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Posted 02 June 2016 | By Nick Paul Taylor
Welcome to our European Regulatory Roundup, our weekly overview of the top EU regulatory news.
The European Medicines Agency (EMA) is proposing to restrict the use of colistin to curb the rise of antibiotic resistance. Under the plan, use of colistin in animals would be limited to last-resort cases, a constraint intended to quell concerns that an emerging resistant mutation will spread quickly around the globe and between different types of bacteria.
Members of EMA’s Antimicrobial Advice Ad Hoc Expert Group (AMEG) began looking into the topic at the request of the European Commission. The request was prompted by the discovery of the MCR-1 gene. This new mechanism of resistance to colistin was first discovered in bacteria in China, but has since spread to Europe. This week, the US Centers for Disease Control and Prevention said the gene had been found within its jurisdiction for the first time. The gene is found on a plasmid and, as such, is capable of spreading easily between different types of bacteria.
These characteristics led AMEG to reassess an opinion on colistin it published in 2013. Back then, the expert group recommended banning the prophylactic use of colistin, an antibiotic that has been used in veterinary medicine for more than 50 years. Farmers were still free to use the antibacterial in infected animals and others that were in contact with carriers of the bacteria. This liberal approach was underpinned by AMEG’s inability to uncover evidence that resistance to colistin could transfer between animals and humans. The discovery of MCR-1 provided that evidence.
In response, EMAG is proposing to reclassify colistin as a Category 2 product. This group is made up of antimicrobials that can only be used when no effective alternative treatments exist. AMEG also wants member states to cap use of the antibiotic. The level recommended by AMEG is 5 mg of colistin per population correction (PCU) unit, although the expert committee would like to see member states aim for even lower targets. Less than 1 mg of colistin per PCU is seen by AMEG as a desirable level.
One way to achieve the reductions in colistin use would be to increase the use of other products, but AMEG is keen to discourage member states and farmers from pursuing this course of action. Rather, AMEG is advocating for the improvement of farming conditions, performance of controlled cleaning, disinfection strategies and other biosecurity actions in between production cycles and wider use of vaccines. Each of these actions is intended to reduce the need to use an antibiotic such as colistin by cutting the risk that an animal will become infected in the first place.
EMA has given the public until 26 June to comment on the draft. The one-month comment period is in keeping with the fast-tracked advance of the revised guidance, which was released just six months after details of the discovery of the MCR-1 gene were published in Lancet Infectious Diseases.
Press Release, Draft Advice
The European Monitoring Centre for Drugs and Drug Addiction (EMCDDA) has raised concerns about the diversion and misuse of synthetic opioids and other medicinal products. Officials want Europe to adopt improved surveillance measures to prevent the misuse of prescription opioids escalating to the point that it has reached in parts of the United States.
EMCDDA made the proposal after identifying an increase in treatment demand linked to synthetic opioids and reports of deaths related to the drugs. In 2014, 18 countries reported that more than 10% of people seeking services for problems related to opioids were users of drugs other than heroin. The previous year, just 11 countries passed that threshold. In some countries, non-heroin opioids are now the primary problem.
In Estonia, fentanyl now accounts for the majority of cases of people seeking support with opioid use, while buprenorphine is frequently misused in the Czech Republic and Finland. Member states are using registers of pharmacy transactions, electronic medicine dispensers, toxicology tests, pill counts and unannounced monitoring in an attempt to curb misuse. EMCDDA thinks many of these actions can reduce diversion, but it is concerned by the lack of data on their effect on legitimate supply.
“At present, the challenge remains one of maintaining good patient access to substitution medicines while establishing appropriate prevention and regulation responses that minimize the leakage of these medicines onto the illicit market,” EMCDDA wrote in its report.
EMA’s Committee for Medicinal Products for Veterinary Use (CVMP) has published a draft reflection paper on the impact of social media and the internet on the adverse event reporting responsibilities of animal health manufacturers. The committee thinks marketing authorization holders (MAHs) could make better use of online platforms in their pharmacovigilance campaigns.
Manufacturers of all types of drugs have fretted over the implications of online patient communities for their adverse event reporting responsibilities since the early days of forums and social media. The reflection paper goes some way to clarifying the situation for manufacturers of animal health drugs. In the draft paper, CVMP sets out how it expects veterinary MAHs to manage adverse event reports that originate on the internet and offers advice on how manufacturers can make better use of social media and search engines in pharmacovigilance.
Importantly, the paper stops short of making MAHs responsible for finding and writing up all online discussions of adverse events relating to their products. “MAHs would not be expected to trawl the internet to search for potential adverse event reports,” EMA wrote in the paper. “However, if the MAH becomes aware of potential adverse events, every effort should be made to follow up on the reports to obtain at least the minimum reporting criteria so that the events can be channeled into the formal pharmacovigilance reporting system.”
The regulator acknowledges that obtaining information that covers the minimum reporting criteria can be challenging when dealing with online reports. When a pet owner goes online to discuss an adverse event experienced by their animal, they do not typically present the information in the systematic manner that is needed for pharmacovigilance reporting. Details such as time to the onset of the event may be missing. Also, if a post generates multiple responses and discussion threads, it can be hard to parse out the details of each individual adverse event report.
While recognizing the difficulties these issues create for MAHs, EMA still thinks manufacturers can make better use of the internet. Specifically, the regulator is encouraging pharmacovigilance teams to follow certain forums and set up searches of Google and Facebook. EMA notes that the advanced search capabilities of Google can enable MAHs to home in on discussions about adverse events that are linked to their products. The regulator is accepting comments on the draft reflection paper until the end of August.
Draft Reflection Paper
EMA has posted draft guidelines on plant toxicity testing of veterinary medicines. The text covers the use of plant toxicity tests as part of the terrestrial environmental risk assessment of veterinary drugs. EMA has drafted the guideline to replace an earlier reflection paper on the topic, which lacks some of the options for higher-tier assessments covered by the latest text. Draft Guideline
Tags: EU Regulatory Roundup, antibiotic resistance, synthetic opioids
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