Adverse Drug Reaction Reporting Systems

Echinacea spp. are native to North America and were traditionally used by the Indian tribes for a variety of ailments, including mouth sores, colds and snake-bites. The three most commonly used Echinacea spp. are E. angustifolia, E. pallida and E. purpurea. Systematic literature searches were conducted in six electronic databases and the reference lists of all of the papers located were checked for further relevant publications. Information was also sought from the spontaneous reporting programmes of the WHO and national drug safety bodies.

OBJECTIVE: To apply the Bradford Hill criteria, which are widely used to establish causality between an environmental agent and disease, to evaluate the relationship between over-the-counter intranasal zinc gluconate therapy and anosmia. DESIGN: Patient and literature review applying the Bradford Hill criteria on causation. SETTING: University of California, San Diego, Nasal Dysfunction Clinic.

OBJECTIVE: To evaluate the safety of homeopathic medicines by critically appraising reports of adverse effects published in English from 1970 to 1995. METHOD: Systematic review on information regarding adverse effects of homeopathic medicines identified using electronic databases, hand searching, searching reference lists, reviewing the bibliography of trials, and other relevant articles, contacting homeopathic pharmaceutical companies and drug regulatory agencies in UK and USA, and by communicating with experts in homeopathy.

OBJECTIVES: Morbidity in Traditional Chinese Medicine (TCM) research is an emerging field. Few studies have been published, and there is a lack of international standards for data collection and reporting. Based on the experience of developing a computerized system for patient data collection at the University of Technology, Sydney, (UTS) Acupuncture Clinic (Sydney, Australia), and reporting results from that database, a start can be made toward developing guidelines for reporting similar results from TCM clinical audits.

OBJECTIVES: Morbidity in Traditional Chinese Medicine (TCM) research is an emerging field. Few studies have been published, and there is a lack of international standards for data collection and reporting. Based on the experience of developing a computerized system for patient data collection at the University of Technology, Sydney, (UTS) Acupuncture Clinic (Sydney, Australia), and reporting results from that database, a start can be made toward developing guidelines for reporting similar results from TCM clinical audits.

OBJECTIVE: To evaluate the personality characteristics of a group of participants in Phase 1 studies and to study the relation between the personality traits and the adverse events during participation. METHODS: Study population consisted of 139 healthy volunteers to Phase 1 studies. Personality was assessed through the Revised NEO Personality Inventory (NEO-PI-R) and adverse events were monitored during participation.

WHAT IS KNOWN AND OBJECTIVE: Adverse drug reactions to prescribed medication are relatively common events. However, the impact such reactions have on patients and their attitude to reporting such events have only been poorly explored. Previous studies relying on self-reporting patients indicate that altruism is an important factor. In the United Kingdom, patient reporting started in 2005; though, numbers of serious reports remain low.

PURPOSE: Web-based intensive monitoring is a method to actively collect information about adverse drug reactions (ADRs) using patients as a source of information. To date, little is known about patients' motivation to participate in this kind of active post-marketing surveillance (PMS). Increased insight in this matter can help us to better understand and interpret patient reported information, and it can be used for developing and improving patient-based pharmacovigilance tools.

Pharmacovigilance, defined as "the science and activities relating to the detection, assessment, understanding and prevention of adverse effects or any other possible drug related problem", is increasingly being recognized in Africa. Many African countries have simultaneously adopted artemisinin derivative based combination therapy (ACT) as first-line treatment for uncomplicated malaria, offering an opportunity to assess the safety of these drugs when used widely.

BACKGROUND: New antimalarial regimens, including artemisinin-based combination therapies (ACTs), have been adopted widely as first-line treatment for uncomplicated malaria. Although these drugs appear to be safe and well-tolerated, experience with their use in Africa is limited and continued assessment of safety is a priority. However, no standardized guidelines for evaluating drug safety and tolerability in malaria studies exist. A system for monitoring adverse events in antimalarial trials conducted in Uganda was developed.