Product Surveillance, Postmarketing

Publication Title: 
Drug Safety

Vitex agnus castus L. (VAC) [Verbenaceae] is a deciduous shrub that is native to Mediterranean Europe and Central Asia. Traditionally, VAC fruit extract has been used in the treatment of many female conditions, including menstrual disorders (amenorrhoea, dysmenorrhoea), premenstrual syndrome (PMS), corpus luteum insufficiency, hyperprolactinaemia, infertility, acne, menopause and disrupted lactation. The German Commission E has approved the use of VAC for irregularities of the menstrual cycle, premenstrual disturbances and mastodynia.

Author(s): 
Daniele, Claudia
Thompson Coon, Joanna
Pittler, Max H.
Ernst, Edzard
Publication Title: 
Pharmacoepidemiology and Drug Safety

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.

Author(s): 
H‰rmark, Linda
Lie-Kwie, Miguel
Berm, Lisette
de Gier, Han
van Grootheest, Kees
Publication Title: 
Malaria Journal

BACKGROUND: In Sudan, chloroquine (CQ) remains the most frequently used drug for falciparum malaria for more than 40 years. The change to artemisinin-based combination therapy (ACT) was initiated in 2004 using the co-blister of artesunate + sulfadoxine/pyrimethamine (AS+SP) and artemether + lumefantrine (ART+LUM), as first- and second-line, respectively. This article describes the evidence-base, the process for policy change and it reflects the experience of one year implementation. Relevant published and unpublished documents were reviewed.

Author(s): 
Malik, E. M.
Mohamed, T. A.
Elmardi, K. A.
Mowien, R. M.
Elhassan, A. H.
Elamin, S. B.
Mannan, A. A.
Ahmed, E. S.
Publication Title: 
Malaria Journal

BACKGROUND: Artemisinin-derivative formulations are now widely used to treat falciparum malaria. However, the dry powder suspensions developed for children are few and/or are of poor quality. In addition to the active compound, the presence of a suitable preservative in these medicines is essential. In this study, an evaluation of the preservative content and efficacy in some dry suspensions available on the Kenyan market was performed. METHOD: UV spectrophotometry was used to identify the preservatives in each sample while HPLC-UV was used for quantification.

Author(s): 
Atemnkeng, Magnus A.
De Cock, Katelijne
Plaizier-Vercammen, Jacqueline
Publication Title: 
Journal of Clinical Pharmacy and Therapeutics

BACKGROUND AND OBJECTIVE: There are several reports of sub-standard and counterfeit antimalarial drugs circulating in the markets of developing countries; we aimed to review the literature for the African continent. METHODS: A search was conducted in PubMed in English using the medical subject headings (MeSH) terms: 'Antimalarials/analysis'[MeSH] OR 'Antimalarials/standards'[MeSH] AND 'Africa'[MeSH]' to include articles published up to and including 26 February 2007.

Author(s): 
Amin, A. A.
Kokwaro, G. O.
Publication Title: 
Malaria Journal

BACKGROUND: Pharmacovigilance programmes can monitor and help ensure the safe use of medicines that are critical to the success of global public health programmes. The widespread deployment of artemisinin-based combination therapy (ACT) by national malaria control programmes as part of the overall Global Malaria Action Plan for malaria control to elimination and eradication makes ACT an excellent candidate for pharmacovigilance activities. In 2008, The Roll Back Malaria partnership issued guidelines for inclusion of pharmacovigilance in Global Fund and other related proposals.

Author(s): 
Stergachis, Andy
Bartlein, Rebecca J. K.
Dodoo, Alexander
Nwokike, Jude
Kachur, S. Patrick
Publication Title: 
Toxicology

Currently, the regulation of complementary and alternative medicines and related health claims in Australia and New Zealand is managed in a number of ways. Complementary medicines, including herbal, minerals, nutritional/dietary supplements, aromatherapy oils and homeopathic medicines are regulated under therapeutic goods/products legislation. The Therapeutic Goods Administration (TGA), a division of the Commonwealth Department of Health and Ageing is responsible for administering the provisions of the legislation in Australia.

Author(s): 
Ghosh, Dilip
Skinner, Margot
Ferguson, Lynnette R.
Publication Title: 
Annals of the New York Academy of Sciences

Forms of menstrual protection have evolved with time. Today's disposable feminine hygiene products, notably sanitary pads, include a wide range of designs and features to meet women's needs for reliable, discreet, and comfortable protection. Manufacturers support substantive research and testing programs to ensure the safety of these products.

Author(s): 
Farage, Miranda A.
Publication Title: 
Pharmacoepidemiology and Drug Safety

PURPOSE: The purpose of this report is to characterize reports to poison control centers (PCCs) involving two widely used herbal dietary supplements (HDSs), Echinacea, and St. John's wort (SJW). METHODS: We purchased data from the American Association of Poison Control Center's (AAPCC) toxic exposure surveillance system (TESS(R)) on reports made to PCCs in 2001 involving Echinacea or SJW. Analyses were limited to those cases in which Echinacea or SJW were the only associated products, and in which these HDSs were deemed primary to observed adverse effects.

Author(s): 
Gryzlak, Brian M.
Wallace, Robert B.
Zimmerman, M. Bridget
Nisly, Nicole L.
Publication Title: 
Homeopathy: The Journal of the Faculty of Homeopathy

BACKGROUND: The homeopathic method is based on the application of the principle of therapeutic similitude (similia similibus curentur), using medicines that cause effects similar to the symptoms of disease in order to stimulate the reaction of the organism against disturbances. Such vital, homeostatic or paradoxical reaction of the organism can be scientifically explained on the basis of the rebound effect of modern drugs. AIMS: This article presents the conclusion of a study aiming at a method to use modern drugs with homeopathic criteria.

Author(s): 
Teixeira, Marcus Zulian

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