Medicines and Healthcare Products Regulatory Agency
Other
Action Planned
The MHRA acknowledges the concerns about propranolol toxicity and states it is currently evaluating whether an article in its 'Drug Safety Update' bulletin would effectively increase doctors' awareness of overdose risks. (AI summary)
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Dear Dr Morris Regulation 28: Report to prevent future deaths, Lee Derek Jamie Adams Thank you for submitting a Regulation 28 Report to Prevent Future Deaths in relation to your investigation into the tragic death in July 2020 of Lee Derek Jamie Adams aged 36 from a propranolol overdose. Mr Adams had last been prescribed propranolol in 2017 and it was unclear where he had obtained the tablets that he took. Your report outlines the following matters of concern:
1) Propranolol is absorbed quickly (the court heard within 30-60 minutes of ingestion) and dose related.
2) As a drug it is very effective in what it is prescribed for being used for, for example, in the community to treat hypertension, anxiety and migraines BUT unfortunately, it is highly toxic at even small doses.
3) There is no specific anti-dote to a propranolol overdose, the only form of treatment is supportive and therefore hospital based.
4) Doctors and specifically GPs should be aware of the consequences, at relatively small doses, of excess propranolol ingestion; especially when there is no specific anti-dote and treatment is restricted to supportive measures only. The Medicines and Healthcare products Regulatory Agency (MHRA) is responsible for regulating medicines, medical devices and blood components for transfusion and for ensuring the safety, quality and effectiveness of these products throughout their lifecycle.
[Page 2] The MHRA approved product information for healthcare professionals on the safe use of medicines is provided in the Summary of Product Characteristics (SmPC) and for patients in the Patient Information Leaflet (PIL) that accompanies the medicine. Propranolol is an effective medicine and the balance of benefits and risks is favourable when the guidance in the product information is followed. The SmPC states that ‘Propranolol is known to cause severe toxicity when used in overdose. Patients should be informed of the signs of overdose and advised to seek urgent medical assistance if an overdose of propranolol has been taken.’ The PIL states that ‘Propranolol is severely toxic if used in overdose. If you have accidently taken more than the prescribed dose or are experiencing symptoms of overdose, you should urgently seek medical attention. If you accidentally take an overdose of your medicine, either call your doctor straight away, or go to your nearest hospital casualty department. Always take any remaining tablets, the container and the label with you, so that the medicine can be identified.’ In February 2020 the Healthcare Safety Investigation Branch (HSIB) published a report on harms from propranolol (Potential under-recognised risk of harm from the use of propranolol) and issued recommendations to the BNF and NICE to update their guidance in relation to the use of propranolol in anxiety with particular reference to toxicity in overdose. The report also recommended that a number of healthcare professionals and healthcare system bodies take actions to address this issue. Since then a number of Trusts have issued guidance to clinical teams on the risks of propranolol prescribing in relation to its toxicity in overdose. In response to your matter of concern that ‘Doctors and specifically GPs should be aware of the consequences, at relatively small doses, of excess propranolol ingestion; especially when there is no specific anti-dote and treatment is restricted to supportive measures only’ we are currently evaluating whether an article in the MHRA’s safety bulletin for healthcare professionals ‘Drug Safety Update’ would be an effective way to further increase the awareness of doctors of the risks of propranolol in overdose.
1) Propranolol is absorbed quickly (the court heard within 30-60 minutes of ingestion) and dose related.
2) As a drug it is very effective in what it is prescribed for being used for, for example, in the community to treat hypertension, anxiety and migraines BUT unfortunately, it is highly toxic at even small doses.
3) There is no specific anti-dote to a propranolol overdose, the only form of treatment is supportive and therefore hospital based.
4) Doctors and specifically GPs should be aware of the consequences, at relatively small doses, of excess propranolol ingestion; especially when there is no specific anti-dote and treatment is restricted to supportive measures only. The Medicines and Healthcare products Regulatory Agency (MHRA) is responsible for regulating medicines, medical devices and blood components for transfusion and for ensuring the safety, quality and effectiveness of these products throughout their lifecycle.
[Page 2] The MHRA approved product information for healthcare professionals on the safe use of medicines is provided in the Summary of Product Characteristics (SmPC) and for patients in the Patient Information Leaflet (PIL) that accompanies the medicine. Propranolol is an effective medicine and the balance of benefits and risks is favourable when the guidance in the product information is followed. The SmPC states that ‘Propranolol is known to cause severe toxicity when used in overdose. Patients should be informed of the signs of overdose and advised to seek urgent medical assistance if an overdose of propranolol has been taken.’ The PIL states that ‘Propranolol is severely toxic if used in overdose. If you have accidently taken more than the prescribed dose or are experiencing symptoms of overdose, you should urgently seek medical attention. If you accidentally take an overdose of your medicine, either call your doctor straight away, or go to your nearest hospital casualty department. Always take any remaining tablets, the container and the label with you, so that the medicine can be identified.’ In February 2020 the Healthcare Safety Investigation Branch (HSIB) published a report on harms from propranolol (Potential under-recognised risk of harm from the use of propranolol) and issued recommendations to the BNF and NICE to update their guidance in relation to the use of propranolol in anxiety with particular reference to toxicity in overdose. The report also recommended that a number of healthcare professionals and healthcare system bodies take actions to address this issue. Since then a number of Trusts have issued guidance to clinical teams on the risks of propranolol prescribing in relation to its toxicity in overdose. In response to your matter of concern that ‘Doctors and specifically GPs should be aware of the consequences, at relatively small doses, of excess propranolol ingestion; especially when there is no specific anti-dote and treatment is restricted to supportive measures only’ we are currently evaluating whether an article in the MHRA’s safety bulletin for healthcare professionals ‘Drug Safety Update’ would be an effective way to further increase the awareness of doctors of the risks of propranolol in overdose.