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Aim: To explore nurses' experiences of handling medications in paediatric clinical practice, with a focus on factors that hinder and facilitate safe medication practices., Methods: Twenty nurses (registered nurses) from four paediatric wards at two hospitals in Sweden were interviewed in focus groups. The interviews were analysed using content analysis., Results: Six themes emerged from the analysed interviews: the complexity specific for nurses working on paediatric wards is a hindrance to safe medication practices; nurses' concerns about medication errors cause a considerable psychological burden; the individual nurse works hard for safe medication practices and values support from other nurse colleagues; circumstances out of the ordinary are perceived as critical challenges for maintaining patient safety; nurses value clear instructions, guidelines and routines, but these are often missing, variable or changeable; management, other medical professionals, the pharmacy, the pharmaceutical industry and informatics support need to respond to the requirements of the nurses' working situations to improve safe medication practices., Conclusion: Weaknesses were apparent in the long chain of the medication-delivery process. A joint effort by different professions involved in that delivery process, and a nationwide collaboration between hospitals is recommended to increase safe medication practices in paediatric care., (©2013 Foundation Acta Paediatrica. Published by Blackwell Publishing Ltd.)

Background: As a first step towards implementing routine screening of safety issues specifically related to children at the Uppsala Monitoring Centre, this study was performed to explore reporting patterns of adverse reactions in children., Objective: The first aim of this study was to characterize and contrast child reports against adult reports in an overall drug and adverse reaction review. The second aim was to highlight increases in reporting of specific adverse reactions during recent years subdivided by age group., Study Design: This was an exploratory study of internationally compiled individual case safety reports (ICSRs)., Setting: Reports were extracted from the WHO global ICSR database, VigiBase, up until 5 February 2010. The reports in VigiBase originate from 97 countries and the likelihood that a medicine caused the adverse effect may vary from case to case. Suspected duplicate and vaccine reports were excluded from the analysis, as were reports with age not specified. The Medical Dictionary for Regulatory Activities (MedDRA®) and the WHO Anatomical Therapeutic Chemical (ATC) classification were used to group adverse reactions and drugs., Patients: In the general review, reports from 1968 to 5 February 2010 were divided into child (aged 0-17 years) and adult (≥ 18 years) age groups. To highlight increases in reporting rates of specific adverse reactions during recent years, reports from 2005 to February 2010 were compared with reports from 1995 to 1999. The ten adverse reactions with the greatest difference in the proportion of reports between the two time periods were reviewed. In the latter analysis, the reports were subdivided into age groups: neonates ≤ 27 days; infants 28 days-23 months; children 2-11 years; and adolescents 12-17 years., Results: A total of 3,472,183 reports were included in the study, of which 7.7% (268,145) were reports for children (0-17 years). Fifty-three percent of the child reports were for males, whilst 39% of reports in the adult group were for males. The proportion of reports involving children among Asian reports was 14% and was 15% among reports from Africa and Latin America, including the Caribbean. Among reports from North America, Oceania and Europe, 7% of the reports involved children. For the ATC drug classification groups, the largest difference in percentage units between the child and adult groups was seen for the anti-infective (33 vs 15%), respiratory (11 vs 5%) and dermatological (12 vs 7%) drug groups. Skin reactions were most commonly reported for the children; these were recorded in 35% of all reports for children and 23% of all reports for adults. Medication error-related terms in the younger age groups were reported with an increased frequency during recent years. This was particularly noticeable for the infants aged 28 days-23 months, recorded with accidental overdose and drug toxicity. Reactions reported in suspected connection to medicines used for attention-deficit hyperactivity disorders (ADHD) completely dominated the 2- to 11-year age group and were also common for the adolescents. This study presents variations in the reporting pattern in different age groups in VigiBase which, in some cases, could be due to susceptibilities to specific drug-related problems in certain age groups. Other likely explanations might be common drug usage and childhood diseases in these age groups., Conclusions: Reports in VigiBase received internationally for more than 40 years reflect real concerns for children taking medicines. The study highlights adverse reactions with an increased reporting during recent years, particularly those connected to the introduction of ADHD medicines in the child population. To enhance patient safety, medication errors indicating administration and dosing difficulties of drugs, especially in the younger age groups, require further attention.

Objectives: This study assesses the ability of Pharmacovigilance Centres (PVCs) to detect medication errors (ME) and to proceed to building Patient Safety (PS) via their information networks and to underline the limits for this challenge., Methods: This was an exploratory study conducted in PVCs members of the World Health Organization International Drug Monitoring network. A questionnaire specifically designed for the needs of the study was sent to a network via a confidential email system. The questionnaire asked for information, progress and improvement made by PVCs in PS and ME., Results: Among the 88 countries, 21 answered. Reporting of Adverse Drug Reactions (ADRs) by health care professionals (HCP) is mandatory for 42% of PVCs. 100% of countries receive reports from HCP, 66% from patients and 24% from PCCs. ADRs reports are received by all communications means. There is an heterogeneity between countries regarding PVCs and PS activities. Among them, 4 PVCs have the prime activity of PS organization., Conclusion: PVCs are able to detect and analyze ME. There is a need to coordinate efforts between countries to optimize ME detection, and its analysis. Bridges need to be built linking PVCs, PCCs and PS organizations in order to avoid duplication of workload.

The role of patients as key contributors in pharmacovigilance was acknowledged in the new EU pharmacovigilance legislation. This contains several efforts to increase the involvement of the general public, including making patient adverse drug reaction (ADR) reporting systems mandatory. Three years have passed since the legislation was introduced and the key question is: does pharmacovigilance yet make optimal use of patient-reported safety information? Independent research has shown beyond doubt that patients make an important contribution to pharmacovigilance signal detection. Patient reports provide first-hand information about the suspected ADR and the circumstances under which it occurred, including medication errors, quality failures, and 'near misses'. Patient-reported safety information leads to a better understanding of the patient's experiences of the ADR. Patients are better at explaining the nature, personal significance and consequences of ADRs than healthcare professionals' reports on similar associations and they give more detailed information regarding quality of life including psychological effects and effects on everyday tasks. Current methods used in pharmacovigilance need to optimise use of the information reported from patients. To make the most of information from patients, the systems we use for collecting, coding and recording patient-reported information and the methodologies applied for signal detection and assessment need to be further developed, such as a patient-specific form, development of a severity grading and evolution of the database structure and the signal detection methods applied. It is time for a renaissance of pharmacovigilance. [ABSTRACT FROM AUTHOR]

The world changes continuously and pharmacovigilance as a new discipline also must change. There are new fields opening with novel challenges whilst we are still perfecting ways to manage and improve the basic challenges such as inadequate data for decision making and under-reporting. Traditional medicines, vaccines, poisoning and medication error are all aspects of the safety of medicines that we have monitored for decades, though without perhaps paying enough attention to their special aspects. There are many new stakeholders taking serious interest in pharmacovigilance outside the regulatory sphere and they often focus on improving individual patient care, rather than the more traditional concentration on broad public health. The same stakeholders are also drawing attention to other iatrogenic outcomes that should be recognised, evaluated and their outcomes compared and contrasted with medication, such as harm from medical devices. The vigilance methods used for medication are very much applicable to all these new fields, though more and different expertise will be needed to evaluate outcomes. [ABSTRACT FROM AUTHOR]

A thorough analysis of a case that involves a medication that may have caused or contributed to an adverse outcome, or a comparison of two compounds in a patent dispute, requires consideration of many processes that affect the clinical effects of a medication. These include its chemical structure, its pharmacological actions (pharmacodynamics), the pharmaceutical formulation, and its absorption, distribution, metabolism, and excretion (pharmacokinetics). They also include analysis of clinical details, including the diagnosis, the quality of the prescribing decisions, the accuracy of the prescription, dispensing, and administration of medications, and how appropriately the case was managed, including monitoring. A causality assessment should be attempted for both the general case and the particular case. Knowledge of the systems that describe a medication's mechanisms of action (EIDOS) and the dose-relationships and time-courses of adverse outcomes and individual susceptibilities to them (DoTS) can inform several aspects of the analysis. Reports should be written in clear English and should not contain statements that rely on expertise that the expert does not possess. [ABSTRACT FROM AUTHOR]