NHS HIGHLAND. Significant Event Report

Transcription

1 NHS HIGHLAND Significant Event Report Report to - Quality & Patient Safety Raigmore Committee Subgroup of Findings from Significant Event Review Meeting 26/06/2012 QPS069 This note is a factual summary of a significant event review meeting. Whilst not a verbatim account of the meeting, it is an accurate representation of the information presented at the meeting, and the overall views of those present as to the management of the case. 1.0 Outline of Significant Event A 64 year old lady was admitted to Raigmore Hospital Acute Medical Assessment Unit at the request of her GP following a 1 week history of increasing shortness of breath. She was managed and treated for pulmonary emboli using warfarin therapy. Six days after commencing warfarin therapy she deteriorated over a short period of time with abdominal pain, drop in blood pressure and increasing heart rate. Following surgical and anaesthetic review she was taken to theatre for an abdominal laparotomy where a finding of significant retroperitoneal bleeding was made. Despite significant effort and medical management the bleeding continued. Later that evening following discussion between the family and consultant anaesthetist, supportive measures were withdrawn and the patient passed away. 2.0 Background 64 year old lady, recent history of breast carcinoma treated by surgery, chemotherapy and radiotherapy. All thought to be curative measures. She presented to Raigmore Hospital Acute Medical Assessment Unit on 7 th June 2012 following consultation with her GP. Her main complaint was of increasing shortness of breath. 64 Year old female Admitted as emergency via GP with 1 week history of SOB Past medical history August Breast carcinoma with wide local excision + axillary lymph node clearance; chemo & radiotherapy May Acalculous cholecystitis Recent admission to surgical unit (20/05/ /05/2012) Sudden onset right upper quadrant pain Elevated inflammatory markers Mildly deranged LFTs, normal bilirubin Abdominal ultrasound - slightly thick walled oedematous gallbladder, 1

2 no gallstones Diagnosis of acalculous cholecystitis Treated with oral antibiotics and improved Discharged with plan to repeat abdominal ultrasound Clinic review Diagnosis probable pulmonary embolus (PE) D Dimer elevated at 4380 CTPA negative for PE Consultant impression Unable to identify alternative cause for hypoxia, high suspicion of PE persists. Continue treatment for PE. Plan to discuss with radiologist in morning Discussed as planned and ventilation perfusion scan recommended (VQ scan) VQ scan shows high probability for PE 08/06/ SEWS 0 Feels better Abdominal ultrasound performed (previous request) For transfer to ward 11; left 6A approx 15:00 hrs Indirect transfer patient taken for VQ Scan + doppler of Legs Arrived ward 11 between 17:15 and 17:45 hrs 17:45 hrs FY1 review await result VQ scan 18:10 hrs Discussion with Respiratory Consultant VQ scan - high probability for PE. Continue treatment dose Enoxaparin Initiate Warfarin Discussed with patient - no contraindications identified Over weekend mild pyrexia, hypotensive increased respiratory rate SEWs 2 & 3 11/06/2012 Consultant review - impression PE Home Tues/Wed if well with Enoxaparin until INR Therapeutic GP to monitor INR as per protocol 18:30 Sp02 82% on air - oxygen recommenced 14/06/ :45hrs c/o abdominal pain similar to previous gall bladder pain 07:00 hrs Sp02 88% on 1 L 02 Tachycardia :30 hrs Consultant ward round?enlarged liver Plan Bloods, repeat abdominal ultrasound Noted by ward pharmacist to be on miconazole gel with possible interaction with warfarin - documented on drug kardex 15/06/ :20 hrs Medical Emergency Team call SEWS 4 Sp02 88% on 2L 02 Bp 98/59 Pulse /06/ :00 hrs Further Medical Emergency Team call SEWS 6 Respiratory rate 36 per minute 15/06/ :35 hrs INR > 10 15/06/2012 Reversal of anticoagulation & ITU & surgical review 16:45 hrs Abdominal laparotomy Blood Stained intra peritoneal fluid 2

3 Grossly cirrhotic liver Retroperitoneal haematoma around duodenum 17:55 Returned from theatre to ITU 21:00 hrs continuing to bleed Hb below 7g/dl Pupils size 7 poorly reactive concern re intracerebral bleed not stable for CT 22:00 hrs BP Un-maintainable Broadening ECG complexes Acidosis ph 6.99 Discussed with family & support discontinued 22:30 Died Family declined post mortem examination Death Certificate issued -1a, Septicaemia 1b, Retroperitoneal haemorrhage 1c, warfarin therapy 1d, Presumed pulmonary embolus Glossary of terms CTPA - Computed Tomography Pulmonary Angiography (A specialised radiology test to look at the structure of the lungs in particular the blood vessels) LFTs Liver Function Tests (blood tests to aid diagnoses of abnormal liver function) VQ scan Ventilation Perfusion scan (a lung test to determine if blood clots present in the small blood vessels of the lungs) FY1 - Foundation Year one doctor INR International Normalised Ratio (A blood test to indicate clotting time of blood) MET Medical Emergency Team (A team of nurse practitioners and doctors tasked to review patients identified as having a deterioration in their condition) CAD Common Admission Document (A document used on admission by nurses and doctors to asses patients and document a medical management plan) SEWS Scottish Early Warning Score (A system for recording patients vital signs and ensure appropriate interventions taken) NNP Night Nurse Practitioner 3.0 Findings of the review group The review group agreed the time line of the patient s pathway as presented with a minor alteration to the time enoxaparin therapy was commenced for a presumed diagnosis of pulmonary embolism. The receiving consultant confirming that treatment with enoxaparin had commenced prior to the CTPA being performed as the evidence for the diagnosis being pulmonary embolism was strong. The chair then took the review group through the event in chronological order. The admission of 20 May 2012 to the surgical unit was briefly discussed, with the responsible surgeon confirming that the clinical picture was one of cholecystitis confirmed by the ultrasound finding of thickened gall bladder wall. She was commenced on antibiotic therapy and rapidly improved. It was agreed the further ultrasounds of 8 th &14 th June also demonstrated a picture of cholecystitis. It is possible that this was a source of low grade 3

4 sepsis but cannot be confirmed. The group discussed the differential and working diagnosis at length and in particular the CTPA finding that indicated no pulmonary embolus. The group all agreed that there had been strong evidence to suggest a diagnosis of pulmonary embolism. In particular the degree of hypoxia, clinical history as taken from the patient and the significantly elevated D-dimer were all supportive of this diagnosis. It is also important to note that although the CTPA found no evidence of pulmonary emboli it also demonstrated no other lung abnormalities that could account for the patient s persistent hypoxia. Following consultation with a consultant radiologist, the receiving consultant requested a ventilation perfusion scan. The meeting facilitator had discussed the radiological tests utilised in this patient s management with a senior radiologist who confirmed that having had a negative CTPA but with the clinical picture as described it was entirely appropriate to use ventilation perfusion scanning as a secondary test. The SIGN guideline on management of pulmonary embolism indicates that CTPA is the gold standard diagnostic test. However, there is evidence to suggest that the sensitivity of this test may be less than 100%. The high probability result of the VQ scan for pulmonary embolism gave significant diagnostic security to the original working diagnosis of pulmonary embolism. Overall the review group considered the diagnosis of pulmonary embolism was correct and therefore to initiate anticoagulation therapy was the appropriate medical management. The group looked at the transfer of the patient from AMAU to ward 11 noting that having left AMAU at about 3 pm she did not arrive on ward 11 until around 5:30 pm having been taken for the VQ scan and Doppler scan of her legs. The FY1 doctor was just about to finish for the day but stayed to examine the patient and progress her medical management. He noted that she had been for a VQ scan and obtained the result before discussing the patient with a respiratory consultant who was still in the unit. They agreed after reviewing the clinical history and test results that the clinical picture was one of pulmonary embolism and it was therefore appropriate to commence the patient on low dose warfarin therapy using the NHS Highland protocol for inpatient initiation of warfarin. This protocol was developed as part of the Scottish Patient Safety Programme in response to the high number of identified issues with patients being commenced on warfarin. It is generally recognised that warfarin is a drug that carries significant risk of harm if not prescribed and monitored with care. There is good evidence that introduction of the protocol has significantly reduced risk to the majority of inpatients being commenced on warfarin. The group heard how the FY1 completing the protocol had considered all the 4

5 contraindications listed using the medical notes in the CAD, his clinical examination and discussion with the patient and concluded that there were no clinical contraindications for commencement of warfarin therapy as per the protocol. He confirmed that he took into account the abnormal LFTs and was aware of the recent episode of cholecystitis along with the ultrasound finding of that morning and had no concern that the patient had any evidence of severe hepatic (liver) disease. It was agreed that the clinical picture of normal coagulation, normal synthetic liver function and normal ultrasound findings (in relation to the liver) was strong evidence of no gross hepatic abnormality and that the ultrasound finding of thickened gall bladder wall was in keeping with cholecystitis and could account for the abnormal LFTs. It was noted that the patient s INR was to be checked in 7 days following initiation of warfarin as per the NHS Highland protocol. The group discussed this point at length and agreed a review of this time scale was required. Acknowledgment was made that the 7 day period would be reasonable in the majority of cases but that this case highlights a possible increased risk to a very small number of patients. It was agreed the current version of the low dose initiation protocol requires review and amendment. Discussion moved to the patient s concurrent medication and in particular the use of miconazole at the same time as warfarin was being initiated. The patient had been prescribed topical miconazole gel for oral candidiasis prior to this hospital admission and this was recorded as part of the medicines reconciliation process on admission and prior to warfarin therapy being initiated. On checking with the patient s GP it was confirmed that she had been given 3 prescriptions for miconazole oral gel since March It was therefore considered appropriate to continue the medication on admission. A medicine information request described a number of reported cases of patients having raised INRs and experiencing significant bleeding when taking the oral gel form of miconazole concurrently with warfarin therapy. It should be noted that these cases were patients who were on stable does of warfarin therapy with INR within normal therapeutic range having had miconazole introduced at a later date and not as in this instance being commenced on warfarin therapy for the first time. It was acknowledged that the prescriber of any drug has the primary responsibility to consider the potential for adverse drug interactions. Only one of the clinicians present at the meeting was aware of this possible adverse interaction with miconazole in oral gel form. It was recognised that an electronic prescribing system for hospital inpatients (similar to systems used in primary care) may have prevented the co-administration of miconazole with Warfarin. It was noted that there is no tick box on the warfarin initiation protocol to prompt consideration for potential interactions with concurrent drug therapy. The group agreed that such an amendment may have prevented the concurrent administration of miconazole and warfarin 5

6 In this patient s case, the organisation s medicine reconciliation process worked as she was correctly identified as being on miconazole in the community and correctly continued on admission however a significant failure in our process occurred as the next review of her medication by a pharmacist was on day 8 of her admission, by which time she had been receiving warfarin for 6 days. Discussion moved on to the patient s 7 day stay in ward 11. In general it was agreed that the majority of her stay had been uneventful with a picture of slowly improving respiratory function. She had continued on oxygen therapy but was maintaining her oxygen saturation levels with normal respiratory rate. Concern first grew on day 6 of her admission (Thursday 14 th June) when the patient started to complain of abdominal pain/discomfort describing it as being similar to her previous episode of cholecystitis. On examination of the patient, the responsible consultant considered there was evidence of an enlarged liver. He instructed a repeat abdominal ultrasound and bloods including amylase to be obtained. This was considered by the group to be an appropriate medical management plan at this time. It should be noted that the ultrasound finding on this occasion was confirmation of cholecystitis with no focal abnormality of the liver demonstrated. The junior doctor involved in the patient s care informed the group that he had significant difficultly in obtaining venous access for blood sampling. The ward phlebotomists had failed to obtain a blood sample and had requested the doctor s help. He experienced great difficulty, managing to obtain only enough blood to fill one blood tube. He also noted the patient had no overt signs of a prolonged bleeding time. There was no bruising and the venepuncture site stopped bleeding in the normal manner. This confirmed that there was no recognised clinical indication at this time to deviate from the low dose warfarin initiation protocol and check the patient s INR earlier than day 7 as planned. Discussion moved to events of the morning of 15 June 2012 when the nursing staff on night duty requested a Medical Emergency Team (MET) review of the patient following a SEWS score of 4 triggered by decreased oxygen saturation, drop in blood pressure with increasing heart rate. The patient was reviewed by the duty night nurse practitioner who documented a full examination of the patient s chest and abdomen. The findings at review indicated the patient had some decreased air entry to the base of her right lung and some generalised tenderness in her abdomen. They noted the finding of cholecystitis on abdominal ultrasound less than 24 hours earlier. The management plan at this time was to increase her oxygen therapy and order a repeat chest x-ray and bloods for the morning. This was agreed with the middle grade doctor on duty (also part of the MET). 6

7 There was a further MET call at 8 am when the patient had a SEWS score of 6, due in the main to her respiratory rate increasing to 36 (this scores 3). A chest x-ray was obtained at this time which showed no significant abnormalities. An increase in the patient s oxygen therapy saw the SEWS score decrease to 2. The NNP at this time considered commencing the patient on intravenous fluids and treatment for cholecystitis. The group considered the possibility that the clinical picture at this time may have prompted consideration of sepsis and a case could have been made for commencing antibiotic therapy. They agreed that this would have been a reasonable course of action but would in all probability not have altered the poor outcome for this patient. The group acknowledges that there followed prompt review by middle grade medical staff quickly followed by a consultant respiratory physician and thereafter by both anaesthetic, intensivist and surgical consultants culminating in the patient going to theatre for laparotomy where significant active retroperitoneal bleeding was found along with a grossly cirrhotic liver. Despite the best efforts of all concerned the bleeding could not be controlled and the patient succumbed later that evening. Significant discussion occurred around changes in systems and procedures to improve patient safety and reduce risk of harm from similar events. Conclusion The review group considered that there were a number of factors that lead to the tragic outcome in this lady s case. It was felt that the use of miconazole oral gel concurrently with warfarin therapy was in all probability the most significant avoidable factor in the patient s uncontrollable bleeding. It was recognised that awareness of this important interaction among clinical staff was low and that other treatments are available for oral candidiasis. The finding of a grossly cirrhotic liver on laparotomy indicated the presence of severe occult hepatic disease and this would have contributed to the patient s sensitivity to warfarin. If previously recognised, this would have been a significant caution in the use of warfarin therapy. However, this finding was not apparent until the laparotomy and could not have been predicted in the light of the previous blood results and abdominal ultrasound findings. The group concluded that without post mortem examination it is impossible to determine the cause of her cirrhotic liver and occult hepatic disease. There may also have been additional influences on the metabolism and effect of warfarin such as nutritional state and genetic factors. The review group believes the recommendations listed below will address the system failings that contributed to this patient s death and significantly improve patient safety in the future. 7

8 Additionally, the review group agreed that this lady s death was attributable to therapeutic hazard and therefore should have been discussed at an early stage with the procurator fiscal s office. 4.0 Recommendations 1. A review of the NHS Highland protocol for the initiation of inpatient warfarin therapy to be performed in relation to the following areas: A shorter interval for checking INR after commencing warfarin Amend the current contraindication check list to include possible adverse drug interactions The definition of hepatic disease to be revised The protocol to have explicit instruction as to what grade of doctor has authority to sign the contraindication check list 2. NHS Highland to review the use of warfarin and consider its replacement with rivaroxaban 3. NHS Highland to develop a plan to implement an electronic prescribing system for inpatients within a realistic time frame 4. All oral preparations of miconazole to be withdrawn from the Highland Formulary 5. Publicise the hazard of Miconazole oral gel interaction with warfarin through the Pink One 6. All inpatients on warfarin therapy to have prioritised review of their medication prescription chart by a hospital pharmacist 7. Ensure a yellow card ( suspected adverse drug reactions ) form completed and notified to Commission on Human Medicines Compiled by - S U Struthers Q & PS Facilitator / Dr K McDonald (Chair) Date 27/06/2012 8

9 5.0 Recommendations Following QPS RMT Review & Approval Ratified 1. A review of the NHS Highland protocol for the initiation of inpatient warfarin therapy to be performed in relation to the following areas: A shorter interval for checking INR after commencing warfarin Amend the current contraindication check list to include possible adverse drug interactions The definition of hepatic disease to be unambiguously revised The protocol to have explicit instruction as to what grade of doctor has authority to sign the contraindication check list, as modified and with new related recommendation 8 To include the word unambiguously 2. NHS Highland to review the use of warfarin and consider its replacement with rivaroxaban 3. NHS Highland to develop a plan to implement an electronic prescribing system for inpatients within a realistic time frame 4. All oral preparations of miconazole to be withdrawn from the Highland Formulary No, replaced by recommendation 9 5. Publicise the hazard of Miconazole oral gel interaction with warfarin through the Pink One 6. All inpatients on warfarin therapy to have prioritised review of their medication prescription chart by a hospital pharmacist 7. Ensure a yellow card ( suspected adverse drug reactions ) form completed and notified to Commission on Human Medicines 8. The revised NHS Highland protocol for the initiation of warfarin therapy in in-patients should be shared with colleagues in primary care 9. NHS Highland should develop a plan to implement an electronic prescribing system for in-patients, with in-built drug alerts, with functionality equivalent to the system that exists in Primary Care new - new Compiled by - Liam Gaffney, Quality & Patient Safety Facilitator, and Dr Rod Harvey (Chair) on behalf of the Subgroup of the Quality & Patient Safety Committee Date 10/07/12 Date 10/07/12 9