Jamie O’Connor

Dear Mrs Hocking Regulation 28 Report to Prevent Future Deaths Thank you for your Regulation 28 Report ‘To Prevent Future Deaths’. I am responding as the Medical Director and Director of Education and Standards for the General Medical Council (GMC). I am grateful to you for raising the matter with us, and I am sorry to hear of the circumstances of Jamie Francis O'Connor’s death. The GMC is the regulator for the medical profession in the UK. As part of our role, we publish guidance for doctors setting out the principles of good practice and the professional standards expected of them in the course of their work. We do not, however, give clinical guidance or comment on clinical matters, such as the appropriateness of specific treatments. All doctors must be aware of and follow our guidance and we have powers to take action if those standards are not met. I appreciate that the events giving rise to this inquest date from several years ago. In late 2019 we launched a call for evidence in relation to remote consultations and prescribing. This explored whether our existing guidance, which was last updated in 2013 and which applied at the time of Mr O’Connor’s death, had kept pace with changes in practice and the use of technology. Following this exercise, we published updated guidance for doctors on prescribing in February 2021. This now places a greater emphasis on following the principles of good practice regardless of the medium through which a consultation is taking place, face to face or online. We recognise that some models of remote prescribing can pose greater risks, including where there is no mechanism for doctors to have two-way dialogue or communication with patients. In our updated guidance we are clear that, if they cannot meet our standards

through the mode of consultation they are using, doctors should offer an alternative if possible, or signpost to other services. If doctors think that systems, policies or procedures are, or may be, placing patients at risk of harm, they must follow our guidance in ‘Raising and acting on concerns about patient safety’. For clarity below we have set out our response to each concern you raise, with references to our updated guidance. While the first and last concerns below are outside our remit, I hope our response to the remaining areas gives assurance that the GMC provides clear guidance for doctors that addresses these issues. ‘There is no central tracking system or central database to record what each person has been prescribed and dispensed and by whom. This is open to abuse as the person requesting the drugs has potential access to multiple online pharmacies who have no knowledge of what each other have been prescribing thus risking contra-indicated drugs being dispensed or over prescribing of drugs.’ Systems for accessing and sharing information about the prescribing and dispensing of medicines are outside the GMC’s remit. However, we strongly agree that effective systems are vital to ensuring safe and effective care. In our prescribing guidance we say that doctors should only prescribe medicines if they have adequate knowledge of the patient’s health and are satisfied that the medicines serve the patient’s needs (paragraph 20). It is essential that doctors and other healthcare professionals can easily access or verify the information they need to prescribe safely, especially when prescribing medicines which present a risk of addiction, misuse or overuse. We know doctors in both remote and face-to-face settings will sometimes find themselves in a position where they cannot easily access or verify the information they need to prescribe safely. In England, we are aware that NHSX has published a ‘Delivery Plan’, which is looking at how all those involved in the delivery of care can access the information they need. We hope this will be an opportunity to remove barriers for doctors and other healthcare professionals when accessing and sharing relevant patient information. ‘There is no requirement to contact the GP of the person requesting drugs to let them know what has been prescribed. If the person requesting the drugs chose not to share with the GP there were no red flags which might indicate further enquiries should be made with that person as to why they did not want to share with the GP.’ Our prescribing guidance is clear that doctors must only prescribe if it is safe to do so and we say that:
• It’s not safe to prescribe if doctors don’t have sufficient information about the patient’s health or if the mode of consultation is unsuitable to meet their needs.
• It may be unsafe if relevant information is not shared with other healthcare providers involved in the patient’s care – for example because the patient refuses consent (paragraph 27).

In relation to accessing and sharing information, our guidance (paragraphs 29-32) says that if:

• a doctor is not the patient’s regular prescriber, they should ask for the patient’s consent to contact their GP or other treating doctors if they need more information or confirmation of the information they have before prescribing, and to share information with the patient’s GP when the episode of care is completed.
• the patient objects to information being shared with the doctor, or does not have a regular prescriber who can be contacted, the doctor must be able to justify a decision to prescribe without that information.
• the patient refuses to consent to the doctor sharing information with their GP, or does not have a GP, the doctor should explain to the patient the risks of not sharing this information and document this in their medical records.
• failing to share information with others could pose a risk to patient safety, the doctor should explain to the patient that they cannot prescribe. The doctor should also outline the patient’s options and signpost them to appropriate alternative services. Finally, the doctor should clearly document their reasons for any decisions made.

We have also specifically strengthened our guidance in relation to controlled drugs and medicines liable to abuse, overuse, misuse or addiction. This includes emphasising that, if doctors do not have access to relevant information from the patient’s medical records, apart from in limited circumstances, they must not prescribe such medicines.

‘There was no necessity for a face to face consultation with the person requesting the drugs and the prescriber before drugs were dispensed’

Our guidance says that doctors must consider the suitability of the mode of consultation they are using, taking account of any need for physical examination or other assessments (paragraph 20a). Before prescribing, doctors must be satisfied that they can make an adequate assessment, establish a dialogue and obtain the patient’s consent through the mode of consultation they are using (paragraph 24).

We provide further guidance on circumstances in which a face-to-face consultation may be more appropriate than a remote consultation. This includes, but is not limited to, when the doctor is not the patient’s usual doctor or GP and the patient has not given the doctor consent to share their information with their regular prescriber. We add that this is particularly important if the treatment needs following up or monitoring, or if the doctor is prescribing medicines where additional safeguards are needed – such as those liable to addiction and abuse (paragraph 22).

We also say that, where different options exist, and it is within their power, doctors should agree with the patient which mode of consultation is most suitable for them (paragraph 21).

‘There was a very limited questionnaire about the history of the person requesting the drugs. If the answer was 'no' to one question which meant that the drugs could not be prescribed it was very easy to go back and alter it to 'yes' (or vice versa) if that meant that the drugs could be dispensed.’

‘Persons requesting the drugs were able to ask specifically for which drug they wanted before contact with the prescriber.’

Our updated prescribing guidance highlights that, when prescribing medicines, doctors must establish a dialogue with their patient to help them consider information about their options and so they can decide whether or not to have care or treatment. We say that good dialogue should give both the doctor and their patient the opportunity to ask questions to get the information they both need (paragraph 34).

Doctors must obtain an adequate history, which includes, but is not limited to, current and recent use of other medicines, including non-prescription and herbal medicines, illegal drugs and medicines purchased online or face to face (paragraph 35). Doctors should encourage their patient to be open about their use of such medicines (paragraph 36).

We specifically say that, if it is not possible to clarify or ask for more information from the patient in the environment they are working, doctors should consider whether it is safe to prescribe, and raise concerns as appropriate. We highlight that it may, for instance, be appropriate to raise concerns if the system in which a doctor is working involves prescribing remotely on the basis of a questionnaire and there is no mechanism for two-way dialogue or communication with patients (paragraph 38).

‘By virtue of where the company prescribing the drugs was registered there was limited regulation.’

The GMC’s remit does not extend to organisations that provide health services. The Department of Health and Social Care and the Care Quality Commission may be better placed to comment on this issue as far as it relates to England.

I hope the information above is helpful.

Dear Mrs Hocking Regulation 28: Report to prevent future deaths Thank you for sending us your report regarding the circumstances surrounding the death of Jamie O’Connor. We would like to pass on our sincere condolences to Jamie’s family. Our standards and guidance To provide some background context, the GPhC has a statutory purpose to protect patients by setting and upholding the standards for registered pharmacies and the standards for pharmacy professionals to ensure that registered pharmacies are safe to provide services, and that pharmacy professionals are fit to practise. We seek assurance that pharmacy professionals and pharmacies continue to meet our standards. One of the methods we use to monitor compliance and establish if safe and effective care is being provided is by inspecting pharmacies. Since April 2019 we have published inspection reports on our inspection website here. We act to protect the public and to uphold public confidence in pharmacy if there are concerns about a pharmacy professional or pharmacy on our register. One of our key roles is to investigate concerns about pharmacists and pharmacy technicians that could suggest they pose a risk to patient safety or could affect the public’s confidence in pharmacy. We also investigate concerns about registered pharmacies. Pharmacy professionals must also take action to safeguard people, particularly those that are vulnerable. All pharmacy professionals are personally accountable for meeting the standards. We expect pharmacy professionals to meet our standards, comply with their legal duties, as well as considering any relevant guidance when making decisions. In addition, pharmacy owners are responsible for meeting our standards for registered pharmacies and everyone in the pharmacy team should be familiar with these standards and play a key role in delivering person-centred care. 25 Canada Square, London E14 5LQ T 020 3714 8000 | F 020 3713 8145

The issues in the report I wanted to provide some further information about what we expect from registered pharmacies, specifically in the context of providing online services, as this is relevant to the issues you have raised. We acknowledge your concern that there is no central tracking system or central database to record what each person has been prescribed and dispensed and by whom. Although this specific aspect is outside of our remit, we do produce guidance, which is designed to support pharmacy owners and pharmacy professionals to meet our standards. Our guidance for registered pharmacies providing services at a distance, including on the internet highlights the different risks that pharmacy owners should consider as part of their initial risk assessment for the pharmacy when deciding whether or not they can safely, and effectively, sell and supply medicines at a distance, rather than in the traditional face-to face way. We published this updated guidance in April 2019, which includes more stringent safeguards where medicines are supplied to patients at a distance. To ensure the safe management and supply of medicines, the guidance sets out the key responsibilities of the pharmacy owner in relation to the issues you have outlined in your report. In particular, we expect pharmacy owners to:  Make sure that their website and the websites of companies they work with are arranged so that a person cannot choose a prescription only medicine and its quantity before there has been an appropriate consultation with a prescriber. It should be made clear that the decisions about treatment are for both the prescriber and the person to jointly consider during the consultation. However, the final decision will always be the prescriber’s.  Make sure that their pharmacy staff can identify requests for medicines that are inappropriate, by being able to identify multiple orders to the same address or orders using the same payment details – this includes inappropriate combinations of medicines and requests that are too large or too frequent.  Make sure they consider the design and layout of their website and make sure that it works effectively and looks professional. We also expect pharmacy owners make sure that an online prescribing service, or a prescriber, that they choose to work with is aware that some categories of medicines are not suitable to be supplied online unless further safeguards have been put in place to make sure that they are clinically appropriate. This includes medicines liable to abuse, overuse or misuse, or when there is a risk of addiction and ongoing monitoring is important. In this scenario, the following additional safeguards need to be put in place:  The person has been asked for the contact details of their regular prescriber, such as their GP, and for their consent to contact them about the prescription.

 The pharmacy owner has assured themselves that the prescriber will proactively share all relevant information about the prescription with other health professionals involved in the care of the person (for example their GP).  The pharmacy owner has assured themselves that the prescriber has contacted the GP in advance of issuing a prescription, and that the GP has confirmed to the prescriber that the prescription is appropriate for the patient and that appropriate monitoring is in place.  If there are circumstances where the person does not have a regular prescriber such as a GP, or if there is no consent to share information, and the prescriber has decided to still issue a prescription, the pharmacy owner should assure themselves that the prescriber has made a clear record setting out their justification for prescribing. You can read more about our approach to regulating online pharmacies here:

pharmacies-guidance-faqs We have also worked with other healthcare organisations including regulators, royal colleges and faculties and have jointly-agreed High level principles for good practice in remote consultations and prescribing that set out the good practice of healthcare professionals when prescribing medication online. The ten principles, underpinned by existing expected standards and guidance, include that healthcare professionals are expected to:  Understand how to identify vulnerable patients and take appropriate steps to protect them  Carry out clinical assessments and medical record checks to ensure medication is safe and appropriate We have also published ‘In practice: Guidance for pharmacist prescribers’, which set outs the key areas we expect pharmacist prescribers to consider when applying the standards to their prescribing practice. The guidance states that prescribing information should be shared with the person’s prescriber, or others involved in their care, so the person receives safe and effective care. Taking action if our standards are not met Our standards set out compulsory requirements which all pharmacies must follow, and our guidance describes how we expect them to do this, in different contexts. The guidance is clear that the pharmacy owner is responsible for making sure the guidance is followed. Not following our guidance, or not taking the appropriate steps to achieve a desired outcome under our standards, could mean that the pharmacy fails to meet one or more of our standards and enforcement action may be taken. We have taken enforcement action against the owners of online pharmacies who are supplying high risk, habit-forming medicines without appropriate steps being taken to check that the medicine being prescribed and dispensed is clinically appropriate for the patient. Where our inspectors have found insufficient safeguards in place to manage risks to patients, we have served Improvement Notices and/or put conditions on a pharmacy’s registration. Typically, where the pharmacies are supplying high-risk medicines, the conditions imposed restrict the sale or supply of controlled drugs in line with our enforcement policy. As a result of our enforcement action, there have been a number of examples where pharmacies have either decided to stop supplying high-risk medicines, or, where this was the main focus of their service, have decided to cease trading altogether.

We have also referred individual pharmacy professionals involved in both the prescribing and supply of medicines to our Fitness to Practise process where their conduct has fallen short of professional standards. If a pharmacy professional’s fitness to practise is found to be impaired, our Fitness to Practise Committee can impose a range of sanctions, including suspension or removal from the register. We hope this is helpful in providing some further background information about what we expect from pharmacies in this context.