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

2021/22

NHS England and NHS Improvement (NHSE&I) has advised that that community pharmacies need to fulfil all aspects of their terms of service for 2021/22.

They have also reminded contractors that the declaration of emergency requiring the flexible provision of pharmaceutical services, was extended from the 30th September 2021 to January 31st 2022. This allows contractors with adequate reason to request temporary opening hours (days or times) provided they give 24 hours’ notice to NHSE&I.

2020/21

In light of the COVID-19 pandemic and the impact that this was having on community pharmacies, PSNC gained agreement from NHSE&) 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

2021/22

NHS England and NHS Improvement has advised that community pharmacy contractors need to fulfil all aspects of their Terms of Service for 2021/22.

2020/21

PSNC pressed for the NHS to take a pragmatic and flexible approach to the regulations were amended as follows.

Disposal of unwanted medicinesPSNC 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The contractual requirement for community pharmacies to accept unwanted/out-of-date/waste medicines for disposal from the public remained an important service during the COVID-19 pandemic, but it brings potential risks for pharmacy teams.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: contractors were given an extended deadline for completion of the 2020/21 toolkit, with submissions required by 30th June 2021.

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

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

Practice leaflets: NHSE&I advised that they would not take action against contractors who had not updated their practice leaflets during the period of the pandemic.

Public health campaigns: NHSE&I and PSNC have agreed that contractors will be asked to participate in a COVID-19 vaccination campaign as the first mandated health campaign for 2021/22. The focus of the other campaigns will be discussed in the negotiations for 2021/22.

NHS complaints process: NHSE&I announced a system wide “pause” of the NHS complaints process, initially for three months from 28th March 2020. The pause was not being enforced for any healthcare providers who did 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 also did 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)

PQS 2021/22

Due to the extension of the PQS Part 2 2020/21 until 30th June 2021, the PQS 2021/22 will not start until July 2021 at the earliest. Negotiations on this are ongoing.

2020/21

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 had until 30th June 2021 to complete any elements of the scheme they have declared as having met. Contractors who made declarations in February received any PQS payment due as part of the overall payment made by the NHSBSA to contractors on 1st April 2021.

Read more on our Pharmacy Quality Scheme – Archive page.

Discharge Medicines Service (DMS)

Whilst its introduction was delayed due to the ongoing pandemic, the DMS became an Essential service for contractors from 15th February 2021. From this date, NHS Trusts have been 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.

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.

Other Advanced Services

The choice of provision, or not, of Advanced Services 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, 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 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 would not require quarterly NMS and MUR data submissions during the period of the pandemic. The requirement to submit NMS data to the NHSBSA returns for quarter 2 of 2021/22 onwards.

Phase out of MURs
The targeting requirements for MURs in 2020 were amended to retain the previous targeting requirements (70% of MURs must be for patients taking high-risk medicines or those recently discharged from hospital) until 31st December 2020. Then, as previously agreed in the five-year CPCF deal, the service was decommissioned on 31st March 2021.

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

Locally commissioned (Enhanced) services

NHSE&I regional teams were asked to review the need for any local pharmacy Enhanced services. Those that were not essential during the pandemic may have been 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

The 2021/22 Community Pharmacy Assurance Framework (CPAF) screening questionnaire will be available to complete on the Manage Your Service (MYS) Portal between Monday 28th June 2021 and midnight on Saturday 24th July 2021, for each of their NHS pharmacies. Note, the CPAF is now being carried out in accordance with new NHS Regulations introduced at the end of 2020 and it is a requirement of the Terms of Service that community pharmacy contractors complete the process.

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.

Updated template PNA questionnaire 2021

PSNC has updated its template questionnaire to help support the local development of PNAs. The template questionnaire is intended to be assist LPCs to support the process by gathering information on the services offered by their contractors. The use of this template pharmacy questionnaire is not mandatory but may prove to be a useful resource to inform any PNA development discussions with HWBs. The template is in line with the regulations and previous guidance issued by NHS Employers, covering all the questions relevant to development of the PNA.

Whilst this information should be known to the Clinical Commissioning Groups (CCGs), LPCs may wish to issue the questionnaire as a useful way to check that the data is as accurate as possible. The questionnaire can also be used to determine future willingness to provide services.

 Template PNA pharmacy questionnaire (April 2021)

If LPCs have queries on this or require more information, please contact Layla Rahman, Regulations Officer

Supplying medicines to care homes

The Department of Health and Social Care (DHSC) has published guidance on new regulations which make COVID-19 vaccination a requirement for people working or deployed in care homes; the regulations will come into force on 11th November 2021.

The guidance will apply to community pharmacy contractors who are providing services to care homes, for example, providing a locally commissioned service or delivering medicines to care homes.

The guidance provides information on demonstrating evidence of vaccination, medical exemptions and guidance for visiting professionals, as well as requirements when making deliveries to care homes.

View the DHSC Vaccination of people working or deployed in care homes guidance

NHS England and NHS Improvement has also written to NHS staff, including community pharmacy contractors, on how this will be delivered operationally.

Contractors who provide services to care homes will need to:

  • actively support staff to have their first COVID-19 vaccine by 16th September 2021 (as eight weeks is required between the two doses);
  • carry out proactive workforce planning to ensure:
    • only staff who are vaccinated, or exempt, are deployed to a care home from 11th November 2021;
    • service provision is not disrupted once this regulation comes into force; and
  • ensure that relevant staff can demonstrate to care home staff, via the NHS COVID Pass service, that they have either had two doses or are exempt.

NHSE&I has also published FAQs, which will be updated on a regular basis, to support implementation of the new regulations.

Read the NHSE&I letter and FAQs


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