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.