Mental Health Evaluation in Community Pharmacies-A Cross-Sectional Study.

Portugal has a high prevalence of anxiety and depression, and community pharmacists are well-placed to identify mental health problems and monitor their treatment. This study aimed to screen undiagnosed people for symptoms of anxiety and depression and to monitor these conditions in diagnosed patients. We conducted an observational, cross-sectional study of a sample of community pharmacy users. Anxiety and depression symptoms were assessed using the Generalised Anxiety Disorder-7 (GAD-7) and Patient Health Questionnaire-9 (PHQ-9). Altogether, 591 participants were enrolled between September 2020 and July 2021, 74.9% of whom were female. Of the 477 undiagnosed participants who completed the GAD-7, 87 (18.2%) had moderate or severe anxiety symptoms. Of the 485 participants who completed the PHQ-9, 59 (12.1%) had moderate or severe symptoms of depression. Of the 94 patients diagnosed with anxiety, 37 (39.4%) reported moderate to severe symptoms. Similarly, of the 97 patients with depression, almost half (49.5%) reported moderate to severe symptoms. Anxiety levels were lower among men and among those who reported not taking any medication (p < 0.001). Moderate or severe symptoms of depression were more common among women (p < 0.001), participants with lower education levels (p < 0.005), participants who live alone (p < 0.007), and those taking medication for insomnia (p < 0.001), pain (p < 0.001), anxiety (p < 0.001), and/or depression (p < 0.001). Screening for anxiety and depression revealed that a significant proportion of undiagnosed participants had clinically relevant symptoms of anxiety and depression. However, among participants diagnosed with anxiety and depression, between 40% and 50% were uncontrolled, respectively. These data highlight pharmacists' role in identifying customers at risk of anxiety and depression as well as the need for better monitoring of those already diagnosed.

A Regulatory Perspective on Biosimilar Medicines.

By definition, biosimilar medicinal products are biological medicinal products that are similar to other biological medicinal products that are already on the market-the reference medicinal products. Access to biosimilar medicines is a current reality. However, to achieve this goal, it is extremely important to consistently and scientifically substantiate the regulatory requirements necessary for biosimilar medicines when accessing the market. Based on an analysis of the raw materials and the type of methods used in the manufacturing processes of biological medicines, it is known that this tends to be more complex for the quality of the finished product than the manufacture of molecules obtained through a chemical process. It is then relevant to highlight the main differences between both products: biological medicines manufactured using biotechnology and the current generics containing active pharmaceutical ingredients (APIs) obtained from synthetic processes. Once arriving at the approval process of these medicinal products, it is imperative to analyse the guidance documents and the regulatory framework that create the rules that allow these biosimilar medicinal products to come to the market. The present review aimed at documenting comparatively the specific provisions of European legislation, through the European Medicines Agency (EMA), as well as the legislation of the United States of America, through the Food and Drug Administration (FDA). This was then translated into a critical appraisal of what concerns the specific criteria that determine the favourable evaluation of a biosimilar when an application for marketing authorisation is submitted to different regulatory agencies. The gathered evidence suggests that the key to the success of biosimilar medicines lies in a more rigorous and universal regulation as well as a greater knowledge, acceptance, and awareness of health professionals to enable more patients to be treated with biological strategies at an earlier stage of the disease and with more affordable medicines, ensuring always the safety and efficacy of those medicines.

Smoking Cessation at the Community Pharmacy: Determinants of Success from a Real-Life Practice.

The objectives of this study are to report the contribution of pharmacists to smoking cessation and study the determinants of smoking cessation success in eight pharmacies in Portugal (south) between 2009 and 2019. A real-life study was conducted with a sample of smokers who participated in pharmacist consultations. The sample included 135 smokers (average age of 47.9 ± 1.21 years), 79 (58.5%) of whom were male. In parallel with the motivation and behavioral approach, 116 (85.9%) smokers received pharmacological therapies: 108 (80.0%) were treated with nicotine replacement products and eight (5.9%) with non-nicotine medications. The interventions resulted in 70 (51.9%) smokers complying with the quit day, of whom 59 (43.7%) were smoking-abstinent at the end of the first month. Success rates were reduced to 32.6%, 28.1%, and 20.7% at the end of the 3rd, 6th, and 12th months, respectively. Smoking cessation was more successful for the participants receiving pharmacological therapies (Fisher's exact test, p < 0.001) and those who participated in more pharmacist consultations (χ2 = 59.994, p < 0.001) and more telephone sessions (χ2 = 17.845, p < 0.001). Pharmacists can contribute significantly to the promotion of smoking cessation. Smokers who are more thoroughly followed up by pharmacists showed increased success rates when compared with smokers having fewer sessions with pharmacists.

Biologicals and biosimilars: safety issues in Europe.

INTRODUCTION: Medicinal products of a biological origin are approved by the EMA at a centralized level. However, there is no harmonization about their use in Europe. The current regulation referring to the safety of biological medicinal products and biosimilars in Europe has been identified. The safety associated with medicinal products of a biological origin is assured by the pharmacovigilance system, which has evolved, but doesn't yet incorporate all of the specific information from this market segment, namely that related to the identification of drugs, and its use - including the prescription and dispensing, given the possibility of interchangeability and substitution. The terminology, information systems and traceability systems aren't entirely appropriate to ensure the safety requirements for therapy with medicinal products of a biological origin. Areas covered: This article aims to identify the prescription and dispensing profiles of reference biological medicines and biosimilars in the EU, and the determinants that support their safe use. Expert opinion: The European pharmacovigilance system must evolve to ensure the safety along all of the biologicals' therapeutic cycle. It must consider the safety for each of the medicines in addition to their safety pattern related to the eventual switching procedure.

[Biologicals and Biosimilars: Gaps in the Pharmacovigilance System in Portugal]. / Medicamentos Biológicos e Biossimilares: Descontinuidades no Sistema de Farmacovigilância em Portugal.

INTRODUCTION: Biological and biosimilar medicinal products have specific characteristics that call for a closer monitoring of their safety profile. Since the current legal framework stems from both European and national regulations, some gaps in the operational field may be expected. The goal of this paper is to identify these gaps and propose changes to the current information systems and pharmacovigilance regulations. MATERIAL AND METHODS: A qualitative analysis of current pharmacovigilance regulatory framework and supporting information system was conducted. RESULTS: Current pharmacovigilance system does not seem to vouch for the safe use of biologicals and biosimilar drugs. The gaps found in reviewed materials may be attributable to their lack of specificity for biopharmaceuticals. DISCUSSION: Biologicals therapy presents specific determinants related with the drugs, prescription, and traceability, without replication in any other segment of the pharmaceutical market. They are able to shape their safety profile. CONCLUSION: The existing pharmacovigilance's regulatory framework should be adjusted in order to improve the safety related with biopharmaceutical therapy. Some intervention measures are proposed.

Introdução: A monitorização da segurança associada aos medicamentos biológicos e biossimilares exige um sistema de informação alinhado com o enquadramento regulamentar. Tendo em conta que podem ocorrer descontinuidades entre a regulamentação europeia, nacional e a respetiva tradução operacional, importa pesquisar e identificar essas lacunas. Material e Métodos: Foi desenvolvida uma análise qualitativa dos suportes legais vigentes em julho de 2016 ao nível europeu e nacional, com foco na farmacovigilância. Desta análise decorreu a caracterização operacional do sistema em Portugal. Resultados: Foram identificadas zonas de descontinuidade no âmbito do sistema de farmacovigilância em Portugal, pela ausência de especificidade para os medicamentos biológicos e biossimilares. Discussão: A segurança associada à terapêutica biológica apresenta determinantes específicos relacionados com os medicamentos, prescrição e traçabilidade, que não encontram replicação nos outros segmentos do mercado farmacêutico. Conclusão: Com base nas lacunas identificadas, são apresentadas propostas de intervenção com o objetivo de incrementar a segurança associada à utilização clínica de medicamentos biológicos e biossimilares.

Smoking cessation in a community pharmacy: preliminary results of a pharmaceutical care programme / Cesación tabáquica en farmacia comunitaria: resultados preliminares de un programa de atención farmacéutica

Background: According to the World Health Organisation, tobacco use is one of the most widespread public health threats in the world, making it particularly urgent to promote smoking cessation. The effectiveness of pharmacist interventions in smoking cessation has been documented in the international literature, but not sufficiently in Portugal. Objective: To report the preliminary results of study to assess the effectiveness of a smoking cessation programme delivered in Portuguese community pharmacies using an outsorcing-based regimen. Methods: Within the scope of a pharmaceutical care programme implemented in seven community pharmacies by an outsourced pharmacist, a specific consultation for smoking cessation was developed, in accordance with Portugal's General Directorate of Health's recommendations and instruments. The smokers were identified and invited to join the programme by the pharmacy staff during their daily activities. Patients that accepted signed an informed consent. Through several face-to-face and phone consultations and based on a comprehensive patient approach, personalised plans to quit tobacco were defined with the patients' agreement. The effectiveness of the service was assessed through the evaluation of quit rates at 1, 6 and 12 months. The continuous variables were expressed as mean ± standard error of the mean. Results: During approximately 5 years (between January 2009 and July 2014), 69 smokers joined the programme. Of these, 17 desisted during the first consultation. Of the remaining 52 patients, the mean age was 47.4 ± 2.11 years old and 55.8% were male. A total of 264 pharmaceutical consultations were delivered and, on average, each patient received 7.7 ± 0.81 interventions. Most interventions (60.1%) were pharmacological (e.g. nicotine replacement products), while non-pharmacological measures (e.g. motivational interviewing) represented 39.9%. Five patients were referred to a physician. At 1 month after the quit date, 37 patients were abstinent (53.6%); 6 months later the number reduced to 24 (34.8%) and, 1 year later, 16 patients remained abstinent (23.2%). Conclusions: The implementation of a smoking cessation programme in community pharmacies using an external pharmacist may contribute effectively to tobacco cessation in Portugal.

Antecedentes: Según la Organización Mundial de la Salud, el tabaco es una de las mayores amenazas del mundo, siendo urgente promover el abandono tabáquico. La efectividad de las intervenciones farmacéuticas en cesación tabáquica ha sido documentada en la literatura, pero no en Portugal. Objetivo: Comunicar los resultados preliminares de un estudio para evaluar la efectividad de un programa de cesación tabáquica desarrollado en farmacias comunitarias portuguesas usando un régimen de out-sourcing. Métodos: En el ámbito de un programa de atención farmacéutica implantado en siete farmacias por un farmacéutico externalizado, se desarrolló una consulta de cesación tabáquica siguiendo las recomendaciones e instrumentos de la Dirección General de Salud de Portugal. Se identificó a los fumadores y el personal de la farmacia durante sus actividades rutinarias les invitó a unirse al programa. Los que aceptaban firmaban un consentimiento informado. Mediante consultas presenciales y telefónicas y a través de un abordaje global del paciente, se definieron en acuerdo con el paciente planes personalizados de abandono del tabaquismo. La efectividad del servicio se midió mediante las tasas de cesación a 1, 6 y 12 meses. Las variables continuas se expresaron como media ± error estándar de la media. Resultados: Durante aproximadamente 5 años (entre enero 2009 y julio 2014), 69 fumadores se unieron al programa. De estos, 17 desistieron durante la primera consulta. Entre los restantes 52 pacientes, tenían 47.4 ± 2.11 años y el 55,8% eran hombres. Se realizaron 264 consultas farmacéuticas y, en media cada paciente recibió 7.7 ± 0.81 intervenciones. La mayoría de las intervenciones (60,1%) eran farmacológicas (p.e. productos de substitución de nicotina), y el restante 39,9% fueron medidas no farmacológicas (p.e. entrevista motivacional). Cinco pacientes fueron remitidos al médico. Después de 1 mes de la fecha convenida para el inicio de la cesación, 37 pacientes (53,6%) estaban en abstinencia; 6 meses más tarde el número se reducía a 24 (34,8%) y un año más tarde 16 pacientes (23,2%) permanecían abstinentes. Conclusión: La implantación de un programa de casación tabáquica en farmacias comunitarias, utilizando un farmacéutico externo, puede contribuir efectivamente a la cesación tabáquica en Portugal.