New NHS Pharmacy Regulations laid

New NHS Pharmacy Regulations laid

October 20, 2020

New NHS regulations have been laid today (20th October 2020) to introduce changes to the Terms of Service for community pharmacy contractors.

Some of these changes relate to the ongoing coronavirus pandemic, but most are changes which were previously agreed as part of the five-year Community Pharmacy Contractual Framework (CPCF) and were originally planned to be introduced in July 2020.

Some of the provisions relating to the pandemic could be introduced only after related changes to the Human Medicines Regulations 2012; these were made on Friday 16th October 2020.

The pandemic-related additions to the Terms of Service are:

  • The introduction of a Pandemic Treatment Protocol, which can be used to allow for the supply of medicines for the prevention or treatment of diseases for a current or anticipated pandemic, such as coronavirus, if and when this is required. This addition becomes a new part of the Essential service Dispensing provisions;
  • The flexible provision of flu and coronavirus vaccination or immunisation services during a pandemic, for use during a time of a declared emergency under the regulations (as is currently the case). This allows NHS England and NHS Improvement (NHSE&I) to agree the limiting or stopping of other pharmaceutical services at specified times during core or supplementary hours, to prioritise the administration of such vaccinations;
  • Remote access to services – contractors must facilitate remote access to their services to a reasonable extent, where patients wish to access these services in that way. For example, if a patient always has their prescription delivered by the pharmacy, the contractor still needs to provide the necessary advice and other relevant services to the patient, and if the patient wishes, this could be undertaken via the phone or using a video consultation; and
  • Owing slips – these may be in an electronic form as well as a hard copy form.

The other new regulations, agreed as part of the five-year CPCF, include:

  1. The introduction of the Discharge Medicines Service, as a new Essential service from 1st January 2021;
  2. The requirement for all pharmacies to meet the Healthy Living Pharmacy Level 1 requirements (with compliance with some of these requirements being delayed until 1st April 2021);
  3. NHSmail – at least two members of staff to have active personal NHSmail accounts linked to the pharmacy’s shared premises NHSmail mailbox;
  4. Updating pharmacy profiles – ensuring pharmacy’s Directory of Services and NHS website profiles are up to date and verifying this each quarter of the financial year;
  5. Central Alerting System (CAS) – registering with the MHRA the pharmacy’s shared premises NHSmail mailbox so CAS alerts are received direct from the MHRA (an initial bulk upload of current pharmacy NHSmail addresses will be arranged by NHSE&I – more details will be provided in due course);
  6. Access to the Electronic Prescription Service (EPS) must be constant and reliable in all pharmacies, in so far as the pharmacy can control this. If EPS is temporarily unavailable, an item prescribed to a patient should be provided in a reasonable timescale and certain steps, which are currently advised by PSNC, must be considered;
  7. Access to NHS Summary Care Records (SCR) must be constant and reliable in all pharmacies, so far as the pharmacy can control this, and SCRs should be accessed when the pharmacist’s clinical judgement considers this appropriate;
  8. Health campaigns – NHSE&I can request that contractors provide additional information (anonymised if necessary), having consulted PSNC, to evaluate the effectiveness of the campaign and to support policy development;
  9. Access to information – NHSE&I may request information from contractors in electronic form which they would have access to when undertaking a contract monitoring visit and consequently, completion of the Community Pharmacy Assurance Framework (CPAF) becomes part of the terms of service;
  10. Administration – if a contractor goes into administration, it must notify NHSE&I; and
  11. Notice of commencement – notice of commencements must now be given no fewer than 30 days in advance (to ensure, for example, that EPS changes can be made), although the date of opening may be revised, provided that this is done before the notified date and the pharmacy’s opening date. This does not apply to submission of notices of consolidation.

More information on the various provisions of the new regulations will be published shortly.

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