ASMI Media Releases – 1. OTC Labels Key for Safe Use NSAID’s 2. Advertising to Drive Consumer Health with Pharmacist Involvement

1. OTC labels the key to safe use of NSAID painkillers
17 March, 2017 –

The Australian Self Medication Industry acknowledges that a Danish study examining the use of non-steroidal anti-inflammatory drugs (NSAIDs) has further explored the association between NSAIDs and cardiovascular disease in people who are elderly, sick and using other medications.

However, the study should not cause any alarm for people who do not fall into these categories and who follow the instructions on the labels of over-the-counter (OTC) NSAID medicines such as ibuprofen and diclofenac.

ASMI was responding to a recent publication in the European Heart Journal – Cardiovascular Pharmacotherapy(1) , which examined the use of non-steroidal anti-inflammatory drugs (NSAIDs) by patients who later experienced cardiac arrest.

The study included 28,947 patients, more than 3300 of whom were treated with an NSAID up to 30 days before cardiac arrest. Ibuprofen and diclofenac were the most commonly used NSAIDs.

Steve Scarff, ASMI Regulatory and Legal Director, said:
“It is important to note that the study was conducted in patients with an average age of 70 years who were prescribed NSAIDs, usually at higher doses and for longer durations than are recommended and available for OTC use.
 “These elderly patients had pre-existing health conditions and were on other medications, some of which could have increased their risk factors.
“OTC NSAIDs have a good safety profile and a long history of use, allowing people to access effective pain relief products for common problems of short duration (2), such as headache, toothache, sprains and strains,” Mr Scarff said.

The Therapeutic Goods Administration recently completed a rigorous review of the cardiovascular risks associated with OTC NSAIDs, concluding that:
“These drugs provide effective pain relief when used according to the label at recommended doses for short durations (2),” and that;
“The use of OTC NSAIDs was safe when they were used according to the recommended doses for short durations, as instructed on the label.” (3)

It is important to note that the percentage increases in risk factor for cardiac arrest that have been widely reported in the media from this study are increases on a number that is already very low in otherwise healthy people.

Chief medical officer at the Australian Heart Foundation, Prof. Garry Jennings, told AAP:
“These drugs won’t cause the ordinary person to just drop dead of a cardiac arrest, because they only tend to aggravate the symptoms of those with heart disease. There is really no information which suggests that they can cause either a cardiac arrest or heart attack out of the blue.”

Mr Scarff says that it is important that consumers take note of the label warnings on NSAID medicines and use them only as directed.

 “These warnings advise consumers to first seek the advice of their pharmacist or doctor if they have certain existing health problems, require longer term treatment or if they are taking other medications.” (2)


1. Non-steroidal anti-inflammatory drug use is associated with increased risk of out-of-hospital cardiac arrest: a nationwide case–time–control study, Eur Heart J Cardiovasc Pharmacother (2017) 3 (2): 100-107.
2.  (at page 65)

2. Advertising can drive a greater role for pharmacists in consumer health
9 March, 2017 –

ASMI Chair Lindsay Forrest has outlined how pharmacists can play a larger role in Australian healthcare, which will provide benefits for consumers, reduce healthcare costs to government and help drive investment and innovation in the pharmaceutical industry.

Speaking today at the Australian Pharmacy Professional Conference, Mr Forrest outlined the potential positive impact of a model for direct-to-consumer advertising for Schedule 3 (S3 or ‘Pharmacist Only’) medicines that ASMI has advocated and trialled through a discrete choice experiment conducted by the Centre for Health Economics Research and Evaluation (CHERE) at the University of Technology Sydney.

The Australian Self Medication Industry Association (ASMI) represents sponsors of non-prescription medicines, which includes over-the-counter (OTC) and complementary medicines.

ASMI members make up 80% of the $5bn+ non-prescription market.

Mr Forrest explained how a lifting of the current restrictions on S3 medicine advertising has the potential to reignite both the S3 category and ‘switch’ – the process of downscheduling prescription medicines to S3 (available over-the-counter through consultation with a pharmacist).

“So many more categories can be OTC,” Mr Forrest said.

 “We just need to look across the Tasman to see what other exciting opportunities exist as potential OTC categories – erectile dysfunction medicines and the contraceptive pill, just to name a couple.”

The ASMI proposal first involves the national distribution of clinical protocols and product information prior to any particular S3 product advertising to consumers.
The model then calls for a mandatory ‘infomercial-style’ advertising format that gives equal prominence to:

1. Disease state awareness,
2. Branded product information 3.
The pharmacist’s role in determining whether the advertised therapy right for the consumer.

This would be the ‘default’ position for S3 products, with the exception of those products for which it would not be in the public interest to advertise (e.g. products which can be abused, misused, etc.).

The CHERE experiment tested the influence of a mock TV advertisement  for a fictitious product in an existing S3 category – an antiviral cold sore treatment.

The experiment was conducted with 1,295 consumers (50% sufferers & 50% non-sufferers), 501 pharmacists and 500 pharmacy assistants (PAs).
The results made it clear that this advertising format influenced consumers’ health-seeking behaviour and did much more than just “sell brands”.

Consumers who saw the advertisement were more likely to visit a pharmacist than a GP, not just for cold sore treatment, but also for other minor health conditions.
S3 advertising drove more ‘health conversations’ between consumers and pharmacists, which has the potential to slash government spending on healthcare (i.e. Medicare, PBS, hospital visits).

Another key finding was that pharmacists and PAs were not influenced by the advertisement. 

 “The only significant driver to recommendation was whether the therapy was appropriate for the consumer’s symptoms/condition… pharmacists were more scrutinizing of appropriateness of therapy for the advertising test group than the non-advertising control group,” Mr Forrest said.

“The vast majority of pharmacists were also comfortable referring up (to a GP) or denying consumer requests if the medicine was not appropriate.”

The experiment also addressed concerns that advertising would drive inappropriate demand.

“The evidence showed that consumers are very comfortable with pharmacists determining whether advertised S3 product is right for them,” Mr Forrest said.

Mr Forrest also noted that the proposed S3 advertising model encourages industry to reinvest back into S3 category (often considered a ‘dead zone’ because of the lack of options to increase consumer awareness of products) and provides motivation to ‘switch’ prescription medicines to OTC.

Both these measures will drive further ‘front of shop’ growth for pharmacies.

“The proposed S3 advertising model is a win on all fronts with better QUM (quality use of medicines) outcomes,” Mr Forrest said.

“The next step for us is to feed these findings into the Government’s medicines scheduling framework review, which is slated for this month.”

National President of the Pharmacy Guild of Australia, George Tambassis, immediately pledged the Guild’s support for the proposed S3 advertising model in the up and coming scheduling review.

See the full presentation  with figures and infographics from the CHERE S3 advertising experiment

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