Category Archives: People

17Oct/06

A Bar-Code In The Hand Is Worth Two RFID Tags In The Bush

On February 26, 2004, the FDA published its final rule onBar Code Label Requirements for Human Drug Products and Biological Products.  According to the Agency, “Bar Codes will allow health care professionals to use bar code scanning equipment to verify that the right drug (in the right dose and right route of administration) is being given to the right patient at the right time.  This new system is intended to help reduce the number of medication errors that occur in hospitals and health care settings.” 

The Bar-Code rule requires linear bar codes on most prescription drugs and on over-the-counter drugs commonly used in hospitals and dispensed pursuant to an order. The bar code is required to contain, at minimum, the drug’s National Drug Code (NDC) number, which uniquely identifies the drug. The rule also requires the use of machine-readable information for blood and blood components intended for transfusion. The machine-readable information must include, at a minimum, the facility identifier, the lot number relating to the donor, the product code, and the donor’s ABO and Rh. 

During the same month, February 2004, the FDA’s Counterfeit Drug Task Force issued its report on “Combating Counterfeit Drugs”. This report called for the implementation of Radio Frequency Identification (RFID) technology to allow the tracking of pedigree and mass serialization for all drug products. The Agency set forth a phased approach to the implementation of RFID technology starting at the case and pallet level for products likely to be counterfeited and progressively including all products at the case, pallet, and package level by 2007. 

In February of 2006, the FDA conducted a Counterfeit Workshop in Bethesda, MD to get an update from stakeholders on the status of RFID implementations. Affected stakeholders, including manufacturers, distributors and pharmacists, presented progress made and concerns associated with RFID and e-Pedigree initiatives. During my remarks to the Task Force, I stated that RFID technology should be used as an enabler, not a silver bullet. I conveyed the agency’s role to set regulatory requirements, gathered in cooperation with all affected stakeholders. However, in my opinion, the FDA should not mandate specific technologies to be utilized to achieve compliance.  

In June 2006, the task force issued its update on the FDA Counterfeit Drug Task Force Report. The agency admitted that although in 2004 it was optimistic that widespread implementation of e-pedigree was feasible by 2007, unfortunately, this goal most likely will not be met. The report went on to say:

“…it is clear from our recent fact-finding efforts that the voluntary approach that we advocated in the 2004 Task Force Report did not provide industry with enough incentives to meet FDA’s deadline.
We continue to believe that RFID is the most promising technology for electronic track and trace across the drug supply chain. However, we recognize that the goals can also be achieved by using other technologies.
Based on what we have recently heard, we are optimistic that this hybrid environment of electronic/paper and the use of RFID/bar code is achievable in the very near future. We believe that efforts to ensure that hybrid pedigrees are secure and verifiable should be a priority consideration.” 

Is this a case of one step forward and two steps back? I don’t believe so. I see it as a net gain for all stakeholders, especially patients.  The FDA estimates that the bar code rule, once implemented, will result in more than 500,000 fewer adverse events over the next 20 years.

Hospitals have recently made major investments in Bar-Code systems to comply with these regulations and minimize medication errors. Asking them to now reinvest in RFID technology without realizing the benefit of Bar-Codes would be a mistake. 

As the saying goes, A Bar-code in the hand is worth two RFID tags in the bush.
 

Copyright 2006 Daniel R. Matlis – AXENDIA

09Oct/06

It’s Time to Deepen the Gene Pool

By Daniel R. Matlis

In my “Final Word” column, published in Pharmaceutical Formulation and Quality, I discussed the need to deepen our industry’s gene pool. 

Johnson and Johnson has taken a huge leap to diversify the industries’ gene pool.  J&J recently announced the appointment of LaVerne H. Council to the position of vice president and chief information officer.

Council comes to J&J from Dell Inc.  She brings to the position a wealth of global experience in information technology, supply chain management and business operations. During her tenure at Dell, Council was responsible for infrastructure engineering, networking, security, and enterprise application interfaces and was the global supply chain technology leader for Dell’s core operations.

Skeptics might ask how her experience at a major computer maker qualifies her for the position at one of the most prestigious life-science companies? After all, what do PCs and healthcare have in common? Well, more than you think.

Read the complete column in Pharmaceutical Formulation and Quality.

13Jul/06

Doctors Don’t Treat Populations, They Treat Individual Patients

This week, Scott Gottlieb, MD Deputy Commissioner for Medical and Scientific Affairs at the Food and Drug Administration made an interesting speech before the 2006 Conference on Adaptive Trial Design in Washington, DC.Dr Gotlieb commented how today’s clinical trials are highly empirical. Drugs are tested on general populations for a response and a treatment effect that is statistically not likely to be a chance result. This approach is rigorous and focused, but inflexible. According to Dr. Gotlieb, “another problem with the empirical approach is that it yields statistical information about how large populations with the same or similar conditions are likely to respond to a treatment. But doctors don’t treat populations, they treat individual patients. Doctors need information about the characteristics that predict which patients are more likely to respond well, or suffer certain side effect. The empirical approach doesn’t tell doctors how to personalize their care to their individual patients.” This results in a highly empirical approach to the practice of medicine. Gone are the days of: Take two off these and call me in the morning. Gottlieb comments “Doctors prescribe treatments knowing full well that only a certain percentage of their patients will receive a benefit from any given medicine.” This approach is akin to: Take all of these and call me if you have a side-effect. 

But with the demands for personalized medicine and the advent of Pharmaco-genomics, there are potentially better alternatives. By enabling more trials to be adapted based on knowledge about gene and protein markers or patient characteristics, we can help predict whether patients will respond well to a new medicine. “These new approaches to clinical trials can result in trial designs that tell us more about safety and benefits of drugs, in potentially shorter time frames, exposing fewer people to experimental treatments, and resulting in clinical trials that may not only be more efficient but are more attractive to patients and their physicians to enroll in.” said Gottlieb. This is only a first step in the process to develop more adaptive clinical trials. This process will lead to more targeted therapies and in turn, Ii is my hope, more personal and personalized medicine.

04Jul/06

"Medicine is for the People, not for the Profits."

During my senior year, I was lucky to have a few job offers to evaluate. The top two were from Johnson & Johnson and Exxon. As part of my research I looked at how each company handled adversity. For me it was an easy choice when I compared J&J’s handling of the Tylenol situation vs. Exxon’s Valdez.  I was drawn by the impact I could make in people’s lives and by the industry’s reputation in general and J&J’s in particular.

But in recent years, our industry has gone though some tough times. We’ve have seen record FDA fines, product recalls and withdrawals as well as the erosion of consumer confidence.  In my opinion executives at some Life-Science companies lost focus on the patient and began to concentrate on profits for Wall Street.

It is in times like these that we must reach for our roots and reflect on the legacy left by our industry’s founders.

In the August 1952 Time magazine interview, George W. Merck said “Medicine is for people, not for profits.” He went on “…if we remembered that, the profits have never failed to appear. The better we remembered, the larger they have been.”

In 1943 General Robert Wood Johnson wrote: “We believe our first responsibility is to the doctors, nurses and patients, to mothers and fathers and all others who use our products and services.” This Credo is still etched in stone at the J&J world Headquarters.
In 1899 Charles Pfizer said, “Our goal, has been and continues to be the same: to find a way to produce the highest-quality products and to perfect the most efficient way to accomplish this, in order to serve our customers. This company has built itself on its reputation and its dedication to these standards, and if we are to celebrate another 50 years, we must always be aware that quality is the keystone.”

In this post Sarbanes-Oxley era, I am heartened to see that our industry is once again putting patients first.

Let us remember to chase after the cures for human ailments, then and only then will fair profits follow.

29Jun/06

I Lost the Cure for the Common Cold!

By Daniel R. Matlis 

It’s 3:00 AM and your newborn baby wakes up crying. You want to go back to sleep, but his circadian rhythm is set for Beijing, not Philadelphia, and he is wide awake.So you get a cup of coffee, turn on your laptop and start to do some work. In a moment of inspiration, you discover the cure for the common cold. It’s all there on the screen right in front of your eyes and then your baby kicks, the coffee spills on your laptop and, just like that, the cure is gone. Who do you call?

Monday, at the Corporate Computing Show in NY, I met the people for the job. DriveSavers Data Recovery is a company that recovers data from crashed and damaged media. They have been doing this for over 20 years and when James Bond looses the data in his laptop he doesn’t call Q. Instead he deals with Kelly Chessen, Data Crisis Counselor DriveSavers (Yes, Sean Connery is a client).

With the prospect of irretrievable information loss, many of the callers with whom Chessen deals are as distraught. The emotional trauma associated with the loss of critical data can be disruptive both at work and at home.

Chessen came to DriveSavers with a background in psychology that serves her well in her dealings with often-frantic customers. She worked with a suicide prevention hotline for more than five years, including one year as the manager and trainer. This is exactly the kind of training I want the person on the other end of the line to have under these circumstances.

In addition to the soft skills, DriveSavers has technical skills and facilities to back them up. They have recovered data from drives that have been damaged, dropped, deleted, burnt, crushed and drowned in the Amazon River. The company has a success rate of over 90%, and recovers data in as little as 24 hours from all operating systems and storage media including hard drives, disk arrays, floppies, CD-ROM, DVD, removable cartridges and digital camera media. They have they own calls 100 clean room, and if they work on your drive, the manufacturer’s warranty is still good, although I’m not sure that a drive full of Amazon River water is covered.

So the next time your husband, wife, son, daughter, dog, cat or self spill a cup of coffee on your laptop containing the cure for the common cold, or the therapeutic area you are working on, don’t sweat it, lay on the couch and call the Data Shrink.