses. So now the mainquestion is that:Page 5

SubjectResponsiblePartyDiscussionAction Due Date(Assigned To)Are we able to do point of care testing for Covid-19 specifically using theBD Veritor system for Rapid Detection of SARS-CoV-2 when we have aCLIA Waiver from CMS and the State of Maryland? The reason we wantthis clarification is based on the email from Maryland Dept. of HealthOffice of Health Care Quality who said“Maryland is requiring that the Covid-19 EUA point of care tests beperformed in a non-waived laboratory setting. While it states it isauthorized to be distributed and used in settings outside a clinical labenvironment, this is not binding for Maryland. Due to the infectious natureof the virus and the risks to safety in manipulating the test swab for theseinstruments, in Maryland we are requiring these testing sites hold nonwaived CLIA Compliance or Accreditation certification (at least BSL-2) areperformed in a Biosafety cabinet.The performance of these points of care tests have not been appropriatelyevaluated or reviewed by FDA, and using these tests in a CLIA waivedsetting, by inexperienced CLIA waived personnel, may put staff, patients,and their contacts in danger due to the infectious nature of this pathogen.Providers and laboratories are responsible for ensuring that any testingperformed is done so in compliance with all applicable state policies duringthis emergency.”Proposed Response: Governance of test kits is not under the purview of theMaryland Board of Pharmacy. For further information on this matter,please contact the Maryland Office of Health Care Quality. (OHCQ)Kwabena Nimarko-Central Pharmacy: I have two questions concerning thecollaborative practice agreement.1. Does a patient consent form need to be signed by the physician,pharmacist, and patient? Can it only be signed by the patient?2. Can a CPA be established between a nurse practitioner and physician andwithout the involvement of a physician?Page 6

SubjectResponsiblePartyDiscussionAction Due Date(Assigned To)Proposed Response:1. Pursuant to COMAR 10.34.29.06, a collaborative practice agreementmust include a contract, signed by the prescriber, the pharmacist, and thepatient.2. COMAR 10.34.29.01B(2-1) defines an “authorized prescriber” as “alicensed physician, licensed podiatrist, or certified advanced practice nursewith prescriptive authority.” Assuming that your question is whether acollaborative practice agreement may be established between a pharmacistand a nurse practitioner without the involvement of a physician, the answeris yes, this is permissible.B. LicensingCommitteeK. Rusinko,Chair1. Review of Pharmacist Applications:a. #124662 - Applicant is requesting an extension ofher Board’s application. Due to COVID 19 closuresshe has been unable to sit for the exams.Per verification with Pearson Vue, both exams havebeen scheduled prior to the expiration of her Boardapplication.Committee recommendation: If you do not pass theexams, you are welcome to reapply which will giveyou additional time to retest.b. # 123213 - Reciprocity applicant is requesting anextension to take the MPJE. Approval for the examexpired 04/24/2020.Committee recommendation: Extend ATT for 6months, applicant will need to reapply.c. # 127448 - Applicant is requesting that her NAPLEXscore be accepted outside of the Score Transferwindow. She took the exam 09/2020.Committee recommendation: Will accept NAPLEXscore. Will need to notify applicant and NABP.Page 7

SubjectResponsiblePartyDiscussionAction Due Date(Assigned To)d. AW - Applicant is requesting a waiver of the 520hours’ experience hours.Committee recommendation: No exemption to the520 hours’ requirement. Applicant may apply viaexamination to Maryland.e. # 124776 - Applicant is requesting approval to takethe NAPLEX for a 7th attempt.Committee recommendation: Approvef.# 121725 - Applicant is requesting an extension ofMPJE score. In September 2020, the Boardapproved an extension of her score until 12/31/2020.In April 2020, her application was extended. She isalso requesting an extension of her NAPLEXeligibility date, which was previously extended inApril 2020 until February 2021.Committee recommendation: Approve bothrequests for 6 months. Will need to reapply ifapplication expires.2. Review of Pharmacy Intern Applications:a. DD - Registrant is requesting additional time for herIntern registration as she had to repeat two years ofpharmacy school. She is requesting an extensionuntil 05/23/2021.Committee recommendation: Approve extensionuntil 05/31/2021.3. Review of Pharmacy Technician Applications:Page 8

SubjectResponsiblePartyDiscussionAction Due Date(Assigned To)a. #127790 (127790 A1, 127790 A2, 127790 A3, 127790 A4,127790 A5, 127790 A6- The applicant is requestingapproval of her application as she has worked in thepharmacy for 15 years. The Board received an InitialTechnician Application on 12/04/2020. A statusemail was sent to the applicant on 12/07/2020requesting the following information: Date ofCompletion from Board-approved Training Program.The applicant provided a notarized PharmacyTechnician Work Experience Affidavit. Accordingto the affidavit, she has worked in the pharmacysince November 06, 2006 in the role of a pharmacytechnician. Applicant explains: She has beenemployed as an unlicensed pharmacy technician for15 years. In the past, she has practiced duties as atechnician until the pharmacy was inspected. At thistime, she only does deliveries for the pharmacy.However, she was informed by her employer and theMDBOP that she could be Grandfathered in andwould only need to submit a Pharmacy TechnicianWork Experience Affidavit to meet the trainingrequirements.Committee recommendation: Must complete aBoard approved Technician training program andexam. Approve a refund.4. Review of Distributor Applications: NONE5. Review of Pharmacy Applications: NONE6. Review of Pharmacy Technicians Training Programs:a. Craig’s Drug StoreCommittee recommendation: ApprovePage 9

SubjectResponsiblePartyDiscussionAction Due Date(Assigned To)b. Health MartCommittee recommendation: Approvec. Wise Technician Training Program (WiseTechnician Training Program 1, Wise TechnicianTraining Program 2)Committee recommendation: Approve7. New Business:a. Jacob Creel - Mr. Creel is requesting an exceptionto the 6-month requirement for completion of theTechnician training program. The trainee was hired02/2020 and left the job in 07/2020, they wererehired 12/2020. The trainee has completed theprogram; however, it is outside of the 6-monthrequirement.Committee recommendation: Will accept thecompletion of the program, although outside of the6-month period.KEVIN MORGAN RECUSEDC. PublicRelationsCommitteeD. DisciplinaryE. EmergencyPreparednessTask ForceIV. OtherBusiness & FYIE. Yankellow,ChairPublic Relations Committee Update:J. Hardesty,ChairN. Leikach,ChairDisciplinary Committee UpdateEmergency Preparedness Task Force UpdateK. Morgan,PresidentPage 10

SubjectV. AdjournmentResponsiblePartyK. Morgan,PresidentDiscussionAction Due Date(Assigned To)A. The Public Meeting was adjourned.B. K. Morgan convened a Closed Public Session to conduct amedical review committee evaluation of confidential applications.C. The Closed Public Session was adjourned. Immediatelythereafter, K. Morgan convened an Administrative Session forpurposes of discussing confidential disciplinary cases.D. With the exception of cases requiring recusals, the Boardmembers present at the Public Meeting continued to participatein the Closed Public Session and the Administrative Session.Page 11

pharmacy permit in Maryland. Your law is very specific stating a pharmacy cannot provide prescription forms that have the pharmacy name, address, or other identifiers. Pharmacy Incorporated provides only nebulizer medication and almost all of our patients are Medicare part B recipients. Often the prescriptions we