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News ArticleIn a letter to healthcare professionals, drugs manufacturer Pfizer is to warn of serious and fatal adverse reactions following inadvertent administration of tranexamic acid instead of local anaesthetics. The letter, seen by The Pharmaceutical Journal and dated 30 April 2026, says: “Serious, including fatal, adverse reactions have been reported after inadvertent intrathecal administration [of tranexamic acid] due to mix-ups, mostly with injectable local anaesthetics.” Pfizer said it was sending the letter on behalf of marketing authorisation holders and in agreement with the Medicines and Healthcare products Regulatory Agency (MHRA). Tranexamic acid is an antifibrinolytic, used in the prevention and treatment of haemorrhages. “Intrathecal, epidural, intraventricular and intracerebral use of tranexamic acid solution for injection is contraindicated,” the letter added. “Cases of medication errors have been identified, including cases reported in the EU, where tranexamic acid injection was inadvertently administered intrathecally or epidurally. “Most of these cases involved mix-ups of vials or ampoules resulting in erroneous administration of tranexamic acid instead of the intended injectable local anaesthetic (e.g. bupivacaine, levobupivacaine, prilocaine).” It has added that, when administered intrathecally, serious patient harms had been reported, including prolonged hospitalisation and death, while serious adverse reactions that were reported include severe back, gluteal and lower limb pain, myoclonus, generalised seizures and cardiac arrhythmias. “Extreme caution should be taken when storing, handling and administering IV formulations of tranexamic acid to ensure the correct route of administration. This includes clearly labelling syringes containing tranexamic acid for IV use only and storing tranexamic acid injectables separately from injectable local anaesthetics,” it added. Read full story Source: The Pharmaceutical Journal, 14 April 2026
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News ArticleMillions of Americans use injectable drugs like Novo Nordisk’s Ozempic and Wegovy to help them lose weight - knowing there are possible side effects such as nausea, vomiting and diarrhea. Now, the U.S. Food and Drug Administration has written a letter alleging that the Danish drugmaker failed to report adverse effects in patients who took semaglutide drugs, including death. The 5 March letter cited three deaths in unidentified patients, including one patient who died by suicide, and Director of the Office of Scientific Investigations Dr. David Burrow wrote that Novo Nordisk had failed to failed to report “serious and unexpected” adverse drug experiences within the FDA’s required time frame. “Based on your written procedure, your staff or contractor cancelled or rejected serious and unexpected adverse drug experiences that were required to be reported within 15 calendar days because they documented these events as being unrelated to the product,” Burrow said. However, the FDA stopped short in deciding whether any of the adverse effects were directly linked to the drug. The findings were based on an inspection of a New Jersey facility last year that Burrow said “revealed serious violations” of reporting requirements. Since then, Novo Nordisk had taken corrective and preventive actions that officials claimed were “inadequate” because the pharmaceutical giant “did not provide sufficient details to determine whether [Novo Nordisk’s] actions will effectively prevent similar violations in the future.” Read full story Source: The Independent, 12 March 2026
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Content Article
The pharmaceutical industry plays a vital role in protecting human life and health. Medicines, vaccines and healthcare products directly impact millions of people around the world. Because of this, pharmaceutical companies must operate ethically and responsibly and social due diligence is becoming increasingly important. Social due diligence helps pharmaceutical companies identify, assess and manage social risks related to people, communities and ethical practices. It ensures that business operations respect human rights, employee welfare, patient safety and community well-being. Understanding social due diligence Social due diligence is a structured process used to evaluate how a company’s activities affect people. It focuses on social risks such as unsafe working conditions, unfair labour practices, community health impacts, and ethical issues in clinical trials and supply chains. In the pharmaceutical industry, where trust is critical, social due diligence is essential to maintain transparency, compliance and long-term sustainability. Why social due diligence is critical in the pharmaceutical industry 1. Protecting human rights and worker safety Pharmaceutical manufacturing involves chemical handling, laboratory work and high-risk processes. Social due diligence ensures: Safe working conditions. Fair wages and working hours. Protection from workplace hazards. This helps prevent accidents and promotes employee well-being. 2. Ethical clinical trials and ersearch Clinical trials involve human participants. Social due diligence ensures: Informed consent is properly taken. Participants are treated ethically. Vulnerable groups are protected. Ethical research practices build public trust and meet international standards. 3. Responsible supply chain management Pharmaceutical companies rely on global suppliers for raw materials and active ingredients. Social due diligence helps identify risks such as: Child or forced labour. Poor working conditions. Human rights violations. Monitoring suppliers ensures ethical sourcing and compliance. 4. Community health and social impact Manufacturing plants and research facilities affect nearby communities. Social due diligence evaluates: Community health risks. Access to healthcare. Social disruptions caused by operations. This helps companies reduce negative impacts and support local development. Key elements of social due diligence in pharmaceutical companies Employee welfare assessment This includes reviewing labour policies, safety standards, training programmes and grievance mechanisms to ensure employees are treated fairly and respectfully. Stakeholder engagement Engaging with employees, patients, regulators and local communities helps identify concerns early and improves decision-making. Risk identification and mitigation Social risks can be identified through audits, assessments and surveys. Companies can then create action plans to reduce or eliminate these risks. Compliance with regulations and standards Social due diligence ensures compliance with: National labour laws. International human rights standards. Industry-specific guidelines. Benefits of social due diligence for pharmaceutical companies Builds trust with patients and regulators. Reduces legal and reputational risks. Improves employee morale and productivity. Supports sustainable and ethical growth. Enhances brand credibility in global markets. Companies that invest in social due diligence are better prepared to face regulatory challenges and social expectations. Conclusion Social due diligence in the pharmaceutical industry is not just a regulatory requirement—it is a moral responsibility. By focusing on people, ethics and transparency, pharmaceutical companies can ensure safe operations, protect human rights and contribute positively to society. In an industry where human lives are at stake, responsible practices create long-term value and sustainable success. Social due diligence helps pharmaceutical companies move forward with integrity, accountability and trust. -
News Article
USA: Patients needing home IV nutrition fear dangerous shortages
Patient Safety Learning posted a news article in News
CVS Health confirmed last year it was closing half its Coram home infusion branches and firing about 2,000 nurses, dietitians and pharmacists. Their patients with life-threatening digestive disorders depend on parenteral nutrition, or PN — in which amino acids, sugars, fats, vitamins and electrolytes typically are pumped through a catheter into a large vein near the heart. A day later Optum Rx, another big supplier, announced its own consolidation. Suddenly, thousands were scrambling for their complex essential drugs and nutrients. “With this kind of disruption, patients can’t get through on the phones. They panic,” said Cynthia Reddick, a senior nutritionist laid off last summer in the CVS restructuring. “It was very difficult. Many emails, many phone calls, acting as a liaison between my doctor and the company,” said Elizabeth Fisher Smith, a 32-year-old public health instructor in New York, whose Coram branch closed. A rare medical disorder has forced her to rely on PN for survival since 2017. “It added to my mental burden,” she said Home and outpatient infusions in the USA are a growing business, as new drugs for chronic illness expand treatment options and enable patients, providers and insurers to avoid hospitalisation. But while reimbursement for expensive new drugs has attracted corporations and private equity, the industry is constrained by a lack of nurses and pharmacists. The less profitable parts of the business — and the vulnerable patients they serve — are at risk. This includes the 30,000-plus Americans who rely on parenteral nutrition — including premature infants, post-surgery patients and those with damaged bowels because of genetic defects. Read full story (paywalled) Source: The Washington Post, 6 February 2023 -
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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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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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 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
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EventuntilHuman performance in pharmaceutical and biopharmaceutical manufacturing: successes and challenges to meaningful industry change Adopting the principles and practices of human performance has led to valuable business and safety performance improvements in high-risk high-consequence industry sectors, such as energy and aviation. Eager to realise similar levels of improvement, several companies in the pharmaceutical and biopharmaceutical manufacturing sector have begun the adoption of human performance within their operations. However, the unique industry context and regulatory environment of this sector has proven the adoption of human performance principles and practices to be more challenging and complex than simply copying from the successes of other industries. In this webinar, you’ll hear from industry professionals who will share their experiences and perspectives on human performance adoption value, successes and challenges. Register now for free Topics and presenters Chairs Dr Brian Edwards trained at Guy’s Hospital, London in hospital medicine and clinical research. He has worked for the Medicines Control Agency, Parexel and Johnson & Johnson, there as a deputy qualified person for pharmacovigilance. For the last 13 years, he was Principal Consultant in Pharmacovigilance at NDA Regulatory Science based in the UK. Brian is Director of ISoP Secretariat Ltd and co-chairs the ISOP Medication Error Special Interest Group, Vice President Pharmacovigilance & Drug Safety in the Alliance Clinical Research Excellence and Safety (ACRES) and Chair of the UK Pharmaceutical Human Factors Group. He has recently been awarded a Fellowship with the International Society of Pharmacovigilance. Currently he consults for his own company, Husoteria Ltd. Julie Avery is former Global Lead for human factors at GSK, with over 20 years in Quality and Operational Excellence. As an independent practitioner, Julie now integrates human performance into existing systems strategically and tactically supporting business goals and KPIs. Julie leads the CIEHF Human Factors Pharmaceutical Manufacturing COP and is a Trustee of the CIEHF representing Associate Members. Topic 1: Why we focus on human performance James Morris, executive director at NSF Health Sciences, has over 30 years’ pharmaceutical operations experience in quality and manufacturing; He’s often leading consulting and training projects in investigation and CAPA management. Topic 2: How human performance reflects a way of thinking – beliefs and principles Amy Wilson has more than 20 years’ experience in biopharma manufacturing, focusing on human and organisational performance, operational excellence, risk management and technical training. John C Wilkes is Human Performance lead for biologics at AstraZeneca. He has more than 25 years’ experience in industry, in manufacturing operations, operational excellence, quality systems and quality control. Topic 3: In terms of internal challenges, how can we get out of our own way? Clifford Berry is head of business excellence for Takeda at its Massachusetts Biologics Operations site. He’s been a human and organisational performance practitioner for over 20 years, with experience in commercial nuclear electrical generation, electric transmission and distribution, and biopharma.
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Event
Veracuity: Innovative approaches to drug safety
Sam posted an event in Community Calendar
Veracuity was conceived out of a recognition that the practice of pharmacovigilance is performed suboptimally. That is because it relies entirely on a voluntary reporting system – one in which consumers and healthcare professionals must devote considerable energy if they were so inclined to notify somebody about a side effect they attribute to a bio-pharmaceutical product. Adverse event reporting is infrequent and cumbersome because stakeholders are only vaguely aware of their responsibility and the current system is neither easy nor fast to use. Nor does it provide reporters with any immediate helpful feedback. With only a very small percentage of adverse drug events ever reaching the attention of manufacturers or regulators, it is easy to conclude that the medical community and the public may be wholly unaware of tremendous risks and liabilities that may be attributed to drug products. This workshop allows participation in insightful conversation on the future of our industry. Program: Fishbein, J: Introduction and closing remarks. Barrett, CP: Implementation of Post-marketing Risk Management Commitment. Laugel, I: The future of pharmacovigilance with the use of artificial intelligence sounds good. Marschler, M: The use of pharmacogenomic methodologies in the pharmacovigilance evaluation of medicinal products. This webinar meets two times. Fri, Jan 29, 2021 12:00 PM - 2:00 PM GMT Fri, Jan 29, 2021 6:00 PM - 8:00 PM GMT Register 2021-workshop-flier.pdf -
Content Article“Sunshine” policy, aimed at making financial ties between health professionals and industry publicly transparent, has gone global. Given that transparency is not the sole means of managing conflict of interest, and is unlikely to be effective on its own, it is important to understand why disclosure has emerged as a predominant public policy solution, and what the effects of this focus on transparency might be. Grundy et al. used Carol Bacchi’s problem-questioning approach to policy analysis to compare the Sunshine policies in three different jurisdictions, the United States, France and Australia. We found that transparency had emerged as a solution to several different problems including misuse of tax dollars, patient safety and public trust. Despite these differences in the origins of disclosure policies, all were underpinned by the questionable assumption that informed consumers could address conflicts of interest. The authors conclude that, while transparency reports have provided an unprecedented opportunity to understand the reach of industry within healthcare, policymakers should build upon these insights and begin to develop policy solutions that address systemic commercial influence.
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Content ArticleBioPhorum has developed a risk-based deviation management system (DMS). 13 member companies have implemented this approach, and summary data from these companies shows improved quality performance plus an average time saving of 22,200 work hours per site per year, which is equivalent to a $888k cost saving. An effective deviation management process is one that identifies and removes risk from processes using root cause analysis (RCA) principles and a corrective and preventive action (CAPA) programme. The current model used by many biopharmaceutical companies considers all deviations or events are equal and require a 30-day closure, known as the ‘30-day rule’1. Treating all events as equal and following the ‘30-day rule’ drives an inefficient process and wasteful behaviours. This guide outlines the work of the BioPhorum DMS Workstream in defining and creating a simplified and effective risk-based deviation management system with advanced RCA methodologies, and a track-and-trending process of low-risk events. It includes everything required to build a risk-based approach to DMS, including the business case for change, the new process, risk-based tools, and a detailed sharing of post-implementation benefit.
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