The FDA has delayed enforcement of “track and trace”

Hear that? That’s a collective sigh of relief from pharmacy directors everywhere.

Modern Healthcare: “The Food and Drug Administration is giving pharmacies another four months before they’re penalized if they can’t document the chain of custody for the drugs they dispense. The requirement was adopted under a 2013 law passed in response to a meningitis outbreak traced to a compounding pharmacy.” – The original deadline for enforcement was July 1. Groups such as ASHP have been lobbying to get the FDA to hold off enforcing the July 1 deadline. Looks like it worked.

Just in case you didn’t know, the Drug Quality and Security Act (DQSA) was signed into law on on November 27, 2013. Title II of the DQSA, the Drug Supply Chain Security Act (DSCSA) creates new definitions and requirements related to product tracing. The idea of the DSCSA is to build an electronic, interoperable system of tracking prescription drugs (“products”) by November 27, 2023.

The DSCSA replaces the pedigree requirements of the Prescription Drug Marketing Act (PDMA) and preempts state requirements – killing what California was trying to do – and applies to transactions or changes in ownership of products.

Under the DSCSA manufacturers, wholesale distributors, repackagers, and dispensers are required to provide the subsequent purchaser with product tracing information when engaging in transactions involving certain prescription drugs, thus creating a barrier for counterfeit medications entering the market.

People have been scrambling for a while to be compliant, but it’s been an uphill battle for many. I’ve sat through several webinars, and it’s clear that there is still much confusion. It’s a good thing the FDA handed out a four month reprieve. However, it’s unclear whether or not an additional four months is enough.

You can read more about the DSCSA at the FDA website here. Enjoy!

Cool Pharmacy Technology – Aesynt REINVENT [it’s about the data]

Data surrounds us. We’re deluged by it in every facet of our lives, from the bank statements we receive in our personal life to the mountains of data collected in healthcare. Regardless of the data collected, there are basically three things that can be done with the information. It can be ignored, archived, or used. Unfortunately only one of those three things is truly meaningful, using it.

Many, especially in pharmacy, chose to ignore or archive data rather than use it. That’s not because the information isn’t valuable, but rather because they are overwhelmed with the amount of information they receive and simply have no idea what to do with it. Throw in the fact that the more data we collect, the more useful it becomes, and things get weird. Seems counterintuitive, but data collected from a single source, say one pharmacy i.v. room, offers little value.

Single source data creates several problems, such as potential bias, the inability to find trends that may be available in larger data sets, and failure to create usable comparisons to others that may offer insight into improved operations. Only when data is collected from several different sources does one truly begin to understand its value.
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Aethon launches TraySafe at #ASHPSM15 in Denver

I’ve been at the ASHP Summer Meeting in Denver this week roaming the exhibit hall looking for interesting new products. One product that caught my attention was TraySafe by Aethon.

TraySafe is a medication tray management system. There are several such systems currently on the market, but what makes TraySafe different is its approach to the replenishment process. The system utilizes a combination of photo recognition and barcode scanning to analyze tray content and notify the user of items that are missing, in the wrong location, or about to expire.

TraySafe1
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Saturday morning coffee [June 6 2015]

“Three things you cannot recover in life: the word after it’s said, the moment after it’s missed, and the time after it’s gone.” – unknown

So much happens each and every week, and it’s hard to keep up sometimes. Here are some of the tabs that are open in my browser this morning along with some random thoughts….

The mug below is the sister of the one from my May 16 2015 SMC post. I picked them up from the Starbucks Roastery & Tasting Room in Seattle, Washington at the same time. I liked them both. Couldn’t leave one behind.

MUG_RoasteryWhite
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Kit Check announces two patents issued by USPTO

baby_cryingI receive press release emails for several companies. One of those companies is Kit Check. I’ve written about Kit Check several times before.

Yesterday I received and email from Kit Check stating that “the U.S. Patent and Trademark Office has issued two meaningful patents with two more expected on June 16, 2015. The patented innovations reach back to Kit Check’s founding and are fundamental to automating key hospital pharmacy processes”. Ok, that caught my attention. I’m always curious when patents are granted.

The two patents issued are U.S. Patent Numbers 8,990,099 and 9,037,479. Both have to do with the management of pharmacy kits. I proceeded to the USPTO where I found the same abstract for both:

“A system for managing pharmacy kits comprises a reading station configured to read tag information from a plurality of radio frequency identification (RFID) tags associated with a pharmacy kit, and an information processing system operatively connected to the reading station and configured to receive the tag information from the reading station and determine a status of the pharmacy kit based on the tag information, a plurality of stored templates defining contents to be included in each of a plurality of pharmacy kits, and a plurality of kit records indicating the current contents of a plurality of pharmacy kits.”

I didn’t spend any great amount of time reading through the details of the patents because let’s face it, people who write patents do a masterful job of filling space with useless dribble. Seriously, patents make pouring a cup of coffee sound like someone has created a method for generating perpetual motion. With that said, I did do a cursory overview.

I was surprised at the gist of what was patented. In summary, the patents were given for a system that uses RFID tags to read things inside a closed container. Obviously there’s a bit more to it than that, but that’s my understanding of the patents in a nutshell.

I cringe when I see patents like this because it’s proof that you can patent just about anything these day. And in my opinion it stifles innovation, creativity, and ingenuity.

Does this mean that other companies won’t be able to develop a closed system that reads multiple items with RFID tags? I certainly hope not. Only time will tell what Kit Check plans to do with these patents, but I can only guess that they didn’t spend all that time, energy, and money for the heck of it.

Pharmacy – entrenched in outdated dogma

Dogma: belief or set of beliefs that is accepted by the members of a group without being questioned or doubted (Merriam-Webster)

I have opinions, lots of opinions. And like most, I believe my opinions are valid; it’s human nature. It’s not uncommon for me to find people within a group that agree and disagree with my opinions. However, once in a while I come across an entire group of people that stand in disagreement with my thoughts. That’s not crazy to imagine, but when that happens I’m forced to re-evaluate. Let’s face it, if everyone thinks I’m wrong, it’s possible that I am.

Such is the case with my thoughts on the use of technology and personnel in the i.v. room, which are on record at this site and are quite transparent. In a nutshell I believe that:
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Saturday morning coffee [May 23 2015]

“I was out on a date recently and the guy took me horseback riding. That was kind of fun, until we ran out of quarters.” – Susie Loucks

So much happens each and every week, and it’s hard to keep up sometimes. Here are some of the tabs that are open in my browser this morning along with some random thoughts….

MUG_SMC
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“Improving Safety and Efficiency in the IV Room” : thoughts on the ASHP webinar

I previously wrote about a live webinar put on by ASHP – Improving Safety and Efficiency in the IV Room: Key Features of Automated Workflow Systems – on Wednesday, May 20 2015. The webinar was made up of three separate, 20 minute presentations:

  • Medication Error Reduction Strategy Using Dispense Preparation and Dispense Check by Tom Lausten, RPh, Director of Pharmacy at Children’s Hospital of Wisconsin.
  • IV Workflow Systems: Barcode Plus Volumetric Verification by Steve Speth, RPh, Pharmacy Operations Manager at IU Bloomington.
  • Automated i.v. Workflow Systems and Technologies by Caryn Bellisle, RPh, Director of Pharmacy Regulatory Compliance at Brigham and Women’s Hospital.

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Saturday morning coffee [May 16 2015]

Repetition does not transform a lie into a truth.” — Franklin D. Roosevelt

So much happens each and every week, and it’s hard to keep up sometimes. Here are some of the tabs that are open in my browser this morning along with some random thoughts….

The mug below comes from the Starbucks Roastery & Tasting Room in Seattle, Washington. A friend of mine recently took me on a field trip to the roastery. Neat, neat place. It’s the kind of place I could spend an entire afternoon just kicking back, surfing the web, and drinking different coffees cup after cup. I highly recommend a visit if you’re in the area. A word of advice, don’t ask about “blond roast coffee”. Apparently they find it to be quite the abomination.

MUG_StarbucksRoastery
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Upcoming ASHP Webinar: Improving Safety and Efficiency in the IV Room

This caught my attention. ASHP is holding a live webinar – Improving Safety and Efficiency in the IV Room: Key Features of Automated Workflow Systems – on Wednesday, May 20 2015 at 2:00 PM ET.

According to the webinar site “Technology for IV rooms can be used to streamline work processes and support staff.  However, despite the advancements in technology there are still significant challenges in the compounding of sterile products. This webinar will take a look at IV room technologies and how it has improved IV room operations and overall safety for patients.  The speakers will also review the cost benefits, the key safety components including barcode scanning, imaging and gravimetric technology, and the best practices related to implementation and maintenance of these automated processes.

Objectives listed include:

  • Describe the most common IV Compounding Safety technologies available in workflow programs today
  • Describe and contrast the types of errors that the workflow technologies may affect
  • List key benefits of workflow systems beyond the reduction of errors
  • List and describe key considerations when choosing an IV workflow system

I look forward to attending as this is an area of great interest for me. I will be looking for depth of information presented in an unbiased manner. Not sure how deep they can go in an hour, but should be worthwhile nonetheless.

You can register for the webinar here, or by following the link above.