How do you (or the organization) provide oversight to ensure the company is compliant with applicable laws and regulations? I review the ___________________ to confirm that we are accurately following the standard regulations.
How do you (or the organization) provide oversight to ensure the company is compliant with applicable laws and regulations?The _______________team conducts internal audits and reviews all POPs for regulatory compliance and accuracy.
If you participate in multiple states, how are staff trained to resolve variations in processes that impact their job functions? We design our processes to be compliant with the ______________ regulations. Resource documents, reminders on work tasks, flags/alerts in PharmacyOS, and state-specific guides, e.g., controlled substances, are available for all staff.
How does the organization continue business operations during a disaster? Our policies and procedures describe these ______________ and have a business
How does the organization continue business operations during a disaster? continuity management (_____X_________) document that addresses disasters across all sites. Our policies and procedures describe these ______________ and have a business
How does the organization continue business operations during a disaster? We can redirect shipments and shift tasks, as needed, to other ______________
How does the organization continue business operations during a disaster? Generators are available for______________ outages at our large sites
How does the organization continue business operations during a disaster?Our __________ work with Boards of Pharmacy to allow for remote work, where allowed.
If an emergency occurred at your location, how would customers continue to be serviced? We are able to _____________ customers between facilities to fulfill their shipments or we can transfer their prescription to a different pharmacy of their choice.
How does the organization service customers if their location is impacted where the company does not have a physical facility, e.g., California wildfires? Our Shipment Success team monitors _______________ View for carrier alerts, anticipates any results of disasters and loss, and receives weather alerts from Amazon.
How does the organization service customers if their location is impacted where the company does not have a physical facility, e.g., California wildfires? If shipments will be delayed, they coordinate with Customer Care and _______________ to transfer the customer’s medications to another PillPack facility or another pharmacy of the customer’s choice.
How often is your business continuity plan (BCP) tested? Tabletop tests are conducted annually to simulate _______________ situations and determine protocols for natural and/or human-made disasters.
Are technicians required to be licensed and certified in your state? ______________: Yes, unless the technician was “grandfathered” in at the time of the rule change to require certification, all licensed pharmacy technicians are required to have and maintain national certification.
Are technicians required to be licensed and certified in your state?____________: No
Are technicians required to be licensed and certified in your state? ____________: All technicians must be licensed in XXXXX prior to working in the pharmacy. The state does not require certification but does require either the licensee to go through a board-approved technician training program or a certification program.
Are technicians required to be licensed and certified in your state? ___________: Technicians performing data entry and prescription acquisition tasks must be certified in addition to being registered. Other technicians, i.e., billing and fulfillment, only require registration.
Are technicians required to be licensed and certified in your state? ______________: Technicians are allowed to operate under a temporary license, up to three years, and must pass the certification exam to obtain a state-approved technician license.
Are technicians required to be licensed and certified in your state? _____________: Technicians are required to be registered but not certified. If technicians are in a board-approved technician training program, they can be placed in a pharmacy for practical experience prior to being registered (since completion of the said training program is a requirement of actual registration).
Are technicians required to be licensed and certified in your state? __________: Technicians are allowed to operate under a temporary license, up to three years, and must pass the certification exam to obtain a state-approved technician license.
Who is responsible for verifying new licenses? How do you verify a license upon hire? Our Compliance team completes a _______________________ (PSV) through the Board of Pharmacy, looking for active licenses in good standing. ( what does PSV stand for)?
How often are PSVs completed? Upon hire, _____________ on all employees, and upon potential license expiration.
How is your staff trained on URAC standards? ___________ lessons, in-person training, and follow-up training if standards change.
How are staff trained on conflict of interest (COI)? COI is presented in multiple ways, including: HIPAA training Fraud, waste, and abuse (FWA) training Amazon’s ethics training, which also discusses ethical dilemmas And all employees sign a _____________(NDA) upon hire. ( what does NDA stand for?)
How do you prevent security breaches? External security monitors the facilities 24/7 Areas with HIPAA are limited to only approved employees Contract with Shred-it for secure paper documentation destruction _____-factor authentication to log into secure networks
Have you had a PHI breach? Yes Compliance notifies the affected customer(s), in writing, within ________ days and reports the incident to the Department of Health and Human Services (DHHS).
How often do you conduct security risk assessments? (physical and digital) _____________ by PillPack’s IT department and the loss prevention and security teams Infosec completes all Amazon audits company-wide
What clinical support tools do you provide staff? Resources available include: Clinical Resource Folder Clinical practice guidelines Links to Clinical ________________ Senior Clinician is also available to answer questions Resource pharmacists are available to support Front End teams and the Clinical Customer Care pharmacists are available to support non-clinical Customer Service staff.
What is your policy if a staff member has a change in licensure, i.e., suspension, revoked, etc? They are no longer allowed to work in the pharmacy until further review is conducted. The agent must notify _____ and their _____ immediately and, depending on the type of issue, they may be reassigned to other tasks
How does your organization define “high risk” patients? PillPack defines high-risk customers as those taking ___ or more prescription medications High-risk customers are noted on their profile and in Docupack.
How do you report concerns related to the quality of inventory/distribution? Immediately quarantine anything suspected to adulteration and notify the purchaser _____ related to Fulfillment are collected and reviewed on a daily basis
How do you identify and report quality-of-service issues? QREs are submitted to the Quality team, who set the benchmarks in QRE _____ Our complaints protocol defines how to collect customer complaints related to service issues
How does the organization conduct proactive risk assessments? The Quality team proactively monitors high-risk medications/prescriptions The Quality Management Committee (QMC) and the Quality team monitor our ts (NMEs) ( what does NME stand for?)
How are errors reviewed and reported on? All employees report QREs to the Quality team via a reporting form. The Quality team reviews all reported errors on a _______ basis
What are “unacceptable” drugs? Unacceptable drugs are any medications that are: Adulterated Expired Misbranded _____________ Received after it was dispensed from our facility
Who is responsible for processing “unacceptable drugs”? The _____________ control team
How are unacceptable drugs handled, removed, and stored? Immediately upon recognition, the unacceptable drugs are ____________ and stored until destroyed by a reverse distributor
How are staff notified of unacceptable drugs? We receive notification from our wholesalers about recalled medications and we follow the wholesalers’ processes to return to them, with a preference to send the medication to a reverse distributor for destruction The Compliance Team reviews the FDA Recalls website daily and notifies ______________ as needed.
How are consumers and providers notified of unacceptable drugs? Our Customer Care and Clinical Customer Care teams will email and/or call our customers in to notify them of the ___________
