s ASMI Media Releases for Nov./Dec. 2011 | I2P: Information to Pharmacists - Archive
Publication Date 01/07/2014         Volume. 6 No. 6   
Information to Pharmacists


From the desk of the editor

Welcome to the July 2014 homepage edition of i2P (Information to Pharmacists) E-Magazine.
At the commencement of 2014 i2P focused on the need for the entire profession of pharmacy and its associated industry supports to undergo a renewal and regeneration.
We are now half-way through this year and it is quite apparent that pharmacy leaders do not yet have a cohesive and clear sense of direction.
Maybe the new initiative by Woolworths to deliver clinical service through young pharmacists and nurses may sharpen their focus.
If not, community pharmacy can look forward to losing a substantial and profitable market share of the clinical services market.
Who would you blame when that happens?
But I have to admit there is some effort, even though the results are but meagre.
In this edition of i2P we focus on the need for research about community pharmacy, the lack of activity from practicing pharmacists and when some research is delivered, a disconnect appears in its interpretation and implementation.

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Recent Comments

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News Flash

Newsflash Updates for July 2014

Newsflash Updates

Regular weekly updates that supplement the regular monthly homepage edition of i2P. 
Access and click on the title links that are illustrated

Comments: 1

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Feature Contribution

Woolworths Pharmacy - Getting One Stage Closer

Neil Johnston

It started with “tablet” computers deployed on shelves inside the retailer Coles, specifically to provide information to consumers relating to pain management and the sale of strong analgesics.
This development was reported in i2P under the title Coles Pharmacy Expansion and the Arid PGA Landscape”
In that article we reported that qualified information was a missing link that had come out of Coles market research as the reason to why it had not succeeded in dominating the pain market.
Of course, Woolworths was working on the same problem at the same time and had come up with a better solution - real people with good information.

Comments: 5

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Intensive Exposition without crossing over with a supermarket

Fiona Sartoretto Verna AIAPP

Editor's Note: The understanding of a pharmacy's presentation through the research that goes into the design of fixtures and fittings that highlight displays, is a never-ending component of pharmacy marketing.
Over the past decade, Australian pharmacy shop presentations have fallen behind in standards of excellence.
It does not take rocket science - you just have to open your eyes.
Recently, our two major supermarkets, Woolworths and Coles, have entered into the field of drug and condition information provision - right into the heartland of Australian Pharmacy.

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The sure way to drive business away

Gerald Quigley

I attended the Pregnancy, Baby and Children’s Expo in Brisbane recently.
What an eye and ear opening event that was!
Young Mums, mature Mums, partners of all ages, grandparents and friends……...many asking about health issues and seeking reassurances that they were doing the right thing.

Comments: 1

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‘Marketing Based Medicine’ – how bad is it?

Baz Bardoe

It should be the scandal of the century.
It potentially affects the health of almost everyone.
Healthcare providers and consumers alike should be up in arms. But apart from coverage in a few credible news sources the problem of ‘Marketing Based Medicine,’ as psychiatrist Dr Peter Parry terms it, hasn’t as yet generated the kind of universal outrage one might expect.

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Community Pharmacy Research - Are You Involved?

Mark Coleman

Government funding is always scarce and restricted.
If you are ever going to be a recipient of government funds you will need to fortify any application with evidence.
From a government perspective, this minimises risk.
I must admit that while I see evidence of research projects being managed by the PGA, I rarely see community pharmacists individually and actively engaged in the type of research that would further their own aims and objectives (and survival).

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Organisational Amnesia and the Lack of a Curator Inhibits Cultural Progress

Neil Johnston

Most of us leave a tremendous impact on pharmacies we work for (as proprietors, managers, contractors or employees)—in ways we’re not even aware of.
But organisational memories are often all too short, and without a central way to record that impact and capture the knowledge and individual contributions, they become lost to time.
It is ironic that technology has provided us with phenomenal tools for communication and connection, but much of it has also sped up our work lives and made knowledge and memory at work much more ephemeral.

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Academics on the payroll: the advertising you don't see

Staff Writer

This article was first published in The Conversation and was written by Wendy Lipworth, University of Sydney and Ian Kerridge, University of Sydney
In the endless drive to get people’s attention, advertising is going ‘native’, creeping in to places formerly reserved for editorial content. In this Native Advertising series we find out what it looks like, if readers can tell the difference, and more importantly, whether they care.
i2P has republished the article as it supports our own independent and ongoing investigations on how drug companies are involved in marketing-based medicine rather than evidence-based medicine.

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I’ve been thinking about admitting wrong.

Mark Neuenschwander

Editor's Note: This is an early article by Mark Neuenschwander we have republished after the soul-searching surrounding a recent Australian dispensing error involving methotrexate.
Hmm. There’s more than one way you could take that, huh? Like Someday when I get around to it (I’m not sure) I may admit that I was wrong about something. Actually, I’ve been thinking about the concept of admitting wrong. So don’t get your hopes up. No juicy confessions this month except that I wish it were easier for me to admit when I have been wrong or made a mistake.
Brian Goldman, an ER physician from Toronto, is host of the award-winning White Coat, Black Art on CBC Radio and slated to deliver the keynote at The unSUMMIT for Bedside Barcoding in Anaheim this May. His TED lecture, entitled, “Doctors make mistakes. Can we talk about it?” had already been viewed by 386,072 others before I watched it last week.

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Dispensing errors – a ripple effect of damage

Kay Dunkley - BPharm, Grad Dip Hosp Pharm, Grad Dip Health Admin, MPS, MSHPA

Most readers will be aware of recent publicity relating to dispensing errors and in particular to deaths caused by methotrexate being incorrectly packed in dose administration aids.
The Pharmacy Board of Australia (PBA), in its Communique of 13 June 2014, described a methotrexate packing error leading to the death of a patient and noted “extra vigilance is required to be exercised by pharmacists with these drugs”.
This same case was reported by A Current Affair (ACA) in its program on Friday 20 June

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Take a vacation from your vocation

Harvey Mackay

Have you ever had one of those days when all you could think was, “Gosh, do I need a vacation.”
Of course you have – because all work and no play aren’t good for anyone.
A vacation doesn’t have to be two weeks on a tropical island, or even a long weekend at the beach. 
A vacation just means taking a break from your everyday activities. 
A change of pace. 
It doesn’t matter where.
Everyone needs a vacation to rejuvenate mentally and physically. 
But did you also know that you can help boost our economy by taking some days off? 
Call it your personal stimulus package.

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Explainer: what is peer review?

Staff Writer

This article was first published in the Conversation. It caught our eye because "peer review" it is one of the standards for evidence-based medicines that has also been corrupted by global pharma.
The article is republished by i2P as part of its ongoing investigation into scientific fraud and was writtenby Andre Spicer, City University London and Thomas Roulet, University of Oxford
We’ve all heard the phrase “peer review” as giving credence to research and scholarly papers, but what does it actually mean?
How does it work?
Peer review is one of the gold standards of science. It’s a process where scientists (“peers”) evaluate the quality of other scientists' work. By doing this, they aim to ensure the work is rigorous, coherent, uses past research and adds to what we already knew.
Most scientific journals, conferences and grant applications have some sort of peer review system. In most cases it is “double blind” peer review. This means evaluators do not know the author(s), and the author(s) do not know the identity of the evaluators.
The intention behind this system is to ensure evaluation is not biased.
The more prestigious the journal, conference, or grant, the more demanding will be the review process, and the more likely the rejection. This prestige is why these papers tend to be more read and more cited.

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Dentists from the dark side?

Loretta Marron OAM BSc

While dining out with an elderly friend, I noticed that he kept his false tooth plate in his shirt pocket. He had recently had seven amalgam-filled teeth removed, because he believed that their toxins were making him sick; but his new plate was uncomfortable. He had been treated by an 'holistic dentist'. Claiming to offer a "safe and healthier alternative" to conventional dentistry, are they committed to our overall health and wellbeing or are they promoting unjustified fear, unnecessarily extracting teeth and wasting our money?

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Planning for Profit in 2015 – Your key to Business Success

Chris Foster

We are now entering a new financial year and it’s a great time to reflect on last year and highlight those things that went well and those that may have impacted negatively in the pursuit of your goals.
It's also a great to spend some time re-evaluating your personal and business short, medium and long term goals in the light of events over the last year.
The achievement of your goals will in many cases be dependent on setting and aspiring to specific financial targets. It's important that recognise that many of your personal goals will require you to generate sufficient business profits to fund those aspirations

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ReWalk™ Personal Exoskeleton System Cleared by FDA for Home Use

Staff Writer

Exoskeleton leader ReWalk Robotics announced today that the U.S. Food and Drug Administration has cleared the company’s ReWalk Personal System for use at home and in the community.
ReWalk is a wearable robotic exoskeleton that provides powered hip and knee motion to enable individuals with Spinal Cord Injury (SCI) to stand upright and walk.
ReWalk, the only exoskeleton with FDA clearance via clinical studies and extensive performance testing for personal use, is now available throughout the United States.

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Attracting and Retaining Great People

Barry Urquhart

Welcome to the new financial year in Australia.
For many in business the past year has been described as a challenging period.
Adjectives are a key feature of the English language.  In the business lexicon their use can be, and often is evocative and stimulate creative images.  But they can also contribute to inexact, emotional perceptions.
Throughout the financial pages of newspapers and business magazines adjectives abound.
References to “hot” money draw attention and comment.  The recent wave of funds from Chinese investors, keen to remove their wealth from the jurisdiction and control of government regulations is creating a potential property bubble in Australia.

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Updating Your Values - Extending Your Culture

Neil Johnston

Pharmacy culture is dormant.
Being comprised of values, unless each value is continually addressed, updated or deleted, entire organisations can stagnate (or entire professions such as the pharmacy profession).
Good values offer a strong sense of security, knowing that if you operate within the boundaries of your values, you will succeed in your endeavours.

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Evidence-based medicine is broken. Why we need data and technology to fix it

Staff Writer

The following article is reprinted from The Conversation and forms up part of our library collection on evidence-based medicines.
At i2P we also believe that the current model of evidence is so fractured it will never be able to be repaired.
All that can happen is that health professionals should independently test and verify through their own investigations what evidence exists to prescribe a medicine of any potency.
Health professionals that have patients (such as pharmacists) are ideally placed to observe and record the efficacy for medicines.
All else should confine their criticisms to their evidence of the actual evidence published.
If there are holes in it then share that evidence with the rest of the world.
Otherwise, do not be in such a hurry to criticise professions that have good experience and judgement to make a good choice on behalf of their patients, simply because good evidence has not caught up with reality.

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Laropiprant is the Bad One; Niacin is/was/will always be the Good One

Staff Writer

Orthomolecular Medicine News Service, July 25, 2014
Laropiprant is the Bad One; Niacin is/was/will always be the Good One
by W. Todd Penberthy, PhD

(OMNS July 25, 2014) Niacin has been used for over 60 years in tens of thousands of patients with tremendously favorable therapeutic benefit (Carlson 2005).
In the first-person NY Times best seller, "8 Weeks to a Cure for Cholesterol," the author describes his journey from being a walking heart attack time bomb to a becoming a healthy individual.
He hails high-dose niacin as the one treatment that did more to correct his poor lipid profile than any other (Kowalski 2001).

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Culture Drive & Pharmacy Renewal

Neil Johnston

Deep within all of us we have a core set of values and beliefs that create the standards of behaviour that we align with when we set a particular direction in life.
Directions may change many times over a lifetime, but with life experiences and maturity values may increase in number or gain greater depth.
All of this is embraced under one word – “culture”.
When a business is born it will only develop if it has a sound culture, and the values that comprise that culture are initially inherent in the business founder.
A sound business culture equates to a successful business and that success is often expressed in the term “goodwill” which can be eventually translated to a dollar value.

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ReWalk™ Personal Exoskeleton System Cleared by FDA for Home Use

Staff Writer

Exoskeleton leader ReWalk Robotics announced today that the U.S. Food and Drug Administration has cleared the company’s ReWalk Personal System for use at home and in the community.
ReWalk is a wearable robotic exoskeleton that provides powered hip and knee motion to enable individuals with Spinal Cord Injury (SCI) to stand upright and walk.
ReWalk, the only exoskeleton with FDA clearance via clinical studies and extensive performance testing for personal use, is now available throughout the United States.

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Pharmacy 2014 - Pharmacy Management Conference

Neil Johnston

The brave new world of health and wellness is not the enemy of Pharmacy, it is its champion.
Australian futurist, Morris Miselowski, one of the world's leading business visionaries, will present the Opening Keynote address on Pharmacy's Future in the new Health and Wellness Landscape at 2.00pm on Wednesday July 30.
Morris believes the key to better health care could already be in your pocket, with doctors soon set to prescribe iPhone apps, instead of pills.
Technology will revolutionise the health industry - a paradigm shift from healthcare to personal wellness.
Health and wellness applications on smartphones are already big news, and are dramatically changing the way we manage our personal health and everyday wellness.

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Generation and Application of Community Pharmacy Research

Neil Johnston

Editor’s Note: We have had a number of articles in this issue relating to pharmacy research.
The PGA has conducted a number of research initiatives over the years, including one recently reported in Pharmacy News that resulted from an analysis of the QCPP Patient Questionnaire.
Pharmacy Guild president, George Tambassis, appears to have authored the article following, and there also appears to be a disconnect between the survey report and its target audience illustrated by one of the respondent comments published.
I have asked Mark Coleman to follow through, elaborate and comment:

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ASMI Media Releases for Nov./Dec. 2011

Bob Bowden

articles by this author...

Information and news from the Australian Self Medication Industry provided by Bob Bowden, Foresight Communications. Contact him on (02) 9241 2811 or 0412 753 298.He is supported by Filomena Maiese (ASMI Marketing & Business Development Director) and Michelle Sollitt-Davis (ASMI PR Manager).

Information and news from the Australian Self Medication Industry provided by Bob Bowden, Foresight Communications.
Contact him on(02) 9241 281 or 0412 753 298 .

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29 November 2011

ASMI response to TGA reform blueprint

The Australian Self-Medication Industry (ASMI) today welcomed the announcement of a series of significant reforms to the Therapeutic Goods Administration (TGA) and the regulation of non-prescription products. 

The measures will impact areas including product advertising and promotion, regulation of complementary medicines, and the transparency of TGA decision-making.

The Executive Director of ASMI, Dr Deon Schoombie said: “We are generally pleased with the thrust of the blueprint and the very strong commitment to industry consultation, but in a document of this magnitude, there are inevitably areas where we are disappointed.”

In regard to advertising reforms, ASMI welcomes the moves toward a strengthened framework for advertising controls, including expanded pre-approval processes for advertising, as well as appropriate sanctions, penalties and complaints handling.

ASMI is also pleased that Pay TV has been included in the pre approval process.

“We support these measures and have worked with all stakeholders to pursue a clear and consistent framework to guide all aspects of advertising. We strongly support an approach that retains the existing self-regulatory process within a broader co-regulatory framework,” Dr Schoombie said.

The issue of ethical promotion of therapeutic goods to healthcare professionals has been the subject of a comprehensive process of industry consultation.  ASMI has been a member of the working group that prepared recommendations to government earlier this year.

“We are disappointed that the government has not accepted the findings of the working group because this would have established a very clear and consistent approach right across the industry, binding both those who belong to industry associations as well as those who don’t.

“This was a missed opportunity to implement changes that would have prevented renegades from continuing to bring the industry into disrepute,” Dr Schoombie said.

The TGA also announced changes to the regulatory framework for complementary medicines.

ASMI is pleased that the TGA has decided to proceed with reforms that flow from the recent report of the Australian National Audit Office (ANAO) into the complementary medicines sector.

“ASMI has consistently called for the implementation of key recommendations of the Expert Committee on Complementary Medicines in the Health System, established in 2005.

“ASMI supports a further strengthening of the framework to ensure greater compliance through increased post-market surveillance. The TGA currently undertakes both random and targeted surveillance, and this should be extended to ensure early detection of non-compliance.

Penalties and sanctions should be in place to act as an effective deterrent against non-compliance.

“There is a need for more accurate and timely information on complementary medicines, and for measures to protect the credibility of those products that are proven and evidence-based.”

The TGA also considered the issue of labelling of complementary medicines, including measures to identify those products where the TGA does not assess evidence to support efficacy. 

ASMI believes that the use of the product label to educate about regulatory processes has not yet been demonstrated as an effective means to help consumers to better understand complementary medicines.  It would be more helpful to undertake comprehensive consumer research to test the most effective and efficient means of communicating this information to consumers.

We are pleased with the government’s recommendation on working with stakeholders to scope and develop these options.

The TGA also announced changes to improve clarity and awareness of regulatory decision-making, arising out of the recent review, chaired by Professor Dennis Pearce AO.

“The non-prescription products industry welcomes these measures which aim to increase the flow of information, improve certainty and clarity, and produce more timely TGA decisions,” Dr Schoombie said.

“Our key concern is the need to balance this transparency with protection of commercially confidential information

“There has been a good deal of industry frustration with the lack of clarity from the TGA about important regulatory decisions.  We look forward to seeing these measures implemented to help reduce red tape and improve transparency on how and why decisions are made by the TGA,” he said.


ASMI welcomes progress on updating of OTC medicine requirements

The Australian Self-Medication Industry (ASMI) has been lobbying for progress on the Australian Regulatory Guidelines for OTC Medicines (ARGOM) Review Project, and today welcomed the commencement of stakeholder consultation by the TGA on key sections of the guidelines.

ARGOM sets out the information to be supplied to the TGA with applications for registration or variation of OTC medicines, and thus forms a critical element in the registration of products prior to commercialisation for the consumer healthcare sector in Australia. The current ARGOM was published in 2003 and has only had minimal change since that time.

The Executive Director of ASMI, Dr Deon Schoombie said that ASMI has been active in supporting the progress of the ARGOM review with the TGA, and commencement of the consultation marks a milestone in the updating and reform of OTC Medicines regulation in Australia.

As part of the ARGOM Review Project, the TGA and industry have been working collaboratively, with the TGA drafting the revised sections and small industry project teams providing feedback on these sections.  The updated sections released for broad consultation today describe the data required to support a successful new registration or variation application for an OTC Medicine.

In the meantime, the Business Process Reform (BPR) Project for OTC medicines, which is just commencing, will deliver the new processes by which these applications will be evaluated. Those sections of the ARGOM 2003 which describe the current evaluation process will remain unchanged until then.

Clarity of the TGA’s current requirements for OTC Medicine applications will help industry to design products and prepare medicine applications to meet those updated expectations, which will be of benefit to both TGA and industry. The availability of up-to-date guidelines will be fundamental to the success of the BPR Project for OTC medicines.

“The TGA’s BPR project for OTC medicines is expected to deliver predictability of evaluation timeframes based on the submission of OTC medicine applications which comply with published requirements. It is therefore vital that these updates to the ARGOM proceed in a timely manner to allow OTC medicine sponsors time to factor the revised guidelines into their development programs,” Dr Schoombie said. 

“The outcomes of the Labelling and Packaging Review will also be fundamental to the success of this reform initiative. Clarity on labelling and “umbrella branding” requirements will also be a determinant of better quality OTC medicine applications and must be achieved before a revised business process can deliver the results of predictable processing timeframes,” Dr Schoombie said

ASMI will be consolidating member comments to the ARGOM consultation.

24 November 2011

Evidence–based natural medicines company signs up GP detailing team

Flordis will be expanding the reach of its range of specifically clinically proven natural medicines, through a new initiative that will bring the products to the attention of general practitioners (GPs). 

Flordis’ Managing Director, Craig Weller says that since the company’s products meet the same high clinical standards as pharmaceutical products, it makes sense to enable GPs to learn more about how they can benefit patients.

“There is a tendency to think that because it’s a complementary medicine, it is not backed by clinical evidence.  Our approach is to ensure that all our products have rigorous scientific evidence, and that we can scientifically support every health claim that we make,” Mr Weller said.

“We have very solid evidence to support the efficacy and safety of our range and we think it’s time that this was better shared with the GP community”.

Flordis has entered an agreement with the pharmaceutical commercialisation business, Invida, to engage 10 doctor “detailers” to provide information about the clinical evidence supporting the efficacy of the Flordis range to GPs around Australia, starting in late January.

The Flordis products that will be included in the latest initiative are Iberogast® (for Irritable Bowel Syndrome and functional dyspepsia), Sinupret Forte® (sinusitis), Premular® (premenstrual syndrome), Femular® (menopause) and Remotiv® (anxiety and stress).

“We are conscious that this is breaking new ground because complementary medicines have not typically been a priority for many GPs. Hopefully, when they are able to see that these products are produced and researched in a manner similar to pharmaceutical products, that mindset will change.

“Our research has found that GPs are looking for a range of natural medicines that they can recommend to their patients with confidence.

“All our products are kept behind the counter at pharmacies to ensure the Quality Use of Complementary Medicines. Patients are encouraged to talk to their pharmacist about their condition to ensure that they are receiving the appropriate treatment,” Mr Weller said.

Unlike most other natural medicines companies, Flordis products are the exact same ones that have been specifically clinically proven in robust trials. This is important because plant based medicines cannot be copied in the same way as pharmaceutical compounds. For this reason, GPs can recommend Flordis products to their patients, confident that they are very well tolerated and highly effective.

To learn more, go to www.flordis.com.au


17 November 2011 


ASMI Sales and Marketing Awards recognise excellence in consumer healthcare promotion


Awards for innovative consumer healthcare products, promotions and self care initiatives were announced last night at the Australian Self-Medication Industry (ASMI) Conference in Sydney.

The Marketing & Business Development Director of ASMI, Ms Filomena Maiese said the awards recognise best practice by ASMI members in healthcare promotion, in keeping with the Quality Use of Medicines (QUM), and have become a focus of excellence across the industry.

The judging of the awards was conducted independently of ASMI by an expert panel comprising a pharmacist, a consumer representative, a pharmaceutical trade journalist, a senior executive from the healthcare industry, and representatives from the healthcare public relations and advertising industries.

“This was an extremely competitive market with some outstanding contributions. The winning entries all demonstrated clever approaches to the education of consumers about important health or lifestyle messages and thus have contributed to advancing health literacy and wellbeing in the community,” Ms Maiese said.

The winners of the 2011 Sales & Marketing awards were:

Best Self Care Program 

Canesten – Women’s Confidential, Bayer Australia 

Judges’ comment: This campaign centred on an innovative approach to overcoming the problem particularly among younger women, of being embarrassed to discuss vaginal thrush with the pharmacist. Bayer took a two pronged approach in developing a support package for both pharmacy and consumers. This was critical given the product’s “pharmacist-only” scheduling. It was an outstanding example of empowering the consumer with knowledge about treating the condition in an effective and discrete way.  

Joint winners of the Best Marketing Campaign of a Consumer Healthcare Product (Large Budget)

Nicabate – Little Wins, GlaxoSmithKline Consumer Healthcare

Judges’ comment: The campaign was based around the fact that many smokers make multiple quit attempts, and that every “no” to a smoking opportunity was a “little win”. This translated into a campaign that encompassed multiple touch points along a smoker’s journey to quitting. It was supplemented by a strong pharmacy staff training program, as well as the “Quit Partner” behavioural support program.

Ostelin – Vitamin D Campaign, Sanofi Consumer Healthcare 

Judges’ comment: A striking consumer campaign that created high level awareness about Vitamin D deficiency, and a call to action to discuss the issue with a GP. This resulted in a significant increase in awareness and corresponding vitamin D testing, with the brand reaching the top position in the category. An excellent example of a preventative health initiative from industry. 

Best Marketing Campaign of a Consumer Healthcare Product (Small Budget)

Nurofen PainPod, Reckitt Benckiser

Judges’ comment: The campaign was based around the insight that consumers go to a pharmacy for better information and advice about pain relief solutions. It led to a comprehensive education package for pharmacy. The program was endorsed as a QCPP approved training module by the Pharmacy Guild of Australia for pharmacy assistants. It was also approved as Pharmacist CPD training by the Pharmaceutical Society of Australia. This accreditation enabled further penetration of the training package across the pharmacy sector.

Best Launch of a Consumer Healthcare Product

K-Y Yours+Mine, Johnson & Johnson Pacific 

Judges’ comment: The team’s challenge was to promote this ‘lifestyle’ OTC in a manner that was tasteful yet light-hearted, especially given the “embarrassment” factor historically associated with the category.  A strong 360° campaign with innovative and creative execution saw the new product jump from zero market share to become the number one selling product during the launch phase and has since become the leader in this segment.

Best PR initiative 

Berocca Focus 50+ Launch Campaign, Bayer Australia 

Judges’ comment: This involved an integrated PR campaign encompassing healthcare professionals, media, and event marketing. By linking the product to the Australian Sudoku Challenge, the team established a powerful synergy with the concept of mental agility and focus. The celebrity connection with former Wallabies captain and Sudoku champion, John Eales, helped to generate strong awareness and support for a new product.

 Information on the 2011 ASMI Conference is available at www.asmiconference.com


16 November, 2011

OTC medicines sector to get less regulation but more scrutiny, regulator tells ASMI Conference 

The over-the-counter (OTC) medicines sector will benefit from greater certainty and predictability from regulators, but should expect to come under increased community scrutiny, the Australian Self Medication Industry (ASMI) national conference in Sydney heard today.

Dr Rohan Hammett, the National Manager of the Therapeutic Goods Administration (TGA) told the conference that the business reform process underway for the OTC sector will bring significant benefits in medicine approvals and timelines.

“You are going to see greater clarity from the TGA on what you are required to do. You will see greater predictability, faster approvals, and we will be working much more closely with our international counterparts, adopting similar approaches to regulation of over-the-counter medicines.

“What I hope we will see from you is actually improved dossiers. The information that we evaluate is much better evaluated if the information you provide is accurate, correct and complete.

“Ultimately what we have found when doing this with other sectors is that there is a loss of flexibility in processes that have arisen over decades within the TGA. But the trade-off in loss of flexibility is more than outweighed by the predictability, clarity and efficiency of the regulatory environment.

“I think the other thing you need to prepare yourselves for is greater scrutiny. I have no doubt that the community will continue to look at what we as the regulator do very closely, but also at what you, as the responsible and viable industry do, particularly as it pertains to marketing approaches to consumer literacy which may not always provide the accurate information that is required.”

Dr Hammett also warned of a “fragility of trust” arising from marketing approaches that lack a thorough evidence base.

“One very bad marketing idea can do a lot of damage to trust that has been built up in our attempts to improve health literacy,” he said.

In response to a question, he said that in the prescriptions medicine sector, approval times at the TGA have been reduced from approximately 500 days to as little as 270 days. He said that the business improvement process for OTC medicines should lead to “similar efficiencies with predictable timelines”. 

He conceded that for some OTC medicines, the level of regulation is excessive given the length of time that they have been on the market.

He said that a consultation paper on the planned OTC reforms would be released early in 2012. 

Dr Hammett was speaking at the ASMI conference, titled Promoting Self Care Literacy, at Sydney Olympic Park. 

Further information on the 2011 ASMI Conference is available at www.asmiconference.com


15 November 2011

Flordis natural medicines to go national under new agreement with wholesalers

Flordis specifically clinically proven natural medicines will be available through pharmacies across Australia under a national distribution agreement with Sigma, Symbion and Australian Pharmaceutical Industries (API), announced today.

Flordis has also engaged PharmaBrokers to provide a contract sales team.

The agreement means that the Flordis products – Iberogast  (for Irritable Bowel Syndrome and functional dyspepsia), Sinupret Forte (sinusitis), Premular (premenstrual syndrome), Femular (menopause) and Remotiv (anxiety and stress) - can be easily ordered by pharmacists across the country.

Previously, these products were distributed to a limited number of pharmacies and naturopaths through specialist wholesalers.
This existing distribution arrangement will also continue.

“This means it will be much easier for pharmacists to order Flordis products based on requests from customers, and patients of healthcare professionals,” said Flordis Managing Director, Craig Weller.

“Flordis products are the exact products that have been specifically clinically proven in robust trials.This is important because plant based medicines cannot be copied in the same way as pharmaceutical compounds. For this reason, pharmacists can recommend Flordis products to their patients, confident that they are consistently safe and effective.

“All the products are Practitioner Only in order to ensure the Quality Use of Complementary Medicines, which means they must be kept behind-the-counter in pharmacies. It is important that qualified staff with appropriate knowledge are available to provide advice on the right treatment, and to check what other medicines the patient may be using,” Mr Weller said.

 To learn more, go to www.flordis.com.au or contact 1800 334 224

15 November 2011

Consumer self care under the spotlight at 2011 ASMI Conference 

Australian and international healthcare industry experts will discuss key issues impacting health literacy in the non-prescription medicines sector at the 2011 Australian Self Medication Industry national conference in Sydney tomorrow.

With the theme, Promoting Self Care Literacy, the conference will hear experts from government, the healthcare industry, academia, the pharmacy profession, GPs, private health insurance and consumers on latest trends in consumer self care and health literacy.

Speakers include:

* Dr Rohan Hammett, National Manager, Therapeutic Goods Administration

* Prof Saul Shiffman PhD, Research Professor of Psychology (Clinical and Health Psychology), University of Pittsburgh (USA)

* Professor Kerryn Phelps AM,
President, Australasian Integrative Medicine Association

* Rhonda White
, Co-Founder of the Terry White Chemists Group of Pharmacies; Managing Director, White Retail Group

* Kate Carnell AO
, Chief Executive, Australian Food & Grocery Council

* Carol Bennett
, Executive Director, Consumers Health Forum of Australia

* David Ballhausen
, CEO, Life Education Australia

* Audra Millis
, Manager, Health Content, Bupa Australia

* Trish Greenway
, Medical Technology Association of Australia, Code of Practice Committee

* Marcel Sieira
, General Manager - Business Development, GS1 Australia

When: Wednesday 16 November 2011

Where: Waterview Convention Centre, Bicentennial Park, Sydney Olympic Park

Time: Commencing 10.00 am

The conference will conclude with the ASMI Sales & Marketing awards which recognise best practice in healthcare sales & marketing initiatives, and this year the “new” format awards program has seen a record number of entries submitted.

Further information on the 2011 ASMI Conference is available at www.asmiconference.com


13 November 2011

ASMI applauds global push for new approach to regulatory decision-making for over-the-counter medicines

The Australian Self-Medication Industry (ASMI) today welcomed the release of a proposed new model designed to better evaluate and measure the benefits of over-the-counter (OTC) medicines, and thus aid regulatory decision-making.

The model is based around a tailored benefit/risk framework that applies a broader definition of “benefits”, beyond clinical trial data, and includes elements such as consumer satisfaction, dependency on healthcare systems, and time-off work.

It was developed through a grant from the World Self Medication Industry to independent researchers and has been published in the journal, Clinical Pharmacology and Therapeutics, under the title ‘Improving the Decision-Making Process for Nonprescription Drugs: A Framework for Benefit-Risk Assessment’. i

The Executive Director of ASMI, Dr Deon Schoombie said the model was developed as tool to assist sponsors in determining the benefit/risk profile of non-prescription medicines, and to assist with the assessment of these factors in regulatory decision-making.

In an environment where there is an increasing demand for sound evidence and evidence-based decision-making, it is important for the medicines industry to collaborate with regulators to develop a practical benefit/risk framework to apply to the OTC sector,” he said.

The proposed model is based on a value-tree method that seeks to define specific benefit/risk outcomes across a number of key areas relevant to non-prescription medicines. It was previewed to Australian industry representatives in October by one of the lead authors, Professor Eric Brass, of the David Geffen School of Medicine at UCLA.

Dr Schoombie said the presentation was timely, in light of the business process improvement program set to commence for OTC medicines at the Therapeutic Goods Administration (TGA), since the new model has the capacity to help maintain a strong non-prescription regulatory culture.

Our view is that there has often been a narrow definition of benefits in regard to OTC medicines, which has overlooked the role that they play in public and individual health outcomes by helping consumers to stay well, keep active and remain productive.

More recently, we have seen a progressive imbalance, where risk has been afforded greater weight, in the absence of sound arguments around likely benefits, Dr Schoombie said. 

The proposed new model is designed to assist both regulators and manufacturers to better assess risks and benefits, to improve risk management, and to enhance communication to consumers. It is anticipated that as the model evolves over time, it will serve as a guide to industry and regulators on the approach for future submission and product applications

Our hope is that this will help to start discussions between regulators and industry on the way that product submission and applications can be assessed with greater consistency and certainty in the future,” Dr Schoombie said.


 Brass E P, Lofstedt R, & Renn O; Improving the Decision-Making Process for Nonprescription Drugs: A Framework for Benefit–Risk Assessment, Clinical Pharmacology & Therapeutics, November2011


11 November 2011

Paracetamol and asthma link remains unclear

The Australian Self-Medication Industry (ASMI) said today that the association between paracetamol exposure and the incidence of childhood asthma remains unclear, and that further, carefully-conducted research would be necessary to establish any causal link. 

ASMI was responding to a publication in Pediatrics,[1] the official journal of the American Academy of Pediatrics, by Dr John T McBride, as well as related media coverage on the association between paracetamol use and asthma.

ASMI Regulatory and Scientific Affairs Director, Steven Scarff said that while examination of this issue was important, Dr McBride’s publication did not, in itself, shed new light on the association between paracetamol use and childhood asthma.

Mr Scarff noted that the authors of a recent Australian study[2] had concluded that paracetamol use in early life was not an independent risk factor for childhood asthma.

Paracetamol has been available for more than 50 years and the vast majority of adults and children experience no undesirable effects, when used as directed. It remains an effective and safe option for the treatment of pain and fever, and is the most commonly recommended over the counter analgesic/antipyretic for use during pregnancy and in children.


[1] John T. McBride, The Association of Acetaminophen and Asthma Prevalence and Severity, Pediatrics, originally published online November 7, 2011, DOI: 10.1542/peds.2011-1106

[1] Lowe AJ, Carlin JB, Bennett CM, et al. Does frequent paracetamol exposure in the first two years of life increase risk of childhood asthma? Respirology 2008; 13: A36.


7 November 2011

ASMI advice regarding the use of NSAIDs and the risk of stroke

Current label warnings and existing advice regarding the non-prescription use of non-steroidal anti-inflammatory drugs (NSAIDs) remains sound, in light of a new study that examines the use of these medicines and the risk of stroke in older patients, the Australian Self-Medication Industry (ASMI) said today.

The study, published in the Medical Journal of Australia, examines the use of prescription doses of NSAIDs in an Australian veteran population with an average age of 76 years.[i] 

In this setting, the authors concluded that the prescription use of NSAIDs was associated with an increased risk of stroke. However, as the authors said, the absolute risk is low and the increased risk found is therefore also small.

“Importantly this study did not examine lower non-prescription doses or over-the-counter (OTC) use of NSAIDs, and was conducted in a very specific study population. Many of the veterans studied suffer from a range of medical conditions and will, on average, be prescribed 11 unique medicines in a year,” said ASMI Regulatory and Scientific Affairs Director, Steven Scarff. 

The study in question was an observational study in a veteran population with comorbidities, and was based on hospitalisation records and prescription use of NSAIDs. The authors state that “the analysis is associative only and does not prove causality”.

While the authors were unable to examine the OTC use of NSAIDs, they did find no association between Ibuprofen use and an increased risk of stroke in this specific population. 

Generally speaking, OTC NSAIDs are safe and effective for the temporary relief of pain and inflammation. 

“OTC use of NSAIDs involves taking low doses for short periods of time. Anyone who is in a high risk category, such as the elderly or people with heart problems, should, as with any medication, consult their GP or pharmacist before using an NSAID.

“It is important that consumers take note of the label warnings and only use the products as directed. Based on all the information available, we believe that these label warnings and advice around these products remains appropriate.

“Among other things, these warnings advise elderly consumers and those with certain existing health problems or who are taking other medications to first seek the advice of their healthcare professional. 

“It is important to read labels carefully, and to strictly follow all the directions and, if the pain or other symptoms persist, to consult a doctor or pharmacist,” Mr Scarff said.

[1] Caughey E. Et al; Stroke risk and NSAIDs: an Australian population-based study, Medical Journal of Australia, 7 November 2011, MJA 195 (9).

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