By Sally Crossing AM, Cancer Voices.
Cancer Voices notes that the health and wellbeing of Australians is regarded as an important objective in most pharmaceutical companies’ Mission Statements. As consumers of their products, we see that information about their safe and effective use is a key responsibility of pharmaceutical companies operating in Australia. Sadly, hardly any agree with this basic premise.
Cancer Voices approached 15 prescription product pharmaceutical companies to ask them to address the huge problem related to the safe and effective delivery of the prescription medicines their company offers to Australians. Only five responded, all advocating for the present unsatisfactory status quo, or calling for more “consumer awareness” – i.e. that it’s OUR responsibility as product consumers to gather information about the safe and effective use of THEIR products.
There is something very amiss in this concept, and it is probably not legally tenable.
Most Australians are receiving their medicines, some of which have serious side effects and specific dosing requirements, from hospital and community pharmacies with no information about the drug at all.
This is despite the fact that pharmacists are funded, though the Community Pharmacy Agreements to provide Community Medicine Information (CMIs) as they dispense the drug.
There is real confusion as to whether the patient should be offered a CMI automatically, or must ask for it. Of course most health consumers will not know what their information options are, and if there is nothing inside the packaging, will have no information about safe and effective use, side effects, contraindications and so on.
Studies have shown that CMIs are rarely offered or provided. The CMI arrangements alone have patently failed and other solutions must be found.
We note that the “Safe Use of Medicines” is one of the central objectives of Australia’s National Medicines Policy. The Quality Use of Medicines strategy (QUM) sees “using medicines safely and effectively” as one of its three major prongs. The CMI concept, developed in 1998 and promulgated in a CMI Guide in 2000, was meant to meet this objective. CMIs were “designed to inform consumers about prescription and pharmacy-only medicines” in a reader friendly, standardised way.
While the intention was laudable, 16 years later we are in an unsafe and patently less effective QUM situation, due to general non-receipt of this essential information. Cancer Voices sees one logical solution being the restoration of appropriate information to the packaging of all prescription products.
Over the years, Cancer Voices has raised the problem with several pharmaceutical companies since the disappearance of Product Information inserts. We were delighted when one major company responded positively. We now ask that all pharmaceutical companies do likewise.
The Australian health consumer is at a real disadvantage as far as being adequately informed about the safe use of prescribed medicines. Very few other western countries are in such a parlous situation; in the EU it is mandatory to provide adequate information with the product. The only advance so far, in response to our (and others’) earlier concerns, has been that CMIs were domiciled in one accessible website, that of the Therapeutic Goods Administration (TGA). However, very few health consumers know that they are there.
Messages like “Take one when needed/ as doctor suggests” stuck on the packet are not enough.
The CMIs, if accessed, are often standardised to such an extent, that the information is not adequate, especially for major drugs like those for cancer. This is no doubt the case for many other serious illnesses and conditions. We should not have to know to ask for CMIs, especially when sick, or try to access our doctor or pharmacist to clarify, or be expected to muddle through the internet, when another fail-safe solution is available.
Surely providing information about a product is the responsibility of the manufacturer – we get more instructions about safety and efficacy with a can of paint than we do for a prescription medicine!
Challenges for industry
We understand that there would be a small extra cost to restore printed information to product packaging. However, we are convinced that the benefit would far outweigh the cost in terms of safe and effective use. Many pharmaceutical companies, especially those whose products are Over the Counter (OTC) do provide inserts.
We have also heard the concern that the information may occasionally become outdated. This is easily addressed by a statement that “the information provided was correct at xx date – see our website if you would like to check for updates”.
We understand that important changes would be rare.
So if informational inserts that can be done for OTC, why not for those prescribed medicines which need considerably more specific information for their safe and effective use?
Cancer Voices is pleased that the industry body, Medicines Australia, has agreed to hold a stakeholder meeting of all interested parties – industry, consumer, researchers and government agencies, in early August.
We hope that stakeholders will wish to act – and be seen to act – in a community minded way, recognising the need to protect the interests of those using prescription medicine products.
Sally Crossing AM is Chair Cancer Voices NSW and Convenor, Cancer Voices Australia. Sally has been involved in the Australian cancer consumer movement since 1997, and has had breast cancer since 1995. This year she received an Honorary Doctorate from the University of Sydney for “extraordinary leadership and contributions to supporting those with cancer from diagnosis, though treatment, care support and survivorship, in both advocacy and research”.
You can learn more about Cancer Voices here.