Letter from the Chief Inspector of General Practice

Previous inspection February 2018 when the service was found to be not meeting some areas of the regulations.

We carried out an announced focused inspection at Polypill (Alto House) on 30 August 2018 to follow up on breaches of regulations. During this inspection we looked at the key questions: is the service safe, effective, caring and well led.

Polypill is an online health programme for the prevention of cardiovascular disease, aimed at patients aged 50+. The programme combined the prescribing of medicines and provision of lifestyle advice. Patients initially completed a free online assessment, and if suitable for the programme patients could then order a prescription for the medicines, which was sent to Polypill’s partner pharmacy who dispatched to the patient’s address. When patients required a further supply of medicines they completed a further online questionnaire before a repeat prescription would be issued.

Our findings in relation to the key questions were as follows:

Are services safe? – we found the service was providing a safe service in accordance with the relevant regulations. Specifically:

• Arrangements were in place to safeguard people, including arrangements to check patient identity.
• Suitable numbers of staff were employed and appropriate background information about current staff had been obtained and recorded.
• Risks were assessed and action taken to mitigate any risks identified.

Are services effective? - we found the service was providing an effective service in accordance with the relevant regulations. Specifically:

• Information was appropriately shared with a patient’s own GP in line with GMC guidance in cases where the patient consented to this. When the patient did not provide this consent, the service did not follow GMC guidance, as they did not explore the reasons why the patient did not want their GP to know about their participation in the programme or explain the benefits of information sharing. During the inspection the service committed to developing a process to achieve this.
• Quality improvement activity, including clinical review of prescribing decisions, took place.
• Staff received the appropriate training to carry out their role.

Are services caring? – we found the service was providing a caring service in accordance with the relevant regulations. Specifically:

• The provider carried out checks to ensure consultations by clinicians met the expected service standards.
• Appropriate arrangements were in place to protect confidential patient information.

Are services well-led? - we found the service was providing a well-led service in accordance with the relevant regulations. Specifically:

• The service had clear leadership and governance structures
• A range of information was used to monitor and improve the quality and performance of the service.
• Patient information was held securely.

The areas where the provider should make improvements are:

• Develop and implement processes, in line with GMC guidance, for communicating with patients who choose not to consent to information about their participation in the programme being shared with their registered GP.
• Amend their process for identifying impaired kidney function in prospective patients.

Professor Steve Field CBE FRCP FFPH FRCGP

Chief Inspector of General Practice

We carried out an announced comprehensive inspection at Alto House (Head Office of Polypill Limited) on 1 February 2018 as part of our inspection programme.

Polypill is an online health programme for the prevention of cardiovascular disease, aimed at patients aged 50+. The programme combined the prescribing of medicines and provision of lifestyle advice. Patients initially completed a free online assessment, and if suitable for the programme patients could then order a prescription for the medicines, which was sent to Polypill’s partner pharmacy who dispatched to the patient’s address. When patients required a further supply of medicines they completed a further online questionnaire before a repeat prescription would be issued.

Our findings in relation to the key questions were as follows:

Are services safe? – we found the service was not providing a safe service in accordance with the relevant regulations. Specifically:

• Insufficient arrangements were in place to safeguard people; for example, staff were unfamiliar with the service’s safeguarding policy.
• Patients were not made aware of the implications of taking a medicine that was unlicensed.
• Ordinarily, suitable numbers of staff were employed; however, we were told that the prescribing doctor continued to work remotely for the service whilst they were on holiday. Staff had not been appropriately recruited.

Are services effective? - we found the service was not providing an effective service in accordance with the relevant regulations. Specifically:

• Following patient consultations information was not always appropriately shared with a patient’s own GP in line with GMC guidance.
• Quality improvement activity, including clinical audit, did not take place. The provider did not carry-out reviews of consultations by clinicians to ensure that appropriate decisions were made in relation to prescribing.
• Staff did not receive the appropriate training to carry out their role.

Are services caring? – we found some areas where the service was not providing a caring service in accordance with the relevant regulations. Specifically:

• The provider did not carry out checks to ensure consultations by clinicians met the expected service standards with regards to the care provided to patients.
• Patient feedback reflected they found the service treated them with dignity and respect.
• Patients had access to information about clinicians working at the service.

Are services responsive? - we found the service was providing a responsive service in accordance with the relevant regulations. Specifically:

• Information about how to access the service was clear and where patients contacted the service to apply to join the programme or to raise a query, they were responded to promptly.
• The provider did not discriminate against any client group.
• Information about how to complain was available and complaints were handled appropriately.

Are services well-led? - we found the service was not providing a well-led service in accordance with the relevant regulations. Specifically:

• The service did not have clear leadership and governance structures, as some individuals working for the service were not employees and had no formal contractual arrangement with Polypill Ltd.
• The service did not have systems in place to monitor and improve the quality and performance of the service.
• Patient information was stored using a secure IT system; however, the service had failed to ensure that its own confidentiality policy was being followed, and were therefore not assured that individuals were maintaining the security of patient information.

The areas where the provider should make improvements are:

• Review the arrangements in place for the safe delivery of medicines to patients.
• Introduce arrangements to gather feedback from patients about the service being provided.

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

• Establish effective systems and processes to ensure good governance in accordance with the fundamental standards of care.

You can see full details of the regulations not being met at the end of this report.

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