Dear Ms Topping; INQUEST INTO THE DEATH OF GAVIN PETER PENDLEMAN: REGULATION 28 REPORT Thank you for your report of 30 December 2022, following the inquest into the tragic death of Gavin Peter Pedleham, which was forwarded to the Home Ofice on 6 January: Mr Pedleham inadvertently consumed liquid morphine (under the brand name "oramorph") prescribed to another after having consumed alcohol; and the report suggests that action should be taken to place regulatory duties on the storage, handling and use of oral morphine once prescribed. am replying as the Minister of State for Crime, Policing and Fire with responsibility for regulations under the Misuse of Drugs Act 1971, including the Misuse of Drugs Regulations 2001 "the 2001 Regulations") . In considering the report; the Home Office has sought views from the Department for Health and Social Care, which has responsibility for medicines policy: consider that appropriate measures to reduce the risk of accidents like this from happening are already in place_ Prescribers and dispensing pharmacists are obligated to provide advice to patients or carers on what the medicines are and how they should be taken, including any risks information on drug interactions_ This advice is also a statutory requirement in the patient information leaflet provided with licensed medicines, which for oramorph includes that alcohol should be avoided whilst taking this medicine As the report mentions, the 2001 Regulations make controlled drugs available in healthcare, and impose administrative obligations and requirements to mitigate risks of harm, misuse and diversion of controlled drugs_ Before making decisions on the appropriate safeguards under the 2001 Regulations, Ministers take expert advice from Advisory Council on Misuse of Drugs (ACMD): Liquid morphine in this form is placed in Schedule 5 to 2001 Regulations_ Extending the legal requirements applicable in healthcare, for example; those requiring safe custody. to patients would risk criminalising patients lawfully prescribed a controlled drug; and potentially put in place barriers to legitimate and timely access to pain relief. Therefore_ have no plans at present to consider additional controls on oral morphine. However; drugs controls are kept under review, and should further evidence emerge indicating the need for additional controls will consider whether it is appropriate to seek advice from the ACMD:

Dear Ms Topping,

I write in response to your regulation 28 report of 30 December 2022 regarding the very sad death of Mr Gavin Peter Pedleham. I would like to express my sincere condolences to Mr Pedleham’s family.

Having reviewed your report, and the circumstances surrounding Mr Pedleham’s death, we believe our guideline on controlled drugs: safe use and management [NG46] is directly relevant to this case. The scope of this guideline covers all settings, including people's own homes, where publicly funded health and social care is delivered. It was developed in line with UK controlled drugs legislation and regulations. In the guideline we recommend that health professionals should provide advice and information to people who are prescribed controlled drugs about how to store controlled drugs safely. This includes discussing storage options, taking into account the person's preference for a lockable or non-lockable storage box; whether the controlled drugs will be accessible to people who should and should not have access to them; whether the storage method could increase the risk of controlled drug-related incidents, including patient safety incidents (recommendation 1.8.2). Furthermore, we recommend documenting and giving information to the person taking the controlled drug or the carer administering it, including: that it is to be used only by the person it is prescribed for (recommendation 1.5.9).

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Our information for the public explains the advice set out in NG46 and advises that ‘You must not let anyone else take your medicine. Your healthcare professional should explain this clearly.’ We therefore believe that there is sufficient national guidance on the use of controlled drugs in a community setting.

Please do let me know if you require any further information.

Dear Ms Topping,

Report to Prevent Future deaths - Gavin Peter Pedleham

Thank you for your report dated 30 December 2022 which was received on 10 January
2023. I would like to offer my sincere condolences to Mr Pedleham’s family on their tragic loss. The MHRA monitors the safety of all medicines to ensure that up-to-date information on the benefits and risks of a medicine is available for healthcare professionals and patients. The Summary of Product Characteristics (SmPC) for a medicine provides information for healthcare professionals (HCPs) about the medicine, including warnings and precautions of use in higher risk situations. The same information is provided to patients in a patient information leaflet, which is written in language that can be understood by the lay person and accompanies each medicine. However, this tragic event did not occur to a patient but to an unintended recipient, therefore, will not have seen the product information. In 2019 we undertook a review of the benefits and risks for all opioid medicines in the treatment of non-cancer pain and risks associated with dependence and addiction and sought the advice of an Opioid Expert Working Group of the Commission on Human Medicines, the MHRA’s advisory body. The Expert Working Group considered the positive benefit-risk profile of opioid-containing medicines and made recommendations for regulatory action to better support appropriate use of prescription opioids including morphine oral solutions like Oramorph. An investigation into the potential for accidental exposure and accidental overdose has been undertaken. Oramorph oral solution contains morphine in strengths of either 10mg/ml or 20mg/ml. The patient information leaflet and labels include clear guidance on the correct use of Oramorph.

The leaflet states: This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.

Opioids should only be used by those they are prescribed for. Do not give your medicine to anyone else. The leaflet highlights that the oral solution should not be taken with alcohol. If it is diluted in a soft drink, then it should be consumed immediately. This was a tragic accident which was not circumvented by the warnings and guidance clearly present in the product information. However, it is evident that the glass containing Oramorph was left unattended. Therefore, we will work with the Marketing Authorisation holders to update the product information to highlight the need to keep the medicine in a secure place and not leave any diluted Oramorph unattended. We continually monitor for accidental deaths of opioid containing medicines and will take further prompt regulatory action when necessary.

Should you have any further questions, I should be pleased to assist.