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Content ArticleOne way pharmaceutical companies try to prolong revenue streams from their expensive brand-name drugs is by using various strategies collectively referred to as “product hopping.” Product hopping involves creating new formulations of existing drugs using the same active ingredients and then switching patients to the new product, often as generic competition is set to emerge. Product-hopping strategies include switching from a tablet to a capsule, switching from a short- to a long-acting form or incorporating new inactive ingredients. Some may offer incremental benefits, but all lead to greater spending by patients and the health care system. A new form of product hopping—drug versioning—may have crossed a line at which the desire to maximise profits led to patient harm. Drug versioning is when a manufacturer delays a new version of an existing product to maximise profits from an older one. In this JAMA article, S. Sean Tu and Timothy Bonis describe at a recent California lawsuit against the pharma company Gilead, which is accused of delaying the release of a safer medication to treat HIV in order to maximise the profits from its existing licensed product. They look at the benefits of preventing unethical, negligent drug versioning, which include avoiding unnecessary patient deaths and enabling timely access to affordable generic medicines.
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Content Article
Top picks for Healthcare Science Week
Patient Safety Learning posted an article in Patient Safety Learning
Healthcare Science Week, 10–16 March 2025, brings together over 50 scientific specialisms and professional groups to celebrate and raise awareness of this diverse NHS workforce. These experts play a crucial role in diagnosing diseases, developing treatments and ensuring the effectiveness of medical technologies. Their work is essential for patient care. To celebrate Healthcare Science Week, Patient Safety Learning has pulled together 13 blogs and interviews published on the hub showcasing the important work healthcare professionals, scientists and researchers are doing to improve patient safety. 1. Decoding diabetes research – an innovative approach that makes scientific knowledge accessible to everyone D-Coded is an online resource that presents easy-to-understand summaries of diabetes research studies. It aims to make the latest knowledge and developments accessible to people who don't have a medical or scientific background. In this blog, Jazz Sethi, Founder and Director of the Diabesties Foundation and part of the global team that developed D-Coded, discusses the need for the resource and outlines how it will help people living with diabetes to better understand and manage their condition. 2. WireSafe®: Designing a new patient safety solution WireSafe® is an innovative solution designed to prevent retained guidewires during central venous catheter (CVC) insertion. Retained guidewires are never events that require urgent removal if accidentally left in. They occur in about 1 in 300,000 procedures. We interviewed Maryanne, who developed the WireSafe®, on the innovation, the human factor considerations in designing it and the difficulties she faced getting a new product into the NHS. 3. Using barcode scanning technology to improve blood group testing in unborn babies In this blog, the NHS Blood and Transfusion (NHSBT) and the Scan4Safety Team in the NHS England National Patient Safety Team explore how barcode scanning technology has improved testing for the D blood group in unborn babies. This technology has made the process more efficient, reduced errors and improved patient experience. 4. Patient Safety Spotlight interview with Chidiebere Ibe, medical illustrator and medical student Chidiebere Ibe is passionate about increasing representation of Black people in all forms of medical literature. In this interview, he explains how lack of representation at all levels of the healthcare system leads to disparities in healthcare experiences and outcomes. He outlines the importance of speaking openly about how racial bias affects patient safety, and argues that dispelling damaging myths about particular patient groups starts with equipping people with accurate health knowledge from a young age. 5. Applying a robust approach to digital clinical safety in diagnosis Diagnostics and digital go hand in hand. Digital healthcare has brought so many advancements in diagnostics and we are at the point of another paradigm shift with the advancements in artificial intelligence (AI), with some early and convincing diagnostic-use cases. New things also bring (new) risks. Some we can predict and plan for, perhaps some we haven’t, and some we can’t yet. In this blog, Ben Jeeves, Associate Chief Clinical Information Officer and Clinical Safety Officer, looks at the digital clinical safety aspects in relation to diagnostic safety. 6. Lost tissue samples a thing of the past with new innovative tracking system? The stress and anxiety felt by patients awaiting a potential cancer diagnosis can be made much worse if they are told their sample has been lost. Delays can impact treatment options and patient outcomes. Dil Rathore is a Biomedical Scientist and Pathology Innovation Lead at Leeds Teaching Hospitals NHS Trust. In this interview, he tells us about a new tracking system he’s developed to reduce the number of patient tissue samples going missing. 7. Medical device safety: effective testing is key In this blog, University of Sheffield based researcher Dr Nicholas Farr explains why investing in the development of testing methods is key to ensuring medical devices are safe to use. Nicholas and colleagues at the University of Sheffield have developed innovative testing methods that mimic key features of the human body within the lab. He believes this will improve our understanding of the materials being used in the development of medical devices at an early stage in the process – saving time and money, and reducing the risk of patient harm. 8. “Our message about public involvement is don’t be afraid to start.” Interview with Barbara Molony-Oates from the NHS Health Research Authority In this interview, we speak to Barbara Molony-Oates, public involvement manager at the Health Research Authority about why it's important to involve patients and members of the public in health research. Barbara tells us about the Shared Commitment to Public Involvement, a partnership of research organisations working together to promote, support and improve public involvement in health and social care research. She describes how the Shared Commitment was developed and how it is helping researchers involve individuals and communities who have never before considered taking part in research. 9. Coil procedures: Exploring negative experiences through qualitative research Trainee Clinical Psychologist, Sabrina Pilav tells us about her latest research project exploring negative experiences of coil/ intrauterine device (IUD) procedures. Sabrina explains how their in-depth qualitative methodology could contribute to improvements in the future. 10. Patient Safety Spotlight interview with Mark Sujan, Chartered Ergonomist and Human Factors Specialist Mark talks to us about how he came to work in healthcare, the vital role of safety scientists and human factors specialists in improving patient safety, and the challenges involved in integrating new technologies into the health system. 11. Improving diagnostic safety in surgery: A blog by Anna Paisley Safe diagnosis requires the gathering of information from multiple sources, including clinical history, examination, and laboratory and radiological tests. This information must then be distilled and interpreted to form a working diagnosis for treatment or further investigation. In this blog, Anna Paisley, a Consultant Upper GI Surgeon, talks about the challenges to safe surgical diagnosis and shares some of the strategies available to mitigate these challenges and aid safer, more timely diagnosis. 12. CardMedic: Empowering staff and patients to communicate across any barrier In this interview, anaesthetist Rachael Grimaldi tells us about CardMedic, the organisation she founded to empower staff and patients to communicate across any barrier. Rachael explains how their tools can be used to support vulnerable groups and reduce inequalities. 13. Implementation of bedside electronic transfusion checks at Barts Health Trust: Quantifying benefits In this blog, Laura Green, Consultant Haematologist at NHS Blood and Transplant and Barts Health NHS Trust, describes how a new electronic process to improve the safety of blood transfusions was implemented across all four Barts Health sites. She explains why the new system was needed, outlines the benefits for staff and patients and highlights the role of project governance and staff training in successful implementation. Can we help you with your research? Where the topic is relevant to patient safety, we can work with researchers in a number of ways: To help recruit participants To share links to published papers via the hub and through our social media. To create content (blogs, interviews, videos) that help provide context around findings or research projects. Contact the hub team at [email protected] to discuss further. -
Content ArticleIn the US, compounding drugs are medications produced by compounding pharmacies, who typically make personalised versions of medications, such as custom dosages, combinations or allergen-free options. In this JAMA article, US journalist Kate Ruder looks at patient safety concerns linked to the rapid increase in demand for anti-obesity medications including semaglutide and tirzepatide. Kate highlights how high demand, ensuing scarcity, prohibitive costs and restrictive insurance coverage have fuelled the production of compounded versions of these medications under a provision allowing compounding pharmacies to make copycats during drug shortages. Concerns have been raised about the quality of ingredients, accuracy of doses and the supply of counterfeit medications by companies selling fake products, as well as about the potential for user error when they give themselves the medication.
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News ArticleThe pharmaceutical watchdog has reprimanded Wegovy maker Novo Nordisk for failing to correctly disclose dozens of payments to the UK health sector as it sought to boost sales of its slimming drugs. The Danish drug giant – Europe’s most valuable listed company – systematically misreported, under-reported or did not disclose funding given over seven years to pharmacy firms, obesity charities, training providers, professional bodies and patient groups. Even after admitting to errors and conducting an internal review, it failed to accurately report its spending. The company has now been formally reprimanded by the Prescription Medicines Code of Practice Authority (PMCPA), which said it had brought the industry into disrepute. Finding 48 breaches of the industry code, it said serious compliance failings – committed while Novo Nordisk was already the subject of an audit after previous breaches – “raised questions about the culture of the company and demonstrated poor governance and a lack of care”. It said that “by failing to publicly disclose payments, inaccurately reporting and misreporting payments to healthcare organisations and patient organisations over an extended period of time”, it “had brought discredit upon, and reduced confidence in, the pharmaceutical industry”. Read full story Source: The Guardian, 26 January 2025
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Content ArticleIt is widely recognised that pharmaceutical marketing contributed to the ongoing US opioid epidemic, but less is understood about how the opioid industry used scientific evidence to generate product demand, shape opioid regulation and change healthcare professionals' behaviour. This qualitative study looks at select scientific articles used by industry to support safety and effectiveness claims and uses a novel database, the Opioid Industry Documents Archive, to look at industry and non-industry documents citing the scientific articles to advance each claim. The authors found that 15 scientific articles were collectively mentioned in 3666 documents supporting five common, inaccurate claims: Opioids are effective for treatment of chronic, non-cancer pain. Opioids are “rarely” addictive. “Pseudo-addiction” is due to inadequate pain management No opioid dose is too high Screening tools can identify those at risk of developing addiction. The articles contributed to the eventual normalisation of these claims by: symbolically associating the claims with scientific evidence building credibility expanding and diversifying audiences and the parties asserting the claims obfuscating conflicts of interest. These findings have implications for regulators of industry products and corporate activity and can inform efforts to prevent similar public health crises.
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Content ArticleThere is growing national interest in the potential for wider and deeper partnerships between the NHS and life sciences sector. The UK life sciences industry is a significant asset and there is a sense that more could be done to bring its strengths together with the NHS to improve both the nation’s health and economic prosperity. This King's Fund report examines how the NHS can collaborate with industry partners in the life sciences sector by exploring four case studies of collaborative working projects between NHS organisations and pharmaceutical companies (a well-established and codified way for the NHS and industry to work in partnership). Between February and August 2024, 18 people involved in these projects were interviewed and relevant documents reviewed to understand the experience and impact of the partnerships. The report found that, in the right circumstances, these partnerships can be powerful catalysts for improvement, bringing benefits for patients, staff and services. The involvement of industry can bring much-needed resource to pump-prime change, as well as access to valuable skills and expertise. Making a success of these partnerships is not easy: it requires significant time and effort from all partners, as well as a high level of rigour around the design and delivery of projects. Our work suggests NHS–industry partnerships could bring benefits if used more widely and on a more strategic basis. This will require NHS and industry bodies to create a supportive context and put in place practical support at local and national levels, addressing key issues around openness and trust, access and experience, and leadership and oversight.
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News Article
Women plan UK legal action over talc cancer claims
Patient Safety Learning posted a news article in News
Hundreds of women in the UK are planning to take on one of the world's biggest pharmaceutical companies over alleged links between talc and cancer. Diagnosed with ovarian cancer in 2021, Cassandra Wardle is one of the women launching a group action against the biggest seller of talcum powder, Johnson & Johnson (J&J). Cassandra, who stumbled on a Facebook article linking cancer and talc following her diagnosis, said it was used on her as a baby and she continued to use it "for 20 years or more". If it proceeds, the legal action would be the first of its kind brought against the pharmaceutical multinational in the UK. With 1,900 potential claimants, including cancer patients, survivors and families, lawyers say it is set to be the largest pharmaceutical product group action in English and Welsh legal history. The BBC has spoken to a number of women with gynaecological cancers - many are part of the group action - who believe their repeated use of talcum powder played a part in their diagnosis. Their lawyers allege that for decades, talcum powder was contaminated with cancer-causing asbestos - something they claim J&J was aware of but sought to suppress. J&J denies suppressing any information and denies any links between its baby powder, asbestos and cancer. Read full story Source: BBC News, 20 November 2024 -
Content ArticleThis policy brief from the Institute for Policy Research recommends key legislative reforms to enhance financial transparency in industry-NHS collaborations. The Government faces a key balancing act: growing a world-leading life sciences sector while safeguarding patients from the risks posed by financial conflicts of interest between pharmaceutical and medical device companies and the NHS, its staff and professional bodies. Ensuring full transparency of these ties is essential, but the current disclosure system, created and overseen by the industry, does little to address these risks. Independent research and the Independent Medicines and Medical Devices Safety Review have highlighted its failures. In addition, cases of avoidable patient harm and instances of major companies failing to disclose payments underscore the urgent need for reform. The Government’s proposals in 2023 offered only modest improvements. This policy brief, written by a team of international academic researchers and UK-based patient advocates, recommends legislative changes in three key areas based on patient experience, international best practices and research evidence. The reforms will promote transparency by being comprehensive, enforceable and actionable. In so doing, they will support the Government’s core missions to strengthen the NHS and drive investment in life sciences. Following the scope of the IMMDS Review, the reforms focus on England, but their core transparency principles are relevant for all devolved administrations within the UK.
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Content ArticleAn analysis by The BMJ has found that pharmaceutical companies pay tens of millions of pounds to the NHS each year without the public being told what the payments are for. The findings have led to calls for a shake-up of current transparency rules so that patients can see why payments are being made to the NHS. Pharmaceutical companies paid £156m to NHS trusts in England between 2015 and 2022, according to new analysis of the Disclosure UK database. The Association of the British Pharmaceutical Industry (ABPI) database requires participating companies to disclose cash payments and other benefits in kind to healthcare professionals and organisations. Even though the scheme has been lauded as one of the best among its industry run peers in Europe, The BMJ has uncovered widespread confusion about the intended purpose of the payments. For example, if any of these payments are for “educational” purposes that could be linked to the promotion of pharmaceutical products.
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News Article
Makers of Wegovy and Ozempic issue warning over deadly weight-loss copycats
Patient Safety Learning posted a news article in News
Healthcare giant Novo Nordisk has said it was aware of reports of 10 deaths and 100 people left in hospital who had taken compounded copies of its weight-loss and diabetes drugs. U.S. regulations allow compounding pharmacies to copy brand-name medicines that are in short supply by combining, mixing or altering drug ingredients to meet demand. Novo Nordisk’s popular weight-loss injection Wegovy and diabetes drug Ozempic, both known chemically as semaglutide, were until recently in shortage in the United States. Given all the regulatory surveillance of Novo Nordisk’s production of the two drugs, CEO Lars Fruergaard Jorgensen said it was puzzling that people in the United States could inject themselves with a product that was not regulated, approved or inspected. Read full story Source: The Independent, 7 November 2024 -
Content ArticleUK pharmaceutical industry self-regulatory bodies require member companies who sign up to their code of conduct to publish details of their payments to healthcare professionals and organisations. They are also required to publish the methodologies underlying these payments in the form of methodological notes. This study in Health Policy aimed to analyse UK pharmaceutical companies’ methodological notes. It also looked at their adherence to the Association of the British Pharmaceutical Industry code of conduct and other relevant guidance. The authors conducted a content analysis of methodological notes for the years 2015, 2017 and 2019 and assessed companies’ adherence to self-regulatory bodies’ requirements and recommendations for methodology disclosure. Overall, 90 companies made payment disclosures in all three years, publishing 269 methodological notes. The study found gaps in adherence to self-regulatory requirements. Only three companies provided clear information for all self-regulatory body recommendations and regulations in all of their notes and there was evidence of widespread non-adherence to requirements. This suggests that there are flaws in the concept of self-regulation and a need for greater enforcement of rules or consideration of a publicly mandated disclosure system.
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Content ArticleIn this blog post, Kath Sansom, founder of the Sling the Mesh campaign, looks at the issue of payments being made to doctors and lobby groups by pharma and medical tech companies. She argues that these payments are a patient safety concern as it can lead to doctors displaying bias in advising treatments, with benefits being overstated and risks downplayed. This is especially concerning when industry money is given to consultants or researchers trialling new treatments. Kath highlights an investigation carried out by the Observer into the issue and explains why Sling the Mesh have lobbied the UK Government for a UK Sunshine style payment act, which would allow the public to look up the names of doctors, surgeons and researchers to see if they have taken money from industry.
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Content ArticleUS endocrinologist Richard Plotzker shares a recent experience of buying over-the-counter medication from a grocery store. When he opened the outer packaging, the blister packs were empty apart from one pill in each being resealed by scotch tape. Richard called the manufacturer and returned the medication for investigation. He describes how the incident highlights the need to be vigilant about any unusual appearance in the packaging of medication.
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Content ArticleHow would you feel if your doctor offered you a treatment your health condition with good results and very little risk? You might snap it up. But what if you subsequently found out your doctor took thousands of pounds from the treatment makers to write a scientific paper promoting it, attend an all-expenses paid conference to talk about it, or spent time working as their expert consultant? In America, industry must log payments which are published on the open database system. Reporting to this is backed up by law following the American Sunshine Payment Act (2013). Sling the Mesh is calling for similar legislation in the UK to provide up-to-date evidence on industry money exchanging hands we Kath Sansom discusses in a blog on the Patient Safety Commissioner website.
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News Article
AstraZeneca faces legal challenge over Covid vaccine
Patient Safety Learning posted a news article in News
AstraZeneca is facing legal action over its Covid vaccine, by a man who suffered severe brain injury after having the jab in April 2021. Father-of-two Jamie Scott suffered a blood clot that left him with brain damage and unable to keep working. The action, taken under the Consumer Protection Act, alleges the vaccine was "defective" as it was less safe than individuals were entitled to expect. Studies suggest Covid vaccines have saved millions of lives. In June 2022, the World Health Organization said the AstraZeneca vaccine was "safe and effective for individuals aged 18 and above". A further claim from about 80 people who say they were injured by the AstraZeneca vaccine is also due to be launched later this year but Mr Scott's case is expected to be heard first. AstraZeneca said: "Patient safety is our highest priority and regulatory authorities have clear and stringent standards to ensure the safe use of all medicines, including vaccines. "Our sympathy goes out to anyone who has lost loved ones or reported health problems. "From the body of evidence in clinical trials and real-world data, Vaxzevria [the vaccine against Covid] has continuously been shown to have an acceptable safety profile and regulators around the world consistently state that the benefits of vaccination outweigh the risks of extremely rare potential side effects." Read full story Source: BBC News, 9 November 2023 Related reading on the hub: Interview with Charlet Crichton, founder of UKCVFamily -
News Article
Record NHS drug shortages as HRT, contraceptives and ADHD medicines run low
Patient Safety Learning posted a news article in News
Britain faces record shortages of medicines amid a row between drug makers and the NHS over payments. Patients face issues getting hold of drugs for epilepsy and ADHD, as well as hormone replacement therapy (HRT) for the menopause. A total of 111 drugs are currently facing supply issues, according to the British Generic Manufacturers Association (BGMA). This is the highest level on record and more than double the number of drugs facing shortages at the start of 2022. The BGMA blamed an NHS drugs levy for the supply issues, saying it was discouraging pharmaceutical companies from supplying the health service. Dr Leyla Hannbeck, chief executive of the Association of Independent Multiple Pharmacies, said pharmacists were “spending long hours in the day trying to source medicines for patients and this is on top of all the other activities they do in a busy pharmacy”. She said: “Our pharmacy teams see firsthand the anxiety and stress experienced by patients caused by medicines shortages.” Shortages have also led to more abuse and aggression towards pharmacists, she said. Read full story (paywalled) Source: The Telegraph, -
News Article
NHS ombudsman warns Sciensus that patients ‘should not be ignored’
Patient Safety Learning posted a news article in News
The boss of Britain’s biggest medicines courier has been told to urgently improve its complaints system by the NHS ombudsman amid concerns patients let down by missing deliveries are repeatedly ignored. In a highly unusual development, Darryn Gibson, the chief executive of Sciensus, has received a written warning from Rob Behrens, the parliamentary and health service ombudsman (PHSO). It says patients “should not be ignored” and must be “listened to and taken seriously” or he will consider taking further action. The PHSO investigates complaints that have not been resolved by the NHS or by private providers of NHS care. Sciensus is the single largest provider of homecare medicines services to the NHS and has contracts worth millions of pounds. In an email seen by the Guardian, Behrens told Gibson he had been unable to investigate most reports received about Sciensus because patients had not been able to complete the company’s complaints process. “That is not acceptable or fair to complainants,” Behrens wrote. In a statement, Sciensus said it worked “very hard” to ensure NHS patients received their medicines on time. Its services had “a 95% satisfaction rating”, it added. The move follows a Guardian investigation that exposed how Sciensus put NHS patients at risk of harm with delayed, missed or botched deliveries of medicines for conditions including cancer, heart disease, diabetes, dementia and HIV. It also uncovered how patients’ alarm at vital drugs and medical devices not arriving at their home was often compounded by a struggle to reach Sciensus to complain and fix the problems. Read full story Source: The Guardian, 19 October 2023 -
News ArticleADHD patients around the UK are finding they can't get hold of medication since a national shortage was announced. Three different medicines are affected, and the government says some supply issues could last until December. The Department for Health and Social Care (DHSC) says "increased global demand and manufacturing issues" are behind the shortages. Medication helps to manage symptoms, which can include difficulty concentrating and focusing, hyperactivity and impulsiveness. Dr Saadia Arshad, a consultant psychiatrist, who specialises in diagnosing and treating people with ADHD. She says the shortage of medication is "not a new issue, but it's a recurring one". Dr Saadia says suddenly stopping meds can lead to patients "feeling jittery, finding it difficult to pay attention, staying focused and feeling restless". Even though she understands the shortage can be worrying, Dr Saadia says it's important that people don't take measures into their own hands. "These medicines can be quite potent and the response to medication for two individuals is not the same," she says. "So please do not take any action without discussing it with your clinician." Read full story Source: BBC News, 6 October 2023
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News Article
USA: Walgreens and CVS warned about selling illegal eye products
Patient Safety Learning posted a news article in News
The US Food and Drug Administration (FDA) has sent warning letters to pharmacy chains Walgreens and CVS accusing them of illegally marketing eye care products. The FDA’s warning letters said the products in question, which were falsely labelled as potential treatments for conditions like glaucoma, cataracts, and pink eye, should be modified if the companies and manufacturers that make and distribute them want to avoid legal action. “The FDA is committed to ensuring the medicines Americans take are safe, effective and of high quality,” Jill Furman, Director of the Office of Compliance at the FDA’s Center for Drug Evaluation and Research, said in a statement. “When we identify illegally marketed, unapproved drugs and lapses in drug quality that pose potential risks, the FDA works to notify the companies involved of the violations.” Ms Furman wrote in the letter sent to Walgreens: “Your ‘Walgreens Allergy Eye Drops,’ ‘Walgreens Stye Eye Drops,’ and ‘Walgreens Pink Eye Drops’ products are especially concerning from a public health perspective. Ophthalmic drug products, which are intended for administration into the eyes … pose a greater risk of harm to users because the route of administration for these products bypasses some of the body’s natural defences.” Read full story Source: The Independent, 21 September 2023 -
News ArticleIn September last year, Ebrima Sajnia watched helplessly as his young son slowly died in front of his eyes. Mr Sajnia says three-year-old Lamin was set to start attending nursery school in a few weeks when he got a fever. A doctor at a local clinic prescribed medicines, including a cough syrup. Over the next few days, Lamin's condition deteriorated as he struggled to eat and even urinate. He was admitted to a hospital, where doctors detected kidney issues. Within seven days, Lamin was dead. He was among around 70 children - younger than five - who died in The Gambia of acute kidney injuries between July and October last year after consuming one of four cough syrups made by an Indian company called Maiden Pharmaceuticals. In October, the World Health Organization (WHO) linked the deaths to the syrups, saying it had found "unacceptable" levels of toxins in the medicines. A Gambian parliamentary panel also concluded after investigations that the deaths were the result of the children ingesting the syrups. Both Maiden Pharmaceuticals and the Indian government have denied this - India said in December that the syrups complied with quality standards when tested domestically. It's an assessment that Amadou Camara, chairperson of the Gambian panel that investigated the deaths, strongly disagrees with. "We have evidence. We tested these drugs. [They] contained unacceptable amounts of ethylene glycol and diethylene glycol, and these were directly imported from India, manufactured by Maiden," he says. Ethylene glycol and diethylene glycol are toxic to humans and could be fatal if consumed". Read full story Source: BBC News, 21 August 2023
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News Article
Drug firms funding UK patient groups that lobby for NHS approval of medicines
Patient Safety Learning posted a news article in News
Drug companies are systematically funding grassroots patient groups that lobby the NHS medicines watchdog to approve the rollout of their drugs, the Observer has revealed. An investigation by the Observer has found that of 173 drug appraisals conducted by the National Institute for Health and Care Excellence (NICE) since April 2021, 138 involved patient groups that had a financial link to the maker of the drug being assessed, or have since received funding. Often, the financial interests were not clearly disclosed in NICE transparency documents. Many of the groups that received the payments went on to make impassioned pleas to England’s medicines watchdog calling for treatments to be approved for diseases and illnesses including cancer, heart disease, migraine and diabetes. Others made submissions appealing NICE decisions when medicines were refused for being too expensive. In one case, a small heart failure charity that gave evidence to a NICE committee arguing for a drug to be approved received £200,000 from the pharmaceutical company, according to the maker’s spending records. In another case, a cancer patient group supplied evidence relating to drugs made by 10 companies – from nine of which it had received funding. Read full story Source: The Guardian, 22 July 2023 -
Content ArticleDoes your manufacturing facility experience an undesirable frequency of costly product losses? Are recurring operational issues impacting productivity and morale? Do people believe the causes of these production issues are ‘human error’? Do Quality Differently will show you: How to take a systems-based risk management approach to create more operational success. Practical examples to guide improvement in your operations. Ways to apply comprehensive approaches that reveal and address the combination of factors that influence performance outcomes. The lessons in this book were gathered while integrating human and organisational performance principles and practices at multiple biopharmaceutical companies and manufacturing sites—real-time experiences with frontline workers, support staff, and leaders. Do Quality Differently offers practical guidance for biopharmaceutical manufacturing plants and beyond—anywhere managing risk is paramount. Clifford Berry and Amy Wilson share a recent presentation that summarise key points from the book: HOP Integration - Berry Wilson.pdf
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EventPatient safety is a paramount concern in healthcare systems worldwide. Empowering patients and their families to actively participate in the process of care and pharmacovigilance contributes significantly to reducing medical errors and adverse events. This webinar proposes an exploration of the crucial role patients and families play in enhancing patient engagement and pharmacovigilance, ultimately leading to improved patient safety and better healthcare outcomes. Objectives of the webinar: Raise awareness on patient safety amongst stakeholders. Help to understand the role of all stakeholders in medication safety. Strengthen awareness of the Global Patient Safety Action Plan, Strategic Objective 4: Patient & Family Engagement Engage and educate patients and families to become the patient advocates for patient safety. Intended audience: The intended audience includes patients, caregivers, patient advocates, patient-led organisations, civil society organisations and NGOs, pharmaceutical companies, pharmacists and pharmacies, HCPs, regulators etc. Register
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EventuntilThis FDA/PQRI Workshop will bring together leaders from regulatory agencies, industry, and academia to discuss critical topics in distributed manufacturing and point of care manufacturing. Further information
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EventuntilThe Europe Forum will follow the established model of the CMC Forum series with focus on topics and regulatory updates relevant for Europe. The Forum strives to share information with the regulatory agencies to assist them in merging good scientific and regulatory practices. Register
