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Artificial intelligence tools promise transformative impacts in drug development. Regulatory agencies face challenges in integrating AI while ensuring reliability and safety in clinical trial approvals, drug marketing authorizations, and post-market surveillance. Incorporating these technologies into the existing regulatory framework and agency practices poses notable challenges, particularly in evaluating the data and models employed for these purposes. Rapid adaptation of regulations and internal processes is essential for agencies to keep pace with innovation, though achieving this requires collective stakeholder collaboration. This article thus delves into the need for adaptations of regulations throughout the drug development lifecycle, as well as the utilization of AI within internal processes of medicine agencies.

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OBJECTIVES: Access to innovative and effective medication is a citizen's right. The main objectives of this study were to build an indicator to measure access to medicines within hospitals, the Global Medicines Access Index, and to identify the main existing barriers. METHODS: Cross-sectional study carried out in Portuguese National Health Service hospitals. A consensus methodology (expert panel of 7 members) was used to define which dimensions should be included in the index and the weighting that each should take. The panel identified 6 dimensions: access to innovative medicines, proximity distribution, shortages, access to medicines before financing decision, value-based healthcare, and access to medication depending on cost/funding. Data were collected through an electronic questionnaire (September 2021). RESULTS: The response rate was 61.2%. Most hospitals used medicines with and without marketing authorization before the funding decision. Monitoring and generating evidence of new therapies results is still insufficient. The identified barriers were the administrative burden as the major barrier in purchasing medicines, with a relevant impact on shortages of medicines. Most respondents (87%) had a proximity distribution program, mainly implemented in the pandemic context, and the price/funding model was only identified by 10% as a barrier to access. The 2021 Global Medicines Access Index was 66%. Shortages and value-based use of medicines were the dimensions that had more influence in lowering the index value. CONCLUSIONS: The new formula used to obtain a unique and multidimensional index for access to hospital medicines seems to be more sensitive and objective and will be used to monitor access.

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Pharmacovigilance stands out for its importance in obtaining existing knowledge about medicine and patient safety and should be recognized as a continuous line of study. It constitutes a highly relevant component in the activities of health professionals, with spontaneous notification of suspected adverse drug reactions being its main emphasis. The underreporting that persists can be overcome through continuous professional development programs, reinforcing theoretical and practical knowledge in the curricular plans of health courses. As a result, more educated professionals will also allow citizens to recognize the importance of pharmacovigilance. The main objective of this study was to describe and characterize the teaching-learning process of pharmacovigilance in Portugal, analyzing the knowledge, perceptions and attitudes of students and health professionals. In total, ninety-three curricular unit forms of the seventeen healthcare courses included were analyzed, among which only three referred to pharmacovigilance as mandatory and thirty-nine did not address any keywords. The questionnaire applied was answered by 650 participants, both students (62%) and professionals (38%). Approximately 84.4% of the students and 54.7% of the professionals affirmed that they had never spontaneously reported an adverse drug reaction. Only 24.6% of the students and 17.8% of professionals referred to the existence of specific course content dedicated to pharmacovigilance in their coursework. In view of these results, it is evident that there is a need for a wider reflection regarding the further training and constant update of practicing professionals as well as in diverse health institutions, investing in the creation of an academic curriculum that integrates pharmacovigilance in healthcare courses.

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Background: During the COVID-19 pandemic, community pharmacy (CP) professionals were among those who experienced the greatest risk of contracting SARS-CoV-2, which forced major adaptations. Objectives: The objectives of the study were to describe the changes implemented in CP professionals during the pandemic, understand the perception of professionals about their experience, and explore changes to remain. Methods: An observational and cross-sectional study was conducted via an online questionnaire (June-September 2020). The target population was CP professionals working in Portugal for >2 years and serving the public during the pandemic. Results: Of a total of 353 participants, 84% were female (mean age of 37.6 years), and 81% were pharmacists (mean professional experience of 12.9 years). In the management and organizational dimensions, the most mentioned changes were adaptation to legislative changes (90%), fluctuations in the treasury (82%), and reduction of working hours (46%). Only 2% resorted to simplified layoff. In the back office, there was a need to adapt stock management (93%) and purchase personal protective equipment (99%). In the front office, there was a change in service policies - wicket or conditional opening (92%), routes of the arrival of user requests (91%), and home delivery (82%). Physical changes occurred in 100% of pharmacies. The most frequently implemented procedures were the use of protection systems and PPE, articulation with hospital pharmacies for dispensing in proximity (75%), and training in this area (55%). Regarding interpersonal climate, improvements in the connection between team members are evident: increase in mutual help (57%), solidarity (54%), and group cohesion (50%); in the relationship with clients, the majority indicated the replacement of the usual user by third parties (71%), and changes in communication channels (increase in use of technological means 68%). Conclusions: Results illustrate the profound impact of the pandemic on CP professionals, both professionally and personally. It also highlights the importance of their roles in proximity and community support.

Introdução: Durante a pandemia de COVID-19, os profissionais de farmácia comunitária (FC) estiveram entre os que apresentaram maior risco de contrair SARS-CoV-2, o que obrigou a grandes adaptações. Objetivos: Descrever as alterações implementadas nas FC durante a pandemia, compreender a percepção dos profissionais sobre as suas vivências e explorar as mudanças a serem mantidas. Metodologia: estudo observacional e transversal (junho-setembro de 2020). A população alvo foram os profissionais de FC a trabalhar em Portugal há >2 anos e atender o público durante a pandemia. Resultados: 353 participantes, 84% do sexo feminino (idade média - 37,6 anos) e 81% eram farmacêuticos (média de experiência profissional de 12,9 anos). Nas dimensões "gestão e organização", as mudanças mais referidas foram a adaptação a alterações legislativas (90%), flutuações de tesouraria (82%) e redução do horário de trabalho (46%). Apenas 2% recorreram ao lay-off simplificado. No back office: necessidade de adequação do stock (93%) e aquisição de equipamentos de proteção individual (99%). No front office: alteração das políticas de atendimento ­ atendimento ao postigo ou abertura condicional (92%), vias de chegada dos pedidos dos utentes (91%) e entrega ao domicílio (82%). Alterações físicas ocorreram em 100% das farmácias. Os procedimentos implementados com maior frequência foram a utilização de sistemas de proteção e EPI, a articulação com farmácias hospitalares para dispensa de medicamentos de proximidade (75%) e formação nesta área (55%). Em relação ao clima interpessoal, foram evidentes as melhorias na ligação entre os membros da equipa: aumento da inter-ajuda (57%), solidariedade (54%) e coesão do grupo (50%); no relacionamento com os utentes, a maioria referiu a substituição do utente habitual por terceiros (71%) e alterações nos canais de comunicação (aumento da utilização de meios tecnológicos 68%). Conclusões: Os resultados ilustram o profundo impacto da pandemia nos profissionais de FC, tanto a nível profissional como pessoal. Também de destacar a importância do papel da FC como espaço de saúde de proximidade e apoio à comunidade.

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PURPOSE: Spontaneous notification systems are essential in a post-marketing safety context. However, using this method, only about 6% of all adverse drug reactions are notified. To overcome this sub-notification problem, new methods need to be developed to improve and facilitate reporting. In this sense, the use of digital media, mainly medical mobile apps, has been presented as a powerful tool, including in pharmacovigilance. We performed a scope review to identify the available apps used to report adverse drug reactions around the world to eventually identify which of them best fits the Portuguese pharmacovigilance system. METHODS: The Joanna Briggs Institute guidelines were considered, and the framework proposed by Arksey and O'Malley was followed. All the articles that met the inclusion criteria were examined for this review. When the studies lacked in information about the app, Google was used to enhance the search for further information. RESULTS: A final number of five articles were included, revealing seven implemented mobile apps for adverse drug reaction report (Medwatcher, VigiBIP, Yellow Card, Bijwerking, Halmed, Med Safety, and ADR PvPi). These apps are implemented in the United States, France, United Kingdom, The Netherlands, Croatia, and India. Med Safety was originally designed for multi-region use and is implemented in 12 low and middle-income countries. CONCLUSIONS: Apps are easier and faster ways of reporting. The integration of such a tool in an individual care plan would allow to maintain a complete electronic health record at both individual and global level and could be eventually seen as an added value by both health professionals and patients. A country specific version of the WEB-RADR could be a solution for Portugal, in order to introduce an app to notify ADRs at the national level, due previous successful experiences in European countries.

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Daily medication use can be affected by the gradual loss of functional ability. Thus, elderly patients are at risk for nonadherence due to functional decline, namely, decreases in cognitive skills and visual and manual dexterity. The main objective was to assess the ability of older people to self-manage their medication and to identify the main predictors for unintentional nonadherence. A cross-sectional study was conducted (2014-2017) in community centers and pharmacies. Functional assessment was performed with the Portuguese versions of the Drug Regimen Unassisted Grading Scale (DRUGS-PT) and the Self-Medication Assessment Tool (SMAT-PT). A purposive sample including 207 elderly patients was obtained. To identify the main predictors, binary logistic regression was performed. The average DRUGS-PT score was slightly lower than that in other studies. On the SMAT-PT, the greatest challenge for patients was identifying medications by reading labels/prescriptions. The main difficulties identified were medication memorization and correct schedule identification. The scores were higher with the real regimen than with the simulated regimen, underlining the difficulties for patients in receiving new information. Regarding the predictors of an older individual's ability to self-manage medications, two explanatory models were obtained, with very high areas under the curve (> 90%). The main predictors identified were cognitive ability, level of schooling and daily medication consumption.

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OBJECTIVES: To determine the face and content validity of items for measuring safe medication practices in Portuguese hospitals. METHODS: 128 items were drafted from content analysis of existing questionnaires and the literature, employing preferred terms of the WHO International Classification for Patient Safety (Portuguese version). A two-round e-Delphi was convened, using a purposive multidisciplinary panel. Hospital-based experts were asked to rate the relevance of items on a 7-point Likert scale and to comment on their clarity and completeness. RESULTS: The response rate was similar in both rounds (70.3% and 73.4%, respectively). In the first round 91/128 (71.1%) items reached the predefined level of positive consensus. In the second round 23 additional items reached positive consensus, as well as seven items newly derived by the panel. CONCLUSIONS: Most items have face and content validity, indicating relevance and clarity, and can be included in a future questionnaire for measuring safe medication practices in Portuguese hospitals.

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Background The evaluation of the elderly's ability to manage medication through the use of a validated tool can be a significant step in identifying inabilities and needs, with the objective of increasing their self-care skills, and promoting successful aging. Aim of the review To identify studies assessing the elderly's functional ability to manage their own medication. Method For the search strategy, the PICO method was used: P-Population (elderly), I-Instruments (tools for assessing medication management ability), C-Context (community) and O-Outcomes (functional ability to manage medication). The final search query was run in MEDLINE/PubMed, CINAHL Plus, ISI Web of Science and Scopus. The whole process was developed according to the PRISMA statement. Results The search retrieved 8051 records. In each screening stage, the selection criteria were applied to eliminate records where at least one of the exclusion criteria was verified. At the end of this selection, we obtained a total of 18 papers (17 studies). The results allow the conclusion to be drawn that studies use several different instruments, most of them not validated. The authors agree that medication management abilities decrease as cognitive impairment increases, even if a lot of studies assess only the physical dimension. DRUGS was the instrument most often used. Conclusion Older adults' ability to manage their medication should be assessed using tools specifically built and validate for the purpose. DRUGS (which uses the real regimen taken by the elderly) was the most widely used assessment instrument in the screened studies.

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AIMS: To compare the temporal trends in the consumption patterns of glucose lowering drugs (GLD) between Portugal and the Netherlands from 2004 to 2013 and to examine possible reasons behind the cross-national variation found. METHODS: All GLD (ATC pharmacological subgroup A10B) were selected for analysis. Consumption data were obtained for the 10-year period. Portuguese and Dutch drug estimates were obtained from nationwide databases. RESULTS: The consumption of GLD increased in Portugal from 52.9 defined daily dose per 1000 inhabitants per day (DHD) in 2004 to 70.0 DHD in 2013 and in the Netherlands from 44.9 DHD in 2004 to 50.7 DHD in 2013. In Portugal, the use of fixed-dose combinations, especially with dipeptidyl peptidase-4 inhibitors (DPP-4) increased remarkably and in 2013 represented almost a quarter of total GLD consumption. In the Netherlands, the use of combinations was residual. CONCLUSIONS: The consumption of GLD rose over the 10-year period in both countries. However, Portuguese overall consumption and costs of GLD were higher. The differentially rapid uptake of DPP-4 inhibitors in Portugal was the main driver of the cost difference.

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BACKGROUND: Complex medication regimens may adversely affect compliance and treatment outcomes. Complexity can be assessed with the medication regimen complexity index (MRCI), which has proved to be a valid, reliable tool, with potential uses in both practice and research. OBJECTIVE: To use the MRCI to assess medication regimen complexity in institutionalized elderly people. SETTING: Five nursing homes in mainland Portugal. METHODS: A descriptive, cross-sectional study of institutionalized elderly people (n = 415) was performed from March to June 2009, including all inpatients aged 65 and over taking at least one medication per day. MAIN OUTCOME MEASURE: Medication regimen complexity index. RESULTS: The mean age of the sample was 83.9 years (±6.6 years), and 60.2 % were women. The elderly patients were taking a large number of drugs, with 76.6 % taking more than five medications per day. The average medication regimen complexity was 18.2 (±SD = 9.6), and was higher in the females (p < 0.001). The most decisive factors contributing to the complexity were the number of drugs and dosage frequency. In regimens with the same number of medications, schedule was the most relevant factor in the final score (r = 0.922), followed by pharmaceutical forms (r = 0.768) and additional instructions (r = 0.742). CONCLUSION: Medication regimen complexity proved to be high. There is certainly potential for the pharmacist's intervention to reduce it as part as the medication review routine in all the patients.

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OBJETIVO: Estimar a prevalência, tratamento e controlo da hipertensão e identificar factores associados em utentes de farmácias comunitárias. MÉTODOS: Estudo transversal com 1.042 utentes de 40 a 65 anos em 60 farmácias comunitárias de Portugal Continental entre outubro de 2005 e janeiro de 2006. Os dados foram obtidos pela aplicação de questionário e medição de parâmetros biológicos. Foram realizadas três regressões logísticas sequenciais para verificar associação entre as variáveis. RESULTADOS: A idade média foi de 53,7 anos e a razão homem/mulher foi 0,68. A prevalência da hipertensão arterial foi de 54,8 por cento. Cerca de 70 por cento dos hipertensos encontravam-se sob tratamento anti-hipertensivo e, destes, 47,7 por cento estavam controlados. A hipertensão esteve positivamente associada à idade mais elevada, sexo masculino, ser casado, apresentar índice de massa corporal e nível de colesterol total mais alto, ser diabético, ter doença cardiovascular pessoal ou familiar precoce e reportar mais consultas médicas por ano. A hipertensão tratada mostrou-se positivamente associada a ser mulher, não casado, ser diabético, viver numa área urbana e reportar mais de três consultas médicas por ano. Nos hipertensos tratados, estar controlado foi positivamente associado a ter comportamento aderente à terapêutica anti-hipertensiva (auto-reporte), percepcionar o efeito desta medicação e ser de baixo risco cardiovascular. Os modelos preditivos apresentaram áreas sob as respectivas curvas ROC entre 0,72 e 0,78, com capacidade discriminatória aceitável. CONCLUSÕES: A prevalência da hipertensão foi elevada, mas similar à encontrada em outros estudos realizados em Portugal. A proporção de doentes tratados foi satisfatória, em contraste com o nível insuficiente de controlo.

OBJETIVO: Estimar la prevalencia de la hipertensión, tratamiento y control, así como identificar factores asociados en usuarios de farmacias comunitarias.MÉTODOS: Estudio transversal con 1.042 usuarios de 40 a 65 años en 60 farmacias comunitarias de Portugal Continental entre octubre de 2005 y enero de 2006. Los datos fueron obtenidos por la aplicación de cuestionario y medición de parámetros biológicos. Se realizaron tres regresiones logísticas secuenciales para verificar asociación entre las variables.RESULTADOS: La edad promedio fue de 53,7 años y el cociente hombre/mujer fue 0,68. La prevalencia de la hipertensión arterial fue de 54,8%. Cerca de 70% de los hipertensos se encontraban bajo tratamiento anti-hipertensivo y, de estos, 47,7% estaban controlados. La hipertensión estuvo positivamente asociada con la edad más elevada, sexo masculino, ser casado, presentar índice de masa corporal y nivel de colesterol total más alto, ser diabético, tener enfermedad cardiovascular personal o familiar precoz y reportar más consultas médicas por año. La hipertensión tratada se mostró positivamente asociada a ser mujer, no casado, ser diabético, vivir en un área urbana y reportar más de tres consultas médicas por año. En los hipertensos tratados, estar controlado fue positivamente asociado a tener comportamiento adherente a la terapia anti-hipertensiva (auto-reportada), tener percepción del efecto de este medicamento y ser de bajo riesgo cardiovascular. Los modelos predictivos presentaron áreas bajo las respectivas curvas ROC entre 0,72 y 0,78, con capacidad discriminatoria aceptable. CONCLUSIONES: La prevalencia de la hipertensión fue elevada, más similar a la encontrada en otros estudios realizados en Portugal. La proporción de enfermos tratados fue satisfactoria, en contraste con el nivel insuficiente de control.

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OBJECTIVE: To estimate the prevalence, treatment and control of hypertension, and to identify factors associated in community pharmacy users. METHODS: A cross-sectional study was conducted with 1,042 pharmacy users, aged between 40 and 65 years, in 60 community pharmacies of continental Portugal, between October 2005 and January 2006. Data were obtained with the application of a questionnaire and measurement of biological parameters. A total of three sequential logistic regressions were performed to verify an association among variables. RESULTS: Mean age was 53.7 years and the male/female ratio was 0.68. Prevalence of arterial hypertension was 54.8%. Approximately 70% of hypertensive individuals were undergoing antihypertensive treatment and, of these, 47.7% were controlled. Hypertension was positively associated with older age, male sex, being married, higher body mass index and higher total cholesterol level, being a diabetic, having a family or personal history of premature cardiovascular disease, and reporting more medical visits per year. When treated, hypertension was found to be positively associated with the female sex, not being married, being a diabetic, living in an urban area, and reporting more than three medical visits per year. In hypertensive users who were treated, being controlled was positively associated with self-reporting adherent behavior towards antihypertensive treatment, perceiving the effect of these drugs and having a low cardiovascular risk. The predictive models showed areas under the respective ROC curves between 0.72 and 0.78, with an acceptable discriminatory power. CONCLUSIONS: The prevalence of hypertension was high, although similar to that found in other studies conducted in Portugal. The proportion of hypertensive individuals under treatment was satisfactory, in contrast to an insufficient level of control.

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OBJECTIVE: To characterize the use of medicines and to evaluate the inappropriateness of drugs in elderly outpatient population. SETTING: Twelve community pharmacies in different districts of Lisbon-Portugal. METHOD: Observational cross-sectional survey, in a sample of 213 elderly outpatients (age>or=65-years-old) presenting a prescription with two or more drugs, for their own use. MAIN OUTCOME MEASURES: Drug use pattern and prevalence of potentially inappropriate medication. RESULTS: We have studied 213 outpatients, who were taking a total of 1,543 drugs, with an average of 7.23 per patient. The drugs were distributed mainly in the following 3 ATC (Anatomical Therapeutic Chemical Classification) classes: C (cardiovascular system), N (nervous system) and A (alimentary tract). Using the 1997 Beers Explicit criteria, 75 occurrences of inappropriate medicines were detected in 59 patients (27.7%), while with the 2003 Beers Explicit criteria we detected 114 cases of inappropriate medication in 82 patients (38.5%). The occurrence of inappropriate medicines was significantly associated with the consumption of a high number of drugs. According to the ATC Classification, more than one half of the cases of inappropriateness were related with long acting benzodiazepines and with ticlopidine. The 2003 version detected a significantly higher prevalence of inappropriate drug use having potentially adverse outcomes of high severity. CONCLUSIONS: The application of the updated Beers criteria lead to higher rates of potentially inappropriate medication, and especially those responsible for more severe adverse outcomes. The results suggest that there is a need for interventions to improve instructions for safe drug use in the elderly patients and to decrease the number of medications whenever it is possible. This study suggests a high prevalence of potentially inappropriate drug use by the elderly patients of Lisbon region, Portugal.

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