MISSOURI BOARD OF PHARMACY ANNUAL REPORT FY 2020 Michael L. Parson, Governor State of Missouri Chlora Lindley-Myers, Director Department of Commerce and Insurance Sarah Ledgerwood, Interim Director Division of Professional Registration Annual Report 1 Michael L. Parson Department of Governor Sarah Ledgerwood, Interim Division Director Commerce and Insurance State of Missouri DIVISION OF PROFESSIONAL REGISTRATION Chlora Lindley-Myers, Director MISSOURI BOARD OF PHARMACY Kimberly A. Grinston 3605 Missouri Boulevard Executive Director P.O. Box 625 www.pr.mo.gov/pharmacists Jefferson City, MO 65102-0625 email: [email protected] 573-751-0091 PHONE 573-526-3464 FAX 800-735-2966 TTY Relay Missouri 800-735-2466 Voice Relay Missouri To The Honorable Governor Michael L. Parson: In compliance with § 338.140.3, RSMO, the Missouri Board of Pharmacy is pleased to submit its Annual Report which contains the proceedings of the Board for the fiscal year ending June 30, 2020 (“FY 20”). The Board’s mission is to protect the public in the regulation of pharmacy practice. The Board of Pharmacy is pleased to report another successful year. Respectfully yours, MISSOURI BOARD OF PHARMACY By: Kimberly Grinston Executive Director Annual Report 2 Department of Commerce and Insurance Division of Professional Registration Missouri Board of Pharmacy FY 2020 Board Members Douglas Lang, R.Ph., President James Gray, PharmD., Vice-President Colby Grove, PharmD., Member Christina Lindsay, PharmD., Member Pamela Marshall, R.Ph., Member Anita K. Parran, Public Member Christian Tadrus, PharmD., Member Missouri Board of Pharmacy P.O. Box 625 3605 Missouri Boulevard Jefferson City, Missouri 65102 Phone (573) 751-0091 Fax (573) 526-3464 Web Site http://www.pr.mo.gov/pharmacists Email: [email protected] Kimberly A. Grinston, J.D., Executive Director Annual Report 3 TABLE OF CONTENTS Executive Summary 5 About the Board 8 Board Operations 9 Financial Summary 14 Licensing 16 Complaint Handling 29 Disciplinary Actions 32 Inspections/Investigations 36 Compounded Drug Testing 38 Rulemaking 39 Strategic Initiatives 40 Rx Cares for Missouri 44 Annual Report 4 Executive Summary This Annual Report covers the activities of the Missouri Board of Pharmacy from July 1, 2019 to June 30, 2020 (FY20). The Board is pleased to announce another successful regulatory year as reflected below: Board Operations • The Board held 44 meetings during FY 20, representing a 91% increase from FY 19 The increase is primarily attributable to COVID-19 related Board meetings, including, three emergency meetings. Additionally, the Board also facilitated (3) three Missouri Hospital Advisory Committee meetings. • COVID-19 significantly impacted the state and Board operations in FY 20. The Board was able to maintain all critical functions, however, several modifications were initiated to protect the public/staff, including: a remote work program, a modified risk-based inspection schedule, and enhanced COVID-19 screening and sanitation procedures. The Board also worked with state and national partners to address pharmacy related COVID-19 issues. At the request of the Board, seventeen (17) emergency waivers were issued by the Governor, pursuant to Executive Order 20-12. • As part of its ongoing efforts to protect patients through voluntary compliance, the Board hosted seven (7) educational webinars which included two (2) COVID-19 webinars. Educational programs were free and approved for pharmacist continuing education. Financial Overview • The Board’s total appropriation and authorized transfers for FY 20 were $3,711,927. Of the amount appropriated, Board expenditures remained consistent at $ 2,679,673.39, representing a slight 0.64% decrease from FY 19. • In compliance with § 338.070 and to address a 55% increase in FY 19 revenue, renewal fees were decreased in FY 20 from $ 450 to $ 300 for pharmacies, drug distributors, drug outsourcers and third-party logistics providers. As anticipated, increases in Board revenue slowed to a moderate 5%. The Board will continue monitoring revenue trends to ensure compliance with § 338.070. Licensing Summary • The Board’s total licensee/registrant count increased by 11% to 42,084 licensees/registrants. All license categories increased, excluding pharmacies (-5%), drug distributors (-.2.6%), drug distributor registrants (-1%), and temporary pharmacists (-59%). The licensing increase is the largest since FY 12 with third-party logistics providers experiencing the largest increase of 26.5% • Total licensees/registrants at the close of FY19 were: o Drug Distributors (1,300) o Drug Distributor Manufacturer Registrants (102) o Drug Outsourcers (39) o Intern Pharmacists (1,978) o Pharmacists- Active & Inactive (11,822) o Pharmacists- Temporary (15) o Pharmacies (2,618) o Pharmacy Technicians (24,043) o Third-party Logistics Providers (167) • While total license counts increased, new licensees/registrations decreased for the second consecutive fiscal year from 6,239 in FY 19 to 6,018 in FY 20 (a 3.5% decline). • Thirty-seven (37) Missouri counties/areas experienced a decrease in pharmacies in FY 20, compared to 11 counties in FY 19. Only Christian County experienced an increase in the number of pharmacies. Ralls county continues as the only county without a pharmacy. Annual Report 5 Executive Summary Complaint Handling • New complaints increased by 8.8% to 607 complaints. While the Board experienced an overall complaint increase, complaint numbers were historically lower for the second fiscal year due to no tax compliance cases being referred to the Board by the Missouri Department of Revenue while the Department of Revenue transitioned to a new software system. New complaint numbers are expected to increase in FY 21 as the Department of Revenue resumes tax compliance referrals. • The Board issued final dispositions on approximately 620 complaints/cases, representing an 8% decrease. The decrease is attributable to a sharp decrease in tax compliance complaints being referred to the Board in FY 19 and FY 20 by the Missouri Department of Revenue. • Six-hundred and eighteen (618) of the 620 complaints/cases were non-tax related, while two (2) cases were tax referrals. Of the 618 non-tax related complaint dispositions, 89.6% resulted in no disciplinary action (554 cases), while disciplinary action was taken in the remaining 10.3% of cases (64 cases). Disciplinary Actions • The Board issued disciplinary action in 64 cases in FY 20. All disciplinary actions were practice-related; No tax related disciplinary cases were referred by the Department of Revenue in FY 20. Overall, practice-related disciplinary actions declined by 51%, with the largest decrease in pharmacy technician disciplinary actions (51.8%). Inspections • 985 inspections of pharmacies, drug distributors, drug outsourcers and third- party logistics providers were conducted, representing a 19% decrease from FY19. Similarly, total investigations decreased by 9% in FY 20 to 211 investigations. The decreases are primarily attributed to COVID-19 related state travel and work restrictions during FY 20, which included a seven (7) week suspension of all non-emergency Board inspections. Additionally, a modified inspection schedule was implemented in February 2020 to reduce the risk of COVID-19 exposure for Board staff and Missouri patients. • Inspection results remained consistent in FY 20 with 32% of inspections ending with no violations observed, 49% with violations noted and 18% ending with a compliance notice issued requiring official documentation of corrective measures. Compounded Drug Testing • Pursuant to statutory authority, the Board conducts a testing program for drug preparations compounded by licensed pharmacies. 80.7% of products tested in FY20 were satisfactory while 19.3% were unsatisfactory. Rulemaking • The Board continued its review of Missouri’s pharmacy rules to ensure appropriate and consistent regulation. Eight administrative rules were adopted or amended in FY 20. The Board also submitted five (5) legislative proposals for approval by the Governor. Strategic Initiatives • The Board continued its focus on implementing standards-based regulation that would: 1. Establish standards of practice to ensure patient safety 2. Eliminate unnecessary regulatory requirements and barriers to practice, and Annual Report 6 Executive Summary 3. Maximize pharmacist skill, training and education to enhance patient access to care. • The Board’s annual strategic planning meeting was held in October 2019, resulting in adoption of the Board’s FY 20 – FY 21 Strategic Focus Goals as reflected herein. Rx Cares for Missouri • The Rx Cares for Missouri Medication Destruction and Disposal Program (the Program) began its first full year of implementation in FY 20. The statewide Program provides funding to approved participants for collection and destruction of unused/unwanted medication, including, controlled substances. As part of the Program, approved participants are provided a free medication collection receptacle that complies with state and federal controlled substance laws. Collected medication can be mailed/submitted to the Program vendor (Sharps Compliance®) up to twelve (12) times per year at no cost to the participant. • Sixty-two (62) program participants were approved and enrolled in the Program in FY 20. $ 220,385.71 was expended for the Program, with 836.95 pounds of medication being destroyed between January 2020 and June 30, 2020. Program totals only reflect medication destruction during a portion of the fiscal year and were likely impacted by COVID-19 related pharmacy closures and public access/travel restrictions at the end of FY 20. The Board anticipates an increase in Program reach in FY 21 and will continue marketing the Program to increase awareness and participation. Annual Report 7 About the Board Mission Statement The Board’s mission is to serve and protect the public by providing an accessible, responsible and accountable regulatory system that: • Protects the public from incompetence, misconduct, gross negligence, fraud, misrepresentation or dishonesty; • Licenses only qualified and competent professionals, and; • Ensures compliance with professional standards and federal and state pharmacy law. ABOUT THE MISSOURI BOARD OF PHARMACY The Missouri Board of Pharmacy was statutorily created in 1909 and has served the citizens of Missouri through the regulation of pharmacy practice for over 100 years. The Board of Pharmacy is an autonomous Board within the Division of Professional Registration, an agency of the Department of Insurance, Financial Institutions and Professional Registration. MEMBERSHIP The Board consists of seven (7) members, including, six (6) licensed pharmacists actively engaged in the practice of pharmacy and one (1) public member. By statute, at least one member must provide pharmaceutical services to a hospital, skilled nursing facility or intermediate care facility on a full-time basis. Board members are appointed by the Governor and confirmed by the Missouri Senate. All members hold office for five (5) years from the date of their appointment or until their successors have been appointed and qualified. The Board annually elects a president and vice-president, each of whom serve one (1) year terms. FUNCTIONS Pursuant to Chapter 338, RSMo, the Board has superintending control over the practice of pharmacy in the State of Missouri and its primary duties consist of: • Ensuring compliance with Chapter 338, RSMo, and the rules of the Board; • Licensing/registering pharmacists, pharmacy technicians, intern pharmacists, pharmacies, drug distributors, drug outsourcers and third-party logistics providers; • Investigating complaints within the Board’s statutory jurisdiction; • Disciplining licensees which may include, public censure, probation, suspension or revocation of a licensee/registrant; • Inspection of pharmacies, drug distributors, drug outsourcers and third-party logistics providers; • Approval of preceptors and intern training facilities. Annual Report 8 Board Operations General Board Operations The Board held forty-four (44) meetings during FY 20, including, four (4) regular session meetings, twenty (20) conference call meetings, three (3) email ballot meetings and seventeen (17) Board sub-committee meetings [Pilot Project Sub-Committee (15), Sterile Compounding Sub-Committee (2)]. Total Board meetings increased by 91%, which is primarily attributable to COVID-19 related Board meetings during the last fiscal quarter. In addition to Board meetings, the Missouri Hospital Advisory Committee established by § 338.165, RSMo, held three (3) meetings facilitated by the Board. Staff The following staff were employed by the Board at the close of FY20: Staff Inspectors • Kimberly Grinston, J.D., Executive Director • Tom Glenski, R.Ph., Chief Inspector • Jennifer Boehm, Administrative Coordinator • Bennie Dean, R.Ph. • Laura Henke, Pharmacy/Drug Distributor Coordinator • Katie DeBold, PharmD. • Sarah Decker, Compliance Coordinator • Andrea “Andi” Miller, PharmD. • Angela Fulton, Pharmacy Technician Coordinator • Scott Spencer, R.Ph. • Kimberly Hatfield, Pharmacist Coordinator • Lisa Everett, R.Ph. • Erin Parks, Pharmacist Coordinator • Daniel Vandersand, R.Ph. • Elaina Wolzak, R.Ph. • Barbara Wood, R.Ph. COVID-19 Pandemic: On January 31, 2020, the U.S. Secretary of Health and Human Services declared a public health emergency due to the COVID-19 pandemic. Governor Parson declared a similar State of Emergency on March 13, 2020, finding that COVID-19 poses a serious health risk for Missouri residents and visitors. Governor Parson subsequently ordered the closure of state office buildings on March 24, 2020, followed by several Missouri municipalities issuing similar travel and business restrictions. As a result of the State of Emergency, Board offices were closed for approximately three (3) weeks, while Inspectors were restricted from travel for approximately seven (7) weeks (excluding emergency travel). A series of safety measures were implemented after Board operations resumed to maintain core Board functions while reducing the risk of COVID-19 exposure for staff and the public, including: • Enhanced safety and sanitation procedures consistent with guidelines from the Centers of Disease Control and Prevention (CDC), including, requiring personal protection equipment (PPE) for all Board staff and enhanced cleaning/ disinfection procedures for the Board office and Board equipment. • Establishing a remote work program for office staff that allowed staff to maintain core Board functions from home (e.g., application processing, complaint intake, phone/e-mail inquiries). Necessary equipment and training was provided by the Board office. • A modified risk-based inspection schedule, with limited inspections of locations servicing vulnerable patient populations, such as long-term care facilities and infusion/chemotherapy clinics. • Revised COVID-19 inspection procedures based on CDC guidelines, including, daily temperature checks for Board inspectors and a COVID-19 inspection screening survey. • Modified application procedures to assist applicants unable to complete application requirements due to COVID-19 restrictions (e.g., application notarization, fingerprinting, non-resident state inspections, etc.). Modifications included: (1) accepting electronic filings/documents, (2) expedited application procedures for 2020 pharmacy graduates, (3) early Annual Report 9 Board Operations testing authorization for pharmacist applicants, and (4) issuing temporary pharmacy permits/licenses for non-resident entity applicants licensed and in good standing in another U.S. state or territory (pharmacy, drug distributor, drug outsourcer and third-party logistics provider applicants). Final licenses were issued upon completion of all statutory/rule application requirements. All Board meetings were conducted virtually beginning April 2020; Instructions for accessing/participating in the open session meetings were provided to the public and posted on the Board’s website. As reflected above, Board meetings increased by 91%, including, three (3) emergency COVID-19 related conference calls. The Board also hosted two (2) free webinars in March and April 2020 to provide COVID-19 updates, and established an online pharmacy COVID-19 resource center. Additionally, the Board coordinated with state and federal partners to address COVID-19 related pharmacy issues, including, the United States Food and Drug Administration, CDC, Missouri Department of Health and Senior Services, and MoHealthNet. At the Board’s request, the following COVID-19 statutory/rule waivers were approved by Governor Parson pursuant to Executive Order 20-12:*** • Section 338.010: Waived to allow Missouri-licensed pharmacists to provide childhood vaccines as authorized by the United States Department of Health and Human Services (DHSS) • Section 338.010: Waived to allow Missouri-licensed pharmacists to provide COVID-19 vaccines as authorized by DHSS • Section 338.013: Waived to extend the pharmacy technician renewal deadline from May 31, 2020, to July 31, 2020. • Section 338.013 & § 338.020: Waived to allow pharmacists and pharmacy technicians registered/licensed in other states to assist a Missouri licensed pharmacy or a Missouri-licensed hospital or healthcare facility during the COVID-19 State of Emergency. • Section 338.056: Waived to allow pharmacists to substitute albuterol inhalers during the State of Emergency with other albuterol inhalers listed in the FDA’s Approved Drug Products with Therapeutic Equivalence Evaluations (Orange Book), if the prescribed albuterol inhaler is unavailable due to a shortage. • Section 338.200: Waived to allow pharmacies/pharmacists to dispense up to a sixty (60) day emergency supply of medication or the smallest unit of use available in inventory. Current law only authorizes a thirty (30) day emergency supply. • Section 338.220: Waived to allow pharmacies licensed in another U.S. state or territory to assist a Missouri pharmacy during the State of Emergency. • 20 CSR 2220-2.010(1)(A): Waived to allow pharmacy technicians/intern pharmacist to dispense medication without a pharmacist present if dispensing is necessary to provide disaster or emergency relief or for patient safety, provided the medication has been previously verified by a pharmacist. • 20 CSR 2220-2.010(1)(B): Waived to allow remote final product verification by a pharmacist if needed to provide disaster or emergency relief. • 20 CSR 2220-2.200(10(B): Waiver granted to allow portability of qualified sterile compounding staff to prevent interruptions in patient care or to ensure the availability of pharmacy services during the State of Emergency. • 20 CSR 2220-2.200(14): Waiver granted to allow expanded compounding for hospitalized patients, pursuant to the FDA’s temporary authority during the COVID-19 pandemic. • 20 CSR 2220-2.400(12): Waiver granted to allow hospital pharmacies to compound preparations without a patient- specific prescription to treat COVID-19 patients, or to assist other hospitals unable to provide compounding services during the State of Emergency. • 20 CSR 2220-2.650: Waiver granted to allow pharmacies to assist/share pharmacy services with another pharmacy Annual Report 10