Thursday, 21 February 2013

New rules for rational antibiotic use in China

by Xiao Yonghong and Li Lanjuan
On Aug 1, 2012, China formally implemented a decree issued by its Ministry of Health on administrative regulations for clinical use of antibacterial agents. This ruling defines all aspects of antibiotic use in hospitals, including selection, procurement, prescription, use, monitoring, and legal responsibility, and is the strictest regulation yet for antibiotic management in China. The major purpose of the new regulations is to ensure rational use of antimicrobial agents.
China has extensively reformed its health-care system, which is expected to ultimately give all citizens access to basic medical care. To achieve this aim, the current profit-orientated philosophy in public hospitals should be completely abandoned, and administration of drugs, including antimicrobial agents, should be rationalised. Irrational long-term use of antibiotics allowed by current hospital managements strategies in China has generated antibiotic-resistant bacterial strains, despite the health-care authority releasing several sets of guidelines during the past 10 years to promote rational use, including principles for clinical use of antibiotics (2004), a national formulary (2008), and guides for hospital drug therapeutic committee (2002). Bacterial resistance is now a major problem in China.
In a national survey, 60% of isolates of some species were drug resistant, including meticillin-resistant Staphylococcus aureus, extended-spectrum β-lactamase-producing Escherichia coli, quinolone-resistant E coli, and carbapenem-resistant Pseudomonas aeruginosa, and Acinetobacter baumannii.  Rational use of antimicrobial agents and the implementation of other methods to prevent resistance from worsening have become crucial.
The recently introduced regulations for antibiotic use incorporate the internationally accepted notion of antimicrobial stewardship, and include some administrative requirements tailored to the Chinese health-care system. The regulations also include specific instructions for leaders of medical institutions who are responsible for the rational administration of antimicrobial agents, for establishing an effective antibacterial drug-management system, and for forming a working group composed of infectious disease physicians, pharmacists, microbiologists, and managers. Medical institutions must ensure that antibiotics are classified as non-restricted, restricted, or special-grade. Physicians and pharmacists need specific training in antibiotic prescription before they are granted different levels of prescribing privileges depending on their professional title. The health-care authority will set administrative goals for institutions, review of antibacterial drug prescriptions, regularly publish information about antibacterial drug use in hospitals, commend physicians who closely follow the regulations, and impose penalties on medical staff who violate them.
The regulations also encourage medical institutions to explore alternative strategies to improve the rational use of antibacterial drugs, such as diverse antibiotic use, active intervention for antibiotic use, implementation of clinical guidelines, and hospital infection control. At the same time, pharmaceutical companies should implement a standardised drug-promotion procedure and stop attempting to increase drug sales for economic incentives. Medical institutions need to regularly report the use of antibacterial drugs to the health-care authority. To improve the administration of antibiotics, institutions that seriously or persistently violate the regulations will be appropriately penalised by the authority, by means such as downgrading the hospital to a lower level of classification, and dismissing the leaders of the institutes involved. Medical staff who seriously violate the regulations could lose permission to prescribe antibacterial drugs, have their professional qualification revoked, or even be prosecuted if their actions have serious consequences.
To promote the implementation of these regulations, in 2011 the Chinese Ministry of Health initiated a 3 year campaign with a special task force in antibiotic management. By strict implementation of these regulations and the introduction of legal penalties, the rational use of antibiotics in public medical institutions can be enforced quickly and efficiently. Although these steps are appropriate to reduce antibiotic use in the current Chinese health-care system, long-term management of the strategies needs more planning and the establishment of a sustainable back-up system such as antibiotic stewardship professionals, guidelines, ongoing staff training, and procedures for identifying illegal practice. Unfortunately, antibiotic sales in high-street pharmacies are not within the legal jurisdiction of the regulation.
Source: Lancet Infectious Diseases

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