CONTINUITY OF BUSINESS OPERATIONS JUNE 25, 2015 Leah Tolliver Pharm.D. Kentucky Pharmacists Association Director of Pharmacy Emergency Preparedness
2 OBJECTIVES Describe the benefits for developing a continuity of business operations plan. Identify one key step for pre-disaster, during disaster and post-disaster planning. Describe the role and importance of the community pharmacist in emergency response.
3 ROLE AND IMPORTANCE OF COMMUNITY PHARMACISTS IN EMERGENCY RESPONSE Pharmacists are highly visible members of health care community; involvement in emergency preparedness begins at the local level. Pharmacists encourage their patients to have a personal and family emergency plan in place. Pharmacies are an important part of any local response and pharmacy professionals are adequately equipped to assist the public during response efforts.
4 COMMUNITY RESILIENCE Pharmacies and pharmacy care are part of critical healthcare infrastructure and community recovery. Members of the pharmaceutical supply chain are resilient partners in community response after disaster. Partnering with public health can increase community s access to medications during disaster.
5 KENTUCKY S EXPERIENCE Tornado; West Liberty, March 2012 Winter Storms; entire state, February 2015
6 WHAT S AT RISK WITH SMALL BUSINESS Global climate changes lead to more frequent and more intense natural disasters Climate change, demographic and economic trends leading to population growth in higher risk coastal and urban areas could increase the number of disasters, greater loss of life, greater economic impact. As a society, the whole community must apply preparedness solutions.
7 REASONS FOR PLAN Protects employees, community and environment; protect your investment Facilitates compliance with regulatory requirements of federal, state, tribal, territorial and local agencies. Enhances company s ability to recover from financial losses, regulatory fines, loss of market share, damage to equipment. Provides products and services to the community with minimal interruption in business operations. Disaster Planning Can Reduce Time to Recovery and Expense Prepare to Become Resilient
8 SMALL BUSINESS AND PHARMACY STATISTICS 40-60% of small businesses never reopen following a disaster, without a disaster plan. 90% of companies fail within the first year following a disaster, unless they can resume operations within 5 days. Up to 29% of households have identified access to pharmacy services as an unmet need.
9 TESTING BUSINESS CONTINUITY PLANNING Critical component; if systems went down, how long would it take to be up and running again? What would be required to go live? Where are the gaps in the recovery plan? How would you close the gaps before disaster strikes? Through testing, recovery time and risks are reduced, ultimately protecting your business and employees and customers who rely on you.
10 9/11 TESTIMONIAL MORGAN STANLEY
11 PREPARE RESPOND RECOVER
12 PREPARE AHEAD OF TIME Assemble list of employees and contact numbers Assemble list of physician offices and hospitals Obtain contact information for emergency management, police, fire, public health, local health departments, providers Assemble list of wholesalers and delivery services Identify alternate delivery routes for couriers
13 PREPARE AHEAD OF TIME Develop pharmacy disaster team and identify role for each employee; includes non-pharmacy and pharmacy employees Develop continuity of business operations plan assign to employee to manage/maintain Consider immunization and CPR training for non-certified staff Have payroll continuity plan in place
14 EMPLOYEES AND FAMILIES Develop plan and educate family members; have a plan in place for pets Refer to resources on KPhA website, emergency preparedness Choose alternate meeting site if evacuating home Determine alternate route to work Identify out of town phone number in the event phone lines are down
15 PERSONNEL POLICIES The Fair Labor Standards Act (FLSA) is the federal law concerning wages and hours of work. The FLSA outlines the required amount of wages for non-exempt employees. During a natural disaster and recovery efforts, these requirements are not subject to waiver. Refer to additional information: Employment and Wages Under Federal Law During Natural Disasters and Recovery http://www.dol.gov/whd/regs/compliance/whdfs72english. htm
16 TRAIN AND EDUCATE EMPLOYEES Train and educate employees on continuity of business operations plan regularly Schedule drills Provide education for employees on emergency preparedness programs https://ky.train.org IT DOES NO GOOD TO HAVE A WRITTEN PLAN IF EMPLOYEES ARE NOT TRAINED AND EDUCATED ON EMERGENCY PREPAREDNESS! PREPARATION SAVES LIVES!
17 PREPARE AHEAD OF TIME Identify off-site data storage site and server back-up. Update anti-virus and fire walls, cyber security. Elevate valuable inventory, equipment and records off the floor in case of flooding - Very common in KY! Review current insurance coverage and consider additional coverage for business interruption, flood or earthquake
18 PREPARE AHEAD OF TIME Consider sprinkler system, fire extinguisher, fire-resistant doors and walls, fire safe for records Ensure building meets standards and codes: i.e., complete full risk assessment of assets and building; take pictures; perform risk assessment of assets before and after disaster to determine needs for restoration of business Coordinate plan with businesses next door; Develop agreement with another pharmacy for cooperation depending on damage of pharmacy
PREPARE AHEAD OF TIME Develop Go-Box to include copies of (store in waterproof and fireproof container in alternate site away from pharmacy or store electronically): Insurance policies and agent contact information Inventory list of furniture, office equipment and maintenance contracts, including computer desktops, laptops, servers, printers, network devices and serial numbers, model brand, assignment and physical location of the equipment Building and storage facility management lease and contact information Utility companies Vendor contracts Tax and business financials 19
20 Supplies on hand: PREPARE AHEAD OF TIME Plastic covering for computer work stations and server Emergency supply kit First aid kit NOAA weather radio Commercial radio Partial or total destruction of building: temporary continuity of business operations plan Relocate to temporary alternative site to continue operations uninterrupted. Inform employees, agencies and the public about relocation plan.
21 ANTICIPATE POWER OUTAGES Identify alternate sources of power services (generator, batteries) Identify alternate sources to salvage refrigerated and frozen medications (Ice and coolers) May need to quarantine medications Phone lines Computer system Store one set of patient records off-site i Cloud Develop manual method for filling prescriptions
22 IMMEDIATELY BEFORE OR DURING DISASTER Follow rules associated with each type of natural disaster including thunderstorms, lightning, tornados and hurricanes/storms Notify employees via text, email, phone call that continuity of business operations plan is being activated Monitor staffing needs Monitor patient and prescription needs
23 IMMEDIATELY BEFORE OR DURING DISASTER Maintain constant communication with Kentucky Pharmacists Association, Kentucky Board of Pharmacy; refer to emails and enewsletters, website Maintain communication with providers and wholesalers; maintain flow of pharmaceuticals Ensure data is backed up Secure computer equipment and files; turn off and disconnect equipment EXCEPT PHONES; cover equipment in plastic Obtain go-box from pharmacy or retrieve from alternate site Determine transportation needs-drugs, staff, customers
IMMEDIATELY BEFORE OR DURING DISASTER Protect building (glass doors and windows) Identify need for security if necessary to prevent theft and diversion Monitor development of the disaster (radio, TV, phone, agency websites); if evacuating do not return to office until All Clear is given by local authorities Move desks, file cabinets and equipment away from windows and off floor including records if applicable Determine building capability- relocate business or request mobile pharmacy from Kentucky Pharmacists Association If evacuating, notify employees of temporary meeting site 24
MAPPING TOOL 25
26 POST DISASTER PHARMACY RESTORATION Follow county, Governor or other authority regarding postdisaster proceedings Maintain communication with KPhA, BOP, DEA, wholesalers; website, email, enewsletters Contact building management; obtain status of utilities, phone, IT systems and severity of building Conduct assessment of loss Submit insurance claims if applicable Request 24/7 security if necessary to prevent theft and diversion
POST DISASTER PHARMACY RESTORATION Contact personnel as to when to return to the pharmacy or an alternate work site; if unable to reach employee, determine another method of contact; provide status of disaster Complete personnel status report for each employee and determine degree of injury/damage to staff and their home Assure flow of medications to pharmacy Monitor staffing needs and availability; need for volunteers Notify store personnel, customers providers, radio, TV EMS, etc. when store opens Maintain accurate records for hours worked 27
28 PHARMACY OPERATIONS Power outage-implement manual prescription filling process When using online data system, follow KY BOP rule for entering information into system once power restored Submit KASPER report once power restored Controlled substances-report theft or loss with DEA form 41; contact state and federal DEA, KY BOP Move Schedule II-V drugs to locked, secure place
PHARMACY OPERATIONS Quarantine medications not stored properly; includes room temperature medications during power outage Dispose improperly stored medications according to law (reverse distributor, hazardous waste disposal)-keep record Follow USP standards for storage temperatures and stability Utilize non-power dependent thermometer or temp/humidity data logger to maintain temperature Maintain flow of medications from wholesaler; ordering controlled substances-manually or electronically, PIC and POA assignments http://www.fda.gov/drugs/emergencypreparedness/ucm08520 0.ht29m 29
30 Refill options: PHARMACY OPERATIONS Maintain contact with the Kentucky Pharmacists Association for communications regarding a possible Executive Order Verify Executive Order has been activated to refill non-control medications up to a 30 day supply Obtain identification from patient Attempt to verify prescription with the original prescriber or the original dispensing pharmacy or using a common prescription management system, where available
31 Refill options: PHARMACY OPERATIONS If the patient has the original bottle, pharmacist may refill medication based upon the information presented In all cases, and if pharmacist is unable to verify prescription using the options above, pharmacist must use his or her professional judgment when dispensing pursuant to any emergency refill request. All attempted communications as well as all information regarding the refill must be properly documented either in the pharmacy profile system or by handwritten records.
PHARMACY OPERATIONS Other regulatory considerations: Transfer of inventory between pharmacies Temporary pharmacy facilities Operating from another pharmacy Relocating pharmacy to another building/site Non-resident pharmacy Recovery of records (paper, electronic) Irrevocable loss of inventory-keep record 201 KAR 2:175. Emergency/seventy-two (72) hour prescription refills KRS 315.500- Emergency authority for pharmacists during state of emergency KAR 2:330-Emergency Pharmacy Powers 32
1. www.ready.gov REFERENCES 2. Fema.gov/voluntary-private-sector-preparednessprogram 3. Fema.gov/small-business 4. Preparemybusiness.org 5. www.sba.gov/content/disaster-preparedness 6. Homeland Security: 2014 Business User Guide-Sample Emergency Plan 7. Continuity Of Operations Plan Sample Template 8. NCPA Foundation Disaster Preparedness Checklist 9. Risk Assessment Form 33
34 REFERENCES 10. Hurricane and Tropical Storm Preparation 11. Thunderstorms, Lightning and Tornado Guidelines 12. NASPA Emergency Preparedness Plan 13. NABP Emergency Preparedness Plan 14. Pharmacy Plan for Natural Disasters 15. Emergency Dispensing Policies in Aftermath of Hurricane Sandy 16. www.rxresponse.org Erin Mullen RPh, PhD, CEM 17. http://www.michiganpharmacists.org
35 KPhA Director of Pharmacy Emergency Preparedness Leah Tolliver Pharm.D. ltolliver@kphanet.org http://kphanet.org Office: 502-227-2303 Cell: 859-333-4748