s Fingers crossed as FDA considers drug bar code packaging rule | 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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Fingers crossed as FDA considers drug bar code packaging rule

Mark Neuenschwander

articles by this author...

Mark Neuenschwander has earned his reputation as one of the nations' leading authorities on dispensing and point of administration automation. Whether writing, lecturing or problem solving with a client, Mark communicates in terms and concepts that are easy to grasp and apply. His fresh perspective and keen insight stem from having invested thousands of hours in research and in-depth consulting with clients.

I’ve been thinking about baseball, movies, ambiguous bar codes, and the FDA.
On June 26, 1974, New York Yankee All-Star Derek Jeter was born, two-time Academy Award winner Elizabeth Taylor divorced (for the fifth time), and Sharon Buchanan, a young grocery clerk in Troy, Ohio, was the first ever to ring up a retail purchase by scanning a bar code. On the same day in 2011, I drove from Arlington, Virginia, to Silver Spring, Maryland, to meet with people at the FDA to talk about the future of bar-code labeling on drug packaging.

Speaking of movies and baseball, did you enjoy Sandlot as much as I? The movie is set in a Los Angeles suburb like Lynwood where I played little league during the early 1960s—the era in which the drama unfolds. One afternoon, some little boys of summer bump into a game delay. Their sandlot, gloves, and bat are not much good without a ball. Scotty, the least-skilled, most-ridiculed boy on the field, wears a quick path to acceptance by borrowing a baseball from his stepfather’s collection of sports memorabilia. The treasure had been autographed by the pin-stripped legend—Babe Ruth. “Play ball!”

At the turn of the millennium, forward-thinking hospitals, interested in incorporating bar coding at the point of care, met with their own game delay. We had access to computers, scanners, and electronic-medication-administration software—everything but bar-coded medications.

Finally, in February 2004 (after several years of drafts, comments, hearings, and more comments), the FDA issued a requirement that manufacturers and repackagers must include bar codes containing National Drug Code (NDC) numbers on all immediate drug packages. “Play ball.”

While some of us were disappointed the regulation restricted machine-readable codes to a simple linear format (why not more complex data-rich codes?), we were just glad to have a ball to hit. And, though many of us had hoped the Feds would also have required encoding lot numbers and expiration dates, we were consoled by their promise to revisit such requests at a later date.

In retrospect, I believe the FDA’s decisions were wise. Including lot and expiration would have necessitated two-dimensional (2-D) codes at a time when the advanced-imager technology required to read them was outside the reach of most hospitals.

Like Liz’s unions, prior to the regulation, numerous marriages of scanning with medication administrations had their struggles. But I could argue there would have been many more failures in the ensuing years had Silver Spring not restricted their regulation to linear bar codes and minimal information.

Keeping true to their promise, on May 31, 2011, the FDA posted a notice entitled, “Updating regulations in recognition of changing technology.” The announcement said they had been considering which economically significant rule to subject to a cost-benefit reassessment, and they have tentatively concluded that the Bar Code Rule is the best candidate for such review. “The goal of the review,” the memo stated, “will be to assess the costs and benefits and to determine if the rule should be modified to take into account changes in technology that have occurred since the rule went into effect.”

This announcement prompted my FDA visit where the thoughtful people I met with listened carefully and spoke sparingly. They did agree that “changes in technology” include (whatever else) newer machine-readable codes and the devices required to read them. However, they also made it clear that the FDA has not and will not make modifications to the bar-code rule before receiving comments, holding hearings, and weighing the input.

While newer codes could range from 2-D bar codes to radio-frequency ID (RFID) tags, which require devices from imagers to RFID readers, I cannot imagine that the FDA’s next rule modification would be so encompassing. If the administration acts, and I believe it will, I predict that “linear” will be lifted from the requirement, allowing 2-D into the game. I can’t imagine they’ll write RFID into the rulebook this time around. Expect their 2004 logic to prevail and accommodate technology that most hospitals have or can readily obtain rather than allow for technology whose ubiquity is years if not decades away. Presently, most bar-coding hospitals utilize imagers capable of processing today’s 2-D as well as yesterday’s linear codes.

Once the linear limitation is removed from the bar-code requirement, I anticipate manufacturers will move rapidly toward 2-D for both external and internal reasons. Externally, I anticipate numerous hospitals asking drug companies for 2-D, and if (or should I say when?) any one of them rushes to comply, competitors will waste little time following. Internally, drug manufacturers and repackagers will be happy to use 2-D codes since they require less label real estate than linear codes.

If FDA modifies the rule to require lot and expiration date (they might, and I hope they do), labelers will surely have to convert to 2-D formatting to include this additional information without making their packages bigger. However, even if FDA doesn’t require lot and expiration, I anticipate most manufacturers will add both simply because with 2-Ds they can.

Beyond their value to accommodate lot and expiration, I will push for 2-D codes because it will help solve another problem we have with today’s drug package codes—namely, the ambiguity inherent in strings of non-delineated numbers embedded in linear bar codes.

Stick with me through one complex paragraph of explanation. Each NDC contains a triplet of numbers: one number for the labeler code, another for the drug code, and a third for the package code. To make matters worse, labeler codes may be four or five characters, and drug codes may be three or four characters, and package codes may be one or two characters—making it impossible to tell where one piece of information ends and the other begins. Since these numbers appear without delineators, computing systems can’t discern if 1234567890 means 1234-5678-90, 12345-678-90, or 12345-6789-0.

Human eyes bump into a similar problem with some URLs. Though computers get the addresses correct, sometimes it’s impossible for us to know exactly where one word ends and another begins. Note the ambiguity of these examples:

shortstoponsubway.com
lionstalking.com
therapistfinder.com

Ambiguity may be fun when decoding URLs but it’s no laughing matter when it shows up in strings of numbers, which can create medication errors if not rightly divided.

Two-D codes carry enough characters to allow for the insertion of delineators to correctly parse the numbers represented in bar codes.

Please, FDA, help us get this right.

What do you think?
markssignature1a1a1a1a1a1a
Mark Neuenschwander a.k.a. Noosh

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