Key causes of anti-infective medication error claims:

• Failure to check allergy status.
• Failure to cross-check the ingredients of a medication against allergy status.
• Failure to adjust dose of medication to the patient’s weight.
• Failure to adjust dose of medication according to renal function.  

What can you do?

• When prescribing antibiotics, refer to the British National Formulary (BNF) for guidance on adjusting dosages according to patient weight, kidney function and the frequency of monitoring.
• Refer to the traffc light system for antibiotics and penicillin allergy.
• Ensure that the weight of a patient is regularly checked and adjust drug doses accordingly. • Check the allergy status of the patient at each point of the medication process.
• Review local guidelines to ensure they incorporate national guidance and support clinicians to prescribe, administer and monitor the effects of anti-infectives appropriately. Examples of relevant national guidance include NICE quality standards on on antimicrobial stewardship and sepsis.
• Access the NICE guidelines on acute kidney injury to fnd information and advice on the prevention, detection, and management of acute kidney injury.
• Review your organisation’s claims history regarding medication errors and ensure that learning is shared with clinicians.  

Medication errors in the NHS

Question: To ask the Secretary of State for Health and Social Care, how many incidences of medication error have been reported since 2017.

Answer: From 2017 to 7 June 2022, 1,309,128 medication-related incidents have been reported to the National Reporting and Learning System (NRLS). Patient safety events which occur in healthcare, including incidences of medication error, are voluntarily reported by health and care staff through the NRLS and its successor, the national Learn from Patient Safety Events (LFPSE) service. The LFPSE service is also managed by NHS England and is currently being deployed.

Information is analysed to allow effective learning from events and advance patient safety. NHS England reviews emerging patient safety risks and can take action where it finds cases of preventable harm, such as issuing National Patient Safety Alerts to the health system through the Central Alerting System.[1]

Implementation of the WHO Medication Without Harm initiative

Question: To ask the Secretary of State for Health and Social Care, what recent assessment he has made of the progress that has been made towards the World Health Organization’s global initiative to reduce severe, avoidable medication-associated harm in all countries by 50 per cent by 2022.

Answer: The World Health Organization has recognised that no signatory of its third global challenge has identified a method for monitoring all severe avoidable medicines associated harm incidents over time. Research commissioned by the Department in 2018 estimated 237 million medication errors per year in England, of which 28% were potentially clinically significant. Further research supports the approach adopted in England of targeting national programmes and processes known to contribute to severe avoidable harm. This includes the implementation of Electronic Prescribing and Medicines Administration in acute hospitals.

Through the National Patient Safety Alerts system, NHS England monitors organisations’ declarations that specified risk management actions have been undertaken in response to alerts. NHS England routinely monitors medicines safety improvement activity, including the delivery of the community pharmacy Discharge Medicines Service, which can prevent up to 10% of hospital readmissions and structured medication reviews in general practice to reduce over and under-dosing of high-risk medication. While it is voluntary, reporting through the National Reporting and Learning System and its successor, the Learn from Patient Safety Events Service, has increased which provides data on such incidents and can identify learning and reduce risks.[2]

References

1. House of Commons, NHS: Negligence – Question for Department of Health and Social Care, UIN 15784, tabled on 10 June 2022.
2. House of Commons, Medical Treatments: Safety – Question for Department of Health and Social Care, UIN 15785, tabled on 10 June 2022.

A recent investigation report published by HSIB intends to improve patient safety in relation to the use of oral morphine sulfate solution (a strong pain-relieving medication taken by mouth).[1]

The investigation focused on the case of Len, who took an accidental overdose of morphine sulfate oral solution. He had previously been diagnosed with Charcot-Marie-Tooth disease, a progressive disease that affects the nervous system, and had been prescribed morphine sulfate by his GP for persistent symptoms of breathlessness and pain following a fall.

Len was prescribed morphine sulfate, which has a concentration of 10mg in 5ml, at a dose of 1.25ml to 2.5ml, to be taken up to every four hours when required. His Wife collected his prescription from the pharmacy and subsequently Len took three doses of 5ml (two to four times the suggested dose) over the course of a day.

The next morning, he was taken by ambulance to the local emergency department due to breathing difficulties, thought to be caused by a suspected accidental overdose of morphine, pneumonia and worsening of his Charcot-Marie-Tooth disease. He initially recovered after receiving treatment, but sadly died a short time later. After his death, when the family asked about why he had been prescribed such a high dosage, it was discovered that that Len and his Wife had not seen the dispensing label on the outer packaging which advised that he should take a dose of 1.25ml to 2.5ml.

Findings of the investigation

HSIB’s investigation found that the decision-making process that resulted in Len being prescribed morphine sulfate oral solution had followed national guidance. However, when it came to the prescription of morphine sulfate:

• The dosage guidance label was on the outer box that contained the morphine sulfate bottle, not on the bottle itself. This label was not seen by Len or his Wife.
• Len and his Wife read the manufacturers text on the morphine bottle, which showed the strength of the liquid (5ml), which they mistook for the required dose (which is actually 1.25ml to 2.5ml).
• The morphine sulfate bottle came with a measurement aid, a 5ml syringe. With this measure being the same as the strength of the liquid shown on the bottle, this confirmed in the minds of Len and his Wife that the dose was 5ml.

Key patient safety concerns

Patient Safety Learning welcomes the publication of this HSIB report, and the patient safety issues that it highlights. We publish all HSIB reports on the hub, our learning platform for patient safety.

In this report we believe there are several patient safety issues that require further consideration, with action needed to prevent incidents of avoidable harm such as this reoccurring in future.

Labelling and measurement aids

The report highlights significant patient safety concerns relating to the packaging of morphine sulfate and the measurement aid it was dispensed with in Len's case.

Firstly, considering the packaging, the dosage information was contained on a small label on the outer box, but not on the oral solution bottle itself. This appears to have created an error trap for patients, with an assumption that they will read both the box label and the bottle label when looking for dosage information, and that they will understand from these what the correct dosage is and act accordingly.

Secondly, there are issues with measurement aids, in this case a 5ml oral syringe that came with the morphine sulfate. The investigation notes that this measurement is in line with the standard dose for an adult (10mg at 5ml) and older person (5mg at 2.5ml). However, due to Len’s health condition, he was prescribed a smaller dose, 1.25ml to 2.5ml. The report states that it was not possible to accurately measure this dose with the syringe provided.

Responding to these issues, HSIB made the following safety observation:

“It may be beneficial if manufacturers of morphine oral solution 10mg in 5ml ensure that any dose measurement aid, if supplied with the medication, is able to measure a full range of possible doses.”

We agree with the intent of this observation, but are concerned that this measure alone will not prevent a similar incident occurring in future. The issue with the morphine sulfate labelling differing on the box and bottle is not addressed by this or any other observation or recommendation. Furthermore, regarding manufacturers making changes to the measurement aid, our concern is that there is no assurance that HSIB’s observation will be acted on.

As noted in our report Mind the implementation gap: The persistence of avoidable harm in the NHS, there appears to be no formal framework on a national level to review and act on HSIB’s safety observations.[2] While the steps outlined in this safety observation for manufacturers are desirable, in practice there is no system to implement or monitor this.

Failure by the community pharmacy to participate in the investigation

A crucial point of concern in this case pertains to what information and advice was provided when morphine sulfate was prescribed and dispensed to Len. Understanding this process could be vital in preventing similar incidents occurring in future.

We are dismayed to read that HSIB found that a key organisation involved in this process, the community pharmacy, declined to participate in the investigation. Their report states:

“The investigation tried to engage with the pharmacy on a number of occasions by email, telephone, and recorded post. The investigation also spoke with local commissioners and NHS England and NHS Improvement national pharmacy teams to identify whether any further support could be offered to assist in engaging with the pharmacy. Despite this, the investigation was unable to obtain engagement from the pharmacy and so was unable to complete investigation work that may have assisted in fully considering the patient safety risks presented in Len’s care.”

We consider this to be both a puzzling and unacceptable response by the pharmacy, demonstrating a frankly shocking degree of disregard towards the family affected by this tragic case. Defensive and closed approaches to patient safety investigations severely limit our ability to learn from patient safety incidents, resulting in the continuation of avoidable harm and unnecessary loss of life.

This lack of cooperation underlines the importance of HSIB receiving new powers to compel witnesses to give evidence by law, and for organisations to provide access to materials, equipment and records that it considers necessary for an investigation. The Health and Care Bill currently passing through parliament would provide them with these powers, as part of plans to convert the regulator into a new statutory organisation, the Health Service Safety Investigations Body.[3]

In response to the failure of the community pharmacy to engage with the investigation, HSIB made the following safety observation:

“It may be beneficial if professional bodies provided guidance and further support to their members to maximise the learning that can be achieved from safety investigations that may improve patient care.”

We believe there is a need for a stronger and more specific action in response to this. Professional bodies and regulators, such as the Royal Pharmaceutical Society and General Pharmaceutical Council, make it clear that defensive and closed cultures in organisations are not acceptable.[4] [5] We consider that such behaviours must be identified and addressed.

Yellow Card scheme

In our recent Mind the implementation gap report, one of the areas where we identified a significant gap between what we know about patient safety and what is done in practice was incident reporting.[2] When discussing this we specifically mentioned the Medicines and Healthcare products Regulatory Agency (MHRA) Yellow Card scheme. This is a system for voluntary reporting of safety issues concerning medicines and medical devices by the public and healthcare professionals.

HSIB noted the following regarding the Yellow Card scheme in this case:

“The investigation was told by the Trust that a Yellow Card report should have been submitted in Len’s case. However, it had not happened. The investigation was told that when staff were under great pressure Yellow Card reports did not always get submitted and that side effects related to respiratory issues from morphine sulfate were already recognised.”

The shortcomings of the Yellow Card scheme in effectively identifying medication safety issues have been well documented, particularly by the Independent Medicines and Medical Devices Safety (IMMDS) Review published in 2020.[6] In light of this, the Government and MHRA have committed to take steps to improve the scheme.

This case illustrates the one of the challenges of ensuring that the Yellow Card scheme is used effectively and that the importance of routinely recording and reporting these types of incidents is embedded throughout the healthcare system. This is an area where we feel an additional safety recommendation could have been added to this report. 

Patient engagement

Patient engagement is key to improving patient safety. In our report, A Blueprint for Action, we identify this as one of the six foundations of safe care.[7] We believe that patients should be engaged for safety at the point of care, if things go wrong, in improving services, in advocating for changes and in holding the system to account.

In this case, gaps in information hinder our understanding of how Len and his Wife were communicated with during the prescription of morphine sulfate. HSIB stated that they were unable interview the GP, therefore the only information on this was taken from Len’s medical notes. It is not known what advice was given on how to take the morphine sulfate. Due to the lack of cooperation by the community pharmacy, there is also an information gap about what dispensing advice was given.

The report does note another factor that may have impacted on the communication of advice on the dosage, stating:

“Len’s Wife was recovering from surgery on her ears for an existing hearing problem and had some known memory problems. When taken together with the passage of time since she collected the prescription, the investigation cannot be certain whether any advice given could have been heard, and if it was heard, whether Len’s Wife now remembers it.”

Patients and carers need to be assured that medication prescription processes involve clear communication and account for any barriers to this. Unsafe medication practices and medication errors are a leading cause of avoidable harm and are the focus of this year’s forthcoming World Patient Safety Day in September.[8] There is a wealth of existing research and good practice on this, including the World Health Organization’s 5 Moments for Medication Safety campaign, which highlights to patients and carers the key moments where action by the healthcare professional, patient or carer can greatly reduce the risk of harm associated with the use of medications.[9]

With significant gaps in information, it is difficult to make any firm recommendations stemming from this specific case, however this case does point towards wider work that is needed to improve medication safety.

Safety concerns about liquid morphine

Patient safety concerns relating to the risk of unintentional overdose involving liquid morphine have also been raised more widely, beyond this case. Research published in The Pharmaceutical Journal last year revealed that liquid morphine has contributed to the cause of death in Coroner’s Prevention of Future of Deaths reports in the cases of at least three men and ten women since 2013.[10] In three of these cases, the coroner’s recommendations appealed for healthcare bodies and government departments to put in place additional restrictions on the prescription of morphine sulfate. This research highlighted some themes in common with the HSIB investigation around unintentional overdoses and questions around the guidance provided when this was being prescribed.[11]

Concerns about patient safety incidents associated with morphine sulfate have also been raised previously in Controlled Drugs Newsletters in the NHS in the North Midlands and South West Midlands in 2016.[12] [13] They have also been raised more recently in a Care Quality Commission Controlled Drugs Newsletter, published in April 2021, which stated that there “is significant under-reporting of incidents with this medicine to Controlled Drugs Accountable Officers.”[14]

We believe that may be a need for a further investigation of this patient safety issue by NHS England and NHS Improvement.

References

1. HSIB, Unintentional overdose of morphine sulfate oral solution, 28 April 2022
2. Patient Safety Learning, Mind the implementation gap: The persistence of avoidable harm in the NHS, 7 April 2022
3. Department of Health and Social Care, Health and Care Bill: Health Services Safety Investigations Body, Last Updated 10 March 2022
4. Royal Pharmaceutical Society, Professional standards for the reporting, learning, sharing, taking action and review of incidents, November 2016
5. General Pharmaceutical Council, Standards for registered pharmacies, Revised June 2018
6. The Independent Medicines and Medical Devices Safety Review, First Do No Harm, 8 July 2020
7. Patient Safety Learning, The Patient-Safe Future: A Blueprint For Action, 2019
8. World Health Organization, World Patient Safety Day 2022, Last Accessed 27 April 2022
9. World Health Organization, 5 moments for medication safety, 1 July 2019
10. Carolyn Wickware, Government fails to respond to calls for tighter controls after liquid morphine deaths, The Pharmaceutical Journal, 2 September 2021
11. Carolyne Wickware, Investigation: should liquid morphine be reclassified?, 2 September 2021
12. NHS England, North Midlands Controlled Drugs Newsletter, December 2016
13. NHS England, Controlled Drugs Newsletter: Sharing Good Practice in the South West, August 2016
14. Care Quality Commission, CQC’s Controlled Drugs National Group Newsletter, 10 April 2021

1. France Duvivier, Vice President of the Belgian Oncology Pharmacist Practitioners (BOPP) presented the results of a survey of Belgian pharmacists conducted in 2020
2. Daniel Schuermans, Vice President of the Belgian Association of Nurses spoke about the changes to the European Directive 2004/37/EC on the protection of workers against the risks related to exposure to carcinogens or mutagens at work and what this looks like in practice in Belgium
3. Ian Lindsley, Secretary of the European Biosafety Network, gave a presentation outlining the changes in the Carcinogens, Mutagens and Reprotoxic substances Directive (CMRD), the work of ANSES in France on a list of HMPs and the development and publication of new EU guidelines on handling HMPs
4. Eline Versheure, Medical Faculty at KU Leuven, provided an overview of the unintended exposure to antineoplastic agents in a Belgian context
5. Marijke Quaghebeur, Clinical Nurse Specialist at UZ Gent, gave a presentation on the root location of contamination spread

To conclude the roundtable, the chair took attendees through the recommendations made in the recently published EBN consensus document, which focused on:

• Training and learning
• Prevention and PPE
• Aftercare
• Medical control
• Guidelines
• Department of employment

• Patient engagement tool: “5 Moments for Medication Safety”, Nagwa Metwally and Helen Haskell
• Patients, families and health workers partnering for medication safety, Dr Irina Papieva
• Developing programmes for patient and family engagement - Canadian experience, Ioana Popescu and Maryann Murray

View presentations from the first webinar in the series.