Background Information:
The Therapeutic Goods Administration (TGA) is an Australian government organisation that is
responsible for approving and regulating the supply of therapeutic goods such as prescription
medications. Before the TGA approves products and allows them to be made available to consumers,
they must first assess the risks versus the benefits of any particular prescription drug using clinical
trials. In assessing the level of risk, factors such as side effects, potential harm through prolonged
use, toxicity and effects to unrelated organs and systems are all taken into account.
The TGA is presented with a new drug called AquiFix, a fast-acting fluid replacement injection
intended for professional sportspeople, fire fighters, and manufacturing technicians working in
conditions of extreme heat. Early research indicates that this medication is able to replace body
fluids rapidly without the need for intravenous drips, saving time and money. The AquiFix injection
consists of a high dose each of electrolytes, glucose and water, as well as several preservatives. In
preliminary trials conducted by the TGA, sodium concentrations in the blood plasma have been
elevated following injections, becoming hypertonic, and one of the preservatives has been linked to
stimulation of the adrenal glands.
Task 1:
Identify how the AquiFix fluid replacement injection works to restore balance with respect to
thermoregulation, osmoregulation and glucose regulation. In your response, ensure that you
mention specific systems / organs and the ways in which they work together to maintain a steady
state.
Task 2:
Based on the side effects of the AquiFix injection noted in preliminary trials, predict any other
possible side effects that may appear over time and identify the expected time frame that each of
these side effects will take to present. In your response, you must link the effects of the medication
to impacts upon other systems in the body to reveal meaningful interrelationships.
Task 3:
Determine whether further testing on the AquiFix fluid replacement injection by the TGA should run
for 1, 2, 5 or 10 years, and justify why. As part of your decision making process, consider the present
and future implications on the human body of taking this medication over a prolonged period. You
should also consider the alternatives available to this fluid replacement injection when assessing the
best testing schedule for this product. Ensure that your response is in accordance with the TGA’s
practice of assessing risks versus benefits prior to making medications available to the public.