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The Medicines and Healthcare products Regulatory Agency (MHRA) has published its response to the Independent Medicines and Medical Devices Safety Review. In its response, the MHRA said: “Today’s publication of the Independent Medicines and Medical Devices Safety Review is of profound importance for the MHRA, since the safety of the public is our first priority." "We therefore take this report and its findings extremely seriously. Throughout the Review’s work we have listened intently to the many distressing experiences of women and their families. We will now carefully study the findings and recommendations of the Report. We recognise that patient safety must be continually protected and that many of the major changes recommended by the Review cannot wait. We are therefore making changes without delay to ensure that we listen to patients and involve them in every aspect of our work. We are already taking steps to strengthen our collaboration with all bodies in the healthcare system and will strive to ensure that, working with these other bodies, the safety changes we advise are embedded without delay in clinical practice. We wholeheartedly commit to demonstrating to those patients and families who have shared their experiences during the Review, and anyone else who has suffered, that we have learned from them and are changing and improving because of what they have told us. We are determined to put patients and the public at the heart of everything we do." Read full statement Source: GOV.UK, 8 July 2020

Former health secretary Jeremy Hunt has warned ministers not to let the Cumberlege review “gather dust on a shelf”. The chair of the Commons Health and Social Care Committee told The Independent it was vital action was taken to implement the recommendations. Mr Hunt, who made patient safety a key focus of his tenure as health secretary, backed the idea of an independent patient safety commissioner that would be outside the NHS and have powers to advocate for patient issues. Mr Hunt said: “This report should be a powerful wake-up call that our healthcare system is still too closed, defensive and focused on blame rather than learning lessons. It’s truly harrowing to hear of all the women and families who live with permanent anguish because of these medicines and devices, and it has clearly taken too long for their voices to be heard.” “The NHS is one of the safest health systems in the world, and we’re all rightly in awe of our frontline heroes. But in healthcare getting it right ‘most’ times isn’t good enough because the exceptions wreak lifelong devastation on families. So we must not allow this seminal report to gather dust on a shelf: lessons must be learnt once and for all.” Read full story Source: The Independent, 8 July 2020

Many lives have been ruined because officials failed to hear the concerns of women given drugs and procedures that caused them or their babies considerable harm, says a review. More than 700 women and their families shared "harrowing" details about vaginal mesh, Primodos and an epilepsy drug called sodium valproate. Too often worries and complaints were dismissed as "women's problems". It says arrogant attitudes left women traumatised, intimidated and confused. June Wray, 73 and from Newcastle, experienced chronic pain after having a vaginal mesh procedure in 2009. "Sometimes the pain is so severe, I feel like I will pass out. But when I told GPs and surgeons, they didn't believe me. They just looked at me like I was mad." The chairwoman of the highly critical review, Baroness Julia Cumberlege, said the families affected deserved a fulsome apology from the government. She said: "I have conducted many reviews and inquiries over the years, but I have never encountered anything like this; the intensity of suffering experienced by so many families, and the fact that they have endured it for decades. Much of this suffering was entirely avoidable, caused and compounded by failings in the health system itself." Read full story Source: BBC News, 8 July 2020

A Scottish Government committee has found that the “profound failings” of IT systems are the biggest problem facing a medicine-prescribing service that does not sufficiently focus on patients. A report from the members of Scottish Parliament on the Health and Sport Committee describes a medicines system “burdened by market forces, public sector administrative bureaucracy and under resourcing, inconsistent leadership and a lack of comprehensive, strategic thinking and imagination, allied to an almost complete absence of useable data”. The committee particularly criticised the failure of the NHS to introduce appropriate IT systems. “We are extremely disappointed that once again all roads lead to the dismal failure of the NHS in Scotland to implement comprehensive IT systems which maximise the use of patient data to provide a better service,” the report says. Committee members are calling for an overhaul of the system to allow for collection and analysis of data that would ensure the best possible outcomes for patients and cost savings for the NHS. MSPs found a “lack of care” to understand patients’ experience of taking medicines and a lack of follow up to ensure that medicines were effective or even being used. Prescribers were “instinctively reaching for the prescription pad” and not taking the time to discuss medicines with patients, nor were the principals of realistic medicine, in which patients and clinicians share decision making about their care, being followed. Read full story Source: Public Technology.net, 1 July 2020

Police in Bristol have launched investigations into the circumstances that led to the death of a teenager with autism and learning disabilities. Avon and Somerset Police told HSJ they are investigating the circumstances behind the death of Oliver McGowan in 2016, at North Bristol Trust. They said: “As part of the enquiry [officers] will interview a number of individuals as they seek to establish the circumstances around Oliver’s death before seeking advice from the Crown Prosecution Service.” Oliver died in 2016 at Bristol’s Southmead Hospital after being admitted following a seizure. He had mild autism, epilepsy and learning difficulties. During previous hospital spells he experienced very bad reactions to antipsychotic medications, prompting warnings in his medical records that he had an intolerance to these drugs. Despite this Oliver was given anti-psychotic medication by doctors at Southmead against his own and his parents’ wishes. This led him to suffer a severe brain swelling which led to his death. His death has since prompted a national training programme for NHS staff on the care of people with autism and learning disabilities. Read full story (paywalled) Source: HSJ, 1 July 2020

Low dose dexamethasone reduces deaths in patients hospitalised with COVID-19 who need ventilation, according to preliminary results from the RECOVERY trial. The drug was also found to reduce deaths by one-fifth in other hospitalised patients receiving oxygen only, but no benefit was seen among COVID-19 patients who did not need respiratory support. The chief investigators from the University of Oxford trial said that the findings represent a “major breakthrough” which is “globally applicable” as the drug is cheap and readily available. Peter Horby, Professor of Emerging Infectious Diseases at the University of Oxford and a chief investigator on the trial, added, “This is the only drug that has so far been shown to reduce mortality, and it reduces it significantly. It is a major breakthrough.” Read full story Source: BMJ, 16 June 2020

Selected NHS coronavirus patients will soon be able to access an experimental treatment to speed up their recovery, with the health secretary Matt Hancock suggesting it is probably “the biggest step forward’’ in medication since the beginning of the COVID-19 crisis. The anti-viral drug remdesivir will be made available to patients meeting certain clinical criteria to support their recovery in hospital. The drug is currently undergoing clinical trials around the world, including in the UK, and peer-reviewed data showed it can shorten the time to recovery by about four days. Treatment will initially be prioritised for patients who have the greatest likelihood of deriving the most benefit, according to the Department of Health and Social Care (DHSC). Satisfied the drug can help boost recovery, the government’s Medicines and Healthcare products Regulatory Agency (MHRA) approved the use of remdesivir through its early access to medicines scheme. The experimental anti-viral drug was granted emergency authorisation to treat Covid-19 in the US by the Food and Drug Administration earlier this month. Read full story Source: The Independent, 26 May 2020

People carrying Emerade 500 microgram adrenaline auto-injector pens should return them and get hold of a prescription for a different brand. A fault has been detected in the pens, meaning the dose of adrenaline may not be delivered when needed for people with severe allergies. The official advice comes from the Medicines and Healthcare products Regulatory Agency (MHRA). Alternative brands - EpiPen and Jext - are available up to 300 micrograms. "Action has been taken to protect patients, following detection of a fault in one component of the Emerade adrenaline auto-injector pens," an MHRA spokesperson said. "Patients should return all Emerade 500 microgram pens to their local pharmacy once they have a new prescription and have been supplied with pens of an alternative brand." If an Emerade pen does need to be used before a patient can get hold an alternative pen, the advice is that it should be pressed very firmly against the thigh. If this does not work, the patient should immediately use their second pen. Read full story Source: BBC News, 19 May 2020

The government is under pressure to go further on measures to relax rules on powerful painkillers such as morphine to prevent patients suffering “unnecessary pain and distress in the last days of their lives”. On Tuesday the health secretary, Matt Hancock, announced staff in care homes and hospices would be allowed to “re-use” controlled drugs such as morphine and midazolam, with medication prescribed for one patient used for another where there is an immediate need. But the Home Office today confirmed to The Independent that it had no plans to extend the rules to the care of patients in their own homes – a restriction experts and charities have warned could leave people suffering at the end of their lives. The government announced the changes following concerns over the supply of drugs. The Royal College of GPs (RCGP) welcomed the changes announced by Mr Hancock, calling them “a significant step forward”, but added: “This only applies to patients living in care home and hospice settings, so there is still work to be done to ensure patients living in their own homes have appropriate access to necessary medication in a timely way.” Last week the RCGP wrote to home secretary Priti Patel warning that people were suffering unnecessarily due to problems accessing drugs. Read full story Source: The Independent, 30 April 2020

UK medicines agencies have changed their advice on ibuprofen to say that the drug can be used to treat patients with symptoms of COVID-19, although the evidence that prompted the revision has not been made public. The change follows a review by the Commission on Human Medicines’ expert working group on COVID-19 which, along with previous reviews of evidence, concluded that there is currently insufficient evidence to establish a link between use of ibuprofen, or other non-steroidal anti-inflammatory drugs (NSAIDs), and contracting or worsening of COVID-19. The group’s review has not been published, but prompted the Medicines and Healthcare Products Regulatory Agency (MHRA), NHS England, and the National Institute for Health and Care Excellence (NICE) to update their advice to say that patients can take paracetamol or ibuprofen for symptoms of COVID-19, such as fever and headache. This is a change to NICE’s recommendation on 3 April that paracetamol should be used in preference to NSAIDs for managing fever in patients with suspected COVID-19 until more evidence is available. Read full story Source: BMJ, 17 April 2020

Doctors have been warned that crucial drugs used to help sedate and ventilate patients in intensive care are running out due to the demand caused by coronavirus. An alert to hospitals from NHS England today said there were “limited supplies” of muscle relaxant drugs atracurium, cisatracurium and rocuronium, which are used during intubation when patients are sedated and paralysed with a ventilator used to help them breathe. As a result of the shortages, and to help maintain supplies, NHS England said it would now manage existing supplies “centrally”. Its said supplies of atracurium and cisatracurium were likely to be exhausted in coming days, and hospitals would need to switch to alternatives that were still available. A critical care nurse working in ICU in the south of England told The Independent they were already using alternatives but that this had to be used at different concentrations and run for longer to achieve the same sedation. She said changes like this with staff overstretched could increase the likelihood of drug errors. Read full story Source: The Independent, 17 April 2020

Scientists and senior doctors have backed claims by France’s health minister that people showing symptoms of COVID-19 should use paracetamol (acetaminophen) rather than ibuprofen, a drug they said might exacerbate the condition. The minister, Oliver Veran, tweeted on Saturday 14 March that people with suspected COVID-19 should avoid anti-inflammatory drugs. “Taking anti-inflammatory drugs (ibuprofen, cortisone . . .) could be an aggravating factor for the infection. If you have a fever, take paracetamol,” he said. Jean-Louis Montastruc, Professor of Medical and Clinical Pharmacology at the Central University Hospital in Toulouse, said that such deleterious effects from NSAIDS would not be a surprise given that since 2019, on the advice of the National Agency for the Safety of Medicines and Health Products, French health workers have been told not to treat fever or infections with ibuprofen. Experts in the UK backed this sentiment. Paul Little, Professor of Primary Care Research at the University of Southampton, said that there was good evidence “that prolonged illness or the complications of respiratory infections may be more common when NSAIDs are used—both respiratory or septic complications and cardiovascular complications.” Read full story Source: BMJ, 17 March 2020

An 87-year-old woman died after her carers gave her the wrong medication, a coroner was told. Heather Planner, from Butler's Cross in Buckinghamshire, died at Wycombe Hospital on 1 April from a stroke. Senior coroner Crispin Butler heard three staff from Carewatch Mid Bucks had failed to spot tablets handed over by the pharmacy were for a male patient. Mr Butler said action should be taken to prevent similar deaths. A hearing in Beaconsfield on Thursday, where he issued a Prevention of Future Deaths report, followed an inquest in November. In the report he said he was told at the inquest that the carers from Carewatch Mid Bucks gave widow Mrs Planner the wrong medication four times a day for two and a half days. She suffered a fatal stroke because she did not receive her proper apixaban anticoagulation medication. Mr Butler said he would send his concerns to the chief coroner and the Care Quality Commission. He said there was no procedure in place to ensure individual carers read and specifically acknowledged any medication changes. Read full story Source: BBC News, 27 February 2020

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

A national strategy is needed to tackle health risks linked to antipsychotic drugs because current policy is letting tens of thousands of people fall through the gaps, commissioners in London are warning. Commissioners and clinicians in City and Hackney found more than 1,000 patients in their area who were on these drugs without having regular medication reviews or health checks. They warned that, if their findings applied across England, 100,000 patients could be in the same position. Although NHS England funds GP practices to carry out regular health checks on patients who are on the serious mental illness register, this excludes patients who are prescribed antipsychotics without having an SMI diagnosis — which typically covers psychoses, schizophrenia or bipolar active disorder. An audit by City and Hackney Clinical Commissioning Group, carried out in July 2019 and shared with HSJ, found 1,200 patients in the area were taking antipsychotics but did not have a formal SMI diagnosis. The audit found most of these patients were not receiving regular health checks and a significant number may have benefited from having their medication reduced. Read full story (paywalled) Source: HSJ, 27 January 2020

An electronic health record (EHR) bug that transmits and medication order for 25 mg of a drug – not the prescribed 2.5 mg – could be the difference between life and death. And it’s that seemingly impossible reality that’s bringing more industry stakeholders to the table working to better understand EHR usability and its effects on patient safety. “Often times when people think about usability, they think about design and then they think about the EHR vendor,” Raj Ratwani, PhD, Director of MedStar Health Human Factors Center, said in an interview with EHRIntelligence. “In reality, it's a very complex space. The products that are being used by frontline clinicians are shaped by the vendor. But they are also shaped by how that product is implemented at that provider site, how it's customized, and how it’s configured. All of those things shape usability.” EHR usability issues are an exceptionally common issue, Ratwani reported in a recent JAMA article. About 40% EHRs reported having an issue that can potentially lead to patient harm and about 786 hospitals and 37,365 individual providers may have used EHRs with potential safety issues based on required product use reporting. Direct safety challenges typically come from EHR products that are sub-optimally designed, developed, or implemented. Usability issues stem from a very cluttered interface or a complex medication list. Seeing a cluttered list can lead to a clinician selecting the wrong medication. A major usability issue also comes from data entry. EHR users want that process to be as clean as possible. Consistency in the way information is entered is also key, Ratwani explained. Ratwani also wants to ensure that certification testing is as realistic as possible. He compared it to when a vehicle is certified to meet certain safety standards each year. This type of mechanism does not exist when it comes to EHRs because right when the product is certified, it then gets implemented, and there is no further certification of safety done at all after the initial testing. “One way to do that, at least for hospitals, is to have that process be something that the Joint Commission looks to do as part of their accreditation standards,” Ratwani said. “They could introduce some very basic accreditation standards that promote hospitals to do some very basic safety testing.” Read full story Source: EHR Intelligence, 13 January 2020

New research from the UK’s Drug Safety Research Unit (DSRU) has found that hospital pharmacists, doctors and nurses only recorded batch numbers for biologic medicines between 38% and 58% of the time during routine hospital practice. Further, an analysis of spontaneous adverse drug reaction (ADR) reports showed that brand names were only included 38% of the time, while batch number traceability was only 15%. Because of the study results, the DSRU is encouraging health professionals to improve the recording in order to aid patient safety, suggesting that it has “some way to go to encourage health professionals to record this information.” Read full story Source: PharmaTimes Online, 7 January 2020

More than 80% of patients who have signs of a deadly sepsis infection before high-risk surgery are not getting antibiotics fast enough, a major NHS report has warned. Sepsis kills an estimated 44,000 people in England every year and rapid access to antibiotics within the first hour after diagnosis is vital to halt the infection. However, a review of performance across 179 NHS hospitals has found a majority of patients undergoing emergency bowel surgery are not getting medication early enough. A leak of the bowel can cause sepsis and while antibiotics will help treat the infection, surgery is essential to repair any sepsis-causing leak. The Royal College of Anaesthetists, which carried out the study for the NHS, said although the number of patients getting surgery in time had improved over the last five years, the numbers receiving antibiotics within an hour had not. Read full story Source: The Independent, 4 January 2020

Two people died and hundreds of others were harmed following prescription errors in North East hospitals last year, new figures reveal. Staff at North East health trusts reported 2,375 prescribing mistakes to an NHS watchdog in 2018, including patients being given the wrong drug, failure to prescribe medicine when needed or given the wrong dosage. At County Durham And Darlington NHS Foundation Trust, where 359 errors were found, 103 patients were harmed by prescription mistakes while one person died. City Hospitals Sunderland NHS Foundation Trust was the second worse in the region for patients coming to harm as a result of prescription errors. One person was killed while 56 were harmed. An NHS spokesperson said: “NHS staff dealt with over a billion patient contacts over the last three years, while serious patient safety incidents are thankfully rare, it is vital that when they do happen organisations learn from what goes wrong - building on the NHS’ reputation as one of the safest health systems in the world." “As part of the NHS Long Term Plan a medicines safety programme has been established, meaning more than ever before is been done to ensure safe medicine use, and nearly £80 million been invested in new technology to prescription systems.” Read full story Source: Chronicle Live, 22 December 2019

A hospital has been fined £45,000 after the death of a leukaemia patient who was given five times the amount of drugs she needed. Royal Bournemouth Hospital Trust ignored repeated warnings from inspectors raising concerns about the unit where the 80-year-old patient, who was taking part in a clinical trial, was given the wrong dose on two separate occasions. The trust was fined at Bournemouth Crown Court on Monday after pleading guilty in August to supplying a medicinal product that was not of the nature or quality demanded. Investigations revealed that, while staff spotted the incorrect dosage, they were wrongly told it was fine, meaning the pensioner, who was terminally ill, was given five times the prescribed amount over four days rather than a lower dose over 10 days. An investigation by the Medicines and Healthcare products Regulatory Agency (MHRA) found staff were working “beyond capacity”. Inspections in 2012, 2013, 2015 and 2017 all found the unit was running over capacity and highlighted it as an issue that urgently needed addressing to prevent any mistakes being made. Read full story Source: The Independent, 12 December 2019

Stakeholders from across various sectors in Australia attended a medicine safety forum convened in Canberra on Monday. Held by the Consumers Health Forum of Australia (CHF), Pharmaceutical Society of Australia (PSA), the Society of Hospital Pharmacists of Australia (SHPA), NPS MedicineWise and academic partners Monash University and University of Sydney, the forum challenged participants to ‘think differently’ on the safe use of medicines in Australia. This included brainstorming on what success in improving medicine safety would look like in 10 years. “Medicine safety is a priority for us all and we each have a role to play,” PSA National President Associate Professor Chris Freeman said. “It was inspiring to see the sector work together today to proactively identify those measures we can cooperatively pursue to make a real difference and protect patients.” Read full story Source: AJP.com.au

More deaths could occur unless action is taken to keep people safe when obtaining medications from online health providers, says a UK coroner. Nigel Parsley has written to Health Secretary Matt Hancock highlighting the case of a woman who died after obtaining opiate painkillers online. Debbie Headspeath, 41, got the medication, dispensed by UK pharmacies, after website consultations. Her own GP was unaware of what she had requested from doctors on the internet. The Suffolk coroner has now written to the Department of Health asking for urgent action to be taken. The General Pharmaceutical Council – the independent regulator for pharmacies – said it was responding to the coroner's report and would continue to take necessary action to make sure medicines are always supplied safely online. Read full story Source: BBC News, 9 December 2019

It is a requirement that patient cards detailing information on the risks are issued every time valproate is dispensed, under Medicines and Healthcare products Regulatory Agency (MHRA) guidance. Only 40% of pharmacists are meeting a patient safety requirement when dispensing valproate to women, an audit carried out by the Company Chemists’ Association (CCA) has found. The drug can cause birth defects in women who take it when pregnant. In April 2018, the Medicines and Healthcare products Regulatory Agency (MHRA) stated that valproate must not be used by women and girls of childbearing age unless a pregnancy prevention programme (PPP) is in place. Duncan Rudkin, Chief Executive of the General Pharmaceutical Council (GPhC), said pharmacies must do more to ensure the safe dispensing of valproate. Read full story Source: The Pharmaceutical Journal

Australia needs to “get real on medicine safety”, Federal Parliament heard this week. Speaking in the House of Representatives, Julian Hill (ALP, Vic) said “too many Australians are being seriously injured, sometimes with lifelong impacts or dying, because of the weakness in our pharmacovigilance system”. Mr Hill, Deputy Chair of the Parliamentary Joint Committee of Public Accounts and Audit, referred to a recent study by the Pharmaceutical Society of Australia which “estimated the extent of the problem at 250,000 annual hospital admissions as a result of medication related problems and 400,000 additional presentations to emergency departments, likely because of medicine related problems. There’s an annual cost of $1.4 billion, and yet 50 per cent of this harm is estimated to be preventable,” he said. “I have spoken before about my concerns in this area, and so have many other advocates, but the government is still not taking these issues seriously. Every day of inaction means Australians are at risk of death or serious harm from medicines when it could be avoided”. Read full story Source: AJP.com.au, 28 November 2019

More than 2.8 million antibiotic-resistant infections occur in the U.S. every year, and more than 35,000 people die as a result of those infections, according to a newly released Centers for Disease Control and Prevention (CDC) report. The updated Antibiotic Resistance Threats in the United States (AR Threats Report) also estimates when antibiotic-resistant bacterium Clostridium difficile (or C. diff) is included, that number exceeds 3 million infections and 48,000 deaths. The report, which used data sources such as electronic health records not previously available, shows that there were nearly twice as many annual deaths from antibiotic-resistant infections as the CDC originally reported in 2013. CDC officials called the numbers in this report "more precise, though still conservative, estimates of the human costs of antibiotic resistance. Read full story Source: FierceHealthcare, 13 November 2019