Should the chickenpox vaccine be included in the National Immunization Schedule in India?

Varicella (chickenpox) is an acute, highly contagious viral disease with worldwide distribution. The highest prevalence occurs in the 4-10 year age group but tends to be more severe in adults. It may be fatal in neonates, immunocompromised persons, and normal adults, especially smokers. Varicella is usually a benign childhood disease, and rarely rated as an important public health problem, but this can be severe and even fatal in otherwise healthy children (< 1 out of every 10,000 cases). Chickenpox can cause pneumonia (23 out of every 10,000 cases), and is an important risk factor for developing severe invasive "strep" (group A streptococcal disease). Complications of varicella include bacterial infections (up to 5% of cases), decreased platelets, arthritis, hepatitis, pneumonia (more commonly in adults) or encephalitis (1 in 10,000 cases), which may cause a failure of muscular coordination, sometimes resulting in persistent sequelae or death. Varicella is the leading cause of vaccine-preventable death in children. Universal vaccination can cause a dramatic reduction in the incidence of varicella, associated complications, hospitalizations and fatality rates. In India, due to the high cost of the vaccine, it would be difficult to vaccinate a large percentage of the children. The government of India should consider the inclusion of varicella vaccine in the National Immunization Schedule with the help of International agencies.     

Continuing the epidemiological function of the addicts index—evidence from matching the home office addicts index with the National Drug Treatment Monitoring System

Aims: We discuss the Addicts Index (AI) and examine whether the epidemiological trends of the AI can be continued by the regional drug misuse databases (DMDs, now known as National Drug Treatment Monitoring System (NDTMS). Methods: (i) Matching individuals recorded as addicted to opiates and/or cocaine in the AI with those reported to the North Thames Drug Misuse Database (NT-DMD) 1992–1996; (ii) comparison of trends over time. Findings: Of 26,120 notifications to the AI from North Thames 73% were also reported to drug misuse database. There were no significant differences in the proportion of notifications reported over time or by sex. At least 80% of reports from specialist drug agencies were matched compared to approximately 60% of reports from GPs (χ² p < 0.001). Compared to specialist drug agencies the adjusted odds ratio of being reported to NT-DMD was 0.45 (95% CI 0.40 to 0.49) for GPs. Nationally time trends in notifications to AI and reports to DMDs were highly correlated (Pearson correlation coefficients of 0.98). Conclusions: The epidemiological function of the AI can be continued. However, new strategies are urgently required to improve reporting from GPs.     

Monitoring Ecstasy Content in France: Results From the National Surveillance System 1999–2004

The French National Identification System for Drugs and Other Substances (SINTES) is an original scheme gathering analytical information for synthetic drugs, both through police and customs' seizures in the entire country and collection of samples and questionnaires directly from the users by social field workers. Between July 1999 and June 2004, 9543 samples were included. Tablets (7004) were mainly containing MDMA (82%) and caffeine was the most frequent blended psychoactive substance. Mean MDMA dosage of tablets decreased from 1999 to 2003 and dosage for tablets bearing the same logo appeared to be highly variable. Notwithstanding the difficulties for data collection due to the illicit nature of these drugs, this surveillance and early warning system, which combines the cooperative efforts of law enforcement laboratories and social workers, provided relevant and timely information. It is accurate regarding the follow-up of trends in drugs' composition, and the identification of new or potentially dangerous substances, to the professionals, the public, and the European partners.     

Cell-cycle protein modifications in the kidney of Mus spretus from Doñana National Park

On April 1998 a tailing dam of the Aznalcollar pyrite mine partially collapsed and released to the Guadiamar river acidic water and mud containing toxic metals threatening the Doñana National Park, a Spanish wildlife reserve located near the estuary of Guadalquivir river. To assess the possible biological effects on terrestrial ecosystems, biochemical markers were assayed in the kidneys of Algerian mice (Mus spretus) collected in several areas of Doñana and Guadiamar river. Biomarkers assayed are proteins involved in cell cycle regulation, in particular cyclins and their associated kinases, and some cell cycle inhibitors. Moreover Mitogen Activated Protein Kinases (MAPK), a signal transduction system involved in cell division, p53, a protein involved in growth arrest after DNA damage, and HSP70, an early stress‐induced protein, were assayed. The kidneys of animals collected one year after the ecological disaster had increased levels of PCNA (proliferating cell nuclear antigen), indicating an increased number of cells in the S phase of cell cycle. This shift of cells from G0 to S phase is due to increased levels of cyclins D1, E, and A, to decreased levels of p21 and p27 cdk inhibitors, and to activation of MAPK cascade. On the other hand, p53 and HSP70 levels are not changed. These data demonstrate that the presence of toxic metals after ecological disaster provoked the induction of kidney cell proliferation interpretable as a compensatory cell growth after tissue damage and apoptosis, and that could lead to the genomic instability characteristic of cancer cell. © 2008 Wiley Periodicals, Inc. Environ Toxicol, 2008.     

A review of the National pharmacovigilance system in Malta – implementing and operating a pharmacovigilance management system

Introduction: Regulatory authorities have a legal mandate to implement and maintain a Pharmacovigilance System designed to monitor the safety of authorised medicinal products and detect any change to their risk-benefit balance.

Areas covered: This review maps the implementation of pharmacovigilance activities in Malta since accession in the EU in mid 2004 and discusses the challenges the Maltese Regulator encountered while setting up adequate and effective systems to fulfil its legal mandate. Areas reviewed are those around ADR reporting, promotion and safety communications including rapid alerts and recalls, direct healthcare professional communications, risk minimisation measures and safety circulars and quality systems.

Expert opinion: Within a ten year period, 3 EU directives on pharmacovigilance were implemented by our agency. Despite limitations to resources, based on a prioritised implementation, the legislation provisions are now fully operational with a good level of sustainability. Lessons learnt from this process are discussed in this review. The coming years will involve strengthening and consolidation of existing processes.     

Fact or fiction? A critique of the National Aboriginal and Torres Strait Islander Social Survey 2002

The ability of policy makers, practitioners and the broader public to respond appropriately in reducing the harms caused by alcohol misuse depends in large part on our understanding of the nature of the problem. In the case of consumption patterns and associated harms among indigenous minority peoples—in Australia and elsewhere—such an understanding is often difficult to achieve. There are a host of reasons for this including cultural differences between indigenous peoples and the broader populations within which they are located, cultural heterogeneity among indigenous peoples themselves, political and economic disadvantages which exacerbate misuse and its effects, methodological difficulties in the appropriate design of data collection instruments, sampling issues and the issues in the interpretation of data. All these difficulties mean that we need to subject any studies of substance misuse among indigenous peoples to a high level of scrutiny. This is particularly the case when such studies are conducted by organisations that are generally regarded as 'authoritative' sources of information. Chikritzhs & Brady have done this in the case of the National Aboriginal and Torres Strait Islander Social Survey 2002, conducted by the Australian Bureau of Statistics. In their review of this and other surveys, they demonstrate that to produce valid information about indigenous alcohol misuse, as well as having the skills to conduct broad population surveys, it is necessary to have an understanding of both methods of collecting data on alcohol consumption and Indigenous cultures themselves.

GuestEditor:DennisGray     

DNA repair protein levels vis-à-vis anticancer drug resistance in the human tumor cell lines of the National Cancer Institute drug screening program

Nucleotide excision repair (NER) is a multi-enzyme DNA repair pathway in eukaryotes. Several NER genes in this pathway including XPB, XPD, XPA and ERCC-1 have been implicated in anticancer drug resistance in human tumor cells. In this study, we assessed the levels of the above-mentioned proteins in the NCI panel of 60 human tumor cell lines in relation to the cytotoxicity patterns of 170 compounds that constitute the standard agent (SA) database. The database consists of drugs used in the clinic for which a mechanism of action has been at least partially defined. The ERCC-1, XPD and XPB protein expression patterns yielded significant negative Pearson correlations with 13, 32 and 17 out of the 170 compounds, respectively (using p<0.05). XPA produced a random assortment of negative and positive correlations, and did not appear to confer an overall resistance or sensitivity to these drugs. Protein expression was also compared with a pre-defined categorization of the standard agents into six mechanism-of-action groups resulting in an inverse association between XPD and alkylating agent sensitivity. Our present data demonstrate that XPD protein levels correlate with resistance to alkylating agents in human tumor cell lines suggesting that XPD is implicated in the development of this resistance. NER activity, using the in vitro cell-free system repair assay, revealed no correlation between NER activity and the level of XPD protein in four cell lines with widely varying XPD protein levels. This lack of correlation may be due to the contribution of XPD to other functions including interactions with the Rad51 repair pathway.     

Usual Alcohol Consumption and Risks for Nonfatal Fall Injuries in the United States: Results From the 2004–2013 National Health Interview Survey

Background: Acute alcohol consumption is known to be a risk factor for fall injuries. Objective: The study sought to determine whether usual alcohol consumption increases the risk for nonfatal fall injuries. Method: Data from 289,187 sample adults in the 2004–2013 U.S. National Health Interview Surveys were analyzed. Of these, 3,368 (～1%) reported a total of 3,579 fall-injury episodes requiring medical consultation in the past 3 months. Latent class analysis based on four contextual indicators identified four ecological subtypes of fall injury within two age groups (18–49 and 50+). Five drinking patterns (i.e., lifetime abstainer, former drinker, low-risk drinker, increased-risk drinker, and highest-risk drinker) were categorized according to the National Institute on Alcohol Abuse and Alcoholism (NIAAA) low-risk drinking guidelines. Controlling for potential confounders, negative binomial regression estimated the adjusted rates of any type and subtypes of fall injury, by gender, for each drinking pattern relative to lifetime abstainer. Results: Compared with lifetime abstainers, the adjusted rate of any fall injury for adults ages 18–49 was significantly higher among highest-risk drinkers (men: incidence rate ratio [IRR] = 2.59, 95% confidence interval [CI] [1.60, 4.20]; women: IRR = 1.90, 95% CI [1.24, 2.91]) and increased-risk drinkers (men: IRR = 1.94, 95% CI [1.25, 3.00]; women: IRR = 1.51, 95% CI [1.11, 2.07]). Furthermore, highest-risk drinkers had higher adjusted rates of either leisure- or sports-related fall injuries than lifetime abstainers. Conclusions: Alcohol consumption exceeding NIAAA's low-risk drinking guidelines is associated with elevated rates of nonfatal fall injuries. Findings underscore the importance of adhering to these recommendations.     

News from The National Institute of General Medical Sciences: What IS Training in the Pharmacological Sciences?

Pharmaceutical Research -     

Policy Change and the National Essential Medicines List Development Process in Brazil between 2000 and 2014: Has the Essential Medicine Concept been Abandoned?

Brazil has had a National Essential Medicines List (EML) since 1964. From 2000 to 2010, five consecutive evidence‐based editions were produced, building on the essential medicine concept. In 2012, the government changed course to establish a new paradigm, introducing adoption of new medicines as the main aim within the recommendation process. The objective of the article was to report efforts to develop Brazil's national EML, policy changes from 2000 to 2014, discussing results, challenges and perspectives. Brazilian EML history and development process were collected from legislation, minutes, reports and legal ordinances, from 2000 to 2014. The Brazilian EML and the WHO Model Lists were compared using the Anatomical Therapeutic Chemical system. Overlap between lists was verified, and linear trends were produced. Type of membership, inclusion criteria, procedures, flow and listed medicines varied greatly between the selection committees acting before and after 2012. Paradigm‐changing legislation aiming at linking list compliance to public financing in 2012 produced (i) greater importance given to political and administrative stakeholders, (ii) increasing trends in number of medicines over the years, (iii) decrease in use of WHO Model List as a reference and (iv) substitution of an essential medicines list review and update process by an adoption decision output. Other issues remained unchanged. Insufficient efforts for list implementation, such as lack of physician education, presented consequences to the health system. Substantial efforts were made to produce and update the list from 2000 to 2014. However, continuous and intense health litigation disproves process outcome effectiveness.     

Review of the Medical Research Ethics Committee (MREC), National Research Center of Egypt, 2003–2011

Abstract

Background:

Globally, ethical issues in research are becoming of major importance, being well established in developed countries with little information about research ethics committees (RECs) in Africa to assess whether these committees are actually improving the protection of human research participants.     

Implementing a National Alcohol Consumption Prevention Program at the Local Level: What Does Early Evaluation Tell Us?

The current Swedish national plan for preventing alcohol consumption-related problems puts greater emphasis on community-level prevention measures. This report describes early results from the implementation of this plan in the county of Västra Götaland, in southwestern Sweden. During 2002–2004 interviews were conducted with the main project representative in each of the county's 49 municipalities. In addition, more extensive data gathering, involving interviews with a broad range of stakeholders and systematic examination of project-related documentation, was undertaken in four representative municipalities. Findings indicated that community alcohol consumption prevention has been strengthened and that the activity level is high in all municipalities, especially in relation to youth. However, problematic alcoholic beverage consumption by adults was rarely targeted; the limited resources were dispersed over too many projects; there was too little collaboration between stakeholding authorities and adherence to evidence-based practice still is lacking.