| Title | Post-marketing surveillance for adverse drug reactions: some recent aspects of interest to practitioner | |
| Authors | Charalampos T. Plessas¹, George Asimakopoulos², Antonios Charlaftis², Despina Dessou³ and Stavros T. Plessas⁴
1. Pharmakon-Press, Athens 2. Breast Cancer Department, Oncological Hospital of IKA, Athens 3. Department of Aesthetics and Cosmetology, School for Professions of Health and Welfare, Technological Educational Institution of Athens, Athens 4. University of Athens, Athens, Greece |
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| Citation | Plessas, C.T., Asimakopoulos, G., Charlaftis, A., Dessou, D., Plessas , S.T.: Post-marketing surveillance for adverse drug reactions: some recent aspects of interest to practitioner, Epitheorese Klin. Farmakol. Farmakokinet. 20(1): 12-21 (2006) | |
| Publication Date | Accepted for publication (Final version): 15 April 2006 | |
| Full Text Language | English | |
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| Keywords | Drug development, pre-marketing surveillance, adverse drug reactions, post-marketing surveillance, pharmacovigilance, methods to identify, role of clinicians, spontaneous reporting systems, MEDWATCH. | |
| Other Terms | review article | |
| Summary | All drug effects are the result of a complex interaction between the drug, the patient and his or her pathophysiological condition, and a number of extrinsic factors which can modify drug response. Al-most all effective drugs, no matter how skillfully used, can cause adverse reactions (ADRs) in some patients. Therefore, the risk of ADRs is an unavoidable consequence of any potent drug. Few ADRs are life-threatening, but almost all effective drugs, no matter how skillfully used, can cause adverse reactions in some patients. The risk of serious ADRs is generally acceptable if the disease being treated is itself very serious. The liability of a particular drug to cause ad-verse reactions, the profile of reactions and their seriousness dictate both the choice of drugs and the risks which are acceptable. The experience of the last decades has shown that a profound knowledge of a drug requires more than the pharmacological and clinical data which have been collected in order to obtain a new drug application (NDA) in USA or a drug marketing authorization in EU. This has led authorities in every country as well as international organizations to look for more appropriate means of closely and systematically monitoring the effects of drugs after their release onto market. Whether these activities are called pharmacovigilance, monitoring, post-marketing surveillance or another, the aim is always to determine, as soon as possible, the nature and frequency of any new effect of the drug, especially any adverse reaction. This activity pre-supposes a knowledge of the real conditions of use of the drug and the ordinary or accidental circumstances in which it may be used. Various surveillance programs, including cohort studies, case-control studies, meta-analyses, have been used to identify serious ADRs. This identification of ADRs consists in collecting information on the patient treated with a certain drug so that the effects can be analyzed. Spontaneous reporting systems can be effective in revealing unusual or rare adverse events, occurring with the use of drugs and such reports may often be sufficient to assign causality. Finally, the conclusions drawn from these data need to be communicated to the medical profession. | |
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