WILL UNIVERSAL DRUG TRACKING IN THE U.S. EVERY SEE THE LIGHT OF DAY?

On May 17, the House Energy and Commerce Committee approved its version of the prescription-drug tracking bill, HR 1919, “by voice vote Wednesday, the Senate Health, Education, Labor and Pensions Committee will mark up” its version, S 957, on May 22. Both bills aim to “move to an interoperable, electronic, unit-level tracing system throughout the drug supply chain,” but they differ in terms of how fast they would transition from lot-level tracking to the unit level. The Senate’s bill would “transition to a unit-level tracing system over 10 years, with the Food and Drug Administration conducting pilot projects and holding public meetings for comment on moving toward the interoperable, electronic, unit-level system.” In contrast, the House’s measure “would establish national standards for a lot-level tracing system and create a process” for the FDA and supply chain stakeholders to work together, but the agency would not have to propose any regulations until 2027. The Energy and Commerce Chair Fred Upton (R-MI) has vowed to get the bill to Obama by the August recess.

Well, it's good to know there's some movement afoot since May 8, when bipartisan legislation gave federal regulators the power to track individual medications. (As a side note: At Shamrock Medical we currently are developing a system for e-pedigree for tracking at the lot-level, which is a requirement for VAWD accreditation.)

Essentially, the bill is designed to close loopholes in the supply chain and aim to prevent counterfeit drugs from reaching consumers, thus preventing harm to patients. It's also supposed to ensure that overlapping red tape does not impose dramatic costs on patients in the form of higher prescription drug costs or potential drug shortages.

I've read about squabbling among party lines already, such as, the regulatory framework will take too long to implement, as the bill will not require regulations from the FDA until 2027, and grumblings in the House that the burden that these new requirements may place on small pharmacies.

Dr. Janet Woodcock, the director of the FDA's Center for Drug Evaluation and Research summarized the situation accurately when she stated, "Criminals are getting more sophisticated at copying drug labels and profiting from putting counterfeit medications in the $300 billion U.S. prescription drug market (and) if we don't know the chain of custody of a product... if we have to reconstruct that later, through questioning people, that could cause great delays..." (in recalling the product or finding out where the problem occurs).

The sad truth is, in recent years very little has passed through a divisively bipartisan government. What are your feeling about this bill seeing the light of day?

Here's to better solutions, 

Dave Bystrom

PLAGUED BY MEDICUS INTERUPTIS. Do you suffer from this potentially lethal problem?

Obviously, there's no such disease as Medicus Interuptis, but as medical professionals we're all plagued by constant interruptions while documenting medical reports, seeing patients, or, in the case of pharmacists, dispensing medications that are designed to help patients.

Actually, studies indicate that nurses administering medications and pharmacists and technicians dispensing medications are distracted and interrupted as often as once every two minutes!

While we are all subject to interruptions during our work day, the argument that distractions and interruptions contribute to medication errors is pervasive in recent studies on this topic. One study suggests that the risk of any medication error increases 12.7% with each interruption, and the risk of a harmful medication error is doubled when nurses are interrupted four times during a single drug administration and tripled when interrupted 6 times (Westbrook JI, Woods A, Rob MI, Dunsmuir WT, Day RO. Association of interruptions with an increased risk and severity of medication administration errors: Archives of Internal Medicine 2010; 170(8):683-690).

While distractions and interruptions in healthcare can't be fully eliminated, there are tactics that may help cut down on some of them:

STAFF EDUCATION: Ask all staff to avoid interruptions during the preparation, mixing, labeling, or checking of medications, except during a significant emergency. Educate staff about the risks involved, and set up specific hours for interaction with staff for updates and other important matters.

BEST TIME FOR NECESSARY INTERRUPTIONS: If interruptions or notifications are necessary when dispensing medications, attempt to intervene during transitions between subtasks, such as between medications being prepared.

PREPARATION: To minimize interruptions, make sure all needed supplies and documents are available before preparing medications.

SYSTEM IMPROVEMENTS: Attempt to identify the sources of regular interruptions and try to remedy them. For example, the system may be improved by providing medications to patient care units in the most ready to use form to minimize interruptions associated with mixing, diluting, or crushing. Also, consider establishing a fax, email, or other electronic form of communication between nurses and pharmacists for routine issues to help minimize minor interruptions.

These are just a few examples of how to diminish the constants flow of interruptions that plague most of us during critical periods of time. I'd like to hear what you may find helps during your work day.

Here's to better solutions,
Dave Bystrom

STILL POTENT AFTER ALL THOSE YEARS. Drug potency much longer than earlier believed. How long would you hold on to your pharmacy's drugs?

Remember mom throwing out unused drugs after a few months? Of course, there was good reason for most of them to be discarded, mostly misuse, or self-diagnosis mistreatment. And, let's remember that pharmacies don't have a choice in holding on to drugs longer than the expiration date. So, often usable drugs are destroyed. or self diagnosis and treatment.

Seems that all these years we've had nothing to fear. In a study published online in the Archives of Internal Medicine (Expired Medications and Potency) on October 8, 2012, Lee Cantrell, PharmD, from the California Poison Control System, San Diego Division, University of California San Francisco School of Pharmacy and several colleagues used liquid chromatography/mass spectromety to measure the amounts of active ingredients in several medications, decades after the drugs' expiration dates. According to the study, the medicines, which had expired 28 to 40 years ago, were found in a retail pharmacy in their original, unopened packaging.

All drugs tested, except aspirin and amphetamine, met US Food and Drug Administration (FDA) standards which state an active ingredient must be present in 90% to 110% of the amount indicated on the label.

The new findings are consistent with the efforts of the Shelf-Life Extension Program, which has extended the expiration dates on more than 80% of 122 drugs tested so far, with extensions ranging from 66 to 278 months.

The authors conclude, "Our results support the effectiveness of broadly extending expiration dates for many drugs," and state that extending shelf life can significantly lower costs to consumers.

For this to work, the manufacturers will need to implement extended self-life studies in order to document the feasibility of extended expiration dates. In lieu of that, manufacturers generally take back viable-for-use drugs, in unopened containers for full credit. With longer expiration dates, it is likely that manufacturers would cut production, reduce waste, and eliminate the return good policy. However, the existing scenario results in robust control of the prescription drug cycle, which may not be a bad thing. Let me know what you think about this evolving situation?

Here's to better solutions, 

Dave Bystrom

SPLITTING THE DIFFERENCE - PART TWO. At Shamrock Medical, we have some past experience with tablet splitting.

In my last post, I spoke of the FDAs new drug application (NDA) regarding scoring drugs. I raised the issue that the recommendations are not simply a matter of splitting a tablet.

There are 5 FDA guidelines by which a scored tablet’s characteristics will be evaluated:

1. The dosage amount meant to be achieved after splitting the tablet should not be below the minimum therapeutic dose indicated on the approved labeling.

2. The split tablet should be safe to handle and not pose risk of unintended drug exposure.

3. Modified release products for which the control of drug release can be compromised by tablet splitting should not have a scoring feature.

4. The split tablet, when stored in pharmacy dispensing containers (no seal/no desiccant), should demonstrate adequate stability for a period of 90 days at 25º C, plus or minus 2º C/60 percent Relative Humidity (RH), plus or minus 5 percent RH.

5. The split tablet portions should meet the same finished-product testing requirements as for a whole-tablet product with equivalent strength.

According to the FDA, data to indicate all requirements are met must be provided to the Agency for evaluation, and the assessment should be undertaken on both tablets that are split non-mechanically (by hand) and tablets that are split mechanically (with a tablet splitter), on a minimum of 12 individual split tablet portions.

These are our concerns at Shamrock Medical: Currently, we at Shamrock don’t do that type of testing on tablets. To do so might require outsourcing or other measures costly to the customers we serve, and　the demand for split tabs may not support the cost of compliance.

To my knowledge, hospital pharmacies have a small number of drugs that need to be split to achieve the dose ordered by the physician. Are you splitting tablets in your pharmacy and sending a half tablet? How do you label them, and how do you handle the NDC issue?

It also appears, upon reading the full document that the FDA seems to discourage the splitting of tabs for economic reasons. Some drugs are priced the same whether the strength is 25mg or 50mg, for example; thus you can create two 25mg tabs from a 50mg tab, and save the cost of one tablet.

In many hospitals, the tablets are split by the nurse on the nursing unit, using a small hand held device. In that setting, one half of the tab gets wasted, and the patient gets the other, and the hand held device seldom gets cleaned, thus leaving the opportunity for "cross contamination" between drugs. The Joint Commission (Hospital Accreditation organization) often cites hospitals for having unclean tablet splitters on the nursing unit.

I believe we can help alleviate the problems hospitals have with drug splitting, but creating a "raw edge" from splitting a tab does affect the stability and we don’t currently do drug stability studies to determine an expiration date.

What are your thoughts on the FDAs recommendations for drug splitting? Does it make sense to you in the hospital environment? Is it safe? Does it raise costs unnecessarily? This may become a bigger issue in the future, and your feedback will provide valuable input.

Here's to better solutions,
Dave Bystrom

SPLITTING THE DIFFERENCE. At Shamrock Medical, we have some past experience with tablet splitting.

To give you some background, in March 2013, the FDA issued a Guidance for Industry that provides recommendations to sponsors of new drug applications (NDAs) and abbreviated new drug applications (ANDAs). It outlines what criteria should be met when evaluating and labeling tablets that have been scored. Scoring facilitates the practice of tablet splitting. (Just a reminder: Previously, the FDA considered tablet scoring as an issue when determining whether a generic drug product is the same as the reference listed drug [RLD]. One characteristic of a tablet dosage form is that it may be manufactured with a score or scores.) As of this writing, the guidance does not establish legally enforceable responsibilities, but it details current thinking on the topic.

According to the FDA, this characteristic is useful because the score can be used to facilitate the splitting of the tablet into fractions when less than a full tablet is desired for a dose, although, presently, there are no standards or regulatory requirements that specifically address scoring of generic vs. RLD tablets.

The FDA goes on to say that, "Consistent scoring ensures that the patient is able to adjust the dose, by splitting the tablet, in the same manner as the RLD. This enables the patient to switch between products made by different manufacturers without encountering problems related to the dose. In addition, consistent scoring ensures that neither the generic product nor the RLD has an advantage in the marketplace because one is scored and one is not.

This, folks, is a considerable issue to consider.

A SHORT HISTORY CONTEMPLATING DRUG SPLITTINGThe Center for Drug Evaluation and Research (CDER) Drug Safety Oversight Board considered the practice of tablet splitting at its October 2009 and November 2010 meetings. During those meetings, they discussed how insurance companies and doctors are increasingly recommending that patients split tablets, either to adjust the patients’ dose or as a cost-saving measure. Because of this, the Agency conducted internal research on tablet splitting and concluded that in some cases, there are possible safety issues, especially when tablets are not scored or evaluated for splitting. The Agency’s concerns with splitting a tablet included variations in the tablet content, weight, disintegration, or dissolution,
which can affect how much drug is present in a split tablet and available for absorption. In addition, there may be stability issues with splitting tablets.

WHERE SHAMROCK MEDICAL STANDS ON THIS ISSUEIf you remember, drug repackagers used to split tabs for the customers, but the FDA said a split tab was a new drug, and required a new drug application, stability studies, etc. So we no longer split tabs. This guidance document may lay the groundwork for allowing drug repackagers to once again split tabs; but there are other outcomes to consider before the drug repackaging industry can feel comfortable with this concept.

These FDA recommendations on are not simply a matter of splitting a tablet. In my next post on this topic, I'll discuss the criteria that the industry would have to follow, and the pros and cons of this proposal by the FDA.

Here's to better solutions,　
Dave Bystrom

FAKE DRUGS -- REAL DANGERS

In a previous post I talked about the California Pedigree Law, which will require tracking drugs whenever a change in ownership occurs from the sale of drugs to other trading partners, and how this may inevitably affect every state via a nationally mandated policy. Why? Here are three major reasons:
·    Federal regulators in February 2013 discovered another batch in a string of fake versions of the cancer drug, Avastin.
·    Early in 2013, a doctor in La Jolla pleaded guilty in federal court to treating patients with unapproved drugs.
·    Tainted steroids produced by a Massachusetts compounding pharmacy led to a fungal meningitis outbreak in September 2012 that killed 45 people and sickened more than 650.
As concerned caregivers, we cannot allow this to continue.

The problem of fake, contaminated or prescription drugs that don't meet proper quality standards may be worse in developing countries, but drug security is clearly a concern here, too. And I, like other health officials, believe that as we become more globalized it's more than likely the problem will only increase. So a national mandate may be part of our future.

A 360-page report from the Institute of Medicine and sponsored by the U.S. Food and Drug Administration states that "...quantifying the problem in the United States is difficult, but the trade of adulterated prescription drugs is considered more profitable than that of illicit drugs, like heroin...".

"Many of these fake drugs are the subject of sophisticated criminal networks," said Larry Gostin, professor of health law at Georgetown University, who headed the committee that produced the report.

And the tragedy continues when expired or adulterated prescription drugs often fall into the hands of unwitting health care providers from a secondary wholesaler offering what appears to be a good deal for the medication, because the United States at present has no national system to track and trace drugs through the maze of wholesalers and secondary marketers.

No one system or technology will completely resolve the problem because of its complexity, but the Institute of Medicine report calls for a variety of potential solutions, such as better ways to authenticate packaging so that regulators may be able to identify and detect counterfeit drugs. This could include better inks, holograms or other security features that could outwit counterfeiters.

The report also calls for improved tracking systems for keeping tabs on every time a drug changes hands. This "electronic pedigree," could better secure the supply chain, leaving fewer opportunities for bad drugs to enter the health market.

Bar-coding and wireless radio-frequency identification, or RFID, are some of the technologies being used or considered to better track drugs. Much of the technologies are focused on securing company drug packaging so it is more difficult to counterfeit.

Use of a trusted drug repackager is another step one can take to ensure safety in the drugs you provide for your patients. As a highly regulated drug repackager, Shamrock Medical is required to ensure that the safety, identity, strength, quality, and purity of the drugs we handle are maintained. We take every precaution to verify the identity and legitimacy of suppliers sending us products through the “normal channel of distribution”. Now, and always, we continue to remain vigilant, both with you and for you, our customer.


Here's to better solutions, 

Dave Bystrom

WHO IS TO BLAME FOR DRUG SHORTAGES?

Are politics to blame for the current drug shortage crisis, which according to a recent Associated Press Review of the health industry, including interviews with experts, discovered at least one death per month being caused by drug shortages in hospitals? Or, is the reason health care providers have to scramble to find drugs for their patients more fundamental than that? It’s inevitable that when a problem exists and persists that someone or something is blamed. There has been plenty of finger pointing going on lately as various experts, politicians and government officials try to explain why the United States is in such a dire situation with our drug supply. Some blame the current administration for the shortage and others blame the manufacturers for lack of quality control. And that's just the tip of the blame game.

A fairly recent congressional committee report blamed the FDA, stating the FDA has failed to ensure that enforcement and compliance activities are conducted in a manner that does not create unnecessary shortages of critical drugs. Although the shortages have been attributed to a myriad of factors from a lack of raw materials to increased demand, information obtained by the Committee on Oversight and Government Reform shows that the crisis was largely sparked by actions of the FDA.

Drug manufacturers' feet have also been held to the fire. Ideally, there would be an early warning system for impending drug product shortages that would provide ample opportunity to prepare for all implications of the shortage. Manufacturers are required to give the FDA six months’ advance notice only when they plan to stop producing a single-source, medically necessary drug. However, even this requirement has been criticized as being “soft,” since “medically necessary” is not statutorily defined, so, the manufacturer is given free rein to decide whether or not notification is required, and the manufacturer isn’t penalized in any way if it fails to provide the required notification. Therefore, manufacturers are criticized for providing little or no notice of an impending drug shortage or providing little advance notice and no estimate of the projected duration. Thus, the FDA lays the blame at drug manufacturers.

Now, according to a recent article in MedScape Today, GPOs (Group Purchasing Organizations) are to blame for drug shortages. According to Physicians Against Drug Shortages, the blame can be laid firmly at the feet of GPOs, who state in this article that "The real reason for the current situation is that there is no free market for drugs, medical devices, or healthcare supplies in the United States."

The GPO blame for drug shortages is upheld by Phillip L. Zweig, MBA, executive director of Physicians Against Drug Shortages. However, it should be noted that Zweig previously worked as communications director for Retractable Technologies (the maker of safety needles) and as a consultant for Masimo (the leading maker of pulse oximeters). Although, Zweig states he has had no financial ties to the medical-device industry for nearly 5 years, and has been working entirely on a pro bono basis to uncover the underlying causes of the drug shortage, and states related expenses come out of his own pocket.

S. Prakash Sethi, PhD, Baruch College, The City University of New York, corroborates Zweig's remarks by stating "GPOs are a major, if not the primary, contributor to the market distortions in the healthcare industry... Through exclusive contracting, which has given GPOs effective monopolistic control of this industry, they have contributed to product shortages and disincentives for legitimate producers to manufacture and stock essential drugs." (It's interesting to note that a 1987 Medicare anti-kickback “safe harbor” provision exempted GPOs from criminal prosecution for taking kickbacks from healthcare suppliers in the form of administrative fees, or “pay-to-play” arrangements. Physicians Against Drug Shortages want the “safe harbor” provision repealed.)

Curtis Rooney, president of the Healthcare Supply Chain Association (HCSA ), in what may be considered a rebuttal to Zweig and Sethi, said that "the group purchasing industry is the most transparent sector in healthcare, and we have a longstanding commitment to promoting openness, accountability, and the highest ethical standards in business practices."

The issue regarding GPOs has prompted Congressional action. In a letter sent November 2012, Ed Markey (D-Massachusetts), Henry Waxman (D-California), John Dingell (D-Michigan), Frank Pallone (D-New Jersey), Diana DeGette (D-Colorado), and Anna Eshoo (D-California) asked the Government Accountability Office to investigate whether contracting practices by GPOs are a driving cause of drug shortages.

With Congress involved, I wonder where this will end up. Do you believe Congressional actions will result in a more “free market”, or more regulation? As always, your comments are welcome, and may be the basis for a follow up post on this subject.

Here's to better solutions, 

Dave Bystrom

DO YOU KNOW YOUR PEDIGREE?

Pedigree (noun): The recorded purity of breed of an individual or strain; a register recording a line of ancestors.

You may be asking, "What does a pedigree have to do with my pharmacy and the chain of events that get the drugs I need to me?" I'd say, "Plenty."

BACKGROUND

In 2007, California legislators issued The California Pedigree Law, which requires pharmaceutical and biotech manufacturers, wholesalers, and pharmacies to generate electronic pedigrees whenever a change in ownership occurs from the sale of drugs to any of their trading partners. Prescription drug manufacturers who want to continue offering their products to patients within California after 2015-2016 must add unique serial numbers to each drug package and start an electronic drug pedigree.

These pedigrees must track each drug at the smallest package or immediate container level and each item must have a unique serial number a register recording a line of ancestors.  

 The most significant rationale for this law is to detect the introduction of illegitimate drugs (counterfeit, stolen, up-labeled, diverted, etc.) into the legitimate supply chain as early as possible, preferably at the very first transaction. These laws accomplish this by requiring companies buying drugs within the supply chain to receive the full supply chain history of those drugs at the time of the purchase (contained in a “pedigree”), and, most importantly, by requiring them to verify the legitimacy of those prior transactions. In California, this verification can only be performed through the use of digital signatures.

California is the only state that requires both of those things but most manufacturers are forced to treat the California state law as if it applies nationwide. That’s because most drug manufacturers sell through distributors in the United States and so they have no way of knowing which drug package will end up being shipped into California and which ones will not. Voila! Pharma manufacturers end up having to serialize and create a pedigree for every single package that enters the U.S. supply chain.

Will the pharmaceutical supply chain be “safer” or will the counterfeiters still be able to penetrate it ; do you think the cost of implementation and maintenance of such a system will be passed on to the consumer? Stay tuned.

Here's to better solutions, 

Dave Bystrom

2013 WILL BE THE YEAR OF ACCOUNTABILITY

Earlier this month I stated my prediction that hospitals will be held accountable for their actions, and suffer consequences that will affect their bottom line if they do not perform up to specific sets of standards.
So, how will hospitals be held accountable for outcomes? In 2013 and beyond, hospitals will have their feet to the fire through a process and outcome measurements (Hospital Safety Score), which is now and will continue to be published in the news as well as on the internet, including letter grades for each hospital. I believe this will affect not only the bottom line for hospitals and their medical staff, but the hospital pharmacy and staff as well.

Briefly, the Hospital Safety Score grades general acute care hospitals on how safe they are for patients. The grades are determined from publicly available data from the Centers for Medicare and Medicaid Services (CMS), The Leapfrog Hospital Survey (published by The Leapfrog Group, a national not-for-profit organization founded by the nation's leading employers, including behemoths such as General Motors and FedEx, and private healthcare purchasers). The Leapfrog Group's aim is to enhance the safety, quality, and affordability of healthcare in the U.S. by promoting transparency and value-based hospital incentives. The Leapfrog Survey is considered to be a trusted, transparent, and evidence-based national tool that more than 1100 hospitals voluntarily participate in free of charge.

The Hospital Safety Score is based on 26 measures*, including Computerized Physician Order Entry (CPOE). However, scanning meds at bedside is not listed among the 25 measures, although, in my opinion, scanning meds at bedside is more effective than CPOE in reducing med errors.

Leapfrog is serious about its grading. The grades are calculated under the guidance of a 9-member panel of patient safety experts. Among the 25 hospitals receiving an F for Safety in Fall 2012 include the University of California Ronald Reagan UCLA Medical Center, as well as three additional hospitals in California, 5 hospitals in Illinois (including three in Chicago), and 5 in Texas.

MEDICARE PAYMENTS ALSO TIED TO ACCOUNTABILITYIn 2013 Medicare funding will also be tied to how well hospitals perform. A recent article in The Columbus Dispatch (December 22, 2012), stated that the federal government released new data that base nearly $1 billion in Medicare payments to U.S. hospitals next year on their performance. The data show how much hospitals stand to gain or lose -- as much as 1 percent in Medicare reimbursement -- based how well they follow 12 clinical standards of care and score on certain patient-satisfaction criteria.

It's reasonable to conclude that, if hospitals lose funding based on poor grades, we all will suffer, including patients, physicians and medical staff -- and pharmacists who serve at these hospitals.

Fortunately, we have it in our power to ensure good grades by delivering the utmost in care to all patients at all level of service. And as always, you can be assured that Shamrock Medical is at your side, ready to help the hospital community with drug repackaging to ensure the safety of your patients' medication needs, which will certainly help raise the safety standards of every healthcare institution we serve.

*All 26 measures include 15 process and structural measures and 11 outcome measures, including foreign object retained; air embolism, pressure ulcer-stages 3 and 4; falls and trauma; death among surgical inpatients; post-op respiratory failure, to name a few.
 
Here's to better solutions,

Dave Bystrom

WHAT WILL THE NEW YEAR BRING?

Unfortunately, I don't have the gift of prognostication, but I can safely predict that in 2013 hospitals and health care institutions will continue to be held accountable for the health and welfare of patients.

The pressure will continue to be placed on hospitals to improve quality and safety, and CMS (Centers for Medicare and Medicaid Services) will continue to place incentives and penalties for hospital outcomes.

During the month of January I will explore two topics. The first, discussed in this post, will be Meaningful Use, which describes the incentives for hospitals and physicians to develop the Electronic Medical Record (EMR), which includes 15 core criteria. Note that CPOE (computerized physician order entry) is included, but scanning of medications at the bedside is not. I, and many hospital pharmacists, agree that while this is not mandated, bedside scanning of meds is becoming highly valued in the field. This government sponsored EMR program doesn’t place enough emphasis on medication safety, or it would mandate bedside scanning. If we focus on med safety; scanning is less expensive and more effective than CPOE.

While the pharmacy staff may not be directly affected by much of this, we can all generally agree that hospital pharmacists should be aware of incentives/penalties, and the impact of making this public. In the pharmacy, we are (and should be) very focused on medication safety. But as we go into 2013 and beyond, it appears that electronic medical records, readmission rates, patient satisfaction surveys, and now some clinical measurements, are of utmost importance to our government and to the general population. In fact, to some degree, the focus on EMR gives us some lead time, so that when the U.S. government does begin counting medication errors, pharmacies will already be heavily invested in the process.

The second topic, which I plan to discuss mid-month, is the process and outcome measurements (hospital safety scores) being published in the news as well as on the internet, including letter grades for each hospital. The pressure is on improving quality, with incentives for success. Nothing wrong with that. The onus will remain on hospitals to be transparent and honest in their practices and reporting. 

MEANINGFUL USE

Simply put, Meaningful Use is a government program that encourages medical providers to adopt and use an Electronic Health Record (EHR). Incentive funds are utilized to help doctors implement and make the transition. To receive payments, physicians must demonstrate a set of 20 Meaningful Use criteria for effective EHR adoption. Any physician who sees Medicare or Medicaid patients may be eligible for Meaningful Use incentives.

Meaningful Use is overseen by HITECH (Health Information Technology for Economic and Clinical Health Act), CMS (Center for Medicare and Medicaid Services), and ONC (Office of the National Coordinator for Health Information Technology.

Meaningful Use includes 15 core criteria and 10 additional measures, of which a physician must choose five. Of interest to pharmacists would be four of the 15 core criteria, which includes Active Medication List; Medication Allergies; Hospital Discharge Instructions and Drug-Drug and Drug-Allergy Interactions.

We hospital pharmacists tend to believe the world revolves around meds and med errors, but as the parameters for Meaningful Use exhibit, they aren't exactly the number one priority at the moment. Unfortunately, the opportunity for a med error is much greater than the opportunity for a sponge to be left in a patient post surgery. But, as we enter 2013, let's maintain the momentum toward 100% scanning at the bedside. It is the most effective medication safety tool, and be assured that Shamrock Medical Solutions Group stands ready to support your efforts.

Here's to better solutions, 

Dave Bystrom

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

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

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

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

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

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

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

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

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

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