s ASMI Media Releases for Nov./Dec. 2011 | I2P: Information to Pharmacists - Archive
Publication Date 01/12/2011         Volume. 3 No. 11   
Information to Pharmacists

Editorial

From the desk of the editor

There is no other word for it other than depressing.
The world of pharmacy is falling on its own sword with pharmacist organisations at loggerheads with pharmacy organisations, principally the PGA.
Essentially it is wrong for a minority pharmacy organisation to dominate all others and leave in its wake some very unhappy people.
It is not a pretty sight seeing the juggernaut that is the PGA begin the process of decimation, wasting  resources in a negative fashion that ought to have been distributed more equitably.
It is neither smart or strategic to be entering into warfare when leadership would offer the more decent alternative.

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News Flash

Newsflash Updates for December 2011 & January 2012

Newsflash Updates

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

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Pipeline

Pipeline for Dec. 2011 & Jan.2012

Pipeline Extras

A range of global and local news snippets and links that may be of interest to readers.
Pipeline Extra simply broadens the range of topics that can be concentrated in one delivery of i2P to your desktop.

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Feature Contribution

A SUMMARY OF PHARMACISTS POTENTIAL, PROVIDING PROFESSIONAL PRACTICES.

Dr John Dunlop (PGDipPharm, MPharm, DPharm(Auck), FACPP, FNZCP, FPSNZ, MCAPA)

Over the past year I have written about the need to recognize and remunerate pharmacists appropriately in order that pharmacy can take a necessary step forward in the new Millenium. Following are some points that are worthy of note.

1. In New Zealand, we now have approximately four hundred owners of pharmacies. Within this group, incomes range between $200,000 and $600,000.00. The average income for an employed pharmacist working in community pharmacy is around $65,000.00, and the salaries for young graduates in Auckland, (and Melbourne too I believe) is $24.00 per hour - around $48,000.00 per year. Not much of a reward for 5 years of study and very indicative of the value and respect placed on the employed professional by the employer!!! 

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Inquiry into the PBS – GET IT RIGHT FIRST TIME

Rollo Manning

A failing in the push for a Senate Inquiry into the 5th Community Pharmacy Agreement is recognition that the Pharmacy Guild is named in the National Health Act as the party the Government must liaise with before making decisions on fees paid to pharmacists for supply and services.
It is not the Society of Hospital Pharmacists, the Pharmaceutical Society, the National Australian Pharmacy Students Association or APESMA - but the Pharmacy Guild.
It is therefore no wonder that the Guild is the party at the negotiating table.
An amendment to the National Health Act would be needed to change this and while there is a Clause that says another organisation can be included if it represents a majority of pharmacists this has never been tested.

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Who’s driving our Heath Robinson?

Neil Retallick

Last month I likened the community pharmacy industry to a “Heath Robinson”.
According to Wikipedia, “William Heath Robinson (signed as W. Heath Robinson, 31 May 1872 – 13 September 1944) was an English cartoonist and illustrator, best known for drawings of eccentric machines....
In the UK, the term "Heath Robinson" has entered the language as a description of any unnecessarily complex and implausible contraption...”
This month I’m worried about who’s driving it.

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It's Raining Training

Barry Urquhart

Some choice.
For most business leaders and owners the next decade will provide scope for two strategic options - "hard" or "bad".
A touch of reality is needed.
It will be a daunting prospect for some. For others, who do not recognise or appreciate the unfolding marketplace there will be blissful ignorance and a shortened business life.
Among those who are "hanging on until things turn up for the better", there will be disappointment.
This is not the time to hang in our hang out.
Let me emphasise, the circumstances being confronted at present are neither cyclical nor seasonal. They are structural and accordingly, changes are essential in philosophies, operations and outputs.
The next three years will inevitably be "bad" for those who adopt a "victim mentality" and do little or nothing. Those well-reported "headwinds" will remain and will eventually push the inert (becalmed) "boats" backwards and out of the race.
Rationalisations and consolidations will be in evidence across a wide sweep of industry sectors. Established companies, brands, products and services will disappear from the corporate landscape, replaced by high-energy, and focused new applications, innovations and belief-driven entrepreneurs.
Thus from "bad" will come "good".

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Man bites dog – mongrel rules needed

Pat Gallagher

Here I am.
Back from another lengthy and self enforced break and reporting in i2P on things and matters with ICT in pharmacy-land and health generally.
It is not that I am lazy.
It is that there hasn’t been much ‘news’ happening worth getting our knickers in a knot.
It is all the same old; same old in e-health playing field and that is rather uninspiring to say the least. So I have taken the view that if there is nothing positive to say it’s best to stay stum.
But now as 2011 is coming to a rattling death perhaps there are some things worth saying, usefully or otherwise.
What is a snapshot of some of the year’s achievements in the e-health community?
Hard to say that the world is on fire with overwhelming success, but a summary of the activities that might interest the i2P reader, in some order of oomph are:

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A TGA-Managed Database of Fully Evaluated Complementary Medicines Evidence – a Real Possibility

Neil Johnston

Last month when the controversy surrounding the PGA/Blackmore’s proposed alliance brought out a large number of critics, the PGA found itself in an extremely vulnerable position.
Some criticism was well-deserved - other criticism arose from misperception surrounding the proposed alliance, while other criticism evolved surrounding the “evidence” relied on by the alliance to underpin their clinical promotion - was blown out of all proportion, or negatively criticised.
More positively, academic Dr Ken Harvey called for the TGA to manage an evidence database for complementary medicines that have had a full evaluation.

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Hypnotherapists - Hero's or heisters?

Loretta Marron OAM BSc

He spoke softly as he lifted my arm while telling me it would stay afloat.  It didn't. 
In fact, several times during the session, it fell back to my side no matter he said. 
While I felt reasonably relaxed after my first visit to a hypnotherapist, I left disappointed. 
So does hypnotherapy work and why do some of my skeptical friends support it and, more interestingly, why do they say it is part of acupuncture?

Comments: 1

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Support services for pharmacists and doctors in the United Kingdom – Part 2 Practitioner Health Programme

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

In Australia the Pharmacists’ Support Service (PSS) provides a listening ear and support over the telephone to pharmacists in Victoria, Tasmania, South Australia and the Northern Territory and has plans for expansion to all states of Australia.  The medical profession in Australia has a range of state based Doctors’ Health Advisory Services including the AMA Victoria Peer Support Service which provides peer support over the telephone.  Victorian is the only state to have a state based health program for doctors; the Victorian Doctors Health Program (VDHP)
Funding from the Cyril Tonkin Fellowship enabled me to undertake a study tour of services which support pharmacists and doctors in the United Kingdom (UK) in March 2011.

The aim of the visit was to find out how these services support the health and well being of pharmacists and doctors, including the services provided and how they are funded.

The support services visited were Pharmacist Support, including participation in a Listening Friends training weekend; the Royal Pharmaceutical Society; the Practitioner Health Programme; the Royal Medical Benevolent Fund; the British Medical Association Doctors for Doctors program and the National Clinical Assessment Service.  In addition to obtain background material on the environment for health professionals in the United Kingdom visits were also made to the General Pharmaceutical Council; Manchester University School of Pharmacy and Pharmaceutical Sciences and the Pharmacy Department of the Central Manchester University Hospitals NHS Foundation Trust.
This article is the second in a series reporting on my visit and will detail the services available to doctors and dentists living in London through the Practitioner Health Programme.

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INTEREST HIGH WITH STUDENTS IN ABORIGINAL HEALTH

Rollo Manning

The future supply of pharmacists to work in Aboriginal health is healthy if the outcome of a National Australian Pharmacy Students’ Association survey is anything to go by.
While 83% of respondents felt it is important to be taught about Aboriginal and Torres Strait Islander health issues as part of their pharmacy course curriculum, only 60% have access to such education. Furthermore, only half of those respondents feel they are taught enough about this topic.

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Thankful for an MRI

Mark Neuenschwander

I’ve been thinking about magnetic resonance imaging, sleeping bags, allergies, and great hospitals.
Well, I went in for an MRI, and the diagnosis was not good: Claustrophobia. But I’m getting ahead myself.
While studying x-rays of my shoulder, my doc ordered an MRI. I told him we were nearing eight on the p
ain scale and pressed for the earliest appointment.
Seven o’clock the next morning, after being scanned for metal, a rad tech strapped me to the transport board and pushed a button.
Moving into the magnetic abyss, I felt like dead man walking. Except, I couldn’t walk. But I could talk. It took about two seconds to find my authoritative voice:
“I NEED OUT NOW.”
She got the hint, and I was pardoned.

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The power of 'why'

Harvey Mackay

Whether you're managing a team of employees or you're on your own, remember that although what you do and how you do it are important, it's the "why" that provides real motivation to succeed.
An experiment conducted by the University of Pennsylvania's Wharton School of Business demonstrates the power of "why." 
At a university call center where employees phone alumni to solicit contributions to scholarship funds, the staff was randomly divided into three groups:  The first group read stories written by former call center employees about the benefits of the job (such as improved communication and sales skills).  The second group shared accounts from former students about how their scholarships helped them with their education, careers and lives. 
The third, a control group, read nothing, just explained the purpose of the call and asked for a contribution.

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The Farmerscy Guild and the straw man argument

Geoff March PhD B.Pharm

Straw Man “An argument deliberately put up so that it can be knocked down, usually as a distraction from other arguments which cannot be so easily countered,”  - The Macquarie Dictionary.

Comments: 2

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Kos Sclavos Superstar

Peter Sayers

It appears that pharmacists, in general, are tired of the leadership style imposed by Kos Sclavos, the incumbent president of the Pharmacy Guild of Australia (PGA).
While criticism of PGA leadership style and policy has been building for some time, opposition solidified recently with formation of the Pharmacy Coalition for Health Reform – a body that boasts over 20,000 pharmacists among its membership.

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NAPSA and the PGA

Neil Johnston

Recently, i2P was sent a media release from APESMA, the pharmacist trade union.
It was embargoed until Saturday December 10, which was a point at the beginning of the i2P update cycle.
The release contained a link to an email that is alleged to have emanated from NAPSA – the National Australian Pharmacy Students' Association.
Because it was politically sensitive to that organisation and because it also contained a number of normally private contact details for their members, i2P decided to withhold the information unless it became public knowledge through other media sources - and that has happened..
The email provided the basis for published claims that the PGA was engaged in a bullying process with NAPSA to force their disengagement with the newly-formed PCHR- the Pharmacist Coalition for Health Reform, and it is hard to avoid this view when an examination of the pressures exerted by the PGA are examined in broad daylight.

Comments: 1

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Where is the Best Future Business Model for Pharmacy?

Neil Johnston

Because it is near the end of the year, I thought it appropriate to highlight one of our earlier articles published in July 2010, because it gave a foretaste of things to come -
 “The New Competitors- Wholesalers, Manufacturers, Pharmacists and Nurses”
The gist of the article was that because global pharma companies would be unable to sustain the “blockbuster” business model and that there would be only modest growth in future drug developments, an unstoppable chain reaction would begin to occur where global pharma would create a new disruptive business model that would remove wholesaler discounts and begin a process of different segments of the health services “scavenging” from each other.

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Pharmacy Needs a Peak Body

Neil Johnston

Once upon a time pharmacy was a small, typically one-person show that focussed on patients (as distinct from customers).
It was considered very bad form if a patient presented with a problem and ;
(i) they were not immediately attended to by a qualified pharmacist and;
(ii) they left the pharmacy holding a product in their hands that had not been personally compounded by the pharmacist.
Most patients asked for “their pharmacist” by name and entered into an obvious and valued pharmacist/patient relationship. The care was obvious and not substituted with branded medicines or had the patient interviews delegated to pharmacy assistants or technicians.
In other words the human relationships were respectful and this respect extended between pharmacists as a collegiate relationship.

Comments: 1

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Come to Shop – Return to Learn

Neil Johnston

I started the New Year by researching retail environments that could be adapted to pharmacy and deliver pharmacy 2012 marketing requirements, with emphasis on "professional".
When I got to the Apple retail environment, it simply jumped off the page.
This could be the most important article you read this year.
Few would realise that the title to this article is actually the slogan for Apple Retail Stores, and is in fact the base philosophy behind one of the most successful forms of retail enterprise experienced in the 21st century.
The story of the Apple retail experience has a direct translation across to the malaise that is currently being felt by most Australian pharmacists, so a brief history of the Apple company may help to illuminate a realigned direction for community pharmacy that would capitalise on its strengths and help get off the discount treadmill.

Comments: 3

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A New Escalation of Turf Wars - Is the best defence, offence?

Mark Coleman

Recently I noticed an article published in "The Conversation" authored by John Dwyer Emeritus Professor at University of New South Wales. The article opens with:

"It’s difficult enough to counter the massive amount of misleading information provided to consumers through the media and online. But the task becomes much harder when tertiary institutes give an undeserved imprimatur to pseudo disciplines by offering them as courses. Central Queensland University (CQU) is the latest to do so, announcing it will offer a Bachelor of Science degree (Chiropractic) from 2012. I’m one of thirty-four doctors, scientists and clinical academics who, in an attempt to protect health-care consumers from the dangers associated with unscientific clinical practices, have today written to the science deans at CQU urging them, as fellow academics, to reconsider this decision.
We want the deans to acknowledge the importance of our universities remaining champions of rigorous academic standards and remind them of the primacy of the evidence base for scientific conclusions and health-care practices." Read more at this link

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New Year Uncertainty

Peter Sayers

Coming up to speed after the festive break, I have been astounded at the number of community pharmacy prescription out-of-stocks, both short-term and long-term, that are mounting by the day.
This has a number of financial impacts on a community pharmacy and one assumes that the PGA has a strategy to lessen these impacts - but where is it?

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Take care of your customers or someone else will

Harvey Mackay

No business can stay in business without customers.
How customers are treated and sadly, mistreated, determines how long the doors stay open. Poor quality service has probably doomed as many businesses as poor quality products.
Enter the "guru of customer service," John Tschohl.
He earned that moniker from USA Today, Time and Entrepreneur magazines. After 31 years focused solely on customer service, he is president of Service Quality Institute, which has representatives in 40 countries.
He's authored hundreds of articles and six best-selling books. And he is willing to share his wisdom with my readers. I don't often devote so much of my column to one resource, but John is the best of the best.

 

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Nicola Roxon’s Parting Advice

Neil Johnston

I was thumbing through my January copy of the AJP when I noticed a small column covering a conversation with Nicola Roxon, the ex-Minister for Health and Ageing.
She, along with other commentators on the same page, was basically encouraging pharmacists to “jump in” to reform health.
The encouraged pathway was through fee for service arrangements, some of which are covered under the 5CPA.

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Big Pharma impacts on the pharmacy profession

Peter Jackson

“Staff in almost one fifth of pharmacies could be wasting more than five hours per week, the equivalent of one month's working time a year, trying to source out-of-stock medicines.”
So claims a report published in the UK newsletter Chemist & Druggist this month.
The report goes on to claim:

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Do you have the urge to speak out?

Mark Coleman

With all the change and distress that is apparent in all ranks of pharmacy at the moment, do you have the urge to lash out at someone or some organisation or just something?
All pharmacists want to evolve their version of an ethical practice, balancing some commercialism with professional core business – whether they own a pharmacy or not.
Multiple groupings of pharmacists have formed up around each special interest and this has created a range of competitive groups, some more aggressive than others, to compete for absolute dominance of pharmacy – and endeavour to create a single voice.

Comments: 1

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Drug Shortages Require Urgent Government Intervention

Neil Johnston

When something does not make sense I always find there is a political objective involved.
And underlying the politics always is the motivation of greed.
Make no mistake about it, Australian pharmacy is about to enter a period of manipulation never before experienced, and it involves supply chain manipulation by government and by Big Pharma.
It is globally orchestrated and tactics vary slightly country to country and the victims of this strategy are very ill patients and the pharmacies behind them desperately trying to bridge supply to keep them alive.

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APESMA PROPOSES NEW TERMS OF REFERENCE FOR SENATE INQUIRY INTO PHARMACY

Staff Writer

APESMA today proposed a new Terms of Reference for a Senate Inquiry into pharmacy which focuses on new potential benefits to the pharmacy profession including providing a role for pharmacists in medicare locals and GP clinics and new measures to reform the health care system.
Mr Walton said despite incorrect and mischievous claims by the Pharmacy Guild there was nothing in the Senate Inquiry before the Senate that would cause the current Community Pharmacy Agreement to cease.

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Pharmacists heading to Hobart for Medicines Management 2011, the 37th SHPA National Conference

Staff Writer

More than 850 delegates will be in Hobart this week for Medicines Management 2011, the 37th SHPA National Conference.

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SHPA commences celebration of a milestone year at Medicines Management 2011, the 37th SHPA National Conference

Staff Writer

At Medicines Management 2011, the 37th SHPA National Conference, SHPA will celebrate 50 years as a national organisation and 70 years since its inception.
In 1941, 25 pioneer pharmacists from public hospitals in Victoria first conceived SHPA, and in 1961 SHPA moved formally to become a national organisation and held its first national conference in Adelaide.

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Bill Thomson receives SHPA’s highest award

Staff Writer

Medicines Management 2011, the 37th SHPA National Conference opened today in Hobart.  With over 800 delegates, 80 presented papers and 200 posters, this year’s conference is yet another example of the enthusiasm and dedication of pharmacists in hospitals and other parts of the healthcare system to share their work and learn from their peers.

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Australian Clinical Pharmacy Award 2011 to Adelaide Pharmacist, Greg Roberts

Staff Writer

During Medicines Management 2011, the 37th SHPA National Conference, held in Hobart last weekend, the SHPA Australian Clinical Pharmacy Award for 2011 was awarded to Mr Greg Roberts, Clinical Research Pharmacist at the Repatriation General Hospital in Adelaide.

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Pharmacist Coalition for Health Reform and the call for a Senate Inquiry

Staff Writer

SHPA believes that consumer interests should be at the centre of health delivery and the health reform agenda.  SHPA members have a strong ethos of working collaboratively within interdisciplinary healthcare teams and across the continuum of care.

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NTU-led research probes potential link between cancer and a common chemical in consumer products

Staff Writer

Editor's Note: Nano-particles have been adopted by various manufacturers of consumer products because they improve absorption of their active ingredients and the cosmetic appearance of the product.
Early researchers in this field warned that conditions similar to mesothelioma may result through exposure to nano-particles and that more research is required before endangering the general public.
Very few manufacturers identify that their products contain nano-particles, but recent studies have confirmed the potential for an association with cancer.
Certainly, the least that needs to occur is a warning label, particularly as some sunscreen preparations contain zinc oxide.
It is ironical that the Australian Cancer Council promote the message of "slip, slop and slap" yet allows for another form of potential cancer exposure through the "back door" involving nano-particles in sunscreen products, including the zinc oxide identified in the following study.

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Apply First Aid – Guild Clinical 2012

Staff Writer

Guild Clinical is pleased to announce the course dates for Apply First Aid 2012.
REVIVA First Aid Training provides industry specific, highly interactive training perfect for pharmacists, graduates and pharmacy assistants.

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Award Winning NPS IPhone APP Now Includes a Medicines Reminder Function

NPS Spokesperson

No more forgetting to take your medicine! NPS has introduced a range of new features to its award-winning Medicines List iPhone app that allow people to schedule in reminders to prompt them to take their medicine.
As part of the upgrade, people can also record whether they took their medicine on time — and if not, why not, which is useful information to share when they next see their doctor.

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ASMI response to TGA reform blueprint

Bob Bowden

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.

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New test to indicate likely spread or recurrence of breast cancer

Staff Writer

A Queensland University of Technology (QUT) PhD student has developed a potential breakthrough test for predicting the likelihood of the spread or return of breast cancer.
"While in recent years there have been fantastic advances in the treatment of breast cancer there has been no way of predicting its progress," said Helen McCosker, a PhD student at the Institute of Health and Biomedical Innovation (IHBI).

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PSA Releases Guidance For Pharmacists Using Internet and Social Media

Staff Writer

In our July edition of i2P, Kay Dunkley wrote an excellent article relating to social media and its use by health professionals. In that article Kay noted:
The Medical Journal of Australia recently published an excellent article on the topic of social media and the medical profession. It was this article that prompted me to write this opinion piece and I recommend that it should be read by all health professionals who are users of social media. I believe that many of the issues raised for medical practitioners are equally applicable to pharmacists and other health professionals. That article can be found at http://www.mja.com.au/publicissues/194_12_200611/man10874_fm.html

Now the PSA have weighed in with an official version for pharmacists.

Comments: 1

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Athletes warming up incorrectly

Staff Writer

Dynamic warm-ups included range of motion activities like high-knee raises, leg swings and run-throughs or change of direction tasks.
Mr Zois said the study proved that, from a power point of view, static stretching was worse than no warm up at all.

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Last Pre-Christmas News Roundup- APESMA - Australian Prescriber - NSW Guild - NPS on Methotrexate - PSA - Competency Tool

Staff Writer

i2P news and articles will continue to be published weekly over the Christmas/New Year period, but not quite so "in-depth".
You are invited to explore the recent archives of i2P when you begin to plan for the coming year.
We also encourage you to post comments at the foot of each published item.
i2P knows that the coming year will be more challenging than in previous years.
It will be a year of sorting out priorities - those within the industry wishing to needlessly fight to prop up inappropriate structures will be seen to waste time and resources.
They will be judged harshly by participants at the "coalface"- the silent majority.

i2P hopes that all of its subscribers have a peaceful and safe festive season.

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No Deaths from Vitamins - America's Largest Database Confirms Supplement Safety

Staff Writer

The following news item from Orthomolecular.org adds one more dimension to the debate on nutritional supplements. It seems that safety is definitely not an issue where nutritional supplements are used.

Comments: 3

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Multiple medicines may double fall rate for young and middle aged

Staff Writer

Editor's Note: In Australia, criteria for generating a medication review includes a patient currently taking five or more regular medicines or taking more than 12 doses of medicine per day.
Patient falls are a major reason for patients being admitted to a hospital and quite commonly, patients are further damaged through falls while they are already in a hospital.
The system currently requires a referral by a GP to an accredited pharmacist, which is a slow and cumbersome (sometimes very unrewarding) process.

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Pharmedia: Academic Manipulation & the Growth of "Junk Science"

Neil Johnston

Editor"s Note: Global Pharma has an unusual and pervasive influence on politicians, regulators and statutory bodies around the globe.
I’ve always had a philosophy of recognising that when things do not go as they are supposed to, first look at the surrounding politics and then follow the money trail.
In the US the main regulator for drug registration and marketing is the Food and Drug Administration (FDA) which has come under greater scrutiny by industry commentators because of seemingly corrupt and improper decisions increasingly made in favour of drug manufacturers.

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Does the PGA Really Represent its Members

Neil Johnston

This month we have selected a media story that appeared in Pharmacy News on the 3 November 2011, and it is story of the continuing saga of direct distribution by Pfizer.
The bigger story underneath is - what is the Pharmacy Guild of Australia doing to represent its members in this ongoing dispute?
i2P has covered the direct distribution saga since its inception here in Australia.
The problem seems to be worsening rather than improving, so we have asked Mark Coleman to comment.
His comments appear below the media item that follows.

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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

www.nature.com/clpt/journal/vaop/ncurrent/index.html


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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