Pharmaceutical Industry Representatives Research Articles

Is enhancing the professionalism of healthcare providers critical to tackling antimicrobial resistance in low- and middle-income countries?

BackgroundHealthcare providers’ (HCPs) professionalism refers to their commitment and ability to respond to the health needs of the communities they serve and to act in the best interest of patients. Despite attention to increasing the number of HCPs in low- and middle-income countries (LMIC), the quality of professional education delivered to HCPs and their resulting professionalism has been neglected. The Global Action Plan on Antimicrobial Resistance (AMR) seeks to reduce inappropriate use of antibiotics by urging patients to access antibiotics only through qualified HCPs, on the premise that qualified HCPs will act as more responsible and competent gatekeepers of access to antibiotics than unqualified HCPs.MethodsWe investigate whether weaknesses in HCP professionalism result in boundaries between qualified HCPs and unqualified providers being blurred, and how these weaknesses impact inappropriate provision of antibiotics by HCPs in two LMIC with increasing AMR—Pakistan and Cambodia. We conducted 85 in-depth interviews with HCPs, policymakers, and pharmaceutical industry representatives. Our thematic analysis was based on a conceptual framework of four components of professionalism and focused on identifying recurring findings in both countries.ResultsDespite many cultural and sociodemographic differences between Cambodia and Pakistan, there was a consistent finding that the behaviour of many qualified HCPs did not reflect their professional education. Our analysis identified five areas in which strengthening HCP education could enhance professionalism and reduce the inappropriate use of antibiotics: updating curricula to better cover the need for appropriate use of antibiotics; imparting stronger communication skills to manage patient demand for medications; inculcating essential professional ethics; building skills required for effective collaboration between doctors, pharmacists, and lay HCPs; and ensuring access to (unbiased) continuing medical education.ConclusionsIn light of the weaknesses in HCP professionalism identified, we conclude that global guidelines urging patients to only seek care at qualified HCPs should consider whether HCP professional education is equipping them to act in the best interest of the patient and society. Our findings suggest that improvements to HCP professional education are needed urgently and that these should focus not only on the curriculum content and learning methods, but also on the social purpose of graduates.

PCN490 MAKING OUTCOME-BASED PAYMENT A REALITY IN THE NATIONAL HEALTH SERVICE FOR ENGLAND

Many cancer medicines are made available on the National Health Service for England (NHS) based on a price discount agreed between the NHS and the manufacturer. However, such negotiations can have a power imbalance, lack transparency, and be protracted thus delay patient access. More innovative ways for the NHS to pay for medicines, such as Outcome-Based Payment (OBP), which links a medicine’s price to NHS patients’ treatment outcomes, could provide a solution. This research explores the feasibility of introducing an OBP approach for new cancer drugs in England. A literature review explores the current funding landscape in England, the available evidence on existing OBP schemes internationally, and which outcomes cancer patients value most. Two focus groups and an online survey with patients and carers, as well as interviews with NHS and government stakeholders, healthcare professionals, and pharmaceutical industry representatives, provided additional evidence on the feasibility and suitability of OBP schemes. Implementation of OBP in the NHS is desirable and particularly suitable for medicines with the following characteristics: potentially large benefit to patients receiving the medicine; small to moderately-sized patient populations; immature clinical trials data; and a disease profile where improvements in outcomes measurable in the short-term (including overall survival and non-progression/relapse) are particularly valuable. As part of any future OBP schemes negotiated between NHS purchasers of cancer medicines and manufacturers, specific metrics should be included to measure the drug’s effects on patients in the NHS, on the following four types of outcomes as standard: survival; disease progression, relapse or recurrence; long-term side effects; and return to normal activities. Significant advances in understanding the principles on which an OBP approach might be based for new cancer medicines for the NHS in England have been achieved. Future research will establish the necessary steps for implementing a pilot OBP scheme.

Paces of Costly Care: Rare Disease Drug Access in Canada

ABSTRACT Pharmaceutical industry representatives and public drug plan managers hold competing visions of drug access, ones I theorize as “fast” and “slow” care paces. The relationship between free market imaginaries and population-based biopolitics is negotiated through these paces from within the flexible political category of rare disease. In this article, I explore expensive rare disease drug access in Canada’s universal health system through a temporal lens. I show how two families navigate these powerful negotiations, asserting themselves as deserving of resources while finding ways to consider life and death outside of this clash between health system pragmatics and pharmaceutical promise.

The 1st WFH Gene Therapy Round Table: Understanding the landscape and challenges of gene therapy for haemophilia around the world.

In this first in a series of round table meetings, the 1st World Federation of Hemophilia Gene Therapy Round Table was convened to initiate a global dialogue on the expected challenges and opportunities that a disruptive therapy, such as gene therapy, will bring to the haemophilia community. Perspectives from key stakeholder groups, including healthcare professionals, regulators, payors, people with hemophilia and pharmaceutical industry representatives, were sought in the identification of the key issues we expect to face. Didactic presentations and open discussion covered the clinical development of gene therapy in haemophilia; regulatory perspectives of gene therapy; making informed decisions; accessibility, affordability and pricing of gene therapy; and ethical issues of gene therapy clinical trials. These were followed by small group work. This manuscript outlines the key issues identified and the path forward.

Advancing the Development of Patient-reported Outcomes for Adult Myositis at OMERACT 2016: An International Delphi Study.

Objective To define a set of core patient-reported domains and respective instruments for use in idiopathic inflammatory myopathies (IIM). Previously, we reported a systematic literature review on patient-reported outcomes (PRO) in IIM followed by conducting international focus groups to elicit patient perspectives of myositis symptoms and effects. Methods Based on qualitative content analysis of focus groups, an initial list of 26 candidate domains was constructed. We subsequently conducted an international modified Delphi survey to identify the importance of each of the 26 domains. Participants were asked to rate each domain on a scale of 0–10 (0 = not important, 10 = very important). Results In this first round of the Delphi survey, 643 patients participated from the United States (n = 543), Sweden (n = 49), and South Korea (n = 51). Of the 26 domains, 19 (73%) were rated of high importance (≥ 7/10). The top 5 domains were muscle symptoms, fatigue, interactions with healthcare, medication side effects, and pain. During Outcome Measures in Rheumatology (OMERACT) 2016, we discussed the goal for ultimate reduction in the number of domains and the importance of considering representation of healthcare providers from other specialties, caregivers, representatives of pharmaceutical industries, and regulatory authorities in the next rounds of Delphi to represent broader perspectives on IIM. Conclusion Further prioritization and a reduction in the number of domains will be needed for the next Delphi. At the next biennial OMERACT meeting, we aim to present and seek voting on a Myositis Preliminary PRO Core Set to enable ultimate measure selection and development.

O contexto atual da pesquisa clínica nas indústrias e faculdades de Medicina Veterinária do Estado de São Paulo, Brasil

O mercado farmacêutico veterinário do Brasil é considerado um dos maiores do mundo e está em expansão. A pesquisa clínica é uma etapa importante para o desenvolvimento de produtos veterinários, no entanto, informações sobre essas atividades nas indústrias, fazendas experimentais terceirizadas e faculdades de Medicina Veterinária são escassas. Neste contexto, são descritas as atividades de pesquisa clínica nessas instituições do Estado de São Paulo. Para tanto, foram enviados questionários a representantes das indústrias farmacêuticas veterinárias e das faculdades de Medicina Veterinária do Estado. Os resultados mostraram que a maioria das indústrias tem seus escritórios na cidade de São Paulo, que em 2016 a maioria delas patrocinou entre 11 e 20 estudos, muitos deles em parceria com as faculdades. Todas as indústrias participantes já contrataram serviços de Contract Research Organization (CRO), embora relatem insatisfações com os mesmos. Por outro lado, representantes das faculdades de Medicina Veterinária declararam, em sua maioria, que conduziram dez desses estudos no ano de 2016, muitos deles com patrocínio das indústrias. Já estas se ressentem da falta de agilidade e compromisso das faculdades. A aproximação entre as indústrias de produtos veterinários e as faculdades de Medicina Veterinária foi vista pelos representantes tanto das faculdades quanto das indústrias como benéfica.

Advancing the Development of Patient-reported Outcomes for Adult Myositis at OMERACT 2016: An International Delphi Study.

To define a set of core patient-reported domains and respective instruments for use in idiopathic inflammatory myopathies (IIM). Previously, we reported a systematic literature review on patient-reported outcomes (PRO) in IIM followed by conducting international focus groups to elicit patient perspectives of myositis symptoms and effects. Based on qualitative content analysis of focus groups, an initial list of 26 candidate domains was constructed. We subsequently conducted an international modified Delphi survey to identify the importance of each of the 26 domains. Participants were asked to rate each domain on a scale of 0-10 (0 = not important, 10 = very important). In this first round of the Delphi survey, 643 patients participated from the United States (n = 543), Sweden (n = 49), and South Korea (n = 51). Of the 26 domains, 19 (73%) were rated of high importance (≥ 7/10). The top 5 domains were muscle symptoms, fatigue, interactions with healthcare, medication side effects, and pain. During Outcome Measures in Rheumatology (OMERACT) 2016, we discussed the goal for ultimate reduction in the number of domains and the importance of considering representation of healthcare providers from other specialties, caregivers, representatives of pharmaceutical industries, and regulatory authorities in the next rounds of Delphi to represent broader perspectives on IIM. Further prioritization and a reduction in the number of domains will be needed for the next Delphi. At the next biennial OMERACT meeting, we aim to present and seek voting on a Myositis Preliminary PRO Core Set to enable ultimate measure selection and development.

Development of a core outcome set for clinical trials in inflammatory bowel disease: study protocol for a systematic review of the literature and identification of a core outcome set using a Delphi survey

IntroductionCrohn’s disease (CD) and ulcerative colitis (UC), the main forms of inflammatory bowel disease (IBD), are chronic, progressive and disabling disorders of the gastrointestinal tract. Although data from randomised controlled...

Measuring the Impacts of Quality of Work Life Indicators on the Marketing Representatives of Pharmaceutical Industries

In modern Human Resource Management (HRM) practice, the concept of ‘Quality of Work Life’ (QWL) is relatively a new strategy for employee retention. The idea of QWL is developed upon the increasing importance of reducing employee turnover rate in a highly competitive market. Better QWL practice in sales and marketing oriented companies is inevitable to ensure employee productivity and therefore needs to be studied in detail. The core objective of the study was to measure the impact of QWL variables on the lives of Marketing Representatives (MR) of pharmaceutical companies. First, the variables influencing QWL are elaborated with the help of extensive literature review. Then this study tried to identify the current scenario of QWL Practices in ten renowned pharmaceutical companies through a survey of 112 MRs. This was supplemented with in-depth interviews of HR executives of three different companies. The study discovered job stress as a high priority indicator of QWL. The research also revealed organizational atmosphere based on fairness, experience sharing culture, employee suggestion scheme, opportunity to use skill and satisfactory reward system as influential determinants of QWL. This paper recommends the installation of QWL practices in other pharmaceutical companies with few short and long-term suggestions. There is room for conceptualizing and actualizing standard QWL practice in the Bangladeshi pharmaceutical companies. An initiative like this one will encourage discussion and debates in applying much needed QWL practices in other sectors.Bangladesh Pharmaceutical Journal 20(1): 46-53, 2017

НЕОІНСТИТУЦІОНАЛІЗМ ЯК ТЕОРЕТИКО-МЕТОДОЛОГІЧНА ОСНОВА СОЦІОЛОГІЧНОГО ДОСЛІДЖЕННЯ ФАРМАЦІЇ

In the context of the institutional reforms that are ongoing in Ukrainian society, one of the most controversial and at the same time necessary is the reform of the health care institution. The need for a radical revision of the principles of the functioning of this institution is combined with numerous risks, which actualizes the problem of sociological evaluation of measures to reform the health care institution in general and its component. The neoliberal vector of reforms envisages, among other measures for optimizing public administration and public expenditures, a gradual transition to a model of insurance medicine. The threats associated with the introduction of insurance medicine, in particular, in pharmaceutical activities, require sociological monitoring of social situations, needs and concerns of key agents involved in the problem situation: professional pharmacists, drug users, pharmaceutical manufacturers, and pharmaceutical industry representatives. The problem of sociological support of pharmaceutical activity, and its sociological evaluation, in particular, covers a range of issues such as: an assessment of the effectiveness of measures to reform pharmaceutical sector by various groups of involved agents; vision of the risks of transition to the insurance system of medicine and pharmaceutical activities, in particular; degree of satisfaction of drug users. It should be noted that in the process of pharmaceutical activity there are contradictions of ethical, financial and professional motives. Due to competition in the pharmaceutical market, its further commercialization is compounded by the financial and economic, not the medical and social component of pharmaceutical activity, which exacerbates the moral risks associated with this area of activity. The risk of unscrupulous behavior by pharmacists and even drug manufacturers is increasing; the problem of self-treatment, the presence of counterfeit medicines on the market, asymmetric information on medicinal products and their non-optimal consumer choice remains an acute problem. This, in turn, actualizes the sociological perspective on evaluation of pharmaceutical sector functioning. Key words: neo-institutionalism, pharmacy, evaluation

Do Wise Choices Translate Into Cost Savings and Improved Outcomes?

Do Wise Choices Translate Into Cost Savings and Improved Outcomes?

Design and evaluation of a software for the objective and easy-to-read presentation of new drug properties to physicians.

BackgroundWhen new pharmaceutical products appear on the market, physicians need to know whether they are likely to be useful in their practices. Physicians currently obtain most of their information about the market release and properties of new drugs from pharmaceutical industry representatives. However, the official information contained in the summary of product characteristics (SPCs) and evaluation reports from health agencies, provide a more complete view of the potential value of new drugs, although they can be long and difficult to read. The main objective of this work was to design a prototype computer program to facilitate the objective appraisal of the potential value of a new pharmaceutical product by physicians. This prototype is based on the modeling of pharmaceutical innovations described in a previous paper.MethodsThe interface was designed to allow physicians to develop a rapid understanding of the value of a new drug for their practices. We selected five new pharmaceutical products, to illustrate the function of this prototype. We considered only the texts supplied by national or international drug agencies at the time of market release. The perceived usability of the prototype was evaluated qualitatively, except for the System Usability Scale (SUS) score evaluation, by 10 physicians differing in age and medical background.ResultsThe display is based on the various axes of the conceptual model of pharmaceutical innovations. The user can select three levels of detail when consulting this information (highly synthetic, synthetic and detailed). Tables provide a comparison of the properties of the new pharmaceutical product with those of existing drugs, if available for the same indication, in terms of efficacy, safety and ease of use.The interface was highly appreciated by evaluators, who found it easy to understand and suggested no other additions of important, internationally valid information. The mean System Usability Scale score for the 10 physicians was 82, corresponding to a “good” user interface.ConclusionsThis work led us to propose the selection, grouping, and mode of presentation for various types of knowledge on pharmaceutical innovations in a way that was appreciated by evaluators. It provides physicians with readily accessible objective information about new drugs.Electronic supplementary materialThe online version of this article (doi:10.1186/s12911-015-0158-2) contains supplementary material, which is available to authorized users.

Why the Shift? Taking a Closer Look at the Growing Interest in Niche Markets and Personalized Medicine

Pharmaceutical research and development is increasingly focused on niche markets, most notably treatments for rare diseases and “personalized” medicine. Drawing on the results of a qualitative study of 34 key Canadian stakeholders (including drug regulators, funders, scientists, policy experts, pharmaceutical industry representatives, and patient advocates), we explore the major trends that are reportedly contributing to the growing interest of the pharmaceutical industry in niche markets. Informed by both these key informant interviews and a review of the relevant literature, our paper provides a critical analysis of the many different—and sometimes conflicting—views on the reasons for and extent of the shift toward niche markets. We consider some of the potential advantages to industry, as well the important implications and risks that arise from the increasing pursuit of niche markets and pharmacogenomics. While there are many potential benefits associated with targeted therapies and drug development for historically neglected rare diseases, niche market therapies also present evidentiary challenges (e.g., smaller clinical trials and enrichment strategies) that can make approval decisions difficult, and uncertainties remain around the true benefits of many therapies.

Use of Twitter at a major national pharmacy conference.

The results of a study of Twitter use by attendees of the 2013 ASHP Midyear Clinical Meeting (MCM) and other interested parties are presented. All messages posted on the social media platform Twitter under the official MCM "hashtag" (#ashpmidyear) during the five-day conference were archived and evaluated. Demographic data on authors of MCM-related tweets were collected by evaluating information provided by Twitter users in their public profiles. The archived messages were classified by content type. A total of 1539 messages originating from 400 unique U.S.- and foreign-based Twitter accounts were posted under the MCM hashtag, an average of 3.84 tweets per account. The estimated rate of conference-related Twitter use by MCM attendees was 1.7%. One third of Twitter users posting conference-related tweets were identified as pharmacists; 86 (21.5%) and 65 (16.25%) tweets originated from accounts held by pharmacy students and pharmaceutical industry representatives, respectively. The authors of MCM-related tweets represented a broad cross-section of pharmacy practice settings and specialties. About 39% of the evaluated Twitter postings were classified as social, with about 31% of postings pertaining to specific MCM educational sessions and nearly 25% classified as advertising. The majority of MCM-related tweets by onsite and remote Twitter users were social in nature or pertained to educational sessions held over the course of the conference.

AACR-NCI-EORTC - 27th International Symposium - Molecular Targets and Cancer Therapeutics (November 5-9, 2015 - Boston, Massachusetts, USA).

The 27th joint meeting of the European Organization for Research and Treatment of Cancer, National Cancer Institute and the American Association of Cancer Research (EORTC-NCI-AACR) International Conference on Molecular Targets and Cancer Therapeutics was held this year in Boston. Approximately 3,000 international academics, scientists and pharmaceutical industry representatives discussed new discoveries in the field of molecular biology of cancer and presented the latest information on drug discovery, preclinical research, clinical research and target selection in oncology. This report summarizes data on advances in cancer drug discovery.

The High Costs of “Free” Drug Samples

The High Costs of “Free” Drug Samples

The Harmonising Outcome Measures for Eczema (HOME) statement to assess clinical signs of atopic eczema in trials

The lack of core outcome sets for atopic eczema (AE) is a major obstacle for advancing evidence-based treatment. The global Harmonising Outcome Measures for Eczema (HOME) initiative has already defined clinical signs, symptoms, quality of life, and long-term control of flares as core outcome domains for AE trials. This article deals with the standardization of measurement instruments to assess clinical signs of AE. To resolve the current lack of standardization of the assessment of clinical signs of AE, we followed a structured process of systematic reviews and international consensus sessions to identify 1 core outcome measurement instrument for assessment of clinical signs in all future AE trials. Systematic reviews indicated that from 16 different instruments identified to assess clinical signs of AE, only the Eczema Area and Severity Index (EASI) and the objective Scoring Atopic Dermatitis (SCORAD) index were identified as extensively validated. The EASI has adequate validity, responsiveness, internal consistency, and intraobserver reliability. The objective SCORAD index has adequate validity, responsiveness, and interobserver reliability but unclear intraobserver reliability to measure clinical signs of AE. In an international consensus study, patients, physicians, nurses, methodologists, and pharmaceutical industry representatives agreed that the EASI is the preferred core instrument to measure clinical signs in all future AE trials. All stakeholders involved in designing, reporting, and using clinical trials on AE are asked to comply with this consensus to enable better evidence-based decision making, clearer scientific communication, and improved patient care.

Better therapeutic trials in ovarian cancer.

The Ovarian Task Force of the Gynecologic Cancer Steering Committee convened a clinical trials planning meeting on October 28-29, 2011, with the goals to identify key tumor types, associated molecular pathways, and biomarkers for targeted drug intervention; review strategies to improve early-phase screening, therapeutic evaluation, and comparison of new agents; and optimize design of randomized trials in response to an evolving landscape of scientific, regulatory, and funding priorities. The meeting was attended by international clinical and translational investigators, pharmaceutical industry representatives, government regulators, and patient advocates. Panel discussions focused on disease types, early-phase trials, and randomized trials. A manuscript team summarized the discussions and assisted with formulating key recommendations. A more integrated and efficient approach for screening new agents using smaller selective randomized trials in specific disease-type settings was endorsed, together with collaborative funding models between industry and the evolving national clinical trials network, as well as efforts to enhance public awareness and study enrollment through advocacy.

A Situational Analysis of Pharmacovigilance System in Republic of Benin

Background: To date, no investigation has been carried out to systematically assess pharmacovigilance systems including quality control and resistance monitoring of artemisinin based combination therapies (ACTs) and other essential medicines in Benin. Objective: To assess Benin’s pharmacovigilance system, identify the gaps and define elements of strategy which could lead to successful establishment of a functional system in Benin. Methods: Quantitative approach using structure questionnaires was applied to investigate physicians, pharmacists and pharmaceutical industry representatives’ knowledge, attitude and practice regarding Adverse Drug Reactions (ADRs) reporting and the pharmacovigilance system in Benin. Specific questions examining the ADRs related to ACTs were also asked. Questions regarding reasons for non-reporting and important factors in a decision to report were also addressed. The Indicator-based Pharmacovigilance Assessment Tool (IPAT) developed by the USAID-funded Strengthening Pharmaceutical Systems (SPS) program was also used to assess the current landscape with different stakeholders. Collecting data on the IPAT indicators was performed during different interviews of key informants. Reviewing documents from different stakeholders was done as well. Results: All physicians and pharmacists have suspected at least one occurrence of ADR in their practice. 30.77% physicians and 31.11% pharmacists acknowledged that they faced at least one time ADRs suspected to be associated with antimalarial drug treatment (P-value<0.01). However none of the physicians or the pharmacists have ever reported ADRs to the national pharmacovigilance service. Significant difference (Chi2, P<0.05) was found between the proportion of physicians and pharmacists trained in pharmacovigilance (20% versus 1%). The main reasons for not reporting were ‘‘yellow card not available’’ and “not aware about the existence of pharmacovigilance center”. A small percentage (6.97%) of representatives of the pharmaceutical companies in the country monitors the safety of their products and none of them have ever reported ADRs to the health authority (DPM). In return, none of the laboratories have ever received a report related to quality or ADRs related to their drugs on the market from LNCQ or DMP. Use of the IPAT tool led to these respective overall scores for core and supplementary indicators: 10 and 7 demonstrating that there is no functional pharmacovigilance system in place. Using these findings, a SWOT analysis was done. The major shortcoming is the lack of expertise in pharmacovigilance despite the availability of qualified human resource in the country. Several recommendations were also made with respect to critical immediate next steps to be taken to ensure that pharmacovigilance and medicine safety systems are developed and sustained in Benin. Conclusions: This study has helped identify some of the critical challenges and barriers to promoting pharmacovigilance including control of quality and monitoring of ACTs resistance in Benin. There is a need to identify and implement adequate human resources use in order to build capacity and sustain the drug safety system for essential medicines and ACTs in particular. The Ministry of Health should involve all relevant stakeholders including the Faculty of Medicine and researchers to discuss these strategies and develop interventions for the successful implementation of pharmacovigilance in Benin.

Ethical, legal and social implications of rare diseases and orphan drugs in Europe: meeting report of a Brocher symposium

Ethical, legal and social implications of rare diseases and orphan drugs in Europe (Brocher symposium)Geneva, Switzerland 18–19 April 2013As part of the Scientific Program of the Fondation Brocher, a two-day symposium on orphan drugs and rare diseases was held on the shores of Lac Léman in Geneva. Specific focus was on the ethical, legal and social implications of rare diseases and orphan drugs in Europe. The symposium gathered about 30 international stakeholders and experts, representing different scientific disciplines, the pharmaceutical industry and patient representatives.