Track topics on Twitter Track topics that are important to you
The health benefits of the antimicrobial's use is inherently associated to the risk of antimicrobial resistance (AMR), an ever-increasing multifactorial problem, closely related with injudicious use of antimicrobials, and the lack of new antimicrobial medicines on the market, particularly for veterinary use. Currently, an increasing number of regulatory "One Health" action plans on AMR are running worldwide, already based on monitoring and surveillance systems for resistance and antimicrobials consumption. Such plans are still not mandatory in the European Union member States (EU-MS), but post marketing annual programmes for quality controls of medicines are, to verify and ensure full compliance with the marketing authorizations. The European "risk level" sampling is not based on the conventional risk-ranking process of severity factors vs the probability of occurrence, but instead, on the conviction that in the European Union (EU) all medicines are produced under good manufacturer practices (GMP) and rigorously controlled for quality by the marketing authorization holders (MAH). The present paper links poor-quality antimicrobials and AMR, highlighting examples of regulatory initiatives on this subject outside the EU, particularly those resulting from the World Health Organization (WHO) recommendations. It also intends to trigger a discussion on the role of such quality control programmes, particularly for antimicrobials, beyond the control at any stage of the quality parameters of a marketed medicine, to reflect whether or not it might be relevant to other regulatory coordinated actions against AMR.
This article was published in the following journal.
Name: Regulatory toxicology and pharmacology : RTP
Antimicrobial resistance is a growing public health problem of global concern and, unless action is taken, the burden of death could reach 10 million per year by 2050. Resistance has been associated w...
Prescription veterinary medicine (PVM) use in the UK is an area of increasing focus for the veterinary profession. While many studies measure antimicrobial use on dairy farms, none report the quantity...
Antimicrobial resistance is increasing at an alarming rate in The Gulf Cooperation Council (GCC) due to the over and misuse of antimicrobials. The novel and rare multi-drug resistant strains can sprea...
Antimicrobial resistance (AMR) is among the most pressing challenges facing humanity. This survey of dairy cow farmers (n=372) was conducted to explore knowledge, attitudes and practices surrounding v...
Healthy volunteers will receive treatment to two body locations with the investigational product and placebo and the antimicrobial effectiveness of each treatment will be measured.
This is a four-year study, funded by the Center for Disease Control and Prevention, related to antimicrobial resistance in rural communities. The project consists of four components: A) ...
The main objective of the clinical trial is to evaluate the effectiveness of two home ergonomics programmes, by reference to a control group, on functional capacity and quality of life in ...
The purpose of this investigation is to study the relationships between antimicrobial stewardship program efforts, antimicrobial drug use, and infection control efforts to the incidence r...
Antimicrobial resistance is one of the greatest threats to human health, and is driven by inappropriate antimicrobial use. Antimicrobial stewardship programs (ASPs) improve the use of anti...
Antiprotozoal and antimicrobial agent used mainly in veterinary practice.
A sulfonamide antimicrobial used for urinary tract infections and in veterinary medicine.
A system for verifying and maintaining a desired level of quality in a product or process by careful planning, use of proper equipment, continued inspection, and corrective action as required. (Random House Unabridged Dictionary, 2d ed)
A board-certified specialty of VETERINARY MEDICINE, requiring at least four years of special education, training, and practice of veterinary surgery after graduation from veterinary school. In the written, oral, and practical examinations candidates may choose either large or small animal surgery. (From AVMA Directory, 43d ed, p278)
Chemical, biological, or medical measures designed to prevent the spread of ticks or the concomitant infestations which result in tick-borne diseases. It includes the veterinary as well as the public health aspects of tick and mite control.