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{
    "id": 1494124,
    "url": "https://info.mzalendo.com/api/v0.1/hansard/entries/1494124/?format=api",
    "text_counter": 561,
    "type": "speech",
    "speaker_name": "Endebess, UDA",
    "speaker_title": "Hon. (Dr) Robert Pukose",
    "speaker": null,
    "content": "events may be detected by asking the patient directly or screening patient records; “adverse drug reaction” means a response to a drug which is noxious and unintended, and which occurs at doses normally used in humans for the prophylaxis, diagnosis or therapy of disease, or for the modification of physiological function and is characterized by the suspicion of a causal relationship between a medical product and an occurrence; “adverse event” means any untoward medical occurrence that may present during treatment with a pharmaceutical product, but which does not necessarily have a causal relationship with the treatment; “alternative medicine” means complementary medicine and includes a broad set of health care practices that are not part of Kenya’s tradition and are not integrated into dominant health care system; “biologicals” means a diverse group of medicines which includes vaccines, growth factors, immune modulators, monoclonal antibodies and includes products derived from human blood and plasma; “Board” means the Board of the Authority established under section 8; “Centre” means the National Pharmacovigilance Centre established under section 59B; “clinical trial” means any systematic study on pharmaceutical products in human subjects, whether in patients or other volunteers, in order to discover or verify the effects of, identify any adverse reaction to investigational products, study the absorption, distribution, metabolism and excretion of the products with the object of ascertaining their efficacy and safety; “dietary supplement” means a product taken by mouth that is added to the diet to help meet daily requirements of essential nutrients, and which usually contains one or more dietary ingredient and includes vitamins, minerals and herbs; “enrolled pharmaceutical technologist” means a person enrolled as such by the body for the time being responsible for the enrolment of pharmaceutical technologists; “falsified medical product” means a product that is deliberately or fraudulently misrepresented in relation to its identity, composition or source; “Field Safety Corrective Action” means any action taken by a product owner to reduce a risk of death or serious deterioration in the state of health associated with the use of a medical device, and includes— (a) the return of a medical device to the product owner or its representative; (b) device modification which may include— (i) retrofit in accordance with the product owner’s modification or design change; The electronic version of the Official Hansard Report is for information purposesonly. A certified version of this Report can be obtained from the Hansard Editor."
}