Employer obligations and the Epipen

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Employer obligations and the Epipen

Who is responsible for providing EpiPens in the workplace? Jim Wilson explains.

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Are we required to stock EpiPens in the workplace? 

This question was recently sent to our Ask an Expert service.

Q We have about 15 first aid kits in our offices in NSW, Qld and Vic and we do not stock Epipens. Can you confirm there are no legal requirements to do this? We are concerned because EpiPens are pricey and they expire quickly. Also we don't hold employee medical records for allergies. We believe that employees have a duty of care to carry their own EpiPens and should ask whether foods provided in the workplace contain allergens such as shellfish and nuts.

A Employers need to ensure that adrenaline auto-injectors, such as EpiPens, are available at the workplace to provide emergency medical treatment if someone experiences a severe allergic shock. Failing to do so could expose employers (and individual managers personally) to criminal prosecution and fines. If a person were to be harmed when he or she could have been adequately treated by an adrenaline auto-injection, then the managers and the company could also be sued in negligence, which would likely be an extraordinarily costly matter. 

Background


Anaphylaxis describes a severe and dangerous allergic reaction that may quickly and unexpectedly occur in people. Symptoms include swelling of the tongue and tissues of throat. This can result in difficulties in breathing, which can lead to death. Anaphylaxis is an abnormally extreme allergic reaction of the immune system to an otherwise harmless foreign substance that has been introduced into the human body, such as peanuts and plant pollen, among other things. 

A person undergoing severe anaphylaxis is experiencing a life-threatening medical emergency and needs immediate-on-the-spot treatment to survive.

Unfortunately, the true incidence of anaphylaxis is unknown although it is said to be “under-recognised and under-reported”. Meanwhile, the Australasian Society of Clinical Immunology and Allergy says that allergies are “very common” and affect about one in five people at some time in their lives.

Injecting adrenaline


An injection of adrenaline (aka “epinephrine”; hence “EpiPen”) is the recommended immediate treatment for anaphylaxis.

An injection of adrenaline will basically tell the body to reverse the symptoms of anaphylaxis – it will reduce inflammation of bodily tissues and help clear the airways. However, be warned: inappropriate use of adrenaline may be harmful, even dangerous. Hazards of inappropriate use can include severe pain, damage to bodily tissues and, in one reported case, a heart attack. Immediate medical advice, and possibly a trip to the emergency room, may be necessary if a person is inappropriately injected with adrenaline. 

Adrenaline injectors


“EpiPens” are life-saving medical devices used to inject adrenaline (aka “epinephrine”) into the muscles of a person experiencing anaphylaxis. Readers may not be aware that “EpiPen”, specifically, is the brand name for a specific device for the auto-injection of adrenaline. The owner of the brand is a US company called Mylan. However, there is now the prospect of generic non-branded adrenaline auto-injectors being introduced to the market although they are not yet available in Australia.

Legal duties


WHS law around Australia is largely the same in each jurisdiction as it is based on the Model Work Health & Safety Act and regulations. As the Model Act is not, in itself, law, we will refer to the NSW law.

Primary duty


Section 19 of the Work Health and Safety Act 2011 imposes a duty of care on persons conducting a business or undertaking (PCBUs) to ensure, so far as is reasonably practicable, the health and safety of workers. It also requires PCBUs to provide adequate facilities for the welfare at work of workers. 

This duty is very broad: it is to prevent or minimise the risk of harm. There are few limitations on the duty other than being “reasonably practicable”.

The Safe Work Australia interpretative guidelines suggest that “reasonably practicable” means that a duty holder should consider what can be done and whether it is reasonable in the circumstances. Duty holders will need to weigh up all the relevant matters including the likelihood of the risk, the degree of harm, what a person does know or ought to know, the availability and suitability of ways to eliminate or minimise the risk and the cost of dealing with the risk including whether it is “grossly disproportionate to the risk”. 

Duty-holders under the Act have an obligation to “exercise due diligence” (s27 et seq) which includes ensuring that the PCBU has available, and uses, appropriate resources to eliminate or minimise risk to health and safety from work carried out as part of the business. 

Incidentally, business managers may want to note that workers are not excused from looking after their own health and safety just because the employer has a duty of care. The WHS Act says (s16) that more than one person can have the same duty of care at the same time. And each duty-holder must comply with, and discharge, the duty of care to the same standard regardless of the fact that another person must also comply with the same duty. So employers and workers cannot point to each other and claim that the other party must comply with the duty of care — both the employer and the worker must meet the duty of care

Risk identification


Reg 34 of the WHS Regulation 2017 says that a duty holder must identify reasonably foreseeable hazards that could give rise to risks to health and safety.

A duty holder must then eliminate or reduce the risks so far as is reasonably practicable (reg 35).  A duty holder who implements a control measure to eliminate or minimise risk must ensure the control measure is, and remains, effective (reg 37).

First aid


PCBUs must have first aid equipment (reg 42) that is accessible to workers and the duty holder must consider the nature of the hazards at the workplace, the size and location of the workplace, along with the number and composition of the workers. 

PCBUS are also required to have an emergency plan (Reg 43) for emergency procedures including “medical treatment and assistance” (Reg 43(1)(a)(iv)). 

PCBUs also have to consider codes of practice. Approved codes of practice are admissible in proceedings as evidence of whether or not a duty or obligation has been complied with. A court may have regard to the code as evidence of what is known about a hazard or risk, risk assessment, or risk control to which the code relates (See s275 WHA 2011). 

The applicable code of practice is “First Aid in the Workplace”. The First Aid Code specifically addresses the issues of allergies in the workplace. It says (p14) that PCBUs must seek information when a worker starts work about any first aid needs that may require specific treatment in a medical emergency “such as severe allergies”. It also adds (p8) that “allergic reactions” are common workplace hazards that may require first aid. Finally, in relation to training, it says that when workers have severe allergies, “first aiders should be trained to respond to anaphylaxis”.

Applying the law


Employers appear to have a duty of care to inquire of workers whether they have any particularly severe allergies, and then have a plan for managing allergic reactions. Even if no worker in particular is known to be prone to anaphylaxis, given that allergies are widespread in the population and anaphylaxis is under-reported, it is reasonable to assume that some workers may be allergic to a variety of substances but just don't know it. It seems reasonable to assume visitors to the workplace may have allergies too. Employers have WHS duties to look after the health of such employees and visitors too.

Given that anti-anaphylaxis treatments are available for sale from pharmacies, there are few restrictions on how they can be stored, and given treatments can be kept for about a year, it could be argued that it is reasonably practicable to keep effective anti-anaphylaxis treatments in the workplace to treat allergic workers and visitors.

Also, it would seem to be invalid to argue anti-anaphylaxis treatments are too expensive as the cost of a few hundred dollars per device is not “grossly disproportionate” to the aim of saving a life. Employers also have to keep their first aid equipment effective so, if the treatment has expired, then the employer must get a replacement. 

As anaphylaxis has a rapid onset and there is an urgent need for on-the-spot treatment to ensure survival, anti-anaphylaxis devices need to be easily and quickly accessible to first aiders. If a first aider has to make a trip somewhere to get access to anti-anaphylaxis treatment to give to a sufferer, then it could be argued that an employer is failing in its duties. That said, given the potential dangers of accidental or inappropriate use of adrenaline auto-injectors, it would seem sensible to put controls on who may access anti-anaphylaxis devices as they present a health risk in and of themselves. 

Employers are not specifically required to have EpiPens – any effective anti-anaphylaxis treatment will suffice. However, there is a practical problem: it appears that, at the time of writing (11/09/2018), the only auto-injecting anti-anaphylaxis device allowed to be sold in Australia is, in fact, the EpiPen. In the future, generic products from other providers may become available, although these are not yet licensed for sale in Australia.

Consequences


WHS or other managers who choose not to have effective anti-anaphylaxis devices available in the workplace, or who choose not to have enough or not make them accessible, should be aware of several possible consequences. 

Firstly, and most importantly, workers and visitors could potentially suffer anaphylactic shock and could be severely hurt, or die. 

From a legal perspective, there are several possible consequences. Employers are, as PCBUs (and this includes individual people), under a variety of duties to ensure the health and safety of workers. Failure to do so is a criminal offence. In the tragic event that someone, who could have been saved by the administration of adrenaline, dies of anaphylactic shock, then it is possible that the appropriate manager(s) and the company could be prosecuted, be criminally convicted and fined. 

Secondly, a successful criminal prosecution does not eliminate the possibility of the manager(s) and the organisation being sued for the tort of negligence by the injured person or his/her relatives if the person has died. Negligence lawsuits are very costly to defend and there is the possibility of being made subject to a order for a large amount of compensatory damages. 

The bottom line: Severe allergic reactions are a hazard that can happen to workers in the workplace. There are WHS laws that impose general duties on employers to look after the health and safety of workers and other people in and around the workplace. An inference could be drawn that employers should have anti-anaphylaxis treatments available for use in the workplace to satisfy the requirements of these WHS duties.

However, there are more specific regulations that direct employers to have effective first aid responses, including medical treatments. There is also a code of practice – which is admissible as evidence in a court – that specifically states that employers need to have first aid-trained workers that should be able to respond to anaphylaxis. A failure to provide an adequate response by, for example, providing effective, accessible, anti-anaphylaxis devices could cause a worker to die. It could also render both the individual manager(s) and the company liable to conviction, fines, legal fees and orders for a large amount of compensatory damages. 

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