Bryan A. Liang

The global counterfeit drug trade: Patient safety and public health risks

Counterfeit drugs are a global problem with significant and well-documented consequences for global health and patient safety, including drug resistance and patient deaths. This multibillion-dollar industry does not respect geopolitical borders, and threatens public health in both rich and resource-poor nations alike. The epidemiology of counterfeits is also wide in breadth and scope, including thousands of counterfeit incidents per year, encompassing all types of therapeutic classes, and employing a complex global supply chain network enabling this illegal activity. In addition, information technologies available through the Internet and sales via online pharmacies have allowed the criminal element to thrive in an unregulated environment of anonymity, deception, and lack of adequate enforcement. Though recent global enforcement efforts have led to arrests of online counterfeit sellers, such actions have not stemmed supplies from illegal online sellers or kept up with their creativity in illegally selling their products. To address this issue, we propose a global policy framework utilizing public-private partnership models with centralized surveillance reporting that would enable cooperation and coordination to combat this global health crisis.

A system of medical error disclosure

External mandates for medical error disclosure are often justified by potential cost savings, the belief in individual moral obligations in health care, and the concept that patients have rights and providers have responsibilities. Such an approach does not recognise the systems nature of error and outcomes and the important quality role disclosure can play in a system of medical error disclosure. Systems concepts, the patient-provider partnership, and overall quality of care can be enhanced using a system of disclosure that provides for education about the systems nature of error, fulfils the delivery system philosophy of mutual respect, and integrates the patient and his/her family as a partner in the error reduction enterprise. Such a system can result using clear disclosure policies and procedures sensitive to patient and family needs, open communications with concerned, committed, and compassionate system representatives, and use of mediation methods that foster communication, allow for venting, and are flexible in their approach to resolving conflict, including using apology. Although a system may also result in conflict resolution costs, more importantly it may foster and solidify a team approach to reducing errors and promoting patient safety.

Direct-to-Consumer Advertising With Interactive Internet Media: Global Regulation and Public Health Issues

DIRECT-TO-CONSUMER ADVERTISING (DTCA) IS LEgal only in the United States and New Zealand and has been linked with drug overutilization, public health concerns, and higher costs. Despite global proscriptions, DTCA is the most rapidly increasing form of pharmaceutical marketing, with approximately

Prevalence and Global Health Implications of Social Media in Direct-to-Consumer Drug Advertising

4 billion in US expenditures, outpacing physician marketing and research and development. The Internet has rapidly developed, with users moving from passive information using read-only “Web 1.0” technology to interactive tailored relationships using “Web 2.0” technology. This includes social networking sites and other interactive systems, resulting in new online DTCA marketing opportunities that transcend geopolitical borders. Currently, the US Food and Drug Administration (FDA) has not issued guidelines on this form of DTCA marketing. Yet electronic DTCA with Web 2.0 technology already has the potential for significant presence and may have unrealized public health effects.

Searching for Safety: Addressing Search Engine, Website, and Provider Accountability for Illicit Online Drug Sales

Background Direct-to-consumer advertising (DTCA), linked to inappropriate medication use and higher health care expenditures, is the fastest growing form of pharmaceutical marketing. DTCA is legal only in the United States and New Zealand. However, the advent of online interactive social media “Web 2.0” technologies—that is, eDTCA 2.0—may circumvent DTCA legal proscriptions. Objective The purpose of this study was to assess the prevalence of DTCA of leading pharmaceutical company presence and drug product marketing in online interactive social media technologies (eDTCA 2.0). Methods We conducted a descriptive study of the prevalence of eDTCA 2.0 marketing in the top 10 global pharmaceutical corporations and 10 highest grossing drugs of 2009. Results All pharmaceutical companies reviewed (10/10, 100%) have a presence in eDTCA 2.0 on Facebook, Twitter/Friendster, sponsored blogs, and really simple syndication (RSS) feeds. In addition, 80% (8/10) have dedicated YouTube channels, and 80% (8/10) developed health care communication-related mobile applications. For reviewed drugs, 90% (9/10) have dedicated websites, 70% (7/10) have dedicated Facebook pages, 90% (9/10) have health communications-related Twitter and Friendster traffic, and 80% (8/10) have DTCA television advertisements on YouTube. We also found 90% (9/10) of these drugs had a non-corporate eDTCA 2.0 marketing presence by illegal online drug sellers. Conclusion Pharmaceutical companies use eDTCA 2.0 to market themselves and their top-selling drugs. eDTCA 2.0 is also used by illicit online drug sellers. Regulators worldwide must take into account the current eDTCA 2.0 presence when attempting to reach policy and safety goals.

Error in Medicine: Legal Impediments to U.S. Reform

Online sales of pharmaceuticals are a rapidly growing phenomenon. Yet despite the dangers of purchasing drugs over the Internet, sales continue to escalate. These dangers include patient harm from fake or tainted drugs, lack of clinical oversight, and financial loss. Patients, and in particular vulnerable groups such as seniors and minorities, purchase drugs online either naïvely or because they lack the ability to access medications from other sources due to price considerations. Unfortunately, high risk online drug sources dominate the Internet, and virtually no accountability exists to ensure safety of purchased products. Importantly, search engines such as Google, Yahoo, and MSN, although purportedly requiring “verification” of Internet drug sellers using PharmacyChecker.com requirements, actually allow and profit from illicit drug sales from unverified websites. These search engines are not held accountable for facilitating clearly illegal activities. Both website drug seller anonymity and unethical physicians approving or writing prescriptions without seeing the patient contribute to rampant illegal online drug sales. Efforts in this country and around the world to stem the tide of these sales have had extremely limited effectiveness. Unfortunately, current congressional proposals are fractionated and do not address the key issues of demand by vulnerable patient populations, search engine accountability, and the ease with which financial transactions can be consummated to promote illegal online sales. To deal with the social scourge of illicit online drug sales, this article proposes a comprehensive statutory solution that creates a no-cost/low-cost national Drug Access Program to break the chain of demand from vulnerable patient populations and illicit online sellers, makes all Internet drug sales illegal unless the Internet pharmacy is licensed through a national Internet pharmacy licensing program, prohibits financial transactions for illegal online drug sales, and establishes criminal penalties for all parties—including websites, search engines, and health care providers—who engage in and facilitate this harmful activity.

The Minamata Convention on Mercury: attempting to address the global controversy of dental amalgam use and mercury waste disposal.

Error in medicine is common and can lead to significant patient injury. Although successful systematic efforts to reduce human error have been applied in other complex systems, the field of medicine has just begun to make a broad-based effort in this regard. However, both research in and implementation of patient safety measures may not occur without a consideration of important legal issues that may impede these health policy efforts. Tort and contract law may interact with the vagaries of managed care to limit participation in these error reduction efforts by health care providers as well as by managed care organizations. Thus, for patient safety research to be successful, all members of the health care enterprise must participate in a coordinated effort to identify and establish effective practices that may reduce human error in medicine. But it is imperative that legal impediments be recognized and addressed before the goal of a continuously improving, increasingly safe health care system can become a reality.

Fade to Black: Importation and Counterfeit Drugs

In October 2013, a new international binding treaty instrument called the Minamata Convention on Mercury opened for signature in Minamata City, Japan, the site of arguably the worst public health and environmental disaster involving mercury contamination. The treaty aims to curb the significant health and environmental impacts of mercury pollution and includes provisions addressing the mining, export and import, storage, and waste management of products containing mercury. Importantly, a provision heavily negotiated in the treaty addresses the use of dental fillings using mercury amalgam, an issue that has been subject to decades of global controversy. Though use of dental amalgam is widespread and has benefits, concerns have been raised regarding the potential for human health risk and environmental damage from emissions and improper waste management. While the Minamata Convention attempts to address these issues by calling for a voluntary phase-down of dental amalgam use and commitment to other measures, it falls short by failing to require binding and measurable targets to achieve these goals. In response, the international community should begin exploring ways to strengthen the implementation of the dental amalgam treaty provisions by establishing binding phase-down targets and milestones as well as exploring financing mechanisms to support treaty measures. Through strengthening of the Convention, stakeholders can ensure equitable access to global oral health treatment while also promoting responsible environmental stewardship.

Global Reach of Direct-to-Consumer Advertising Using Social Media for Illicit Online Drug Sales

Importation of medicines from Canada and other countries has been proposed to provide relief from high drug prices in the US and greater access for underserved patients. Yet importation necessarily raises the issue of counterfeit drugs. The latter are a worldwide problem that have affected even the US closed regulatory and supply system. Counterfeit drugs were previously limited to lifestyle drugs; yet they now encompass virtually all types of medicines and extend to lifesaving drugs. Organized crime and terrorist groups are increasingly involved in their production. The expansion of counterfeit drug manufacture is due to their ease of production and this activitys tremendous financial rewards, coupled with limited potential for being caught, and light penalties even if prosecuted. Further, the gray market in the US, and parallel trade in others, make it simple to introduce fake drugs into the medicine supply. Detection of counterfeit medicine is virtually impossible, with provider low index of suspicion, high quality packaging and product, and ignorance regarding sources of imported drugs, including the Internet. The major importation bill being considered in Congress has significant weaknesses in addressing many of these crucial issues and may expand this countrys vulnerabilities that arise from its domestic gray market to that of the international black market. To fully address the international issues associated with importation and counterfeit drugs, an international solution must be engaged. Cooperation and empowerment of law enforcement and regulators, public and private agencies, and entities across country lines are essential. Sharing the cost of research and development based on WTO and OECD wage standards should also be considered. Finally, providers must have a high index of suspicion when confronted with therapeutic medication failure, public-private partnerships should be expanded to provide safe and affordable domestic drugs now, and patients must be educated to be the last barrier to harm from counterfeit drugs. Only by adopting a systemic effort can we address the systemic problems associated with importation and counterfeit drugs.

Combating healthcare corruption and fraud with improved global health governance

Background Illicit or rogue Internet pharmacies are a recognized global public health threat that have been identified as utilizing various forms of online marketing and promotion, including social media. Objective To assess the accessibility of creating illicit no prescription direct-to-consumer advertising (DTCA) online pharmacy social media marketing (eDTCA2.0) and evaluate its potential global reach. Methods We identified the top 4 social media platforms allowing eDTCA2.0. After determining applicable platforms (ie, Facebook, Twitter, Google+, and MySpace), we created a fictitious advertisement advertising no prescription drugs online and posted it to the identified social media platforms. Each advertisement linked to a unique website URL that consisted of a site error page. Employing Web search analytics, we tracked the number of users visiting these sites and their location. We used commercially available Internet tools and services, including website hosting, domain registration, and website analytic services. Results Illicit online pharmacy social media content for Facebook, Twitter, and MySpace remained accessible despite highly questionable and potentially illegal content. Fictitious advertisements promoting illicit sale of drugs generated aggregate unique user traffic of 2795 visits over a 10-month period. Further, traffic to our websites originated from a number of countries, including high-income and middle-income countries, and emerging markets. Conclusions Our results indicate there are few barriers to entry for social media–based illicit online drug marketing. Further, illicit eDTCA2.0 has globalized outside US borders to other countries through unregulated Internet marketing.