Department of Health
Central Government
Noted
The Department of Health acknowledges the concerns but states that the MHRA considers current warnings for olanzapine to be adequate and will keep the issue under scrutiny. NHS England will encourage medical directors to remind prescribers of the risks highlighted within the SPC when prescribing antipsychotic medication to people who are known users of synthetic cannabinoids. (AI summary)
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From the Baroness Blackwood Parllamentary Under Secretary of State far Innovalion Department of Health 39 Victoria Street London SWIH OEU 020 7210 4850 Our Ref: PFD-1171237 Ms Jacqueline Devonish HM Area Coroner; Suffolk Coroner's Office Beacon House 53-65 White House Road Ipswich IP] SPB 2$ June 2019 en M _erai L Thank you for your correspondence of 19 March to Matt Hancock about the death of Mr Mohammed Shabol Ahmed: Iam replying as Minister with responsibility for medicines and I am grateful for the additional time in which to do s0_ Firstly, I would like to say how saddened I was to read of the circumstances of Mr Ahmed's death: It is important that we look to make improvements where we can to ensure the safety of healthcare, including within the system, and I am grateful to you for bringing these matters to my attention: My officials have made enquiries with NHS England to which You also issued yOur report; and with the Medicines and Healthcare products Regulatory Authority (MHRA) which has responsibility, among others, to ensure medicines are efficacious and acceptably safe. [am advised by the MHRA that it considers the current warnings on the Summary of Product Characteristics (SPC) for olanzapine about adverse reactions of eosinophilia, and of drug reaction with eosinophilia and systemic symptoms with olanzapine appropriately address the nature of these risks, and given the absence of similar reported cases, does not intend to take further regulatory action at this time prison drug
The MHRA will keep the issue under scrutiny through its Yellow Card scheme. This is the system in the UK for collecting and monitoring information on suspected adverse reactions. The MHRA has added this case to its Yellow Card database (reference number ADR 24400766). The MHRA is running a national pilot in collaboration with Public Health England for reporting unexpected or severe illicit reactions The system is piloted to better understand the adverse effects of newer illicit Or new patterns of use, including alongside licensed medicines, and how these adverse effects might be treated , A further aim of the pilot is to reduce the length of time between related health harms emerging and developing effective treatment responses. Reports are analysed and examined alongside other data by a multi-disciplinary clinical network to determine emerging harms across the UK. A search of the database did not identify similar cases invol synthetic cannabinoids and olanzapine: However; again, the MHRA will keep this issue under scrutiny through the national Finally, I am aware that NHS England has responded to you directly to advise that it will encourage medical directors across the NHS to remind prescribers of the risks highlighted within the SPC when prescribing antipsychotic medication to people who are known users of synthetic cannabinoids, and to use the Yellow Card scheme to report future suspected cases of eosinophilic related reactions in patients prescribed olanzapine and who may have also taken a synthetic cannabinoid. I hope this response is helpful Nis Gx NICOLA BLACKWOOD drug drug- being - drugs drug- ving pilot: Ymr Scs-1
The MHRA will keep the issue under scrutiny through its Yellow Card scheme. This is the system in the UK for collecting and monitoring information on suspected adverse reactions. The MHRA has added this case to its Yellow Card database (reference number ADR 24400766). The MHRA is running a national pilot in collaboration with Public Health England for reporting unexpected or severe illicit reactions The system is piloted to better understand the adverse effects of newer illicit Or new patterns of use, including alongside licensed medicines, and how these adverse effects might be treated , A further aim of the pilot is to reduce the length of time between related health harms emerging and developing effective treatment responses. Reports are analysed and examined alongside other data by a multi-disciplinary clinical network to determine emerging harms across the UK. A search of the database did not identify similar cases invol synthetic cannabinoids and olanzapine: However; again, the MHRA will keep this issue under scrutiny through the national Finally, I am aware that NHS England has responded to you directly to advise that it will encourage medical directors across the NHS to remind prescribers of the risks highlighted within the SPC when prescribing antipsychotic medication to people who are known users of synthetic cannabinoids, and to use the Yellow Card scheme to report future suspected cases of eosinophilic related reactions in patients prescribed olanzapine and who may have also taken a synthetic cannabinoid. I hope this response is helpful Nis Gx NICOLA BLACKWOOD drug drug- being - drugs drug- ving pilot: Ymr Scs-1