s Noble attempt to tease out benefits of dose supervision in OTP. | 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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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
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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Noble attempt to tease out benefits of dose supervision in OTP.

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.

Noble attempt to tease out benefits of dose supervision in OTP.
Holland R, Maskrey V, Swift L, Notley C, Robinson A, Nagar J, Gale T, Kouimtsidis C. Treatment retention, drug use and social functioning outcomes in those receiving 3 months versus 1 month of supervised opioid maintenance treatment. Results from the Super C randomized controlled trial. Addiction 2014 109;4:596-604

Summary: Dose supervision is the last frontier of our OTP evidence base. All seem agreed with early supervised induction doses yet there are very different views on the use of unsupervised (take-home/take-away) doses and when these can safely be introduced. The UK has commonly used unsupervised methadone while America and France introduced unsupervised buprenorphine despite virtually no research on these protocols (Fudala used supervision for most of his trial). This second attempt, although inconclusive, should encourage these authors to try again, perhaps using some international input.

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Dear Colleagues,

These authors assessed 627 patients entering opioid maintenance treatment of whom 32% were deemed to need daily, supervised doses and 5% were deemed to need (or ‘deserve’?) unsupervised dosing.  Another ~15% were excluded for other reasons, leaving 298 subjects who were randomised to 3 months daily supervised dosing or daily dose collection with self administration, at the clinician's discretion after the first month of daily supervised dosing.  The primary outcome was retention at 3 months which showed no significant difference (74% in the un-supervised group versus 60%).  By 6 months the retention was within 1% for the two groups, approximately 55% a finding which is in keeping with other reports (Bell 2006).   Nor were any differences found in illicit opioid use. 

Some ‘trends’ here seemed to run contrary to a pilot study in Scotland by the same first author yet these differences are not addressed directly although another study from Italy is quoted as being consistent in some respects.  It would be a spurious to conclude that ‘no significant difference’ proves ‘supervision is unnecessary’ until or unless a larger and more rigorous study were conducted. 

This protocol also prevents a valid comparison with other studies comparing varying numbers of dispensed doses each week (see Rhoades et al. who examined 2 versus 5 dispensed doses weekly on two dose levels).

Some parts of the UK have poor quality maintenance treatments: very little methadone was supervised and doses were often grossly inadequate (mean 37mg daily in 1999 according to J. Strang and Sheridan).  It should therefore be of no surprise that there is a vigorous market locally for illicit opioid including methadone (more than one third of these subjects reported the use of illicit methadone on entering treatment).  Furthermore OTP in the UK has a poor ‘image’ it would appear. 

This study by Holland et al. excluded fully half the possible subjects based on whether the clinician believed the patient did or did not need supervised dosing, the very subject which the researchers are trying to test.  It makes rather a mess of the thesis being examined … yet this subject is serious and worthy of debating and research which has been sorely lacking to date. 

The authors point out that the data were collected by existing staff which may introduce a favour bias.  Many UK clinicians defend unsupervised treatment yet there is still no controlled research to demonstrate its safety and effectiveness (and much to indicate that opioid maintenance in the UK is a disaster with the government effectively trying to ban all but reduction treatment programs if my reading is correct).  I believe that as with Rhoades work, the effort should be to carefully examine the use of extended take-home protocols and examine the numerous outcome measures.  Of course one cannot perform a double blind trial of two such physically different interventions. 

In America over the past ten years a national guideline (not evidence based in my view) has allowed many patients to take 4 weeks supply of methadone (one supervised dose plus 27 take-home bottles) even after a relatively short period of documented stability.  Yet I could find no published research on this ‘noble experiment’ apart from the very old monthly maintenance trial at Beth Israel, New York (Novick et al.) which mostly had positive results. 

Holland et al. discuss an apparently significant finding in their data whereby unsupervised patients seem to be involved in less crime.  However, they to not canvass the possibility that those receiving unsupervised methadone may have less financial pressure if selling a proportion of their medication.  When I contacted the authors I was told this was a possibility despite denials of diversion in patient questionnaires.  The mean daily dose (sent to my kindly by the first author) at 58mg is in fact less than the minimum effective dose for the majority of patients as quoted by Strang’s group at 60mg daily.  They advised 60-120mg daily for most opiate dependent patients.  The dose level of buprenorphine was much the same as elsewhere at 10.5mg daily (for which I thank Dr Holland).  Vincent Dole, whose group originally devised methadone maintenance treatment in New York, stated that with appropriate treatment illicit opiate use should be eliminated in 90% of dependent individuals.  But this requires sufficient psychosocial support, adequate doses and some degree of supervision. 

The elephant in the room on this subject, not addressed by these authors, is public perception.  It is far easier to justify a program which supervises methadone doses for a population who, by definition, have lost some control over their drug use.  As these authors state at the start of their article: “Supervision ensures that patients take their medication as prescribed and prevents illicit drug diversion [sic].” Daily supervised treatment (often with one take-home dose for Sunday) is the proven standard for treatment induction, as long as there is no contraindication (homelessness, actively using family members, current psychosis, acute concurrent alcoholism, etc where even Sunday supervision is advised where possible). 

As in other fields of medicine all decisions should be reviewed in light of the patient’s response to treatment, in this case, judged by attendance, self-report, physical examination of veins, pupils, etc and urine or blood testing.  Most patients can be successfully treated by second or third daily attendance within the first year in our experience (meaning 3 to 5 take-home doses weekly).  Increased supervision occasionally has to be reintroduced if the clinician and or the patient finds their control is again being lost.  Others can move to less frequent attendance before leaving treatment after sufficient time on reducing dose schedules when this is tolerated. 

Another ‘canard’ is prison entry.  For an inmate on supervised treatment a dose, any dose level can confidently be administered on receipt of written confirmation of last-dose and ID information from the community pharmacy or clinic.  For non-supervised patients however, prison medical staff are obliged to follow induction protocols in the case of a patient who might not be taking all of their daily doses.  In such a case even a single dose could be fatal (~70mg is considered a lethal dose in non-dependent adults where the average dose on most well run programs is higher than this). 

Comments by Andrew Byrne ..  Andrew's blog http://ajbtravels.blogspot.com/   

http://methadone-research.blogspot.com/

Declaration of potential conflict of interest: Dr Byrne’s clinic charges a fee for supervising the administration of methadone and buprenorphine. 

References:

Holland R, Matheson C, Anthony G, Roberts K, Priyardarshi S, Macrae A, Whitelaw E, Appavoo S, Bond C. A pilot randomised controlled trial of brief versus twice weekly versus standard supervised consumption in patients on opiate maintenance treatment. D&A Rev 2012 6:483-91

Strang J, Sheridan J, Hunt C, Kerr B, Gerada C, Pringle M. The prescribing of methadone and other opioids to addicts: national survey of GPs in England and Wales. Brit J General Practice 2005 55;515: 444-451

Rhoades HM, Creson D, Elk R, Schmitz J, Grabowski J.  Retention, HIV Risk, and Illicit Drug Use during Treatment: Methadone Dose and Visit Frequency. 1998 Am J Public Health 88:34-39

Novick DM, Joseph H, Salsitz EA, Kalin MF, Keefe JB, Miller EL, Richman BL. Outcomes of Treatment of Socially Rehabilitated Methadone Maintenance Patients in Physician's Offices (Medical Maintenance). J Gen Intern Med. 1994 9:127-30

Fudala PJ, Bridge TP, Herbert S, Williford WO, Chiang CN, Jones K, Collins J, Raisch D, Casadonte P, Goldsmith RJ, Ling W, Malkerneker U, McNicholas L, Renner J, Stine S, Tusel D. Office-Based Treatment of Opiate Addiction with a Sublingual-Tablet Formulation of Buprenorphine and Naloxone. NEJM (2003) 349:949-958

Drug Misuse and Dependence - Guidelines on Clinical Management. (1999) HMSO Department of Health. Working Group Chair: Strang J.

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