Chapter one - qualitative and quantitative risk analysis

Chapter one - qualitative and quantitative risk analysis -...

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Chapter 1 Qualitative and Quantitative Risk Analysis 1. INTRODUCTION: A NEED FOR NEW METHODS In late 2003, the World Health Organization (WHO), the Food and Agricultural Organization of the United Nations (FAO), and the World Animal Health Organisation (OIE) issued a joint report on risk analysis of human health risks arising from the use of antibiotics in food animals. Written by an expert group that included prominent opponents of animal antibiotic use and regulators from several countries, the report stated that traditional quantitative risk assessment methods are inadequate for antimicrobial resistance risk assessment, due primarily to the uncertainty, complexity and dynamic nature of biological risks and of the evolution and spread of antibiotic resistance among bacteria. It advocated using a more qualitative, expert judgment-based approach instead as a primary basis for risk management decision-making and to categorize animal antibiotics for regulatory action on the basis of human medical need. This approach was to be based largely on precautionary principles and on expert judgments about the importance of drug classes in human medicine, with classes of antibiotics judged “critically important” to be considered for maximal restriction in applications to animals. The report concluded that: “Antimicrobial resistance issues crosses (sic) many disciplines, including microbiology, toxicology and pharmacology, and risk assessment approaches for chemical and microbial contamination are not currently adequate for risk assessment on antimicrobial resistance . Therefore, when issues pertaining to antimicrobial resistance arise… the questions may need to be referred to a
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2 Chapter 1 WHO/FAO expert body for risk assessment, preferably JEMRA” (WHO, 2003, emphasis added. JEMRA is the Joint Expert Microbial Risk Assessment group that drafted the report.) It further recommended that: “A qualitative approach for risk assessment should be used to make the pre- marketing or postmarketing decision [about approval of animal antibiotics]. Depending on the outcome, the drug sponsor has the option to develop a quantitative risk assessment. ….When dealing with a high level of uncertainty, precaution should be applied in risk management.” “The consequences of antimicrobial resistance are particularly severe when pathogens are resistant to antimicrobials critically important in humans. Therefore, the expert workshop recommends that an expert clinical medical group appointed by WHO defines which antimicrobials are considered critically important in humans. … Antimicrobial classes could be classified as critically important when the drug is in a class that is the only available therapy or one of a limited number of drugs available to treat serious human disease or enteric pathogens that cause food borne disease. … Based on the criteria listed previously, a list of critically important classes of antimicrobials should include: the fluoroquinolones and 3rd generation cephalosporins for Salmonella spp. and other
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Chapter one - qualitative and quantitative risk analysis -...

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