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