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Pharmacovigilance systems are important to monitor the safety of on-market drugs after approval. The aim of this study was to assess the impact of rosiglitazone safety alerts on trends in the sale of rosiglitazone and other oral antidiabetic drugs. An ecological study was conducted, using temporally aggregated data and linking safety alerts to countrywide sales of all oral antidiabetic drugs in Portugal from January 2002 to December 2012. Sales figures for oral antidiabetic drugs marketed in Portugal were supplied by IMS Health Portugal with a breakdown by active substance and fixed combinations. The number of defined daily doses per 1000 inhabitants per day (DIDs) of each oral antidiabetic drug sold to the estimated diabetic population using oral antidiabetic drugs in Portugal was calculated. Particular attention was paid to the case of rosiglitazone, with the results being adjusted for changes in rosiglitazone reimbursement policies. A total of four safety alerts were issued about rosiglitazone. Rosiglitazone sales registered an increase of 32.9% (0.202 DIDs; P < 0.001) after the first alert (risk of macular oedema or worsening of pre-existent macular oedema) in January 2006. After subsequent alerts about cardiovascular risks, this trend was not, however, repeated and sales fell. Following the January 2006 and January 2008 safety alerts, rosiglitazone sales described a long-term downward trend, with decreases of 3.75% (-0023 DIDs; P > 0.05) and 0.24% (-0.001 DIDs; P > 0.05), respectively. It is important to promote the dissemination and publication of drug safety alerts., (© 2016 Société Française de Pharmacologie et de Thérapeutique.)

Objectives: The aim of this study was to develop a novel, self-administered questionnaire to identify primary-care physicians' knowledge and attitudes regarding antibiotics and resistance (KAAR)., Methods: The study population comprised primary care physicians. The study was conducted in five phases. Phase I consisted of a systematic review and qualitative focus-group study (n = 33 physicians), in which items were formulated so as to be measured on a continuous, visual analogue scale (VAS); in Phase II, content validation and face validity were evaluated by a panel of experts, which reformulated, added and deleted items; Phase III consisted of a pilot study on a population possessing similar characteristics (n = 15); in Phase IV, we analysed reliability by means of a test-retest study (n = 91) and calculated the intraclass correlation coefficients (ICCs); and in Phase V, we assessed construct validity by applying the known-groups technique, measuring the differences between contrasting groups of physicians formed according to antibiotic prescription quality indicators (group 1, n = 156 versus group 2, n = 191)., Results: Following Phases I and II, the questionnaire contained 16 knowledge and attitude items. Participants in the pilot study (Phase III) reported no difficulty. The test-retest study (Phase IV) showed that 11 of the 16 initial knowledge and attitude items yielded an ICC > 0.5, while analysis of known-groups validity (Phase V) showed that 13 of the 16 initial items which assessed knowledge and attitudes discriminated between physicians with good and bad indicators of antibiotics prescription., Conclusion: The final 11 item KAAR questionnaire appears to be valid, reliable and responsive., (© The Author 2016. Published by Oxford University Press on behalf of the British Society for Antimicrobial Chemotherapy. All rights reserved. For Permissions, please e-mail: journals.permissions@oup.com.)

Aim: To decrease population antibiotic use through an educational intervention targeting primary care physicians' and community pharmacists' attitudes and knowledge., Methods: We designed a pragmatic cluster-randomized trial covering all National Health System primary care physicians and all community pharmacists' in a region in the north of Portugal. The study protocol was registered on ClinicalTrials.gov (identifier: NCT02173509)., Results: After adjustment for baseline values and comparison with the control group, the intervention was associated with a significant reduction in overall antibiotic use in the year following the intervention. The effect was most marked for tetracyclines, macrolides and cephalosporins. No statistically significant differences were observed for fluoroquinolone consumption., Conclusion: Multifaceted interventions involving physicians, pharmacists and general public proved effective in reducing antibiotic consumption in the population.

Objectives Antibiotic misprescription is a major driver of resistance, which is a worldwide public health problem. Therefore, our aim is to assess the influence of the determinants of physician prescribing on the quality of antibiotic use. Methods A 3 year cohort study including all primary-care physicians working in Portugal's Central Regional Health Administration (n = 1094) was conducted. We assessed the determinants of prescribing using a pre-validated, personally addressed, reply-paid, self-administered questionnaire (sent four times to non-responders, between September 2011 and February 2012) designed to collect information on physicians' attitudes to and knowledge of antibiotic prescribing as well as their socio-demographic and professional data. To evaluate antibiotic prescribing, we've calculated ESAC 12 quality indicators per physician per year, allowing us to stratify them as good or poor prescribers according to their performance on those indicators. Associations between determinants and outcomes were fitted with generalized linear mixed models. Results The overall response rate was 46.1%. Emergency activity (OR [95% CI] = 0.29 [0.16-0.54]; p < 0.05) and workload (number of patients seen per day: OR [95% CI] = 0.97 [0.94-1.00]; p < 0.05; number of patients seen per week in emergencies: OR [95% CI] = 0.98 [0.97-0.99]; p < 0.05) were both related to poor quality of antibiotic prescribing. Statistically significant odds ratios were also obtained for ignorance (IqOR [95% CI] = 2.14 [1.31-3.52]), complacency (1/IqOR [95% CI] = 1.19 [1.01-1.41]) and responsibility of others (1/IqOR [95% CI] = 1.78 [1.10-3.06]). Conclusions The above results serve to emphasize workload, working at emergency departments and physicians' attitudes identified as critical factors affecting antibiotic prescribing. This provides new insights for clinicians, researchers and policy makers when it comes to developing and improving the clinical and economic outcomes of antibiotic use. Key limitations of the study included the difficulty of results extrapolation and the limitations of the stratification method based on the antibiotic prescribing quality indicators.

Aim: To identify the attitudes and knowledge associated with adverse drug reactions (ADR) under-reporting by nurses., Background: The voluntary reporting system is fundamental for expediting the detection of ADR during post-marketing surveillance., Methods: We performed a case-control study. A self-administered questionnaire was sent by mail to 1325 nurses. The knowledge and attitudes related to ADR under-reporting were primarily based on Inman's seven deadly sins., Results: The overall response rate was 34.2%. Nurses working in primary care were 12-fold more likely to report an ADR. A change of attitude increased the probability of ADR reporting for:'The belief that the one case an individual nurse might see could not contribute to medical knowledge'; 'I do not know how the information reported is used by the system'; 'I would be more likely to report if the method was easier'; 'I think the most correct way to report is to inform the doctor' and 'I do not have time to think about the involvement of the drug in ADRs'., Conclusions: Our study shows that the beliefs of nurses, such as 'one single report would not make any difference' and 'the pharmacovigilance system is very complex', act as a barrier to ADR reporting., Implications for Nursing Management: It is important to clarify the ADR reporting procedure and increase the nurses reporting rate., (© 2015 John Wiley & Sons Ltd.)

Background: Understanding physicians' antibiotic-prescribing behaviour is fundamental when it comes to improving antibiotic use and tackling the growing rates of antimicrobial resistance. The aim of the study was to develop and validate--in terms of face validity, content validity and reliability--an instrument designed to assess the attitudes and knowledge underlying physician antibiotic prescribing., Methods: The questionnaire development and validation process comprised two different steps, namely: (1) content and face validation, which included a literature review and validation both by physicians and by Portuguese language and clinical psychology experts; and (2) reliability analysis, using the test-retest method, to assess the questionnaire's internal consistency (Cronbach's alpha) and reproducibility (intraclass correlation coefficient--ICC). The questionnaire includes 17 items assessing attitudes and knowledge about antibiotic prescribing and resistances and 9 items evaluating the importance of different sources of knowledge. The study was conducted in the catchment area covered by Portugal's Northern Regional Health Administration and used a convenience sample of 61 primary-care and 50 hospital-care physicians., Results: Response rate was 64% (49% to retest) for primary-care physicians and 66% (60% to retest) for hospital-care physicians. Content validity resulted in 9 changes to professional concepts. Face validity assessment resulted in 19 changes to linguistic and interpretative terms. In the case of the reliability analysis, the ICC values indicated a minimum of fair to good reproducibility (ICC > 0.4), and the Cronbach alpha values were satisfactory (α > 0.70)., Conclusions: The questionnaire developed is valid--in terms of face validity, content validity and reliability--for assessing physicians' attitudes to and knowledge of antibiotic prescribing and resistance, in both hospital and primary-care settings, and could be a very useful tool for characterising physicians' antibiotic-prescribing behaviour.

Resistance increases with the use and abuse of antibiotics. Since physicians are primarily responsible for the decision to use antibiotics, ascertaining the attitudes and knowledge that underlie their prescribing habits is thus a prerequisite for improving prescription. Three-year follow-up cohort study (2008-2010) targeting primary-care physicians (n = 2100) in Galicia, a region in NW Spain. We used data obtained from a postal survey to assess knowledge and attitudes. A physician was deemed to have demonstrated Appropriate Quality Prescription of Antibiotics (dependent variable) in any case where half or more of the indicators proposed by the European Surveillance of Antimicrobial Consumption had values that were better than the reference values for Spain. The mail-questionnaire response rate was 68·0% (1428/2100). The adjusted increase in the interquartile OR of displaying good prescribing of antibiotics for each attitude was: 205% for fear ("When in doubt, it is better to ensure that a patient is cured of an infection by using a broad-spectrum antibiotic"; 95%CI: 125% to 321%); 119% for better knowledge ("Amoxicillin is useful for resolving most respiratory infections in primary care"; 95%CI: 67% to 193%); and 21% for complacency with patients' demands ("Antibiotics are often prescribed due to patients' demands"; 95%CI: 0% to 45%). Due to the fact that physicians' knowledge and attitudes are potentially modifiable, the implementation of purpose-designed educational interventions based on the attitudes identified may well serve to improve antibiotic prescription.

Purpose: The information that is available when marketing authorizations are approved is limited. Pharmacovigilance has an important role during the postauthorization period, and alerts published by national authorities allow health care professionals to be informed about new data on safety profiles. This study therefore sought to analyze all safety alerts published by the Portuguese National Authority of Medicines and Health Products I.P. (INFARMED)., Methods: We conducted an observational study of all alerts published on the INFARMED website from January 2002 through December 2014. From the data included in the alerts, the following information was abstracted: active substance name (and trade name), event that led to the alert, and the resulting safety measures. Active substances were classified according to the Anatomical Therapeutic Chemical (ATC) code., Findings: A total of 562 alerts were published, and 304 were eligible for inclusion. The musculoskeletal system was the ATC code with more alerts (n = 53), followed by the nervous system (n = 42). Communication of the information and recommendations to the health care professionals and the public in general was the most frequent safety measure (n = 128), followed by changes in the Summary of the Product Characteristics and package information leaflet (n = 66). During the study period, 26 marketing authorizations were temporarily suspended and 10 were revoked., Implications: The knowledge of the alerts published during the postmarketing period is very useful to the health care professionals for improving prescription and use of medicines and to the scientific community for the development of new researches., (Copyright © 2015 Elsevier HS Journals, Inc. All rights reserved.)

Background: The yellow-card scheme continues to be one of the principal methods for signal generation in pharmacovigilance. Nevertheless, under-reporting, one of its disadvantages, delays alert signals and has a negative influence on public health. Educational interventions in pharmacovigilance may have a positive impact on the spontaneous reporting of adverse drug reactions (ADRs)., Objectives: To assess the duration of the effect and effectiveness of an educational intervention in pharmacovigilance designed to improve ADR reporting in a robust pharmacovigilance system., Methods: A spatial, cluster randomized controlled trial was conducted covering all National Health System physicians in the northwest of Spain and targeting those who were actively engaged in clinical practice (n = 7,498). Of these, 2,120 were assigned in three spatial clusters to the intervention group (six hospitals and 138 primary care centers) and 3,614 in four clusters to the control group (seven hospitals and 267 primary care centers). The educational intervention consisted of two complementary approaches--one active (group sessions), the other passive (educational material, reporting form)-implemented from November 2007 to December 2008, with a follow-up period of 8 months., Results: Intervention participation was 53.7 % in a hospital setting and 60.5 % in primary care settings. ADR reporting in the intervention group increased by 65.4 % (95 % confidence interval [CI]: 8.2-153.4) across the follow-up. The ADR reporting rate per 1,000 physicians/year in the intervention group rose from 28.1 to 39.6 following the intervention (51.7 and 27.4 in the first and second 4-month period, respectively). For the intervention group, relative risk (RR) was 2.31 (95 % CI: 1.46-3.68) and 1.04 (95 % CI: 0.61-1.77) in the first and second 4-month period, respectively adjusted to baseline values. There was an increase in unexpected ADR reporting (RR 2.06, 95 % CI 1.19-3.55)., Conclusions: Pharmacovigilance educational interventions that have proved effective can be successfully applied in different geographical areas. A high baseline notification rate could account for the educational program having a moderate effect.

Purpose: The emergence of microbial resistance is widely associated with inappropriate antibiotic use. Self-medication with antibiotics acquired directly from pharmacies without a medical prescription has been reported by several European countries as being an important cause of such inappropriate use. The goal of this study was to identify and evaluate community pharmacists׳ attitudes toward and knowledge of antibiotics and microbial resistance and to assess what influence, if any, these attitudes might have on their propensity to dispense unprescribed antibiotics., Methods: We conducted a cross-sectional study covering all community pharmacists registered with the Official College of Pharmacists in Portugal׳s Central Region. A self-administered questionnaire on attitudes toward microbial resistance and antibiotic use was mailed to 1197 pharmacists. Responses ranged from 0 (total disagreement) to 10 (total agreement). Logistic regression was used to model the association between respondents׳ attitudes and their propensity to dispense antibiotics without an earlier medical prescription., Findings: The overall response rate was 64.8%. Agreement with the dispensing of unprescribed antibiotics was highest in the case of dental diseases and ailments, followed by urinary tract infections. Although none of the sociodemographic data were associated with a propensity to dispense antibiotics without a medical prescription, the attitudes shown to be significantly associated with this propensity were complacency about patients, responsibility of others, and precaution or fear., Implications: Because the attitudes of community pharmacists can influence their readiness to dispense unprescribed antibiotics, educational interventions addressing such attitudes should be implemented to improve antibiotic use., (Copyright © 2015 Elsevier HS Journals, Inc. All rights reserved.)

Objective: Adverse drug reactions (ADR) are a public health problem. They cause significant morbidity, mortality and health costs. Less is known about pediatric ADR. Our goal was to characterize a pediatric case series of ADR reported to the Portuguese Pharmacovigilance System (PPS) during the past 10 years., Research Design and Methods: Retrospective analysis of ADR reports concerning patients till 17 years old received by the PPS between 2003 and 2012. We evaluated patients' demographic data and involved drugs, as well as characteristics and seriousness of reactions, stratified by age groups., Results: We found 1742 reports (50% females) corresponding to 9.7% of the total received. The age of the patients varied from 0 to 17 years (median: 5 years, interquartile range: 10.6), with 566 cases (32%) occurring in patients younger than 2y. Among the 1195 serious cases, 31% (370) episodes led to hospitalization. In 32 cases (2%) there was a fatal outcome. Most of the ADR reported referred to general disorders and administration site conditions, followed by skin and subcutaneous tissue reactions. Vaccines were the most represented group (42%) followed by antibacterials for systemic use (17%)., Conclusions: Pediatric ADR represents about 10% of the reports received by the PPS. Most ADR were considered serious. Major findings varied according to age groups.

Purpose: The aim of this review is to assess the extent of the use of off-label and/or unlicenced drugs among hospitalised children., Methods: A systematic search was made in MEDLINE-PubMED for papers published from 1994 to 2012, addressing the prescription of off-label and/or unlicenced drugs for the paediatric population in hospital care., Results: Of the 829 studies retrieved, 34 met the inclusion criteria. Prescriptions ranged from 12.2 to 70.6 % for off-label and from 0.2 to 47.9 % for unlicensed drugs. The percentage of children who received at least one off-label and/or unlicensed drug ranged from 42.0 to 100 %, with newborns being the population that received most of such drugs. Off-label prescriptions were essential for dose modification (7.1-73.1 %) and unlicensed prescriptions for formulation modification purposes (3.6-100 %)., Conclusions: These findings show that: (i) off-label and/or an unlicensed prescribing is widespread among the hospitalised paediatric population worldwide, (ii) there is no consensus on a definition of off-label and/or unlicensed drugs and (iii) preterm newborns receive most off-label and/or unlicensed drugs. By shedding new light on off-label and/or unlicensed drug prescribing, these findings will hopefully contribute to generating new, more effective knowledge about the paediatric population's need for quality drugs that are both safe and efficacious.

Background: Excessive and inappropriate antibiotic use contributes to growing antibiotic resistance, an important public-health problem. Strategies must be developed to improve antibiotic-prescribing. Our purpose is to review of educational programs aimed at improving antibiotic-prescribing by physicians and/or antibiotic-dispensing by pharmacists, in both primary-care and hospital settings., Methods: We conducted a critical systematic search and review of the relevant literature on educational programs aimed at improving antibiotic prescribing and dispensing practice in primary-care and hospital settings, published in January 2001 through December 2011., Results: We identified 78 studies for analysis, 47 in primary-care and 31 in hospital settings. The studies differed widely in design but mostly reported positive results. Outcomes measured in the reviewed studies were adherence to guidelines, total of antibiotics prescribed, or both, attitudes and behavior related to antibiotic prescribing and quality of pharmacy practice related to antibiotics. Twenty-nine studies (62%) in primary care and twenty-four (78%) in hospital setting reported positive results for all measured outcomes; fourteen studies (30%) in primary care and six (20%) in hospital setting reported positive results for some outcomes and results that were not statistically influenced by the intervention for others; only four studies in primary care and one study in hospital setting failed to report significant post-intervention improvements for all outcomes. Improvement in adherence to guidelines and decrease of total of antibiotics prescribed, after educational interventions, were observed, respectively, in 46% and 41% of all the reviewed studies. Changes in behaviour related to antibiotic-prescribing and improvement in quality of pharmacy practice was observed, respectively, in four studies and one study respectively., Conclusion: The results show that antibiotic use could be improved by educational interventions, being mostly used multifaceted interventions.

Antidepressants have been associated with a low incidence of idiosyncratic hepatic injury. Some of them, nefazodone or amineptine, were observed to induce severe hepatic injury and withdrawn from the market. Recently, some cases of this severe condition have been reported in association with agomelatine use. Therefore, the objective of this study is to learn the risk of hepatic damage with agomelatine as compared with other new antidepressants. We took data from the Spanish, French, Italian, and Portuguese pharmacovigilance system databases. A case/noncase approach to assess the strength of the association between whichever antidepressant and hepatotoxicity was performed; cases were defined as reports of hepatotoxicity; noncases were reports of all reactions other than hepatotoxicity. Exposure was the recording of a new antidepressant in a report, whether or not it was suspected of causing the reaction. During the period surveyed, 3300 cases of hepatotoxicity were collected for the antidepressants assessed. They represent 10.3% of all cases collected for these drugs; the corresponding figure for all drugs was 6.0%. Meanwhile, 63 cases of hepatotoxicity associated with agomelatine were collected since its introduction until the end of the period studied; they account for a percentage of 14.6. Agomelatine was statistically associated with hepatotoxicity in Spain [reporting odds ratio (ROR), 4.9 (95% confidence interval [CI], 2.4-9.7)], France (ROR, 2.4 [95% CI, 1.5-3.7]), and Italy (ROR, 5.1 [95% CI, 1.7-14.0]). Current results support the idea of agomelatine to be related to a higher hepatotoxicity risk. Physicians should consider early discontinuation if the condition is suspected; health authorities should promptly explore the best regulatory actions to be taken.

Objective: To develop and evaluate the reliability of a self-administered questionnaire designed to assess the attitudes and knowledge of community pharmacists in Portugal about microbial resistance and the antibiotic dispensing process., Methods: This study was divided into the following three stages: (1) design of the questionnaire, which included a literature review and a qualitative study with focus-group sessions; (2) assessment of face and content validity, using a panel of experts and a pre-test of community pharmacists; and, (3) pilot study and reliability analysis, which included a test-retest study covering fifty practising pharmacists based at community pharmacies in five districts situated in Northern Portugal. Questionnaire reproducibility was quantified using the intraclass correlation coefficient (ICC; 95% confidence interval) computed by means of one-way analysis of variance (ANOVA). Internal consistency was evaluated using Cronbach's alpha., Results: The correlation coefficients were fair to good (ICC>0.4) for all statements (scale-items) regarding knowledge of and attitudes to antibiotic resistance, and ranged from fair to good to excellent for statements about situations in which pharmacists acknowledged that antibiotics were sometimes dispensed without a medical prescription (ICC>0.8). Cronbach's alpha for this section was 0.716., Conclusions: The questionnaire designed in this study is valid and reliable in terms of content validity, face validity and reproducibility.

Background: The inappropriate use of antibiotics is considered a main cause of microbial resistance. This is an important public health problem. Community pharmacists have an important role in the management of drugs for outpatients., Objective: Our study sought to explore pharmacists' knowledge, attitudes, perceptions and dispensing habits insofar as to antibiotics and microbial resistance., Setting: The study was developed with community pharmacists in the North of Portugal., Methods: Qualitative research in the form of focus groups (FG). Focus groups were conducted with 4-7 pharmacists, using a moderator. A topic guide was developed to lead the discussions, which were audio-recorded and transcribed. The study was carried out between December 2010 and March 2011 in the five districts of the Northern Health Region of Portugal (ARS-N). Pharmacists from different regions of each district were invited to participate in the study by an investigator responsible for the study. Participants were informed about the study and that sessions were audio-recorded to facilitate data interpretation. They signed an informed consent form before taking part in the focus groups. The Ethical Committee of ARS-N was informed of this study., Main Outcome Measure: Pharmacists' knowledge and perceptions on antibiotic use and microbial resistance, attitudes related to antibiotic dispensing habits, and pharmacists' suggestions to improve antibiotic use., Results: A total of 6 focus groups were conducted with community pharmacists (n = 32). Attitudes related to the problem of resistance were attributed external responsibility, to patients, to physicians, to other pharmacies, and to veterinary consumption. Some attitudes were identified that could lead to antibiotic dispensing without a prescription. These attitudes are complacency, precaution and external complacency., Conclusions: Portuguese pharmacists perceive that antibiotic use and bacterial resistance could be improved, showing a behavioural intention to improve antibiotic dispensing habits.

Background: Underreporting is the major limitation of a voluntary adverse drug reaction (ADR) reporting system. Many studies have assessed the effectiveness of different interventions designed to reduce underreporting., Objective: We aimed to conduct a critical review of papers that assessed the effectiveness of different strategies to increase ADR reporting, regardless of the health professionals or patients included., Data Sources: Scientific papers were selected after a search of the MEDLINE-PubMed and EMBASE scientific databases up to 7 December 2010., Study Selection: We included papers in English, French or Spanish that analysed an intervention aimed at increasing the number of reported ADRs, and quantify the results of the intervention in terms of number of reports., Data Extraction: The abstracts retrieved in both computerized searches were reviewed independently by two of the authors. Initially selected papers were thoroughly read to evaluate if they met inclusion and exclusion criteria. Data in finally selected papers were independently extracted by both authors and set in pre-designed tables. A third author took the final decision in case of disagreement. For each study, we analysed study design, type of intervention, assessment period, and results of the intervention., Results: Of the 4,221 papers located that fulfilled the search criteria, 43 met the selection criteria. With the exception of one study, the interventions assessed were deemed to be effective. The vast majority of papers displayed methodological and formal limitations that lowered the grade of evidence. Multiple interventions seem to have had more impact than did single interventions. There were very few cases in which interventions were designed on the basis of inappropriate attitudes and mistaken beliefs about ADRs., Conclusions: In general, there is a need for studies of better methodological quality in this topic, so that more evidence of the effectiveness of the respective strategies can be collected for the purpose of improving ADR reporting by health professionals. It is probable that multiple interventions cause greater increases in the ADR reporting rates than single.

Inappropriate prescription has been associated with mounting rates of antibiotic resistance worldwide, demanding more detailed studies into physicians' decision-making process. Accordingly, this study sought to explore physicians' perceptions of factors influencing antibiotic prescribing. A systematic search was performed for qualitative studies focused on understanding physicians' perceptions of the factors, attitudes and knowledge influencing antibiotic prescription. Of the total of 35 papers selected for review purposes, 18 solely included physicians and the remaining 17 also included patients and/or other healthcare providers. Data collection was based mainly on interviews, followed by questionnaires and focus groups, and the methodologies mainly used for data analysis were grounded theory and thematic analysis. Factors cited by physicians as having an impact on antibiotic prescribing were grouped into those that were intrinsic (group 1) and those that were extrinsic (group 2) to the healthcare professional. Among the former, physicians' attitudes, such as complacency or fear, were rated as being most influential on antibiotic prescribing, whilst patient-related factors (e.g. signs and symptoms) or healthcare system-related factors (e.g. time pressure and policies/guidelines implemented) were the most commonly reported extrinsic factors. These findings revealed that: (i) antibiotic prescribing is a complex process influenced by factors affecting all the actors involved, including physicians, other healthcare providers, healthcare system, patients and the general public; and (ii) such factors are mutually dependent. Hence, by shedding new light on the process, these findings will hopefully contribute to generating new and more effective strategies for improving antibiotic prescribing and allaying global concern about antibiotic resistance., (Copyright © 2012 Elsevier B.V. and the International Society of Chemotherapy. All rights reserved.)

Background: Adverse drug reactions are a major public health problem. Underreporting is an important limitation of all reporting systems, partially due to attitudes of health professionals., Objective: This study sought: (1) to evaluate the reproducibility of a questionnaire on attitudes to and knowledge of adverse drug reaction (ADR) reporting among physicians, nurses and pharmacists: and (2) to compare the attitudes and knowledge of these three groups of health professionals., Methods: This study targeted a sample of physicians (n = 30), nurses (n = 30) and pharmacists (n = 20) in the central region of Portugal. A structured questionnaire was administered to each health professional twice, at an interval of 2-4 weeks. Most attitudes were based on Inman's 'seven deadly sins' and measured using a continuous visual analog scale (VAS), with answers scored from 0 (total disagreement) to 10 (total agreement). Questionnaire reproducibility was determined using the intraclass correlation coefficient (ICC)., Results: The response rate was 100 %. Attitudes that registered the highest ICCs were Complacency (the belief that really serious ADRs are well documented by the time a drug is marketed) (physicians, ICC 0.84; nurses, ICC 0.70; pharmacists, ICC 0.99), and Diffidence (the belief that one would only report an ADR if one were sure that it was related to the use of a particular drug) (physicians, ICC 0.73; nurses, ICC 0.65; pharmacists, ICC 0.98). In most cases, there were no differences among the three groups of professionals in terms of attitudes and knowledge., Conclusions: The Horizontal continuous VAS is reliable to detect the knowledge and attitudes about ADRs.

In Portugal, the National Pharmacovigilance System (NPS) was created in 1992, completing during this year 20 years of existence. Having been established in a centralized manner, it soon became aware that its geographic decentralization would bring advantages in terms of proximity of the System to health professionals as well as the involvement of the universities. The NPS currently has four regional pharmacovigilance centres, which cover the entire mainland, which became centers of scientific vocation, carrying out pharmacoepidemiological studies in the area of drug safety. Also, they are the guarantee of proper collection, processing and evaluation of spontaneous reports of adverse drug reactions (ADRs), as well as the continuing disclosure of the System among health professionals and promotion of spontaneous reporting. Over these 20 years, the NPS has been adapting to the EU requirements in the area of pharmacovigilance, and is currently a mature and well implemented system, with the objectives of the evaluation of the safety profile of marketed drugs and triggering of actions to reduce the risk of these drugs. From the second half of 2012, new adaptation will be run with the implementation of recent European legislation on Pharmacovigilance, published in December 2010. Among other changes, there is the possibility for consumers to report their suspicious of ADR directly to the NPS (exclusive, so far, to health professionals). This work aims to be a reflection about the evolution of the National Pharmacovigilance System and its growing importance in the protection of public health.

Objective: To evaluate the results of an intervention to improve the number and relevance of reports of adverse drug reactions., Methods: A cluster-randomized controlled trial was conducted with pharmacists working in Northern Portugal, in 2007. After randomization, 364 individuals were placed into the intervention group (261 in telephone interviews and 103 in workshops), while the control group was comprised of 1,103 pharmacists. The following were approached in the educational intervention: the problem of adverse drug reaction, the impact on public health and spontaneous reporting. With regard to relevance, adverse reactions were classified into severe and unexpected. Statistical analysis was performed, based on the intention-to-treat principle; generalized linear mixed models were applied, using the penalized quasi-likelihood method. The pharmacists studied were followed during a period of 20 months., Results: The intervention increased the rate of spontaneous reporting of adverse reactions three times (RR = 3.22; 95% CI 1.33;7.80), when compared to the control group. The relevance of reporting rose, with an increase in severe adverse reactions by approximately four times (RR = 3.87; 95% CI 1.29;11.61) and in unexpected adverse reactions by five times (RR = 5.02; 95% CI 1.33;18.93), compared to the control group., Conclusions: During a period of up to four months, educational interventions significantly increased the number and relevance of spontaneous reporting of adverse drug reactions by pharmacists in Northern Portugal.

The use of herbal complementary and alternative medicines is growing among Portuguese cancer patients, contributing to a higher risk for unwanted interactions, especially due to the narrow therapeutic index of most oncolytic drugs. A literature review was carried out in order to determine which medicinal plants are most commonly used by cancer patients, in Europe and USA, and their risk of interaction with the multiple medications taken by those patients. The collected information reveals a high degree of herb-drug interaction suggesting that patients under antineoplastic treatments should avoid the concomitant use of herbal medicines. These findings show that it is extremely important to have a clear knowledge of the herbal complementary and alternative medicines used by Portuguese cancer patients and to assess healthcare professionals' familiarity and attitude towards its use by cancer patients.

Introduction: Pharmacists can play a fundamental role in adverse drug reaction (ADR) reporting, although the factors that affect underreporting among these professionals are unknown. The objectives of this study were to identify (i) professional or demographic characteristics; and (ii) attitudes associated with pharmacists' ADR reporting in northern Portugal., Methods: We conducted a case-control study on a population of pharmacists employed in hospital and community pharmacies across Portugal's Northern Regional Health Authority catchment area in 2003. Cases (n=34) comprised pharmacists who had reported at least one ADR to the northern region's drug surveillance unit, and controls (n=280) were randomly sampled from pharmacists who had never reported an ADR. All were interviewed using a mail questionnaire. Most attitudes were based on Inman's 'seven deadly sins' and were measured using a continuous visual analogue scale. Answers were recorded in a range from 0 (total disagreement) to 10 (total agreement). Logistic regression was used to determine the ADR reporting adjusted odds ratio (OR) for a change in exposure corresponding to the interquartile range for each attitude., Results: The response rate was 86.8%. Reporting probability proved higher among hospital versus community pharmacists (adjusted OR 20.0; 95 CI 3.3, 125.0; p<0.001). Attitudes to ADRs were strongly associated with reporting probability. Hence, an interquartile decrease in any of the following attitudes increased the probability of reporting by (i) 223% (95% CI 51, 595; p < 0.05) for "Really serious ADRs are well documented by the time a drug is marketed"; (ii) 240% (95% CI 89, 508; p=0.002) for "I would only report an ADR if I were sure that it was related to the use of a particular drug"; (iii) 316% (95% CI 44, 1104; p=0.010) for "It is only necessary to report serious or unexpected ADRs"; and (iv) 171% (95% CI 13, 549; p=0.020) for "I do not have time to think about the involvement of the drug or other causes in ADRs"., Conclusions: ADR under-reporting is strongly associated with certain attitudes, possibly indicating that under-reporting could be minimised through educational interventions targeted at changing such attitudes. Pharmacists' ADR education must be improved and educational programmes should be focused on altering attitudes identified by the study as being associated with under-reporting. Our data also indicate that community pharmacists must be a priority target for this intervention.

Objectives: Voluntary adverse drug reaction (ADR) reporting is fundamental to medical drug safety surveillance; however, substantial under-reporting exists and is the main limitation of the system. This study sought to identify the knowledge- and attitude-related factors associated with ADR reporting by physicians in Northern Portugal., Methods: Case-control study covering a population of National Health Service medical practitioners. The 88 cases comprised physicians who had reported at least one ADR to the drug surveillance unit from the year 2000 to the date of enrolment in the study. The 771 controls were randomly selected from among the remaining physicians. All interviews were conducted using a self-administered questionnaire. Knowledge and attitudes regarding spontaneous ADR reporting were based on Inman's 'seven deadly sins'. Agreement with the questions included in the questionnaire was measured using a horizontal, continuous visual analogue scale, which was unnumbered. Recorded answers were read in a range from zero (total disagreement) to ten (total agreement). We used logistic regression to determine the ADR reporting adjusted odds ratio (ORadj) for a change in exposure corresponding to the interquartile range for each attitude., Results: A total of 397 questionnaires were received from 731 eligible practitioners (54.3%). Physicians who worked in primary versus hospital care (ORadj 7.74 [95% CI 1.85, 32.30]) and in general medicine (ORadj 1.05 [95% CI 0.30, 3.69]) versus medical specialities were more likely to report ADRs. In contrast, physicians working in the medical-surgical/surgical fields were significantly less likely to report ADRs compared with medical specialists (ORadj 0.10 [95% CI 0.02, 0.46]). Attitudes to ADRs were strongly associated with reporting probability. Hence, an interquartile decrease in any of the following attitudes increased the probability of reporting by: (i) 87% (p < 0.05) for complacency (the belief that really serious ADRs are well documented by the time a drug is marketed); (ii) 109% (p < 0.01) for insecurity (the belief that it is nearly impossible to determine whether a drug is responsible for a particular adverse reaction); (iii) 143% (p < 0.001) for diffidence (the belief that one would only report an ADR if one were sure that it was related to the use of a particular drug); (iv) 220% (p < 0.001) for indifference (the belief that the one case an individual doctor might see could not contribute to medical knowledge); and (v) 71% (p < 0.05) for ignorance (the belief that it is only necessary to report serious or unexpected ADRs)., Conclusion: This study shows that there are attitudes strongly associated with under-reporting. The implementation of purpose-designed educational interventions based on the attitudes identified in this study may serve to improve reporting substantially.

Rationale, Aims and Objectives: The spontaneous reporting of adverse drug reactions (ADRs) through the yellow card and made concrete by the knowledge and attitudes of doctors, has been rousing a great deal of bibliographical interest in recent years. However, there does not seem to be any actual revision in the theme on which the theoretical models that explain the process of decision in reporting are proposed. In this work an explanatory model of the factors that condition reporting is proposed and a revision of the literature on the subject has also been carried out., Methods: The proposed model is centralized in the medical professional and it considers the habit of reporting as the result of the doctor's formation and his interaction with the environment. The combination of knowledge-attitudes-practices and the theory of the satisfaction of needs seemed very adequate for ADR systematization., Results and Conclusions: The results also indicate that, to improve the participation of health professionals in surveillance systems through spontaneous reporting, it might be necessary to design combined strategies that modify both intrinsic (knowledge, attitudes) and extrinsic (relationship between health professionals and their patients, the national health system and pharmaceutical companies) factors.