RSV and Pertussis Vaccination Service – FAQs

Q. Can all pharmacies provide the RSV and Pertussis Vaccination Service?
No. NHS England, working with Integrated Care Boards will first decide if they have an unmet population need. Where this need is identified, they will then consider if a pharmacy service would assist with local provision or improved uptake. If they wish to commission a pharmacy service, they will put the service out to tender and will select providers from qualifying successful applicants who they identify as best able to meet the local identified needs.

Q. Why are all GPs commissioned to administer the RSV vaccine?
Provision of vaccinations, including RSV vaccinations, is an Essential service within the General Medical Services contract, which means all practices must offer the service.

Q. What insurance should you have for the RSV and Pertussis Vaccination Service?
All usual insurance requirements apply to the service, including professional indemnity insurance. If you are planning to tender to provide the service, advice should be sought from your insurance provider.

Q. My pharmacy doesn’t have a consultation room; can I provide the RSV and Pertussis Vaccination Service?
No. Having a consultation room is a prerequisite for provision of the RSV and Pertussis Vaccination Service. Vaccinations can be offered in any area of the pharmacy where suitable facilities are available and patient confidentiality is able to be respected. However, the vaccination must take place in the consultation room wherever the patient expresses this preference. The consultation room must comply with the requirements in the Terms of Service.

Q. Does a pharmacy owner have to make a ‘prescription register’ entry for each administration of vaccine under the patient group directions (PGD)?
No. The records required to be maintained by the PGDs, made on the date of administration meet the requirements to make records in the Human Medicines Regulations.

Q. Do pharmacists, pharmacy technicians (and other individuals authorised to work under the PGDs) have to sign a copy of the PGDs?
Yes, pharmacists, pharmacy technicians (and other individuals authorised to work under the PGDs) must sign a copy of the PGDs to indicate that they understand the PGD requirements and agree to work under those requirements.

Q. Can the PGDs be signed remotely (electronic signature) by the authorising manager, for example, from the pharmacies’ head office for all their pharmacies?
Yes. It is possible for the PGDs to be signed remotely (electronic signature); however, the authorising manager still needs to be able to confirm the pharmacist, pharmacy technicians (and other individuals authorised to work under the PGDs):

• • Are aware of the service specification and requirements for provision of the service;

• • Can demonstrate their competence to provide the service and has printed and signed the statement of declaration (pharmacist and pharmacy technician only); and

• • Has the organisation’s approval to provide the service.

Q. Should a copy of the signed PGDs be kept at the pharmacy for each pharmacist, pharmacy technician (or other individuals authorised to work under the PGD) providing the service at the pharmacy?
Yes. The PGDs states that a copy of the PGD with the completed practitioner authorisation sheet should be retained and available at the pharmacy premises as a record of those practitioners authorised to work under the PGDs.

Q. Does a pharmacy owner need to keep evidence of vaccinator competency for all individuals that deliver the RSV and Pertussis Vaccination Service?
Yes. The service specification states that pharmacy owners must keep evidence of competency relating to any staff that they employ/engage to deliver the service.

Q. What is the legal basis for the administration of vaccinations in the RSV and Pertussis Vaccination Service?
The PGDs associated with the service provide the legal authority for administering the vaccines.

Q. Can a nurse administer the vaccine as part of the service?
Yes. Nurses must only provide the service under the supervision of a pharmacist, trained in vaccinations (including a clear understanding of this service).

Q. Can a pharmacy technician administer the vaccine?
Yes. Pharmacy technicians must only provide the service under the supervision of a pharmacist, trained in vaccinations (including a clear understanding of this service).

Q. Can pharmacy technicians supervise NHS vaccination services in a community pharmacy?
No. When pharmacy technicians were added to the list of professionals able to operate under a PGD, there was no change to the clinical supervision requirements. This is in keeping with other registered healthcare professionals legally able to operate under PGDs but not able to act as a clinical supervisor, such as physiotherapists, occupational therapists and paramedics.

Q. Can a pharmacist providing the service and qualified as an independent prescriber prescribe the vaccine for patients, rather than using the national PGD?
No. The Enhanced service only uses the PGDs to authorise administration of the associated vaccines.

Q. Do the NHS PGDs authorise administration of the vaccine for other patients not covered by the NHS eligibility criteria (i.e. as a private service)?
No. In addition, vaccine stocks for the service will be centrally procured and must only be used for provision of NHS vaccinations as part of the service.

Q. Do pharmacists, pharmacy technicians (or other individuals authorised to work under the PGD) have to send copies of the signed PGDs to NHS England or another organisation?
No. The signed PGDs should be retained in the pharmacy where the pharmacist, pharmacy technician (or other individuals authorised to work under the PGD) is administering vaccines.

Q. Can a pharmacy company with multiple pharmacies nominate one authorising manager for all pharmacists (and other individuals authorised to work under the PGDs) signing the PGDs, for example, the superintendent pharmacist?
Yes, as it is for the pharmacy owner to determine who should be an authorising manager within their organisation.

Q. Who should complete the authorising manager declaration section on the PGDs?
It is for the pharmacy owner to determine who should be an authorising manager within their organisation. The authorising manager’s role is to confirm that individuals providing the service:

• • Are aware of the service specification and requirements for provision of the service;

• • Can demonstrate their competence to provide the service; and

• • Has the organisation’s approval to provide the service.

In certain circumstances, for example, a community pharmacy where the pharmacist who will administer vaccines is also the superintendent pharmacist or pharmacy owner, it may be necessary for the authorising manager to be the same person as the practitioner, though this situation should be avoided wherever possible.

Q. What are the knowledge and skills required in order to provide a vaccination service?
The National Minimum Standards and Core Curriculum for Immunisation Training for Registered Healthcare Practitioners set out the knowledge and skills that healthcare professionals undertaking vaccination services need to have. Within the service specification, NHS England will determine any other additional training and the frequency of this that will be required to safely provide the service.

Regarding face-to-face training and basic life support training, it is for pharmacy owners and vaccinators to consider when it would be appropriate to attend refresher training or if ongoing competence of an individual vaccinator can be evidenced, without the need for face-to-face training.

An individual’s continued competence may be influenced by their prior experience vaccinating patients, including the overall number of vaccines administered and the regularity with which they administer vaccines.

The standards recommend that immunisers should keep a portfolio of completed competency checklists, knowledge test score sheets, reflective logs, completion of e-learning course certificates and certificates of attendance at immunisation training courses and updates. This will provide vaccinators with a means to be able to show evidence of completion of training and achievement of competence to both current and future employers. It will also provide useful evidence of continuing professional development for professional revalidation.

Q. Where can I undertake training to provide vaccination services?
A range of organisations provide training on vaccination. Some LPCs have arranged training, so you may want to check with your LPC about the availability of local training. A list of training providers is also available on the Community Pharmacy England website.

Q. Is there any other training I should consider?
As well as training specifically on vaccination provision and that associated with the specific vaccines being provided, pharmacy owners and individuals should consider training for themselves or their team on topics such as consultation skills or first aid, or even marketing or time management, as these may better equip them to provide the service. The core vaccination training will cover matters such as management of allergic reactions and the patient consultation.

Individuals may also wish to consider training to support their awareness and understanding of their responsibilities under the Mental Capacity Act. Support with this topic can be found on the Social Care Institute of Excellence website where there are a range of training resources.

Q. The Vaccination services declaration of competence (DoC) provides a list of recommended learning and assessments; should all of these be completed?
This is a decision that needs to be made by the individual pharmacy professional. A pharmacy professional is personally responsible for keeping their knowledge and skills up to date and relevant to their roles and responsibilities. Working through the DoC system provides a pharmacy professional with the opportunity to reflect on their current competencies and identify and meet their learning and assessment needs.

The list of recommended learning and assessments will help pharmacy professionals to fill any gaps in their knowledge or competence to provide the RSV and Pertussis Vaccination Service.

Q. I completed the DoC two years ago. Do I need to complete it again?
Yes, if this is your chosen method to confirm your competency. The DoC framework and statement of declaration need to be completed every two years. Alternatively, competence can be assessed in another way, such using alternative vaccination competency assessment tools where available.

Q. Who does the recommendation for a period of supervised clinical practice apply to?
The National Minimum Standards and Core Curriculum for Immunisation Training for Registered Healthcare Practitioners document states that those new to immunisation should receive comprehensive foundation immunisation training, either through a face-to-face taught course or a blended approach of both e-learning and a face-to-face taught course. New immunisers should also have a period of supervised practice and support with a registered healthcare practitioner who is experienced, up to date and competent in immunisation.

Q. Does the recommendation for a period of supervised clinical practice apply to pharmacy professionals who have previously been trained to vaccinate?
If you have vaccinated patients in the past and consider yourself to be an experienced vaccinator, supervised practice would only be required if you feel it would benefit your professional practice, for example, if a long duration of time has passed since you last vaccinated patients.

Q. What is the idea behind undertaking a period of supervised practice?
In addition to acquiring knowledge through a theoretical taught course, practitioners need to develop clinical skills in immunisation and apply their knowledge in practice. A period of supervised practice will allow acquisition and observation of clinical skills and application of knowledge to practice when the practitioner is new to immunisation.

Q. What happens during a period of supervised practice?
Before starting to give immunisations, it is recommended that all new immunisers should spend time with an experienced registered practitioner, such as an experienced pharmacist immuniser, who has undertaken training that meets the national minimum standards and is experienced in advising about immunisation and administering vaccines. The new immuniser should have the opportunity in these sessions to observe and discuss relevant issues with the experienced practitioner.

Those new to their role in immunisation should also demonstrate an appropriate standard of practice to their supervisor. This supervised practice should be structured and robust and follow a clear, comprehensive checklist so each step of the consultation is considered. A competency checklist such as that included in Appendix A of the National Minimum Standards and Core Curriculum for Immunisation Training for Registered Healthcare Practitioners should be used for formal assessment and sign-off of the practitioner’s clinical competency in immunisation. A copy of the completed checklist should be retained in the practitioner’s personnel file.

Q. How long should a period of supervised clinical practice be?
The UK Health Security Agency (UKHSA) advise that there is no agreement or evidence as to how many times supervised practice should occur, but both the supervisor and new practitioner need to feel confident that the practitioner has the necessary skills and knowledge to advise on and/or administer vaccines. If the practitioner administers a range of different vaccines to patients of different ages, their supervisor should ensure this is considered and they should be given the opportunity to observe and be assessed on this range.

Q. Are there any qualifications which apply to the experienced healthcare practitioner?
The supervisor does not require a formal teaching and assessing qualification but should be competent in immunisation and can make an assessment of a new immuniser’s knowledge and skills. One of the supervisor’s key roles is to go through the assessment document with the new immuniser and assure themselves that the new immuniser has the appropriate level of knowledge and skill to undertake their role in immunisation.

Q. Can another pharmacist act as the experienced healthcare practitioner within a period of supervised clinical practice?
Yes, if the pharmacist is competent in immunisation and can assess a new immuniser’s knowledge and skills.

Q. How can a period of supervised clinical practice be arranged?
There are several ways a supervision session could be arranged, for example:

• • At the point of arranging face-to-face immunisation training, trainees could enquire whether the training provider could arrange such a session;

• • New immunisers could speak to the pharmacy owner they work for to enquire whether they could arrange a supervised session with an experienced immuniser, within the same organisation; or

• • New immunisers could contact local pharmacist colleagues, who are experienced immunisers, and ask them whether they would be willing to supervise a session within their pharmacy.

Q. I want to develop my own promotional materials for the RSV and Pertussis Vaccination Service, am I allowed to do this?
Yes; however, pharmacy owners must ensure they comply with the requirements of the Terms of Service relating to promotion of services funded by the NHS and if the NHS logo is used in materials related to the service, this must comply with the guidelines for use of the NHS identity by community pharmacies.

The RSV and Pertussis Vaccination Service page on our website provides links to resources from Community Pharmacy England, UKHSA and other organisations which pharmacy owners can use if they do not want to develop their own materials.

Q. Can a pharmacy owner provide a patient with any kind of free gift if they have a vaccination under the Enhanced Service?
No. The Terms of Service state that a pharmacy must not offer any gift or reward to any person as an inducement to receive any directed services.

Q. Why are adults over 80 years of age not eligible for RSV vaccinations?
The Government decides which groups will be eligible for NHS vaccinations based on the independent advice of clinical experts on the Joint Committee on Vaccination and Immunisation (JCVI). JCVI review the latest clinical evidence and data, including how long protection lasts and how common RSV infection is within different age groups. The JCVI considered all available information when advising on which age groups would benefit most from having the RSV vaccine and concluded there is limited evidence of efficacy in those aged over 80. The same principle applies to those under 75 years or within a clinical risk group.

Q. At what stage of pregnancy should pregnant women be offered the RSV and Pertussis vaccines?
Pregnant women can be offered RSV vaccinations from 28 weeks of pregnancy until delivery and can be offered a pertussis vaccination from 16 weeks of pregnancy until delivery.

It is recommended that women have their pertussis vaccines at 20 weeks and this is usually offered as part of their mid-pregnancy scans. Maximum protection for the baby from pertussis is achieved when vaccination occurs between 20 and 32 weeks of pregnancy.

Q. Should pregnant women be offered the RSV and Pertussis vaccines in each pregnancy or are the covered if they have previously been vaccinated?
Yes, all pregnant women should be offered an RSV and a Pertussis vaccination in each pregnancy. Vaccination in a previous pregnancy does not result in sufficient antibody transfer to infants. Studies have demonstrated that pregnant women can safely receive RSV and pertussis vaccines during pregnancy and that infants also receive some protection from maternal antibodies because of their mother having the vaccination whilst pregnant.

Q. Will it be OK to administer the RSV vaccine at same time as pertussis?
Yes. It is recommended that women have their pertussis vaccine at 20 weeks and RSV at 28 weeks. However, where a woman has not received a pertussis-containing vaccine by the time she presents for an RSV vaccine, both vaccines can and should be given at the same appointment to provide timely protection against both infections to the infant.

Q. Can the RSV and Pertussis vaccines be given to women who are breastfeeding?
No. The vaccination programme is part of a programme to protect infants. Pregnant women are only eligible for vaccination from the defined weeks for pregnancy specified in the service specification and PGDs up until birth.

Q. Will it be OK to administer RSV at the same time as COVID-19 and/or flu vaccines; what is the recommended time interval between them?
RSV can be co-administered with COVID-19 and/or flu vaccine during pregnancy, there is no minimum time interval. Full details on co-administration are in the Green Book: Respiratory syncytial virus: the green book, chapter 27a – GOV.UK

Q. Should pharmacy teams check with the patient’s GP practice to confirm if the patient has already had an RSV or pertussis vaccination?
In most cases the patient will be able to verify if they have received an RSV or pertussis (pregnant women only) vaccination from their GP practice or NHS trust; however, if the patient is unsure, relevant care records should be checked or the GP practice should be contacted to confirm whether they have already been vaccinated or not to prevent the risk of the patient being vaccinated twice. This is especially important for patients who fall into vulnerable groups such as those with dementia who may not remember if they have been vaccinated or not.

Q. What should I do if there is a power failure to the fridge containing the vaccines?
You should refer to the Vaccine incident guidance document and the vaccine product’s Summary of Product Characteristics. Further advice could be obtained from your local screening and immunisation team.

Q. Can a pharmacy buy RSV and Pertussis vaccines direct from the manufacturer?
Yes, but only for provision of private vaccination services.

Q. Is it mandatory for a pharmacy to have a Standard Operating Procedure (SOP) for the service?
Yes.

Q. Do we need to have a needle stick injury procedure?
Yes.

Q. Do pharmacy owners have to arrange their own clinical waste disposal service to dispose of waste resulting from the RSV and Pertussis Vaccination Service?
Yes.

Q. What would normally be contained in an anaphylaxis pack?
The Green Book states that an anaphylaxis pack normally contains two ampoules of adrenaline (epinephrine) 1:1000, four 23G needles and four graduated 1ml syringes, and Laerdal or equivalent masks suitable for children and adults. The mask for children would only be required if the pharmacy is providing a vaccination service to children; the Enhanced Service does not include the vaccination of children.

Q. Can I use an adrenaline auto-injector to treat anaphylaxis?
The Green Book states that auto-injectors for self-administration of adrenaline should not be used as a substitute for a proper anaphylaxis pack (see above). However, if an adrenaline auto-injector is the only available adrenaline preparation when treating anaphylaxis, health care providers should use it.

Q. If a pharmacist or pharmacy technician administers adrenaline in an emergency to treat anaphylaxis, is a PGD required to authorise the administration?
No.  Regulation 238 of the Human Medicines Regulations 2012 allows adrenaline to be administered by anyone for the purpose of saving life in an emergency.

Q. What should I do if a patient requests or is eligible for another vaccination, for example, a pneumococcal vaccine?
Unless the pharmacy is commissioned at a local level to provide additional vaccinations, the patient should be referred to their GP practice.

Q. What are the storage requirements for vaccines?
Vaccines should be stored in line with the requirements set out by their manufacturer in the Summary of Product Characteristics. The former National Patient Safety Agency issued an alert in 2010 giving guidance on vaccine cold storage for all healthcare providers, including community pharmacies.

Q. What records should I make if a patient has an adverse reaction to a vaccine?
A record of any adverse reaction from a vaccine and any treatment administered or advised should be made by the pharmacy. Where the adverse reaction is deemed to be clinically significant by the pharmacist, this information may also be shared with the patient’s GP practice. Pharmacists are reminded to report all serious suspected ADRs, even if the effect is well recognised, and all suspected ADRs linked to new medicines and vaccines to the Medicines and Healthcare products Regulatory Agency (MHRA) via the Yellow Card scheme. New medicines and vaccines that are under additional monitoring are indicated by an inverted black triangle symbol (▼) displayed in their package, leaflet and summary of product characteristics.

Pharmacy professionals can report suspected side effects to the MHRA via:

• • The Yellow Card website; or

• • The free Yellow Card app, downloadable from the Apple App Store or Google Play Store.

Q. How long does the passive immunity provided by RSV-vaccinated mothers last in babies after delivery?
The vaccination provides at least six months of protection.

Q. Must patient consent be recorded in writing?
No. Patient consent can be obtained verbally and should be recorded in the pharmacy’s clinical record for the service. A signed consent record is not required.

Some patients may be unable to provide verbal or written consent, but this is not synonymous with lacking capacity. The individual just needs to be able to communicate their decision clearly and this decision should then be captured in the pharmacy’s clinical record for the service.

Q. Can I vaccinate a person who seems unable to understand consent?
Where there is a concern that a patient may not have the capacity to provide informed consent, pharmacists should ensure that an appropriate mental capacity assessment is conducted. A process to support pharmacists meet their responsibility under the Mental Capacity Act (MCA) and provide appropriate care for their patient is available here. Additional advice can also be sort here.

Q. What other public health information can we give parents who may decline the vaccine, to help reduce the risks of RSV post birth?
RSV is very hard to avoid. 50% of babies catch it at least once before they are 12 months old, and 90% have had it by the age of two years. Amongst other things that can be advised:

• • Parents can try and discourage people with colds from visiting a newborn baby. It can be challenging keeping older siblings away, and clearly parents as the main caregivers will not reasonably be able to avoid contact with baby if they have colds.
  • Avoid smoking around babies or exposing them to other indoor air pollution (like smoky fireplaces) as this is a very substantial and well-established risk for severe RSV infection in infants.
  • Keeping baby well-nourished is important. Breastfeeding, if you can, is recommended to help pass many different immune antibodies from mum to baby.
  • All parents, vaccinated or not against RSV, should be alert for any of the warning signs associated with RSV bronchiolitis as listed on the NHS website.

Q. Can I use an alternative point of care IT system instead of the record a vaccine system (RAVS)?
No. RAVS is the commissioned IT system and currently, it must be used to record provision of the service.

Q. What do I do if RAVS is temporarily not available?
The is an NHS England guide to assist with troubleshooting if RAVS is unavailable. As a temporary measure, if you urgently need to record vaccinations, download a paper form. When the service is available, you can enter the information from the form into RAVS.

Q. Does the patient’s GP practice always need to be informed of the vaccination administered to their patient?
Yes.