GPhC inspection 2021 findings and the common trends split into the 5 principles.
The data has been taken from the published inspection reports from the GPhC website which can be found here: https://inspections.pharmacyregulation.org/
A detailed explanation of each principle can be found here: https://www.pharmacyregulation.org/sites/default/files/document/standards_for_registered_pharmacies_june_2018_0.pdf
Common trends of Principle 1, Governance:
- No governance arrangements in place
- Failure to identify and manage all the risks associated with delivering its services
- Failure to have a mechanism in place to identify new risks
- Failure to reassess risks after undertaking a new service including ensuring the pharmacy has the correct insurance in place for that service
- Failure to record mistakes, not act on mistakes or learn from mistakes recorded to prevent future occurrence
- Failure to ensure the remediation as a result of a mistake is maintained
- Mistake records disproportionate to the volume of dispensing
- Standard Operating Procedures out of date, not regularly reviewed or do not accurately reflect the working practises
- Staff members fail to follow their Standard Operating Procedures
- Training inadequacies in relation to confidentiality and data protection
- Records required by law, such as responsible pharmacist register, CD register, not maintained accurately
- Online prescribing services: no appropriate safeguards in place. This means people might be able to obtain medicines which are not always appropriate for their needs including the potential misuse of Codeine based products
Common trends of Principle 2, Staff:
- Too little staff or resource not distributed appropriately for the dispensing tasks resulting in a backlog of work and more pressured environment
- Struggle to manage both the dispensing workload and carrying out the clinical governance tasks
- Not enough time assigned for training and development to improve skills and knowledge
- Training incomplete or not completed within the required timeframes
- Team members carrying out tasks they are not qualified or trained to do so
- Communications feedback from the staff not recorded or responded to appropriately
- Online sales: Pharmacist on site had limited oversight of online sales
Common trends of Principle 3, premises:
- Untidy and/or not clean
- Small clear space for dispensing and checking medicines
- Trip hazards in the dispensary
- Consultation room untidy or being used as a storage room rather than for intended use
- Online prescribing service: website allows for patients to select prescription only medicines prior to consultation. This means the patient may not receive the most appropriate treatment for their needs
- Online prescribing service: the prescriber’s details are not easily located or are missing on the pharmacy’s website and as such a patient may not have enough information to make an informed decision about their care
- The pharmacy’s website does not provide the owner or superintendent pharmacist details
- The pharmacy’s website does not provide information on how to check the pharmacist or prescriber’s registration
- The pharmacy’s website does not provide enough information about the pharmacy and its services meaning the people are not supported to make an informed decision when accessing the services
Common trends of Principle 4, services:
- The pharmacy obtains a number of unlicenced medicines from unauthorised suppliers which introduces a patient safety risk
- Medicines are not stored or managed correctly which could result in incorrect or expired stock being supplied to a patient
- Medicines are not suitably separated which could result in mis-picking
- Failure to store Controlled Drugs in accordance with the law so can not guarantee the safety of these medicines
- Failure to store medicines in their original packaging
- No evidence provided to illustrate that cold chain items have been held at the correct temperature
- Failure to act when the temperature has deviated outside acceptable parameters
- When medicines have been returned by the courier after failing to be delivered to the patient the medicines are returned to stock with no proof of temperature conditions whilst the medicine has been outside the control of the pharmacy. Therefore, there is no proof the medicine is still suitable for use
- No routine date check or recording of date of opening a liquid medicine
- Failure to follow written procedures for date checking
- No medicinal recall procedure in place
- No records illustrating that recalls are being appropriately actioned
- Failure to take appropriate action with medicines when there is a safety concern
- Patient information leaflet not routinely supplied to patient
- Pharmacy processes are not effective at managing the volume of dispensing resulting in a backlog and a more pressured environment
- Pharmacy team carry out unauthorised activities whilst the pharmacist on duty is absent
- Online supply: limited systems in place to ensure online supplies and sales of higher risk products are made safely. For example: unable to justify the large quantities of codeine-based products and other medicines liable to abuse that the pharmacy orders and supplies. The safety mechanisms are not strong enough to demonstrate the risk for a patient to become addicted is being managed
- Online prescribing service: pharmacy does not conduct enough checks to ensure medicines obtained through the prescribing service are appropriate. Some medicines supplied may not be appropriate as they require physical examination, blood tests or ongoing monitoring.
- Online prescribing service: the pharmacy often supplies medicines without informing the patient’s regular doctor. This means the use of the medicines is not adequately controlled as the condition may not be properly managed
- Online prescribing service: the online system highlights to the patient any responses in the questionnaire which will stop the supply from being made. This allows a patient to change their answer. Neither the prescriber or the pharmacist has visibility if a change has been made
- Online prescribing service: prescriber’s justification or explanation for prescribing certain medicines to a patient is not recorded. Therefore, medicines could be supplied that are clinically inappropriate
- Online prescribing service: prescriber can issue a repeat prescription without reviewing previous issue dates or the patient’s questionnaire
- Online prescribing service: the system in place for taking a patient’s history and health details is insufficient meaning a prescriber is issuing a prescription with limited knowledge of the patient
Common trends of Principle 5, equipment and facilities:
In 2021, there were limited pharmacies that failed to meet this standard. The only report with a failure to meet this standard was linked directly to the preventative measures for Covid-19. In the fact that the gap in the screens to protect staff members were too large creating a risk.
This highlights that the GPhC are taking the current pandemic into consideration when considering if equipment and facilities are fit for purpose.
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