Drug Information Bulletin

Bengal Branch Tele fax: 033 24612776, E-mail: ipabengal.dic@gmail.com Web Site: http://www.ipabengal.org Contact: 09830136291

Drug Information Centre (DIC) Indian Pharmaceutical Association

Volume: 06

Number: 03
Content

28th April 2012

Lymphadenitis suspected with BCG vaccine at Singapore USP-NF revised monograph of six drugs Malaria resurgence directly linked to funding cuts Book Review on: Fundamentals of Pharmcognosy and Phytotherapy Immediately Past Event

Lymphadenitis suspected with BCG vaccine at Singapore The Health Sciences Authority (HSA) has updated healthcare professionals on suspected reports of lymphadenitis following the administration of the Bacillus Calmette-Gurin (BCG) Vaccine Staten Serum Institute (SSI). This observation arose from the active surveillance and monitoring of vaccine adverse events (VAEs) at the sentinel site at KK Womens and Childrens Hospital (KKH). In 2009, HSA collaborated with KKH to initiate active surveillance for VAEs related to H1N1 vaccines in pregnant women and children. This was subsequently expanded to include all VAEs following childhood immunization. In Singapore, BCG vaccine is routinely given to newborns as part of the National Childhood Immunization Schedule. Since June 2003, the BCG vaccine manufactured by SSI is the sole BCG vaccine registered in Singapore. BCG Vaccine SSI contains an attenuated strain of Mycobacterium bovis (BCG), Danish strain 1331. In 2009, there were 26 reports of BCG associated lymphadenitis of which 23 cases (88%)

presented as suppurative lymphadenitis. Of these, 22 cases required surgical intervention such as excision or incision and drainage. In 2010, there were 25 reports of lymphadenitis. Sixteen cases (64%) presented as suppurative lymphadenitis which required surgical intervention. From January 2011 to October 2011, the reports of lymphadenitis increased to 53. An increase in the number of suspected reports of BCG-associated suppurative lymphadenitis has also been identified in some countries such as Ireland and Latvia in recent years. However, the overall rate and pattern of VAEs remain consistent with the expected frequency of occurrence listed in the package insert of BCG Vaccine SSI. Reference: Health Sciences Authority (HSA) Safety Announcement at http://www.hsa.gov. sg/publish/hsaportal/en/health_products_r egulation/safety_information/product_safet y_ alerts/safety_alerts_2011/reports_of_lymp hadenitis.html

2 USP-NF revised monograph of six drugs This email notice has been sent to keep you up-to-date on important announcements related to the USP-NF. The U.S. Pharmacopeial (USP) Convention posted the following notices on its Web site: * Six New Revision Bulletins: - Alfuzosin Hydrochloride (posted 27Apr-2012; official 01-May-2012) - Alprazolam Orally Disintegrating Tablets (posted 27-Apr-2012; official 01May-2012) - Divalproex Sodium Extended-Release Tablets (posted 27-Apr-2012; official 01May-2012) - Docetaxel Injection (posted 27-Apr2012; official 01-May-2012) - Losartan Potassium Tablets (posted 27-Apr-2012; official 01-May-2012) - Valacyclovir Tablets (posted 27-Apr2012; official 01-May-2012) Ref.: http://www.usp.org/usp-nf/officialtext/revision-bulletins

with higher transmission rates that were attempting to control it. Among those resurgences, 91 per cent or 68 out of the 75 were caused at least in part by weakened malaria control programmes, with 39 of the 68 tied to funding constraints, according to the research led by the Clinton Health Access Initiative, in conjunction with the UCSF Global Health Group and the Johns Hopkins Malaria Research Institute. The study also categorized malaria resurgence according to whether it was related to increased intensity of malaria transmission due to population movement or weather changes, as well as technical obstacles such as drug and insecticide resistance. The results are significant in light of an estimated $9.7 billion gap between funds available and funds needed for malaria programmes worldwide over the next three years, according to the international partnership Roll Back Malaria, a global partnership linked to the United Nations that is coordinating a plan among 500 member nations and organizations to eliminate the disease worldwide. Included in that gap is the decision by the Global Fund to Fight AIDS, Tuberculosis and Malaria to postpone the majority of its malaria-based funding for new grants through 2013. As recently as 2009, the Global Fund was providing roughly half of the $2 billion in development assistance for malaria. We cannot afford to let history repeat itself, said Richard Feachem, the founding executive director of the Global Fund who now directs the UCSF Global Health Group. It is imperative that we not lose the gains that these countries have achieved in malaria control.

Malaria resurgence directly linked to funding cuts Washington: Funding cuts for malaria control are the single most common reason for the resurgence of the deadly disease, according to a new study that has linked overall weakened malaria control programmes to the majority of global resurgences since 1930. The study, published in the Malaria Journal, analysed the causes of 75 documented episodes of malaria resurgence throughout the world over the past 80 years, both in countries that were close to eliminating the disease and those

3 Past failures to maintain such gains underscore the fragility of success in the field. Both Sri Lanka and India, for example, saw significant reductions of the illness in the 1960s, but both had dramatic resurgences when funding was withdrawn, the paper found. although the Institute for Health Metrics and Evaluation (IHME) estimates malaria deaths at 1.2 million that year. Nine in 10 of those deaths are in Africa, and 86 per cent were in children under age five. WHO estimates that in countries where it is common, malaria can measurably lower the gross domestic product and consume nearly half of all public health expenditures. Malaria eradication defined as ending malaria worldwide vs. eliminating it within a specific geographic area was a major public health effort in the first half of the 20th century and was intensively pursued after World War II. Since that effort was launched, 108 countries have eliminated malaria from within their borders, with another 36 countries moving rapidly toward that goal. Despite those efforts, almost half the worlds population still lives in places where the disease is common. Since 2000, investments in malaria control and efforts to apply low-cost solutions such as bed nets and indoor insecticide spraying on a broad scale had created unprecedented momentum in controlling malaria and brought several countries to the brink of elimination. The paper reflects the impact current funding declines could have in reversing those gains. Malaria is an infectious disease caused by a parasite transmitted from person to person by the bite of a mosquito. In the past two centuries, numerous research and public health efforts worldwide have sought to combat this ancient scourge.
Ref.:http://www.aalatimes.com/2012/04/27/malariaresurgence-directly-linked-to-funding-cuts/

In India, for example, the US Agency for International Development funded an eradication programme that led to a massive drop in annual malaria cases, from about 100 million in the early 20th century to about 100,000 in 1965. But when that commitment ended, malaria resurged to a peak of 6 million cases by 1976. Malaria control programmes have been shown to be extremely successful in reducing the number of cases of malaria to very low levels, but history demonstrates that gains can be lost rapidly if financial and political support is not sustained, said lead author Justin Cohen of the Clinton Health Access Initiative. Finding ways to ensure continued funding for malaria control today will be crucial to building on the gains of the past decade. An estimated 216 million people contracted malaria in 2010 in 106 countries and 655,000 died from it, according to the World Health Organisation (WHO),

Book Review on: Fundamentals of Pharmcognosy and Phytotherapy

4 Authors: Micheal Heinrich, Joanne Barnes, Simon Gibbons, Elizabeth M Williamson Published by: Churchill Livingstone, Elsevier UK Chemical entity from plant, animals, and microbes of both terrestrial and marine origin continue to be important worldwide for the treatment and prevention of many diseases. At the early of 20th centuries, the field of nature- derived pharmaceuticals and poisons had confined at its basic label. Later within 50 years, it was exponentially focused on chemical and biological study also. At present, the scope of the pharmacognosy and phytotherapy covers a wide range of phyto pharmaceuticals and is defined in this book as the science of biogenic or nature derived pharmaceuticals and poisons. Centers for Disease Control and Prevention (CDC) have reveal their survey report in 2007 that about 20% of the US adult population relies upon nonvitamin, nonmineral natural products, which cost of $14.8 billion. Therefore societal interest of pharmacognosy is likely to increase in the future as the biochemical role of phytomedicines, Nutraceuticals and natural drugs. I found this book very useful for the students and the scientists working in this area. It can help in boosting the knowledge of pharmacognosy and importance of phytotherapy. This book has been systemically organized into two parts that is Part A and Part B. In part- A the authors have discussed with principals of botany and ethanobotany, chemistry of secondary metabolites, safety evaluation process of phytomedicines, nutraceuticals and insight knowledge of traditional medicines which are used in Asian and western medicine as well. Consequently, Part B dealt with the use of phytomedicines in various therapeutic applications and highlight on their health benefit. The enigma of the comprehensive book is better carried forward by the co-authors in term of their meticulous technical expertise in area of ethanobotany, ethnopharmacology, chemistry of natural product and related area. This book may be recommended for its great impact in continuing courses of pharmacy, dentists, nurses and physicians also. Particularly, this book will provide reliable source of information in the area of herbalism and complimentary and alternative medicine, biochemical role of phytomedicines, Nutraceuticals and natural drugs to the readers. It is paperback, 325 pages. Reviewed by: Pulok K. Mukherjee, PhD, FRSC Director School of Natural Product Studies Jadavpur University Kolkata 700032, India Immediately Past Event

Dr. Sandip Roy, Medical Officer, STBC, Govt. of West Bengal delivering lecture in a seminar entitled Engaging Pharmacists in TB control and care organized by IPA, Bengal Branch on the World Health Day-2012.