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Version Date Prepared by Version Updates

V4.0 22/11/2021 ● Update on Administration to Pregnant Women ● Update on Administration of Booster Programme ● Notification of Clinical Waste Service ● Risk Management Considerations when Covid -19 vaccines and Flu

vaccines are both in use in a pharmacy ● Update on PharmaVax System

V5.0 20/12/21 Addition of Spikevax® (Moderna) COVID-19 Vaccine

V6.0 30/12/21 Reduction in time for booster dose to three months since COVID-19

infection

Prioritisation of persons who received COVID -19 Vaccine Janssen®

V7.0 19/4/22 Update on Administration of Booster to 12-15 years

Update on Recording of stock

National COVID-19 Vaccination Programme -

Community Pharmacy

Operational Guidance for Vaccination in Community Pharmacy mRNA Vaccines

- Comirnaty® (Pfizer BioNtech) COVID-19 Vaccine

- Spikevax (Moderna) COVID-19 Vaccine

V7 19/4/2022

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Contents

Overview & Introduction 4

Pharmacy Regulation and the Vaccination Programme 4

Governance 5

Indemnity 5

Training for Pharmacists on Vaccine Administration 6

Communications 6

Public 6

Vaccine 8

Vaccine Type 8

Ordering Vaccine 10

Vaccine Storage in Community Pharmacy 11

Cold Chain Preservation & Monitoring of Fridges 11

Receipt of Vaccines 12

Secure Storage and Disposal of Vaccines 12

HSE Removal of Waste from Community Pharmacy Sites 13

Vaccine Equipment for Community Pharmacy 13

Patient Vaccine Information for Community Pharmacies 14

Record Keeping 14

Preparation for Rollout 15

Community Pharmacy Premises Requirements 15

Community Pharmacy Staff Requirements 16

Workflow Considerations 17

Covid-19 Recipient Vaccination Pathway 17

Contingency List 18

Comirnaty® (Pfizer/BioNTech) COVID-19 mRNA Vaccine 18

Emergency Cover 19

Administering 19

Recovery 19

Consent 20

ICT 21

Fees, Contractual Arrangements & Reimbursement 24

Fees 24

Reimbursement 25

Notes on PPSN to Support Queries 25

Appendix 1A– Overview of Handling Requirement for Comirnaty (Pfizer/BioNTech) COVID-19 Vaccine 27

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Appendix 1B – Overview of preparation of Comirnaty (Pfizer/BioNTech) COVID-19 Vaccine 28

Appendix 2 - (Appendix VIII of NIO Cold Chain Guidance) 29

Appendix 3 – Sample Checklist for COVID-19 Vaccination Clinics 30

Appendix 4 – Comirnaty (Covid 19 vaccine) Reconstitution 32

Appendix 5 – Patient Consent Checklist 33

Appendix 6– Guidance on Photographic ID 34

Appendix 7: Risk Management Considerations when multiple vaccines are in use in a pharmacy. 35

Appendix 8 – HSE PharmaVax Vaccination Recording 37

Primary Course & Booster Vaccination Administration Recording – New Features 37

Healthcare Workers Search & Recording – New Features 37

Vaccination History Search – New Features 39

HSE PharmaVax User Guide 40 Appendix 9 - Spikevax (Moderna®) COVID-19 Vaccine Overview 43

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Overview & Introduction COVID-19 is a highly infectious disease that can cause serious illness, hospitalisation and even death. The COVID-19 vaccination programme offers protection from COVID-19. If people do test positive for COVID-19 after vaccination, they should have increased levels of protection from the serious illness that the virus can sometimes cause. The aim in offering the vaccine and subsequent booster vaccines to the population is to protect people and reduce the illness and deaths caused by this virus.

The vaccine is not mandatory. People who are most at risk from COVID-19 will be offered the vaccine first. The COVID-19 vaccine is free to all persons of the State. It will not be available privately. The Department of Health has devised a priority list of groups for vaccination using vaccines authorised by the European Medicines Agency (EMA). The Strategy was developed by the National Immunisation Advisory Committee (NIAC) and the Department of Health, endorsed by the National Public Health Emergency Team (NPHET), and approved by Government on 8 December 2020 and updated on 30 March 2021. The Strategy is a further component to the State’s response to the COVID-19 pandemic and will evolve and adapt with more detailed information on the vaccines and their effectiveness. For a quick guide to the updated provisional vaccine allocation groups please see link to the government website https://www.gov.ie/en/publication/39038-provisional-vaccine-allocation-groups/ Community Pharmacists, who have already made a significant positive contribution to efforts to manage this public health crisis since the outbreak of COVID-19 in the spring of 2020, will play a key role in the delivery of the vaccination programme in accordance with the agreed national vaccination schedule. Community Pharmacists will have a key role in delivering the COVID-19 vaccination programme as the HSE seeks to maximise delivery capacity. This document sets out guidance in relation to the approach, logistical arrangements and processes established for the rollout of the vaccine programme within a community pharmacy setting. The National Immunisation Office (NIO) is the primary source of clinical guidelines for national immunisation programmes, including COVID-19. Please refer to its website regularly, as the NIO monitor and update information in relation to vaccinations. Please see: https://www.hse.ie/eng/health/immunisation/hcpinfo/covid19vaccineinfo4hps/clinicalguidance.pdf The NIO also issues regular bulletins that are useful for keeping up to date when changes occur please see: https://www.hse.ie/eng/health/immunisation/hcpinfo/covid19vaccineinfo4hps/bulletin/

Pharmacy Regulation and the Vaccination Programme Community pharmacies are regulated by the Pharmaceutical Society of Ireland (PSI) in accordance with the Pharmacy Act 2007 and Regulations made thereunder (the term used in the Act for pharmacies is “retail pharmacy business”). PSI views community pharmacies as an essential part of the healthcare system response to COVID-19 and are keen to ensure that relevant and proportionate regulation plays an appropriate role in ensuring the safety and effectiveness of the national vaccination programme. During 2020, and in response to the COVID-19 pandemic, PSI developed “COVID-19 Operational Standards for Pharmacies”. These Standards are primarily intended for those in statutory governance and leadership positions in community pharmacies, i.e., pharmacy owners, superintendent and supervising pharmacists. The Standards set out clearly what the public can expect from pharmacies by way of safe services and a safe environment during COVID-19.

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The legislative framework and the PSI’s “COVID-19 Operational Standards” are also supported by a number of guidelines designed to support the safe delivery of particular services by pharmacies, including the delivery of vaccination services in pharmacies and guidelines for retail pharmacy businesses (pharmacies) relating to premises and equipment requirements and requirements on the storage of medicines.

In addition the Code of Conduct supports all registered pharmacists in their practice; this is the public declaration of the principles and ethical standards which govern pharmacists in the practice of their profession, and which the public, patients, other healthcare professionals and society require and expect from pharmacists. The public and other healthcare professionals place significant trust in every pharmacist. He/she must maintain a high level of professionalism, competence, act with probity and integrity in order to earn and maintain that trust.

Taken together, all of the foregoing regulatory instruments are intended to support safe and reliable pharmacy services during COVID-19. PSI expects all pharmacists and pharmacies involved in providing COVID-19 vaccinations through pharmacies to meet the relevant regulatory requirements. PSI is committed to working with all involved in the national vaccination programme to ensure the success of the overall programme. This includes working with the HSE and IPU to develop and refine the helpful and supportive guidance set out later in this document.

Governance

Pharmacy owners, superintendent and supervising pharmacists have overall responsibility for the governance of community pharmacies and must ensure the delivery of a consistently high quality and safe vaccine service. The clinical governance for administering the vaccine and managing the person post-vaccine rests with the pharmacists and their existing governance and regulatory structures i.e. Superintendent Pharmacist and Supervising Pharmacists.

Clinical Guidelines and information for Healthcare Professionals are available for the COVID-19 vaccines and include information such as how to administer the vaccine, the possible side effects, the required post vaccination observation times, management of anaphylaxis and FAQs. These are available at: https://www.hse.ie/eng/health/immunisation/hcpinfo/covid19vaccineinfo4hps/ Community Pharmacists can direct clinical queries which are not addressed in this guidance to the National Immunisation Office via immunisation@hse.ie

Indemnity Claims management in relation to claims and litigation initiated in connection with COVID‐19 vaccination has been delegated to the State Claims Agency by means of Government Order. Registered medical practitioners (including GPs); nurses; pharmacists; and other health professionals in receipt of relevant training with regard to administration of the vaccine, who are administering vaccines on the direction of, or on behalf of, the HSE, will be indemnified with regard to any adverse product liability‐related events arising from their administration of the vaccine. GPs, GP Practice Nurses and community pharmacists however, will not be indemnified in respect of

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malpractice events occurring during the administration of the vaccine. Such malpractice events will be indemnified by their professional insurers.

Training for Pharmacists on Vaccine Administration

The Medicinal Products (Prescription and Control of Supply) (Amendment) (No.7) Regulations 2020 (S.I. 698 of 2020) and subsequent amendments authorise a registered pharmacist to supply and administer a COVID-19 vaccine where they have received training approved by the PSI. This legislation also outlines the recording keeping requirements for the COVID-19 vaccination programme. The approved training pathway for vaccinating pharmacists for inclusion in the COVID-19 vaccination programme is outlined below. All training must be up to date, as per the validity periods published on the PSI website.

You can contact the Irish Institute of Pharmacy (IIOP) to find out how to register and complete the required training programmes. You can check the validity for training programmes on the PSI website. Accessible through - www.hseland.ie. The relevant NIO COVID-19 vaccine training programmes are available through HSElanD. Extensive information and training on the various COVID-19 vaccines has been prepared by the National Immunisation Office and other clinical experts. This information is updated regularly and it is recommended you check this information often to ensure you have up to date and accurate information when vaccinating. This includes the weekly vaccine bulletins. www.immunisation.ie The pharmacy owner and Superintendent Pharmacist must be satisfied that all pharmacists and other staff, employed or engaged, have the requisite knowledge and skills to deliver the vaccination service safely. The pharmacy owner and Superintendent Pharmacist must be satisfied that all pharmacists are registered and completed the required training and all other pharmacy staff are familiar with the provision of vaccination services and are trained according to their level of involvement in the process.

Communications

Public HSE.ie has comprehensive information available on the vaccine for the people of Ireland including:

● Getting the vaccine

● Safety

● Immunity

● Side Effects

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● Leaflets (available in various languages and in accessible formats)

This information is available at: https://www2.hse.ie/covid-19-vaccine/ The public can opt to receive their vaccine at a community pharmacy. It is important to highlight to the public that they should cancel any duplicate bookings in a centralised vaccination clinic so that these bookings are not left unattended and can be offered to someone else. The patient can cancel the booking in the CVC by texting back the word ‘REJECT’. Community Pharmacy can now offer a vaccine or booster vaccine in line with the age cohorts supporting the vaccination centres and also includes the 12-15 years of age cohort (see below for details on consent) Pregnant women can also receive the vaccine in pharmacies. Pregnant women should be offered mRNA COVID-19 vaccines (Comirnaty® (Pfizer BioNTech) or (Spikevax® COVID-19 Vaccine Moderna® if over 30 years of age) at any stage of pregnancy. This includes the additional mRNA vaccine dose recommended for immunocompromised individuals and the booster dose. Information for women who are pregnant or breastfeeding and their healthcare professionals about COVID-19 vaccine can be found at https://www.rcpi.ie/news/releases/information-for-women-who-are-pregnant-or-breastfeeding-about-thecovid-19-vaccine-update/. There is a checklist developed by NIO for use by pharmacies and other settings which includes the questions about pregnancy and the discussion with an obstetric care giver; https://www.hse.ie/eng/health/immunisation/hcpinfo/covid19vaccineinfo4hps/covidchecklistpm.pdf

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Vaccine Vaccine Type This operational guide focuses on the guidance for two mRNA vaccines - Comirnaty® (Pfizer BioNtech) COVID-19 Vaccine and Spikevax® (Moderna COVID-19 Vaccine), and their administration within community pharmacies.

Vaccine Details

Name of Vaccine Comirnaty® (Pfizer BioNtech) COVID-19 Vaccine

Spikevax® (Moderna COVID-19 Vaccine)

Type of Vaccine mRNA vaccine mRNA vaccine

Primary Vaccination Course

Age Age 12 years and older Age 30 years and older

Number of doses required 2 2

Dose (Administered intramuscularly)

0.3ml 0.5ml This is also the dose for 3rd dose for immunocompromised See below for booster dose

Interval between dose 1 and dose 2

21 to 28 days 28 days

Timing since Covid-19 infection

4 weeks 4 weeks

Minimum interval 17 days* 21 days*

Booster Dose for Eligible Groups

Age See below (& as per current national priority cohorts)

Age 30 years and older (as per current national priority cohorts)

Dose (Administered intramuscularly)

16 years and older 0.3ml 12-15 years 0.3ml

0.25ml

Interval since finishing primary vaccination course

16 years and older at least 3 months 12-15 years at least 6 months**

At least 3 months

Timing since Covid-19 breakthrough infection

16 years and older at least 3 months 12-15 years at least 6 months (includes immunocompromised)

At least 3 months

* If the second dose is given less than these intervals, they are not considered a valid vaccine. A third dose should be given 28 days after the second (invalid) vaccine **Children aged 12-15 who are immunocompromised at the time of primary vaccination should

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receive the booster at least 3 months after the additional dose was given If a young person turns 16 in the three months after their primary course they can receive the booster dose using the interval of 3 months or longer for people aged 16 years and older. If a child turns 12 between the 1st and 2nd dose of the primary vaccination schedule, they should receive the appropriate dose and interval for people aged 12-15 years for their second dose: 30 micrograms of Comirnaty (purple cap). Updated in NIO Vaccine Bulletin 45. N.B. The age of the individual at the time of vaccination determines the dose and the dose interval. As the COVID-19 vaccination programme now includes additional doses for those who are immunocompromised as well as booster doses, please check before each vaccination:

Is this a primary course, an additional dose for a person who is immunocompromised or a booster dose?

What is the age of the person? What is the recommended vaccine for this age-group? What is the recommended dose? What is the recommended interval since the last dose? Has the person had COVID-19 infection? What is the recommended interval since COVID-19

infection? Prior to the administration of a fourth dose to an immunocompromised person with a

suboptimal response to the COVID-19 primary course, the pharmacist screens the person against the information recorded on the Pharmavax system and reviews previous records of administration. If the patient’s records do not accurately reflect their health status and the third dose has been recorded as a booster dose rather than as an extended primary vaccination dose by the previous vaccinator, the pharmacist cannot record the fourth dose as a booster dose. In this case, the pharmacist or patient needs to contact the previous vaccinator to request an update as to the patient’s health status to confirm that the patient is immunocompromised with a suboptimal response. Once this information is updated the third dose can be recorded as extended primary vaccination course and the fourth dose will be recorded as a booster dose

Additional Handling Information

Name of Vaccine Comirnaty® (Pfizer BioNtech) COVID-19 Vaccine

Spikevax® (Moderna COVID-19 Vaccine)

How it is supplied by National Cold Chain Service (NCCS)

+2°C to +8°C with approx 4-week shelf-life

+2oC to +80C with approx. 30-day shelf life

Dilution Yes, with 1.8ml of 0.9% sodium chloride

No dilution required

Handling DO NOT SHAKE. Cannot be used if shaken Invert vial 10 times prior to dilution

DO NOT SHAKE Swirl gently before each withdrawal

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Number of doses per vial 6 doses of 0.3ml/30 micrograms

If a 7th dose can be safely and accurately withdrawn from the vial, then it can be used as a valid dose.

10 doses of 0.5ml (primary vaccine course and additional doses) or 20 doses of 0.25ml (booster vaccine dose)Maximum number of times vial can be pierced is 20 times, even if some residual volume remains

Shelf life of an unopened vial @ +2°C to +8°C (NOTE must be stored upright)

Until “use before” time and date as labelled by NCCS (approximately 4 weeks)

Until “use before” time and date as labelled by NCCS (30 days from thawing).

Shelf-life once vial is in use - “discard time”

6 hours after dilution 19 hours after first puncture of vial (at fridge or room temperature 20C –to25OC)

The NIO is the primary source of clinical guidelines for national immunisation programmes, including COVID-19. Please refer to its website regularly, as the NIO monitor and update information in relation to vaccinations. Please see: https://www.hse.ie/eng/health/immunisation/hcpinfo/covid19vaccineinfo4hps/ Extensive information and training on the various COVID-19 vaccines has been prepared by the National Immunisation Office and other clinical experts. This information is updated regularly and it is recommended you check this information often to ensure you have up to date and accurate information when vaccinating. This includes the regular COVID-19 bulletins. For a quick reference table on the different types of COVID-19 vaccines currently available, please see: https://www.hse.ie/eng/health/immunisation/hcpinfo/covid19vaccineinfo4hps/covid19vaccinereferenceguide.pdf

The NIO webpages contain the specific information on the safe handling and administration of each vaccine. An overview of handling requirements for Comirnaty® (Pfizer BioNtech) COVID-19 Vaccine is available in Appendix 1A and dilution steps for this vaccine are available in Appendix 1B. An overview of Spikevax® (Moderna) COVID-19 vaccine is available in Appendix 9.

Ordering Vaccine The HSE National Cold Chain Service (NCCS) will deliver COVID-19 vaccines. On initial roll out the HSE will allocate a set amount to each community pharmacy. Each pharmacy will be contacted to advise of this delivery in advance of vaccinations. Appointments should be scheduled based on the expected vaccine delivery and deliveries will be on a fortnightly schedule. As more supply becomes available, and the HSE will allocate a set amount of vaccines based on the supply available in the country and the number of vaccine doses that a community pharmacy can administer. Community pharmacies will be supported by relationship managers via a dedicated email address PharmacyVaccines@vision.com

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For those receiving their primary course, community pharmacists must ensure that individuals receive a second dose (where indicated in the vaccine schedule) of the same vaccine that they received as their first dose at the appropriate interval. They should confirm the date for the second appointment with people at the appointment for the first dose. It is important to note that there is no requirement to retain vaccines in reserve; the HSE will provide a vaccine for second doses.

It is not possible to provide people with a choice as to their preferred vaccine. They can only be offered the vaccine that has been made available to the Community Pharmacy. Update March 22 NIAC is now recommending the expansion of the Booster Vaccination Programme to people aged 12 years and older, including pregnant women. (Individuals below 30 years of age should receive Comirnaty®) The HSE has made the necessary IT update to enable the recording of the Booster Vaccine in pharmacies to children aged 12-15 years.

Vaccine Storage in Community Pharmacy Adapted from ‘HSE Guidelines for maintenance of cold-chain in vaccine fridges and management of vaccine stock’. These are available at: https://www.hse.ie/eng/health/immunisation/hcpinfo/vaccineordering/sopnio01.pdf

Cold Chain Preservation & Monitoring of Fridges Comirnaty® (Pfizer BioNtech) COVID-19 Vaccine can be stored for up to 31 days (use before date and time). The total or cumulative duration of transit of the undiluted product at temperatures between +2 °C and +8 °C, must not exceed 12 hours. The 12 hours must include all travel time commencing at time of departure from NCCS to the pharmacy and all other transportation of the undiluted vaccine thereafter. Each delivery box is over labelled with time of departure label which is stamped when leaving NCCS and is completed by driver at time of handover to recipient. Sodium chloride 0.9% diluent used for Comirnaty® Pfizer BioNTech vaccine will be included in the same delivery as the vaccine from the NCCS. Sodium Chloride 0.9% is stored at room temperature in the designated storage area. N.B. Once the vaccine is removed from the fridge it must be diluted within 2 hours. There is additional data in the SmPC that this duration can be extended to 4 hours in handling temperature excursions. The room temperature must remain under 30oC. Spikevax® (Moderna) Covid-19 Vaccine can be stored for 30 days between +2 and +8OC (Use before date and time) after thawing from -250C to -15OC and this date and time will be over labelled by the NCCS prior to delivery to the pharmacy. Within the 30 days storage of the unopened vaccine at +2°C to +8°C, up to 12 hours may be used for transportation. Once Spikevax is removed from the fridge, it must be used within 24 hours. Once the vaccine has been punctured for the first time it must be used within 19 hours (within the allowed use period of 30 days at +2°C to +8ºC and 24 hours at +8°C to +25ºC). All other or longer instances of temperature excursions should be emailed to immunisation@hse.ie for advice. Definitions of “expiry date”, “use before” and “discard time” for Comirnaty® (Pfizer/BioNTech)

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vaccine and for Spikevax (Moderna®) Covid-19 vaccine - for further detail please see the Clinical Guidance https://www.hse.ie/eng/health/immunisation/hcpinfo/covid19vaccineinfo4hps/clinicalguidance.pdf 1. A pharmaceutical fridge must be used to store vaccines. When a new pharmaceutical fridge is

installed or when a fridge is moved to a different location, the manufacturer’s instructions should be followed before use.

2. The fridge should be levelled in a way that allows the door to close and seal automatically if left ajar.

3. The set point for the fridge temperature and alarms should take into account the need to maintain the temperature above +2°C to prevent freezing and remain less than +8°C. The temperature should be set to maintain +5°C +/- 3°C.

4. In the event of a temperature excursion outside of the recommended storage conditions, affected stock must be quarantined and the NIO contacted.

i. Quarantined stock must be appropriately labelled and stored in a separate section of the pharmaceutical fridge.

ii. The form in Appendix VIII of the NIO cold chain guidance (Appendix 2 of this document) should be completed and sent to immunisation@hse.ie

iii. Affected stock should not be used or disposed of but must be quarantined until advice received from the NIO.

Receipt of Vaccines 1. Maintaining the cold chain is critical and staff receiving deliveries must undertake the process

promptly. The NIO Cold Chain Policy is available from:

https://www.hse.ie/eng/health/immunisation/hcpinfo/vaccineordering/sopnio01.pdf

2. Vaccine deliveries must be signed for by the pharmacist and must be checked against the order for discrepancies. Any discrepancies or any damage must be reported to the NCCS immediately via email: vaccines@udd.ie. The deliveries must also be recorded on the PharmaVax system. (Diluents will also be delivered if required for vaccine type by the NCCS and will also need to be recorded in the PharmaVax system.)

3. Vaccines must be removed from delivery boxes but not original containers and allocated to the appropriate area in pharmaceutical fridge without delay. The shortest dated vaccines should be stored in the foremost position to ensure adequate stock rotation. The batch information i.e. batch number (NOT serial number) and use before date and time should be recorded in HSE PharmaVax so that is available for selection by pharmacist vaccinators.

4. Vaccines should always be stored in the fridge in their original packaging in an upright position.

5. There may be more than one brand of COVID-19 vaccine being used in community pharmacies. If so, particular care is required. Stock must be stored so that the different brands are clearly segregated either by shelf or if an additional fridge is available, in separate fridges, and all vaccinating pharmacists must be alerted that more than one brand is on site. The administration of different types of vaccine should be separated in time and space, for example a morning session with vaccine A and an afternoon session with vaccine B.

Secure Storage and Disposal of Vaccines 1. Vaccines must be stored securely at all points of use between receipt and use/disposal.

2. Waste must be handled in such a way as to prevent theft and/or misuse.

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3. Used vial labels should be removed or defaced using an indelible black marker.

4. Waste vaccines and empty vials must be disposed of into sharps bins.

5. Sharps bins containing used vaccine vials should not be left unattended during vaccination session and should be stored securely at the end of each working day.

6. The sharps bins should be labelled as per the requirements of local waste management policy.

7. Original cartons must have their labels defaced using permanent black marker pens, and placed into appropriate non healthcare waste for disposal.

8. In line with flu vaccine arrangements, community pharmacies will deliver the Falsified Medicines Directive (FMD) requirements and will scan the vaccines at the point that they break the security seal. This is only applicable if an original unopened box of vaccines is delivered.

Each delivery point must return a reconciliation form prior to their next delivery. A sample reconciliation form for Comirnaty® (Pfizer BioNtech) COVID-19 Vaccine is available at: https://www.hse.ie/eng/health/immunisation/hcpinfo/covid19vaccineinfo4hps/comirnatyvaccinereconciliationform.pdf An on-line monthly stock return is in development. When it goes live, a reminder email to conduct the stock return will be issued to each pharmacy which will be pre - populated up to the last order of the previous month.

HSE Removal of Waste from Community Pharmacy Sites Stericycle Services will be providing a COVID 19 Clinical Waste service on behalf of the HSE. Pharmacies should contact serviceireland@stericycle.com or 1800 937 628 in this regard for removal of waste quoting account number 9607596. Stericycle will only accept those sharps bins supplied by the HSE for this service.

Vaccine Equipment for Community Pharmacy A national distribution service (JMC Logistics) will deliver PPE and critical clinical and non-clinical consumables. Consumables will be delivered one day ahead of the arrival of the vaccine, in the required quantities to match the quantity of vaccine allocated. There is no requirement to place a separate order for consumables. The following generic equipment will be delivered: ● Sharps Container ● Cotton Wool

● Tape

● Surface Wipe ● Kidney Dishes ● Hand Disinfectant ● Masks – FPP2 from January 2022

● Medium Gloves

● Tissues ● Large Black Sacks ● 10 Inch Paper Roll The following equipment will be delivered for Comirnaty® (Pfizer BioNtech) COVID-19 Vaccine ∙ 23G X 25MM Needle ∙ 21G X 38MM Needle ∙ 1ml Syringe (Luer Lock / Luer Slip) ∙ 3ml Luer Cone Syringe

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∙ Alcohol Swabs The following equipment will be delivered for Spikevax® (Moderna) COVID-19 Vaccine ∙ 23G X 25MM Needle ∙ 1ml Syringe (Luer Lock / Luer Slip) ∙ Alcohol Swabs Anaphylaxis supplies - Adrenaline auto injectors will be purchased by community pharmacies as outlined in circular 20/21. This is performed as required and reimbursement of these will be through an agreed PCRS reimbursement process. Pharmacists can claim under their pharmacy GMS contractor number using the assigned 5-digit Product codes set out below.

Product Claiming

Code

NAME FORM STRENGTH

UNIT MEAS.

PACK SIZE

PACK SIZE

NAME

REIMBURSEMENT PRICE

NON-PROPRIETARY NAME

39108 ANAPEN SOLN. FOR INJ. PRE-FILLED

SYRINGE 500 MCG/ 0.3 ML

2 2 x 0.3 ML €71.64 EPINEPHRINE

30214 EMERADE SOLN FOR INJ IN

PRE FILLED PEN

500 MCG 1 1 €36.70 EPINEPHRINE

There is no need to have a different dose of adrenaline for 12-15 year olds. The anaphylaxis section of the immunisation guidelines has been updated to clarify that 12 years and over require 500-600micrograms. Available at: https://www.hse.ie/eng/health/immunisation/hcpinfo/guidelines/anaphylaxis.pdf

Patient Vaccine Information for Community Pharmacies

In line with vaccine orders, the NIO will provide printed information to community pharmacies who are involved in the vaccine administration rollout. This information includes a HSE leaflet, patient information leaflet (PIL) from the manufacturer, aftercare leaflet and record card. These will be delivered to community pharmacies in advance of vaccine programme roll out. Materials such as the patient record card should be stored with care in a location which avoids misuse. Community Pharmacists can email immunisation@hse.ie to order additional materials.

Separate deliveries will be received of leaflets and consent forms to support the 12-15 year old programme.

For the most up to date patient information leaflets and resources please see: https://www.hse.ie/eng/services/news/newsfeatures/covid19-updates/covid-19-vaccine-materials/covid-19-vaccine-materials.html and https://www2.hse.ie/covid-19-vaccine/.

Record Keeping There are a number record keeping requirements that apply to the supply and administration of a COVID-19 vaccination. Data will be recorded on the day of the vaccination but it is a legal requirement to forward to the Health Service Executive, within 7 days, by electronic means, the following particulars in respect of such administration:

a) the date of administration;

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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) Consent (see further information in section on consent); d) the patient’s PPSN number; e) the name and batch number of the product (not serial number); f) expiry date / use before date (and/or time) of the product; g) 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;

h) 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

i) such other relevant and necessary information as may be specified by the Minister. The HSE has developed HSE PharmaVax an IT portal solution which will allow these records to be transferred to the national COVAX IT system. A pharmacy vaccine administration record must be retained in the pharmacy (HSE PharmaVax end of day administration record must be stamped and dated by all vaccinating pharmacists). A patient vaccination record card with batch level detail must be provided to the patient.

Preparation for Rollout In preparation for the rollout, Pharmacists should conduct a risk assessment and capacity assessment to determine if their site is appropriate (premises and staffing levels) for the preparation and administration of the COVID-19 vaccines and to determine the number of vaccinations that they can administer safely. Please see Appendix 3 for a Sample Checklist for Preparing for COVID-19 Vaccination Clinics within your community pharmacy. They should also have returned the Expression of Interest (EOI) to the HSE to ensure that they are approved with the NCCS to receive vaccines.

Community Pharmacy Premises Requirements

All Community Pharmacies will already be meeting the premises standards as set out in the Regulation of Retail Pharmacy Businesses Regulations 2008 (as amended) and in the more detailed PSI guidelines on the Premises Requirements of a Retail Pharmacy Business (version OCT 2017).

In order to provide the COVID-19 vaccines in a safe and efficient manner, community pharmacies will require the following:

● Sufficient number of pharmacists, trained in the relevant vaccines, to ensure that all activities involved in reconstitution, drawing-up and administering the vaccine are carried out in a safe and timely manner by a pharmacist

● Registration/Reception area for patients - sufficient to allow for social distancing. ● Preparation/ Reconstitution* of vaccine (should that be required for vaccine type) and

refrigeration area. ● Vaccination area for patients.

● Observation area for patients - this need not be within the community pharmacy building but must allow for social distancing.

*Reconstitution should take place in a dedicated area separate from the administration to allow for aseptic techniques throughout the process. This area should be free from distraction and have wipe-

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able services and should have an appropriate disinfectant solution or wipes available. Before each reconstitution, the area should be disinfected and a sharps bin should be available with sufficient free capacity. Surgical face masks and hand sanitiser should be available in this section for the pharmacist who will be undertaking the reconstitution process.

Appendix 1A and 1B details the handling and recommendations for Comirnaty® (Pfizer BioNtech) COVID-19 Vaccine. Appendix 1B details the preparation of Comirnaty® (Pfizer BioNtech) COVID-19 Vaccine by a pharmacist. In the interest of safety and accountability, the pharmacist must personally carry out all of the activities involved in reconstitution, drawing-up and administering the vaccine. A second or double check of the dilution and preparation should be undertaken with a colleague, where possible, and recorded in the Comirnaty (COVID-19 vaccine) reconstitution record in Appendix 4 Equipment required for dilution of Comirnaty® (Pfizer BioNtech) COVID-19 Vaccine (this equipment will be provided by the HSE). ● One unopened/ undiluted vaccine vial (do not remove from the fridge until needed) ● Sodium chloride 0.9% (preservative free) solution for injection 10mL ampoule x 1 ● A 2.5ml, 3ml or 5ml Syringe x 1 ● 21 gauge green needle x 1 ● Sterile single use 70% alcohol antiseptic swabs x 2 ● Yellow Sharps Bin Dilution should be completed using Aseptic Non-Touch Technique (ANTT). Please also refer to the PSI guidance on providing a pharmacy vaccination services including guidance during the COVID-19 pandemic and providing vaccination services off site from the pharmacy premises. Particularly in relation to children, superintendent pharmacists and pharmacy owners are reminded of obligations under the Children First Act 2015. Risk Management Considerations are outlined in Appendix 7 when Covid -19 vaccines and flu vaccines are both in use in a pharmacy. Community pharmacy must have a pharmaceutical grade fridge and must be able to certify that the fridge meets required requirements as outlined in the PSI guidelines on the storage of medicinal products within a retail pharmacy business.

Community Pharmacy Staff Requirements The community pharmacy should have the following personnel available for the vaccination

programme:

● One staff member available for registration* ● One staff member for observation area* ● Pharmacist Vaccinator

*Depending on the size of the vaccination clinic, the registration staff member could also be the observation staff member. The supervising pharmacist together with the superintendent pharmacist and pharmacy owner should use their professional judgement to ascertain the appropriate staffing levels to provide a safe service. In determining the staffing levels, they should be cognisant on the need to gather patient details at registration, have appropriately trained staff available for the 15 minute observation period,* and be able to comply with all the infection control standards and the demands of the vaccination service in addition to the requirements of their ongoing service to patients.

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* In line with updated NIAC recommendations December 2021 –

* NIAC currently recommends that the 15-minute observation period following

administration of a homologous or heterologous booster COVID-19 mRNA vaccine can be temporarily waived.

This recommendation does not apply to those:

receiving a primary COVID-19 vaccine course, who should be observed for 15 minutes. with a history of anaphylaxis from any cause receiving a booster vaccine, who should

be observed for at least 30 minutes.

Read the letter NIAC sent to the CMO from this link - Waiver of 15 minute observation period post booster COVID-19 mRNA vaccine.

Workflow Considerations Covid-19 Recipient Vaccination Pathway

It is envisaged that Community Pharmacies will:

● Identify patient’s cohort and ensure that they are within designated group for receiving vaccine as per implementation strategy. Determine previous COVID-19 vaccination history via HSE Vaccination history Lookup Portal (please see Appendix 8 for guidance on how to log on and use the lookup tool).

● Set up initial and follow-on vaccination timeslots with patients (e.g., Monday 10-11:30am as per

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vaccination schedule for the individual vaccine and patient cohort guidance). ● Be informed of the vaccine that has been allocated by the HSE based on available supply ETA

(e.g., 50 doses to arrive next Monday). ● Contact patients to confirm appointment times and run through COVID-19 pre-screen.

● Receive vaccines from the NCCS as per agreed delivery schedule.

● Check, verify and accept the vaccine delivery ● Store correctly in fridge and monitor fridge temperature. ● Enter patient details and vaccine specific data (as relevant) on HSE PharmaVax (with

manufacturers, batch number and expiry date / use before date and time) (as per S.I. 698 of 2020).

● Pre-clinic setup (e.g., stock control, patient/clinic list). ● Patient arrival/reception. ● Patient registration (ID checks Please see Appendix 6 for guidance) ensure details are on HSE

PharmaVax (e.g., verify and update PPSN, mobile phone number and email address). Note

patient must have photographic ID in order to complete ID checks

● Verify patient consent and eligibility, ensure consent is provided by parent or legal guardian in

case of young person aged 12-15 years and record assent to vaccination of young person on

consent form.

● Vaccinate patient. ● Record and save details on the pharmacy record. ● Submit final details on HSE PharmaVax and fill in patient vaccination record card with batch level

detail. ● Patient waits 15 minutes if required in line with NIAC advice (or 30 minutes if clinically needed)

–ensure that they receive patient information leaflet. ● Treat and record any immediate adverse reactions (Report to HPRA).

● Book appointment for 2nd dose (if applicable).

● Complete HSE patient vaccination record card ● Arrange next appointment for individual if receiving dose 1 of a primary vaccination course ● If required, opportunistically vaccinate other patients – contingency list utilisation in line with

HSE implementation strategy (e.g., make use of vaccines that will otherwise expire). ● Treat and/ or refer as appropriate and record any later adverse reactions (Report to HPRA)

● Complete Post-clinic wrap up (e.g. number of patients vaccinated, stock used/cannot be used). ● Print daily audit of vaccinations completed using the report function in HSE PharmaVax – stamp,

date, and signed by vaccinating pharmacists. Retain this record within the pharmacy.

Contingency List Comirnaty® (Pfizer/BioNTech) COVID-19 mRNA Vaccine Community Pharmacy should book appointments in batches of 6-7 within a 6-hour session to ensure no wastage.

Spikevax® (Moderna) COVID-19 mRNA Vaccine Pharmacists should plan for 20 appointments of booster doses (for individuals over 30 years of age)

from each vial of Spikevax® (COVID-19 Vaccine Moderna) over a 19 hour period. This can include

using some doses the following day provided the vial is clearly labelled and remains within the

discard date/time. The discard date/time should be clearly labelled using the 24-hour clock format.

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Emergency Cover Community Pharmacists should have emergency cover arranged with a suitably trained colleague in case of any reason where they are unable to attend their practice to provide the vaccines.

Administering For the most up to date information on the administration of COVID-19 Vaccines please see vaccine specific information available on www.immunisation.ie and also follow the pharmacy specific SOPs. Pharmacists should keep up to date with the latest HSE clinical guidance document available on www.immunisation.ie https://www.hse.ie/eng/health/immunisation/hcpinfo/covid19vaccineinfo4hps/ and the information obtained in Appendix 1A and 1B.

Recovery Scheduling of people should allow for a safe space to observe the person for 15 minutes if required after the vaccine (30 minutes if they have a history of allergic reactions in line with NIAC advice). The Pharmacist should ensure that the person is provided with evidence of vaccination (vaccination record card) and aftercare information. The Pharmacist must be aware of signs and symptoms of adverse reactions and manage any that arise. For more information regarding anaphylaxis, please refer to: https://www.hse.ie/eng/health/immunisation/hcpinfo/guidelines/anaphylaxis.pdf The HPRA must be informed using the Adverse Reaction Report (Yellow) Card System available at: https://www.hpra.ie/homepage/about-us/report-an-issue/covid-19-vaccine-adverse-reaction.

The contraindications and precautions to vaccination, as per the recommendations of the National Immunisation Advisory Committee, are detailed in the clinical guidelines. These are available at:

https://www.hse.ie/eng/health/immunisation/hcpinfo/covid19vaccineinfo4hps/

Pharmacists should be aware of the risk of fainting particularly in hot weather and in younger patient cohorts.

Advice to minimise the risk can be found here: https://www.hse.ie/eng/health/immunisation/hcpinfo/covid19vaccineinfo4hps/considerations-for-prevention-and-management-of-syncope.pdf

Adverse Reaction Reporting The Health Products Regulatory Authority (HPRA) is responsible for managing the national pharmacovigilance system. The HPRA reports nationally occurring adverse reactions to the EMA. Adverse reaction reporting is an important part of the EMA intensive monitoring plan for COVID-19 vaccines, so that any changes in benefit risk balance can be promptly detected and acted upon. This enables the EMA to continue to safeguard public health safety. COVID-19 vaccines are subject to additional monitoring. This will allow quick identification of new safety information. You and your patients are encouraged to report any suspected adverse reactions to the HPRA following the instructions available on the HPRA website www.hpra.ie. As much information as is known should be provided, and where possible, the vaccine batch number should be included.

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Report any incidents during a vaccination session In the case of medication errors that directly involve the vaccine recipient, i.e., wrong medication/dose/route being administered or another medication error, the incident must also be recorded in your pharmacy incident records and a full investigation should be undertaken to identify the root cause of the incident. The vaccine recipient and/or significant others should be informed of the incident. The national immunisation office will be able to advise on required follow up contact using immunisation@hse.ie do not use patient identifiers in this communication.

Any suspected adverse reactions associated with medication errors should be reported to the HPRA.

Consent

For specific information on consent for those aged 16 years and over, please see Consent for Vaccination for COVID-19: Guiding Principles at: https://www.hse.ie/eng/health/immunisation/hcpinfo/covid19vaccineinfo4hps/

A module on HSEland has been developed to provide advice and guidance on the process for gaining consent from parents and legal guardians of 12-15 year olds to support the programme. We strongly recommend that any pharmacist offering vaccine to this age group views this module on https://lms.hseland.ie/ (search for Covid-19 Vaccine Training Programmes and complete the programme). Pharmacists must be aware of who can give consent to a young person aged 12-15 years: https://www.hse.ie/eng/health/immunisation/hcpinfo/covid19vaccineinfo4hps/who-can-give-consent-for-young-people-aged-under-16.pdf

● Patients aged 16 years and above can provide their own consent.

● Consent for children in the age cohort 12-15 must be given by the parent/legal guardian.

An adult who is legally able to consent for the child will need to be present and provide consent for the child aged 12-15 at the time of the vaccination appointment. They should complete and sign the HSE consent form. A child cannot attend this appointment alone. The child should also be asked to assent to the vaccination which must be recorded on the consent form. A child who does not assent should not be restrained or vaccinated against their will.

A new leaflet, consent form, guidance on who can give consent, a frequently asked questions document and decision aid for parents to support them in the decision on whether to vaccinate their 12-15 year old are available on the HSE website https://www.hse.ie/eng/health/immunisation/hcpinfo/covid19vaccineinfo4hps/prog1215/ These materials, along with a consent form for 12-15 year olds will be circulated to pharmacies. This consent form should be completed and retained securely within the pharmacy

HSE PharmaVax will allow the Pharmacist to record that the patient has or has not consented, or their parent or legal guardian has provided consent (i.e. consent = yes or ‘for their benefit and according to will and preference’ as per Appendix 5 below). The patient’s medical eligibility must be assessed before consent. Particular care should be taken in cases where the patient is not well known to the pharmacist and where there is a question as to capacity.

The consent will be sent electronically from the HSE PharmaVax portal to COVAX along with details of the vaccine administered, on an almost real-time basis.

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The Pharmacist should keep a note if a patient does not consent & the reason for non-consent in their local records.

ICT Community Pharmacies engaged in the COVID-19 vaccination programme must have access to the Internet and a Healthmail account. A national ICT Solution has been developed to support the community pharmacy administered COVID-19 vaccination programme. This solution is called HSE PharmaVax. HSE PharmaVax allows pharmacies to record details of, and claim reimbursement for, COVID-19 vaccinations that are administered. The portal is used to record vaccination events. It is not a tool to be used to support clinical decision making. It does not have scheduling functionality. Note: Please do not enter any “test” vaccinations on the system as these will be treated as bona fide records.

Accessing the portal

● Log in at https://www.services.hse.ie preferably at the same computer where you normally access Healthmail.

● Log in using your Healthmail address & password. ● Once logged in, a verification code will be sent to the alternative email account associated

with your Healthmail account. Please check this account for the code and enter at verification stage.

Verification Code

● Required on first login daily. ● Sent to alternative email address registered with your Healthmail account. ● Check junk/spam/promotions folders if it cannot be found in inbox

T&Cs

You must accept the Confidentiality Notice, Terms and Conditions, Cookies and Data Sharing Agreement in order to access the portal.

When setting up your pharmacy on the HSE PharmaVax system you will be asked for a number of details these include the following:

● Pharmacy PSI number ● Pharmacy GMS contract number ● National Cold Chain Account Number

National Cold Chain Account The cold chain account number can be obtained from a recent invoice. This is not a United Drug customer number and can only be found on a NCCS order confirmation or invoice. It is 7 digits long and

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begins with a 3, it can be found on top right of NCCS invoice please see yellow box in image below.

You can alternatively obtain your cold chain account number by logging into your cold chain account and looking at the top right-hand side of the screen

https://ordervaccines.ie/Account/Login?ReturnUrl=%2F

Individual Health Identifier (IHI)

An Individual Health Identifier is a number that identifies each person who has used, or may use a health

or social care service in Ireland. Each individual will be assigned their own personal number which is

unique to them. The main benefit of having an Individual Health Identifier is to uniquely identify each

service user and therefore, improve patient safety by reducing errors that might happen, such as

ensuring patients receive the correct medication, vaccinations, and treatment. The IHI is established

first and foremost as a patient safety mechanism.

Phase 1

The first phase of HSE PharmaVax will enable pharmacists to:

● Register people for the COVID-19 vaccination programme and record required patient

identifiers as outlined in the legislation.

● Record their PPSN and contact details

● Record their eligibility and consent.

● Record the batch number and expiry/’use by’ and time (if required for individual vaccines)

date of each vaccine administered.

Phase 2

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The second phase will include some additional features such as:

● Automatically communicate electronic vaccination details to the COVID Immunisation System

(COVAX).

● Automatically communicate electronic payment claims to PCRS.

● Vaccination History Lookup to allow you to search for vaccination records on COVAX.

Phase 3

The third phase will include the ability to record a Booster dose to

Healthcare Workers from 17th November 2021

Other cohorts as determined by the HSE as the Booster campaign rolls out.

N.B. In all circumstances, there must be at least a 3 month period between last

dose administered and the Covid Booster Vaccine. (As applicable, at least 3

months post a previous confirmed COVID-19 infection.)

Technical Support

Technical support is available Monday - Friday from 8 am - 8 pm. Please note if emailing the

a2ihids.support@healthmail.ie account you will need to do so from your Healthmail account.

Technical Support

Support Query Email Phone number

Healthmail Password Issues ictsupport@three.ie 1800 800 002 (option 2)

Verification Code Issues ictsupport@three.ie 1800 800 002 (option 2)

PSI Details Update ictsupport@three.ie 1800 800 002 (option 2)

Usability Queries

a2ihids.support@healthmail.ie 087 1056654

087 2941377

System Issues

a2ihids.support@healthmail.ie

087 1056654

087 2941377

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Vaccination History Lookup Portal

The Vaccination History Lookup will check if the patient/client has previously been identified as a Healthcare Worker and already has a vaccination record, where it exists on the COVAX system. In cases where only one dose has been administered, the system will alert the Community Pharmacist, at which point it should be manually validated. A step by step guide to set up can be found in Appendix 8 Accessing the portal

● Login at https://www.services.hse.ie preferably at the same computer where you normally access Healthmail.

● Login using Healthmail address & password. ● Once logged in, a verification code will be sent to the alternative email account associated

with your Healthmail account. Please check this account for the code and enter at verification stage.

Verification Code

● Required on first login daily. ● Sent to alternative email address registered with your Healthmail account. ● Check junk/spam/promotions folders if it cannot be found in inbox

T&Cs You must accept the Confidentiality Notice, Terms and Conditions, Cookies and Data Sharing Agreement in order to access the portal. How to Search for a patient

● Patient first name, last name, DOB and gender are mandatory. ● Either PPSN or mobile number must be completed.

Browser

● Google Chrome, Firefox and MS Edge (latest version) are the recommended browsers. ● Internet Explorer is not recommended. Chrome is preferred.

Time Out Period System will automatically log you out after 30 minutes of inactivity. Logging out To logout of the application click the 'Log out' button on the top right corner of the home page and then click on 'X' on the browser tab to close the session.

Fees, Contractual Arrangements & Reimbursement

Fees

Following a process of consultation involving the Department of Health, the HSE and the Irish Pharmacy Union, the Minister for Health, with the consent of the Minister for Public Expenditure, pursuant to

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Section 42 of the Public Service (Pay and Pensions) Act, 2017 has determined a schedule of fees rates be paid to Pharmacists for the delivery of the COVID-19 Vaccination Programme. Please see: www.hse.ie/eng/staff/pcrs/circulars/pharmacy/pharmacy-circular-vaccination-programme-nco-03-2021.pdf for agreed schedule of fees.

Reimbursement The Primary Care Reimbursement Service (PCRS) will receive, process, and integrate electronic COVID-19 vaccination payment claims from HSE PharmaVax to ensure that Community Pharmacists are paid promptly for services provided with minimal administration overhead. Payments will be based on the electronic claims which are submitted by the vaccinations recorded in HSE PharmaVax. Payment claims will be validated, loaded, reimbursed, and included on the pharmacies monthly statement.

Each patient will be asked to bring their PPSN (if they have one) when attending for vaccination, so that a valid PPSN can be submitted with each electronic claim to facilitate automated payment by the PCRS. Claims for the small number of people that do not have a PPSN (e.g. an international worker posted in Ireland for a short term project) will be processed by PCRS using an exceptional reimbursement process. Claims for the people who do not bring their PPSN to the pharmacy will be reimbursed when the pharmacy acquires the PPSN from that person.

Notes on PPSN to Support Queries What is a PPSN? It is a person’s Personal Public Service Number. A PPSN is always seven numbers, followed by either one or two letters. Why does the Vaccination Programme need a PPSN? The PPSN is required to assist in retrieving a unique IHI (Individual Health Identifier) from the National Register of Individual Health Identifiers. The IHI will be used to uniquely identify a person for vaccination purposes. Where can a person find their PPSN? It is on the following documents: · Public Services Card · Medical Card or GP Visit Card · European Health Insurance Card · Drugs Payment Scheme Card · Payslips received from an employer · Correspondence from the Revenue Commissioners or the Department of Social Protection What if they cannot find their PPSN? Due to the public health emergency, a person should make every effort to locate their PPSN using the sources above. If they have checked all of the sources suggested and still cannot locate their PPSN, they can contact the DSP (Department of Social Protection) at 071 9672616 / 1890 927999 If they are under 18, their parent or guardian will have to make this contact on their behalf. Guidance for those who do not hold a PPSN (exceptional process)? To facilitate reimbursement through an exceptional process for those who genuinely don’t have a PPSN please ensure that a minimum you retain a record in the pharmacy of the Name/Address/Date

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Of birth/Place of Birth/mobile number. In cases where a patient does not have a PPSN, they will have to provide further documentation as set out below.

1) Photo-id including date of birth And

2) Proof of Address: A current utility bill (e.g. electricity/phone/gas) in your own name, showing your current address, or other evidence of your address. If your bill is not in your name, please ensure the bill payer confirms that you are living at the address by either writing on the bill or attaching a separate note. – required for proof of address And One of the documents below (some of which are sufficient as photo-id) If you were born (or birth was registered) outside the Republic of Ireland

UK – current passport or your full birth certificate and current full driving licence

EU/EEA* (other than Irish and UK) – current passport or national identity card

Non EU/EEA* - current passport or 1951 travel document

Irish citizen via naturalisation – current passport or certificate of naturalisation

Foreign Births Registration – your Foreign Births Registration certificate if you were born abroad and received Irish citizenship by means of Foreign Births Registration

*EEA = EU countries and Iceland, Liechtenstein, Norway, Switzerland

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Appendix 1A– Overview of Handling Requirement for Comirnaty (Pfizer/BioNTech) COVID-19 Vaccine Please refer to the Summary of Product Characteristics and the following resources Comirnaty® (Pfizer BioNTech) COVID-19 mRNA Vaccine available from the NIO website:

● Comirnaty® (PfizerBioNTech) Summary Sheet ● SOP – Pharmacy Comirnaty® COVID-19 Vaccine ● Preparing Comirnaty® (PfizerBioNTech) COVID-19 mRNA Vaccine Version 3.0

Overview of Handling Recommendations for the Comirnaty® (Pfizer/BioNTech) Vaccine

Receiving vaccine from National Cold Chain Service (NCCS)

Diluting and labelling vaccine in pharmacy preparation area

Drawing vaccine into syringes Administering vaccine and completing record

Step 1: Receive vaccine from NCCS Step 2: Dilute and label vaccine Step 3: Draw vaccine from diluted vial into syringes Step 4: Vaccinate and complete record

Transfer vaccine from delivery area to refrigerated area – maintain cold chain conditions Enter batch specific information into the HSE PharmaVax system – Batch number, use before date and time. Sodium chloride 0.9% diluent batch information should also be entered into HSE PharmaVax, expiry date and batch number. Place in temperature-monitored pharmaceutical fridge in dispensary.

Confirm pre-dilution “use before” date and time of vial has not expired Dilute vaccine vial with 1.8ml of Sodium Chloride (0.9%) - gently invert 10 times before and after dilution Confirm liquid is white to off-white - no discolouration / non-standard particulate matter Post dilution, vaccine vial is stable for six hours - at room temperature Label the diluted vial with the date and discard time (6 hours after time of dilution) using a 24 hour format. e.g. vail diluted at 10.00 01/01/2021 discard time is 16.00 01/01/2021.

Confirm post-dilution date and “discard time” has not expired - dilution was within last 6 hours Use a new sterile syringe for each drawing of the vaccine - before each drawing clean top of vial with single use 70% alcohol swab (allow to air dry) Draw exactly 0.3ml of vaccine into the syringe – up to 7 complete 0.3ml doses can be drawn from each vial

Confirm post-dilution date and “discard time” has not expired - dilution was within last 6 hours Verify volume is 0.3ml Administer vaccine - dispose of used needle and syringe in sharps bin Complete vaccination record in the HSE PharmaVax system When all doses administered, deface the vial label with permanent marker to ensure they cannot be misused, prior to safe disposal. At end of session, complete the NIO vaccine reconciliation form

Vaccines should be stored in the fridge in original packaging in an upright position - until they are required for step 2 If transferring vials onsite - maintain cold chain conditions - vials must be upright - vials must not be touching

Pre-dilution, vaccine vials are stable at room temperature up to +30oC for two hours – reconstituted vial is stable for six hours

Doses drawn up in syringes should be used as soon as possible - must be used within 6 hours of dilution of the vial.

For all steps, keep vials in upright position, avoid any shaking / knocking of vials and ensure temperature is controlled

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Appendix 1B – Overview of preparation of Comirnaty (Pfizer/BioNTech) COVID-19 Vaccine (see Preparing Comirnaty® (PfizerBioNTech) COVID-19 mRNA Vaccine Version 3.0 for full information https://www.hse.ie/eng/health/immunisation/hcpinfo/covid19vaccineinfo4hps/preparecomirnaty.pdf)

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Appendix 2 - (Appendix VIII of NIO Cold Chain Guidance)

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Appendix 3 – Sample Checklist for COVID-19 Vaccination Clinics Note: This is a support document for the safe practices for COVID-19 vaccination. Additional requirements may arise based on the type of vaccines, cohort of vaccinators, recipients, and location of the clinics. For specific information relating to PPE and hand hygiene, please see: https://www.hpsc.ie/a-

z/respiratory/coronavirus/novelcoronavirus/guidance/pharmacyguidance/Interim%20guidance%20to%20minimise%20the%20risk%20of%20transmission%20of%20COVID-19%20infection%20in%20pharmacies.pdf

https://www.thepsi.ie/Libraries/Standards/Covid-19_Operational_Standards_for_Pharmacies.sflb.ashx

Before the Vaccine clinic

Physical Environment / Layout of the Vaccine clinic

YES NO A designated space for registration

YES NO Awaiting area for patients to be called for vaccination. This may be the same space as for Registration

YES NO A designated clean area for vaccine storage and preparation (dilution) in the pharmacy

YES NO A designated area for vaccine administration

YES NO Area for post vaccine observation for 15 minutes (30 minutes if they have a history of allergic reactions) with adequate space for physical distancing and a private space for medical emergencies (anaphylaxis management)

Documentation (Check for most up to date version of documents www.immunisation.ie)

YES NO Clinical and administrative guidance for Vaccinators

YES NO National immunisation Advisory Committee Immunisation Guidelines for Ireland. https://www.hse.ie/eng/health/immunisation/hcpinfo/guidelines/covid19.pdf

YES NO Copy of a relevant COVID-19 vaccine standard operating procedure

YES NO Anaphylaxis management in the community- Copy of an algorithm https://www.hse.ie/eng/health/immunisation/hcpinfo/guidelines/anaphylaxis.pdf

YES NO Copy of information on Cold chain management or access to the same https://www.hse.ie/eng/health/immunisation/hcpinfo/vaccineordering/

YES NO Vaccination record cards and HSE advice leaflets for after vaccination for the recipients (if hard copies are available)

YES NO Current up to date copies of: HSE vaccine information leaflets and European Medicines Agency Patient Information Leaflets (please see www.ema.eu/en for most up to date version)

Infection Prevention & Control Precautions:

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YES NO Posters in relation to COVID-19 Do NOT visit if you have symptoms of COVID-19

Physical distancing Cough etiquette/respiratory hygiene Posters are available from the HSE website

YES NO Hand Sanitiser (alcohol gel/foam sanitiser) for staff and patients

YES NO PPE for the vaccinator i.e. adequate stocks of surgical face masks

YES NO Disposable tissues available for patients and a foot pedal bin for disposal

YES NO Disinfectant wipes for worktops and other areas

YES NO Signs and floor markers to instruct patients to remain 2 metres apart from other patients and clinic staff have been set up before the clinic.

YES NO Appropriate seating arrangements with physical distancing markings displayed

YES NO Sharps waste bin, Clinical & Nonclinical risk waste bins

Clinical equipment

YES NO Access to pharmaceutical grade fridge with a display of current temperature

YES NO An anaphylaxis medical kit as per Guidelines (https://www.hse.ie/eng/health/immunisation/hcpinfo/guidelines/anaphylaxis.pdf )

YES NO Gloves □ Sharps boxes □ Alcohol Gel □ Clinical Tray □ Cotton wool □ Tape □ Clinical waste bags □ 70% Alcohol swabs □needles □syringes

After the vaccination

YES NO Post-vaccination monitoring (recommended for 15 minutes or 30 minutes if patient has a history of allergic reactions): Allocation of staff for post vaccine observation for 15 -30 minutes. The IPU has designed a time to leave ticket to enable community pharmacists to manage this process.

YES NO Post vaccine documentation Vaccinations administered recorded in HSE COVID-19 Vaccination Management System via HSE PharmaVax

YES NO All patient medical information placed in a secured storage location for data protection. Provide patient with a card detailing the vaccine that they received and when they are due their second dose, as applicable

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Appendix 4 – Comirnaty (Covid 19 vaccine) Reconstitution

Date of Preparation: ________________

Time of Dilution:

Discard Time:

(Note: Discard Time = Time of dilution + 6 hours)

Product Manufacturer Batch Number Expiry Date Sig 1 Sig 2

Comirnaty vaccine Pfizer/BioNtech

Sodium Chloride 0.9% B Braun

Method

Step Signature 1 Signature 2

1. Remove from box

2. Invert 10 times

3. Inspect liquid for particulates in vial

4. Remove cap and clean bung of vaccine vial & Sodium Chloride 0.9% vial

with 70% alcohol swab. Allow to dry

5. Draw up 1.8ml of Sodium Chloride 0.9%

6. Add 1.8ml of Sodium Chloride to Comirnaty vial and withdraw 1.8ml of air

7. Invert 10 times

8. Check for particular matter

9. Note time and complete documentation

10. Complete documentation

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Appendix 5 – Patient Consent Checklist

When a patient aged 16 years and above attends their community pharmacy and is offered COVID-19 vaccination, the pharmacy will use the following Consent Checklist to select the appropriate consent response. The response is then recorded on HSE PharmaVax.

One of these options is appropriate when establishing consent:

● Yes, I confirm this person has given me their consent to be vaccinated to protect against COVID-19. They have read and understood the vaccine information provided, including known side effects.

OR

● No, I confirm this person has informed me that they do NOT consent to be vaccinated to protect against COVID-19. They have read and understood the accompanying vaccine information, including risks of not vaccinating.

OR

● I confirm that this person cannot consent and they are being vaccinated against COVID-19 for their benefit and according to their will and preference, and the above is recorded in their healthcare record and includes information about any consultation that has taken place to help determine their will and preference.

For young people aged 12-15 : Parents should be supported to make the best choice for their child- there are patient information leaflets and a decision aid available to support this in pharmacy. There is a new consent form for vaccinating 12-15 year olds available on the NIO website too. https://www.hse.ie/eng/health/immunisation/hcpinfo/covid19vaccineinfo4hps/prog1215/ Only the person who can legally give consent on behalf of the child can attend the appointment with them so they can give consent at the appointment. Pharmacists will need to document the name of the person giving consent and their relationship to the child. The consent covers both doses unless consent is withdrawn by the parent/legal guardian. Other important reminders:

● Only certain people can give consent for a child e.g. legal guardian. See this information on who can give consent for a child under 16 https://www.hse.ie/eng/health/immunisation/hcpinfo/covid19vaccineinfo4hps/who-can-give-consent-for-young-people-aged-under-16.pdf

● Remember to get assent from the child before vaccinating and ● Undertake the HSELand consent module in this age group available here-

https://lms.hseland.ie/ (search for Covid-19 Vaccine Training Programmes and complete the programme)

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Appendix 6– Guidance on Photographic ID

Patients are required to bring photographic ID and this must be validated. The HSE acceptable forms of identification are provided below:

● passport - book or card

● driving licence

● Public Services Card

● travel pass

● National Age Card - issued by the Gardaí

● identification form with a photograph signed by a member of the Gardaí - get this from a Garda station

For those aged 12-15 years old where photo ID is not available a birth certificate is sufficient as proof of age

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Appendix 7: Risk Management Considerations when multiple vaccines are in use in a pharmacy.

Introduction

The administration of booster doses for COVID-19 vaccines is ongoing. This coincides with the seasonal flu vaccination programme. Internationally, there have been multiple reports of administration mix-ups between COVID-19 vaccines and flu vaccines1. Note that vaccine requirements for recipients may vary:

Some may require COVID-19 vaccine only

Some may require flu vaccine only

Some may require both COVID-19 vaccine and flu vaccine Note that there are different types of COVID-19 vaccines in use with different doses and different age cohorts and there are also different types of flu vaccines in use, increasing the complexity of the process. Effective planning for safe and robust workflow practices is required. No one single step will eliminate the risk and an active approach to risk reduction is required at all steps in the process from scheduling, to arrival/ registration at the pharmacy, to vaccination and record keeping.

Key steps to reduce risk

Schedule vaccine-specific days or sessions where possible;

Training to ensure awareness of the risks of multiple vaccines being in use is required for all

staff involved in any of the steps in the process, even if not working as a vaccinator.

Avoid the use of the term ‘booster’ without specifying which vaccine;

A second independent check on the vaccine(s) to be administered

and/or

Ask the vaccine recipient to read the syringe label / vial aloud to confirm the correct vaccine.

COVID-19 Vaccines Confirm vaccine type with recipient at check-in, consent and immediately prior to administration;

and please check before each vaccination:

Is this a primary course, an additional dose for a person who is immunocompromised or a booster dose?

What is the age of the person? What is the recommended vaccine for this age-group? What is the recommended dose? What is the recommended interval since the last dose? Has the person had COVID-19 infection? What is the recommended interval since

laboratory-confirmed COVID-19 infection? Correct Dose selection for Spikevax (Moderna)

0.25ml booster dose OR 0.5ml dose for primary vaccination (1st or 2nd dose) or for 3rd dose for immunocompromised

1 https://www.ismp.org/alerts/mix-ups-between-influenza-flu-vaccine-and-covid-19-vaccines

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Ensure the correct patient information is available for the vaccine in use for the primary vaccination programme and/or the booster programme as appropriate.

COVID-19 Vaccines and Flu Vaccines If provision is being made to administer both COVID-19 and flu vaccines at the same appointment ensure that:

Only the required vaccine(s) for the individual recipient are taken into the vaccination area;

and

Two vaccines are given in two different arms

- one vaccine in right arm and other vaccine in left arm.

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Appendix 8 – HSE PharmaVax Vaccination Recording

Primary Course & Booster Vaccination Administration Recording – New Features A ‘Course’ dropdown menu has been added to the Add Vaccination screen to allow users to choose between recording a Primary Course or a Booster Course vaccination. Booster course selection is limited to mRNA vaccine products at present.

Restriction is in place to prevent a user from recording more than one Booster Course Dose 1 vaccination record for a given client.

Restriction and warning is in place to prevent a user from recording a Booster Dose vaccination for a client before the minimum interval of 2 months from last recorded authorised COVID vaccination has elapsed. The User cannot override this.

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A warning message is displayed if a user tries to record a Booster Dose vaccination for a client before the recommended interval of 3 months from last recorded authorised Covid vaccination has elapsed. User can still proceed to save the Booster Dose if this is clinically-indicated, prior to 3 months.

The user will be asked to confirm that a client has received their full Primary Course when they are saving a Booster Dose vaccination if the system detects that there is no/partial Primary Course vaccination records for that client. User can still proceed to save the Booster Dose if they are satisfied client has received their full Primary Course elsewhere.

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Vaccination History Search – New Features Click on the Search Tab to access the Vaccination History Search. This allows the user to search for a vaccination record in the National COVID-19 Vaccination Records System (Covax).

These above fields must be populated with the correct information in order to search a Client’s Vaccination Record in the National COVID-19 Records System (COVAX). Either the Client’s PPSN or Mobile Phone Number is required.

The Mobile Number must be in the format 003538XXXXXXXX. Click Search when the correct information has been entered. When valid search criteria are entered, the data returned is from the National COVID-19 Vaccination Records System (Covax). The record will indicate if the Client is a Healthcare Worker or not. It will also indicate the vaccination records held for the Client: including any primary course vaccinations, any additional doses (for immunocompromised Clients) and any booster doses administered. The search result also shows where the source record(s) emanated from, i.e. Mass Vaccination Centre (MVC), Pharmacy or GP (inc. GPVax), which is detailed in the Source System Group field.

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The system has been updated to enable Administration records of Spikevax (Moderna®) to be displayed.

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24 March 2022 update to enable recording of Booster vaccine to 12-15 year old children

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HSEPharmaVax User Guide The latest User Guide for HSE PharmaVax can be found below:-

PharmaVax User Guide v3.5.1.docx

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Appendix 9 Spikevax (Moderna®) COVID-19 Vaccine Overview

Please refer to the Summary of Product Characteristics and the resources available from the NIO website for full information:

STEP 3. Preparation and administration of one dose of vaccine

Note: The maximum number of times a vial can be pierced is 20. Any remaining residual volume should be discarded. Printing of leaflets is challenging over the Christmas period but relevant resources are available at https://www.hse.ie/eng/health/immunisation/hcpinfo/covid19vaccineinfo4hps/a4-covid-19-vaccine-posters-cvcs-moderna-copy.pdf

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Access to this platform is reported to be challenging through the HSE Website. Pharmacists may find it easier to access through the PSI website

https://www.thepsi.ie/Libraries/COVID/guide_for_community_pharmacists_to_access_HSEland.sflb.ashx

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