What is Consumer Medicine Information?
They say you should write what you know.
I know how to write Consumer Medicine Information (CMI). Admittedly, it’s not the stuff of Tolstoy or Rowling, but it’s what I know.
When I applied for my first job as a graduate, one of the interview tasks was to translate a piece of medicine information into plain English. Evidently, I did okay. I got the job.
From that point, I shadowed and was mentored by Heather Friedel – a long-time regulatory professional and pharmacist who had been involved in the development of CMI from the beginning. Heather was an impressive medical writer, a no-nonsense and pragmatic type, and I learned so much from her.
The mantle of company CMI ‘expert’ shifted to my shoulders on her retirement. Big shoes to fill, but it became one of the most rewarding parts of my job. I enjoy writing CMI because I believe it provides an opportunity to empower patients to be better informed about their medicines.
What’s so special about Consumer Medicine Information?
Well, nothing. Essentially, CMI is just an instruction manual for a medicine.
I have a drawer for instruction manuals. I never read them except when there is a problem. Actually, I throw most of the instruction manuals away and look the information up online when I need it. Maybe that’s how you feel about CMI.
However, there is a lot riding on you using a medicine correctly. Your health, certainly. Your life, potentially. So getting CMI content right is crucial. It is written to help you use your medicine correctly. Having the CMI at hand is also crucial.
CMI contains what you need to know about your medicine. It is not an advertising brochure.
We’re lucky, I think, that pharmaceutical companies aren’t allowed to advertise prescription medicines directly to the consumer in Australia. That can cause all sorts of confusion and mixed health messages for the public.
The flip side, however, is that so much concerning prescription medicines, from test-tube to tummy, is pretty opaque to the average consumer. It can feel like there are significant barriers to finding information on your medicines.
You need, and have a right to, the instructions for your medicine.
And you should be given the instructions when you receive your medicine, or be directed to where you can get the most up-to-date version. And it should be well-written and usable.
But defining what is “well-written and usable” is a bit tricky. “Well-written and usable” according to whom?
The pharmaceutical company? The doctor or pharmacist? The patient?
There are many groups, with slightly differing priorities, that would seek to define how best to write CMI.
Competing interests?
All these groups have (or should have) a say in what is in the CMI and how it is designed and written:
The pharmaceutical company. CMI is written and updated by the pharmaceutical companies that make the medicines. They know the most about the products they make – all the benefits, and all the risks. The contents of the CMI are the ‘communication point’ of that knowledge to the consumer.
The Therapeutic Goods Administration (TGA) is the Australian regulator of all things therapeutic. What the TGA approves concerning a medicine goes in the Product Information (PI). This PI directs and underpins what a company can and can’t say about the product. The CMI is the plain English version of the PI.
Your doctor, obviously, prescribes a medicine. Doctors know the reasons for directing patients to have particular medicines.
Your pharmacist cross-checks, double-checks and rechecks that your prescribed medication is good for you. Pharmacists make sure the medicine plays nicely with any other medicine you take. They make sure you know what you’re doing with your medicine.
And finally, there’s you. And you are the most important, because the medicine is for YOU. You need, and have a right to, good instructions for your medicine.
Each stakeholder has particular ideas about the content and design of CMI. For example, the TGA needs it to conform to the legislative principles and requirements. Pharmacists will want it to be useful in consultations with customers.
With so many needs to be met – won’t that just mean longer and longer documents?
And what does the consumer want?
CMI and the user experience
Do you remember the good old days? You received your prescribed medicine. You opened the pack. And tightly wedged in there was your medicine with a Wikipedia entry’s worth of information printed in 6pt font on an origamied piece of paper the size of your kitchen table.
Heady days. And also a pretty unhelpful way of attempting to communicate how to use your medicine.
So, for quite some time and for lots of good reasons, the pack-insert has mostly been a thing of the past. In Australia, CMI can be printed out by your pharmacist when you get your medicine. They are also available and kept updated online.*
Has your pharmacist ever printed CMI for you?
Me neither. Or, at least, not often.
Why is that? Is there something wrong with the CMI? Perhaps the CMI is too long. TMI in the CMI.
The big problem – does size really matter?
As part of my role as an in-house CMI writer for a pharmaceutical company, I interviewed consumers to see how easily they could find and use information in CMI. This is called “usability testing”. Most of the time, the CMI performed very well, and not much would have to change as a result.
At the end of the interview, I’d ask more general questions, like “What do you think of the CMI overall?”
“It’s a bit long,” some would say. Or, “It’d be great if the most important information was on the front page.”
I’d often respond, genuinely asking, “What would you remove?”, or “What would you like to see up-front?” A variety of answers followed, mostly pretty sensible. And this kind of consistent feedback has been a catalyst for further research into CMI improvement.
Over the last decade or so, experts from a number of fields – from pharmacist to consumer – have been researching the question of “Is it too long?”, and if so, “How can we change it?”
Driving the research has been Parisa Aslani, Professor in Medicines Use Optimisation at The University of Sydney.
“Pharmacists have always thought that the information was too long, too detailed, too hard for people to understand,” she says. “Too much on side effects and not enough on benefits. So, when people read this information all they’re thinking is ‘I’m going to get those side effects, therefore I don’t want to take the medication’, or ‘I need to go back and talk to the pharmacist about all of this information that they’ve given me’. And so, pharmacists have been reluctant to use it.”
One-page CMI. Just what the doctor (or pharmacist) ordered
The TGA announced back in July 2019 that they had successfully concluded the development of an improved CMI format, including one page of information “highlights”.
Professor Aslani believes it’s been essential for pharmacists to have a bigger stake in the new CMI format: “I think it’s really important because pharmacists are the main people who would use this kind of information in counselling, who would use it for their own knowledge to convey to patients, to educate patients, [and] who would also use it in talking to other healthcare professionals … having pharmacists involved will ensure that the medicine information that we are preparing is fit for purpose.”
Having a CMI format that is “fit for purpose” will encourage healthcare professionals to print and use it with their customers or patients. It is a great first step – and a big one. But the improvement to CMI needs to go beyond format.
The next big step will be to improve the quality of the CMI content.
You can find out more about the new CMI format here.
*Do you know where to go online to get CMI? Try the National Prescribing Service (NPS) Medicine Finder.
Sally Bathgate is a freelance medical writer with a decade of experience in research and the pharmaceutical industry in Australia.