Archived: White Pharmacy Ltd

Letter from the Chief Inspector of General Practice

We carried out an announced focused inspection at White Pharmacy Ltd on 14 July 2017.

We carried out our initial inspection on 12 and 16 January 2017. Following this inspection conditions were placed on the provider’s registration. Further inspections were undertaken on 28 March 2017 and 22 May 2017. At these inspections we found further improvements were still required.

This report covers the findings from the 14 July 2017 focused inspection. This inspection was carried out to review the provider’s compliance with the conditions imposed on their registration following our inspection in May 2017. During the inspection we found further improvements were still required. The reports from our comprehensive inspections in January 2017, March 2017 and May 2017 can be found by selecting the ‘all reports’ link for White Pharmacy Ltd on our website at www.cqc.org.uk.

We found this service did not provide safe and well led services in accordance with the relevant regulations.

Our key findings were:

• We identified continued significant risks to the safety of patients’ health and welfare, which related to insufficient or ineffective systems in place in relation to remote prescribing of medicines having regard to the General Medical Council (GMC) ‘Good practice in prescribing and managing medicines and devices’ guidance.
• We found cases of long term opioid analgesic and neuropathic pain relief prescribing with no access to the patients’ full medical history. We saw individual risks had not been identified in the prescribing of these specific medicines and no contact had been made with the patients’ GP. Furthermore, there was no documented consideration of the risks of long term opioid analgesics use and management plans for individual patients.
• Patients were at risk of harm because effective governance systems and processes were not in place to keep them safe
• The care and treatment records of patients did not always contain sufficient documentation of clinical rationale for decisions to prescribe medicines where consent was not given to contact a registered GP.
• The prescribing policy (implemented on 12 June 2017) did not outline the corporate responsibilities in relation to the issuing of prescriptions, or the governance processes in place to ensure patient safety is assured.

We identified regulations that were not being met. The areas where the provider must make improvements are:

• Ensure care and treatment is provided in a safe way for all patients. Including the safe and effective prescribing of medicines.
• Implement effective governance systems and processes to enable the provider to assess, monitor and improve risks relating to the health, safety and well being of patients and staff.

Summary of any enforcement action

We are now taking further action in relation to this provider and will report on this when it is completed.

Professor Steve Field CBE FRCP FFPH FRCGP

Chief Inspector of General Practice

Letter from the Chief Inspector of General Practice

We carried out an announced focused inspection at White Pharmacy Ltd on 22 May 2017.

We carried out our initial inspection on 12 and 16 January 2017. Following this inspection conditions were placed on the provider’s registration. A second inspection was undertaken on 28 March 2017. At this inspection we found the provider had not met all of the requirements of the conditions and further improvements were still required.

This report covers the findings from the 22 May 2017 inspection. This inspection was carried out to check whether the provider had made the improvements required following the inspection in March 2017 and to review the provider’s compliance with the conditions imposed on their registration following our inspection in January. During the inspection we found there had not been sufficient improvement to meet the conditions imposed. The report of our comprehensive inspection in January 2017 can be found by selecting the ‘all reports’ link for White Pharmacy Ltd on our website at www.cqc.org.uk.

We found this service did not provide safe and well led services in accordance with the relevant regulations.

Our key findings were:

• Patients were at risk of harm because effective governance systems and processes were not in place to keep them safe
• We identified continued significant risks to the safety of patients’ health and welfare, which related to insufficient or ineffective systems in place in relation to remote prescribing of medicines having regard to the General Medical Council (GMC) ‘Remote patient consultations and prescribing’ guidance.
• Where letters had been sent to the GP, they did not always contain sufficient clinical information to facilitate effective continuity of care.
• Since the last inspection in March 2017 the provider’s medical director had undertaken a review of patient questionnaires. However, we found the review had not ensured that full and comprehensive information was ascertained or recorded on the patient’s condition prior to prescribing.
• There were systems in place for identifying, investigating and learning from incidents relating to the safety of patients and staff members. However, we saw that the learning and actions were not always recognised or acted upon.
• There was no system of quality improvement. For example there was no continuous clinical and internal audit to monitor quality and to make improvements.
• The care and treatment records of patients were not always complete or contemporaneous and the rationale around the decisions about prescribing were not recorded. We noted records were legible and securely kept.
• We found changes to clinical process and governance systems continued to be made with minimal clinical oversight. This included a lack of clinical awareness and acknowledgement of the risks of opioid analgesics and neuropathic pain medicine prescribing.

We identified regulations that were not being met (please see the enforcement notices at the end of this report). The areas where the provider must make improvements are:

• Implement effective governance systems and processes to enable the provider to assess, monitor and improve the quality of the service and identify, assess and monitor risks relating to the health, safety and well being of patients and staff.
• Maintain accurate, complete and contemporaneous records in respect of all patients.
• Respond and act on feedback from the Care Quality Commission for the purposes of evaluating and improving the services to patients.
• Ensure care and treatment is provided in a safe way for all patients. Including the proper and safe supply and management of medicines.
• Ensure policies are in place to ensure children are safeguarded from harm and all staff have completed children’s safeguarding training to the level required for their role.

Summary of any enforcement action

We are now taking further action in relation to this provider and will report on this when it is completed.

Professor Steve Field CBE FRCP FFPH FRCGP

Chief Inspector of General Practice

Letter from the Chief Inspector of General Practice

We carried out an announced comprehensive inspection at White Pharmacy Ltd on 12 and 16 January 2017.

We found this service was not providing safe, effective, responsive and well led services in accordance with the relevant regulations. However, we found they were providing caring services in accordance with the relevant regulations.

Our key findings across all the areas we inspected were as follows:

• Whilst the provider recorded dispensing near misses, there were no effective systems in place for recording, reporting and learning from significant events.
• Risks to patients were not appropriately assessed or managed.
• One clinician working for White Pharmacy Ltd was not registered with the General Medical Council (GMC). The GMC is the statutory body responsible for licensing and regulating medical practitioners.
• There was no evidence of clinical training for clinicians available at the time of our inspection; since our inspection the provider has provided some evidence of staff training.
• The medical questionnaires used to assess a patient’s condition were not all evidence based or risk assessed, did not enable clinicians to make an informed decision and did not ensure safe prescribing.
• There was a system in place for checking a patient’s identification; however this system was not failsafe and we saw evidence of several orders being dispatched without an identification check.
• There was no evidence of sharing information with a patient’s own GP. Patients were given the option of providing GP details; this was not compulsory. Patients were not asked for consent in order information could be shared with their GP.
• Medicines and safety alerts were received by the provider, checked for relevance and actioned if appropriate. At the time of our inspection this system was not recorded; however since our inspection the provider has taken action address this.
• There was a selection of policies available; however these were not readily available to clinicians working remotely.
• There was no safeguarding lead, the safeguarding policy did not include guidance on who to contact if there was concerns about a patient.
• There had only been one formal complaint since 2013. This had been responded to in a timely manner. Informal complaints were recorded in brief. There was no evidence of thematic reviews of complaints or of sharing learning outcomes.
• There was no continuous programme of audits or quality improvement.
• Whilst there was a leadership structure, there was no clear clinical leadership.
• There was no business continuity plan in place at the time of our inspection.

We identified regulations that were not being met and the provider must:

• Ensure the safety of patients by having appropriate systems to manage incidents, consultation forms, prescribing, patient consent and identity verification, safeguarding, recruitment and business continuity.

• Ensure the quality of the service by having appropriate clinical leadership and governance strategies including policies and protocols available for all staff, training, quality assurance monitoring and learning from complaints.
• Ensure patient identification verification is carried out for every patient.
• Take into account the ‘Good practice in prescribing and managing medicines and devices’ Guidance produced by the General Medical Council when deciding how to protect patients from the risk of unsafe prescribing of medicines (including opioid based medicines) at White Pharmacy Ltd.
• Ensure that its clinical members of staff do not prescribe medicines (including opioid based medicines) to patients unless the clinician has sufficient, reliable information to enable them to prescribe safely.
• Ensure that where patients are registered with a general practitioner, in order to ensure safe care and treatment is provided to the patient overall, the provider must decide whether they are able to treat patients who refuse to give consent to White Pharmacy Ltd for their general practitioner to be contacted and informed of the medicines (including opioid based medicines) that have been prescribed.
• Carry out a comprehensive review of all medical questionnaires used to ensure they are evidence based. A GMC registered General Practitioner must sign off each of the final questionnaires to confirm they are satisfied that the revised versions meet the standard required for safe prescribing.

We have taken urgent action in response to the concerns identified at White Pharmacy Ltd; we have imposed conditions on the provider’s registration.

Professor Steve FieldCBE FRCP FFPH FRCGPChief Inspector of General Practice