s Three articles addressing details of buprenorphine treatment. | I2P: Information to Pharmacists - Archive
Publication Date 01/07/2014         Volume. 6 No. 6   
Information to Pharmacists

Editorial

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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News Flash

Newsflash Updates for July 2014

Newsflash Updates

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

Comments: 1

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Feature Contribution

Woolworths Pharmacy - Getting One Stage Closer

Neil Johnston

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

Comments: 5

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Intensive Exposition without crossing over with a supermarket

Fiona Sartoretto Verna AIAPP

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

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The sure way to drive business away

Gerald Quigley

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

Comments: 1

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‘Marketing Based Medicine’ – how bad is it?

Baz Bardoe

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

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Community Pharmacy Research - Are You Involved?

Mark Coleman

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

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Organisational Amnesia and the Lack of a Curator Inhibits Cultural Progress

Neil Johnston

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

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

Staff Writer

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

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I’ve been thinking about admitting wrong.

Mark Neuenschwander

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

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Dispensing errors – a ripple effect of damage

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

Most readers will be aware of recent publicity relating to dispensing errors and in particular to deaths caused by methotrexate being incorrectly packed in dose administration aids.
The Pharmacy Board of Australia (PBA), in its Communique of 13 June 2014, described a methotrexate packing error leading to the death of a patient and noted “extra vigilance is required to be exercised by pharmacists with these drugs”.
This same case was reported by A Current Affair (ACA) in its program on Friday 20 June
http://aca.ninemsn.com.au/article/8863098/prescription-drug-warning

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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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Three articles addressing details of buprenorphine treatment.

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.

Dear Colleagues,

Three interesting articles (citations below) have come out recently each addressing a limitation of buprenorphine in clinical practice. 
This week’s JAMA has a description of a trial using a depot form of buprenorphine in America. 
There is also a supporting editorial from Patrick O’Connor from Yale University who points out the restrictions of current opioid treatments and the need for alternatives. 
Unsurprisingly, the implant patients had more opiate-free urine tests (40%) than placebo patients (25%) and better retention (60% versus 30%). 
Just over 50% of the recipients reported significant local reactions at the implant sites, both active and placebo groups but none had to be removed early. 
One developed frank cellulitis.  The blood levels of buprenorphine were found to be in the low range yet it is pointed out that retention rate is about double that of trials of sublingual buprenorphine. 

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I find it hard to understand how the disadvantages of a fixed dose and surgical insertion of implants could outweigh the high patient acceptability and modest cost of custom dosing of sublingual buprenorphine.  

Rather than comparing the buprenorphine 80mg implants with evidence based methadone maintenance treatment (O’Connor calls it the ‘gold standard’ in his editorial) these veteran researchers used placebo implants and ‘rescue’ sub-lingual buprenorphine as a control group. 
Nor was there any third group for comparison with existing treatments. 
In my experience this is what is commonly seen in drug company funded trials aimed at marketing approval rather than scientific investigations to determine clinically important questions (see below).  O’Connor states that criticism of the use of a placebo group is moderated to some degree by the need for a definitive assessment of a new delivery method and the fact that the placebo group was smaller than the active cohort (55 versus 108) with supplemental sub-lingual buprenorphine available under certain circumstances. 
While this design may improve the statistical power of the findings, it lowers the credibility of the researchers involved in my view, like the HIV cases in Africa who were denied treatment ‘in the interests of science’. 
It must be said, sadly, that it is consistent with the much quoted statistic that up to 6 out of 7 American drug addicts are denied appropriate treatment.  

The reader is informed that the study was funded by a pharmaceutical company whose personnel collected and monitored data and were involved in the design of the study, management, analysis, and interpretation of the data and preparation, review, and approval of the manuscript. 
One is left wondering just what the named authors did by comparison with the anonymous ones. 
The researchers’ financial disclosure statement runs to 33 lines of small print. 
This may be a record in my own reading. 

Another report comes from Malaysia where the combination buprenorphine/naloxone tablet replaced the pure product which was being widely abused, including injecting. 
While there was a reduction in some harmful behaviour, the focus group reports make fascinating reading. 
They would appear to confirm James Bell’s finding that the combination product is significantly weaker than the pure product it replaced (a 50% increase was required on average). 
Malaysian patients here reported the need for double the dose for the same degree of effect when the antagonist was added, despite claims that its absorption is clinically insignificant.  

The present researchers, who had previously investigated HIV transmission in Kuala Lumpur, state: “ … the results of the second wave survey suggest a continuing widespread [intravenous use buprenorphine/naloxone], at least in Kuala Lumpur.”
“The introduction of BNX and withdrawal of BUP may have helped to reduce, but did not eliminate the problems with diversion and abuse.” 
Some addicts reported that the combination pill was not as desirable. 

These findings accord with Robinson’s report from New Zealand 20 years ago when injecting of buprenorphine combination was so prevalent that it was withdrawn from the market completely. 
They also quote Bruce et al who concluded in 2009 that introduction of combination buprenorphine to Malaysia ‘did not reduce BNX injection or associated risk behaviors’. 
His group also found that the change to combination buprenorphine was associated with increased quantities injected in about half of the patients interviewed. 
Their informants also reported that injecting smaller quantities of the combination product or using additives of benzodiazepines or heroin could avoid withdrawal reactions. 
Paradoxically, the change to a combination drug had made buprenorphine generally less attractive, more expensive and less available to addicts than street heroin in many cases. 
It is surprising that such a study has not been performed in Australia where both forms of the drug are available and widely used. 

The third report is from a group in New York which found high rates of precipitated withdrawal in commencements onto buprenorphine treatment (17%). 
Such reactions were more common with lower initial doses, recent methadone use and concurrent benzodiazepine use. 
To her great credit, Dr Whitley reported in 2007 on the co-locating of buprenorphine and methadone treatments. 
While she called this ‘novel’, for the rest of the world it is just normal. 
The American legislative requirement to isolate methadone prescribed patients is indeed bizarre and counter-productive.  

One problem with the high rate of precipitated withdrawals may have been due to the use of combination product containing the antagonist naloxone. 
This is contrary to the original American treatment guidelines which advised stabilising patients on pure buprenorphine before transferring to the combination product. 

Equivalence studies have still not been performed despite such research being relatively simple and cheap. 
Furthermore, despite 0.4mg pure product being marketed in Australia for ten years, there is still no low-dose combination product available (eg. 0.4mg or 0.2mg increments for those taking less than, say, 4mg daily). 
40 years of experience with methadone have shown that carefully graduated dose reductions are often necessary to achieve abstinence. 

It was the low potency preparations, both pure and combination, which became subject to wholesale abuse 20 years ago in New Zealand (Robinson, D&A Dependence 1993 13;1:86). 
I understand that in America the smallest tablet available is a non-bisectable 2mg pill, making reductions towards abstinence extremely challenging for patient and clinician alike. 
It would be like the lowest dose of methadone available being around 20mg daily in my estimation.  Some ultimately successful abstinence patients have taken very low doses for a long period before eventually ceasing their pharmacotherapy.  

Our own practice experience with buprenorphine inductions has been similar to what one might expect from the literature. 
We have had a very low rate of precipitated withdrawal reactions (<5%) but a failure rate for inductions of approximately 20-40%, mostly due to the drug not abolishing withdrawals. 
This is about double our failure rate with methadone. 
Our impression is that there are also excess early dropouts in those successfully inducted onto buprenorphine, as also reported by others. 

Personal disclosure: I first prescribed buprenorphine (off-label) in 1986 and have been an enthusiastic supporter of its use for dependency ever since. 
While methadone is the ‘gold standard’ it does not suit everyone with opioid dependency. 
For many years our dispensary has had about 20% of our opioid pharmacotherapy patients taking (pure) buprenorphine. 
I personally do not prescribe the combination product due to the lack of safety and equivalence data as well as a lack of the 0.4mg preparation allowing low-dose titration. 
Our Concord Dependency Seminar group receives sponsorship for refreshments by Reckitt Benckiser who have also generously donated a data projector.  

Comments by Andrew Byrne ..

Full citations: 

Ling W, Casadonte P, Bigelow G, Kampman KM, Patkar A, Bailey GL, Rosenthal RN, Beebe KL. Buprenorphine Implants for Treatment of Opioid Dependence A Randomized Controlled Trial. JAMA 2010 304;14:1576-1583

Vicknasingam B, Mazlan M, Schottenfeld RS, Chawarski MC. Injection of buprenorphine and buprenorphine/naloxone tablets in Malaysia. Drug and Alcohol Dependence 2010 111;1/2:44-
http://www.ncbi.nlm.nih.gov/pubmed/20478668  

Whitley SD, Sohler NL, Kunins HV, Giovanniello A, Li X, Sacajiu G, Cunningham CO. Factors associated with complicated buprenorphine inductions. J Subst Abuse Treat. 2010 39;1:51-57

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