Changes to the sale of cough and cold medicines in Australia

By ahhb
Monday, 22 July, 2013

Winter is always a busy month for healthcare professionals, says Grant Kardachi, president of the Pharmaceutical Society of Australia, not the least because it is what is often referred to as the coughs and colds season, particularly for children. 

Codeine-containing products are often used to treat varying pain conditions – including headache, back pain, injury and trauma – and a recent study has added to calls for action to be taken to help address issues over the misuse of over-the-counter (OTC) pain relief medications containing codeine. We must all be aware of the potential for addiction to codeine-containing products. 
With this season now upon us, I thought it timely to look at the decision made by the Therapeutic Goods Administration (TGA) following its comprehensive review of the use of cough and cold medicines in children. As a result of this review, there have been a number of changes have been made to the way such medicines can be sold.
These changes include stating that a number of cough and cold medicines are not recommended for children under six years of age. In addition, the TGA recommends that cough and cold medicines should only be given to children aged six to 11 years on the advice of a doctor, pharmacist or nurse practitioner. Another change is that from September last year new stocks of cough and cold medicines must include warnings and instructions reflecting these changes and will be in child-resistant packaging.
The TGA, perhaps foreseeing some confusion about these changes, was at pains to point out that its decisions were taken in the interests of children’s health. Despite this, the decisions have caused some anger and confusion among pharmacists, and the difficulty in now how to manage that young age group with cough and cold systems.
Regardless of the varying views about this decision, the reality is that we have a new set of procedures under which to operate and PSA, in conjunction with the Pharmacy Guild and PDL, has been active in educating its members about the new requirements and helping to address any confusion experienced by members.
Basically, the TGA has advised the following under the new requirements.

  • No changes have been made to the scheduling of over-the-counter cough and cold medicines and a prescription is not required.

  • Recommendation for treatment with a cough and cold medicine in a child aged less than six years constitutes off-label use and should not be made without serious consideration of the risks and benefits.Your professional judgment would then need to be used in individual cases.

  • The TGA maintains there is no robust evidence of efficacy for these medicines in children and there are a number of safety concerns.

  • While the safety concerns are lower in children aged six to 11 years of age than in children aged less than six years of age, the TGA advises such safety considerations should be taken into account when advising parents on the management of coughs and colds.

  • The new labels will provide no dosing information for children aged less than six years of age and, in some cases, for children aged less than 12 years of age.

  • The use of the individual medicines for indications other than cough and cold (for example for pain or allergies) is not affected by the new system.

The changes have caused some confusion in a number of areas, not least of which is when a patient presents a doctor’s prescription or note for an over the counter cough and cold medicine for a child aged less than six years of age. The new requirements are that in such situations, there is great scope for pharmacists to be confused and the first thing that needs to be done is to ascertain if the doctor is aware of the new TGA recommendations. This will help to determine the pharmacist’s course of action.
Options in a situation such as this include asking the customer what the doctor has told them about the medication as it may well have been prescribed for an allergy or inflammatory condition rather than cough and cold.
To further help pharmacists deal with the changes, PSA has developed a range of resources including a fact sheet which looks at six possible scenarios where a pharmacist may face a confusing situation.
In the PSA fact sheet, one scenario examines a case where a customer enters the pharmacy and appears to be in a hurry and says to the staff: “Could I please have a bottle of Phenergan (promethazine) or Polaramine (dexchlorpheniramine) for my four-year-old? We are going overseas tomorrow and I’ve used it with my other children when we have travelled on long flights.”
The scenario examines whether this should be treated the same as the cold and flu scenarios and can the pharmacist make the decision on whether this is appropriate.
Another scenario looks at a situation where a customer presents to the pharmacy with her three-year- old daughter who has a cold. She self-selects some liquid cold and flu medicine and brings it to the counter to pay where the pharmacist determines that the medicine is for the child and that she has used it before. However, the customer is informed that it is no longer recommended for children under six years of age.
The scenarios examines issues such as the age of the child, the dosing instructions still being on the product label, the fact the customer has used it before with no adverse effects and also how does the pharmacist refuse the sale without losing the customer. All the scenarios offer advice and solutions for what may be difficult situations. The resources are available at the PSA website at

Grant Kardachi
President, Pharmaceutical Society of Australia

Grant Kardachi was elected Present of the PSA after service as Vice President and a Board Member for three years. He is a community pharmacist who recently sold his business interests but is still accredited to undertake medication reviews and sits on the Australian Association of Consultant Pharmacy
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