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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 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.
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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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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.
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Content Article
US Joint Commission's Sentinel Event Alerts
Patient Safety Learning posted an article in Patient Safety Alerts
Sentinel Event Alert newsletters identify specific types of sentinel and adverse events and high risk conditions, describes their common underlying causes, and recommends steps to reduce risk and prevent future occurrences. Accredited organisations should consider information in a Sentinel Event Alert when designing or redesigning processes and consider implementing relevant suggestions contained in the alert or reasonable alternatives. -
Content ArticleAn otherwise healthy patient is taken to the operating room for the removal of a neck mole under monitored sedation. After the patient is given two litres of oxygen through nasal cannula and administered intravenous sedation, an alcohol-based skin preparation is applied to the surgical field. As the surgeon uses electrocautery to coagulate bleeding, a flash occurs, and the surgical drapes ignite. After extinguishing the fire by pouring water on the surgical field, assessment of the patient reveals second-degree burns on the patient’s face. Oxygen from the nasal canula had accelerated the fire and caused the nasal cannula to melt and adhere to the patient’s face. The patient was transferred to the burn unit for care, and ultimately required reconstructive plastic surgery. This case illustrates one type of injury that can be sustained during a surgical fire. The Joint Commission issues this alert to help healthcare organizations recommit to surgical fire prevention.
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Content ArticleThis National Patient Safety Alert has been issued by the NHS England National Patient Safety Team, co-badged by the Association of Anaesthetists, Royal College of Anaesthetists and the Safe Anaesthesia Liaison Group, instructing all relevant NHS funded providers to transition to NRFit™ connectors for all intrathecal and epidural procedures, and delivery of regional blocks. Transition should be completed by 31 January 2025.
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Content ArticleThis is a safety critical and complex National Patient Safety Alert. Implementation should be co-ordinated by an executive lead (or equivalent role in organisations without executive boards) and supported by clinical leaders in diabetes, GP practices, pharmacy services in all sectors, weight loss clinics, private healthcare providers and those working in the Health and Justice sector.
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Content ArticlePotential serious risks to patient safety have been identified with the use of Magentus Software Limited’s Euroking maternity information system. These concern specific data fields: certain new patient information, recorded during a patient contact, can overwrite ('back copy') information previously recorded in the patient’s pregnancy record. certain pregnancy-level data (information relevant only to a specific pregnancy event) can be saved at a patient level (where information relevant throughout a person's life is recorded), causing new information to overwrite (‘back copy’) previously recorded data across an entire patient record. certain recorded pregnancy-level data can pre-populate into new pregnancy records (‘forward copy’), which can mean clinicians will see incorrect patient information, and attempts to correct this can result in the issue described at (ii) above.
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Content ArticleThe MHRA is asking organisations to put a plan in place to implement new regulatory measures for sodium valproate, valproic acid and valproate semisodium (valproate). This follows a comprehensive review of safety data, advice from the Commission on Human Medicines and an expert group, and liaison with clinicians and organisations. This alert is for action by: Integrated Care Boards (in England), Health Boards (in Scotland), Health Boards (in Wales), and Health and Social Care Trusts (in Northern Ireland).
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Content ArticleThis report from the Action against Medical Accidents (AvMA), authored by Dr David Cousins, reveals serious delays in NHS trusts implementing patient safety alerts, which are one of the main ways in which the NHS seeks to prevent known patient safety risks harming or killing patients. The report identifies serious problems with the system of issuing patient safety alerts and monitoring compliance with them. Compliance with alerts issued under the now abolished National Patient Safety Agency and NHS England are no longer monitored – even though patient safety incidents continue to be reported to the NHS National Reporting and Learning System. The report recommends a number of urgent actions to address these risks to patients.
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Content ArticleThe number of cyberattacks and information system breaches in healthcare has grown steadily, escalating from isolated incidents to widespread targeted and malicious attacks. In 2022, 707 data breeches occurred in the US, exposing more than 51.9 million patient records, according to data from the Department of Health and Human Services (DHHS). To help healthcare organisations address this growing patient safety concern, The Joint Commission has issued this Sentinel Event Alert that focuses on risks associated with cyberattacks and provides recommendations on how healthcare organizations can prepare to deliver safe patient care in the event of a cyberattack.
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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 Article
Patient safety alerts
PatientSafetyLearning Team posted an article in Patient Safety Alerts
Typically issued in response to a new or under-recognised patient safety issue with the potential to cause death or severe harm. NHS Improvement aim to issue warning alerts as soon as possible after becoming aware of an issue and identifying that healthcare providers could take constructive action to reduce the risk of harm. Warning alerts ask healthcare providers to agree and coordinate an action plan, rather than to simply distribute the alert to frontline staff. -
Content ArticleA safety alert from the US Patient Safety Authority and ECRI.
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Content ArticleThere are supply disruptions affecting various strengths of the following medications which are licensed for the treatment of attention deficit hyperactivity disorder (ADHD): methylphenidate (Equasym® XL) capsules, methylphenidate (Xaggitin XL® , Concerta XL® , Xenidate XL® ) prolonged-release tablets, lisdexamfetamine (Elvanse® ) capsules, and guanfacine (Intuniv® ) prolonged-release tablets. This is a safety critical and complex National Patient Safety Alert. Implementation should be co-ordinated by an executive lead (or equivalent role in organisations without executive boards) and supported by clinical leaders in pharmacy, community pharmacy, GP practices, mental health services and those working in the health and justice sector.
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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 ArticleV60 and V60 Plus devices are designed for in-hospital use. They can be used to provide average volume assured pressure support (AVAPS), pressure-controlled ventilation (PCV), continuous positive airway pressure (CPAP), and positive pressure ventilation (PPV) treatment to patients in critical care and high dependency unit (HDU) settings. The safety concern identified relates to a number of electrical faults in the devices, which can result in an unexpected shutdown, leading to loss of ventilation. There are two ways in which this shutdown can occur: The first will sound a warning to alert the user that the machine is shutting down. This will let the user know they need to switch to an alternative source of ventilation. There is a risk that the patient will be unventilated while this second source of ventilation is prepared. The second failure mode will cause the device to shut down with no warning alarm. If a ventilator fails in use and does not alarm, the patient will be unventilated until the clinician becomes aware and responds. If unnoticed by healthcare professionals, ventilation failure can have a severe health impact on patients. This can include hypoxia, which can result in long-term cognitive impairment to the patient. There is also a risk of death if a patient is without ventilation for a sustained period of time Philips has no permanent solution to correct this issue and as such we are issuing this alert to help hospitals manage the risk.
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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 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 ArticleSodium nitrite has one licensed indication: as an antidote to cyanide poisoning. The Royal College of Emergency Medicine (RCEM) and National Poisons Information Service (NPIS) guideline recommends that it should be “immediately available in the emergency department”. Sodium nitrite can cause significant side effects and is categorised as ‘highly toxic’. Historically, sodium nitrite 30mg/ml has been an unlicensed product supplied in ampoules by ‘Specials’ manufacturers. However a licensed product, supplied as a vial, has been available since 2016. 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. Hospitals have been given until 6 November to physically check all wards for the wrong drug and to destroy any unlicensed sodium nitrite supplies. This alert is an action for all acute trusts (children and adult).
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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.
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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.
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Content ArticleA joint National Patient Safety Alert has been issued by NHS Improvement and NHS England national patient safety team, Royal College of General Practitioners, Royal College of Physicians and Society for Endocrinology, regarding the introduction of a new Steroid Emergency Card to support the early recognition and treatment of adrenal crisis in adults.
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Content ArticleA National Patient Safety Alert has been issued on the risk of harm from interruption of high flow nasal oxygen (HFNO) during transfer.
