Pharmaceutical

 

 

https://sm.asisonline.org/Pages/The-Fight-Against-Fake-Pharmaceuticals.aspxThe Fight Against Fake PharmaceuticalsGP0|#21788f65-8908-49e8-9957-45375db8bd4f;L0|#021788f65-8908-49e8-9957-45375db8bd4f|National Security;GTSet|#8accba12-4830-47cd-9299-2b34a43444652015-02-01T05:00:00Zhttps://adminsm.asisonline.org/pages/lilly-chapa.aspx, Lilly Chapa<p>​<span style="line-height:1.5em;">Described by experts as one of the most insidious organized crimes as well as one of the most difficult to track, pharmaceutical counterfeiting is a $75 billion industry that is notoriously low-risk and high-reward. Counterfeit medications make up an estimated 10 percent of pharmaceuticals globally, and as much as 25 percent in developing countries. </span></p><p>The World Health Organization (WHO) defines a counterfeit pharmaceutical as a drug that is deliberately and fraudulently mislabeled with respect to identity or source. This means that counterfeits can range from changing the expiration date on a drug’s packaging to altering the raw materials to removing the active ingredients in a medication. The WHO says the extent of the problem is hard to determine since there are no global studies on counterfeit medications, and tracking the drugs from creation to distribution and beyond can be unreliable.</p><p>In November 2013, the U.S. Drug Supply Chain Security Act was signed into law. In an effort to better track pharmaceuticals and share counterfeit information between organizations, the law requires the Food and Drug Administration (FDA) to issue guidance for how pharmaceutical companies should report suspected counterfeits to the government. The law was implemented at the beginning of this year, but Thomas Kubic, president and CEO of the Pharmaceutical Security Institute (PSI), says the reporting requirements are still hazy, and pharmaceutical manufacturing companies are unsure how to comply with the law. He calls the act “a work in progress.”</p><p>But a work in progress is better than nothing, he notes. Although pharmaceutical counterfeiting is becoming more sophisticated and more prevalent, according to the PSI’s numbers, there is a more widespread awareness of the problem, and both developing and Western countries are passing legislation addressing the issue as well as implementing harsher penalties for criminals.</p><p>   Tackling pharmaceutical counterfeiting will take a combination of legislation, federal and state enforcement action, industry and association collaboration, and tracking technology, Kubic explains. “From manufacturer to distribution to the pharmacy there’s a need for folks to be tuned in to what’s going on,” he tells Security Management. </p><p>Following is a discussion of how pharmaceutical counterfeiting has evolved over the past few years and what lawmakers and security experts are doing to combat the threat.</p><h4>A Global Problem<br></h4><p>The counterfeit pharmaceutical industry is attractive to criminals, especially organized crime groups. Criminals can charge near-market prices for big-ticket medicines they’ve counterfeited, which makes it easy to mass produce knockoffs for big profits. India is home to 15,000 known illicit drug factories, which supply approximately 75 percent of the world’s counterfeit drugs, according to the National Crime Prevention Council. </p><p>Medical information services manager and researcher Doug Taylor tells Security Management that the return on counterfeit drugs is 20 times better than heroin.</p><p>“If you’re going to be in the drug industry, you should probably be in the counterfeit drug business if you want to make some real money,” he says.</p><p>Taylor, whose report RFID in the Pharmaceutical Industry: Addressing Counterfeits with Technology was published in November 2014, notes that many countries have weak regulations and oversight when it comes to pharmaceuticals, which makes it easy for criminals to take advantage of the system.</p><p>Vulnerabilities. Following is a look at how counterfeit drug schemes are carried out, why counterfeiting is on the rise, and which victims are hardest hit. Here’s how a drug is created, packaged, and distributed: The chemical compounds that make up the active ingredients of a drug are generally made in India or China due to the low price of raw materials in those regions. The raw materials are made into their formulations—capsules, injectables, creams—either in the country of origin or in the United States or Europe. The drugs are shipped in large quantities to packaging facilities, where they are prepared for distribution. Some pharmaceutical companies handle their own distribution, Taylor explains, while many drugs are distributed to stores and pharmacies via third party organizations. This process can take up to 300 days and involves many countries.</p><p>Taylor says that the pharmaceutical supply chain allows plenty of opportunities for counterfeit materials to enter the main distribution network. </p><p>“Contaminated raw materials can be making their way back into the American supply chain, and there’s very little oversight,” Taylor explains. “So it’s easy for adulterated materials to slip in the supply chain of American or European drugs.”</p><p>Another vulnerable area in the supply chain is the distribution process. Taylor says connected criminals can deposit convincing dupes to be combined with a supply of legitimate drugs.</p><p>“It’s really difficult to tell them apart once they move through the distribution chain because the lots will be so mixed that on the shelf one can be completely legitimate and one can be completely fake,” he says.</p><p>Kubic notes that pharmaceutical theft often precedes counterfeits, as criminals can relabel stolen medications or create dupes to mix in with the stolen drugs and sell them together.</p><p>Knockoff drugs don’t have to enter the legitimate supply chain to be disseminated. Internet and mail-order markets, street vendors, and other backdoor methods allow criminals to distribute dupes straight to the consumers. This is especially rampant in developing regions where medication is typically expensive or hard to acquire.</p><p>Steve Chupa, CPP, a global security director for a major manufacturer, says that consumer goods, such as lotions, creams, and oils, are popular counterfeit items because they’re easy to make and are often sold by street vendors or other illegitimate suppliers. These products are also less regulated because knockoffs are less damaging than pills or injectables. </p><p>“The outcome, if it’s detrimental, is getting red skin,” Chupa says. “They’re not going to kill you.”</p><p>Trends. The PSI is a nonprofit organization made up of 28 research-based pharmaceutical manufacturing companies from around the world. The organization conducts research and works with law enforcement agencies, drug regulatory authorities, and customs officers to try to better understand counterfeiting trends.</p><p>In 2013, there were more than 11,000 reported incidents of counterfeit pharmaceutical activity globally, according to PSI. That’s an 8 percent jump from 2012, and PSI’s Kubic explains that may be due to increased reporting and enforcement efforts. </p><p>There were 317 different types of counterfeit medications discovered in 2013, down from 523 the year prior. “That tells us that to a certain extent the traffickers have shifted their product mix and are looking at more specific medicines in particular categories than they had before,” Kubic explains.</p><p>PSI looks at two sources where counterfeit drugs are prevalent: in stores and pharmacies, and through internet orders or other informal markets. Kubic says he’s seen an increase in the number of counterfeits found on the shelves of pharmacies, which means criminals are targeting clinics and medical offices with higher-priced medications. That’s supported by the fact that more than a quarter of all counterfeit drugs found in the legitimate supply chain were injectables, which tend to cost more. </p><p>Specifically, criminals have increasingly focused on distributing metabolic medication, such as insulin and other anti-diabetic medications, as well as cancer treatment drugs and anti-infectives, like malarial pills, according to the PSI.</p><p>“We saw a shift in trafficker patterns from Internet sales to you and me through spam and e-mails—a shift where the individual counterfeiters and operators were moving toward direct efforts to sell to clinics, doctors, and independent oncology practices here in the U.S.,” Kubic explains. </p><p>Impact. In 2013, Asia and Europe were the top two regions most frequently linked to pharmaceutical crime. However, the PSI, the WHO, and other organizations agree that the percentage of fake drugs is probably much higher in developing countries due to a lack of oversight and reporting.</p><p>“It’s a big problem in the developing world,” Taylor says. “If antimalarials are fake and being distributed to children in West Africa that really need them, that’s a public health crisis.” A report by Malaria Journal states that fake antimalarials contribute to nearly 450,000 preventable deaths every year in Africa alone. </p><p>Chupa says that Africa is the largest consumer of counterfeit goods, and China has been considered the counterfeiting capital of the world. That’s changing, though, as Chinese citizens become more financially successful and demand the real product.</p><p>In places like India, where consumers often have to purchase their own medical supplies before having an operation, counterfeit products are prevalent. Chupa explains that if a person in India is going to have surgery, they receive a list of products to bring with them. They go to a medical supply stores, “which look like hot dog stands in some instances,” he notes, and buy whatever is available.</p><p>“The vendors will say, ‘well, I have this suture, it’ll cost you this much, or this one, which is a lot cheaper.’ And that cheaper one may be a counterfeit. It’s totally up to the consumer,” Chupa explains.</p><p>The developed world isn’t immune to counterfeits, either. Kubic says that when it comes to chronic conditions, it’s hard to tell if a counterfeit medication is in play.</p><p>“If the doctor sees your cholesterol levels are elevated and the medicines don’t seem to be working, they can switch medications and if you’re smart enough, you go to the corner drug store rather than the Internet, and all of a sudden you’re better,” he explains. However, for diseases such as cancer, counterfeit medications can not only prohibit recovery but even worsen the condition.</p><p>“You rarely see criminals who have less of an interest in the impact of their illegal operations and illegal activity,” Kubic says. “Most of the counterfeit medicines don’t kill you right away. It’s much more insidious. You basically don’t get better.”​</p><h4>Anticounterfeiting Measures</h4><p>Despite the prevalence of counterfeit medications in some parts of the world, Kubic has a positive outlook on the steps being taken globally to combat the problem. The U.S. Drug Supply Chain Security Act, for example, requires pharmaceutical firms to add serial numbers to all packages over the next few years, which should aid in tracking drugs through the supply chain. </p><p>Similar legislation and regulation is being applied globally, especially in the countries that need it most: Brazil and Peru have passed track-and-trace legislation; Kenya and Russia have approved harsher penalties for counterfeiters; and countries like Ecuador are giving more funding to anticounterfeiting programs. </p><p>Nonprofits are also taking a more active role. PSI reported that the number of pharmaceutical crime incidents in Africa has jumped by 260 percent thanks to significant reporting efforts by NGOs in the region. Kubic explains that more accurate numbers and increased awareness have spurred many pharmaceutical manufacturers to join international associations and federations, which support educational anticounterfeiting campaigns. </p><p>Taylor advocates for a technological solution. His report goes a step further and recommends that pharmaceuticals be tracked with RFID technology, intelligent barcodes that are tracked by a network system. Currently, most medications are scanned via line-of-sight barcodes, which are relatively easy to alter, Taylor says. </p><p>RFID technology, on the other hand, uses radio waves to transmit information between a tag affixed to the medication packaging, a reader, and a computer. The data shared between tag and reader is comprehensive, allowing the computer to identify which lots are present and where they have been scanned previously, according to the report. </p><p>Taylor acknowledges that the solution isn’t cheap, but he recommends pharmaceutical companies implement RFID technology as early in the supply chain as possible—ideally, by using providers in China or India that have invested in the products. “This will streamline the manufacturing process, enhance transparency in the supply chain, and collect auditable data before the medicines are created,” the report states. </p><p>Product branding can also alert investigators to potential counterfeits. Chupa says that brand protection teams work with engineers to create covert markers on the packaging—either electronic or visible identifiers that will help manufacturers determine whether the packaging is authentic. </p><p>Kubic acknowledges technological and legislative advances in the field are important, but stopping the illegitimate medication before it enters the supply chain is paramount.</p><p>“All of those are pieces of the solution to the extent that you can track-and-trace medicines through the supply chain, and that’s good, but if some doctor orders from an advertisement and he has not vetted who the supplier is, all of those numbers don’t mean much. My view is that while those are elements of the solution, you really need a good enforcement effort.” </p><p>Here’s an example: A small oncology practice with one or two doctors buys $5 to $10 million in medicines over the course of a year. The doctor gets a fax offering those same medications for a discount of 40 percent—that’s a savings of $2 million. The doctor contacts the company, which ostensibly looks like a legitimate supplier, and orders the drugs. But when the medications arrive, the packaging is in Turkish. Most doctors will just assume it’s the same medication with international packaging, and distribute it to their patients. </p><p>“My remedy includes a good enforcement effort at the city, county, state, and federal level,” Kubic says. “We think that’s going to be propagated in other countries where they’re source countries for some of the counterfeit medicines.”</p><p>This has already begun to play out in countries like China, India, and Pakistan. Kubic says he knows the prevalence of major operators from those countries because the governments have been aggressively addressing the issue and working with PSI to conduct seizures and make arrests. Last year, 1,460 people were arrested worldwide for their involvement with counterfeit pharmaceuticals, an 18 percent increase from the previous year, according to PSI.</p>

Pharmaceutical

 

 

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https://sm.asisonline.org/Pages/online-pharmacies-0012052.aspx2013-03-01T05:00:00ZOnline Pharmacies
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https://sm.asisonline.org/Pages/how-do-financial-asset-investigations-0011080.aspx2012-12-01T05:00:00ZHow to Do Financial Asset Investigations
https://sm.asisonline.org/migration/Pages/colorado-discuss-retinal-scans-fingerprinting-secure-prescription-drugs-009665.aspx2012-03-12T04:00:00ZColorado to Discuss Retinal Scans, Fingerprinting to Secure Prescription Drugs
https://sm.asisonline.org/Pages/Fake-Medicines-Require-Global-Remedy.aspx2009-09-01T04:00:00ZFake Medicines Require Global Remedy
https://sm.asisonline.org/Pages/Making-Drugs-that-Kill.aspx2008-09-01T04:00:00ZMaking Drugs that Kill
https://sm.asisonline.org/migration/Pages/making-drugs-kill-004596.aspx2008-09-01T04:00:00ZMaking Drugs That Kill
https://sm.asisonline.org/Pages/drug-makers-protection-prescription.aspx2007-05-01T04:00:00ZDrug Makers’ Protection Prescription
https://sm.asisonline.org/Pages/pharmaceutical-crimes.aspx2007-02-01T05:00:00ZPharmaceutical Crimes
https://sm.asisonline.org/Pages/smart-solutions-security-problems.aspx2007-01-01T05:00:00ZSmart Solutions To Security Problems
https://sm.asisonline.org/Pages/rfid-primer.aspx2005-08-01T04:00:00ZRFID: A Primer
https://sm.asisonline.org/Pages/rfid-primer-0.aspx2005-08-01T04:00:00ZRFID: A Primer
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https://sm.asisonline.org/Pages/The-Fight-Against-Fake-Pharmaceuticals.aspxThe Fight Against Fake Pharmaceuticals<p>​<span style="line-height:1.5em;">Described by experts as one of the most insidious organized crimes as well as one of the most difficult to track, pharmaceutical counterfeiting is a $75 billion industry that is notoriously low-risk and high-reward. Counterfeit medications make up an estimated 10 percent of pharmaceuticals globally, and as much as 25 percent in developing countries. </span></p><p>The World Health Organization (WHO) defines a counterfeit pharmaceutical as a drug that is deliberately and fraudulently mislabeled with respect to identity or source. This means that counterfeits can range from changing the expiration date on a drug’s packaging to altering the raw materials to removing the active ingredients in a medication. The WHO says the extent of the problem is hard to determine since there are no global studies on counterfeit medications, and tracking the drugs from creation to distribution and beyond can be unreliable.</p><p>In November 2013, the U.S. Drug Supply Chain Security Act was signed into law. In an effort to better track pharmaceuticals and share counterfeit information between organizations, the law requires the Food and Drug Administration (FDA) to issue guidance for how pharmaceutical companies should report suspected counterfeits to the government. The law was implemented at the beginning of this year, but Thomas Kubic, president and CEO of the Pharmaceutical Security Institute (PSI), says the reporting requirements are still hazy, and pharmaceutical manufacturing companies are unsure how to comply with the law. He calls the act “a work in progress.”</p><p>But a work in progress is better than nothing, he notes. Although pharmaceutical counterfeiting is becoming more sophisticated and more prevalent, according to the PSI’s numbers, there is a more widespread awareness of the problem, and both developing and Western countries are passing legislation addressing the issue as well as implementing harsher penalties for criminals.</p><p>   Tackling pharmaceutical counterfeiting will take a combination of legislation, federal and state enforcement action, industry and association collaboration, and tracking technology, Kubic explains. “From manufacturer to distribution to the pharmacy there’s a need for folks to be tuned in to what’s going on,” he tells Security Management. </p><p>Following is a discussion of how pharmaceutical counterfeiting has evolved over the past few years and what lawmakers and security experts are doing to combat the threat.</p><h4>A Global Problem<br></h4><p>The counterfeit pharmaceutical industry is attractive to criminals, especially organized crime groups. Criminals can charge near-market prices for big-ticket medicines they’ve counterfeited, which makes it easy to mass produce knockoffs for big profits. India is home to 15,000 known illicit drug factories, which supply approximately 75 percent of the world’s counterfeit drugs, according to the National Crime Prevention Council. </p><p>Medical information services manager and researcher Doug Taylor tells Security Management that the return on counterfeit drugs is 20 times better than heroin.</p><p>“If you’re going to be in the drug industry, you should probably be in the counterfeit drug business if you want to make some real money,” he says.</p><p>Taylor, whose report RFID in the Pharmaceutical Industry: Addressing Counterfeits with Technology was published in November 2014, notes that many countries have weak regulations and oversight when it comes to pharmaceuticals, which makes it easy for criminals to take advantage of the system.</p><p>Vulnerabilities. Following is a look at how counterfeit drug schemes are carried out, why counterfeiting is on the rise, and which victims are hardest hit. Here’s how a drug is created, packaged, and distributed: The chemical compounds that make up the active ingredients of a drug are generally made in India or China due to the low price of raw materials in those regions. The raw materials are made into their formulations—capsules, injectables, creams—either in the country of origin or in the United States or Europe. The drugs are shipped in large quantities to packaging facilities, where they are prepared for distribution. Some pharmaceutical companies handle their own distribution, Taylor explains, while many drugs are distributed to stores and pharmacies via third party organizations. This process can take up to 300 days and involves many countries.</p><p>Taylor says that the pharmaceutical supply chain allows plenty of opportunities for counterfeit materials to enter the main distribution network. </p><p>“Contaminated raw materials can be making their way back into the American supply chain, and there’s very little oversight,” Taylor explains. “So it’s easy for adulterated materials to slip in the supply chain of American or European drugs.”</p><p>Another vulnerable area in the supply chain is the distribution process. Taylor says connected criminals can deposit convincing dupes to be combined with a supply of legitimate drugs.</p><p>“It’s really difficult to tell them apart once they move through the distribution chain because the lots will be so mixed that on the shelf one can be completely legitimate and one can be completely fake,” he says.</p><p>Kubic notes that pharmaceutical theft often precedes counterfeits, as criminals can relabel stolen medications or create dupes to mix in with the stolen drugs and sell them together.</p><p>Knockoff drugs don’t have to enter the legitimate supply chain to be disseminated. Internet and mail-order markets, street vendors, and other backdoor methods allow criminals to distribute dupes straight to the consumers. This is especially rampant in developing regions where medication is typically expensive or hard to acquire.</p><p>Steve Chupa, CPP, a global security director for a major manufacturer, says that consumer goods, such as lotions, creams, and oils, are popular counterfeit items because they’re easy to make and are often sold by street vendors or other illegitimate suppliers. These products are also less regulated because knockoffs are less damaging than pills or injectables. </p><p>“The outcome, if it’s detrimental, is getting red skin,” Chupa says. “They’re not going to kill you.”</p><p>Trends. The PSI is a nonprofit organization made up of 28 research-based pharmaceutical manufacturing companies from around the world. The organization conducts research and works with law enforcement agencies, drug regulatory authorities, and customs officers to try to better understand counterfeiting trends.</p><p>In 2013, there were more than 11,000 reported incidents of counterfeit pharmaceutical activity globally, according to PSI. That’s an 8 percent jump from 2012, and PSI’s Kubic explains that may be due to increased reporting and enforcement efforts. </p><p>There were 317 different types of counterfeit medications discovered in 2013, down from 523 the year prior. “That tells us that to a certain extent the traffickers have shifted their product mix and are looking at more specific medicines in particular categories than they had before,” Kubic explains.</p><p>PSI looks at two sources where counterfeit drugs are prevalent: in stores and pharmacies, and through internet orders or other informal markets. Kubic says he’s seen an increase in the number of counterfeits found on the shelves of pharmacies, which means criminals are targeting clinics and medical offices with higher-priced medications. That’s supported by the fact that more than a quarter of all counterfeit drugs found in the legitimate supply chain were injectables, which tend to cost more. </p><p>Specifically, criminals have increasingly focused on distributing metabolic medication, such as insulin and other anti-diabetic medications, as well as cancer treatment drugs and anti-infectives, like malarial pills, according to the PSI.</p><p>“We saw a shift in trafficker patterns from Internet sales to you and me through spam and e-mails—a shift where the individual counterfeiters and operators were moving toward direct efforts to sell to clinics, doctors, and independent oncology practices here in the U.S.,” Kubic explains. </p><p>Impact. In 2013, Asia and Europe were the top two regions most frequently linked to pharmaceutical crime. However, the PSI, the WHO, and other organizations agree that the percentage of fake drugs is probably much higher in developing countries due to a lack of oversight and reporting.</p><p>“It’s a big problem in the developing world,” Taylor says. “If antimalarials are fake and being distributed to children in West Africa that really need them, that’s a public health crisis.” A report by Malaria Journal states that fake antimalarials contribute to nearly 450,000 preventable deaths every year in Africa alone. </p><p>Chupa says that Africa is the largest consumer of counterfeit goods, and China has been considered the counterfeiting capital of the world. That’s changing, though, as Chinese citizens become more financially successful and demand the real product.</p><p>In places like India, where consumers often have to purchase their own medical supplies before having an operation, counterfeit products are prevalent. Chupa explains that if a person in India is going to have surgery, they receive a list of products to bring with them. They go to a medical supply stores, “which look like hot dog stands in some instances,” he notes, and buy whatever is available.</p><p>“The vendors will say, ‘well, I have this suture, it’ll cost you this much, or this one, which is a lot cheaper.’ And that cheaper one may be a counterfeit. It’s totally up to the consumer,” Chupa explains.</p><p>The developed world isn’t immune to counterfeits, either. Kubic says that when it comes to chronic conditions, it’s hard to tell if a counterfeit medication is in play.</p><p>“If the doctor sees your cholesterol levels are elevated and the medicines don’t seem to be working, they can switch medications and if you’re smart enough, you go to the corner drug store rather than the Internet, and all of a sudden you’re better,” he explains. However, for diseases such as cancer, counterfeit medications can not only prohibit recovery but even worsen the condition.</p><p>“You rarely see criminals who have less of an interest in the impact of their illegal operations and illegal activity,” Kubic says. “Most of the counterfeit medicines don’t kill you right away. It’s much more insidious. You basically don’t get better.”​</p><h4>Anticounterfeiting Measures</h4><p>Despite the prevalence of counterfeit medications in some parts of the world, Kubic has a positive outlook on the steps being taken globally to combat the problem. The U.S. Drug Supply Chain Security Act, for example, requires pharmaceutical firms to add serial numbers to all packages over the next few years, which should aid in tracking drugs through the supply chain. </p><p>Similar legislation and regulation is being applied globally, especially in the countries that need it most: Brazil and Peru have passed track-and-trace legislation; Kenya and Russia have approved harsher penalties for counterfeiters; and countries like Ecuador are giving more funding to anticounterfeiting programs. </p><p>Nonprofits are also taking a more active role. PSI reported that the number of pharmaceutical crime incidents in Africa has jumped by 260 percent thanks to significant reporting efforts by NGOs in the region. Kubic explains that more accurate numbers and increased awareness have spurred many pharmaceutical manufacturers to join international associations and federations, which support educational anticounterfeiting campaigns. </p><p>Taylor advocates for a technological solution. His report goes a step further and recommends that pharmaceuticals be tracked with RFID technology, intelligent barcodes that are tracked by a network system. Currently, most medications are scanned via line-of-sight barcodes, which are relatively easy to alter, Taylor says. </p><p>RFID technology, on the other hand, uses radio waves to transmit information between a tag affixed to the medication packaging, a reader, and a computer. The data shared between tag and reader is comprehensive, allowing the computer to identify which lots are present and where they have been scanned previously, according to the report. </p><p>Taylor acknowledges that the solution isn’t cheap, but he recommends pharmaceutical companies implement RFID technology as early in the supply chain as possible—ideally, by using providers in China or India that have invested in the products. “This will streamline the manufacturing process, enhance transparency in the supply chain, and collect auditable data before the medicines are created,” the report states. </p><p>Product branding can also alert investigators to potential counterfeits. Chupa says that brand protection teams work with engineers to create covert markers on the packaging—either electronic or visible identifiers that will help manufacturers determine whether the packaging is authentic. </p><p>Kubic acknowledges technological and legislative advances in the field are important, but stopping the illegitimate medication before it enters the supply chain is paramount.</p><p>“All of those are pieces of the solution to the extent that you can track-and-trace medicines through the supply chain, and that’s good, but if some doctor orders from an advertisement and he has not vetted who the supplier is, all of those numbers don’t mean much. My view is that while those are elements of the solution, you really need a good enforcement effort.” </p><p>Here’s an example: A small oncology practice with one or two doctors buys $5 to $10 million in medicines over the course of a year. The doctor gets a fax offering those same medications for a discount of 40 percent—that’s a savings of $2 million. The doctor contacts the company, which ostensibly looks like a legitimate supplier, and orders the drugs. But when the medications arrive, the packaging is in Turkish. Most doctors will just assume it’s the same medication with international packaging, and distribute it to their patients. </p><p>“My remedy includes a good enforcement effort at the city, county, state, and federal level,” Kubic says. “We think that’s going to be propagated in other countries where they’re source countries for some of the counterfeit medicines.”</p><p>This has already begun to play out in countries like China, India, and Pakistan. Kubic says he knows the prevalence of major operators from those countries because the governments have been aggressively addressing the issue and working with PSI to conduct seizures and make arrests. Last year, 1,460 people were arrested worldwide for their involvement with counterfeit pharmaceuticals, an 18 percent increase from the previous year, according to PSI.</p>GP0|#21788f65-8908-49e8-9957-45375db8bd4f;L0|#021788f65-8908-49e8-9957-45375db8bd4f|National Security;GTSet|#8accba12-4830-47cd-9299-2b34a4344465
https://sm.asisonline.org/Pages/security-officers-007598.aspxSecurity Officers<p>A New Jersey prosecutor has dismissed a felony assault charge against a security guard. The guard was indicted after a scuffle at his workplace resulted in an injury to a thief who had come to rob the facility. Recordings of the guard’s 911 calls led prosecutors to rethink the charge. Read the New Jersey prosecutor’s petition to dismiss the case.</p><ul><li><a href="/migration/Documents/State_of_New_Jersey_v_Boyd.pdf">State_of_New_Jersey_v_Boyd.pdf</a></li></ul><p> </p>GP0|#cd529cb2-129a-4422-a2d3-73680b0014d8;L0|#0cd529cb2-129a-4422-a2d3-73680b0014d8|Physical Security;GTSet|#8accba12-4830-47cd-9299-2b34a4344465
https://sm.asisonline.org/Pages/A-History-of-Grievances.aspxA History of Grievances<p>​<span style="line-height:1.5em;">By most accounts, they did everything right. Their new reporter had demonstrated concerning behavior, so they'd brought him in to discuss it. They had monitored his progress, and when he didn't improve, they mandated professional services. And when that didn't work and complaints continued to come in, they terminated him, and they had him escorted by police from the building. Employees were instructed to call 911 if they saw the former reporter near the facility.</span></p><p>Yet, nearly two years later, Vester Lee Flanagan II tracked down two of his former colleagues at WDBJ and shot and killed them on live television in a horrific act of violence that shocked the world.</p><p>In the aftermath, questions remained: What drove Flanagan to murder his former colleagues? Could he have been stopped? And if the unthinkable happens, how should companies respond?</p><p>With unparalleled access to memos and personnel data from lawsuits Flanagan filed, <em>Security Management</em> spoke with experts to answer those questions.​</p><h4>The Hiring</h4><p>Flanagan, who went by the name of Bryce Williams on air, was hired by WDBJ—a Roanoke, Virginia, television station—as a multimedia journalist in March 2012 for $36,000 per year. He had nearly 10 years of experience, with positions as a communications director, production assistant, news writer, reporter, anchor, and producer in California, Texas, Georgia, Florida, and North Carolina.</p><p>Almost immediately after arriving in Roanoke, his behavior at work concerned his colleagues. Some of them reported a "heated confrontation" with Flanagan in a broadcast vehicle on April 28, 2012, that left them feeling threatened and "extremely uncomfortable," according to a memo included in a civil lawsuit filed by Flanagan against the station. </p><p>Weeks later, on May 30, Flanagan's photographer reported another disagreement while the two were out on assignment shooting B-roll. When the photographer finished, Flanagan told him, "…the shaky video isn't going to work," and told an interview subject who was present that the photographer's work was "completely unusable." The incident ended with Flanagan storming off in anger.</p><p>This type of behavior would be repeated numerous times during the 11 months that Flanagan worked at the station. These moments were indications that Flanagan had the potential to be a dangerous person: a grievance collector.</p><p>Dr. Larry Barton, a threat assessment specialist and professor of management at the American College in Bryn Mawr, Pennsylvania, says anyone can have a grievance at work—a change in hours, a change in shift, a daycare issue because their hours have changed, and so on. </p><p>"A grievance is in many ways a benefit because it allows us to know you're upset," he explains. "The key here is to get onto that concept of the collector. This is the person who will not let this go. And so instead of one complaint, they have six complaints….and they truly will not let it go."</p><p>Grievance collectors also engage in repeated behaviors. They keep very specific journals, like chronicles, of names of people, names of those in a meeting, and notes on who said what. </p><p>"They tend to write very long and, often, elegant letters," Barton adds. "In other words, they're not scattered; they're actually often people who spend hours to write an e-mail that's very well crafted because they're upset and they're moving in that space of 'I am right; there is no gray in this, and you, employer, are wrong.'"</p><p>Within the letters, they often refer to God because "they believe that God is on their side, righteousness is on their side," Barton says. The letters are then sent to employers, politicians, federal agencies, and more, "to do whatever it takes to ensure that their cause is heard."</p><p>Often, these communications are shared during off hours—late at night or on weekends. "It shows that it's not just at work. They're willing to give up their entire weekend, and they're willing to write at two o'clock in the morning," Barton says. (Barton discusses the other top 5 red flags from problem employees in "The List" in the December 2015 issue of <em>Security Management</em>.)</p><p>Flanagan did this by documenting his grievances in a manifesto sent to ABC News and by filing a lawsuit, alleging a hostile work environment, racial discrimination, sexual harassment, mental anguish, and credit card debt caused by his eventual termination from WDBJ.</p><p>"Your Honor, what I encountered while employed at WDBJ-7 was nothing short of vile, disgusting, and inexcusable," Flanagan wrote to District Judge Francis Burkart, III, in 2014 when he filed his suit representing himself. "I realize this is the ultimate David vs. Goliath scenario, so to speak. However, I am neither intimidated nor fearful. While I may not be an expert with regards to case law and legal terms, I AM an expert when it comes to integrity, character, and the difference between right and wrong."</p><p>Flanagan also said that he would not rest until the matter was resolved. "I am a very, very persistent person and will utilize every resource I have to achieve justice and stand up for the rights of others at the same time."</p><p>Identifying grievance collectors is crucial because "once a person crosses that threshold, it's very hard to get them off that track," Barton says. To help identify these individuals, Barton says employees should be encouraged to use their natural sense of intuition that something is not right, that something seems wrong with what a coworker is saying or doing.</p><p>"Pay attention to intuition because so much of the focus today is on analytics, forensics, and what people are writing on the Web," Barton adds. "And all of that is important, but we have to come back to some of the fundamentals…the real opportunity, which is that it just doesn't seem right."</p><p>When an employee notices that a coworker is depressed or anxious, they should take a partner and talk to the person they are concerned about. They should ask that person how he or she is doing before requesting a formal investigation. </p><p>"Sometimes we make it worse, and we love to throw around this phrase of 'we're going to conduct an investigation,'" Barton says. "The words we use, when you take a person who's just struggling, can make them feel like a criminal."</p><p>What's crucial, though, is to identify issues while they're small problems and address them—before they've had a chance to turn into something bigger, says Jay Hart, executive director of Force Training Institute.  </p><p>For companies that don't already have them, Hart recommends creating a safety committee that brings together people who see different risks or concerns within the organization, such as legal, HR, security, and those who are passionate about safety in the organization as a whole.</p><p>When someone acts out of bounds, it can be brought to the committee to address the behavior right away and determine if it is a credible threat and whether it's imminent. If it is, such as an employee overheard threatening to hurt someone at work, the committee can call in outside resources or law enforcement to address it.</p><p>However, if the committee decides it's not an immediate threat—such as an employee bullying a coworker—it can suggest mental first aid first, like emotional counseling through an employee assistance program. The committee can then monitor the employee's progress, make regular check-ins, and document the process.</p><p>"There are defibrillators everywhere; if somebody gets hurt, you go, 'Hey, take that off the wall and help them,'" Hart says. "Well, we need to start thinking about mental first aid. If somebody does have some type of issues, they may need some psychological help. And because your company or organization does have resources, they can get people the help that they need."</p><p>This approach gives employees the impression that their colleagues care about them, but it also lets them know that if they begin to pose a problem or a threat—to themselves or others—it may cost them their job, Barton explains.​</p><h4>The Termination</h4><p>As Flanagan's employment with WDBJ continued, he had regular meetings with News Director Dan Dennison to discuss his behavior. In a memo that was included in Flanagan's lawsuit, Dennison told Flanagan to work on the "tone of your interpersonal relationships and exercise great care in dealing with stressful situations or disagreements and your response to them."</p><p>Dennison also encouraged Flanagan to bring any concerns he had about his coworkers to his direct supervisor or members of the management team, and to seek help from the employee assistance program if he thought it would be beneficial.</p><p>"Any further incidents of inappropriate behavior or situational response that is not professional or leaves a co-worker feeling threatened or uncomfortable will lead to more serious disciplinary action up to and including termination of employment," according to the memo.</p><p>However, Flanagan's behavior did not improve, even after contacting WDBJ's employee assistance program. In January 2013, everything came to a head in numerous incidents where Flanagan verbally clashed with his superiors and colleagues, creating an uncomfortable work environment.</p><p>Dennison and others called Flanagan to a human resources representative's office on February 1, and explained that he was being terminated due to unsatisfactory job performance and inability to work as a team member. Flanagan was then presented with a severance letter, which he said was unacceptable.</p><p>Instead, Flanagan demanded that WDBJ provide him with three months' severance, and said "you better call police because I'm going to make a big stink. This is not right." He insisted on speaking to Todd Schurz, CEO of WDBJ's parent company, then said he had to go to the bathroom, storming out of the office and slamming the door.</p><p>However, Flanagan did not go to the bathroom but instead went to his desk to collect his things and look for Schurz's phone number. He was interrupted, though, when Dennison and two police officers came into the room and told him he needed to leave.</p><p>One of the police officers attempted to take the phone that Flanagan was using, causing Flanagan to say: "Take your hands off me. Leave me alone." Other staff members observed and recorded the incident. </p><p>One of the employees recording the incident was Adam Ward, a WDBJ photographer. When Flanagan saw him, he told Ward he needed to "lose your big gut" and flipped him off.</p><p>Flanagan then gave a hat and small wooden cross to Dennison, telling him he would need them, and police officers removed Flanagan from the room. WDBJ employees were then informed that if they saw Flanagan on company property, they were to call 911 immediately. Management also made arrangements to have an off-duty police officer on premises from 6 a.m. to midnight that following weekend.</p><p>Separations like this are why it's critical for security to partner with the HR community within their organizations: it is common for security to get a call from HR saying, "We need you to walk out somebody because we're going to have a provocative separation; we think this guy could be violent," Barton says. "And what that does immediately is not only place the security officer in harm's way, but it really creates tension."</p><p>Instead, HR needs to tell security why this individual has raised concerns. Based on that information, security can help determine whether there's a more discreet way to terminate the person to avoid embarrassing him or her. </p><p>"The big issue, the overwhelming issue, is humiliation," Barton explains. "When people are embarrassed, it plays a role in retaliation, and that's why managing people in terms of how they exit that company is so critical."</p><p>And, Barton says, often companies fail to complete the termination process with integrity. "Sometimes because of the speed or because we're just not comfortable or we're not sure what's going to happen with this person, we don't treat them with dignity," he adds, which can lead to retaliation.</p><p>Additionally, when someone is terminated and is considered potentially dangerous—either to the facility or staff—companies need to have a method of communicating that with employees, despite concerns that it might make employees nervous.</p><p>"If we don't tell them, then we're at more risk because nobody knows," Hart explains. Instead, companies need to craft a message that communicates to employees appropriately, and that doesn't scare them but shows that the company cares and wants them to be safe. This message should include "influential" information about the issue and what employees should do if they see an emergency situation.</p><p>Hart explains what he means by "influential" information: "When you're communicating to your employees about a subject as sensitive as a terminated employee, it's important that the message is based on influence versus just information," Hart says. "Sometimes we can get legalese on it and be very calculated…and then what happens is it starts this wildfire of rumors throughout the organization that starts to take off and the message gets out of control."</p><p>Instead, Hart says companies should write messages that reassert that the company cares about its employees and include general information about what the threat is, how the company is handling it, and what employees are expected to do about the threat, such as calling 911 if a former employee is seen outside the building. </p><p>"It's really important when you are crafting that message to start off with the fact that you care about your employees—they're the most important asset," he explains.</p><p>Employers also need to identify whether they need to monitor a former employee once he or she has been terminated if they believe that individual presents a threat. There are various methods that companies can use, Hart says, but one of the easiest and most effective is to monitor the former employee's public social media activity. </p><p>For instance, Flanagan had a public Twitter account that he began using approximately two weeks before shooting his former colleagues. However, since his account was suspended, it is unclear if he used it to post threats prior to the incident. </p><p>In June 2014, less than a year after he was fired, Flanagan filed his lawsuit against WDBJ. The initial filing is revealing, showing Flanagan's belief that WDBJ's photographers sabotaged his efforts in an attempt to get him fired. </p><p>"There was a carefully orchestrated effort by the photography staff to oust me—a conspiracy," Flanagan wrote. "The chief photographer, Lynn Eller, even told the photographers to 'roll on me' if they caught me doing something wrong. Why did one of the photographers go to HR on me after working with me ONLY ONCE. There was nothing to report! That, Your honor, is just plain wrong."</p><p>He also accused Dennison of coercing and intimidating him, and claims that WDBJ broke the law by not paying him for overtime hours. Additionally, Flanagan explained incidents involving his former colleagues where they allegedly attacked him, verbally assaulted him, displayed a watermelon as a racist symbol, and sent "egregious" text messages. </p><p>A district judge, however, dismissed the case in July 2014, and Flanagan did not file another. Instead, as we now know, he began plotting to murder his former colleagues.​</p><h4>The Response</h4><p>A year after his lawsuit was dismissed, Flanagan ambushed reporter Alison Parker and Ward on August 26, 2015, while they were interviewing Vicki Gardner, head of the Smith Mountain Lake Regional Chamber of Commerce, as part of the station's morning show.</p><p>Flanagan shot Parker and Gardner on air, then turned his gun on Ward while his camera continued to roll, showing the horrific chain of events to Parker and Ward's colleagues in the control room at WDBJ and to viewers on live television. The footage was broadcast on social media around <span style="line-height:1.5em;">the world.</span></p><p>The reach of the shooting escalated when Flanagan began posting his own updates on his Twitter feed and Facebook page—which have since been taken down—of video footage he'd taken of the attack and grievances against Ward and Parker.</p><p>Flanagan then fled the scene and was apprehended five hours later when his car ran off Interstate 66 after being pursued by law enforcement. He shot himself and was transported to Inova Fairfax Hospital in Falls Church, Virginia, where he died from his injuries at approximately 1:30 p.m., according to <em>The Roanoke Times</em>. Parker and Ward also died from their injuries, but Gardner survived.</p><p>Remarkably, WDBJ continued to report the news that day, coming together with support from executives, staff members, the Roanoke community, and other media outlets. WDBJ held a memorial service for Ward and Parker, and provided staff with access to a grief counselor and a pastor.</p><p>The incident served as a stark reminder that along with working to prevent workplace violence from happening, companies also need to develop reaction and recovery plans to respond to incidents when they do happen. Kevin Doss, CPP, PSP, president and CEO of Level 4 Security, a security consultancy, says there are two parts of response: organizational response and individual response. </p><p>The organizational response is to protect those under the company's duty of care, such as employees, guests, or visitors, and should begin with how to determine what the threat is, where it is, and how law enforcement can neutralize it. </p><p>Additionally, organizational response includes communicating with those under duty of care that there is a threat, how to evacuate the building, and where individuals should go for the reunification process so law enforcement can screen and debrief them.</p><p>Organizations also need to think through how they will prepare for press coverage of the incident and communicate what's happening to stakeholders outside of the facility that's under threat. There needs to be a plan in place, Doss says, to have a designated spokesperson who will be responsible for giving timely updates to the media.</p><p>When it comes to individual response, companies need to teach their employees what to do if there is an active shooter or threat in their facility. One method Doss likes is the Run.Hide.Fight model, which can allow organizations to build their policies and procedures around whether employees can run away from the threat, need to hide from the threat, or need to fight back. This ensures that the company is "doing its part to help the individual employee make their decision," he adds.</p><p>After the initial response and the elimination of the threat comes the recovery phase, or reacclimation, as Barton calls it. Reacclimation is like a soldier who has fought in Iraq or Afghanistan, say, who goes through acclimating to society, he explains. "They take them first to Germany and kind of get them to think about pizza and life, and their families, and doing more Skype calls, and kind of ramping it up…well, the same has to do with the workplace."</p><p>When an incident happens, whether it's a shooting, or a fight, or a fire, there's a lot of rumors and people don't want to come back to work. They are worried that another incident will happen, or their spouse is concerned about their welfare at the office.</p><p>To help begin the reacclimation process, Barton says that organizations need to acknowledge that there's been a tragedy by memorializing the victims and making senior leaders visible throughout the process. </p><p>"Don't push this down to HR. Your CEO and your president need to speak to the issue," Barton explains. "This is a homicide at work; it requires dignity, and it requires…that you speak from your heart as to this tragedy."</p><p>For instance, after Ward and Parker were killed, WDBJ created a Web page to remember their work for the station and to memorialize them. It remains regularly updated, with reports on charity efforts and scholarships created in their names, options to leave condolence messages, and updates on Gardner's recovery progress.</p><p>After the initial acknowledgment, the company should require that the victim's immediate work group attend a counseling session with a professional counselor, such as a trauma counselor from a local hospital.</p><p>"Everyone on that shift who knew that person should attend," Barton says. "Even if they sit there with their arms crossed, it allows them to think about and process change and grief. And a lot of people will speak up and a lot of people will be silent. But it's a really important part of this whole process."</p><p>Hart concurs with this, and recommends planning an organizational response that includes agreements with local counselors and therapists who can provide services if an incident does occur.</p><p>"You're starting to see mental health advocates, mental health organizations that are run by the state, the county, the government, starting to take a more active role in the private sector in giving them resources to address these issues," he adds. "And I think that's where we're going to see the next steps taking place, addressing this mental health issue ahead of time."</p><p>However, Barton cautions that workplace homicides are not spiraling out of control; he points out that the number has remained static for about 15 years, with an average of one person killed per day at work in the United States by a coworker or a former coworker, according to his research.</p><p>"So remain vigilant, not paranoid," he says. "Stick with the facts, don't be alarmists, and know that people do want to be informed. Our kids are getting this training in first grade, so we can talk about it at work."</p>GP0|#28ae3eb9-d865-484b-ac9f-3dfacb4ce997;L0|#028ae3eb9-d865-484b-ac9f-3dfacb4ce997|Strategic Security;GTSet|#8accba12-4830-47cd-9299-2b34a4344465