Now we have started 2025, this blog highlights the common trends identified from GPhC inspections carried out in 2024.
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/pharmacies/standards-and-guidance-registered-pharmacies
Do you fall into one of these pitfalls?
Common trends of failure to meet the standards of Principle 1, Governance
(12% of pharmacies inspected last year attained standard not met):
- Doesn’t take the action it needs to in response to feedback from organisations such as the General Pharmaceutical Council
- Repeat failure witnessed from previous inspections
- Prescription only medicines, including medicines liable for misuse identified in the retail area and sold by staff who are not suitably trained
- They do not make effective changes to their practices to help make the pharmacy’s services safer
- NHS smartcards are used inappropriately
- There is a failure to record, assess, monitor and review mistakes/incidents/near misses/errors. This means that root causes are not identified and the opportunity to learn and prevent future occurrence is missed
- Non-reporting of CD register errors
- Complaints are not managed in an effective and timely manner
- Failure to maintain records required by law, such as RP, private prescription, emergency supply, unlicensed medicines, CDs including patient returns and destructions
- Supply and medicine management records incomplete
- Do not keep adequate records in relation to their vaccination service
- Does not clearly define roles, responsibilities and accountability
- The skill mix of the pharmacy is not suitable for the services provided
- Staff do not know which activities cannot be carried out in the absence of the Responsible Pharmacist
- Unable to evidence appropriate indemnity insurance
- SOPs out of date/not approved by the Superintendent Pharmacist/not readily available/not read by team members/missing/not been regularly reviewed/not followed/do not accurately reflect actions undertaken/lack detail
- Operating outside the scope of their SOPs
- Not introduced governance processes to support the safe running of the pharmacy
- Does not have a specific documented safeguarding policy/unable to evidence how they safeguard vulnerable individuals
- Does not clearly identify or manage the risk associated with all of its services
- Does not carry out sufficient audits of their service
- Incorrectly handling confidential waste
- No patient verification at point of delivery
- Disregards patient safety alerts designed to safeguard medicines for specific patient groups
- No valid Patient Group Direction for the provision of travel vaccinations
- Operating with a PGD for a treatment outside the scope of PGDs and thus the supply is illegal
- Prescribing failures:
- Prescribing solely on an online questionnaire with no independent verification of the information submitted
- Did not adequately assess third party clinical services
- Insufficient consultation notes especially for unlicensed medicines and CDs
- No monitoring of prescribing and supplies
- Do not issue legal prescriptions
- No prescribing policies
Common trends of failure to meet the standards of Principle 2, Staff
(6% of pharmacies inspected last year attained standard not met ):
- Staff not enrolled on appropriate learning courses including delivery drivers/not adhering to training timescales/provide evidence that staff have completed or enrolled on appropriate training in accordance with GPhC training requirements
- Does not have a culture of openness, honesty and learning
- Inadequately supported staff
- Unable to discuss feedback or raise concerns as no reviews, updates or team meetings
- Prescribers do not complete adequate additional training for some of the specialist services provided
- Prescriber cannot adequately demonstrate that they are working within their competency for certain conditions
- Allows its team members to work unsupervised for significant periods of time while they are still undergoing their training
- Doesn’t have enough team members to deliver its services safely and effectively
- Limited evidence that sufficient action has been taken when team members have raised legitimate concerns about the lack of staff
- They carry out tasks for which they are not appropriately qualified or trained
- They have not read the pharmacy’s standard operating procedures (SOPs) to help them work safely
- The pharmacist is not always able to verify that systems and checks are completed properly. So they do not always have appropriate professional control to provide assurances that the services are operating effectively.
Common trends of failure to meet the standards of Principle 3, Premises
(4% of pharmacies inspected last year attained standards not met):
- Pharmacy is dirty/cluttered/disorganised/ lacks adequate clear space/looks unprofessional/blocking emergency exits/ does not have adequate security arrangements
- No/insufficient cleaning undertaken
- Consultation room/dispensary/front counter has personal information accessible to people within the area
- Consultation room not fit for purpose
- The pharmacy premises is not adequately safeguarded from unauthorised access
- Some areas of the premises present a significant health and safety risk to the team
- Regulated activities are not always undertaken on the registered premises, so there is a risk these services are not provided in line with current regulations
- Website failures:
- Misleading resulting in an unclear path of accountability and responsibility over the supply of the medicines
- Contains inaccurate information about the superintendent pharmacist’s identity
- Advertises off-label medicines on its website
- Makes unsubstantiated claims about unlicensed medicines
- People may not always receive the most appropriate treatment as they are able to select a product prior to completing an online consultation
- Allowed the selection of some prescription-only medicines (POMs)
- Does not always contain accurate description
Common trends of failure to meet the standards of Principle 4, Services
(11% of pharmacies inspected last year attained a standards not met):
- Failing identified was raised in previous inspection so improvements outlined was not maintained
- Dispensing labels do not contain the required information by law
- Has compromised the safety of medicines and medical devices due to inadequate management of its medicines/excessive ordering which is unexplainable or resulting overstocked shelving/underordering/inadequate storage including CDs/removal of medicines from outer packaging/not licensed for the product being held
- Does not ensure the pharmacist has direct supervision over safe custody medicines
- No date checking process/processes ineffective in removing expired medicines from stock
- Incorrect handling of patient returned medicines
- Unable to evidence/does not maintain temperature monitoring records (fridge and ambient)
- Unable to demonstrate prescribing rationale/demonstrate supply is safe and legal/unable to verify patients’ identity when supplying medicines online/demonstrate medicinal supply is appropriate to their needs/
- Unable to evidence medicines have been successfully delivered to the correct patient
- Cannot demonstrate that the medicines are kept at an appropriate temperature during transportation to the patient
- Unable to show that it took any additional precautions when dispensing high-risk medicines
- Team members prepare packs without referring to the prescriptions. And packs are stored inappropriately without dispensing labels
- Does not have information from prescribers to allow for adequate pharmacist clinical checks and to make sure the medicines it supplies are safe and appropriate for people
- Do not have access to the PGDs or valid PGDs required to carry out the service/ does not always make sure that it makes supplies of prescription-only medicines against current Patient Group Directions
- Consultation questionnaires are not specific to different conditions and people are not always asked for consent to share information with their regular GPs to independently verify their medical information
- Has not completed all of the requirements to provide the ‘Pharmacy First’ service
- Team members do not know how to access safety alerts and recalls/do not have a process in place to manage recalls safely and effectively/unable to evidence that safety alerts and recalls have been acted upon
- Does not make the required reports about adverse reactions under the Yellow Card Scheme/cannot demonstrate that it has appropriate procedures in place to raise concerns when medicines or medical devices are not fit for purpose
Common trends of failure to meet the standards of Principle 5, Equipment and Facilities (1% of pharmacies inspected last year attained a standards not met):
- Does not adequately store medicines in accordance with legal requirements
- Unable to evidence cold storage medicines have been stored appropriately
- Does not have all the equipment it needs to provide the services it is commissioned to do so
- Measuring equipment are not safe to use or fit for purpose
- Fridge isn’t big enough, fit for purpose or appropriately maintained
- Doesn’t use the equipment properly to check the temperature range is as it should be
- CD cabinet is not secured fully in line with legal requirements
- No evidence that the safes currently being used to store controlled drugs have the appropriate exemptions
- Computer systems do not allow for the safe and effective running of the Pharmacy for example intermittent internet/PMR system
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!