Update to NHS Pharmacy Regulations

New NHS Pharmacy Regulations effecting the five year Community Pharmacy Contractual Framework and other areas were laid before parliament on Thursday 19th October 2020.  The new NHS Pharmacy Regulations will come in to force on Monday 9th November.  These new regulations cover the following areas:

  • Further matters related to the ongoing Covid-19 pandemic.
  • Changes to terms of service and other regulations in line with the five-year Community Pharmacy Contractual Framework (CPCF).
  • Changes to the procedures for serving a ‘notice of commencement’ where an application has been approved for change of ownership, a new contract or a relocation.

The updated regulations can be found here.  Some of the more interesting and relevant changes are as follows:

Pandemic

  • All contractors must make a reasonable effort to ensure patients can access their services remotely to avoid having to attend the pharmacy in person.  This includes providing advice to patients by phone or using a video consultation.  Whilst providing advice over the phone may not be new, pharmacy owners may wish to consider the wider implications in terms of confidentiality and data protection when they are providing remote services.
  • NHS England & NHS Improvement (NHSE&I) will have the powers to limit the requirement to provide other pharmaceutical services where it is necessary to prioritise the provision of ‘flu and (hopefully in the near future) Covid-19 vaccinations.
  • A new pandemic treatment protocol will be introduced which will allow pharmacy contractors to provide certain prescription only medicines to treat conditions relevant to pandemics without the need for a prescription.
  • A pharmacist must take all reasonable steps to ensure a product ordered is supplied within a reasonable timescale and would be expected to provide details of other NHS pharmacists or Local Pharmaceutical Services chemists whose premises are situated in the same area and who may be able to provide the product ordered by the prescriber more quickly.

CPCF

  • A new essential service will be introduced, the Discharge Medicines Service, from January 2021.  Whilst full details of the service are yet to be released, all contractors must be in a position to provide this service as it will be a contractual requirement.  This includes distance selling pharmacies.
  • All pharmacies must also meet the Healthy Living Pharmacy (HLP) level 1 requirements fully from 1st April 2021.
  • There are specific requirements in respect of ensuring pharmacies have stable and reliable access to the Electronic Prescription Service and to NHS Summary Care Records.
  • There is also an obligation to provide NHSE&I with access to additional information relating to health campaigns and matters covered in contract monitoring visits.  Additionally, completion of the Community Pharmacy Assurance Framework (CPAF) becomes part of the terms of service.

Notices of commencement

At present, where a contractor has had an application approved for a new pharmacy contract, a relocation or a change of ownership, they are required to notify NHSE&I ‘within 14 days’ of the date they wish the approval to take effect.  In practice this has meant that the notice can be provided as late as the day before it actually takes place. 

This creates a number of difficulties with matters such as the issuing of new contractor codes for change of ownership applications, for example, as it invariably takes a number of days for these to be issued, leaving the new owner with difficulties accessing EPS.

From 9th November, the regulations change to require these notices to be sent at least 30 days before the change is due to come into effect.  If 30 days’ notice is not provided, the commencement notice will not be accepted unless NHSE&I have agreed to a shorter notice period.

Whilst this will address the problem of delayed contractor codes, it will mean that applicants will need to build in additional time to projects to ensure sufficient notice can be provided. Given that approvals generally last for 6 months, it will be important not to miss the deadline for submitting the notice, which will be no more than 5 months after the application has been granted.  

Interestingly, these changes do not apply for applications for consolidation where the requirement to serve the notice ‘within 14 days’ remains.

Additional information on all these changes can be found on the PSNC website here.