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Tracking Prescription Drugs When we are ill and seek medical treatment from our doctors, many of us have received free samples of prescription drugs along with a prescription for that drug. The reason behind this benevolence is that pharmaceutical companies desire to increase sales, promote the dispensing of free trials through this form of distribution that ultimately results in stimulating prescriptions for that drug. The doctor then receives more free samples and the cycle has begun. The more scripts, the more samples, and the more samples the greater the revenue for the drug company. This is the very heart of growth for ethical drugs. Demand creates profits and funds new research. The more demand the better. This perceived value makes for inflated stock prices and so the story goes. At times, pharmaceutical sales personnel may not accurately account for the drugs distributed and these drugs may get into the market or distributed by unauthorized sources. There are at least 50 popular street scams to collect drugs to supply the black and gray markets. The amount of money to be made is enormous based on the costs of today?s prescription medications. With demand created, unscrupulous doctors, pharmacies, hospitals and care centers are the best conduit for this elicit activity. The FBI has been monitoring this form of medical fraud for many years. Operation Gold Pill from 1992 was the kick off for exposure of this problem. By identifying outlets, sources and distribution of ethical drugs the FBI, FDA and other governmental service agencies identified just how big this problem really was. It has just gotten worse over the years. For every conviction there are new dealers and increased demand. When this happens at the national and international level, the potential for disaster is eminent. The liability associated with the wrongful deaths, injury or poisoning of a person reflects directly back to the manufacturer regardless of the source of the drug. Stolen drugs are sold as piggybacks to legally distributed drugs and blended by pharmacies and dealers to hide the activity. The blending of counterfeit drugs along with original drugs is an additional concern. In the past, most free samples had not been diligently accounted for. Records were incomplete and the distribution activity was fertile ground for abuse, theft and deception. These abuses were the basis for the FDA enacting the PDMA ruling which took effect 12/4/00. PDMA is an acronym for Prescription Drug. The FDA and congress have determined that the public interest can only be served by passing legislation to assure that none of these products invade the market. Needless to say this is an ambitious task. Unauthorized channels for distribution of ethical drugs begin at the street level in units as small as a few pills. It also encompasses cargo theft of drugs, robberies of pharmacies, hospitals and nursing homes to mention a few sources. Certain targeted products, such as those household known names like Viagra, Valium and Prozac are in high demand on the black market for street sale. Less known drugs for dermatological conditions, cancer, insulin, Aids and pain management are also in high demand through the standard channels of distribution. Demand creates the need and the ready supply of products fills the void. Dispensed inappropriately drugs can do a considerable amount of harm to users and immeasurable harm to the manufacturers and intellectual property holders. A bad name in the press, an associated death or other impropriety can make stock prices tumble thereby becoming the death knell for companies unaware of this threat. Just remember back to the Tylenol fiasco. That incident was the basis for significant legislation and it was additionally the catalyst for the birth of tamper evident packaging. Pharmaceutical sales personnel know the value of the commodity they distribute. They are really misnamed in being called salesmen and women, because they offer products free of charge to physicians. Their limited expertise in the drug is useful in establishing a market but, like the Easter bunny, they hop around to the 1 million US physicians and hospitals and drop off their products. At times they may be prone to dispense ?just a few? to their friends or sell some to get extra revenue. This condition is almost impossible to monitor in many companies given the magnitude of the sales force, the products they distribute and the doctors or nurse practitioners that receive these goods. Sample drugs are distributed from warehouses and they are often times not uniquely packages. They are delivered in mass to sales personnel and CSO's (third party fulfillment companies) typically shipped products to their homes or warehouses. These products are also distributed through logistic providers who store them for the drug company's field sales force. The salesman who lives in a condo surely cannot place a pallet of drugs in his living room, so he often times stores them in an off site and unattended facility. These facilities can be anything from a roadside storage room to a secure public warehouse. Regardless of the facility the drugs are typically prescription ethical drugs that require dispensing by a qualified physician. They are most often times expensive, name brand items that have significant advertising behind them and considerable brand identity. The products are typically time sensitive and need to be distributed on a preset schedule in order to be acceptable to the manufacturer and to maintain the ethical value of the product. The sales personnel have defined routes and medical clients; speed and coverage are the order of the day. The drugs are most often moved in an unsecured company car or van through the streets of every city. Some places are obviously safer than others! Drug sales personnel and their cars are easy to identify. They are dressed in suits and dresses and they visit doctor's offices regularly with their products in hand. They are easy prey for thieves but they also have the propensity to become white collar thieves themselves. When these pallets are shipped to salesmen, accountability requirements begin under PDMA regulations. The manufacturer now has cradle to grave responsibility for the products. Failure to comply is met with significant sanctions and recurring fines in the millions of dollars. Once identified as an offender, pharmaceutical companies become vulnerable for spot audits and site inspections by both the FDA and FBI to explore abuses under the PDMA laws. The problem of who receives the drugs, who accounts for products given as samples and the status of this lose inventory, is the essence of compliance mandated by the new laws. Products are moving in and out daily from warehouses to salesmen and from salesmen to doctors. The job of the compliance officer at drug companies has just grown from a logistic function to a nightmare of paperwork, record keeping and logistic protocols unknown to that element of most drug companies. It goes without saying that security must be made a part of the design of this type of monitoring system. No one can be a master at all facets of this law based on the lack of specific interpretation of its components, but to test the waters can cost millions. Security departs now find themselves immersed in learning logistics. Traffic and warehouse personnel have been tasked with getting these drugs into the hands of their sales personnel on a timely and repetitive basis but they lack the expertise of security packaging and chain of custody accountability. Blending compliance for PDMA with security packaging and protocols for distribution is a formidable task. Training and sharing of information pertaining to the most appropriate way to handle this problem is the key to avoiding penalties. By staying ahead of the curve and addressing these problems before compliance is mandated is essential. By looking at the problems in a unified manner drug companies have established a counsel for sharing information and defining the issues so that there is uniformity in dealing with the problem. With uniformity comes acceptance and the hopes that FDA will embrace planned GMP's and use them as the basis of enforcement for distribution regulations. New problems and changing corporate culture demand today's security professional wears many hats. Las Vegas was the host city for the PDMA sharing conference, where over 60 of the world's largest suppliers and manufacturers of prescription drugs met to determine just how to comply with these issues. There were conspicuously few security personnel and no logistic personnel present. The PDMA meeting was the unprecedented mechanism that competitive pharmaceutical manufacturers could get together to discuss issues without it being considered illegal! The conference theoretically was designed to allow security, logistic and regulatory groups within these companies to outline their unique roles in dealing with compliance issues. By sharing their internal procedures with one another they were supposed to come away with the how to of compliance. All this was to be done without any fear of reprisals by the IRS or FDA. I came away from the meeting with a sense that the participants were now more scared than ever but still not having the tools (in a unified or any sense) to move ahead. The dynamic diverse procedures, unique manufacturing idiosyncrasies of each company, multiplicity of monitor able sites, packaging plants, segregation of drugs for distribution, shipping and receiving paperwork and documentation makes this a real challenge for the fourth quarter of 2000. How best to define security's role but crucial. Without their focused input vulnerabilities will not be clearly identified. Logistic personnel are far too removed from the threats against corporate profits but rather they focus on getting goods in and out of their respective companies. They rarely deal with losses unless they produce paperwork for claims or surveyors. They are quick to choose carriers but rarely certify their tariffs to examine their fleets or procedures for dealing with problems. Because security personnel are not logistic experts they too need to be brought up to speed on the real working of a loading dock and the requirements to move products safely, quickly, securely and at a cost effective price. The synergy needed for this ambidextrous task is formidable and one not easily mastered. Corporate culture has long separated functions and now when they are most necessary to interface each has a different place in the organization. The PDMA conference is therefore a most critical meeting. |
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