Many pharmacies may have prepared standard downtime procedures but may not have given much thought to developing a crisis continuity plan.

The purpose of continuity planning is to ensure that dispensing operations continue, that pharmacy information systems’ data remain protected and accessible, and that telecommunications to support critical organization function during and after business interruption. Interruptions can occur for various reasons, such as earthquakes, fires, flooding, hurricanes, pandemics, power loss, tornadoes, and wildfires. Devising a crisis continuity plan can enable pharmacies to continue to provide patient care, ensure staff safety, and maintain financial viability after a disaster. The coronavirus disease 2019 (COVID-19) pandemic and the resulting business closures brought about by the shutdown have highlighted this need to plan for all health care–related essential businesses.1

Planning and Preparation
Each year, the National Hurricane Center reinforces through public service announcements and planning tools the importance of planning for floods, hurricanes, and other disasters.2 Also, the Small Business Administration (SBA) has developed a free, online practical guide that is directly applicable to pharmacies.3 It provides guidance for business owners on incorporating their past operational changes into current procedures, a template for combining their tools, and SBA insight into the updated policy. The guide also identifies lessons learned from previous disasters. This gives pharmacies a tool to help ensure that staff members have been trained on any changes that were made and that they are all on the same page in the event of an emergency. In addition, for more in-depth information, the US Department of Health and Human Services (HHS) has a comprehensive crisis assessment and vulnerability analysis plan. It covers contingency policy and procedures, cybersecurity, data backup and recovery strategies, electronic health records, pharmacy disaster recovery, pharmacy operation plans, risk assessment, and utility failure.4

During the planning process, pharmacies should assess which events would cause the business to close or require a necessary change of operations. They should determine how to function with reduced staffing if employees must work from home and which personnel are key to restoring operations. For pharmacies that are institution based, the American Society of Health-System Pharmacists has developed a pandemic assessment tool that covers communication with the media and public affairs, coordinating planning with area health systems, departmental leadership and succession, downtime operations, education and training, policy and procedures, and staffing.5

For those who are unsure about where to start or which hazards might affect a pharmacy in a particular geographic area, the Federal Emergency Management Agency offers guide templates to help with natural disasters such as earthquakes, floods, hurricanes, landslides, and wildfires.6

Cybersecurity, Electronic Health Records, Data Recovery
Cybersecurity, data recovery, and downtime access to data have become crucial as pharmacies rely more extensively on integrated electronic data systems. Boards of pharmacy and other regulatory bodies, the Centers for Medicare & Medicaid Services, and the Drug Enforcement Administration have issued multiple waivers during the COVID-19 pandemic. Further, various governors have announced executive orders that make procedures more straightforward, and with less regulatory burden, when continuing work during a disaster.7 However, pharmacies must plan to operate regardless of whether waivers are implemented to reduce the burden.

Note that during an event such as a cyberattack, flood, or hurricane, those who provide essential services, including pharmacies, have to figure out how to continue business without access to the internet and sometimes even power, and they may need to recover data quickly. A plan for accessing or assessing patient health records in such a setting can be applied to many types of events and is vital for developing proper downtime procedures.8 This strategy has become even more vital as the frequency of cyberattacks, including ransomware attacks, has increased. Infrastructure and Utility Failure Continuity plans should address infrastructure and utility failures and what to do in the event that crucial personnel have been affected or cannot get to work, facilities have been impacted, and there is an associated communication crisis. Pharmacies should determine which processes are the most important and in which order they would need to be brought back online, and document applicable procedures in advance. Staff members may not be able to contact health care providers or insurers during an event. Also, there could be drug shortages and/or interruptions in pharmacy deliveries and a lack of access to online claim adjudication, and patients may not be able to use credit or debit cards. A continuity plan’s procedures should reflect how to handle these events. Understanding how to meet regulatory guidelines in terms of assessment and documentation is critical, as patients will continue requesting service during most disaster events.

Conclusion
Having a well-drafted business continuity plan could enable pharmacies to stay operational, while mitigating potential risk circumstances. Many resources are available to help pharmacists, and they should integrate continuity planning into their regular downtime operations plans. Poorly performing these tasks or skipping the process altogether could result in adverse patient impact, significant interruption to operations, or business closure. Devoting the appropriate thought and time now can prevent catastrophic loss later.
 
Kenneth Maxik, MBA, MBB, FACHE, RPhis the vice president of operations support at CompleteRx in Lexington, Kentucky.

Craig Kimble, PharmD, MBA, MS, BCACP, is the director of experiential learning, manager of clinical support services, and an associate professor of pharmacy practice, administration, and research at Marshall University School of Pharmacy in Huntington, West Virginia.

Alberto Coustasse, DrPH, MD, MBA, MPH, is a professor of health care administration in the Management and Healthcare Administration Division at Marshall University Lewis College of Business.



REFERENCES
  1. Comprehensive hospital preparedness checklist for coronavirus disease 2019 (COVID-19). Centers for Disease Control and Prevention. March 24, 2020. Accessed June 29, 2020. https://www. cdc.gov/coronavirus/2019-ncov/downloads/HCW_Checklist_508.pdf
  2. National hurricane preparedness. National Weather Service. Accessed June 29, 2020. https://www.weather.gov/wrn/ hurricane-preparedness
  3. Disaster preparedness and recovery plan. SBA. Accessed June 29, 2020. https://www.sba.gov/document/support--disasterpreparedness- recovery-plan
  4. Healthcare coalition recovery plan template. HHS. Accessed June 29, 2020. https://files.asprtracie.hhs.gov/documents/aspr-tracie-hccrecovery- plan-template.pdf
  5. ASHP COVID-19 pandemic assessment tool for healthsystem pharmacy departments. American Society of Health-System Pharmacists. Accessed June 29, 2020. https://www.ashp.org/-/media/ assets/pharmacy-practice/resource-centers/Coronavirus/docs/ASHP_ COVID19_AssessmentTool.ashx?loc= ashphero3-covid19assessmenttool-03182020
  6. Hazard identification and risk assessment. Federal Emergency Management Administration. Accessed June 29, 2020. https://www. fema.gov/hazard-identification-and-risk-assessment
  7. Federal recovery programs for healthcare organizations. HHS. July 2019. Accessed June 29, 2020. https://files.asprtracie.hhs.gov/ documents/aspr-tracie-federal-recovery-programs-for-healthcare-organizations- final.pdf
  8. Tips for retaining and caring for staff after a disaster. HHS. Updated September 2018. Accessed June 29, 2020. https://files. asprtracie.hhs.gov/documents/tips-for-retaining-and-caring-for-staffafter- disaster.pdf