Prescription drugs Australia

The DRA in Venezuela allows prescription drugs to be advertised in the press on a onetime basis as an announcement that the dmg is now registered in Venezuela. Information presented in the promotion and advertising materials must be based on the product information, as specified in the summary of product characteristics (SPC), approved at the time of registration. In all countries except Australia, patient information leaflets and labels are also subject to approval. In Australia, although approval is not needed, the information must not conflict with the approved product information. 

Americans spent more on prescription drugs in 2004 than they did on gasoline or fast food. They paid twice as much for their prescription medicines that year as they spent on either higher education or new automobiles. Americans spend more on medicines than do all the people of Japan, Germany, France, Italy, Spain, the United Kingdom, Australia, New Zealand, Canada, Mexico, and Argentina combined.11... 

In Australia, the most commonly utilized and accessible information sources about prescription drugs are based on a drug s Product Information, the document approved by Australia s drug regulation authority, the Therapeutic Goods Administration (TGA). 

Virtually all other industrialized countries have national health insurance programs that include prescription drug benefits. Good examples, later in this chapter, are Australia, Canada, France, Japan, and the United Kingdom, which illustrate what other nations are currently doing to control expenditures for prescription drugs and what these controls mean for revenues from new drugs yet to be developed. 

OTA reviewed recent trends in payment methods for prescription drugs in five countries Australia, Canada, France, Japan, and the United Kingdom. To a greater or lesser extent in each of these countries, drug payment policy is governed by two potentially conflicting objectives to minimize health insurance prescription drug costs and to help the country s domestic pharmaceutical industry. Payment policies represent a blend between these objectives. 

Australia s domestic pharmaceutical industry is very small, and the country represents a small proportion of the world market for prescription drugs.31 Consequently, Australia has not had a major economic stake in promoting pharmaceutical R D. Instead, the main objective of Australia s pharmaceutical payment policies has been to minimize the cost of drugs, both to the government and to its citizens. Recently, though, the government has made efforts to promote the... 

P. McManus, N. Donelly, D. Henry et at. Prescription drug utilization following patient co-payment changes in Australia, Pharmacoepidemiology and Drug Safety 5 (1996), 385-392. 

Each of the countries operates a quality analysis system for post-marketing control of drug quality, albeit with vast differences in capacity. Data on the outcome measure for drug quality— the number of dmg samples that failed quality tests compared with the total number of samples collected— are available in all the countries, except the Netherlands. Failure rates are high in some countries, e.g. Tunisia and Uganda. In Australia, high failure rates are found for herbal and other complementary products, compared with prescription dmgs. Empirical data on sanctions applied in such instances are not available. 

The requirements for reporting adverse drug reactions to prescription medicines occurring in Australia or overseas are described in the Australian Pharmacovigilance Guidehne, which is available at the TGA website. 

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