Medical devices play a crucial role in human health. These are instruments, machines or even software programs used to diagnose, treat, monitor or prevent health conditions. They are designed to help improve patients’ quality of life and range from simple items, such as thermometers, to more advanced technologies, such as pacemakers. In order to guarantee the safety and efficacy of medical devices intended for use on patients, the establishment of appropriate regulatory frameworks is crucial to ascertain whether devices function as intended, comply with safety standards and offer benefits that outweigh the associated risks. Depending on the country, different regulatory agencies are responsible for the evaluation of these products. The regulatory landscape for medical devices varies significantly across major markets, including the European Union, the United States of America and Japan, reflecting diverse approaches aimed at ensuring the safety and efficacy of medical technologies. However, these regulatory differences can contribute to a “medical device lag,” where disparities in approval processes and market entry timelines driven by strict regulatory requirements, increasing device complexity and the lack of global harmonization, result in delays in accessing innovative technologies. These delays impact patient access to cutting-edge medical devices and competitiveness in the market. This review aims to address the regulatory framework of medical devices and the approval requirements by the European Commission (EC), the Food and Drug Administration (FDA) and Pharmaceuticals and Medical Device Agency (PMDA).

Food fortification with micronutrients was initially justified in developed countries by a lack of availability of micronutrients in staple crops, mainly due to soil exhaustion. However, in Sub-Saharan arable lands, soil fatigue is not predominant, and communities consume mostly home-grown, organic, non-processed crops. Sub-Saharan food systems are nevertheless deeply entwined with food insecurity, driver of illnesses. Family production can promote subsistence, food stability, and self-sufficiency, the main SSA setback being the vicious cycle of poverty and the lack of dietary variety, contributing to malnutrition. Poverty reduction and women’s education are significant strategies for reducing child and adolescent undernourishment. Fortification of foods consumed daily by individuals makes sense and can minimize, if not entirely, eliminate deficiencies. Compulsory mass fortification of foods in Sub-Saharan Africa (SSA) with single micronutrients is, however, controversial since they work in synergy among each other and with the food matrix, for optimal absorption and metabolism. Since the causes of malnutrition are many, caused by diverse, unequal, and unjust food distribution, interrelated with political, social, cultural, or economic factors, education status of the population, season and climatic changes, and effectiveness of nutrition programs, just food fortification cannot solve the composite of all these elements. Further, compulsory fortification is excessive, unproductive, and likely harmful to human health, while many challenges remain in assessing the quality of available premixes. Furthermore, aiming at dietary diversification is the best approach of increasing trace element intake from commonly accessible and easily available food sources.

Chronic diseases are a leading cause of death worldwide and have a significant negative impact on public health, overall well-being, national economies, and the long-term sustainability of already burdened health systems. In addressing some of the current health challenges, the contribution of pharmacists and community pharmacies is of particular significance. Pharmacists play a vital role in the medication use process, enhancing the efficacy of pharmacological interventions and facilitating the delivery of health services. Community pharmacies occupy a key position within the healthcare system, acting as a primary point of contact with the public and frequently representing the most accessible healthcare facility for patients. In recent times, community pharmacies have undergone a process of adaptation, shifting from a narrow focus on the dispensing of medications towards a more comprehensive approach that is patient-centered and incorporates a range of healthcare services, while also prioritizing the quality of the services provided. This work aims to explore the role of pharmacists in the provision of pharmaceutical services in three countries with distinct healthcare systems, examining how these services operate, the requirements for their delivery, the associated remuneration structures, and the extent of out-of-pocket costs for patients—ultimately analyzing their impact on health outcomes.

Healthy ageing has become one of the most significant challenges in a society with an increasing life expectancy. Older adults have a greater prevalence of chronic disease, with the need for multiple medications to appropriately control these issues. In addition to their health concerns, ageing individuals are prone to loneliness, dependence, and economic issues, which may affect their quality of life. Governments and health professionals worldwide have developed various strategies to promote active and healthy ageing to improve the quality of life of older adults. Pharmacists are highly qualified health professionals, easily accessible to the population, thus playing a pivotal role in medication management. Their proximity to the patient puts them in a unique position to provide education and training to improve therapeutic adherence and identify medication-related problems. This paper aims to address the importance of Portuguese community pharmacists in the medication management of older adults, emphasising their intervention in health promotion, patient education, medication-related problems, deprescription, dose administration aids, and medication review and reconciliation. We also discuss home delivery services and medication management in long-term care facilities.

Biosimilars are a new category of medicines that have revolutionized the treatment of patients with life-threatening conditions, such as cancer and autoimmune diseases. A biosimilar is a biological product that is very similar to an already approved biological medicine that is used as its reference. These medicines go through less clinical studies than their reference product and therefore the cost of their development process is significantly lower, giving patients access to them more quickly and at a more affordable price. However, due to the structural complexity and inherent degree of variability of these products, it is very difficult to develop biosimilar medicines that are exactly the same as the reference product. Thus, it is extremely important to define strict controls to guarantee that these minor differences are not clinically significant in terms of safety and efficacy. Like any other medicine, biosimilars have to go through a complex approval process, which involves a thorough assessment by regulatory authorities to ensure these products meet the necessary standards of quality, safety, and efficacy before being placed on the market. Due to their nature and complexity, the approval process of biosimilar medicines contains some unique and specific considerations. This review aims to address the regulatory framework of biosimilar medicines, their development process and the approval requirements by the European Medicines Agency (EMA) and the Food and Drug Administration (FDA).

Background: Falls are a major public health issue, given their prevalence and social impact. Older adults living in long-term care facilities (LTCF) are at greater risk of injury resulting from a fall due to multiple factors, such as nutritional, functional/cognitive impairment, postural instability, polypharmacy, and the presence of potentially inappropriate medications (PIMs). Medication management in LTCF is complex and often sub-optimal and might be crucial for falls. Pharmacist intervention is important, since they have a unique knowledge of medication. However, studies mapping the impact of pharmaceutical activities in Portuguese LTC settings are scarce. Objective: This study aims to assess the characteristics of older adult fallers living in LTFCs and examine the relationship between falling and several factors in this population. We also intend to explore the prevalence of PIMs and their relationship with the occurrence of falls. Methods: The study was conducted in two long-term care facilities for elderly people, in the central region of Portugal. We included patients aged 65 and older with no reduced mobility or physical weakness and with the ability to understand spoken and written Portuguese. The following information was assessed: sociodemographic characteristics, comorbidities, polypharmacy, fear of falling, functional, nutritional and cognitive status. PIMs were evaluated according to the Beers criteria (2019). Results: A total of 69 institutionalised older adults, 45 women and 24 men, with a mean age of 83.14 ± 8.87 years were included. The prevalence of falls was 21.74% Out of these, 46.67% (n=7) fell once, 13.33% (n=2) fell twice, and 40% (n=6) fell 3 or more times. Fallers were mainly women, had lower levels of education, were well nourished, had moderate to severe levels of dependence, and displayed moderate cognitive impairment. All adult fallers had a fear of falling. The main comorbidities of this population were related to the cardiovascular system. Polypharmacy was present in every patient, and at least one PIM was identified in 88.41% of the subjects. Fear of falling (FOF) and cognitive impairment (in subjects with 1 to 11 years of education) showed statistically significant associations with the occurrence of falls (p=0.005 and p=0.05, respectively). No significant differences were found between fallers and non-fallers for any other factors. Conclusions: This present study is a preliminary contribution to characterise a group of older adult fallers living in Portuguese LTCFs and demonstrated that fear of falling and cognitive impairment are associated with the occurrence of falls in this population. The high prevalence of polypharmacy and PIMs emphasises the need for tailored interventions featuring the collaboration of a pharmacist to optimise medication management in this population.