OTCs: When headlines and sensationalism cause conflation and confusion

46189991 - cough and cold medicine

Headlines can cast undeserved shade onto pharmacy, writes Jarrod McMaugh—and the issue of kids and cough medicine is a good example

The Royal Children’s Hospital recently released an editorial document based on an electronic survey of parents in Australia, asking them various questions about their use of Over The Counter medications. Interestingly, the questions and the raw data collected in the survey have not been included in the published data.

This document was labelled a “detailed report”, and was preceded with a set of highlighted points that seem to take aim at both health professionals and parents alike, pointing out a range of things that we all seem to do wrong, and giving the definite impression that the authors of the document clearly know better, and we all need a good long think about what we’re doing to children.

The rest of the document provides an editorialised assessment of the results collected from the survey, presented in an otherwise logical progression that covers the most important issues discussed – at least, it should be said that the importance of these issues has clearly been graded by the opinion of the author, rather than actual risk to the children of the parents who responded.

I think it should be clear from the tone in my assessment so far, that I don’t entirely agree with the presentation of this document. The data itself is very interesting and valuable, but I take a fair bit of issue with the way it was presented, and with the comments that have been attached to the release of this document by the Director of The Australian Child Health, Poll Dr Anthea Rhodes.

Specifically, Dr Rhodes asks parents to doubt and second-guess the advice of their health professionals. While asking questions and seeking an explanation for the use of a medication is always appropriate, encouraging patients to doubt the advice of their health professional is not helpful to anyone.

Up to this point, perhaps my opinion on the document could be regarded as sour grapes – I just don’t like it when people criticise the entire profession of pharmacy in a broad sweep.

Then again, perhaps there are a number of glaring errors in logic, lack of solid data, and misplaced focus for the important issues that this article raised. To that end, I’d like to point out the following:


Is OTC Supply for children appropriate?

One of the overriding attitudes that is pervasive in this document, is that parents accessing OTC medications for their children is a “bad thing” – the first highlight in the article is that 92% of children has been given an OTC medication in the last 12 months, and 65% have been given two.

Now, I don’t want to be alarmist, but surely these numbers are a little low. Despite this, one has to ask the question, is this a problem?

OTC medications, as we know, cover a very broad range of conditions. In the first six weeks of life (let alone 6 months), a baby may have need for paracetamol or ibuprofen, clotrimazole, barrier creams, salicylic preparations for cradle cap, simethicone, poloxamer drops, etc.

There are situations in which OTC supply in a child is not appropriate – there are failsafes and guidelines for these situations. This document would call in to question whether these failsafes and guidelines are being applied, but I don’t think that the original survey is adequately powered to answer the question it poses.

The reality is, OTC supply of medications to children is just as appropriate as it is for any other age group – that is, the supply needs to be based on the individual and the appropriateness of the case presented, within the laws and guidelines that are applicable, based on the health professional’s clinical expertise.


TGA ruling – what it means for OTC supply of cough and cold medications

Since the use of cough and cold medications got the top billing in this article, I think it is worth addressing the original TGA decision.

The decision by the TGA had a fairly controversial basis. Specifically, in the USA, many of these types of medications are available without the intervention of a health professional, and while marketed for various specific indications, they pretty much all contained the same thing.

This lead to inadvertent overdoses when patients had a product for cough and a product for pain and a product for fever, and they all contained the same classes of medications.

Given the danger experienced outside of its jurisdiction, and despite the more stringent regulations in Australia, the TGA undertook a review of cough and cold medications in Australia. While the motivation may have been misplaced, I think we can all agree that if the TGA is going to achieve an outcome, the original motivation isn’t really important.

In the end, what the TGA came out with was a blanket recommendation that no medications be used in children under six years of age for cough and cold.

This is a pretty good decision, since there isn’t great evidence for the effectiveness of these medications (maybe they do work, but no one has proven it very well). In addition, some of these medications – especially the ones with potential to affect the central nervous system – can cause actual harm.


TGA enforcement – how inconsistency has made the ruling ineffective

Unfortunately, the TGA followed this first decision with a bad one. That is, they published a list of active ingredients that should not be used for treating cough and cold in children under six years of age. Why was this a bad decision? Because the ruling to restrict sale of products for cough and cold was never intended to be restricted to these ingredients.

By providing a list of examples, what actually happened was confusion and misplaced reliance on other products with ingredients that were not included on the list. So, now we have a proliferation of “natural” or similar cough and cold medications that are still covered by the original TGA decision, yet are sold and marketed because they aren’t on the list!

The TGA failed in giving advice on these products, and failed in enforcing their own decision, by allowing products that claim to be “natural” or similarly obfuscative terminology to be marketed for cough and cold in Australia.

The second problem with the list is that we don’t know if these were the only ingredients that the TGA evaluated. Are there other items that aren’t on this list that are effective, yet still technically not approved for use?

Now, getting past the fact that there is not one single product in the Australian market that is approved for cough and cold in children under six years of age (prescribed or not), the question is, CAN we supply these products for cough and cold in children under six?

The answer is yes, with a but….

The But is, you must be able to clinically justify your decision, and also prove that the parent was given enough information to make an informed choice. The TGA decision on cough and cold medications under six years of age does not make the use of these products for cough and cold illegal.

What it does, is make the indication of “cough and cold” in this age group OFF LABEL. Medications can be used off label legally in Australia, so long as this does not countermand scheduling laws.


Conflation of indications – when using medications in children can be both appropriate and inappropriate in the same measuring cup

There are, of course, more issues with the editorialised document released by The Royal Children’s Hospital. Part of this stems from a problem that many people (including pharmacists, but definitely doctors and other health professionals) fail to realise – medications have multiple indications, and the appropriateness of a treatment is based on indication.

There are some products that are contraindicated for a specific patient based on one of their conditions, but would be the first line indicated treatment for another.

What does this actually mean here? Why am I heading in this direction? The reason is, respondents to the survey were asked to discuss six types of medications: Pain relief, Cough and Cold medications, Vitamins and Supplements, Antihistamines, probiotics, and Herbal Medicines.

Right off the bat, you can have one product in your hand that fits in to multiple categories! We don’t actually know at this point if these were the only categories listed, or if patients were aware that one medication could appear in several lists, but you can see that there is already an issue with the type of information that may be gathered – we can’t be sure if it’s accurate.

So, let’s look at cough and cold medications – we all know that some of the brands that had previously been marketed as cough and cold were relaunched with different indications that allow for their use under six years of age (without being off label).

We also know that there are a range of products that proliferated (as mentioned earlier) that are marketed for cough and cold, and are thus given seeming legitimacy – I mean, how many pharmacists were actually aware that Ivy Leaf Extract is also affected by the TGA ruling?

Did the parents answer “cough and cold” for a product that could be used for this, but were recommended for another indication? Have pharmacists been recommending products that are currently on the market for cough and cold in children, unaware that these are off-label under the TGA recommendations? Will we ever actually know the answer to these questions?


The Philosophy of Dr House – or “Patients Lie To You”

I’ve never actually watched House, but I do know that he quite famously states that every patient lies to you. Of course the show is a dramatisation, but this still carries over in to real life.

As Debbie Rigby pointed out in the AJP, parents won’t always tell you the indication, or perhaps the age of the patient; they’re often aware of the restrictions, have prior experience with the products, and believe this gives them enough information to make a decision about the appropriateness for their child.


Missing the big issues – why making a song-and-dance about ineffective treatment is masking the greater issue of dangerous medication use

So, getting away from cough and cold, there are some bigger issues that this survey revealed – specifically, sedation.

Personally, I’ve never seen a patient have an adverse outcome due to the use of cough and cold medications.

This doesn’t mean off-label use can be justified any time a product is requested, but on the whole, the use of a cough and cold product in a child under six is far more likely to be ineffective than it is to be dangerous.

Can we say the same thing for the use of sedatives? I think the answer is “definitely not”.

The information reported that 30% of people had used cough and cold medications for their children under six. Based on the one in seven figure, 15% of people had used sedatives on their children (age not indicated). I find this figure to be dramatically more alarming than 30% of children receiving an ineffective treatment.

Let’s not confuse the issue here – 30% of children using an ineffective product is bad. 15% of children using a sedative is horrific.

Sedatives can be deadly, and there is a positive correlation between some sedating antihistamines and SIDS in children under two. How the results of this survey can create such an indignant response from the authors on the first point, but give only one brief entry on the second point is beyond me.


The Devil Is In The Detail, but we can’t actually see the Devils here

The final comment I’ll make on this document is that we don’t know the details. I’m not sure what the agenda is for its release, but this isn’t a clinical paper – it’s a survey that doesn’t provide methodology, yet is thick with opinion.

Without the finer detail of the results collected or even the questions that were posed, we can’t really look at this document as being a true representation of the issue at hand. It’s certainly an important topic, but the reality is, with the way it’s been presented so far, it’s not very useful to us clinically.


So is this document useful in the end?

On the whole there is still some benefit to be found in this article, despite its deficiencies. It certainly generated discussion, and it has highlighted some worrying use of sedatives.

It also bring to light the importance of understanding the TGA decision on cough and cold medications – too often pharmacists can go with the status quo, not really breaching regulation, but also not understanding the significance of their actions.

It’s interesting that the TGA decision is STILL causing confusion this far on, but maybe this document will make pharmacists re-read the TGA position and take some care with their clinical decisions.

Jarrod McMaugh is a community pharmacy practitioner in the northern suburbs of Melbourne. He has extensive experience in developing and delivering professional services in the community pharmacy setting.

Previous 'I will do whatever it takes to make sure she doesn't fall pregnant to him.'
Next Forum: Non-adherence: a case for targeted pharmacist intervention?

NOTICE: It can sometimes take awhile for comment submissions to go through, please be patient.


  1. David Haworth

    “In the end, what the TGA came out with was a blanket recommendation that no medications be used in children under six years of age for cough and cold.”
    You haven’t mention that the same medications banned for cough and cold have been approved by the TGA for children with Allergies. Demazin Allergy

    • Jarrod McMaugh

      Yeah I have David. Don’t tell me you just skimmed this…..

      The point I made in the article is that the “ban” is on the indication, not on the product. And the “ban” was the removal of an approved indication, which means they still can be used, but as an “off label” use.

      As I advise anyone who asks, you can recommend them if you like, but once a government department has taken a stance, you’ve got an uphill battle if you ever get reported.

Leave a reply