Contractual and regulatory changes during the pandemic

Contractual and regulatory changes during the pandemic

PSNC has been working with HM Government and NHS leaders to provide as much support for community pharmacy teams as possible during the COVID-19 pandemic. This includes temporary amendments to some of the NHS Community Pharmacy Contractual Framework (CPCF) requirements.

Changes to the CPCF during the pandemic

In light of the COVID-19 pandemic and the impact that this is already having on community pharmacies, PSNC has gained agreement from NHS England & NHS Improvement (NHSE&I) and the Department of Health and Social Care (DHSC) on several measures to help contractors.

PSNC Briefing 045/20: Regulatory and contractual dispensations agreed to assist contractors with the ongoing COVID-19 pandemic
This briefing sets out the regulatory and contractual dispensations agreed with DHSC and NHSE&I for 2020/21. These have been agreed to support contractors in their continuing efforts to provide core services and meet the needs of their patients.

Further information is listed below.

Terms of Service requirements

PSNC is pressing for the NHS to take a pragmatic and flexible approach to the regulations and terms of service, to enable community pharmacies and pharmacists to concentrate on patient care. Specifically, the terms relating to the following usual mandatory requirements have been amended as follows.

Disposal of unwanted medicinesPSNC has worked with the National Pharmacy Association, the Royal Pharmaceutical Society and the Community Pharmacy Patient Safety Group to produce joint guidance on dealing with unwanted medicines that have been returned to community pharmacies in England.

The contractual requirement for community pharmacies to accept unwanted/out-of-date/waste medicines for disposal from the public remains an important service during the COVID-19 pandemic, but it does bring potential risks for pharmacy teams. This guidance has been compiled to help contractors determine how best to safely handle returned unwanted medicines at this time. It contains a list of considerations and a suggested procedure, as well as a checklist to work through.

Data Security and Protection Toolkit: no action will be taken against contractors who have not completed the Data Security and Protection toolkit for 2019/20, provided they are working to complete the toolkit for 2020/21. Contractors have an extended deadline for completion of the 2020/21 toolkit, with submissions required by 30th June 2021.

Community pharmacy patient questionnaire (CPPQ): contractors are not required to undertake the CPPQ during 2020/21.

Clinical audits: contractors are not required to undertake an NHSE&I determined national clinical audit or a contractor chosen clinical audit during 2020/21.

Practice leaflets: NHSE&I will not take action against contractors who have not updated their practice leaflets during the period of the pandemic.

Public health campaigns: At the start of 2020/21 we agreed that the campaigns would be suspended due to the COVID-19 pandemic. PSNC and NHSE&I have now agreed that community pharmacies will need to participate in two health campaigns during the rest of 2020/21, the first of which will be the annual campaign which encourages eligible people to get vaccinated against flu. This campaign will begin in early October with campaign resources being delivered to pharmacies at that time (further details on the campaign materials and delivery schedule will be published when they are available). A second campaign, which will focus on the management of winter illnesses, is expected to take place in the New Year; further details will be provided on the timings of this campaign as soon as they are confirmed.

NHS complaints process: NHSE&I has announced a system wide “pause” of the NHS complaints process, initially for three months from 28th March 2020. The pause is not being enforced for any healthcare providers who do wish to operate as normal with regard to complaints. As of 26th March 2020, the Parliamentary and Health Service Ombudsman has stopped accepting new NHS complaints and has stopped work on open cases. NHSE&I will also not require annual complaints report submissions from contractors during the period of the pandemic.

Changes originally planned for July 2020: The regulations required to enact several changes to the Terms of Service due to commence in July 2020 – including the requirement for all community pharmacies to be Healthy Living Pharmacies – were delayed due to the Government focusing on the COVID-19 response. The new NHS regulations were laid on 20th October 2020 and PSNC issued a series of 14 Regs explainer articles to help pharmacy contractors and their teams to understand the new requirements – access them all here.

Pharmacy Quality Scheme (PQS)

NHSE&I and DHSC agreed to PSNC’s request for more flexible timings for completion of the work within the PQS Part 2 2020/21. Whilst the declaration still took place as planned in February 2021, contractors have until 30th June 2021 to complete any elements of the scheme they have declared as having met. Contractors who made declarations in February will still receive any PQS payment due as part of the overall payment made by the NHSBSA to contractors on 1st April 2021.

Read more on our PQS Part 2 page.

Discharge Medicines Service

Whilst its introduction was delayed due to the ongoing pandemic, the Discharge Medicines Service (DMS) is now due to become an Essential service for contractors from 15th February 2021.

From this date, NHS Trusts will be able to refer patients who would benefit from extra guidance around new prescribed medicines for provision of the DMS at their community pharmacy. NHSE&I will initially adopt a light touch approach to contractual assurance with regards to the service and contractors should also note that not all Trusts will be fully ready to make referrals at the time the service commences.

NHSE&I are in the process of developing guidance and a DMS Toolkit for hospitals, Primary Care Networks, community pharmacy teams and others involved in the rollout of the service.

Read more about the service on our DMS webpage.

Flu Vaccination Service

Full details of how this year’s service will operate – including the expansion of eligible groups – are available in our flu hub.

NMS and MURs

The choice of provision, or not, of Advanced Services such as the New Medicine Service (NMS) and Medicines Use Review (MUR) is down to individual contractors. Some have decided to stop, whilst others are continuing but with safety precautions  in place. 

From September 2020, it is no longer a contractual requirement that written consent is obtained from patients prior to the provision of the Flu Vaccination Service, Medicines Use Reviews (MUR), the New Medicine Service (NMS) and Appliance Use Reviews (AUR).

Instead, for these services, verbal consent can be obtained and a record of that made in the pharmacy’s clinical record for the service. These changes were agreed by DHSC and NHSE&I, following a proposal to move to a verbal consent model made by PSNC.

Additionally, all MUR, NMS and AUR consultations may now be provided by phone or video consultation, without the contractor having to seek prior approval from NHSE&I. This should only happen where it is clinically appropriate to do so, and in circumstances where the conversation cannot be overheard by others (except by someone whom the patient wants to hear the conversation, for example a carer).

Read more about the Advanced service changes

NHSE&I has also said that they will not require quarterly NMS and MUR data submissions during the period of the pandemic.

Changes originally planned for 2020/21

PSNC is considering the point at which the other service developments planned for 2020/21 could commence, such as the Discharge Medicines Service (DMS). This has implications for the targeting requirements for the MUR service, as the target group for patients who have recently been discharged from hospital is due to be removed at the point the DMS is launched.

The targeting requirements for MURs in 2020 have therefore been amended to retain the current targeting requirements (70% of MURs must be for patients taking high-risk medicines or those recently discharged from hospital) until 31st December 2020.

Other amendments in preparation for the phasing out of MURs – such as a maximum of 100 MURs payable per pharmacy for 2020/21 and removing MUR accreditation as a prerequisite for providing the NMS – have been implemented.

Further information can be found on in our Advanced services section.

Community Pharmacist Consultation Service (CPCS)

Patients being referred to the CPCS are now being told to phone the pharmacy and to speak to the pharmacist. Unless there is a clinical need for the patient to be seen in the pharmacy, the pharmacist can provide a consultation by telephone, as is provided for in the service specification. If the consultation is conducted in this manner, the pharmacy is eligible to claim the fee for provision of the service.

NHS 111 Online CPCS urgent supply referrals: the NHS 111 Online service now makes CPCS referrals to community pharmacies where people need urgent access to their usual prescribed medicines. Whilst successfully piloted in the north west of England, plans to roll out the functionality across the whole of England have been brought forward in response to the huge surge in demand for NHS 111 services and the direction for people to use the online service in the first instance. For contractors and their teams, the CPCS consultation should be conducted in the normal way, as the source of the referral – NHS 111 telephony service or NHS 111 Online – makes no difference to the process which the pharmacist needs to follow with the patient.

CPCS GP referrals: whilst previously delayed by the pandemic, this extension to the service is now underway – find out more here.

Further information can be found on our CPCS page.

Hepatitis C testing service

The planned introduction of this Advanced Service in April 2020 was delayed by five months because of the COVID-19 pandemic. However, the service has since commenced (on 1st September 2020) and further details can be found on our Hepatitis C testing service webpage.

Pharmacy Integration Fund (PhIF) pilots

The three pilots announced in February 2020 (blood pressure testing; stop smoking support; and point of care testing) have been postponed until further notice.

Locally commissioned (Enhanced) services

NHSE&I regional teams have been asked to review the need for any local pharmacy Enhanced services. Those that are not essential during the pandemic are likely to be paused. Please contact your LPC for information about local pharmacy services.

Drug and alcohol services

COVID-19 guidance for commissioners and service providers for those dependent on drugs or alcohol has been published.

The updated guidance highlights that people who misuse or are dependent on drugs and alcohol may also be at increased risk of becoming infected, and infecting others, with coronavirus (COVID-19). People in these groups may also be more vulnerable to poor health outcomes due to underlying conditions.

The guide covers a range of topics and provides additional sources of support that community pharmacies can use to further assist people through signposting.

Pharmacists who provide services to support people dependent on drugs or alcohol are encouraged to ensure they are familiar with the guidance.

Learn more and read the guidance here

Contract monitoring or CPAF

NHSE&I’s regional teams use the Community Pharmacy Assurance Framework (CPAF) to monitor pharmacy contractors’ compliance with the terms of the CPCF. Due to the ongoing pandemic, it has been agreed that the CPAF process will not run in 2020/21, but this will run as normal in 2021/22.

Read more on our contract monitoring page

Regulatory changes

Market entry applications

NHSE&I has announced that, as part of its overall recovery plan to restore services paused during the lockdown, staff are now being returned to their Market Entry roles and resuming work to process applications and that full market entry function will be resumed from 1st June 2020.

Many of those with existing applications will have received letters from Primary Care Support England (PCSE) and it is understood that priority will be given to those with applications relating to – business or pharmacy service continuity – or where there are pressing reasons for the contractor.

Business or pharmacy service continuity could include consolidations, closures (for example, as part of a business merger), relocations and change of ownership applications. Pressing reasons for contractors might involve, for example, issues associated with leases and health and safety requirements (e.g. social distancing concerns).

Granted applications where deadlines have passed or where they are close to passing – for example, where there is a Notice of Commencement to be submitted – and other related issues should be raised urgently with NHSE&I. PSNC can assist with advice on the regulations. NHSE&I are seeking to take a pragmatic and fair approach to resolving any issues, with national oversight, and are taking mitigating steps so that issues for contractors and other applicants are minimised.

For more information see our clarification announcement on 28th April 2020.

NHSE&I and PSNC sought changes to the NHS regulations to assist the process for contractors as the practical difficulties of keeping to specified timescales during the COVID-19 outbreak may continue. These regulations were drafted some time ago but have been delayed while the whole Amendment Regulation was finalised. They provide that:

  1. Where a six month opening period expires after the Amendment Regulations come into force, this automatically extends to 12 months (amendment to paragraph 34(4)(b)).
  1. Where a three month discretionary extension expires after the Amendment Regulations come into force, this is automatically extended so that it ends 6 months after the Amendment Regulations come into force.
  2. Where a three month discretionary extension expires in the six months before the Amendment Regulations came into force. This extension is revived and the period automatically extended to 6 months after the Amendment Regulations come into force.

For any queries, please contact Gordon Hockey, PSNC’s Director of Operations and Support.

Next publication date of Pharmaceutical Needs Assessment

The Department of Health and Social Care (DHSC) announced that due to ongoing COVID-19 pressures across all sectors, the requirement to publish renewed Pharmaceutical Needs Assessments (PNAs) will be suspended until October 2022 – an extra six months. The National Health Service (Pharmaceutical and Local Pharmaceutical Services) Regulations 2013 will be updated to reflect this change in due course.

The announcement followed requests by PSNC and Local Authorities and is welcomed by PSNC.

In the meantime, before a renewed PNA is published, in most cases Local Health and Wellbeing Boards (HWBs) retain the ability to issue supplementary statements to respond to changes in the availability of pharmaceutical services, where those changes are relevant to the granting of applications.

DHSC has also announced that updated guidance on PNAs will be published this summer, which should assist HWBs and LPCs with the process of renewing PNAs.

Return to the main COVID-19 hub page.

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