Introduction

The Pharmacy Quality Scheme (PQS) forms part of the Community Pharmacy Contractual Framework (CPCF). It supports delivery of the NHS Long Term Plan and rewards community pharmacy contractors who deliver quality criteria in three quality dimensions: clinical effectiveness, patient safety and patient experience.

NHS England, in collaboration with internal and external stakeholders, has developed the PQS for 2023/24. Details of the PQS for 2023/24 have been provided in Part VIIA of the Drug Tariff. This document replaces guidance issued for all previous schemes and provides further detail for contractors regarding how they demonstrate compliance with this year’s scheme requirements.

The 2023/24 PQS consists of one gateway criterion and three quality domains. Each domain within the PQS has a designated maximum number of points – see Table 1 Summary of PQS 2023/24 gateway criterion, domains and quality criteria. For further details on points and banding refer to section 8.1.

As in previous years PQS 2023/24 includes an aspiration payment. The aspiration payment must be claimed between 09.00 on 4 September 2023 and 23.59 on 29 September 2023. The maximum number of points for which a pharmacy can be paid an aspiration payment is 70% of the number of points they aspire to achieve. The aspiration payment is optional for pharmacy contractors and not claiming it will not impact on the pharmacy contractor’s ability to claim payment for the PQS 2023/24. For further information, refer to section 8.2 of this guidance.

Contractors participating in the PQS 2023/24 will need to submit a declaration between 09.00 on 5 February 2024 and 23.59 on 1 March 2024. Contractors will have until the end of 31 March 2024 to complete some elements of the PQS. Where this is the case, they will be asked to declare that the requirements of the criterion will be met by the end of 31 March 2024.

The total funding for PQS 2023/24 is £45 million. The funding will be divided between qualifying pharmacies based on the number of points they have achieved up to a maximum of £137.50 per point. Each point will have a minimum value of £68.75, based on all pharmacy contractors achieving maximum points. Payments will be made to eligible contractors depending on their band and how many domains they have declared they are meeting. Contractors must declare that all the criteria for each domain will have been completed by 31 March 2024 using the Manage Your Service (MYS) portal to achieve the allocated points for each domain. Further details on the payment structure can be found in the Payments and declarations section of this guidance.

It is recommended that contractors thoroughly familiarise themselves with this guidance document if they are considering taking part in the PQS 2023/24.

Copies of previous quality scheme guidance can be requested by contacting ENGLAND.CommunityPharmacy@nhs.net.

Table 1: Summary of PQS 2023/24 gateway criterion, domains and quality criteria

Please note, the maximum number of points for the Medicines Safety and Optimisation domain and the Prevention domain, will be fixed irrespective of the participating contractor’s total prescription item volume for bands 2-6. For the Respiratory domain the maximum number of points will be on a banding system and is shown based on a pharmacy in band 4. Contractors in band 1 will be eligible for a lower number of points. Contractors are advised to refer to section 8.1 table 3, to determine the maximum number of points available.

Gateway Criterion

By the end of 31 December 2023, pharmacy contractors must meet the gateway criterion to qualify for a PQS 2023/24 payment as outlined in section 2.1.

2.1 Advanced Services – New Medicine Service (NMS)

2.1.1 Aim

To ensure that all pharmacies taking part in the PQS meet all the terms of service requirements and are choosing to actively provide clinical support to patients by providing NMS.

2.1.2 Rationale

The NMS service provides initial support to people who are newly prescribed a medicine to manage a long-term condition and has been shown to improve their medication adherence.

Pharmacists can successfully intervene when a medicine is newly prescribed. The NMS significantly increased the proportion of patients adhering to their new medicine by about 10% compared with normal practice.

2.1.3 Gateway criterion

Only contractors who have delivered a minimum of 15 NMS between 1 April 2023 and by the end of 31 December 2023 and have claimed for these by 5 January 2024 will be eligible for any PQS payment. Any claims for NMS submitted to the NHSBSA after 5 January 2024 will not be considered for the PQS gateway.

For further information for contractors who open or change ownership from 1 June 2023 see Payments and declarations.

Contractors are therefore advised to regularly check the NMS that have been undertaken, and the associated claims that they have submitted in the lead up to the 5 January 2024 deadline to ensure that they have delivered and claimed for the 15 NMS target by 5 January 2024 to meet this gateway requirement for PQS.

Contractors should also be aware that the claims submitted via MYS are also checked for eligibility. Where a contractor has been found to have submitted claims for NMS that are ineligible then these will not be paid, and their number deducted from the NMS total calculated for NMS. If a contractor is then found not to have met the 15 NMS target then their PQS declaration will not have met the gateway and an overpayment recovery will be made.

2.1.4 Reporting

Contractors must have delivered a minimum of 15 NMS between 1 April 2023 and the end of 31 December 2023. Contractors will not be required to make a declaration for this gateway criterion as the automatic verification assessment of whether a contractor has met the NMS gateway criterion will be confirmed against the NHSBSA’s payment data for NMS.

Any pharmacies that fail to have claimed for 15 NMS by 5 January 2024 will not have met this gateway requirement and will not be able to submit a declaration for the quality domains during the declaration period.

Quality criteria

The PQS 2023/24 contains three domains. Table 1 shows the allocation of points per domain.

For the PQS 2023/24, the maximum number of points for the Medicines Safety and Optimisation domain and the Prevention domain, will be fixed irrespective of the participating contractor’s total prescription item volume for bands 2-6.

For the Respiratory domain the maximum number of points will be on a banding system and is shown based on a pharmacy in band 4 (as the majority of contractors dispense at this prescription volume).

There is a different points allocation for contractors in band 1. To view the allocation of points for the other bands, please see section 8.1 table 3.

Contractors must declare that all the criteria for each domain have been completed on the MYS portal to claim the allocated points for each domain.

Medicines safety and optimisation

4.1 High risk medicines – anticoagulant audit

4.1.1 Aim

To reduce preventable patient harm from oral anticoagulant medicines and to embed the actions, recommendations and learning from the audit carried out in the PQS 2021/22.

4.1.2 Rationale

In response to the WHO Global safety patient safety challenge: medication without harm, NHS England instigated a Medicines Safety Improvement Programme with anticoagulant safety being one of four initial areas of focus.

Anticoagulants are life-saving medicines that can prevent strokes related to atrial fibrillation and treat venous thromboembolism. However, these medicines are high risk and have a heightened risk of causing significant harm if not their use is not optimised. This class of medicines is frequently identified as a cause of preventable harm and admission to hospital. The National Patient Safety Agency issued a patient safety alert with actions to improve anticoagulant safety, which included:

• providing specific patient information;
• ensuring regular blood monitoring; and
• checking drug interactions.

Since this was issued, newer non-vitamin K antagonist oral anticoagulants, also known as Direct Oral Anticoagulants (DOACs) have come into widespread use. Although many of the principles of the 2007 alert still apply, some aspects such as regular International Normalised Ratio (INR) monitoring and dietary considerations are not relevant for the newer medicines.

4.1.3 Quality criterion

IMPORTANT: No patient identifiable data should be entered into the MYS portal. There must be follow up of any patient where the prescriber was contacted to identify what actions were taken.

By the end of 31 March 2024, contractors must have implemented into their day-to day practice, the findings and recommendations for community pharmacy from the 2021/22 PQS anticoagulant audit found in the Community pharmacy oral anticoagulant safety audit 2021/22 report.

The pharmacy must also have completed the revised audit (see section 10.1 Oral Anticoagulant Safety Audit 2023/24), including notifying the patient’s GP where concerns are identified, sharing their anonymised data with NHS England, and incorporating any learning from the audit into future practice by the 31 March 2024.

The audit must be carried out over two weeks with a minimum of 15 patients or four weeks if 15 patients are not achieved within two weeks, and there must be a follow up of any patient that is referred to their prescriber to identify what actions were taken. Contractors should make a record of the start and end date of the audit as they will be required to enter this information into the MYS application when they make their declaration. Contractors must have completed the anticoagulant audit by the end of 31 March 2024.

Where a prescriber has been contacted regarding anticoagulant concerns, any subsequent actions must be followed up and documented in the patient medication record (PMR) to ensure all necessary corrective actions have been taken. These actions should be recorded on the MYS audit data collection tool.

The pharmacist or a competent member of staff should discuss the anticoagulant medicine with the patient or representative to help ensure safe and effective use. Attempts should be made for this discussion to occur with all patients, including patients who have their medication delivered, or patients who live in a care home. It may be appropriate to speak to an identified patient representative, family member or member of care staff.

If attempts to contact the patient have failed, and there is a potential risk of anticoagulant related adverse effects or concerns about the patient’s therapy, the prescriber should be contacted to suggest a review is undertaken and the details recorded in the PMR. This would not constitute a breach of patient confidentiality as the referral is in the best interests of the patient and necessary to ensure patient safety.

The pharmacy team should support the patient to reduce the risk of adverse effects arising from ongoing anticoagulant therapy and optimise outcomes through education and advice as well as adopting principles of shared decision making. Good practice includes recording INR levels in a patient’s PMR (where applicable) with dates and details of where the result was obtained from.  

In the extremely unlikely event where a contractor is unable to complete the anticoagulant audit due to the fact that they have not identified any eligible patients during the audit period, the contractor will still be eligible for payment if they can evidence that they have robustly attempted to identify suitable patients. They will need to declare no patients have been identified as being suitable for review on the data collection tool on MYS by the end of 31 March 2024.

4.1.4 Reporting

When making a declaration for this criterion, the following information must be reported on the MYS application:

• A declaration that by the end of 31 March 2024 the contractor will have completed the anticoagulant audit.
• The start and end date of the audit period (which may be different from the date data are first entered on the MYS data collection tool).
• A declaration that where concerns are identified when completing the audit, that the patient’s GP was/will be promptly notified.
• A declaration that by the end of 31 March 2024 the contractors will have shared their anonymised data or have declared that no patients have been identified as being suitable for audit via the data collection tool on the MYS application.

4.2 Palliative and end of life care (PEoLC)

4.2.1 Aim

For sufficient arrangements to be in place so patients and their relatives/carers and healthcare professionals can obtain palliative/end of life care medicines in a timely manner and support dying at home.

4.2.2 Rationale

WHO defines palliative care as:

“an approach that improves the quality of life of patients and their families facing the problems associated with life-threatening illness. This is achieved through the prevention and relief of suffering by means of early identification and impeccable assessment, and treatment of pain and other problems”.

Being symptom-free is one of the most important factors for patients when considering end of life care. How symptoms are treated may change over time and may depend on many factors, including the symptom being treated, the patient’s ability to swallow (owing to disease process causing fatigue and weakness), and level of consciousness.

As a patient’s disease progresses, it is likely that medication will be changed and adjusted. It is vital that patients, relatives and/or carers can access commonly prescribed palliative care medication in a timely manner. Pharmacy teams should either supply the medication or be able to reserve the medication and signpost to the nearest pharmacy of choice, recognising that any delay is likely to cause heightened distress.

4.2.3 Quality Criterion

The 16 critical medicines for palliative and end of life care are:

1. Cyclizine solution for injection ampoules 50mg/1ml
2. Cyclizine tablets 50mg
3. Dexamethasone solution for injection ampoules 3.3mg/1ml
4. Dexamethasone tablets 2mg
5. Haloperidol tablets 500mcg
6. Hyoscine butylbromide solution for injection 20mg/1ml
7. Levomepromazine solution for injection ampoules 25mg/1ml
8. Metoclopramide solution for injection ampoules 10mg/2ml
9. Midazolam solution for injection ampoules 10mg/2ml
10. Morphine sulfate oral solution 10mg/5ml
11. Morphine sulfate solution for injection ampoules 10mg/1ml
12. Morphine sulfate solution for injection ampoules 30mg/1ml
13. Oxycodone solution for injection ampoules 10mg/1ml
14. Oxycodone oral solution sugar free 5mg/5ml
15. Sodium chloride 0.9% solution for injection ampoules 10ml
16. Water for injections 10ml

Drug availability for patients is the main concern, and therefore there are no stipulated pack sizes that must be kept by contractors.

Contractors who routinely hold the 16 palliative and end of life critical medicines listed and can support local access to parenteral haloperidol must:

• as soon as possible after 1 June 2023 and by the end of 31 March 2024, have updated NHS Profile Manager to show they are a ‘Pharmacy palliative care medication stockholder’, by accessing the ‘NHS Profile Manager‘ and following the steps provided.
• If NHS Profile Manager is updated centrally by head office, it will need to be confirmed that this will be done by the end of 31 March 2024.
• Contractors with profiles that cannot currently be updated via NHS Profile Manager may still claim for this domain and update the Directory of Services (DoS) profile via contacting their Regional DoS lead. Contact details are available on the NHS Service Finder.

Contractors who are not stockholders of these 16 palliative and end of life critical medicines are not required to update NHS Profile Manager but can still claim for this domain if they can support access to these medicines by completing an action plan.

By the end of 31 March 2024, all contractors, whether they do or do not routinely stock the 16 critical medicines, must have an action plan in place to use when they do not have the required stock of the 16 critical medicines or parenteral haloperidol available for a patient. This must include collated information from pharmacies in their area to be able to aid a patient, relative/carer in obtaining medication as swiftly as possible by redirecting them to the nearest open community pharmacy that stocks the 16 critical end of life medicines and/or parenteral haloperidol.

The action plan must include:

• an awareness of any locally commissioned services for palliative care including any on-call and delivery arrangements;
• a list of community pharmacies in their area stocking the 16 critical medicines for palliative and end of life care and the ability to check the DoS to find pharmacies stocking these medicines;
• details of where parenteral haloperidol can be accessed locally e.g., through any local commissioning arrangements; and,
• awareness of other support services that may be useful for patients/relatives/carers.

Contractors who claimed for the Addressing Unwarranted Variation in Care domain in the PQS 2022/23 must ensure their status is correct and updated for 2023/24 by logging into NHS Profile Manager and confirming this. An update to the previous action plan will also be required. The action plan for 2023/24 must be available for inspection from the end of 31 March 2024 at premises level.

Updates to NHS Profile Manager will be reflected on the pharmacy’s DoS profile. The NHS Service Finder or MiDoS can be used by pharmacies and other healthcare professionals with authorised access to identify those pharmacies in their area who have updated their DoS profile to indicate they are holding the 16 critical end of life medicines. Updates to the NHS Profile Manager with respect to whether the pharmacy hold the 16 critical end of life medicines will not be reflected on the public facing nhs.uk pharmacy profile.

Pharmacies are encouraged to update their NHS Profile Manager as early as possible after 1 June 2023. This will help inform those pharmacies that are not stockholders to develop their action plans to support patients in obtaining medication.

4.2.4 Reporting

When making a declaration for this criterion, the following information must be reported on the MYS application:

• Confirm if the pharmacy does or does not stock the 16 palliative and end of life critical medicines.
• If the pharmacy does stock the 16 palliative and end of life critical medicines, a declaration that by the end of 31 March 2024, the DoS will have been updated to indicate that the pharmacy is a ‘Pharmacy palliative care medication stockholder’.
• A declaration that by the end of 31 March 2024, the pharmacy will have completed, or updated, an action plan available for inspection on how they will manage patients requesting palliative and end of life medicines within their local area, with collated information from pharmacies in their local area to be able to aid a patient, relative/carer in obtaining medication as swiftly as possible by redirecting them to the nearest open community pharmacy that stocks the 16 critical palliative and end of life medicines and/or parenteral haloperidol.

Respiratory

Aim

• To continue work from previous PQS in reducing morbidity and preventable deaths from asthma through targeted clinical surveillance and evidence-based interventions.
• To contribute to optimising inhaler technique and outcomes in patients with asthma and/or chronic obstructive pulmonary disease (COPD).
• To promote safe and environmentally friendly disposal or all unwanted and used inhaler devices by engaging in discussions with all patients, their carers and/or representatives and to contribute to the delivering a ‘Net Zero’ National Health Service agenda of being carbon neutral.

5.1 Inhaler technique checks

5.1.1 Rationale

A key finding of the National Review of Asthma Deaths (NRAD) report identified asthma sufferers with poor inhaler technique as being at increased risk of poor asthma control, potentially resulting in an attack. Incorrect use of inhalers is very common and subsequently leads to poor control for both patients with asthma and COPD. For patients with COPD, incorrect inhaler technique increases the risk of severe flare-ups and hospitalisation.

In addition, incorrect inhaler technique when using inhaled corticosteroids increases the risk of some side-effects like dysphonia and oral thrush.

Pharmacists are important health educators and are able to check inhaler technique at the point of dispensing medication. This quality criterion seeks to ensure patients are supported to get the most from their medicines and minimise preventable exacerbations of asthma and/or COPD.

5.1.2 Quality criterion

By the day of the declaration, the contractor must be able to evidence that pharmacy staff have offered the NMS, with the appropriate inhaler technique check, to all patients presenting with a prescription for a new inhaler (i.e., for the first time or changed to a new inhaler device) where patients would benefit from this service, especially those switched from a metered dose inhaler (MDI) to a dry powder inhaler.

By the end of 31 March 2024, all pharmacists working at the pharmacy on the day of the declaration, who are providing NMS, with the appropriate inhaler technique check, must have satisfactorily completed, within the last four years (between 1 April 2020 and end of 31 March 2024), the CPPE Inhaler technique for health professionals: getting it right e-learning or attended a CPPE optimising inhaler technique: improving outcomes workshop and passed the inhaler technique for health professionals e-assessment.

The e-assessment must be completed if pharmacists have completed the e-learning or attended the face-to-face workshop before providing inhaler technique checks.

5.1.3 Reporting

When making a declaration for this criterion, the following information must be reported on the MYS application:

• The total number of patients identified as having been prescribed a new inhaler device who were offered an NMS.
• The total number of patients who were subsequently provided with a face-to-face NMS, including an inhaler technique check.
• The total number of patients who were subsequently provided with a remote NMS, including an inhaler technique check.
• The total number of patients who were referred to their prescriber due to issues identified during the NMS.
• The total number of pharmacists working in the pharmacy on the day of the declaration who have satisfactorily completed the CPPE inhaler technique for health professionals: getting it right training e-learning and passed the e-assessment Inhaler technique for health professionals between 1 April 2020 and the day of the declaration.
• The total number of pharmacists working in the pharmacy on the day of the declaration who have not satisfactorily completed the CPPE inhaler technique for health professionals: getting it right training e-learning and passed the e-assessment Inhaler technique for health professionals between 1 April 2020 but who will undertake this requirement by the end of 31 March 2024.
• The total number of pharmacists working in the pharmacy on the day of the declaration who have attended a CPPE optimising inhaler technique: improving outcomes inhaler technique workshop and passed the e-assessment inhaler technique for health professionals since 1 April 2020 and the day of the declaration.
• The total number of pharmacists working in the pharmacy on the day of the declaration who have not attended a CPPE optimising inhaler technique: improving outcomes inhaler technique workshop and passed the e-assessment inhaler technique for health professionals since 1 April 2020 but who will undertake this requirement by the end of 31 March 2024.

5.2 Inhaler waste management

5.2.1 Rationale

Inhalers still account for approximately 3% of the NHS’ carbon footprint, mostly due to the propellants used to deliver the medications. These propellants will, if disposed of via landfill, continue to emit greenhouse gasses into the atmosphere.  

Interventions to reduce emissions focus on the reductions available from inhalers, including commitments made in the NHS Long Term Plan that are already underway. These interventions include optimising prescribing, substituting high carbon products for low-carbon alternatives, and improvements in production and waste processes. Pharmacy teams are in a good position to identify and support patients who have been affected by this and prescribed a new or different inhaler, as well as educate about the importance of the return of used inhalers for appropriate disposal.

5.2.2 Quality criterion

By the end of 31 March 2024, all patient-facing pharmacy staff working in the pharmacy on the day of the declaration must have been trained on the reasons why used, unwanted and expired inhalers should be returned to the pharmacy for safe disposal and the adverse effects on the environment when inhalers are disposed of in domestic waste. There is no set training course for this requirement, however the PSNC (soon to be called Community Pharmacy England) has published a briefing ‘Reducing the climate change impact of inhalers; environmentally safe disposal’ which contractors can choose to use to meet this requirement.

By the end of 31 March 2024, the pharmacy must be able to evidence that they have spoken (a verbal conversation rather than written communication) with all patients, their carer or representatives, for whom they have dispensed an inhaler between 1 June 2023 and the day of the declaration, about the environmental benefits of safe and environmentally friendly disposal. Discussions can be supplemented with other communication methods such as leaflets, emails, and texts.

5.2.3 Reporting

When making a declaration for this criterion, the following information must be reported on the MYS application:

• The total number of patient-facing pharmacy staff working in the pharmacy on the day of the declaration who have been trained on the reasons why used, unwanted and expired inhalers should be returned to the pharmacy for safe disposal and the adverse effects on the environment when inhalers are disposed of in domestic waste.
• The total number of patient-facing pharmacy staff working in the pharmacy on the day of the declaration who have not been trained on the reasons why used, unwanted and expired inhalers should be returned to the pharmacy for safe disposal and the adverse effects on the environment when inhalers are disposed of in domestic waste but who will undertake to meet this requirement by the end of 31 March 2024.
• The total number of conversations had with patients and/or their carer or representatives on the safe and environmentally friendly disposal of their inhalers between 1 June 2023 and the day of the declaration.

5.3 Use of a spacer in patients aged 5 to 15 years

5.3.1 Rationale

A new analysis from Asthma + Lung UK identified hospital asthma admissions in children in England and Wales had increased by 149% between 2021 and 2022, while identifying the UK as having the worst death rate in Western Europe in children and young people for asthma. NICE technological appraisal (NICE TA38) guidance recommends the use of spacer devices in combination with press and breathe pressurised metered-dose inhalers (pMDIs) to achieve optimum asthma management in children between the ages of 5 to 15 years (inclusive). Pharmacy professionals are in an ideal position to identify children between the ages of 5 and 15 years (inclusive) that may benefit from a spacer device.

5.3.2 Quality criterion

By the end of 31 March 2024, the pharmacy must be able to evidence that between 1 June 2023 and the day of the declaration they have:

• Checked that all children aged 5 to 15 (inclusive) dispensed an inhaled press and breathe pMDI for asthma have a spacer device where appropriate, in line with NICE TA38.
• Referred children aged 5 to 15 (inclusive) with asthma to an appropriate healthcare professional where this is not the case.

5.3.3 Reporting

When making a declaration for this criterion, the following information must be reported on the MYS application:

• The total number of children aged 5 to 15 (inclusive) referred to a prescriber for a spacer device where appropriate in line with NICE TA38 between 1 June 2023 and the day of the declaration.
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5.4 Personalised asthma action plan (PAAP)

5.4.1 Rationale

The NRAD report made recommendations identifying that people with asthma should be provided with a PAAP, which can help identify worsening asthma, support corrective action and advise patients and carers of how and when to seek help. Patients with a PAAP were four times less likely to die from having an asthma attack but 77% of patients included in the NRAD report had no record of having a PAAP.

5.4.2 Quality criterion

By the end of 31 March 2024, the pharmacy must be able to evidence that they have checked that all patients aged five years and above dispensed an inhaler for asthma between 1 June 2023 and the day of the declaration have a PAAP.

The pharmacy contractor must be able to show that pharmacy staff have referred all patients aged five years above dispensed an inhaler for asthma between 1 June 2023 and the day of the declaration, to an appropriate healthcare professional where this is not the case.

5.4.3 Reporting

When making a declaration for this criterion, the following information must be reported on the MYS application:

• The total number of patients aged five years and above with asthma referred for a PAAP between 1 June 2023 and the day of the declaration.

5.5 Referrals for patients using 3 or more bronchodilators in 6 months

5.5.1 Rationale

To improve the care of people with asthma, NRAD recommended:

• People with asthma should have a structured review by a healthcare professional with specialist training in asthma, at least annually.
• All patients who have been prescribed more than 6 short-acting reliever (bronchodilator) inhalers in the previous 6 months should be invited for an urgent review of their asthma control, with the aim of improving their asthma through education and changes in their treatment if required.

For the purposes of this criterion, this has been reduced to all patients prescribed 3 or more short-acting bronchodilator inhalers in the previous 6 months. Research has shown that patients who received intervention at this point had improved outcomes and a better quality of life.

5.5.2 Quality criterion

By the end of 31 March 2024, the pharmacy must be able to evidence that between 1 June 2023 and the day of the declaration that patients with asthma, for whom three or more short-acting bronchodilator inhalers were dispensed without any corticosteroid inhaler within a six-month period have, since the last review point, been referred to an appropriate healthcare professional for an asthma review.

5.5.3 Reporting

When making a declaration for this criterion, the following information must be reported on the MYS application:

• The total number of patients with asthma, for whom three or more short-acting bronchodilator inhalers were dispensed without any corticosteroid inhaler within a six-month period and who were referred to an appropriate healthcare professional for an asthma review between 1 June 2023 and the day of the declaration.

The contractor will normally be referring the patients to their GP, GP practice based respiratory nurse, specialist/asthma nurse or practice-based pharmacist for a routine appointment. Contractors should retain evidence that they have completed all aspects of this domain at the pharmacy premises, which should be available for inspection.

It is up to pharmacy teams how they choose to engage and implement regular monitoring and review of patients with asthma and COPD into their processes and procedures. As a minimum, they must review all patients who were prescribed a new inhaler and offer an NMS, including an inhaler technique check.

In the extremely unlikely even where no patients are identified for any of the criteria of this domain, the contractors will still be eligible for payment if they can evidence that they have been working to identify suitable patients through, for example, a standard operating procedure (SOP) or evidence of staff training and that they have processes in place for delivering the NMS or making referrals should they identify a patient who is suitable. The contractor will need to declare no patients have been identified on the MYS declaration. Information from the NHSBSA dispensing data will be checked to confirm this declaration.

Contractors must record any intervention or referral made in the PMR. These records may be required for post payment verification purposes.

For contractors who have claimed elements of these criteria in previous PQS, the pharmacy team’s knowledge and understanding of the process to identify suitable patients should be reviewed. Methods used to identify ‘at risk’ patients for referral should be reviewed for effectiveness.

Prevention

6.1 Antimicrobial stewardship

6.1.1 Aim

To further support vital work to limit antimicrobial resistance (AMR) through effective stewardship and prepare pharmacy staff for the future pharmaceutical services developments. This builds on last year’s PQS to promote antimicrobial stewardship (AMS) through community pharmacy, influencing responsible antibiotic prescribing and patients’ personal attitudes and social norms around the use of antimicrobials.

6.1.2 Rationale

One of the most pressing problems faced globally by healthcare services is the increasing prevalence of AMR. Compounded by a diminishing number of new agents entering clinical practice, such resistance is widely recognised as a major threat to public health, meriting inclusion on the National Risk Register. Tackling AMR is a UK strategic priority, with the aim of reducing the number of serious infections that are resistant to treatment.

In primary care, there are concerns that some common infections are becoming increasingly difficult to treat and that illnesses due to bacteria resistant to antimicrobials may take longer to resolve.

Some incidents of AMR may be due to inappropriate use of antibiotics. In response, initiatives at local, national and international levels are trying to promote AMS with the goal of improving the appropriateness of antimicrobial use, which include antibiotics, antifungals and antivirals. However, for success such initiatives rely on the continuing education of prescribers and patients, which needs to be supported by high quality evidence link antimicrobial use to the emergence of resistance.

In England, the majority of antibiotics are prescribed in primary care, 84.5% of which are prescribed in general practice. Pharmacy teams have an increasingly important role in AMS.

6.1.3 Quality criterion

6.1.3.a TARGET antibiotic checklist

IMPORTANT: No patient identifiable data should be entered into the MYS data collection tool. There must be follow up of any patient where the prescriber was contacted to identify what actions were taken.

By the end of 31 March 2024, contractors must have implemented, into their day-to-day practice, the recommendations for community pharmacy from the first TARGET antibiotic checklist review from the PQS 2021/22 found in the Findings from the antimicrobial stewardship initiatives report. Contractors must also have reviewed their current practice using the TARGET antibiotic checklist, in order to provide tailored advice to patients and promote antibiotic awareness and stewardship.

This review must be completed by the end of 31 March 2024 and carried out over four weeks with a minimum of 25 patients; or up to eight weeks if the minimum number of patients are not achieved within four weeks. Contractors should make a record of the start and end date of the review as they will be required to enter this information into the MYS application when they make their declaration.

Using the TARGET antibiotic checklist, appropriately trained staff must discuss the antibiotic prescribed with the patient or representative to help ensure safe and effective use. Attempts should be made for this discussion to occur with all relevant patients to promote AMS. It may be appropriate to speak to an identified patient representative, family member or member of care staff.

If there is a potential risk of antibiotic related adverse effects (for example, change in allergy status) or concerns about the patient’s therapy, the prescriber must be contacted to suggest a review is undertaken and the details of this intervention recorded in the PMR. The pharmacy team should support the patient to reduce the risk of adverse effects arising from ongoing antibiotic therapy and optimise outcomes through education and advice as well as adopting principles of shared decision-making.

The data from the checklists must be added to the MYS data collection tool by the end of 31 March 2024.

In the extremely unlikely event that a contractor is unable to complete the antibiotic review due to the fact that they have not identified any eligible patients during the audit period, the contractor will still be eligible for payment if they can evidence that they have robustly attempted to identify suitable patients. They will need to declare no patients have been identified as being suitable for review on the data collection tool on MYS by the end of 31 March 2024.

6.1.3.b TARGET treating your infection leaflets

To be completed between 1 September 2023 and end of 31 March 2024

IMPORTANT: No patient identifiable data should be entered into the MYS data collection tool. There must be follow up of any patient where the prescriber was contacted to identify what actions were taken.

Pharmacy staff must have reviewed their practice to include two TARGET leaflets:

• Treating your infection – Urinary Tract Infection (UTI) and
• Treating your infection – Respiratory Tract Infection (RTI)

to help them assess walk-in / Community Pharmacist Consultation Service (CPCS) patients presenting to the pharmacy for advice and/or requesting antibiotics with suspected UTIs or RTIs without a prescription, who have not already seen a GP or other healthcare professional for the current illness and provide tailored advice to patients and promote awareness of AMR and AMS.

The leaflets are designed to be used interactively with the patient by a trained member of the pharmacy team to help them assess the patient’s condition and facilitate discussions on when they would need to seek additional clinical/medical help and when self-care is the most appropriate option. Pharmacies will have received a laminated copy of both the UTI and RTI leaflets as well as a flowchart to aid their consultations from the UK Health Security Agency (UKHSA) as part of PQS 2022/23, but further printable copies are available here.  

Contractors should review the recommendations of the 2022/23 TARGET Treating Your Infection leaflet data collection report, which will be published alongside new data collection sheets by 1 September 2023 by NHS England prior to completing the 2023/24 review.

This review must be completed by the end of 31 March 2024 and must be carried out over four weeks with a minimum of 15 patients for each leaflet, or up to eight weeks if the minimum number of patients are not achieved within four weeks for each leaflet. The data from the leaflets must be submitted via the MYS data collection tool by the end of 31 March 2024. The contractor must enter the start and finish dates of the data collection period on the MYS application at the point of declaration (which may be different from the date data is first entered on the MYS portal).

Where no patients are identified for the review, the contractor will still be eligible for payment if they can evidence that they have robustly attempted to identify suitable patients. This might be demonstrated through action plans, training or SOPs. They will need to declare no patients have been identified as being suitable for review on the data collection tool on MYS by the end of 31 March 2024. Information from the NHSBSA dispensing data will be checked to confirm this declaration.

6.1.3.c Training

By the end of 31 March 2024, all non-registered staff working at the pharmacy on the day of the declaration must have satisfactorily completed, within the last three years (between 1 April 2021 and 31 March 2024), the Infection prevention and control Level 1 e-learning and assessment on the elearning for healthcare (elfh) website.

By the end of 31 March 2024, all registered pharmacy professionals working at the pharmacy on the day of the declaration must have satisfactorily completed, within the last three years (between 1 April 2021 and 31 March 2024), the Infection prevention and control Level 2 e-learning and assessment on the elfh website.

By the end of 31 March 2024, all patient-facing pharmacy staff that provide advice on medicines or healthcare working at the pharmacy on the day of the declaration must have satisfactorily completed, within the last three years (between 1 April 2021 and 31 March 2024), Antimicrobial Stewardship for Community Pharmacy e-learning and assessment on the elfh website.

6.1.3.d Antibiotic Guardian pledge

By the end of 31 March 2024, all patient-facing staff that provide health advice working in the pharmacy on the day of the declaration, must have become Antibiotic Guardians, if they have not already done so, and have an awareness of the local antibiotic formulary and how to access it.

6.1.3.e Action plan

By the end of 31 March 2024, contractors must have available, at premises level, an AMS Action Plan for the pharmacy, which details how they will promote AMS available for inspection. The action plan must include details of how all pharmacy staff involved in the provision of self-care advice will incorporate the principles of AMS into self-care advice, including reinforcing the messages around appropriate use of antibiotics, and the uptake of vaccinations, including the flu vaccine. There must be documented evidence, at the pharmacy, that the actions within the plan have been implemented by the day of the declaration. While the action plan needs to be available for inspection from 31 March 2024, contractors are encouraged to have this ready before using the leaflets to aid consultations with patients.

For contractors who claimed for the Prevention domain in the PQS 2022/23, an update to the previous action plan will be required. Pharmacy teams must have reviewed and updated their existing AMS action plan and have implemented changes to further promote AMS in their day-to-day practice.

6.1.3.f Safe disposal

By the end of 31 March 2024, all patient-facing pharmacy staff working in the pharmacy on the day of the declaration must have been trained on the reasons why unwanted and expired antibiotics should be returned to the pharmacy for safe disposal and the adverse effects on the environment and AMR when antibiotics are disposed of in domestic waste. The Royal Pharmaceutical Society has provided some short videos and material available here.

The pharmacy must be able to evidence they have spoken (a verbal conversation rather than written communication) with all patients, their carer or representative, for whom they have dispensed antibiotics between 1 June 2023 and the day of the declaration, about the benefits of them returning all unwanted antibiotics to a community pharmacy for safe and environmentally friendly disposal.

6.1.4 Reporting

6.1.4.a TARGET antibiotic checklist

When making a declaration for this criterion, contractors must confirm the following on the MYS application:

• A declaration that by the end of 31 March 2024 the contractor will have completed the TARGET Antibiotic Checklist
• The start and end date of the review period.
• A declaration that the contractor has notified the patient’s prescriber where concerns are identified.
• A declaration that by the end of 31 March 2024, the contractor will have shared their anonymised data or have declared that no patients have been identified as being suitable for review via the data collection tool on the NHSBSA MYS application.

6.1.4.b TARGET treating your infection leaflets

When making a declaration for this criterion, contractors must confirm the following on the MYS application:

• A declaration that by the end of 31 March 2024 the contractor will have completed the TARGET treating your infections leaflets review.
• The start and end date of the review period.
• A declaration that where concerns are identified when completing the review, the patient’s GP practice will be promptly notified.
• A declaration that by the end of 31 March 2024, the contractor will have shared their anonymised data or have declared that no patients have been identified as being suitable for review via the data collection tool on the NHSBSA MYS application.

6.1.4.c Training

When making a declaration for this criterion, contractors must confirm the following on the MYS application:

• The total number of non-registered pharmacy staff working at the pharmacy on the day of the declaration who have satisfactorily completed the Infection prevention and control level 1 e-learning and assessment on the elfh website since 1 April 2021.
• The total number of non-registered pharmacy staff working at the pharmacy on the day of the declaration who have not satisfactorily completed the Infection prevention and control level 1 e-learning and assessment on the elfh website since 1 April 2021 but will undertake this requirement by the end of 31 March 2024.
• The total number of registered pharmacy professionals working at the pharmacy on the day of the declaration who have satisfactorily completed the Infection prevention and control level 2 e-learning and assessment on the elfh website since 1 April 2021.
• The total number of registered pharmacy professionals working at the pharmacy on the day of the declaration who have not satisfactorily completed the Infection prevention and control level 2 e-learning and assessment on the elfh website since 1 April 2021 but will undertake this requirement by the end of 31 March 2024.
• The total number of patient-facing pharmacy staff that provide advice on medicines or healthcare working at the pharmacy on the day of the declaration who have satisfactorily completed the Antimicrobial Stewardship for Community Pharmacy e-learning and assessment on the elfh website since 1 April 2021.
• The total number of patient-facing pharmacy staff that provide advice on medicines or healthcare working at the pharmacy on the day of the declaration who have not satisfactorily completed the Antimicrobial Stewardship for Community Pharmacy e-learning and assessment on the elfh website since 1 April 2021 but will undertake this requirement by the end of 31 March 2024.

6.1.4.d Antibiotic Guardian pledge

When making a declaration for this criterion, contractors must confirm the following on the MYS application:

• The total number of patient-facing pharmacy staff that provide health advice working in the pharmacy on the day of the declaration who have become Antibiotic Guardians and have an awareness of the local antibiotic formulary, including how to access it.
• The total number of patient-facing pharmacy staff that provide health advice working in the pharmacy on the day of the declaration who have not yet become Antibiotic Guardians and do not have an awareness of the local antibiotic formulary, including how to access it but will undertake this requirement by the end of 31 March 2024.

6.1.4.e Action plan

When making a declaration for this criterion, contractors must confirm the following on the MYS declaration:

• A declaration that by the end of 31 March 2024, the contractors will have at premises level, a new or updated AMS action plan on how they would promote AMS in their day-to-day practice.

6.1.4.f Safe disposal

When making a declaration for this criterion, contractors must confirm the following on the MYS application:

• The total number of patient-facing pharmacy staff working in the pharmacy on the day of the declaration who have been trained on the reasons why unwanted and expired antibiotics should be returned to the pharmacy for safe disposal.
• The total number of patient-facing pharmacy staff working in the pharmacy on the day of the declaration who have not been trained on the reasons why unwanted and expired antibiotics should be returned to the pharmacy for safe disposal but who will undertake this requirement by the end of 31 March 2024.
• The total number of conversations had with patients and/or their carers or representatives on the reasons why unwanted and expired antibiotics should be returned to the pharmacy for safe disposal between 1 June 2023 and the day of the declaration.

Training

Table 2: Training summary for the PQS 2023/24

Validity of training

Pharmacy staff may be required to repeat training and e-assessments that they have previously completed. The table above details the time period that the training and assessment (where applicable) must have been completed. The validity period for training for PQS 2023/24 runs until the end of 31 March 2024. For example, if a pharmacist needs to complete the CPPE inhaler technique for health professionals: getting it right e-learning and inhaler technique for health professionals e-assessment, this will need to be completed within the four years prior to 31 March 2024 (between 1 April 2020 and the end of 31 March 2024).

The following applies to all training that is associated with the PQS 2023/24.

Many of the criteria in this scheme include training and related assessments being undertaken by pharmacy team members. The following terms are used in the requirements to define different types of staff:

• Registered pharmacy professionals are pharmacists and pharmacy technicians.
• Non-registered pharmacy staff include all trainee pharmacists, trainee pharmacy technicians, dispensary staff, medicine counters assistants and delivery drivers.
• Patient-facing staff that provide advice on medicines or healthcare include all registered pharmacy professionals, trainee pharmacists, trainee pharmacy technicians, dispensary staff and medicine counter assistants.

An electronic certificate of completion of the training will be provided following the completion of each of the assessments. Contractors must keep a copy of the certificate for each member of staff as evidence that the training and e-assessment has been completed for each of the criteria that the contractor is claiming for. The training must have been successfully completed by those staff present on the day of the declaration by the end of 31 March 2024.

If staff members have previously completed any of the training and, where applicable, successfully passed the e-assessments which are within the validity period, they are not required to complete this training again.

Where new staff who have recently joined the pharmacy or staff returning from long term leave, for example maternity leave, have not undertaken the training and assessment by the end of 31 March 2024, the pharmacy contractor can count them as having completed the training and assessment, if the pharmacy contractor has a training plan in place within 30 days of the declaration or by 31 March 2024 to ensure that these staff complete the training and assessment. This training plan and demonstrable evidence of completion of training and assessment must be retained at the pharmacy to demonstrate that the pharmacy contractor has met this quality criterion.

By the end of 31 March 2024, the contractor must have for each staff member, excluding those staff for whom there is a training plan in place as described above, at premises level, a copy of the personalised certificate (paper or accessible digitally) provided upon completion of the training and assessment (where applicable), as evidence that all relevant members of staff have completed the training.

Payments and declarations

Pharmacy contractors must claim payment during the declaration period, which is between 09.00 on 5 February 2024 and 23.59 on 1 March 2024 through the NHSBSA’s MYS application. Contractors must have claimed for the 15 NMS gateway requirement on MYS by the end of 5 January 2024 to be able to make their PQS declaration. Contractors must have evidence to demonstrate meeting the quality criteria they have claimed for by the end of the 31 March 2024.

Contractors who opened from 1 June 2023 or had a change of ownership resulting in a new ODS code must deliver two NMS multiplied by the number of months, or part months, they are open, by the end of 31 December 2023, to qualify for payment for the PQS 2023/24. For example, a contractor that opens on 30 September 2023 will need to delivery 8 NMS by the end of 31 December 2023.

Pharmacies on a pharmaceutical list in England can take part in the PQS and earn a payment for meeting the scheme requirements. This does not include Local Pharmaceutical Services (LPS) contracts. However, in some circumstances, the commissioner may make local payments that are equivalent to the PQS where LPS contracts mirror the contractual arrangements of those of the CPCF. These payments would also need to be claimed via the NHSBSA MYS PQS payment declaration. LPS contractors who wish to take part in an equivalent to the PQS but are unsure if they would be eligible, should contact their  Integrated Care Board for advice.

The PQS is a voluntary scheme that is open to all listed pharmacy contractors other than LPS contractors, who wish to take part. To date, participation in the scheme has been consistently high, with the vast majority of contractors submitting a declaration of meeting at least some of the quality requirements. Submitting a declaration is an essential part of the scheme and it enables the efficient management of the payment process. The submission of a declaration for completing any of the quality requirements of the scheme, both accurately and within the timescales outlined in the Drug Tariff, is a significant part of demonstrating that the quality requirements have been met. Consequently, any contractor who fails to successfully submit their declaration during the declaration period will not be eligible for a PQS payment.

Contractors who are new to the pharmaceutical list since the last scheme, either as owners of new pharmacies or as new owners of existing listed pharmacies are able to take part in the PQS. However, in doing so they must ensure that when they make their declaration, they are able to demonstrate how they, the new contractor, will meet the requirements of the PQS 2023/24 on the day they make their declaration. The contractor must have evidence of how they have met the requirements of the PQS and cannot use the evidence of a previous or different contractor. If there has been a change of ownership of a pharmacy that results in a change of ODS code, the new contractor would not be able to use the evidence of the previous contractor. To meet the PQS requirements, the contractor would need to be able to demonstrate how they themselves had undertaken all the work to meet the requirements since the change of ownership.

For PQS 2023/24, contractors will be paid as part of the overall payment made by the NHSBSA to contractors on 1 April 2024.

8.1 Pharmacy payment bands

For the PQS 2023/24, the maximum number of points for the Medicines Safety and Optimisation domain and the Prevention domain, will be fixed irrespective of the participating contractor’s total prescription item volume for bands 2-6. There is a different points allocation for contractors in band 1. For the Respiratory domain the maximum number of points will be on a banding system, to better reflect the workload of meeting the Respiratory domain requirements for different contractors.

The Respiratory domain has a designated maximum number of points dependent on the participating contractors total prescription fee item volume in 2022/23*/**/***/**** according to the NHSBSA’s payment data shown in Table 3.

* Contractors, who opened part way through 2022/23, will have their total prescription volume determined as the average number of prescriptions dispensed per month during the full months they were open in 2022/23, multiplied by 12. Please note that for the purpose of the PQS banding only, change in ownership is not treated as a new contractor.

** Contractors who opened after 31 March 2023, will be placed in band 2 for the PQS 2023/24. Please note that, for the purpose of the PQS banding only, change in ownership is not treated as a new contractor.

*** Contractors who are eligible for the 2023/24 Pharmacy Access Scheme (PhAS) are automatically placed in band 4 if according to their prescription volume they would have been placed in band 1 to 3. Note that PhAS pharmacies which are in band 5 and 7 according to their prescription volume will be paid according to these bands.

**** Where two pharmacies have consolidated, in accordance with Regulation 26A since 1 April 2022, will have the total prescription volume of the continuing pharmacy determined as the item volume for the continuing pharmacy only. The item volume for the closing pharmacy will not be attributed to the continuing pharmacy. This is not the same as a change in ownership situation.

Table 3: Maximum number of points per domain for each band

Confirmation of which band a pharmacy has been put into will be published by the NHSBSA, on their PQS webpage, to support contractors in making their aspiration payment declaration should they choose to make one.

Most pharmacies will be in Band 4. This band is for pharmacies that dispensed an average prescription fee item volume between 60,001-150,000 fee items between 1 April 2022 and 31 March 2023 according to the NHSBSA’s payment data.

The total funding for PQS 2023/24 is £45 million. The funding will be divided between qualifying pharmacies based on the number of points they have achieved up to a maximum £137.50 per point. Each point will have a minimum value of £68.75, based on all pharmacy contractors achieving maximum points. Payments will be made to eligible contractors depending on the band they are placed in and how many domains they have declared they are meeting, and hence points claimed.

8.2 Aspiration payment

The aspiration payment must be claimed between 09.00 on 4 September 2023 and 23.59 on 29 September 2023 through the NHSBSA’s MYS application.  

The aspiration payment is optional for pharmacy contractors and not claiming it will not impact on the pharmacy contractor’s ability to claim payment for the PQS 2023/24.

The aspiration payment for each domain is paid to the contractor on the understanding that the contractor will have made a declaration within the declaration period and that they will have completed the PQS 2023/24 before 23.59 on 31 March 2024. If the contractor fails to meet the gateway criterion by 5 January 2024, they would not be eligible for the PQS 2023/24. If an aspiration payment is claimed but the contractor then fails to submit their declaration within the declaration period of meeting the PQS 2023/24 before 23.59 on 31 March 2024 then they would not be eligible for the PQS 2023/24. In both instances the aspiration payment will be reclaimed from the contractor.

There is no requirement to have claimed for a previous PQS to claim an aspiration payment for the PQS 2023/24.

Once contractors have reviewed the requirements of the PQS 2023/24, they will need to decide which domains they intend to meet when they make their aspiration declaration during the PQS 2023/24 declaration period.

Pharmacy contractors will need to make an aspiration payment claim, between 09.00 on 4 September 2023 and 23.59 on 29 September 2023, using NHS BSA MYS and indicate which domains they intend to achieve before the end of the declaration period. Further information can be found in section 8.3.

The maximum number of points for which a pharmacy can be paid an aspiration payment is 70% of the number of points within their band. The value of the point for the aspiration payment is set at £68.75 (i.e., the minimum value of a point for the PQS 2023/24).

The aspiration payment will be paid to contractors on 1 November 2023.

The aspiration payment will be reconciled with the payment for the PQS 2023/24 on 1 April 2024. Part VIIA of the Drug Tariff for the PQS has worked examples of how the aspiration payment will work in practice.

In making a declaration for an aspiration payment, contractors are thereby accepting that a reconciliation will take place; and that their final PQS payment will be adjusted to either recover an overpayment or to receive a further payment based on the declaration made between 5 February to 1 March 2024.

For contractors who have ceased trading between receiving an aspiration payment and the commencement of the declaration period between 5 February and 1 March 2024, this aspiration payment will be recovered.

Similarly, where there is a change of ownership during the course of 2023/24 which results in a new ODS code for the contractor, and the previous contractor received an aspiration payment and does not make their final declaration during the declaration period, this aspiration payment will be recovered.

A contractor claiming for the PQS must have met the requirements of the scheme during that contractor’s ownership of the pharmacy. A new contractor, who has acquired the pharmacy from another on a non-debts and liabilities basis, cannot use the PQS activities undertaken by the previous contractor when making a PQS declaration. In such cases the change of ownership will have resulted in a new ODS code being issued for the acquiring contractor. The new contractor will, therefore, need to ensure they are able to demonstrate how they have met the PQS requirements since the change of ownership.

Any contractor or applicant looking to acquire a pharmacy during the PQS will need to ensure they will be able to meet the scheme’s requirements, especially the gateway requirement, after the change of ownership should they wish to take part in the scheme and make a PQS declaration under a new ODS code.

8.3 Declarations: Manage Your Service

The payment declarations for the aspiration payment and the PQS must be submitted online via the NHSBSA’s MYS application.

Unless a contractor makes a valid claim by submitting the declaration via the NHSBSA’s MYS application during the appropriate declaration period (for the aspiration payment or the PQS payment), they will not receive the relevant payment.

Further support on MYS is available in the ‘Frequently asked questions on MYS’ which can be found on the PSNC (soon to be called Community Pharmacy England) website.

8.4 Declaration process

Contractors can make their PQS declaration at any time during the declaration window, between 09.00 on 5 February 2024 and 23.59 on 1 March 2024.

For the PQS 2023/24, contractors will be required to confirm in their declaration that they will have the evidence that they have met the gateway criterion and quality criteria that they are claiming for by the end of 31 March 2024. The evidence of meeting the requirements of the gateway criterion and each domain should be retained for two years as it may be required for post-payment verification purposes.

Should a contractor find that, despite declaring in good faith, they do not have the evidence of having met gateway or a quality criterion they should inform the NHSBSA Provider Assurance Team so that a reclaim of the PQS overpayment can be made.

Where possible, assurance is obtained by verifying declarations against national datasets and evidence sources. This reduces the burden on contractors to provide evidence for all requirements.

There may be instances where the NHS does not hold a full record of activity; or where the information held is incomplete or in rare cases incorrect. In such instances the NHSBSA Provider Assurance Team may require contractors to provide evidence of how their pharmacy has met the scheme requirements. In such cases, the team will support contractors with a claim that has not been verified against a national dataset by helping to identify evidence that could be used to demonstrate compliance with the PQS requirements. Contractors are encouraged to work with the NHSBSA to provide any evidence required as quickly and thoroughly as possible to minimise the extra burden that these assurance checks bring to both the contractor and the NHS.

No PQS declaration submissions will be accepted after 23.59 on 1 March 2024. Contractors are advised to complete their submissions early in the declaration window to ensure that they meet the specified declaration timescales.

MYS allows a contractor to start their declaration and then return to it later should this be necessary. Where a declaration has been started but not submitted, it will not be eligible for payment.

Contractors are asked to check their declaration for accuracy and precision before final submission of their online declaration via MYS as this is what their payment will be made against.

Contractors must keep their declaration confirmation email as evidence of declaration submission and should note that submission of audit data is not evidence of submission of a PQS declaration.

The timescales for making these payments after the declarations close are made as short as possible to maximise the time contractors have to meet the scheme requirements. The full £45 million funding for the year is paid out according to declaration submissions once the declaration window is closed, leaving no funding to make amendments after the event. The responsibility lies with the contractor to ensure they make their PQS declarations within the timescales set out, and that the declarations submitted accurately reflect the criteria that the contractor has met and has evidence to demonstrate how the requirements were met.

Validation of claims

NHS England has a duty to be assured that where contractors choose to take part in the PQS that they meet the requirements of the scheme and earn the payments claimed. NHS England will work with the NHSBSA Provider Assurance Team to undertake verification checks on all declarations. The verification checks include comparing the information provided by contractors in their declarations against the datasets and evidence sources available.

When contractors make their submission for the PQS 2023/24, they are making a declaration that they have met the gateway criterion and will meet the quality criteria in each of the domains they are claiming for by the end of 31 March 2024. It is the contractor’s responsibility to be able to provide evidence of meeting the scheme requirements and this may be required by the NHSBSA for post-payment verification.

In cases where NHS England consider that a claim has been made for a PQS payment for which the contractors is not eligible, it will be treated as an overpayment. In such cases, contractors will be contacted by the NHSBSA and notified of the overpayment recovery process. Any overpayment recovery would not prejudice any action that NHS England may also seek to take under the performance related sanctions and market exit powers within The National Health Service (Pharmaceutical and Local Pharmaceutical Services) Regulations 2013.

9.1 Provider Assurance

As well as providing assurance to NHS England, the NHSBSA Provider Assurance Team can assist contractors if they are having problems with any of the systems or processes involved in the PQS. It is expected that this guidance will provide contractors with the information required to successfully meet the scheme requirements and so should be read thoroughly before seeking alternative assistance. However, if the answer to a problem cannot be found within the guidance, please contact pharmacysupport@nhsbsa.nhs.uk.

It is essential that contractors experiencing any difficulty with collating evidence of meeting the scheme requirements or making the declarations for the PQS 2023/24 contact the NHSBSA Provider Assurance Team to make them aware of these difficulties at the time the difficulties occur. This will enable the NHSBSA to provide support to resolve the difficulty; or in the unlikely event of not being able to do so, to escalate the problem to NHS England to resolve. This will not be possible after the declaration window closes and, if the declaration is not submitted, this will result in the payment not being made.

Appendix

10.1 Oral Anticoagulant Safety Audit 2023/24

Introduction

Anticoagulants are high risk medicines; they have a heightened risk of causing significant harm when used in error. This class of medicines is frequently identified as a cause of preventable harm and admission to hospital. In 2007, the National Patient Safety Agency issued a patient safety alert with actions to improve anticoagulant safety which included providing specific patient information, regular blood monitoring and checking drug interactions. Since then, direct-acting oral anticoagulants (DOACs) have come into widespread use. Although the principles of the 2007 alert still apply, some aspects, such as regular International Normalised Ratio (INR) monitoring and dietary considerations, are not relevant for the newer medicines.

The World Health Organization (WHO) has initiated work on medicines safety, with one key area being high risk medicines. In response to the WHO, NHS England have instigated a Medicines Safety Improvement Programme with anticoagulant safety being one of four initial areas of focus. Prevention of heart attacks and strokes is a priority in the NHS Long Term Plan, which will increase use of anticoagulants in the coming years.

An anticoagulant audit was previously conducted as part of the 2021/22 PQS. This audit has been analysed and learnings, findings and recommendations can be found on the NHS England website. All contractors should familiarise themselves with and adhere to the recommendations provided in this report.

Aims

• To reduce preventable patient harm from oral anticoagulant medicines.
• To embed the actions, recommendations and learning from the audit carried out in the PQS 2021/22 into day-to-day clinical practice and measure any improvement seen between 2021/22 and 2023/24.

Audit time frame

Data must be collected for 2 weeks, with a minimum sample size of 15 patients. In cases where there is difficulty in obtaining the minimum sample size, the audit should be extended to 4 weeks after which contractors will be able to submit the data for the number of patients they have, if less than 15.

Audit sample

Population – All adult patients (aged 18 or over) presenting a prescription for an oral anticoagulant (i.e. vitamin K antagonists (VKAs), factor Xa inhibitors or thrombin inhibitors) as listed below:

• Acenocoumarol
• Apixaban
• Dabigatran
• Edoxaban
• Phenindione
• Rivaroxaban
• Warfarin

Audit standards

Audit standard 1 Information and awareness 

• All patients prescribed an oral anticoagulant are aware of or are provided with the following key information:
  • The medicine is an anticoagulant, i.e. a medicine to thin the blood/ prevent blood clots.
  • The symptoms of over-anticoagulation, e.g. unexplained bruising, nose bleeds.
  • They need to check with a doctor or pharmacist before taking over-the- counter medicines, herbal products or supplements.
  • If taking a VKA, that dietary change can affect their anticoagulant medicine.

Audit standard 2 Alert cards

• All patients have a standard yellow anticoagulant alert card or are offered one.

Audit standard 3 Safe use with other prescribed medicines – Antiplatelets

• The prescriber is contacted about all patients prescribed an anticoagulant with an antiplatelet but not co-prescribed gastro-protection unless contact has been made about this in the previous 6 months or the patient has already discussed with their prescriber.

[The PINCER summary (Query E) states that ‘Gastro-protection should always be considered and offered when combination therapy is indicated’.]

Audit standard 4 Safe use with other prescribed medicines – NSAIDs

• The prescriber is contacted about all patients prescribed an anticoagulant with an NSAID.

[The PINCER summary (Query D) states that ‘It is advisable to avoid this combination whenever possible’.]

Audit standard 5 – INR monitoring and recording

• INR monitoring within the last 12 weeks is confirmed for all patients prescribed vitamin K antagonists.

How to complete the audit

You will need to implement a local system to identify patients in the audit population. The audit can be undertaken at any time from 1 June 2023. Ensure the pharmacy team are familiar with the recommendations of the 2021/22 oral anticoagulant audit report.

A paper data collection form is provided below. Please familiarise yourself with the questions before beginning the audit. The data can be collected on paper forms for online submission at a later date or the data can be entered directly via the online portal. If using paper data collection forms, you should print one copy for each patient included in the audit. This data form does not include patient identifiable details, so you need to keep a record locally of each patient included in the audit to prevent duplication. Contractors should make a record of the start and end date of the review as they will be required to enter this information into the MYS application when they make their declaration. All pharmacies can enter their data for each patient via the NHS Business Services Authority (NHSBSA) Manage Your Service (MYS) Portal from 1 June 2023.

The MYS online portal will be available to record audit data until the end of 31 March 2024. A maximum of 20 patients can be added to this portal. 

Contractors must submit their data by the end of 31 March 2024. In addition, they must make a PQS 2023/24 declaration between 9.00 on 5 February 2024 and 23.59 on 1 March 2024.

Alert cards

Community pharmacies can obtain supplies of the standard yellow anticoagulant alert card via the Primary Care Support England (PCSE) website at pcse.england.nhs.uk/pharmacies (also used to order EPS tokens etc.); order code Oral Anticoagulant Therapy Alert Card (‘OATALERTCARD’). The card can be used for any oral anticoagulant.

This audit was originally developed by Dr Carina Livingstone,1961-2023 and is dedicated to her memory.

Quick guide

What’s the point? The number of patients prescribed DOACs instead of warfarin has increased substantially. Supporting patients’ knowledge and use of anticoagulant medicines is as important as it has ever been. Pharmacy teams must continue to make sure people taking anticoagulants know that the medicines affect blood clotting and to check safety issues which could harm patients.

Include all adult patients prescribed these medicines

• Acenocoumarol
• Apixaban
• Dabigatran
• Edoxaban
• Phenindione
• Rivaroxaban
• Warfarin

Time frame and sample

Any two weeks starting before 4 March 2024. Minimum sample size = 15 patients.

The audit will need to be extended for a further two weeks if less than 15 patients, so allow enough time for this. The last date for data submission is 31 March 2024.

The data collection form is provided below and you need to be familiar with the questions before starting the audit. Data can be entered directly into the approved electronic platform or you can use paper forms and then enter your data on the electronic platform later (see How to complete the audit). If using paper, you will need to print at least 15 copies of the form.

Audit reminders

• Do you have some yellow anticoagulant alert cards in stock to offer to patients before commencing the audit?
• Before talking to the patient, check what other prescribed medicines they are taking. You may need to follow up with the patient and prescriber, e.g. if co-prescribed anticoagulant and an antiplatelet without gastro-protection
• When talking to patients for the audit, you need to find out:

Do they have a yellow card and where is it?

If not, do they want one?

Do they know:

• The medicine is an anticoagulant i.e. thins blood to prevent clots?
• Symptoms of over-anticoagulation e.g. unexplained bruising, nosebleed?
• To check with pharmacist or doctor before taking over-the-counter medicines?
• Dietary change can affect their medicine? (VKA patients only)
• Date of most recent INR test? (VKA patients only)

Were the audit standards met?

Audit standard 1 Information and awareness Questions 11 to 14

All patients prescribed an oral anticoagulant are aware of or are provided with all specified key information.

Audit standard 2 Alert cards Questions 15  

All patients have a standard yellow anticoagulant alert card or are offered one.

Audit standard 3 Safe use with other prescribed medicines – Antiplatelets Question 9

The prescriber is contacted about all patients prescribed an anticoagulant with an antiplatelet but not co-prescribed gastro-protection unless contact has been made about this in the previous 6 months or the patient has already discussed with their prescriber.

Audit standard 4 Safe use with other prescribed medicines –NSAIDs Question 8

The prescriber is contacted about all patients prescribed an anticoagulant with an NSAID.

Audit standard 5 – INR monitoring and recording Questions 16

INR monitoring within the last 12 weeks is confirmed for all patients prescribed vitamin K antagonists.       

Audit actions

 Any queries or problems?

Technical issues about accessing/using the NHSBSA online data entry audit tool: mys@nhsbsa.nhs.uk

Questions about the audit and the Pharmacy Quality Scheme: ENGLAND.CommunityPharmacy@nhs.net  or services.team@cpe.org.uk

Thank you for completing this audit

PQS Oral Anticoagulant Safety Audit 2023/24 – Data Collection Form

Please see the PDF version of this document for this form.

Publication reference: PRN00176