BACKGROUND Spontaneous reporting of adverse drug reactions (ADRs) is fundamental to drug safety surveillance (pharmacovigilance); however, substantial under-reporting exists and is the main limitation of the system. Several factors could favour under-reporting. OBJECTIVE The aim of this pilot study was to assess the effect of regular visits of a Clinical Research Assistant (CRA) on the improv...

BACKGROUND Spontaneous reporting on adverse drug reactions (ADR) has been established in Malaysia since 1987, and although these reports are monitored by the Malaysia drug monitoring authority, the National Pharmaceutical Control Bureau, information about ADRs in the paediatric patient population still remains unexplored. The aims of this study, therefore, were to characterize the ADRs reported...

BACKGROUND Severe adverse drug reactions (ADRs) are an important cause of childhood morbidity and mortality. 95% of ADRs are likely not reported, less than 25% of marketed drugs can be advertised as safe and effective in children; yet over 50% of Canadian children receive prescription drugs annually. OBJECTIVES To increase understanding of reported ADRs in Canadian children. METHODS A retro...

AIMS Current trends in pharmacovigilance systems are veering towards patient involvement in spontaneous reporting of adverse drug reactions (ADRs). The aim of the current systematic review was to identify what is known and what remains unknown with respect to patient reporting to pharmacovigilance systems. METHODS A systematic literature search was conducted in PubMed, CINAHL, Journals@Ovid a...

PURPOSE To identify the prevalence and preventability of adverse drug reactions (ADRs) in an emergency ward setting in a tertiary hospital in Sweden and to what extent the detected ADRs were reported to the Medical Product Agency (MPA). METHODS In this prospective cross sectional observational study, 706 patients admitted to one of the Emergency Wards, at the Karolinska University Hospital in...

Background and objectives: Adverse drug reactions (ADRs) constitute a major problem in society and in drug therapy, both as a health care problem and as an economic burden on society. They are a common cause of short-term hospitalization, prolonged hospitalization and death, especially among the elderly. Spontaneous reporting of ADRs remains one the most effective methods for the detection of n...

OBJECTIVE To detect the adverse drug reactions (ADRs) through spontaneous reporting system in IGGMC&H, Nagpur and analyze them using World Health Organization (WHO) assessment scales. METHOD An observational, prospective study was conducted based on ADRs reported between 1st June '05 to 31st May '09 to the ADR reporting unit of the hospital. The ADRs reported by spontaneous reporting system w...

BACKGROUND To review empirical studies of adverse drug reactions (ADRs) reported to be associated with the use of medications generally licensed for treatment of attention deficit hyperactivity disorder (ADHD) symptoms in the pediatric population. METHODS PubMed, Embase, and PsycINFO(®) databases were searched from origin until June 2011. Studies reporting ADRs from amphetamine derivates, ato...

detection of probable harmful consequences arised from the usage of pharmaceutical products requires decisive, continuous and close monitoring by medical staff whom should have knowledge of adverse drug reactions and they should also have to report any suspected instances, when any kind of adverse drug reactions have been observed. this study has been carried out on the knowledge, attitude and ...

Background: Community Pharmacists are one of healthcare professionals who can play an important role in the reporting of Adverse Drug Reactions (ADRs) due to the advantageous position in terms of direct contact with the patients and specialization in medicine. Nevertheless, literatures indicated that ADRs under-reporting are common among community pharmacists in both developed and developing co...