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Due to corruption and limited oversight, philanthropy in China has come under increasing scrutiny by both the Chinese government and public. In particular, corruption has impacted charities, resulting in operational funding declines that have also impacted legitimate charities serving the vulnerable. Hence, an increase in the number of Chinese charities without adequate transparency and needed good governance threatens the health of these organizations and their service groups. In response, the Chinese government enacted the 2016 Charity Law, implemented on September 1, 2016. Yet the impact of this law, if any, is unknown. We therefore conducted a literature review of the academic and gray literature to assess characteristics of the law, its strengths and limitations, and to explore anti-corruption case studies. In addition, we reviewed publicly available secondary data on the transparency status—complete financial information and responsible staff—of Chinese charity organizations and a group of health-related specific charities before and after the Law’s enactment. This included the transparency scores of the top 100 charities and top 30 health-related charities in China. The academic literature we reviewed focused on general governmental corruption and little on charity-related corruption. However, the gray literature reflected a poor view of charities in China due to publicized claims of fund and abuse. Based on our secondary data analysis, we found charity organizations’ transparency shows some variation but as a total continues to score low overall across the top net asset holding charities. Importantly, based on a regression analysis, the transparency scores of Chinese charities did not experience a significant change despite the Charity Law’s enactment. In response, strengthening the Charity Law by enhancing enforcement of financial regulations and implementing systemic good governance measures is needed. Further, efficiency initiatives such as philanthropy de-administration, e-government, and outsourcing monitoring of Chinese charities to external agencies would promote trustworthiness and credibility of Chinese charity organizations now and in the future.

The usage of indocyanine green (ICG) dye is commonly associated with decreased anastomotic leakage rates in colectomies. This study aims to perform a network meta-analysis to assess the usage of ICG fluorescence imaging in right-sided colectomies. Medline, Embase, Cochrane Trials, CNKI, and WanFang electronic databases were reviewed, and meta-analysis of proportions, comparative meta-analysis, and network meta-analysis were conducted in this review. Studies comparing ICG usage with conventional approaches of anastomosis were selected, with postoperative anastomotic leak rate being the primary outcome. Ten articles were included, with a total of 675 patients involved, of which 515 patients underwent colorectal surgery with ICG. Anastomotic leak rates with ICG were estimated to be 1% (CI 0.00–0.04) and 3% (CI 0.01–0.06) for right and left procedures, respectively. No significant difference was observed in left-sided colectomies (OR 0.587; 95% CI 0.218–1.582; p = 0.292). There were nearly half the odds of anastomotic leakage when ICG was used in right-sided colectomies (OR 0.524; 95% CI 0.128–2.137). With the ability to potentially avert postoperative anastomotic leakage, coupled with its minimal costs and side effects, administration of ICG in colectomies in centers where equipment is available should be encouraged.

The three main types of anastomotic configurations following colorectal resection are Side-to-Side Anastomosis (S-S), End-to-Side Anastomosis (E-S) and End-to-End Anastomosis (E-E). This study aims to present results from a local cohort supplemented by a systematic review with meta-analysis of existing literature to compare the post-operative outcomes between E-S and S-S.A cohort study of patients who underwent right colectomy with E-S or S-S anastomosis, was conducted at the National University Hospital Singapore. Electronic databases Embase and Medline were systematically searched from inception to 21 August 2020, in accordance with the Preferred Reporting Items for Systematic Reviews and Meta-analysis guidelines. Studies were included if they compared post-operative outcomes between E-S and S-S.In the cohort study, 40 underwent E-S and 154 underwent S-S. Both post-operative ileus (12.5% vs. 29.2%, P = 0.041) and length of hospital stay (9.35 days vs. 14.04 days, P = 0.024) favoured E-S, but anastomotic bleed favoured S-S (15.0% vs. 3.2%, P = 0.004). Five studies were included in the meta-analysis with 860 E-S and 1126 S-S patients. Similarly, post-operative ileus (odds ratio [OR] =0.302; 95% confidence interval [CI]: 0.122-0.747; P = 0.010) and length of hospital stay (mean differences = ‒1.54 days; CI: ‒3.00 to ‒0.076 days; P = 0.039) favoured E-S. Additional sensitivity analysis including only stapled anastomosis showed a lower rate of anastomotic leak in E-S patients (OR = 0.185; 95% CI: 0.054-0.627; P = 0.007).This is the first systematic review to show that the E-S technique produces superior post-operative outcomes after right colectomy compared to S-S. However, the choice of anastomosis was largely surgeon dependent, but surgeon factors were not reported.

From the Department of Anesthesiology, Division of Global Public Health, Department of Medicine, University of California, San Diego School of Medicine, San Diego, CA (T.K.M.); Joint Masters Program in Health Policy and Law, University of California, San Diego School of Medicine and California Western School of Law, San Diego, CA (T.K.M.); and Global Health Policy Institute, La Jolla, CA (T.K.M., B.A.L.). O n August 7, 2015, the US District Court in Amarin v FDA handed down a ruling that the US Food and Drug Administration (FDA) lacked the authority to prohibit nonmisleading forms of off-label speech. When a drug is approved by the FDA for a specific indication, licensed clinicians are nevertheless free to prescribe it for any clinical use they see fit. In fact, offlabel drug use (ie, prescribing medications for a different disease or medical condition, different route of administration, and/or different dosage than that approved by the FDA) is relatively common, with a 2006 study estimating that 21% of commonly used drugs are prescribed off-label. Despite regular off-label use of prescription drugs (including high rates in certain patient populations and conditions such as pediatrics, cancer, and psychotic disorders), manufacturers are only allowed to engage in product promotion for the indication approved on the label. When manufacturers engage in promotion for any indication, dosage, or administration outside the FDA approval, they engage in illegal off-label promotion. However, the lines between illegal and permitted off-label promotion are now being blurred in the wake of the Amarin decision, which is likely to have a lasting impact on future drug promotion practices, regulatory and enforcement activities, and the role of the physician in patient care.

Background The coronavirus disease (COVID-19) pandemic is a global health emergency with over 6 million cases worldwide as of the beginning of June 2020. The pandemic is historic in scope and precedent given its emergence in an increasingly digital era. Importantly, there have been concerns about the accuracy of COVID-19 case counts due to issues such as lack of access to testing and difficulty in measuring recoveries. Objective The aims of this study were to detect and characterize user-generated conversations that could be associated with COVID-19-related symptoms, experiences with access to testing, and mentions of disease recovery using an unsupervised machine learning approach. Methods Tweets were collected from the Twitter public streaming application programming interface from March 3-20, 2020, filtered for general COVID-19-related keywords and then further filtered for terms that could be related to COVID-19 symptoms as self-reported by users. Tweets were analyzed using an unsupervised machine learning approach called the biterm topic model (BTM), where groups of tweets containing the same word-related themes were separated into topic clusters that included conversations about symptoms, testing, and recovery. Tweets in these clusters were then extracted and manually annotated for content analysis and assessed for their statistical and geographic characteristics. Results A total of 4,492,954 tweets were collected that contained terms that could be related to COVID-19 symptoms. After using BTM to identify relevant topic clusters and removing duplicate tweets, we identified a total of 3465 ( Conclusions This study used unsupervised machine learning for the purposes of characterizing self-reporting of symptoms, experiences with testing, and mentions of recovery related to COVID-19. Many users reported symptoms they thought were related to COVID-19, but they were not able to get tested to confirm their concerns. In the absence of testing availability and confirmation, accurate case estimations for this period of the outbreak may never be known. Future studies should continue to explore the utility of infoveillance approaches to estimate COVID-19 disease severity.

This study examined interculturality of Indigenous Mapuche healthcare in Chile’s Makewe Hospital. We conducted a descriptive, qualitative, semi-structured, cross-sectional pilot study interviewing key stakeholders, resulting in 11 interviews of patients, Mapuche and occidental providers, public health professionals, administration, and community leaders. We focused on six topics: services and preferences, community participation, interculturality, access to culturally appropriate care, government integration of Indigenous culture and interculturality promotion, and the future of Indigenous care. All groups believed in the need for both kinds of care. However, for community participation, Mapuche indicated no knowledge of interculturality in healthcare, nor any participation, compared with some professionals who believed there was a focus on it. Interculturality expressed by respect for Mapuche ethnomedicine was uniform; however, integration did not appear to Mapuche as effective, whereas professionals and administration interpreted interculturality as a philosophical goal. Regarding culturally appropriate access, Mapuche responses were focused on practical issues, whereas administration and professionals responded by explaining exclusion of Mapuche machi providers as being sensitive to community desires. Government promotion of interculturality was uniformly agreed to be poor. Finally, the future of Indigenous care was seen by Mapuche both optimistically and pessimistically, due to concerns regarding general cultural preservation, whereas professionals emphasized the need to promote preservation. These results indicate a fractionated understanding of definitions and goals among stakeholders. Future policy should focus upon a broader group to implement interculturality, including nongovernmental organizations, academics, and cultural advisors, combined with community-based participatory research, to promote evidence-based, efficient policy efforts and implementation for interculturality in health for the Mapuche.

Three years have passed since the FDA announced that it had detected counterfeit versions of the injectable anticancer drug bevacizumab (Avastin(®), Genentech, USA) in the US drug-supply chain. Following this discovery, almost 1,000 FDA warning letters were sent to physicians and medical practices in 48 different states and two US territories, as more batches of counterfeit Avastin were uncovered. In response, criminal prosecutions have been pursued against certain distributors and clinicians, and other individuals who trafficked, sold, purchased, and/or administered an unsafe and ineffective treatment while also defrauding the government. Although limited and targeted legal action has been taken, patients potentially affected by this seminal patient safety event have not been appropriately identified. Hence, despite the clear and documented patient-safety and public-health risks posed by the transnational criminal trade in counterfeit medicines, the case study of counterfeit bevacizumab detection in the USA demonstrates the continued lack of information, knowledge, and solutions that would be necessary to protect those who are most affected--the patients. In response, we call for greater investment in multisector, multistakeholder strategies to enhance surveillance for counterfeit medicines and enable improvements in communication of risk information, to better protect patients with cancer.

SUMMARY In global health, critical challenges have arisen from infectious diseases, including the emergence and reemergence of old and new infectious diseases. Emergence and reemergence are accelerated by rapid human development, including numerous changes in demographics, populations, and the environment. This has also led to zoonoses in the changing human-animal ecosystem, which are impacted by a growing globalized society where pathogens do not recognize geopolitical borders. Within this context, neglected tropical infectious diseases have historically lacked adequate attention in international public health efforts, leading to insufficient prevention and treatment options. This subset of 17 infectious tropical diseases disproportionately impacts the world's poorest, represents a significant and underappreciated global disease burden, and is a major barrier to development efforts to alleviate poverty and improve human health. Neglected tropical diseases that are also categorized as emerging or reemerging infectious diseases are an even more serious threat and have not been adequately examined or discussed in terms of their unique risk characteristics. This review sets out to identify emerging and reemerging neglected tropical diseases and explore the policy and innovation environment that could hamper or enable control efforts. Through this examination, we hope to raise awareness and guide potential approaches to addressing this global health concern.

Objectives: This study examines whether the assumptions that pathologists understand the medical malpractice negligence rule and have a clear single standard of care are reasonable. Methods: Two hundred eighty-one Texas academic pathologists and trainees were presented 10 actual pathology malpractice cases from publicly available sources, representing the tort system’s signal. Results: Of the respondents, 55.52% were trainees, and 44.48% were pathology faculty. Only in two cases did more than 50% of respondents correctly identify the behavior of pathologists as defined by legal outcomes. In only half of the cases did more than 50% of pathologists concur with the jury verdict. Conclusions: This study provides further evidence that physicians do not understand the legal rule of negligence. Pathologists have a poor understanding of negligence and cannot accurately predict a jury verdict. There is significant divergence from the single standard of care assumption. Alternative methods to provide appropriate compensation and to establish physician accountability should be explored. Additional education about medical negligence is needed.

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.

Objective: Antiobesity drugs have been marketed illicitly by “no prescription” online pharmacies after approval and scheduling by the drug enforcement agency. We assess whether antiobesity drug Belviq® (lorcaserin HCl) was available from illicit online vendors before DEA-scheduling when sales are unauthorized. Design and Methods: Online searches of “buy Belviq no prescription” examining first five result pages marketing the drug. Searches were performed from 11/5/2012-12/8/2012, prior to DEA scheduing. Results: Belviq® is actively marketed by “no prescription” online vendors despite official unavailability and prescription requirements. Approaches included direct-to-consumer advertising using descriptive website URLs; linking to illicit marketers; and directing customers to other weight-loss websites for additional marketing. Finally, large quantities were marketed by business-to-business vendors. Conclusion: Illicit online “no prescription” pharmacies are marketing unauthorized, suspect antiobesity drugs before DEA scheduling and permitted marketing. Regulators must legally intercede to ensure patient safety, and providers must educate patients about online-sourcing risks.

Background Narrow therapeutic index (NTI) drugs, because of proximity of therapeutic amounts to toxic amounts, require close professional oversight, particularly when switching formulations. However, safe use may be compromised by unsupervised switching through access to online “no prescription” Web sites. Objective We assessed no prescription online availability of NTI drugs, using an academically published list (core NTI drugs). Methods Using the Google search term “buy DRUG no prescription,” we reviewed the first 5 search result pages for marketing of no prescription NTI drugs. We further assessed if National Association of Boards of Pharmacy (NABP) Not Recommended vendors were marketing NTI drugs. Searches were conducted from November 3, 2012 to January 3, 2013. Results For core NTI drugs, we found 13 of 14 NTI drugs (92%) marketed as available without prescription, all from NABP Not Recommended vendors. On the basis of these initial findings, we expanded our core list to 12 additional NTI drugs; 11 of 12 of these drugs (92%) were available from no prescription Web sites. Overall, 24 of 26 NTI drugs (92%) were illegally marketed as available online without the need for a prescription. Conclusion Suspect online NTI drug access from no prescription vendors represents a significant patient safety risk because of potential patient drug switching and risk of counterfeit versions. Further, state health care exchanges with coverage limitations may drive patients to seek formulations online. Food and Drug Administration harmonization with tighter international NTI drug standards should be considered, and aggressive action against suspect online marketers should be a regulatory and public health priority.

The appropriate role of innovation and intellectual property (IP) in global public health is a controversial issue. Discussion is one-sided, with potential benefits advocated by industry in stark contrast to condemnation by certain civil society players. WHO's Public Health, Innovation and Intellectual Property Department (PHI) was established to address healthcare resource need for developing countries, assess impact of innovation and IP on access to medicines, explore innovative funding mechanisms for R&D and provide evidence-based policy-making recommendations in response to the changing global health landscape. Importantly, PHI could represent a potential forum to bridge shared, yet often diverse, interests and opportunities between various public and private stakeholders, a crucial issue for ensuring the future viability of WHO.

Generic drugs represent a significant portion of the medical arsenal in treating disease. As copies of originator drugs, these drugs have been permitted abbreviated approval under the Hatch-Waxman Act. Yet with the current cost focus upon generic formulations, potential safety issues with generics have arisen. Although there is an established criterion of “bioequivalence” that generic formulations must demonstrate, narrow-therapeutic index drugs for sensitive clinical circumstances such as epilepsy, antiplatelet therapies, and mental health treatments may require different regulatory treatment than other generic drugs. Further, in these circumstances, differences in generic formulations may lead to adverse clinical outcomes due to less stringent bioequivalence tolerances. Yet there is no mandate for comparison between different generic formulations. Countries outside the United States advocate for narrowing tolerance ranges for these high risk health situations and the drugs for their treatment. We argue in this paper that additional patient safety matters must be taken into account for narrow therapeutic disease drugs, and regulatory bodies should emphasize greater tightness in bioequivalence before these narrow-therapeutic drug generic formulations are approved.

Background Issues surrounding contraception access have been a national focus. During this debate, adolescent and adult women may seek these products online. Due to safety concerns, including potential counterfeit forms, we wished to assess whether online “no prescription” contraceptives were available. Study Design We assessed online availability of reversible, prescription contraceptive methods resulting in Results All contraceptives were available as “no prescription” products. Furthermore, IUDs were advertised as “over-the-counter” and YouTube videos provided “how to” videos, including a cartoon version. We also found that illicit online pharmacy marketing is shifting from direct search engine access to social media (Facebook, Twitter, Slidehare, flickr). Conclusion Online contraceptive sales represent patient safety risks and a parallel system of high-risk product access absent professional guidance. Providers should educate patients, while policy makers employ legal strategies to address these systemic risks.

Objectives Unsupervised online direct-to-consumer (DTC) access to medical services has rapidly expanded to medical screening tests, which have not been critically evaluated for their evidence basis. The objective of this study is to identify the scope of online-advertised DTC screening tests, outline the evidence for use of available DTC testing and suggest regulatory reform to address the relevant issues. Methods An observational study of website advertisements, testing services and counselling/follow-up services for DTC testing was conducted. Data were collected from websites between 4 April and 1 June 2011. Each website was assessed for tests offered, advertised indications and availability of counselling/follow-up services. Advertised testing indications were compared with US Preventive Services Task Force recommendations and/or specialty guidelines and categorized as Supported, Against, Insufficient Evidence or No Guidance. Results Of 20 companies identified as offering DTC screening tests, 95% (19/20) do not clearly offer pretest counselling, post-test counselling and/or test follow-up. One hundred and twenty-seven different tests were identified. Only 19/127 (15%) could be Supported for screening in a target group selected for testing; 38/127 (30%) were given recommendations to avoid use in specific target group(s) selected for testing (‘ Against recommendations’); 29/127 (23%) had Insufficient Evidence of value, and for 64/127 (50%) No Guidance could be given. Only 4/127 (3%) tests were Supported for general screening use. Conclusions Virtually all identified medical tests advertised and offered DTC are not recommended for use in screening by evidence-based guidelines. Limited oversight may lead to inaccurate self-diagnosis, treatment and wasted health resources.

Many potentially useful medicines arise from developing countries’ biodiverse environments and indigenous knowledge. However, global intellectual property rules have resulted in biopiracy, raising serious ethical concerns of environmental justice, exploitation, and health disparities in these populations. Furthermore, state-based approaches have not led to adequate biodiversity protection, management, or resource sharing, which affect access to lifesaving drugs. In response, country delegates adopted the Nagoya Protocol, which aims at promoting biodiversity management, combating biopiracy, and encouraging equitable benefits sharing with indigenous communities. However, the effectiveness of this framework in meeting these objectives remains in question. To address these challenges, we propose a policy building on the Nagoya Protocol that employs a World Health Organization–World Trade Organization Joint Committee on Bioprospecting and Biopiracy.

Kimberly M. Lovett, Kaiser Permanente; University of California San Diego School of Medicine; and Institute of Health Law Studies, California Western School of Law, San Diego, CA Bryan A. Liang, University of California San Diego School of Medicine; and Institute of Health Law Studies, California Western School of Law, San Diego, CA Timothy K. Mackey, University of California San Diego School of Medicine; San Diego State University; and Institute of Health Law Studies, California Western School of Law, San Diego, CA See related article in J Oncol Pract doi: 10.1200/JOP.2011.000513

Vaccines represent half the products on the FDA Biologics Product Shortages list. As a result, providers and patients may purchase them online, a process rife with patient safety risks. We examined vaccine online availability by assessing up to 5 identified online sellers. We determined if sites were accredited by the National Association of Boards of Pharmacy (NABP) VIPPS program, listed as US or international, employed social media linking to suspect online pharmacies, and if they were on the NABP Not Recommended list. All vaccines were advertised by online pharmacies and through data aggregation and social media sites, none were VIPPS-accredited, and most were on the NABP Not Recommended list. We found some online sellers advertising vaccines as over-the-counter. We extended our analysis to WHO Essential Medicines List vaccines and found all are also available online from suspect, non-VIPPS accredited sellers. Stakeholders should be aware of these online patient safety dangers.

No formal system exists to review trade restrictions imposed during international public health emergencies rapidly. Failure to put one in place creates disincentives for surveillance and reporting, thereby undermining protection efforts. The 2003 SARS outbreak exposed weaknesses in global governance that caused uncoordinated public health and economic responses. New International Health Regulations (IHR), applied first during the 2009 H1N1 influenza outbreak, demonstrated improvement. Yet they failed to allow for management of public health emergencies in a way that balanced threats to health and those to economies and trade. Establishment of a joint WHO–WTO committee to adjudicate these conflicts might better achieve that balance.

Context.—The rapid changes in health care policy, embracing quality and safety mandates, have culminated in programs and initiatives under the Patient Protection and Affordable Care Act.Objective.—To review the context of, and anticipated quality and patient safety mandates for, delivery systems, incentives under health care reform, and models for future accountability for outcomes of care.Design.—Assessment of the provisions of Patient Protection and Affordable Care Act, other reform efforts, and reform initiatives focusing on future quality and safety provisions for health care providers.Results.—Health care reform and other efforts focus on consumerism in the context of price. Quality and safety efforts will be structured using financial incentives, best-practices research, and new delivery models that focus on reaching benchmarks while reducing costs. In addition, patient experience will be a key component of reimbursement, and a move toward “retail” approaches directed at the individual patient may supplant traditional “wholesale” efforts at attracting employers.Conclusions.—Quality and safety have always been of prime importance in medicine. However, in the future, under health care reform and associated initiatives, a shift in the paradigm of medicine will integrate quality and safety measurement with financial incentives and a new emphasis on consumerism.

Illicit online pharmacies selling counterfeit drugs in a global virtual marketplace remain a critical problem in global health. Yet they continue to operate with little regulation while growing numbers of consumers access the Internet for health information that may lead them to purchase dangerous drugs online. This global social problem requires immediate action to protect patient safety and public health. Public–private partnerships models represent a potentially effective way to address this issue through promoting mechanisms of collaboration and coordination of multiple stakeholders.

Though mandating adherence to clinical practice guidelines could reduce malpractice litigation costs by making the standard of care explicit and ironclad, it could also impose inflexible or unrealistic standards on clinical practice. Virtual Mentor is a monthly bioethics journal published by the American Medical Association.

Individual conflicts of interest are rife in healthcare, and substantial attention has been given to address them. Yet a more substantive concern-institutional conflicts of interest (“ICOIs”) in academic medical centers (“AMCs”) engaged in research and clinical care—have yet to garner sufficient attention, despite their higher stakes for patient safety and welfare. ICOIs are standard in AMCs, are virtually unregulated, and have led to patient deaths. Upon review of ICOIs, we find a clear absence of substantive efforts to confront these conflicts. We also assess the Jesse Gelsinger case, which resulted in the death of a study participant exemplifying a deep-seated culture of institutional indifference and complicity in unmanaged conflicts. Federal policy, particularly the Bayh-Dole Act, also creates and promotes ICOIs. Efforts to address ICOIs are narrow or abstract, and do not provide for a systemic infrastructure with effective enforcement mechanisms. Hence, in this paper, we provide a comprehensive proposal to address ICOIs utilizing a “Centralized System” model that would proactively review, manage, approve, and conduct assessments of conflicts, and would have independent power to evaluate and enforce any violations via sanctions. It would also manage any industry funds and pharmaceutical samples and be a condition of participation in public healthcare reimbursement and federal grant funding.The ICOI policy itself would provide for disclosure requirements, separate management of commercial enterprise units from academic units, voluntary remediation of conflicts, and education on ICOIs. Finally, we propose a new model of medical education—academic detailing—in place of current marketing-focused “education.” Using such a system, AMCs can wean themselves from industry reliance and promote a culture of accountability and independence from industry influence. By doing so, clinical research and treatment can return to a focus on patient care, not profits.

Study objective The use of tissue plasminogen activator (tPA) in potential stroke victims by emergency physicians is controversial. One factor that may represent a barrier to use is medicolegal concerns resulting from adverse outcomes. The jury verdicts, settlements, and other adjudications associated with tPA and stroke care are assessed to determine the characteristics of these cases, including whether cases arose from adverse consequences associated with tPA or failure to provide tPA. Methods Using 7 primary jury verdict, settlement, and other adjudication legal databases, lawsuits involving tPA and stroke were collected for analysis of the clinical circumstances of the litigation, the causes of action against providers, the basis for liability, and the presence of emergency physicians and neurologist consultation in the litigation. Results Thirty-three cases were found involving tPA ischemic stroke therapy. In 29 (88%) of these cases, patient injury was claimed to have resulted from failure to treat with tPA. Emergency physicians were the most common physician defendants. Defendants prevailed in 21 (64%) cases, and among the 12 with results favorable to the plaintiff, 10 (83%) involved failure to treat and 2 (17%) claimed injury from treatment with tPA. Conclusion The available evidence concerning litigation involving stroke therapy with tPA indicates liability is predominantly associated with failure to provide tPA, rather than adverse events associated with its use.

Institute of Health Law Studies, California Western School of Law, San Diego, CA 92101, USA Department of Anesthesiology, University of California San Diego School of Medicine, San Diego, CA 92103, USA San Diego Center for Patient Safety, University of California, San Diego School of Medicine, San Diego, CA, USA Department of Anesthesia and Critical Care, University of Pennsylvania Health System, Philadelphia, PA, USA

The Patient Safety and Quality Improvement (PSQI) Act enacted in July 2005 constitutes the basis for significant opportunity to improve patient safety in the health care system by creating a voluntary error reporting system. The PSQI Act creates an unprecedented opening to prospectively prev

Illicit online pharmacies are a growing global public health concern. Stakeholders have started to engage in health promotion activities to educate the public, yet their scope and impact has not been examined. We wished to identify health promotion activities focused on consumer awareness regarding the risks of illicit online pharmacies. Organizations engaged on the issue were first identified using a set of engagement criteria. We then reviewed these organizations for health promotion programs, educational components, public service announcements, and social media engagement. Our review identified 13 organizations across a wide spectrum of stakeholders. Of these organizations, 69.2% (n = 9) had at least one type of health promotion activity targeting consumers. Although the vast majority of these organizations were active on Facebook or Twitter, many did not have dedicated content regarding online pharmacies (Facebook: 45.5%, Twitter: 58.3%). An online survey administered to 6 respondents employed by organizations identified in this study found that all organizations had dedicated programs on the issue, but only half had media planning strategies in place to measure the effectiveness of their programs. Overall, our results indicate that though some organizations are actively engaged on the issue, communication and education initiatives have had questionable effectiveness in reaching the public. We note that only a few organizations offered comprehensive and dedicated content to raise awareness on the issue and were effective in social media communications. In response, more robust collaborative efforts between stakeholders are needed to educate and protect the consumer about this public health and patient safety danger.

The Institute of Medicine report, To Err Is Human, recommended that collaborative networks of health care organizations should exchange information regarding medical errors to prevent the same errors from being repeated. Another recommendation, that Congress enact legislation protecting such exchanged information from legal discovery, has not occurred. Even if such legislation does pass, it may conflict with existing federal discovery requirements. Nevertheless, existing state and federal law may offer some protection. The most promising source of existing protection for all members of patient safety collaboratives is 42 U.S.C. §299c-3(c), which extends protection to data collection sponsored by the Agency for Healthcare Research and Quality (AHRQ). The Department of Health and Human Services’ confidentiality certificates and state peer review protection laws may offer little if any protection. However, with AHRQ sponsorship and the proper structure, health care organizations may be able to safely exchange information with one another without fear of liability or disclosure of sensitive information.

TOPIC. The nursing work environment has a critical impact on patient safety. Yet confusion on the specific roles and competencies of nurses, staff ratio issues, and lack of nurse empowerment create weaknesses that result in safety risks. PURPOSE. These interrelated issues must be addressed systemically to impact the nursing care system. DISCUSSION. Educational reform focusing upon standardized, higher level nursing education using a military model, appropriate staff ratio laws derived from the outcomes literature, and recurrent training incorporating policy-making powers can result in nurse empowerment and improved patient safety. CONCLUSION. Improving the nursing environment requires a broad approach to benefit patient safety. By treating the work environment as a complex system, approaches can result in greater nurse professionalism, empowerment, and patient safety.

Background Pharmaceutical marketing is undergoing a major shift in the United States, in part due to new transparency regulations under the healthcare reform act. Changes in pharmaceutical marketing practices include a possible shift from more traditional forms of direct-to-consumer advertising towards emerging use of Internet-based DTCA (“eDTCA”) given the growing importance of digital health or “eHealth.” Though legally allowed only in the U.S. and New Zealand, eDTCA poses novel regulatory challenges, as it can cross geopolitical boundaries and impact health systems and populations outside of these countries. Methods We wished to assess whether changes in DTCA and eDTCA expenditure trends was occurring using publicly available pharmaceutical marketing data. DTCA data was analyzed to compare trends in aggregate marketing expenditures and to assess if there were statistically significant differences in trends and magnitudes for data sources and DTCA sub-categories (including eDTCA). This was accomplished using regression lines of DTCA trend data and conducting pairwise comparisons of regression coefficients using t-tests. Means testing was utilized for comparing magnitude of DTCA expenditure. Results Data from multiple data sources indicate that aggregate DTCA expenditures have slightly declined during the period from 2005–2009 and are consistent with results from other studies. For DTCA sub-categories, television remained the most utilized form of DTCA, though experienced trends of declining expenditures (−13.2 %) similar to other traditional media platforms such as radio (−30.7 %) and outdoor ads (−12.1 %). The only DTCA sub-category that experienced substantial increased expenditures was eDTCA (+109.0 %) and it was the only medium that had statistically significant differences in its marketing expenditure trends compared to other DTCA sub-categories. Conclusions Our study indicates that traditional DTCA marketing may be on the decline. Conversely, the only DTCA sub-category that experienced significant increases was eDTCA. However, to fully understand this possible shift to “digital” DTCA, improvements in publicly available DTCA data sources are necessary to confirm changing trends and validate existing data. Hence, utilizing the newly implemented U.S. physician-payment expenditure transparency requirements, we advocate for the mandatory disclosure of DTCA/eDTCA in order to inform future domestic and international health policy efforts regarding appropriate regulation of pharmaceutical promotion.