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In 1996 APAC released Australian Guidelines for Drug Donations to Developing Countries, [5] based on drug donation guidelines developed by the World Health Organization. In 1997 APAC released Integrated Best Practice Model for Medication Management in Residential Aged Care Facilities, [1] with a 3rd edition released in 2002 as Guidelines for Medication Management in Residential Aged Care ...
The National Safety and Quality Health Service Standards (NSQHS Standards) are Australia's principal health care standards, and apply to all health services including inpatient, outpatient, and community care. [5] There are 8 standards: Clinical governance; Partnering with consumers; Preventing and controlling infections; Medication safety
The Therapeutic Goods Administration (TGA) is the medicine and therapeutic regulatory agency of the Australian Government. [4] As part of the Department of Health and Aged Care, the TGA regulates the safety, quality, efficacy and advertising in Australia of therapeutic goods (which comprise medicines, medical devices, biologicals and certain other therapeutic goods).
cost of the drug is high, or when there is a risk of dependence; The price of many Schedule 4 substances are subsidized by the Australian Government through the Pharmaceutical Benefits Scheme (PBS), when prescribed by an authorised prescriber. Certain medications may require an authority from the PBS. Situations that may require an authority ...
The AMH was first published in May 1998 driven by the need for a local, independent and up-to-date source of drug information to foster rational prescribing. Reflecting contemporary Australian clinical practice and adhering to the principles of the quality use of medicines, it is generally considered the Australian equivalent to the British ...
Rofecoxib represents a drug that was on the market that had not clearly represent the risks associated with the use drug which led to the concept of 'risk management planning' within the field of regulation by introducing the need to understand how various safety concerns would be managed. Various cases over recent years have demonstrated the ...
A stringent regulatory authority is a regulatory authority which is: a) a member of the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH), being the European Commission, the US Food and Drug Administration and the Ministry of Health, Labour and Welfare of Japan also represented by the Pharmaceuticals and Medical Devices Agency (as before ...
The APF was originally a pocket-sized booklet first published in 1902, used by physicians as a drugs reference in Australia. In later editions, rather than simply being a listing of pharmaceuticals, medical and clinical information became incorporated within the publication as well, and eventually the title of the APF was extended to the Australian Pharmaceutical Formulary and Handbook.