The General Pharmaceutical Council (GPhC) has issued an improvement notice to Clear Chemist requiring it to take measures to rectify failures identified at an intelligence-led inspection.
The GPhC had previously taken the unusual decision to make a statement about Clear Chemist.
At an inspection on 5th October, GPhC inspectors identified that the pharmacy was not meeting some of the standards for registered pharmacies that provide the framework to ensure safe and effective care for patients and the public.
The inspectors found ‘serious system-wide failures in the governance and management of risk at the pharmacy and a lack of safeguarding’. The GPhC has said that this presents a risk to patient safety.
The inspectors considered the volume and type of medicines supplied, the age range and potential vulnerability of the patients, and the additional risks of working with prescribers based in the EEA and working outside UK regulatory oversight.
The improvement notice requires the pharmacy to put a number of measures in place to rectify the failures and meet the standards, including developing and putting in place a comprehensive risk assessment for the services they provide and updating their safeguarding policy and procedures. These measures will help to protect patient safety.
The improvements required are as follows:
- The pharmacy must develop and put in place a comprehensive risk assessment that covers each individual service the pharmacy provides at a distance. The risk assessment must be documented and should identify each of the medicines you are supplying, the conditions they are being used to treat and the associated risks. The risk assessment must take account of the age range of the patients being treated and the way in which the online prescribers are managing their treatment. The pharmacy will need to be able to demonstrate the action taken to mitigate the risks identified and show that there is a clear plan in place, with timelines, setting out how systems and processes within the pharmacy will change to manage the risks.
- The pharmacy must develop and put in place a comprehensive contingency plan to provide continuity of care for their patients in the event of any breaks in service.
- The pharmacy must put in place and implement clear procedures for the pro-active and regular review of the quality of services provided with regard to the supply of medicines prescribed by online providers. The pharmacy will need to provide evidence of these procedures, showing that they are embedded within the pharmacy working processes, with specific reviews and audits scheduled which link to the risks identified in your risk assessments.
- The pharmacy must review and update your safeguarding policy and procedures taking account of the risks identified in the risk assessment and make sure there is a clear plan in place to implement any changes required to the system. The pharmacy must be able to demonstrate that the pharmacy team have been trained on the updated policy and procedures to ensure that safeguarding risks are effectively managed.
The deadline for compliance was set as 18th November 2020.
Duncan Rudkin, Chief Executive of the GPhC, said:
“We know that people receiving medicines from Clear Chemist have been concerned about how our actions may affect them.
“We want to reassure everyone that we have not asked the pharmacy to stop supplying medicines to patients undergoing treatment for gender dysphoria. We have directed the pharmacy to make improvements to make sure that people receive medicines that are safe and effective for them.
“Our inspectors will continue to work with the superintendent pharmacist to make the improvements needed and to support continuity of care for the pharmacy’s patients.”