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The latest from MRG medicine inspectors

8th August 2025


We met recently with the MRG Medicine Inspectors to review their findings from pharmacy inspections. By Anne McAlister, NPA Representation Manager for Northern Ireland

Anne McAlister (1)

Inspections are being carried out to current premises standards and legislation, but inspectors are using a revised inspection report.  The common themes they have identified include:

SOPs

  • The NPA’s SOPs are templates and should be adapted to reflect your practice and procedures as relevant

  • Remember that SOPs should be reviewed at least every 2 years, or more frequently if there has been an incident or other change

  • Ensure that you are using appropriate SOP templates – remember that FMD has not been a requirement since January 2025 and SOPs no longer need to reference any processes in relation to this.

  • Please see the update to “Managing a CD Incident” SOP which reflects the updated procedure in notifying the CD Accountable officer and Medicines Regulatory Group (MRG) about incidents involving CDs 

Patient Group Directions (PGDs) – including NHS commissioned and private services

  • All PGDs should have an authorised manager signature

  • Make sure that current PGDs are filed and that date expired PGDs are archived

  • Respond to any updates issued by SPPG or PGD provided

  • PGDs should be read and signed by all who operate these, including locums.  Inspectors have found that the SPPG PGDs are not always signed by locum pharmacists who provide Pharmacy First services.

Near Miss and Incident Logs

  • Inspectors expect to see near miss and error logs being maintained on a weekly basis and evidence of actions taken to review incidents to improve patient safety. 

  • We have a range of resources to support pharmacy teams in managing risk within the pharmacy, including templates for near miss logs, root cause analysis, monthly reports and much more, click here.

Managing Prescriptions

Electronic prescriptions:  With an increase in the transmission of electronic prescriptions from private prescribers the inspectors refer pharmacists to guidance issued in November 2022

  • In particular, pharmacists should ensure that they are maintaining a system of secure storage and retrieval of scanned or digitally issued prescriptions.

  • Electronic prescriptions should not be stored on personal devices or unsecured cloud storage and must be easily retrievable for inspection.  

Electronic prescriptions from EEA and Swiss prescriptions: Prescriptions must include the particulars that are required for such prescriptions are set out in Regulation 218 of the HMR 2012. 

In particular inspectors have noted that prescriptions were missing some or all of the required details including the patient’s full name and date of birth along with the prescriber’s name, professional qualifications and contact details including work address, email address and telephone or fax number with the appropriate international prefix. 

  • Refer to guidance, by clicking here and EEA and Swiss prescriptions emergency services, click here.

  • Private prescriptions for controlled drugs: Pharmacists cannot issue a schedule 2 or 3 controlled drug against an electronic prescription.

  • All private prescriptions for named patients must be written on a PCD1 form.

  • All prescribers (including Drs, dentists, paramedics and vets) requisitioning a stock of CDs for private practice must use a CDRF1.  CDRF1s must be submitted to BSO (other than vet requests) and a copy retained in the pharmacy, find out more.

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Date published: 8th August 2025

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