Background Although clinical pharmacy is a crucial part of hospital pharmacist’s day-to-day activity, its performance is not usually subject to a holistic assessment. Objective To define a set of relevant and measurable clinical pharmacy and support activities key performance indicators (cpKPI and saKPI, respectively). Setting Portuguese Hospital Pharmacies. Method After a comprehensive literature review focusing on the metrics already in use in other countries, several meetings with directors of hospital pharmacies were conducted to obtain their perspectives on hospital pharmacy practices and existing metrics. Finally, five rounds with a panel of 8 experts were performed to define the final set of KPIs, where experts were asked to score each indicator’ relevance and measurability, and encouraged to suggest new metrics. Main outcome measure The first Portuguese list of KPIs to assess pharmacists’ clinical and support activities performance and quality in hospital pharmacies. Results A total of 136 KPIs were assessed during this study, of which 57 were included in the original list and 79 were later added by the expert panel. By the end of the study, a total of 85 indicators were included in the final list, of which 40 are considered to be saKPI, 39 cpKPI and 6 neither. Conclusion A set of measurable KPIs was established to allow for benchmarking within and between Portuguese hospital Pharmacies and to elevate professional accountability and transparency. Future perspectives include the use of both cpKPIs and saKPIs on a national scale to identify the most efficient performances and areas of possible improvement.

Objectives Since the outbreak of severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2), the pressure to minimise its impact on public health has led to the implementation of different therapeutic strategies, the efficacy of which for the treatment of coronavirus disease 2019 (COVID-19) was unknown at the time. Remdesivir (REM) was granted its first conditional marketing authorisation in the EU in June 2020. The European Medicines Agency (EMA) and local health authorities all across the EU have since strongly recommended the implementation of pharmacovigilance activities aimed at further evaluating the safety of this new drug. The objective of this study was to evaluate adverse drug reactions (ADRs) attributed to either REM or hydroxychloroquine (HCQ) in patients hospitalised for COVID-19 in Centro Hospitalar de Lisboa Ocidental, a Portuguese hospital centre based in Lisbon. We present the preliminary results reporting plausible adverse effects of either HCQ or REM. Methods An observational cohort study was carried out between 16 March and 15 August 2020. Participants were divided into two cohorts: those prescribed an HCQ regimen, and those prescribed REM. Suspected ADRs were identified using an active monitoring model and reported to the Portuguese Pharmacovigilance System through its online notification tool. The ADR cumulative incidence was compared between the two cohorts. Results The study included 149 patients, of whom 101 were treated with HCQ and the remaining 48 with REM. The baseline characteristics were similar between the two cohorts. A total of 102 ADRs were identified during the study period, with a greater incidence in the HCQ cohort compared with the REM cohort (47.5% vs 12.5%; p<0.001). Causality was assessed in 81 ADRs, all of which were considered possible. Conclusions Real-world data are crucial to further establish the safety profile for REM. HCQ is no longer recommended for the treatment of COVID-19.

PurposeRiluzole is indicated to prolong life or delay the institution of mechanical ventilation in patients with amyotrophic lateral sclerosis (ALS). Clinical studies have shown that this drug prolongs survival, defined as living patients who are not intubated for mechanical ventilation and without tracheotomy. The purpose of this study is to characterize riluzole’s use as well as the user population in order to contribute to a rational and safe use.Patients and methodsDescriptive, observational, retrospective study describing and characterizing the use of riluzole in ALS patients between July 2006 and December 2016 conducted in a Lisbon’s Central Hospital.ResultsOver the course of the study period, 77 patients with different phenotypes of ALS received riluzole. The majority of patients (63%, n=49) were male. The median survival was 10.1 months, but 12 patients (16%) remained on therapy for more than 3 years; 65% of patients were lost to follow-up. The mean adherence rate was 91.2%, and the median adherence rate was 99.3%. One patient discontinued therapy due to gastrointestinal intolerance. Dyspnea and cough were the most common side effects, with roughly one third of patients experiencing each, followed by asthenia and hepatic effects.ConclusionDespite the extended enrollment period, only 77 patients met the criteria for study inclusion. Nonetheless, statistical data regarding our population is in accordance with reported international data. High adherence rates were observed, but 14% of patients discontinued riluzole. In such cases, assessment by a multidisciplinary team is warranted.

IntroductionLow-level viraemia (LLV) is observed in some patients with HIV-1 infection on stable antiretroviral therapy (ART). The significance of these findings remains controversial as it conflicts with traditional optimal clinic outcome. This study aims to evaluate the effect of LLV on the establishment of virological failure (VF) and immune deterioration.MethodsRetrospective observational study of a cohort of HIV-1 infected patients of an Infectious Diseases Clinic, who presented an HIV-1 viral load of 20 to 200 cp/mL, during the year 2012. Patients who were not on ART or non-adherent in the previous 6 months were excluded. Compliance was quantified by clinical and pharmaceutical records. Adherence was defined as ≥95% compliance rate. Demographic, clinical, immunological and therapeutic data were collected from clinical records. LLV was defined as a range of 20–200 cp/mL and stratified as transient (T-LLV): only one measurement, persistent (P-LLV): 2 consecutive measurements with an interval ≥3 months and recurrent (R-LLV): ≥1 T-LLV during an 18-month follow-up. Statistical analysis was performed with Microsoft Office® – Excel 2012. Kolmogorov–Smirnov test, t-test and chi-square test were performed for a significant p value <0.05.ResultsDuring 2012, 2161 HIV-1 infected patients were evaluated at our Clinic, 93% of which were on ART. LLV was documented in 378 (19%), adherence was verified in 151 (52%). The analysis of this cohort (n=151) revealed: 77 (51%) T-LLV, 13 (8.6%) R-LLV and 61 (40%) P-LLV. Mean viral load was 46 cp/mL. Mean TCD4 count was 665 cells/µL with a variation of +63 cells/µL during the study period. There was no VF documented. ART regimens were switched in 16 (11%) patients. Gastrointestinal disturbance was found in 13 (9%). Analysis showed no statistical differences between the analyzed variables (CD4 variation, time of diagnosis and treatment, duration of LLV persistence (less than or more than one year), number of ART regimens, ART regimen and type of NRTI backbone) for all groups (T-LLV, R-LLV, P-LLV), except for mean viral load that showed significant superiority in the T-LLV(38 cp/mL) and R-LLV(36 cp/mL) vs P-LLV(58 cp/mL) (p=0.01 and p<0.01, respectively).ConclusionsThe absence of significant differences in immunological and virological outcomes in this cohort and the absence of VF in all groups, suggests a scarce impact of LLV in patient's prognosis. Prospective studies, with longer follow-up could bring more accurate information.

Despite the increasing optimization of combined antiretroviral therapy (cART) regimens in the last decades, a significant percentage of patients still do not achieve viral replication control. We present a retrospective analysis focusing on human immunodeficiency virus (HIV)-infected population on cART, followed at our ambulatory care clinic between 1st January and 31st December 2011, in order to identify the causes of virological failure. From the 1895 patients in our population we included 1854 in the study. Ten percent (187) of the included patients had detectable HIV RNA (≥40 cp/mL) at the time of last laboratory evaluation: 70,1% were males, mean age was 46 years and 72,7% were Portuguese. Patients with detectable HIV RNA were divided into group A (HIV RNA <200 cp/mL) - 78 (41,7%) patients and group B (HIV RNA ≥200 cp/mL) 109 (58,3%) patients. The comparison of both groups revealed an higher mean count of TCD4+ (568 vs 334 cells/mm3; p<0,001) in group A, although similar mean TCD4+ count at time of cART initiation (276 vs 262 cells/mm3; p=0,412). Group A patients experienced longer exposure to cART (10 vs 8 years; p<0,05) and have undergone, on average, 3 previous regimens (p<0,05). With regard to cARV current regimen: 32,1% patients in group A and 30,3% in group B were prescribed non-nucleoside reverse transcriptase inhibitors based regimes and 51,3% patients in Group A and 59,6% in group B were under cARV based on Protease inhibitors. The identified causes of virologic failure for patients with detectable HIV RNA were: poor adherence (54%); unsuccessful retention in care (14,4%); sporadic detectable HIV RNA (40≤viral load<200), “blips” (14,4%); mutations of resistance to ARVs (13,4%); intolerance to the current regimen (2,1%) and pharmacokinetics drug interactions (1,6%). The estimated rate of virological failure was 10,1% in this population. Insufficient adherence and unsuccessful retention in care were identified in 68,4% of treatment failed patients as main causes of virological failure. Failure of therapy due to intolerance or adverse effects was reported in 2,1% of cases, reflecting a better safety profile and tolerability of recent prescribed regimens. Early identification of causes of virologic failure, timely adjustment of therapeutic regimens, and the adoption of measures to promote adherence and retention in care are key factors for successful treatment of HIV-infected patients.

Introduction: In late 2014, Portugal implemented a national program for the treatment of patients with chronic hepatitis C with directacting antiviral agents. This program has made Portugal one of the first European countries to implement a structured measure of treatment to eliminate this serious public health problem. The aim of this study was to assess the effectiveness of direct-acting antiviral therapy in the treatment of patients with chronic hepatitis C virus infection.Material and Methods: A retrospective observational study was conducted at Centro Hospitalar de Lisboa Ocidental on the national online platform from December 2014 until February 2017 and included patients with hepatitis C virus infection who underwent treatment. The primary endpoint was sustained virologic response at least 12 weeks post treatment. Data was analyzed with the SPSS 17.0 program.Results: During the study period, 820 patients completed therapy and achieved sufficient follow-up time to assess sustained virologic response with an overall response rate of 97.2% (n = 797) and a response rate of 98.0%, 99.5%, 90.9%, 95.1% and 94.2% for genotypes 1a, 1b, 2, 3 and 4, respectively. Data suggested that advanced fibrosis (F3/F4), human immunodeficiency virus co-infection and treatment failure with interferon and ribavirin were not negatively related with sustained virologic response in our population. Most patients (80.1%) completed treatment with ledipasvir/sofosbuvir ± ribavirin. The most common adverse events were fatigue and insomnia followed by headache and weight loss.Discussion: Patients predominantly had genotype 1 infection which correlates with HCV distribution in Europe, but we found a major proportion in genotype 4 which can be explained by immigration from African countries. Our patients’ ages ranging from 22 to 90 years, reflected a new approach with no upper age limit. Direct-acting antivirals regimens resulted in remarkably high SVR rates compared to interferon-based regimens, which were consistent with clinical trials data.Conclusion: Our data showed that direct-acting antiviral-based regimens are safe and have a high success rate in the treatment of patients with hepatitis C virus infection in a real-world setting.

Objectives HIV outcomes centre primarily around clinical markers with limited focus on patient‐reported outcomes. With a global trend towards capturing the outcomes that matter most to patients, there is agreement that standardizing the definition of value in HIV care is key to their incorporation. This study aims to address the lack of routine, standardized data in HIV care. Methods An international working group (WG) of 37 experts and patients, and a steering group (SG) of 18 experts were convened from 14 countries. The project team (PT) identified outcomes by conducting a literature review, screening 1979 articles and reviewing the full texts of 547 of these articles. Semi‐structured interviews and advisory groups were performed with the WG, SG and people living with HIV to add to the list of potentially relevant outcomes. The WG voted via a modified Delphi process – informed by six Zoom calls – to establish a core set of outcomes for use in clinical practice. Results From 156 identified outcomes, consensus was reached to include three patient‐reported outcomes, four clinician‐reported measures and one administratively reported outcome; standardized measures were included. The WG also reached agreement to measure 22 risk‐adjustment variables. This outcome set can be applied to any person living with HIV aged > 18 years. Conclusions Adoption of the HIV360 outcome set will enable healthcare providers to record, compare and integrate standardized metrics across treatment sites to drive quality improvement in HIV care.

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