Papers by Albert Figueras
Background: Despite the effectiveness of maternal vaccines, low- and middle-income countries grap... more Background: Despite the effectiveness of maternal vaccines, low- and middle-income countries grapple with inadequate safety monitoring systems. Robust safety surveillance is crucial to increasing vaccine confidence and timely identifying any potential safety signal that could put pregnant women and children at risk following vaccination. This study assessed the pharmacovigilance (PV) systems for vaccines used in pregnancy in Uganda. Methods: A qualitative study involves 13 key informant interviews and 8 focus group discussions among key stakeholders. Purposive sampling was used to select study participants. Data analysis was done using Miles and Huberman's matrices approach and conducted in Atlas.ti software. Findings: A passive system involving multistakeholders at various levels of the healthcare structure existed but was inadequate for monitoring adverse events following maternal immunization. The existence of parallel reporting systems for vaccines was noted. Heavy workload, lack of feedback, inadequate knowledge to recognize and report adverse events following maternal immunizations and logistical challenges impeding reporting and follow-up were among the barriers to reporting. Electronic medical records, though underutilized for safety surveillance, offer promising potential. Conclusions: To address the specific needs of maternal vaccination, the PV system in Uganda needs improvement. A multipronged approach, including policy coherence, embracing active surveillance and leveraging existing birth outcome surveillance and electronic medical records, is essential. Harnessing healthcare provider knowledge and advisory committee capacity in causality assessment is also necessary. The study findings can inform priority interventions to enhance PV for existing and new maternal vaccines.
Brazilian Journal of Pharmaceutical Sciences
Hepatic injury has been documented in patients with coronavirus disease 2019 . However, pharmacot... more Hepatic injury has been documented in patients with coronavirus disease 2019 . However, pharmacotherapy can frequently impact liver alterations, given the known hepatotoxic potential of drugs not effective to treat COVID-19. The objective of the present study was to evaluate reports of suspected liver reactions to drugs used for treating COVID-19, compare their use for other indications among patients with COVID-19, and assess possible interactions between them. We obtained reports on drugs used to treat COVID-19 (tocilizumab, remdesivir, hydroxychloroquine, and/or lopinavir/ritonavir), registered on June 30, 2020, from the Food and Drug Administration Adverse Event Reporting System (FAERS) Public Dashboard. We then analyzed the risk of developing liver events with these drugs by calculating the reported odds ratios (ROR). We identified 662, 744, and 1381 reports related to tocilizumab, lopinavir/ ritonavir, and hydroxychloroquine use, respectively. The RORs (95% confidence intervals) were 6.32 (5.28-7.56), 6.12 (5.22-7.17), and 9.07 (8.00-10.29), respectively, demonstrating an increased risk of liver events among patients with COVID-19 when compared with uninfected patients. The elevated risk of reporting adverse liver events in patients with COVID-19 who receive these drugs, alone or in combination, highlights the need for careful drug selection and efforts to reduce drug combinations without notable benefits. Similar to any other condition, the use of drugs without established efficacy should be avoided.
International Journal of Cardiology, 2015
Link to publication on Research at Birmingham portal Publisher Rights Statement: After an embargo... more Link to publication on Research at Birmingham portal Publisher Rights Statement: After an embargo period, this document is subject to the terms of a Creative Commons Non-Commercial No Derivatives license.
BMC Medical Informatics and Decision Making
Background In 2008, in the context of a complete computerisation of medical records, the Institut... more Background In 2008, in the context of a complete computerisation of medical records, the Institut Català de la Salut (ICS, Catalan Health Institute) implemented a system in its electronic clinical workstation (ECW) to assist decision-making at the prescription level. This system is known as Self Audit, and it supports physicians in reviewing the medication of their patients. Self Audit provides lists of patients presenting medication-related problems (MRPs) that have potential for improvement, and provides therapeutic recommendations that are easy to apply from the system itself. The aim of this study was to analyse the main results derived from the use of Self Audit in primary care (PC) in Catalonia, and the effect of an incentive-based safety indicator on the results obtained. Methods A descriptive cross-sectional study was carried out to analyse variations in the MRPs detected by Self Audit during 2016, 2017, and 2018 in PC in Catalonia. The effect of a safety indicator on the re...
BMC Medical Informatics and Decision Making
Background In 2008, the Institut Català de la Salut (ICS, Catalan Health Institute) implemented a... more Background In 2008, the Institut Català de la Salut (ICS, Catalan Health Institute) implemented a prescription decision support system in its electronic clinical workstation (ECW), which automatically generates online alerts for general practitioners when a possible medication-related problem (MRP) is detected. This tool is known as PREFASEG, and at the time of beginning a new treatment, it automatically assesses the suitability of the treatment for the individual patient. This analysis is based on ongoing treatments, demographic characteristics, existing pathologies, and patient biochemical variables. As a result of the assessment, therapeutic recommendations are provided. The objective of this study is to present the PREFASEG tool, analyse the main alerts that it generates, and determine the degree of alert acceptance. Methods A cross-sectional descriptive study was carried out to analyse the generation of MRP-related alerts detected by PREFASEG during 2016, 2017, and 2018 in prim...
European Journal of Clinical Pharmacology
Background Antimicrobial resistance (AMR) is no longer an expected upcoming threat; it has become... more Background Antimicrobial resistance (AMR) is no longer an expected upcoming threat; it has become a real public health concern, challenging all existing control tools, requiring multidisciplinary innovative solutions. Antimicrobial stewardship (AMS) programs require a set of tools and skills which can be put to service by health systems. However, there is an immense capacity gap between health systems in developed countries compared to developing ones. Systems in developed countries can rely on well-established laboratory services that can carry out microbial cultures and drug susceptibility tests. For many low-and middle-income countries (LMICs) with limited laboratory resources, it will take time and long-term investments to have systems that can timely and reliably perform laboratory-based AMR monitoring. In the meantime, we must explore the possibility of using other indirect measures that can provide estimates of the growing burden of AMR in settings with weak laboratory capacity. Objectives In this point of view, we describe the potential contribution of the global pharmacovigilance (PV) networkers in the process of mapping and estimating the AMR burden in settings with less laboratory coverage and capacity, within the framework of AMS. Conclusion The heavy toll caused by AMR will not be brought down by a singular interventional approach, it will require a multidisciplinary and multifaceted set of strategies. Closing the laboratory capacity gap will require tremendous long-term investments, but the AMR data scarcity is a question that cannot wait any longer. The global pharmacovigilance network is a robust scientific community with experience in tracking suspected adverse events caused by new and old medicinal products. As AMR becomes a global health issue, AMS programs need all available tools to address resistance data scarcity and inform appropriate of antimicrobials. The solid global pharmacovigilance infrastructure could play an important role in countries with limited laboratory coverage and capacity.
Pharmacoepidemiology and Drug Safety, 2021
BackgroundThe WHO Programme for International Drug Monitoring (PIDM) is a large Pharmacovigilance... more BackgroundThe WHO Programme for International Drug Monitoring (PIDM) is a large Pharmacovigilance network of countries sharing Adverse Drug Reaction (ADR) reports. Pharmacovigilance Experts have suggested that antimicrobial resistance (AMR) is an overlooked adverse event. We undertook this study to investigate the potential role of Pharmacovigilance databases in the surveillance of AMR.MethodsUsing the AWaRe (Access, Watch and Reserve) list and the WHO Priority Pathogens List, we established a list of antimicrobials and carried out a VigiBase search via VigiAccess, looking for ADR reports with Preferred Terms (PTs) that contained AMR‐relevant information. Identified Terms were matched with codes from the Medical Dictionary for Regulatory Activities (MedDRA Version 21.1).ResultsRecords on 86 drugs were retrieved with a total of 1 170 751 ADR reports submitted between 1968 and 2018. Seventeen PTs suggesting suspected resistance, ineffectiveness, inappropriate use, or medication error ...
European Journal of Clinical Pharmacology, 2020
Purpose There are few studies on the personal view retrieved by patients in the spontaneous repor... more Purpose There are few studies on the personal view retrieved by patients in the spontaneous reports’ free-text section of suspected adverse drug reactions. Methods We analysed the suspected adverse drug reactions (ADRs) spontaneous reports sent to the Catalan Centre of Pharmacovigilance between 2013 and 2017. The information provided in the free-text section was classified as (1) temporal sequence, (2) description of symptoms, (3) description of psychological impact, (4) withdrawal effects, (5) alternative causes, and (6) rechallenge. The concordance level between the perceived severity by the reporter and the pharmacovigilance team was assessed by the Kappa index ( ƙ ). Usual descriptive statistics were used to describe variables. Results Nationally, 190 spontaneous reports described 383 ADRs, which 28.6% were unknown or poorly known in the literature, and 52.1% were serious. The most frequent ADRs were gastrointestinal (19.3%) and neurological (19.1%), and among the most common 213 suspected medicines, there were those used for nervous system conditions (18.8%). The agreement on the perception of ADRs’ severity between citizens and centre’s technicians was ‘good’ ( K = 0.62 (0.51–0.72)). An analysis of the free-text section of reports showed that one-quarter of the reports provided useful additional data, like the psychobiosocial impact, which could explain the discrepancy between patients and health professionals in the classification of the severity of some ADRs. Conclusions Patients’ report free-text section provides relevant information, mainly about symptoms description, psychobiosocial impact and feelings. Therefore, it is a section to be enhanced and analysed. These findings should encourage the strengthening of citizens reporting.
ObjectivesUncertainties in the pharmaceutical management of COVID-19 have led to reports of incre... more ObjectivesUncertainties in the pharmaceutical management of COVID-19 have led to reports of increased indiscriminate uses of antibiotics. The aim of this study was to investigate this at a national level in Pakistan.MethodsWe used IQVIA pharmaceutical sales volume data to analyze antibiotic consumption for January-April 2020 in Pakistan. The consumption of 77 antibiotics for systemic use in 2020 was calculated, and compared against the same period in 2019 to track changes in total consumption and consumption pattern by six assigned therapeutic groups: tetracyclines, quinolones, beta-lactam penicillins, other-beta-lactams, macrolides and “others” – comprising the remaining groups.ResultsThe total consumption for January-April 2020 was 17.76 Defined Daily Doses per 1000 population per day (a 18.8% decrease from 2019). Quinolones, beta-lactam penicillins, other-beta-lactams, and macrolides constituted 80% of total consumption. There were increases between February-April 2020 of macroli...
Pharmacy Practice, 2020
Objective: The aim of this study was to develop and validate a stepwise tool to aid primary healt... more Objective: The aim of this study was to develop and validate a stepwise tool to aid primary health care professionals in the process of deprescribing potentially inappropriate medication in older persons. Methods: We carried out a systematic review to identify previously published tools. A composite proposal of algorithm was made by following the steps from clinical experience to deprescribe medications. A 2-round electronic Delphi method was conducted to establish consensus. Eighteen experts from different countries (Colombia, Spain and Argentina) accepted to be part of the panel representing geriatricians, internists, endocrinologist, general practitioners, pharmacologists, clinical pharmacists, family physicians and nurses. Panel members were asked to mark a Likert Scale from 1 to 9 points (1= strongly disagree, 9= strongly agree). The content validity ratio, item-level content validity, and Fleiss’ Kappa statistics was measured to establish reliability. The same voting method w...
Brazilian Journal of Pharmaceutical Sciences, 2020
To evaluate the clinical outcomes of daptomycin therapy and adherence to treatment recommendation... more To evaluate the clinical outcomes of daptomycin therapy and adherence to treatment recommendations, a retrospective cohort study was conducted with patients that received daptomycin during the period of the study. The adherence and nonadherence to clinical guidelines were assessed through organism identification, dose and time of treatment, management of bacteremia, and vancomycin treatment failure. A multiple logistic regression model analyzed the association between independent variables and clinical success (dependent variable), considering 5% of statistical significance. The study presented 52 patients who received daptomycin for the treatment of bacteremia (21.1%) or infections (osteomyelitis [63.5%], synovial fluid [15.4%]). Most patients (86.5%) received daptomycin as the second line of treatment, and 51.9% achieved clinical success. The patients had a better chance of clinical success when they followed the guideline indications (OR = 16.86; 95% CI = 1.45-195.88) and the medication was prescribed by a specialist in infectious diseases (OR = 4.84; 95% CI = 1.11-21.09). The study demonstrated lower clinical success than that described in the literature because of patients who were not eligible according to the clinical guidelines. Adherence to recommendations and appropriate prescription of reserve antibiotics is important in limiting early resistance, and avoiding clinical failure and unnecessary expenditure.
Psychiatry Research, 2018
The widespread use of dopaminergic agents for the treatment of Parkinson's disease has revealed t... more The widespread use of dopaminergic agents for the treatment of Parkinson's disease has revealed the presence of gambling disorder (GD) as an uncommon, but serious, adverse reaction to these agents. We describe the main characteristics of drug-induced GD reports received by the Spanish Pharmacovigilance System during the period from 1983 to 2016. Fifteen reports of GD have been identified. Dopaminergic agonists, especially pramipexole, are the main drugs involved in inducing GD. Physicians prescribing these drugs should warn patients and families about this disorder. Knowledge of this disorder will encourage early diagnosis, treatment, and reporting of this clinically and socially relevant disorder.
Antibiotics, 2019
Understanding antimicrobials (AM) on offer in a pharmaceutical market, with a particular referenc... more Understanding antimicrobials (AM) on offer in a pharmaceutical market, with a particular reference to drugs categorized as “Watch” active ingredients, is one of the important first steps to prevent their potentially inappropriate use. The March 2019 data of all AM containing registered brands and presentations currently being sold in the country for the J01 Anatomical Therapeutic Chemical (ATC) subgroup from IQVIA Pakistan was used. Each AM was categorized as “Access,” “Watch,” or “Reserve,” according to the WHO AWaRe classification. There were 59 single chemical entities and 14 combinations with 1869 brands and 4648 presentations. The WHO Essential Medicines List included 35 J01 AM while an additional 38 single and combination AM with 425 brands and 977 presentations were present in the country. Looking at the whole list of marketed AM, 8 of the 10 AM with more than 60 brands were classified as “Watch”, offering 962 brands and 2418 presentations. Most AM marketed in Pakistan, of wh...
European journal of clinical pharmacology, 2018
Historically, somatropin has been used for conditions related with ageing, but since the marketin... more Historically, somatropin has been used for conditions related with ageing, but since the marketing of recombinant human growth hormone (rhGH), increasing promotional pressure has prompted aesthetic uses, despite lack of evidences about its efficacy and safety for those purposes. A routine analysis of the Pharmacovigilance Center of São Paulo (Brazil) showed reports of suspected adverse reactions in young adults and mature patients receiving rhGH. After presuming an off-label use of this expensive product, a drug utilisation study within the pharmacovigilance database has been carried out. The analysis showed a bimodal age distribution of the rhGH reports. Up to 17.1% of the 1289 reports (n = 220) involved patients aged ≥ 20 years taking rhGH for off-label uses. This information was the basis to design interventions in order to reduce inappropriate utilisation of this expensive product. Analyses of how medicines are being used through pharmacovigilance databases are a way to identify...
Expert Opinion on Drug Safety, 2017
The completeness and accuracy of the reports of suspected adverse drug reactions is important in ... more The completeness and accuracy of the reports of suspected adverse drug reactions is important in pharmacovigilance. The aim of the present study was to analyze the quality of the information included in the reports sent to the Pharmacovigilance Centre of São Paulo (Brazil). A sample of 999 reports received from January 2013 to December 2014 was selected. The quality of the filled information was evaluated according to a 'sufficiency' criterion to apply the Karch-Lasagna causality algorithm. There were 820 reports from manufacturers and 179 from health centres. Only 4.4% (44) were fully filled, thus allowing the adequate analysis of the causal relationship between the suspected medication and the adverse event. In 30% of the reports from manufacturers, the information about the critical variables was lacking or incomplete, preventing the adequate evaluation of the report. It was also noted that the reports' poor filling quality was not related with less severity or with old and well-known medicines. The poor quality of the information included in the reports received by this centre, especially those sent by pharmaceutical manufacturers, hampers the identification of potential safety signals. Measures to improve the quality of the reports must be urgently adopted.
European journal of clinical pharmacology, 2017
The aim of this study is to analyze the quality of the information contained in the adverse drug ... more The aim of this study is to analyze the quality of the information contained in the adverse drug reactions (ADR) reports and to describe the magnitude and characteristics of the lacking information. All reports of serious ADR received by the Catalan Center of Pharmacovigilance in 2014 were analyzed using the VigiGrade and a more clinical and qualitative approach. Up to 824 reports describing serious ADR were included in the study; of them, 503 (61.0%) were sent by health care professionals (HPs) and the remaining 321 (39.0%) came from pharmaceutical companies (PhC). More than 80% of missing variables such as 'onset date' or 'time-to-onset' of the ADR were from PhCs reports. 'Onset of treatment date' was not filled in 28 (22.2%) of the reports including an 'additional monitoring' medicine, and 'end of treatment' date was not completed in 53 of those reports (42.1%). In summary, 39% of the reports involving a black triangle medicine sent by PhCs...
Annals of Pharmacotherapy, 1993
European Journal of Clinical Pharmacology, 1999
In contrast to tricyclic antidepressants [1], selective serotonin reuptake inhibitors (SSRIs) are... more In contrast to tricyclic antidepressants [1], selective serotonin reuptake inhibitors (SSRIs) are considered safe with respect to hepatotoxicity. AMedline search covering the period January 1982 to April 1999 has identi®ed four cases of ̄uoxetine-induced hepatitis [2, 3, 4, 5]. Through the Spanish Systemof Pharmacovigilance (SSP), based on voluntary reporting of suspected adverse drug reactions [6] until April 1999, more than 58,000 reports have been assembled, 493 describing adverse eects suspected to be due to ̄uoxetine. Six of these reports described acute hepatitis, and ®ve described asymptomatic increase in serum transaminases (Table 1). Four of the six patients with acute hepatitis had only been treated with ̄uoxetine, whereas the other two had taken other drugs not known to cause hepatotoxicity (zolpidem in one patient and alprazolam and one tablet of acetylsalicylic acid per week in the other). Six additional reports of acute hepatitis have been reported in patients treated with ̄uoxetine but they had also taken other well-known hepatotoxic drugs (amineptine, mianserin, clomipramine, amitriptyline and ticlopidine). All patients had been treated with recommended daily doses of ̄uoxetine. The time elapsed between the onset of treatment with ̄uoxetine and the diagnosis (induction period) was one and a half months or more in four patients. All patients completely recovered after drug withdrawal. Viral hepatitis (A, B, and C) were ruled out by serological testing in ®ve patients; patient number 5 had antibodies to hepatitis C (anti-HCV) but the high serum aminotransferase levels (AST/ALT 1600/ 1500 IU) and the fact that they returned to normal 3 months after withdrawing drugs, strongly suggest a toxic cause. Abdominal ultrasonography was performed in three patients (cases 1, 3, and 6), and it was normal. Although no patient was re-challenged with ̄uoxetine, the time sequence and the exclusion of other causes suggest a plausible relationship. Five cases of mild increases in liver enzymes have also been reported (Table 1). Three of these patients had been treated with ̄uoxetine as the sole drug, and all of them had been prescribed the usual recommended doses. Except for one of them, the induction period was shorter than in those with overt hepatitis. Until April 1999, the World Health Organization (WHO) International Programme for Drug Monitoring had assembled 229 reports of acute hepatitis attributed to ̄uoxetine. In 149, ̄uoxetine was the only suspected drug. There are also 54 reports of hepatitis attributed to ̄uvoxamine (22 in which it was the only suspected drug), 80 with paroxetine (50), and 65 with sertraline (51). WHO data is heterogeneous with respect to its source, the extent of information available, and degree of attributability that is applied to each case. Also, no estimate of drug use is given and therefore no comparison between drug products is possible. It is well known that ̄uoxetine can cause an increase in liver enzymes. The frequency of this eect has been estimated as 0.5% among 3000 patients included in clinical trials [7]. As no cases of overt hepatitis were found among these 3000 patients, ̄uoxetine has been perceived as a safe drug in this respect [8]. Clinical trials are the best method for establishing causal relationships, but the low number of patients included along with their short duration preclude identifying adverse drug reactions of low frequency and those that appear after relatively long-term treatments. At least two meta-analyses of SSRIs have been published [9, 10]. In the most recent Eur J Clin Pharmacol (1999) 55: 545±546 Ó Springer-Verlag 1999
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Papers by Albert Figueras