It is recommended that the British National Formulary reviews and updates guidance on the use of propranolol in the treatment of anxiety and the advice provided for beta blocker overdose.
BNF Publications reflect information from a range of sources, including the licensed product information and national guidance. In response to this investigation the information contained in BNF Publications with regard to propranolol for the management of anxiety, and the advice around beta blocker overdose, have been reviewed.
In light of this investigation the side-effects within the propranolol drug monograph have been updated to include the side-effects related to propranolol overdose. This adds to the information already listed about beta-blocker overdose within the monograph.
In addition, within the section on Emergency treatment of poisoning, the information about the management of beta-blocker overdose has been updated in line with TOXBASE recommendations. This is also cross-referenced within the propranolol monograph.
BNF Publications will continue to monitor for emerging guidance, and work with the MHRA, NICE and TOXBASE, to ensure that our content reflects the most up to date recommendations.
Response received on 13 August 2020.
National Institute for Health and Care Excellence
It is recommended that the National Institute for Health and Care Excellence reviews and updates guidance on the use of propranolol in the treatment of anxiety and migraine, with particular reference to the toxicity of propranolol in overdose.
NICE does not recommend the use of propranolol in anxiety. It assumes that organisations which do recommend its use in this indication will be asked to review and update any guidance.
NICE would also like to point out that, while the emphasis of the report is on the harmful effects of propranolol in overdose, it is important that the potential harm from other beta-blockers is not neglected: other beta-blockers are sometimes used for migraine prophylaxis (see British Association for the Study of Headache [BASH] guidelines 2010). Finally, this report is about the potential under-recognised risk of harm from propranolol in overdose, not in usual therapeutic use.
NICE will add a footnote to headache guidance (CG150) that propranolol and topiramate may worsen or cause depression, noting that people with migraine often also have depression, and advising caution when using these medicines in people with depression and referring to toxicity of propranolol in overdose.
The guidance on generalised anxiety disorder and social anxiety disorder does not recommend propranolol for this indication. There is no recommendation in the BNF to use propranolol for the treatment of anxiety in isolation.
The BNF does provide dose information for the treatment of anxiety with symptoms such as palpitation, sweating and tremor, reflecting the licensed dose for these indications. The BNF includes information on overdose of propranolol. NICE holds the contract to provide the BNF to the NHS and we will discuss this issue with them.
Response received 18 February 2020.
Royal College of General Practitioners
It is recommended that the Royal College of General Practitioners supports its members in identifying the potential risk of prescribing propranolol to patients in at-risk groups
The RCGP has produced an e-learning resource on ‘Propranolol toxicity’ to support our members in this area and this can be accessed at the top of this page: https://elearning.rcgp.org.uk/course/view.php?id=226
Response received on 1 September 2020.
Royal Pharmaceutical Society
It is recommended that the Royal Pharmaceutical Society supports its members in identifying the potential risk of prescribing propranolol to patients in at-risk groups.
The Royal Pharmaceutical Society (RPS) is keen to continue supporting patient safety as well as the profession by raising awareness of new and under-recognised risks of medicines.
Propranolol is widely used, and pharmacists are ideally placed to provide advice when prescribing and supplying medicines. The RPS publishes pharmacy guides to support professional practice, as well as pharmacy alerts to share information with pharmacists and will look to support raising awareness of the potential risks through these avenues.
Following the publication of the HSIB report in February the RPS has raised awareness of this with members through its website as a “support alert”.
The RPS will continue to support this patient safety initiative through intermittent interventions when the opportunity arises, such as if an inter-related issue or topic is prominent or if we were to run a wider patient safety conference in the future. Currently RPS conference plans are being revised following the impact of COVID-19.
The RPS is also supporting the wider dissemination of clinical information linked to the risks of propranolol through its publication, the British National Formulary.
Response received on 6 July 2020.
PrescQIPP CIC
PrescQIPP CIC have shared the HSIB safety report through various platforms which include virtual meetings, newsletters and on Twitter. It has also produced a bulletin, an audit and searches for GP clinical systems to support GPs in identifying patients at risk so they can have their medicines reviewed and be given advice where appropriate.
To help inform patients of the risks of propranolol, PrescQIPP CIC have also produced some patient information materials highlighting the risks of propranolol and signposting to healthcare professionals for further advice. PrescQIPP CIC subscribers can access these resources via its website to support review of current practice and implement change. The following actions have also been taken:
- The HSIB report was sent to PrescQIPP subscriber leads via e-mail in February 2020.
- The HSIB report was mentioned in a subscriber leads meeting in February 2020. The PrescQIPP hot topic resource on this subject was produced in February and is available to subscribers. This resource includes a bulletin discussing the recommendations and potential actions, clinical system searches to identify at risk patients, an audit and patient information resources warning of the safety risks with propranolol.
- Resources have been publicised on Twitter in March 2020 with @hsib_org copied into tweet.
- PrescQIPP resources were promoted on the senior leads call in March 2020.
Response received on 13 July 2020.
PrescQIPP CIC have shared the HSIB safety report through various platforms which include virtual meetings, newsletters and on Twitter. It has also produced a bulletin, an audit and searches for GP clinical systems to support GPs in identifying patients at risk so they can have their medicines reviewed and be given advice where appropriate.
To help inform patients of the risks of propranolol, PrescQIPP CIC have also produced some patient information materials highlighting the risks of propranolol and signposting to healthcare professionals for further advice. PrescQIPP CIC subscribers can access these resources via its website to support review of current practice and implement change. The following actions have also been taken:
- The HSIB report was sent to PrescQIPP subscriber leads via e-mail in February 2020.
- The HSIB report was mentioned in a subscriber leads meeting in February 2020. The PrescQIPP hot topic resource on this subject was produced in February and is available to subscribers. This resource includes a bulletin discussing the recommendations and potential actions, clinical system searches to identify at risk patients, an audit and patient information resources warning of the safety risks with propranolol.
- Resources have been publicised on Twitter in March 2020 with @hsib_org copied into tweet.
- PrescQIPP resources were promoted on the senior leads call in March 2020.
Response received on 13 July 2020.
NHS England and NHS Improvement
It is recommended that NHS England/NHS Improvement evaluates current approaches to the clinical oversight of overdose calls within ambulance control rooms and leads on work to develop a national framework to describe the requirements for appropriate clinical oversight of overdose calls.
The guidance on the ‘Clinical Oversight of Overdose Calls’ will be encompassed in a wider programme of work to develop a Clinical Oversight Framework for Emergency Operations Centres. The development of this framework is a longer term piece of work and will be completed in partnership with the Association of Ambulance Chief Executives.
To expedite the HSIB recommendation, NHSE/I will be developing the ‘Clinical Oversight of Overdose Calls’ procedure as a first stage in the Clinical Oversight Framework with a view to incorporating it as the framework develops. This approach should allow NHSE/I to disseminate a draft procedure for the Clinical Oversight of Overdose Calls to 999 and 111 services for their comments by the end of August 2020.
The finalised procedure will be presented to the Emergency Call Prioritisation Advisory Group (ECPAG) and internal governance processes for approval in September 2020 with the intention of publication and implementation by ambulance Trusts in October 2020.
The following actions have also been taken:
- The guidance on the ‘Clinical Oversight of Overdose Calls’ will be encompassed in a wider programme of work to develop a Clinical Oversight Framework for Emergency Operations Centres.
- NHSE/I will be developing the ‘Clinical Oversight of Overdose Calls’ as a first stage in the Clinical Oversight Framework with a view to incorporating it as the framework develops.
Response received on 3 August 2020.
Association of Ambulance Chief Executives
It is recommended that the Association of Ambulance Chief Executives works with the National Poisons Information Service to review its guidance on the treatment and transportation of patients known to have taken an overdose of propranolol or other beta blocker medication.
The AACE develop and publish clinical guidelines, and these are used by ambulance clinicians and paramedics across the NHS ambulance services to guide patient care. The guidelines include a range of conditions that may result in someone calling for an ambulance for, such as cardiac arrest, trauma, maternity, overdose and poisoning and many more.
The AACE liaised with the National Poisons Information Service and consulted with two of their leads that had previously supported with the UK ambulance clinical guidelines, specifically the guidance around people that call for an ambulance in an overdose or poisoning situation.
The AACE reviewed the existing section in the specific substance management of the overdose and poisoning guideline that relates to beta blockers.
The AACE revised this section and added the names of common beta blockers and that they commonly ended in ‘olol’ such as propranolol. It enhanced and added extra wording around the signs and symptoms and management of patients that have taken an overdose of beta blockers to further emphasise the dangers and the serious effects that can occur.
The AACE also added a new general point regarding slow-release medicines to highlight that they may have a delayed clinical effect.
The revised guidance was issued onto the JRCALC App which is used across the UK by ambulance service clinicians on 16 June 2020. The App contains the full set of clinical guidelines and is used frequently by ambulance clinicians.
Response received on 3 July 2020.