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21st June 2024
Escalating workforce shortages are causing ‘growing delays’ in cancer diagnosis and treatment in the UK that are ‘putting patients’ lives at risk’, according to two new reports published by the Royal College of Radiologists (RCR).
Based on 100% response-rate surveys of cancer centre heads and clinical directors of radiology departments, the RCR 2023 clinical radiology and clinical oncology workforce census reports reveal dangerous shortages of doctors essential in the diagnosis and treatment of cancer, and other conditions including stroke.
The data showed patients in half (47%) of cancer centres faced weekly delays to start systemic anti-cancer therapy (SACT), an increase from 28% the previous year. The RCR said the situation is ‘similarly dire’ for radiotherapy, with weekly treatment delays nearly doubling from 22% in 2022 to 43% in 2023.
More than eight in 10 cancer leaders (85%) expressed concern that workforce shortages that contributed to the treatment delays were impacting patient safety.
Released at the same time, a report from Cancer Research UK found that 382,000 cancer patients in England were not treated on time since 2015. The charity warned that only 66.6% of people in England received their diagnosis and started their first treatment within two months of an urgent referral in April 2024, with the 85% target having not been met since December 2015.
The RCR said the results of it 2023 clinical radiology workforce census report reveal a 30% shortfall of clinical radiology consultants (1,962 doctors) and stressed that ‘without further action this shortfall is forecasted to increase to 40% (3,670 doctors) by 2028’.
The RCR report also showed almost all (97%) of the radiology leaders it surveyed saying that workforce shortages caused delays and backlogs.
Noting that the demand for SACT, including chemotherapy, surged by 6-8% in 2023, while the consultant workforce expanded by only 3.5%, the RCR said this ‘glaring imbalance has created a crisis where demand vastly outstrips the capacity of the cancer workforce’.
Similarly, while the clinical radiology workforce grew by 6% in 2023, demand for CT and MRI reporting surged by 11%. As a result, the data showed nearly three quarters of a million patients (745,290) in England waited over four weeks to receive the result of their imaging test following the scan.
Dr Katharine Halliday, president of the RCR, said: ‘[These] reports reveal a stark reality: the crisis in the radiology and oncology workforce is jeopardising patients’ health.
‘Despite our dedication to providing the best possible care, severe workforce shortages are significantly hindering our efforts. We simply do not have enough doctors to manage the increasing number of patients safely, and this problem will only worsen as demand continues to rise and more doctors leave the NHS. The immense strain on an overburdened system, coupled with exhausted staff and increasing demand, creates a toxic cocktail for our NHS.’
Indeed, according to the RCR, every service leader reported concerns that workforce shortages were impacting staff morale and burnout, which is having ‘a clear impact with earlier retirement’ – the average age that clinical oncologists left the workforce in 2023 was just 54, compared to 57 in 2022.
The survey also showed inequities in access to cancer specialists persists across the country, with rural areas disproportionately affected, and the RCR warned that ‘disparities in workforce distribution exacerbate these inequalities, leaving some regions with significantly fewer doctors per patient’.
For example, according to the data, the West Midlands has only 4.9 clinical oncologists per 100,000 population aged 50 plus, while London has almost three times that number in its workforce at 11. The RCR said this ‘introduces clear inequalities whereby people living in certain regions are likely to receive results of their imaging test or start cancer treatment more quickly than those in other regions’.
The RCR warned that despite advancements in cancer treatments, workforce shortages are impeding delivery, depriving patients of potentially life-saving therapies’, adding that ‘any delay is critical for cancer patients, as every month delay in cancer treatment raises the risk of death by around 10%.’
The survey results have led the RCR to issue an urgent call to action to the next Government to address what it calls ‘the dire state of cancer care in the UK due to escalating workforce shortages’.
In a statement, the RCR said: ‘Despite being one year into the Government’s NHS workforce plan, the reports highlight a critical failure to address the worsening workforce crisis. Insufficient training and retention efforts have exacerbated shortages, leaving hospitals struggling to meet patient demand. This is one of the most pressing challenges the new Government must address, and it is imperative that they get it right.’
The RCR said it has written to major political party leaders warning that, without immediate intervention, the UK risks undoing decades of progress in cancer care.
The Royal College is demanding ‘urgent investment in workforce development to ensure patients aren’t left waiting for a diagnosis and can begin lifesaving treatment as soon as possible’, and said it is calling on the next Government to work with the NHS ‘to spell out how they intend to recruit, train and retain clinical oncologists and radiologists ensuring the stability and strength of the workforce for future generations’.
Commenting on these demands, Dr Halliday said: ‘Action from the new Government is essential. Time is critical. Doctors are working under extreme stress and are deeply concerned for their patients.
‘We urge the new Government to heed the advice of doctors and implement a forward-thinking strategy to recruit, train and retain staff. Only this approach can help reset the system, safeguard the NHS, and guarantee patients receive the quality care they deserve.’
Cancer charities have also added their voice to the call to action for the next Government to improve workforce issues and safeguard patient care.
Cancer Research UK’s chief executive Michelle Mitchell said: ‘These reports demonstrate that worsening shortages of radiologists and oncologists are directly impacting cancer patients, with some facing worrying delays in receiving vital treatment.
‘Cancer services are struggling to see people as quickly as they should, and the last time all cancer wait time targets were met in England was as far back as 2015. Demand will increase too. By 2040, there are projected to be around half a million cancer cases a year across the UK.’
She added: ‘To address these issues it is imperative that all political parties commit to making this general election a turning point for cancer. Post-election, any UK Government must invest in the staff and equipment that are desperately needed to ensure patients have access to the best cancer care. Cancer patients expect nothing less.’
Mairaid McMahon, policy manager at Macmillan Cancer Support, said: ‘The incoming Government needs to do more to address recruitment and retention, not just in generalist roles, but also specialist roles that are key to cancer treatment. We need to see targeted funding to increase the size of the cancer workforce, ensuring that everyone receives the timely and quality care they critically need.’
In January 2024, a census report from the Royal College of Surgeons of England also highlighted workforce challenges, treatment delays and staff burnout.
This was followed by the latest NHS Staff Survey results in March, which shows that while the NHS workforce appears to be recovering from the impact of the Covid-19 pandemic, there are still issues around workforce shortages, mounting pressures and widespread dissatisfaction with pay.
13th June 2024
Standard concentration infusions (SCIs) and ‘smart-pumps’ are recognised as best practice for delivering high-risk medications in the paediatric setting. Implementation is complex, requiring multi-stakeholder involvement – a factor leading to delays in implementation into European hospitals. Children’s Health Ireland (CHI) developed a smart-pump drug library of SCIs and led a project to expand its use across acute paediatric and neonatal settings in Ireland. Here, Dr Moninne Howlett PhD, chief pharmacy information officer at CHI, shares how this project came together.
Critically ill paediatric patients routinely require the delivery of high-risk medications via infusion pumps. Key medication error prevention strategies include the replacement of traditional individualised weight-based infusions with standard concentration infusions (SCIs), and the use of computerised infusion devices known as smart-pumps.1,2
Using customised drug libraries, pre-set dose limits and dose calculations based on programmed patient weights, smart-pumps can be highly effective in reducing serious and occasionally fatal medication errors.3 Before initiation of our project, weight-based infusions and traditional pumps were used in all paediatric and neonatal intensive care units in Ireland.
In 2012, a smart-pump drug library of paediatric SCIs was developed and implemented into Ireland’s largest paediatric intensive care unit (PICU) in CHI at Crumlin and its operating theatres. This initiative was in response to substantial evidence on the inaccuracies and risks associated with individualised weight-based infusion preparations4–7 and aligned with recommendations from safety bodies including the Institute for Safe Medication Practices.2,8
At the time of initial drug library development, the use of traditional infusion pumps and weight-based infusions – requiring complex calculations during prescribing, preparation and administration of paediatric infusions – was still common in many European hospitals.9,10
A key consideration during initial development, and subsequently during its iterative expansion, was safety and usability across the full spectrum of the paediatric patient population. Within individual wards, and even in adjacent beds, patient weights can range from <1 kg to >100 kg.
The CHI drug library has, from the outset, been designed by specialist paediatric pharmacists, with multidisciplinary input, to mitigate against the particular risks associated with this complex patient cohort.
The use of a range of weight bands, care areas and judicious setting of concentrations, safety limits and naming conventions allowed the original library (four weight bands and 42 drug lines) to be extended to continuous and intermittent infusions for more than 250 medications, presented within five weight bands and four care areas.
This level of drug library development also highlights the expanding role of the hospital pharmacist and evolution of pharmacy informatics as a specialist field.
Having invested a significant amount of time and expertise in this endeavour, CHI sought to distribute the output as widely as possible throughout acute neonatal and paediatric services. Initial efforts focussed on the other PICU and theatres within CHI’s second large tertiary paediatric hospital, in addition to paediatric transport services, which are run out of the two CHI PICUs.
Simultaneously, through a multidisciplinary collaboration with neonatal ICU (NICU) specialist pharmacists, nurses and doctors, a neonatal-specific sub-library was developed to support the specific needs of infants in NICU and the neonatal transport services.
This component of the project received endorsement from Ireland’s National Clinical Programme for Paediatrics and Neonatology. Key factors leading to this national health service level support were the high volume of movement of sick infants and children across services and access to evidence derived from research undertaken in the originator site.
This research identified a reduction in prescribing error rates from 27.5% to 5.1% on implementation of SCIs and smart-pumps, drug library compliance of 98.9% and with high levels of user satisfaction.11,12
Following the success of these early phases of expansion, achieved between 2014 and 2019, the use of smart-pumps and the SCI drug library was extended to the emergency departments and urgent care centres in the CHI hospitals, subsequently followed by their general wards.
This latter phase occurred during the Covid-19 pandemic, by which time a CHI-funded dedicated smart-pump team was in place, consisting of 1.5 whole time equivalent (WTE) nurses and a 0.5 WTE pharmacist. This team developed and co-ordinated a highly structured nurse training programme involving a two-stage training process.
This training model, used within CHI and external hospitals, utilises a train-the-trainer component and incorporates infusion pump training, followed by drug library training, including SCI preparation and competency self-assessment. Amended training sessions are offered to nursing students, pharmacy and medical staff.
Subsequent phases of the project included expansion to the care of children across Ireland’s paediatric network of 19 hospitals and within adult ICUs. This required revision of existing governance structures, ultimately leading to formal recognition and approval of the CHI drug library as a national standard of care by Ireland’s Health Service Executive; operational control remains with CHI.
The absence of a defined national governance structure to support such a concrete operational level intervention was one of the more difficult elements of the project and necessitated an innovative and iterative approach to governance.
Another key challenge was the lack of centralised funding or allocated budgeting. This challenge persists with responsibility for financing infusion pump hardware remaining with individual sites.
Differences between individual hospitals in aspects such as access to dedicated paediatric and/or neonatal nursing staff and location of care for infants and children within non-specialist paediatric hospitals are further challenges.
Furthermore, patients journey within and between sites depending on their needs, transitioning to and from centres of greater or lesser specialisation and scale according to the nature and stage of their illness and the proximity of these facilities to their homes. This can significantly impact and complicate the choice of drug library, pump management and delivery of training.
Despite these difficulties, this project continues to successfully improve patient safety and support clinicians in the delivery of highly complex, challenging and often urgent delivery of what can be life-saving medication infusions.
To date, implementation has occurred in all areas of CHI, all level-3 NICUs, paediatric and neonatal transport services, 58% of Ireland’s 19 neonatal units, and 23% of paediatric network sites.
The success of this project, recently published in the International Journal of Clinical Pharmacy,13 has been recognised not only in Ireland but also referenced internationally by other regions looking to achieve standardisation of paediatric infusions.14–16
A key benefit of progressing the standardisation of infusion processes at a national level is the opportunity it provides to move away from nurse-prepared infusions at the bedside to centralised preparation by hospital pharmacies or commercially prepared ready-to-administer infusions.1
Specialist hospital pharmacists, working effectively within multi-disciplinary teams, can effectively lead on the delivery of standardisation of infusions at a national level.
This multi-phase project has successfully developed a smart-pump drug library of standard concentration infusions suitable for paediatric and neonatal patients across the Irish acute hospital sector.
In a constrained public health service with limited pharmacy and other specialist resources, collaboration and innovative governance structures have enabled wide-scale implementation of internationally recognised best practices for the safe administration of IV medications in paediatrics.
Dr Moninne Howlett BSc (Pharm) PhD
Chief pharmacy information officer, Children’s Health Ireland, and honorary clinical associate professor, Royal College of Surgeons in Ireland
Dr Howlett would like to thank her fellow study authors:
Sharon Sutton MPharm MPSI
Senior pharmacist, Children’s Health Ireland
Eimear McGrath RGN RCN
Clinical nurse education facilitator, Children’s Health Ireland
Cormac V. Breatnach MRCPI, FJFICMI
Consultant paediatric intensivist, Children’s Health Ireland
1. Neonatal Paediatric Pharmacists Group. Standardising intravenous infusion concentrations in children in the UK 2023.
2. American Society of Health-System Pharmacists. Standardize 4 Safety Initiative – Pediatric Continuous Infusion Standards 2020.
3. Institute for Safe Medication Practices. ISMP Targeted Medication Safety Best Practices for Hospitals 2024.
4. McLeroy PA. The rule of six: calculating intravenous infusions in a pediatric crisis situation. Hosp Pharm 1994;29(10):939–40, 43.
5. Parshuram CS et al. Systematic evaluation of errors occurring during the preparation of intravenous medication. CMAJ 2008;178(1):42–8.
6. Parshuram CS et al. Discrepancies between ordered and delivered concentrations of opiate infusions in critical care. Crit Care Med 2003;31(10):2483–7.
7. Aguado-Lorenzo V et al. Accuracy of the concentration of morphine infusions prepared for patients in a neonatal intensive care unit. Arch Dis Child 2013;98(12):975–9.
8. Institute for Safe Medication Practices. 2018-2019 Targeted Medication Safety Best Practices for Hospitals 2018.
9. Campino A et al. Medicine preparation errors in ten Spanish neonatal intensive care units. Eur J Pediatr 2016;175(2):203–10.
10. Oskarsdottir T et al. A national scoping survey of standard infusions in paediatric and neonatal intensive care units in the United Kingdom. J Pharm Pharmacol 2018;70(10):1324–31.
11. Howlett MM et al. The Impact of Technology on Prescribing Errors in Pediatric Intensive Care: A Before and After Study. Appl Clin Inform 2020;11(2):323–35.
12. Howlett MM et al. Direct Observational Study of Interfaced Smart-Pumps in Pediatric Intensive Care. Appl Clin Inform 2020;11(4):659–70.
13. Howlett MM et al. Implementation of a national system for best practice delivery of paediatric infusions. Int J Clin Pharm 2024;46(1):4–13.
14. Crowley K. Standard Drug Concentrations in the Cardiac Intensive Care Unit. In: Critical Care of Children with Heart Disease (eds Munoz R et al) 2020;Springer:pp 725–8.
15. Sutherland A et al. Developing Strategic Recommendations for Implementing Smart Pumps in Advanced Healthcare Systems to Improve Intravenous Medication Safety. Drug Saf 2022;45(8):881–9.
16. Howlett M. Reducing medication errors for children. Health Manager [Internet]; Nov 2016.
2nd April 2024
The MPS Foundation is inviting healthcare professionals to register their interest and submit proposals for research grants focusing on patient safety and the wellbeing of healthcare professionals and teams, both medical and dental.
Applications for the grants – which are worth £5,000 to £200,000, or equivalent in local currency, depending on the scale, focus and duration of the proposal – are open to both Medical Protection Society members and non-members from countries including the UK and Ireland.
To be eligible, the research projects must be academically robust, evidence-based and address the MPS Foundation’s key research priorities, including:
Dr Graham Stokes, MPS Foundation chair, said: ‘We are delighted to launch our third grant programme to support research projects on patient safety and the wellbeing of healthcare professionals. Funding for research in this area has been limited but our grant programmes have been changing that. Projects that we have supported in previous years have shown great success in promoting best practise and wellbeing across several countries.‘
He added: ‘Our aim is simple: to fund research that improves safety for patients and the wellbeing of healthcare teams.
‘If you have a research project that you think is suitable, register your interest and join our growing community of grant recipients. I strongly encourage healthcare professionals to consider applying for support whatever the scale of the proposal and to make the most of the additional resources available to support applicants this year.’
Applicants can register interest for the grants and apply via the MPS Foundation online grant portal, which also includes a guide for applicants, frequently asked questions and tips on creating a good application.
Calls for expressions of interest are open until 5pm BST on 3 May 2024.
Projects awarded MPS Foundation funding in 2023 included a study aimed at improving safety in gastrointestinal endoscopy, research examining the effects of patient suicide on clinicians, and a project to better understand the role patients’ relatives play in ICU decisions and how the Mental Capacity Act can lead to better outcomes for patients, families and healthcare professionals.
The MPS Foundation is part of the Medical Protection Society – an organisation that aims to protect and support the professional interests of more than 300,000 doctors, dentists and healthcare professionals across the UK, Ireland, South Africa, New Zealand, Australia, Hong Kong, Singapore, Malaysia, the Caribbean and Bermuda.
16th February 2024
Current controls are unable to prevent all patient misidentification and a proactive approach should be adopted to support staff in safety management, according to a new report by the Health Services Safety Investigations Body (HSSIB).
Its ‘Positive patient identification’ report states that patient misidentification is an under-recognised, under-researched and persistent safety risk that can result in significant harm.
The report is therefore aimed at supporting national learning and influencing action across England to reduce the risk of patient misidentification.
And it offers a series of safety interventions for healthcare organisations and policy makers to consider when updating safety processes.
The report analysed evidence from six completed Healthcare Safety Investigation Branch (HSIB) investigations alongside research literature and national policy documents.
These misidentification investigations included a patient who received an invasive procedure not meant for them, a patient who bled after receiving anticoagulation medication not meant for them and a patient who did not undergo a resuscitation attempt because it was thought he was a different patient.
‘HSIB investigations identified a complicated array of interacting factors in different healthcare systems that contribute to misidentifying patients,’ the report said.
Positive patient identification is complex and ‘relies on staff following instructions described in policies and procedures, which might not always be fully appropriate to the circumstances within which staff are identifying patients,’ it added.
Indeed, despite national direction to use the NHS number as the unique patient identifier, the report found that local policies varied in their descriptions of how patient identification should be undertaken. This included what identifiers should be used and the role of the NHS number.
The report concluded that current controls are unable to prevent all misidentifications, and the traditional reactive approach to safety management is ineffective.
The HSSIB recommends a move towards proactively understanding systems and assuring the safety of processes, as well as targeting opportunities to better support staff by improving working conditions.
‘It is not yet possible to eliminate the risk of patient misidentification. However, a series of interventions – including using new technologies and optimising workplaces – may help to reduce the risk,’ the report said.
Prioritising high-risk situations and settings, such as handovers and transfers of patient care, is an area that the HSSIB encourages healthcare organisations particularly focus on to improve patient safety.
And it also championed the effective use of technology such as electronic patient records, electronic prescribing and administration systems, and barcode and QR code scanning, but warned that currently ‘it is not clear which technology is most effective at controlling the risk in different settings’.
As part of its report, HSSIB recommended that ‘NHS England reviews and identifies system-wide requirements for scanning in positive patient identification. This is to support local organisations to use scanning technology to reduce misidentification incidents’.
Commenting on the report, Nick Woodier, senior safety investigator at the Health Services Safety Investigations Body, said: ‘The six HSIB investigations considered misidentification across different areas of NHS care – from outpatient procedures and emergency departments to ambulance services and care homes.
‘The evidence we have collected aligns with research literature and data from national incident databases and emphasises that despite national improvement efforts, misidentification remains a persistent safety risk.
‘Our report offers insight into where effective solutions could be implemented but we recognise that there is difficulty in allocating resources when healthcare organisations tell us that the scale of the problem is not known.’
He added: ‘Our safety recommendations and findings are aimed at influencing national action to better understand the risk and consider how resources can be allocated to drive improvement across England.’
4th October 2023
The ‘cumulative’ impact of doctor strikes is now causing ‘significant disruption’ and risk to patient safety, NHS England has told the British Medical Association (BMA) in a formal warning letter.
However the BMA argued that patient safety is being put at risk due to strike planning failures by NHS England.
Following months of walkouts, consultants and junior doctors are jointly striking for three full days this week, with ‘Christmas Day’-level cover.
NHS England noted doctors are taking ‘lawful industrial action in line with their respective mandates’, but added that it is ‘increasingly concerned that the cumulative impact of this action is causing significant disruption and risk to patients’.
It said: ‘In writing to you, we recognise the stated aim of the BMA to protect urgent and emergency care during industrial action and to maintain patient safety.’
NHS England is ‘extremely concerned’ that Christmas Day cover is ‘insufficient’ to ensure appropriate levels of patient safety are being maintained.
‘This is particularly the case in the current period of industrial action, with three consecutive Christmas Day levels of service.
‘The reasons for this are two-fold: we are not experiencing Christmas Day levels of pressure, when demand falls by around a third, nor are we seeing the drop in bed occupancy levels that occurs immediately prior to Christmas.
‘In addition, successive days of Christmas Day cover are significantly impacting on the ability of systems to maintain flow throughout our emergency pathways, which in turn is resulting in delayed ambulance handovers, deteriorating ambulance response times and long waits for patients in Emergency Departments.’
The letter, signed by workforce chief Dr Navina Evans and national medical director Professor Sir Stephen Powis and others, noted these issues were already raised in regular industrial action operational meetings.
But, it added: ’However, in light of our responsibility to support the NHS and maintain patient safety we feel it is important these concerns are also now raised formally.’
Responding, BMA council chair Professor Phil Banfield said: ‘We have always been open to discussing ways in which together we can maintain patient safety during industrial action, and we communicated this directly to colleagues at NHS England, most recently in a meeting just yesterday.’
He also detailed several ‘planning failures’ including that some NHS trusts ‘had not appropriately rescheduled’ non-urgent elective activity in the days leading up to strikes which has directly impacted the ability to prioritise more urgent care needs, according to the union.
He added: ‘I do not agree that the Christmas and Boxing Day model of industrial action is unsafe or that it is the reason for the issues you have detailed in your letter.
‘This model only applies to consultants and junior doctors eligible to strike. Consequently, actual staffing is higher than Christmas and Boxing Day, given SAS doctors, various non-striking consultant and junior doctors, as well as allied health professionals continue to work as normal.
‘Instead, there is clear evidence of the failure by some trusts to adequately prepare for industrial action.
‘In particular the BMA is aware that some trusts have continued with significant amounts of elective activity during industrial action and have failed to reschedule non-urgent elective care in an attempt to meet political targets. This is causing unnecessary risk of harm.’
He added: ‘As you know, no further industrial action has been called, and it is now incumbent upon the Government to come to the table, drop their refusal to negotiate on pay and settle its dispute with doctors.’
Yesterday the BMA offered to involve reconciliation service ACAS in resolving the dispute over consultants’ pay.
This story was originally published by our sister publication Pulse.
Image credit: Anna Colivicchi.
14th September 2023
New measures recommending the avoidance of all medicines containing topiramate during pregnancy have been published by the European Medicines Agency‘s Pharmacovigilance Risk Assessment Committee (PRAC).
While it is well known that topiramate can cause major congenital malformations and foetal growth restriction if used during pregnancy, recent data also suggest a potential increased risk of neurodevelopmental disorders after exposure in the womb.
Topiramate-containing medicines are used for the treatment of epilepsy and the prevention of migraine, with some EU countries also using the drug in a fixed-dose combination with phentermine for weight reduction.
For patients using topiramate for the treatment of epilepsy, the latest PRAC recommendations state that the drug should not be used during pregnancy unless there is no other suitable treatment available. This builds on existing advice that topiramate is contraindicated during pregnancy when used for the prevention of migraine or for weight management.
Additional recommendations involve the establishment of a pregnancy prevention programme. This means that healthcare professionals should ensure any woman or girl who is able to have children has been made fully aware of and has understood the risks of taking topiramate during pregnancy, as well as the measures that must be taken.
This includes taking a pregnancy test before starting treatment and the need to avoid becoming pregnant during topiramate treatment by using effective birth control for the treatment duration and for at least four weeks after its cessation.
Alternative treatment options should be considered and the need for topiramate treatment should be reassessed at least annually using a risk awareness form.
The product information for topiramate-containing medicines will be updated to further highlight the risks and the measures to be taken and a visible warning added to the outer packaging of the medicines.
In addition, patients and healthcare professionals in Europe will be provided with educational materials regarding the risks of using topiramate during pregnancy, and a patient card will be provided to the patient with each medicine package.
In spring 2018, the UK’s Medicines and Healthcare products Regulatory Agency banned the use of valproate for epilepsy during pregnancy without a pregnancy prevention programme.
These recommendations from the PRAC were based on the findings from three recent observational studies. In the first, prenatal exposure to topiramate was associated with increased risk of neuro-developmental disorders. The second study showed prenatal topiramate was linked to a greater risk of attention deficit hyperactivity disorder.
The third demonstrated that topiramate use late in pregnancy was associated with twice the risk of neurodevelopmental diagnoses in children compared to unexposed pregnancies.
In its review, the PRAC confirmed the known increased risk of birth defects and reduced growth of the unborn child when mothers receive topiramate during pregnancy. It estimated that birth defects will occur in between four and nine out of every 100 children born to women who take the drug during pregnancy, compared with one to three out of every 100 children to women who do not take topiramate.
In further analysis, the PRAC estimates that 18 in every 100 children were smaller and weighed less than expected at birth to mothers taking topiramate compared to only five in every 100 children born to mothers without epilepsy and not taking anti-epileptic medication.
Also triggered by the first study outlined above, the UK’s Medicines and Healthcare products Regulatory Agency announced in July 2023 that it had started a safety review of topiramate in relation to the potential for neurodevelopmental disorders.
31st August 2023
A national patient safety alert has been issued in the UK over the risk of death from entrapment or falls relating to medical beds, with a call for all relevant staff to have appropriate training within the next 12 months.
In an alert issued on Wednesday 30 August, the Medicines and Healthcare products Regulatory Agency (MHRA) said it continues to receive reports of death and serious injuries relating to medical beds and trolleys.
Between 1 January 2018 and 31 December 2022, the MHRA received 18 reports of death and 54 reports of serious injuries related to medical beds, bed rails, trolleys, bariatric beds, lateral turning devices and bed grab handles.
The MHRA confirmed to Nursing in Practice that these incidents included medical beds used outside of a hospital setting.
And it said the ‘majority’ of the reported incidents were because of entrapment or falls.
Investigations into incidents that involved falls ‘often found the likely cause to be worn or broken parts, which should have been replaced during regular maintenance and servicing, but which were either not carried out or were carried out improperly’, the MHRA said in its alert.
Meanwhile, those incidents involving entrapment were due to factors including: a lack of risk assessment or risk assessments not being updated following a change in equipment or patient’s condition, a lack of maintenance and servicing, incompatibility issues and children and adults with ‘atypical anatomy using inappropriate equipment’.
As part of its patient safety alert, the MHRA outlined several actions to be taken by all those responsible for the use, purchase, prescription and maintenance of medical beds, including acute and community organisations, care homes, equipment providers, occupational therapists and early intervention teams, to begin and complete by March 2024.
One action called for role-specific training for staff that covered, where appropriate, the ‘risks and operation of these devices, the provision of training to carers/patients, reporting issues, servicing and maintenance and risk assessments’.
And it said that organisations should develop a plan for all staff to be appropriately trained within the next 12 months.
Other actions asked providers to review their medical device management systems, to implement maintenance and servicing schedules and to implement systems to update risk assessments.
Organisations were also urged to update their polices and procedures on procurement, provision, prescribing, servicing and maintenance of such devices in line with updated MHRA guidance.
In addition, it called for patients currently provided with bed rails or bed grab handles to be reviewed ‘to ensure there is a documented up-to-date risk assessment’.
Patients who are children or adults with atypical anatomy should be reviewed ‘as a priority’, it noted.
A version of this story was originally published by our sister publication Nursing in Practice.
28th July 2023
Medication errors when people go into or are discharged from hospital in England could be reduced by nearly 40% with the introduction of new digital information standards being rolled out this year, say researchers.
Analysis by a team at the University of Manchester found that medication errors would be cut from 1.8 million to 1.1 million (39%) by the easier sharing of information across hospital and GP systems.
They also calculated that there could be around 12,000 fewer people experiencing harm from their medicines, with 14,000 fewer days spent in hospital at a saving to the NHS of £6.6m.
But they stressed, there still needs to be a healthcare professional, usually a pharmacist, doing medicines reconciliation.
The standards, which first came into effect in October 2021 with NHS organisations having to show compliance by this year, should make that work easier and quicker so more patients can have their medicines checked properly, they added.
A report commissioned by NHS England looked at published research on medication errors in the UK as well as evidence from other countries where similar changes to digital information standards have been made.
Overall, they estimated that around 31,000 people experience harm from a transition medication error, with over half of these happening to mistakes made at hospital admission.
They also estimated that such errors lead to 45 deaths a year, 20 of which could be prevented when the standards are introduced.
This is not just a UK issue, the researchers said. Errors relating to medicines missed off the list, extra ones added, or wrong doses written down are common worldwide, and the World Health Organization has made it a priority for health services to find ways to reduce them, they added.
Speaking to Hospital Pharmacy Europe‘s sister publication Pulse, study lead Professor Rachel Elliott, professor of health economics, said the standards were being rolled out this year but it was a very complex process with lots of different stakeholders.
She added: ‘Medicines reconciliation done at admission and discharge has been shown to reduce medication errors. This is not about replacing that process but it is about making it easier to access the information which at the moment is all over the place and all the different systems can’t talk to each other. It is enabling the human element to be done more quickly.’
This article was originally published by our sister publication Pulse.
22nd June 2023
An electronic prescribing (EP) system within an intensive care unit (ICU) requires a lower level of clinical pharmacist input compared to a paper-based system, according to a recent prospective, longitudinal UK study.
Although EP systems are designed to reduce medication errors, the quality of evidence on their effectiveness is variable. Nevertheless, within an ICU setting, the use of commercial computerised provider order entry systems led to an 85% reduction in medication prescribing error rates and a 12% reduction in ICU mortality rates. However, few studies have focused on whether EP systems optimise medication therapy, reduce costs, improve the quality of prescribing and patient outcomes.
In the current study, published in the International Journal of Medical Informatics, researchers compared the clinical significance of pharmacist contributions in two ICU departments to understand the impact of an EP system on the quality of patient care.
The team chose one department that used an EP system and compared the extent of pharmacist input with a second department using a paper-based prescribing (PBP) system. The primary outcome was the distribution of clinical significance levels of pharmacist contributions. This was assessed using a tool that assigned a clinical significance rating to pharmacists’ contributions based on the mitigation of risk or negative outcome for the patient and ranged from I (low level) to V (high level).
A total of 303 patients were included, with EP used in 171 patients. Overall, 1,658 contributions were analysed.
The median number of patient reviews in both groups was similar, as was the proportion of reviews with no change (49.3% vs 48.5%, PBP vs EP). In addition, there were 14.9% highly clinically significant pharmacist contributions (levels III and above) with EP compared to 44.6% with PBP.
The EP group had a lower odds for a higher clinical significance contribution compared to the PBP group (Odds ratio, OR = 0.05, 95% CI 0.02-0.12). However, over time, there was a lower odds of a higher level contribution from the PBP group (OR = 0.57, 95% CI 0.42 – 0.78, p < 0.001).
Based on these findings, the researchers concluded that the clinical significance of pharmacist contributions remained both low and stable in over time in the EP group. Moreover, while initially higher, pharmacists in an ICU using a PBP system actually reduced over time.
Taken together, the study suggests that the use of an EP system required significantly less pharmacist input to maintain patient safety, possibly because the EP system enables access to data to improve decision-making at the point of prescribing.
The use of biologics in women with psoriasis who are either pregnant or planning to conceive is not associated with an increased risk of miscarriage, abortion or congenital malformations, according to the findings of a recent study.
The available literature suggests that psoriasis improves during pregnancy although there is a slight risk of a disease flare following delivery. Although biologics are used for patients with moderate to severe psoriasis, the continued use of biologic therapy in pregnancy is a difficult decision to make because of the lack of safety data. Moreover, these decisions are further hampered by the fact that pregnant women are invariably excluded from clinical trials using biologics.
With uncertainty over the safety of biologics in pregnancy, in the current study, published in Journal of the European Academy of Dermatology and Venereology, Spanish researchers conducted a systematic review and meta-analysis to examine examine pregnancy outcomes in women with psoriasis exposed to biologics within three months before or during pregnancy. The team also included studies where women were planning to conceive and who were exposed to biologics.
A total of 51 observational studies in women with a mean age of 30.3 years and with 739 pregnancies exposed to approved biologics were included in the analysis. In most cases (70.4%) the biologics were administered during the first trimester, with the most common agent being ustekinumab (36.0%), followed by etanercept (19.3%). However, there were no studies with newer agents such as brodalumab, risankizumab or bimekizumab.
The estimated prevalence of miscarriage was 15.3% (95% CI 12.7 – 18.0) and elective abortions, 10.8% (95% CI 7.7 – 14.3). Congenital malformations occurred in about 3.0% (95% CI 1.6 – 4.8) of live births. These estimates were similar to those reported in the general population.
The researchers concluded that biologics used in psoriasis are safe and pose an acceptable risk to foetuses and neonates.
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