Report highlights safety risks of ‘smart’ infusion pump devices


The latest report by the Healthcare Safety Investigation Branch (HSIB) charts the emerging patient safety risks that can come with the introduction of ‘smart’ infusion pump technology into hospitals.


Smart infusion pumps are the latest generation of programmable devices that administer medication. They are seen as a way of improving safety as the smart functionality aims to prevent underdoses or overdoses. They are equipped with features such as alerts or alarms to help detect problems.


The investigation was launched after one NHS Trust recorded three incidents where a smart infusion pump delivered an overdose of fentanyl. The patients weren’t harmed as it was swiftly picked up, however, it emphasised the new risks that come with introducing new technology and the potential for serious medication errors.


HSIB’s investigation focused on the barriers to implementing the technology effectively across the NHS, rather than on the technology itself. They examined these barriers through a ‘ten key considerations’ framework which looks at what is needed at each stage to ensure a successful implementation. This covers everything from clarifying why the change is needed to constant evaluation once the system is in place. Using the framework, HSIB’s investigation identified the safety risks that would need to be managed at each stage.


The investigation highlighted the main implementation challenges. This includes:


  • National consistency in drug libraries – smart infusion pumps have an inbuilt dose error reduction system (DERS) which requires the use of a drug library. The investigation found that drug libraries were developed ‘locally’ and that there is no agreed national drug library for use in NHS. They also found that there is no national guidelines or standards on how to implement the
  • Significant changes in processes – introducing the technology requires significant changes to prescribing and administration processes in trusts. The investigation found that procedure and guidance documents often needed updating, and variations in medication practice were ‘locally managed’ and were rarely shared within and between
  • Provision of specialist IT support and infrastructure – substantial IT infrastructure is needed to support the integration of smart pump technology. Software is needed to upload the drug library to smart pumps, download data logs (including any errors detected) and monitor the status of each smart pump. The investigation highlighted that maintaining the required IT infrastructure required specialist staff roles and often a new skill.


The investigation found that the implementation of smart pump functionality would benefit from the use of risk management practices, as requirements are complex and similar to the introduction of a new IT system. Existing NHS Clinical risk standards could provide a basis for both manufacturers and trusts to work together to manage risks.


Scott Hislop, Principal National Investigator at HSIB said:


“The purpose of the investigation wasn’t to endorse or examine the advantages or disadvantages of the technology but to understand why it can be difficult to implement in hospitals and where this might introduce some new risks to patient safety.


“Our investigation identified that these risks have been seen in trusts of different sizes across England. We have worked closely with manufacturers, regulators and national bodies and its clear a system-wide approach is needed to share learning and manage those risks effectively.


“The ten key considerations framework which underpins the report helped us to see where there may have been gaps at a national level and this has been reflected in the safety recommendations we have made.


“Setting out what an effective implementation journey should look like will help NHS trusts to use smart infusion pump technology to its full benefit, reducing the risk of serious harm to patients.”



Modafinil linked to increased risk of birth defects


Women using modafinil are being warned of an increased risk of birth defects associated with modafinil use during pregnancy.


Modafinil (Provigil) causes an approximate 15% likelihood of birth defects when taken during pregnancy; this compares with 3% in the general population.


Evidence that modafinil also reduces the effectiveness of oral contraception. Healthcare professionals treating narcolepsy with modafinil are also being reminded of the need to ensure patients are taking effective measures to prevent pregnancy.


The warning comes from the Medicines and Healthcare products Regulatory Agency (MHRA) following careful ongoing review of the risks. The drug may also reduce the effectiveness of oral contraception. Women taking modafinil should take effective measures to prevent pregnancy and discuss their contraception options with their healthcare professional.


This new advice is based on reports from a US study (of 61 babies exposed to modafinil in pregnancy) which showed that use of modafinil during pregnancy by women with narcolepsy possibly caused congenital malformations (including congenital heart defects, hypospadias, and orofacial clefts) in affected children.


Modafinil is a prescription-only medicine that is licensed only for the treatment of narcolepsy, a chronic disorder associated with sudden sleep that can cause serious disturbances to a patient’s quality of life. As with any drug, there can be side effects associated with its use, including for modafinil psychiatric disorders (depression, suicidal behaviours, and psychosis) serious skin reactions and cardiovascular disorders.


Dr Sarah Branch, director of MHRA’s Vigilance and Risk Management of Medicines Division said:


“It is important that women are aware of the increased risk of congenital malformations associated with taking modafinil during pregnancy.


“Modafinil can reduce the effectiveness of many hormonal contraceptives, including the pill. Women should discuss their options with their healthcare professional and continue to use their contraceptive for 2 months after stopping modafinil.


“If you have any concerns, you should speak to your healthcare professional.


“Patient safety is our highest priority. We strongly encourage anyone to report any side effects, from this or any medicine to our Yellow Card scheme.


Minister for Women’s Health and Patient Safety Nadine Dorries said:


“It is crucial that everybody is aware of the potential side effects of any medication they are taking.


“Modafinil should only be taken when prescribed by a healthcare professional to treat narcolepsy and it is important all women taking it are aware of the potential risks including reducing the effectiveness of oral contraceptives and possible birth defects.


“I urge all those taking modafinil to educate themselves on the side effects and potential risks, and to contact a healthcare professional if they are concerned.”


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Patient nearly chokes when inhaling capsule through inhaler


After a patient nearly choked when accidentally inhaling their lung medication capsule through the wrong part of their inhaler, Jazz, a concerned pharmacist, alerted the Medicines and Healthcare products Regulatory Agency (MHRA) of the potential risk.


Jazz, pharmacist and Yellow Card reporter, said:


“I reported to Yellow Card because I thought if this happened to one person, it could happen to others, and I wanted to protect patient safety.


“The MHRA did a detailed investigation and found there was potential for confusion when using the medicine and the device in combination. They then worked with the manufacturer to improve the safety information.


“Now the products come with warnings about choking and clearer instructions on how to insert the capsule correctly into the device, including pictures that make it easy to understand.


“The MHRA also alerted doctors, pharmacists and healthcare professionals across the UK about the safety risk. It really goes to show that every piece of information is important and can make such a big difference to patient safety.


Mick Foy, Manager at the MHRA’s Vigilance and Risk Management of Medicines Division, said:


“Patient safety is at the heart of everything we do, and everyone has a role to play in the safe use of medicines.


“The MHRA uses Yellow Card reports to strengthen our investigations and advice on how to use products safely to protect patients. Whether you’ve experienced a side effect, seen a faulty medical device, or observed a potential issue, your report to the Yellow Card scheme helps us take action to protect everyone.”


Reports can be made on the Yellow Card website, via the mobile app from the Google Play Store or Apple App Store, via freephone (0800 731 6789, 9am to 5pm Monday to Friday) or by reporting an issue to their healthcare team who can file a report on their behalf.


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Inadvertent fatal sodium nitrite administration to two babies


A National Patient Safety Alert has been issued on the risk of death from unintended administration of sodium nitrite.


A regular review of the National Reporting and Learning System (NRLS) identified two incidents where unlicensed sodium nitrite was inadvertently administered to premature babies instead of sodium bicarbonate 4.2%.


One very premature baby died soon after this incident occurred and the other died after a period of neonatal intensive care.


Sodium nitrite has one licensed indication: as an antidote to cyanide poisoning. It can cause significant side effects and is categorised as highly toxic. It should only be available in Emergency Departments.


Incidents have been reported where sodium nitrite was inadvertently administered instead of sodium bicarbonate, and other sodium-containing injections. As the packaging and labelling of sodium bicarbonate ampoules are similar to unlicensed sodium nitrite ampoules, selection errors are likely to be due to the inadvertent supply of sodium nitrite outside of Emergency Departments.


NHS acute trusts are asked to remove sodium nitrite injections from all clinical areas except Emergency Departments and replace unlicensed sodium nitrite ampoules with licensed sodium nitrite vials. Pharmacies and Emergency Departments are also asked to change procedures and storage policies for all ‘specialist antidotes’.


Failure to take the actions required under any National Patient Safety Alert may lead to CQC taking regulatory action.


You can access the full alert by clicking here.


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‘First do no harm’ report will have far reaching implications


After two years of work the Independent Medicines and Medical Devices Safety Review, chaired by Baroness Julia Cumberlege has published a far-reaching report largely comprising very difficult testimony from victims of medical harm.


The report looked specifically at issues involving sodium valproate, Primodos and pelvic mesh. The report includes painful testimony from people who have been negatively impacted by these three areas and goes beyond these three areas in its recommendations.


As part of the process of investigating the three areas above the report has unearthed deeper more systemic problems within the healthcare system in this country.


In particular, the report authors highlight the need for the patient to be heard and involved much more in their care. The issue around conflict of interest between practitioners and companies in the market was talked about at length. The report describes the fact that the healthcare system is not good at spotting trends and that this is because the patient is not involved enough.


Reference is made to the fact that we are in an ‘exciting’ time of technological developments but that there are also risks existing and future that will emerge as technology in healthcare develops. The process for reporting of adverse event and the use of patient-reported outcome measures were raised.


The report makes reference to the fact that patient safety issues still exist and that the culture of learning from mistakes could be much better.


The report makes nine recommendations which are as follows:


Recommendation 1: The Government should immediately issue a fulsome apology on behalf of the healthcare system to the families affected by Primodos, sodium valproate and pelvic mesh.


Recommendation 2: The appointment of a Patient Safety Commissioner who would be an independent public leader with a statutory responsibility. The Commissioner would champion the value of listening to patients and promoting users’ perspectives in seeking improvements to patient safety around the use of medicines and medical devices.


Recommendation 3: A new independent Redress Agency for those harmed by medicines and medical devices should be created based on models operating effectively in other countries. The Redress Agency will administer decisions using a non-adversarial process with determinations based on avoidable harm looking at systemic failings, rather than blaming individuals.


Recommendation 4: Separate schemes should be set up for each intervention – HPTs, valproate and pelvic mesh – to meet the cost of providing additional care and support to those who have experienced avoidable harm and are eligible to claim.


Recommendation 5: Networks of specialist centres should be set up to provide comprehensive treatment, care and advice for those affected by implanted mesh; and separately for those adversely affected by medications taken during pregnancy.


Recommendation 6: The MHRA needs substantial revision, particularly in relation to adverse event reporting and medical device regulation. It needs to ensure that it engages more with patients and their outcomes. It needs to raise awareness of its public protection roles and to ensure that patients have an integral role in its work.


Recommendation 7: A central patient-identifiable database should be created by collecting key details of the implantation of all devices at the time of the operation. This can then be linked to specifically created registers to research and audit the outcomes both in terms of the device safety and patient-reported outcomes measures.


Recommendation 8: Transparency of payments made to clinicians needs to improve. The register of the General Medical Council (GMC) should be expanded to include a list of financial and non-pecuniary interests for all doctors, as well as doctors’ particular clinical interests and their recognised and accredited specialisms. In addition, there should be mandatory reporting for pharmaceutical and medical device industries of payments made to teaching hospitals, research institutions and individual clinicians.


Recommendation 9: The Government should immediately set up a task force to implement this Review’s recommendations. Its first task should be to set out a timeline for their implementation.


Chair of the Independent Medicines and Medical Devices Safety Review Baroness Julia Cumberlege commented:


“I publish this report at a time when the NHS has been facing enormous challenges arising from the Covid-19 pandemic. NHS staff have risen to those challenges, proving day after day their ability to provide excellent care often in the most testing of circumstances. All of us have, quite literally, applauded them for their tireless commitment. This Review, however, has been about people who have suffered avoidable harm.


“Having spent two years listening to heart-wrenching stories of acute suffering, families fractured, children harmed and much else, I and my team thought the title of this report an appropriate one. It is a phrase that should serve as a guiding principle, and the starting point, not only for doctors but for all the other component parts of our healthcare system.


“The three areas we were asked to explore, Primodos, sodium valproate and pelvic mesh, were new to us so we travelled the country, not only England but Scotland, Wales and Northern Ireland. We met and listened to over 700 people, mostly women, often accompanied by their partners, other family members and sometimes their children. We are indebted to all of them. Their dignity and courage in telling us the intimate and harrowing details of their damaged lives has made a great and lasting impression on us.


“The patient groups, some of whom have campaigned for decades, have been invaluable to us; well informed, knowledgeable, and research-based. They never failed to ensure we learnt from them and were up to date with emerging developments. They are outstanding communicators and expert in the subject matter.


“We have found that the healthcare system is disjointed, siloed, unresponsive and defensive. It does not adequately recognise that patients are its raison d’etre. It has failed to listen to their concerns and when, belatedly, it has decided to act it has too often moved glacially. Indeed, over these two years, we have found ourselves in the position of recommending, encouraging and urging the system to take action that should have been taken long ago.


“The system is not good enough at spotting trends in practice and outcomes that give rise to safety concerns. Listening to patients is pivotal to that. This is why one of our principal recommendations is the appointment of an independent Patient Safety Commissioner, a person of standing who sits outside the healthcare system, accountable to Parliament through the Health and Social Care Select Committee. The Commissioner would be the patients’ port of call, listener and advocate, who holds the system to account, monitors trends, encourages and requires the system to act. This person would be the golden thread, tying the disjointed system together in the interests of those who matter most.


“We are entering a new world, in which innovation and technology will bring exciting change. There is potential to do so much good, but we must ensure the risks of increasingly complex healthcare are understood and where the system is not sure of the risks it must say so. Had it done so in the case of our three interventions, I have no doubt that much anguish, suffering and many ruined lives could have been avoided.


“My team and I are clear that our recommendations will improve the lives of people who have been harmed and make the system safer in the future. Implementation needs to be approached with a new urgency and determination, founded on the guiding principle that our healthcare system must first do no harm.”


Responding to the publication of the report, Duncan Rudkin, Chief Executive of the General Pharmaceutical Council, said:


“This important report shines a spotlight on how medicines and medical devices can harm as well as help. We will carefully review the report and its strategic recommendations and look at what actions we can take in response.


“We would like to express our sympathies for everyone who has experienced harm from medicines and medical devices. We also want to pay tribute to the patients and family members who have worked tirelessly to raise awareness of these patient safety issues; it is vital that we learn from and act on what they have told us.


“As an organisation we are committed to doing more to enable patients and the public to raise concerns and safety issues with us, to listen to their concerns, share this information with others across the system and to act quickly and effectively in response. Greater involvement of patients and the public in our work will strengthen action we take to ensure safe and effective pharmacy care.


“We expect the pharmacy professionals and pharmacies we regulate to provide person-centred care to all patients and to respond openly and honestly to any safety concerns that patients raise.”


You can read the full report here.


Prevalence of unsafe methotrexate prescribing ‘reduced but remains common’


A recently published study in the British Journal of General Practice has concluded that the prevalence of unsafe methotrexate prescribing has reduced but remains common. The study also indicates that there is still substantial variation between practices and CCGs.


The study was a retrospective cohort study of English GP prescribing data (August 2010–April 2018), and data acquired via freedom of information (FOI) requests. The background to the study was that to minimise risk, it has been recommended for some years only 2.5 mg tablets are used.


Of 7349 practices in England, 1689 prescribed both 2.5 mg and 10 mg tablets to individual patients in 2017, breaching national guidance.


Twenty-one deaths caused by methotrexate poisoning were reported from 1993–2017 in England and Wales.


The authors recommend investment in better strategies around implementation. The authors also recommend that the coroners’ reports for these deaths should be reviewed to identify recurring themes.


You can read the full paper here.