Now we have started 2024, this blog highlights the common trends identified from inspections carried out in 2023.
The data has been taken from the published inspection reports from the GPhC website. https://inspections.pharmacyregulation.org/
A detailed explanation of each principle is available on the GPhC website. https://www.pharmacyregulation.org/sites/default/files/document/standards_for_registered_pharmacies_june_2018_0.pdf
Do you fall into one of these pitfalls?
Common trends of failure to meet the standards of Principle 1, Governance:
- No assessment of risk for supplies of specific higher risk medicines, selling high risk over the counter medicines online or for supplying medicines at a distance.
- Standard Operating Procedures are not available, held offsite, out of date, or not reviewed effectively.
- Standard Operating Procedures are available however, the pharmacy is unable to evidence that the team members operating have read and understood them or are following them.
- No clinical audits of the prescribing function.
- Failure to operate within the national protocol for influenza vaccinations.
- Team members failing to understand their roles and responsibilities specifically the restrictions on team members when the Responsible Pharmacist is offsite.
- Entities failing to record near misses, dispensing errors, negative feedback, or concerns raised.
- Failure to address raised concerns, identified errors or identify trends resulting in missed opportunities to learn and to maintain the safety and quality of the provision.
- Inadequate indemnity insurance for the services offered consideration should be given to additional services provided outside the traditional scope of dispensing such as travel vaccinations.
- Failure to maintain necessary records for the safe provision of pharmacy services such as CD register, Responsible Pharmacist, dispensing private or unlicensed medicine prescription supplies.
- Failure to maintain sufficient records when prescribing such as prescriber verification, consultation notes from prescribing consultations or recording clinical explanations for prescribing.
- Failing to ensure when operating a prescribing function that the prescriber chooses the treatment not the patient particularly when utilising a website for patients to request medication for their ailment.
- Failure to ensure confidential information is restricted resulting in a failure to protect the privacy, dignity, or confidentiality of patients. This includes failing to destroy confidential waste securely.
- Entities sharing NHS smart cards and passwords subsequently resulting in unauthorised access to confidential information.
- Team members not trained on or unaware of safeguarding processes. Pharmacy does not have a safeguarding procedure in place.
Common trends of failure to meet the standards of Principle 2, Staff:
- Insufficient staffing levels for the workload of the pharmacy to ensure the safe and effective provision of pharmacy services.
- Key duties are failing to be conducted as there is insufficient staff levels.
- Team members do not have the appropriate training for their roles.
- Team members do not have the qualification or are on accredited courses relevant to their role.
- The pharmacist providing additional services has limited qualifications in the service being provided.
- Lack of professional leadership.
- Operating without a superintendent pharmacist.
- Staff not provided opportunities to give feedback or concerns.
- Management failing to address concerns raised by the staff therefore making the concern reporting process ineffective.
Common trends of failure to meet the standards of Principle 3, Premises:
- The pharmacy is disorganised, untidy or unclean.
- Insufficient clear workspace or storage space to carry out pharmacy services safely.
- Patients have access to Prescription Only Medicines (POM) and Pharmacy (P) Medicines in self-selection areas.
- Inadequate security to prevent unauthorised access.
- Consultation room doesn’t present a professional image.
- Website allows patients to pick prescription only medicine prior to the questionnaire or consultation.
- Website not displaying accurate information, misleading the public or advertising a medicine for an unlicensed use outside the terms of its marketing authorisation.
Common trends of failure to meet the standards of Principle 4, Services:
- Ineffective medicines management such as incorrectly stored, inadequate date checking, inadequate separation of expired stock, poorly organised, insufficient balance checks, medicines removed from manufacturer packs, insufficient pest control, inadequate waste medicines management.
- Cold chain medicines not stored appropriately such as inadequate temperature recording, failure to take remedial action when the fridge presents with a high temperature, fridge over capacity.
- No evidence of utilising an effective cold chain delivery solution.
- Medicines not always safeguarded from unauthorised access.
- Patients have access to Prescription Only Medicines (POM) and Pharmacy (P) Medicines in self-selection areas.
- Unable to demonstrate multi-compartment compliance packs are being prepared safely including leaving packs unsealed awaiting accuracy check exposing the medicines.
- No clinical check being completed on dispensed prescriptions.
- Prescribing services are not ensuring the safety of people prescribed higher risk medicines or sharing the prescribing with the patient’s usual GP.
- Pharmacy does not always supply medicines lawfully in relation to its travel vaccination service.
- Pharmacy providing an additional service utilising a Patient Group Direction (PGD) is operating with an out of date PGD.
- Failing to action recall alerts appropriately putting patient safety at risk.
Common trends of failure to meet the standards of Principle 5, Equipment and Facilities:
- Conical flasks/measuring cylinders are worn resulting in accurate measuring of liquid medicines.
- Measuring equipment being utilised are not clean resulting in cross contamination of medicines and a significant risk to patient safety.
- Refrigeration equipment working incorrectly, over capacity or not fit for purpose.
Do you feel that your pharmacy is affected by one or more of the common trends listed above. Do you feel that you could benefit from a mock audit to highlight your failings and create a corrective and preventative action plan? Contact us to help your business today!
