TAILIEUCHUNG - CLINICAL PHARMACOLOGY 2003 (PART 10)

Background Definitions Causation: degrees of certainty Pharmacovigilance and pharmacoepidemiology Classification Causes Allergy in response to drugs Effects of prolonged administration: chronic organ toxicity Adverse effects on reproduction Background Cur'd yesterday of my disease I died last night of my Nature is neutral, . it has no 'intentions' towards humans, though it is often unfavourable to them. It is mankind, in its desire to avoid suffering and death, that decides that some of the biological effects of drugs are desirable (therapeutic) and others are undesirable (adverse). In addition to this arbitrary division, which has no fundamental biological basis, 1 From, The remedy worse. | SECTION 2 Unwanted effects and adverse drug reactions SYNOPSIS Background Definitions Causation degrees of certainty Pharmacovigilance and pharmacoepidemiology Classification Causes Allergy in response to drugs Effects of prolonged administration chronic organ toxicity Adverse effects on reproduction Background Cur d yesterday of my disease I died last night of my Nature is neutral . it has no intentions towards humans though it is often unfavourable to them. It is mankind in its desire to avoid suffering and death that decides that some of the biological effects of drugs are desirable therapeutic and others are undesirable adverse . In addition to this arbitrary division which has no fundamental biological basis 1 From The remedy worse than the disease. Matthew Prior 1664-1721 . unwanted effects of drugs are promoted or even caused by numerous nondrug factors. Because of the variety of these factors attempts to make a simple account of the unwanted effects of drugs must be imperfect. There is general agreement that drugs prescribed for disease are themselves the cause of a serious amount of disease adverse reactions ranging from mere inconvenience to permanent disability and death. Since drugs are intended to relieve suffering patients find it peculiarly offensive that they can also cause disease especially if they are not forewarned . Therefore it is important to know how much disease they do cause and why they cause it so that preventive measures can be taken. It is not enough to measure the incidence of adverse reactions to drugs their nature and their severity though accurate data are obviously useful. It is necessary to take or to try to take into account which effects are avoidable by skilled choice and use and which are unavoidable inherent in drug or patient . Also different adverse effects can matter to a different degree to different people. Since there can be no hope of eliminating all adverse effects of drugs it is necessary to evaluate

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