For those who follow the field, the TGA’s plans to restrict availability of cold and cough medicines for children comes as no surprise.
At the risk of a gratuitous self-plug, the use of these medicines in young children was one of the issues of concern that Ray Moynihan and I highlighted in our book, Ten Questions You Must Ask Your Doctor (Allen & Unwin, 2008). We came across several references raising concerns about these products’ use in children when researching the book back in 2007.
So the TGA is certainly not rushing the jump.
Nonetheless, the move will be such a challenge to accepted practices that it will need to be backed by a long-term educational campaign. So argues Ron Batagol, a Pharmacy and Drug Information Consultant.
“In a move that is likely to provoke much spirited debate amongst doctors, pharmacists and, most importantly, the parents and carers who look after the day-to-day health issues of young children in their care, the Therapeutic Goods Administration (TGA) has given notice that it is intending to “upschedule” over-the-counter cold and cough products to Prescription Only for children under six years and Pharmacist Only for children aged between six and 12 years.
As part of the upscheduling exercise, the TGA has also recommended cough and cold medicines should not carry dosage instructions for children under six years old. The TGA says that this approach would bring the regulation of cough and cold preparations in Australia into line with measures in place in the UK and Canada.
After extensive internal and external reviews of the evidence surrounding both efficacy and safety in use, the proposed changes are stated by TGA to have been made ” in light of the current lack of evidence of efficacy and the historical profile of adverse drug reactions (ADRs) in Australia and overseas”.
It is certainly true, that the consensus of informed opinion amongst paediatricians about the usefulness and propensity of side-effects of these products is in concurrence with the TGA assessment.
Now I must say that there is a whole fascinating social phenomenon associated with parents and carers buying cough ands cold products for children in their care.
This has, in fact, been noted in the TGA External Review, where they raise the concept of “social medication” which researchers have found is, in part, aimed at modifying child behaviour to more acceptable patterns, and in part a ‘coping strategy, and that cough and cold medicines were a common “social medication” in this respect’. Pharmacists at the “coal face” will be very familiar with this belief amongst their clients and the associated behaviour patterns.
Presumably, in recognition of the social behavioural re-scheduling moves would certainly make them feel to some extent disenfranchised, turning on its head as it does, a long-held, even if erroneous, understanding that recommending a suitable cough and cold product for use by children served both a therapeutic and, as discussed, also a “social” function.
It seems to me that there will need to be long-term educational campaign on this issue, if the proposed changes are adopted.
Indeed, TGA has said that the changes recommended would need to be widely promoted and explained to medical practitioners, pharmacists, parents and caregivers, and that particular efforts be directed towards educating consumers, medical practitioners and pharmacists that OTC cough and cold medicines have not been shown to be effective, and are potentially harmful in children under 6 years of age.
From recent discussions of this issue, when I raised it on our major pharmacy internet discussion website Auspharmlist, I have no doubt that at all that education and explanation will certainly be needed for many of my pharmacist colleagues, and their professional organizations! This is, of course, quite understandable.
After all, on the face of it, the proposed issue is somewhat analogous to the lengthy but ultimately quite successful campaign over the past 5-10 years, to “educate” doctors and inform the broader community that antibiotics are not required to treat a whole range of common infections, and may ultimately promote bacterial resistance.
Five to ten years ago, of course, patients virtually demanded an antibiotic from their doctors in such situations. These days, most patients are aware of this or, at least, do understand the situation when it is explained to them.
But, with TGA inviting responses from stakeholder organisations, it is going to require a huge effort to achieve the aims of broader community understanding of the rationale for the move by TGA to restrict availability of this group of widely-used, and generally well-regarded infant and childrens’ medicines.”