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News ArticlePatients who take the common blood pressure medicine Lercanidipine HCI 20mg tablets (lercanidipine hydrochloride) from the manufacturer Recordati Pharmaceuticals Limited, should, as a precautionary measure, urgently check if they have the batch number MD4L07 with an expiry date of 01/2028 on any packs they have at home. The batch number is printed on the foil of the blister strips. This follows an error in the strength of the product printed on some of the sides of the pack. The error is limited to one batch of the medicine only. The packs are incorrectly labelled as 10mg on some sides of the pack when they are 20mg tablets. The correct strength (20mg) is printed on the top of the carton and on the blister strips. An alert has been issued by the Medicines and Healthcare products Regulatory Agency (MHRA). Patients prescribed 10mg tablets and have received tablets with this batch number should contact their pharmacist or GP immediately. If the GP or pharmacist cannot be reached, patients should call NHS 111 for advice on continuing their medication. Read full story Source: MHRA, 17 April 2025
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Content ArticleRecordati Pharmaceuticals Limited has informed the MHRA of an error in the strength of the product printed on some of the faces (sides) of the product carton. The error is limited to one batch of Lercanidipine HCl 20mg Tablets. The packs are incorrectly labelled as 10mg on some sides of the product carton when they are 20mg tablets. Advice for Healthcare Professionals: Stop supplying the above batch immediately. Quarantine all stock and return it to your supplier using your supplier’s approved process. This medicine is being recalled as a precautionary measure. Pharmacists who have been supplied this batch and suspect they have dispensed the tablets to patients should contact the patient immediately to make them aware of this error. Please see ‘advice for patients’ section below. Advice for Patients: Patients who have been prescribed 10 mg tablets and have received tablets with this batch number (printed on the foil of the blister strips) should contact your pharmacist or GP immediately. In the event that the GP or pharmacist cannot be reached, please call NHS 111 for advice on continuing your medication. In the event you cannot speak to a healthcare professional before you are due to take your next dose: verify the strength of the tablets is 20 mg from the information on the foil of the blister strips remove one tablet from the blister as normal locate the break line on the tablet snap the tablet in half across the break line and take half of the tablet. This is permitted for the 20mg tablets and is in line with information included in the patient information leaflet (where it states ‘The tablet can be divided into equal doses’). Patients who have been prescribed 20 mg tablets should verify the strength of the tablets by checking the information on the foil of the blister strips prior to taking the tablet. Continue to take the tablets as prescribed by your doctor. Do not stop taking your medicine without consulting your healthcare provider. Patients who are concerned about the strength of the medication they have received should check it with their dispensing pharmacy. Patients concerned they may have accidentally taken a higher dose of the medication than they were prescribed should seek medical attention. Patients who experience adverse reactions or have any questions about the medication should seek medical attention. Any suspected adverse reactions should also be reported via the MHRA Yellow Card scheme. Additional information: For all medical information enquiries and information on this product, please email [email protected], or telephone +353 (0)87 6245669.
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Content ArticleWrist-based wearables in the US have been FDA approved for atrial fibrillation (AF) detection. However, the health behaviour impact of false AF alerts from wearables on older patients at high risk for AF are not known. In this work, the authors analysed data from the Pulsewatch (NCT03761394) study, which randomised patients with history of stroke or transient ischemic attack to wear a patch monitor and a smartwatch linked to a smartphone running the Pulsewatch application vs to only the cardiac patch monitor over 14 days. At baseline and 14 days, participants completed validated instruments to assess for anxiety, patient activation, perceived mental and physical health, chronic symptom management self-efficacy, and medicine adherence. The authors used linear regression to examine associations between false AF alerts with change in patient-reported outcomes. Receipt of false AF alerts was related to a dose-dependent decline in self-perceived physical health and levels of disease self-management. The authors developed a novel convolutional denoising autoencoder (CDA) to remove motion and noise artifacts in photoplethysmography (PPG) segments to optimize AF detection, which substantially reduced the number of false alerts. A promising approach to avoid negative impact of false alerts is to employ artificial intelligence driven algorithms to improve accuracy.
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News Article
Nationwide roll out of AI tool that predicts falls and viruses
Patient Safety Learning posted a news article in News
An AI tool is being rolled out across the NHS that can predict a patient’s risk of falling with 97% accuracy, preventing up to 2,000 falls and hospital admissions each day. The predictive tool, developed by Cera, is being used in more than two million patient home care visits a month, monitoring vital health signs such as blood pressure, heart rate and temperature, to predict signs of deterioration in advance so it can then alert healthcare staff. It is in use across more than two-thirds of NHS integrated care systems and helps to provide care at home by flagging up to 5,000 high-risk alerts a day, reducing hospitalisations by up to 70%. Dr Vin Diwakar, national director of transformation at NHS England, said: “This new tool now being used across the country shows how the NHS is harnessing the latest technology, including AI, to not only improve the care patients receive but also to boost efficiency across the NHS by cutting unnecessary admissions and freeing up beds ahead of next winter, helping hospitals to mitigate typical seasonal pressures. “We know falls are the leading cause of hospital admissions in older people, causing untold suffering, affecting millions each year and costing the NHS around £2 billion, so this new software has the potential to be a real game-changer in the way we can predict, prevent and treat people in the community. “This AI tool is a perfect example of how the NHS can use the latest tech to keep more patients safe at home and out of hospital, two cornerstones of the upcoming 10-year Health Plan that will see shifts from analogue to digital, and from hospital to community care.” The software will also be used to detect the symptoms of winter illnesses like Covid, flu, RSV, and norovirus, allowing NHS and care teams to intervene before hospital care is needed. Read full story Source: Digital Health, 5 March 2025 -
News ArticleThe Food and Drug Administration released an alert notifying patients of a safety concern using diabetes devices such as continuous glucose monitors, insulin pumps and automated insulin dosing systems that rely on a smartphone for delivering alerts. The agency said it received medical device reports in which users reported alerts were not being delivered or heard in situations where the users thought they configured the alerts to be delivered. Some instances may have contributed to serious harm, including severe hypoglycaemia, severe hyperglycaemia, diabetic ketoacidosis and death. The FDA issued recommendations for users and said it is working with diabetes-related medical device manufacturers to ensure that smartphone alert configurations are evaluated prior to use. It is also working with manufacturers to ensure settings for smartphones and mobile medical applications are continuously tested and that updates are communicated quickly and clearly to users. Read full story Source: US Food and Drug Administration, 5 February 2025
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News Article
UK doctors warn of risk from expanding water beads marketed as toys
Patient Safety Learning posted a news article in News
Doctors have issued a warning over tiny beads that can expand up to 400 times their original size when exposed to liquid, amid reports linking them to serious harm and deaths among children. The water beads are marketed for various purposes, including for use as toys, in crafting, as home decor or in floristry, and are especially popular at Christmas. They are sold under a variety of names including jelly balls, water balls, sensory beads and water crystals. If swallowed, water beads expand and can block the gastrointestinal passage, which may then require surgery. The beads can also cause choking and have harmed children in the UK, with reports linking them to deaths globally. Water beads can be difficult to detect and do not show up in X-rays. On Monday, the Royal College of Emergency Medicine (RCEM) issued a “safety flash” over water beads marketed as toys, amid fears they could be given to young children over the holiday period. It follows a safety alert from the UK’s Office for Product Safety and Standards, which advised that water beads should be kept away from children under five years old, and only used with older children or vulnerable adults under close supervision. The safety alert has been issued to emergency doctors to ensure they know what to look out for while working, but the RCEM also wants to warn parents and carers of the dangers. Read full story Source: The Guardian, 23 December 2024 -
Content ArticleThe Royal College of Emergency Medicine have issued a safety alert on children's toys containing water beads. Doctors are warning these gifts could pose a danger to children and vulnerable adults if swallowed.
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News Article
Safety alert over 25 serious incidents linked to common drug
Patient Safety Learning posted a news article in News
Maternity services have been issued with a national patient safety alert over inappropriate use of a common labour-inducing drug following a review of 25 serious incidents. NHS England’s national patient safety team, backed by the Royal College of Obstetricians and Gynaecologists, Royal College of Midwives and the Royal College of Anaesthetists, has issued an official alert instructing all providers to stop pre-preparing oxytocin infusions at ward level, in all clinical areas. Trusts must complete this and three other actions by 31 March 2025. Oxytocin is one of the most commonly used drugs in labour and childbirth and can be administered to initiate contractions. In a much higher dose, it can treat postpartum haemorrhage, severe bleeding after birth. The inadvertent administration of a postnatal dose of oxytocin before a baby is born can lead to significant harm to mother and baby. Safety reports into deaths and harm in maternity services, including the Ockenden reports into Shrewsbury and Telford Hospitals Trust and the seminal case which prompted the East Kent inquiry, that of Harry Richford, mention inappropriate use of oxytocin. Read full story (paywalled) Source: HSJ, 24 September 2024 -
Content ArticleThis National Patient Safety Alert, issued by the NHS England National Patient Safety Team and endorsed by the Royal College of Obstetricians & Gynaecologists, Royal College of Midwives and Royal College of Anaesthetists, instructs all relevant NHS funded maternity care providers to cease pre-preparing oxytocin infusions at ward level in all clinical areas. All actions should be completed by 31 March 2025. Midwives need to complete several tasks immediately and simultaneously following birth to ensure the safety of both the mother and baby. To support this, postpartum oxytocin infusions have been prepared in advance of being required. If a pre-prepared oxytocin infusion is unintentionally given before the baby is born, for example if it is confused with standard fluids or the intrapartum and postpartum infusions are confused, the woman’s contractions will increase in frequency and strength. This can lower the baby’s oxygen levels and alter their heart rate, increasing the risk of placental abruption (where the placenta prematurely separates from the uterus and deprives the baby of oxygen). A review of the National Reporting and Learning Systems over a 5 year period identified 25 incidents. Actions required: Review and update local clinical procedures (or equivalent documents) to ensure: Oxytocin infusions for any indication are not pre-prepared at ward level in any clinical area (including delivery suites and theatres). Post-partum haemorrhage (PPH) kits/ trolleys are immediately available in all clinical areas/theatres where it may be required. Where a woman is identified to be at high risk of PPH: (a) the PPH kit/trolley should be brought into the labour/delivery room/theatre during the second stage of labour, (b) the postpartum oxytocin infusion should be prepared at the time of birth and not before, (c) a second midwife should be available to support the administration of the postpartum oxytocin infusion. Roles and responsibilities of staff groups in the labour setting, including theatres, are clearly defined in terms of prescribing, preparation, administration and disposal of oxytocin infusions. Including: intrapartum oxytocin infusions, postpartum oxytocin infusions and unused, pre-prepared oxytocin. infusions.
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Content ArticleMacarthys Laboratories (trading as Martindale Pharma, an Ethypharm Group Company), has notified the MHRA that a limited number of Prenoxad kits (also called packs) in a batch marketed in France have missing needles. Naloxone is a drug that reverses the effects of an opioid overdose. If no needles are present in the kit, there is a risk that patients, members of the public and/or healthcare professionals may not be able to administer life-saving doses of naloxone from these kits in an emergency. This may impede the treatment for a patient with an opioid overdose, which may result in delay to intervention and possible death. Although no reports of UK marketed kits with missing needles have been received to date, the potential for kits to contain fewer than two needles in all distributed batches cannot be excluded based on the investigation by the company. However, due to the critical need for this product, the specified batches are not being recalled. This alert is for action by: primary and secondary care, specifically those involved in outreach services.
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Content ArticleA safety alert from the US Patient Safety Authority and ECRI. During a cardiac ablation procedure, the catheter irrigation fluid bag emptied and was replaced by staff. While priming the tubing, air was noted in the tube, and the catheter was immediately removed from the patient. The patient experienced a decrease of heart rate and blood pressure requiring a code response. Radiofrequency cardiac ablation requires the use of heparinised irrigation fluid to cool and anticoagulate the ablation site. If the procedure requires more fluid than originally hung, it requires the bag to be replaced. This introduces an opportunity for air to enter the irrigation tubing. Air emboli can then be infused into the patient causing cardiac arrhythmia, myocardial infarction, respiratory symptoms and/or neurologic symptoms, and, potentially, total cardiovascular collapse. Solutions During cardiac ablation procedures, air should be removed from any bags and the pump (or any other pressurized delivery device) tubing primed before being connected to a patient. Do not bypass alarms that detect air in the pump or tubing systems. Do not prime the irrigation line without first disconnecting the tubing set from the patient, even if a stopcock is in use. Review the manufacturer’s instructions for how to change fluid bags to ensure safe operations. Be aware of potential access points for air to enter the system and mitigate the risk.
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Content ArticleSentinel Event Alerts from the Joint Commission identify specific types of sentinel event (a patient safety event that results in death, permanent harm or severe temporary harm), describe their common underlying causes and suggest steps to prevent them occurring in the future. This Sentinel Event Alert looks at the well-documented link between health care worker fatigue and adverse events. It looks at: The impact of fatigue Contributing factors to fatigue and risks to patients Actions suggested by The Joint Commission for healthcare organisations
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Content ArticleThe MHRA is aware of cases of increased intraocular pressure in patients recently implanted with EyeCee One preloaded and EyeCee One Crystal preloaded intraocular lenses (IOLs), which are manufactured by NIDEK and distributed by Bausch + Lomb. The root cause has not been identified and further investigations are ongoing with the manufacturer. Due to the potential risks for patient safety, you should stop using these IOLs and quarantine remaining stock immediately pending the results of further investigations. Additional communications will be issued shortly advising clinicians and affected patients on the next steps. Actions for ophthalmology, ophthalmic theatres, and Medical Devices Safety Officers. To be completed 26 January 2023 Please take the following actions immediately: Nominate a lead person to take responsibility for completing these actions. Note – we recommend including colleagues in purchasing, supplies, and the Medical Device Safety Officer (MDSO). Identify if your organisation uses these IOLs Stop using these impacted products immediately Quarantine these impacted IOLs until further notice. Consider using a suitable alternative product if available following local risk assessment Immediately notify any other departments who need to be aware of this notice.
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Content ArticleDuring periods of extreme pressure, often exacerbated by a surge in respiratory conditions, demand on supplies of oxygen cylinders, especially the smaller sizes, increases in the NHS due to the need to provide essential oxygen treatment in areas without access to medical gas pipeline systems. This surge in demand increases the known risks associated with the use of oxygen gas cylinders, and introduces new risks, across three main areas: patient safety fire safety physical safety A search of incidents reported to the of the National Reporting and Learning System (NRLS) and Learn from Patient Safety Events (LFPSE) service in the last 12 months identified 120 patient safety incidents, including those with these themes: cylinder empty at point of use cylinder not switched on cylinders inappropriately transported cylinders inappropriately secured Some of these reports described compromised oxygen delivery to the patient, leading to serious deterioration and cardiac or respiratory arrest. In addition there is a need to conserve oxygen cylinder use to ensure a robust supply chain process. As a result of current pressures on the NHS, NHS England issued providers with a summary of best practice guidance on the ‘Safe use of oxygen cylinders’ on Friday 06 January 2023 to support providers to optimise and maintain the safe use of oxygen cylinders. This guidance was issued via the Patient Safety Specialist and Emergency Preparedness, Resilience and Response (EPRR) networks. Actions To be completed as soon as possible, and not later than 20 January 2023. 1. The chair of acute trust medical gas committee, working with key clinical/non-clinical colleagues including the local ambulance trust, should review the NHS England ‘Safe use of oxygen cylinders’ best practice guidance and ensure a risk assessment is undertaken in all areas where patients are being acutely cared for (either temporarily or permanently) without routine access to medical gas pipeline systems. Risk assessment should pay particular attention to: avoiding unnecessary use of cylinder oxygen and excessive flow rates by ensuring oxygen treatment is optimised to recommended target saturation ranges. ensuring safe use of oxygen cylinders by clinical staff including; - safe activation of oxygen flow - initial and ongoing checks of flow to patient - initial and ongoing checks of amount of oxygen left in the cylinder - especially during transfer or whilst undergoing diagnostic tests. fire safety, including: - appropriate ventilation (both in physical environments and in ambulances), safe storage of cylinders physical safety, including: - awareness of manual handling requirements - safe transportation of cylinders using appropriate equipment - safe storage of cylinders. 2. Once the risk assessments have been undertaken, convene the acute trust medical gas committee as soon as possible to review the findings of the risk assessments and formalise an action plan. Ensuring that the committee has executive director representation and ambulance trust input.
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Content ArticlePharmaswiss Česka republika s.r.o. and distributor Bausch & Lomb UK Limited is recalling all unexpired batches of Emerade 500 micrograms and Emerade 300 micrograms adrenaline auto-injectors (also referred to as pens) from patients. This is due to an issue identified during an ISO 11608 Design Assessment study where some auto-injectors failed to deliver the product or activated prematurely. Specifically, the 1-metre free-fall (vertical orientation) pre-conditioning resulted in damage to internal components of the auto-injector, leading either to failure to deliver the product or premature activation. This damage was not visibly apparent following the pre-conditioning but was evident only on subsequent functional testing. It is unclear what impact this has on auto-injectors in clinical use, however as a precautionary measure and owing to the inability to identify this issue before the auto-injectors are used, the auto-injectors are being recalled. Healthcare professionals should inform patients, or carers of patients, who carry Emerade 300 or 500 microgram auto-injector pens to obtain a prescription for and be supplied with an alternative brand. They should then be informed to return their Emerade 300 or 500 microgram pens to their local pharmacy.
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Content ArticleTension pneumothorax can occur following chest trauma, respiratory disease and infection, or during resuscitation requiring invasive or non-invasive ventilation. It is a life-threatening condition resulting from a collapsed lung when air trapped in the pleural cavity compromises cardiopulmonary function. Immediate temporary decompression is required to prevent cardiac arrest. This is commonly done by inserting a needle and cannula, usually used for intravenous access, through the chest wall into the pleural cavity (needle thoracostomy). The needle is withdrawn, and the cannula left in place to allow the trapped air to flow out. New blood control (closed system) intravenous cannulas are increasingly used in the NHS; at least 130 trusts bought a total of three million of them in the last year. They look very similar to both traditional and standard safety cannula (with needle guard or shield) but have an extra integral septum which closes when the needle is withdrawn and stops free flow in or out of the cannula. Flow is only possible once an intravenous line or Luer-lock syringe is attached to the hub, which opens the septum. Blood control (closed system) cannulas help prevent blood spillage, exposure and contamination, when used for their intended intravenous purpose, but they cannot be used to decompress a pneumothorax without additional equipment. The main patient safety risks are: staff may select a blood control (closed system) cannula not realising its limitations for this procedure a blood control (closed system) cannula may wrongly be assumed to be functioning in a patient who is deteriorating rapidly a second needle might be introduced risking very significant damage to the lung as it reinflates. Actions Identify if your organisation purchases blood control (closed system) safety cannula. If it does, for all clinical areas and teams likely to undertake needle thoracostomy, including ambulances, emergency departments (EDs), intensive care units, respiratory units or any unit providing invasive or non-invasive ventilation, including units for COVID-19 patients: Provide standard safety cannulas* for needle thoracostomy in appropriate trays, drawers, pockets, within emergency workspaces, emergency kit bags, and resuscitation trolleys, and clearly label ‘For use in tension pneumothorax’. Attach visible warnings/notices to cupboards, drawers, etc in these emergency workspaces, emergency kit bags, and resuscitation trolleys where blood control (closed system) cannula are stored stating: ‘Do not use for tension pneumothorax’, with a direction to where standard safety cannulas can be found. Amend labelling/checklists in store cupboards used to restock these resuscitation areas, emergency kit bags and resuscitation trolleys to ensure clear distinction between standard safety cannula and blood control (closed system) cannula. Inform clinical and materials management staff who restock these resuscitation areas, emergency kit bags and resuscitation trolleys of these changes.
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Content ArticleAir flowmeters attached to piped medical air outlets are primarily used to drive the administration of nebulised medication; typically for short periods to manage respiratory conditions. Most other uses of piped medical air do not require an air flowmeter. Due to the proximity of the piped medical air and oxygen outlets at the bedside, and the similarity in design of flowmeters, there is a significant risk when using air flowmeters that patients may be inadvertently connected to medical air instead of oxygen. A previous alert and additional communications have sought to minimise the use of air flowmeters by encouraging their replacement with compressor or ultrasonic nebulisers, alongside additional risk reduction methods if air flowmeters remained in use. However, despite the measures outlined above, 108 Never Events describing unintentional connection were reported in a recent three-year period ; over a third of incidents occurred in emergency departments. Consequences included respiratory arrest, cardiac arrest, collapse (requiring ITU admission and ventilation), and nine incidents of incorrect connection when responding to cardiac arrest, which will have impacted on the chance of successful resuscitation; six patients subsequently died. Actions Purchase sufficient powered nebuliser devices for use across the organisation; to remove the need for medical air to drive nebulisers via a flowmeter. Remove the need for air flowmeter use in the delivery of humidified air, by purchasing sufficient devices that use ambient air. Review any niche uses of air flowmeters and replace with suitable alternatives. If in exceptional circumstances, an air flowmeter cannot be replaced by an alternative device, ensure the flowmeter is tethered to the equipment. On completion of actions 1,2 and 3, remove and discard all medical air flowmeters except those tethered to equipment for niche use. Reversibly cap off all medical air outlets that are no longer routinely required; secured caps are most appropriate for this. Ensure policies and procedures relating to the prescribing and administration of nebulised medication are updated to reflect this change in practice and that they align with British Thoracic Society (BTS) guidance.
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Content ArticleAll patients with prosthetic mechanical heart valves require life-long oral anticoagulation with a vitamin K antagonist (VKA), usually warfarin, as these valves predispose the patient to systemic embolism. Thrombosis of a prosthetic valve is potentially life-threatening as it can result in haemodynamically severe stenosis or regurgitation and acute heart failure. The risk depends on the type of valve, its position, and other factors. Since 1 March 2020, 14 incidents have been reported of patients with a mechanical heart valve being switched to a a low molecular weight heparin (LMWH) or a direct oral anticoagulant (DOAC); two patients were hospitalised due to valve thrombosis and/or required emergency surgery and one was admitted due to severe anaemia. The reports included cases where patients’ anticoagulation was switched from warfarin in primary and in secondary care. Actions General practices: Practices using EMIS: If you have received a ‘task’ from EMIS identifying specific patients who have a record of a mechanical heart valve and are receiving a DOAC, and you have not already actioned this request, urgently review these patients to ensure they are on the most appropriate anticoagulation therapy and monitoring. Practices using TPP: If you have received a ‘task’ from TPP identifying specific patients who have a record of a mechanical heart valve and are receiving a DOAC, and you have not already actioned this request, urgently review these patients to ensure they are on the most appropriate anticoagulation therapy and monitoring. Practices using other GP system software: If your practice does not use EMIS or TPP software, urgently review all patients with a mechanical heart valve to ensure they are on the appropriate anticoagulant therapy and monitoring. Providers of anticoagulation services: Urgently check patient records from January 2020 to identify any patient with a mechanical heart valve who has been switched from a VKA to an alternative anticoagulant. For identified patients you should either: (i) Urgently review these patients if still under the care of the service to ensure they are on the appropriate anticoagulant therapy and monitoring or (ii) Work with the patient’s GP to ensure the patient receives an urgent review.
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Content ArticleDysphagia (swallowing problems) occurs in all care settings and although the true incidence and prevalence are unknown, it is estimated the condition can occur in up to 30% of people aged over 65 years of age. Stroke, neurodegenerative diseases and learning disabilities can be the cause of some cases of dysphagia, and may also result in cognitive or intellectual impairment, as well as visual impairment, NHS England received details of an incident where a care home resident died following the accidental ingestion of the thickening powder that had been left within their reach. Whilst it is important that products remain accessible, all relevant staff need to be aware of potential risks to patient safety. Appropriate storage and administration of thickening powder needs to be embedded within the wider context of protocols, bedside documentation, training programmes and access to expert advice required to safely manage all aspects of the care of individuals with dysphagia. Individualised risk assessment and care planning is required to ensure that vulnerable people are identified and protected. Actions Identify if the accidental ingestion of dry thickening powder has occurred, or could occur, in your organisation. Consider if immediate action needs to be taken locally, and ensure that an action plan is underway if required, to reduce the risk of further incidents occurring. Distribute this alert to all relevant staff who care for children or adults in primary care, emergency care, and inpatient care settings, including mental health and learning disability units. Share any learning from local investigations or locally developed good practice resources by emailing [email protected].
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Content ArticleSalbutamol is a selective beta2-agonist providing short-acting (4-6 hour) bronchodilation with a fast onset (within 5 minutes) in reversible airways obstruction. The nebuliser liquids are licensed for use in the management of chronic bronchospasm unresponsive to conventional therapy, and in the treatment of acute severe asthma. A Medicines Supply Notification (MSN) issued on 14 February 2024, detailed a shortage of salbutamol 2.5mg/2.5ml and 5mg/2.5ml nebuliser liquid. The resolution date is to be confirmed. The supply issues have been caused by a combination of manufacturing issues resulting in increased demand on other suppliers. Terbutaline, salbutamol with ipratropium, and ipratropium nebuliser liquids remain available, however, they cannot support an increase in demand. Ventolin® (salbutamol) 5mg/ml nebuliser liquid (20ml) is out of stock until mid-April 2024 and cannot support an increased demand after this date. Actions to be completed as soon as possible and not later than 8 March 2024. All providers MUST: 1. Liaise with local pharmacy teams and place urgent orders for unlicensed imports of salbutamol nebuliser liquid - do not wait for supplies to be exhausted before placing orders for imports. 2. Wean all patients off nebulisers as soon as their condition has stabilised. 3. Consider use of high-dose salbutamol pressurised metered-dose inhaler (pMDI) via a large volume spacer in patients with mild to moderate asthma attacks or COPD (see clinical information) ensuring the patient is issued with a new inhaler to avoid risk of using a near empty device and can administer it effectively if not being administered by a healthcare professional. NOTE A Secondary care providers should: 4. Where a pMDI is not appropriate, prescribe salbutamol nebuliser liquids when required (PRN) rather than regularly (QDS), as early as possible during admission, if appropriate. 5. Prioritise supplies of salbutamol nebuliser liquids for the following indications: a. acute, severe exacerbations of COPD and asthma b. bronchospasm secondary to refractory anaphylaxis c. in patients who cannot use a pMDI d. other conditions where the use of high-dose salbutamol pMDI via a spacer is inappropriate e.g. moderate to severe hyperkalaemia Primary care prescribers should: 6. Review need for home nebuliser use, and if deemed necessary, determine if the patient has sufficient supplies of nebuliser liquid at home before issuing repeat prescriptions.
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Content ArticleEarly detection and management of sepsis is an important patient safety target. This systematic review included 22 studies and examined the use of sepsis alert systems in the Emergency Department (ED) on patient outcomes. The researchers found that sepsis alert systems were associated with reduced risk of mortality and decreased length of stay, as well as increased adherence to sepsis management guidelines, such as timely administration of antibiotics.
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Content ArticleThis WHO Medical Product Alert refers to three falsified batches of OZEMPIC (semaglutide). This falsified product has been detected in Brazil (October 2023), the United Kingdom of Great Britain and Northern Ireland (October 2023), and the United States of America (December 2023), and was supplied in the regulated supply chain. OZEMPIC (semaglutide) is from a group of medicines called glucagon-like peptide-1 (GLP-1) inhibitors that are indicated for the treatment of hyperglycemia in type 2 diabetes mellitus in adults, adolescents, and children over 12 years of age. The genuine manufacturer of OZEMPIC has confirmed that the three products referenced in this Alert are falsified: the products misrepresent their identify and source as they were not manufactured by Novo Nordisk: batch number LP6F832 is not recognized. the combination of batch number NAR0074 with serial number 430834149057 does not correspond to genuine manufacturing records. batch number MP5E511 is genuine, but the product is falsified. Risks The use of falsified OZEMPIC may result in the ineffective treatment of patients due to incorrect dosage, contamination with harmful substances, or use of unknown or substituted ingredients. It may pose other serious risks to health because of its subcutaneous injection administration that could be life-threatening. Advice to healthcare professionals, regulatory authorities and the public Healthcare professionals should report any incident of adverse effects, lack of effectiveness and suspected falsification to the National Regulatory Authorities/National Pharmacovigilance Centre. National regulatory/health authorities are encouraged to contact their marketing authorization holders for advice on identification of falsification, increase monitoring of informal including online sale of products; and are advised to immediately notify WHO if they identify these falsified products. If you have any of the affected products, WHO recommends that you do not use them. If you, or someone you know, has or may have used the affected product, or suffered an adverse reaction or unexpected side-effect after use, you are advised to seek immediate medical advice from a healthcare professional.
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Content ArticleTotal parenteral nutrition (TPN, also known as PN) is a method of providing nutrition directly into the bloodstream to those unable to absorb nutrients from the food they eat. TPN is used in all age groups, but in babies its use is often as part of a temporary planned programme of nutrition to supplement milk feeds in those too immature to suckle or too sick to receive milk feeds as a result of intestinal conditions. TPN consists of both aqueous and lipid components, which are infused separately into the baby via specific administration sets and infusion pumps. The rate at which TPN is administered to a baby is crucial: if infused too fast there is a risk of fluid overload, potentially leading to coagulopathy, liver damage and impaired pulmonary function as a result of fat overload syndrome. In a recent three and a half year period 10 incidents were identified where infusion of the aqueous and/or lipid component of TPN at the incorrect rate resulted in severe harm to babies through pulmonary collapse, intraventricular haemorrhage or organ damage, and where intensive intervention and treatment were needed. Most of these incidents involved too rapid a rate of infusion.
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News Article
Global alert issued over fake Ozempic drugs
Patient Safety Learning posted a news article in News
A global alert about fake versions of Ozempic - which has become popular as a way of losing weight - has been issued by the World Health Organization (WHO). The drug is sometimes known as a "skinny jab" despite its main purpose being a treatment for type 2 diabetes. The WHO said the fake medicines could pose a danger to health. The organisation advised people to source the drug only through reputable sources, such as a doctor, rather than obscure sites online or through social media. The active ingredient in Ozempic - semaglutide - helps people with type 2 diabetes control the amount of sugar in their blood. However, the weekly injection also signals to the brain that we're full. So the drug helps people lose weight by reducing the urge to eat. People without diabetes have been getting hold of the drug as a weight-loss medication, which has led to shortages for people with type 2 diabetes and created a market for counterfeit drugs. “[We advise] healthcare professionals, regulatory authorities and the public be aware of these falsified batches of medicines,” said Dr Yukiko Nakatani, WHO assistant director general for essential medicines and health products. "These falsified products could have harmful effects to people’s health," WHO said. Read full story Source: BBC News, 20 June 2024 -
Content ArticleThe MHRA continues to receive serious reports of harm associated with insulin leakage for the NovoRapid PumpCart prefilled insulin cartridge in the Accu-Chek Insight Insulin pump. In some patients, there were serious consequences arising from inadequate supply of insulin, including diabetic ketoacidosis (DKA). Although the manufacturer Roche Diabetes Care (RDC) has implemented a number of risk minimisation strategies to reduce the incidence of these events, the impact of these is inconclusive and we are taking further action to protect patients. To protect patient safety, diabetes healthcare professionals should inform patients who use the Accu-Chek Insight of the risk of leakage. Clinical care decisions should be made to ensure patients are moved onto alternative pumps where possible.
