s Eric Strain talks about the buprenorphine film. | I2P: Information to Pharmacists - Archive
Publication Date 01/07/2014         Volume. 6 No. 6   
Information to Pharmacists


From the desk of the editor

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

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Newsflash Updates for July 2014

Newsflash Updates

Regular weekly updates that supplement the regular monthly homepage edition of i2P. 
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Feature Contribution

Woolworths Pharmacy - Getting One Stage Closer

Neil Johnston

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

Comments: 5

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Intensive Exposition without crossing over with a supermarket

Fiona Sartoretto Verna AIAPP

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

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The sure way to drive business away

Gerald Quigley

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

Comments: 1

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‘Marketing Based Medicine’ – how bad is it?

Baz Bardoe

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

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Community Pharmacy Research - Are You Involved?

Mark Coleman

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

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Organisational Amnesia and the Lack of a Curator Inhibits Cultural Progress

Neil Johnston

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

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

Staff Writer

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

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I’ve been thinking about admitting wrong.

Mark Neuenschwander

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

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Dispensing errors – a ripple effect of damage

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

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

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Take a vacation from your vocation

Harvey Mackay

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

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Explainer: what is peer review?

Staff Writer

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

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Dentists from the dark side?

Loretta Marron OAM BSc

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

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Planning for Profit in 2015 – Your key to Business Success

Chris Foster

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

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ReWalk™ Personal Exoskeleton System Cleared by FDA for Home Use

Staff Writer

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

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Attracting and Retaining Great People

Barry Urquhart

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

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Updating Your Values - Extending Your Culture

Neil Johnston

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

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

Staff Writer

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

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

Staff Writer

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

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

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Culture Drive & Pharmacy Renewal

Neil Johnston

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

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ReWalk™ Personal Exoskeleton System Cleared by FDA for Home Use

Staff Writer

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

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Pharmacy 2014 - Pharmacy Management Conference

Neil Johnston

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

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Generation and Application of Community Pharmacy Research

Neil Johnston

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

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Eric Strain talks about the buprenorphine film.

Dr Andrew Byrne & Associates

articles by this author...

A Harm-Minimisation Research Perspective: Dr Byrne (and his associates) advocate for better policies which are proven to reduce risks for drug users and the general community, under a framework in parallel with Australia’s official policy of harm minimisation.

Clinical Advances in the management of opiate dependence.

Friday 11th March & Saturday 12th March. Intercontinental Hotel, Sydney, Australia.

“Suboxone Sublingual Film - the US Experience”

Organised by the Reckitt Benckiser company.

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While this conference had been billed initially as an update in opioid pharmacotherapies, there were rumours around that it was actually a product launch. Indeed, the first power-point slide stated: "Suboxone Sublingual Film - the US Experience". Professor Eric Strain’s presentation kicked off the first of two papers on the Friday afternoon after a delightful luncheon in the Café Opera provided by the company. I first heard about a mooted wafer version of buprenorphine numerous years ago and was surprised to find that it is now being approved in Australia.

Drug research guru Eric Strain from Johns Hopkins in Baltimore spoke to an audience of about 80 doctors from around Australia and overseas who were welcomed by meeting chair Dr Sue Ballantyne from Brisbane. Unlike most such national and international meetings, I understand that the entire event, travel, meals, transfers and accommodation were all funded by the manufacturer. Indeed, one had the feeling that this was closer to advertising a new product than a balanced educational session.

Dr Strain said that in response to reports of childhood poisonings, diversion and other problems with Suboxone sub-lingual tablets, the film version was developed. There were three main pieces of evidence supporting the ‘film’ (or wafer) … initially there were trials in volunteers of the film with pharmacological data measuring absorption - these were part of the registration process but have not been published. We were shown graphs of detailed blood levels, where the films were substantially better absorbed than the buprenorphine tablets with which they were compared. The levels in the hours after administration were shown to be consistently 20 - 28% higher in subjects given the film versus tablets. Then we were told of some strangely contradictory clinical research work showing that patients who were transferred to the ‘film’ version noted less effect from the film formulation, despite the higher levels in the parallel studies on non-addict volunteers. This was just one of numerous worrying inconsistencies in the field revealed on the day.

We were told that the combination version with naloxone has been approved in the US for about six months and I recall Dr Strain saying that it has now taken a large market share (50% or more in some areas, if I heard correctly).

The speaker then described his own trial in some detail, including the rationale for performing it, something which is not made clear in the article itself. It examined withdrawal symptom indices during the initiation period in two groups taking (1) pure buprenorphine films and the (2) combination film. Performed in volunteers, it showed no difference, although of course this does not prove that they are equivalent. Dr Strain explained that the need for the trial was the [allegedly unfair and inappropriate] FDA requirement under the long-standing US treatment guidelines that patients should be stabilised on pure buprenorphine and only transferred to the combination product later if appropriate (and never in pregnant or potentially pregnant women). He told the audience that few American doctors actually followed this rule and that the Reckitt company was actively fighting to have the provision removed by the FDA. To my mind the use of pure buprenorphine in new patients is just logical for new patients, just as with insulin, warfarin, cortisone or lithium. There may be other commercial implications but these should be secondary to good therapeutics. His study in essence showed what he wanted: that there was no significant difference in induction withdrawals between pure and combination product.

[Comment by AB: I can see why the company might be pressing for this sort of research to be done, yet it would seem to be a low priority clinically when there are so many unknowns in the field. It seems odd that an august institution like Johns Hopkins Medical Center would follow commercial considerations to this extent. As just one example, to date there has still been no simple ‘head to head’ comparison of the combination product against pure buprenorphine despite strong but unsubstantiated contentions from some quarters that they are the same. One non-blinded trial showed that stable patients sought 50% higher doses when transferred to the combination product (see below). The work that Dr Strain discussed at this very conference indicates that absorption is also affected by other constituents. Nor has there been any research to my knowledge on the important matter of patient matching, except by ‘trial and error’ which is hardly scientific.

Equally, there has been no persuasive community evidence produced to suggest that the combination product is any less likely to be abused or diverted than the pure product. Its parallel (pure) product for analgesia was widely abused in New Zealand according to Robinson’s report in D&A Dependence in 1991 (ref below). After nation-wide replacement of pure buprenorphine with the combination version (but with three times as much naloxone per mg) the subjects attending an addiction clinic who used/abused buprenorphine had dropped from 81% to 64%. This is a modest reduction indeed, especially considering the claims by some that naloxone inclusion reduces injecting substantially. At the same time Robinson reported that pharmaceutical morphine use increased from 68% to 86% (and morphine is a much more dangerous drug when used without supervision). Buprenorphine was subsequently withdrawn altogether in New Zealand and not reintroduced for almost 20 years. End of ‘editorial’!]

Dr Strain told the audience that the new formulation came in individual packs which were peeled open to reveal their contents which was a square or rectangle of gel-film which was then inserted by the patient under their tongue. It was hard to remove manually as it quickly merged with the buccal mucosa. Dr Strain went into some detail about why pink/orange was chosen to match the Suboxone tablets (he was surprised to learn from a delegate sitting nearby that in Australia Suboxone is not orange but white). The company may not know that in Australia the drug is often supervised (the only places I know where this does NOT occur by regulation are France and the US). Thus pink/orange may be the most difficult to detect in a patient’s mouth. Also, rather than a peel-pack, an applicator or inserter might be more practical, especially the custodial setting where large numbers of patients need to be given doses in a short space of time. A bright and contrasting colour would seem more sensible … so more effective consultation before introduction might have served the manufacturer and consumers better. This may also explain the fact that the company does not market a formulation smaller than 2mg. Many patients on Subutex are taking reducing (or sometimes increasing) increments of 0.4mg. In my experience most patients who successfully withdraw from the drug nearly always do so from such doses which are well under 2mg daily. It is a mystery to me why the company do not make smaller sized buprenorphine SL tablets available more widely. A sceptical reader might think that the company is more interested in patients remaining on treatment than in those seeking abstinence.

Apart from reports of diversion (which Dr Strain said “where there’s a will there’s a way” or words to that effect), another part of the development rationale included worrying reports of children and even babies involved in Suboxone toxicity incidents in American emergency rooms. While Dr Strain initially raised this issue, when he was asked for details by an audience member at the end he said that he did not know any more about such events. I note that he states in his recently published article (page 1) “unintentional exposure to B tablets in children under the age of 6 years has increased from 53 reported exposures in 2004 to 907 in 2008; from 2000 to 2008 there were 1,786 child-hood exposures to B”. This would seem to have answered the delegate’s enquiry to a tee.

Strain claimed that the use of the new “films” would be likely to reduce such occurrences … and one can only hope that he is right. Apparently Suboxone is presented as loose tablets in a bottle in America whereas elsewhere it is supplied in sealed blister packs. Further, the colour and flavour of Suboxone in America could make them much more interesting to young children than Subutex without the orange colouring and citrus flavouring. The pure formulation is indeed disgusting and children who tasted it would be most likely to quickly spit it out. Some Australian observers may think that we are being sold an American solution to an American problem.

We were told that there were about 300,000 taking buprenorphine in America on any one day. The total taking methadone maintenance in America was probably about 200,000 - and by law these were all restricted to registered clinics giving ‘comprehensive treatment’ under close supervision.

In answer to another question Dr Strain said that officially the next step in someone who was doing well on 2mg reductions was to go to second daily. Although second daily dosing can work well for maintenance patients, since reducing-dose patients are usually in withdrawals by the end of 24 hours the prospect of second daily dosing is just inappropriate when there is an option of reduction to 1.6mg. Unofficially, however, he said that the logical thing to do was to cut the tablet or patch in half. He said that Reckitts had said that they could not guarantee that the drug was evenly distributed amongst the dry tablet or the patch … yet Dr Strain said that this was not really tenable when the company seemed happy that the rectangle, cut from a large sheet of spray-dried film, was the same strength as the same sized rectangle next to it. This is another inconsistency of the presentation where the obvious answer was to use 0.4mg tablets which are commonly available in Australia at least.

Dr Strain’s conflict statement was given and I presume is the same as in his recent publication: “Dr Strain is a consultant to and paid member of the Scientific Advisory Board of Reckitt Benckiser Pharmaceuticals. The terms of this arrangement are being managed by the Johns Hopkins University in accordance with its conflict of interest policies.”

Refs: Robinson GM, Dukes PD, Robinson BJ, Cooke RR, Mahoney GN. The misuse of buprenorphine and a buprenorphine-naloxone combination in Wellington, New Zealand. Drug Alcohol Dependence (1993) 33;1:81-6

Bell J, Byron G, Gibson A, Morris A. A pilot study of buprenorphine-naloxone combination tablet (Suboxone®) in treatment of opioid dependence. Drug Alcohol Rev 2004 23;3:311-318

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