Pharmacy Law CE Column
Counterfeit goods are infamous and ubiquitous. From the streets of New York where people are selling bootlegged copies of Johnny Depp cinema to backrooms in Shanghai where people are selling Chanel knockoffs, counterfeiting is a lucrative and widespread practice. However, it is a curious exercise to think that the prescription bottle on the pharmacist’s shelf also could be counterfeit.
Counterfeit medications are defined as drugs deliberately and fraudulently mislabeled with respect to identity and/or source and manufactured outside the purview of national health regulatory authorities, such as the Food and Drug Administration. 1 Counterfeit medications range in sophistication from exacting to rudimentary. Some counterfeits rely on holograms, color-shift inks and actual industry punches, whereas others simply copy labels and package with water. Often, counterfeit medications contain some (nominal) amount of active drug, but this is not necessarily the case. 1,2
The World Health Organization estimated that counterfeit drugs account for less than 1% of medications in developed such countries as the United States, and 10% to 30% in developing countries, such as those in Africa, Asia and Latin America.1 As globalization of the pharmaceutical supply chain increases, the risk for counterfeit medications infiltrating the United States borders increases. Approximately 200 countries and territories currently manufacture FDA-regulated products.3 Correspondingly, the United States has seen a 42% increase in drug imports between 2001 and 2005, and it is estimated that the total number of finished drug products manufactured in foreign countries has more than doubled since 2002.4 Consequently, the FDA reports an 800% increase in new counterfeit cases between 2000 and 2006.5 Fake Pfizer medications have been found in more than 75 countries.6 The Internet and online pharmacies probably represent the highest risk of counterfeit medications in the United States. Eli Lilly reported в¬Sthat 50% of medicines ordered over the Internet from sites that hide their physical address are counterfeit.в¬э7
Efforts to combat counterfeit medications
Online pharmacy generic Viagra
Counterfeit medications typically enter the market, including the gray market, through diversion, relabeling and fraud.8 Most frequently, diversion involves secondary wholesalers. In the United States, there exists a considerable supply chain for pharmaceuticals, often including several vendors and multiple transactions, each proving a portal for entry of counterfeits.8 In response to this threat, the United States has passed as a series of laws seeking to combat the issue. The Prescription Drug Marketing Act of 1987 is the primary law. The act requires states to license prescription drug wholesalers, prohibits re-importation of pharmaceuticals except by the manufacturer, requires strict accounting of drug samples and exempts “authorized distributors” from pedigree paper requirements.9 Pedigree papers are written or electronic documentation of the sales history of a drug, tracing its origin through the supply chain from manufacturer to the pharmacy and providing an audit trail. Additionally, a number of states have taken proactive roles; Florida requires pedigree papers for its pharmaceuticals, and California is working toward developing and implementing an electronic pedigree system. Numerous states also have increased criminal penalties associated with drug counterfeiting.10
The FDA monitors counterfeit medications and is constantly seeking ways to approach the situation. In 2003, they convened a task force to evaluate the situation and advise relevant stakeholders. Their report developed a number of recommendations, including securing the actual drug product and its packaging, securing the movement of the product as it travels through the U.S. drug distribution chain, enhancing regulatory oversight and enforcement, increasing penalties for counterfeiters, heightening vigilance and awareness of counterfeit drugs, and increasing international collaboration.11 The FDA also established a Counterfeit Alert Network to educate and disseminate information on counterfeit dugs. The industry has responded to the threat of counterfeit medications by incorporating such evolving technology as radio frequency identification tags, such physical-chemical identifiers as molecular taggants and 2-D bar-coding with their pharmaceuticals.12
The drugs most likely to be involved with counterfeiting are 1) expensive drugs (e.g., epoetin alfa and atorvastatin), which have wide profit margins; 2) so-called “embarrassment drugs” (e.g., sildenafil, orlistat and finasteride) for which patients are more likely to use nonconventional channels of distribution, such as the Internet and foreign suppliers; and 3) drugs associated with cancer and HIV, where nonresponsiveness would not be unusual. In 2004, the National Association of Boards of Pharmacy issued a “National Specified List of Susceptible Products” to counterfeiting, which provides a good snapshot of the problem.13 See Table 1 for this list with noted additions by the author.
Local Legislator Wants State to Fight Prescription Drug Abuse
Legislation that would help prevent the misuse and abuse of prescription drugs will be the subject of two public hearings in Harrisburg in June, said Rep. Gene DiGirolamo (R-18th), sponsor of the proposal and chairman of the House Human Services Committee, which is holding the hearings.
“We’re hearing more in news reports about individuals so desperately seeking prescription medications to feed their addictions that they’re visiting doctors and pharmacies just to get prescriptions, sometimes for dangerously addictive drugs,” said DiGirolamo in a release.
Specifically, the proposal would create a database, to be managed by the new Department of Drug and Alcohol Programs, to enable informed and responsible prescribing and dispensing of controlled substances and to reduce diversion and misuse of the drugs of concern. The intent of the bill is to pinpoint the potential for abuse and misuse of prescription drugs, namely those that are highly addictive controlled substances like pain relievers.
DiGirolamo emphasized that the bill encourages treatment for the people who are identified as having an addiction problem. It also provides for continuing medical education for prescribing health care providers to learn more about identification, referral and treatment of addiction.
National Adverse Drug Event Network Launched
Roughly half a million adverse drug events are reported annually to the U.S. Food and Drug Administration (“FDA”) and the number is growing rapidly according to data from the FDA. More than 90 percent of these reports come from pharmaceutical manufacturers who receive them initially from physicians and other providers, typically via telephone. Manufacturers then triage and attempt to investigate these reports, notifying the FDA when appropriate. Published studies indicate that as few as one in ten adverse drug events are actually reported by healthcare professionals largely due to the time-consuming and inefficient processes involved in reporting adverse drug events.
“RxEvent was designed to improve the convenience of adverse event reporting for physicians, the cost-efficiency for manufacturers, and the quality of information ultimately reported to the FDA,” explained Edward Fotsch, MD, CEO of PDR Network, the company providing the RxEvent service along with major EHR vendors and other partners. “RxEvent is part of the new suite of eCare Services that we are rolling out with content integrated into EHRs to increase drug and device efficacy and efficiency.”
“Our network of physicians is growing rapidly and with it grows our ability to contribute to drug safety,” stated Todd Rothenhaus, Chief Medical Information Officer, athenahealth, Inc. “RxEvent integrated into athenaClinicals® supports our mission of physician convenience and patient safety.”
EHR use among physicians in the U.S. has grown dramatically and is approaching 50 percent, in part due to federal and industry subsidies to help cover the cost of these systems. Studies show that adverse drug event reporting integrated into EHRs increases the convenience, content and volume of adverse event reports. (1)
“Through our PrimeRESEARCH™ clinical trials network integrated within Greenway’s PrimeSUITE® EHR, we know that providers are vigilant to adverse events and are seeking a streamlined reporting process,” said Greenway® President and CEO Tee Green. “We are pleased to be working with PDR Network to further improve the efficiencies that enable our provider customers on the front lines to improve drug quality and patient safety through an EHR reporting system that will also advance our ability to enable innovative clinical trials procedures.”
“Adverse drug event reporting is the tip of the spear in ensuring ongoing monitoring of prescription drugs. Drug safety requires a robust mechanism to identify, route, investigate and report adverse drug events,” noted Janet Woodcock, MD, Director, Center for Drug Evaluation and Research, FDA. “Integration of adverse event reporting into EHR systems places this service at the prescriber’s fingertips, adding to convenience and ultimately improved drug safety. We applaud PDR Network and their partners for their efforts.”
Jim Naughton, MD, an internist and EHR user who practices in the San Francisco Bay Area has had early access to the RxEvent service. He commented, “We see adverse drug events in our practice and I have reported them at times in the past. But the process has been cumbersome and certainly inhibits reporting at times. RxEvent improves both EHRs and adverse event reporting by making reporting much more physician-friendly.”
RxEvent will also be used by pharmacists who report tens of thousands of adverse events annually.
“Pharmacists are actively involved in promoting and monitoring safe medication use by their patients. By supporting RxEvent, we hope to facilitate enhanced reporting by pharmacists, who see tens of thousands of adverse drug events annually,” said Thomas Menighan, executive vice president and CEO of the American Pharmacists Association (APhA). “Pharmacists represent a key contributor to drug safety and we are working closely with PDR, as well as pharmacists in all practice settings across the country, to ensure that RxEvent is immediately available to all U.S. pharmacists.”
The RxEvent service integrated into EHRs provides quick and convenient access for physicians and has been designed to include pre-population of information as well as an improved mechanism for pharmaceutical manufacturers or the FDA to contact the reporting provider when additional information is required.
RxEvent and PDR Network’s New eCare Services
PDR® eCare Services provides PDR’s trusted and authoritative drug information and clinical content to prescribers via their Electronic Health Records (EHR) and other digital platforms. Recent studies from industry and the federal government show that nearly 50 percent of physicians are now using EHR systems, and that government and industry incentives will cause that number to continue to grow rapidly. With PDR eCare Services, prescribers are provided a broad suite of drug regulatory and marketing services including RxEvent, as well as FDA-approved labeling, Drug Alerts, REMS programs and CME, product support and medication adherence programs, all within their EHR. eCare delivers an efficient resource that empowers physicians to prescribe with all the drug information and support that they and their patients need. eCare with RxEvent offers the most comprehensive set of regulatory, safety and product support services available.
Together We Stand, Divided We Fall
Last week, Obama announced his campaign for re-election with the goal of reigniting energy and hope among his base. In that same week, I received news of a campaign recently initiated by several female students at HKS to raise awareness and subsequently address issues surrounding the under-representation of female faculty and lack of gendered perspectives throughout the school. This news sparked my own optimism surrounding the resurgence of positive collective action among women and a reminder that it truly does “Begin with Us.”
Women are under-represented in part because they do not have access to various key networks that are currently dominated by men. Therefore, in addition to increasing diversity within existing networks, we as women, must begin to explore alternative networks that we can form and/or better exploit amongst ourselves. Professor of Psychology at the University of Michigan, Barbara Smuts, along with Professor of Law at Harvard University, Diane Rosenfeld, have each described the influence that the strength of male alliances have in relation to those made up of women in maintaining the existing patriarchal systems. Thus, one of the key strategies recommended to escape this existing system is to cultivate the ideology of effective female-female alliances that women have largely resisted to date. To be clear, I am not insinuating that there should be a starker division between women and men, but that women should create and utilize networks in the same positive way that has been realized among men.
Along those lines, the recently envisioned “Pipeline Campaign” appears to be embracing the related notion that success requires a movement “led by women and joined by men.” The campaign, coined in reference to the goal of improving the pipeline for female faculty, was envisioned and initiated by Hannah Peaker, Caroline Pearce and Zan Larsen. These women have already made significant strides to investigate the hiring processes for faculty at HKS and the potential implications for women as a result. A main finding is that the non-tenure and tenure track faculty are hired in very different ways, and tangible actions can be taken by HKS students, faculty and administration alike to improve the presence of women in the former category. In particular, the various Centers associated with the school often bring in speakers as a testing ground for prospective hires. Unfortunately, women are currently in the minority of those represented within this group (20-25% excluding WAPPP), which is an important factor feeding into the currently male dominated faculty distribution. Despite their lack of female representation, the Centers have all been very receptive to finding ways to improve their numbers on this front, and most importantly, open to suggestions for women to approach with regard to speaking engagements.
The hope is to reach complete gender parity among the number of speakers brought to each Center per year. To assuage any potential concerns surrounding this goal, here are a few points. The first is that this is a target and not a requirement, thus the goal is to get as close as possible without forcing it. The second point is that even if it was a requirement, this should not be disconcerting. Given the fact that once the conscious effort and appropriate systems are put in place, finding equal female representation should be neither a struggle nor a detriment with regard to quality or expertise. On this point, recent studies have shown evidence counter to the outdated ideology that quota systems will inevitably replace a more highly qualified applicant with a lesser qualified token representative. Recent research by Professor of Economics at Stanford University, Muriel Niederle, et al. shows that quota systems for women can actually boost the number of high performing applicants to a pool, as it increases entry by high performing women without constraint of severe reverse discrimination.
Dizzy Feet Foundation and the Larry King Cardiac Foundation Partner to Urge Americans to DANCE 4 YOUR LIFE!
The Larry King Cardiac Foundation and Dizzy Feet Foundation today announce the creation of Dance 4 Your Life!, a new national health campaign that asks Americans to dance their way toward an active and healthy lifestyle. Dance 4 Your Life! is centered around National Dance Day, an annual celebration that takes place on the last Saturday in July and was launched in 2010 by Nigel Lythgoe, DFF co-president and co-creator and executive producer of Fox’s “So You Think You Can Dance.” Expanding the message and fun of National Dance Day into a year-around initiative, Dance 4 Your Life! will raise awareness of the benefits of dance and encourage people of every age and physical condition to incorporate dance into their lives as a way to improve heart health and combat obesity.
“Discount Dance Supply is committed to supporting the dance community”
“Dance is an activity that is universally recognized and accessible across all socioeconomic levels, making it an ideal approach to promoting heart health. Our partnership with Dizzy Feet in creating Dance 4 Your Life! is intended to address Americans’ increasingly sedentary lifestyles and the resulting health issues,” says Larry King, longtime host of CNN’s “Larry King Live” and founder of the Larry King Cardiac Foundation.
The Dance 4 Your Life! campaign will feature a nationwide dance celebration and information program during the month of July, leading up to National Dance Day and continuing thereafter through media and tie-in activities throughout the remainder of the year. LKCF and DFF are pleased to have the support of platinum sponsors and partners in this important initiative – leading dancewear retailer Discount Dance Supply and CVS Caremark through its All Kids Can program, committed to making life easier for children of all abilities. Everyday Health has also signed on as media partner and will provide exclusive content for the campaign. Six Flags, the world’s largest regional theme park company, has also joined Dance 4 Your Life! as a national venue sponsor and will host the official National Dance Day events at a number of its parks around the country. Details regarding locations and times will be released in the weeks to come.
“The Dizzy Feet Foundation is committed to supporting better access to dance education for all. I am excited to join my fellow Dizzy Feet co-founders, Adam Shankman, Carrie Ann Inaba and Katie Holmes, and the rest of the foundation in introducing Dance 4 Your Life! — the first national campaign to reduce obesity through dance,” says Lythgoe.
NCPDP and CAQH CORE Partner on Harmonizing Operating Rules and Standards Across Healthcare
The National Council for Prescription Drug Programs (NCPDP) and CAQH CORE® (Committee on Operating Rules for Information Exchange®) today announced a partnership agreement to collaborate on activities related to harmonizing electronic data interchange standards and operating rules across the healthcare industry.
NCPDP and CAQH CORE began exploring the potential partnership in late 2010 when the National Committee on Vital and Health Statistics (NCVHS) recommended NCPDP be formally named as an operating rules entity for retail pharmacy-related eligibility transactions and CAQH CORE serve as the authoring entity for operating rules for non-retail pharmacy-related eligibility and claim status transactions. The NCVHS recommendations were made to the Department of Health and Human Services in response to the Patient Protection and Affordable Care Act administrative simplification requirements which mandate national operating rules. Recent recommendations by NCVHS for CAQH CORE to develop operating rules for electronic funds transfer (EFT) and electronic remittance advice (ERA) have furthered the collaborative efforts between CAQH CORE and NCPDP.
NCPDP President, Lee Ann Stember, stated, “Through standards development and harmonization, we will continue to break down healthcare information technology barriers and improve the cost and quality of care for the patient. We are pleased to collaborate with CAQH CORE on orchestrating operating rules and standards to improve the coordination and delivery of healthcare.”
“CAQH CORE and NCPDP share a mutual commitment to industry collaboration and consensus building processes that focuses on actionable change,” said Gwendolyn Lohse, deputy director and CORE managing director, CAQH. “Aligning our intersecting efforts will help advance widespread industry adoption of effective and productive healthcare exchanges.”
Both organizations are foundational to the healthcare information exchange process: NCPDP, the ANSI-accredited standards development organization for pharmacy, has led the automation of pharmacy through standards development for over 30 years; and CORE, a multi-stakeholder initiative created by CAQH, develops and maintains operating rules to make administrative information available at the point of medical care.