Pharmacy Issues

The Pharmacy Guild of Australia monitors a wide range of ongoing issues relating to community pharmacy practice, and responds to new issues as they arise.

Here you will find valuable information and resources on issues such as:

• Product recalls
• Pandemic planning
• Consumer medicines information
• Certificates for absence from work

 

Medicine & Pharmacy Practice Issues

Changes to the use of cough and cold medicines in children

From 1 September 2012, cough and cold medicines will carry new labelling about use in children. The change comes as a result of a 2009 review by the Therapeutic Goods Administration (TGA) into their safety following reports of misadventure from the USA and similar changes in countries such as the USA, UK, Canada and New Zealand. While the TGA concluded that there were no immediate safety risks, the review found that there were potential risks associated with the use of cough and cold products in children with limited benefits.

 

Summary of Changes

A condition of the registration for affected products is:

• The label does not include dosage instructions for children under 6 years of age
• The inclusion of correct dosage instructions for medicines indicated for children aged 6-11 years
• The label includes a warning statement that medicines for children aged 6 to 11 years should only be used on the advice of a pharmacist or prescriber
• Cough and cold medicines are in child-resistant packaging
• Efforts are made to inform consumers and health care professionals that children under 6 should not be given cough and cold medicines

 

Note – there are no scheduling changes to these products

 

Affected Medicines

Medicines affected by the new regulatory actions are cough and cold products containing any of the following ingredients:

 

Antihistamines:	Brompheniramine, Chlorpheniramine, Dexchlorpheniramine, Diphenhydramine, Doxylamine, Pheniramine, Promethazine, Triprolidine
Antitussives (cough suppressants):	Codeine, Dextromethorphan, Dihydrocodeine, Pentoxyverine, Pholcodine
Expectorants/Mucolytics (for chesty coughs):	Ammonium chloride, Bromhexine, Guaifenesin, Ipecacuanha, Senega and Ammonia
Decongestants:	Oxymetazoline, Phenylephrine, Pseudoephedrine, Xylometazoline

 

The TGA has published a list of cough and cold medicines available in Australia as of 6 June 2012. To check if a particular product is affected, click HERE

 

Note – only medicines registered for the treatment of cough and cold symptoms are affected

 

Key points to keep in mind

• There is no immediate safety risk with these products
• Although there are limited benefits, there are also potential risks
• Possible side-effects include allergic reactions, drowsiness, sleeplessness, nausea, constipation, slow and shallow breathing, increased or uneven heart rate, confusion, hallucinations or convulsions
• Overuse or overdose can be harmful
• Children under 6 are more at risk of harmful effects
• Relying on cough and cold medicines may delay seeking medical advice for more serious conditions such as asthma, influenza, pneumonia, bronchitis or middle ear infection
• Parents and carers should always read the label for directions and NEVER guess a dose
• Other products such as paracetamol, ibuprofen, saline sprays or vapourisers may be useful for some cold symptoms

 

Impact on pharmacy

• There are no product recalls or requirements to return products with the old labelling (by either pharmacies or consumers)
• There is a transition period to allow products with the old labelling to be sold through
• At present, wholesalers and retailers are permitted to sell products with the old labelling, but from 1 September 2012, unless a manufacturer has an exemption from the TGA, products supplied directly from the manufacturer must be labelled with the new advisory statements
• Irrespective of the label, from 1 September 2012, affected cough and cold medicines should not be sold or recommended for use in children under 6 years
• It is anticipated that products with the new labelling will be available from all parts of the supply chain by the 2013 winter season
• Pharmacy should be prepared to explain the changes to consumers and where appropriate, provide suitable health advice for children under 6 years of age

 

Pharmacy Preparation

1. Ensure all staff handling requests for cough and cold medicines understand the changes
2. Review the cough and cold product ranges within your pharmacy and identify which products can be used and recommended for different age groups
3. Review internal processes so that requests for children under 12 years of age are referred to the pharmacist
4. Make sure all staff are adequately trained and pharmacy assistants know when to refer to the pharmacist

 

To assist you in advising consumers of the change, the Guild has prepared a Fact Sheet which can be printed and used by pharmacy staff as needed.

Cough & Cold Fact Sheet – Pharmacy Resource for consumers

 

Consumers can also be directed to the Ask_your_pharmacist website for more detailed information and links to other useful resources and information from the NPS and Better Health Channel.

 

For further general information about the changes, click HERE

 

For product specific information, contact the relevant company representatives.