Cristiano Matos

Objective: The aim was to assess the perception of risk for developing adverse drug reaction (ADRs) and knowledge, attitudes and opinions regarding pharmacovigilance in diabetic patients, and to investigate the effect of being a member of a patient organisation for diabetes on these factors, in comparison with other patients. Methods: A cross-sectional study looking for patients’ risk perception of experiencing ADRs. Diabetes patients followed at the Portuguese Diabetes Association (APDP) were included, together with two comparison groups (patients with and without diabetes). Kruskal-Wallis followed by post hoc Dunn’s multiple-comparison test were used to compare patients’ groups. Results: A total of 314 patients participated in the survey (104 followed at APDP, 106 with diabetes not followed at APDP and 104 without diabetes diagnosis that used chronic medication). APDP patients presented higher risk perception scores for medicines related to their disease compared with two groups. ...

European drug regulations aim for a patient-centered approach, including involving patients in the pharmacovigilance (PV) systems. However many patient organizations have little experience on how they can participate in PV activities. The aim of this study was to understand patient organizations’ perceptions of PV, the barriers they face when implementing PV activities, and their interaction with other stakeholders and suggest methods for the stimulation of patient organizations as promoters of PV. A sequential qualitative method study was conducted and integrated with the quantitative study performed by Matos, Weits, and van Hunsel to complete a mixed method study. The qualitative phase expands the understanding of the quantitative results from a previous study by broadening the knowledge on external barriers and internal barriers that patient organizations face when implementing PV activities. The strategies to stimulate patient-organization participation are the creation of more awareness campaigns, more research that creates awareness, education for patient organizations, communication of real PV examples, creation of a targeted PV system, creation of a PV communication network that provides feedback to patients, improvement of understanding of all stakeholders, and a more proactive approach from national competent authorities. Both study phases show congruent results regarding patients’ involvement and the activities patient organizations perform to promote drug safety. Patient organizations progressively position themselves as stakeholders in PV, carrying out many activities that stimulate awareness and participation of their members in drug safety, but still face internal and external barriers that can hamper their involvement.

IntroductionPatient organizations have a privileged position to be active agents for promoting pharmacovigilance and patient engagement, encouraging direct patient reporting and improving the awareness of pharmacovigilance.AimThe objective of this study was to understand the role of European patient organizations as stakeholders to optimize patient involvement in pharmacovigilance.MethodsA descriptive correlational study was conducted to investigate the opinions and attitudes of patient organizations regarding general patient involvement in pharmacovigilance, and their initiatives to support drug safety through a web-based questionnaire during the months of March and April 2018.ResultsA total of 1898 patient organizations were invited to participate in the survey, including 89 pan-European organizations. In total, 337 questionnaires (17.76%) were collected from 31 countries, including 297 complete answers (88.31%). A large number of organizations stated that they would like to increase the awareness of patients regarding specific adverse drug reactions (ADRs) related to their medicines (43.19%, n  = 130); however, 38.54% (n  = 116) declared they do not have any pharmacovigilance goals. Barriers to supporting pharmacovigilance activities include low budget to promote pharmacovigilance among members (45.45%, n  = 135), lack of resources to participate in pharmacovigilance activities (43.77%, n  = 130), or lack of support from the National Competent Authorities (33.33%, n  = 99). Organizations inform patients to report ADRs (40.40%; n  = 120), information regarding new ADRs related to their medicines (40.07%; n  = 119), or when a new drug is marketed (30.98%; n  = 92); however, more than one-third indicated that they never had any involvement in pharmacovigilance (34.68%; n  = 103).ConclusionBringing pharmacovigilance stakeholders and patient organizations together could create a more optimal reporting culture. Patient organizations appear to have an important role in encouraging patients to talk with their doctors/pharmacists about ADRs experienced, or to help him/her report the ADRs to the pharmacovigilance systems. Lack of resources, budget, and support from NCAs are seen as the main barriers to being involved in pharmacovigilance awareness.

BackgroundAn adverse drug reaction (ADR) is a harmful and unintended response to a drug. The Portuguese National Pharmacovigilance System (NPS) receives reports from healthcare professionals and consumers, then analyzes the reports to help prevent, eliminate or minimize the risks of drugs to consumers. Community pharmacy professionals (CPPs) have privileged access to consumers, and throughout their pharmacotherapeutic follow-up and the professional–consumer relationship, they can perceive possible ADRs and encourage consumers to report. The aim of this survey was to evaluate CPPs as role players in improving consumers’ involvement in pharmacovigilance and to describe their attitudes related to the pharmacovigilance system and consumers’ reporting of ADRs.MethodsAn observational study was performed in a group of Portuguese CPPs contacted through e-mail with a link to a web-based survey created in the Google Docs® platform. Data were collected between April and May 2016 and analysed using Spearman’s correlation coefficients and statistical analysis with SPSS® v.23.0 software.ResultsAlmost all (96.5%) of respondents declared they knew about the NPS, but only 40.7% had reported an ADR. Half (50.0%) of respondents said they usually encourage consumers to report ADRs. However, 1.2% admitted advising consumers not to report if they solicited help from the CPP. Most CPPs (80.2%) were available to help consumers report ADRs. CPPs are encouraged to report ADRs if they are concerned about the situation caused by the reaction or if the ADR is serious or unexpected. Regarding measures to increase the number of ADRs received by the NPS, 91.9% of respondents advised raising awareness of the NPS and 86.1% advised improving the communication between doctors and patients.ConclusionDespite their knowledge of the pharmacovigilance system, only a small percentage of CPPs had reported ADRs, and approximately half did not usually encourage consumers to report possible ADRs. Reporting of ADRs is fundamental to pharmacovigilance, and consumer reporting is a significant contribution to creating useful information on drug safety. Underreporting remains a concern and, in community pharmacies, CPPs can play a major role in pharmacovigilance by reporting ADRs directly or encouraging consumers to report them.

An adverse drug reaction (ADR) is a harmful and unintended response to a drug. The Portuguese National Pharmacovigilance System (NPS) receives reports from healthcare professionals and consumers, then analyzes the reports to help prevent, eliminate or minimize the risks of drugs to consumers. Community pharmacy professionals (CPPs) have privileged access to consumers, and throughout their pharmacotherapeutic follow-up and the professional–consumer relationship, they can perceive possible ADRs and encourage consumers to report. The aim of this survey was to evaluate CPPs as role players in improving consumers’ involvement in pharmacovigilance and to describe their attitudes related to the pharmacovigilance system and consumers’ reporting of ADRs. An observational study was performed in a group of Portuguese CPPs contacted through e-mail with a link to a web-based survey created in the Google Docs® platform. Data were collected between April and May 2016 and analysed using Spearman’s ...

ABSTRACT Introduction: One of the main drug-related problems are the Adverse Drug Reactions (ADR´s) which are often associated to causes of morbidity and mortality and represent a substantial burden on healthcare resources. There are some studies that show obstacles to reporting of Adverse Drug Reactions in hospitals and this is a weakness for the patient’s safety that must be improved. Beyond this clinical cost there is a considerable economic impact, that should be minimized. Objective: To review published papers of Adverse Drug Reactions (ADR’s) leading to hospitalization in Emergency Departments (ED) analysing their costs associated. Methods: Was performed a keyword search on PubMed online database for published papers between January 2000 and April 2012. Record data were collected from selected articles and included: Study design, number of patients included and their demographic characteristics, ADR assessment, duration of admissions and estimated costs of ADR-induced hospitalizations. Were only included prospective observational studies available with abstract and full text. All monetary costs were adjusted and expressed in Euros. Results: A total of 97 articles were found. Ten prospective observational studies were selected for full text review. The mean of overall ADR incidence found on patients presented to ED was 7,6% ±9,3%. 4,5% of all admitted patients were hospitalized due to an ADR. The majority of studies indicate that the elderly population is the most affected. Most studies (8 in 10) performed their cost analysis based on associated direct costs, while the other two included all direct and indirect costs. Discussion: ADR´s can have a significantly impact on hospital’s budget and, consequently, can lead to important charges to healthcare systems. We estimated that ADR-induced hospitalizations can lead to high expenditures for hospitals up to 4844 € per case. The potential savings for a year can reach up to 706M Euros. Furthermore, associated costs incurred by patients can reach up to 1099 € per severe ADR case. Conclusion: This review suggests that ADR’s are an important cause of hospitalization among patients presented to ED, which incurs several charges on hospital’s budget. Measures should be developed to minimize the economic impact of ADR’s in healthcare systems.

ABSTRACT Introduction: Since early 1960s, time of first pill approval, several formulations of oral contraceptive pill have been taken by millions of women worldwide, turning it into one of the most consumed drug classes. Continuous use of combined oral contraceptives (OC) may lead to slight hepatocellular dysfunction, through a direct unfavorable effect on liver, either by triggering the disease or by increasing the effects of pre-existing hepatic problems. The most common focal benign alteration in the liver is hemangioma, that could happen predominantly in women between 30 and 50 years old and which can grow with estrogens. Although these lesions are common in young women, most of them are benign and asymptomatic, so they were rarely reported in medical literature by ultrasound evaluation. Aim: To evaluate the potential harm to the liver of OC trough ultrasound technique. Methods: Was performed an observational descriptive correlational study in a primary health care unit, in the central region of Portugal, with all women, attending family planning, that consumed OC at least during six years. Only the first consultation will be accounted for each patient. Ultrasound technique was used in all evaluations to find focal alterations or hepatomegaly. A questionnaire was conducted to participants to perceive the pharmacological characteristics of OC. Results: Possible hepatic findings induced by OC were assessed through ultrasound technique due to great accuracy and specificity for assessing liver. Due to the widely use of OC, benign abdominal tumors are most frequently identified. From preliminary data analysis of 25 women that take OC at least during the last six years, only 1 have an unusual liver tissue, but is not certain yet that is caused by OC. Discussion: It’s expected that the use of oral contraceptives induce hepatotoxicity, dependent by composition, dosage, type and generation of OC and mainly due to duration of therapy. The risk of developing liver disease may be directly proportional to the length of time a woman has been taking OC. Conclusion: Hemangiomas are asymptomatic, so is important to find, localize and determine the dimensions of the lesion in order to replace contraceptive therapy, generate signal detection concerning to adverse effects of OC and allow faster treatment to hepatic complications. Most consumers of OC would not be subject to adverse hepatobiliary effects. However, due to the high prevalence of the use of these drugs in our society, despite its rarity of these complications, it’s expected that these arise.

ABSTRACT Introduction Adverse drug reactions (ADRs) are a substantial cause of morbidity and mortality worldwide. These events are commonly related to the usage of antineoplastic drugs. The cytarabine (Ara-C) is an antineoplastic drug that is administrated in acute lymphoblastic leukemia (ALL) protocols as Linker Protocol and it can originate severe adverse episodes. Serious acute and late complications are developed by some patients, increasing the risk of leukemia frequency with high drug resistance, poor tolerance and compliance with the treatment and reluctance to accept some adverse effects. Other than increasing morbidity and mortality, they lead to extremely high healthcare costs. Aim The authors intend to ascertain the current burden of ADRs related to the treatment by Ara-C antineoplastic, through identification and analysis of ALL patients’ using this drug. Methods A retrospective observational study model was conducted in a Central Hospital in Portugal. The study has selected ALL patients’ data, with the Linker protocol as chemotherapy regimen that was achieved by the hospital database which provides the national surveillance system. Results Of the total of 76 ADRs reported in 21 ALL patients’ in the course of study, Ara-C is associated with 4 adverse events such as febrile episodes, toxicoderma, pruritus and erythema. The other ADRs are considered related to Linker Protocol in which febrile neutropenia was identified in 7 episodes. Summary/Conclusion Ara-C is responsible for some ADRs, however, the failure of information in medical records and the low report of these events to pharmacovigilance system, make us conclude that these results are not entirely reliable.

IntroductionPatient reporting of adverse drug reactions (ADRs) to spontaneous reporting systems can make a valuable contribution to pharmacovigilance. However, the implementation and promotion of patient reporting systems (PRSs) differ worldwide.ObjectiveThe objective of the study was to describe attitudes toward PRSs, and progress toward implementing such systems among national competent authorities participating in the World Health Organization Programme for International Drug Monitoring.MethodsA web-based questionnaire was constructed based on qualitative interviews, and distributed through SurveyMonkey® to all countries listed on the World Health Organization Programme for International Drug Monitoring (n = 178) during November and December of 2015. Data were analyzed using descriptive statistics and Chi-square tests.ResultsA total of 143 valid questionnaires were received from 141 countries (79.2 %). A spontaneous reporting system for both healthcare professionals and patients was present in 58 countries (41.1 %). An official PRS to report ADRs directly was implemented in 44 countries (31.2 %) and in a pilot stage in five countries (3.5 %). Patients were not allowed to report in 34 countries (24.1 %). The reasons for not having an official PRS were mainly a lack of resources/budget (56.5 %) or a lack of information/education for patients (56.5 %). When analyzing the attitudes among the respondents toward a PRS, most acknowledge that the general public contributes to the detection or strength of drug safety signals (82.2 % agree or strongly agree) and with information that is not present in healthcare professional reports (80.7 % agree or strongly agree). For respondents, giving feedback to patients could be an incentive for patients to report more (80.8 % agree or strongly agree). To be able to further PRSs, guidelines on promoting a PRS efficiently to the general public (87.4 % agree or strongly agree), training courses/conferences (86.7 % agree or strongly agree), or a public list of Lareb’s scientific publications (86.7 % agree or strongly agree) were the support measures most well accepted by the respondents.ConclusionsMost countries accept ADR reports from patients by an official reporting system designed for patients or through the existing system for healthcare professionals. The main reasons for not having a PRS is financial restraints and a lack of information/education of patients. Attitudes toward a PRS are positive, but some countries fear that they will not be able to handle an increase in reports.

A great amount of medicines used in children is prescribed off-label or unlicensed. Children have often been denied the access to new and/or innovative drugs, whether because the drugs have not been duly tested and/or formulated, or because they have not been given the authorization of use in suitable paediatric ages. The lack of reliable data on the paediatric population is associated with specific problems. This work aims to be a revision therefore has used articles already published under this scope in order to get a framework of problems related with the use of drugs unlicensed and off-label. Study literature review of research in databases of reference. Were chosen, selected and included 21 scientific papers published after 2005 that were analysed by identifying the medicines and the pharmacotherapeutic groups most commonly used as off-label/unlicensed and the adverse events verified. The group of drugs most commonly used in Paediatrics with off-label/unlicensed prescription ar...

The spread of the consumption of drugs and the occurrence of the chronic and degenerative diseases in the elderly are the main reasons that increases the vulnerability of the elderly to the adverse drug reactions. Also, the pharmacokinetic and pharmacodynamic changes of aging (changes in drug metabolism, decreased ability of the liver and kidneys to metabolize and excrete drugs, decreased circulatory efficiency, etc..), as well as gender, alcohol use, liver failure and renal disease and type of medication, drug interactions, doses are risk factors for the occurrence of ADR in elderly. Due to this, is needed to be vigilant and aware as regards of the ADR in the to evaluate the occurrence of ADR related to the excessive consumption of medicines in an elderly population.A cross-sectional descriptive-correlational study was conducted to the 49 patients of the nursing home in Coimbra. They were directly interviewed through a questionnaire that was adapted from previous studies.53% of our...

Introduction Plusieurs individus souffrent, pour de nombreuses raisons, de la sécheresse sévère de l'œil (kératoconjonctivite sèche), ce qui pourrait conduire à des symptômes différents et même à la douleur. L’utilisation des lames artificielles na pas montré d'être une solution de grand succès dans le traitement de ces patients. Contre l'utilisation accrue de cette option de traitement le Technicien de Pharmacie joue un rôle clé dans la préparation de plus en plus utilisée, et il ya une grande variété de protocoles décrits dans la littérature. Objectif du travail Cette étude fait partie d'une revue de littérature sur la préparation du sérum autologue (collyre), qui vise à identifier un protocole de procédures, ainsi que le rôle du technicien en pharmacie. Méthode de travail La méthode utilisée consiste à faire une revue bibliographique des différents articles publiés dans des bases de données bibliographiques en ligne. Les articles sélectionnés sont ceux qui décrive...

Introduction: Since early 1960s, time of first pill approval, several formulations of oral contraceptive pill have been taken by millions of women worldwide, turning it into one of the most consumed drug classes. Continuous use of combined oral contraceptives (OC) may lead to slight hepatocellular dysfunction, through a direct unfavorable effect on liver, either by triggering the disease or by increasing the effects of pre-existing hepatic problems. The most common focal benign alteration in the liver is hemangioma, that could happen predominantly in women between 30 and 50 years old and which can grow with estrogens. Although these lesions are common in young women, most of them are benign and asymptomatic, so they were rarely reported in medical literature by ultrasound evaluation. Aim: To evaluate the potential harm to the liver of OC trough ultrasound technique. Methods: Was performed an observational descriptive correlational study in a primary health care unit, in the central ...

Self-medication is an increasing phenomenon which affects global public health. Little research covers the use of self-medication among university students in Portugal. The aim of this study is to evaluate the influence of the pharmacy graduation on the knowledge and attitudes of students concerning to the use of medicines, particularly by self-medication. A descriptive correlational study was conducted in graduating students in Pharmacy, in Portuguese higher education public colleges. A survey containing multiple-choice questions about self-medication and best practices of self-medication was sent to all individuals of the population. Overall, students had a reasonable knowledge and a good behavior about appropriate self-medication. The self-medication prevalence was very high (98%) and similar in all academic years. The most frequent reasons for self-medication were “mild disease”, “demand for rapid relief of symptoms” and “previous experience” and “headache”, “cough” and “nasal c...

Introduction: One of the main drug-related problems are the Adverse Drug Reactions (ADR´s) which are often associated to causes of morbidity and mortality and represent a substantial burden on healthcare resources. There are some studies that show obstacles to reporting of Adverse Drug Reactions in hospitals and this is a weakness for the patient’s safety that must be improved. Beyond this clinical cost there is a considerable economic impact, that should be minimized. Objective: To review published papers of Adverse Drug Reactions (ADR’s) leading to hospitalization in Emergency Departments (ED) analysing their costs associated. Methods: Was performed a keyword search on PubMed online database for published papers between January 2000 and April 2012. Record data were collected from selected articles and included: Study design, number of patients included and their demographic characteristics, ADR assessment, duration of admissions and estimated costs of ADR-induced hospitalizations....

Introduction: Paracetamol is the main derivative of para-aminophenol in use and the most sold over-the-counter drug in Portugal however, despite being safely used by millions of individuals worldwide, as analgesic and antipyretic in the last 15 years, this drug has become a major cause of acute liver injury. Alcohol consumption is a daily practice on the part of the adult population and the concomitant use of paracetamol is frequent. For that reason it's important further analyze of the effects of this association, which will target the liver. Aim: The study intends to evaluate the hepatic changes resulting from consumption of paracetamol and alcohol-paracetamol association through ultrasonography. It’s also intended to analyze demographic characteristics, in order to assess the susceptibility to paracetamol adverse effects or liver damage with worst recovery. Data was supported by a questionnaire to the individuals. Material and Methods: An observational descriptive correlation...

Consumption of OTC drugs is a practice widely used that aims to prevent and relieve symptoms or complaints and treat minor health problems. The aim of this survey was to evaluate the consumption and knowledge of OTC drugs of the population of a Portuguese village in the central region. An observational study was performed, during two months, with consumers of a community pharmacy of this parish that agreed to participate. There were interviewed 262 individuals (61 males and 201 females), with no significant differences regarding knowledge and consumption of OTC drugs. 61.7% of subjects (n=162) have insufficient knowledge about the concept of OTC drugs and 61% (n=159) referred rarely consume. The main causes that lead to the OTC drugs use were minor symptoms such as flu and colds. 97.5% refer the community pharmacy to get the OTC drugs and 84.9% refer the counseling of the professional pharmacy for information about the OTC drugs, whereas 53.2% of the sample does not have any knowled...

Introduction: The phenomenon of the adverse drug reaction underreporting is a field that induced several studies to understand it and it is known the important role played by healthcare professionals in the reporting adverse drug reactions to decrease the underreporting. In Portugal the report of adverse drug reactions traditionally shown to be below of the report average in Europe. Different studies have indentified obstacles to the report of Adverse Drug Reactions and the statistics of ADR report in Portugal show that Pharmacy Technicians (PhT) are away from the National Pharmacovigilance System (NPS). Aim: To identify the impact of the initial education and the continuous professional development (CPD) in the attitudes and knowledge of pharmacy technicians in the adverse drug reactions (ADR) reporting system in the professional context. Methods: A descriptive-correlational study is been performed, trough a web-based questionnaire in the Pharmacy Technician’s population that works...

Introduction Hypertension (HTN) is a disease characterized by increased values of blood pressure, which can lead to the occurrence of other cardiovascular problems. The main goal of treating hypertension is to reduce the risk of cardiovascular disease incidence through an antihypertensive therapy. In this context, patients adherence to therapy is a key factor to its success. Aim Review the literature on the topic of adherence in hypertensive patients, by analyzing the influence of defined variables, pattern recognition and adherence measurement methods thereof. Methods It was performed a systematic review without meta-analysis of existing literature on medication adherence of patients diagnosed with hypertension, based on articles published between 2002 and 2012 by analyzing the type and the way the variables shown may influence adherence. Results Adherence to therapy may be influenced by variables such as gender, age, qualifications and knowledge of the disease. It is found that th...

Consumption of drugs during pregnancy should be rational and controlled, as there are two bodies involved, mother and fetus. Fetus, for not having the same ability to metabolize substances, is more vulnerable to unexpected adverse effects. The accident with thalidomide, created a great concern about the safety of medicines used during pregnancy. Before thalidomide, it was believed that the placenta acted as a barrier. Currently it is known that most drugs cross the placenta and reaches the bloodstream of the fetus.The aim of this study was to describe the profile of medication used in pregnancy, identifying factors that influence the number of drugs and pharmacotherapeutic group used by pregnant, and classify the drugs to the risk for pregnancy.A sample of pregnant from an outpatient’s obstetrics was collected in a maternity, for an observational study of transversal cohort, composed of 260 pregnant.We’ve reached an average consumption of 2.1 drugs. Higher consumption of drugs for C...

The spontaneous reporting system of adverse drug reactions (ADR's) is fundamental to drug safety surveillance but under-reporting is its major restriction. This bibliographic review sought to assess the influence of personal and professional characteristics on ADR reporting and to identify the obstacles and solutions associated with ADR reporting. A systematic review was conducted using the Pubmed, ISI Web of Knowledge and Google Scholar databases, including also search of cited papers. We included papers that were published in English and Portuguese, and covered a study population made up of health professionals (physicians, pharmacists and nurses). The review covered 25 papers that fulfilled the inclusion criteria. Some of the obstacles to spontaneous reporting considered were: ADRs diagnosis problem, problems related to time and resources, lack of information and access, procrastination, the organization of the pharmacovigilance system and problems related to potential confli...

Over the past centuries, there have been significant improvements in living conditions and health of populations, which led to an increased prevalence of chronic and multiple diseases in elderly subjects. The multimorbidity is present in one third of the adult population and its prevalence tends to increase with age, reaching 60% among individuals aged 55 to 74 years. The most frequent pathologies in the elderly are hypertension (HTN), diabetes, Alzheimer´s disease, Parkinson´s disease and Congestive heart failure (CHF). With the increase of disorders in the elderly, the prevalence of polypharmacy is also growing. There are several settings of polypharmacy according to various authors. The subjects exposed to polypharmacy have a higher risk of developing drug interactions and should be intensely monitored. The aim of this study was to draw the pharmacotherapeutic profile of the users of a nursing home, then evaluating the potential drug interactions and their risk, to elderly patien...