Welcome to Community Pharmacy Lincolnshire News
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Welcome to this special edition of our weekly newsletter
This week we are focusing on the new regulations, laid out on 20th October 2020, relating to changes to the Terms of Service for pharmacy contractors
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UPCOMING DEADLINES
- Friday 24th July CPAF short screening questionnaire - EARLY COMPLETION ADVISED.
PSNC have produced a briefing document here, including guidance for each question, which you should go through prior to completion of the questionnaire on MYS. This allows pharmacies to assure themselves that they are compliant with the Terms of Service under the community pharmacy contractual framework when the screening questionnaire is not taking place.
- Sunday 15th August - Covid Costs claims deadline
COVID-19 cost claims must be made between 5th July and 15th August 2021 using an agreed claim form provided by the NHS Business Services Authority (NHSBSA), and payments will be made on 1st October 2021. More details can be found on the PSNC webpage here.
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NHS Terms of Service for Pharmacy Contractors regulation changes summary
On 20th October 2020 new NHS regulations were laid to introduce changes to the Terms of Service for pharmacy contractors. PSNC issued a series of 14 Regs explainer articles in November 2020 to help contractors and their teams to understand the new requirements. These are summarised in the table below in order to help you ensure preparedness to complete the CPAF questionnaire on MYS, which is now open and closes on 24th July 2021.
It is particularly important that these key areas are highlighted when there are changes of staff for example, to ensure continued compliance with the requirements around updating informtion on central systems and accessing both SCRs and nhs mail accounts.
We have also created an easily accessible news item on regulations on our website covering this topic.
Regulation
(inc link to PSNC page) |
What is required? |
Where can I get more support on this?
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| Access to SCR (Summary Care Record) |
Pharmacy contractors must ensure that staff working at their pharmacy can access NHS Summary Care Records (SCR) and that access is consistent and reliable during the pharmacy’s opening hours, in so far as that is within the control of the contractor.
SCRs can only be accessed by pharmacists and pharmacy technicians, and this regulatory change does not amend that. Subject to the normal patient consent requirements, those registered professionals should access patients’ SCRs whenever providing pharmaceutical services to the extent that they consider, in their clinical judgement, that it is appropriate to do so.
Examples of use of the SCR in practice include resolving prescription queries, advising patients on suitable medication, providing emergency supplies and when carrying out medication reviews. |
Further guidance on how to access and use SCRs can be found on PSNC’s SCR webpage. |
| Updating NHS website profiles |
Pharmacy contractors must ensure that there is a comprehensive and accurate profile for their pharmacy on the NHS website (www.nhs.uk). Contractors must also ensure they verify and, where necessary, update the information contained in the profile at least once each quarter of the financial year. The financial quarters are:
- 1st April to 30th June;
- 1st July to 30th September;
- 1st October to 31st December; and
- 1st January to 31st March.
Even if no changes have been made during the current financial quarter, contractors must still verify all elements of their NHS website profile as this creates a record which will act as evidence to NHS England and NHS Improvement that these actions have been undertaken.
The following information forms part of a pharmacy’s NHS website profile:
- Organisation name;
- Address;
- Opening hours (the usual opening hours and those for Bank Holidays, Christmas Day, Good Friday and Easter Sunday) – these must also be updated when the pharmacy’s opening hours change, either temporarily or permanently;
- The facilities the pharmacy provides;
- The services the pharmacy provides;
- Telephone number; and
- Website URL.
Contractors are required to verify and update, where required, all elements of their profile to meet the new contractual requirement. Most contractors are already used to checking and updating their NHS website profile, as this was previously a requirement of the Pharmacy Quality Scheme. Each contractor is able to verify or amend their profile through the NHS Website Provider Information Management System (PIMS).
Contractors must ensure they update their NHS website profile where the pharmacy’s opening hours change, either temporarily or permanently. |
Further information on the NHS website, including how to gain access to update pharmacy profiles, can be found on PSNC’s NHS website page. |
| NHSmail |
Pharmacy contractors must have a premises specific NHSmail account (with an email address using the following naming convention: ‘pharmacy.ODScode@nhs.net’), which their staff can access and can send and receive NHSmail from. There must be at least two members of staff that have live personal NHSmail accounts that are linked to the premises specific NHSmail account.
Most pharmacy contractors will already comply with this requirement, as setting up and maintaining a premises shared NHSmail account and staff having associated personal NHSmail accounts which are used to access the shared mailbox was previously a Pharmacy Quality Scheme requirement. These accounts were originally set up with addresses in the following format: ‘nhspharmacy.location.pharmacynameODScode@nhs.net’, but these were updated earlier in the year to the ‘pharmacy.ODScode@nhs.net’ format.
Pharmacy contractors should ensure staff with personal NHSmail accounts linked to the shared mailbox keep their personal accounts active and staff should regularly check the shared mailbox throughout the opening hours of the pharmacy.
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Further guidance on how to access and use NHSmail in community pharmacies can be found on PSNC’s NHSmail webpage. |
| Updating Directory of Services (DoS) profiles |
Contractors must ensure there is a comprehensive and accurate profile for their pharmacy in the Directory of Services (DoS). Contractors must also ensure they verify and, where necessary, update the information contained in DoS at least once each quarter of the financial year.
The current financial quarter is 1st April to 30th June 2021. If contractors have not yet verified or updated their profile within this quarter, they are encouraged to do so soon to ensure they have included any changes to their opening hours for the Spring bank holiday (31st May 2021).
Even if no changes have been made during the current financial quarter, contractors must still verify the information contained in DoS as this creates a record which will act as evidence to NHS England and NHS Improvement that these actions have been undertaken.
Contractors are able to search and update their DoS profiles using the DoS Profile Updater. As all DoS profiles should contain the ODS code, contractors should search by ODS code or postcode to ensure all of their service profiles are included on the DoS. The tool includes a ‘Date Last Reviewed‘. When pharmacy team members first begin a review of a pharmacy, the updating tool will show the date that it was last reviewed. |
Further guidance on how to access and use the DoS Profile Update can be found on PSNC’s DoS webpage. |
| Health campaigns |
Public health campaigns are now described as health campaigns because the focus may be on matters other than healthy living and public health. For example, campaigns may focus on better use of NHS resources, such as highlighting pharmacy advice to support the management of minor illness. NHS England and NHS Improvement (NHSE&I) can require contractors to participate in up to six such campaigns each financial year i.e. 1st April to 31st March.
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, which contractors must undertake, as part of their NHS contractual requirements.
An existing requirement is that, where requested to do so by NHSE&I, each pharmacy must record the number of people to whom information is provided as part of one of these campaigns. NHSE&I can now also ask for additional information in relation to the campaign after it has been initially discussed with PSNC. NHSE&I will be able to request that the information on the campaign is provided to them electronically. |
PSNC will provide further guidance to contractors on any future health campaigns, where additional information is being requested.
Contractors can also read the NHSE&I guidance. |
| EPS access |
The NHS Electronic Prescription Service (EPS), managed by NHS Digital, is used by virtually all community pharmacies in England and the vast majority of prescriptions written in the community are now prescribed via the system.
Contractors must ensure their staff have access to the Electronic Prescription Service (EPS) at their pharmacy premises and that access must be constant and reliable throughout core and supplementary opening hours, in so far as that is within the control of the contractor.
Situations where constant and reliable access to EPS may be outside the control of the contractor could include the EPS system being down at a national level and internet connection problems or power supply issues which the contractor has reported and their provider is seeking to fix. A failure to ensure a new pharmacist or pharmacy technician member of staff or a locum has a working NHS smartcard which allows access to EPS would be a circumstance within the control of the contractor.
Another new requirement is that where a contractor is unable to access the EPS to dispense an EPS prescription, they must take all reasonable steps to ensure that the item is supplied within a reasonable timescale. These steps may include:
- providing the patient with the details of other pharmacies in the area who may be able to dispense the prescription;
- making an urgent supply at the request of a prescriber; or
- contacting the prescriber and asking them for the urgent provision of a non-electronic prescription form.
These steps match what most contractors would do in the circumstance of access to EPS being temporarily lost. Additional guidance and options that could be considered in this circumstance can be found on PSNC IT business continuity page including the How to manage EPS technical failures factsheet.
Where they haven’t already, contractors may wish to sign up to the utility services Priority Services Register. Inclusion on this register should give the pharmacy priority access to electricity, water and gas supplies.
Find out more about the Priority Services Register
Another minor change to the regulations related to dispensing, allows owing notes which are provided to patients when their full prescription item cannot be dispensed at that time, to be provided in an electronic form, for example via email, text or an app.
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Further information and guidance on EPS and business continuity can be found in the EPS section of PSNC’s website and the NHSE&I guidance. |
| Flexible provision of flu or coronavirus vaccinations |
During a pandemic or in anticipation of a pandemic, a pharmacy contractor may apply to NHS England and NHS Improvement (NHSE&I) to provide from its pharmacy premises, a relevant immunisation service for a specified period within its core or supplementary hours and no other NHS pharmacy services.
There are two processes by which a contractor may limit the pharmaceutical services they provide to relevant immunisation services only: contractor-initiated notification form or NHS E&I initiated where they make an announcement that there are particular arrangements relating to the flexible provision of relevant immunisation services that they are prepared to agree to.
Where only a relevant immunisation service is provided, the pharmacy’s NHS website and Directory of Services profiles should be amended to show that the pharmacy is closed, to ensure that patient referrals, for example to the Community Pharmacist Consultation Service, are not made during this time. It is also suggested that a notice for patients and the public is displayed so it is visible from outside the pharmacy and indicates when the pharmacy is providing only a vaccination service.
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Further guidance will be provided by or through NHSE&I on this new requirement and the application process and forms. Additional guidance can also be read in the new NHS guidance.
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| CAS alert sign-up |
The Central Alerting System (CAS) is a web-based cascading system operated by the Medicines and Healthcare products Regulatory Agency (MHRA) for issuing patient safety alerts, important public health messages and other safety critical information and guidance to the NHS and others, including community pharmacies.
Contractors must register their pharmacy’s shared NHSmail account to receive CAS alerts direct from the MHRA.
Contractors who have not created a shared NHSmail account for their pharmacy will need to do this and then register it with the MHRA. Likewise, if a contractor changes their shared NHSmail account email address, they must immediately notify the MHRA of the new address. Both notifications can be made by emailing safetyalerts@mhra.gov.uk.
Contractors must also ensure their premises-specific NHSmail account is monitored with sufficient frequency throughout core and supplementary opening hours so as to ensure the safe and effective supply of medicinal products at or from their pharmacy premises. They must also act on CAS alerts as appropriate.
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If you need support to register a shared NHSmail account with CAS, please email safetyalerts@mhra.gov.uk. Further information is available in the new NHS guidance. |
| Commencement notices and contractors entering administration |
Commencement notices
Prior to the changes at the end of last year, a contractor or applicant, had to give NHS England and NHS Improvement (NHSE&I) a valid commencement notice (e.g. to open a new pharmacy), in the correct form, no more than 14 days in advance. PSNC guidance has been that at least one month’s informal notice should be given to ensure there is time for NHSE&I to authorise changes to the Organisation Data Service (ODS) code and connectivity to be established to NHS services, including the Electronic Prescription Service (EPS).
Now:
- a contractor, or applicant, must give NHSE&I a commencement notice no fewer than 30 days in advance, unless a shorter period of notice has been agreed with NHSE&I prior to giving NHSE&I the commencement notice; and
- the contractor, or applicant may change the date on which services will commence (from the original to a new opening date) but to do so must notify NHSE&I as soon as reasonably practicable of any change of date, and this must be in advance of both the old and new opening dates.
NHSE&I have made a form available to contractors for applicants to change the date of commencement.
This change does not apply to a notice of consolidation.
Pharmacy contractors entering administration
If a pharmacy contractor’s company enters administration, the contractor must notify NHSE&I of this. The notice must be in writing and may be by electronic means.
A company enters administration when the appointment of an administrator takes effect.
NHSE&I have made a form available to contractors to notify them that the company has entered administration.
Training for repeat dispensing
In addition, a specific requirement for contractors to undertake appropriate training in respect of repeat dispensing is removed from the terms of service, although such training remains a part of general induction and other staff training, as appropriate.
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Further guidance on these Term of Service is contained within NHSE&I’s regulations guidance.
Further guidance on putting your company into administration may be found at GOV.UK or obtained from professional advisers.
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| NHSE&I inspections and access to electronic information |
Prior to the changes at the end of last year, a pharmacy contractor had to allow persons authorised in writing by NHS England and NHS Improvement (NHSE&I), to enter and inspect the pharmacy at any reasonable time, and, subject to certain requirements, allow access to any information which is reasonably required:
- for ascertaining whether the contractor is complying with the terms of service;
- auditing, monitoring and analysing the contractor’s provision made for patient care and treatment in the course of providing NHS pharmacy services, and management of NHS pharmacy services;
- in connection with its functions that relate to NHS pharmacy services.
Pharmacy contractors must now, on request, also send to NHSE&I by electronic means, any information that could be requested at an inspection, if the contractor has the relevant information in electronic form, or information can reasonably be converted into an appropriate electronic form. If that is not possible, NHSE&I may need to visit the pharmacy to inspect the information.
Additionally, at NHSE&I’s request, or at the request of a person authorised in writing by NHSE&I, a contractor must send to NHSE&I a duly completed questionnaire, for example, the Community Pharmacy Assurance Framework (CPAF) screening questionnaire or full questionnaire.
The questionnaire must be approved by NHSE&I and be for the purpose of determining whether an inspection of the pharmacy is necessary or expedient. NHSE&I must consult PSNC before a contractor is asked to complete a questionnaire, as is the normal process in relation to CPAF.
The CPAF Questionnaire is now open for completion. We strongly recommend you complete the short version by the deadline of 24th July 2021. PSNC have produced a guide to help you do this here.
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Further information on contract monitoring can be found on our Contract monitoring page and in the new NHS guidance. |
| Facilitating remote access to pharmacy services |
An addition to the Terms of Service states that pharmacy contractors must, to a reasonable extent:
- facilitate remote access to pharmacy services provided at or from its pharmacy premises, where users wish to access those services under arrangements that make those services available using remote access; and
- establish, maintain and keep under review procedures to facilitate remote access to those services under arrangements that make those services available using remote access.
Providing pharmacy services remotely has increased during the COVID-19 pandemic. This requirement seeks to confirm and ensure that all pharmacies providing services remotely to patients, bricks and mortar and Distance Selling Premises (DSP), facilitate remote access to the full range of NHS pharmacy services provided by a pharmacy, to a reasonable extent, including, for example:
- ensuring that appropriate advice is given to patients about any medicines or appliances dispensed to them;
- accepting and disposing of unwanted medicines from patients, as part of the Disposal of Unwanted Medicines service; and
- supporting patients who are prescribed new medicine via the New Medicine Service (NMS), where this is provided by the pharmacy.
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Further guidance on this term of service is available in NHS England and NHS Improvement’s regulations guidance and our website provides information on Essential and Advanced services. |
| Healthy Living Pharmacy (HLP) requirements |
Most pharmacies in England had previously met the Healthy Living Pharmacy Level 1 (HLP) requirements, following local initiatives with commissioners or the Pharmacy Quality Scheme. From 1st January 2021, all pharmacies had to meet the HLP requirements which are detailed in the NHSE&I regulations guidance.
You can find full guidance and a range of resources to help you become an HLP and maintain that standard in our HLP website section.
To ensure contractors continue to meet their Terms of Service requirements, it is recommended they review their compliance against the requirements at least every 3 years. |
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| Consultation rooms and remote consultations |
As a result of the Healthy Living Pharmacy Level 1 (HLP) criteria becoming Terms of Service requirements, almost all pharmacies need to have a consultation room which are detailed in the NHSE&I regulations guidance.
The requirement for the consultation room is based on the existing requirement for a consultation room which is included in the service specifications of most of the Advanced services; most pharmacies already comply with these requirements.
The requirements for the consultation room are that it is:
- clearly designated as a room for confidential conversations, for example a sign is attached to the door to the room saying Consultation room;
- distinct from the general public areas of the pharmacy premises; and
- a room where both the person receiving the service and the person providing it can be seated together and communicate confidentially.
If the pharmacy was included in a pharmaceutical list on 1st January 2021, but no Advanced services were provided at or from the pharmacy during the 12 months ending 31st December 2020, the contractor has until 1st April 2023 to install a consultation room within their pharmacy.
Contractors who open new pharmacy premises must have a consultation room from the first day they open for business.
Small pharmacies
Where a contractor believes that their pharmacy is too small for a consultation room, they need to complete and submit a request to their NHS England and NHS Improvement (NHSE&I) regional team (NHSE&I have published a form on which to make this request).
NHSE&I will consider the information provided by the contractor and where it is of the opinion that the pharmacy is too small for a consultation room, it will confirm this with the contractor. The contractor must then ensure that they put arrangements in place at the pharmacy which enable staff and patients to communicate confidentially by telephone or another live audio link and a live video link.
Where NHSE&I are of the opinion that the pharmacy is not too small for a consultation room, the contractor will be advised of this and they will need to install a consultation room.
Distance Selling Pharmacies (DSPs)
DSPs must ensure that there are arrangements in place at the pharmacy which enable staff and patients to communicate confidentially by telephone or another live audio link and a live video link.
DSPs can choose to install a consultation room at their pharmacy to allow the provision of Enhanced and Advanced services on the premises, but this is not a requirement of the Terms of Service. |
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| Covid Related: |
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| Pandemic Treatment Protocol |
In the case of Pandemic Treatment Protocols, there are additional relevant NHS regulations (The National Health Service (Charges and Pharmaceutical and Local Pharmaceutical Services) (Coronavirus) (Amendment) Regulations 2021) which introduce a Pandemic Treatment PGD: a PGD that relates to the supply of a prescription only medicine for the prevention or treatment of a disease that is, or is anticipated to be imminently, pandemic.
Contractors are entitled to supply a Prescription Only Medicine (POM) to a person in accordance with a Pandemic Treatment Protocol (PTP) or Pandemic Treatment Patient Group Direction (PTPGD), if and when one is issued. Medicines must be supplied with a dispensing label.
PTPGD: Subject to the requirements of a PT PGD approved by NHS England and NHS Improvement, where the contractor:
- having made appropriate checks, and regard to what is reasonable and appropriate, that a person is entitled to be supplied with a medicine in accordance with a PTPGD, and
- subject to the usual requirements of a PGD,
the contractor must supply the medicines with reasonable promptness.
Certain record keeping requirements will apply as this information is likely to be necessary for contractors to claim a fee and any reimbursement for a supply.
A PTP may not be used for a supply of a Schedule 2, 3, or part 4(1) Controlled Drugs.
Contractors will also have to provide home delivery options where there is a relevant announcement by the Secretary of State.
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Further information on PTPs can be found on PSNC’s
Pandemic Treatment Protocol page and specific PSNC guidance will be provided on each PTP issued. |
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