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Showing results for tags 'Labelling / packaging/ signage'.
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News ArticleOne of the biggest producers of hormone replacement therapy has been censured by regulators for “systemic failures” that jeopardised patient safety. Theramex, the UK producer of HRT drugs Evorel and Intrarosa, was found to have breached fundamental compliance standards including not updating crucial prescribing information – in some cases for several years – and not making it clear that a drug must not be used during pregnancy. The Prescription Medicines Code of Practice Authority (PMCPA), the UK drug industry’s self-regulatory body, issued the public reprimand against Theramex after its own staff blew the whistle over “alarming” compliance issues and incomplete prescribing information for Evorel and Intrarosa that “jeopardise patient safety”. Evorel patches – which contain estradiol – are among the most prescribed form of transdermal HRT, with more than 250,000 items issued in the last financial year, according to NHS Business Services Authority figures. Overall, nearly 10m items of estradiol, including gels, were prescribed in the 2024/25 financial year. The employees’ concerns included failing to provide comprehensive side-effect information in Evorel’s prescribing information, and not updating Intrarosa’s product information since 2019. The PMCPA also reprimanded the company for failures to specify in its advertising at a reproduction and advertising conference that Yselty (linzagolix), used to treat uterine fibroids, should not be taken during pregnancy. In all, PMCPA found that Theramex breached the Association of the British Pharmaceutical Industry (ABPI)’s code of practice 21 times. The panel said these breaches not only jeopardised patient safety, but that Theramex has “brought discredit upon, and reduced confidence in, the pharmaceutical industry”. Read full story Source: The Guardian, 22 April 2026
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News Article
Barcode errors ‘potentially fatal’, warns patient safety commissioner
Mark Hughes posted a news article in News
Barcode errors on medicines “pose critical patient safety risks” and could have “potentially fatal consequences,” Henrietta Hughes has warned. The Patient Safety Commissioner for England’s warning comes as a petition has been launched by pharmacists report growing problems with barcode data errors and missing 2D barcodes on UK medicine packs. The issue has been highlighted by several ‘Class 4 medicines defect notifications’ during 2025 that were linked to barcode or labelling problems, including fexofenadine hydrochloride tablets in August 2025, and simvastatin tablets in July 2025. Read full article. Source: The Pharmaceutical Journal (20 November 2025) -
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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News Article
Boots recalls paracetamol over labelling error
Patient Safety Learning posted a news article in News
The UK High Street pharmacy chain Boots is asking customers to return packs of 500-milligram paracetamol tablets because a labelling error incorrectly states they are a different painkiller, aspirin. More than 110,000 packs, with the batch number 241005 and expiry date "12/2029" on the bottom, are affected. Customers can receive a full refund without a receipt. Boots and the supplier, Aspar Pharmaceuticals Limited, have begun a full investigation. The outer cardboard packaging is correctly labelled: "Paracetamol 500mg Tablets" but the inner foil blister pack of pills instead reads: "Aspirin 300mg Dispersable Tablets". The affected packs should not be used or kept, even if the error is known, as this could lead to an incorrect dose. Dr Stephanie Millican, from the Medicines and Healthcare Products Regulatory Agency (MHRA), said: "Patient safety is always our priority. "It is vitally important that you check the packaging of your Boots Paracetamol 500mg Tablets 16s - and if the batch number is 241005, you should stop using the product and return it to a Boots store for a full refund. "If you are unsure which pack you have purchased or have taken Boots Paracetamol 500mg Tablets and experienced any side effects, seek advice from a healthcare professional. "Please report any suspected adverse reactions via the MHRA's Yellow Card scheme. "If you have any questions or require further advice, please seek advice from your pharmacist or other relevant healthcare professional." Read full story Source: BBC News, 4 March 2025 -
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Fentanyl and naloxone.jpg
Patient Safety Learning posted a gallery image in Medication
Fentanyl, a synthetic opioid, and naloxone, a medication used to reverse or reduce the effects of opioids, both in very similar bottles and packaging. Shared originally on Twitter by @sassistheword -
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Noradrenaline and tranexamic acid.jpg
Patient Safety Learning posted a gallery image in Medication
Shared with hub by Dr Abigail Clark-Morgan: Images shared of our stocked noradrenaline ampules and tranexamic acid – these have been mixed up and we are looking to stock alternative volumes of noradrenaline to reduce the likelihood of confusion. The incident also highlighted the importance of checking all the ampules drawn up, drawing up your own medications at the point of administration and effective second checking. Part of our immediate response was to label the noradrenaline ampules to make them more obviously different (the purple ampules pictured below).© Healthcare UK
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Bupivacaine alongside sodium choloride.jpg
Patient Safety Learning posted a gallery image in Medication
Bupivacaine solution, a medication used to decrease feeling in a specific area, alongside sodium chloride used as a saline solution. What could go wrong?! Another example of almost identical packaging/labelling. -
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Midazolam.jpg
Patient Safety Learning posted a gallery image in Medication
Shared from Twitter: What could go wrong? Same size, same colourings … Time for distinct and standardised size/colouring of paralytic agents? -
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Bupivacaine and sodium chloride
Patient Safety Learning posted a gallery image in Medication
Do we need a magnifying glass in every anaesthetic room? Only a matter of time until something bad happens... -
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Sodium chloride and levobupivacaine
Patient Safety Learning posted a gallery image in Medication
Levobupivacaine is a local anaesthetic. Labelling very similar to the Sodium chloride. -
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Solutions for injections
Patient Safety Learning posted a gallery image in Medication
Three very different solutions for injection - magnesium sulfate, water, sodium chloride - so why is the labelling so similar? -
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Sodium Cholride and Metronidazole.jpg
Patient Safety Learning posted a gallery image in Medication
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Sodium Chloride and paracetamol solution.jpg
Patient Safety Learning posted a gallery image in Medication
These two solutions look very similar. One is paracetamol, the other Sodium Chloride. Example of packaging/labelling contributing to adverse events. -
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Aspirin.jpg
Patient Safety Learning posted a gallery image in Medication
A patient bought wrong aspirin from pharmacy and accidentally overdosed. Easily done with such similar packaging. -
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Calcium Gluconate and Sodium Chloride solutions.jpg
Patient Safety Learning posted a gallery image in Medication
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Medication - generic names.png
Patient Safety Learning posted a gallery image in Medication
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TEARDEW (COMPILED).png
Patient Safety Learning posted a gallery image in Medication
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Stexerol-D3.jpg
Patient Safety Learning posted a gallery image in Medication
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Content ArticleMedication error may occur for a variety of reasons. One of the most common sources of medication error is related to look-alike and sound-alike (LASA) drugs as well as the often-similar appearances of the vials. LASA medications are typically thought of as medications that are similar in physical appearance related to packaging as well as medications whose names are similar in spelling or in the phonetic pronunciation. Tricia A. Meyer looks at cases of LASA drugs and prevention techniques. She concludes that healthcare professionals, safety groups, and professional organisations should continue to work with manufacturers, regulators, and naming entities to explore opportunities to minimise the LASA risks for drugs that are either new to the market or in the pre-marketing stage. Further information on the hub Take a look at our Error traps gallery on the hub
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Content ArticleA service providing bilingual medication information is helping to reduce healthcare inequalities and medical errors. Pharmacies across London are benefitting from the support of Written Medicine; a service providing bilingual dispensing labels in patients’ language of choice. Founded in 2012, Written Medicine’s software is used by pharmacies and hospitals to translate and print medication information, instructions and warnings. Drawn from a dataset of 3,500 phrases, printed labels are available in fifteen different languages. The bi-lingual labels are supporting patients to take ownership of their treatment; giving them a better understanding of how to take their prescribed medication. The solution is helping to reduce errors, improve medication adherence and enhance patient safety and experience. London North West University Healthcare NHS Trust (LNWH) has been using Written Medicine since 2016, starting from their outpatient pharmacy in Ealing Hospital. The Trust serves an ethnically and linguistically diverse demographic across North West London, which requires interpreting services in over 40 languages, mostly from South Asia, Middle East and Eastern Europe. An audit to assess the quality and impact of the bilingual labelling service at LNWH report in 2019 stated, “post-service questionnaire revealed all patients would like the continuation of the service by their community pharmacies demonstrating the impact it has had in patient empowerment and adherence.”. Poureya Aghakhani, Principal Pharmacist at Ealing Hospital, part of LNWH said, “Patients who are unable to speak English are less likely to understand their doctors, pharmacists and written instructions. This can stop them from taking their medication or may result in them taking it in an unhelpful or dangerous way. “Giving patients information in a language they understand increases awareness around how and when medication should be taken. It empowers individuals to take ownership of their treatment, improving how they manage their conditions and reduces their risk of harm."
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News ArticleValproate-containing medicines will be dispensed in the manufacturer’s original full pack, following changes in regulations coming into effect on Wednesday 11 October 2023. The Medicines and Healthcare products Regulatory Agency (MHRA) has published new guidance for dispensers to support this change. Following a government consultation, this change to legislation has been made to ensure that patients always receive specific safety warnings and pictograms, including a patient card and the Patient Information Leaflet, which are contained in the manufacturer’s original full pack. These materials form a key part of the safety messaging and alert patients to the risks to the unborn baby if valproate-containing medicines are used in pregnancy. The changes follow a consultation on original pack dispensing and supply of medicines containing sodium valproate led by the Department of Health and Social Care (DHSC), in which there was overwhelming support for the introduction of the new measures, to further support safety of valproate-containing medicines. Minister for Public Health, Maria Caulfield, said: “This safety information will help patients stay informed about risks of valproate, and I encourage all dispensers of valproate to consult the new guidance carefully. “This continues our commitment to listening and learning from the experiences of people impacted by valproate and their families and using what we hear to improve patient safety.” Read full story Source: MHRA, 11 October 2023
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Content ArticleThe existence of confusing drug names is one of the most common causes of medication error and is of concern worldwide. With tens of thousands of drugs currently on the market, the potential for error due to confusing drug names is significant. This includes nonproprietary names and proprietary (brand or trade-marked) names. Many drug names look or sound like other drug names. Contributing to this confusion are illegible handwriting, incomplete knowledge of drug names, newly available products, similar packaging or labelling, similar clinical use, similar strengths, dosage forms, frequency of administration, and the failure of manufacturers and regulatory authorities to recognise the potential for error and to conduct rigorous risk assessments for nonproprietary and brand names, prior to approving new product names This article from the WHO Collaborating Centre for Patient Safety Solutions looks at the issues and suggests actions.
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EventMedication errors are a leading cause of patient harm globally. Look-alike, sound-alike (LASA) medicines are a well-recognised cause of medication errors that are due to orthographic (look-alike) and phonetic (sound-alike) similarities between medicines, which can be confusing. Look-alike medicines appear visually the same with respect to packaging, shape, colour and/or size, while sound-alike medicines are similar in the phonetics of their names, doses and/or strengths. Confusions can occur between brand-brand, brand-generic or generic-generic names. Organisations need to prospectively design and implement strategies to identify LASA medication errors and build a robust system that intercepts them before they result in patient harm. At this webinar, WHO will launch their publication “Medication Safety for Look-alike, Sound-alike Medicines”, as part of the WHO technical series on “Medication Safety Solutions”. Preventive strategies that can be implemented by healthcare professionals and organizations will be discussed on how to prevent LASA errors to reduce the risk of medication-related harm. Register
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Content ArticleThe Patient Safety Database (PSD), previously called Anesthesia Safety Network, is committed in the delivery of better perioperative care. Its primary goal is to make visible the lack of reliability of healthcare and the absolute necessity to build a new system for improving patient safety. They have begun by developing an open and anonymous incident reporting system focused on non-technical skills. Each quarter they summarise in their newsletter cases reported on the platform. Read the latest newsletter.
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