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The contractual requirement for community pharmacies to accept unwanted/out-of-date/waste medicines for disposal from the public remains an important service during the COVID-19 pandemic, but it does bring potential risks for pharmacy teams.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

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

Public Health England (PHE), the Department of Health and Social Care (DHSC) and NHS England & NHS Improvement (NHSE&I) are undertaking a programme of work to consider what changes may need to be made to the process for administering flu vaccinations during the 2020/21 season, when social distancing measures will no doubt still be in place. The need for the use of personal protective equipment when vaccinating patients seems inevitable, but they will issue guidance to community pharmacies and general practices in due course. PSNC will ensure appropriate guidance is available to contractors and further information will be issued when it becomes available.

Flu vaccination face to face training requirement in 2020/21: Public Health England has confirmed that anyone who has undertaken face to face vaccination training before and is due to undertake face-to-face training this year, can participate in online update training instead, delaying the face-to-face requirement until next year. Read the NHSE&I letter for further information.

Annual flu letter published for 2020/2021: DHSC, PHE and NHSE&I have jointly published a letter to provide further information on the national flu immunisation programme for 2020/21. The letter notes that this coming winter we may be faced with co-circulation of COVID-19 and flu. There will undoubtedly be some changes to the way in which the NHS flu vaccination service is delivered this year in response to the COVID-19 pandemic and new social distancing requirements. As usual, PSNC will be negotiating those details with NHSE&I as soon as they are in a position to do so. More information and the full letter are available here.

Pharmacy Quality Scheme (PQS)

The scheme will be postponed for three months and the period of delay will be kept under review. The released £18.75 million will be delivered to contractors for activity associated with the COVID-19 response.

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. 

For example, NMS can be conducted over the phone instead of face-to-face. MURs can also be provided exceptionally by telephone, but only where the local NHSE&I team gives its approval for a particular patient, and on a particular occasion. The Directions require a telephone MUR to be carried out such that no-one can overhear the consultation. Contractors can use PSNC’s PREM2 forms to make applications to their local NHSE&I team for telephone MURs and offsite MURs. 

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

Hepatitis C testing service

The introduction of this Advanced Service will be delayed from April 2020, for at least three months.

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

NHS England and NHS Improvement (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

The Department of Health and Social Care (DHSC) has 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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