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BACKGROUND: Data about performance measures (PM) in patients with ST segment Elevation Myocardial Infarction (STEMI) in low- and middle-income countries is really scarce. One of the reasons is the lack of appropriate measures for these scenarios where coronary intervention is not the standard treatment. OBJECTIVE: This study aimed to develop a set of PM and quality markers for patients with STEMI in these countries. METHODS: Two investigators systematically reviewed existing guidelines and scientific literature to identify potential PM by referring to documents searched through PubMed from 2010 through 2019, using terms "Myocardial Infarction", "STEMI", "quality indicator", and "performance measure". A modified Delphi technique, involving multidisciplinary panel interview, was used. A 15-member multidisciplinary expert panel individually rated each potential indicator on a scale of 1 (lowest) to 5 (highest) during three rounds. All indicators that received a median score ≥4.5, in final round without significant disagreement were included as PM. RESULTS: Through the consensus-building process, 84 potential indicators were found, of which 10 were proposed as performance measures and 2 as quality metrics, as follows: Pre-Hospital Electrocardiogram; Patients with reperfusion therapy; Pre-hospital Reperfusion; Ischemic time less than 120 minutes; System delay time less than 90 minutes; In-hospital Mortality; Complete in-hospital Treatment; Complete in-hospital Treatment in patients with Heart Failure; 30 day-Re-admissions; 30 day-mortality; Patients with in-hospital stress test performed; and, Patients included in rehabilitation programs. CONCLUSION: This document provides the official set of PM of attention in ST segment Elevation Myocardial Infarction of the Cuban Society of Cardiology and Cuban National Group of Cardiology. [ABSTRACT FROM AUTHOR]

OBJECTIVE: Examination of de-classified Monsanto documents from litigation in order to expose the impact of the company’s efforts to influence the reporting of scientific studies related to the safety of the herbicide, glyphosate. METHODS: A set of 141 recently de-classified documents, made public during the course of pending toxic tort litigation, In Re Roundup Products Liability Litigation were examined. RESULTS: The documents reveal Monsanto-sponsored ghostwriting of articles published in toxicology journals and the lay media, interference in the peer review process, behind-the-scenes influence on retraction and the creation of a so-called academic website as a front for the defense of Monsanto products. CONCLUSION: The use of third-party academics in the corporate defense of glyhphosate reveals that this practice extends beyond the corruption of medicine and persists in spite of efforts to enforce transparency in industry manipulation. [ABSTRACT FROM AUTHOR]

BACKGROUND: Health care workers face a wide range of chemical, physical, and biological occupational hazards in their jobs. OBJECTIVE: The present study aimed to investigate research trends on post-exposure prophylaxis (PEP) against blood-borne viral infections among health care workers. METHOD: Keywords related to health care workers, PEP, and blood-borne viruses were entered in the Scopus database for the period from 1950 to 27 January 2022. RESULTS: The search query returned 271 papers. The earliest publication was in 1984. The ranked first (n = 8, 3.0%), followed by the and with 6 (2.2%) papers for each. One hundred ninety-one journals took part in publishing the retrieved papers. Authors from 63 different countries took part in publishing the retrieved papers. The United States (US) ranked first (n = 53, 19.6%) followed by India (n = 26, 9.6%). The United States Centers for Disease Control and Prevention contributed the most (n = 9, 3.3%) and ranked first in the top active institutions. The mean number of authors per paper was 4.4 and the mean number of citations per paper was 17.0. The most frequent author keywords focused on PEP, health care workers, occupational exposure, HIV, hepatitis B, anti-retroviral and needle-stick injuries. Research themes in the retrieved papers focused on knowledge/attitude/practice and management and epidemiology of occupational exposure and PEP. There was a limited number of research publications in this field. CONCLUSION: Research activity in this field needs to be strengthened in low- and middle-income countries through reporting and training of HCWs. [ABSTRACT FROM AUTHOR]

BACKGROUND: Governmental regulations of drug registration and licensing are not always followed by healthcare providers. OBJECTIVE: To explore the global research growth and patterns on systemic use of off-label and unlicensed drugs to gain knowledge about the magnitude of the problem and the main research themes encountered in this field. METHODS: SciVerse Scopus was searched for papers on off-label and unlicensed drug use from 1990 until December 31, 2020, without any language limitations. A bibliometric methodology was adopted to present the following indicators: top-cited documents, the most productive countries, top active journals, international research collaboration, the most frequent author keywords, and research themes. RESULTS: The search query returned 1320 papers with an h-index of 66, published in 721 different journals. The Hospital Pharmacy journal ranked first (n = 43, 3.3%). In total, 5777 authors (median = 3) from 85 different countries contributed to the retrieved papers. The USA (n = 381, 28.9%) ranked first, followed distantly by Germany and Italy. The percentage of documents with international authors for active countries was from 8.8% for China to 42.3% for the Netherlands. The most frequent author keyword next to off-label was children/pediatrics. The keyword unlicensed was less frequently encountered than that for off-label. Major research themes in the retrieved papers focused on off-label drug use in hospitalized children/pediatrics, biological drugs such as rituximab and rFVIIa, psychiatric disorders, regulations, and questionnaire-based knowledge/attitude studies among community pharmacists and physicians. CONCLUSIONS: Research activity on off-label drug use has witnessed a general increase in the past two decades. The major research theme was off-label drug use in hospitalized children/pediatrics/neonates. The USA and certain European countries made a major contribution to this field. [ABSTRACT FROM AUTHOR]

BACKGROUND: Real-world safety of bevacizumab in cancer patients is limited. OBJECTIVE: To review the adverse drug reactions (ADRs) due to bevacizumab in cancer patients, in published case reports. METHODS: PubMed was searched; case reports of patients with any type of cancer, administered with bevacizumab (monotherapy/combination) and reported ADRs were included. Causality of ADRs was presented as reported in individual papers. ADRs were classified using the information in the USFDA-approved prescribing information (PI) of bevacizumab as 'Serious', 'Common', and 'Post-marketing surveillance' ADRs; ADRs not mentioned in the bevacizumab PI were termed as 'Non-label ADRs'. RESULTS: A total of 130 published papers comprising 154 cases from 22 different countries were included. Most papers (102/130; 78.46%) had moderate methodological quality. Age range of patients was 9-77 years. Off-label use of bevacizumab was found in 34/154 cases (22.08%). Ninety-six unique ADRs were found among 154 ADRs; most reported ADRs affected circulatory, digestive, and respiratory systems (33, 32, and 26 cases respectively). Most commonly reported ADRs were posterior leukoencephalopathy, fistulae, and gastrointestinal perforation (17, 17, and 16 cases respectively). Twenty-eight unique non-label ADRs (29.17%) were found. CONCLUSION: Bevacizumab is associated with more ADRs in the real world among cancer patients than those reported during clinical trials. [ABSTRACT FROM AUTHOR]

BACKGROUND: The Global Health Summit was held in Rome on 21 May 2021, co-hosted by the European Commission and Italy, as chair of the G20. Leaders, heads of regional and international organizations met to share lessons learned from the COVID-19 pandemic and to define the path ahead. OBJECTIVE: The present paper analyses the Rome Declaration as the first global health programme shared among the G20 Member States and based on the One-Health approach. METHODS: Documents such as preparatory work, official documents and observations from international organizations were analysed in order to provide a comprehensive review of the Rome Declaration. RESULTS: Core principles of the Rome Declarations have emerged as well as the goal to improve cooperation among existing international organisations and national authorities. CONCLUSIONS: Governments' future decisions will be the key to determine the end of the pandemic. The interconnected impacts on health, the environment, and social and economic dimensions will be a central theme of the overall narrative aiming at bringing the G20 process towards achieving a more inclusive and sustainable society. [ABSTRACT FROM AUTHOR]

BACKGROUND: The COVID-19 pandemic has shocked society worldwide. Multiple efforts went immediately into developing treatments for managing and vaccines for preventing the disease. National and international initiatives emerged to deal with the deep economic and social inequalities in our world today. OBJECTIVE: To show that the global inequalities that have become salient during the COVID-19 pandemic and specially with the global vaccination campaign, are the result of a highly privatized system of research and development (R&D), which is first and foremost profit-driven, and where epistemic and social concerns are not prioritized. METHODS: Philosophical analysis. RESULTS: After exploring the current organization of scientific research, as well as its impact in the development of research at a global scale, the paper shows the way in which this highly privatized organization of research has permeated scientific research on COVID-19, identifying who is currently benefiting from pandemic science, and who on the contrary is suffering the consequences of this organization. Using the COVAX mechanism as an example, the paper argues that international efforts to counteract the power of commercially-driven science has not rendered the expected results. CONCLUSIONS: The current organization of science ought to be shaken and restructured if we aim to be better prepared to address the global challenges of the future with the relevant scientific and technological development. [ABSTRACT FROM AUTHOR]

BACKGROUND: The pharmaceutical industry is believed to receive considerable support through research and development (R&D) tax credits. OBJECTIVE: The objectives of this paper are (a) to show that many of the pharmaceutical industry's apparent R&D activities are entangled with marketing efforts, and (b) to argue that supporting these activities through tax credits does not serve public interests in health. METHODS: The bulk of this paper summarizes the author's extended qualitative mixed-methods approach to following connections between pharmaceutical research and marketing. RESULTS: The pharmaceutical industry's R&D should be understood as broadly entangled with marketing, and so generally should be understood as integrated research, development and marketing (RD&M). CONCLUSIONS: R&D tax credits to the pharmaceutical industry largely do not serve public interests. [ABSTRACT FROM AUTHOR]

BACKGROUND: Point 7 of the Rome Declaration is aimed at improving data sharing and technological and knowledge transfer as instruments to implement health policies. OBJECTIVE: The objective of the current paper is to understand if the legal framework (especially at a transnational level) may actually help to achieve the objectives laid down by Principle 7 or if some interpretative or legislative actions will be necessary. METHODS: The paper analyses the legal sources at international and EU levels. RESULTS: The applicable rules are based on the idea that the information and material are forms of 'property' of the individuals or of the states (i.e., the sovereign). According to the traditional idea of property, the owner has a sort of absolute power over the res and is entitled to exclude others from any rights over the thing. The 'property paradigm' may be useful to protect some relevant interests, but it can also affect collective interests, such as those concerning health during the COVID-19 pandemic. CONCLUSIONS: In order to build a global system for the exchange of data and materials as provided for by Principle 7 of the Rome Declaration, a new legal approach should be elaborated which takes into consideration the international corpus of fundamental rights, including research freedom, the right to health and the principle of transnational 'digital' solidarity. [ABSTRACT FROM AUTHOR]

The ruling n. 38485, 20 June 2019, of the Italian Supreme Court, III criminal section, addressed by the perspective of the law the very sensitive and new issue of telemedicine.This commentary deals with the issue of authorization of telemedicine activities by the health authority, starting from the Italian Court of Criminal Cassation, III section, decision n. 38485/2019. The case law explored the authorization of a health point, which carries out telemedicine services.Starting from the perspective discussed by Italian health regulations, the paper examines how the health act could be defined, with the possibilities offered by telecommunications, and how it now relates legally to the physical place where it takes place.Even if telemedicine opens the way to virtual spaces of health practice, the Ministry of Health Italian Guidelines pose functional and logistical issues to guarantee users’ safety and health care system accountability. Then, functional requirements for health legitimate practice, and their continuous monitoring, together with the responsibilities of the service centers, health professionals and health facilities, are discussed.The questioning of States’ health law, in a broad health system such as that of the Europe, characterized by autonomous health regulations, is extremely important for cross-border health policy with telemedicine, as overall regulatory compliance in health care is the ground criterion for risk prevention and patient safety, to be properly verified. [ABSTRACT FROM AUTHOR]

BACKGROUND: The prescription opioid epidemic in the United States (US) is well documented, and recent measures have reduced prescribing rates in that country. Evidence suggests opioid prescriptions have been rising recently in other countries too. OBJECTIVE: The current paper aimed to compare trends in opioid prescribing in England and the US. METHODS: Trends in rates of prescriptions per 100 members of the population were calculated for England and the US using publicly available government data on prescriptions and population statistics. RESULTS: Rates of prescribing are converging. At the peak of the US epidemic in 2012, there were 81.3 prescriptions per 100 people, but this had fallen to 43.3 by 2020. Prescribing peaked in England in 2016 at 43.2 prescriptions per 100 people, but has fallen only slightly, so that in 2020 there were 40.9 prescriptions per 100 people. CONCLUSION: The data indicate that levels of opioid prescribing in England are now similar to those in the US. They remain high in both countries, despite recent falls. This suggests the need for further measures to prevent over-prescribing and to support people who would benefit from withdrawing from these drugs. [ABSTRACT FROM AUTHOR]

Best practice consent forms in company clinical trials detail the financial coverage for medical treatment of injuries. In trials undertaken for licensing purposes these arrangements can raise concerns. We detail three cases in which elements of the consent forms appear misleading and designed to elicit a consent to participation that might not be forthcoming if volunteers for these clinical trials were aware that what is outlined in principle is not likely to happen in practice. Beyond clinical trial participants, these consent forms have wider implications. Medical coverage of injuries sustained in a clinical trial is a nexus where business, scientific and ethical considerations meet. It is not clear that anyone to date has grappled with the issues posed. This paper uses three clinical trials to illustrate the problems to be addressed. [ABSTRACT FROM AUTHOR]

BACKGROUND: Paresthesia is defined as a burning or prickling sensation or partial numbness caused by neural injury. OBJECTIVE: The purpose of this paper is to present a rare and unusual case report of odontogenic infection-induced inferior alveolar nerve (IAN) paresthesia along with cutaneous draining sinus on the face of a pediatric patient and to discuss the possible pathophysiologic mechanism of nerve injury. METHODS: A 14-year-old female patient with cutaneous sinus and paresthesia associated with inferior alveolar nerve was enrolled in the study and the clinical and radiological manifestations of sinus lesion were carefully evaluated. RESULTS: The most appropriate treatment was carried out not only to resolve extraoral sinus but also to ensure progressive healing for the complete resolution of neurological disturbance. CONCLUSION: The simultaneous occurrence of infection and paresthesia strongly suggested a definitive relationship. Therefore, there seems to be a correlation between duration, origin, significance of the injury and the prognosis of paresthesia. [ABSTRACT FROM AUTHOR]

This paper discusses unresolved key problems in social sciences research and publishing. Researcher bias can lead to the publication of studies with highly questionable conclusions, which can impact adversely on important social topics (e.g., the influence of heredity on intelligence, criminality). Outright fraud occurs in science, and social sciences in particular [30]. To help counter the prevailing publication bias in research, four editorial suggestions for scientific reporting are proposed: (1) Before the work starts, investigators would be required to submit a written description of their research methodology. An international social sciences evaluation registry would be created to monitor research activity. (2) The Editor's decision about whether to publish a research study would be based on a paper that omitted the results and conclusions sections. These sections would be included in the published paper after an editorial decision was made. (3) With these appropriate scientific safeguards, researchers would also be required to provide raw data to other interested scientists, especially when the study is socially important, or is difficult to replicate. (4) Journal Editors who greenlight socially relevant studies would provide extra publishing space to people whose views differ significantly from the principal investigators. Bias and distortion cannot be completely eliminated from the scientific publication process. Adoption of these four proposals, however, would reduce scientific reporting problems such as data dredging and the dissemination of unsupported conclusions, and would also help to reduce fraud. Such adoption would eventually lead to the publication of improved scientific research in the social sciences. [ABSTRACT FROM AUTHOR]

BACKGROUND: The new type of virus (SARS-CoV-2 or COVID-19) from Coronaviridae family, discovered in 2019, caused a global pandemic with several massive lock-downs around the globe. Science and politicians became the center of world attention, receiving many questions without having clear answers. The hopes of many rested on vaccine development, which was done fast, facing novel challenges such as the massive production and distribution for several billions of people. OBJECTIVE: In this paper, the global reaction to the pandemic is reviewed along with some critical comments. METHOD: Different groups, including nations, took part in global lockdowns, while vaccine development was running in parallel without having enough capacity for some of the biggest medical demands in history. This review will bring together views from all interested groups in this pandemic crisis. RESULTS: The Western world waited too long (4 months), after the first case was confirmed in China, to introduce lock-down and safety measures. On the other side, vaccine development was done too fast to give clear long-term safety profiles of the medications developed. Due to the focus on development, it was overlooked that production and distribution of sterile products such as vaccines might have limitations globally. Usually when such limitations occur, power comes to the surface. Therefore, buyers who had power will get the vaccines they need first. However, we should recognize the economic impact that directly influenced healthcare funding. All of this will lead to post-crisis challenges, including depression, violence, suicide, migration, and many other social problems. CONCLUSIONS: The COVID-19 pandemic is a test for all of us, which many governments, industries and non-state actors are failing. It is a perfect "general probe" to detect some of the weaknesses of the current structure of global health. If politics and science do not work together to make a global production plan for vaccines and learn from this pandemic, then all of the lives lost were for nothing. [ABSTRACT FROM AUTHOR]

BACKGROUND: Public access to data has been a major step in attempting to reduce bias in scientific literature. Data to verify efficacy outcomes are now more accessible; however, little has been done to ensure public access to harms data from RCTs, which are equally important in ascertaining possible misreporting and protecting safety. OBJECTIVE: The treatment for adolescents with depression study (TADS) has influenced most international practice guidelines for treating children and adolescents with depression, supporting first-line prescription of fluoxetine in combination with cognitive behavioural therapy (CBT). However, after over 30 publications by the TADS team, reporting on harms remains highly deficient and we aimed to redress this lack. METHODS: In undertaking a restoring invisible and abandoned trials (RIAT) reanalysis of TADS' effectiveness and safety outcomes, we sought access to de-identified serious adverse events (SAE) data. RESULTS: This paper describes our unsuccessful efforts to obtain more detailed SAE data from TADS' data custodians, highlighting several problematic blocks to comprehensive safety reporting. CONCLUSION: Comprehensive access to clinical trial data is necessary to ensure safe and fully informed guidelines for treating children and adolescents with depression. [ABSTRACT FROM AUTHOR]

BACKGROUND: The health sector has long been affected by programs, actions, plans to digitize data and care processes with a view to better protecting individual health, as well as public health, resulting in a slow and uneven development of different and often incompatible national services. OBJECTIVE: This paper aims to explore the grounds behind the urgency of turning the digital priority into concrete actions, as acknowledged by political leaders in the Rome Declaration, by explaining the capacity of digital tools to enhance healthcare management and the current obstacles. METHODS: It considers the progressive extension of the EU institutions' scope of action during the pandemic, the related supporting financial strategies launched and some examples of digital contact tracing systems. RESULTS: It emerged that the pandemic highlighted the inadequacy of purely national policies and the advantages of leveraging the digital health data processing for governance, surveillance and response to cross-border and global threats. CONCLUSIONS: Considering what emerged during the pandemic and the solemn commitment of the world's major political leaders, the solution to the still existing technical and organizational interoperability issues will no longer be postponed. [ABSTRACT FROM AUTHOR]

BACKGROUND: The COVID-19 pandemic has increased the interest in the right to health, which represents a relatively new concept brought about by progress in medical science and the evolution of societies. The Italian Constitution, in article 32, states the right to health without specifications about the parameter of sex, assuming that this fundamental right is property of women and men indiscriminately. OBJECTIVE: To assess whether the right to health has actually been achieved in an equal way from the standpoint of sex, and whether a hypothetically "neutral" approach is actually convincing and profitable in this context. METHODS: This paper analyzes the topic of gender medicine from a scientific and legal perspective, based on current medical literature and its implementation in the Italian and European legal systems. RESULTS: Gender medicine is the only credible response to sex- and gender-based inequalities affecting the right to health, as it provides tools to address persisting inequalities in prevention and treatment, thus pursuing health for all: women and men. CONCLUSIONS: The importance of this path was underlined also by the Summit and the Rome Declaration of 21 May 2021, acknowledging that the topic of sex and gender can no longer be overlooked in focusing a correct and equal healthcare approach. [ABSTRACT FROM AUTHOR]

BACKGROUND: In the COVID-19 pandemic, coordination was certainly late, also due to the scarcity of information disseminated at the very beginning of the pandemic, when countries were inevitably taken by surprise. The lack of information, mainly attributable to the country from which everything seems to have started, has produced a huge delay and numerous uncertainties in the feedback of the WHO and international organizations. OBJECTIVE: The inevitably relevant issue, from a legal point of view, concerns the legitimacy, formal or in any case shared, of the authority in charge of coordinating reactions and policies. The paper analyses the current legislation, soft and hard law, and the undertaken policies concerning emergency responses. METHODS: International and EU legislation analysis. RESULTS: The G20 understood that sustainable, flexible and agile funding systems for health emergencies are essential elements of pandemic prevention, preparedness and response. In EU there are many regulations about coordination and response to emergencies in practice in the EU and the Regulation (EU) 2021/522 (EU4Health programme), broadly extends the Union's competence in the field of health and has the objective of strengthening the Union's capacity for prevention, preparedness and rapid response in the event of serious cross-border threats to health. CONCLUSIONS: It is essential to formalize, within international agreements, the institutionalization of relationships, procedures, and the possible recognition of the reference figure. If in the European Union, at least partially, the protocols are there (even if the COVID-19 emergency has blown them up in principle), certainly in relations with non-EU countries the story is complicated, requiring specific agreements. This is the goal of the path started by the Rome Declaration of 21 May 2021 within the G20 – Global Health Summit. [ABSTRACT FROM AUTHOR]

BACKGROUND: The improvement of health represents a goal for all countries in the world in a global way and, compared to earlier stages of development, there is a significant focus by the public health system on community and home-based services in particular. OBJECTIVE: This objective was reaffirmed during the last World Health Summit (May 2021), at which the leaders of the G20 countries, together with other member states, signed the "Declaration of Rome". METHODS: The paper contains the study of the impact that the COVID-19 pandemic has determined on the organization of the health system, through the study of the data provided by the main national and international organizations in the health field. RESULTS: It emerged that the field of personal, family and community care are certainly an area of growth for nursing, which also in the European context, is showing an increase importance given to services and care activities outside the hospital and home in particular. In all of this, the roles that nurses can assume are differentiated and articulated. CONCLUSIONS: In the complexity of this perspective, families and community seem to emerge as a point of reference for a nursing care that is certainly going through a decisive moment in the slow, but inexorable path towards the emancipation of its disciplinary status and the development of its ability to provide new, original and autonomous responses to the needs of the assisted population. [ABSTRACT FROM AUTHOR]

BACKGROUND: The COVID-19 pandemic represented a global earthquake that made the review of health policies aimed at strengthening common governance necessary. OBJECTIVE: The paper analyses the reasons for which the One Health approach has become fundamental in the control of pandemic phenomena, by arguing the necessity to place it at the basis not only of health policies but also of intersectoral policies. METHODS: The documents of the world organizations published before and after the pandemic were analyzed and studied in order to unpack the close relationship between new lifestyles and the increase of health risks. RESULTS: It emerged that the One Health approach is a paradigm that has been advanced for more than 30 years, but due to the inadequacy of local and world health policies, this approach was never translated into concrete actions to protect health, feeding problems at the cause of the COVID-19 pandemic. CONCLUSIONS: Having ascertained that the adoption of a One Health approach can no longer be postponed, this must be insisted on several interconnected sectors that establish the new concept of healthcare which, in addition to being interdisciplinary, necessarily takes on a global perspective. [ABSTRACT FROM AUTHOR]

BACKGROUND: The right to fully enjoy the highest possible state of health is certainly nothing new in the agenda of the world's governments, and yet today it becomes a top priority not just in the restructuring of the health care system, but also in the promotion of multi-sector policies aimed at fostering and safeguarding the potential of every individual to achieve what could be defined, in general terms, as "common good". OBJECTIVE: The current paper aimed at singling out the most useful strategies to promoting and achieving a healthy, more resilient and fairer society. METHODS: : Starting from principles 1 and 14 of the Declaration of Rome, the aim was to analyse and develop the concepts of resilience and health, questioning their possible future variations against the background of the current health emergency and the increasingly radical widespread use of new technologies as universally-applied and cross-sectional tools for human progress. RESULTS: The "health for all" objective can only be achieved if we act on three key aspects: 1. Adding life to years; 2. Adding life to life; 3. Adding years to life. CONCLUSIONS: Each individual should raise their health awareness as a key resource to leading a fulfilling existence and to developing the required qualities to fully tap into health possibilities – whether integral or residual – to tackle life. [ABSTRACT FROM AUTHOR]

Agreement on Trade Related aspects of Intellectual Property Rights (TRIPS) was laid on the premises of rewarding monopolistic patent rights to the innovator. Stronger patent protection was advocated to promote technology transfer from developed nations to the rest of the world. To boost domestic innovative potential and to maintain trade ties, most developing countries signed the TRIPS agreement. Impact of patent laws in the pharmaceutical industry was crucial as it posed threat to access health. This paper aims to analyze the impact of pharmaceutical product patent laws incorporated under the TRIPS agreement using 65 countries panel dataset from 1995 to 2016. The data is empirically analyzed using negative binomial regression and Poisson regression. Results clearly indicate that the number of pharmaceutical patents filed in US Patent and Trademark Office (USPTO) has decreased after TRIPS compliance in both low and middle income countries. However, the decline is larger in upper middle and lower middle income countries than in low income countries. The phenomenon of low patent activity has an increasingly declining trend across low and middle income countries. Hence the claimed hypothesis that stronger patent rights would increase innovative potential does not seem to stand true, which raises serious affordability concerns of bringing patents in the pharmaceutical sector. [ABSTRACT FROM AUTHOR]

Selective reporting is prevalent in the medical literature, particularly in industry-sponsored research. In this paper, we expose selective reporting that is not evident without access to internal company documents. The published report of study 329 of paroxetine in adolescents sponsored by GlaxoSmithKline claims that “paroxetine is generally well tolerated and effective for major depression in adolescents”. By contrast, documents obtained during litigation reveal that study 329 was negative for efficacy on all 8 protocol specified outcomes and positive for harm. [ABSTRACT FROM AUTHOR]

BACKGROUND: In 2012, Patient Safety (PS) in AstraZeneca was facing a situation with multiple challenges, scientifically and structurally. OBJECTIVE: To meet these and support AstraZeneca's ambition to return to growth after years of patent expiry, we undertook a project to fundamentally revisit ways of working to create an organisation set up to provide strategic safety in support of drug project decision-making. METHOD: In this paper, we describe the challenges we faced, the project to deliver changes to respond to them, and the methodology used. The project had two main components: creating a new operating model and simplifying the procedural framework. RESULTS: It was delivered in a focused effort by internal PS resources with cross-functional input. The framework simplification resulted in a 71% reduction in procedural documents and a survey of PS staff revealed an increase in satisfaction of 10%–20% across all scores. CONCLUSIONS: With >3 years of observation time, this project has provided AstraZeneca with a PS organisation able to provide strategic safety, supporting successful portfolio delivery, while ensuring patient safety and maintaining compliance with global pharmacovigilance regulations. It has driven efficiency and set the foundation for continued organisational evolution to meet future business needs in an everchanging environment. [ABSTRACT FROM AUTHOR]

BACKGROUND: The impact of the extension of the Consolidated Standards of Reporting Trials (CONSORT) statement, which was published in 2004 and aimed to improve the quality of the safety information presented in clinical trials, remains uncertain. OBJECTIVE: To assess the incorporation of the CONSORT statement extension's recommendations in randomised clinical trials (RCTs) evaluating drug therapies published in high-impact medical journals. METHODS: Using Medline, 122 RCTs published in 2009 were selected from BMJ, JAMA, Lancet, and NEJM. A structured form was used to identify the harms information reported in the RCTs, following the recommendations of the CONSORT statement extension. RESULTS: The most frequently met CONSORT recommendation was the mention of harms in the title or abstract of the paper (72.1% of the papers analysed); the least-met recommendation was the reporting of how the harms information was collected (10.7%). The studies that focused on harms presented better information on safety, but only 10.8% met all recommendations in the CONSORT statement. CONCLUSION: The adverse event information was insufficient for the RCTs published in four high-impact medical journals five years after the publication of the extension of the CONSORT statement. [ABSTRACT FROM AUTHOR]

An introduction is presented in which the editor discusses articles in the issue on topics including the highest possible quality of care, and the condition of being protected from or unlikely to cause danger, risk, or injury.

Objective: In a previous paper, we described the major health tragedy that occurred in Japan involving the use of gefitinib, and recommended steps to prevent such problems occurring again. In that paper, we argued that erlotinib should only be approved on the condition that all users are subject to surveillance. Erlotinib was subsequently approved for use in Japan on October 19, 2007. In the present paper, we examine whether our recommendations have been implemented in the safety measures established for erlotinib use. Methods: We comprehensively reviewed reports regarding erlotinib treatment published between 2007 and 2009 by regulatory agencies and the manufacturer of the erlotinib-containing drug. We evaluated the safety measures established for erlotinib in view of three problems we identified with the treatment of gefitinib marketing: (1) the results of animal experiments and pre-marketing clinical trials, and reports of adverse drug reactions from other countries were not properly incorporated into the product information; (2) indications for the drug were expanded without strict evaluation of the external validity of pre-marketing clinical trials; and (3) despite many serious cases of interstitial lung disease being spontaneously reported, well-designed post-marketing surveillance was not conducted immediately after these problems became evident. Results: We found that appropriate measures were taken for erlotinib in relation to each of the three above-mentioned problems. We found that there were fewer fatal adverse reactions to erlotinib after marketing relative to the pre-marketing period. Conclusions: Our recommendations following the health tragedy caused by gefitinib were implemented in the safety measures for erlotinib, which probably explains the smaller number of fatal adverse reactions to erlotinib in post-marketing surveillance than in pre-marketing trials. [ABSTRACT FROM AUTHOR]

The emerging COVID-19 pandemic poses a threat to the global health care system. Given the lack of antiviral therapies or vaccines for the disease, the antimalarial drug hydroxychloroquine (HCQ) obtained much attention as a treatment for COVID-19. However, there are limited and uncertain clinical data to support the beneficial effect of this drug in COVID-19 treatment. HCQ has several side effects and warnings, including blindness, heart failure, and renal toxicity, even with recommended doses. For severe cases of COVID-19 or in patients with preexisting conditions, administering such a drug could be fatal, particularly when taken at high doses or in combination with other antibiotics. However, further well-designed studies that would address the optimal dose, duration of treatment, possible side effects, and long-term usage outcomes are needed to make the final decision. In this paper, we aim to discuss the risk of using HCQ in treating COVID-19 patients, including its possible side effects. [ABSTRACT FROM AUTHOR]

The world is currently in the throes of the COVID-19 pandemic which has halted the tourism sector and created an unprecedented global economic crisis. This paper will outline economics pertaining to COVID-19 lockdown, recovery and the inevitable competition that will occur between countries for tourists who will be scarcer and therefore more valuable. Countries are competing with a variety of incentives in order to lure visitors. However, persistent first waves that extend into July will put off tourists, further reducing tourism revenues and accelerate job losses and bankruptcies in affected countries. The example of Sweden's response to COVID-19 in this regard will be described. Countries that have COVID-19 relatively under control but experience second waves will also manifest negative tourism effects. Governments and public health must act in unison so as to exit lockdown as speedily and as safely as feasible, with COVID-19 rises that are as low and brief as possible in order to better compete in the tourism sector with other countries. Websites are already online comparing not only safety for travellers vis-à-vis COVID-19 but also the incentives offered by different countries in their attempts to woo tourists in this difficult market. [ABSTRACT FROM AUTHOR]

In Holland, first tier medical care outside of office hours is provided by regular GP's acting as Locum GP's. On several occasions concerns have been expressed about Locum GP's not visiting the patient when necessary. The number of complaints against Locum GP's submitted to the Medical Boards has been increasing over time and relate in particular to refusals of Locum GP's to visit the patient. In many of these cases the patient died. The paper develops a quantitative estimate of the risk for the patient due to negligence of Locum GP's. The measure of the risk is taken as the number of patients who died unnecessarily due to negligence of Locum GP's as determined by the Medical Boards. The paper estimates that in Holland in the year 2000 about 1500 patients would probably not have died had the Locum GP's working out-of-hours not been negligent by contravening professional standards. In more than half of these cases the Locum GP's did not visit the patient, or did not visit the patient in time, when necessary. This level of patient risk must be regarded as socially unacceptable. One important explanation for these accidents could be that doctors are largely unfamiliar with the professional standards developed by the Medical Boards. Because of the assumptions made and the uncertainty regarding the data used, the actual numbers of these accidents may be higher or lower than estimated here. Although more reliable data will allow the results to be determined more reliably, this is unlikely to change the acceptability of the risk. [ABSTRACT FROM AUTHOR]

An introduction is presented in which author discusses articles on topics including focuses on the gap between a profession that has patient care as its vocation and one that called upon to adjudicate on that same professional performance.

The advent of market economy since 1986 in Vietnam has thrown the drug market into chaos with potential risks to consumers from unsupervised widespread self-medication. In the virtual absence of non-commercial drug information to consumers, the mass media may play a key role. The objectives of the study were to describe drug information in the Vietnamese press, particularly in terms of risk/benefit, using a combined journalistic-pharmaceutical coding instrument. A quantitative content analysis was made of all articles (As this is to the best of our knowledge the first study of its kind in a low-income country, the diversity of coverage in the newspapers as well as the sheer volume of drug articles were noteworthy findings. Almost half (44%) of the articles were about traditional medicines, 20% about anti-infectives, and 15% about gastro-intestinal/alimentary drugs. Over half of the articles on modern medicines dealt with drugs on Vietnam’s Essential Drug List. Headline tendency was unbalanced with 39% positive, 55% neutral and 6% negative. Risk/benefit information was inadequate with information on side-effects provided in 12%, and on counter-indications in 13% of all articles. Exactly half (50%) of articles mentioned dosage, but only 2% drug price. Authors were mainly doctors, pharmacists and journalists. The four newspapers differed in profiles. ‘Health’ did the best job of providing drug information followed by the women’s newspaper, the youth paper and the senior citizen paper. However, in general, the relative paucity of information about side effects, counterindications, and drug prices, as well as the lack of independent journalistic drug reporting gives some cause for concern. [ABSTRACT FROM AUTHOR]

This paper argues that information about psychiatric drugs derived from conventionally conducted randomized controlled clinical trials (RCTs) is inadequate to form an accurate picture of drug-induced psychological alterations. Two main lines of argument are presented. The first concerns the disparity between adverse effects established in RCTs and the broader range of adverse drug reaction reports which derive from non-RCT formats. The second concerns the contention that information about drug-induced psychological alterations obtained from RCTs is too limited to address the meaning of observed “target symptom” reduction which occurs during the course of the (typically very brief) investigation. The paper considers the possibility that nominal “therapeutic” drug effects may only be part of a larger, inadequately discerned picture of drug-induced psychological toxicity. [ABSTRACT FROM AUTHOR]

BACKGROUND: Advance care treatment escalation plans (TEPs) are often lost between healthcare settings, leading to duplication of work and loss of patient autonomy. OBJECTIVE: This quality improvement project reviewed the usage of TEP forms and aimed to improve completeness of documentation and visibility between admissions. METHODS: Over four months we monitored TEP form documentation using a standardised data extraction form. This examined section completion, seniority of documenting clinician and transfer of forms to our hospital electronic patient record (EPRO). We added reminders to computer monitors on wards to improve EPRO upload. RESULTS: Initial data demonstrated that 95% of patients (n = 230) had a TEP, with 99% of TEPs recording resuscitation status. However, other sections were not well documented (patient capacity 57% completion and personal priorities 45% completion, respectively). Only 11.9% of TEPs documented consultant involvement. Furthermore, only 44% of TEPs with a do not attempt resuscitation (DNACPR) decision were uploaded. Following this, we added reminders to computer monitors explaining how to upload TEP decisions to EPRO, which increased EPRO uploads to 74%. CONCLUSION: Communication of TEPs needs improving across healthcare settings. This project showed that the use of a physical reminder can greatly improve communication of treatment escalation decisions. Furthermore, this intervention has inspired future projects aiming at making communication more sustainable through the use of discharge summaries. [ABSTRACT FROM AUTHOR]

In an era which marks an exceptional phase of growth in science and technology, the acute disparities in access to healthcare still persist. So where on one hand scientific advancement in medicine aims at increasing life expectancy, on the other hand there are millions who are denied access to existing medicines. Patents on medicines also pose a significant barrier to access new drugs, especially in low and middle income countries which already suffer from poor health financing mechanisms. The patent laws were built on the assumption of incentivizing the innovators by rewarding them with the exclusive right to produce, sell or market the innovation. The basic premise for granting patents was based on the thought that it would increase investment in research and development promoting dynamic gains through newer innovations. However, evidence found to support this justification is meager. So in a situation where the drug gap still persists and we aim to achieve sustainable development goals by 2030, this paper attempts to focus on understanding how compulsory licensing has been used in selected cases to alleviate the major legal and political barriers to access medicines. The methodology comprises of cross-country comparison of patent framework and compulsory licensing cases. The sample selected for study includes both developed as well as developing countries. The aim is to evaluate the policy approaches used by selected countries to grant compulsory licenses and to identify the best practices for evidence-based policy making on international issues related to pharmaceutical patents. In each case, a driving factor has been the international extension of patent laws through trade agreements; first bilaterally (US-Canada) and subsequently internationally (1995 Uruguay round, under which low- and middle-income countries were granted a grace period until 2005 to comply). [ABSTRACT FROM AUTHOR]

BACKGROUND: Millions of people are treated with antidepressants like selective serotonin reuptake inhibitors (SSRIs) or serotonin-norepinephrine reuptake inhibitors (SNRIs). This clinical practice is based on short-term trials that have exaggerated the benefits and underestimated the harms. We also know too little about long-term harms. AIM: To assess harms of SSRIs and SNRIs that persist after end of drug intake. METHODS: Systematic review of placebo-controlled randomised trials of any length in patients with a psychiatric diagnosis and a follow-up of at least six months. Our primary outcomes were mortality, functional outcomes, quality of life and core psychiatric events. We searched PubMed, Embase, and the Cochrane Central Register of Controlled Trials and checked the references for eligible articles. One researcher extracted data and another checked the data extraction. RESULTS: Our searches returned 9,153 unique records. We included 22 papers for 12 trials on SSRIs. Median intervention and follow-up periods were 15 and 52 weeks, respectively. Median number of randomised participants was 51; only two trials had a drop-out rate below 20%. Outcome reporting was less thorough during follow-up than for the intervention period and only two trials maintained the blind during follow-up. All authors concluded that the drugs were not beneficial in the long term. All trials reported harms outcomes selectively or did not report any. Only two trials reported on any of our primary outcomes (school attendance and number of heavy drinking days). CONCLUSION: The randomised trials currently available cannot be used to investigate persistent harms of antidepressants. [ABSTRACT FROM AUTHOR]

This paper argues that health policies should transcend national boundaries yet should not reach the supranational level. Along with multinational global health efforts, such cross-national health policies are essential to leverage joint efforts by countries learning from their peers that experience similar health system challenges. In our analysis, we used World Bank Health, Nutrition, and Population (HNP) data from 1995 to 2014 for East Asia Pacific (EAP) countries to explore health system comparability across member nations. We applied a hierarchical cluster analysis using Ward's method and a squared Euclidean distance approach to classify 24 EAP countries into four relatively stable clusters based on their (dis)similarities over nine selected health expenditure and health system performance related indicators. One-way analysis of variance (ANOVA) was used to assess the discreteness of the formed clusters. Each cluster had unique characteristics based on the included indicators and health system performance of the member countries. We present transnational health policy recommendations for the EAP region based on both our use of robust methodology and the resulting comparative clusters. [ABSTRACT FROM AUTHOR]

BACKGROUND: Data regarding the relative safety profile of anti-malarial drugs in pregnancy is sparse mainly limited by the absence of head-to-head clinical trials. The present study is a network meta-analysis of safety of anti-malarial drugs used to treat malaria in pregnant women. METHODS: A thorough literature search using the search strategy "Malaria [tiab] AND (Pregnant [tiab] OR Pregnancy [tiab])" was carried out for either randomized controlled trials or prospective cohort studies in pregnant malarial women prescribed any of the recommended anti-malarial drugs by World Health Organization (WHO) and that have reported adverse pregnancy outcomes such as miscarriage, still birth, and neonatal deaths. Odds ratio with 95% confidence interval was used as the effect estimate. Random-effects model and Markov Chain Monte Carlo simulation method was used to generate pooled estimates. Sensitivity analysis was performed excluding data from first trimester and GRADE approach was used to categorize the quality of evidence. RESULTS: A total of 1242 papers were obtained with the search strategy, of which seven evaluating 10 treatment arms in a total of 5510 participants were included in the present meta-analysis. The pooled estimates revealed significantly lower risks of abortion with quinine and artemisinin-lumefantrine compared to dihydroartemisinin-piperaquine, artesunate with mefloquine and artesunate with amodiaquine. But when a cohort study that was conducted in the first trimester of pregnancy was excluded, no significant differences were observed in the risk of abortion between the anti-malarial drugs. No significant differences in the risk of either stillbirths or neonatal deaths were observed with any of the drugs. The quality of evidence was found to be very low due to serious limitations in both the precision and indirectness. CONCLUSION: WHO recommended anti-malarials in pregnancy have similar risk profiles with regard to abortion, stillbirth and neonatal deaths. [ABSTRACT FROM AUTHOR]

The data supporting the use of "antidepressants" in children and adolescents is largely unavailable. Academic publications give a different picture as regards benefits and harms to publications from regulatory other sources. Despite disagreements about the data driving use of these medicines, in practice "antidepressants" may now be the most commonly used drugs by adolescent girls, and children's mental health services are attracting increasing attention. This paper reviews the difficulties surrounding the data. It outlines a case for benefits (as well as risks) that would require physicians to exert a greater degree of professional autonomy than service managers might wish. [ABSTRACT FROM AUTHOR]

BACKGROUND: Medication safety is an essential component of patient safety in health care delivery. Providing strategies to effectively prevent medication errors and adverse drug events in hospitals has gained international recognition. OBJECTIVE: The aim of this paper was to review systematically the research literature on the various interventions for providing medication safety in hospitals. METHOD: Eight healthcare databases were searched for full research articles written in English. Reference lists of included studies were also searched. Research studies involving delivery of interventions in hospitals with the aim of preventing or reducing medication errors and adverse drug events were examined. RESULTS: Forty-two studies were selected. Most of the studies were before and after designs without comparative control groups. Forty studies identified interventions contributing to the prevention and reduction of medication errors. Six broad types of interventions were identified: computerized physician order entry with or without clinical decision support systems, automation, computer assisted, barcode technology, pharmacist role, training and system designs. CONCLUSION: Though studies have provided evidence for individual interventions, there are concerns about the extent of their effectiveness. This has implications for policy makers and clinicians to adopt multifaceted approach in providing medication safety in their hospitals. [ABSTRACT FROM AUTHOR]

Background: Infection-associated encephalopathies such as Reye's syndrome have been one of the major public health problems in many countries. The not dissimilar neuropsychiatric adverse reactions, including deaths, observed with Tamiflu (oseltamivir phosphate: OP) have been another current problem especially in Japan. Methods: Among the cases with neuropsychiatric adverse reactions to Tamiflu on which I was consulted, those cases in which medical charts, autopsy records and/or prescription certificates were available were analyzed and described. In order to obtain a complete view of the spectrum of neuropsychiatric adverse reactions attributed to Tamiflu and of existing knowledge of the causal relationship, adverse reaction case reports and accounts of personal experiences were collected using PubMed, Japonica Centra Revuo Medicina, the websites of MHLW, PMDA and FDA and other Internet sources. Information on animal toxicity and clinical trial findings was derived from the texts of the officially approved data sheet for Tamiflu. Results and discussion: This paper reports eight cases in total: five of these died and three survived. Two died as a result of accidents resulting from abnormal behaviour... [ABSTRACT FROM AUTHOR]

In the past decade bipolar disorder in children has been diagnosed with rapidly increasing frequency in North America, despite a century of psychiatric consensus that manic-depressive illness rarely had its onset before adolescence. This emergence has happened against a background of vigorous pharmaceutical company marketing of bipolar disorder in adults. In the absence of a license demonstrating efficacy for their compound for bipolar disorder in children, however, companies cannot actively market pediatric bipolar disorder. This paper explores some mechanisms that play a part in spreading the recognition of a disorder in populations for which pharmaceutical companies do not have a license. These include the role of academic experts, parent pressure groups, measurement technologies and the availability of possible remedies even if not licensed. [ABSTRACT FROM AUTHOR]

Patent rights establish a price level for medicines that makes them unaffordable for the majority of the people in the world. This paper presents some main consequences of the influence of patents on the markets for drugs, and provides some economic arguments that might be useful in the discussion of patent rights. Patents for essential medicines have unacceptable social short run effects. Arguments that in the long run they provide incentives to promote invention seem uncertain and poorly justified. A system of compulsory licensing inside the WTO TRIPS agreement will work better. The paper is not the result of original research by the author, but it attempts to assist in understanding certain of the economic arguments which are advanced in favour of patent rights, and to consider how such rights influence consumers of medicines. [ABSTRACT FROM AUTHOR]

BACKGROUND: Since the mid-20th century, contrast agents have been widely used in radiology due to their ability to provide high-definition radiographic images and greater precision in diagnostic exams. Different types of contrast agents are used in image diagnosis, namely radiological media. Despite being considered safe, there are still uncertainties about their safety profile, interactions, and incidence of adverse drug reactions in real-world settings. OBJECTIVE: To characterise the pattern of adverse events, during 7 years, in a radiology unit. METHODS: We performed a retrospective observational and descriptive study at an Image Center in Portugal between August 2012 and October 2019. A total of 77,449 computed tomography (CT) were registered, and from those 15,640 cases of iopromide were used as a contrast agent. The authors have accessed, under the authorization, the data of adverse events and procedures after the event. RESULTS: Most of the hypersensitivity events were immediate or with a short time of onset, with the majority of cases developing events with skin involvement and mild degree, where the most common events were papules (n = 60), pruritus (n = 42), erythema (n = 27) and urticaria (n = 14). Severe events, including hypersensitivity, were mainly represented by vomiting (n = 11), stridor (n = 8), breathing difficulties (n = 7) and syncope (n = 3). Abdominal-pelvic CT exam presented a higher frequency of adverse events. CONCLUSION: Despite all the current information about iopromide usage, the utilization of this agent is not abstent of risks and its safety profile not fully established. Most frequent symptoms were local, as skin adverse events, including papules, pruritus and erythema. Common medications used to treat or control adverse events were frequently hydrocortisone, clemastine and methylprednisolone. [ABSTRACT FROM AUTHOR]

BACKGROUND: Depression drugs can be difficult to come off due to withdrawal symptoms. Gradual tapering with tapering support is needed to help patients withdraw safely. OBJECTIVE: To review the withdrawal success rates, using any intervention, and the effects on relapse/recurrence rates, symptom severity, quality of life, and withdrawal symptoms. METHODS: Systematic review based on PubMed and Embase searches (last search 4 October 2022) of randomised trials with one or more treatment arms aimed at helping patients withdraw from a depression drug, regardless of indication for treatment. We calculated the mean and median success rates and the risk difference of depressive relapse when discontinuing or continuing depression drugs. RESULTS: We included 13 studies (2085 participants). Three compared two withdrawal interventions and ten compared drug discontinuation vs. continuation. The success rates varied hugely between the trials (9% to 80%), with a weighted mean of 47% (95% confidence interval 38% to 57%) and a median of 50% (interquartile range 29% to 65%). A meta-regression showed that the length of taper was highly predictive for the risk of relapse (P = 0.00001). All the studies we reviewed confounded withdrawal symptoms with relapse; did not use hyperbolic tapering; withdrew the depression drug too fast; and stopped it entirely when receptor occupancy was still high. CONCLUSION: The true proportion of patients on depression drugs who can stop safely without relapse is likely considerably higher than the 50% we found. [ABSTRACT FROM AUTHOR]

An introduction is presented in which the editor discusses articles in the issue on topics including COVID-19 pandemic, medical occupational health, digitalization of health, inappropriate medicine use by healthcare professionals, and specific pharmacological studies.

BACKGROUND: Although antidepressant medication (ADM) has produced small advantages over pill placebo in randomized controlled trials, consuming ADM has predicted prospectively increasing depressive symptom severity in samples of community-dwelling adults. OBJECTIVE: We extended the community literature by testing ADM's relations to changes in personality and quality of life that may underpin depression. METHOD: In this longitudinal, observational study, community-dwelling adults (N = 601) were assessed twice, 8 months apart on average. Assessments included depressive symptoms, personality, life satisfaction and quality, and prescription medication consumption. RESULTS: Consuming ADM at time 1 predicted relative increases in depressive symptoms (dysphoria), maladaptive traits (negative affect, negative temperament, disinhibition, low conscientiousness), personality dysfunction (non-coping, self-pathology), and decreases in life satisfaction and quality from time 1 to 2, before and after adjustment for age, gender, race, income, education, physical health problems, and use of other psychotropics. In no analysis did ADM use predict better outcomes. CONCLUSION: Among community-dwelling adults, ADM use is a risk factor for psychosocial deterioration in domains including depressive symptoms, personality pathology, and quality of life. Until mechanisms connecting ADM to poor outcomes in community samples are understood, additional caution in use of ADM and consideration of empirically supported non-pharmacologic treatments is prudent. [ABSTRACT FROM AUTHOR]

BACKGROUND: The global COVID-19 pandemic has forced people to obtain health products and services from home. Similar to other e-commerce, medicines are bought online and delivered using a courier service. OBJECTIVE: By being fully concerned to patient safety, this study aims to determine development strategies to increase intention in purchasing prescription drugs through e-pharmacy. METHODS: Two stages of measurement are employed in this study, namely confirmatory factor analyis using PLS-SEM and pairwise comparison using AHP method. To discover consumer perception in using e-pharmacy, the basic model of Theory of Planned Behavior (TPB) is employed with several extensions. RESULTS: The results of PLS-SEM express that Trust has a major role as an intervening variable to enhance the indirect effect of Subjective Norms and Perceived Values on Purchase Intention. In general, PLS-SEM structural model is declared "fit" (GFI = 0.93 ≥ 0.90; RMSEA = 0.045 ≤ 0.08; SRMR = 0.033 ≤ 0.05). Measurement model test proves that all selected indicators are valid to represent their related constructs (Loading Factor ≥ 0.50), and all selected constructs are reliable to build the whole path model (CR ≥ 0.7; AVE ≥ 05). Meanwhile, the results of AHP indicate that strengthening government policies and regulations is prioritized to increase consumer intention of purchasing prescription drugs through e-pharmacy, followed by protection of user confidential data in the second place. Those two eigenvectors are 0.236 and 0.185 respectively. CONCLUSION: Future research is suggested to add perceived risk as latent variable in the study of consumer behavior for any high-risk products. [ABSTRACT FROM AUTHOR]