Your Organisation: ANZCA

Transcription

1 Response Sheet Mandatory Reporting of Anaphylaxis discussion paper Your Role: Policy Unit, Australian and New Zealand College of Anaesthetists (ANZCA) Your Organisation: ANZCA Name: ANZCA has consulted with Safety and Quality committee members and the Anaesthetic Allergy Subcommittee to inform this response within the short time frame provided. ANZCA notes that the definition of anaphylaxis and the aim of collecting data on anaphylaxis needs to be clarified in the development of this activity. Particular clarity around the intentions and differences between food allergy vs other triggers of anaphylactic reactions is required. Alongside this, the parameters on type and severity of anaphylaxis need to be set early and definitively. The correct diagnosis of an event of anaphylaxis is important as clinical symptoms and signs differ between individuals and further in patients who are deeply sedated or under general anaesthesia. In addition to clinical evidence, biochemical markers (such as serum mast-cell tryptase) are valuable. Subsequent identification of a known trigger (if not already known from previous investigation) is important corroborating evidence (e.g. presence of specific Immunoglobin E, skin test results). The identification of the trigger antigen source is important for ongoing risk reduction in both the individual and also the community. ANZCA believes reporting would be of value if it were associated with the national e-health record rather than being a discrete registry and if data were used to drive improvements including for labelling and treatment options. The benefits of reporting need to be promulgated and include the provision of a database that can potentially be used to make environmental and clinical recommendations. It is essential that there is feedback to clinicians to highlight the value of a mandated activity.

2 Question for consideration Consideration 1: Cases of anaphylaxis Your response Which cases of anaphylaxis should be considered for mandatory reporting? Should instances of anaphylaxis triggered by food be the only cases to be reported? As only 48% of anaphylaxis presentations in Victoria were due to food, it is important to report all cases. There were about 7 deaths in each of the past two reporting triennia of Australian anaesthetic mortality, there would have been many times this number of non-fatal episodes. It would be of value to the community to identify the broader range of episodes of anaphylaxis, provided that the diagnosis is correct. This would therefore extend to in-hospital events as well as presentations to hospitals from outside. The aim of collecting data on anaphylaxis should be clarified and well defined. Should all cases of anaphylaxis, independent of the trigger, be reported? Yes, as long as the data is robust and accessible. Anaphylaxis occurring in the community has a different presentation to that in a healthcare facility. Definition and reporting must recognise that food/environmental trigger anaphylaxis can manifest differently to drug/chemical induced anaphylaxis especially under anaesthesia. If compiling a database assists in development of public health policy then the data is worth collecting. Should cases where the trigger is unknown be reported? If a diagnosis of an episode of anaphylaxis is certain then it should be reported within this framework. Every effort should be made to ascertain the trigger, however in a hospital environment, a clinical episode that appears to be anaphylaxis may have a number of differential diagnoses and thus anaphylaxis must be confirmed if possible by serum tryptase measurement (noting that no test is 100% sensitive such that negative tryptase does not exclude anaphylaxis. Similarly, skin testing can occasionally fail to identify a specific allergen. Reporting of all cases is important because sometimes things emerge later that in retrospect can be attributed to avoidable allergens. This was the case with latex anaphylaxis and now more so with chlorhexidine anaphylaxis. Unknown trigger cases should be

3 investigated for this reason. Should cases of any trigger, with that trigger specified, be reported? Some cases of anaphylaxis are clearly associated with an allergen and this should be reported with/without skin testing. Consideration 2: Age group to be reported What age group should be considered for mandatory reporting and why? Where further evidence of triggers have been identified through Immunoglobin E or skin testing this should be reported. Should all cases of anaphylaxis be reported regardless of age? Should all cases in children only (age 0-16 years) be reported? Yes, all cases should be reported regardless of age. This is not an age specific problem. People die in all age groups from a variety of triggers. If the aim is reduce morbidity from anaphylaxis it should be from any cause in any age group. No all ages. What is the rationale for your choice? Anaphylaxis is life-threatening at any age and all reasonable efforts should be made to prevent its occurrence. Reducing risks by appropriate, achievable environmental modifications or choices should be applied across all ages. For example, reducing chlorhexidine anaphylaxis in the hospital setting by reducing exposure is not age related. Consideration 3: Timing of reporting In what time frame should the case of anaphylaxis be reported? Given the aims of mandatory reporting, what would be considered a reasonable time frame to report a case of anaphylaxis to the Department of Health and Human Services in order to reduce potential harm to others with allergies? There should be a two-stage notification. 1. Once the diagnosis is reasonably certain then primary notification should occur, perhaps with a list of probable triggers. 2. Subsequent confirmation of the event (through tryptase testing) and triggers (through history, skin and Immunoglobin E testing) would complete the notification. Skin testing does not occur until at least 6 weeks after a clinical event and thus the trigger may not be confirmed for some months.

4 It is recognised that delays in reporting may increase omissions and decrease completeness of the data. Consideration 4: Reporting responsibility Where does the responsibility lie for reporting cases of anaphylaxis? Should the responsibility of mandatory reporting lie with the treating clinician? Multiple clinicians may be involved in the care of a patient with anaphylaxis within a hospital: the clinician at the time of the event, ICU physicians, and the clinician performing skin testing. The clinician notifying the patient of the outcome (assuming they survive) or completing the medical record (ideally e health), should notify the Department. There is the possibility of dual reporting as the original clinician and the allergist may both notify the patient. Time provision must be factored in for treating clinicians to do this. Adequate funding should be put in place to support and staff clinician s to be the reporting agency. Should the responsibility of mandatory reporting lie with the health services? If so, who would be delegated to report? As above. This should be a coding double-check as backup. If anaphylaxis is managed in the primary health care setting, should the case be reported and who would be responsible for reporting? What would be the ideal mode of reporting (e.g. telephone, , website or other)? If mandatory reporting is going to be undertaken then any and all cases should be reported. Otherwise only the near-misses and deaths will be captured, not the serious but well managed episodes outside the hospital setting. As noted above, the clinician notifying the patient of the outcome (assuming they survive) or completing the medical record, should also notify the Department. There is the possibility of dual reporting as the original clinician and the allergist may both notify the patient. Electronic via website access (Web Form). It is suggested that the interface be designed with clinician input and with the ability to get the data out in a reasonable time frame in order to act on trends that are observed. What information should be reported? Patient gender Patient age including date of birth

5 Identifying characteristic (e.g. initials) Location of event (e.g. community, hospital). Signs and symptoms Severity Route of ingestion or exposure details (suspected trigger) Allergen identified Treatment Key clinical findings Follow-up (clinical, blood, skin-testing) Outcome. To avoid duplicate entries patient details should be identified however this is not necessary if the purpose is to gain epidemiologic data and drive health and food-sector change or improvement What would make reporting achievable? Ease of reporting internet based. Communication of the need to report through hospitals and other healthcare facilities as well as Colleges. Widespread consultation and engagement with the people who will be doing it (i.e. clinicians). An appropriate budget to enable reporting. Please your response form to by 30 June 2017