Wednesday, December 5, 2012

BEFORE JANUS

This time of year brings joy and gifts. January introduces a fresh new start, but December is reserved, not only for wrapping up gifts, but wrapping up thoughts and reflections on the past year.

In ancient Roman religion and mythology, Janus is the god of beginnings and transitions, and also of gates, doors, doorways, endings and time. He is usually a two-faced god since he looks to the future and the past. The month of January was named in honor of Janus by the Romans.

Before we face the realities January and a new year bring, I'd like to offer a gift of thanks for a mostly wonderful year at Shamrock Medical Solutions. We made new friends and customers, we hired some pretty great people and we had a year of solid growth.

That growth came with the help of good people, who we wish to acknowledge as the year closes out:
  • In 2012 we were gifted with three new GPO contracts that include VHA/Novation, MedAssets and Amerinet. We're glad to have you on board!
  • We hired two new sales executives. Derek Spencer is a wonderful entrepreneur and his company helped us with some innovative telemarketing strategies. He's an International Politics graduate of Kent State University in Ohio. Chris Shibley was hired this year, too. Chris has an extensive background in hospital and long-term care administration, and is also a member of the Villages of Marymount. Both have added a comprehensive depth of strategic business smarts to our growing team.
  • We added two new board members to our leadership team. Joe Langhenry recently sold his award winning business, Watteredge, LLC, (Cleveland OH) which earned its third Best Workplace designation in a recent competition conducted by Workplace Dynamics, Inc (WDI) under the sponsorship of the Cleveland Plain Dealer. Rich Marrapese formerly was national director of health care for global accounting firm Ernst & Young. He spent more than 30 years as a national partner for the firm, mostly in Cleveland, OH, where he worked with several of the nation's largest academic medical centers. He also served as chairman of the National Principles and Practices Board of the Healthcare Financial Management Association, and as a board member for the National Committee for Quality Health Care. More recently, Rich was the interim CFO of University Hospitals in Cleveland, OH.
It's easy to be optimistic about 2013 with all the wonderful progress we've made in 2012. But we're not going to rest on our laurels. You can be assured that we will strive in 2013, as always, to be among the finest health care partners our health centers and pharmacists choose to work with. Good cheer to all!

Here's to better solutions, 
Dave Bystrom

Wednesday, November 28, 2012

VAWD-Y MERRY NEWS

In November 2012, Shamrock Medical Solutions made an initial submission to the National Association of Boards of Pharmacy to become a Verified Accredited Wholesale Distributor (VAWD).

VAWD is an accreditation for pharmaceutical wholesale distribution facilities, such as Shamrock Medical Solutions. Wholesale distributors that achieve accreditation are in compliance with state and federal laws and NABP's VAWD criteria. Twenty-two states, including Maryland, Indiana, Wyoming, and North Dakota, require VAWD accreditation.

Accreditation is a long, but worthwhile process. In part, we will undergo a criteria compliance review which includes a rigorous review of our operating policies and procedures, licensure verification, survey of our facility and operations, background checks, and screening through the NABP Clearinghouse. Once accredited, we will be reviewed annually and we'll undergo a site survey every three years. The journey to accreditation typically takes 6 to 12 months. It's rigorous, but we believe it's the right thing to do.

So, why is VAWD accreditation such a big deal for Shamrock Medical Solution customers? Well first, it plays a pivotal role in preventing counterfeit drugs from entering the United States drug supply. Second, it helps protect the public from drugs that have been contaminated, diverted, or counterfeited. Keep in mind that the US supply of prescription drugs is produced and delivered to patients via a complex distribution path, and VAWD accreditation helps ensure that the wholesale distribution facility operates legitimately, is licensed in good standing, and is employing security and best practices for safely distributing prescription drugs from manufacturers to pharmacies and other institutions.

VAWD became a "good idea" when NABP convened a task force in 2003 on counterfeit drugs and wholesale distributors. The task force recommended revisions to NABP’s Model Rules for the Licensure of Wholesale Distributors that would make it difficult for illegitimate wholesalers to become licensed and transact business. The task force also proposed the creation of an accreditation program and clearinghouse for wholesale distributers – a plan that was immediately supported by Food and Drug Administration – to further combat counterfeit drugs. The resulting accreditation program, VAWD, was established in 2004.

We are as concerned as you are for the health and safety of your patients. That's why we've taken this proactive step to become VAWD-accredited. I believe it's a good way to start 2013 off on the right path! Of course, as we enter into 2013, we'll keep you updated on our progress along this path.

Here's to better solutions, 
Dave Bystrom

Wednesday, November 14, 2012

REAL-TIME NETWORKING STILL HAS INCREDIBLE VALUE

This week, I'm going to turn this post into an interview with John Reichard, president of Shamrock Medical. John and Mike Cummins, vice president of sales, were invited to speak at the VHA Mid-America Service Solutions (MSS) First Annual Meeting and Product Fair held on October 25 and 26, 2012, in Kansas City.

Dave: John, for those who don't know and for those who didn't attend, can you explain the purpose of the VHA MSS?
John: VHA MSS is a group purchasing organization that is co-owned by 8 hospitals in the Midwest region, with a total of 107 member hospitals. Attendees included directors of pharmacy, supply chain and finance.

Dave: Can you give me an idea of the topics covered?
John: Guest speakers for the hospital pharmacy covered topics that included Chargemaster Oversight, Coding and Reimbursement, Inhaler Optimization, High Risk Medication Containment and Employee Surveillance, Beyond Use Dating Extension, and similar topics of interest to hospital pharmacists.

Dave: What topic did you discuss?
John: Well, naturally, we discussed Repackaging - 3rd Party Solutions.

Dave: Can you provide a general idea of what you discussed?
John: Shamrock Medical was asked to present our repackaging services to the pharmacy group and to highlight the benefits that our service offers. We talked about standardization of label formats, abbreviations and content; compliance assistance with NIOSH, RCRA and ISMP; and our unique repackaging solutions that bring efficiencies to the pharmacy such as placing 5 or 10 oral syringes into a ziplock bag to speed carousel restocking or placing 50 robot-ready pouches on a cardboard tube to speed the restocking of the robot. Of course, we showed Shamrock Medical's cost-savings compared to other repackaging solutions.

Dave: What was the biggest "aha" moment you got out of the VHA MSS Annual Meeting?
John: Of course, there was a wealth of information to learn and share. But for me the biggest takeaway was that, despite the technology that allows us to talk via email, Skype, and other web-based technology, how important it is to have the human touch in a business relationship.  The event gave us a chance for old-time networking, where we could talk face-to-face, feel their reaction, have a meaningful dialog over lunch or dinner, exchange ideas, and interact on a human level.

Dave: Any closing remarks?
John: I just want to say “Thanks” to the organizers of the VHA-MSS Annual Meeting and Product Fair for inviting Shamrock Medical Solutions to share the important operational and quality improvements, as well as allowing us to present the value that our repackaging service offers to  owner and member hospitals. Since the meeting, many of the attending pharmacists have started using our services for bar-coded unit dose repackaging. 


Here's to better solutions, 
Dave Bystrom

Monday, November 5, 2012

SAYING THANK YOU

The month of November and Thanksgiving. It seems natural that we begin to think about all the things we're thankful for in November.

By now, it's my hope that everyone has recovered from the devastation brought on by Mother Nature last week. No matter how hard we plan things, natural occurrences will ultimately laugh at our humble plans. My thoughts are with those who've lost possessions or loved ones in the storm.

Hospitals in areas devastated by this recent storm deserve our thanks for caring for people injured or broken from the ravages of Sandy. And along the same line of reasoning, I'm also thankful that hospitals continue to pursue the implementation of electronic medical records (EMR), and the barcode scanning of medications at the bedside. This is a significant safety net for patients. A nursing executive I once worked for stated that the scanning of medications at the bedside as truly a "gift to nurses."

I also want to hand out gratitude for hospital pharmacists who are taking a leadership role in medication safety initiatives in their institutions. They are vital to the success of implementation of medication safety systems such as barcode scanning and the programming of IV "smart pumps." Both help reduce medication errors and provide data used to improve care of patients.

And finally, I am thankful that the election is now over. Regardless of the candidate we hoped would win, let's be grateful we live in a country that allows freedom to express our thoughts and choose among those who throw their hat in the ring to lead us.

Here's to better solutions, 
Dave Bystrom

Thursday, October 25, 2012

TO DOSE OR NOT TO DOSE...

As a young boy I always loved Halloween. Candy? Costumes? What's not to love. I believe that young children enjoy another aspect of Halloween. The anticipation of the unexpected. Who's going to come out from behind the tree and yell "Boo!"

As we become adults we find less enjoyment in the unexpected. Especially as a pharmacist, I wanted to know what is exact, specific, accurate.

With that in mind, I thought it might be helpful to discuss repackaged doses. I believe pharmacists should consider whether they want to deliver the stated volume (dose), or do they want the cup to contain the stated volume (dose)?
For example, when pouring the dose from the unit dose cup (estimated at about 4 seconds), there is a residual amount of drug remaining on the inner surface of the cup. When repackaging, we account for the volume of this residual by re-creating the “administration of the dose” of the specific drug being repackaged. Before we can do that, we must know the specific gravity of the drug. To determine that, our technician will weigh a series of one milliliter samples of the drug, and calculate the grams per milliliter. Knowing that information, we can weigh, or tare, an empty cup, then fill it with the dose required, and deliver a 4 second “pour”; then weigh the cup again to determine the weight in grams of the residual, which can be used to calculate the milliliters of the residual.
This volume, in milliliters, is the amount of drug added to the desired dose volume in milliliters, to arrive at the “to deliver” volume needed. In other words, the amount of drug in a unit dose cup for a 5 milliliter dose may actually be 6 milliliters.
At times, this can be a critical issue, as pharmacists may not consider the residual, and they may order the “to contain” dose in the cup. When this occurs, we contact the pharmacist and review the options. Pharmacists always choose to have the patient get the “delivered” dose. (Of course, this is not an issue if the drug is packaged in an oral syringe, because the entire content is expelled when the plunger is depressed to the fullest, and there is no remaining residual.)
(We find some drugs to be exceptions to the rule, and they are topical oral use medications. Since they are ordered to be administered in a “rinse, swirl, gargle, and spit” form, there is no specific dose needed, only a volume to be contained in the cup.)
Being trained to accurately measure medications, naturally, pharmacists don’t want any surprises. At Shamrock Medical, we agree. Let's save the surprises for Halloween.
Here's to better solutions, 
Dave Bystrom

Wednesday, October 17, 2012

SPEED DATING ON DRUGS

We just returned from the 2012 Fall Hospital Pharmacy Conference, sponsored by Health Connect Partners. The conference connects healthcare providers and suppliers through educational meetings conferences and networking so that providers learn real solutions and suppliers understand their real needs.
This year, the Fall Hospital Pharmacy Conference offered educational sessions on topics such as nuclear pharmacy, a fatal medication error, and healthcare business models. The conference is known for its innovative approach to supplier and health-system pharmacist networking, including a unique large scale Reverse Expo staffed by hospital pharmacy management. 
I like to think of the Reverse Expo as speed dating, because it offers us the rare opportunity to meet face-to-face with more than 200 pharmacists in the network for 5 minutes each. With so little time, we got right to the core of their problem or needs, without flirting around the issues.
The Reverse Expo lasts two hours per session, and we prepared in advance. We made sure to bring plenty of business cards, our best “elevator pitch” and a warm smile.
HERE'S WHAT WE LEARNED
Some of the critical issues we heard from pharmacists attending the show include the following: 
  • They have trouble obtaining all the dosage forms they need in a unit dose form, with a readable barcode
  • Drug shortages continue, especially liquid unit dose
  • Some repackagers are experiencing very slow turnaround times
  • Hospitals continue to struggle with the “make or buy” decisions

HERE'S HOW WE CAN HELP
Of course, we're prepared to help hospital pharmacies with questions and help, anytime.
We want to make pharmacy directors aware of Shamrock Medical Solutions, the FDA registered repackager. We also want pharmacy directors to know that we are specialists in repackaging unit dose liquids (cups and syringes) as well as oral solids, and that we produce robot ready unit doses as well as robot ready kits. Still have questions? Let us know. We're prepared to help you.

                                Here's to better solutions, 
                  Dave Bystrom

Wednesday, October 3, 2012

DRUG SHORTAGES: REAL, IMAGINED, WHY?

A recent story on Boston's NPR station WBUR, stated that, to help first responders deal with drug shortages, Oregon has taken the unusual step of temporarily allowing ambulance services to carry and administer expired drugs.

And Oregon isn’t alone. The drug shortage crisis is hitting the whole country. Some blame a regulatory crackdown by the FDA. The FDA disputes that claim, and says the shortage is due to manufacturing and quality problems. And others say there’s little incentive to make generic drugs because of a low profit margin.

When did these shortages become so bad? And why?
The shortages go back to at least 2010. The majority of the drug shortage problems are with generic injectable products, which account for about 74% of the shortages; but the more critical issues to patient care are with injectable chemotherapy and anesthesia drugs. These products are more “medically necessary” than the non-sterile generic liquids that affect the drug repackaging world.

It has been noted that posting of drug shortages exacerbates the shortage, as a result of hoarding. (In early July 2012, President Obama signed “The Food and Drug Administration Safety and Innovation Act” to minimize the impact of drug shortages on patients. Hopefully this will help reduce the shortages of critical drugs.)

Other issues which contribute to the shortages include the JIT (just in time) mentality in the supply chain, and the existence of opportunists in the grey market, who acquire these critical products and make them available through alternate supply chains at a great mark-up in price.

For the most part, the product shortages that have had impact on the repackaging world are the generic liquids. They are relatively inexpensive. Also, they are not promoted in the grey market because they are relatively inexpensive and they are not considered “medically necessary”, as compared with chemotherapy and anesthesia drugs (often, these are not even prescription drugs.) The shortages we presently see are a result of manufacturers failing to supply these generic liquids in unit dose cups, and these products are still generally available in bulk packaging.

In my opinion, the newly passed legislation will have little or no impact on this class of drugs. As an FDA registered repackager, we look forward to filling this void in the marketplace with a high quality product, which allows our hospital customers to focus on their core competencies involving patient care, rather than repackaging liquid doses.

Have you experienced drug shortages in your facility? How do you feel the problem might be solved?


Here's to better solutions,  
             Dave Bystrom

Wednesday, September 26, 2012

IS OUTSOURCING REALLY TOO EXPENSIVE?

Most hospital pharmacists appreciate the benefits of outsourcing unit dose repackaging to an FDA regulated repackaging service provider. Some, however, have a perception that outsourcing is too expensive. Let’s explore this a bit further. . .
In the March 2012 issue of Pharmacy Purchasing & Products, Gary Magnus, RPh, MS Pharm at MedStar Montgomery Medical Center in Olney, Maryland, provided some interesting insight into the question of outsourcing unit dose packaging.
As bar-code-assisted medication (BCMA) becomes more prevalent in hospitals (nearly 50% of hospitals with 200 or more staffed beds have implemented BCMA), there are many products and patient situations that require facilities to either package or repackage a medication to ensure BCMA system compatibility. Thus, the question at many health care facilities arises: To outsource or repackage in-house?
Magnus suggests that, to make this decision wisely requires a good understanding of the cost and value of outsourced services and the time and labor involved to repackage in-house. Magnus goes on to say the decision should also include factors such as "...whether the wholesaler has the products you want in unit dose or your facility uses enough of a given product that buying it in bulk and having it repackaged is fiscally responsible."
Magnus states that the decision to outsource or repackage bulk medications in-house is their hospitals' tipping point of 100 doses a year, where less than that amount of use falls to in-house packaging. Magnus states, "For our commonly used drugs that do not come in unit dose, routing these through the repackager provides us with safe, properly packaged doses every time without us having to expend the labor and time of doing ourselves."
Addressing outsourcing costs, Magnus suggests the health care provider does its homework to determine the best outsource provider for the institution's needs.
In speaking with other hospital pharmacists, I have found that there are components of the overall cost of repackaging in-house that are not included in their cost analysis. Usually, at least one of the following cost components are missed, including the repackaging FTEs plus benefits, the capital and maintenance cost of equipment, packaging material acquisition and inventory, usage of limited pharmacy space including overhead, and the cost of quality (pharmacist check). Taking all of this into consideration, the cost of in-house repackaging is approximately 18-cents per dose, whereas, the cost to outsource may be as low as 10-cents per dose, as outlined in a 2009 survey conducted by the independent consulting firm Shack & Tulloch, Inc., and presented in a 2010 White Paper presented by McKesson Corporation.
The argument to outsource or repackage in-house continues to be dependent on many factors, including the size of the health care institution. However, in making this decision, it's wise to consider other factors, including safety (i.e., reducing the risk for packaging error with a qualified third party repackager whose core competency is packaging and labeling accurately), reducing or totally eliminating the capital expenditure to acquire packaging equipment, better use of technicians and pharmacists' time to the core competency of the department, which is patient care and pharmacy clinical services. Additionally, an analysis of the bulk cost of a drug vs. the cost of that drug in unit dose form may more than offset the cost of utilizing the outsource repackaging service.
In the final analysis, it's in the best interest of the health care institution to perform due diligence to determine what is ultimately in the best interest of their pharmacy, their patients, and their bottom line.
Here's to better solutions,  
             Dave Bystrom

Wednesday, September 19, 2012

THE CASE FOR UNIT DOSE AND BAR-CODE PACKAGING

Medication errors in hospitals frequently occur at all phases of the prescribing, dispensing, and administration processes. One of the most significant advancements in reducing administration errors has been to provide medications in unit dose packages, which ensures that the medication name, strength, and other characteristics are available during the administration phase.

Providing medication in a unit dose distribution system was implemented by many hospital pharmacies in the 70’s and early 80’s, and is not only considered a best practice, but is now near universal in its application, with millions of unit dose medications dispensed in hospitals and health systems daily, as stated in an editorial in the American Journal Health System Pharmacy (2002).           

Not quite universal is the drive to convert to bar-code technology, which represents a promising solution to the medication administration errors, which occur at the bedside. Bar-code technology saves time, improves accuracy, and reduces errors.

The benefits of bar-coding are well documented, such as an article in the Annals of Internal Medicine (2006; 145:426-34) on bar-code safety. The article states that the use of such technology provides reduction in errors, which will result in significant improvements in patient safety. As pharmacists, we know this to be true.
Unfortunately, not all hospitals have implemented this technology due to perceived costs. However, a study in Archives of Internal Medicine (2007) suggests that bar-code technology pays for itself within 5 - 10 years, primarily by providing warnings that can actively help prevent ADE’s and medication errors from occurring.
The most recent advancement in technology to improve patient safety is a bar-code-enabled point-of-care (BPOC) system, whereby medications are administered in bar-coded unit dose packages. For this to be effective, patients wear a bar-coded wristband. When the nurse administers the patient's medications, he or she first scans into the system, then scans the patient’s wristband, and then scans the barcode on the medication, which ensures the right medication reaches the right patient, and is documented in “real time”.
As healthcare pharmacy administrators, we all must be aware that our first obligation is always to the patient. If such technologies prevent just one patient death from an overdose, or the wrong medication, then price becomes secondary.
In my next post, I will discuss the cost structure and other advantages of third-party bar-coded unit dose repackaging for hospital pharmacy. Until then…
                                            Here's to better solutions,  
                            Dave Bystrom

Tuesday, September 4, 2012

YOU DON'T KNOW DAVE...

Well, perhaps you do know me, but not that well. I believe that once you read this short message, you will know more about me and why I chose to undertake this exciting challenge for Shamrock Medical. My goal is to write a timely blog about topics of interest to the profession, with weekly posts that provide for healthy, upfront dialog among pharmacists, so that together we can make the entire profession stronger and safer for the staff and the patients we serve.

But first, I'd like to tell you why the Shamrock Medical team chose me as a spokesperson for our industry. I'm a professional pharmacist; I'm not a salesman. I understand the problems facing hospital and other healthcare pharmacies because I've worked in hospital settings. As the director of pharmacy at several leading healthcare centers in Central Ohio, I've faced many of the problems you wrestle with today. I know your concerns and frustrations.

Another goal I have with this blog is to help you find answers to your most pressing concerns and, perhaps, help you overcome some of the daily frustrations you face. I plan to comment on the latest news in drug repackaging, and fill you in on how using a third-party drug repackager can help diminish your most pressing concerns, such as ensuring overall patient safety, handling specific safety issues concerning bedside scanning, managing drug shortages, as well as offering advice and commenting on trends in areas of outsourcing drug repackaging and dispensing.

I promise to keep the blog posts short, informative and to the point, because I know you're busy. I hope we can make the posts a two-way communication. If you have a comment or questions, I will respond with an answer, so that the posts do, indeed, become a healthy dialog among professionals.

If you'd like to sample Dave's Dose by email just enter your information in the “follow by email” box. I look forward to sharing useful information and receiving interesting comments!

Here's to better solutions,

Dave Bystrom