Prescription & medication error news

 

Epilepsy medicine Valproate linked to birth defects

The Medicines and Healthcare products Regulatory Agency (MHRA) has changed the licensing rules controlling the prescription of valproate drugs for women and girls of childbearing age with epilepsy. The new contraindication of drugs such as Epilim in pregnancy, follows evidence that up to 10% of babies born to mothers prescribed the drug have serious birth defects, with as many as 40% suffering developmental problems.

Birth defects associated with valproate in pregnancy

Birth defects suffered by babies of valproate-medicated mothers during pregnancy include congenital malformation of the spine (spina bifida), face and skull (such as cleft palate), limbs and organs including the heart, kidneys and sexual organs.

The long-term effects of the developmental problems suffered by valproate babies are not yet fully understood but include delayed walking and talking, reduced intelligence, impaired speech and language and memory problems.

Children exposed to valproate in the womb also have an increased risk of autism and attention deficit hyperactivity disorder (ADHD).

Valproate – little change despite warnings

“Valproate is a common treatment for epilepsy and bipolar disorder and is prescribed to thousands of women. The drug was introduced in 1974 and its product information for doctors has always included a warning that it carried a potential risk of birth defects.”

Over time, as more information has been gathered in Europe about the drug’s association with congenital malformations and developmental impairments, the MHRA’s warnings to doctors and pharmacists about the risks to the medicated woman’s unborn child have been strengthened. However, the MHRA’s latest alert confirms that despite the strengthened warnings that they issued to prescribers in 2015 and 2016 against prescribing valproate medicines in girls and women of childbearing age unless other treatments are ineffective and they are using effective contraception, one in five women taking valproate remain unaware of its risks in pregnancy. Without such information, women are unable to make informed decisions about their treatment. They risk becoming pregnant with high risk of serious injury to their child. MHRA’s previous communications appear to have had little impact on prescribing practice.

New regulation of valproate prescription from April 2018

In March 2018, after further research revealed the extent to which previous warnings had not been heeded, the European Medicines Agency, CMDh (Coordination Group for Mutual Recognition and Decentralised Procedures – Human), recommended tougher regulation of the prescription of valproate medicines. The new regulations will come into force at the end of April 2018 and will be backed up by amended guidance from The National Institute for Health and Care Excellence (NICE).

Valproate medicines are now contraindicated in women and girls of childbearing potential unless the conditions of a specified Pregnancy Prevention Programme are met, and only if other treatments are ineffective or not tolerated, as judged by an experienced specialist. The Pregnancy Prevention Programme also applies to female patients who are not sexually active unless there are compelling reasons to indicate that there is no risk of pregnancy.

Compliance with the Pregnancy Prevention Programme means that all female patients taking valproate medicines:

  • have been told and understand the risks of pregnancy and have signed a risk acknowledgement form.
  • are on highly effective, user-independent contraception -  such as long acting reversible contraceptive, a copper intrauterine device (coil), progesterone implant or levonorgestrel intrauterine system – or using two complementary forms of contraception including a barrier method and undergo regular pregnancy testing
  • see their specialist for review and re-evaluation at least once every year.

GPs must now identify and recall all valproate-medicated women and girls of childbearing potential to give them the patient guide, check that they have been reviewed by a specialist within the last year and are on highly effective contraception.  

Specialists are required to review and re-evaluate their patients at least annually, provide clear explanations and complete and sign the risk acknowledgement form which must be copied to the patient or their carer and sent to the patient’s GP.

Pharmacists must ensure that where valproate medicines are dispensed to women and girls of childbearing potential the (ideally whole) packs must bear a pre-printed warning label or the pharmacist must place a warning sticker on the pack.  Pharmacists are also required to discuss the risks in pregnancy with female patients each time they dispense their valproate medicines, and to check that they have the Patient Guide and have discussed their treatment and contraception with their GP or specialist.

I’m on valproate. What do I do now?

All women and girls who are prescribed valproate should now contact their GP and arrange to have their treatment reviewed. Meanwhile, MHRA emphasise that it is important women don’t stop taking valproate without first discussing it with their doctor.

Boyes Turner’s specialist birth injury and cerebral palsy lawyers have decades of experience of helping families whose children have suffered severe disability as a result of inappropriate medical care. We welcome the recent action taken by MHRA and NICE to enforce responsible prescribing practice in the hope that fewer babies will suffer the devastating disability caused by in-utero exposure to valproate drugs.

If you are caring for a child with serious disability arising from negligent medical care please contact us on 0118 952 7219 or email us on mednegclaims@boyesturner.com.

Hospital presciption error results in malaria medication overdose

In 2012, a woman recovered a six figure sum after a hospital prescription error at Frimley Park Hospital.

The woman, who was 47 years old at the time of the incident, had attended Frimley Park Hospital for treatment for malaria, which had been diagnosed following a short period of illness after travel abroad.  The hospital sought advice from the Hospital of Tropical Diseases regarding the appropriate treatment for malaria.  Unfortunately, the advice to administer 2 different drugs consecutively over a period of time was not followed by Frimley Park Hospital and, as a result of a misunderstanding, there was a serious prescription error where the 2 drugs were administered simultaneously, with one at a dose which was too high to be safe.  The woman had taken nearly all of the tablets before a doctor intervened to prevent her from finishing them.

The defendant hospital took advice from Guys’ Hospital’s Poison Unit and managed to stabilize the woman’s condition without the need to stop and restart her heart.  Unfortunately as a result of the overdose, the woman developed Post Traumatic Stress Disorder and a co-morbid depressive disorder. Her personality was completely altered. The symptoms of her psychological disorder were significant and prevented the woman from returning back to work. The compensation she received included a sum for future therapy in order to help her recover from her psychological injury as best she could.

£250,000 compensation award for a failure to provide medication resulting in a stroke

In August 2005 Mrs M underwent an operation to insert artificial heart valves. As a result of the operation, she required anti coagulation medication for the rest of her life to avoid blood clots forming. Mrs M was discharged on 2 September, when she fell under the care of the Wrightington, Wigan and Leigh NHS trust.

On 5 September Mrs M attended a clinic regarding her anticoagulation medication, and her dose of Warfarin was increased, with a follow up appointment arranged for 8 September.

On the morning of 8 September, prior to her appointment at the clinic, Mrs M suffered a stroke at home. She was treated at the hospital of another trust, and a CT scan revealed damage to the right parietal region of her brain. She suffered damage to the left side of her body with generalised weakness.

Mrs M brought a claim alleging that the defendant trust was negligent in failing to have a regard to her blood levels, and placing her at high risk of thromboembolism (a blood clot that breaks loose and is carried by the blood stream to plug another vessel). Mrs M also alleged that the hospital was negligent in failing to administer Heparin or a similar agent by injection.

The trust admitted that it had been negligent in inadequately providing the necessary medication and had Mrs M received the appropriate treatment, she would have avoided her stroke.

As a result of the stroke, Mrs M became dependant on a wheelchair and a mobility scooter for outdoor use. She was able to walk indoors, but with the use of an elbow crutch on her right side and support on her left. She was unable to climb stairs. The injuries also left Mrs M with difficulties in various aspects of her personal care in daily living, and she was unable to cook, clean, or wash, and relied upon the assistance of her husband, family and paid help.

In addition to her physical injuries Mrs M suffered a psychological injury in respect of her loss of physical function.

The case settled out of court for the total sum of £250,000. An award was made of £50,000 for the pain, suffering and loss of amenity that Mrs M had suffered, with the remainder of the money making up future care costs, future equipment costs, future occupational therapy and future travel costs.

Julie Marsh, expert medical negligence claim solicitor at Boyes Turner, commented on the cases outcome:

“We are seeing an increasing number of cases where a failure to provide the necessary after care treatment results in devastating consequences for the individual. Following such serious surgery, Mrs M clearly should have been given Heparin or an alternative to prevent blood clots developing. This is standard after the majority of operations. It is clear from the timescales in this case, that had she received the appropriate treatment, the stroke would have been avoided.”

Hospital medication errors affecting diabetics

A recent audit covering nearly 13,000 patients and 230 hospitals has found that nearly a third of diabetic patients in hospital are affected by medication mistakes.

These errors can cause them to experience dangerously high or low blood glucose levels. Diabetes UK, a charity in this field, have stated that this is an “indictment” on NHS care. Patients with medication errors were found to suffer more than double the number of severe hypoglycaemic (low blood glucose levels) than patients without errors. If untreated hypoglycaemia can result in seizures, coma or death. Furthermore, 68 patients were found to develop diabetic ketoacidosis which happens when blood glucose levels are consistently high. This indicates that the patient had not been given their insulin treatment for a significant period of time.

The audit also found that hospitals lacked enough staff with expertise in diabetes, especially those who understand the importance of foot care. Diabetes UK has reported that about 100 people with diabetes undergo leg, foot or toe amputations each week, many of which could be prevented. Foot ulcers are also common.

Gerry Rayman, a Consultant Physician and head of service at Ipswich Hospital Trust’s diabetes and endocrine centre was the clinical lead for the audit. He has commented that most hospital doctors and ward nurses still do not have basic training in insulin management and glucose control. He also stated that diabetic ketosis should not occur in hospital, “its occurrence is negligent and should never happen”.

Nicola Anderson, expert negligence claim solicitor at Boyes Turner, commented on the audit’s results:

“Unfortunately hospital errors such as this can have very severe consequences for patients. Given the number of diabetic patients experiencing medication errors, it seems likely that patients with other serious conditions are also failing to receive their regular medication whilst in hospital. Other prescription errors may also possible, such as being given the wrong medication, or the correct medication in the wrong dosage. At Boyes Turner we have dealt with a number of cases involving prescription errors, both on the part of hospitals, but also caused by General Practitioners and pharmacies.”

£40,000 compensation after man was given a fatal overdose of Diamorphine

Cambridgeshire pensioner David Gray, 70, was given a fatal overdose of a painkilling drug in 2008. He was injected with 10 times the recommended dosage.

Mr Grey was seen by Dr Daniel Ubani, a locum German doctor employed by the NHS. It has been reported by the BBC that Dr Ubani had flown into the UK the day before he treated Mr Grey, and only had a few hours sleep before starting a 12-hour shift.

Dr Ubani was working for SuffDoc, part of the out-of-hours GP service provider Take Care Now, at a rate of £45 an hour.

The evening before he started the shift, he was given several hours’ training on the firm’s computer system at its headquarters in Colchester, Essex.

He was also given an induction by another doctor working for the service, who expressed concerns that Dr Ubani had no experience of working for the NHS. He also reported that Dr Ubani did not know the area, and had not received sufficient training. His report was not read until two days after Mr Gray’s death.

Mr Gray’s family have recently accepted £40,000 compensation from sources which remain confidential as part of the pay-out agreement.

In February a coroner ruled Mr Gray had been unlawfully killed. An investigation has been undertaken by the General Medical Council (GMC) and the organisation has the power to order Dr Ubani to be struck off the medical register which would prevent him from working as a doctor in the UK again.

In a letter to the GMC ten days after the death of Mr Gray, Dr Ubani said he was “very, very sorry and confounded”.

“The remorse and guilt will live with me the rest of my life,” he wrote.

Julie Marsh, leading medical negligence solicitor at Boyes Turner, commented on this example of medication negligence:

“Locum GP substitutes are becoming more common in this county, covering out of hours services regularly. However, they must still provide care to an adequate standard, and ensure the care they are providing is appropriate in the circumstances. Sadly, we have seen a number of cases recently where locum GP’s have not realised the severity of the condition of the patient, which has related in a delay in diagnosis of their condition, and as in this circumstance, some of these delays in treatment can be fatal.”

Child drug errors 'too frequent'

A snap-shot study by the University of London of five hospitals in the city found 13% of the 3,000 prescriptions they examined had an error and a fifth of drugs given to children in these hospitals during 2004 and 2005 were administered incorrectly.

Hospital negligence

Over a period of two weeks, they watched how nurses gave drugs to children on 11 wards at the five hospitals. They picked up 429 administration errors among the 1,554 doses of medicine given to 265 children, giving an overall error rate of 19%.

Medical errors

When pharmacists reviewed the drug charts of 444 children treated in the hospitals over the fortnight, they found and corrected errors in 13% of almost 3,000 prescriptions. The majority were incomplete prescriptions, but a third were dosing errors.

Although the study involved only five London hospitals, the authors believe the results would be similar in other UK hospitals.

Most drugs are formulated for adults not children, meaning doctors have to make their own dose calculations based on the child’s age, weight and clinical condition. Many drugs given to children are used unlicensed, meaning they have not been tested and approved for use on children, which compounds the problem.

The National Patient Safety Association said it had recently looked at patient safety among children in hospital and had identified action points for NHS organisations, which include reviewing local standard operating procedures for medicine management.

Commenting on the findings, Susan Brown, a medical negligence solicitor from Boyes Turner said:

“Sadly although the study was undertaken 5 years ago it isn’t thought that the position is any different today. Fortunately many of these medical errors don’t result in serious harm, but some do and are potentially fatal. The medical negligence solicitors at Boyes Turner are regularly contacted by families whose children have suffered injury as a result of medication errors”.

Compensation for negligent advice regarding medication

£1.25 million compensation for a medication negligence victim who suffered a severe stoke after her treatment passed from hospital to her GP.

The claimant underwent coronary artery bypass, mitral valve replacement in hospital after which she was discharged with medication including Warfarin (anti-coagulant medication). She was discharged to the care of her GP, who became responsible for monitoring her Warfarin.

A subsequent infection led to the claimant being prescribed antibiotics by her GP, who meanwhile mismanaged her Warfarin treatment which led to her suffering a severe stroke.

The claimant suffered total paralysis of the arm, leg and trunk (on the same side of the body) and became fully dependent on her husband.

The claimant’s condition is permanent, with expert evidence indicating a high mortality risk.

Following a claim for medication negligence, the GP admitted liability.  The matter settled out of court for the sum of £1,250,000.

Julie Marsh, medication error negligence claims solicitor, comments:

“This is a clear example of where care is passed from Hospital to GP, without due consideration of the Claimant’s treatment whilst in the hospital, followed by the GP amending a drug regimen without checking the necessary blood results.  This has had a tragic and life altering effect on the individual, and her partner.  This could have been avoided, but for the GP’s negligence.”

Thousands of diabetes patients have been given the wrong doses of insulin

Official figures have revealed that thousands of diabetes patients have been given the wrong doses of insulin. Hospitals and community health organisations have ordered an on-line mass safety training programme for doctors and nurses.

Approximately one million people in the UK with diabetes rely on insulin injections to control levels of glucose in their blood. In most cases they monitor their own blood and adjust the dose appropriately, but the very elderly or very young, or those with other medical complications, have to rely on doctors and nurses to do the prescribing, monitoring and administration.

NHS statistics show that there have been over 3,900 serious incidents involving insulin across the UK since 2001. Officials say the actual figure may be higher as incidents go unrecorded.

Higher than required doses of insulin can lead to hypoglycaemia (too little glucose in the blood). If hypoglycaemia is left untreated, it can lead to confusion, clumsiness or fainting. Severe cases can cause seizures, coma or death.

Around 21,000 doctors and nurses voluntarily registered for the safety training programme, set up by the National Patient Safety Agency and NHS Diabetes. But only 13,000 have successfully completed the course, raising safety concerns among patients groups.

Professor David Cousins of the NPSA said that insulin is safely given to thousands of patients each day. “However, there is a real potential for serious harm if it is not administered and handled properly.”

He urged staff to take the course. “This guidance is essential as the effects of wrong dosage can lead to catastrophic consequences.”

The health charity Diabetes UK welcomed the initiative but was concerned as to why so few doctors and nurses had completed the course. Cathy Moulton, a nurse with expertise in diabetes who is one of the charity’s clinical advisers, said that given the potential for death or serious harm, many hospitals are making the training mandatory. “Many of these shocking errors are avoidable with, for example, the right training, systems and protocols in place. Diabetes specialist teams should be in place to provide training, expertise and support to non-diabetes specialists.”

In January 2005, Sybil Jones, 79, from Poole in Dorset died as a result of an overdose of insulin. An agency nurse failed to monitor her sugar levels properly. Moira Pullar, 62, died at Monklands General hospital in January 2004, when she was given 10 times too much insulin by a nurse who misread her poorly written diabetic records.

The NPSA, which collects data on drug errors, has issued new guidelines stressing that the term “units” must be used in all contexts and staff must never use the abbreviations, “U” or “IU”. which can be misread as “0”. In some cases staff have misinterpreted “1 U” as 10 units – 10 times the required dose.

The NPSA also says that NHS organisations must ensure that all insulin doses are measured and administered using an insulin syringe or pen device and never using intravenous syringes.

Moulton said: “It is puzzling that up until last week around 8,000 health care professionals registered for the online training programme in the safe use of insulin had yet to complete it. This commitment must be taken seriously to help ensure the safety of people with diabetes, and so we welcome the news that many trusts are making this training mandatory.”

Fraser Wood the director of communications at NHS Diabetes said: “It’s hoped the campaign will lead to greater awareness of the potential dangers of poor prescribing.”

Medical negligence solicitor Nicola Anderson comments:

“As this Guardian article highlights, insulin dosage errors can have catastrophic consequences for patients. Inadequate training and difficult to read / unclear handwriting on the part of prescribing doctors, have both been identified as factors contributing to previous untoward and completely preventable incidents. Drug dosage errors, of course, are not confined to the use of insulin and what this article does not highlight is the number of serious incidents in UK hospitals relating to other drugs. The article also does not address errors made in other settings, for instance by General Practitioners and by Pharmacists. Indeed we are currently acting for two clients as a result of mistakes made by their local pharmacies. In one case the incorrect drug was dispensed and in the other the pharmacist dispensed the correct drug but with instructions to take far in excess of the prescribed dosage. For both patients there were serious consequences.”

The service was personal, professional and considered. I was treated so kindly and in the end I knew that not only had I found the right organisation but also the right person.

Boyes Turner client

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