Safety First

The following is the re-posting of a blog written and posted in Secure Pharma Chain by Patricia A. Earl, Vice President, Business Development , XStream Systems in December 2007.

As succinctly stated in the earlier blog post, it is a near certainty that the United States pharmaceutical industry will face growing counterfeiting issues in the coming years.

These increasing occurrences will impact the industry in a number of important ways. The primary, and most obvious, concern is the liability problem. Trial lawyers have eagerly pursued businesses throughout the chain of custody when filing claims in other product liability areas.

A second issue regarding counterfeiting is integrity. From a professional and personal standpoint, members of the pharmaceutical industry do, and should, want to assure the end users of the products that they are safe and effective. Add to this the desire for safety and efficacy in a regulatory environment that when functioning properly will demand accountability. When companies within this industry sell or distribute products, they should be exactly what the customer expects.

The third issue is trust…and reliability. In order for our industry to grow effectively and for each of our companies or institutions to thrive, our customers must be able to trust us and the products that we deliver. Counterfeits, regardless of where they exist in the distribution chain, undermine the customers’ faith in the industry as a whole.

A final issue that I wish to discuss is the possibility of government intervention in the pharmaceutical distribution process. If counterfeiting becomes more prevalent and risks to patients are growing, then Congress, the Executive branch and its regulatory agencies will face increasing public pressure to “do something.” In this scenario is likely that they will respond with knee jerk mandates. Given government history in other industries, those mandates can be too severe, and at the same time, generally ineffective.

Finally, the pharmaceutical distribution chain should address a proactive posture to assure the integrity of the product. If done thoughtfully, this would limit liability, maintain integrity, enhance trust and reliability and, perhaps, preempt overreaching government meddling. Leaders in the pharmaceutical industry should implement counterfeit detection technology now to protect our reputations and our bottom lines.

Ahead of the Curve

Charles R. Earl, M.A., ABD
CEO, Communication Connections

The major portion of our discussions on these pages has focused on the impact of counterfeiting and adulteration on patient safety and supply chain reliability. This is where the primary consideration should be, but there are other important factors in play, too. Much of the recent news coverage has chronicled the challenges facing the national … and global economies. Corporations and businesses everywhere are belt-tightening, downsizing or closing. Some businesses will thrive in this environment by becoming leaner and more efficient while others will enter “panic mode” and never fully recover from these trying times.

From my experience as a business manager and as a corporate and business trainer, I have had the opportunity to witness how truly successful leaders cope with difficult circumstances. Although the “right now” requires intensely concentrated effort and resources, successful leaders never fail to look ahead to tomorrow. They do not abdicate their duties for visionary thinking and acting. They race ahead of the curve.

It is difficult for a corporate officer or manager to justify purchasing new technology when the market is uncharacteristically tough. Concentration is directed to monthly P&L’s, quarterly statements, and annual reports. Every nickel that can be saved and every penny pinched become important for day-to-day operations. “No major expenditures” and “no new commitments” become the rallying cries for weathering the economic storm. Count the pens! Inventory the paper clips! Use both sides of the printer paper! I could go on, but you get the idea.

While the market, the governments, customers and patients are clamoring for safer and more reliable pharmaceutical delivery, you cannot afford to retreat into a posture of preservation. You, as a leader, who wants to guide a leading company of the industry must seize the initiative. The old reliable aphorism “if you’re not moving forward, then you’re falling backward” is still true. Offer more for your customers—better service and safer product.

Imagine this scenario: A customer calls your office and asks you to submit an RFIP. This company is impressed with your innovative efforts to supply safe, trustworthy products as well as your obvious commitment to top-rate customer service. Another customer calls your competitor, and the receptionist responds,” I’m sorry, he can’t come to the phone right now. He’s in the supply closet counting paperclips.”

Where vs. What

By Charles R. Earl M.A., ABD
CEO, Communication Connections

During my misspent youth, I enjoyed a comic strip called “Spy versus Spy.” Well, this column has nothing to do with that classic confrontation between good and evil. This blog is dedicated to a common-sense comparison of two primary drug safety technologies. The Where versus the What. I have been tangentially involved with the pharmaceutical industry for nearly a quarter century and vividly remember the valiant efforts to get manufacturers to accept RFID as a viable method for enhancing supply-chain safety. Many have embraced the concept, and there is no doubt that providers and patients have reaped huge benefits as a result of the industry’s efforts to enhance safety and reliability.

RFID is a valuable asset in the trend toward better, safer and more effective products for pharmaceutical consumers. The buggy was a vital component of our ancestors’ lives. It allowed for easier movement of goods and families than was available by horseback or walking. In fact, a carriage ride through Central Park is a pleasant (and perhaps romantic) diversion from the hustle-bustle routine of our daily lives. But when it’s time for serious endeavors, we rely on the automobile or the truck. The buggy still works and has some intrinsic value, but when the rubber meets the road, the automobile is critical.

The Where is the primary focus of RFID. Where has the product been (Remember when Mother used to say, “Don’t put that in your mouth. You don’t know where it’s been?”). So, now we know where it’s been, but are we confident that we know what it is? Even when we are absolutely, unequivocally, slam-dunk certain where it’s been, are we willing to put it in our mouths? Do we know what it is?

“Where- versus- What” does not necessarily require that we drown in a pool of angst. Both are important . Knowing the Where is important for underscoring confidence and aiding law enforcement. Knowing the What is vital. People’s and pets’ lives are at stake. RFID is invaluable for integrity in the supply chain. EDXRD is critical for confirming that the product requested is the product received.

Now, let’s change the formula suggested by the title of this column. Where is good. What is good. Where+What versus the bad spy.

GOOD and PLENTY

Charles R. Earl, M.A., ABD
CEO, Communication Connections

No, we’re not discussing the licorice candy that resembles cold treatment capsules. Rather, “good and plenty” could be used to describe the current state of the global and national pharmaceutical industry. Just review an episode of “Dr. Quinn, Medicine Woman” to get a sense of how pharmaceuticals have progressed in the last 150 years. Dr. Quinn was generally limited to coal oil (a kerosene derivative), cod liver oil, mustard plaster and various bi-products of opium for her medicines. Local residents without the benefit of a knowledgeable physician were forced to purchase their pharmaceutical products from traveling medicine wagons (often ineffective, generally risky), or to form their own medicines after foraging the land.

The point of this exercise is that Today’s pharmaceuticals are more plentiful and effective than ever would have been imagined in the past. With success, however, comes temptation. As pharmaceutical remedies have become more prevalent, so have the opportunities for fraud and misuse. Individuals have discerned that they can substitute worthless copies for effective drugs and reap enormous profits from resale either in the legitimate supply chain or from illicit sales “on the street.” Unethical entities have also discovered that they can exchange slight variations in certain compounds that dramatically lower the cost of production and…radically undermine the effectiveness of the product, thus placing the well-being and lives of patients in peril.

So, while the availability of effective pharmaceuticals is “good and plenty,” the nefarious schemes by unscrupulous characters can severely affect the value of the products and seriously erode public confidence in the industry. This diminished faith will impact every link in the pharmaceutical supply chain. If patients and end users suspect the reliability of the pharmaceutical industry, then they may become more apt to seek their remedies from the back pages of various supermarket magazines. This type of activity would be the 21st Century version of medicine-show purchasing and foraging. While some “quack” remedies may have a short-term “placebo” effect, the long-term consequences will be unfavorable for patients and the industry.

At every step in the pharmaceutical supply chain, industry representatives must do everything possible to insure that the product has not been substituted or changed. Each and every patient, each and every dispenser, each and every handler of the product must have confidence in its efficacy. One old axiom states that “if you want something done right, do it yourself.” When examining the issue of medical safety, that axiom is warranted.

SAFETY FIRST

By Patricia A. Earl,
Executive Strategist
VP Business Development
XStream Systems, Inc.

As succinctly stated in the earlier blog post, it is a near certainty that the United States pharmaceutical industry will face growing counterfeiting issues in the coming years.

These increasing occurrences will impact the industry in a number of important ways. The primary, and most obvious, concern is the liability problem. Trial lawyers have eagerly pursued businesses throughout the chain of custody when filing claims in other product liability areas.

A second issue regarding counterfeiting is integrity. From a professional and personal standpoint, members of the pharmaceutical industry do, and should, want to assure the end users of the products that they are safe and effective. Add to this the desire for safety and efficacy in a regulatory environment that when functioning properly will demand accountability. When companies within this industry sell or distribute products, they should be exactly what the customer expects.

The third issue is trust…and reliability. In order for our industry to grow effectively and for each of our companies or institutions to thrive, our customers must be able to trust us and the products that we deliver. Counterfeits, regardless of where they exist in the distribution chain, undermine the customers’ faith in the industry as a whole.

A final issue that I wish to discuss is the possibility of government intervention in the pharmaceutical distribution process. If counterfeiting becomes more prevalent and risks to patients are growing, then Congress, the Executive branch and its regulatory agencies will face increasing public pressure to “do something.” In this scenario is likely that they will respond with knee jerk mandates. Given government history in other industries, those mandates can be too severe, and at the same time, generally ineffective.

Finally, the pharmaceutical distribution chain should address a proactive posture to assure the integrity of the product. If done thoughtfully, this would limit liability, maintain integrity, enhance trust and reliability and, perhaps, preempt overreaching government meddling. Leaders in the pharmaceutical industry should implement counterfeit detection technology now to protect our reputations and our bottom lines.