COVID-19 Vaccination in Community Pharmacy Webinar Series
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Webinar 1: COVID-19 Operational Guidance and Expression of Interest Completion Thursday 8 April 2021
Overview Webinar Format • Webinar Logistics • Learning Objectives • Vaccine Implementation Strategy • Operational Considerations • HSE Expression of Interest • Support Resources • Questions and Answers https://ipu.ie/home/professional/vaccination/faq/
Overview Learning Objectives • Recognise the role of Community Pharmacy in the COVID-19 Vaccination Strategy & Implementation Plan • Identify how to apply the HSE COVID-19 Vaccination Operational Guidance to your pharmacy setting • Establish the key considerations for determining capacity for your pharmacy • Describe the resources available to support you in completing the HSE Expression of Interest
Vaccine Implementation Strategy Overview • Sequencing/rationale for order of vaccination was determined • Those in greatest risk prioritised • Those first in sequence received vaccine in initial roll out • Phased approach to roll out • Pharmacists involvement in the second phase – Mass Ramp-Up • Vaccine supply determines stage https://www.gov.ie/en/publication/bf337-covid-19-vaccination-strategy-and- implementation-plan/
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Implementation Plan Workstreams Vaccination Process & Workforce Workstream Design the end-to-end COVID-19 Vaccination process, identify workforce required to deliver it and the sites to be used for the vaccination clinics. Operationalise the capacity to achieve a national vaccination programme. • The requirements for GP and Pharmacy solutions have yet to be fully defined and the national solution will have to facilitate the integration of these systems. • As more doses of vaccines become available during 2021, there will be a need to expand the pool of skilled workforce to administer vaccines and to deliver the programme. General Practice and Pharmacists have successfully delivered very significant numbers of flu vaccines and can offer enhanced capacity for this programme subject to agreement.
Collaborative Working Group National COVID-19 Vaccination Programme – HSE Pharmacy Workstream Working Group 1. Governance & Operating Model 2. Supply Chain & Logistics 3. Vaccination Process & Workforce 4. Surveillance, Monitoring & Reporting 5. Enabling Technology & Information 6. Public Engagement & Communications
Implementation Plan Workstreams PCC Negotiation January–April 2021 IPU goals in this negotiation: • Fees at an economically attractive level • Waste collection and disposal • All necessary consumables and PPE • Reimbursement of Epinephrine (as this was a barrier to provision of service) Funding Structure: • FEE: €25 per dose i.e. €50 per patient where two doses are given • PLUS: Once-off administration fee of €10 per patient vaccinated – reflects complexity of service • PPE, Consumables, Waste, Epinephrine included https://www.hse.ie/eng/staff/pcrs/circulars/pharmacy/pharmacy-circular-vaccination- programme-nco-03-2021.pdf
Overview Learning Objectives • Recognise the role of Community Pharmacy in the COVID-19 Vaccination Strategy & Implementation Plan • Identify how to apply the HSE COVID-19 Vaccination Operational Guidance to your pharmacy setting • Establish the key considerations for determining capacity for your pharmacy • Describe the resources available to support you in completing the HSE Expression of Interest
Operational Guidance Overview • Regulation / Governance • Indemnity • Training • Communications • Vaccine • Type, details, ordering, storage, disposal, equipment • Patient vaccine information • Record keeping requirements • Premises requirements • Staff Requirements • ICT • Workflow considerations • Consent • Reimbursement / contractual arrangements (PPSN) • Appendix
Vaccine Type AstraZeneca – Vaxzevria® - Vaccine stored in fridge in original pack - Maintain cold chain until required - If transferring vials onsite – maintain cold chain conditions - Counterfeit prevention measures - 10 Vials / Pack - 11 Doses /vial - FMD – break seal https://www.hse.ie/eng/health/immunisation/hcpinfo/covid19vaccineinfo4hps/astraz eneca/azvinfo.html https://www.ema.europa.eu/en/medicines/human/EPAR/vaxzevria-previously-covid- 19-vaccine-astrazeneca
HSE PharmaVax Core Functionality ✓ Registration of Pharmacy and Pharmacist Vaccinators ✓ Registration of Vaccine Batches (Expiry /Use by dates) ✓ Registration of Clients, verification of Consent & Medical Eligibility confirmation ✓ Recording of the Vaccination Event, including provision of a client's previous vaccination ✓ Provision of the Pharmacy Daily Audit Log ✓ Sending required data to PCERS to facilitate reimbursement (automatic daily feed) ✓ Requires internet access (does not need a HSE security certificate) It does not X Function as a decision support tool X Does not contain eligibility criteria questions X Schedule/Manage appointments X Allow Client to upload their personal details – only accessed by pharmacy teams
COVID-19 Recipient Vaccination Pathway Client contacts pharmacy for Communication by HSE to appointment slot (cohort 24 hours prior to population cohort for them eligibility confirmed). appointment time - confirm to contact their local Information on appointment appointment and conduct pharmacy to book an logistics and vaccine type COVID-19 pre-screen appointment communicated Client presents for Client consultation on COVID- Vaccine selection – vaccine appointment – identification 19 vaccine, eligibility check administration section on PharmaVax confirmed at registration and (prior vaccination status PharmaVax is completed and PharmaVax client information captured in established) and informed HSE Client vaccine record PharmaVax consent obtained. card completed Client supplied with HSE Post vaccination ADRs – HPRA Vaccination administration vaccine record card, PIL and notification via www.hpra.ie and post vaccination next appointment date and and on internal pharmacy observation (15/30 mins) time as per vaccine schedule incident reporting systems https://www.hse.ie/eng/health/immunisation/hcpinfo/covid 19vaccineinfo4hps/ https://ipu.ie/home/professional/vaccination/ https://covid-19.geohive.ie/pages/vaccinations
Overview Learning Objectives • Recognise the role of Community Pharmacy in the COVID-19 Vaccination Strategy & Implementation Plan • Identify how to apply the HSE COVID-19 Vaccination Operational Guidance to your pharmacy setting • Establish the key considerations for determining capacity for your pharmacy • Describe the resources available to support you in completing the HSE Expression of Interest
Capacity Assessment Considerations • Appointment scheduling (to match supply) • Contingency list management • Vaccine stability (11 doses per vial / six hours) • Waiting time (15 mins maintaining IPC measures) • Client administration activities
Record Keeping Requirements Pharmacy Requirements as detailed in S.I 698 of 2020 “Keeping of records in relation to supply and administration of Covid-19 vaccination 10B. A person who administers a medicinal product pursuant to Regulation 4F (except in the case of epinephrine (adrenaline)) shall within 7 days of the administration, forward to the Health Service Executive, by electronic means or otherwise, the following particulars in respect of such administration: (a) the date of administration; (b) the name, address, contact number(s), email address(es), ethnicity, pregnancy status, date of birth and sex of the person to whom the product was administered, to the extent that the person can provide such particulars; (c) confirmation that prior to the administration of the product— (i) consent was obtained from the person to whom the product was administered for its administration, or (ii) if he or she was unable to give such consent, the will and preferences of the person was established and the administration was for the benefit of the person; (d) the personal public service number (within the meaning of section 262 of the Social Welfare Consolidation Act 2005) of the person to whom the product was administered, or, where that person does not have, or is unable to give, a personal public service number, other identifying particulars as defined in section 2 of the Health Identifiers Act (No. 15 of 2014); (e) the name, batch number and expiry date of the product; (f) the name, business address, email and telephone number of the person who supplied and administered the product and the number of his or her certificate of registration issued by his or her professional regulatory body; (g) the name, address and telephone number of the general medical practitioner (if any) of the person to whom the product was administered to the extent that the person can give such particulars; and (h) such other relevant and necessary information as may be specified by the Minister.
Scenario 1 – Capacity Assessment One Pharmacist vaccinating DURING trading hours • Consider current volume of dispensing business and support staff • Schedule clients at 30 min slots over 6 hours = 11 appointments • Allows time for cleaning consultation room between appointments • Allows for time to use contingency list • Allows for 15 mins wait time and social distancing to be maintained • Run this 5 days per week = 55 vaccines per week i.e. 110 vaccines in 2 week period (1 outer box of AZ vaccine)
Scenario 2 – Capacity Assessment One Pharmacist vaccinating OUTSIDE trading hours E.g. Sunday if currently not open and late nights on days when shut at 6pm Sunday • 4 hour session – book appointments at 10 min slots • Adrenaline requirements (double) • 2 vials – 22 appointments = 3 hours 40 mins • Requires appropriately spaced observation area • Allows plenty of time for contingency Three late nights • 2 hour session – book appointments at 10 min slots • 1 vial – 11 appointments • Adrenaline requirements (double) • Requires appropriately spaced observation area • Allows plenty of time for contingency list Weekly total 55 vaccinations i.e. 110 every two weeks (1 box of AZ) N.B.: Floor space important in this model to allow for adequate social distancing – asked for in EOI
Scenario 3 – Capacity Assessment Multiple Vaccinators Different considerations • Availability of support staff • Anaphylaxis equipment to match appointments • Reception area – staff member to input client details into PharmaVax • Computer access considerations • Wait time and social distancing is most likely a rate limiting consideration (review to identify observation area within or close to pharmacy to facilitate social distancing) (EOI) • 1 pharmacist vaccinating every 10 mins for 6 hours (allowance for breaks = 33 per session) • 5 days per week = 165 vaccinations i.e. 330 in 2 weeks (3 boxes AZ) N.B.: Floor space important in this model to allow for adequate social distancing – asked for in EOI
Overview Learning Objectives • Recognise the role of Community Pharmacy in the COVID-19 Vaccination Strategy & Implementation Plan • Identify how to apply the HSE COVID-19 Vaccination Operational Guidance to your pharmacy setting • Establish the key considerations for determining capacity for your pharmacy • Describe the resources available to support you in completing the HSE Expression of Interest
Supporting Materials IPU Supports • Vaxzevria® SPC and PIL • Excipient Guide • IPU FAQ on COVID-19 Vaccination Programme V8 • IPU Vaxzevria® SOP • Legislation S.I. 698 of 2020, S.I. 8 of 2021, S.I. 43 of 2021 • Q& A Pregnancy and Breastfeeding and COVID-19 Vaccination • Promotional Material • EOI Aid to completion
Questions?
Webinar 2: COVID-19 Community Pharmacy Vaccination Service Thursday 15 April 2021 - 7pm
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