Pharmaceutical Medicine最新文献

The incidence of cardiovascular diseases has significantly increased with the expansion of the industrialization of societies, which is notably linked to lifestyle changes and an unhealthy diet. Hence, determining the healthiest diet habits and supplements seems to be an appropriate way to decrease the global burden of cardiovascular diseases. Currently, caffeine, one of the most widely consumed compounds in the world, has emerged with some promising results in the treatment of numerous pathophysiological conditions of cardiovascular diseases. A literature search was conducted in PubMed, Scopus, Science Direct, Google Scholar, and Web of Science databases for the relevant articles regarding the pharmacology, preclinical, and clinical studies on the potential effects of caffeine on cardiovascular diseases. While caffeine could improve cardiovascular outcomes through several mechanisms of action, the literature review revealed controversial clinical effects of caffeine on blood pressure, cardiac arrhythmias, acute coronary syndrome, stable angina, and heart failure. In the case of dyslipidemia, coffee consumption increased total cholesterol, triglyceride, and low-density lipoprotein. Taken together, the existence of multiple confounding factors in the caffeine studies has resulted in inconclusive data interpretation. Further well-designed studies with adequate control of the confounding factors are warranted to draw a clear conclusion on the cardiovascular efficacy and safety of caffeine.

Customer experience (CX) is essential in any business. In the pharmaceutical industry, the Medical Information Contact Center is a customer-facing unit that provides evidence-based, scientifically balanced information to healthcare professionals and patients in response to unsolicited inquiries. The purpose of this paper is to provide analysis and guidance for designing and measuring interactions in the Medical Information Contact Center to facilitate the delivery of a superior and continuously improving CX. Surveys were conducted to establish current trends in CX among a diverse group of CX professionals and members of phactMI, a non-profit collaboration of Medical Information leaders from the pharmaceutical industry. The top three observations from the CX professionals survey centered on establishing a clear CX strategy, use of technology, and frequency of sharing results. Three potential areas for improvement focus on CX strategy, measurements of CX, and sharing of results. An analysis of quality monitoring results of customer interactions in the pharmaceutical industry from Centerfirst, a contact center quality monitoring service provider, was also reviewed. This analysis found a positive correlation between CX and three agent skills: taking the lead, empathy, and strong compliance skills. Based on these results, a CX guide was developed and specifically tailored for the pharmaceutical industry. This tool may be used to help identify, assess, and possibly improve CX.

An ongoing and increasing shift is occurring in ways in which the healthcare community (healthcare providers, patients, biopharma) disseminates and consumes information. Adoption of digital technologies, accelerated by the virtual environment created by the COVID-19 pandemic, are leading to new and innovative ways in which medical and scientific information and data are communicated. Digital technologies have largely enabled these approaches and led to an explosive increase in availability of information. This article describes considerations in how the healthcare community, and Medical Affairs organizations in biopharma, can effectively harness these channels to communicate effectively, and incorporate changes in behaviors and approaches to redefine what medical information and data look like.

In recent years, there has been a swift rise in the development of digital therapies (DTx). As a result of various technological advances and accessibility to patients, it is now possible to develop and offer therapeutic interventions in a digital manner. These take the form of an evidence-based intervention that is administered in digital form to prevent, manage, or treat a medical condition. What makes DTx significantly different from other types of digital applications or services (e.g., wellness applications) is that they are interventions authorised by regulatory agencies for the treatment, like a drug, of a health condition. Yielding actual therapeutic benefits and being at the crossroads of health and digital means that DTx are subject to both the upsides and downsides of both sectors. Thus, it is of particular interest to look at the facilitators and barriers to be foreseen in the development, assessment, and implementation of DTx. In this article, we will present key observations and outline the main challenges that may be faced in the development and integration of DTx into practice. It is certain that DTx can represent an interesting avenue for physicians to bring their prescribing role into the 21st century. We conclude with broad lessons that the emerging field of DTx can learn from decades of drug industry practice to avoid history repeating itself and to fast-track the development and ethical and optimal use of DTx.

Screening for drug-induced hyperprolactinaemia, a condition characterised by higher-than-normal levels of serum prolactin induced by drug treatments, requires a comprehensive understanding of the clinical presentations and long-term complications of the condition. Using two databases, Embase and MEDLINE, we summarised the available evidence on the clinical presentations and long-term complications of drug-induced hyperprolactinaemia. Clinical and observational studies reporting on drug treatments known or suspected to induce hyperprolactinaemia were included. Database searches were limited to the English language; no date or geographic restrictions were applied. Fifty studies were identified for inclusion, comprising a variety of study designs and patient populations. Most data were reported in patients treated with antipsychotics, but symptoms were also described among patients receiving other drugs, such as prokinetic drugs and antidepressants. Notably, the diagnosis of drug-induced hyperprolactinaemia varied across studies since a standard definition of elevated prolactin levels was not consistently applied. Frequent clinical presentations of hyperprolactinaemia were menstrual cycle bleeding, breast or lactation disorders, and sexual dysfunctions, described in 80% (40/50), 74% (37/50), and 42% (21/50) of the included studies, respectively. In the few studies reporting such symptoms, the prevalence of vaginal dryness impacted up to 53% of females, and infertility in both sexes ranged from 15 to 31%. Clinicians should be aware of these symptoms related to drug-induced hyperprolactinaemia when treating patients with drugs that can alter prolactin levels. Future research should explore the long-term complications of drug-induced hyperprolactinaemia and apply accepted thresholds of elevated prolactin levels (i.e., 20 ng/mL for males and 25 ng/mL for females) to diagnose hyperprolactinaemia as a drug-induced adverse event.Trial Registration PROSPERO International Prospective Register Of Systematic Reviews (CRD42021245259).

European pharmaceutical companies have a legal requirement to provide non-promotional medical information (MI) services to support healthcare professionals (HCPs) using their medicinal products. While we are seeing an increased HCP preference and expectation towards digital channels, the lack of a compliance framework relating to the provision of non-promotional MI services is a key factor complicating and compromising the ability for companies to meet this need. Meanwhile, the internet is dominated by a large volume of unregulated, easy access, and potentially low-quality information from diverse sources. The Medical Information Leaders in Europe (MILE) association is therefore proposing a framework of principles to support pharmaceutical companies with the digital provision of MI services; these relate to digital access to non-promotional, medicinal product information to support clinical decision making and patient care. The three established European national MI associations have already considered the framework and expressed their endorsement. MILE continues to invite stakeholders, including pharmaceutical companies, regulators, national industry associations and healthcare professional bodies to engage and help refine and implement this framework. This publication does not constitute legal advice; decision making and accountability remains with each pharmaceutical company.

Problematic gambling has been suggested to be a possible consequence of dopaminergic medications used mainly in neurological conditions, i.e. pramipexole and ropinirole, and possibly by one antipsychotic compound, aripiprazole. Patients with Parkinson's disease, restless legs syndrome and other conditions potentially treated with dopamine agonists, as well as patients treated for psychotic disorders, are vulnerable patient groups with theoretically increased risk of developing gambling disorder (GD), for example due to higher rates of mental ill-health in these groups. The aim of the present paper is to review the epidemiological, clinical, and neurobiological evidence of the association between dopaminergic medications and GD, and to describe risk groups and treatment options. The neurobiology of GD involves the reward and reinforcement system, based mainly on mesocorticolimbic dopamine projections, with the nucleus accumbens being a crucial area for developing addictions to substances and behaviors. The addictive properties of gambling can perhaps be explained by the reward uncertainty that activates dopamine signaling in a pathological manner. Since reward-related learning is mediated by dopamine, it can be altered by dopaminergic medications, possibly leading to increased gambling behavior and a decreased impulse control. A causal relationship between the medications and GD seems likely, but the molecular mechanisms behind this association have not been fully described yet. More research is needed in order to fully outline the clinical picture of GD developing in patient groups with dopaminergic medications, and data are needed on the differentiation of risk in different compounds. In addition, very few interventional studies are available on the management of GD induced by dopaminergic medications. While GD overall can be treated, there is need for treatment studies testing the effectiveness of tapering of the medication or other gambling-specific treatment modalities in these patient groups.

Background: The concept of health care innovation varies across organizations and countries. Harmonizing the definitions of innovation can augment the discovery of new therapies, minimize costs, and streamline drug development and approval processes. A systematic literature review (SLR) was conducted to gather insights surrounding different elements of innovation in the USA, the UK, France, Germany, and Japan. The SLR identified studies that have defined innovation and captured the types of incentives provided to promote innovation.

Methods: The MEDLINE, Embase, and EconLit databases were searched via the OVID SP platform on October 22, 2020. A secondary desk search literature review was performed to identify additional information of interest in regional languages: French, German, and Japanese. All the relevant literature in English was screened using the Linguamatics natural language processing (NLP) tool, except for articles from EconLit, which were screened manually using structured search strategies. Articles that describe a definition of innovation or refer to a definition of innovation published were included. All full-text articles were reviewed manually, and two reviewers independently screened the full texts for eligibility.

Results: After screening, 90 articles were considered to meet the SLR objectives. The most common dimension of innovation identified was therapeutic benefit as a measure of innovation, followed by newness and novelty aspects of innovations. Incentives around exclusivities were found to be the most prevalent in the data set, followed by rewards and premiums. Among the different therapy areas, the largest number of innovations was targeted at oncology.

Conclusions: This SLR highlights the lack of a unified definition of innovation among regulatory authorities and health technology assessment bodies in five countries, and variation in the types of incentives associated with innovation. The targeted countries cover different dimensions of definition and incentives of innovation at varying levels, with a few focused on specific therapy areas. Harmonization and consensus for innovation would be needed across countries because drug development is a global undertaking. This SLR envisages a more holistic approach to evaluation, wherein the value provided to patients and health systems is accounted for. The results of this SLR will help to promote broader discussion among different stakeholders and decision makers across countries to identify gaps in policies and develop sustainable strategies to promote innovation for pharmaceutical products.