Statement of Principles concerning acute pancreatitis (Reasonable Hypothesis) (No. 5 of 2020) (Cth)

Statement of Principles

concerning

ACUTE PANCREATITIS
(Reasonable Hypothesis)

(No. 5 of 2020)

The Repatriation Medical Authority determines the following Statement of Principles under subsection 196B(2) of the Veterans' Entitlements Act 1986.

Dated      28 February 2020

The Common Seal of the
Repatriation Medical Authority
was affixed to this instrument
at the direction of:

Professor Nicholas Saunders AO

Chairperson

Contents

1Name........................................................................................................................................... 3

2Commencement........................................................................................................................ 3

3Authority..................................................................................................................................... 3

4Repeal......................................................................................................................................... 3

5Application................................................................................................................................. 3

6Definitions.................................................................................................................................. 3

7Kind of injury, disease or death to which this Statement of Principles relates............... 3

8Basis for determining the factors........................................................................................... 4

9Factors that must exist............................................................................................................. 4

10Relationship to service............................................................................................................. 6

11Factors referring to an injury or disease covered by another Statement of Principles. 7

Schedule 1 - Dictionary............................................................................................. 8

1Definitions.................................................................................................................................. 8

1. Name

This is the Statement of Principles concerning acute pancreatitis (Reasonable Hypothesis) (No. 5 of 2020).

1. Commencement

This instrument commences on 23 March 2020.

1. Authority

This instrument is made under subsection 196B(2) of the Veterans' Entitlements Act 1986.

1. Repeal

The Statement of Principles concerning acute pancreatitis No. 85 of 2011 (Federal Register of Legislation No. F2011L01442) made under subsection 196B(2) of the VEA is repealed.

1. Application

This instrument applies to a claim to which section 120A of the VEA or section 338 of the Military Rehabilitation and Compensation Act 2004 applies.

1. Definitions

The terms defined in the Schedule 1 - Dictionary have the meaning given when used in this instrument.

1. Kind of injury, disease or death to which this Statement of Principles relates

(1)This Statement of Principles is about acute pancreatitis and death from acute pancreatitis.

Meaning of acute pancreatitis

(2)For the purposes of this Statement of Principles, acute pancreatitis means an acute inflammatory condition due to auto-digestion of pancreatic tissue by its own enzymes.

Note: Acute pancreatitis typically presents with abdominal pain.  It is usually associated with raised levels of pancreatic enzymes in blood or urine.

(3)While acute pancreatitis attracts ICD‑10‑AM code K85, in applying this Statement of Principles the meaning of acute pancreatitis is that given in subsection (2).

(4)For subsection (3), a reference to an ICD-10-AM code is a reference to the code assigned to a particular kind of injury or disease in The International Statistical Classification of Diseases and Related Health Problems, Tenth Revision, Australian Modification (ICD-10-AM), Tenth Edition, effective date of 1 July 2017, copyrighted by the Independent Hospital Pricing Authority, ISBN 978-1-76007-296-4.

Death from acute pancreatitis

(5)For the purposes of this Statement of Principles, acute pancreatitis, in relation to a person, includes death from a terminal event or condition that was contributed to by the person's acute pancreatitis.

Note: terminal event is defined in the Schedule 1 – Dictionary.

1. Basis for determining the factors

The Repatriation Medical Authority is of the view that there is sound medical‑scientific evidence that indicates that acute pancreatitis and death from acute pancreatitis can be related to relevant service rendered by veterans, members of Peacekeeping Forces, or members of the Forces under the VEA, or members under the MRCA.

Note: MRCA, relevant service and VEA are defined in the Schedule 1 – Dictionary.

1. Factors that must exist

At least one of the following factors must as a minimum exist before it can be said that a reasonable hypothesis has been raised connecting acute pancreatitis or death from acute pancreatitis with the circumstances of a person's relevant service:

(1)smoking at least 15 pack-years of cigarettes, or the equivalent thereof in other tobacco products, before the clinical onset of acute pancreatitis, and where smoking has ceased, the clinical onset of acute pancreatitis has occurred within ten years of cessation;

Note: pack-years of cigarettes, or the equivalent thereof in other tobacco products is defined in the Schedule 1 - Dictionary.

(2)consuming an average of at least 420 grams of alcohol per week for at least the ten years before the clinical onset of acute pancreatitis;

Note: Alcohol consumption is calculated utilising the Australian Standard of ten grams of alcohol per standard alcoholic drink.

(3)having cholelithiasis at the time of the clinical onset of acute pancreatitis;

(4)having biliary microlithiasis or biliary sludge at the time of the clinical onset of acute pancreatitis;

Note: biliary microlithiasis or biliary sludge is defined in the Schedule 1 - Dictionary.

(5)having pancreatic outflow obstruction due to a disorder from the specified list at the time of the clinical onset of acute pancreatitis;

Note: pancreatic outflow obstruction is defined in the Schedule 1 - Dictionary.

(6)having penetrating or major blunt trauma to the upper abdomen or to the back, within the seven days before the clinical onset of acute pancreatitis;

(7)having a spinal cord injury within the seven days before the clinical onset of acute pancreatitis;

(8)undergoing a procedure from the specified list of procedures, within the 30 days before the clinical onset of acute pancreatitis;

Note: specified list of procedures is defined in the Schedule 1 - Dictionary.

(9)undergoing endoscopic retrograde cholangio-pancreatography, endoscopic sphincterotomy of the sphincter of Oddi, or manometry of the sphincter of Oddi within the seven days before the clinical onset of acute pancreatitis;

(10)undergoing a course of peritoneal dialysis or haemodialysis for renal disease at the time of the clinical onset of acute pancreatitis;

(11)having a solid organ transplant before the clinical onset of acute pancreatitis;

(12)being treated with a drug or a drug from a class of drugs from the specified list of drugs, at the time of the clinical onset of acute pancreatitis;

Note: specified list of drugs is defined in the Schedule 1 - Dictionary.

(13)being treated with a drug which is associated in the individual with:

(a)the development of the symptoms or signs of acute pancreatitis within two months of commencing drug therapy; and

(b)the cessation of the symptoms or signs of acute pancreatitis following the discontinuation of drug therapy; and

(c)an absence of clinical or laboratory evidence of acute pancreatitis prior to beginning drug therapy; and

(d)where treatment with the drug continued for at least the three days before the clinical onset of acute pancreatitis;

(14)having diabetes mellitus at the time of the clinical onset of acute pancreatitis; 

(15)having hypertriglyceridaemia resulting in triglyceride levels above 11.3 millimoles per litre (or 1 000 milligrams per decilitre) at the time of the clinical onset of acute pancreatitis;

(16)having hypercalcaemia at the time of the clinical onset of acute pancreatitis;

(17)having a disease from the specified list of diseases at the time of the clinical onset of acute pancreatitis;

Note: specified list of diseases is defined in the Schedule 1 - Dictionary.

(18)having a disorder resulting in disseminated intravascular coagulation and/or profound systemic hypotension with pancreatic acinar damage within the seven days before the clinical onset of acute pancreatitis;

(19)having an acute infection with an organism at the time of the clinical onset of acute pancreatitis;

Note: acute infection with an organism is defined in the Schedule 1 - Dictionary.

(20)having infection with human immunodeficiency virus at the time of the clinical onset of acute pancreatitis;

(21)having an infestation from the specified list of infestations at the time of the clinical onset of acute pancreatitis;

Note: specified list of infestations is defined in the Schedule 1 - Dictionary.

(22)being envenomated by a snake or scorpion from the specified list within the seven days before the clinical onset of acute pancreatitis;

Note: snake or scorpion from the specified list is defined in the Schedule 1 - Dictionary.

(23)having acute toxicity after oral ingestion of mushrooms containing alpha-amanitin within the seven days before the clinical onset of acute pancreatitis;

Note: alpha-amanitin is defined in the Schedule 1 - Dictionary.

(24)ingesting an agent from the specified list of agents and experiencing acute toxicity within the seven days before the clinical onset of acute pancreatitis;

Note: specified list of agents is defined in the Schedule 1 - Dictionary.

(25)for severe acute pancreatitis only, being obese at the time of the clinical onset of acute pancreatitis;

Note: being obese and severe acute pancreatitis are defined in the Schedule 1 – Dictionary.

(26)inability to obtain appropriate clinical management for acute pancreatitis.

1. Relationship to service

(1)The existence in a person of any factor referred to in section 9, must be related to the relevant service rendered by the person.

(2)The factor set out in subsection 9(26) applies only to material contribution to, or aggravation of, acute pancreatitis where the person's acute pancreatitis was suffered or contracted before or during (but did not arise out of) the person's relevant service.

1. Factors referring to an injury or disease covered by another Statement of Principles

In this Statement of Principles:

(1)if a factor referred to in section 9 applies in relation to a person; and

(2)that factor refers to an injury or disease in respect of which a Statement of Principles has been determined under subsection 196B(2) of the VEA;

then the factors in that Statement of Principles apply in accordance with the terms of that Statement of Principles as in force from time to time.

Schedule 1 - Dictionary

Note: See Section 6

1. Definitions

In this instrument:

acute infection with an organism means serological and/or clinical evidence of acute infection with one of the following organisms:

(a)coxsackievirus;

(b)Cryptosporidium;

(c)cytomegalovirus;

(d)Epstein-Barr virus;

(e)hepatitis virus;

(f)herpes simplex virus;

(g)Legionella spp;

(h)Leptospira spp;

(i)measles virus;

(j)mumps virus;

(k)Mycobacterium avium;

(l)Mycobacterium tuberculosis;

(m)Mycoplasma pneumoniae;

(n)Orientia tsutsugamushi;

(o)Salmonella enterica;

(p)Salmonella bongori; or

(q)varicella-zoster virus.

acute pancreatitis—see subsection 7(2).

alpha-amanitin means the cyclopeptide toxin present in some mushrooms such as Amanita phalloides which produces amanita poisoning.

being obese means having a Body Mass Index (BMI) of 30 or greater.

Note: BMI is also defined in the Schedule 1 - Dictionary.

biliary microlithiasis or biliary sludge means the presence of small stones (1-2 millimetres) due to aggregation of bile constituents into a stone or calculus, or a collection of crystals, glycoproteins, protein, cellular debris and mucin in the biliary tract.

BMI means W/H² where:

W is the person's weight in kilograms; and

H is the person's height in metres.

MRCAmeans the Military Rehabilitation and Compensation Act 2004.

pack-years of cigarettes, or the equivalent thereof in other tobacco products means a calculation of consumption where one pack-year of cigarettes equals twenty tailor-made cigarettes per day for a period of one calendar year, or 7 300 cigarettes.  One tailor-made cigarette approximates one gram of tobacco or one gram of cigar or pipe tobacco by weight.  One pack-year of tailor-made cigarettes equates to 7.3 kilograms of smoking tobacco by weight.  Tobacco products mean cigarettes, pipe tobacco or cigars, smoked alone or in any combination.

pancreatic outflow obstruction means a demonstrated obstruction to the pancreatic ductal system, and which may be caused by one of the following disorders:

(a)ampullary, duodenal or pancreatic tumours (primary and secondary tumours);

(b)choledococoele;

(c)foreign body; or

(d)periampullary duodenal diverticula.

Note: A foreign body may include, but is not limited to, a migrating stent or tube, or a bezoar.

relevant service means:

(a)operational service under the VEA;

(b)peacekeeping service under the VEA;

(c)hazardous service under the VEA;

(d)British nuclear test defence service under the VEA;

(e)warlike service under the MRCA; or

(f)non-warlike service under the MRCA.

Note: MRCA and VEA are also defined in the Schedule 1 - Dictionary.

severe acute pancreatitis means acute pancreatitis requiring hospitalisation, or death from acute pancreatitis.

snake or scorpion from the specified list means:

(a)Cerastes cerastes;

(b)Tityus asthenes;

(c)Tityus trinitatis; or

(d)Viperidae family.

specified list of agents means:

(a)aspirin in overdose;

(b)carbamate insecticide;

(c)methyl alcohol;

(d)organophosphorous insecticide; or

(e)paracetamol in overdose.

specified list of diseases means:

(a)Henoch-Schönlein purpura;

(b)inflammatory bowel disease;

(c)microangiopathic haemolytic anaemia;

(d)microscopic polyangiitis;

(e)polyarteritis nodosa; or

(f)systemic lupus erythematosus.

specified list of drugs means:

(a)ACE inhibitors;

(b)analgesics and opioids;

(c)angiotensin receptor blockers;

(d)anti-arrhythmics;

(e)antibacterials;

(f)anticonvulsants;

(g)antipsychotics;

(h)antithyroid agents;

(i)antituberculars;

(j)antivirals;

(k)cancer chemotherapy agents;

(l)cancer immunotherapy agents;

(m)cannabis;

(n)centrally acting adrenergics;

(o)cholesterol lowering drugs;

(p)diuretics (loop, thiazide);

(q)estrogens;

(r)glucocorticoids (systemic);

(s)H2 antagonists,

(t)incretins (dipeptidyl peptidase-4 inhibitors);

(u)inflammatory bowel disease agents;

(v)intravenous lipid emulsion;

(w)propofol;

(x)proton pump inhibitors;

(y)pyridoxine; or

(z)retinoids.

specified list of infestations means:

(a)ascariasis;

(b)clonorchiasis;

(c)Echinococcus granulosus;

(d)Ancylostoma duodenale or Necator americanus; or

(e)strongyloidiasis.

specified list of procedures means:

(a)intra-abdominal surgery;

(b)intrathoracic surgery;

(c)spinal surgery; or

(d)upper gastrointestinal endoscopy.

terminal event means the proximate or ultimate cause of death and includes the following:

(a) pneumonia;

(b) respiratory failure;

(c) cardiac arrest;

(d) circulatory failure; or

(e) cessation of brain function.

VEA means the Veterans' Entitlements Act 1986.