Following fitness to practise concerns and several prevention of future death reports, we explore the risks of harm from propranolol, in particular the risk of toxicity in overdose.
Through our work we have identified common themes that have led to patient harm or death following prescribing and supplying of propranolol. Our Clinical Advisor and Inspector, Jennifer Sinclair, and Lead Clinical Advisor and Inspector, Neha Ramaiya, explore these themes, provide insights into the risks, and share some key recommendations for pharmacy professionals to help keep patients and the public safe.
What is propranolol?
According to the British National Formulary (BNF), propranolol is licensed for a range of conditions, including hypertension, anxiety and prevention of migraines. The British Heart Foundation describes propranolol as a non-selective beta blocker, which means it inhibits beta receptors in other areas of the body, blocking adrenaline and noradrenaline. This is why it should not routinely be prescribed to people with a history of asthma, bronchospasm or obstructive airways disease as it can cause bronchospasms.
In 2022-2023 the National Poisons Information Service (NPIS), who maintain the Toxbase database received 358 enquiries involving intentional propranolol overdose (321 exposures in 318 patients). In 12 cases the overdose resulted in death.
A Health Services Safety Investigations Body (HSSIB) investigation report into the potential under-recognised risk of harm from the use of propranolol highlighted that there is a specific group of patients who may be at an increased risk of using propranolol for self-harm, because they have co-existing migraine, depression or anxiety.
This report led to warnings being added in the BNF and amendments to the NICE guidelines for headaches in relation to prescribing propranolol.
The NPIS report states that of the 321 exposures to propranolol overdose reported, 108 prescriptions were for the management of anxiety symptoms. Although propranolol is licenced for use in anxiety management, there is no mention of this in the guidance produced by NICE. We would expect prescribers to consider the risks identified and use national guidance when prescribing propranolol, ensuring that it is safe and suitable for their patient.
Find out more
- NICE: headache in over 12s: diagnosis and management
- NICE: generalised anxiety disorder and panic disorder in adults: management
- SIGN (Scottish Intercollegiate Guidelines Network): pharmacological management of migraine
What is the risk of harm?
There is a wide variation in individuals’ response to propranolol overdose. Although evidence is limited, Toxbase provides some guidance for healthcare professionals.
Peak plasma concentrations of propranolol occur 1-2 hours after ingestion, so symptoms of overdose will not be seen immediately. Rapid deterioration can occur following a propranolol overdose, this can include confusion and loss of consciousness as well as cardiovascular complications including cardiac arrest. As propranolol can cross the blood brain barrier, the risk of convulsions is higher than with other beta blockers. Delay in treatment increases the risk of fatality, therefore it is important to seek emergency help as soon as possible following overdose.
According to Toxbase, the key features in severe poisoning are:
- cardiovascular collapse
- central nervous system depression
- convulsions
Why are we concerned?
We continue to monitor for reports and respond to queries from coroners in line with the prevention of future deaths reports. In addition to the HSSIB report mentioned above, there have been a number of prevention of future deaths reports involving propranolol.
Examples for pharmacy professionals and teams
Ania Sohail - Prevention of Future Deaths Report
Ania Sohail was an inpatient on a psychiatric ward, with a history of self-harm and suicide attempts. She was detained under the Mental Health Act 1983.
During her inpatient stay, Ania fatally overdosed on propranolol which she purchased from several online pharmacies. For every purchase, Ania completed an on-line questionnaire in which she denied having a mental disorder and declined consent for the prescriber to share information with her GP.
The prescribers were unaware that Ania was an inpatient of a psychiatric hospital or that she was accessing propranolol from multiple online pharmacies. They accepted the information provided at face value.
Ania ordered the propranolol to be delivered to her home address and collected it when on visits home from the ward. She was then able to secrete the tablets on to the ward where she consumed the overdose which sadly led to her death.
The report highlighted that ‘in relation to the online pharmacies, there was a:
- ‘Lack of integrated system or records which could be accessed by multiple pharmacies
- Lack of access to the GP Summary Care Records, other pharmacy supplies; and
- Lack of consent to the sharing of information.’
The report further highlighted that lack of information sharing could lead to a GP or Pharmacist Prescriber unknowingly prescribing a medication that is contraindicated with a medication that has been dispensed through an online pharmacy.
Pharmacy professionals, pharmacy owners and superintendents of distance-selling and internet pharmacies should consider the highlighted matters from the report.
They should consider in their risk assessments how they will mitigate risks to patients and provide treatment in a safe and effective way.
In some circumstances, they may need to consider not prescribing or supplying certain treatments due to the additional risks of providing medication from this setting.
Aoife McAdam - Prevention of Future Deaths Report
Aoife McAdam was prescribed propranolol by a locum GP. The investigation concluded that the primary cause of Aoife’s death was an overdose of propranolol, which she should not have had in her possession.
Aoife was prescribed propranolol to help with the physical symptoms of anxiety and was supplied with 84 propranolol tablets. After reporting that the propranolol was ineffective, she asked to be switched to an antidepressant.
This change was made but there was no advice on what to do with the remaining unused propranolol tablets, such as returning them to a pharmacy. Aoife sadly took an overdose with these tablets.
The report highlights the importance of counselling patients so that they are aware of what to do with their medication and who to contact if they need help. In line with our standards for pharmacy professionals, we expect pharmacists and pharmacy technicians to provide person-centred care to their patients to suit their individual needs and requirements and optimise their best outcomes.
See other examples involving propranolol >
Common themes
We have received some concerns in relation to prescribing or supplying of propranolol. Here are some common themes:
- medicines were supplied to patients from online pharmacies solely using a questionnaire-based approach
- consent to gather further information or share information with the patient’s regular practitioner was not taken or provided
- patients gave incorrect and inaccurate information to obtain supplies of medication
- patients were not being advised to avoid stockpiling medication
- patients and carers were not informed of the risk of harm in overdose
- large quantities of propranolol were supplied to vulnerable patients such as those at increased risk of self-harm
Recommendations
Pharmacy professionals and pharmacy teams should be aware of the risks of overdose from propranolol. Where they identify patients who may be at risk, they should consider if further safety measures could help to safeguard the patient, for example:
- prescribing smaller quantities
- dispensing weekly or reduced frequencies
- referring the person to a specialist
- knowing who to contact to raise any concerns
We expect pharmacy professionals to work with other healthcare professionals to ensure that patients receive safe and effective care.
Where necessary, pharmacy teams should advise people to return any unused propranolol (which could be due to dose changes, or because treatment has ended, for example) to a community pharmacy for destruction.
In line with our guidance for pharmacist prescribers, prescribing pharmacists should ensure that they have reliable and accurate information about the person’s health and medicines before prescribing, to ensure they are providing person-centred care.
This may be through ensuring they have appropriate access to medical records, or by discussing the situation with the person’s regular practitioner, if they have one. If it isn’t possible to verify the information they have, then they should assess the risks, and keep clear records to justify their prescribing decisions.
We expect pharmacy professionals to:
- have sound knowledge of the condition they are prescribing for
- maintain the competencies specific to their scope of practice
- have a thorough and current understanding of the medicine they are prescribing
Prescribing pharmacists should ensure that they follow the necessary national and best practice guidance when prescribing treatment to patients. They should utilise the Royal Pharmaceutical Society's (RPS) Competency Framework for all Prescribers to maintain and expand their knowledge and skills, and to improve their performance so that they can maximise the best outcomes for their patients.
When expanding their scope of practice, pharmacist prescribers should look at the RPS’s professional guidance on expanding their prescribing scope of practice.
Our standards for registered pharmacies outline the importance of having adequate risk assessments in place to safeguard patients and the public, including when providing services at a distance.
It is imperative that pharmacies:
- consider the risks of patients obtaining propranolol from multiple sources
- put adequate systems and safeguards in place to ensure they are prescribing and supplying the medication safely
- adequately counsel patients and their carers, highlighting the risks of propranolol and provide appropriate safety netting advice
In our guidance for registered pharmacies providing services at distance, including on the internet, we set out that pharmacies should gather evidence about the risks for each individual medicine provided at a distance, including on the internet before providing the service.
This should include (but is not limited to):
- the risks of providing propranolol at a distance
- how prescribers will verify the reliability of the information they receive so that they can check that the supply is safe and appropriate
- assurance of prescriber’s training, skills and competencies in prescribing for conditions requiring propranolol
- assurance that prescribers are following all relevant UK national or best practice guidance
- the consent necessary to communicate with other healthcare providers involved in the patients care, such as their GP
- sharing and transferring information to the patient’s regular prescriber or health care provider
- how to provide adequate counselling, advice and safety netting of the patient remotely
- how to identify inappropriate requests for propranolol, such as multiple requests or the use of multiple accounts
Find out more
Below is a list of resources to help you make sure you are meeting our regulatory standards and guidance and working in line with good practice.
GPhC standards and guidance
- The standards for pharmacy professionals highlight that pharmacy professionals must provide person centred care, work in partnership with others, communicate effectively, maintain, develop and use their professional knowledge and skills, and use their professional judgement.
- The standards for registered pharmacies set out the requirements to deliver safe and effective services for patients and the public.
- Our guidance for pharmacist prescribers shares key areas which pharmacist prescribers should consider in order to prescribe safely and effectively.
- Our guidance for registered pharmacies providing pharmacy services at a distance, including on the internet, explains what pharmacy owners should consider before deciding whether any parts of their pharmacy service can be provided safely and effectively at a distance (including on the internet).
Additional resources
- An investigation report by HSSIB: Potential under-recognised risk of harm from the use of propranolol, explores the under recognised toxicity of propranolol in overdose.
See the HSSIB report - The annual report from the National Poisons Information Service (NPIS) is published as a statement of the activity, accountability and governance of the NPIS during the reporting year. In the 2022 to 2023 report, propranolol is covered as an area of interest.
See the NPIS report - See the British National Formulary Propranolol monograph
- The NHS website provides patient information on propranolol
- The Toxbase database is an online poisons information database providing clinical toxicology advice to healthcare professionals.
Go to Toxbase - NHS Improvement Scotland: pharmacological management of migraine
- NHS inform: beta blockers
- SIGN (Scottish Intercollegiate Guidelines Network): pharmacological management of migraine
Further guidance from the National for Health and Clinical Excellence (NICE)
- Headache in over 12s: diagnosis and management
- Generalised anxiety disorder and panic disorder in adults: management