Análise dos Alertas Sobre os Dispositivos Médicos Emitidos pela Agência Portuguesa do Medicamento: Delineando o Propósito de Novas Recomendações Regulatórias

Introduction: Medical devices are healthcare technologies with a significantly growing market worldwide. This study aims to analyze medical device alerts issued by the Portuguese Medicines Agency, INFARMED, I.P. during 2017, as well as to identify the respective regulatory actions and to suggest additional recommendations. Material and Methods: All alerts on medical device alerts publicly available in the website of INFARMED, I.P. were identified and analyzed, including actions taken. Additionally, reports on medical devices from the Portuguese national competent authorities were compared with reports from other European Union member states such as Germany. Results: A total of 32 safety alerts were identified: 18 (56%) related with devices without identified records of commercialization in Portugal, six (19%) related with devices voluntarily withdrawn from the market, such as counterfeit products, and eight (25%) categorized as ‘other’. In both Portugal and Germany, 0.28 and 4.53 reports of national competent authorities per million inhabitants were identified, respectively. Diverse regulatory actions were taken, such as six compulsory indications to not acquire or use devices. Discussion: Considering that the European Union is an open market where citizens should have equal access to medical devices, the Portuguese system of medical device safety alerts seems to be functioning normally. The identified safety alerts seemed relevant, with Portugal registering a proportionally slightly lower number of alerts when compared with higher sales volume markets, which may be explained by an underreporting of this type of problems. Further studies are needed to confirm these preliminary results, although the development of databases comprising data on patients using medical devices is recommended in order to generate automatic email and text message alerts. Conclusion: A limited number of safety alerts on medical devices was identified in Portugal, with few reported cases of counterfeit or falsified devices. The Portuguese Medicines Agency contributes to the citizens’ access to quality medical devices, by issuing safety alerts, recommendations and mandatory market withdrawals for unsuitable or unsafe medical devices.Fundação para a Ciência e a Tecnologia (FCT) project UID/DTP/04567/2016.info:eu-repo/semantics/publishedVersio

Reporting pharmacy staff communication for OTC medicines encounters with simulated patients

Poster presented at the 44th ESCP Symposium on Clinical Pharmacy. Lisbon, 28-30 October 201

Assisting consumers in self-medication: reflections on the role of support staff in community pharmacy

Poster presented at the 43rd ESCP Symposium on Clinical Pharmacy – Patient Safety : Bridging the Gaps. Copenhagen, 22nd-24th October 2014

Feeding back pharmacy staff on their OTC dispensing performance: an exploratory study

Poster presented at the 20th International Social Pharmacy Workshop. Boston, 5-8 August 2014

An exploratory study on teams’ performance, client-reported outcomes and satisfaction

Background: Community pharmacy teams (CPTs) have an established role in assisting self-medication, contributing to the safe and effective use of non-prescription medicines. Objective: The study aimed to describe CPTs’ performance in self-medication consultation, client-reported outcomes, and satisfaction. A secondary purpose was to develop an explanatory model for better understanding clients’ satisfaction with this service. Methods: Descriptive, cross-sectional exploratory study. Data were collected in a purposive sample of pharmacy clients recruited in six community pharmacies in Portugal. CPTs adopted a structured approach to self-medication consultations, encompassing 11 quality criteria (five for case evaluation and six for counselling). An evaluation score, a counselling score and an overall quality score were estimated. Client-reported outcomes and satisfaction were ascertained via a follow-up telephone interview. Besides descriptive statistics, the association with several independent variables on the clients’ overall satisfaction was explored, using linear regression. Results: Product-based dispensing was more frequent for lower educated clients. Reported compliance with the criteria by CPTs was overall high (93.95% of maximum compliance), mostly missing the ‘other medication’ questioning. Most clients (93%) reported improvement after the consultation. Clients’ satisfaction score was 4.70 out of 5. The variables that seem to better explain clients’ overall satisfaction are pharmacy loyalty, the evaluation score, and the female gender. Conclusions: Clients’ reported outcomes were favourable, as well as satisfaction with the service. Clients’ satisfaction appears to be determined by consultation quality (evaluation score), suggesting the advancement of the pharmacists’ clinical role. A larger study is warranted to confirm these findings.publishersversionpublishe

Tackling the quality of non-prescription medicines dispensing in pharmacies by combining a Balanced Score Card with change management: interim findings

Poster presented at the EHMA Annual Conference “New Models of Care. Reinventing Healthcare: Why, What, How” [European Health Management Association]. 14-16 June 2016, Ordem dos Médicos, Porto, PortugalN/

Prescribing-Assessment Tools for Long-Term Care Pharmacy Practice: Reaching Consensus through a Modified RAND/UCLA Appropriateness Method

Supplementary Materials - The following are available online at https://www.mdpi.com/article/10.3390/pharmacy9040194/s1, Table S1: Summary of the identified Prescribing-Assessment Tools.Medicines are the most used health technology in Long-Term Care. The prevalence of potentially inappropriate medicines amongst Long-Term Care patients is high. Pharmacists, assisted by prescribing-assessment tools, can play an important role in optimizing medication use at this level of care. Through a modified RAND/UCLA Appropriateness Method, 13 long-term care and hospital pharmacists assessed as ‘appropriate’, ‘uncertain’, or ‘inappropriate’ a collection of commonly used prescribing-assessment tools as to its suitability in assisting pharmacy practice in institutional long-term care settings. A qualitative analysis of written or transcribed comments of participants was pursued to identify relevant characteristics of prescribing-assessment tools and potential hinders in their use. From 24 different tools, pharmacists classified 9 as ‘appropriate’ for pharmacy practice targeted to long-term care patients, while 3 were classified as ‘inappropriate’. The tools feature most appreciated by study participants was the indication of alternatives to potentially inappropriate medication. Lack of time and/or pharmacists and limited access to clinical information seems to be the most relevant hinders for prescribing-assessment tools used in daily practice.info:eu-repo/semantics/publishedVersio

Non-destructive follow-up of ‘Jintao’ kiwifruit ripening through VIS-NIR spectroscopy – individual vs. average calibration model’s predictions

Visible/near infrared spectroscopy (Vis-NIRS) was used to monitor the yellow-fleshed kiwifruit (Actinidia chinensis Planch 'Jintao') ripening on two selected orchards along 13 weeks, from pre-harvest to the late harvest. Calibration models for several Internal Quality Attibutes (IQA) were built from the spectral data of 375 individual kiwifruit. The analyzed IQA were L*, a* and b* from the CIELAB color space, hue angle, chroma, firmness, dry matter (DM), soluble solids content (SSC), juice pH and titratable acidity (TA). Different pre-processing methods were tested for the construction of PLS calibration models. SSC and Hue were the best performing models with a correlation coefficient of 0.81 and 0.88, and root mean square error of prediction (RMSEP) of 1.27% and 1.95 degrees, respectively. The interpretation of the models in terms of the known absorption bands and the impact of signal to noise ratio (SNR) in them is discussed. The calibration models were used to perform average predictions of the IQA on orchard subareas, for each day of the experiment. These average predictions were compared with the IQA's average reference values on the same subareas and days. The model's metrics improved significantly through the averaging procedure, with RMSEP = 0.26-0.36% and R-2 = 0.99 for SSC; and RMSEP = 0.42 degrees - 0.56 degrees and R-2 = 1 for Hue. Since orchard management is done essentially through averages and not individual values, this result reinforces the applicability of the NIR technology for follow-up of fruit ripening in the tree.info:eu-repo/semantics/publishedVersio

General practitioner residency consultations: video feedback analysis

Objectives: The purpose of this study was to analyse longitudinally two decades of Portuguese general practi-tioner (GP) residents' consultation features, such as consultation length- estimating its major determinants- as well as to compare with GP residents from other Western practices. Methods: This pilot study followed a retrospective and descriptive design, comprising of the analysis of videotaped consultations with real patients from GP residents (southern Portugal), between 1990 and 2008. Main studied variables were consultation length and purpose, participant demographics and residency site characteristics. Results: From 516 residents, 68.0% were females, mainly between 26-35 years old (50.6%). Female patients' proportion equalled doctors', with the most frequent age group being the 46-65 years old (41.3%). The consultation took on average 22 minutes and 22 seconds, with no significant differences by year and residency location. Main consultation purposes were previous scheduling (31.6%) and acute symptoms (30.0%). Duration was consistently longer than practising GPs from other countries, keeping in mind the supervised practice. Significant and positive predictors of consultation length were number of attendants and patients' frequency at the residency site. Conclusions: South Portugal GP residency program consultations were lengthier in comparison to similar practice in Europe and other Western countries. Length correlated preferably with patient related variables than with professionals', while confirming the longitudinal homogeneity in the residency consultation format for the last two decades.The authors would like to thank the residency coordinators, in particular Drs Ricardina Barroso and Francisco Carvalho. This work has been supported by Fundação para a Ciência e Tecnologia, Grant Ref. PTDC/SAU-ESA/098006/2008

Experimental Validation of a Novel Methodology for Fast an Accurate Analysis of Solar Energy Yields Based on Cluster Analysis

The design and optimization of solar power systems requires a detailed knowledge of the dynamic behavior of the meteorology at the site of interest, usually assess by one typical meteorological year (TMY). Even with today’s technology, the computational effort to simulate solar energy system performance with one year of data at high frequency (as 1-min) may become colossal if a multivariable optimization has to be performed. This work evaluates a methodology based on cluster analysis for selecting number of individual days able to represent the long-term performance of a solar energy system. This procedure permits to drastically reduce computational effort related to the calculation of a solar power plant energy yield by simulating a reduced number of days from a TMY, facilitating a fast and optimal design of the plant