Pharmacovigilance workflow in Europe and Italy and pharmacovigilance terminology

The terminology used in pharmacovigilance can cause confusion, because there are similar terms that describe different phenomena (e.g. adverse reactions, adverse drug reactions, and side effects). Incorrect use of terminology can have negative effects on the reporting of adverse drug reactions and on the interpretation of these reports. To explain the most common terms used in pharmacovigilance, this article first describes the pharmacovigilance workflow process in the European Union and, as an example, in Italy. Then, the article reviews common pharmacovigilance terms.     

An historical overview over Pharmacovigilance

Pharmacovigilance started about 170 years ago, although it was not yet named as such at that time. It is structured activity in the professional health field, with important social and commercial implications aimed at monitoring the risk/benefit ratio of drugs, improving patient’s safety and the quality of life. In this commentary we report the milestones of pharmacovigilance up to the present day, in order to understand all the steps that have characterized the historical evolution; from the first reports, which were essentially letters or warnings sent by clinicians to publishers of important and famous scientific journals, up to today’s modern and ultra-structured electronic registries. The historical phases also help us to understand why pharmacovigilance helped us to achieve such important results for man’s health and for pharmacology itself, and to identify the challenges that await Pharmacovigilance in future years.     

Effectiveness of antibiotic therapy in pediatric patients with cat scratch disease

Background Appropriate antibiotic treatment of cat scratch disease (CSD) in pediatrics is not well established. Objective The purpose of this study was to evaluate the response rates of antibiotic therapy in pediatrics with CSD. Methods The electronic medical records of a cohort of pediatric patients with confirmed diagnosis of CSD (2006–2016) were reviewed, retrospectively. Data collection included patient demographics, clinical and laboratory results, antibiotic treatment and follow-up evaluations. Results One hundred and seventy-five patients (aged 7.4?±?4.4 years) had confirmed CSD. Azithromycin and trimethoprim/sulfamethoxazole (TMP/SMX) were the largest groups with documented effectiveness at follow-up visits. Resolution and improvement of CSD was observed in 51.4% and 61.5% of patients with azithromycin and TMP/SMX, respectively among those with follow-up assessment. The effectiveness of azithromycin and TMP/SMX was comparable (p?=?0.56). Conclusion Azithromycin and TMP/SMX were most frequently prescribed antibiotics. Azithromycin appeared to be an appropriate option for the treatment of CSD. TMP/SMX may be considered as an alternative antibiotic when azithromycin cannot be used.     

Population pharmacokinetics of theophylline in adult Chinese patients with asthma and chronic obstructive pulmonary disease

Background Theophylline has a narrow therapeutic range and large interindividual variability in blood levels, so a thorough understanding of its pharmacokinetic characteristics is essential. Population pharmacokinetic (PPK) approaches could achieve it and many PPK studies of theophylline have been reported in infants. However, none was conducted in Chinese adults and none has explored the effect of CYP1A2 genotypes on the PPK characteristics of theophylline in adults. Objective To evaluate the PPK characteristics of theophylline and to assess the possible influence of covariates, including CYP1A2 genotypes, on theophylline clearance in Chinese adult patients. Setting The study is conducted at the department of respiration in Zhujiang Hospital, Guangzhou, China. Methods Theophylline concentrations were obtained from eligible patients and were measured by high performance liquid chromatography. The polymorphisms of ??3860G?>?A, ??163C?>?A, C5347T (CYP1A2*1B) and G-3113A were genotyped using a direct sequencing method. Then, CYP1A2 genotypes, age, fat-free mass (FFM) and other covariates were used to develop a PPK model by NONMEM software. Bootstrap analysis was used to asses the accuracy and prediction of the PPK model. Main outcome measure The concentration and clearance of theophylline. Results A total of 134 theophylline concentrations from 95 patients were obtained. The final model was as follows: CL/F(L/h)?=?4.530?×?(FFM/56.1)^0.75 ×?0.713^CYP1A2*1B, the inter-individual variability in clearance/bioavailability (CL/F) was 44.0%, and the residual variability was 9.8%. The final model was proved to be reliable by bootstrap analysis. Conclusion Theophylline clearance was significantly associated with FFM and CYP1A2*1B genotypes in Chinese adult patients.     

Introducing Motivational Interviewing in a Sickness Insurance Context: Translation and Implementation Challenges

Purpose Motivational interviewing (MI) is a conversational method to support clients in need of behavioral change. In an organizational reform, most Swedish sickness insurance officials were trained in MI to promote clients’ return to work (RTW) after sick leave. The aim of this article is to investigate experiences of introducing MI as a tool to promote clients’ RTW within a sickness insurance context, with special focus on the translation and implementation of the method. Methods A qualitative approach, comprising 69 interviews with officials, managers, and regional coordinators on two occasions. The material was analyzed through qualitative content analysis. Results Officials were positive about MI, but the application was limited to using certain tools with extensive individual variation. Officials struggled with translating MI into a sickness insurance context, where the implementation strategy largely failed to offer adequate support, due to low managerial priority, competing initiatives, and a high workload. Results of the educational intervention could therefore be seen on an individual but not an organizational level. Conclusions In order to translate MI into a sickness insurance context, training needs to be supported by organizational approaches that promote collective learning and sharing of experiences among officials. The results also illustrate how a method cannot be assumed to be implemented simply because training has been provided. Consequently, the application of the method needs to be carefully monitored in studies of interventions where MI is claimed to be used, in order to measure its effectiveness.     

Modeling Clinical Outcomes in Prostate Cancer: Application and Validation of the Discrete Event Simulation Approach

Objectives

Treatment landscape in prostate cancer has changed dramatically with the emergence of new medicines in the past few years. The traditional survival partition model (SPM) cannot accurately predict long-term clinical outcomes because it is limited by its ability to capture the key consequences associated with this changing treatment paradigm. The objective of this study was to introduce and validate a discrete-event simulation (DES) model for prostate cancer.

Practices and Processes Used in the Return to Work of Injured New South Wales nurses: Are These Consistent With RTW Best Practice Principles?

Purpose Workplace injury and illness rates are high within the nursing profession, and in conjunction with current nursing shortages, low retention rates, and the high cost of workplace injury, the need for effective return to work (RTW) for injured nurses is highlighted. This study aimed to identify current practices and processes used in the RTW of injured nurses, and determine if these are consistent with the seven principles for successful RTW as described by the Canadian Institute for Work & Health. Method As part of a larger cross-sectional study, survey data were collected from New South Wales nurses who had sustained a major workplace injury or illness. Survey questions were coded and matched to the seven principles for successful RTW. Results Of the 484 surveys eligible for analysis, most were from Registered Nurses (52%) in the Public Hospital Sector (48%). Responses indicated four main areas of concern: a commitment to health and safety by the workplace; early and considerate employer contact; provision of modified work; and individual knowledge of and involvement in the RTW process. Positive participant responses to co-worker and supervisor involvement were identified as areas consistent with best practice principles. Conclusions These findings suggest the practices and processes involved in the RTW of injured nurses are inconsistent with best practice principles for RTW, highlighting the need for interventions such as targeted employer education and training for improved industry RTW outcomes.     

Maternal Depressive Symptoms Mediate the Association between Socio-economic Status and Adolescent Weight Outcomes: A Longitudinal Analysis

Introduction The prevalence of pediatric obesity is an issue in the United States, in which approximately one-third of children and adolescents are overweight or obese. Youth living in low socioeconomic (SES) households are at an increased risk for developing obesity; yet, research is needed to understand the mechanisms that might better explain the relationship between SES and obesity risk. Maternal depression presents a potential mechanism by which SES might predict a later risk for obesity in pediatric populations. Methods The present study used a national dataset from the National Institute of Child Health and Human Development—Study of Early Child Care and Youth Development (NICHD-SECCYD) to examine whether maternal depressive symptoms (at an age of 9 years) mediated the association between early SES (the income-to-needs ratio measured at an age of 1 month) and adolescent weight outcomes [Body Mass Index z-scores (zBMI) for age and sex, at an age of 15 years]. Results The results suggested that greater maternal depressive symptoms helped to explain a significant amount of the variance of lower SES predicting poorer weight outcomes in adolescents. Discussion These findings illustrate the role of maternal depressive symptoms in explaining how SES predicts adolescent weight outcomes. Implications are discussed, and future research is needed to identify women from lower SES households who are experiencing depressive symptoms to provide support and initiate points of early intervention to address relevant health outcomes in youths.     

Exploring Lactation Consultant Views on Infant Safe Sleep

Objectives The purpose of this qualitative study was to explore the infant safe sleep beliefs and occupational practices of lactation consultants and to determine if lactation consultants give advice to clients that is consistent with the American Academy of Pediatrics’ recommendations on this topic. Methods Focus groups were conducted with certified lactation consultants in two cities in Ohio. Participants discussed the role of lactation consultants, the infant sleep advice they provide to women, their views on the American Academy of Pediatrics’ infant safe sleep recommendations and related policies, and perceived benefits and barriers associated with providing infant safe sleep education as part of their work. A member-checking session was held to ensure the credibility of the findings. Results Four focus groups were conducted with 22 certified lactation consultants between September and November 2015. Major themes that emerged included: lactation consultants’ beliefs regarding the importance of bedsharing for supporting breastfeeding success; their disagreement with the infant safe sleep recommendations of the American Academy of Pediatrics; their frustration with policies that restrict consultants’ ability to discuss bedsharing; and the impact of infant safe sleep policies on their work and the advice they provide. Conclusions for Practice Lactation consultants interact with mothers of newborns at a critical time for infant safe sleep decision-making and may influence a woman’s choices related to this topic. Women may not be receiving messages from lactation consultants that are consistent with the infant safe sleep recommendations of the American Academy of Pediatrics.