Australian Consumer Medicines Information (CMI)
has a new home, giving us all access to an extraordinarily valuable resource of over 2,500 CMI in the one place. The Therapeutic Goods Administration (TGA)—the Australian Equivalent of the FDA in the USA, and EMEA in the EU (so many initialisms!)—has created an extraordinary resource which should be celebrated and used by anyone interested in quality health information for consumers and patients round the world. And it continues to grow.
After 16 years of hard work by many dedicated writers of consumer medicines information (CMI) in pharmaceutical companies in Australia, their collective achievement can be seen in a single world-class collection published by the TGA.
The story of CMI in Australia began in the early 1990s with major changes in government policy on medicines. In 1992, with funding from the Commonwealth Government, we undertook research into consumer medicine information. This led in 1994 to the publication of the first edition of Writing about medicines for people(WAMFP), now in its 3rd edition.
WAMFP quickly became the defacto standard among CMI writers and has remained so through three editions, with each edition adding more information and examples based on the best practices of CMI writers, and the cumulative experience from CMI testing and research. This book has been applied to some degree in all these CMI. But nothing happens in a vacuum.
The real achievement here is that of the dedicated CMI writers, and the supportive industry and government environment that was created in order to nurture and support those writers. Juliet Seifert, mentioned in my previous blog, was one of the chief architects of that environment. And it was not easy.
Not everyone thought that giving people easily usable and detailed information about their medicines was a good idea. Some questioned whether or not people needed that information, that it might interfere with them complying with their doctor’s instructions. Some questioned whether or not people were entitled to this information as a right. Some suggested that it was all too hard, would cost too much time and money without any obvious benefit. Despite the many, often powerful nay-sayers, other voices such as Juliet’s were there to vigorously protect and defend people’s right to easily usable medicines information.
The credit for this massive and impressive work goes to Juliet Seifert, the many people who worked with her in supporting this work, and of course, the CMI writers.
TGA has published the CMI alongside the drugs’ Product Information (PI)—a formal technical document containing the detailed clinical and pharmecological data submitted by companies to TGA for approval to sell the products in Australia.
The TGA collection of CMI is the single most impressive and comprehensive collection of well written medicines information for consumers that has ever been published and made available in the public domain.
There are some faults and weaknesses in this collection, not least of which is the clunky 1980s word processor layout of the documents—something we were forced to use in WAMFP because of the technical limitations on production of CMI in pharmacies—a limitation that persists to this day with few major improvements on the horizon. Some of the writing could also be improved. But many of these CMI are well written and properly tested as part of the Consistency Working Groups that were set up by the pharmaceutical industry. These groups each took a therapeutic class—hypertensives, antibiotics, etc.—and collectively wrote and tested a core CMI. Once finalised, each company marketing products in that class took the core CMI and adapted it to their own product. It is this type of collaboration that characterises the approach that has infused this area under the guidance of people like Juliet Seifert.
I commend the collection to you.