Australian Prescriber最新文献

Reporting adverse events (adverse drug reactions) associated with medicines and vaccines assists with identifying previously unrecognised side effects and other safety concerns. Reporting adverse events to the Therapeutic Goods Administration is mandatory for sponsors (pharmaceutical companies), and strongly encouraged but voluntary for healthcare professionals and consumers. Adverse events should be reported even when causality is uncertain, as reports may contribute to identification of a safety signal for new or uncommon events. Suspected adverse events associated with new medicines and vaccines (registered in the last 5 years), and medicines included in the Black Triangle Scheme, should be prioritised for reporting. For other medicines, serious adverse events and unexpected adverse events should be prioritised. The Therapeutic Goods Administration analyses adverse event reporting data and uses signal detection methods to identify and evaluate emerging safety signals, which may lead to regulatory actions and communication to address safety issues.

The Australian Government has enacted laws restricting the supply of electronic cigarettes (vapes) to people requiring them for smoking cessation or the treatment of nicotine dependence, under the care of a medical practitioner, nurse practitioner or pharmacist. Currently no vapes are included on the Australian Register of Therapeutic Goods, meaning that the prescription and supply of therapeutic vapes must be through the Special Access Scheme or Authorised Prescriber pathways. Clinical guidelines state that therapeutic vapes may be considered for supporting people who have been unable to quit smoking using first-line therapies (a combination of behavioural support and registered nicotine replacement therapies or oral smoking cessation medicines). Clinical review should occur 1 week after vape initiation, with additional follow-up according to an individualised management plan, to monitor progress, review adverse effects (e.g. cough, irritated throat, headache or nausea), encourage the use of behavioural smoking cessation supports, and discourage dual use of vapes and conventional cigarettes. An attempt to wean or stop vaping after 12 weeks is recommended, with a possible transition to registered smoking cessation medicines if required (in addition to ongoing behavioural support). The maximum recommended duration of vape use is 12 months.

Antiphospholipid syndrome is an autoimmune disease characterised by thrombotic and/or obstetric manifestations with persistent antiphospholipid antibodies. Diagnosis involves confirming the persistence of antiphospholipid antibodies in symptomatic patients, using validated classification criteria as a guide. The likelihood of obtaining false-positive or false-negative test results in certain settings, and the lack of standardisation between laboratory methods, are important considerations. Patients who have had thrombotic manifestations require lifelong anticoagulation from the first thrombotic event, typically with warfarin. Patients with a history of thrombotic and/or obstetric manifestations who become pregnant should receive low-molecular-weight heparin and low-dose aspirin during pregnancy and postpartum. Testing asymptomatic people is not recommended, except in the context of systemic lupus erythematosus. Management of asymptomatic people with persistent antiphospholipid antibodies depends on their individual antibody profile and risk factors.

Medicine shortages are increasingly common and disruptive to the optimal delivery of health care. They are caused by a variety of factors, including manufacturing and supply-chain issues, regulatory and trade issues, and fluctuations in demand. Prescribers and pharmacists in Australia can manage a shortage by switching to another brand, strength or dosage form of the same medicine, switching to a different registered medicine, or accessing an unregistered medicine that has been made available via section 19A of the Therapeutic Goods Act 1989 or through the Special Access Scheme. There are a range of resources and tools that can assist clinicians with identifying and managing medicine shortages in Australia. Shortages are managed most effectively when prescribers, pharmacists and nurses work together, in collaboration with patients, to develop, implement and monitor strategies to manage the shortage.