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News Article
Precautionary recall of antidepressant medication due to manufacturing error
Patient Safety Learning posted a news article in News
The Medicines and Health products Regulatory Agency (MHRA) has advised healthcare professionals to stop supplying the affected batch of Sertraline 100mg and return all remaining stock to their suppliers. Amarox Limited is recalling one batch of Sertraline 100mg film-coated tablets as a precautionary measure due to a manufacturing error that led to two antidepressant medicines being packaged incorrectly. The recall follows a patient complaint which helped identify that a pack of Sertraline 100mg film-coated tablets contained one blister strip of Citalopram 40mg film-coated tablets inside the sealed carton. Sertraline and citalopram are both selective serotonin reuptake inhibitors (SSRIs) used to treat depression, anxiety disorders, and related mental health conditions by boosting brain serotonin. Both SSRI medications are produced by the same manufacturer, at the same site, and the error appears to have occurred during secondary packaging of the blister strips into the cartons. Patients who believe they have already taken any Citalopram 40mg tablets by mistake or are experiencing side effects, are advised to seek medical advice immediately. Read full press release Source: MHRA, 28 April 2026 -
Content ArticleThis case study is one in a set of NHS England patient safety ‘how we acted on patient safety issues you recorded’ case studies which show the direct action taken in response to patient safety events recorded by organisations, staff and the public, and how their actions support the NHS to protect patients from harm. The National Patient Safety Team identified an incident where the incorrect treatment was given to a patient when the wrong point of care (POC) test strip was used. This led to a ketone result being interpreted as a blood glucose result. Mistaking a ketone value for a blood glucose value can obscure detection of dangerously high levels of ketones in the blood, ultimately leading to a harmful condition called diabetic ketoacidosis (DKA). A review of incident data revealed other examples of wrong strip selection due to their visual similarity, local labelling, and storage issues. The review also showed that some staff didn’t realise that certain POC devices can be used with multiple different strips. Despite the strips meeting design and packaging criteria to prevent such errors, it was clear the potential for errors exists. A request was made to include insight from our review into educational material through the National Association of Medical Device Educators and Trainers (NAMDET) and POC leads. Resources for the management of hospital POC systems also now exist to support the implementation, management, and use of POC devices in clinical practice.
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Content ArticleMedical errors are major hazards, and lapses in non-technical skills such as situational awareness contribute to most incidents. Risks are concentrated in acute care, and in crisis situations clinicians can apparently ignore vital information. Poor workplace ergonomics contributes to risk. Existing work into perceptual errors offers insights, but these phenomena have been little researched in medicine. This thesis considers medical non-technical skills and how they are taught, and explores vulnerability to inattentional and change blindness.
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Content ArticleThe MHRA has reviewed the warnings regarding addiction, dependence, withdrawal, and tolerance for gabapentin, pregabalin, benzodiazepines, and z-drugs. The findings (detailed in the Public Assessment Report) were that it was necessary to strengthen these warnings in the product information and on packaging to better inform healthcare professionals and patients of these known risks. Advice for healthcare professionals: Gabapentinoids (pregabalin and gabapentin), benzodiazepines and z-drugs are three classes of medicines used to treat a variety of conditions such as neuropathic pain, anxiety and insomnia. Specialist use of these medications for conditions such as epilepsy, or sedation during medical procedures are not included in this review. All three classes of medications are known to pose risks of addiction, dependency, withdrawal and tolerance. The Summary of Product Characteristics, Patient Information Leaflets and Outer Packaging of these medicines will have strengthened warnings to better communicate the risks of addiction, dependency, withdrawal and tolerance to healthcare professionals and patients. Updates are in progress and will be rolled out over the coming months. Prior to starting treatment with these medicines, a discussion should be held with patients to put in place a strategy for reducing or ending treatment. By doing this the risk of addiction, dependence, and drug withdrawal syndrome is reduced. NICE guideline, NG215, has resources that include visual summaries which are available to support these discussions. The Agency has also developed additional patient resources for benzodiazepines, gabapentinoids and z-drugs which highlight key messages concerning these risks and should be made available to patients when these medications are prescribed. Addiction and dependence are related but have distinct presentations. Healthcare professionals are reminded of the importance of using non-judgmental language when discussing these terms. Patients may find that treatment is less effective with chronic use and express a need to increase the dose to obtain the same level of symptom control as initially experienced. This could be a sign that the patient is developing tolerance. The risks of developing tolerance should be explained to the patient. Drug withdrawal syndrome may occur upon abrupt cessation of therapy or dose reduction. When a patient no longer requires therapy, it is advisable to taper the dose gradually to reduce symptoms of withdrawal. Tapering from a high dose may take weeks or months. Patients should be informed of this when the medication is first prescribed and should be encouraged to speak to their healthcare professional or prescriber before stopping their medicine. See NICE guideline NG 215 for identifying and managing withdrawal symptoms. Provide regular support especially to individuals at increased risk of drug withdrawal syndrome, such as those with current or past history of substance use disorder (including alcohol misuse) or mental health disorder. Addiction, dependence, withdrawal or tolerance in response to these medications can be reported via the Yellow Card scheme Advice for healthcare professionals to provide to patients: As these medicines carry risks of addiction, dependence and withdrawal reactions, before starting treatment with these medicines, your healthcare professional should explain how long you might need to take them for, and how to stop safely. This helps reduce the risk of addiction, dependence, and drug withdrawal syndrome. Anyone can become physically dependent on these medicines, meaning that their body gets used to it, and this can cause them to have withdrawal symptoms if the medicine is suddenly stopped, or the dose is reduced. Drug addiction can feel like a strong desire to take the medicine, and difficulties in controlling medicine use (for example feeling like you want to take more or use the medicine when you shouldn’t). Addiction and dependence are related but they are not the same, being physically dependent on a medicine does not necessarily mean you are addicted to it. Drug tolerance can mean no longer feeling like the medicine is working well, or feeling that a higher dose is required to achieve the same symptom relief as before. If you want to stop taking your medicine there are additional resources to help you. Never stop taking your medication without asking a healthcare professional first. If you are taking this medicine for epilepsy, you should keep taking it for as long as your doctor says it’s needed. If you find that your treatment is not working as well, you should speak to your healthcare professional about possible alternative treatment options, and you should never take more of your medicine than you have been prescribed. When it is time to stop your medication, your healthcare professional will tell you how to gradually reduce the amount of medicine you are taking over time (known as dose tapering). This is very important to reduce the risk of drug withdrawal syndrome. Dose tapering can sometimes take weeks or months. Mild symptoms may still occur, but you should contact your healthcare professional if the withdrawal symptoms become intolerable.
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Content ArticleGlobally, there is increasing evidence that incorrect penicillin allergy labels negatively affect patient outcomes, antibiotic prescribing and antimicrobial resistance, leading to growing concern about this patient safety issue and how to resolve it. While many millions of patients worldwide have incorrect penicillin allergy labels, there are too few specialist allergists and a lack of ‘point-of-care’ tests to address this problem. Numerous research studies now provide evidence of the feasibility and importance of widening access to penicillin allergy assessment. This article draws on a discussion between researchers from two UK-based studies (SPACE and ALABAMA), in collaboration with key stakeholders including patient representatives, on shaping a high-level implementation plan to facilitate widening access to penicillin allergy assessment in the UK. It describes the basis of the implementation plan and summarises the key actions required for successful delivery.
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Content ArticleStandardised nomenclature for combination formulations could “minimise confusion and prevent medication errors”, suggests the authors of this study. The authors identified 26 combination formulations with ‘co-drug’ names in the UK. Eleven were prescribed more than 2,000 times during 2023, including paracetamol + codeine (co-codamol), which saw an average of 1.26 million items dispensed each month; carbidopa + levodopa (co-careldopa – 114,656 items a month); dihydrocodeine + paracetamol (co-dydramol – 110,506 average monthly items; and amoxicillin + clavulanic acid (co-amoxiclav), with an average of 106,504 items a month. A literature review found examples of errors involving, with decreasing frequency, co-amoxiclav, co-amilofruse, co-beneldopa, co-careldopa, co-codamol, co-dydramol and co-trimoxazole. The authors noted that packaging of co-drugs can also be inconsistent. For example, some co-codamol products do not prominently display the individual active ingredients, while the strength is unclear on others. To reduce the risk of errors, the authors advocate a standardised nomenclature on the box and in prescribing resources so that the international non-proprietary name (INN) of each component is followed by the strengths in the x + y format.
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Content ArticleOn 27 March 2024 an investigation took place into the death of Sewa Kaur Chaddha, then aged 82. Mrs Chaddha had been living with her husband in Slough. They both had a number of physical health conditions requiring multiple prescribed medications. They both had cognitive impairment due to their age. On 5 May 2023 Mrs Chaddha was found collapsed on the floor at their home. It was discovered that she had been taking her husbands medication instead of her own for several days, including diabetes medication. Her blood sugar levels were found to be extremely low. She died on 10 May 2023 at Wexham Park Hospital of hyponatraemia caused by the necessary treatment for hypoglycaemia which was in turn caused by the accidental ingestion of hypoglycaemic medication. The investigation concluded at the end of the inquest on 24 May 2024. The conclusion of the inquest was accident, the medical cause of death being: I a Hyponatraemia I b Treatment for hypoglycaemia I c Ingestion of hypoglycaemic medication II Frailty of old age, decompensated heart failure, cognitive impairment. Matters of Concerns The medications were provided to the couple by the local pharmacy, then known as Lloyds Pharmacy, in separate dosset boxes. Mrs Chaddha’s medications were provided on a weekly basis. Mr Chaddha’s were provided on a monthly basis. Both patients were elderly and had cognitive impairment. (The two patients’ dosset boxes were identical to each other except for a small pharmacist’s label with small type with the relevant patient’s name. Mrs Chaddha used one of Mr Chaddha’s dosset boxes, rather than her own, for several days. Evidence was given at the inquest that there was no guidance or policy in place for Pharmacists to follow when issuing medication to patients with cognitive impairments, or if there was, it was not well disseminated among the pharmacist population. Evidence was given at the inquest that dosset boxes of different colours or labels with different colours were not routinely given to elderly or cognitively impaired patients living at the same address.
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Patient Safety Learning posted a gallery image in Medication
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Content ArticleThis investigation aims to improve patient safety by supporting healthcare staff in a surgical setting to select and insert the appropriate type of implant (vascular graft) for haemodialysis treatment. The Healthcare and Safety Investigation Branch (HSIB) explored the factors that affect the ability of staff to safely select and insert vascular grafts for haemodialysis treatment. The national investigation focused on: The identification of factors within the healthcare system as a whole that influence patient safety risks associated with the selection and insertion of vascular grafts in an operating theatre environment. Exploration, using a systems approach, of the design of labelling and packaging used for the different types of vascular grafts for patients on haemodialysis treatment. Exploration of the impact on operating theatre teams of staff redeployment and repurposing of working environments in response to the COVID-19 pandemic. Reference event Teri had chronic kidney disease and needed regular haemodialysis. He had previously received haemodialysis via a connection between an artery and a vein. However, this connection was failing due to narrowing of the blood vessels and she needed to have a vascular graft implanted so that her treatment could continue. Teri was referred to her local hospital for insertion of a ‘rapid access’ type of vascular graft, to enable her haemodialysis treatment to be carried out as planned. Before Teri’s operation, a consultant vascular surgeon and members of the operating theatre team went to the store cupboard to look at the types of vascular grafts stocked. The consultant vascular surgeon was not sure which size would be needed, so two different sized vascular grafts were selected. However, it was not recognised at the time that they were different types of vascular graft, with one being the intended rapid access type and the other a delayed use graft. Following surgery, the consultant vascular surgeon immediately realised that a delayed use vascular graft had been inserted instead of a rapid access graft. Because the wrong type of vascular graft was inserted, Teri needed to have another surgical procedure and an overnight stay in hospital, which may not have otherwise been needed. Findings The packaging of rapid access and delayed use vascular grafts may be very similar, resulting in an increased risk of staff selecting and inserting the wrong type of graft. The wording used on packaging and labels to describe vascular grafts does not reflect the terminology used by clinicians in the operating theatre. There is Medicines and Healthcare products Regulatory Agency (MHRA) guidance for the labelling and packaging of medicines, but not for medical devices such as vascular grafts. There was a lack of standardisation and therefore variation in how checklists and ‘team briefs’ (procedures that aim to ensure patient safety) were completed/ conducted and recorded in different operating theatres. The incorporation of national safety standards alone may not be successful without an embedded safety culture being in place. Barcode scanning technology (Scan4Safety) can be used to mitigate the risk of an incorrect medical device being selected/inserted. Due to the reduced central management of the Scan4Safety programme, trusts have been developing applications and using adaptations of the scanning technology, resulting in inconsistent use and variable effectiveness. Safety recommendations HSIB made four safety recommendations as a result of this investigation. HSIB recommends that NHS England reviews system requirements for barcode scanning technology, in order to support local organisations to reduce the risk of incorrect selection and insertion of prostheses/implants. HSIB recommends that the British Standards Institution updates the applicable standard/s, and raises with the International Organization for Standardization, to state that medical device labelling and packaging should detail the specific use of an item. This should be developed with user input to drive consistency in the terminology used on medical device labelling/packaging. HSIB recommends that the Medicines and Healthcare products Regulatory Agency ensures the assurance processes for designated approved bodies (to check medical device manufacturers conform to packaging standards) are amended to consider context of use and usability guidelines, to reduce the risk of selecting and inserting the incorrect device. HSIB recommends that the Medicines and Healthcare products Regulatory Agency publishes guidance on the labelling and packaging of medical devices, to promote best practice and reduce selection of the incorrect item. Safety observations HSIB makes the following safety observations: It may be beneficial if the term ‘user’ in the context of medical devices was defined in international and national standards to incorporate all staff who interact with the device, including those who select the device, check it before use and use it. It may be beneficial for healthcare organisations to deliver multi-disciplinary team training on the key principles of the revised ‘National safety standards for invasive procedures’ to support the implementation and embedding of these standards. It may be beneficial for trusts to assign experienced operating theatre clinicians to lead on the implementation of the ‘National safety standards for invasive procedures’, to address the cultural issues hindering implementation. Related resources on the hub: NatSSIP2 sequential steps: The NatSSIPs Eight – Flow chart Error traps gallery
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Content ArticleSexual dysfunction is a common side effect of Serotonergic antidepressants (SA) treatment, and persists in some patients despite drug discontinuation, a condition termed post-SSRI sexual dysfunction (PSSD). The risk for PSSD is unknown but is thought to be rare and difficult to assess. This study, published in the Annals of general psychiatry, aims to estimate the risk of erectile dysfunction (ED) and PSSD in males treated with SAs.
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Content ArticleA set of enduring conditions have been reported in the literature involving persistent sexual dysfunction after discontinuation of serotonin reuptake inhibiting antidepressants, 5 alpha-reductase inhibitors and isotretinoin. The objective of this study, published by the International Journal of Safety and Risk in Medicine, was to develop diagnostic criteria for post-SSRI sexual dysfunction (PSSD), persistent genital arousal disorder (PGAD) following serotonin reuptake inhibitors, post-finasteride syndrome (PFS) and post-retinoid sexual dysfunction (PRSD).
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Content Article
This opinion piece is by Luke* who suffers from post-SSRI sexual dysfunction (PSSD) after he was prescribed a selective serotonin reuptake inhibitor (SSRI) antidepressant. Luke introduces the condition, drawing on the experiences that others have shared through PSSD communities, to highlight the devastating impact on patients. He calls for widespread recognition, improved risk communication and better support for sufferers. *Name has been changed I am Luke. I’ve been suffering with PSSD for more than 10 years. My life has been drastically altered. I am now an active member of the PSSD UK patient group and PSSD Network, through which I help raise awareness and support fellow sufferers in the hope that our situations can improve and a cure can be found. Post-SSRI sexual dysfunction Post-SSRI sexual dysfunction (PSSD) is a disorder in which individuals, who have been administered selective serotonin reuptake inhibitors (SSRIs) or other serotonin reuptake-inhibiting (SRI) drugs, experience persistent changes in sexual function and/or genital numbness for an extended period after ceasing to take the drug. Although it is most commonly caused by SSRIs (a widely prescribed group of antidepressants), cases have also been reported following the use of serotonin-norepinephrine reuptake inhibitors (SNRIs), SRI tricyclic antidepressants, SRI antihistamines, tetracycline antibiotics such as doxycycline, and analgesics such as tramadol.[1] Antidepressants have been known for some time to impact sexual function (while being taken) and this risk is included, to some extent, in the medication information. However, the risk of long-term impact to sexual function, after a person ceases to take the medication, has lacked widespread recognition for many years despite being highlighted by patients and researchers around the world.[2,3,4] Awareness remains poor despite some formal recognition In 2019, the European Medicines Agency formally recognised that sexual dysfunction can persist beyond discontinuation of SSRI and SNRI antidepressants[5]. The Pharmacovigilance Risk Assessment Committee stated: “Sexual dysfunction, which is known to occur with treatment with SSRIs and SNRIs and usually resolves after treatment has stopped, can be long-lasting in some patients, even after treatment withdrawal.”[6] Despite this, awareness is still very poor and formal recognition still does not exist in most countries. Although some urologists and sexual medicine specialists seem familiar with the condition, many general practitioners have not heard of PSSD. Psychiatrists often dispute the legitimacy of the illness or claim that it is exceedingly rare, but don’t have any data to prove the prevalence. For a long time, PSSD has been dismissed by many doctors as being a psycho-somatic illness – for example, the result of untreated depression. It is still typical for patients to be disbelieved like this, despite the clear distinction between the diagnostic criteria for clinical depression and the diagnostic criteria that has been developed by researchers for PSSD.[7] The latter outlines two ‘necessary’ criteria for PSSD to be diagnosed. (1) Prior treatment with a serotonin reuptake inhibitor. (2) An enduring change in somatic (tactile) or erogenous (sexual) genital sensation after treatment stops. ‘Additional’ criteria includes: Enduring reduction or loss of sexual desire. Enduring erectile dysfunction (males). Enduring inability to orgasm or decreased sensation of pleasure during orgasm. The problem is present for ≥3 months after stopping treatment. Also listed are both sexual and non-sexual symptoms of PSSD as per below: genital pain reduced nipple sensitivity decreased or loss of nocturnal erections (males) reduced ejaculatory force (males) flaccid glans during erection (males) decreased vaginal lubrication (females) emotional numbing depersonalisation other sensory problems involving skin, smell, taste or vision. The lack of awareness amongst the medical community also means that there is no available treatment or support for PSSD sufferers, who will often turn to the internet for help. Many sufferers, desperate to improve things, end up trialling a variety of drugs and supplements, some of which seem to make symptoms permanently worse. Medication labelling and communicating risk Only Canada and the EU countries (plus post-Brexit Britain) require any warning of persistent sexual side effects on the drug labels. In the rest of the world, there are still no warnings about persistent sexual side effects of SRI antidepressants. Non-English speakers have additional challenges finding information about PSSD, even online. With so many doctors still unaware of the illness, the risks are frequently not being communicated to patients, meaning they can’t possibly give informed consent when taking antidepressants as prescribed. A community abandoned (Image: PSSD Network photo campaign) PSSD sufferers in our communities are absolutely desperate. They feel lied to, mistreated and abandoned. We know from those with lived experience that PSSD often includes complete loss of libido and ability to function sexually, complete emotional dysfunction (anhedonia) and cognitive dysfunction. This frequently results in the breakup of existing romantic relationships and extreme difficulty in forming new ones. PSSD sufferers can find it hard to bond and connect emotionally with others due to emotional dysfunction, and struggle to find any kind of enjoyment in activities that were previously enjoyable. It can cause alienation from friends and family. Some are unable to continue working due to severe cognitive impairments. They often describe it as like being chemically castrated and lobotomised, bearing no resemblance to the experience of suffering clinical depression. Despite PSSD being a result of a prescribed medication, sufferers frequently report being gaslit by doctors, who have typically claimed that their complaints are really symptoms of underlying depression. However, patients prescribed SRI antidepressants for conditions as diverse as irritable bowel syndrome, nerve pain and premenstrual dysphoric disorder have also developed PSSD. These harmful attitudes, and the lack of any known treatment or available support, makes PSSD sufferers feel like there is no hope. Some have ended up taking their lives as a result of PSSD, despite never having been suicidal at any point in their lives previously. Improvements needed Thankfully, further research[8] and an increase in media coverage in the UK,[9] including a recent Panorama documentary, are helping draw attention to this issue and change attitudes. There needs to be further action taken if we are to see long-lasting improvements in the care and treatment of patients with PSSD. I would like to see: Widespread acknowledgement of the condition. Doctors provided with up-to-date information and training (informed by lived experience) on the dangers of antidepressants and how to support patients. Warnings on instructions for the medications updated and prescribing clinicians alerted to ensure patients are adequately informed. An awareness and media campaign launched targeting patients, prescribers and the public. Funding secured for research that helps us gain an understanding of the underlying pathophysiology, identification of a diagnostic biomarker and, eventually, a cure for PSSD. Doctors listening to patients so they can understand how PSSD is a life-changing condition and be able to refer to support services. PSSD is a modern-day tragedy which devastates the lives of sufferers and their families. There are people with this condition who still don’t know that there is a name for it and more of them come out of the woodwork with each new media mention. It is vital that the medical community begins listening and supporting sufferers, and researching a cure before more lives are lost. How you can help I’d encourage you to visit the PSSD Network website to help you understand PSSD and our campaigning work. Clinicians can offer their support by watching this powerful podcast made by PSSD sufferers, discussing the issue with their healthcare organisation and by joining the list of doctors and specialists acknowledging the condition. Researchers can get involved by contacting PSSD network or RxISK. Patients can speak out about PSSD using the initiatives under the ‘take action’ section of the PSSD Network website. Anyone can donate to research via the RxISK website or PSSD Network. References Healy D, Bahrick A, Bak M et al. Diagnostic criteria for enduring sexual dysfunction after treatment with antidepressants, finasteride and isotretinoin. Int J Risk Saf Med. 2022;33(1):65-76. Healy D. Post-SSRI sexual dysfunction & other enduring sexual dysfunctions. Cambridge University Press, 2019. Access online 18/09/2023. Healy D, Le Noury J and Mangin D. Enduring sexual dysfunction after treatment with antidepressants, 5α-reductase inhibitors and isotretinoin: 300 cases. Int J Risk Saf Med. 29 (2018) 125–134. PSSD UK. Our stories. Accessed online 18/09/2023. Pharmacovigilance Risk Assessment Committee (PRAC). New product information wording – Extracts from PRAC recommendations on signals. European Medicines Agency. 2019. Lane C. Post-SSRI Sexual Dysfunction Recognized as Medical Condition. Psychology Today. 2019. Accessed online 18/09/2023. Healy D, Bahrick A, Bak M et al. Diagnostic criteria for enduring sexual dysfunction after treatment with antidepressants, finasteride and isotretinoin. Int J Risk Saf Med. 2022;33(1):65-76. Ben-Sheetrit J, Hermon Y, Birkenfeld S at el. Estimating the risk of irreversible post-SSRI sexual dysfunction (PSSD) due to serotonergic antidepressants. Ann Gen Psychiatry 22, 15 (2023). 9. RxISK. Media Articles: PSSD & Related Conditions. Accessed online 18/09/2023. Do you have an experience or insights to share? Have you ever experienced adverse and/or long-lasting side effects of a medication you were prescribed that you didn't feel you adequately warned about beforehand? Perhaps you are a prescribing clinician who can share some of the challenges and complexities involved in medication safety? What did you think of the points raised and calls to action in Luke's article? Please comment below (sign up first for free) or get in touch with us at [email protected] to tell us more.- Posted
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Content ArticleThe Medicines and Healthcare products Regulatory Agency issued this guidance following recent cases, including cases with fatal outcomes, in which patients have received the wrong medicine due to confusion between similarly named or sounding brand or generic names. Advice for healthcare professionals: be extra vigilant when prescribing and dispensing medicines with commonly confused drug names to ensure that the intended medicine is supplied if pharmacists have any doubt about which medicine is intended, contact the prescriber before dispensing the drug follow local and professional guidance in relation to checking the right medicine has been dispensed to a patient report suspected adverse drug reactions where harm has occurred as a result of a medication error on a Yellow Card or via local risk management systems that feed into the National Reporting and Learning System.
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News Article
‘Horrifying’ failure to provide safety warnings for high-risk medicine
Patient Safety Learning posted a news article in News
Concerns have been raised that patients may not be receiving “vital” safety information after HSJ discovered a high-risk medication was frequently not being dispensed as originally packaged. In 2018, the Medicines and Healthcare Products Regulatory Agency asked pharmacies to dispense valproate-containing medications in their original pack where possible, to ensure packages include safety warnings. It also asked manufacturers to produce smaller pack sizes and add pictorial warnings, while pharmacists were additionally asked to add stickered warnings to the outer box of any valproate-containing medication not dispensed in its original packaging. Yet, data obtained via freedom of information requests to the NHS Business Services Authority revealed that while the proportion and number of valproate-containing items dispensed as split packs – as opposed to whole packs – had decreased over the last five years, split packs still accounted for more than half of items dispensed in 2022-23. Emma Murphy, of campaign group In-Fact, said the figures on split pack dispensing were “quite horrifying” and showed “the system is not working”. She added: “Attitudes have got to change – prescribers, GPs etc need to be proactive and warn women of the risks because this isn’t just a side effect, this is harming real babies. As a mum of five affected children, the consequences of valproate in pregnancy on that baby is devastating.” Alison Fuller, of Epilepsy Action, said the high proportion of split packs being dispensed made it “clear why the change in guidance introduced in October 2023 was necessary”, adding: “The manufacturer’s original full pack always contains all the relevant information, which is why it’s the best option for patient awareness.” Read full story (paywalled) Source: HSJ, -
News Article
NHS hospitals ordered to remove drug after mistakes led to two baby deaths
Patient Safety Learning posted a news article in News
All NHS hospitals in England have been told to destroy a powerful medicine mistakenly used by staff because its packaging looks the same as another drug. A national safety alert was issued following several incidents, including two deaths of babies, in which patients were inadvertently given a dose of sodium nitrite – which is used as an antidote to cyanide poisoning – rather than sodium bicarbonate. The errors are thought to have been caused by similarities between the labelling and drug packaging used by manufacturers. Now hospitals have been told to check all wards and medicine storage areas for sodium nitrite and to destroy any of the unlicensed product. The drug should only be available in emergency departments and may have been supplied to medical wards by mistake. There are an estimated 237 million medication errors in the NHS every year – with a third linked to packaging and labelling. Read full story Source: The Independent, 9 August 2020 -
News Article
Not enough pharmacists are aware of the yellow card scheme
Clive Flashman posted a news article in News
Every pharmacist must report adverse drug reactions using the yellow card scheme, says chair of the Community Pharmacy Patient Safety Group, Janice Perkins Polypharmacy, when different medications are used by an individual at the same time, is becoming increasingly common because people are living for longer and with multiple different illnesses. One study, published in 2018 by the Oxford University Press, found that over half (54%) of those aged 65 years and above who took part in the study had two or more long-term conditions, for which they could have been taking a range of medicines. Read full story Source: Community Pharmacy News, 17 February 2020 -
News Article
Boots criticised over pill boxes for the elderly
Patient Safety Learning posted a news article in News
Some pharmacies run by the High Street chain Boots have been criticised for telling some patients on multiple drugs that they can no longer have blister pack boxes, known as dosette boxes or multi-compartment compliance aids (MCCAs). Weekly pill organisers can help users keep track of their daily medication and stay safe. Pharmacists put the tablets into individual boxes in the trays, each one indicating when they should be taken. The NHS says boxes are not always available for free on the NHS and they're not suitable for every type of medicine. Tracey Hobbs' mother, Pat Garner, lives at home with care visits. For several years, she has had her MCCAs provided by her local Boots pharmacy. She takes more than 15 pills each day. Tracey says she was phoned by Boots and told that from one month later her mother would receive all the drugs in the original packaging, rather than organised into morning and night doses for each day of the week. Tracey told the BBC: "I pointed out that the blister packs were the only way we could know she had taken her medication at the right time. Handing seven individual boxes with different instructions on each one was totally unworkable and - quite frankly - dangerous". A Boots spokesperson said: "The latest Royal Pharmaceutical Society guidance indicates that the use of multi-compartment compliance aids is not always the most appropriate option for patients that need support to take their medicines at the right dose and time." "Pharmacists are speaking with patients who we provide with MCCAs to discuss whether it is the right way to support them, depending on their individual circumstances and clinical needs." Prof Gill Livingston, an expert in elderly medicine at University College London, said she was concerned to hear that some patients and their families were being told the boxes were being scrapped. She said: "Blister packs enable people with mild dementia or some memory problems to take their own medication and remain independent. They can check that they have taken it and they know they have taken the right thing, as it is already sorted out. "Later on in dementia or with other disabilities, it enables paid carers and families to help them take their medication and remain in the community and remain as well as possible." Read full story Source: BBC News, 21 June 2022 -
Content ArticleThis was the first Chartered Institute of Ergonomics and Human Factors (CIEHF) Pharmaceutical Sector group organised event, where the systems and human factors challenges of labelling and packaging were discussed by a wide-ranging audience across the healthcare and pharmaceutical sectors. The attached report summarises the event. Morning presentations included a keynote address from Professor Coleman, University of Birmingham, and a moving and inspiring presentation from Lisa Richards-Everton, a Patient Safety Campaigner. Delegates then participated in a taster workshop looking at challenges around labelling and used the SIEPS 2.0 model to conduct a systems analysis of the management of a patient’s condition. The afternoon branched into parallel syndicate workshops with the first workshop focusing on training and education around labelling; what challenges needed addressing with training, and how a human factors approach could optimally start to address these training issues. The second workshop looked to identify and discuss challenges around the medicine label and how these could be addressed using a human factors approach. This included looking at some of the issues that exist with current labelling design, before discussing what information is necessary and then providing recommendations for the design from a human factor’s perspective. All syndicate groups gave recommendations for next steps to address these challenges, which were shared at the conclusion of the meeting. Several delegates then volunteered to be involved in a steering team, whose remit would be to address the identified challenges by exploring ways in which these systembased recommendations might be implemented. Recommendations around training perspectives included areas such as education and communication; system redesign, use of technology and recommendations about the design of medical packaging with a human factors approach.
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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 ArticleIn Calgary, each of the three acute-care adult hospitals had different anesthetic medication carts with their own type and layout of anaesthetic medications. A number of anaesthesiologists moved among the different sites, increasing the potential for medication errors. The objective of this study from Schultz et al., published in the Canadian Journal of Anesthesia, was to identify the anesthetic medications to include and to determine how they should be grouped and positioned in a standardised anesthesia medication cart drawer. Implementation of the standardised medication drawer is expected to reduce the likelihood of medication errors. Future research should include testing the clinical implications of this standardization and applying the methodology to other areas.
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Content ArticleKathleen Sutcliffe is a Bloomberg Distinguished Professor at Johns Hopkins University and the co-author of a forthcoming book Still not safe: patient safety and the middle-managing of American medicine (Oxford University Press). This blog discusses the barriers in tackling some of healthcares biggest patient safety problems - medication labelling and drug errors to name just one. It highlights the need to listen to experts outside of healthcare as localised solutions do not solve the wider, more complex issues of patient safety.
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Content ArticleThe Institute for Safe Medication Practices (ISMP) is the only US nonprofit organisation devoted entirely to preventing medication errors. In this short video, produced by ISMP in partnership with the Temple University School of Pharmacy, experts discuss current medication safety concerns and offer practical error prevention recommendations. This issue (episode 3) focuses on: safe administration of concentrated insulin products errors with confusing product labelling educating patients about safe medication practices.
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Content ArticleThe Institute for Safe Medication Practices (ISMP) is the only nonprofit organisation in the US devoted entirely to preventing medication errors. In this video, produced by ISMP in partnership with the Temple University School of Pharmacy, experts discuss medication safety concerns and offer practical error prevention recommendations. This issue (episode 2) focuses on: the most common safety issues associated with measuring patient weight steps to eliminate drug concentration confusion understanding Patient Care Analgesia (PCA) by proxy.
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Content ArticleGuidance from the Medicines and Healthcare products Regulatory Agency (MHRA), explains how to package medicines for sale and what information you must provide to consumers and healthcare professionals. Overview Labelling for medicines Safety features legislation Patient information leaflets (PILs) Warnings on labels and leaflets for medicines Braille on labelling and in PILs Child resistant packaging for medicines Submit information for full assessment Notification scheme registration Fees Make a submission or notification Complaints about labels, leaflets or packaging UK and European regulation
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Content ArticleSeveral factors contribute to medication errors in clinical practice settings, including the design of medication labels. The objective of this study from Estock et al., published in the Journal of Patient Safety, was to quantify the impact of label design on medication safety in a realistic, high-stress clinical situation.
