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.

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 medicines: PSNC 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The contractual requirement for community pharmacies to accept unwanted/out-of-date/waste medicines for disposal from the public remains an important service during the COVID-19 pandemic, but it does bring potential risks for pharmacy teams.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.

Guidance on dealing with patient-returned / unwanted medicines

Checklists on dealing with patient-returned / unwanted medicines

Data Security and Protection Toolkit: the current submission deadline has been amended from 31st March 2020 to 30th September 2020.

Community pharmacy patient questionnaire (CPPQ): NHSE&I will not take action against contractors who did not complete the CPPQ process by 31st March 2020.

National Antimicrobial Stewardship Clinical Audit for 2019/20: the requirement to complete this audit was waived.

Pharmacy-selected clinical audit: NHSE&I will not take action against contractors who did not complete their pharmacy-selected clinical audit by 31st March 2020.

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: for the time being these campaigns are suspended and any that are agreed to run during the period of the pandemic will only be focused on the national COVID-19 response.

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 – have not been laid due to the Government focusing on the COVID-19 response. PSNC is discussing with DHSC and NHSE&I when the best time would be for these requirements to commence. It is likely that many will be introduced at some point in the autumn, but we will confirm the exact date once this is agreed.

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: existing pilots for GP referrals to the service will remain in place, but will not be extended at this time.

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.

Pharmacy Quality Scheme (PQS)

PSNC has agreed the requirements for a new Pharmacy Quality Scheme (PQS) for 2020/21 with DHSC and NHSE&I. The scheme has two parts, both of which are focused on activities that support the response to and recovery from the COVID-19 pandemic.

Full details of how the scheme will operate are available in our PQS 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.

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.

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


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 1 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.

NHSE&I and PSNC are also seeking 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.

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

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

Suspension of Pharmaceutical Needs Assessment renewals

DHSC announced that the requirement to publish renewed Pharmaceutical Needs Assessments (PNAs) will be suspended for a year.

PNAs are due to be renewed and published by Local Authority Health and Wellbeing Boards (HWBs) in April 2021. However, as most resources have been diverted to the COVID-19 pandemic response, PSNC requested an extension of the term of the current PNAs to reduce unnecessary extra pressure on local authorities and LPCs.

DHSC’s announcement means that renewed PNAs will not need to be published until April 2022, but HWBs will retain the ability to issue supplementary statements to respond to local changes and pharmaceutical needs during this time.

Read more here


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