Tackling antibiotic resistance requires well-run diagnostic laboratories, says Pradeep Seth.
Antibiotic resistance has important health implications for developing countries. Infections caused by resistant microorganisms lead to higher rates of hospitalisation, with patients often staying in hospital longer than usual, thereby increasing the cost of treatment and the economic burden on the community.
Although excessive use of antibiotics has been the major cause of resistance in industrialised countries, this alone cannot explain the increasing emergence of resistant microorganisms in developing countries. Overcrowding in hospitals as well as in homes, particularly in urban and semi-urban areas, poverty, poor sanitation, inappropriate use of antibiotics and the availability of antibiotics without prescription are also contributing factors. Poor healthcare infrastructure, inadequate hospital hygiene, and the absence of reliable diagnostic tools exacerbate the problem.
Apathetic infection control
Infection control practices in hospitals in developing countries are far from satisfactory and tend to be reactive rather than proactive. In India, for example, a hospital's infection control committee exists only on paper, and swings into action only in the wake of a serious outbreak of infection within the hospital — although outbreaks are common precisely because of this apathy towards infection control.
In the mid-1990s, the use of expired or 'resterilised' disposables such as intravenous infusion sets and catheters in a government hospital in New Delhi led to a serious outbreak of septicaemia that killed 26 people.
Despite these outbreaks, few, if any, Indian government hospitals have policies for using antibiotics, nor have they established an antibiotic monitoring system. Information on the antibiotic resistance pattern of bacterial isolates is by and large unknown in developing countries, as facilities for routine susceptibility testing of isolates are scarce and limited to a handful of microbiology laboratories, which do not provide a holistic view of distribution of resistant bacteria.
Poor diagnostics are almost entirely responsible for prescribing patterns in developing countries. In most poor countries, antibiotics are prescribed empirically for all types of infections, whether they are bacterial or viral in origin. Even for life-threatening bacterial infections, antibiotics are prescribed on the physicians' judgement and preference rather than on the basis of sensitivity data.
In India, laboratory facilities often simply don't exist; even when they do, a staggering lack of regulation means that many operate with extremely poor standards. Although there are more than 100,000 medical diagnostic laboratories in the public and private sectors, only 103 diagnostic laboratories in the private sector have been accredited by the National Accreditation Board for Testing and Calibration Laboratories (NABL).
Shockingly, none of the diagnostic laboratories in government hospitals have been accredited. Most are poorly funded and ill-equipped to conduct standardised antibiotic sensitivity assays. They do not have access either to standard bacterial strains or standard antibiotic disks. Substandard storage facilities often lead to degradation of reagents, including antibiotics. Most government-owned laboratories prefer to make their own disks using either injectable antibiotics from the hospital dispensaries or commercially available antibiotic powders.
Few laboratories compare the efficacy of in-house prepared disks with the standard antibiotic disks using standard bacterial strains. Inevitably, these methods often lead to inconsistent and unreliable results of antibiotic susceptibility assays. With no means of determining which antibiotic to prescribe, doctors rely on clinical judgement alone.
Need for regulation
India has no government regulations on establishing a diagnostic laboratory. In theory, anyone with the funds can do it: accreditation by NABL is voluntary rather than mandatory. This means laboratories tend to invest in qualified and well-trained staff only when they intend to seek certification from NABL.
Additionally, such well-equipped laboratories charge exorbitantly for providing quality testing, and after obtaining NABL accreditation they generally attract patients from the middle- and upper-classes who do not mind paying for quality services.
In some cases accreditation has attracted international collaboration. A few accredited laboratories have even expanded their operations as clinical trial laboratories.
Like most developing countries, India also lacks a national policy or guidance on the use of antibiotics. Developing national policies is vital to combat the escalation of resistance, and policies should include clear definitions of the role of the diagnostic laboratory.
A database should be created on the antibiotic susceptibility pattern of common infectious agents circulating in various regions of the country. It should be mandatory for hospitals to have their own antibiotic policy, updated at regular intervals by generating laboratory data on the susceptibility of bacterial strains circulating in the hospital environment. This is particularly important for diseases such as tuberculosis: an estimated 13 to 38 per cent of patients with the disease have been infected with multidrug-resistant strains of Mycobacterium tuberculosis.
Such measures require political will, government commitment and significant levels of funding — always in short supply in poor countries. Nevertheless, without these measures, the threat of antibiotic resistance in developing countries could grow out of control.
Pradeep Seth is president of the non-profit Seth Research Foundation. He is also Consultant: Research and Academics with Dr. Lal Pathlabs Private Limited, New Delhi.