Names have been removed to protect privacy. Identifying letters are assigned in alphabetical order and bear no relationship to the person’s actual name

1. This Office received a complaint from Mr A about the care provided to his sister, Ms B, by a public hospital (Health New Zealand|Te Whatu Ora (Health NZ) Counties Manukau). The complaint concerns an overdose of opioid[1] medication, which caused a hypoxic brain injury[2] and permanent memory dysfunction.

Summary of events

2. Ms B (aged 46 years at the time of events) has a history of anxiety, paranoia, post-traumatic stress disorder, obstructive sleep apnoea (OSA), obsessive compulsive disorder, and depression. Ms B also experienced chronic pain syndrome in 2011.[3]
   
   
3. In the evening of 4 March 2021, Ms B presented to the public hospital’s Emergency Department (ED) with abdominal pain radiating to her back, and a three-day history of diarrhoea and decreased appetite. Her pain score on admission was documented as 6/10 and she was given intravenous (IV) fentanyl[4] and paracetamol for pain relief. Ms B was transferred to the Short Stay Unit (SSU) in the early hours of 5 March 2021, where she continued to receive regular doses of IV fentanyl. At approximately 11.17am, Ms B was prescribed fast-acting (oral) oxycodone.[5] Her pain score was documented as 6/10 and she received further doses of IV fentanyl around the same time.[6] Ms B was also given her usual medications of quetiapine[7] and valproate[8] throughout the day.[9]
   
   
4. A CT scan and chest X-ray identified no abnormalities, and the clinical impression was gastroenteritis (stomach flu). At approximately 2.10pm, Ms B was reviewed by a junior doctor, who noted that Ms B’s ‘pain [was] out of proportion [with] clinical and radiological findings’, and that Ms B had been administered long-acting oxycodone.[10]
   
   
5. Ms B was admitted to the surgical ward around 4pm.[11] Her pain score was documented as 7–8/10, and she continued to receive regular doses of fentanyl[12] and fast-acting oxycodone[13] to help manage her pain.[14] In addition, Ms B was given her usual nightly medications of diazepam[15] and zopiclone[16] (taken between 7 and 8.20pm).
   
   
6. The staff recalled that Ms B rang the patient call bell multiple times throughout the shift to request additional pain relief, and that extra monitoring of Ms B was undertaken owing to the amount of medication she had received. In particular, the staff checked Ms B’s oxygen and respiration rates every 30 minutes; however, none of these observations were documented in the clinical notes or in eVitals (the electronic observations record). The staff member recalled that Ms B requested more pain relief at approximately 10.45pm but was advised to wait until the next dose was due. At a verbal bedside handover between the clinical staff, no concerns were noted.[17]
   
   
7. In response to the provisional opinion, Mr A[18] disputed the recollections of the staff. Mr A told HDC that although Ms B was in pain and requested pain medication, he recounts that the patient call bell was not rung ‘multiple times’ prior to his departure at around 6pm. Mr A recalled ‘very little interaction with staff’ and that observations were not made on a half-hourly basis.
   
   
8. At approximately 12.15am on 6 March 2021, Ms B was found unresponsive[19] and not breathing properly. Oxygen and naloxone[20] were administered, and Ms B was transferred to ICU. Subsequent CT and MRI scans confirmed that Ms B had suffered a hypoxic brain injury with a decreased level of consciousness, likely secondary to opioid-induced hypoxia.[21] Ms B was discharged from hospital on 31 March 2021.

Serious Adverse Event Review (SAER)

9. Health NZ Counties Manukau undertook an SAER, which included input from an Acute Pain Team (APT) consultant and a Complex Pain Team pharmacist. The SAER, dated 22 November 2021, found the following:

• • Despite adherence to the Opioid Protocol[22] (medication administered was within normal recommended doses), narcosis[23] still occurred. The APT consultant considered that polypharmacy[24] led to Ms B’s inadvertent overdose/narcosis.
    
    
  • Opiates and benzodiazepines need to be prescribed with caution, particularly in the context of OSA. Ms B was at increased risk of respiratory depression due to her routine sedating medication and pre-existing OSA. There are no prompts available in the Medication Chart (Medchart) to alert medical staff prior to prescribing.
    
    
  • The requirement for pain relief was out of proportion to Ms B’s symptoms, which often indicates a possible acute/chronic pain syndrome flare-up or increased anxiety; however, this was not escalated to determine another cause for her pain. Ms B may have benefitted from earlier involvement of the acute pain service and psychiatry liaison teams. If Ms B had been reviewed by a senior doctor when she arrived on the ward, her pain relief requirement may have been identified as being abnormal.
    
    
  • Long-acting opioids should not be used for acute pain. In addition, it was noted that IV and oral opioid doses were often given in very close proximity and sometimes simultaneously. The APT consultant reported that they would not normally give oral or IV protocol opioids within the same hour; however, this did not appear to be included in the Opioid Protocol.
    
    
  • Routine nursing observations of pain score in the ED and the ward, and observations taken prior to Ms B’s collapse were not recorded as per the Opioid Protocol. The senior staff had recently introduced bedside handovers and auditing of electronic vitals (eVitals) to the ward, so these were not yet up to the expected standard.

10. The SAER outlined several recommendations for improvements:

• • Make co-prescribing[25] hints available in Medchart for fentanyl and other respiratory depressant drugs used in combination, particularly with OSA. In addition, it was recommended that a Medchart alert be added to all long-acting opioids, stating that they are not recommended for acute or chronic non-cancer pain, and to contact the acute pain service prior to prescribing.
    
    
  • Review the Opioid Protocol to ensure that more emphasis is given to risks and prescribing contraindications, and the need to escalate care when the pain is out of proportion or maximum pain relief has been reached; in particular:
    • Ensuring that after one ‘cycle’ of IV opioid protocol, a resident medical officer (RMO) is called for review/discussion before another cycle can be given. A prompt for this could be added on Medchart.
    • Adding Medchart alerts or lockouts so that fast-acting forms of opioids (IV and oral) cannot be given concurrently.
    • A wait time of 60 minutes after IV protocol administration until oral opioids can be given unless reviewed by an RMO/SMO.
    • A wait time of 30 minutes after oral opioids are given before IV protocol can be given unless reviewed by an RMO/SMO.
      
      
  • Fast-track the incorporation of an opioid-induced sedation scale into eVitals.
    
    
  • Consider ensuring that those who are admitted late to the ward receive an SMO review.
    
    
  • The senior staff is to follow up on a lack of documentation with the staff involved in the ED and surgical wards.

Further information

11. Health NZ Counties Manukau told HDC the following:

• • Ms B was assessed and managed appropriately; however, this case provides important learnings regarding the dangers of the prescription of IV analgesia.
    
    
  • It is possible that the connection was not made between the large amounts of opioids Ms B received in the ED/SSU and the fact that she was about to be dispensed her nightly medication once transferred to the ward.
    
    
  • The ward was very busy with multiple admissions, and at the end of the shift, the ward was at full capacity. A Care Capacity Demand Management (CCDM)[26] score of seven was assigned, meaning that staffing was ‘stretched’; however, the skill mix of the staff on duty was lower than expected (there was a junior work force caring for patients). In retrospect, a CCDM score of 14 should have been assigned,[27] which may have resulted in admissions being limited or additional staff being redeployed to help out. The busyness of the shift contributed to Ms B’s clinical observations not being documented.
    
    
  • It is concerned about the use of the SAER to make HDC findings, noting that using the report ‘to scrutinise individual clinical decision making is inappropriate and undermines the purpose of these reports’. Furthermore, Health NZ Counties Manukau stated that as the SAER provides specialist opinions (an APT consultant and a Complex Pain Team pharmacist), who were not peers of the medical team, it is not appropriate to use the SAER to assess the standard of care provided to Ms B.

Responses to provisional opinion

Mr A

12. Mr A was given the opportunity to respond to the provisional opinion. Mr A noted the significant impact this experience has had on Ms B’s and her family’s lives. While Mr A acknowledged that Ms B’s underlying condition made ‘matters complex’, he told HDC that this event has dramatically altered Ms B’s mental state and function, and that ‘she no longer has any quality of life’.
    
    
13. Mr A told HDC that he found it ‘extraordinary’ that Health NZ Counties Manukau could conclude that Ms B was assessed and managed appropriately in light of its failings in administering pain medication in conjunction with Ms B’s regular medications. He stated that while there were ‘many amazing, competent and caring individuals’ who looked after Ms B and his family over the course of the events, ‘the initial care and attention leading to the event was lacking’. 
    
    
14. Mr A welcomed the breach finding of Health NZ Counties Manukau but told HDC that regardless of protocols, ‘the nature and appropriate use of … opioids should be well understood by appropriately trained professionals’, and the risk of interactions with other medications should be a ‘fundamental consideration’ when charting medications.
    
    
15. Other comments from Mr A have been incorporated elsewhere in this report where relevant.

Health NZ Counties Manukau

16. Health NZ Counties Manukau was given the opportunity to respond to the provisional opinion. Health NZ Counties Manukau accepted that there were ‘gaps’ in its protocols at the time of the events. Other comments have been incorporated elsewhere in the report where relevant.

Relevant policies and procedures

17. Both the Health NZ Counties Manukau ‘Intravenous Morphine and Fentanyl (Adult Emergency Department)’ protocol, dated 31 July 2019, and the ‘Intravenous Opioid (Adult)’ protocol, dated 1 October 2020, outline that before prescribing IV opioids, the prescriber should consider ‘[n]ot administering oral opioids within an hour of using the IV protocol unless discussed with a medical officer’, and monitoring patients with OSA more closely for respiratory depression.
    
    
18. Furthermore, both protocols state that a patient’s pain must be assessed prior to the administration of opioids. In addition, both vital signs and further pain assessment must be undertaken at both three and 20 minutes after opioid medication is given (and should be documented in the clinical notes), and if further opioid doses (over the maximum of five doses within an hour) are necessary due to sub-optimally managed pain, ‘the appropriate medical officer should be notified and a review requested’.

My decision

19. I have reviewed all the information, including the findings outlined in the SAER. I acknowledge Health NZ Counties Manukau’s concerns regarding the use of the SAER to scrutinise decision-making for individual clinicians. I note that this information has been used to inform systems-level concerns in conjunction with the relevant policies and procedures available at the time of the events, alongside all other evidence, to determine whether a breach of the Code of Health and Disability Services Consumers’ Rights (the Code) has occurred, for the purpose of learning and quality improvement. To avoid duplication and to support safety improvements already underway, the recommendations of the SAER have also been used to determine whether appropriate measures have been taken since these events to minimise future recurrence, as referenced below. 

Inadequate protocols — breach

20. While I accept the finding in the SAER that the opioid medication was administered within normal recommended doses, it is noted that both the IV and oral opioid doses were often given to Ms B in very close proximity and sometimes simultaneously. In addition, I note that Ms B was at increased risk of respiratory depression due to her routine sedating medication and pre-existing OSA, yet she was still prescribed multiple doses of opioids over 24 hours. Although both protocols outlined that oral opioids should not be administered within an hour of using the IV protocol (unless discussed with a medical officer) and that patients with OSA need to be monitored more closely for respiratory depression, I am critical that neither protocol sufficiently emphasised the risks of prescribing contraindications.
    
    
21. Furthermore, I am critical that neither protocol emphasised the need to escalate care when pain is out of proportion or maximum pain relief has been reached. Both protocols state that a medical officer should be notified (and a review requested) if further opioid doses (outside the maximum amount per hour) are necessary. However, as the opioid medication was administered within normal doses, Ms B’s care was not escalated to determine another cause for her pain. This was despite the junior doctor recognising that the requirement for pain relief was out of proportion to the symptoms and that Ms B was continuing to experience pain despite receiving the maximum doses of opioid medication.
    
    
22. For failing to have in place sufficient, clear policies to support safe practices, I find Health NZ Counties Manukau in breach of Right 4(1)[28] of the Code. However, in making these comments, I acknowledge the changes made by Health NZ Counties Manukau. Co-prescribing hints/advice, as well as alerts and lockouts, have been added into Medchart, and a review of the Opioid protocol has been undertaken, which I consider to be appropriate remedial actions.

Documentation — adverse comment

23. Both opioid protocols state that a patient’s pain must be assessed prior to the administration of opioids. In addition, both vital signs and further pain assessment must be undertaken at three and at 20 minutes after opioid medication is given.
    
    
24. I am critical that despite Ms B receiving multiple doses of opioids over 24 hours, her pain score was documented only five times, particularly given that it was recognised that the requirement for pain relief was out of proportion to the symptoms, and that Ms B continued to experience pain even when the maximum doses of opioid medication had been given. In addition, I am concerned that Ms B’s vital signs were not recorded when she was on the ward; however, I note the mitigating factor of processes not being fully embedded, as well as the remedial actions already taken (discussed further below).
    
    
25. Given the consistent lack of documentation in both the ED/SSU and on the ward, I consider this to be a systems issue for which Health NZ Counties Manukau is responsible. Furthermore, while I acknowledge the busyness on the ward at the time of events, I note that the ward was full and consider that Health NZ Counties Manukau had a responsibility to ensure that the ward was staffed appropriately so that appropriate care could be provided. 

Changes made

26. As a result of these events, the following changes occurred:

• • The senior staff member reported seeing a ‘dramatic improvement in all documentation’. The senior staff member will use this case review to help promote critical thinking amongst the clinical team.
    
    
  • The clinical staff member discussed the failure to document observations with the senior staff, and a care improvement plan was put in place. The senior staff member stated that the staff member ‘now has the best and most thorough documentation out of the entire team’.

27. In response to my recommendation made in the provisional opinion, Health NZ Counties Manukau provided an update on the recommended changes outlined in the SAER:

• • Co-prescribing hints/advice, and alerts and lockouts have been added to Medchart.
    
    
  • The Health NZ Counties Manukau ‘Intravenous Opioid (Adult)’ protocol has been updated.
    
    
  • The incorporation of pain-related observations (including the assessment for level of sedation as the first sign of opioid toxicity) into e-Vitals did not go ahead. This was due to an organisation-wide decision to place a large number of digital projects on hold with the aim of creating regional or national initiatives and preventing duplication.
    
    
  • It was considered not to be feasible for patients who are admitted to the ward late in the evening to receive an SMO review. Health NZ Counties Manukau told HDC that currently it is not funded or resourced for an SMO to review patients on surgical wards routinely soon after being admitted to the ward, regardless of the time of day; however, if there is a change in the condition of the patient following admission, and the patient is assessed as requiring an SMO review, a senior registrar will assess the patient following an SMO consultation.

Recommendations and follow-up actions

28. I recommend that Health NZ Counties Manukau:

• • Provide a written apology to Ms B and her family for the deficiencies in care identified in this report. The apology is to be sent to HDC within three weeks of the date of this report, for forwarding to Ms B.
    
    
  • Following publication of this report, develop a summary and share the learnings of this case with its clinical teams via the Clinical Quality and Risk Manager network. A copy of the summary of learnings is to be provided to HDC within six months of the date of this report.

29. An anonymised copy of this decision (naming only Health NZ Counties Manukau) will be published on the HDC website.  

 

 

Dr Vanessa Caldwell

Deputy Health and Disability Commissioner

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