Archives for category: Arizona

Compounding the Issue

May 31, 2012 //
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The legal status of compounding, particularly in Arizona, has come into sharper focus of late with the never ending stream of pharmaceutical products going on back order which has left compounding pharmacies as the only source for several medications.

After numerous articles appeared in the AZVMA’s magazine regarding the legal status of compounding multiple people asked for my input and so I decided to reach out and do a little digging. Because I did not explicitly state that I would be writing about this situation when I talked with various people, I have decided not to quote anyone. Therefore this post is purely my opinion as to the current state of regulations in the State of Arizona and how they are interpreted by the various boards and agencies. Some of these issues may well transfer to other states, but regardless I would urge anyone with an interest in this subject to contact the agencies most directly responsible – including the agencies in Arizona (in your State or Providence you may find that not only are you under the State VMA practice act but also must follow the Pharmacy board Practice Act – which is the situation in AZ). I have no great expertese in this area at all other than an interest in the subject. From my personal experience and that of the friends and colleagues who helped collate this information for this blog post all the various agencies and players has been very open and honest about the current state of play in Arizona regaurding compounding.

What is Compounding?

This is a surprisingly complicated questions to answer. In essence, compounding is the act of changing the nature of a FDA approved pharmaceutical product. Adding a flavoring to a medication, crushing a tablet and combining it with a liquid medication, and obviously creating a medication from a set of ingredients are all examples of compounding. Interestingly, taking a liquid inject-able medication and dispensing that medication for use orally is also considered compounding as the method of FDA Approved administration is being changed.

So what is the difference between compounding and “off label use?”

It is my understanding that “off label” essentially means using a product in a way that is consistent with the labeling of that product but is not explicitly defined. For example, using an inject-able medication that is licensed for dogs as an inject-able medication for a cat would be an example of off label use. However, taking that same inject-able medication for dogs and using it as an oral medication for a cat would be an example of compounding.

It should also be noted that the “off label” use of medications carries considerable risk to the prescribing veterinarian and it is always recommended to get the owners express consent and be sure to check the latest literature about using any product in this way.

Can a Veterinary Hospital Compound for its own internal Use?

Technically no. Only a pharmacy can compound, but it does seem that the major issue for the Pharmacy board and the State Veterinary board is the dispensing and re-dispensing, of compounded medications.

What is the legal issue with dispensing compounded medications?

TITLE 4. PROFESSIONS AND OCCUPATIONS

CHAPTER 23. BOARD OF PHARMACY

 

Supp. 11-4

 

Authority: A.R.S. § 32-1904 et seq.

ARTICLE 1. ADMINISTRATION

Section

 

Neither the pharmacy permittee nor a pharmacist employed by the pharmacy permittee provides a compounded pharmaceutical product to a pharmacy, medical practitioner, or other person for dispensing or distributing except that a compounded pharmaceutical product may be provided to a medical practitioner to administer to a patient of the medical practitioner if each container is accompanied by the written list required in subsection (I)(5) and has a label that includes the following:

a. The pharmacy’s name, address, and telephone number;

b. The pharmaceutical product’s name and the information required in subsection (I)(4);

c. A lot or control number;

d. A beyond-use-date based upon the pharmacist’s professional judgment, but not more than the maximum guidelines recommended in the Pharmacy Compounding Practices chapter of the official compendium unless there is published or unpublished stability test data that shows a longer period is appropriate;

e. The statement “Not For Dispensing;” and

f. The statement “For Office or Hospital Administration Only.”

The upshot of above article is that medical practitioners, such as veterinarians, in the state of Arizona cannot purchase a medication from a compounding pharmacy and then repackage it for sale – dispensing in other words. A compounded medication can be bought and used internally but if a patient needs compounded medications to go home they need to be dispensed directly by the compounding pharmacy.

What does the Future Hold?

The re-dispensing of compounded medications by medical practitioners, according to the Arizona Pharmacy Board, will never be allowed. However, veterinarians being able to compound medications themselves and then dispense them to their clients does have a brighter future.

The AZVMA are planning to submit legislation to ask for a compounding exemption for veterinarians. However, this legislation has not been written and its passage is by no means guaranteed. It is also worth noting that if an exception for veterinarians is passed there will be significant regulations that practitioners will have to comply with to allow for the creation of compounded medications. There are also potentially areas where Federal law will trump State law with regards to compounding.

So Where does this Leave Us?

I have been informed by several reliable sources that both the pharmacy board and the veterinary medical board are not currently actively seeking out compounding cases to find veterinarians in violation. There is an understanding that compounding should be a tool available to Arizona veterinarians and it is considered a significant priority to have the law changed. However, it should be understood that should issues arise it is against the law and is potentially a source of liability.

The re-dispensing of compounded medications, however, is a black and white issue. Patients who need a compounded medication must have it dispensed by the compounding pharmacy.

This post is only meant as a starting point for your own research on the subject, and as a primer as far as the various issues.

As usual, comments, questions, and general abuse are always welcome.

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Categories Arizona, Regulations, Veterinary

Book Review: Accelerate! by Arnie Kuenn

August 24, 2011 //
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(Click on the image above to view the book on Amazon!)

With possibly the longest subtitle ever: “Move your business forward through the convergence of search, social & content marketing,” Accelerate! cannot be accused of false advertising.

Quiet simply, Accelerate is a blueprint for successfully using 21st century tools for small business online marketing. Written by Arnie Kuenn, the president of Vertical Measures in Phoenix, and a co-founder of the Arizona Interactive Marketing Association; Mr. Kuenn certainly knows his stuff. In fact, it is one of the few criticism of the book that I have, is that it gets a little dense at times, particularly early on. The Search Engine Optimization (SEO) section while being very detailed gets to be a little much and will require a couple of readings for all but the most experienced of readers. However, the style does settle down, and it would be a mistake to give up on the book as and what you are left with in the end is, a user friendly handbook for search, social media, and content marketing.

The book covers all the major players as you might expect; Facebook, Twitter, LinkedIn and Google; but is also covers a lot of the less mainstream sites. Accelerate! plucks a number online tools out from the magic geek SEO toolbox to help with almost every aspect of the radical overhaul of your marketing strategy that will undoubtedly unfold once you have finished the book. I myself, am already looking carefully at how I put posts together for my site and have joined a number of social bookmarking sites directly because of this book.

A self published book, also available in a Kindle edition, I was initially concerned about the physical binding on Accelerate! I’ve had problems in the past with the spines of self published books cracking and then loosing pages after a single reading. I’m happy to report that this is not the case with Accelerate! I did take care not to be too absusive to the spine, but i needn’t have worried, the book is in great shape and looks the same as when it arrived.

I mention the self publishing issue, not just because of quality, but also because the text of the book directly references it as well. With a subject such as search and social media marketing, it is easy to get very out of date very quickly – Google+, for example, is not mentioned once. As the text explains, being a self published book, in addition to being an E-book, allows for easier updates than traditional publishing. I, for one, hope we do get new editions on a fairly regular basis, because this a great resource and one I know I will be referring to for quite some time. In fact, I found it quite odd to see URLs in the footnotes and be unable to click on them – should have got the Kindle version!

Mr. Kuenn’s book will not tell you how to brand and create a marketing strategy for your business – hopefully that is why you read my blog! What Accelerate! will do, however, is tell you how to navigate the waters of the increasingly complex world of search, social media, and content marketing. This still might not mean that you still don’t need to hire someone of Mr. Kuenn’s caliber, or the man himself, to work with you on these magic things. But if you do you’ll at least know what they are talking about and why.

If you want to get serious about search, social media and content marketing, you need to buy this book – it does what is says on the cover!

(Clicking on the cover above will take you to the book’s Amazon page and contribute to my book buying habit / problem.)

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Categories Arizona, Books, Business, Content Marketing, Marketing, Search, Social Media, Uncategorized

Wildfire, Pets, and Excel (or how I spent the weekend & why this blog post is late)

June 23, 2011 //
2

The wildfires that have been threatening Sierra Vista, Arizona created a epic pet emergency in addition to the human drama.

Dr. Pam Drake and Hospital Administrator Kathryn Honda from New Frontier Animal Medical Center, threw open their doors as soon as the evacuations were announced. By the 17th, New Frontier was looking after 300 pets spread across three locations.

Having run a practice in, and lived in, Sierra Vista and consider Kathryn and Dr. Drake friends, I felt that I needed to help if I could.

The view of the Monument Fire from the New Frontier parking lot.

When I arrived at New Frontier on the morning of 18th the scene that greeted me was on of controlled and cheerful chaos. A loose dog, in the parking lot which I helped to retrieve from underneath a parked pickup truck, seemed to underline the whole morning. After touching base with Kathryn, and finding out how I could help, I headed for the main dog shelter – annex 2. New Frontier’s main building was acting as a triage center and treatment center for any pets that required significant medications. Annex 1, the main cat shelter was an empty office space in a strip mall. Annex 2, the main dog shelter, was behind the main Fedx depot in Sierra Vista. Both annexes had been generously donated by a local property management company.

Annex Two – the carriers and cages had been donated by members of the public.

Although the staff of New Frontier had done a great job of documenting the influx of pets, the sheer volume, inexperienced volunteers and multiple locations had led to multiple lists of pets. My job, for the day it would turn out, was to inventory and create an single list in Excel that the staff could refer to and find pets for the owners and contact owners about their pets. With a population of that size just knowing how many we had and where they were seemed a minor problem until you tried to manage them as a pollution rather than as just an evacuation.

After a 14 hour day, I headed home as the fire seemed to have quieted down and things were very much under control at New Frontier and the two annexes.

Annex Two held 80 dogs and 45 cats

How wrong could I have been.

Due to a previous engagement I spent the 19th in Tucson. In the afternoon, my phone started to go crazy. The wind had dramatically picked up, the fire had jumped the highway and was baring down on both the major boarding facilities that were also acting as shelters – one was evacuated that that day. New Frontier was on pre-evacuation and had taken the decision to evacuate all their evacuees to a third annex. Coronado Veterinary Hospital was evacuated for the second time. My Tucson colleagues who are part of the Southern Arizona Veterinary Managers Group (SAVMG) were already raising the alarm and getting staff and supplies on their way to Sierra Vista, along with my boss who reached out to vendors and other veterinary practices. So off I headed back to Sierra Vista.

The cat room in Annex three

When I arrived, Annex three was already setup, annex one was completely full and annex two had become the central triage center. As night fell the mountains could be seen burning and smoke still covered Sierra Vista. I updated my spreadsheet, spoke to the media on behalf of New Frontier, and worked on a plan of action with Kathryn for the following day(s). I spent the night at Annex three as all the hotels for miles were full of evacuees.

The biggest issue on Monday the 20th was management. Lots of new volunteers, who needed to be trained to handle both unfamiliar dogs and cats as well as how we needed to document. It was also unfortunate that we had a number of volunteers who were comfortable with dogs of whom we had 100, but we had a shortage of cat friendly volunteers and we had 200 cats. Luckily for us, Laurie Miller from AAHA as well as a number of technicians and doctors from Tucson were on hand throughout the morning. They worked tirelessly, and very much got into the spirit of having to make things up as we went along. It was definitely a balancing act between the standards we like to uphold as veterinary professionals – particularly when it came to documentation and at the same time making things easy and friendly enough for the volunteers who were going to be the day in and day out help that would keep the operation running.

Sunday the 19th saw the creation of Annex Three

A scare in the morning of the 20th, brought up the specter of of parvovirus. Although the test was negative, a rush request was put into our SAVMG colleagues in Tucson to see if we could get 150 dose of Bordatella intranasal vaccine as kennel cough was potentially a bigger threat to our hastily thrown together population.

The view from Annex Three

As I left Sierra Vista for the second time it was interesting to reflect on the issues and problems that my weekend had brought up. The complete lack of infrastructure made communications extremely difficult, phones were a huge issue – I spent an incredible amount of time just driving between the various annexes. Facebook became a significant communications channel for both the pet rescuing community and the entire Sierra vista community at large. However, having spotty Internet access (iPhones and iPads) made access a chore with so much else going on.

Considering that New Frontier went from 0 to 300 pets in a matter of a day or two they did a remarkable job, made even more extraordinary that Kathryn and several other staff were evacuated themselves. The entire community pulled together in a quite extraordinary way and the support from our Tucson veterinary community and distributors / manufactures made everything possible.

As I write this much longer blog post than planned, the fires are seemingly under control (60% contained) and the Annexes are beginning to empty. Almost 60 homes have been destroyed and many more buildings damaged and one hopes that this is a once in a life time disaster.

Why we do what we do.

 

Photos of the fire can be found here: www.svherald.com/coronado_fire

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Categories Arizona, medical, Veterinary

Bored of hearing about Heartworms?

June 3, 2011 //
1

Since it seems like everyone wants to talk about heartworms in an effort to sell you something, but is rare to hear anything new, it was really refreshing to really be scared by some of the statistics and language being used by the experts.

I was recently the guest of Novartis, the makers of Interceptor Heartworm prevention, at a small two day meeting in Tucson, on parasite control. Speaking were Dr. Noble Jackson from the University of Arizona (U of A) and Dr. Bowman of the Companion Animal Parasite Council (CAP-C).

Dr. Jackson has been looking at heartworm levels in the Coyote population in Arizona and the data is quite startling for those who believe that heartworm does not exist in Arizona. In Pinal County, which Includes Casa Grande where I live, the infection rate Dr. Jackson has seen is 34%. In Cochise county, that includes Sierra Vista where I used to live, the infection rate is 11%.

Now Dr. Jackson’s work is not finished or published yet, and the sample sizes are relatively small – 160 Coyotes for the whole state. But even allowing for statistical anomalies these results make you sit up and take notice.

Dr. Bowman, however, had the most disturbing news to my ears, in that there have been two confirmed cases of heartworms in humans. Heartworm infection in humans is extremely difficult to detect, since it looks a lot like lung cancer (infection shows up as coin sized lesions in the lungs that can only be definitively diagnosed by thoracotamy) and so the actual rate of infection is sure to be significantly higher.

There is currently mandatory reporting of heartworm positive cases in three states, and significant restrictions on exporting positive dogs.

Heartworms are not that scary for dogs, cat or humans compared to a lot of other parasites, the issue is that prevention is so easy and so successful that makes the current epidemic so sad.

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Categories Arizona, medical, Veterinary
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