The Committee received overwhelming evidence that the management and treatment standards for allergies and anaphylaxis are not consistent throughout Australia.
In addition to inconsistent management of allergies by medical specialists, many individuals suffering from allergies had to endure long waiting lists to seek professional advice whilst living with a potentially life threatening condition.
Some of the issues that will be discussed in this chapter include:
work currently undertaken by the Department of Health;
access to specialists and treatment in regional and rural Australia;
drug allergy management; and
sting allergy management.
The Australian Government’s Department of Health recognises the significant impact allergy and anaphylaxis place on the quality of life and overall health of individuals and their families, as well as the burden these conditions place on Australia’s health system.
The Department provides ‘ongoing support for the implementation of many of the actions in the National Allergy Strategy, including prevention initiatives, support for young people with allergies, and the development of standards and guidelines for management of allergy and anaphylaxis.’
The NAS is a partnership between the Australasian Society of Clinical Immunology and Allergy (ASCIA), the leading medical and patient support organisations in Australia and Allergy and Anaphylaxis Australia (A&AA), a peak national charity health advisory body. The NAS document was developed with key stakeholder organisations and provides an overarching framework for a national response to the rise in allergic diseases. It identifies the most effective ways to:
address allergic disease as a chronic disease and manage it with a public health approach;
provide an effective and coordinated plan to guide future actions to optimise the management of allergic diseases in Australia; and
improve the health and quality of life of people with allergic diseases, their carers and the community.
The NAS received some funding from the Australian Government which has allowed them to undertake a number of projects, including the 250K Youth Project and the Food Service Project.
The NAS told the Committee that ‘While we have been successful in engaging with the relevant target groups and providing resources and support, there is still a lot of work that needs to be done in these areas.’
The NAS was asked by the Department of Health to undertake some scoping work, relating to better recognition and management of drug allergy and the development of a shared care model for allergic diseases. Recommendations for drug allergy management were submitted to the Department of Health in 2017, and recommendations regarding a Shared Care Model for allergic diseases were finalised and submitted in December 2019. The findings in these two reports are confidential and hence information from them has not been included in this report.
Access to treatment
The evidence highlighted the critical need for more timely and equitable access to quality care for patients with allergic disease. Many people reported long waiting times to see specialists, both for public and private specialist allergists and immunologists.
Some personal accounts described how long waiting times exacerbated their or their child’s conditions and led to delays in getting correct medical advice. Others reported that long wait times led to delays in access to adrenaline auto-injectors as these devices can only initially be prescribed by an allergy specialist.
The Committee was told that long wait lists for patients to see allergy specialists sometimes resulted in patients seeking help from practitioners who were not adequately trained. This may lead to potential harm, additional healthcare encounters, increased costs and burden on the health system. The NAS stressed that:
Access to appropriate care is often delayed with long waiting times to see the relevant medical specialist/s and has resulted in patients receiving inappropriate advice from alternative/unorthodox health practitioners. Absence of appropriate care carries a significant risk of serious adverse events and increases healthcare encounters and associated costs as well as the use of unproven therapies.
ASCIA commented that timely and quality care is particularly important for infants:
Timely access to quality care for infants and young children with suspected food allergy is particularly important as it can prevent food allergy and anaphylaxis, reduce unnecessary food restrictions and decrease the risk of nutritional and growth problems.
Many of the public hospitals across Australia informed the Committee that they have long waiting lists and that they do their best to triage the most critical patients.
For example, the WA Child and Adolescent Health Service stated that ‘there are currently over 2000 children on the waitlist for their first immunology clinic appointment at public hospitals in Western Australia, with patients waiting between 12 weeks to five years based on their postcode and hospital catchment zone.’
The Royal Children's Hospital in Melbourne, which remains the only public service for paediatric allergy in Victoria, commented that the waiting list times for allergy evaluation and food challenges was around six to seven months.
Dr Melanie Wong of The Children's Hospital at Westmead, Sydney commented:
We have insufficient public hospital allergy clinics. Although we have urgent patients who are squeezed in by our overloaded staff—and we actually triage our referrals so that we only see the more complex end of the spectrum of disease—we have a waiting period of at least six months. If you're a young child, that six months is a long wait.
Dr Patrick Quinn of The Women's and Children's Hospital, Adelaide, commented that:
We have more than 1,100 children on our public waiting list with median wait times of more than a year to be seen. And these are median wait times, so some of those children are waiting two or three years or more to see us. The long public waiting times disproportionately affect those most disadvantaged in our community and those with the most complex clinical needs.
Professor Connie Katelaris of Campbelltown Hospital commented:
…last year we saw 3,200 children in consultation at Campbelltown Hospital in our paediatric immunology and allergy clinic. We have 385 children on our food challenge waiting list, and, with present resourcing, on average a two-year wait for a food allergy challenge in our hospital setting.
Professor Peter Smith commented that private practice waiting lists are just as long as some of the public hospitals:
There is a nine month wait at a private allergy clinic in Queensland for food challenges and an 18 month waitlist to see me… and somewhere between nine months and two years in a public hospital.
Dr Hew from Alfred Health suggested that some states fund inadequate placements for immunologists in the public hospitals:
My suggestion is that there is no good funding mechanism that allows the hospitals to take up allergy procedures within Victoria. Hospitals decide funding, and these procedures are fairly low priority based on the hospital KPIs of keeping inpatients out of hospital.
Dr Wong also noted the insufficient funding levels provided to public hospitals for allergy specialists:
There's been an exponential increase in the number of children with allergic disease, and also the complexity of that disease, over the last 20 to 30 years. Resourcing of hospital services hasn't kept up with this increasing need.
City, regional and rural perspectives
The Committee received evidence that highlighted the lack of access to allergy specialists in regional and rural Australia. ASCIA commented:
The issue of timely and equitable access to quality care for patients with allergic disease is critical. At present many parts of Australia, particularly regional, rural and remote areas, are underserved in terms of the availability of clinical immunology/allergy specialists.
Dr Adriana Le also raised concerns about the lack of allergy specialist services facing rural and regional Australia:
Timely access to specialist allergy services is an issue in both urban and regional/rural settings in Australia, but is particularly poor for the latter, with a shortage of allergy specialists and health professionals with allergy expertise in these locations.
The current model of allergy care in Australia is urban based and often requires regional and rural patients to travel long distances, including interstate, for specialist care. While it is obviously not practical to have an allergy specialist located in every rural location, ensuring there is adequate provision for allergy specialists in major regional public hospitals is a key part of improving rural allergy care.
In many rural locations, while it would not be practical to have a private allergist working full time, periodic visits by an allergist would fulfil an important area of need. However, unlike other specialties such as cardiology and psychiatry, there is currently no support, subsidies or incentives (such as even travel and accommodation grants) for private allergists to visit these areas.
Professor Douglass noted that in Victoria ‘Just under 20 per cent of patients are from outside the metropolitan regions…I think rural and remote patients are at a disadvantage. We do run quite an active telehealth service, and that's great. I always like to see the patient once, but after that you can usually do it by telehealth’.
Professor Douglass discussed the merits of telehealth to assist in providing a solution to this issue facing many people with allergies in Australia:
It seems to me that telehealth is an option. Even for patients that could be seen—there are a lot of tests you could do on the blood. Maybe not everyone has to come down to Melbourne, because it costs patients to come down. Despite transport access schemes, it's a lot.
She also advocated for a more determined public outreach program to increase knowledge and understanding of allergies and anaphylaxis:
I think upskilling and educating the rural GP workforce would be really important. Unlike asthma, where there has been outreach, with the National Asthma Campaign and Asthma Council Australia going out and getting asthma care out there, I think allergy and anaphylaxis care has not been so well done. We all know about asthma-friendly schools. That's educated everyone, from laypeople up. It isn't the same with allergy. It could be done. A similar resource still exists, and the network is there to do it.
The Australian College of Nurses commented that they have an important role to play in providing better access to allergy patients throughout Australia:
Development of a variety of nursing roles as suggested in the National Allergy Strategy can only enhance and improve care for those with an allergy, or those who experience allergy induced anaphylaxis. That role is especially significant in rural and remote areas where a registered nurse is often the only health care practitioner available.
Inquiry participants reported that they had applied, often multiple times, for government assistance such as the carer’s allowance or health care cards but had suffered from lengthy delays or been found ineligible.
Improvements to services
Shared Care Model
The NAS has undertaken work for the Department of Health that outlines how a Shared Care Model could assist patients with allergies and anaphylaxis in Australia to receive improved care and better and more timely access to all allergy services. The Shared Care Model ‘is a patient centred approach to ensuring that the right care by the right health professional is received at the right time in the right place.’
Australians with allergic diseases face many challenges in accessing quality health care in a timely manner, particularly those living in rural and remote areas. There is no quick-fix Shared Care Model. The model that is going to improve access to quality health care requires engagement with many key stakeholder organisations and will need to address multiple issues, including education for both health professionals and consumers. Ms Vale commented:
The National Allergy Strategy believes that a shared care model for allergy is not simply the upskilling of primary healthcare providers in allergy, as this does not recognise the complexity of the problem and will not achieve the desired outcomes.
A Shared Care Model would improve access to care for allergy patients particularly in rural and remote areas. The Australian Paediatric Society (APS) supported the NAS Shared Care Model that was put forward at a forum in Sydney in April 2019. The APS stated:
The guiding principles of a Shared Care Model requires it to be patient-centred, safe, quality evidenced-based care. It should support health professionals with consultation collaboration and communication, with a clearly defined referral pathway and support. It also needs to be effective, efficient, accessible including the use of telemedicine, and supports integrated care with localised flexibility.
In order to make this work and attract quality medical staff to regional and rural areas the APS commented that the Australian Government should:
Increase the loading of the Medicare rebate for clinical services in rural and remote Australia to assist people to afford treatment and to attract quality medical staff to areas where people with allergy do not have the financial resources to cover the Medicare gap payment.
Dr Richard Loh, immunologist and allergy specialist, commented:
To progress a Shared Care Model for allergic diseases we will also require leadership and commitment at the highest levels at Commonwealth, State, and Territory as no minister in any one jurisdiction can solve this epidemic of allergic diseases. We must avoid cost shifting, duplication, gaps in service delivery, or an unwillingness of any single government to take leadership for delivering a shared care model for allergic diseases.
Professor Douglass discussed the fact that allergies are a national problem and therefore allergy care should be federally mandated. Professor Douglass suggested that ‘If you had a federal standard of care for allergy, it would be incredibly helpful.’
Clinical care standards for anaphylaxis
The Committee received evidence from specialists and people affected by allergies who called for a nationally consistent pathway or Clinical Care Standards for anaphylaxis to be agreed to and regulated.
The NAS commented that Clinical Care Standards would be a critical component of an effective Shared Care Model. Ms Vale commented:
In particular, we would like to see a Clinical Care Standard for the acute management of anaphylaxis developed as an urgent priority by the Australian Commission on Safety and Quality in Health Care. Despite having multiple national guidelines for anaphylaxis management in Australia since 2011, deaths from anaphylaxis continue to occur due to failures in diagnosis, inappropriate treatment and lack of appropriate management of the patient on discharge. Unlike guidelines, a Clinical Care Standard linked to hospital accreditation requires auditing and accountability.
Currently, in Australia, there is no requirement to report anaphylaxis deaths to the coroner. In addition, we have limited ability to capture information about anaphylaxis events in hospitals and the community, as we have inconsistent education of health professionals in the recognition of anaphylaxis and there are no nationally accepted diagnostic criteria.
Dr Loh advocated for national Clinical Care Standards on allergies and anaphylaxis. He emphasised the benefits of a nationally consistent Clinical Care Standard:
These documents would provide summary statements on key areas of clinical practice for a specific condition where there is evidence of variation from best practice.
They are based on evidence contained in clinical guidelines. Clinical guidelines, such as ASCIA’s and Victoria’s anaphylaxis guidelines, detail all aspects of treatment and care for anaphylaxis. They are broader and extensive. Deaths from anaphylaxis in Australia (Mullins, 2016) continue to rise despite guidelines. In order to address this issue, Clinical Care Standards for Anaphylaxis need to be developed and implemented to stop this variation from best practice.
The NAS discussed the benefits of Clinical Care Standards as opposed to the current anaphylaxis management guidelines:
The existing anaphylaxis management guidelines, and there are several available across Australia, do not have indicators that assist local health services to monitor the quality of implementation. A national Clinical Care Standard does not exist but would help to address many of these issues.
Parents of infants and children who have severe allergies and anaphylaxis told the Committee of the anxiety, stress and trauma that they live with when caring for children with anaphylaxis.
Many parents of children with allergies who participated in the inquiry reported feelings of anxiety, depression, distress and fear for their children. Some went as far as to say that the emotional cost was worse than the financial cost.
Many inquiry participants reported that living with allergy was highly socially isolating. Eczema sufferers in particular reported very high rates of depression, feelings of hopelessness, and even suicidal thoughts.
My father also had eczema later in life. He lived in a rural area and didn't have access to treatment. The day that he went to the doctor and was told that there was no further treatment is the day we lost him to suicide. I do not blame his doctors for what happened—they didn't know any better. That's a big loss. After my dad died we found that he actually had exposed bone where he had scratched through. But that wasn't looked at when he went to the doctor—because they didn't know that it could be that bad. This was somebody who had suffered for many, many years without access to treatment and with no awareness in the community. It was a loss that could have been avoided.
Many parents reported that their children also suffered from anxiety and that this could occur in very young children who might not even understand their feelings.
Adults with allergies reported bullying in the workplace and workplaces not making allowances for a person’s allergies.
Some people reported experiencing trauma from being poorly cared for by paramedics immediately after an episode of anaphylaxis.
Many inquiry participants gave evidence of how helpful therapy had been for them.
Ms Jenny Murtagh described how the anxiety that comes with having a child or being a child with severe food allergies can be overwhelming, and noted that with the benefit of hindsight:
…counselling being offered to parents of newly diagnosed children would have been wonderful, and also for children themselves as they navigate through to their teens and early adulthood. The hypervigilance that is required is exhausting for the sufferer and for their families, and there is a level of social isolation that comes about.
Socialising in our society almost always involves eating, and it is sometimes easier to just avoid being a part of it, which is sad for young people. Severe reactions can cause post-traumatic stress issues for the patient and their family. Having a counsellor who understands these issues could be useful (although I’m sure my son would not avail himself of such a service at this stage of his life, so again an earlier childhood start would be good).
Ms Hagiliassis explained that after her son suffered a severe reaction in 2016, she went into post-traumatic stress. She told the Committee:
I felt like our doctors and specialists let us down in terms of carers, and there was no referral to seek any support from an emotional perspective.
This led Ms Hagiliassis to create a charitable organisation called Anaphylaxis Network Australia, that provides online support for parents with children who have allergies and may have had an anaphylactic reaction.
Adrenaline auto-injectors (EpiPens)
In Australia, after a specialist has diagnosed risk of anaphylaxis or after an anaphylactic episode, patients are usually prescribed two subsided scripts for adrenaline auto-injectors. Each adrenaline auto-injector costs approximately $80 each or $40 when subsidised on the PBS.
Many individuals and organisations raised concerns in relation to adrenaline auto-injector (EpiPens) shortages in Australia. The Committee heard that these shortages occur intermittently but when there is a shortage it becomes critical and life threatening for many people who need to replace out-of-date EpiPens.
Ms Emily Marney outlined this problem in her submission:
Numerous times I have gone to fill a prescription for EpiPens, more commonly after I have used our previous ones so need them replaced that day, and I have been told they are out of stock with the supplier and unsure when they will be back in stock. This has therefore left me with an allergic child and no lifesaving medication. I have been known to call all pharmacies in the 100km radius to find any pharmacy with available EpiPens and have been willing to travel, but had no luck. When the EpiPens would finally come back in stock they would have short expiry’s, some dated only 4 months away. This then left me spending $40 on an EpiPen to then have to replace it in 4 months’ time again when there could potentially be a shortage again. I am exhausted with playing roulette with my child’s life.
Many submitters wrote about having to visit several pharmacies trying to find an EpiPen, being limited to one EpiPen per person due to shortages and having to rely on expired or close to expired pens.
Numerous submissions commented that the number of government subsided EpiPens which people can access is inadequate. Many parents reported having to buy more than two pens a year in order to supply schools with an individual EpiPen for their child, plus wanting to have injectors available in their homes and in person when going out which can become a financial burden given the expense of non-PBS prescribed adrenaline auto-injectors.
With the required EpiPen supply at home as being two in the instance that the first EpiPen fails, as well as requiring additional EpiPens for the school AND for the after-school care program our daughter attends, we incur a total cost of approximately $260 per year to purchase four EpiPens (two on prescription at a reduced cost, and two at full over the counter cost without a prescription). Anaphylaxis management means we have no choice but to purchase this life saving medication. The EpiPen prescription allowance per patient needs to be increased to four per year at a reduced cost to allow families to purchase this medication without the financial burden of hundreds of dollars per year…
A&AA made the following comment in relation to the shortages:
Currently, Australia only has one brand of adrenaline auto-injector (EpiPen). There have been several EpiPen shortages with the most significant being in 2017/2018.The impact on individuals at risk of anaphylaxis, A&AA, ASCIA, the Therapeutic Goods Administration, pharmacies and Mylan Australia was huge. The safety of individuals at risk of anaphylaxis was compromised with people being asked to rely on expired devices, parents and childcare staff not giving the EpiPen when indicated because of fear they would not be able to replace it, and ill-informed health professionals showing people how to use ampoule, needle and syringe.
A&AA suggested the following issues should be taken into consideration when making an alternative available in Australia:
Make alternative adrenaline auto-injectors available to Australians with potentially life-threatening allergy. Serious consideration needs to be given to the doses available (i.e. is there a dose for infants or a dose for those 60 kg and over?), the size and shape of the device and how easily it can be carried (especially by males, who do not generally carry hand bags), needle length (shorter needles may not penetrate into the muscle for quick absorption of adrenaline), and temperature control in Australia’s hot climate.
Food allergy management
The food challenge is the gold standard used for food allergy diagnosis. Many individual submitters and medical professionals commented that waiting times for food challenges in public hospitals are unacceptably long. Food challenges are not only important for diagnosing initial food allergies but they are used to confirm whether patients have outgrown their allergies throughout their lifetime.
The Melbourne Allergy Centre and Children’s Specialist described the food challenge process:
A food challenge is the process by which small, incremental quantities of a food allergen is given to a patient. The purpose of a food challenge is to determine whether a child is either truly allergic to the food, or if food allergy has resolved, and the child is now able to tolerate the food. Arguably, food challenges are the most important assessment tool that we have as allergists.
Food challenges are highly labour-intensive and require constant supervision throughout the challenge. During a challenge, the patient is given increasing doses of the food at 15-20 minutely intervals. The patients have nursing observations performed every 15-20 minutes and are being constantly observed during this period. The doctor also frequently reviews the patient throughout the course of the challenge. A typical challenge takes approximately 4-5 hours to complete, but can be much longer if the patient reacts or if they have anaphylaxis, which will involve a further 4 hour observation period.
Dr Joanne Smart explained the reason why food challenges are resource intensive, as patients need to be monitored in an appropriately resourced setting in case there is an anaphylactic reaction to the food challenge:
In our hands, at the children's hospital and also in some private settings, generally 20 to 25 per cent of food challenges result in an allergic reaction. The majority of these are mild to moderate and managed simply with antihistamine or steroid. But two per cent—and this is unpredictable—result in anaphylaxis requiring adrenaline.
Dr Smart also told the Committee that she had put in an application to the Australian Government to request a Medical Benefits Scheme (MBS) allergy item number for food challenges that was unsuccessful.
Dr Mullins highlighted food challenge logistics in his submission and discussed some of the existing barriers to improving waiting lists for food challenges:
the availability of facilities, such that most public hospitals have wait lists of over 12 months to do so;
reliance on state health departments to fund these facilities within their current budgets; and
the costs of doing so given the absence of any specific Medicare item number for food or drug challenges.
CFAR raised the issue of access equity noting that there is an acute lack of publically available access to allergy management specialists. Dr Smart commented:
It seems to me that the disproportionate availability of public allergy services really disenfranchises and disadvantages particularly those of lower socioeconomic status throughout our state who are unable to utilise private providers. And the gaps in care for things like private allergy testing and the availability of that are substantial, so it is a great concern to me.
Access to Food Oral Immunotherapy (OIT)
After a food allergy diagnosis has been confirmed, there are limited treatments available for food allergy sufferers. Food allergen avoidance is currently the only recommendation in Australia. There are limited clinical research food oral immunotherapy (OIT) trials occurring in Australia.
The Committee received evidence from allergy sufferers and their families calling for immediate access to food OIT in Australia. At present, families are travelling to the United States to access food OIT treatments which comes at considerable expense. One witness estimated the cost of travelling to the United States for a four week food OIT treatment was ‘just over $20,000 for everything: the accommodation, the flights, the transport while we were there and the doctor's fee.’
CFAR outlined the reasons why food oral immunotherapy is not yet available in Australia. Dr Perrett commented:
OIT is an emerging, experimental treatment and refers to feeding an allergic individual increasing amounts of food they're allergic to with the goal of increasing the threshold to which triggers a reaction. This is known as 'desensitisation' and desensitisation is a temporary state. It does occur in the majority of children and adults who undergo food oral immunotherapy but there are significant safety concerns.
We do not believe food oral immunotherapy is ready to be offered in the clinic setting (in Australia). But these trials and studies have taught us so much and we believe we are now ready to act in Australia.
Dr Perrett explained to the Committee that food oral immunotherapy puts people into remission rather than cure:
Essentially, when we are talking about treatments for food allergy, we are talking about this temporary desensitisation state whereby if you consume the food allergen that you are allergic to regularly, on a daily basis, you have raised the threshold such that you shouldn't have a reaction below that threshold. We do know that that is a temporary state and it does change as your immune system changes. This is the tricky thing about immunotherapy. If you have a fever or an infection, or if it is during your menstruation or you do exercise or your temperature is overheated, you may have a lower threshold that you react to. This is why we have a lot of ongoing reactions with people on immunotherapy.
Further information on OIT research is discussed in chapter 5.
Drug allergy management
Australia does not have an adequate drug and medicine allergy management strategy. ASCIA informed the Committee that ‘if Australia can improve its drug allergy management it would lead to preventable deaths from drug allergy.’
The NAS provided the Department of Health with a scoping paper on drug allergy management. The NAS urged the Australian Government to fund and implement all recommendations.
The Pharmacy Society of Australia (PSA) informed the Committee that ‘Pharmacists have a considerable role in supporting patients and carers in the management or treatment of allergies and anaphylaxis. This may be in relation to patient medicines or medication management, as well as education, advice and support provided on various health conditions which may span a spectrum of complexity.’
Pharmacists may obtain information on a patient’s drug allergy status (or contribute this information to their record) through a number of ways, for example:
patient’s My Health Record;
patient’s dispensing or medication supply record;
in the context of a recommendation of an over-the-counter medicine;
during a medication management review (e.g. MedsCheck service, Home Medicines Review) consultation; and
other pharmacist-delivered health service.
The PSA commented that maintaining drug allergy information and sharing between different healthcare professionals and settings (with patient consent) are important in order to deliver optimal care to a patient. The PSA added that ‘increasing uptake and use of the My Health Record will, in part, facilitate this process going forward.’
The PSA informed the Committee that there will soon be improvements to labelling some allergens in medicines.
Currently substances in medicines that need to be declared currently include gluten, lactose, peanuts and tartrazine. PSA understands that under the new rules there will be a longer list of substances that must be declared on a label if they are present in the medicine. Additional substances required to be declared include crustacea, fish, eggs, soya, milk and tree nuts.
PSA is supportive of this initiative and has commenced advising pharmacists about the changes so that patients and carers can be supported and educated appropriately.
Antibiotic avoidance and drug de-labelling
Antibiotic avoidance due to an unsubstantiated belief in having a drug allergy is an increasing issue in Australian medical care. The Committee received evidence about antibiotic avoidance and the urgent need to ‘de-label’ patients from their unproven drug allergies in Australia.
The NAS stated that around 25 per cent of patients in hospitals report having drug allergies, usually to antibiotics, however studies have found only 10 per cent of those claiming to have a drug allergy are truly allergic. This unnecessary avoidance can have a significant effect on antimicrobial stewardship and can prevent patients from receiving the best treatment for their illnesses.
Dr William Smith of the Royal Adelaide Hospital has done a survey of the adult population in South Australia which showed that 22 per cent of the population reported an allergy to one or more drugs, 13 per cent reported an allergy to one or more antibiotics, and 9.3 per cent reports an allergy to penicillin.
Dr Smith said this is concerning, as published studies have shown between 90 and 98 per cent of the population have no penicillin allergy and can take it safely.
Dr Sara Barnes wrote that antibiotic allergy de-labelling allows more targeted treatment and reduces the use of broad spectrum antibiotics. Dr Barnes commented:
This benefits not just the individual patients but also has flow-on effects to the rest of the Australian healthcare system in the form of reduced hospital stays for common infections, reduced antimicrobial resistance and less incidences of clostridium difficile (a disease of the large intestine caused by the bacterium clostridium difficile, appearing usually after recent antibiotic use).
Dr Barnes continued:
There are many reasons a person might believe they are allergic to a certain drug when they are not. A person may experience adverse symptoms while taking a drug. In some cases this is a true allergic reaction to the medication (and such medication should be avoided), but in many cases the person has experienced adverse symptoms due to the illness they had at the time, such as a rash caused by virus being mistaken for a reaction to prescribed antibiotics. In other cases, a person may continue to report drug allergies based on childhood reactions which the person has outgrown or based on more spurious information, such as a family member having the same allergy.
Dr Smith expanded on this, saying that false antibiotic labelling tends to ‘metastasise’:
…what starts out as a minor rash with amoxicillin becomes, after a while, an allergy to all penicillins, which, later on—because people don't remember the initial event—gets called an anaphylaxis to penicillins, and that later forces avoidance not only of all penicillins but also of cephalosporins…because there's a theoretical cross-reaction rate. So if you see somebody who has a label of penicillin allergy and you don't know how bad the allergy was, you just tend to avoid all of those antibiotics, which puts the person at a disadvantage.
The NAS recommended the creation of a national standardised drug allergy de-labelling guideline in order to confirm people’s drug allergy status. It also recommended that the Australian Government create a new Medicare Benefits Schedule (MBS) item number for drug allergen challenges.
The NAS gave evidence that such a program would reduce costs by allowing medical professionals to prescribe ‘basic, safe and cheap’ drugs which might otherwise be avoided unnecessarily. This would result in shorter hospital stays, reduced complications and would reduce the rate of antibiotic resistance in the community.
Professor Brendan Murphy, Chief Medical Officer of the Department of Health emphasised the importance of scientifically validating allergies and said he hoped clinics for antibiotic allergy de-labelling would be set up in public hospitals.
Dr Smith of the Royal Adelaide Hospital gave evidence that drug de-labelling is being carried out in hospital allergy and immunology clinics and other specialist clinics but with a very limited capacity. He went on to say that there were a large number of people who would be eligible for ‘low risk de-labelling’ which could be performed in other medical settings if there were clinical guidelines for other doctors to follow.
The Royal Hobart Hospital has commenced an antibiotic allergy clinic. Mrs Jennifer Gudden of the Royal Hobart Hospital said that this work is important to the community but the service is currently unfunded and unsustainable for the hospital.
Professor Jo Douglass at the Royal Melbourne Hospital said that although drug allergy de-labelling is important to the community, it is rarely available in the public health system.
Professor Douglass said further that there are international models for drug de-labelling which can be done effectively and cheaply, but these models require resourcing.
Professor Dominic Mallon wrote that inaccurate drug allergy labelling can lead to patients not being prescribed the most effective medications which in turn leads to further impacts on patient care and the overall efficacy of the health system.
The APS confirmed that unnecessary drug avoidance is an issue particularly in regional Australia and that it would support protocols or professional programs to address the problem.
A paramedic stated that many of their patients confuse drug side effects with allergy to certain drugs. This is often an issue of education between the patient and their medical practitioner but has the follow on effect of that patient not being able to receive the drug which would be most effective for their medical needs. This leads to allergies being taken less seriously by the wider community and viewed as an inconvenience rather than a serious medical condition.
The Australian College of Nursing (ACN) commented that ‘drug allergy labelling is a particular area of concern for nurses as they deliver the majority of direct care to patients. The ACN recommended that the Australian Commission on Safety and Quality in Health Care (ACSQHC) develop an Allergy/Anaphylaxis Clinical Care Standard which would set out consistent national management standards for drug allergy. It also recommended a national database for recording food and drug allergies, working on a similar model to the Australian Immunisation Registrar (AIR).
The ACN practitioners wrote that health professionals need more training in the assessment of allergy to prevent antibiotic allergy labelling. It commented further that the overprescribing of antibiotics in medical practice needs further attention.
The Government of Western Australia Child and Adolescent Health Service noted:
…that the most commonly reported drug allergy is to penicillin, with 18 per cent of adults and between five and eight per cent of children reporting having a penicillin allergy, though most of these people are avoiding it unnecessarily. Patients who report this allergy have increased rates of morbidity and mortality. The WA Government recommended the creation of national guidelines for drug allergy confirmation as well as increased national education about drug allergies.
A&AA stated that health professionals and consumers are generally not well informed about true drug allergy. It said:
Accurate diagnosis of drug allergy can be difficult without adequate and skilled investigation. Health professionals are very aware of poor outcomes when an individual with true drug allergy has the medication, so they rarely question consumers who say they are allergic when they are not, for fear of getting it wrong. With antibiotic allergy, the truth around the label of antibiotic allergy is generally not questioned until a person is in a compromised situation where the drug of choice cannot be used.
Dr Richard Loh stated that there needs to be a larger emphasis on drug allergy de-labelling in health care. He went on to say that all patients reporting a drug allergy, particularly for antibiotics, should undergo diagnostic evaluation to determine if the allergy is real. Skin testing and oral drug challenges are methods that can be used to determine drug allergy.
Migraine Australia supported the implementation of accurate and affordable drug allergy diagnosis in the Australian health care system. Effective migraine management often requires rotating several medications to avoid the side effects of medication overuse. As such, unconfirmed drug allergy which limits the medications of a patient can make migraine management more difficult.
The Royal Adelaide Hospital Department of Immunology performed a study on self-reported drug allergy, in particular penicillin, and found that 90 per cent of respondents to the survey were good candidates for de-labelling.
Dr Smith of the Royal Adelaide Hospital stated that testing a person for drug allergy with the aim to de-label them from the allergy would involve skin prick testing and then drug challenges administered over the course of a day for higher risk patients.
Dr Smith also gave evidence that after a person is de-labelled the problem becomes removing that allergy label from their medical records in other health facilities. He said that My Health Record could be an excellent resource for recording the results of patient de-labelling.
Dr Birgit Marchand, a Paediatric Allergist and Immunologist from the Queensland Allergy Service suggested that, until some sort of universal medical record was set up showing a person’s drug allergy de-labelling, a medic-alert type bracelet identifying that a person has been de-labelled from their drug allergy would be an option for emergency situations where a person may not be able to confirm their de-labelling.
The Royal Adelaide Hospital Department of Immunology made several suggestions for the implementation of any national drug allergy de-labelling program:
national guidelines should be developed for drug allergy evaluation;
low-risk drug allergy de-labelling procedures should be developed for usage in a variety of medical settings;
Medicare items should be developed to encourage drug allergy testing in private medical care settings;
hospital resources should be allocated to drug allergy testing facilities (i.e. Nursing, pharmacy and specialist resources); and
electronic health records such as My Health Record should facilitate the recording of drug allergy reaction information, as well as current de-labelling status.
Sting allergy management
In addition to food and drug allergies, the Committee heard that insect allergy is on the rise in Australia. Stings from bees, wasps and ants can result in anaphylaxis.
Dr Pravin Hissaria, Immunologist and Allergist, Clinical Immunology and Allergy Department, Royal Adelaide Hospital, commented that bee sting anaphylaxis is common but treatable in Australia. He stated:
Honey bee venom allergy is the major cause of insect sting anaphylaxis in southern and south-eastern Australia. Venom immunotherapy for the treatment of stinging insect anaphylaxis involves the administration of increasing doses of purified insect venom with the aim of inducing clinical tolerance.
Dr Hissaria said that ‘because honey bee venom allergy is prevalent worldwide, there are commercially available venom extracts which are subsided on the PBS for immunotherapy.’
Immunotherapy is not yet available for treating tick allergy or reactions triggered by other species of ants and wasps.
Venom desensitisation programs – Jack Jumper Ants
Jack Jumper Ants are found in southern areas of Australia and there is currently only limited access to Jack Jumper Ant venom immunotherapy in Tasmania, South Australia and Victoria. However, Jack Jumper Ants are found in parts of New South Wales (NSW), and Australian Capital Territory (ACT), Queensland (QLD) and Western Australia (WA). Jack Jumper Ants are increasingly contributing to anaphylaxis admissions to hospitals.
Research into Jack Jumper Ants commenced in 2001 with a successful clinical trial at the Royal Hobart Hospital looking into ant venom allergy research:
In the ten years prior to the establishment of the Jack Jumper Allergy Program, there were four reported deaths from anaphylaxis to Jack Jumper Ant stings. There have been no documented deaths to Jack Jumper Ant sting anaphylaxis since the Program began in 2001.
The research team at Royal Hobart Hospital have developed a lifesaving venom immunotherapy treatment for people with severe Jack Jumper Ant venom allergy. The Committee heard that ‘what started as a small research project has developed into a program providing venom immunotherapy treatment to anaphylactic patients across three states.’
The Tasmanian Jack Jumper Allergy Program (JJAP) is an example of Government support for innovative health care services that have had real benefits for patients and the community at a national level.
The Committee heard from several hospitals and community groups about the Jack Jumper Ants and the allergy management strategy that is available in Tasmania, Victoria and South Australia only. The Committee was told there is currently only limited access to Jack Jumper Ant venom immunotherapy.
Access to venom immunotherapy clinics is vital for patients who are anaphylactic to Jack Jumper Ants. The fear and anxiety that the risk of anaphylaxis can create is significant:
Educating patients around their allergy is of vital importance, however we must ensure GPs are supported with information and education around available services and have clear pathways for referrals.
The Royal Hobart Hospital is the only manufacturer of Jack Jumper Ant venom worldwide. The capacity of the Royal Hobart Hospital to produce venom immunotherapy products affects all states in treating patients.
Demand for services in both insect venom allergy assessment and Venom Immunotherapy (VIT) is high. In Tasmania, there are currently 90 people medically assessed by the JJAP waiting to commence VIT. This equates to more than one year wait for some patients to start treatment. Many patients remain at very high risk of further stings, anaphylaxis and subsequent hospital admissions. Referrals are increasing, however the ability to treat patients is restricted by lack of resources to support demand and service growth.
The JJAP told the Committee:
Tasmania is the only state or territory in Australia that does not have an integrated and coordinated Allergy and Immunology service. It has an outstanding team of dedicated staff and volunteers that have achieved the goal of developing a scientifically-proven treatment strategy for patients with Jack Jumper Ant venom allergy.
Researchers at Royal Adelaide Hospital have collaborated closely with the Royal Hobart Hospital in Jack Jumper Ant venom research for many years and currently have two clinical trials underway. South Australia offers a Jack Jumper Ant Venom Immunotherapy clinic through Royal Adelaide Hospital, however unlike Tasmania and Victoria, South Australian patients have been funding their own treatment. As such, treatment was cost prohibitive for many patients.
As of July 2019, the Royal Adelaide Hospital began absorbing the high cost of VIT through its own budget however this is a precarious way to fund a valuable program and it takes funding away from other important programs. Dr Hissaria told the Committee:
…in the last six months, we have actually put in an application to the hospital and most likely the hospital pharmacy is going to fund it, but it is going to come out of the clinical immunology and allergy budget, which, as you can imagine, is very low, and this might take up the whole budget. We won't be able to treat any other immunological conditions even if we wanted to so it is going to be a significant strain on that.
Dr Adriana Le described the prevalence levels of sting presentations in South Australia and discussed the regions around Australia where Jack Jumper Ants are found.
In Tasmania, the Jack Jumper Ant is the most common cause for anaphylaxis presentation in hospital. In South Australia the most common presentation in our venom allergy clinic is still around 60 per cent bee venom. That means one-third of presentations are for Jack Jumper Ants and only a minority are for wasps. It's the dominant cause of anaphylaxis in South Australia and actually in other areas of Australia.
The ant is very endemic in Tasmania but it's widespread in the Adelaide Hills. It's found on Kangaroo Island. It's found in the southern parts of the area like the York Peninsular. It's found throughout the ACT and NSW where treatment is not accessible. It can even be found in WA and Queensland. So it is a national issue.
Manufacturing the venom extracts
The Royal Hobart Hospital Jack Jumper Allergy Program is licensed by the TGA to manufacture standardised Jack Jumper Ant venom extracts for immunotherapy in the form of Active Pharmaceutical Ingredients (API). API is manufactured locally in Hobart and provides lifesaving treatment to patients in Tasmania, Victoria and South Australia.
Manufacture of Jack Jumper Ant Venom Immunotherapy products is an extremely labour intensive process:
Manufacture of each batch involves manual collection of thousands of stinging ants from bushland areas within Tasmania where these ants are known to be abundant, followed by dissection of ant venom sacs under microscope, sterile manufacturing processes in a Pharmacy Clean Room, followed by extensive quality control testing before release. The Royal Hobart Hospital aims to maintain standardised Jack Jumper ant venom extracts price as low as practicable, however the increasing costs of TGA licensing and quality control activities must be met.
Pharmaceutical companies have shown little interest in manufacturing this product, likely due to the market being limited to Australia, which negatively impacts their return on investment.
The Committee was concerned to hear so much evidence about the lack of access to allergy specialists throughout Australia. Whilst the Committee understands that the funding of hospitals is a state and territory issue, the Committee urges these jurisdictions to review the evidence and consider a long term strategy to fund and manage the workforce demand for allergy and immunology specialists. Over time this will alleviate the pressures and long waiting lists if more funding of specialists is provided for in public hospitals across Australia.
The Committee believes there is merit in the National Allergy Strategy working with the Australian Government and states and territories to roll out a national Shared Care Model for allergy management.
Clinical Care Standards for the acute care of anaphylaxis should be implemented alongside a shared care model. The Australian Commission on Safety and Quality in Health Care should work with the National Allergy Strategy and the Australian Government to agree on National Clinical Care Standards for the acute care of anaphylaxis.
The Committee believes it is important for Australia to have a national standard to report anaphylaxis deaths to the coroner in all states and territories. Such a referral will assist with the development of a robust national data collection for anaphylaxis.
The Committee was concerned to hear evidence suggesting inconsistent discharge practices were taking place across Australia from Emergency Departments for patients suffering from anaphylaxis. The Committee believes patients should receive a script for an adrenaline auto-injector, a referral to see a specialist between 4-6 weeks after discharge, and a referral to a counsellor or psychologist trained in the area of anaphylaxis trauma.
For people suffering from anaphylaxis for the first time, patients and carers of patients should receive information about the seriousness of anaphylactic reactions and should receive referrals to counsellors and psychologists as required.
The Committee was impressed with the educational resources available on the ASCIA website for patients, carers, consumers, school staff, early childhood education/care staff, first aid providers and healthcare workers. The Committee encourages ASCIA to promote these resources to relevant sectors, including in newborn information packs for new parents.
Drug allergy management is an area of concern that is getting little attention despite the significant health issues that arise from drug allergy mismanagement, including preventable deaths. The Committee supports the creation of a drug allergy database and standardised clinical drug allergy education and training for all medical staff. The National Allergy Strategy has put forward recommendations to the Department of Health in a Drug Allergy Project. The Committee urges the Australian Government to consider funding the implementation of recommendations in the National Allergy Strategy Drug Allergy Project.
The Committee is concerned by the high incidence of drug de-labelling, particularly for antibiotics, and the effects this can have on the community in the form of increased antimicrobial resistance, increased hospital stays, and reduced patient outcomes. It is very important that people be de-labelled from unconfirmed drug allergies, such as penicillin.
The Committee believes that a public health based drug allergy de-labelling program and associated education campaign would be an important step to reducing drug de-labelling. In chapter 2 the Committee recommended the creation of a national anaphylaxis and severe drug allergy register. The drug de-labelling program would need to feed its data into the National Centre for Allergies and Anaphylaxis.
The Committee was impressed by the innovative research and treatment programs that have been developed in Tasmania to treat Jack Jumper Ant allergy. The Committee believes it is important that the Royal Hobart Hospital receives ongoing funding from the Australian Government for this uniquely Australian problem. In addition, the Committee believes that the venom immunotherapy treatment should be available in all states and territories as required as a nationally funded program.
The Committee recommends that the Australian Government work with all states and territories to provide a consistent national framework for patients being discharged from an Emergency Department after an anaphylactic reaction. These patients should be provided with the following:
an adrenaline auto-injector script for up to a maximum of 3 adrenaline auto-injectors and an appropriate emergency action plan (including digitised action plans) as per the Australasian Society of Clinical Immunology and Allergy (ASCIA)’s recommendation;
if not already diagnosed with anaphylaxis, the patient should be given a priority referral (this referral must be for the period four to six weeks after discharge) to an immunologist or allergy specialist; and
information pamphlets on allergies and anaphylaxis. For example, information that outlines support and information on allergies from peak bodies such as ASCIA and Allergies and Anaphylaxis Australia (A&AA).
The Committee recommends that the Australasian Society of Clinical Immunology and Allergy (ASCIA) receive ongoing long term funding to continue its partnership work with the Department of Health and the National Allergy Strategy, to develop minimum standards of allergy training for health professionals including:
funding for the promotion of the e-resources ASCIA has already developed to all relevant communities throughout Australia;
minimum standards of allergy training in the curriculum for all university medical schools and training of general practitioners, physicians and paediatricians, nurse practitioners, psychologists, dieticians, and paramedics; and
funding support for ASCIA to provide training for all health professionals listed above.
The Committee recommends that the Australian Government provide telehealth funding support for doctors and allied health workers in order to provide professional services and support to allergy patients in rural, regional and remote Australia.
The Committee recommends that the Australian Government consider an Medical Benefits Scheme (MBS) item number for food challenges carried out by appropriate clinicians.
The Committee recommends that the Australian Government provides funding for a public health system drug de-labelling program including:
developing a program in the public health system to run community education campaigns to encourage people to participate in drug allergy de-labelling programs;
create clinical guidelines for drug allergy de-labelling; and
give consideration to the need for a Medicare Benefits Scheme (MBS) item number for drug allergy testing and drug allergy challenges.
The Committee recommends that the Australian Government should mandate consistent labelling for all products containing chlorhexidine, iodine and latex to ensure consumers and healthcare workers can readily identify these products. In addition:
alternatives for chlorhexidine, iodine and latex should be readily available;
all government procurement should maintain a database of all chlorhexidine, iodine and latex containing products;
the broader healthcare sector should be educated about the risks of anaphylaxis to chlorhexidine, iodine and latex.
The Committee recommends that the Australian Government provide additional funding support to ensure the Royal Hobart Hospital can provide ongoing Jack Jumper Ant venom immunotherapy treatment to Australians in all states and territories.
The Committee recommends that the Australian Government work with states and territories to ensure that all allergy and anaphylaxis fatalities receive an automatic referral to the coroner for assessment.
The Committee recommends that the Australian Government work with the Therapeutic Goods Administration (TGA) to:
proactively encourage competition for pharmaceutical companies to supply alternative adrenaline auto-injectors to the Australian market in order to prevent future shortages;
investigate the expiry dates of adrenaline auto-injectors; and
investigate reasons for intermittent supply of adrenaline auto-injectors.
The Committee recommends that the Australian Government work with states and territories to:
review the sufficiency of the current allergist and immunologist workforce in hospitals throughout Australia; and
ensure that there is funding for increased placements of these specialists in all hospitals (if a need is found).