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