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

Neil Johnston

articles by this author...

Neil Johnston is a pharmacist who trained as a management consultant. He was the first consultant to service the pharmacy profession and commenced practice as a full time consultant in 1972, specialising in community pharmacy management, pharmacy systems, preventive medicine and the marketing of professional services. He has owned, or part-owned a total of six pharmacies during his career, and for a decade spent time both as a clinical pharmacist and Chief Pharmacist in the public hospital system. He has been editor of i2P since 2000.

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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The uproar caused the PGA and Blackmore’s to abandon their proposed alliance, and many PGA “enemies” were able to use the incident to their advantage.
There was some concern by i2P in that while the basic idea had some merit, project implementation as originally described, had the potential for abuse.
However, some of the elements of the original proposal, if used correctly, may have had the potential to assist pharmacy patients.

The clinical evidence relied upon seemed impossible to evaluate because:

* No single Australian database existed for evidence (drugs or complementary medicines) that had been properly rated by a reliable external ratings agency.

* No database existed that could authenticate even supposed “gold standard” evidence because at least 20-30 percent of that data is contaminated through big-pharma manipulation involving the use of “ghost writers”, to magnify benefits of their drug or point to a conclusion not supported by the original investigational data.
A description of the process of “ghost writing” is explained further along this article – a process that I believe must constitute academic fraud!

i2P was recently contacted by well-known academic Dr Ken Harvey to support an initiative he was preparing in respect of an evidence database managed by the TGA, with the consumer organisation CHOICE facilitating the process.
i2P agreed to support this initiative and added a signature to the CHOICE letter addressed to the TGA.
The following is the original full text of this letter and the TGA response.

CHOICE letter

Dr Rohan Hammett
National Manager
Therapeutic Goods Administration
PO Box 100
WODEN ACT 2606

Dear Dr. Hammett,

Re: A TGA list of registered (and properly evaluated) Complementary Medicines (CMs)

The recent Australian National Audit Office (ANAO) report titled, “Therapeutic Goods Regulation: Complementary Medicines” said (43):

“It would enhance transparency and help inform both consumers and healthcare professionals if the TGA were to place the summary of evidence it collects from sponsors, as received, on its website—with a clear indication of whether it had been assessed or evaluated by the TGA.”

There are a small number of registered CMs on the Australian Register of Therapeutic Goods (ARTG). If these products have been registered recently, it means that they have been properly assessed for quality, safety and efficacy (unlike Listed CMs which predominate on the ARTG). Examples of registered CMs include Blackmores Flexagil Pain Relief cream (a clinically proven comfrey root extract) for the topical treatment of sprains and osteoarthritis and Flordis Iberogast (a clinically proven nine herb mixture) for Irritable Bowel Syndrome.

Unfortunately, some registered CMs were “grandfathered” into the ARTG, without proper evaluation, e.g. ARTG no: 68083 ARTHRO-AID Glucosamine hydrochloride (see appended).

At this point in time, there is no way the ARTG can be searched to obtain a list of registered CMs let alone those that have been properly evaluated as distinct from “grandfathered”.

We believe that it is important for the medical profession and community to be aware of the more evidence-based CMs that are currently registered by the TGA and for us to provide constructive feedback where needed. Can you please provide us with this data?

May we also suggest that the TGA compiles a list of properly evaluated registered CMs and places this on the TGA website. In the longer term, we suggest that the ARTG database should contain an additional searchable field to distinguish CMs from other medicines.

We believe that these initiatives by the TGA would make a nice response to paragraph 43 of the ANAO report.

Sincerely,


Nick Stace (CEO, CHOICE)

Carol Bennett (CEO, CHF)

Dr Vicki Kotsirilos, GP and expert on CM

Neil Johnston, Editor, Information to Pharmacists (I2P)

Dr Ken Harvey, School of Public Health, La Trobe University
cc Lynn Weekes CEO, NPS

TGA response (the same response was sent individually to each signatory)

Mr Neil Johnston
Editor
Information for Pharmacists (12P)
PO Box 297
Alstonville NSW 2477

Dear Mr Johnston,

TGA list of registered Complementary Medicines

Thank you for your letter of 18 October 2011 concerning access by consumers to information about registered complementary medicines. I note the several co-signatories to your letter who share an interest in this matter.

At the current time, there are some 200 registered complementary medicines on the Australian Register of Therapeutic Goods (ARTG). As you point out in your correspondence, a small number of these have been fully evaluated while the majority were 'grandfathered' onto the ARTG at the time that the register was created, along with many other registered medicines, non-complementary OTC medicines, prescription medicines and listed products.

I acknowledge that the searchability of the ARTG for consumers and health professionals in relation to complementary medicines has some limitations. However, the TGA is committed to improving the transparency of our operations and increased regulatory effectiveness.  I will seek advice as to the options for ARTG enhancements to allow identification of registered complementary medicines and fully evaluated registered complementary medicines, respectively.

In the interests of enhanced information for consumers and health professionals, 1 agree with your suggestion that the TGA should publish on our website a list of those registered complementary medicines that have been fully evaluated. I have asked the relevant officers in the TGA to develop this list for publication.

Should you have any queries regarding these matters please don't hesitate to contact Mr Ian Stehlik in the Office of Complementary Medicines on 02 62328439 in the first instance.

Yours sincerely

Dr Rohan Hammet,
National Manager
November 2011

Finally, the start of a reliable database that establishes a standard, and for the first time may prove to be an extremely useful tool for any clinician wishing to engage in clinical practice, without having unwarranted criticism descend on them.
For an explanation of how this type of criticism arises, view comments about the “flip-flop” rhythm of science contained in the article: Truth in Medicine – Weighing the Evidence.

Ideally, any evidence posted to the TGA site will include a full investigation, including a determination whether any input was “ghost-written”, and if so, disallow that “evidence” until it is properly authenticated.

One of the more flagrant offences committed by pharmaceutical companies and the medical profession is the practice of "ghost writing" medical articles.

A new cross-sectional survey published in an article in the British Medical Journal found that more than 20 percent of articles published in six leading medical journals during 2008 were likely written by honorary and/or ghost writers. 

This is lower than it was in 1996, but still far too prevalent; contaminating data to deliberately confuse and mislead- but always directing a reader disproportionately towards the claimed benefits represented by a sponsored drug.

For medical journals, ghost writing usually refers to writers sponsored by a drug or medical device company, who make major but uncredited research or writing contributions. 

The articles are instead published under the names of other academic authors.

Such "inappropriate authorship" leads to a lack of transparency and accountability, which has become an important concern for the academic community.

According to the article in the British Medical Journal:

"Inappropriate authorship (honorary and ghost authorship is an important issue for the academic and research community and is a threat to the integrity of scientific publication.

Our findings suggest that 21 percent of articles published in 2008 in the general medical journals with the highest impact factors had an inappropriate honorary author, and that nearly eight percent of articles published in these journals may have had an unnamed important contributor.

The highest prevalence of both types of inappropriate authorship occurred in original research articles, compared with editorials and review articles.

...Both honorary and ghost authorship are unacceptable in scientific publications, and each form of inappropriate authorship has important consequences.

...Honorary authorship has implications for scientific integrity... Likewise ghost authorship has important implications and consequences. If un-identified authors are involved in the work and manuscript preparation, readers not only will be unaware of the contributions, perspectives, and affiliations of these individuals, but also may not appreciate the influence or potential underlying agenda these individuals may have on the reporting of material in the article (such as may occur with ghost authors employed by industry)."

Two Canadian law professors have called for legal sanctions.
“It's fraudulent for academics to give their names to medical articles ghost written by pharmaceutical industry writers”, says Trudo Lemmens, one of the law professors, based at the University of Toronto.
“Studies suggest that industry-driven drug trials and industry-sponsored publications are more likely to downplay a drug's harms and exaggerate a drug's virtues”.
“The integrity of medical research is also harmed by ghost written articles.”
“False representation of authorship is in our view, fraud.”

Ghost writing is part of a marketing process that can distort the evidence of a drug.
Industry author's identities are concealed to enable insertion of marketing messages in the primary text, and academic experts are recruited as "guest" authors to lend credibility despite not fulfilling criteria for authorship, such as participating in the design of the study, gathering data, analysing the results and writing up of the findings.

Class actions involving drugs such as Vioxx, hormone replacement therapy and antidepressants suggest guest authors often fail to meet criteria for authorship, according to the policy paper in a recent issue of Public Library of Science's journal PloS Medicine.

In the article, Lemmens and his colleague Prof. Simon Stern argue that legal remedies are needed for medical ghost writing since medical journals, academic institutions and professional disciplinary bodies haven't succeeded in enforcing sanctions against the practice.
Ghost Writers make over $100,000 a year and if an article makes its way into a prestigious medical journal — like the Lancet, British Medical Journal, or The New England Journal of Medicine —that will earn up to $20,000 in an extra bonus payment.
“You’re being told what to do and if you don’t do it, you’ve lost the job”, said one ghost writer interviewed for a US TV segment.
“As long as I do my job well, it’s not up to me to decide how the drug is positioned. I’m just following the information I’m being given.”

 Once the article is written to the pharma company’s satisfaction, the pharma company then starts "shopping around" for an academic physician or physicians that are well known in the field, encouraging them to put their name on the article.

From there, they "massage" the article past peer review in one of the more prestigious medical journals, preferably one that strongly influences practicing doctors. Once the article is published, the pharmaceutical company then purchases tens of thousands of reprint copies to be distributed to doctor's offices by their pharmaceutical representatives. The unsuspecting doctor thinks the study is reliable since it clearly appears to be written by a leading name in the field, and has been published in a prestigious peer-reviewed medical journal.

Why would medical journals play along with this apparent sham?
Why aren't they doing more to eradicate this practice?

Perhaps the primary incentive to turn a blind eye is that it's very lucrative for them, as the reprints purchased by the pharmaceutical companies for distribution are quite expensive. And medical journals are, after all, for-profit businesses.
All these costs are added into the selling price for the drug, so it follows that if these practices were disallowed, there would be a facility to reduce drug prices by a large amount.

Even the institutions have divided loyalties which may explain why they've been slow to act.
For example, universities wish to protect academic integrity while also protecting their employees from unjust accusation.

It is thought that a legal response could act as a powerful deterrent. Even if the data in an article appearing in a peer-reviewed journal is accurate, misrepresentation of authorship still constitutes medical fraud.

Doctors, pharmacists and patients perceive published studies to be independent assessments made by academic experts.
The plot becomes even murkier, if ghost written publications are used in a court of law to support a manufacturer's arguments about a drug's safety and effectiveness.
Building on this deceit, academic experts who appear as witnesses for pharmaceutical and medical device companies also boost their credibility with these fraudulent publications on their CV. It’s a corrupt circular problem that has no end.

Lemmens and Stern suggest that imposing legal liability on guest authors in the U.S. "may give rise to claims that could be pursued in a class action based on the Racketeer Influenced and Corrupt Organizations Act (RICO)."

The policy paper and a related conference held at the University of Toronto in May were supported by a grant from the Social Sciences and Humanities Research Council on the Promotion of Integrity in Biomedical Research.

Summary:

* Ghost writing of medical journal articles raises serious ethical and legal concerns, bearing on the integrity of medical research and scientific evidence used in legal disputes.

*Medical journals, academic institutions, and professional disciplinary bodies have thus far failed to enforce effective sanctions.

* The practice of ghost writing could be deterred more effectively through the imposition of legal liability on the “guest authors” who lend their names to ghost written articles.

* A guest author's claim for credit of an article written by someone else constitutes legal fraud, and may give rise to claims (in the US) that could be pursued in a class action based on the Racketeer Influenced and Corrupt Organizations Act (RICO).

* The same fraud could support claims of “fraud on the court” against a pharmaceutical company that has used ghost written articles in litigation. This claim also appropriately reflects the negative impact of ghost writing on the legal system.

In Conclusion:

Doctors today commonly assert that they practice "scientific medicine," and patients think that the medical treatments they receive are "scientifically proven".
 However, this ideal is a dream, not reality, and a clever and profitable marketing ruse, not a fact.

The British Medical Journal's "Clinical Evidence" analysed common medical treatments to evaluate which are supported by sufficient reliable evidence (BMJ, 2007). They reviewed approximately 2,500 treatments and found:

• 13 percent were found to be beneficial

• 23 percent were likely to be beneficial

• Eight percent were as likely to be harmful as beneficial

• Six percent were unlikely to be beneficial

• Four percent were likely to be harmful or ineffective.

• 46 percent were unknown whether they were efficacious or harmful

In the late 1970s, the US government conducted a similar evaluation and found a strikingly similar result.
They found that only 10 percent to 20 percent of medical treatments had evidence of efficacy (Office of Technology Assessment, 1978).

It would appear that the conventional medical model, from start to finish, is pervasively corrupted with massive conflicts of interests that make it exceedingly difficult to make a rational decision in health matters.
One of the biggest complaints the conventional medical industry has against alternative medicine is the lack of scientific research to support their practices.
This perception needs to be revised and the medical house put in order before criticising other health practitioners. Pharmacists have been continually criticised by medical practitioners along similar lines – it is time to reject these claims, but it is also time for pharmacy to update its own clinical model.

The scientific method works and I personally uphold its principles, but it has been so perverted by corporate interests, that it becomes very difficult to find the truth.

If pharmacists are to be successful in developing ethical clinical practices, they will certainly need to be vigilant in their professional processes. They will need to establish and maintain their own databases of clinical evidence and have input into the TGA database when it emerges.
The lack of integrity in the whole of the medical industry, including pharmacy, also needs a revision. The November edition of i2P featured four articles involving pharmacist integrity or integrity-related issues.
It is suggested to pharmacists that you print out all relevant articles relating to integrity, medical fraud and evidence-based practice and use them as a reference base to re-invent your clinical practice for the year 2012.
That year looks like being a watershed year for pharmacy with continuing bankruptcies, a major round of unemployment for employed pharmacists and no business plan in place to develop clinical practices with new income streams.
There will be financially-generated pressures to cut corners – don’t be tempted.

And have a happy New Year!

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