Negar Almassi MPS[/caption]
Dr Brian Chia MPS[/caption]
COPD is significantly underdiagnosed
Associate Professor Debbie Rigby FPS[/caption]
Nicolette Ellis MPS[/caption]
A national education program for pharmacists funded by the Australian Government under the Quality Use of Diagnostics, Therapeutics and Pathology program.[/caption]
Both these disorders can occur separately, but if they co-occur, this is termed COMISA. Approximately 30–50% of people with OSA have comorbid insomnia, and 30–40% of people with chronic insomnia have comorbid OSA.9,12 A recent population-based study reported that 11% of Australian adults report symptoms of COMISA.13
The ‘gold standard’ measure of OSA presence and severity is an overnight sleep study (Table 1).25 The most common single metric to determine OSA presence and severity is the apnoea-hypopnoea index (AHI), representing the average number of airway narrowing and closure events occurring per hour of sleep.24 Identifying the most appropriate management approaches for OSA also requires consideration of lifestyle factors, symptoms and consequences, occupation, chronic conditions, and other sleep conditions. Self-report questionnaires may be used to screen for a high-risk of OSA and identify patients suitable for referral and consideration of overnight sleep study assessment (Table 1).24
Although evidence-based guidelines unanimously recommend avoiding long-term use of hypnotics, they are indicated for a minority of patients that present with severe acute insomnia that is causing significant psychological distress or functional impairment.29 Most people who experience short-term insomnia symptoms (1–2 weeks) can be reassured that sleep will return to ‘normal’ after the underlying precipitant has subsided, without targeted treatment (i.e. hypnotic medicines).29,33 For those who experience persistent insomnia, cognitive behavioural therapy for insomnia (CBTi) is the first-line treatment. Pharmacotherapy may be considered in patients with severe insomnia that is causing significant impairment or distress (e.g. times of acute work/exam stress, bereavement).34
Tailored recommendations for non-CPAP therapies may also be provided to patients with different levels of OSA severity and presenting features.17 For example, weight management advice where indicated, positional devices (in the presence of supine-predominant OSA), mandibular advancement splints (in patients with mild-to-moderate OSA), and upper airway surgery are effective treatments that may be tailored to each individual patient.24
Dr Alexander Sweetman (he/him) PhD
Senior Program Manager, and chair of the psychologist education subcommittee at the Australasian Sleep Association.
Associate Professor Sutapa Mukherjee (she/her) MBBS, FRACP, PhD
Respiratory and sleep physician, Associate Professor of Respiratory and Sleep Medicine at Flinders University and past President of the Australasian Sleep Association.
Professor Garun Hamilton (he/him) MBBS, FRACP, PhD
Respiratory and sleep physician, clinical professor at Monash Health and Monash University and President of the Australasian Sleep Association.
Professor John Turnidge AO[/caption]
The TGA is aware that the US Food and Drug Administration’s (FDA) Nonprescription Drugs Advisory Committee met in September 2023 to discuss the available efficacy data for oral phenylephrine used as a nasal decongestant and whether it should be reclassified from being ‘Generally Recognized as Safe and Effective’ (GRASE) due to its efficacy. The FDA’s advisory committee makes non-binding recommendations to the FDA, which generally follows the recommendations but is not legally bound to do so.
The TGA is not aware that the FDA has identified safety concerns or made a decision that phenylephrine is ineffective. At this time, the TGA has no plans to conduct a review of the effectiveness of oral phenylephrine but will continue to monitor the outcomes of the FDA review.
In Australia, medicines containing phenylephrine are required to be ‘registered’ in the Australian Register of Therapeutic Goods (ARTG). Medicines that are registered in the ARTG have an AUST R number on their medicine label. The full formulations of these medicines undergo an evaluation and approval by the TGA for safety, quality, and efficacy before they can be sold to consumers. The TGA Delegate considers all current information to ensure the benefits of the medicine outweigh the risks before approving a medicine.
Phenylephrine has a long history of use in cough and cold medicines and its safety and efficacy has been documented in standard reference texts. However, the perceived effectiveness of medications indicated to relieve symptoms such as nasal congestion can vary between individuals.
The TGA is constantly monitoring actions taken by, and communicating with, comparable overseas regulators and will take action as required. Further, as new scientific information becomes available ingredients may undergo further evaluation to consider the risk benefit profile. Sponsors are required to notify the TGA when they become aware of significant new information about the safety, quality or efficacy of a medicine.
Australian legislation requires that the active ingredient is displayed prominently on the main label of the medicine to enable consumers to make informed choices when purchasing over-the-counter medicines.
