Dear Mr Davies

Thank you for your letter of 7 May 2021 about the death of Helen Spicer. I am replying as Minister with responsibility for medicines.

Firstly, I would like to say how saddened I was to read of the circumstances of Helen Spicer’s death and I offer my sincere condolences to her family and loved ones. The circumstances your report describes are very concerning and I am grateful to you for bringing these matters to my attention.

Decisions on the scheduling of controlled drugs under the relevant legislation are taken by the Home Office. This is done with the provision of advice from the Advisory Council on the Misuse of Drugs (ACMD) and any decisions made by the ACMD weigh up the risks of misuse, abuse and diversion, against not impeding legitimate use within healthcare.

I note that you have issued your report to the ACMD and am aware that it has responded to you directly on this matter. I can assure you that the Department of Health and Social Care, and its Arm’s Length Bodies, work closely with the Home Office and the ACMD to help inform such decisions.

In relation to the wider context and the increasing concern internationally and here in the UK, about the overuse and misuse of opioids leading to a growing problem of dependence and addiction, I would like to outline the range of action that has been taken to protect patients from harm.

In 2017, the Government asked Public Health England (PHE) to conduct an evidence review to identify the scale, distribution and causes of prescription drug dependence, and what might be done to address it. PHE’s report of the review was published in September 20191, providing evidence for dependence on, and withdrawal from, prescribed medicines, with the aim of making sure that local healthcare systems build awareness and support to enhance clinician and patient decision making.

In support of this, NHS England and NHS Improvement (NHSEI) is co-ordinating a programme to implement the recommendations of the review, working closely with relevant health system partners. The programme covers five classes of medicines including benzodiazepines; Z-drugs; gabapentinoids; opioids, for chronic non-cancer pain; and antidepressants.

The Medicines and Healthcare products Regulatory Agency (MHRA) recently reviewed the risk of addiction and dependence with opioid medicines, as a result of which, all opioid medications now carry prominent front-of-pack warnings that the product contains opioids and may cause addiction. In addition, warnings on the risk of dependence in product information have been strengthened and harmonised. The MHRA has also worked closely with stakeholders and Trades Associations to develop an additional, user-tested, safety information leaflet for distribution directly to patients at pharmacies and on the MHRA government website.

Finally, since October 2020, Primary Care Networks of GPs have been required to identify and prioritise patients, including patients using potentially addictive pain management medication, who would benefit from a structured medication review2. You may also wish to note that further to the February 2020 update to the GP contract agreement 2020/21 to 2023/243, a Quality Improvement Module in the Quality and Outcomes Framework for general practice on preventing prescription drug dependency is in development.

I hope this response is helpful.

LORD BETHELL

1 Prescribed medicines review: summary - GOV.UK (www.gov.uk)

2 Report template - NHSI website (england.nhs.uk)

3 Criteria for registration as a pharmacy technician in Great Britain (england.nhs.uk)

Dear Mr Davies,

Thank you for setting out your concerns in the Regulation 28 notice about a death which involved the unintentional overdose of morphine sulfate oral solution .

The role of the Advisory Council on the Misuse of Drugs (ACMD) is to keep under review the situation in the UK with respect to drugs which are being or appear to them likely to be misused and of which the misuse is having or appears to them capable of having harmful effects sufficient to constitute a social problem.

Firstly, I would like to set out the work which has already been completed by the ACMD on this important issue. In 2016, the ACMD published a major report on diversion and illicit supply of medicines: One of the recommendations in that report concerned setting up a monitoring system for emerging prescribed substances with the potential for diversion and illicit supply. The ACMD’s Secretariat has recently developed a standard operating procedure and a watch-list for medicines misuse as proposed in the report above which will be overseen by the ACMD’s Technical Committee going forward. In fulfilment of that recommendation, a number of Government departments have agreed to provide information relevant to misuse of prescription medicines and to make this information available to the ACMD.

I would like to assure you that there are currently actions being taken forward by the ACMD.

The ACMD has published a standard operating procedure on the use of evidence in ACMD reports. This SOP details how the ACMD collects, analyses and presents evidence in reports, available at:

The Regulation 28 notice was discussed at a recent ACMD Full Council meeting, where the ACMD agreed that there was a need to gather more information on the scale of the issue, being mindful of the legitimate use of morphine sulfate solution. The ACMD has interaction with the MHRA through representation at ACMD meetings and data provided from the Yellow Card System. The MHRA are able to raise any issues concerning misuse of medicines to the ACMD. The ACMD will also request information from DHSC and NHS-E&I regarding patient safety incidents recorded throughout the National Reporting and Learning System (NRLS) to help us assess the evidence.

Best regards,

Secretary to the ACMD