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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>

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https://sm.asisonline.org/Pages/The-Dirty-Secret-of-Drug-Diversion.aspxThe Dirty Secret of Drug Diversion<p>​Controlled substances were going missing at Hennepin County Medical Center (HCMC), and the hospital’s security investigator, William Leon, was determined to get to the bottom of it. So, at 11 p.m. on a Friday, Leon settled in for a night of observation at the Level I trauma center in Minneapolis, Minnesota. He kept a trained eye on one registered nurse who was suspected of stealing hydromorphone, an opioid pain medication, for her personal use.</p><p>HCMC has cameras set up in the medication room to monitor controlled substances, and Leon watched as the nurse began gathering prescribed medication for a patient in the emergency department. The process, called wasting, requires the healthcare worker to take a fresh vial or syringe full of medication and then dispose of the excess, leaving only the correct dosage—all with a witness present. Leon observed the nurse dispense a syringe of hydromorphone from the medicine cabinet, and, while a fellow nurse was signing off on the withdrawal, she placed the syringe in her pocket and pulled out an identical syringe, which Leon later learned contained saline. The nurse held up the saline syringe and wasted the required amount, tricking her fellow nurse, and left the room.</p><p>At this point, Leon knew exactly what was going on, and watched with increasing alarm as the nurse headed to a patient’s room in the orthopedic area of the hospital. “In that area, I knew immediately, this patient could have a broken bone—they were in intense pain and requiring this medication,” Leon says. “I see a lot of doctors standing around and I’m thinking ‘uh oh, this patient is going to get saline.’”</p><p>Leon raced to the room and saw that the doctors had given the patient the saline the nurse had brought up. “The patient was still screaming in pain and the doctor was frantically asking the nurse, ‘Are you sure you got the right dosage? Are you sure it was hydromorphone?’ and she was insisting she had,” Leon says. He called the doctor and the nurse into the hall and explained that the patient had just gotten saline and still needed the proper pain medication because the nurse had diverted the hydromorphone in the medication room. The doctor went to properly treat the patient and Leon called the nurse manager and the local sheriff’s detective in to begin an official investigation into the nurse’s actions.</p><p>Drug diversion in the United States is a nebulous problem that is widespread but rarely discussed, experts say. Whether in manufacturing plants, retail pharmacies, hospitals, or long-term care facilities, healthcare workers are stealing drugs—typically for their own personal use—and putting themselves, patients, and coworkers at risk. </p><p>“I hate to tell you, but if you have controlled substances and dispense narcotics, you’ve got diversion going on,” says Cherie Mitchell, president of drug diversion software company HelioMetrics. “It’s just a question of whether you know it or not.”</p><p>The scope and frequency of drug diversion is almost impossible to grasp, due in large part to how diversion cases are addressed. A facility that identifies a diversion problem might bring in any combination of players, from private investigators and local law enforcement to state accreditation boards or the U.S. Drug Enforcement Agency (DEA). There is no overarching agency or organization that records every instance of drug diversion in the United States.</p><p>Controlled substance management is dictated by a number of laws, including the U.S. Controlled Substances Act of 1971, which classifies substances based on how they are used and the potential for abuse. It also dictates how the substances are dispensed, and a facility may be fined if it does not comply. </p><p>The closest estimates of drug diversion rates come from people or organizations who dig up the numbers themselves. The Associated Press used government-obtained data in its investigations on drug diversion at U.S. Department of Veterans Affairs (VA) medical centers. Reported incidents of diversion at about 1,200 VA facilities jumped from 272 in 2009 to 2,926 in 2015, the data revealed, and the VA inspector general has opened more than 100 criminal investigations since last October. John Burke, president of the International Health Facility Diversion Association, extrapolated data he obtained from facilities in Ohio to estimate the presence of 37,000 diverters in healthcare facilities across the country each year. </p><p>Mitchell points out that any statistic derived from officially collected data still wouldn’t accurately reflect the extent of drug diversion in the United States. “There’s a lot of people investigators really suspected were diverters but had to be chalked up to sloppy practice due to a lack of concrete evidence, so any statistic is talking about known diverters who are fired for diversion,” she tells <i>Security Management</i>. “Even if you did have a statistic, it would be off because how do you incorporate those so-called sloppy practicers, or diverters who thought they were about to get caught so they quit on you and left? No matter what number you come to, it’s probably bigger in reality.”​</p><h4>Addiction and Diversion</h4><p>Although more people are paying attention to drug diversion due to recent high-profile cases and the current opioid epidemic in the United States, experts say they have been dealing with the same problems their entire careers. </p><p>“I can personally tell you that I dealt with the same issues 15 or 20 years ago that the healthcare arena is facing today, specifically in the drug abuse and diversion by their own hospital healthcare employees,” says Charlie Cichon, executive director of the National Association of Drug Diversion Investigators (NADDI) and a member of the ASIS International Pharmaceutical Security Council. “There are different drugs today, of course, than there were 20 years ago.”</p><p>Susan Hayes has been a private detective for healthcare facilities for more than a decade and says the opioid epidemic has magnified the drug diversion problem in recent years. “The opioid addiction in America has lit my practice on fire,” she says.</p><p>It’s no secret that opioid addiction has reached epidemic levels in the United States. In 2010, hydrocodone prescriptions were filled 131.2 million times at retail pharmacies alone, making it the most commonly prescribed medication, according to the Mayo Clinic. However, those are just the numbers that were legally prescribed—about 75 percent of people who take opioids recreationally get them from a friend or family member. According to the U.S. Centers for Disease Control and Prevention (CDC), approximately 52 people in the United States die every day from overdosing on prescription painkillers.</p><p>Healthcare workers are not immune to the draw of opioids. In fact, up to 15 percent of healthcare workers are addicted to drugs or alcohol, compared to 8 percent of the general population, according to the Mayo Clinic. </p><p>“Healthcare providers are in very stressful jobs,” Hayes says. “They all have problems. Nurses have emotional attachments to patients that they see die. Even orderlies have very stressful physical jobs, they’re lifting patients. Pharmacists can make mistakes that mean life or death. You have people that are already in very stressful situations, and now you give them access to drugs…. I think the combination is almost deadly.”</p><p>While a bottle of 30mg oxycodone tablets can sell on the street for up to 12 times its price in the pharmacy, most drug diverters are addicts using the drugs themselves. Because of this, diversion shouldn’t be considered just a security concern but a patient safety concern, Cichon says. He references several high-profile diversion cases in which the diverters used the same syringe full of medicine on both themselves and their patients, spreading bacterial infections and hepatitis. In one especially egregious case, a traveling medical technician with hepatitis C would inject himself with his patients’ fentanyl and refill the same syringe with saline, ultimately spreading the virus to at least 30 people in two states.</p><p>Unfortunately, experts acknowledge that most diverters don’t get caught until they have been diverting for so long they start to get sloppy. “The people who are your real problem are the people who are hiding in the weeds, not doing enough to get caught, and those are the ones you want to find,” Mitchell says. “The people they are finding now are the people that have the needle in their arm or somebody has reported them. You want to try to find them before that.”​</p><h4>Out of the Loop</h4><p>Hayes details the path of drugs through a hospital: a pharmacy technician orders the medication from a wholesaler, who will deliver them to the hospital pharmacy. The drugs are sorted and stocked in the pharmacy, where they will remain until they are brought up to the patient floors and stored in various types of locking medicine cabinets. When a patient needs medication, a nurse goes to the medicine cabinet and dispenses the drug for the patient. </p><p>Another ASIS International Pharmaceutical Council member—Matthew Murphy, president of Pharma Compliance Group and former DEA special agent—describes this as the closed loop of distribution. “Once a drug is outside of the closed loop, when it gets dispensed from a pharmacy or administered by a doctor, it’s no longer in the purview of DEA rules and regulations,” he explains. Drugs are most likely to be diverted during those times when they are in transit or exchanging hands, outside of the closed loop.</p><p><strong>Wholesalers.</strong> When fulfilling a pharmacy’s request for medication, wholesalers have just as much of a responsibility to notice if something is amiss as the pharmacy does. Whether it’s a retail pharmacy or a hospital pharmacy, wholesalers are responsible for cutting them off if they start to request unusually high amounts of opioids. </p><p>In 2013, retail pharmacy chain Walgreens was charged $80 million—the largest fine in the history of the U.S. Controlled Substances Act—after committing record-keeping and dispensing violations that allowed millions of doses of controlled substances to enter the black market. Cardinal Health, Walgreens’ supplier, was charged $34 million for failing to report suspicious sales of painkillers. One pharmacy in Florida went from ordering 95,800 pills in 2009 to 2.2 million pills in 2011, according to the DEA. </p><p>Hayes says the fine against the wholesaler was a wake-up call, and now suppliers use algorithms to identify unusual spikes in orders of opiates. Wholesalers can even stop the flow of medication to pharmacies if they believe diversion is occurring—which can be disastrous to a trauma center, Hayes notes.</p><p><strong>Pharmacies.</strong> To restock the shelves, pharmacy technicians compile lists of what medications they are low on to send to the wholesalers at the end of each day. Hayes notes that many pharmacies do not conduct a retroactive analysis on what is being purchased—which is why wholesalers must pay attention to any unusual changes in orders. She stresses the importance of constantly mixing up the personnel who order and stock medications. </p><p>“If you’re both ordering and putting away drugs, that’s a bad thing because you can order six bottles when you only need five and keep one for yourself,” Hayes notes. </p><p>Similarly, it is important to rotate who delivers the drugs to the patient floors. “John the technician has been taking the drugs up to the floors for the last 20 years,” Hayes says. “Well gee, did you ever notice that John drives a Mercedes and has two boats and a house on Long Island? He makes $40,000 a year, did you ever do any investigation into why?”</p><p><strong>On the floor. </strong>Experts agree that the most egregious diversion occurs during the wasting and dispensing process in scenarios similar to the incident Leon witnessed at HCMC. Mitchell explains that all hospitals have different wasting procedures—some require nurses to waste the medication immediately, before they even leave the medication rooms, while others may have a 20-minute window. Other hospitals may prohibit nurses from carrying medication in their pockets to prevent theft or switching. ​</p><h4>Investigations</h4><p>Any company involved with controlled substances, whether manufacturing, distributing, or dispensing, must be registered with the DEA and must adhere to certain rules and regulations—which aren’t always easy to follow.</p><p>Murphy, who worked for the DEA for 25 years, now helps companies follow mandates he calls “vague and difficult to interpret.” For example, DEA requires anyone carrying controlled substances to report “the theft or significant loss of any controlled substance within one business day of discovery.”</p><p>“This hospital had 13 vials of morphine that ‘went missing’ and someone called me in to find out why,” Hayes says. “They asked me, ‘Are 13 vials substantial or not? Do I really need to fill out the form?’ I counsel them on what’s substantial because the language is very loose.”</p><p>Depending on the frequency or significance of these or similar forms, the DEA may open an investigation, Murphy explains. “DEA will look at these recordkeeping forms and determine if in fact everything has been filled out correctly, that they have been keeping good records,” he says. “If DEA determines that they are lax or have not been adhering to requirements, there could be anything from a fine to a letter of admonition requiring corrective actions.” In more serious cases, DEA could revoke the registration because the activity or behavior was so egregious that it was determined that the facility is not responsible enough, Murphy explains. If a facility loses its DEA registration, it cannot dispense controlled substances.</p><p>However, DEA does not get involved in every suspected case of diversion. “There are only so many DEA diversion investigators, so they have to prioritize what they get involved with,” Murphy says. “It has to be pretty egregious for them to get involved to seek a revocation or fine.”</p><p>That’s where people like Hayes come in. “They want me to come in instead of DEA or law enforcement,” she explains. “I’m a private citizen, I understand law enforcement procedures, and I can help them get at the root of the problem before they call in law enforcement.” </p><p>After an investigation into a diverter is opened, it is unclear what happens to the offender. Hayes says that she typically gathers evidence and gets a confession from diverters, at which point her client calls in law enforcement to arrest them. Leon, who was in charge of diversion in­vest­igations at HCMC for 20 years before becoming a consultant for HelioMetrics, was able to investigate but not interview suspected diverters. He tells <em>Security Management</em> that he would call in a sheriff’s detective to interview the suspect.</p><p>Although most diverters are fired when their actions are discovered, they are not always arrested—it’s often at the discretion of their employer. Depending on the diverter’s role, state accreditation boards—such as those that license nurses and pharmacists—would be notified and could potentially conduct their own investigations. </p><p>Cichon cautions that some hospitals hoping to avoid bad press and DEA scrutiny may look for loopholes. “We found out through the course of investigations that if someone resigns and was not sanctioned it may not be a reportable action,” he says. “If we allow this person to resign rather than take action against him, then we don’t have to report it.”</p><p>Murphy notes that DEA typically has no role in individual cases of diversion. “If the diverter has a license from one of those state agencies, usually it’s required that they be reported, and then it’s up to the board how they proceed with the personal license of the individual,” he says. The DEA doesn’t regulate the personnel—that’s up to the state and the facility. </p><p>Cichon notes that the lack of standards when addressing diversion makes it more likely that offenders could slip through the cracks and move on to continue diverting drugs at another facility. “Unfortunately, there are different laws and statutes in every state that set up some sort of reporting requirements,” he says. “There are medical boards, nursing boards, pharmacy boards, and not every worker even falls under some sort of licensing board for that state.” ​</p><h4>Staying Ahead</h4><p>Due to the stigma of discovering diverters on staff, many hospitals just aren’t preparing themselves to address the problem proactively, Cichon explains.</p><p>“This is something that is probably happening but we’re not finding it,” he says. “The statistics I’ve seen at hospitals that are being proactive and looking at this are finding at least one person a month who is diverting drugs in their facility. If a 300-bed hospital is finding one person a month, and Hospital B has the same amount of staff and beds and is finding nothing…”</p><p>NADDI has been providing training for hospitals to develop antidiversion policies. Cichon notes that many hospitals throughout the country have no plan in place to actively look for diverters. “As big as the issue is, many of them are still just not being that proactive in looking at the possibility that this is happening in their facility.”</p><p>Cichon encourages a team approach to diversion that acknowledges diversion as a real threat. “Not just security personnel should be involved with the diversion aspect,” he says. “Human resources, pharmacy personnel, security, everyone is being brought into this investigation, because the bigger picture is patient safety. The diverting healthcare worker typically isn’t one who’s going to be selling or diverting his or her drugs on the street, but they are abusing the drugs while they are working.”</p><p>Leon worked hard on diversion prevention at HCMC after discovering a surprising pattern: almost all of the diverters he investigated wanted to be caught. “What got me on this path of prevention was observing the nurses as they would admit to what they did,” he explains. “More often than not the nurses would say, ‘I wanted somebody to stop me. I needed help, didn’t know how to ask for it, and I was hoping somebody would stop me.’ That’s pretty powerful when you’re sitting there listening to this on a consistent basis.”</p><p>Leon implemented mandatory annual training for everyone in the hospital—from food service workers to surgeons—to recognize the warning signs of drug diversion. “If a nurse or anesthesiologist or physician is speaking with you and telling you they are having these issues, then you should say something,” Leon explains. “It’s not doing the wrong thing—you’re helping them, and that’s the message we sent out. Look, these individuals are not bad individuals. Something happened in their lives that led them down this path.”</p><p>Leon also had cameras installed throughout the hospital that allowed him to observe diversion but also kept his investigations accurate. “We had a nurse who was highly suspected of diverting,” he says. “With the cameras I was able to show that she wasn’t diverting, just being sloppy. The employees appreciated the cameras because it showed they weren’t diverting medication, they just made a mistake.”</p><p>Over time, HCMC personnel became more comfortable coming forward with concerns about their coworkers. Before the facility started the annual training, Leon caught at least one diverter a month. Before he retired, he says, that number had dropped to one or two a year.</p><p>“The success of our program at HCMC was the fact that we paid more attention to educating rather than investigating,” Leon says. “You have to keep those investigative skills up, but you have to spend equal amount of time on prevention and awareness.”</p><p>Mitchell points to algorithmic software that can identify a potential diverter long before their peers could. Taking data such as medicine cabinet access, shift hours, time to waste, and departmental access allows software to identify anomalies, such as a nurse whose time to waste is often high, or a doctor who accesses patients’ files after they have been discharged. </p><p>“Most people are using the logs from the medicine cabinets trying to do statistical analysis,” Mitchell explains. “You find out 60 days or six months later, or you don’t see that pattern emerge by just using one or two data sets. That doesn’t help. The goal is to identify these people as quickly as possible so they are no longer a risk to themselves or the patients or anyone they work with.”</p><p>Murphy encourages facilities to be in full DEA compliance to mitigate diversion. “If somebody wants to steal or becomes addicted, they are going to find a way to do it, and sooner or later they are going to get caught, but then there’s a problem because the hospital has to work backwards to determine how much was stolen and reconcile all that,” he says. He also notes the importance of following up internally on each diversion case and figuring out what went wrong, and adjusting procedures to address any lapses. </p><p>“Every entity that has a DEA program should have diversion protocols in place because if they don’t they are playing Russian roulette with theft and loss and their DEA registration,” Murphy says.  ​</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/Q-and-A---Soft-Targets.aspxQ&A: Soft Targets<p>​<span style="line-height:1.5em;">Jennifer Hesterman, Colonel, U.S. Air Force (Retired), discusses her book <em>Soft Target Hardening</em>, which was named the 2015 ASIS Security Book of the Year. Available from ASIS; asisonline.org; Item #2239; 322 pages; $69 (members); $76 (nonmembers).</span><span style="line-height:1.5em;">​</span></p><p><strong><em>Q.</em></strong><em> Why are soft targets increasingly attractive to terrorists?  </em></p><p><strong>A. </strong>Soft target, civilian-centric places that are not typically fortified—such as schools, churches, hospitals, malls, hotels, restaurants, and recreational venues—have little money to spend on security. Frequently, they must balance security, aesthetics, and a positive experience for customers.  </p><p>Terrorists select soft targets because there are many, possibly hundreds, of them in small towns and cities; they are vulnerable, so the odds of success are high and the terror effect is amplified among civilians. The story also stays in the news longer—the soft target attack in San Bernardino received far more coverage for almost twice the length of time compared to the Ft. Hood shooting. Military and government workers are generally seen as more legitimate targets than civilians, so soft targets provide more of the outrage, shock, and fear that terrorists crave.</p><p><em><strong>Q.</strong> What inspired you to write a book on hardening soft targets? </em></p><p><strong>A.</strong> I was living in the Middle East and close to several soft target attacks. I also realized that in the United States after 9-11, we further reinforced hard targets like government buildings and military installations, while soft targets are increasingly in the crosshairs but unprotected. I traveled all over the Middle East and Southwest Asia, and saw how soft targets are protected against attack. I wanted to apply some of these lessons to the civilian sector.  </p><p><em><strong>Q.</strong> Which soft targets are being hardened in the United States?</em></p><p><strong>A.</strong> Schools are further along the spectrum due to the rise of school shootings and stabbings. Mall security is much improved after the Westgate Mall attack in Nairobi, but shopping venues are still extremely vulnerable. Churches have a unique problem due to their open, inviting culture even after the Charleston shooting. Of course synagogues, mosques, and Sikh temples are moving towards a more hardened posture as the result of a rise in domestic terrorist activity. Hospitals usually don’t realize they are targets for terrorist attack or exploitation. Every type of soft target is different and requires tailored hardening tactics. </p><p><em><strong>Q. </strong>What trends should security professionals look out for?</em></p><p><strong>A. </strong>The insider threat is a growing concern. Insider attacks have the greatest possibility of success in terms of destruction of a target and mass casualties. The perpetrator can preposition items, understands the layout of the facility, has unfiltered access, and knows vulnerabilities to exploit. </p><p>We spend a great deal of time in vetting people during the hiring process, but new employees are basically left alone after the onboarding process. Venues like stadiums or concert halls may perform inadequate background checks on seasonal workers. The book discusses added layers of protection such as using behavioral detection techniques, a buddy system where a seasoned worker is paired with a new worker, and rules ensuring that no one is ever alone.</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/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