s New York Pain Conference | 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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New York Pain Conference

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.

Pain and addiction conference, Beth Israel Medical Center. Friday 19th and Sat 20th March 2010.

“Emerging Practices in Pain and Chemical Dependency - 2010 Update on Opioid Therapy” 

Times have changed since I attended a Darwinian progenitor of this pain conference in New York in 1996.  The present conference was held at the Times Square Marquis Marriott Hotel, starting promptly at 7.30am.  The conference room was crowded with perhaps 300 attending.  I sat in the front row, near convenor Dr Russell Portenoy, pain expert from Beth Israel Medical Center.  Also present at the front were Ricardo Cruciani, expert on cardiac effects in methadone pain patients; Joyce Lowinson, editor of the big text on dependency; Herman Joseph; Mary Jeanne Kreek; Charles Inturrisi and Howard Heit.  The latter is a close research colleague of Canadian pain and dependency expert Doug Gourlay.

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Each speaker gave a list of potential conflicts of interest including sponsorship from drug companies. One quipped that in the past this declaration was considered a badge of honour. Nowadays however, we were told, it was more a matter of shame! It is interesting to consider the different situations of speakers with one single declared conflict of interest over those with many. “Render unto Caesar …”.

Howard Heit gave the second key-note dissertation entitled ‘Understanding risk in terms of chemical dependency: abuse, addiction and diversion during pain treatment’. In it he quoted his recent article with Dr Doug Gourlay (‘Universal Precautions Revisited’ 2009) with its ‘ten point rules’ for assessing risk of dependency. He called them his Ten Commandments. These carefully codify what should normally be done in good practice: history and physical; differential diagnosis; patient education and consent (oral/written); treatment trial; clinical review … and finally: careful documentation of each step. These are part of the clinical interaction which can help reveal features of substance use instability as well as the benefits or otherwise of current pain treatment.

Dr Heit also covered pseudo-addiction in the pain patient (usually diagnosed in retrospect).  He reminded us that all medical interventions need an ‘exit strategy’, outlining a way of contracting with the patient what might occur if all else failed in the therapeutic relationship.  He spoke about a “golden moment” in the patient’s ‘growth’ when they realised they are through playing games and are addicted.  This acceptance of addiction and associated lack of control can be very moving.  A Sydney colleague once described this, saying the patient always had a tear in the eye as it was related.  We were reminded about the continuum between chronic pain and addiction and the need to treat according to individual need, utilising all the means at our disposal after non-opioid measures have failed … including dose supervision, urine testing, drug diary, counselling, adjuvant prescribing (eg. antidepressants, anxiolytics) etc. 

Dr Ricardo Cruciani gave a talk about choice of opioid and matching patient to appropriate treatment.  He placed opioid prescribing into its proper clinical context along with other physical, surgical, psychological, life-style and alternative pharmacological approaches.  He advised that in the absence of clear evidence opioid treatment is still considered effective and ‘conventional’ in many clinical settings.  We were reminded of the risks of all such prescribing: abuse, addiction, diversion and overdose.  Dr Cruciani broached the rising incidence of deaths involving methadone which was explained by Herman Joseph in question time as being related to the recent expansion of its use in pain patients.  The long half life of methadone has particular benefits in pain management but also requires that physicians be wary of dose escalations which can be toxic. 

Dr Cruciani also gave one of the three morning break-out sessions entitled “Methadone Cardiac Toxicity”.  I was disappointed that he used such a ‘loaded’ title when methadone has still not been scientifically proven to have any clinical cardiac toxicity and may indeed be cardio-protective.  Methadone is associated with electrical changes to the QT interval which are nearly always asymptomatic.  Dr Cruciani gave a roll-out of the literature with more about the ‘unknowns’ that the ‘knowns’.  He repeated that more research needed to be done but did not seem to be aware of the 2009 publication from Norway which has discounted the worrying conclusions he quoted from the studies of Chugh and Fanoe.  These both concluded that torsade may be very common, yet  Anchersen’s comprehensive national study did not find one single confirmed arrhythmia case out of 90 deceased methadone patients in a 7 year period in Norway.  Dr Cruciani correctly emphasised how little we know about torsade de pointes tachycardia and the (supposed) toxicity of methadone.  I believe that this is largely due to the small number of cases ever seen in normal dependency or pain practice.  I continue to meet doctors who have worked full-time in this area for decades without seeing a single case of syncope due to torsade de pointes.  Two experienced colleagues responded separately from Melbourne this month - one had just seen his first case, an older female patient, the other had seen none in 20 years. 

Rather than having cardiac toxicity, it is quite possible that methadone treatment (at least for addiction) promotes cardiac health as pointed out eloquently by Mori Krantz in his paper with Stewart Leavitt from 2001.  This involves a likely lower risk of endocarditis, dyslipidaemia interventions, blood pressure treatment and smoking cessation which are all thought to be better in those taking methadone than in those using street drugs.  There is also some indication of lower rates of myocardial infarction in MMT subjects.  Dr Lisa Borg’s work has shown that higher doses of methadone can reduce cocaine use while the work of Forest Tennant has implied that in some cases alcohol use may diminish in those prescribed methadone.  Both of these could be expected to cause less cardiac irritability and lowered chance of torsade, quite contrary to the prevailing scare campaign. 

It is to his credit that Dr Cruciani has consistently said that there is still no evidence to alter existing practice.  However, he leaves the door open to further research which might do so … and that caution needs to be exercised regarding the risk of torsade tachycardia.  It was just a shame that he did not separate the two clear clinical groups: the young, ‘uncomplicated’ opioid users or pain subjects who have virtually no risk of this complication … as contrasted with an older, more complex group in which torsade risk is a reality, albeit very low.  Reddy’s study from Texas has shown prospectively that methadone is safe in cancer patients even though QT intervals are often raised even before patients were prescribed the methadone.  All clinicians who prescribe methadone will have to learn to deal with this problem as our patients get older and other life-saving drugs are co-prescribed (most notably anti-virals and anti-fungals).  However presently, few will encounter more than one or two in a clinical lifetime so collaboration is essential to elucidate the best ways to deal with torsade de pointes cases. 

I asked Dr Cruciani a loaded question regarding the use of methadone in over a million patients under close supervision and whether the almost complete absence of confirmed torsade deaths and paucity of non-fatal torsade reports were not better than the prospective evidence he and his ‘expert panel’ were calling for.  Dr Cruciani seemed annoyed at the question and alluded to my suggestion of ignoring the cardiac risk until it was proven.  I had stated that doctors who were ignorant of the issue probably give their patients better quality treatment than those who worry over it, thereby restricting doses or using a less effective drug in cases where there is a choice. 

Dr Cruciani said that he would not advise anyone to ignore this issue.  The evidence is now overwhelming that the minor but important issue of possible cardiac toxicity of methadone has been fanned along by ignorance, the long-standing prejudice against methadone and also strong commercial considerations.  My view is to treat all patients individually.  The risk of torsade - and many other rare but serious events - can be stratified and possibly prevented using simple clinical details.  Screening ECG was recommended by only one of 13 citations given (Krantz 2009 did; Krantz 2007 did not: ‘for high risk patients’).  A compulsory ECG in the present state of knowledge (or ignorance) is more likely to harm the patient than help them in my view.  The largest literature review by Justo found that 85-100% of torsade cases had predisposing factors such as hypokalemia, structural heart disease, older age, QT prolonging drugs, drugs slowing methadone metabolism, female sex, older age, HIV status, alcohol use/withdrawal, stimulant use, inter alia. 

We then had two interesting talks which probably only had peripheral relevance to doctors and patients in the fields of addiction and pain management.  Firstly Mary Jeanne Kreek spoke about genetic aspects of addiction and the work her lab has been doing for over twenty years.  While she gave an excellent summary of the natural history of addiction, I venture to say that, while fascinating academically and promising for the future, few if any of their recent scientific papers on this subject have been of direct benefit to patients or public health.  Dr. Kreek also provided some interesting insights about the early days at Rockefeller University working with Drs Dole and Nyswander.  Dr Kreek omitted to mention that it was in fact Dr Robert Halliday in Vancouver who first used methadone for opioid addiction between 1959 and 1964.  There were, however, major conceptual differences (Newman, 2009). 

Dr Charles Inturissi then spoke about ‘hyperalgesia’ in those taking opioids short and long term.  Once again, apart from the obvious situations of withdrawal and break-through pain, the relevance of such albeit interesting findings of ‘priming’, conditioning and increased pain sensitivity in some at certain periods seemed a long way from the clinical setting.  If patients are still in significant discomfort they deserve consideration of a higher dose of additional medication/modality for relief of those symptoms.  Much of clinical medicine involves relatively simple ‘trial and error’ strategies while the complex diagnostics/therapeutics are more the exception than the rule in my experience. 

A lunch time talk by FDA official Mark Caverly quipped about the space shuttle having a supply of opioids which had passed their expiry date and needed to be destroyed. This normally requires a visit from an FDA official but an exception was made and the expired drugs were put into a fatal orbit and was witnessed by Hubble telescope to burn up on re-entry to the atmosphere (laughter from lunchtime audience).  It is a interesting that nobody even considered that perhaps American law would not extend to outer space!  On a more serious note, we were told that the FDA did not visit doctor’s offices very often - and when they did they did so “to help”. There are American doctors in jail for what in many other countries would have been considered a relatively minor infringements of technical regulations on prescribing.  As he also pointed out (and as it is in Australia too), the standard of health care is regulated by the States and FDA and national legislation only has overarching responsibilities under the Controlled Substance Act of 1970 (‘TGA’ in Australia). 

In the first session after lunch (of salad, poached chicken, followed by blanc-mange) Dr Steven Passik spoke about numerous new medications which are either in development or recently released which contain constituents which are aimed at less abuse.  In each case he referred to certain benefits, most of which consisted of quite modest trends, that there were fewer subjects likely to misuse particular medications, the prototype being combination buprenorphine utilising naloxone (originally used and discredited and withdrawn in the early 1990s in New Zealand). 

Dr Passik mentioned a combination of morphine with naltrexone (Embeda, approved by FDA in 2009).  This hardly sounded possible until he revealed that the antagonist was contained in a vitreous bead in the center of the pill which would normally not be absorbed but would pass intact through the gut.  The theory is that if drug mis-users crushed the pill indiscriminately they could get a rude shock if injecting anything containing naltrexone which is a long acting opioid antagonist.  In certain circumstances it could also be quite dangerous, inducing persistent vomiting and dehydration (this was not discussed). 

Another combination in the final stages of approval was hydromorphone in a viscous gel which it was believed would discourage injecting.  Another method was to use the ‘push-pull’ osmotic controlled delivery system which also delayed absorption according to the membrane put around a tablet which may also have some short acting component for pain control.  Oxycodone provided in waxy micro-particles is another as yet investigational product under trial at present (“Deter-Ex”).  Yet another is the ‘Oros’ technology which has an internal membrane for slow delivery of drugs such as methylphenidate (already approved) and hydromorphone (under investigation). 

Niacin (vitamin B3) can also be added to other drugs to induce an unpleasant flushing (‘niacin reaction’) if taken at certain high dose levels.  This raises the issue that adding just about anything to an opioid will make is less attractive to drug users, just like adding anything to neat alcohol will do likewise for an undiscerning alcoholic. 

Dr Passik was at pains to point out that for every combination and anti-abuse device developed, there were those intent on thwarting the attempts.  He detailed various ways including differential dissolution in water or alcohol, chemically manipulating them or simply crushing tablets intended to be swallowed whole. 

Dr Passik did not touch on the issue that these medications are invariably far more expensive than morphine, methadone, aspirin, acetaminophen or most of the NSAIDs (eg. ibuprofen).  This is related to the new opportunities for drug companies to re-patent old drugs and secure higher prices for what are essentially cheap drugs with modest development costs compared to brand new drugs. 

As with all these mixtures, the manufacturers have not considered that the most likely person to abuse such a drug is an existing buprenorphine pharmacotherapy patient who could probably inject the combination with impunity as happened in New Zealand in 1991 as documented carefully in Robinson’s famous paper in D&A Dependence (1993 33;1:81-6). 

In question time Dr Passik was asked (by me) if there were any other areas of medicine in which a second drug of no immediate benefit to the patient was added to known effective medications in this way.  He said that he was not, but that compulsory treatment for tuberculosis might have some parallels.  He did not cite the old use of naloxone with methadone invented in the 1970s and reported at one of the very first methadone conferences.  This was quickly dropped as a ‘useless precaution’ (see Barber of Seville, Rossini 1813). 

Yet another of these ethicals was reportedly released for use in America in March 2010: a waxy new Oxycontin formulation. 

In parallel to the research on diversion potential, there is not much carefully controlled comparative research to show equivalence of efficacy of these new formulations, nor was this required by the FDA in all cases, such as Suboxone.  The only small pilot study (n=17) showed that changing to the mixed product required a 50% increase in dose for the average patient when compared to the pure product, Subutex.  This has never been replicated in other studies to my knowledge.  Dr Russell Portenoy had detailed to the audience the importance of differentiating the concepts of efficacy and effectiveness.  “Efficacy” is the ability of the drug when administered to obtain the desired effects whereas “effectiveness” goes further and determines if the benefits outweigh the costs and side effects in the field. 

Saturday’s opening plenary was by Dr Martin Cheatle from Philadelphia who spoke with clarity about the prevalence of chronic non-cancer pain and the consequences of inadequate treatment.  These included delayed healing, depression, stress, suicide and addiction.  Up to 50 million Americans may suffer from this at some time and as many as 40% reporting inadequate pain relief from treatment received.  The conflicting pressures in primary care were broached, initially the essential nature of opioid prescription for serious pain, yet the reported increase in non-medical use of opioid drugs increasing four-fold from 1990 to 2002, up to 2.5 million citizens being involved. 

The second day saw yet another talk about opioid regulations (State regulations by Dr Aaron Gibson of the Carbone Cancer Center in Madison, Wisconsin.  He tried to reassure the audience that visits by regulators to doctor’s offices hardly ever happen and they are not in the business of putting doctors in jail.  More than any other country, I understand that America convicts doctors for matters relating to psycho-active drug prescribing.  Many of us have colleagues who have experience it, and often in circumstances which, while always regrettable, are not always the ‘hanging’ offences they are made out to be by the authorities who seem to need to make an example of such souls. 

At another session entitled “Office-Based Buprenorphine Therapy for Opioid Addiction: Lessons for Pain Management” Randy M. Seewald of BIMC gave an enlightened description of her lower Manhattan dependency practice.  Having originally worked in the hospital and methadone clinic system, she found private office practice to be liberating as well as challenging.  One main difference was that in her new ‘middle class’ subjects drug diversion was a minor concern rather than the constant bug-bear it can be in the clinic population.  Although unable to prescribe methadone in parallel with buprenorphine, and despite having ties with the buprenorphine manufacturer, she was frank enough to say that if one could have only one drug, her choice would be for methadone. 

Dr Seewald told us of the high retention rates in her practice … but this corresponded with low rates of successful withdrawal from buprenorphine – she only related one or two cases.  In question time I raised the matter of smaller dose increments than 2mg in the virtually unbisectable Suboxone tablets.  Dr Seewald had used the 2mg Subutex which can be broken in two but 0.4 or 0.2mg sublingual preparations are apparently not available in America (perhaps the company wants patients to remain on their drug for life!).  There was a discussion about the legal but off-label prescribing of Suboxone for pain management which paradoxically in America requires no special licence as it does for addiction patients, even at the same dose levels. 

Comments by Andrew Byrne .. http://methadone-research.blogspot.com/

References:

Krantz MJ. Clinical Concepts- Cardiovascular Health in MMT Patients. Addiction Treatment Forum 2001 No 4 http://www.atforum.com/SiteRoot/pages/current_pastissues/fall2001.shtml#anchor1222388

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