Adverse Event Following Immunization (AEFI) Surveillance in India: Position Paper of Indian Academy of Pediatrics, 2013.

Adverse event following immunization (AEFI) is a critical component of immunization program. The risk of AEFI with vaccination is always weighed against the risk of not immunizing a child. There is an evolving AEFI surveillance system in India for the vaccines delivered through ‘universal immunization program’ (UIP) of government sector, but the reporting remained suboptimal for long in the country, and there is almost no participation from private sector. The AEFI reporting from private sector will provide vital information on the safety of new and underutilized vaccines, not part of the UIP in India. The national guidelines are recently revised and updated. The Indian Academy of Pediatrics believes that pediatricians, especially in private sector have a crucial role to play with reporting of AEFI with newer/underutilized vaccines. Programmatic error, vaccine reaction, injection reactions, coincidental and unknown are the five broad categories of AEFI for programmatic purposes. The serious AEFIs (death, disability, cluster and hospitalization) need to be reported immediately and investigated in detail as per the laid down procedures. Once a serious AEFI happens, primary or urban health centre should be immediately informed by the pediatricians practicing in rural or urban areas, respectively. This advocacy paper from the academy provides guidelines to practitioners on how to report cases, and suggests ways for IAP members to help in ongoing efforts of the government in improving AEFI surveillance in the country. The details about the diagnosis and management of known/expected AEFI with UIP and newer vaccines shall be published later.

50 years of Immunization in India: Progress and Future.

Immunization is one of the most cost effective public health interventions and largely responsible for reduction of under-5 mortality rate. However, vaccine preventable diseases (VPDs) are still responsible for over 5 lakh deaths annually in India. This underlines the need of further improvement. Today, India is a leading producer and exporter of vaccines, still the country is home to one-third of the world’s unimmunized children. There are a number of reasons why India lags behind its many less developed neighbors in vaccination rates. They include huge population with relatively high growth rate, geographical diversity and some hard to reach populations, lack of awareness regarding vaccination, inadequate delivery of health services, inadequate supervision and monitoring, lack of microplanning and general lack of inter-sectoral coordination, and weak VPD surveillance system. In this article, we discuss some of the remedial measures to remove obstacles and improve immunization status of the country. Heightened political and bureaucratic will, increasing demand for vaccination by using effective Information, education and communication (IEC), creating more ‘delivery points’ for routine immunization, proper monitoring of the program, and changing overall objective of the program from merely targeting coverage to more meaningful monitoring of the ‘VPD reduction’ and ‘demand creation’ referred as the ‘output’ of entire vaccination program. Successful AFP surveillance network should serve as platform for an efficient integrated disease surveillance system. AEFI and postmarketing surveillance systems should be urgently upgraded, and there is need of strengthening the regulatory capacity of the country. Restructuring of EPI with induction of some new vaccines, clear-cut guidelines on the policy of introduction of newer vaccines, and establishing a separate, independent department of public health are few other areas that need urgent attention.

50 Years of Tuberculosis Control in India: Progress, Pitfalls and the Way Forward.

India established the National Tuberculosis Control Project (NTCP) 50 years ago and re-designed it as Revised NTCP (RNTCP) 19 years ago. Tuberculosis (TB) control was beset with obstacles — BCG vaccination was found ineffective in TB control in 1979; human immunodeficiency virus began spreading in India since 1984 with TB as the commonest opportunistic disease; multi-drug resistance was found to be prevalent since 1992. The World Health Organization declared TB as global emergency in 1993. Yet, RNTCP was extended to the whole nation very slowly, taking 13 years from inception. The first objective of RNTCP, namely 85% treatment success has been achieved and case-fatality had dropped by 90%. Still, TB burden continues to remain huge; about half the cases are not getting registered under RNTCP; pediatric TB is neglected; TB drains national economy of US$ 23 billion annually. Therefore, TB control is in urgent need of re-design and re-invigoration, with additional inputs and system re-organization to cover all such gaps. We highlight the need for Public Health infrastructure under which all vertical disease control projects such as RNTCP should be synergized for better efficiency and for establishing Public Health Surveillance for collecting denominator-based data on incidence and prevalence to guide course corrections. India ought to spend 3 to 5 times more on TB control than at present. Control needs clear epidemiologic definition and measurable parameters for monitoring the level of control over time. TB control is both a measure of, and a means to, socioeconomic development.

Clinical & pathological features of acute toxicity due to Cassia occidentalis in vertebrates.

Cassia occidentalis is an annual shrub found in many countries including India. Although bovines and ovines do not eat it, parts of the plant are used in some traditional herbal medicines. Several animal studies have documented that fresh or dried beans are toxic. Ingestion of large amounts by grazing animals has caused serious illness and death. The toxic effects in large animals, rodents and chicken are on skeletal muscles, liver, kidney and heart. The predominant systems involved depend upon the animal species and the dose of the beans consumed. Brain functions are often affected. Gross lesions at necropsy consist of necrosis of skeletal muscle fibres and hepatic centrilobular necrosis; renal tubular necrosis is less frequent. Muscle and liver cell necrosis is reflected in biochemical abnormalities. The median lethal dose (LD 50) is 1 g/kg for mice and rats. Toxicity is attributed to various anthraquinones and their derivatives and alkaloids, but the specific toxins have not been identified. Data on human toxicity are extremely scarce. This review summarizes information available on Cassia toxicity in animals and compares it with toxic features reported in children. The clinical spectrum and histopathology of C. occidentalis poisoning in children resemble those of animal toxicity, affecting mainly hepatic, skeletal muscle and brain tissues. The case-fatality rate in acute severe poisoning is 75-80 per cent in children.

Cassia occidentalis poisoning as the probable cause of hepatomyoencephalopathy in children in western Uttar Pradesh.

BACKGROUND & OBJECTIVE: Recurrent annual outbreaks of acute encephalopathy illness affecting young children have been reported for several years in many districts of western Uttar Pradesh (UP). Our earlier investigations over three consecutive years (2002-2005) proved that these outbreaks were due to a fatal multi-system disease (hepatomyoencephalopathy syndrome) probably caused by some phytotoxin and not due to viral encephalitis as believed so far. We conducted a case-control study to investigate the risk, if any, from various environmental factors and also to identify the putative toxic plant responsible for development of this syndrome. METHODS: Eighteen cases with acute hepatomyoencephalopathy syndrome admitted in 2005 in a secondary care paediatric hospital of Bijnor district of western UP were included in the study. Three age-matched controls were selected for each case. A semi-structured questionnaire was developed and applied to all 18 cases and 54 controls. All interviews were conducted within one week of discharge or death of each case. Quantitative data were analyzed using the relevant established statistical tests. RESULTS: Parents of 8 (44.4%) cases gave a definite history of their children eating beans of Cassia occidentalis weed before falling ill, compared with 3 (5.6% controls), the odds ratio being 12.9 (95% CI 2.6-88.8, P<0.001). History of pica was the other associated factor with the disease, odds ratio 5.20 (95% CI 1.4-19.5, P<0.01). No other factor was found significantly associated with the disease. INTERPRETATION & CONCLUSION: Consumption of C. occidentalis beans probably caused these outbreaks, described earlier as hepatomyoencephalopathy syndrome. Public education has the potential to prevent future outbreaks.

Recurrent annual outbreaks of a hepato-myo-encephalopathy syndrome in children in western Uttar Pradesh, India.

BACKGROUND & OBJECTIVE: Outbreaks of an acute encephalopathy syndrome affecting children, with high case-fatality, have been reported in western Uttar Pradesh, India for the last many years.We investigated these cases in Bijnor district and present our findings. METHODS: Fifty five children aged 2-10 yr hospitalized from 2003 to 2005 in Bijnor, Uttar Pradesh, with features of acute encephalopathy were selected by defined clinical criteria. Various laboratory investigations were performed. RESULTS: The disease had peak incidence in early winter months. Previously healthy, 2-4 yr old rural children (mean age-3.78 yr) of very low socio-economic background were most vulnerable. Almost all had vomiting preceding unconsciousness and a majority had mild fever and abnormal behaviour/agitation. Abnormal posture of trunk and limbs were distinctive features. Fluctuation of blood pressure was seen in three-quarter cases. Serum aminotransferases, creatine phosphokinase and lactic dehydrogenase levels were found markedly raised virtually in all cases in whom the tests were performed. Serum glucose was found low (<50 mg/dl) in 47.3 per cent cases at presentation. Cerebrospinal fluid (CSF) was under normal or low pressure and without pleocytosis in all cases. No microorganism could be isolated from serum, CSF, urine and visceral specimens. Neuroimaging performed in two cases was also normal. Liver biopsy performed in 21 cases showed acute hepatotoxic injury in all with marked hydropic change and perivenular necrosis. Tibial muscle biopsy done in 8 cases showed focal necrosis while brain biopsy taken in 2 cases had mild spongiosis with focal gliosis. Forty two children succumbed to their illness (case fatality 76.4%), most within 72 h of presentation. Survivors did not show any neurological deficit. INTERPRETATION & CONCLUSION: Our findings showed that the outbreaks were due to a multi-system disease with toxic injury to liver, muscles and brain (hepato-myo-encephalopathy) and not due to viral encephalitis as believed so far. The cause remains unknown but several features suggest the possibility of phytotoxin-induced pathology.

Per rectal diazepam therapy in convulsive disorders.

One hundred and twenty children with persistent convulsions (lasting > or = 10 min) were treated with per rectal diazepam (dosage: 0.2 to 0.7 mg/kg/dose). Another group of 100 age matched children with convulsions, along with those who did not respond to rectal therapy were given intravenous diazepam in a dosage of 0.2 to 0.3 mg/kg/dose. Rectal treatment was effective in 80.83% cases while intravenous diazepam was effective in 90% cases which is statistically just significant (p < 0.05). No significant difference was observed in the efficacy of two routes of administration in controlling convulsions of different clinical types and various etiological groups (p < 0.05), except for primary generalized type where intravenous route was more effective than the rectal one (p < 0.05). No significant side-effect was observed with rectal therapy. Among the 23 (19.17%) children in whom rectal therapy failed, 12 (10%) responded to intravenous diazepam while the remaining 11 (9.17%) cases were resistant to both routes of administration.