ASMI Media Releases – 1. S3 Advertising Reform 2. TGA Review of OTC NSAIDs

ASMI says S3 advertising reform long overdue

13 October 2014 – The Australian Self Medication Industry (ASMI) said that S3 advertising restrictions constrain the ability of sponsors to make consumers aware of medicines that are available without a prescription, and regulatory reform is long overdue.

In a presentation at the annual Pharmacy Australia Conference (PAC), ASMI Executive Director, Dr Deon Schoombie, proposed a new regulatory model of consumer communication for S3 medicines, based on a structured framework to provide information in a balanced way.

“The two main objectives of the proposed model are to create consumer awareness of therapeutic options in the Schedule 3 category in a structured, balanced and responsible way, and to encourage consumers to seek counselling from pharmacists,” explained Dr Schoombie.

“All Schedule 3 medicines should be permitted to be advertised, as is the case in a number of comparable markets overseas,” said Dr Schoombie, “although provision needs to be made for exceptions, on a case-by-case basis, where it can be demonstrated that direct-to-consumer advertising would not be in the public interest, such as for products containing pseudoephedrine and codeine containing analgesics.”

Dr Schoombie proposed a structured communication format comprising three key components:

 Information about the condition: this aims to inform consumers about the symptoms and/or condition for which the product is indicated.

 Mandatory intervention by a pharmacist: this component of the communication strategy/process aims to promote and reinforce the professional role of the pharmacist. It

will emphasise the need for counselling to determine whether the product is appropriate for a particular condition and/or consumer and aims to clarify that a product request does not

automatically result in the supply of that product.

 Branded product information: the brand awareness component is a critical element to make the model viable, but it takes a secondary role to the more important educational aspects of the communication.

“Removing restrictions on consumer communication about S3 medicines should help to expand the professional role of pharmacists, who are well-placed to play a greater part in the delivery of primary healthcare.

“The ageing population and increasing burden of disease pose enormous challenges for continuing to provide health services at sustainable levels. Empowering consumers to take more responsibility for their health and measures to make better use of scarce healthcare resources are some of the policy responses to these challenges,” added Dr Schoombie

ASMI welcomes TGA review of OTC NSAIDs

7 October, 2014-The Australian Self Medication Industry (ASMI) welcomes the release by the Therapeutic Goods Administration (TGA) of its review of cardiovascular risks of non-steroidal anti-inflammatory drugs (NSAIDs) and the announcement of its public consultation about options to reduce the risks associated with over-the-counter (OTC) NSAIDs.

The TGA reviewed the cardiovascular risks associated with eight NSAIDs, only four of which are available without a prescription. The TGA also completed a full safety review of diclofenac.

The TGA found that OTC NSAIDs are safe when they are used according to the recommended doses for short durations, as instructed on the label. However, the TGA also noted that inappropriate use or overuse of these medicines can pose a significant health risk.

In the TGA’s view, there is a need to raise awareness among consumers and health professionals of cardiovascular risks of NSAIDs, and the risk of liver damage with diclofenac, for prescription and OTC medicines.

The TGA has developed four options to reduce the risks of side effects associated with OTC NSAID’s and is currently undertaking public consultation regarding these alternatives.

ASMI Director Regulatory and Scientific Affairs, Steve Scarff, said:

“The industry is always concerned about the Quality Use of Medicines and medicines safety and welcomes the release of the TGA’s review. We look forward to participating in the public consultation about the proposed mitigation strategies.

“Over-the-counter (OTC) NSAIDs have a known safety profile when used as directed and allow people to quickly access effective pain relief products for common problems of short duration like headache, toothache, sprains and strains.

“It is important that consumers take note of the label warnings and only use the products as directed.

Importantly, these warnings advise consumers with certain existing health problems or who are taking other medications to first seek the advice of their healthcare professional,” Mr Scarff added.

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