Correction: Financial incentives for childhood immunisation — a unique but changing Australian initiative

Corrections

Error in footnote: In “Financial incentives for childhood immunisation — a unique but changing Australian initiative” published in the 17 June 2013 issue of
the Journal (Med J Aust 2013; 198: 590-592), the second footnote in
Box 2 should read: “† In Queensland, immunisation providers receive $3
per notification of completion of
all vaccines at each age-based NIP schedule point, in recognition of
the fact that a separate register,
the Vaccination Information and Vaccination Administration System,
is maintained in that state.”

Why can’t we get permanent general practitioners for our country town?

To the Editor: A rural general practitioner’s workload is significantly larger than that of his or her urban colleagues, and this is attributable
to work activities in rural public hospitals.1 A GP who provides
after-hours on-call service to the community through the local hospital or emergency department is not only valued, but also more likely to be retained in the rural workforce.2 However, on-call commitments and the unrelenting nature of after-hours care can negatively affect professional and personal wellbeing, family life and opportunities to enjoy the rural location.3

I currently work in the city, but did much of my training in rural and regional areas. Doing GP locums allows me to stay in touch with rural and regional practice. However, working as a locum has highlighted to me how arduous on-call commitments can be. When you are working as the solo town doctor, or one of two, there is not much opportunity to share the on-call roster as recommended by the Rural Doctors Association of Australia.4

In my experience, some hospitals have restrictive service contracts, which further contribute to the GP’s burden. For example, the doctor is mandated to be within 10–15 minutes away from the hospital at all times while on-call, and must attend, when requested, within the times specified in the contract. These times are the same as those expected in large urban hospitals.

In large urban tertiary teaching hospitals with on-site doctors, the median time taken for a doctor to attend patients whose condition has deteriorated unexpectedly is 13 minutes. One in five episodes had a recorded response time longer than 30 minutes.5 By requiring on-call GPs to meet or better the expected response times of urban tertiary hospitals, “on-call” in effect becomes “on duty”.

An on-call weekend results in being confined to home from 8 am Friday to 8 am Monday. I empathise with GPs working permanently in a country town and having to cope with such restrictions.

Given what we know about the negative impact of onerous on-call and after-hours commitments on doctors, including GPs, and the subsequent negative effect on workforce retention in rural and remote Australia,2 why are we still setting ourselves up for continuing failure?

Telehealth and equitable access to health care

To the Editor: I write in protest about the short-sighted decision of the Australian Government to remove outer metropolitan areas from eligibility for Medicare rebates for telehealth from 1 January 2013. Since then, there has been a 29% drop in the number of video consultations, with 9476 recorded from 1 January to 28 February 2013, compared with 13 311 from 1 November to 31 December 2012.1

Telehealth is usually proposed as a tool suitable for the rural and remote locations of Australia, providing lower costs, increased access to specialists, improved collaboration, increased quality of local service and greater access to professional development.2 Yet barriers to care are more than geographical; they can be temporal, financial and cultural.3 In particular, the health care system remains inequitable while patients with disabilities face a range of barriers in achieving access.4 Telehealth assists in overcoming these barriers, enabling improved access to care in urban areas.5

We instituted a telehealth service in psychiatry and pain management to a general practice super clinic located
in the City of Playford council area in Adelaide’s outer northern suburbs. This area is underserved, with a low socioeconomic status and poorer health outcomes.6 The South Australian branch of the Royal Australian and New Zealand College of Psychiatrists, and the Australian Pain Society, informed us that there were no private locally resident or visiting specialists in this area, and the referring general practitioners said that the particular patients seen would not otherwise have accessed specialist care. They included patients who were homeless, patients with disabilities or those who lacked their own transport.

I understand that the boundary changes were intended not to undermine existing outer metropolitan private specialists but,
in this case, we were clearly able to bring private specialist resources into the area with benefit to patients. Additionally, we recruited health
care students on clinical attachments to assist patients with their teleconsultations. At the same time, the students were able to learn from the specialists during the video communication sessions.

I propose two recommendations that would result in telehealth increasing equitable access to care: first, that underserved outer metropolitan areas of low socioeconomic status be reinstated for Medicare rebates for telehealth, and second, that patients with a disability should be eligible for video consultations regardless of their place of residence.

General practice patients in the emergency department

Mostly, it is more appropriate for patients to seek care in the emergency department rather than visit a general practitioner

One of the mysteries of public policy is that at times the public discourse settles on a perspective that is based on flimsy or even contradictory evidence. One such discussion relates to the factors that contribute to the congestion of hospital emergency departments (EDs) in Australia.

In Australia, 30% of people attend EDs each year and that rate is growing at 2% per annum.1,2 The reasons behind this are unclear; however, demographic factors (eg, ageing population), epidemiological factors (eg, rising rates of chronic disease), health system changes (eg, the scope and availability of primary care) and individual factors (eg, socioeconomic status) are likely contributing factors. The relative contribution of these factors is unknown. The growth in ED attendance is across all age groups, among more urgent categories and highest for trauma.3

There are more people seeking care in EDs (increased demand) and EDs continue to experience difficulty obtaining access to ongoing care for their patients (access block). Access block is a direct consequence of diminishing per capita hospital bed numbers and inefficient bed use in an environment of increasing demand for inpatient care. However, despite the clarity of the evidence, many still believe that a major contributor is the “inappropriate” use of the ED by “general practice-type” patients.

In this issue of the Journal, Nagree and colleagues4 compare four different methods of determining the proportion of general practice-type patients attending EDs; one of which is that used by the Australian Institute of Health and Welfare (AIHW). These data are often cited in the public debate. The study found that three of the methods based on diagnostic and outcome criteria arrived at similar figures (about 10%), whereas the AIHW approach relatively overestimated the proportion (about 25%).

The study highlights the dichotomy between the tone of the public debate and the evidence. The public and political discourse maintains that ED congestion is contributed to significantly by “inappropriate” attendance by general practice-type patients. Some imply that this view is a deliberate ploy by politicians and health bureaucrats to shift responsibility between tiers of government.

However, each method used by Nagree and colleagues is potentially flawed. They are all statistical methods that do not (and cannot) take into consideration the particularities of each case. Additionally, each is based on diagnosis or outcome, neither of which is predictable by the patient when deciding where to obtain urgent medical advice. Extensive international research into the concept of ED attendance by general practice-type patients demonstrates not only a variable rate ranging from 4.8% to 90%5 but also exceptional variability between clinicians.6

While it is clear that some ED patients can be treated in a general practice setting, we reject the premise on which the methods of determining general practice-type patients is based. Interviews with actual patients have shown that the vast majority genuinely perceive that they have a serious illness and need urgent advice.6–8 It is absurd to expect patients to make clinical judgements when they do not have the expertise to do so.

The authors of the article conclude that the AIHW method grossly overestimates the load of general practice-type patient attending EDs. The use of the Australasian Triage Scale categories 4 and 5 as a surrogate indicator of inappropriate attendance represents a misunderstanding of the concept of triage.9 The Australasian Triage Scale assesses urgency, which is different from complexity and severity. These three concepts are distinct, although complementary.

The problem is complicated further by the definition of a general practitioner and therefore of a general practice-type patient. Reasonable patients may well seek attention from GPs if those services are available when the illness occurs and the GP has the requisite skills and facilities to meet the patient’s needs. Further, the nature of community care means that investigations require further appointments and travel. It actually represents a sound and sophisticated choice for many to seek care in an ED for purely practical reasons of timely access to all of the services required at a single location (one-stop shop), even when they could otherwise be treated in general practice.

It is also important to emphasise that notwithstanding the difficulty in defining general practice-type patients, these patients are not a significant contributor to ED congestion or burden. They account for less than 5% of ED length of stay1,10 and a very small proportion of ED costs.11

We appeal for a more rational basis to this discussion and thank the authors for their contribution.

First, we contend that there are not general practice patients or ED patients; there are just patients, who need medical care. The onus is on our health system to understand those needs and to provide accessible, affordable and quality services that meet those needs. Patients should not be blamed for our failure to do so.

Second, we need to understand that demand for acute health care is growing among those who need it. We should understand that need, and attend to the capacity constraints that are the real cause of the current system-wide congestion.

Finally, we need to better compile the evidence to inform the public debate and identify ways in which that evidence can be made accessible to those responsible for policymaking.

Challenges of transition to adult health services for patients with rare diseases

What can be done for young people stuck in “health care limbo” when they leave paediatric services?

The teenage years are a time of transition, when young people must adapt to enormous physiological and emotional changes but also need time to aspire to the future. Young people living with chronic complex disease have dreams, but their challenges are amplified as they face transition from paediatric to adult health services and begin to take charge of their own complex health care needs.1

Young people need the assistance of adult health services to deal with adult issues: sexual health, fertility, drug and alcohol use, mental health, lifestyle-related disease and issues related to disability, employment, education and training. For most of their lives, young people with chronic diseases have been engaged in a paediatric, family-centred multidisciplinary model of care. They need preparation and support to move into adult services, which are more specialised, less integrated, and centred more on the individual than on the family.1,2 Failed transition leads to poor engagement with health services and adverse health outcomes.2

Despite a number of policy initiatives to provide age-appropriate and stage-appropriate care for adolescents and the development of disease-specific transition pathways (eg, for cystic fibrosis, spina bifida and diabetes),1,3–5 transition is fraught for young people living with chronic and complex diseases, especially rare diseases.

Providing disease-specific clinics for every rare disease is unrealistic; there are almost 10 000 rare genetic diseases alone. Most rare diseases have their onset in childhood, are chronic, complex, disabling and require frequent, specialist care throughout the life span.6 This necessitates access to multiple doctors, allied health workers, pathology and pharmacy services.7 Better recognition of rare diseases and increasing survival rates have led to a greater demand for transition services from this group and we must respond to their needs.

Regardless of which chronic and complex disease they have, these young people face similar problems with the transition to adult care:

inadequate preparation
difficulty finding appropriate adult health services
inadequately coordinated specialist adult services
unwillingness of general practitioners to take on complex cases
inadequate resources to coordinate the transition process
lack of psychological support.

These issues were affirmed in the recent Forum for Young People Living with Rare Disease, attended by 15 young people and 15 parents or carers representing a wide variety of rare chronic conditions: Ehlers–Danlos syndrome, Klippel–Trenaunay syndrome, narcolepsy, cataplexy, Phelan–McDermid syndrome, Duchenne muscular dystrophy, Rasmussen’s encephalitis, congenital panhypopituitarism, hypochondroplasia and other skeletal dysplasias.8

Forum participants called for:

comprehensive preparation for transition, involving the family and adult services
timing of transition according to developmental stage and maturity, not age
flexibility from adult specialists to allow parents and carers to attend some consultations
clinics that treat many different rare chronic conditions
GP clinics that are competent and confident to coordinate care and refer appropriately
accessible transition coaches or coordinators.

One 18-year-old with a rare syndrome said:

I’m still transitioning, but it’s been a trial. I’m too old for paediatrics but too difficult a case for adult services to treat. I am worried about my health . . . I don’t know who will treat me properly if I end up in hospital.

As most rare chronic diseases are initially diagnosed and treated in childhood, much of the expertise resides with paediatricians, and often there is simply nowhere to transition to. We need to address this imbalance by supporting education on chronic complex diseases in young people — both for medical students and through continued medical education. The ongoing development of the specialty of Adolescent Medicine will support this.

Multidisciplinary clinic models catering for young adults could be adapted to cater simultaneously for many different rare diseases.5 Such innovative models provide economic efficiencies,9 facilitate communication among the many health professionals involved in care and ease access for patients. Establishing clinics that involve both adult and paediatric specialists enables sharing of expertise and provides a practical training platform. Incentives beyond the current Medicare rebates are needed to support specialist GP clinics willing to look after young people with rare chronic diseases. Trapeze, a primary health transition service, has been established in New South Wales, although its current focus is limited to diabetes and respiratory disease.10

Young people living with rare chronic disease have the right to equitable access to appropriate health care. We need a network of appropriately trained and well resourced transition coordinators to facilitate linkages between young people and health and psychological services and peer support.8 Evaluation of existing transition services and clinics to inform future service needs should be a priority. Successful transition requires more than a referral letter. It is a process that takes time and requires a coordinated system-based approach.

Vitamin B12 and folate tests: the ongoing need to determine appropriate use and public funding

It’s not as simple as new for old: we need to follow a process for “disinvestment” in existing medical procedures, services and technologies

Criteria have been developed for assessing the safety, effectiveness and cost-effectiveness of new and emerging health interventions, but additional challenges exist in identifying opportunities for reducing the use of existing health technologies
or procedures that are potentially overused,
(cost-)ineffective or unsafe.1 Criteria have been proposed to flag technologies that might warrant further investigation under quality improvement programs.1 These criteria are: new evidence becomes available; there is geographical variation in use; variation in care between providers is present; the technology has evolved and differs markedly from the original; there exists a temporal trend in the volume of use; public interest or controversy is present; consultation with health care workers and funders raises concerns; new technology has displaced old technology; there is evidence of leakage (use beyond the restriction or indication); the technology or intervention is a “legacy item” that has never been assessed for cost-effectiveness; use is not in accordance with clinical guidelines; or the technology is nominated by clinical groups.

After such a nomination was made by members of the clinical laboratory community regarding vitamin B12 and folate tests, we sought to determine whether these tests met other criteria. We hope that this article will encourage debate and discussion about the appropriate use of these tests.

Testing for vitamin B12 and folate deficiency

Diagnosing vitamin B12 and folate deficiencies is difficult. The symptoms are diverse (such as malaise, fatigue and neurological symptoms), as are the signs (including megaloblastic anaemia and cognitive impairments). Defining target conditions is, therefore, also difficult. Tests include a full blood count and blood film examination, serum B12, serum folate and red-cell folate (RCF) assays, as well as examination of metabolic markers such as methylmalonic acid (MMA) and homocysteine (Hcy). Untreated vitamin B12 deficiencies may cause serious health problems, including permanent neurological damage (which may occur with low serum B12 levels without haematological changes). Maternal folate deficiencies have been associated with neural tube defects in infants. Potential vitamin B12 or folate deficiencies therefore need to be appropriately investigated and managed.

New evidence

The utility of a diagnostic test is influenced in part by its precision (the ability of a test to faithfully reproduce its own result) and its diagnostic accuracy (ability to discriminate between a patient with a target condition and a healthy patient). Evidence suggests serum B12 tests have poor discriminative ability in many situations, and debate is ongoing over which folate assay is most useful.

The only systematic review and meta-analysis of the diagnostic accuracy of serum B12 tests (conducted by members of our group) suggested that these tests often misclassify individuals as either B12 deficient or B12 replete.2 These findings are consistent with other reports in the literature. One recent report states:

Both false negative and false positive values are common (occurring in up to 50% of tests) with the use of the laboratory-reported lower limit of the normal range as a cutoff point for deficiency.3

And further:

There is often poor agreement when samples are assayed by different laboratories or with the use of different methods.3

Widespread CBLA (competitive-binding luminescence assay) malfunction has also been noted, with assay failure rates of 22% to 35%4 (interference due to intrinsic factor antibodies may explain some of this variation). While a critical overview has suggested that “falsely normal cobalamin concentrations are infrequent in patients with clinically expressed deficiency”, the author notes challenges in diagnosing subclinical deficiency5 (mild metabolic abnormalities without clinical signs or symptoms). Assessment of this evidence base is complicated by the lack of a universally accepted gold standard and by target conditions that are difficult to define, variable clinical presentations and variable cut-off values used to define deficiency.

For investigating folate status, RCF assays are thought to be less susceptible to short-term dietary intake than are assays for serum folate. However, it has been reported that:

The red cell folate assay is more complex to perform than the serum folate assay and requires more steps in sample handling before analysis, and this may be one of the reasons why the precision of the red cell folate assay is less than that of the serum folate assay.6

As discussion continues over which folate test is preferable, new evidence related to the prevalence of folate deficiencies in countries with mandatory food fortification has shifted the focus toward whether there is a need to perform any folate investigations in these jurisdictions. In Australia, mandatory fortification of wheat flour with folic acid was introduced in September 2009.7 Prevalence estimates from a sample of inpatients and outpatients suggested that folate deficiency stood at 0.5% in April 2010, showing an 85% reduction in absolute numbers since April 2009.7 While there is currently no evidence to suggest that the prevalence of megaloblastic anaemia caused by folate deficiency has been reduced, the low frequency of low serum RCF test results in countries where there is mandatory fortification of grain products with folic acid supports the perspective that “there is no longer any justification in ordering folate assays to evaluate the folate status of the patients”.8

Technology development

Over time, multiple technologies for analysing vitamin B12 status have become available, including assays for measuring holotranscobalamin (holoTC, the bioavailable form of vitamin B12), as well as metabolic markers such as MMA and Hcy.3,5 However, like all tests, these are imperfect: holoTC is expensive, not routinely available, itself reliant on poorly defined serum B12 reference ranges, and is yet to be confirmed as a superior test to the serum B12 assay.5 Hcy measurement is subject to artefactual increases due to collection practices, and reference ranges are variable. The availability of MMA tests is restricted to some clinical and research laboratories. As a result, the optimal procedure for measuring vitamin B12 is unclear. As noted above, while a number of approaches exist for assessing folate status, there is currently no consensus on the most appropriate laboratory investigation process.

Temporal, geographical and provider variations

Australian Medicare utilisation data have shown substantial growth in the use of item 66602, which relates to the combined use of serum B12 and folate tests. Between the financial years 2000–01 and 2009–10, use increased from 1082 services per 100 000 population to 7243 services per 100 000 population (21.78% average annual growth rate).9 Over the same period, spending on pathology services overall grew at an average annual rate of 6.3%.

Geographical variation was also present, with the number of services reimbursed for item 66602 ranging from 1962 per 100 000 population in the Northern Territory to 8658 per 100 000 population in the Australian Capital Territory in 2009–10.9 While some of this variation may be due to demographic differences and populations known to have access to fewer health services (eg, Indigenous Australians), the substantial temporal and geographical differences in use raise more questions about appropriate use of these tests, and whether or not they are underused or overused.

Guidelines

Guidelines related to the use of vitamin B12 and folate tests vary widely in their recommendations. While some recommend B12 and folate tests as screening tools in commonly encountered illnesses such as dementia, others suggest restricting testing to patients who have already undergone pretest investigations (such as full blood examinations; however, we note that neurological damage may occur in patients with low serum B12 levels and without haematological changes).10,11 Guidelines may differ on key recommendations, such as the preferred first-line investigation for establishing folate status, while some question the utility of folate investigations at all in jurisdictions where food is fortified with folate.12–14

Leakage

With wide variability in guideline recommendations, and with few appearing to consider the diagnostic accuracy of B12 or folate tests, determining the extent to which services have “leaked” beyond their clinical indications is difficult. Possible leakage is evidenced by the use of serum B12 tests among patients presenting with weakness and tiredness, which is not supported by any available guidelines.15 A large study of general practitioners indicated that between April 2000 – March 2002 and April 2006 – March 2008 their use of serum B12 tests among patients presenting with weakness and tiredness increased by 105%.15

Discussion

Tests for investigating patients’ vitamin B12 and folate status have become widely used in clinical practice. Yet existing evidence suggests that the diagnostic accuracy of serum B12 tests is difficult to determine and may be highly variable. While other tests are available for investigating suspected B12 and folate deficiency (such as holoTC, MMA and Hcy), the diagnostic accuracy of these tests is also contested. Challenges in examining the diagnostic accuracy of serum B12 tests include highly variable clinical presentations, lack of a gold standard and inconsistent cut-off values used to define deficiency. While it remains under debate whether the serum or red-cell folate test is most useful for investigating folate status, mandatory folate fortification in Australia may call into question any use of these tests.

Temporal variation in use and geographical differences in how these tests are employed are both evident in Australian data. Moreover, available clinical guidelines are highly inconsistent in their recommendations. Collectively, the issues of test accuracy, wide variability in test use, and inconsistent guideline recommendations suggest that the use of vitamin B12 and folate tests is an area with much scope for quality improvement.

To improve the use of these tests, further assessment is needed that examines the complexity associated with clinical decision making and the various factors influencing why doctors request these tests. The decision to request an investigation such as a B12 or folate test may be driven by a range of factors, including ease of use, cost, absence of significant patient risk, the perceived need to respond to patient requests, lack of appreciation of the diagnostic accuracy of the tests, or ready availability of results.16 Understanding how these factors influence the use of B12 and folate tests may best be achieved through direct consultation with general practitioners, pathologists, specialists and consumers and is a critical step in advancing the assessment of these tests.

Financial incentives for childhood immunisation — a unique but changing Australian initiative

Will another shift in Australia’s unique system of immunisation incentives continue to encourage high levels of childhood vaccination?

The Immunise Australia: Seven Point Plan1 (Box 1) was launched in 1997 to increase childhood immunisation coverage from its then level of 53%.2 A range of financial incentives for general practice and parents was one component, unique among high-income countries when it commenced in 1998.3 Incentives targeted at general practice remained largely unchanged for over a decade, but those targeted at parents have been modified several times. The 2012 Federal Budget heralded significant reforms to financial incentives for immunisation, and there has been discussion about their possible impact. Here we document the history and consider the potential impact of changes to financial incentives for immunisation targeting providers and parents in Australia.

General practice immunisation incentives

The original General Practice Immunisation Incentive scheme offered two financial incentives for general practices that registered for it: the Service Incentive Payment and the Outcomes Bonus Payment. Since 1996, the Australian Childhood Immunisation Register (ACIR) has offered general practitioners a notification payment for reporting vaccines administered to children under 7 years of age. The National Human Papillomavirus (HPV) Vaccination Program Register introduced the same notification payment for the time-limited community catch-up program. Although not strictly an incentive, the Medicare Benefits Schedule has included several item numbers directly supporting immunisation service provision (Box 2).

The Service Incentive Payment ceased in 2008 and in May 2013 the Outcomes Bonus Payment will end (Box 2). The latter will mean a general practice with 600 whole-patient equivalents will lose around $2100 per quarter, while a smaller practice of 30 whole-patient equivalents will lose around $100 per quarter. These changes align general practice and state and local government immunisation providers (eg, community health) as, although eligible for the ACIR notification payment, these providers have never been eligible for the General Practice Immunisation Incentive scheme. The ACIR notification payment continues at $6, the same amount offered when it was first introduced.

Immunisation incentives for parents

Under the Seven Point Plan, immunisation was linked to the existing Maternity Immunisation Allowance (MIA) and childcare-related payments (Box 2). In 2009, the MIA was split into two payments: continuing financial incentives for vaccines due by 12 months of age and introducing a financial incentive for vaccines due at 4 years of age, when coverage and timeliness were lowest. From July 2012, the MIA was discontinued; instead, immunisation status became linked to the existing means-tested Family Tax Benefit (FTB) Part A supplement for each child at ages 1, 2 and 5 years.4 To be eligible for this offset at these three age milestones, a child must be recorded as fully immunised. From July 2013, the fully immunised criteria will expand from nine to 12 antigens (Box 2). Immunisation status is also reviewed by a health professional during a health check offered from 3 years of age that meets the criteria for a Healthy Start for School check (including but not limited to the Healthy Kids Check). Documented completion of a Healthy Start for School check is linked to receipt of the FTB Part A supplement for 4-year-old children. In line with the tax system, parents will have two financial years to fulfil the immunisation requirements for the FTB Part A supplement, a grace period greater than was allowed for the MIA.4 Parents who do not want or cannot have their children immunised will still need to apply for an exemption in order to receive the family tax and childcare benefits for which they are eligible.

The impact of incentive changes

Since the Seven Point Plan was introduced, national childhood immunisation coverage has risen to over 90%.5 After the removal of the Service Incentive Payment, coverage remained stable,5 although there is concern that it will fall following the cessation of the Outcomes Bonus Payment.6 With the addition of three more antigens to the “fully immunised” criteria, it is possible that coverage will appear lower; however, it will be difficult to disentangle the relative impact of the various changes to incentives and the “fully immunised” criteria.

Legislated parental incentives for childhood immunisation have been broadly accepted among Australian parents and have had a positive impact on uptake and timeliness.5,7 These incentives are likely to have been sufficient to motivate parents to immunise their children and to prompt their provider to notify the ACIR in a timely manner.5 Based on data from the Australian Bureau of Statistics, of the 2.05 million recorded families in Australia in 2011, around 73% appear eligible for the FTB Part A supplement.8,9 For many of these families, there will now be more dollars at stake for ensuring that their children are fully immunised. For the minority of higher income families who are not eligible for this and/or the childcare-related benefits, there will no longer be any financial incentive for immunisation. Other families will be eligible for some or all of these incentives in part but, due to means-testing of these payments, the dollar value may not be as great as that previously provided by the MIA. The larger incentive could increase the 1.5% currently registered conscientious objectors,5 because parents who previously did not attempt to claim the MIA but are eligible for the FTB Part A supplement may now be more motivated to register their objection.

The Outcomes Bonus Payment was intended to supplement some of the infrastructure and administration costs for vaccination services provided by general practice. It is possible that the remaining ACIR notification payment and the non-immunisation-specific Practice Nurse Incentive Program may not supplement this to the same extent. However, demand from parents, accreditation requirements, established reporting habits and public health altruism are likely to continue to drive the provision of childhood immunisation and ACIR reporting at the provider level. A reduction in bulk-billing for childhood immunisation is also unlikely, as the Medicare Benefits Schedule item incentive to bulk-bill those under 16 years of age remains, and there is no current evidence of a decline in bulk-billing rates nationally.10

The impact of the financial incentives for childhood immunisation introduced in Australia from 1998 has been challenging to evaluate, given the many other changes in the immunisation landscape1 over this period. Retrospective evaluations and ecological evidence indicate that the childhood immunisation incentives introduced in Australia are likely to have made a significant contribution to increasing childhood immunisation coverage to over 90%.5,7 However, the relative impact of incentives for parents and for GPs is likely to be difficult to disentangle.

1 Immunise Australia: Seven Point Plan1

1. Initiatives for parents

Maternity Immunisation Allowance
Childcare Assistance Rebate and/or the Childcare Cash Rebate

2. A bigger role for general practitioners

General Practice Immunisation Incentive Scheme
Support from Divisions of General Practice

3. Monitoring and evaluation of immunisation targets

4. Immunisation days

5. Measles eradication

6. Education and research

7. School entry requirements

2 History of payments provided by the Australian Government for immunisation in Australia, 1996–2013

Parent/carer

General practice

Year

Payment type

Amount and timing

Payment type

Amount and timing

1996

ACIR notification payment*

$6† per notification of completion of all vaccines at each age-based NIP schedule point*

1998

Childcare Assistance Rebate and/or the Childcare Cash Rebate‡

Varies depending on income, number and age of child(ren), type and duration of care. In 1998, $20–$122 per child per week

GPII SIP (for individual general practitioner)

$18.50 per notification of completion of all vaccines at each age-based NIP schedule point

MIA

$200§ per fully immunised¶ child at 19 months of age

GPII OBP (for general practice)*

$3.50 per fully immunised¶ WPE if practice coverage is ≥ 90%** for children aged < 7 years*

2000

Child Care Benefit (replaced previous Childcare Assistance and Cash rebates)*‡

Varies depending on income, number and age of child(ren), type and duration of care*

May 2004

MBS Item 10993, immunisation provided by practice nurse

$10.20 per consultation††

July 2004

Means testing removed from MIA

July 2008

National HPV Vaccination Program Register notification payment§§

$6 per dose notified

Healthy Kids Check*

$58.20-$263.55* ¶¶

October 2008

GPII SIP ceased

January 2009

MIA split into two payments

$129 (2009–end June 2012) for a fully immunised¶ child aged 18–24 months and 4–5 years

May 2010

National HPV Vaccination Program Register notification payment ceased§§

December 2011

MBS Item 10993 ceased

July 2012

MIA ceased

Immunisation status of child at ages 1, 2 and 5 years linked to existing FTB Part A supplement*‡

Maximum of $726 per child, per age milestone*

May 2013

GPII OBP to cease

July 2013 (projected change)

Meningococcal C, pneumococcal and varicella added to the fully immunised¶ criteria

Affects eligibility for FTB Part A supplement for each child aged 1, 2 and 5 years and the Childcare Benefit

ACIR = Australian Childhood Immunisation Register. FTB = Family Tax Benefit. GPII = General Practice Immunisation Incentive. HPV = human papillomavirus. MIA = Maternity Immunisation Allowance. MBS = Medicare Benefits Schedule. NIP = National Immunisation Program. OBP = Outcomes Bonus Payment. SIP = Service Incentive Payment. WPE = whole-patient equivalent; the proportion of care provided to a child at a general practice during a 12-month reference period, compared with the overall care provided to that child by all other general practices the child visited during the same period; calculated from the MBS fee value of non-referred services. * Available at March 2013. † In Queensland, immunisation providers receive $3 per notification of completion of all vaccines at each age-based NIP schedule point, in recognition of the fact that a separate register, the Vaccination Information and Vaccination Administration System, is maintained in that state. ‡ Means-tested. § Amount in 1998; increased annually to $233 by 2008. ¶ As defined in annual coverage report (Hull et al).5 ** GPII OBP applied to general practices with 70%, 80% and 90% coverage levels in first year, then 80% and 90% coverage levels in second year and 90% coverage levels from third year onwards; general practices must have been registered with the GPII scheme and have had ≥ 10 WPEs to qualify for the payment. †† Amount in 2004; indexed annually on 1 November and increased to $11.80 in November 2011. §§ Paid only to GPs registered with the National HPV Vaccination Program Register who notified vaccines administered under the community-based catch-up component of the program. ¶¶ Range for March 2013 MBS scheduled fee for health assessments, depending on the time taken and type of health professional conducting the check; MBS scheduled fees indexed annually.

Evidence-based medical workforce planning and education: the MSOD project

How will this survey change medical workforce management?

Overcoming medical workforce shortages and maldistribution remains critical in Australia.1 Numerous government initiatives have targeted these issues.2 Despite recent modest progress in increasing the supply of doctors to underserved regions,3 overall success has been limited.4

After auditing Australia’s rural and regional health workforce, the Australian Government recognised the need for longitudinal data for strategic medical workforce planning.2 The Medical Schools Outcomes Database and Longitudinal Tracking (MSOD) Project of Medical Deans Australia and New Zealand Inc (MDANZ) has been funded from 2004, initially by the Department of Health and Ageing and now by Workforce Australia, to collect data from medical students, tracking them through medical school and into prevocational training. Collection of national data began in 2006.5

As reported in the Journal in 2009, the MSOD Project aims to provide a national dataset that can be used to explain career choices and workforce patterns and inform policy.6 Four years on, to what extent are these uses being achieved?

The MSOD collection is comprehensive, with response rates to voluntary surveys at commencement and exit from medical school being maintained at 95% and 83%, respectively. Surveys are now being administered annually at the end of the first and third postgraduate years with follow-up rates of approximately 70%. The first survey at the fifth postgraduate year will be administered in 2013. Questionnaire responses provide detailed information on demographic background, educational experiences, career intentions and preferred and actual locations of practice for medical students and graduates from all Australian and New Zealand medical schools.5 Since 2005, more than 30 000 questionnaires have been collected. There is no known similar national study of medical students in any other country.

MSOD data inform medical workforce modelling undertaken by Health Workforce Australia1 and Health Workforce New Zealand, which enables analysis of trends in the supply of doctors and the training places required. Data from further administration of MSOD postgraduate questionnaires will contribute to development of national approaches to intern allocation. The data will allow assessment of the success of new initiatives such as the Prevocational General Practice Placements Program and private hospital sector internships.

MSOD data are also used by the Medical Training Review Panel in their annual reports presented to the federal Minister for Health.7 At the MDANZ medical education conference in 2012, Minister for Health Tanya Plibersek said, “The MSOD is an ambitious initiative that has provided invaluable information to stakeholders on government investment in medical education and workforce planning”.8 In particular, publications on rural career intentions and rural medical student placements provide strong support for a policy of continued government investment in rural clinical schools and training posts.9

Evidence related to medical education and workforce has to date been anecdotal. The MSOD dataset has provided the core platform for a number of studies that provide empirical evidence and were conducted by academics and medical students5 and presented at national and international forums.10 Some key findings from these studies are presented in the Box. With greater understanding of factors shaping career choices, it becomes possible to make innovations in medical education and training programs and assess the impact of those changes.

The MSOD Project has achieved international recognition for its scientific quality and capacity to contribute to development of evidence-based health policy. Details of the project were presented at the 14th International Health Collaborative Conference in Quebec.14 Through collaborations with the Australian Primary Health Care Research Institute and the Robert Graham Center in the United States, geospatial analysis and interactive web-based mapping tools are used on MSOD data to reveal the geographical footprint of medical students’ intentions to practise.15 This offers visually engaging outputs to illustrate complex issues, such as maldistribution of intentions to practise, and to help develop relevant funding mechanisms and policies to meet workforce needs.

While it may be early days for MSOD, its value as a prospective cohort study will increase over the next 5 to 10 years. Linkage with the National Health Workforce dataset with appropriate privacy constraints will augment workforce analyses. As workforce shortages within particular medical specialties are identified, linkage will provide the rationale, through consideration of data on students’ early career intentions, to make changes to educational programs and provision of incentives to meet these shortages. Over time, the linked data will also allow evaluation of such initiatives. Linkages with the Australian Rural Clinical Schools Program Survey and the Undergraduate Medical and Health Sciences Admission Test Longitudinal Study are planned. These will assist in analyses of medical school selection processes and further curriculum development.

The MSOD dataset provides mechanisms for evaluating and comparing outcomes of different medical programs (eg, graduate and undergraduate entry; shorter and longer programs) and alignment with national workforce needs.

So what does the future hold? The success of workforce research lies in its contribution to resolving medical workforce shortages and maldistribution. With close engagement between policymakers and researchers, the MSOD Project provides evidence that will continue to underpin innovative approaches to teaching and training, inform appropriate internship and specialty training placements, and contribute to further development of assessment tools and measurement of the quality of clinical training.

The outcomes of these developments should provide the medical workforce required to meet the future needs of Australia and New Zealand.

Key findings from four studies based on Medical Schools Outcomes Database and Longitudinal Tracking Project data

A predictive model and index of rural medical practice intention has been produced based on medical students’ characteristics.11 The model can provide a means for optimising use of scarce medical program resources, thereby helping to improve the supply of rural medical practitioners
Clinical placements in early years pose significant resource costs for placement providers and may be better prioritised for senior students12
Medical graduates with a rural background are more likely to become rural doctors. This association strengthens when the option to work in locations with attractive climates is given13
Rural placements are associated with a shift towards rural practice intentions, while students who intend to practise rurally at the start and end of medical school tend to be older and interested in a generalist career

Stent insertion for palliation of advanced oesophageal carcinoma symptoms by level of socioeconomic disadvantage in urban New South Wales

To the Editor: For patients with advanced oesophageal carcinoma, palliation of debilitating symptoms such as dysphagia and odynophagia is important for improving quality
of life.1 Owing to the possibility
of complications, it is generally recommended that stents be used as a palliative measure when expected survival is less than 3 months.2 We analysed linked records from the NSW Central Cancer Registry, the NSW Admitted Patient Data Collection, NSW Registry of Births, Deaths and Marriages death registrations data and Australian Bureau of Statistics mortality data to investigate the association between socioeconomic disadvantage and palliation of advanced (stage IV) oesophageal carcinoma symptoms by stent insertion in urban-dwelling patients in New South Wales, from July 2001 to December 2007. The study was approved by the NSW Population and Health Services Research Ethics Committee.

Of the 479 patients who were diagnosed with primary advanced oesophageal carcinoma before death and for whom linked hospital records were available, 28.4%
(136 patients) received stents. The proportion who received stents decreased with increasing disadvantage (P = 0.006 for association; P < 0.001 for trend). After adjustment for patient and tumour characteristics, greater disadvantage remained significantly associated with decreasing odds of stent insertion (Box) (P = 0.01 for association; P = 0.001 for trend). Dysphagia or oesophageal obstruction was reported for some patients and was associated with receiving a stent (χ2 test, P < 0.001) but not associated with level of socioeconomic disadvantage (χ2 test, P = 0.37). As this information is more likely to be reported for those who received a stent, it was not included in the multivariable analysis of association between stenting and socioeconomic disadvantage.

Increased socioeconomic disadvantage has been associated with reduced access to treatment for many cancers.3 Further, research on access to palliative care (generally and for advanced cancer in Australia) has identified barriers such as lack of standardised referral processes and lack of consensus about appropriate timing for access to palliative care.4,5 These factors, plus others that could not be measured reliably or at all from the data we used (such as indication for stenting, patient choice, and use of chemotherapy and radiotherapy), are likely to have contributed to the variation we observed.

For patients with expected survival of less than 3 months, stenting is recommended over alternative treatments such as brachytherapy.2 Because the proportion of patients with less than 3 months between diagnosis and death increased with increasing disadvantage (P = 0.004 for trend), immediate palliation of symptoms by stenting should be a priority for more disadvantaged patients. Later diagnosis for more disadvantaged patients may contribute to the observed variation in stenting, but is at odds with recommended treatment.2 Although patients who die soon after diagnosis may have reduced opportunity to receive a stent, excluding patients who survived
1–2 months after diagnosis made no difference to the findings.

Given the variation in use of stents by level of socioeconomic disadvantage that we observed and the possible role of other factors, further research is required to fully understand patient and health system factors that affect access to palliative care for patients with advanced oesophageal carcinoma. Understanding treatment pathways for more disadvantaged patients should be a priority because stent insertion can provide patients with immediate improvement to quality of life.

Association between stent insertion and socioeconomic disadvantage in 479 urban-dwelling patients with advanced oesophageal carcinoma, New South Wales, 2001–2007

Quintile of socioeconomic disadvantage*	No. (%) of patients	No. (%) of patients who died ≤ 3 months after diagnosis	No. (%) of patients who had stent inserted	Adjusted odds ratio† (95% CI)

Least disadvantaged	87 (18.2%)	26 (29.9%)	37 (42.5%)	2.00 (1.10–3.64)
Second least disadvantaged	102 (21.3%)	38 (37.3%)	32 (31.4%)	1.22 (0.67–2.23)
Middle	122 (25.5%)	56 (45.9%)	32 (26.2%)	1.00‡
Second most disadvantaged	96 (20.0%)	46 (47.9%)	22 (22.9%)	0.85 (0.45–1.60)
Most disadvantaged	72 (15.0%)	32 (44.4%)	13 (18.1%)	0.60 (0.29–1.26)
All	479 (100.0%)	198 (41.3%)	136 (28.4%)	—

* Quintiles of the Index of Relative Socio-Economic Disadvantage, based on the local government area of each patient’s residence at the time of diagnosis. † Model included: age group, sex, country of birth, year of diagnosis, diagnostic group (oesophageal squamous cell carcinoma, oesophageal adenocarcinoma, and other specified or unspecified oesophageal carcinoma), number of comorbidities, and time between diagnosis and death (≤ 3 months or > 3 months). The Hosmer–Lemeshow test indicated that the model was a reasonable fit (χ2 = 7.02, df = 8, P = 0.54). ‡ Reference category.

Human papillomavirus vaccine in boys: background rates of potential adverse events

Cervical cancer is the most common cancer affecting women in developing countries. It is caused by persistent infection with specific types of human papillomavirus (HPV).1 Quadrivalent human papillomavirus (4vHPV) vaccine is a recombinant vaccine administered as a three-dose course to provide protection against four types of HPV (6, 11, 16 and 18).2 The vaccine is highly efficacious for the four included types, of which 16 and 18 are reported to cause 70% of cervical cancers and 6 and 11 cause anogenital warts.1,3 4vHPV vaccination was introduced under the Australian National Immunisation Program (NIP) in April 2007 for adolescent girls, with an initial catch-up program including women up to 26 years of age. The current ongoing funded program is only for girls in the first year of high school (aged 12–13 years). Recent data suggest that the 4vHPV vaccination program has caused a rapid decline in genital wart presentations in females,4,5 and there are early indications of a reduction in high-grade cervical dysplasias.6

Following advice from the Australian Technical Advisory Group on Immunisation, vaccination of males was recommended as a cost-effective intervention by the Pharmaceutical Benefits Advisory Committee in November 2011.7 Accordingly, 4vHPV vaccination for boys has been added to the Australian NIP, commencing in 2013 and targeting boys aged 12–13 years in a school-based program, with a catch-up program over 2 years for boys aged 14–16 years.7,8 The program aims to reduce the incidence of HPV disease in males, such as anogenital warts and anal intraepithelial neoplasia,9 and reduce sexual pathways of virus transmission. Australia will be the first nation to implement HPV vaccination for boys in a national program.

Vaccines, as with any medicine, have potential adverse reactions varying from mild and expected to rare and/or serious events. Vaccination may cause such events — the nature of adverse events following immunisation (AEFI) and the timing of onset after vaccination are important factors when assessing causation. Adverse events may also coincide temporally with vaccine administration by chance. To interpret postlicensure surveillance data, it is useful to know the background rates of common and rare potential adverse events before introduction of the vaccine.10,11 With this understanding, increases above background rates can be rapidly identified, which can assist with the evaluation and reporting of potential vaccine-associated adverse event rates.

The mass school-based introduction of female 4vHPV vaccination raised a number of well publicised initial safety concerns, including “scares” regarding potential episodes of anaphylaxis and multiple sclerosis after vaccination.12–14 In addition, a mass psychogenic reaction was seen in a Melbourne school vaccination environment,15 with syncope and syncopal seizures occurring in response to the vaccination process.16 Such spurious events may arise from the psychological impact of the vaccination process, particularly when using mass vaccination strategies in a school-based teenaged population.

Release of the 4vHPV vaccine to boys has the advantage of adverse event information from prelicensure clinical trials and postlicensure surveillance of adverse events arising from administration to adolescent girls. However, additional information on the background rates of potential adverse events in teenaged boys is critical for assessing the safety of this vaccination program.

Our aim was to explore the use of routinely collected information for estimating potential adverse event rates. We used population-level health outcome administration data to describe the background rates of potential AEFI before the introduction of 4vHPV vaccination for boys into the NIP in Australia, and to estimate numbers of a range of neurological, allergic and other events that can be expected following vaccination, assuming temporal association with administration of vaccine but no other association.

Methods

Two statewide Victorian datasets were accessed — the Victorian Admitted Episodes Dataset (VAED; hospital discharge data) and the Victorian Emergency Minimum Dataset (VEMD; emergency department visit data) — both of which include International Classification of Diseases 10th revision Australian modification (ICD-10-AM) codes. The data included a unique identifier that enabled linking of individuals across the datasets, but were otherwise non-identifying, according to Victorian Department of Health data linkage protocols.17 Ethics approval for the study was provided by the VAED and VEMD data custodians.

Multiple records of the same event within a dataset or across datasets — for example, a person presenting at emergency who is subsequently admitted, or a person admitted to hospital who is then discharged to a different hospital or to home and who later returns with continuation of the same episode (with each presentation recorded as a separate event) — were linked via the unique identifier. All events occurring within 28 days of a previous event were combined into a single episode.

The data that we analysed comprised all episodes that occurred in boys aged 12 to < 16 years and were recorded in the VAED and/or VEMD with one of the ICD-10-AM codes listed in Box 1 and an admission or presentation date from 1 July 2004 to 30 June 2009.18 Conditions selected for inclusion are rare adverse events, conditions that patients are likely to present to hospitals with after vaccination, and conditions that have previously been raised as potential sources of concern in Australia and overseas.10,19

Age was taken to be the youngest age at which an episode occurred, and records were excluded from the analysis if sex was recorded inconsistently among records with the same unique identifier. Some records had more than one ICD-10-AM code, and these were preserved. Events with an interstate or overseas postcode were excluded, but those with “unknown” (8888 and 9988) and “of no fixed abode” (1000) postcodes were preserved under the assumption that these occurred in Victoria. Episodes that were ongoing from the 3 months before the study period, the washout period (31 March to 30 June 2004), were also excluded.

Events were described as the number of episodes and the number of first events. An episode was considered a discrete event if it occurred more than 28 days after a prior event in the same individual, as patients were deemed to still be “at risk” of the same event during their recovery from an acute condition. First events were defined as the first time a condition was diagnosed in each patient during the study period. First events are more relevant for chronic conditions and episodes are more relevant for acute conditions.

We calculated background annual incidence rates as the number of events during the 5-year study period divided by the population at risk during this period, using Australian Bureau of Statistics 2006 mid-year resident population data for males.20

The analysis was restricted to boys aged 12 to < 16 years — the target age range for vaccination. We used these background rates to estimate the number of events expected within 1 day, 1 week and 6 weeks of vaccination per 100 000 vaccinees. We then estimated the expected number of events for each condition 1 day, 1 week and 6 weeks after vaccination across Australia following the introduction of 4vHVP into the NIP, assuming there is no association (other than temporal) with the vaccine.

Seasonal variation was analysed by graphing the number of first events or episodes by month of presentation. As the numbers of chronic neurological presentations in the study group were small, they were combined and compared with numbers of all-age presentations in males for individual neurological conditions. For multiple sclerosis, data were also presented omitting presentations in the first 12 months of the study period to assess the effectiveness of the study’s 3-month washout period.

Results

The numbers of and incidence rates for potential AEFI in boys aged 12 to < 16 years are shown in Box 2, and the estimated numbers of cases of potential AEFI per 100 000 adolescent boys that would occur, even in the absence of vaccine, are shown in Box 3. Assuming an 80% vaccination rate with three doses per person — which equates to about 480 000 boys vaccinated and a total of 1 440 000 doses administered nationally per year in the first 2 years of the program — about 2.4 episodes of Guillain-Barré syndrome would be expected to occur within 6 weeks of vaccination. In addition, about 3.9 seizures and 6.5 acute allergy presentations would be expected to occur within 1 day of vaccination, including 0.3 episodes of anaphylaxis.

There was minimal seasonal variation in the occurrence of potential AEFI (Box 4, Box 5). However, repeating this analysis with a larger number of neurological presentations (using data for all age groups) revealed a notable peak in the number of multiple sclerosis presentations in July. This peak was reduced but not eliminated when the washout period was increased to 15 months (Box 4).

Discussion

Using statewide morbidity data, we estimated background rates of neurological and allergic events in adolescent boys in Victoria to be 252.9 and 175.2 per 100 000 person-years, respectively. Such adverse events may be mistakenly assumed to be caused by vaccination, owing to temporal association, when the 4vHPV vaccination program is expanded to include adolescent boys.10 Postlicensure safety assessments of 4vHPV vaccine programs in adolescent girls have shown little evidence of increased risk of neurological and allergic adverse events after vaccination.3,21,22

Expected rates of potential AEFI in recent studies vary widely, but direct comparisons are restricted because of differences in methods, health care systems and data collection and analyses.10,11,23 In particular, caution is required when using emergency presentation databases as these may record preliminary diagnoses, rather than final diagnoses. Studies limited to analysis of ICD-10 coded data, such as ours, lack the rigour of diagnosis verification and conformity to standardised case definitions, although coding standards are maintained. Our study identified higher reporting rates for anaphylaxis compared with similar studies.10,11 While data aberrations are possible, marked increases in anaphylaxis rates Australia and the United States over the past two decades may play a part.24,25

Background rates of potential AEFI and consequent thresholds for safety flags should not be informed merely using data on adolescent girls because sex-related differences could cause misinterpretation of potential signals.10,11 For example, the rate of adolescent boys presenting with a first multiple sclerosis event in the 6 weeks following vaccination would be expected to be one-third of the rate seen for adolescent girls assuming no relationship with vaccine other than temporal.26

In our study, we used a 3-month washout period to attempt to remove the risk of categorising events as incident cases when they were part of a pre-existing illness than was ongoing from before the study period. However, the 3-month washout period did not remove this issue for multiple sclerosis. While our study showed little seasonal variation in potential AEFI, school-based vaccination programs are conducted in blocks (as convenient to the vaccine schedule and the school year), which may give rise to false signal detection. Specific investigation of appropriate washout periods, as well as seasonal variation in the occurrence potential AEFI and implementation of the vaccine program, must therefore be explored before conducting in-depth analyses for specific conditions or extrapolating data to other jurisdictions.

In Victoria, first-dose 4vHPV vaccine coverage for adolescent girls has reached 80%,27 but challenges of uptake and course completion by males may be anticipated.28 If coverage for boys is less than 80%, the expected rates in our study should be recalculated to avoid erroneous alert thresholds.

The background rates of potential AEFI that we have estimated can be used to inform surveillance systems, health care providers and the community regarding health care events that may be temporally related to vaccination. In mass vaccination programs, where vaccine exposure is a common event in the target group, many incident acute health conditions will occur following vaccination, irrespective of causal association. While current passive surveillance system reporting is likely to underascertain postvaccination events, prior knowledge of expected numbers of events are valuable in helping determine whether reports or clusters of reports represent real safety flags that require urgent investigation.26

Our data highlight the value of statewide and nationwide health datasets in providing information that can improve public safety. In addition to establishing background rates of diseases, international systems such as those in Denmark and the US, have been used to link vaccination databases to health care event databases, enabling direct investigation of potential associations with adverse events.29–31 These methods, conducted in accordance with state and federal privacy protections, offer a promising future for further improving vaccine safety in Australia.32

Routinely collected state health outcome data can enable informed postlicensure safety surveillance of conditions that may be perceived as AEFI. When the 4vHPV vaccine program is expanded to adolescent boys, such data can be used for targeted active surveillance of potential vaccine safety flags.

1 Conditions included in the study

ICD-10-AM codes

Neurological

Guillain-Barré syndrome*

G61.0

Transverse myelitis*

G37.3

Multiple sclerosis*

G35

Optic neuritis*

H46, G36.0

ADEM

G04.0

Bell’s palsy

G51.0

Syncope

R55

Seizures

R56, R56.0, R56.8

Allergic

Anaphylaxis

T78.2, T88.6

Urticaria

L50.0, L50.1, L50.9

Serum sickness

T80.6

Adverse effect of drug or medication†

T88.7

Other

Adverse events

T78.8, T78.9, T88.1, T78.3

ICD-10-AM = International Classification of Diseases 10th revision Australian modification. ADEM = acute disseminated encephalomyelitis. * Conditions considered chronic. † Not otherwise specified.

2 Numbers of and incidence rates for potential AEFI in boys aged 12 to < 16 years (Victoria, July
2004 – June 2009)

First events

Episodes

No. of events

Incidence rate (95% CI) per 100 000 person-years

No. of events

Incidence rate (95% CI) per 100 000 person-years

Neurological

Guillain-Barré syndrome

1.46 (0.56 to 2.37)

1.61 (0.66 to 2.56)

Transverse myelitis

0.29 (− 0.11 to 0.70)

0.44 (− 0.06 to 0.94)

Multiple sclerosis

0.29 (− 0.11 to 0.70)

Optic neuritis

0.59 (0.01 to 1.16)

0.88 (0.18 to 1.58)

ADEM

0.17 (0.45 to 1.90)

1.61 (0.66 to 2.56)

Bell’s palsy

8.78 (6.56 to 11.00)

Syncope

807

118.0 (109.9 to 126.2)

831

121.5 (113.3 to 129.8)

Seizures

666

97.4 (90.0 to 104.8)

830

121.4 (113.1 to 129.7)

Total

1516

221.7 (210.6 to 232.9)

1729

252.9 (241.0 to 264.8)

Allergic

Anaphylaxis

7.17 (5.16 to 9.17)

7.46 (5.41 to 9.51)

Urticaria

620

90.7 (83.6 to 97.8)

647

94.6 (87.3 to 101.9)

Serum sickness

3.4 (2.0 to 4.7)

Allergic reaction

495

72.4 (66.0 to 78.8)

517

75.6 (69.1 to 82.1)

Total

1125

164.6 (154.9 to 174.2)

1198

175.2 (165.3 to 185.1)

Other

Total

1.02 (0.27 to 1.78)

AEFI = adverse events following immunisation. ADEM = acute disseminated encephalomyelitis.

3 Estimated numbers of cases of potential AEFI in vaccinated boys aged 12 to < 16 years, assuming no relationship with vaccine*

No. of first events per 100 000 population

No. of episodes per 100 000 population

1 day

1 week

6 weeks

1 day

1 week

6 weeks

Neurological

Guillain-Barré syndrome

0 (0.00–0.01)

0.03 (0.01–0.05)

0.17 (0.06–0.27)

0 (0.00–0.01)

0.03 (0.01–0.05)

0.19 (0.08–0.29)

Transverse myelitis

0 (0.00–0.00)

0.01 (0.00–0.01)

0.03 (0.00–0.08)

0 (0.00–0.00)

0.01 (0.00–0.02)

0.05 (0.00–0.11)

Multiple sclerosis

0 (0.00–0.00)

0.01 (0.00–0.01)

0.03 (0.00–0.08)

0 (0.00–0.00)

0.01 (0.00–0.01)

0.03 (0.00–0.08)

Optic neuritis

0 (0.00–0.00)

0.01 (0.00–0.02)

0.07 (0.00–0.13)

0 (0.00–0.00)

0.02 (0.00–0.03)

0.10 (0.02–0.18)

ADEM

0 (0.00–0.01)

0.02 (0.01–0.04)

0.15 (0.05–0.25)

0 (0.00–0.01)

0.03 (0.01–0.05)

0.19 (0.08–0.29)

Bell’s palsy

0.02 (0.02–0.03)

0.17 (0.13–0.21)

1.01 (0.75–1.26)

0.02 (0.02–0.03)

0.17 (0.13–0.21)

1.01 (0.75–1.26)

Syncope

0.32 (0.30–0.35)

2.26 (2.11–2.42)

13.57 (12.64–14.51)

0.33 (0.31–0.36)

2.33 (2.17–2.49)

13.98 (13.03–14.93)

Seizures

0.27 (0.25–0.29)

1.87 (1.73–2.01)

11.20 (10.35–12.05)

0.33 (0.31–0.35)

2.33 (2.17–2.48)

13.96 (13.01–14.91)

Total

0.61 (0.58–0.64)

4.25 (4.04–4.46)

25.50 (24.22–26.78)

0.69 (0.66–0.72)

4.85 (4.62–5.07)

29.08 (27.71–30.45)

Allergic

Anaphylaxis

0.02 (0.01–0.03)

0.14 (0.10–0.18)

0.82 (0.59–1.05)

0.02 (0.01–0.03)

0.14 (0.10–0.18)

0.86 (0.62–1.09)

Urticaria

0.25 (0.23–0.27)

1.74 (1.60–1.87)

10.43 (9.61–11.25)

0.26 (0.24–0.28)

1.81 (1.67–1.95)

10.88 (10.04–11.72)

Serum sickness

0.01 (0.01–0.01)

0.06 (0.04–0.09)

0.39 (0.23–0.54)

0.01 (0.01–0.01)

0.06 (0.04–0.09)

0.39 (0.23–0.54)

Allergic reaction

0.20 (0.18–0.22)

1.39 (1.27–1.51)

8.33 (7.59–9.06)

0.21 (0.19–0.22)

1.45 (1.32–1.57)

8.70 (7.95–9.44)

Total

0.45 (0.42–0.48)

3.15 (2.97–3.34)

18.92 (17.82–20.03)

0.48 (0.45–0.51)

3.36 (3.17–3.55)

20.15 (19.01–21.29)

Other

Total

0 (0.00–0.00)

0.02 (0.01–0.03)

0.12 (0.03–0.20)

0 (0.00–0.00)

0.02 (0.01–0.03)

0.12 (0.03–0.20)

AEFI = adverse events following immunisation. ADEM = acute disseminated encephalomyelitis. * Data are based on one dose of vaccine per vaccinee.

4 Numbers of first events of chronic conditions, by month (Victoria, July 2004 – June 2009)

* Data are numbers of first events for chronic neurological conditions analysed in boys aged 12 to
< 16 years and numbers of presentations for individual neurological conditions in males of all ages.
† Conditions included were Guillain-Barré syndrome, transverse myelitis, multiple sclerosis and
optic neuritis.

5 Number of episodes of acute conditions by month in boys aged 12 to < 16 years (Victoria, July 2004 – June 2009)

ADEM = acute disseminated encephalomyelitis.