Medication Incident 3 - Paracetemol Excerpts from INQUIRY UNDER THE FATAL ACCIDENTS AND INQUIRIES (SCOTLAND) ACT 1976 INTO THE SUDDEN DEATH OF DANIELLE WELSH v. , 02 February 2011, Sheriff A.M. Cubie2011 FAI 7 SHERIFFDOM OF GLASGOW AND STRATHKELVIN DETERMINATION INTO THE CAUSES OF DEATH OF DANIELLE WELSH In terms of Section (1)(b) that the cause of her death was: Liver failure due to Paracetamol toxicity due to Iatrogenic paracetamol overdose. Danielle Welsh (Danielle) was born on 5 June 1989. She had an undefined condition; her sister Catherine is the only other diagnosed case in Scotland. This condition gave rise to spondyloepiphyseal dysplasia, short stature, mild but longstanding learning difficulties, problems with hearing and chronic pain particularly in the limbs and joints. Danielle had for some time been under the care of inter alia Dr John Currie at the Royal Hospital for Sick children, Yorkhill. He is a consultant paediatric anaesthetist with an interest in pain relief. If the normal analgesics did not assist, then Danielle would see him. At June 2008 she weighed 35 kilogrammes. Danielle was on a regular regime of prescribed medicines which included Tramadol and paracetamol. These were taken orally, although on occasion Danielle did not like taking pills. Danielle had been an inpatient at the Southern General Hospital (SGH), Glasgow following her presentation at the Accident & Emergency Department of the Hospital late on Sunday 15 June 2008. She was transferred to the Royal Infirmary of Edinburgh (RIE) from the SGH in the early hours of Monday 23 June 2008 suffering from fulminant liver failure. She died in the Intensive Care Unit of the Scottish Liver Transplant Unit at the RIE at 10.25 on Tuesday 24 June 2008 aged 19. [Section 6(1)(a)] 15th June 2008 Danielle was increasingly confused argumentative and aggressive. This was out of character. She complained of feeling unwell. Her parents were sufficiently concerned to take her to the SGH. They presented at about 23.23. She was seen by a triage nurse at the Accident and Emergency Department and then by the locum registrar, Dr Bardham. Danielle was referred to the on call Specialist registrar. She was found to be responsive but very anxious, with confused speech. Her temperature and blood pressure were normal. A number of laboratory tests were carried out, disclosing raised white cell count which might point to infection. The initial concern was encephalitis or meningitis. A brain scan was arranged with a view to a lumbar puncture if that was negative. 16th June 2008 The CT scan was normal. Danielle was seen by Dr Wallace again about 03.45. A lumbar puncture was attempted but could not be effected. An MRI brain scan was considered but Danielle's condition, where she continued to be agitated, precluded that as the patient requires to be still. The presumptive diagnosis was addressed by the administration of anti-viral and antibiotic drugs. 1 Danielle's height and weight were not entered on the Kardex, although there is a space for weight; (P51) However, in the hospital notes, Dr Wallace recorded Danielle's weight and prescribed the drugs "according to weight/paediatric doses." Danielle was also prescribed 1g paracetamol "as required". The route of prescription was given as "IV/PO", meaning either intravenously or orally. The prescriber of that drug cannot be identified. It must have been prescribed before 6.45am. At 10.30 am Danielle was seen in ward 20 by Dr Semple. Danielle was transferred to Ward 21 where she remained until the 19th June. The "as required" paracetamol was stopped during the course of the 16th June. Danielle remained on Ward 21; she was seen by a number of junior doctors. That ward was normally the responsibility of Lesley Perry, a clinical Pharmacist; she was not on duty and her responsibilities fell upon Saima Afzal, who reviewed Danielle's Kardex. She was aware, (although she could not remember why) that Danielle's weight was 35kg and consulted both the adult and paediatric BNF to confirm that the antibiotic prescription was appropriate. Danielle was noted to be vomiting by the evening. Oral administration of drugs was accordingly more difficult. She continued to be in pain. Dr Das was on duty. She was then a foundation year one doctor. This was some time around 10.00pm. She was asked, probably by way of a post-it note on the Kardex, to prescribe pain relief and anti-emetic drugs. She had had no previous dealings with Danielle; she did not see Danielle, she did not know her weight. She proceeded to prescribe on the basis that Danielle was an adult and prescribed intravenous paracetamol 1g four times daily. The practice was to revert to oral administration at the earliest opportunity; any prescription would be subject to review. Danielle received 2 doses of the prescribed IV paracetamol in the evening. An MRI scan was attempted but abandoned due to significant agitation. It was determined that she should have an MRI scan and a lumbar puncture in the Institute of Neurological Sciences at ward 67 SGH. 18th June 2008 Danielle was admitted to ward 67 for the administration of the MRI and lumbar puncture under general anaesthetic, as well as for general assessment. This transfer was necessary as these procedures could not be undertaken in any other ward. The intravenous administration of paracetamol continued. 19th June 2008 Danielle remained in ward 67; for the purposes of the enquiry the care was not noteworthy. A lumbar puncture was performed and was normal. The intravenous paracetamol continued. An MRI scan was normal. Her white cell count was still high, but the medical staff were able to discount any neurological disease. The diagnosis otherwise was still unclear. Further tests were undertaken. Danielle's Kardex was reviewed there by Pharmacist Lesley Murray. She may not have seen Danielle in person. She did not alter the prescription. She did not know that the intravenous and oral dosages of intravenous paracetamol were different. She assumed that they were the same. She did not check. The need for intravenous rather than oral painkillers continued with Danielle still on a drip; she was prescribed a second, additional, anti-emetic for nausea in the course of the evening, 2 showing that she continued to be nauseous, and undermining the utility of oral administration of paracetamol. 20th June 2008 Danielle was still agitated. Danielle was transferred back to ward 25; this was a different medical ward. By this time the combination of infection indicators and the identification of what appeared to be "crackles" on the lungs gave rise to a possible diagnosis of atypical pneumonia. As a result of this, her prescription of Acyclovir was stopped as this was an antiviral drug no longer felt to be addressing the condition. 21st June 2008 There are no medical notes or nursing notes for the 21st June. The clinical notes go from the 20th June to 22nd. No tests appear to have been undertaken 22nd June 2008 Danielle continued to be treated for atypical pneumonia; there seemed to be an improvement noted to her demeanour. Her condition initially caused concern because her SEWS score was 4. Blood tests were taken and showed grossly abnormal Liver Function Tests. She was referred to a consultant who at 23.25 referred to the liver unit at Royal Infirmary of Edinburgh (RIE). There was considerable concern about Danielle's fitness for transfer. 23rd June 2008 At 01.30 Danielle was transferred by ambulance to Surgical ITU with acutely deranged Liver Function tests with coagulopathy and raised paracetamol levels. Danielle was in a critical condition so was intubated and ventilated to provide a degree of stability for the transfer, arriving at 03.45 am. She was stabilised. She was considered for Transplant but having regard to the appropriate criteria, she was considered to be unsuitable. She was considered to be likely to survive. Although ill, the prognosis was reasonable. 24th June 2008 Danielle suffered a cardiac arrest. She was subject to intensive CPR for a period of 35 minutes or so; she appeared to recover but was very unwell. She then suffered another heart attack and was pronounced dead at 10.25 am. It was recorded that Danielle died of liver failure due to paracetamol toxicity due to paracetamol overdose. There was ample evidence accepted by all that from the period 17 June until 22 June Danielle was given 20 doses of intravenous paracetamol at one gram when each dose should have been 525 milligrammes. 3