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Medication safety - prescribing errors (07HDC09719)

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In June 2007 the Health and Disability Commissioner (HDC) received a complaint from Mr A, regarding the services provided to his mother, Mrs A, by two district health boards in 2003. The complaint raised serious concerns about the collection and use of information regarding medication allergies.

Overview
In late July 2003, Mrs A, a 72-year-old woman, was admitted to Hutt Hospital and diagnosed with an abscess on her spine. Antibiotics and initial treatment were given at Hutt Hospital and she was then transferred to a private hospital for an MRI scan. Following the scan Mrs A was admitted to Wellington Hospital where an operation was performed to clear the abscess.

During her initial admission at Hutt Hospital and while at Wellington Hospital, Mrs A was given various antibiotics. She had previously been identified as having an allergy to cephalosporin antibiotics, but was nonetheless given such medications at both hospitals. Mrs A developed toxic epidermal necrolysis, a rare and serious condition characterised by the detachment of top and lower layers of the skin, which also severely affects the mucous membranes causing damage to airway linings.  It appears that in Mrs A's case it led to respiratory failure, which was the cause of her death.

Care at Hutt Hospital
Allergy history
Mrs A had operations at Hutt Hospital in 1982 and 1995 during which she had allergic reactions to cephradine (a cephalosporin antibiotic) and cefamandole (another cephalosporin antibiotic). This caused a severe rash over all her skin with purpuric or petechial appearance and some blistering. Her GP was informed of this allergy and it was noted on her GP record "AVOID CEPHALOSPORINS".

In January 2002 Mrs A was referred to Hutt Valley DHB again. The referral form from her new GP, Dr B, clearly indicated allergy to cephalosporins and possibly aspirin.

On 22 July 2003 she was referred to Hutt Hospital by the same GP for severe back pain with urinary retention. The referral note indicated an allergy to aspirin and Ceclor.  However, the allergy section of the admission form was not completed. Instead, someone wrote "refer to GP letter".

There are differing accounts about the discussion of Mrs A's allergy information. Her daughter, who was with her at the time, recalls discussions about Mrs A's allergy to antibiotics and the reaction during previous operations. Mrs A was a retired nurse and apparently reasonably alert when admitted.

The orthopaedic registrar who saw Mrs A said that he read the referral from Dr B but recalled that Mrs A only mentioned an allergy to aspirin. He recalled the reaction as being severe and thought that she may have mentioned a rash or swelling of the face but could not be sure. He remembered asking about Ceclor and that Mrs A said she might have had a symptom which the registrar considered to be more of a side effect - along the lines of an upset stomach. The orthopaedic registrar did agree that the previous reaction during an operation was discussed with him but he did not recall being told about it making Mrs A's skin peel or that an antibiotic was the cause.

Mrs A was given intravenous ceftriaxone (a cephalosporin antibiotic) before transfer to Wellington Hospital.

Care at Wellington Hospital
Mrs A was transferred from Hutt Hospital to Wellington Hospital on 23 July. The Emergency Department record noted only an allergy to aspirin, which caused a rash. The admission notes (based on information from Mrs A and her notes) also recorded an allergy to aspirin, with this being flagged by a drug reaction sticker. However, the preoperative checklist queried an antibiotic allergy while the pre-anaesthetic assessment form noted a drug sensitivity to Ceclor.

An operation was carried out to drain Mrs A's abscess on 23 July, and Mrs A was transferred to ICU. Patients are often transferred to ICU after drainage of epidural abscesses because they may become more unwell as a result of the dislodgement of infective material. Mrs A's postoperative recovery was complicated by significant sepsis, pulmonary problems, acute kidney failure and the development of a skin condition (the probable reaction).

Antibiotics - rash
After the operation at Wellington Hospital Mrs A was given flucloxacillin (a penicillin antibiotic), ceftriaxone (a cephalosporin antibiotic) and metronidazole. The flucloxacillin was thought to have caused a fall in her blood pressure and a rash on her torso and thighs and, on 24 July, an infectious diseases specialist, Dr C, was consulted and recommended stopping the current antibiotics and switching to clindamycin (a lincosamide antibiotic) immediately. However it was two days before flucloxacillin was stopped and, a day later, cefazolin (a cephalosporin antibiotic) was started.

On 27 July Dr D, an infectious diseases registrar, recommended continuing cefazolin, but the next day Dr E, a microbiologist, recommended stopping it immediately, which was done. Over this period Mrs A's rash continued to spread and worsen and was described as red and sore with blistering and peeling. She also developed mouth ulcers and a "positive Nikolsky sign" - which means that blisters spread easily on the application of pressure to the skin, a sign of toxic epidermal necrolysis.

Transfer to ward
Mrs A was discharged from ICU to the neuroscience ward 11 days after her operation on 3 August (during her time in ICU she had two failed extubations). She returned to ICU on 8 August after a cardiorespiratory arrest. The ICU records refer (sporadically) to allergies to aspirin and flucloxacillin (both noted as causing a rash). Mrs A was in ICU only 24 hours then was transferred back to the neuroscience ward on 9 August. Following a respiratory arrest on 13 August she was transferred back to ICU and subsequently died.

Action taken by Capital & Coast DHB
Investigation report
Capital & Coast DHB agreed to carry out an independent inquiry into Mrs A's treatment, and engaged Dr F to do so. The inquiry commenced in November 2003 was not completed until September 2004.

The executive summary in the report concluded that "Mrs A presented with a serious illness. In the course of her treatment she developed a number of complications. A number of systemic weaknesses, none of them individually lethal, combined allowed her condition to deteriorate to a critical point."

The report considered the matter of Mrs A's drug reaction at Wellington Hospital and identified the various points at which any reaction to cephalosporin antibiotics was noted. While the full notes from Hutt Hospital were not available, the GP referral letter (mentioning the Ceclor allergy) and ED notes were. The report described the trail of documentation as "disrupted and inconsistent". It stated that antibiotic choice in situations where a patient has a life-threatening infection is very difficult, and that the risk of reaction has to be balanced against the need to act against infection. The report also noted that there is a known cross-reactivity between cephalosporin and penicillin antibiotics (such as flucloxacillin) of around 4-10 percent.

The report stated that those treating Mrs A did not have a clear picture of her past history and presumed reaction. The appearance and disappearance of drug reactions from history taken from the same patient over a period of time is not unusual. However, the evidence was there for clinicians at both hospitals to consider, if only in the GP's referral letter. The report stated that there is considerable potential to improve systems for the collecting, recording and disseminating of information about a patient's drug sensitivities. This ranges from the use of Medic Alert bracelets to local and national electronic alert systems in hospital patient management systems.

The report recommended that:
1. systems for documentation of allergies and adverse drug reactions should be reviewed and strengthened. The use of electronic alerts may be helpful;
2. documented information that comes with the patient should be recognised, reviewed and incorporated in the hospital record.

The report identified the main issue to be addressed as Mrs A's suitability for placement in a generalised clinical setting rather than the intensive care unit, and her subsequent movement between these two areas. A number of conclusions and recommendations were made on this issue.

Implementation of recommendations
Capital & Coast DHB has taken the following actions to address the issues around collection and use of information about medication allergies/sensitivities:

  • discussion with staff about the importance of incorporating documented information that arrives with patients in hospital records
  • an upgrade of the database in ICU in May 2005 to allow for easier recognition of allergies
  • a move from paper to electronic health records (both are currently used), which has resulted in:

- an Admission to Discharge Planner document in the hard copy of patient records to record allergies for admitted patients
- the recording of allergies in the alerts section of patient medication charts (which aligns with the Safe and Quality Use of Medicines Group's national chart - this has a standardised allergy and drug reaction section, which will eventually make it easier to see the information where medication is charted)
- documentation of allergies on checklist type forms, eg, preoperative and pre-procedure checklists
- the recording of allergies through the patient information management system (IBA) with an alert that shows when the electronic patient record is opened

  • a formal reminder to staff by the Chief Medical Officer and Director of Nursing of the importance of ensuring that allergy information is appropriately sought and documented.

Action taken by Hutt Valley DHB
Hutt Valley DHB then requested Dr G (Chief Medical Advisor at another DHB) to investigate and report on the circumstances surrounding the care and treatment of Mrs A while at Hutt Hospital in July 2003 and to recommend any further action Hutt Valley DHB should take. The report was completed in August 2005 and concluded:

  • The GP referral was inadequate as it noted only Ceclor as an allergy rather than a cephalosporin allergy.
  • Mrs A should have worn a Medic Alert bracelet.
  • There was medical error by the orthopaedic registrar on the basis that he did not take adequate note of the information on Mrs A's allergy, which was reasonably available from the GP note or "likely communication from the patient and her daughter".
  • The fact that the Emergency Department nursing notes did not indicate any allergy despite having this information reasonably available also did not reflect a reasonable and appropriate standard of care.

The report went on to identify opportunities for quality improvement including:

1. using an electronic alert system
2. reviewing the documentation used in the Emergency Department
3. documenting discussions with patient and family.

In November 2007 Hutt Valley DHB advised that staff received ongoing education in relation to the importance of concise professional documentation, which includes the need to document discussions with patients or their family. Hutt Valley DHB is moving to a full electronic medical record, which will change the way allergy information will be stored and accessed, and includes an alert system. The DHB anticipates piloting the electronic alert system by December 2008.

ACC
Mrs A's estate made an ACC claim for medical misadventure in June 2004. It was only in late 2006 that the claim process concluded.

Expert advice - Dr Everts
ACC obtained advice from Dr Richard Everts (an infectious diseases specialist and medical microbiologist) in March 2005. He concluded that Mrs A appeared to have suffered toxic epidermal necrolysis with severe bronchial mucosal sloughing leading to respiratory failure and death. This was most likely an allergic reaction to ceftriaxone or even both ceftriaxone and flucloxacillin. The reaction may have been further aggravated by cefazolin. Because of Mrs A's previous severe reaction to cefamandol, all cephalosporin and penicillin-group antibiotics should have been avoided. Dr Everts identified the following points of "suboptimal care and unfortunate events" as leading to the inappropriate prescribing:


1. Mrs A's GP, Dr B, did not accurately determine the history of the cefamandole allergy.
2. Hutt Hospital did not have an electronic alert of the reaction.
3. Mrs A did not have a Medic Alert bracelet.
4. Mrs A and her daughter could not recall the exact name of the medication when communicating the allergy history to staff at Wellington Hospital.
5. Dr B's letter of referral did not mention cefamandole allergy (it did mention Ceclor).
6. Neither of the two hospital staff who enquired about drug allergies detected the cefamandol reaction documented in Mrs A's old hospital notes despite probably being warned that it had occurred.
7. None of the Hutt Hospital staff and only two of the Wellington Hospital staff who were supposed to enquire about drug allergies detected the Ceclor allergy despite it being written on Dr B's referral letter.
8. The two staff members who did detect the Ceclor allergy did not determine or document the nature of the severity of the allergy.
9. Flucloxacillin was not stopped until two days after Dr C recommended stopping it.
10. Cefazolin should not have been recommended or prescribed after the severe rash developed and flucloxacillin and ceftriaxone were suspected of being the cause.

Dr Everts initially concluded that there had been medical error on the part of the orthopaedic registrar at Hutt Hospital. The basis for this view was that the registrar had misread the GP letter, not looked at old notes, and did not document a full allergy history. Dr Everts noted that the registrar did make some attempt to determine or consider allergies in that he documented the allergy to aspirin. He concluded that it was likely that the registrar was told about a serious drug reaction and that the information could have been found in the Hutt Hospital old notes, but he did not follow this up before prescribing ceftriaxone.

Initial ACC decision and response
ACC subsequently advised Mrs A's estate that it had accepted the claim on the basis of "medical error". The report was sent to Hutt Valley DHB and Capital & Coast DHB. At this point the identity of the orthopaedic registrar was not known. Hutt Valley DHB then identified the orthopaedic registrar and he provided a report on the matter and asked that Dr Everts review his report in light of this new information.

The orthopaedic registrar stated:
1. The old notes were not available to him during Mrs A's admission and there was no computerised database.
2. He took a full history including medications and allergies and, based on the details given by Mrs A and her daughter, noted only an allergy to aspirin.
3. The orthopaedic registrar agreed that the problem with Mrs A's operation (when there was a reaction to cephalosporin) was mentioned but he was not sure that the head-to-toe peeling of skin was mentioned. He does not recall Mrs A or her daughter mentioning that an antibiotic caused it.

Revised ACC decision
On the basis of this further information, Dr Everts provided a supplementary report in August 2005. He changed his initial view and advised that he did not think there was medical error on the part of the orthopaedic registrar. A legal review of the matter was undertaken and it was recommended that the finding of "medical error" be set aside and that the claim be accepted as an "organisational error" on the part of both DHBs. Both DHBs objected to this recommendation, and the claim was accepted by ACC as "medical mishap" in November 2006.

Conclusions
1. Mrs A's case highlights the importance of accurate and consistent collection of information regarding medication allergies/sensitivities. Collecting such information is of little use if it is not readily accessible to practitioners treating the patient or if such practitioners do not refer to it.
2. All relevant information should be set out in the admission form - it is inadequate simply to refer to another document.
3. Taking an accurate history of a patient's condition, including allergies/sensitivities, is a key competency for all doctors and nurses. Referring to old clinical records is essential, particularly when faced with information that is unclear or where its accuracy is not certain. It was done poorly in this case.
The Centre for Adverse Reactions to Medicines (CARM) in Dunedin provides a service to verify allergies, and should have been contacted after the patient's first reaction.
It is concerning that, despite the apparent severity of the reaction to the medications given, the practitioners treating Mrs A did not identify her allergy. The allergy had been identified at least twice in the preoperative and pre-anaesthetic checks. Staff at Wellington Hospital did not identify this information, or seek information from Hutt Hospital or Dr B (Mrs A's GP). I note Dr Everts' advice to ACC that "penicillin and cephalosporin-group antibiotics are among the most common causes of Toxic Epidermal Necrolysis".
4. Moving to an electronic record and alarm system may address some of the concerns raised by Mrs A's case. It will not necessarily address the issue for patients being transferred between DHBs - medication reconciliation when transferring patients between hospitals should include an allergy identification system. Nor will such a system remove the need to accurately document allergies/sensitivities in the first instance.

For several reasons I have decided not to undertake a formal investigation of this matter. The events occurred nearly five years ago, and Mrs A's family has already gone through a lengthy investigation by Capital & Coast DHB, a belated inquiry by Hutt Valley DHB, and a protracted ACC investigation process. All parties recognise the need for closure.

However, it is important that the educative value of these events is recognised and used to assist in improving medication safety. I will bring this case to the attention of the Safe and Quality Use of Medicines Group and the Quality Improvement Committee. Copies of this casenote will be sent to all DHBs.

 

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