*SAFE INJECTION GLOBAL NETWORK* SIGNPOST *SAFE INJECTION GLOBAL NETWORK* SIGN 2009 30 November to 2 December 2009 at WHO HQ Geneva Post00519 Prevention + Abstracts + News 4 November 2009 CONTENTS 1. Canada: Preventing the unsafe use of injection devices 2. Abstract: Investigation of health care waste management in Binzhou District, China 3. Abstract: The prevalence and risk factors for percutaneous injuries in registered nurses in the home health care sector 4. Abstract: Patient-days: a better measure of incidence of occupational bloodborne exposures 5. Abstract: Needle-stick injury: a novel intervention to reduce the occupational health and safety risk in the haemodialysis setting 6. Abstract: Adherence to management after occupational exposure to bloodborne pathogen among health care workers in Taiwan 7. Abstract: Accidental exposures to blood and body fluid in the operation room and the issue of underreporting 8. Abstract: Occupational blood exposure accidents in the Netherlands 9. Abstract: The changing face of the HIV epidemic in Taiwan: a new challenge for public health policy strategies 10. Abstract:Risk assessment and screening for sexually transmitted infections, HIV, and hepatitis virus among long-distance truck drivers in New Mexico, 2004-2006 11. Abstract: An immunological overview of allergen specific immunotherapy -- subcutaneous and sublingual routes 12. Abstract: The needle catcher--a safer way to suture 13. Abstract: Optimization of contrast injection protocol for coronary CTA: adjustment of injection iodine volume on test bolus parameters and patients' sex and BSA 14. Abstract: Breast augmentation by autologous fat injection grafting: management and clinical analysis of complications 15. Abstract: Hand hygiene compliance among health care staff and student nurses in a mental health setting 16. Abstract: Inactivation of chlorhexidine gluconate on skin by incompatible alcohol hand sanitizing gels 17. Abstract: E-learning may improve adherence to alcohol-based hand rubbing: a cohort study 18. Abstract: Nasogastric tube feeding--which syringe size produces lower pressure and is safest to use? 19. Abstract: A project to improve the validity rate for nursing staff operating single door autoclave sterilizers 20. Abstract: Survey of the decontamination and maintenance of dental handpieces in general dental practice 21. Abstract: Use of oral ketamine in chronic pain management: A review 22. No Abstract: Double-gloving recommendations 23. No Abstract: Subcutaneous catheter tunneling 24. No Abstract: Unsafe injections 25. No Abstract: Adverse acupuncture effects. "It is a case of malpractice and not side effects" 26. No Abstract: Medical product safety and patient safety--challenges at the "human-medical product" interface 28. Prophylactic Acetaminophen Before Vaccination in Infants Reduces Vaccine Response 30. News - Africa: World's largest malaria vaccine trial now underway in 7 African countries - Africa: Promising Malaria Vaccine Being Tested Across Africa - UK: Extra cleaners 'would save lives' - How long does hepatitis B vaccine protection last? - Studies reaffirm 2 vaccine doses in kids, show safety in pregnant women - USA: Hospitals still looking for hundreds of patients in contaminated needle case - EECAAC: Regional HIV/AIDS Conference Opens In Russia - Russia: AIDS Experts Say Russia Needs New HIV Strategy - Australia: Needle exchanges save money: report - India: Pollution Control Board (PCB) issues strict warning to hospitals - Russia: Russia warned about HIV epidemic - Russian drug policies under spotlight at AIDS conference (Roundup) - Russia: Russia Rejects Methadone to Stem HIV Epidemic - UK: HIV transmission through injecting drug use on the increase in the UK - DIY Botox: Site Offers Injectable Drug Without Prescription - With How- To Video - Ghana: Health Access Network declares war against fake drugs This edition of SIGNpost is located at: http://uqconnect.net/signfiles/Archives/SIGN-POST00519.txt and is printer friendly. If your email reader truncates your SIGNpost - click on the link above to download the complete posting. Please send your requests, notes on progress and activities, articles, news, and other items for posting to: sign@uq.net.au Normally, items received by Tuesday will be posted in the Wednesday edition. Subscribe or un-subscribe by email to: sign@uq.net.au, sign@who.int More information follows at the end of this SIGNpost! Visit the WHO injection safety website and the SIGN Alliance Secretariat at: http://www.who.int/injection_safety/en/ __________________________________________________________________________ _____________________________________*____________________________________ 1. Canada: Preventing the unsafe use of injection devices Crossposted with thanks from From Dialogue, The College of Physicians and Surgeons of Ontario Canada. __________________________________________________________________________ Preventing the unsafe use of injection devices The College of Physicians and Surgeons of Ontario From Dialogue, April 2009 Ontario Canada One of the biggest global concerns is the spread of the human immunodeficiency virus (HIV), the hepatitis B virus (HBV), and the hepatitis C virus (HCV) due to the reuse of injection devices. This problem is worldwide, affecting developed countries as well as developing countries, and many studies have demonstrated the extent and the severity of the problem. According to the United States Centers for Disease Control and Prevention, four of the largest outbreaks of hepatitis in the United States were traced back to health-care workers in doctors’ offices reusing needles and employing other unsafe procedures. Outbreaks of HBV and HCV in the states of New York, Oklahoma, and Nebraska between 2000 and 2002 infected more than 300 people. The infections stemmed from "unsafe injection practices, primarily reuse of syringes and needles or contamination of multiple-dose medication vials." A mathematical model developed by the World Health Organization suggests that in developing and transitional countries in 2000, the reuse of injection devices accounted for an estimated 22 million new cases of HBV infection (about one third of the total), 2 million cases of HCV infection (about 40% of the total), and about a quarter-million cases of HIV infection (about 5% of the total) for the whole world. These infections acquired in 2000 alone are expected to lead to an estimated nine million years of life lost, and disability, between 2000 and 2030. In addition, all those who inject drugs and may at some time share needles, syringes, or other paraphernalia are at risk of blood borne infections. There were an estimated 13.2 million people who injected drugs around the world at the end of 2003, with 10.3 million of them living in developing countries. While there is significant variation between countries, WHO estimates that in sub-saharan Africa, approximately 18% of injections are given with reused syringes or needles that have not been sterilized. However, unsafe medical injections are believed to occur most frequently in South Asia, the Eastern Mediterranean, and the Western Pacific regions. Together, these account for 88% of all injections administered with reused, unsterilized equipment. The severe consequences of needle reuse also underscored the need to reinforce fundamental infection control techniques among health-care workers. Three papers published in 2003 contended that the AIDS epidemic in Africa was fueled by unsafe medical practices, including injections and blood transfusions using unsterile needles. As part of the $15 billion Global AIDS Initiative, the United States Senate heard debate in a public forum regarding evidence of unsafe medical practice being implicated in the spread of HIV. As a result, the Senate accepted an amendment designed to help stop the transmission of HIV/AIDS in Africa through unsafe medical injections and unscreened blood transfusions. The Senate directed the United States federal government to spend at least US$75 million on injection and blood safety programmes in Africa. These facts emphasize the need for immediate and decisive action to prevent the unsafe reuse of injection devices. A safe injection should not harm the patient, expose the health-care worker to any avoidable risks, or result in waste that is dangerous to the community. The widespread publication and distribution of solutions to address this global problem is urgently required to reduce the risk to patients due to poor medical care. Suggested Actions The following strategies should be considered: Promote the single use of injection devices as a health-care facility safety priority that requires leadership and the active engagement of all frontline health-care workers. Develop ongoing training programmes and information resources for health- care workers that address: Infection control principles, safe injection practices, and sharps waste management. The effectiveness of non-injectable medications. The education of patients and their families about alternatives to using injectable medications (e.g., oral medication). New injection technologies (e.g., "needle-less" systems). Evaluate and measure the effectiveness of health-care worker training on injection safety. Provide patients and their families with education regarding: Treatment modalities that are as effective as injections in order to reduce injection use. Transmission of blood borne pathogens. Injection safety practices. Identify and implement safe waste management practices that meet the needs of individual health-care organizations. Promote safe practices as a planned and budgeted activity that includes the procurement of equipment. Specifically consider implementation of "needle-less" systems. Opportunities for Patient and Family Involvement Patients and their families should receive education on the principles of infection control and different modalities for treatment. Educate patients to directly observe and encourage providers to immediately dispose of injection devices within accepted standards of practice and into appropriate sharp instrument waste receptacles after their use. Assist patients and families in the safe disposal of needles if injectable medications must be used in the home setting - reinforce that the safest number of times to use a needle is once. __________________________________________________________________________ _____________________________________*____________________________________ 2. Abstract: Investigation of health care waste management in Binzhou District, China __________________________________________________________________________ Waste Manag. 2009 Oct 26. Investigation of health care waste management in Binzhou District, China. Ruoyan G, Lingzhong X, Huijuan L, Chengchao Z, Jiangjiang H, Yoshihisa S, Wei T, Chushi K. Department of Health Policy and Planning, Graduate School of Medicine, The University of Tokyo, Hongo 7-3-1, Bunkyo-ku, Tokyo 1130033, Japan. In China, national regulations and standards for health care waste management were implemented in 2003. To investigate the current status of health care waste management at different levels of health care facilities (HCF) after the implementation of these regulations, one tertiary hospital, one secondary hospital, and four primary health care centers from Binzhou District were visited and 145 medical staff members and 24 cleaning personnel were interviewed. Generated medical waste totaled 1.22, 0.77, and 1.17kg/bed/day in tertiary, secondary, and primary HCF, respectively. The amount of medical waste generated in primary health care centers was much higher than that in secondary hospitals, which may be attributed to general waste being mixed with medical waste. This study found that the level of the HCF, responsibility for medical waste management in departments and wards, educational background and training experience can be factors that determine medical staff members' knowledge of health care waste management policy. Regular training programs and sufficient provision of protective measures are urgently needed to improve occupational safety for cleaning personnel. Financing and administrative monitoring by local authorities is needed to improve handling practices and the implementation of off-site centralized disposal in primary health care centers. __________________________________________________________________________ _____________________________________*____________________________________ 3. Abstract: The prevalence and risk factors for percutaneous injuries in registered nurses in the home health care sector __________________________________________________________________________ Am J Infect Control. 2009 Sep;37(7):525-33. The prevalence and risk factors for percutaneous injuries in registered nurses in the home health care sector. Gershon RR, Pearson JM, Sherman MF, Samar SM, Canton AN, Stone PW. Mailman School of Public Health, Columbia University, New York, NY 10032, USA. rg405@columbia.edu BACKGROUND: Patients continue to enter home health care (HHC) "sicker and quicker," often with complex health problems that require extensive intervention. This higher level of acuity may increase the risk of percutaneous injury (PI), yet information on the risk and risk factors for PI and other types of exposures in this setting is exceptionally sparse. To address this gap, a large cross-sectional study of self-reported exposures in HHC registered nurses (RNs) was conducted. METHODS: A convenience sample of HHC RNs (N=738) completed a survey addressing 5 major constructs: (1) worker-centered characteristics, (2) patient-related characteristics, (3) household characteristics, (4) organizational factors, and (5) prevalence of PIs and other blood and body fluid exposures. Analyses were directed at determining significant risk factors for exposure. RESULTS: Fourteen percent of RNs reported one or more PIs in the past 3 years (7.6 per 100 person-years). Nearly half (45.8%) of all PIs were not formally reported. PIs were significantly correlated with a number of factors, including lack of compliance with Standard Precautions (odds ratio [OR], 1.72; P=.019; 95% confidence interval [CI]: 1.09-2.71); recapping of needles (OR, 1.78; P=.016; 95% CI: 1.11-2.86); exposure to household stressors (OR, 1.99; P=.005; 95% CI: 1.22-3.25); exposure to violence (OR, 3.47; P=.001; 95% CI: 1.67-7.20); mandatory overtime (OR, 2.44; P=.006; 95% CI: 1.27-4.67); and safety climate (OR, 1.88; P=.004; 95% CI: 1.21-2.91) among others. CONCLUSION: The prevalence of PI was substantial. Underreporting rates and risk factors for exposure were similar to those identified in other RN work populations, although factors uniquely associated with home care were also identified. Risk mitigation strategies tailored to home care are needed to reduce risk of exposure in this setting. __________________________________________________________________________ _____________________________________*____________________________________ 4. Abstract: Patient-days: a better measure of incidence of occupational bloodborne exposures __________________________________________________________________________ Am J Infect Control. 2009 Sep;37(7):534-40. Patient-days: a better measure of incidence of occupational bloodborne exposures. Chen LF, Sexton DJ, Kaye KS, Anderson DJ. Division of Infectious Diseases, Duke Infection Control Outreach Network, Duke University Medical Center, Durham, NC 27710, USA. Luke.Chen@duke.edu BACKGROUND: There is currently no accepted standard denominator to calculate and to report the incidence of occupational exposures to bloodborne pathogens (OEBBPs) in health care. METHODS: We performed a multicenter study of OEBBP injuries reported from 31 community hospitals in the southeastern United States from January 2003 to December 2006. A qualitative design was used to assess 4 commonly used denominators to calculate the incidence of OEBBP: patient-days; staffed beds; occupied beds and full-time employee equivalents (FTEs). Six criteria were used to assess the quality and suitability of each denominator as a standard method to calculate incidence of OEBBP. We also analyzed the correlation of hospital rankings produced by these 4 denominators. RESULTS: During 4 years of study, a total of 3375 occupational exposures were reported. Patient-days outperformed others as a denominator to calculate rates of OEBBP when judged by 6 predefined criteria. Data for staffed beds, occupied beds, and FTE were manually collected, infrequently reported, and often subject to missing data. Furthermore, FTE and staffed beds data also captured unoccupied beds and non-clinical employee data that were not associated with risk of OEBBP. CONCLUSION: Patient-days may be the most suitable and readily available denominator for standard reporting and benchmarking of incidence of OEBBP. Patient-days may be used as a standard method for comparing rates of OEBBP. __________________________________________________________________________ _____________________________________*____________________________________ 5. Abstract: Needle-stick injury: a novel intervention to reduce the occupational health and safety risk in the haemodialysis setting __________________________________________________________________________ J Ren Care. 2009 Sep;35(3):120-6. Needle-stick injury: a novel intervention to reduce the occupational health and safety risk in the haemodialysis setting. Chow J, Rayment G, Wong J, Jefferys A, Suranyi M. Cardiovascular Stream, Sydney South West Area Health Service, New South Wales, Australia. josephine.chow@sswahs.nsw.gov.au Needle-stick injury (NSI) is a major occupational health and safety issue facing healthcare professionals. The administration of erythropoiesis- stimulating agents (ESA) in haemodialysis patients represents a major cause for injections. The purpose of this initiative was to familiarise nursing staff with needle-free administration of an ESA in haemodialysis patients to reduce the risk of NSI. Epoetin beta comes in a commercial presentation with a detached needle. Epoetin beta was administered to 10 haemodialysis patients via the venous bubble trap short line of the haemodialysis circuit. An audit was conducted that included a retrospective assessment of NSI for the previous six months; and a prospective assessment for eight weeks to assess whether there is a nursing staff preference for needle-free administration of ESA. There were no reports of NSI in the needle-free group. Haemoglobin levels were maintained. Ninety-one percent of the nursing staff preferred needle-free administration of ESA. In conclusion, the commercial presentation of epoetin beta with the detached needle presents an opportunity to reduce the potential risk of NSI in haemodialysis units. __________________________________________________________________________ _____________________________________*____________________________________ 6. Abstract: Adherence to management after occupational exposure to bloodborne pathogen among health care workers in Taiwan __________________________________________________________________________ Am J Infect Control. 2009 Sep;37(7):609-11. Adherence to management after occupational exposure to bloodborne pathogen among health care workers in Taiwan. Ko NY, Yeh SH, Tsay SL, Pan SM, Feng MC, Chiang MC, Lee YW, Chang LH, Jang JF. Department of Nursing and Center of Infection Control, College of Medicine, National Cheng Kung University and Hospital, Tainan, Taiwan. nyko@mail.ncku.edu.tw The study purpose was to investigate the adherence to postexposure management of health care workers (HCWs) in Taiwan. A total of 685 HCWs of 1164 HCWs who had reported exposure incidents during 2003-2005 completed questionnaires. Only 33% of the 567 exposed HCWs adhered to the postexposure management. Adherence was associated with percutaneous injury and knowledge of the seropositive status of source patients. Regular follow-ups for seroconversion testing are essential to improving the quality of postexposure management. __________________________________________________________________________ _____________________________________*____________________________________ 7. Abstract: Accidental exposures to blood and body fluid in the operation room and the issue of underreporting __________________________________________________________________________ Am J Infect Control. 2009 Sep;37(7):541-4. Accidental exposures to blood and body fluid in the operation room and the issue of underreporting. Nagao M, Iinuma Y, Igawa J, Matsumura Y, Shirano M, Matsushima A, Saito T, Takakura S, Ichiyama S. Department of Infection Control and Prevention, Kyoto University Hospital, Kyoto, Japan. mnagao@kuhp.kyoto-u.ac.jp A retrospective review of all exposure injuries affecting members of the operative care line at a single university hospital between January 2000 and December 2007 was performed. A questionnaire survey on current status of adherence to barrier precautions was also completed by 164 staff members. Of 136 exposure injuries, 87 (64.0%) were in surgeons, and 49 (36.0%) were in scrub nurses. Surgeons were most commonly injured during suturing (49, 56%), followed by "handing over sharps" (7, 8%), whereas scrub nurses were most commonly injured during "counting and sorting of sharps" (15, 41%), followed by "handing over sharps," and "splash." The questionnaire survey revealed that compliance with goggles, face shields, and double gloving was poor, and only 9% of respondents routinely used the hands-free technique. Only 22% of staff who had experienced exposure injuries reported every incident. Because circumstances of exposure injuries in operating rooms differ by profession, appropriate preventive measures should address individual situations. To reduce exposure injuries in the operating room, further efforts are required including education, mentoring, and competency training for operation personnel. __________________________________________________________________________ _____________________________________*____________________________________ 8. Abstract: Occupational blood exposure accidents in the Netherlands __________________________________________________________________________ Eur J Public Health. 2009 Oct 28. Occupational blood exposure accidents in the Netherlands. van Wijk PT, Schneeberger PM, Heimeriks K, Boland GJ, Karagiannis I, Geraedts J, Ruijs WL. 1 Department of Medical Microbiology and Infection Control, Jeroen Bosch Hospital, 's-Hertogenbosch, The Netherlands. BACKGROUND: To make proper evaluation of prevention policies possible, data on the incidence and associated medical costs of occupational blood exposure accidents in the Netherlands are needed. METHODS: Descriptive analysis of blood exposure accidents and risk estimates for occupational groups. Costs of handling accidents were calculated. RESULTS: Each year, an estimated 13 000-15 000 blood exposure accidents are reported in the Netherlands, 95% in occupational settings. Hepatitis B (HBV) vaccination is offered free of charge only to people in risk groups, the seroprevalence of HBV, hepatitis C (HCV) and human immunodeficiency virus (HIV) is low and few infections are related to blood exposure accidents. High-risk accidents occur mainly in hospitals. In nursing homes and home care settings, the majority of the accidents are low-risk. Limited data are available about occurrence of accidents in other occupational groups. Associated medical costs from occupational blood exposure accidents are mainly determined by the initial risk management. CONCLUSIONS: Accidents must be managed effectively to prevent infection and reduce anxiety in injured employees. While strategies to reduce HCV and HIV infection should be primarily aimed at reducing the occurrence of high-risk accidents, vaccination can prevent HBV infection and cut the costs of handling low- risk accidents. The implementation of vaccination strategies, safe working policies and the proper use of safe equipment should be monitored better. __________________________________________________________________________ _____________________________________*____________________________________ 9. Abstract: The changing face of the HIV epidemic in Taiwan: a new challenge for public health policy strategies __________________________________________________________________________ AIDS Patient Care STDS. 2009 Mar;23(3):195-201. The changing face of the HIV epidemic in Taiwan: a new challenge for public health policy strategies. Chen KT, Chang HL, Chen CT, Chen YA. Department of Public Health, College of Medicine, National Cheng Kung University, No. 1, University Road, Tainan 70101, Taiwan. ktchen@mail.ncku.edu.tw The goals of this study were to examine trends, risk factors, and survival rates of people diagnosed with HIV/AIDS. We used national surveillance data reported to the Taiwan Center for Disease Control (Taiwan CDC). The subjects of this study were all confirmed HIV and AIDS cases in Taiwan. From 1990 through 2005, the number of people that have been reported to have HIV/AIDS is 9961. Among individuals with HIV/AIDS, the male-to-female ratio was 11:1, the median age was 32 years. The number of HIV and AIDS diagnoses increased significantly for both men and women during the study period. The number of HIV cases among men who have sex with men (MSM) increased from 24 in 1990 to 527 in 2005, while diagnoses among injection drug users (IDUs) rose rapidly from 3 in 1990 to 2450 in 2005. The incidence-to-prevalence ratio (IPR) has risen sharply in recent years and has exceeded the epidemic threshold (IPR(t) = 0.1) for IDUs, indicating a growing epidemic. The corresponding hazard ratios for the highly active antiretroviral therapy (HAART) era versus pre-HAART era in the earlier and late HIV diagnosis groups were 0.45 (95% confidence interval [CI] 0.36-0.54) and 0.39 (95% CI 0.31-0.49), respectively. There was no significant difference in the survival rate of HIV testers. The increasing number of HIV infection places Taiwan among the worst IDU- concentrated epidemic areas in Asia. HIV intervention and prevention strategies, especially targeting IDUs, are urgently needed to reduce the ongoing spread of HIV infections in Taiwan. __________________________________________________________________________ _____________________________________*____________________________________ 10. Abstract:Risk assessment and screening for sexually transmitted infections, HIV, and hepatitis virus among long-distance truck drivers in New Mexico, 2004-2006 __________________________________________________________________________ Am J Public Health. 2009 Nov;99(11):2063-8. Risk assessment and screening for sexually transmitted infections, HIV, and hepatitis virus among long-distance truck drivers in New Mexico, 2004-2006. Valway S, Jenison S, Keller N, Vega-Hernandez J, Hubbard McCree D. Public Health Division, New Mexico Department of Health, Infectious Diseases Bureau, 1190 South Saint Francis Drive, Santa Fe, NM 87502, USA. s.valway@att.net OBJECTIVES: We examined sexually transmitted infection (STI), HIV, and hepatitis virus prevalence and risk behaviors among truck drivers. METHODS: We asked participants about their risk behaviors, and we screened them for STIs, HIV, and hepatitis infections. We used logistic regression to identify factors associated with outcomes. RESULTS: Of the 652 enrolled participants, 21% reported sex with sex workers or casual partners in the prior year. Driving solo (odds ratio [OR] = 15.04; 95% confidence interval [CI] = 1.92, 117.53; P = .01), history of injection drug use (IDU; OR = 2.69; 95% CI = 1.19, 6.12; P = .02), and history of an STI (OR = 2.47; 95% CI = 1.19, 5.09; P = .01) were independently associated with high-risk sexual behaviors. Fourteen percent of participants reported drug use in the previous year, and 11% reported having ever injected drugs. Participants tested positive as follows: 54 for HCV antibodies (8.5%), 66 for hepatitis B anticore (anti-HBc) antibodies (10.4%), 8 for chlamydia (1.3%), 1 for gonorrhea (0.2%), 1 for syphilis (0.2%), and 1 for HIV (0.2%). History of injecting drugs (OR = 26.91; 95% CI = 11.61, 62.39; P < .01) and history of anti-HBc antibodies (OR = 7.89; 95% CI = 3.16, 19.68; P < .01) were associated with HCV infection. CONCLUSIONS: Our results suggest a need for hepatitis C screening and STI risk-reduction interventions in this population. __________________________________________________________________________ _____________________________________*____________________________________ 11. Abstract: An immunological overview of allergen specific immunotherapy -- subcutaneous and sublingual routes __________________________________________________________________________ Ther Adv Respir Dis. 2009 Oct;3(5):253-62. An immunological overview of allergen specific immunotherapy -- subcutaneous and sublingual routes. Ozdemir C. Division of Pediatric Allergy and Immunology, Marmara University, Seher Yildizi Sokak 16/10 Etiler, Istanbul, Turkey cozdemir@superonline.com. Allergen-specific immunotherapy remains the most likely effective treatment modality for allergic disorders by targeting the underlying immune mechanisms and possibly causing modifications in the disease course, as well as treating the symptoms. Treatment and compliance experiences been gained over nearly a century in injection-type allergen- specific immunotherapy have motivated the development of newer, alternative routes. Adverse events and safety concerns, efficacy and ease of application seem to be the stimulating factors for the development of a sublingual form of this treatment modality, wherein the principal factor is the capture of the antigen (allergen) by dendritic cells, in the location where oral tolerance arises. Due to the presence of high numbers of tolerogenic dendritic cell subsets in this region, programming of the immune system towards a regulatory state with unresponsiveness to specific allergens occurs. Induction of peripheral tolerance through the generation of regulatory T cells is the key event, with several functional modulations in the allergic immune response. With an increase in understanding of the mechanism of regulatory pathways, promising progresses in the field of allergen-specific immunotherapy will ensue and may provide new options for the treatment of allergic disorders. __________________________________________________________________________ _____________________________________*____________________________________ 12. Abstract: The needle catcher--a safer way to suture __________________________________________________________________________ Surgeon. 2009 Aug;7(4):251-2. The needle catcher--a safer way to suture. Bell PR, McNicholl BP. The needle catcher is a novel surgical instrument which has been developed in Belfast in conjunction with Queen's University Belfast that aims to reduce suture needle exposure and increase operator safety during suturing. The instrument was used to close wounds in 20 patients presenting to A&E in the Royal Group of Hospitals and to the plastic surgery service in the Ulster Hospital. This letter includes a technical description of the instrument, evaluation of needle exposure, comments from users, evaluation of the needle catcher and a discussion on the need for additional protection for medical staff in surgical based specialties where there is frequent exposure to blood, open wounds and sharps. __________________________________________________________________________ _____________________________________*____________________________________ 13. Abstract: Optimization of contrast injection protocol for coronary CTA: adjustment of injection iodine volume on test bolus parameters and patients' sex and BSA __________________________________________________________________________ Nippon Hoshasen Gijutsu Gakkai Zasshi. 2009 Aug 20;65(8):1073-80. [Optimization of contrast injection protocol for coronary CTA: adjustment of injection iodine volume on test bolus parameters and patients' sex and BSA] [Article in Japanese] Akiyama N, Nakamura Y. Central Radiology Department, Tosei General Hospital. The purpose of this study was to correlate test bolus (TB) parameters and patient information and cardiac function with main bolus (MB) contrast density for 64-slice computed tomography, and to evaluate MB contrast density on a fixed injection rate, in comparison with an injection rate adjusted with TB parameters and patient information. A total of 256 patients underwent coronary CT angiography. In 126 patients (group 1), contrast material was administered at a flow rate of 4 ml/sec. The peak enhancement, the time needed to reach the peak of the TB and cardiac function of the MB were calculated for each patient in this group. The dependency of MB contrast attenuation on these parameters was evaluated. Significant correlations were obtained between the peak density of the TB and the patient's body surface area (BSA) with the enhancement of MB. Furthermore, females showed a higher peak enhancement of MB than males. In view of the results of group 1, in the other 130 patients (group 2) injection protocols were computed by using regression analysis of each patient's attenuation response to a TB and patient sex and BSA. Compared with group 1, the variations of MB contrast density of group 2 were reduced. Optimized contrast injection protocols are useful to reduce variations of MB contrast density, by taking these TB parameters and patient sex and BSA into account. __________________________________________________________________________ _____________________________________*____________________________________ 14. Abstract: Breast augmentation by autologous fat injection grafting: management and clinical analysis of complications __________________________________________________________________________ Breast augmentation by autologous fat injection grafting: management and clinical analysis of complications. Mu DL, Luan J, Mu L, Xin MQ. Center for Mammoplasty and Breast Reconstruction, Plastic Surgery Hospital, Peking Union Medical College, Chinese Academy of Medical Sciences, Beijing, China. Autologous fat is an excellent soft-tissue filler, given its abundance and ease of harvest. Nevertheless, the technique is accompanied by postoperative complications such as fat necrosis, calcification, and sclerotic nodules. These problems directly influence surgical efficacy. Computed tomography or magnetic resonance imaging was used to confirm the location of abnormal adipose tissue preoperatively. Depending on the characteristics of the lesion, the liquefied fat was aspirated or the sclerotic lesion excised. Pressurized dressings were used postoperatively for both techniques. Seventeen patients who experienced complications after autologous fat injection were treated. Pathologic examination of excised samples demonstrated changes including fat necrosis, calcification, hyalinization, and fibroplasia. Intramammary autologous fat injection should only be used with caution. Selecting suitable indications and correct surgical techniques make autologous fat grafting an ideal method for breast augmentation. Strictly controlling the injection volume and injecting diffusely in multiple layers to allow fat granules to distribute evenly within the breast, are effective methods to reduce postoperative complications. __________________________________________________________________________ _____________________________________*____________________________________ 15. Abstract: Hand hygiene compliance among health care staff and student nurses in a mental health setting __________________________________________________________________________ Issues Ment Health Nurs. 2009 Nov;30(11):702-4. Hand hygiene compliance among health care staff and student nurses in a mental health setting. Ott M, French R. Fanshawe College, School of Nursing, London, Ontario, N4S 7V9 Canada. mott@fanshawec.ca Hand hygiene practice among health care workers is considered to be the single most effective method of preventing nosocomial infection in hospital settings. Infection control practices in psychiatric facilities are particularly challenging as hand hygiene protocols are specific to acute care facilities, areas where hands are visibly soiled, and when procedures are completed that may involve body fluid exposure. The inability to motivate and change the hand washing practices of health care workers suggests that hand washing behaviour is complex, involving individual beliefs and attitudes and institutional commitment and rigor. __________________________________________________________________________ _____________________________________*____________________________________ 16. Abstract: Inactivation of chlorhexidine gluconate on skin by incompatible alcohol hand sanitizing gels __________________________________________________________________________ Am J Infect Control. 2009 Sep;37(7):569-73. Inactivation of chlorhexidine gluconate on skin by incompatible alcohol hand sanitizing gels. Kaiser N, Klein D, Karanja P, Greten Z, Newman J. STERIS Corporation, St Louis Operations, St Louis, MO, USA. Incompatibility of leave-on products with an antimicrobial residual can negate the efficacy benefits of chlorhexidine gluconate (CHG) persistence. Two marketed alcohol products containing Carbomer were tested using a pigskin substrate model against Staphylococcus aureus. The CHG residual achieved a 4.22 log(10) reduction (standard deviation [SD] = 0.32) in this study, which was dramatically reduced to a 0.54 (SD = 0.50) and 0.46 (SD = 0.56) after subsequent treatment with incompatible alcohol gel products. A marketed alcohol product containing a nonionic thickener maintained the efficacy of the CHG chemical reservoir (log(10) reduction = 4.26, SD = 0.00). Similar findings were demonstrated when alcohol solutions containing the individual thickening agents were tested as simple formulations. An in vivo test using human forearms and Serratia marcescens similarly demonstrated that the activity of a CHG reservoir (log(10) reduction = 3.73, SD = 0.86) was not reduced by a nonionic thickened product (log(10) reduction = 3.98, SD = 0.72) but was significantly reduced by treatment with alcohol products containing anionic thickeners carbomer (log(10) reduction = -0.32, SD = 0.34) or acrylates/C10-30 alkyl acrylate crosspolymer (log(10) reduction = -0.20, SD = 0.32). The use of anionic thickeners or emulsifiers in leave-on products, including alcohol hand sanitizers, may inactivate the persistent antibacterial activity of CHG. __________________________________________________________________________ _____________________________________*____________________________________ 17. Abstract: E-learning may improve adherence to alcohol-based hand rubbing: a cohort study __________________________________________________________________________ Am J Infect Control. 2009 Sep;37(7):565-8. E-learning may improve adherence to alcohol-based hand rubbing: a cohort study. Laustsen S, Bibby BM, Kristensen B, Møller JK, Thulstrup AM. Department of Clinical Microbiology, Aarhus University Hospital, Skejby, DK-8200 Aarhus N, Denmark. sussie.laustsen@ki.au.dk BACKGROUND: Since 2004, we have promoted alcohol-based hand rubbing (HR) with an e-learning program (ELP) among hospital staff. This study sought to determine whether an ELP improves adherence to correct HR. METHODS: This was a cohort study of staff members at Aarhus University Hospital, Skejby, Denmark who completed the ELP and were repeatedly observed for correct HR before and after clinical procedures in 2006 and/or 2007. RESULTS: Of the 496 participants, 13% completed the ELP in both 2006 and 2007, 29% completed the ELP only in 2006, 15% completed the ELP only in 2007, and 43% never completed the ELP. Compared with noncompleters, completers of the 2006 and 2007 ELP had a significantly higher adherence to correct HR both before clinical procedures (odds ratio [OR] = 1.54; 95% confidence interval [CI] = 1.11 to 2.13) and after clinical procedures (OR = 1.40; 95% CI = 1.03 to 1.89). Time since completing the ELP seemed to be inversely associated with adherence to correct HR. CONCLUSION: Completion of an ELP may have a positive impact on the performance of correct HR. The demands of lifelong education and training of hospital staff may call for the use of an ELP as a supplement to existing efforts aimed at improving HR to help prevent health care-related infections. __________________________________________________________________________ _____________________________________*____________________________________ 18. Abstract: Nasogastric tube feeding--which syringe size produces lower pressure and is safest to use? __________________________________________________________________________ Nurs Times. 2009 Jul 14-20;105(27):24-6. Nasogastric tube feeding--which syringe size produces lower pressure and is safest to use? Knox T, Davie J. Paediatric Unit, Royal Berkshire NHS Foundation Trust. BACKGROUND: For this research, we worked on the hypothesis that larger syringe sizes would not generate greater pressures (negative or positive) than smaller ones. This contradicts current practice and theory, which states that larger syringes produce lower pressures and are safer. AIM: To establish the most appropriate syringe size in a laboratory experiment. METHOD: We attached a manometer to a syringe with and without nasogastric tubes and measured negative pressures generated when aspirating, and positive pressures generated when injecting fluids. RESULTS: The findings suggest that smaller syringes generate lower pressures; further research is needed to confirm this. CONCLUSION: If we are correct there is a patient safetyissue, which must be addressed urgently. Also, smaller syringes may lead to significant cost savings. __________________________________________________________________________ _____________________________________*____________________________________ 19. Abstract: A project to improve the validity rate for nursing staff operating single door autoclave sterilizers __________________________________________________________________________ Hu Li Za Zhi. 2009 Aug;56(4):53-61. [A project to improve the validity rate for nursing staff operating single door autoclave sterilizers] [Article in Chinese] Chen CH, Li CC, Chou CY, Chen SH. Department of Nursing, Chung-Gung Memorial Hospital in Kaohsiung, ROC. This project was designed to improve the low validity rate for nurses responsible to operate single door autoclave sterilizers in the operating room. By investigating the current status, we found that the nursing staff validity rate of cognition on the autoclave sterilizer was 85%, and the practice operating check validity rate was only 80%. Such was due to a lack of in-service education. Problems with operation included: 1. Unsafe behaviors - not following standard procedure, lacking relevant operating knowledge and absence of a check form; 2. Unsafe environment - the conveying steam piping was typically not covered and lacked operation marks. Recommended improvement measures included: 1. holding in-service education; 2. generating an operation procedure flow chart; 3. implementing obstacle eliminating procedures; 4. covering piping to prevent fire and burns; 5. performing regular checks to ensure all procedures are followed. Following intervention, nursing staff cognition rose from 85% to 100%, while the operation validity rate rose from 80% to 100%. These changes ensure a safer operating room environment, and helps facilities move toward a zero accident rate in the healthcare environment. __________________________________________________________________________ _____________________________________*____________________________________ 20. Abstract: Survey of the decontamination and maintenance of dental handpieces in general dental practice __________________________________________________________________________ Br Dent J. 2009 Aug 22;207(4):E7; discussion 160-1. Survey of the decontamination and maintenance of dental handpieces in general dental practice. Smith GW, Smith AJ, Creanor S, Hurrell D, Bagg J, Lappin DF. Glasgow Dental Hospital and School, 378 Sauchiehall Street, Glasgow. a.smith@dental.gla.ac.uk OBJECTIVES: To determine how dental handpieces are decontaminated and maintained in general dental practice. DESIGN: Observational survey. SETTING: The survey was carried out in general dental practice in Scotland. Survey visits ran from January 2003 until the end of March 2004. METHODS: Data were collected by interview and observation in 179 dental surgeries in Scotland. RESULTS: In virtually all surgeries, handpieces were cleaned before disinfection or autoclaving (99%; n = 177), most commonly by wiping the external surface with a cloth impregnated with disinfectant. Most surgeries lubricated their handpieces after cleaning and before sterilisation (91%; n = 162), although a number of surgeries (24%; n = 42) also lubricated their handpieces after sterilisation. In the majority (97%; n = 174) of dental surgeries, all handpieces were autoclaved after use, most frequently (89%; n = 160) in a bowl and instrument steriliser. In 38 surgeries (21%), handpieces were being wrapped (paper pouches) before sterilisation in bowl and instrument sterilisers. A minority of surgeries (20%; n = 36) had a dedicated handpiece for surgical procedures. CONCLUSIONS: The majority of dental handpieces are manually cleaned externally with a disinfectant impregnated cloth and processed in a type N (bowl and instrument) bench top steam steriliser. Handpieces are lubricated with non-water soluble lubricants at different stages of reprocessing, indicating clarification is required in this area. More work is required by manufacturers to establish a validated cleaning and lubrication process to facilitate the sterilisation of handpieces. __________________________________________________________________________ _____________________________________*____________________________________ 21. Abstract: Use of oral ketamine in chronic pain management: A review __________________________________________________________________________ Eur J Pain. 2009 Oct 28. Use of oral ketamine in chronic pain management: A review. Blonk MI, Koder BG, Bemt PM, Huygen FJ. Department of Hospital Pharmacy, Erasmus Medical Center, P.O. Box 2040, 3000 CA Rotterdam, The Netherlands. The analgesic effect of ketamine is primarily based on the antagonism of the N-methyl-D-aspartate (NMDA) receptor. Activation of NMDA receptors may play a crucial role in the pathogenesis of chronic pain. Little formal research has been performed on the efficacy and safety of ketamine in chronic pain, especially concerning long-term oral administration. This review provides an overview of the available clinical data on the use of oral ketamine in chronic pain management. A literature search was performed in MEDLINE, EMBASE and the Cochrane Library, resulting in 22 relevant articles. Because most retrieved articles were of a descriptive nature (e.g. case reports and case series) a quantitative analysis was not possible. There was no consistent dose- response relation. A recommended starting dosage in ketamine-naive patients is 0.5mg/kg racemic ketamine or 0.25mg/kg S-ketamine as a single oral dose. The dosage is increased by the same amount if required. For a continuous analgesic effect it is usually given 3-4 times daily. The injection fluid can be taken orally. When parenteral ketamine is switched to oral administration the daily dosage can be kept equal and, depending on clinical effect and/or adverse effects, is slowly increased. The pharmacologically active metabolite norketamine is believed to contribute to the analgesic effect of oral ketamine. Lack of evidence regarding efficacy, and the poor safety profile, do not support routine use of oral ketamine in chronic pain management. Oral ketamine may have a limited place as add-on therapy in complex chronic pain patients if other therapeutic options have failed. __________________________________________________________________________ _____________________________________*____________________________________ 22. No Abstract: Double-gloving recommendations __________________________________________________________________________ AORN J. 2009 Aug;90(2):181. Double-gloving recommendations. Young J. No abstract available __________________________________________________________________________ _____________________________________*____________________________________ 23. No Abstract: Subcutaneous catheter tunneling __________________________________________________________________________ Reg Anesth Pain Med. 2009 Jul-Aug;34(4):379. Subcutaneous catheter tunneling. Rose GL. No abstract available __________________________________________________________________________ _____________________________________*____________________________________ 24. No Abstract: Unsafe injections __________________________________________________________________________ Am J Nurs. 2009 Nov;109(11):15. Unsafe injections. Kamphaus J. __________________________________________________________________________ _____________________________________*____________________________________ 25. No Abstract: Adverse acupuncture effects. "It is a case of malpractice and not side effects" __________________________________________________________________________ MMW Fortschr Med. 2009 Sep 24;151(39):7. [Adverse acupuncture effects. "It is a case of malpractice and not side effects"] [Article in German] Bahr FR. __________________________________________________________________________ _____________________________________*____________________________________ 26. No Abstract: Medical product safety and patient safety--challenges at the "human-medical product" interface __________________________________________________________________________ Zentralbl Chir. 2009 Aug;134(4):277-80. [Medical product safety and patient safety--challenges at the "human- medical product" interface] [Article in German] Franz D, Roeder N. Geschäftsbereich Medizinisches Management, Medizincontrolling, DRG- Research-Group, Universitätsklinikum Münster, Domagkstrasse 5, Münster. __________________________________________________________________________ _____________________________________*____________________________________ 28. Prophylactic Acetaminophen Before Vaccination in Infants Reduces Vaccine Response Crossposted from Medscape Medical News CME with thanks and edited. __________________________________________________________________________ Prophylactic Acetaminophen Before Vaccination in Infants Reduces Vaccine Response Medscape Medical News CME News Author: Fran Lowry, CME Author: Charles P. Vega, MD (26.10.09) October 26, 2009 - Prophylactic administration of acetaminophen (paracetamol) to reduce fever or febrile convulsions after vaccination in infants actually results in reduced immunogenicity and should not be routinely recommended, according to a new study published in the October 17 issue of The Lancet. "Although fever is part of the normal inflammatory process after immunization, prophylactic antipyretic drugs are sometimes recommended to allay concerns of high fever and febrile convulsion," write Roman Prymula, MD, from the University of Defence, Hradec Kralove, Czech Republic, and colleagues. "Evidence lending support to this approach is scarce; the level of fever is unrelated to the onset of convulsion, and antipyretic drugs are ineffective in prevention of benign febrile convulsion in children who are at risk." The aim of the study was to assess the effect of acetaminophen on infant febrile reaction rates and vaccine responses. Vaccination Open-Label Studies Performed The authors performed 2 consecutive (primary and booster) vaccination open-label studies. Healthy infants aged 9 to 16 weeks were randomly assigned to receive 3 prophylactic acetaminophen doses every 6 to 8 hours in the first 24 hours (n = 226 infants) or to no acetaminophen (n = 233 infants) after each vaccination with a 10-valent pneumococcal nontypeable Haemophilus influenzae protein D-conjugate vaccine (PHiD-CV) coadministered with the hexavalent diphtheria-tetanus-3-component acellular pertussis-hepatitis B-inactivated poliovirus types 1, 2, and 3-H influenzae type b (DTPa-HBV-IPV/Hib) and oral human rotavirus vaccines. Prophylactic acetaminophen did reduce febrile reactions, the investigators report. The percentage of children with a temperature of 38ºC or greater after at least 1 dose was significantly lower in the prophylactic acetaminophen group after primary vaccination (94/226; 42%) and after booster (64/178; 36%) vs the no-prophylactic acetaminophen group after primary vaccination (154/233; 66%) and after booster (100/172; 58%). Fever greater than 39.5ºC was uncommon in both groups. Unexpected Finding Reported However, an unexpected finding was a substantial reduction in the primary antibody response to each of the 10 pneumococcal conjugate vaccine serotypes and to Hib polysaccharide, diphtheria, tetanus, and pertactin antigens. "After boosting, lower antibody GMCs persisted in the prophylactic...[acetaminophen] group for antitetanus, protein D, and all pneumococcal serotypes except for 19F," the study authors write. "To our knowledge, such an effect of prophylactic...[acetaminophen] on postimmunisation immune responses has not been documented before. Remarkably few published studies have assessed the effects of antipyretic drugs on child vaccine responses," Dr. Prymula and colleagues write. They conclude that the clinical relevance of their findings is unknown and needs further assessment but suggest that the prophylactic administration of antipyretic drugs at the time of vaccination "should nevertheless no longer be routinely recommended without careful weighing of the expected benefits and risks." Comments: Important Question Raised In an accompanying comment, Robert T. Chen, MD, from the Centers for Disease Control and Prevention in Atlanta, Georgia, and colleagues, write that Dr. Prymula and colleagues raise an important question regarding the clinical and public health implications of reduced antibody concentrations with the use of acetaminophen. This is particularly important with regard to the extent to which acetaminophen might reduce population protection. "This point has implications, especially for Haemophilus influenzae and pneumococcus, for which higher and sustained antibody concentrations are needed to interrupt the carrier state and reduce transmission within the population," they write. Dr. Chen and colleagues add that vaccine policymakers should assess the implications of the study findings for vaccination programs, concluding, "Prymula and colleagues present a compelling case against routine use of...[acetaminophen] during paediatric immunizations." Anna Taddio, PhD, from the Hospital for Sick Children and the University of Toronto, Toronto, Ontario, Canada, agrees. Dr. Taddio told Medscape Pediatrics that today's vaccines are safer, with fewer adverse effects, and that recent studies have begun to show that antipyretics do not do as much to reduce fever and alleviate pain and other uncomfortable symptoms associated with infant vaccinations as previously believed. "In general, fewer people are recommending routine use of Tylenol, so this study is helping that pendulum sway more to the 'don't use' end by suggesting that you shouldn't give...[acetaminophen] just in case a child may develop side effects, because this might be contributing to a problem which no one else has ever shown before - that...[acetaminophen] interferes with the vaccine." She concurred with Dr. Chen and colleagues that the new finding raises public health concerns. "The amount of protective antibody was a little bit lower for some of these vaccines, so if everybody's levels are a little lower, some people may continue to carry the organism. This might not mean much for an individual, but we don't know whether other people in the population will be getting infected." Dr. Taddio added that she considers the use of prophylactic acetaminophen an option to be considered in case a child has a severe reaction after being vaccinated. "Because this study showed reduced protective antibodies with... [acetaminophen] and because other studies fail to show that... [acetaminophen] actually helps as much as we thought, I won't recommend that parents give it to their kids. I would say that's out of the books now. If a child does develop a fever and is very uncomfortable, then you can give it. That’s a common sense approach anyway. Why would you give drugs unnecessarily?" This study was funded by GlaxoSmithKline Biologicals. Dr. Prymula has disclosed various financial relationships with GlaxoSmithKline. Dr. Chen and Dr. Taddio have disclosed no relevant financial relationships. Lancet.2009;374:1305-1306, 1339-1350. __________________________________________________________________________ _____________________________________*____________________________________ 29. 14th ICID - Abstract Submission Deadline Extended: 30 November 2009 __________________________________________________________________________ 14th ICID - Abstract Submission Deadline Extended Dear Colleague: On behalf of the International Society for Infectious Diseases, I would like to invite you to submit abstracts for presentation at the 14th International Congress on Infectious Diseases. The Congress will be held in Miami, Florida on March 9-12, 2010. The scientific program for the Congress is nearly complete and we have an outstanding line up of speakers and topics that will be of interest to anyone active in the fields of infectious diseases or travel medicine. The deadline for abstract submissions to the 14th ICID has been extended to November 30th. I urge you to submit your abstract as soon as possible, and plan on joining your colleagues and peers from around the world in Miami for this educational and enjoyable meeting. Take advantage of reduced registration fees by registering on or before January 15, 2010. Please visit http://www.isid.org for complete information including Congress registration, hotel reservation, and abstract submission instructions. I look forward to seeing you in Miami. Sincerely yours, Raul Isturiz MD President, ISID __________________________________________________________________________ _____________________________________*____________________________________ 30. News - Africa: World's largest malaria vaccine trial now underway in 7 African countries - Africa: Promising Malaria Vaccine Being Tested Across Africa - UK: Extra cleaners 'would save lives' - How long does hepatitis B vaccine protection last? - Studies reaffirm 2 vaccine doses in kids, show safety in pregnant women - USA: Hospitals still looking for hundreds of patients in contaminated needle case - EECAAC: Regional HIV/AIDS Conference Opens In Russia - Russia: AIDS Experts Say Russia Needs New HIV Strategy - Australia: Needle exchanges save money: report - India: Pollution Control Board (PCB) issues strict warning to hospitals - Russia: Russia warned about HIV epidemic - Russian drug policies under spotlight at AIDS conference (Roundup) - Russia: Russia Rejects Methadone to Stem HIV Epidemic - UK: HIV transmission through injecting drug use on the increase in the UK - DIY Botox: Site Offers Injectable Drug Without Prescription - With How- To Video - Ghana: Health Access Network declares war against fake drugs Selected news items reprinted under the fair use doctrine of international copyright law: http://www4.law.cornell.edu/uscode/17/107.html __________________________________________________________________________ Africa: World's largest malaria vaccine trial now underway in 7 African countries PATH Malaria Vaccine Initiative, GSK Biologicals Press Release (3.11.09) Pivotal testing of RTS,S is on track for target enrollment of 16,000 children NAIROBI, KENYA November 3, 2009 -A pivotal efficacy trial of RTS,S, the world's most clinically advanced malaria vaccine candidate, is now underway in seven African countries: Burkina Faso, Gabon, Ghana, Kenya, Malawi, Mozambique and Tanzania. The trial, which is expected to involve up to 16,000 children, is on schedule, with more than 5,000 children already enrolled, researchers announced Tuesday at the 5th Multilateral Initiative on Malaria Pan-African Malaria Conference. Developing a vaccine against malaria, a scientific challenge for decades, is critical to defeating the disease. A vaccine would complement existing interventions, such as bed nets and effective drug therapies. GlaxoSmithKline Biologicals' (GSK Bio) RTS,S is the first malaria vaccine candidate to demonstrate significant efficacy during early development to warrant Phase III testing. It is the leading vaccine candidate in the global effort by the PATH Malaria Vaccine Initiative (MVI) to develop a malaria vaccine. "A malaria vaccine could help save countless lives and redefine the future for Africa's children," said Dr. Patricia Njuguna, RTS,S principal investigator (KEMRI-Wellcome Trust, Kilifi, Kenya) and chair of the Clinical Trials Partnership Committee, a collaboration of African research institutions, MVI, and GSK Bio that is leading the clinical development of RTS,S. "Communities all across Africa are dedicated to this future and are participating to ensure that we develop a vaccine with an acceptable safety and efficacy profile." RTS,S is the first vaccine designed primarily for use in Africa, where malaria kills more than 800,000 people every year, the majority of them children under the age of five. By conducting the trial in seven different countries across Sub-Saharan Africa, researchers will be able to evaluate the vaccine candidate's efficacy in a variety of settings, with diverse patterns of malaria transmission. For example, some trial sites are located in areas where there is a year-round threat of malaria, while others experience only seasonal transmission. All of the research centers were chosen for their track record of world- class clinical research, strong community relations and commitment to meeting the highest international ethical, medical, clinical and regulatory standards. "This is a tremendous moment in the fight against malaria and the culmination of more than two decades of research, including 10 years of clinical trials in Africa," said Dr. Joe Cohen, co-inventor of RTS,S and Vice President of R&D, Vaccines for Emerging Diseases and HIV, at GSK Biologicals. "The Phase III trial is a huge undertaking that depends on effective coordination between researchers, regulators, families and communities. Everyone involved has invested significant energy and resources to pave the way for what could become the world's first malaria vaccine." Recent Phase II studies showed that RTS,S reduced clinical episodes of malaria by 53 percent over an eight-month follow-up period. Findings from a Phase II trial initiated in 2002 and conducted with more than 2,000 children in southern Mozambique, published in the medical journal The Lancet in 2004 and 2005, showed that RTS,S was efficacious for at least 18 months in reducing clinical malaria by 35 percent, and severe malaria by 49 percent. , In addition, RTS,S was shown to have a promising safety and tolerability profile when used alongside the World Health Organization's (WHO) standard infant vaccines. "This historic trial could lead to the availability of a vaccine with the potential to save the lives of hundreds of thousands of African children, if the data are positive," said Dr. Christian Loucq, director of the PATH Malaria Vaccine Initiative. "But development is only half the mission; MVI and its partners are committed to ensuring this vaccine reaches those who need it most. We hope the international community will respond by starting to prepare for the day when-if all goes well-this vaccine will be available for distribution and use." The Phase III trial The Phase III trial will evaluate the vaccine's efficacy in two groups of children. One group, aged 6 to 12 weeks, will be vaccinated as part of their regular schedule of infant immunizations; the second group includes children aged 5 to 17 months. The vaccine profile is intended primarily for infants, as they and children under the age of five are the most vulnerable to malaria. "This is the largest trial ever conducted in Africa of a vaccine specifically designed for use with African children. We have great appreciation for the families and children participating," said Dr. Salim Abdulla, director of the Ifakara Health Institute, Tanzania, which is participating in the Phase III trial. "Development of RTS,S across Africa has strengthened our research capacity, a legacy that will far outlast the trials." Each country hosting a study site has undertaken independent reviews to ensure the trial meets national safety, ethical and legal standards for medical research. In addition, an independent data and safety monitoring board oversees the entire trial with support from local safety monitors. The trial has been designed in consultation with appropriate regulatory authorities in the European Union, the United States and African countries, in conjunction with the WHO. Looking ahead If the Phase III program progresses as expected, RTS,S could be submitted for regulatory review under Article 58 as early as 2012. Article 58 is a special review procedure that allows the European Medicines Agency (EMEA), in close collaboration with the WHO, to issue a scientific opinion regarding the quality, the efficacy and the safety of a medical product that is intended for use exclusively outside the European Union. Under current plans, the RTS,S vaccine candidate would be submitted to regulatory authorities in 2012 based on efficacy in children 5-17 months of age. Additional safety and immunogenicity data from the infant population will be submitted soon thereafter, followed by efficacy data for infants once available. Depending on the final clinical profile of the vaccine and the timetable of the regulatory review process, the first vaccine introduction could take place over the next three to five years. "GSK's approach is to make every effort possible to accelerate the availability of this life-saving vaccine," said Mr. Jean Stéphenne, President and General Manager, GlaxoSmithKline Biologicals. "Ever conscious of the burden of malaria, we have no time to lose and we will exhaust every avenue at our disposal. This is our commitment as a company." MVI, the WHO and US Agency for International Development developed the Malaria Vaccine Decision-Making Framework to help countries prepare to make decisions related to future adoption of a malaria vaccine and thereby avoid unnecessary delay between the recommendation for use of a vaccine and its availability in low-income countries. GSK and MVI are already working with malaria-affected countries and international institutions to ensure that, if successful, a malaria vaccine will be readily available and affordable to those who need it most. ### About RTS,S GSK and MVI signed a collaboration agreement in 2001 to pursue the pediatric clinical development of RTS,S in Africa. To advance the development program, African research centers in five countries, and collaborating institutions, joined the partnership. Centers in two additional African countries have joined for the Phase III trial. The vaccine was invented, developed and manufactured in laboratories at GSK Bio's headquarters in Belgium, with the research starting in the late 1980s. The vaccine was initially tested in US volunteers, in the mid-1990's, as part of a collaboration with the Walter Reed Army Institute of Research. Funding for the development of this vaccine candidate has been made possible through the support of the Bill & Melinda Gates Foundation, which has provided more than $200 million in grant monies to MVI for this project since 2001. GSK has invested more than $300 million to date and expects to invest at least another $100 million before the completion of the project. About the PATH Malaria Vaccine Initiative (MVI) The PATH Malaria Vaccine Initiative (MVI) is a global program established at PATH through an initial grant from the Bill & Melinda Gates Foundation. MVI's mission is to accelerate the development of malaria vaccines and ensure their availability and accessibility in the developing world. MVI's vision is a world free from malaria. For more information, please visit www.malariavaccine.org. PATH is an international nonprofit organization that creates sustainable, culturally relevant solutions, enabling communities worldwide to break longstanding cycles of poor health. By collaborating with diverse public- and private-sector partners, PATH helps provide appropriate health technologies and vital strategies that change the way people think and act. PATH's work improves global health and well-being. For more information, please visit www.path.org. About GlaxoSmithKline Biologicals (GSK Bio) GlaxoSmithKline-one of the world's leading research-based pharmaceutical and healthcare companies-is committed to improving the quality of human life by enabling people to do more, feel better and live longer. For company information, please visit www.gsk.com/media. GSK Biologicals, one of the world's leading vaccine manufacturers, is headquartered in Rixensart, Belgium, where the majority of GlaxoSmithKline's activities in the field of vaccine research, development and production are conducted. In 2008, GSK Bio distributed more than 1.1 billion doses of vaccines to 176 countries. Close to 80 percent of these doses went to developing countries. .......................................................................... __________________________________________________________________________ Africa: Promising Malaria Vaccine Being Tested Across Africa By Alan Boswell, VOA News, USA (03.11.09) Nairobi Researchers behind the world's leading malaria vaccine candidate announced a major clinical trial involving thousands of children in seven African countries is well underway and on schedule. Top experts are converging in Nairobi from around the globe this week to attend the largest malaria conference in four years. The vaccine, known as RTS-S, is the first malaria vaccine to ever reach Phase III testing. RTS-S is designed primarily to fight malaria in Africa, where 91 percent of children killed by the virus are found. The critical vaccine trial is expected to enroll up to 16,000 African children, 5,000 of which have already been recruited. Spreading the testing across a variety of sub-Saharan nations was necessary in order to ensure a diversity of malaria breeding grounds were represented. In some areas malaria is a seasonal threat, whereas in others transmission can happen year-round. Under a best case scenario, the researchers say the vaccine could be introduced into the market in as little as three years, although more realistically the process will take longer. Research first began in Belgium two decades ago, with initial testing in the United States starting during the mid-1990's. The British pharmaceutical company behind the malaria vaccine, GlaxoSmithKline, said last week that it was committed to keeping the drug affordable should it reach the market. Nairobi is host this week to the 5th Multilateral Initiative on Malaria Pan-African Conference, which was last held in 2005. More than 800,000 people die each year from malaria, most of its victims having not yet reached the age of five. Dr. Wen Kilama, a long-time malaria researcher and one of the conference organizers, says some African countries have made significant progress in the fight against malaria, including Eritrea, Zambia, and Ethiopia. But Kilama says many other states in the region are still losing the malaria battle. He places the blame for this discrepancy on the shoulders of the failing nations' governments. "It is good governance; it is political will; it is the commitment - because financing to me is not as big a problem as it used to be. So it is putting their act together and getting the work done," said Dr. Kilama. He also cautions against treating the RTS-S vaccine as panacea solution, saying that most likely more than one vaccine would be necessary to completely finish the fight against the virus. An additional study presented at the conference concludes that mosquitos are shifting their feeding times to earlier in the evenings in order to adapt to the widespread use of malaria bed nets in at-risk areas. The researchers urge combining use of the bed nets with mosquito repellants for full protection. .......................................................................... __________________________________________________________________________ UK: Extra cleaners 'would save lives' The Press Association, UK (03.11.09) Lives would be saved and millions of pounds cut from NHS budgets if hospitals took on just one extra cleaner on each ward, according to new research. The study for Unison found that an extra cleaner had a "measurable effect" on the clinical environment, cutting the number of patients who contracted MRSA and saving an estimated £30,000 to £70,000 per hospital. The union sponsored microbiologist Dr Stephanie Dancer to carry out in- depth research into MRSA and cleaning at the Southern General Hospital in Glasgow. The findings revealed that enhanced cleaning led to a 32.5% reduction in microbial contamination at hand-touch sites, while cases of MRSA fell in the six months of targeted cleaning on one of the wards. They rose again when the extra cleaner moved to another ward, which in turn saw the number of cases fall. Dr Dancer's research focused on targeting cleaning around specific areas close to patient beds, such as lockers, trays, buzzers, curtains and the beds themselves. Dave Prentis, general secretary of Unison, said: "MRSA has a devastating effect on patients and can cost lives. Dr Dancer's work has shone new light on the absolute importance of putting effective cleaning practices at the heart of infection control. "It busts the myth that expensive solutions and disinfectants are needed to keep wards clean and it provides a blueprint for hospitals to cut their own infection rates." Dr Dancer said: "It is very tempting to look for easy ways to clean a hospital ward. Look at all the wonderful ideas out there...bug-buster dusters, clean air machines, kill-all disinfectants and gases, electrostatic wall tiles, copper toilets, silver pyjamas and self-clean computers, for example. "Whilst such things are innovative and interesting, we should not forget that basic hospital cleaning with detergent and water is the first line of defence against hospital infections. Cleaning is hard work, and complicated work, and the gadgets, gimmicks and gizmos cannot, and should not, replace a hospital cleaner." Copyright © 2009 The Press Association. .......................................................................... __________________________________________________________________________ How long does hepatitis B vaccine protection last? Reuters (02.11.09) NEW YORK (Reuters Health) - The hepatitis B vaccine - given to protect against infection by a virus that can cause severe liver damage and cancer - may protect for more than two decades, according to a new study. In 1981, Dr. Brian J. McMahon, from the Alaska Native Medical Center, Anchorage, and his colleagues gave more than 1500 Alaska Native adults and children over age 6 months three doses of hepatitis B vaccine. Before the hepatitis B vaccine was licensed for U.S. use in 1981, as many as one in 12 Alaskan Natives were infected. In 2003, the team checked with almost 500 of those given the shots and had a response to them at the time to see who was still showing evidence of an immune system response. Blood tests found that more than half - 60 percent -- were still considered immune to the virus. To test whether the other 40 percent were immune, they were given a booster dose of the vaccine, to simulate infection. Most of those people - more than 80 percent - showed a response. Overall, the researchers estimate that more than 90 percent of the original group was protected. There were no long-term hepatitis B infections in the group, which also suggests a high level of protection, they note in a report in the Journal of Infectious Diseases. They conclude, "in light of the strong evidence we present here, hepatitis B vaccine booster doses are not currently indicated." SOURCE: Journal of Infectious Diseases, November 1, 2009. ......................................................................... __________________________________________________________________________ Studies reaffirm 2 vaccine doses in kids, show safety in pregnant women Lisa Schnirring Staff Writer, CIDRAP - Minneapolis,MN,USA (02.11.09) Nov 2, 2009 (CIDRAP News) - Interim clinical trial findings announced today affirm that children younger than 10 need two pandemic H1N1 vaccine doses, and initial findings in pregnant women reveal no safety concerns and a need for only one dose. Federal officials also detailed the role of an independent panel of experts to review vaccine safety data and released a report outlining the government's vaccine safety monitoring system. At a media briefing today, Bruce Gellin, MD, director of the National Vaccine Program at the US Department of Health and Human Services (HHS), said federal officials realize that, despite problems with vaccine supply and demand, Americans still have concerns about its safety. He told reporters that an independent expert group charged with reviewing vaccine safety data met for the first time today to become familiar with the data sources they'll be reviewing. In addition, a federal task force today released a 20-page report that outlines beefed-up systems that officials have put in place to monitor the safety of the vaccine. US health officials are mindful of the 1976 swine flu vaccination campaign, which reached more than 40 million people but was associated with an increase in cases of Guillian-Barre syndrome, a temporary paralytic condition. Though vaccine safety and purifications steps are much more advanced today, officials have added new systems to track the pandemic H1N1 vaccine and are taking extra steps to add transparency to the process, in hopes of reassuring the public. Anne Schuchat, MD, director of the CDC's National Center for Immunization and Respiratory Diseases, told reporters that a cumulative total of 30 million doses of pandemic H1N1 vaccine have been produced for states to order, which represents an increase of 3.4 million since Friday. Vaccine data for children The latest findings of vaccine efficacy in children come on the heels of a recommendation from World Health Organization (WHO) vaccine experts who on Oct 30 recommended that most people, even young children, receive just one dose of the vaccine. Though the group acknowledged they didn't have much data to base their guidance on, they said countries that have placed children as a high- priority group to receive the vaccine should administer one dose so they can immunize as many children as possible. Anthony Fauci, MD, director of the National Institute of Allergy and Infectious Diseases, said the findings today, from National Institutes of Health (NIH) studies, are critical to public health officials who are charged with making policy decisions and to the public for making personal decisions for themselves and their loved ones. He said interim results on vaccine in healthy children ages 6 months to 17 years confirm early results reported on Sep 21. The new findings show that children younger than 10 who receive a second 15-microgram (mcg) dose of pandemic H1N1 vaccine have significant immune response improvement. The new data were obtained 8 to 10 days after the second vaccine dose, compared with the first findings, which were obtained 21 days after the first dose. In the youngest children (6 to 35 months), 100% had a robust immune response after the second dose compared with only 25% after the first dose. In those ages 3 through 9, 94% had a robust immune response after the second dose, compared with 55% after the first dose. Immune responses were comparable in those receiving two 15-mcg doses and in those who got two 30-mcg doses, suggesting that the smaller dose is enough to elicit a strong immune response, according to an NIH press release today. "Our guidelines seem to fit quite nicely with the science," Fauci said at the news conference. "We would like to get children as fully protected as we can." Efficacy in pregnant women In the initial results on the vaccine in pregnant women, immune response to the pandemic H1N1 shot was similar to that seen in healthy adults. Public health officials have placed pregnant women at the front of the line to receive the vaccine because they have been disproportionately hit by the virus. So far the CDC has received reports of at least 100 pandemic flu infections in pregnant women that required intensive care unit (ICU) treatment, as well as reports of 28 deaths. In a subgroup of 50 pregnant women participating in an NIH clinical trial, a preliminary analysis of blood drawn 21 days after vaccination showed the vaccine was likely protective in 23 of 25 women (92%) who received a single 15-mcg dose and that it was likely protective in 24 of 25 (96%) who received a single 30-mcg dose. The trial began on Sep 9, according to an NIH press release. Participants were between ages 18 and 39 and were in their second or third trimester when they began the study. The ongoing study will also assess the effects of a second dose. Investigators are using Sanofi's pandemic H1N1 vaccine, which does not contain the preservative thimerosal or an immune-response- boosting adjuvant. Despite the heightened threat of the virus to pregnant women, public health officials worry about the uptake of the pandemic vaccine in this group, because only about 15% of pregnant women typically receive the seasonal vaccine. Safety monitoring of the drug conducted by researchers and an independent expert panel so far suggests that the vaccine is well tolerated, with no safety concerns so far. "For pregnant women, who are among the most vulnerable to serious health problems from 2009 H1N1 infection, these initial results are very reassuring," Fauci said. Vaccine-safety group Gellin said the independent vaccine safety expert group that met today in its first face-to-face meeting will meet biweekly to review the latest data and will report its findings each month in a publicly accessible conference call with the HHS's National Vaccine Advisory Committee. The vaccine safety group will be receiving regular briefings from the NIH and the Biomedical Advanced Research and Development Agency (BARDA) and can convene rapidly if needed. Center for Infectious Disease Research & Policy, Academic Health Center - University of Minnesota © 2009 Regents of the University of Minnesota .......................................................................... __________________________________________________________________________ USA: Hospitals still looking for hundreds of patients in contaminated needle case By Associated Press, KDVR Denver CO USA (02.11.09) DENVER (AP) - Hundreds of people who may have been exposed to hepatitis C through dirty syringes may not have been tested for the disease yet. A surgery technician with hepatitis C, Kristen Parker, pleaded guilty last month to stealing the painkiller fentanyl and then refilling the contaminated needles with saline solution. Hospitals where she worked set out to test about 5,700 patients to see if they may have contracted the liver disease from the syringes. Parker worked first at Rose Medical Center in Denver and then at Audubon Surgery Center in Colorado Springs. Rose is still looking to test or get test results for 375 patients. Audubon hasn't been able to reach 57 patients. Test results so far show that a total of 15 patients contracted hepatitis C from Parker. .......................................................................... __________________________________________________________________________ EECAAC: Regional HIV/AIDS Conference Opens In Russia Kaisernetwork.org (29.10.09) A regional conference kicked off Wednesday in Moscow with experts calling on Russian authorities to change their approach to preventing the spread of HIV among injection drug users [IDUs], Deutsche Presse-Agentur/M&C reports (10/28). "The calls came in the face of a doubling in the number of HIV infections in Russia in the past eight years," the Associated Press reports. "The rapid growth of the epidemic in Russia is in contrast to sub-Saharan Africa and South and Southeast Asia, where prevalence of the virus fell during the same eight-year period, according to UNAIDS," the AP writes (Birch, 10/28). "Russia now has around 1 million HIV-infected people and around 2 million [IDUs], the head of the International AIDS Society (IAS), Robin Gorna, told the [Eastern Europe and Central Asia AIDS] conference," Deutsche Presse-Agentur/M&C writes in a second story (10/28). The Russian government estimates that there are just over 500,000 people living with HIV in the country, Reuters reports. Experts worry "that Russia's epidemic will spread rapidly beyond drug users to the general population of 143 million through sexual activity unless preventative steps are taken," according to Reuters (Ferris-Rotman, 10/28). During the meeting Wednesday, health experts said Russia should increase funding for HIV/AIDS education as well as needle exchange programs, and encouraged the legalization of methadone, a drug that has been shown to reduce the spread of HIV among drug users, Agence France-Presse reports. Russia's chief medical official, Gennady Onishchenko, told the AIDS conference he opposes providing methadone to drug users because the government believes the data demonstrating the beneficial effects of doing so are lacking. "Michel Sidibe, executive director of UNAIDS, called methadone provision 'an essential element of universal access to HIV prevention' and called for Eastern European countries to introduce the programmes," the news service writes. "I fear that in this region the legal barrier to harm reduction programmes also makes injected drug users a target for harassment, driving the people most affected by this epidemic underground," Sidibe said (Malpas, 10/28). "Maybe methadone therapy can be implemented in some countries, but not in Russia," Onishchenko said, the Moscow Times reports. "Onishchenko also criticized needle exchange programs," according to the newspaper (Odynova, 10/29). In general, "Russian officials view [the] so-called 'harm reduction' efforts [embraced by the international HIV/AIDS community] as encouraging criminal or shameful behavior, and the government has chosen to promote a just-say-no approach to the epidemic that urges people to adopt healthier lifestyles," the AP reports (10/28). Russia Commended For Treatment Program Gains Speakers at the conference commended Russia on its treatment programs and increased investment in HIV/AIDS programs. "Since the Group of Eight summit in St. Petersburg in 2005, the government has boosted annual HIV spending by 33 times to 9.5 billion rubles ($325 million), but most of the funds are spent on treatment, [UNAIDS Regional Director Denis] Broun said," the Moscow Times reports (10/29). According to the AP, the country has also "expanded drug treatment dramatically ... and is among the leaders in reducing the incidence of transmission of the disease between mothers and their babies" (10/28). Reuters adds that IAS Executive Director "Gorna praised the Russian government for putting aside 9 billion roubles ($310 million) this year for treatment, with that sum set to more than double to 19 billion roubles by 2011" (10/28). The AP/New York Times reports: "Russia has some highly successful needle exchange programs and free condom programs, several experts said, but many have been paid for through grants from the Global Fund to Fight AIDS, TB and Malaria, an international public-private partnership. Now those grants are being terminated under Global Fund rules, the specialists said, because Russia is too wealthy to qualify for them" (10/28). The Moscow Times reports that Global Fund Executive Director "Michel Kazatchkine, said he hoped the government would keep the programs in place" (10/29). According to a joint statement issued by IAS, the Eurasian Harm Reduction Network and the International Harm Reduction Association, "The Russian Government has not upheld a promise made ... in 2008 to finance the continuation of the services started by this [Global Fund] grant. The funding crisis leaves projects in ten regions subject to staff layoffs and closures, despite the fact that they have averted an estimated 37,000 HIV infections (10/28). .......................................................................... __________________________________________________________________________ Russia: AIDS Experts Say Russia Needs New HIV Strategy Douglas Birch, Associated Press (29.10.09) Russia's abstinence-based approach to injection drug use is not working to curb HIV, AIDS experts said on Wednesday during the Eastern Europe and Central Asia AIDS Conference in Moscow. HIV infections have doubled in Russia in the past eight years, and there is evidence that HIV's route of transmission there is shifting from drug injection to heterosexual sex. Russia's chief public health official, Gennady Onishchenko, said the country is "emphatically against" methadone substitution therapy, and he criticized needle-exchange programs (NEPs) as encouraging drug use and HIV infections. Health officials in the country want to promote healthy lifestyles, said Onishchenko, who blamed rising infections on a poppy boom in Afghanistan over the past decade. "International studies show that an abstinence-based message on drug use or sex simply doesn't work," said Robin Gorna, executive director of the International AIDS Society. In Russia, "it does appear that ideology is getting in the way of public health care policy," she said. Russian officials "have never really embraced" NEPs, free condom distribution, and other harm-reduction methods, said Chris Beyrer, director of Johns Hopkins' AIDS International Training and Research Program. "It is the reason I think that they continue to have one of the most severe epidemics in the region," he said. Some 75 NEPs in Russia are funded chiefly by international donors, and 22 were shuttered in August after their grants from the Global Fund to Fight AIDS, TB and Malaria expired, said Gorna. Regions where NEPs have operated have experienced slower HIV transmission rates than the rest of Russia, she and other experts said. Russia has 13 percent of the world's heroin users, and they consume about one-fifth of the heroin used worldwide each year, according to an October UN Office on Drug Control report. The country has 501,000 registered HIV cases; the UN estimates Russia actually has 1.1 million HIV cases. .......................................................................... __________________________________________________________________________ Australia: Needle exchanges save money: report By Rob Bates, NEWSHEALTH, Wentworth Courier (29.10.09) Needle exchange facilities have prevented more than 32,000 HIV transmissions and 100,000 cases of hepatitis C in Australia, a University of NSW report claims. Darlinghurst-based Associate Professor David Wilson, who led the team of researchers behind the report, said the Federal Government had saved $4 for every $1 spent on exchange programs, and that an expansion should be considered. "Needle exchange programs are by far one of the most effective public health programs that we have available," Prof Wilson said. "For almost every other program you have to spend money. "These surpass any other programs I have seen in terms of cost and they have probably prevented HIV from becoming generalised in the larger population," he said. Clean syringes were first exchanged for drug users at St Vincent’s Hospital in 1986, and about 1000 facilities are now established around the country, including three within the Eastern Suburbs. Anti-drug activists have argued that such programs appear to condone drug use but Prof Wilson said these claims weren’t based on data. "We’re not seeing an increase in injecting drug use; if anything we may be seeing a decline," Prof Wilson said. NSW Opposition health spokeswoman Julian Skinner said the Government shouldn’t just resort to handing out more needles to deal with HIV and hepatitis C, and that more effort was required to get people off drugs and into rehabilitation. "Needle exchange plays a very important part in the strategy for dealing with drug use but I think for the last decade we’ve spent far too much time just maintaining people on their drug addictions rather than providing the assistance to get them off it," Ms Skinner said. "Expanding needle exchange could be part of the solution," she said. "But we need to focus more on discouraging people from getting on drugs in the first place and encouraging them to get off drugs." Prof Wilson said needle exchange programs were critical not just for injecting drug users and that contracting HIV or hepatitis C was a real danger for everyone. "Injecting drug users are people from all demographics," he said. "There are educated professionals who inject recreationally and some who are addicted. "It goes across the entire spectrum." .......................................................................... __________________________________________________________________________ India: Pollution Control Board (PCB) issues strict warning to hospitals Express Buzz, Express News Service, India (28.10.09) THIRUVANANTHAPURAM: The Pollution Control Board (PCB) has decided to close down hospitals, including government hospitals, which are not handling and disposing bio medical and hospital waste properly. This was announced by PCB chairman S.D. Jayaprasad, at a press meet on the sidelines of a national seminar on Hospital and Biomedical Waste Management the other day. "Only 2,500 hospitals in the State manage hospital waste in accordance with the rules and regulations of the Pollution Control Board. The deadline for taking action against the hospitals which are not handling the bio medical waste in a scientific manner ended in 2002,’’ he added. When asked whether this was a decision of the government, Jayaprasad said this was the decision of the Board. "Hospitals create solid and liquid waste. In Palakkad, there is a plant to dump the solid bio medical waste. This is the only plant in Kerala to dispose such waste. The discussions at the seminar indicate that Kerala is an utter failure in hospital waste management,’’ he said. "Unsafe disposal of syringes is a major cause of the spreading of communicable diseases all over the world,’’ said Air Marshal Lalji Varma, founding president of Indian Society of Hospital Waste Management (ISHWM) while presenting a paper on Sharps waste management’ in the seminar on Tuesday. In India, 16 million children are born every year. As many as 48 million people need injections in a year. People have a tendency to go for an injection even for minor diseases. This must be discouraged, he added. Learning and giving awareness about waste management, implementing non- burn technology, usage of glass syringes etc are the solutions to control the sharps waste in a hospital. Sharps waste is just one percentage of the total waste of a hospital. But it is harmful to the society. Safe disposal of such wastes and giving security to such waste handlers are still problematic, said Lalji. .......................................................................... __________________________________________________________________________ Russia: Russia warned about HIV epidemic By Richard Galpin, BBC News, UK (28.10.09) Moscow A top international HIV/Aids expert has told the BBC that the epidemic in Russia is now out of control. Robin Gorna, head of the International Aids Society, urged Russia to do much more to prevent the spread of HIV among an estimated two million drug users. Ms Gorna was speaking ahead of a major international conference on Aids which is taking place in Moscow. It is believed there are now at least a million people infected with HIV in Russia. This represents a dramatic increase over the past decade. The vast majority are people under the age of 30. Most were infected because they share needles for injecting heroin. According to some estimates, there are almost two million intravenous drug users in the country - the result of the large quantities of heroin flowing from Afghanistan into Russia. Wider epidemic fears International experts have raised concerns over Russian laws which they say hamper efforts to slow down the HIV infection rate. It is illegal to give drug addicts substances such as methadone as an alternative to injecting heroin. As the conference opened on Wednesday, Russia's chief medical official acknowledged the scale of the epidemic, but insisted there would be no change of policy on methadone. Gennady Onishchenko said that HIV infections in Eastern Europe and Central Asia were "a highly important problem for all of us, not only for medical but also for social reasons". "The danger is that the epidemic will cross over from a concentrated one to a general one," he said. But he added that methadone would remain illegal. "Russia speaks out categorically against this component in prevention programmes," he said. The Russian government also does not fund any needle exchange programmes. There is particular concern because until now international donors have financed the major prevention programmes in Russia. But they are having to stop their funding because Russia is now considered to be a middle-income country and does not want to receive financial aid from abroad. http://news.bbc.co.uk/go/pr/fr/-/2/hi/health/8329122.stm © BBC MMIX .......................................................................... __________________________________________________________________________ Russian drug policies under spotlight at AIDS conference (Roundup) Oct 28, 2009, 15:12 GMT Moscow - The number of HIV cases in Russia is rising and potentially out of control due to poor health policies, a regional conference hosted in Moscow on AIDS heard Wednesday. Russia now has around 1 million HIV-infected people and around 2 million injecting drug addicts, the Head of the International Aids Society (IAS), Robin Gorna, told the two-day conference. Experts at the seminar called on the government to spend more on education and on providing clean syringes and needles to intravenous drug users. Whilst there is still no known cure for AIDS, treatment for HIV- infected patients has improved radically in recent years with the growth of retroviral drugs. 'It's about time the government was truly committed to preventing HIV infection,' Gorna warned. 'The HIV epidemic among drug users in Russia could easily be prevented,' added scientist Gerry Stimson. He blamed the rapid increase in infections on 'years of government inaction on prevention policies.' The conference also heard calls for the authorities in Moscow to permit the use of the heroin substitute methadone. Russia's chief doctor, Gennady Onischenko, however, refused point blank to do so, citing other effective Russian treatment programmes - without naming any. Russia is now the world leader in drug abuse, local media reported this week, with cheap heroin from Afghanistan combining with dirty needles to push up the number of HIV infections. The number of drug addicts has risen 20-fold since the collapse of Communism 20 years ago, whilst each year around 30,000 people die from illegal drug use. Around 80 per cent of those infected with HIV are under the age of 30, the conference heard. However, Russia intends to spend 13.4 billion roubles (309 million euros) on the fight against AIDS in 2010, Russian parliamentarian and member of the Duma health committee, Larissa Shoigu, said. The two-day Eastern Europe and Central Asia Aids Conference (EECAAC) - the third of its kind - is taking place in Moscow. Representatives of around 60 countries in the region, as well as experts and organizations from other parts of Europe and the United States, are working to combat HIV/AIDS at the conference. .......................................................................... __________________________________________________________________________ Russia: Russia Rejects Methadone to Stem HIV Epidemic Agence France Presse (28.10.09) More than 60 percent of people with HIV in Eastern Europe and Central Asia acquired the virus through injection drug use, Russia's chief medical official said Wednesday. However, Russia will not be embracing methadone maintenance treatment for injection drug users (IDUs), Gennady Onishchenko told the Eastern Europe and Central Asia AIDS Conference in Moscow. More than 500,000 people are officially listed as HIV-positive in Russia. "The danger is that the epidemic will cross over from a concentrated one to a general one," Onishchenko said. Russia offers IDUs effective programs other than methadone maintenance, he said. "Russia speaks out categorically against this component in prevention programs," he said, noting that the synthetic drug is illegal in the country. "We aren't simply denying this problem, we are proposing our solution," he added. At the conference, international speakers criticized Russia's policy against methadone, which is given to IDUs to help them cease drug injection. The International AIDS Society and the Eurasian Harm Reduction Network released a statement urging Russia to support methadone programs. Such interventions are "an essential element of universal access to HIV prevention," said Michel Sidibe, executive director of UNAIDS. "I fear that in this region the legal barrier to harm-reduction programs also makes [IDUs] a target for harassment, driving the people most affected by this epidemic underground," he said. "I urge each country in this region to define within its own legislation the harm-reduction program it needs, just like China has done with great success." .......................................................................... __________________________________________________________________________ UK: HIV transmission through injecting drug use on the increase in the UK Roger Pebody, Aidsmap (27.10.09) HIV transmission among injecting drug users is happening more often now than at the beginning of the decade, the Health Protection Agency says in a report issued this week. Infections in people who began injecting recently indicate recent transmissions, and prevalence in this group has risen considerably in recent years. However, overall HIV prevalence in drug users is stable. The Health Protection Agency’s Unlinked Anonymous Prevalence Monitoring Programme’s Survey of Injecting Drug Users is an annual study of over 3,000 current and former injectors. The study is carried out at specialist services such as needle exchanges or methadone treatment programmes in England, Wales and Northern Ireland. Participants complete a questionnaire and provide an oral fluid sample for HIV testing. Looking at the whole group of current and former injectors, 1.6% had HIV (51 of 3209 people), two-thirds of whom were aware of their infection. Prevalence was considerably higher in London (3.8%) than elsewhere. Whereas survey results in 2006 and 2007 suggested that prevalence might be decreasing, this now appears not to be the case. Prevalence in 2008 was exactly the same as that recorded in 2005. Turning now to HIV prevalence in those who began injecting in the past three years, it remained below 0.5% from 1991 to 2002. However, in the 2008 study it was 1.3% (5 of 391 people). Another key indicator is prevalence among people who have injected in the past month. In London, which has the greatest concentration of infection, this has remained stable. However, elsewhere in England and Wales it increased from 0.25% in 2003 to 1.1% in 2008 (18 of 1604 people). In addition, prevalence of hepatitis C remained high. Among those who began injecting in the past three years, 22% had hepatitis, half of whom were aware of their infection. On a more optimistic note, the numbers reporting sharing equipment are lower than earlier in the decade. A total of 19% reported sharing needles or syringes, and 37% reported sharing spoons, mixing containers, filters or water. Reference Shooting Up. Infections among injecting drug users in the United Kingdom 2008, an update: October 2009. London: Health Protection Agency, 2009. .......................................................................... __________________________________________________________________________ DIY Botox: Site Offers Injectable Drug Without Prescription - With How-To Video By Alexis Madrigal, Wired.com USA (27.10.09) Categories: Ethics, Health A website that sells a prescription drug similar to Botox without requiring a prescription claims it has more than 2,000 customers. Some have learned how to inject the botulism-derived drug into their own faces from YouTube videos produced for the site. Video at: http://www.wired.com/wiredscience/2009/10/botox-without-prescription/ Discountmedspa sells a variety of other DIY cosmetic treatments, including prescription Renova, and lip-filling gels. The botulinum toxin-derivative for sale on the site is Dysport, produced by the pharmaceutical company Ipsen and is a competitor of Allergan’s Botox. The site simply calls it "the Freeze." A Grand Prairie, Texas, woman, Laurie D’Alleva, who appears to be the site’s proprietor, performs treatments on herself in self-made videos posted to the site’s YouTube channel. In one video, D’Alleva pulls out a vial of what is presumably Dysport and a syringe filled with saline. "It’s important to remember that you are mixing the potency of the botox," she says, mixing the contents of the vial with the saline solution. She then injects her forehead and the areas around her eyes. Ipsen received FDA clearance to sell Dysport in the United States a few months ago, but it’s a prescription medication. It’s the first direct competitor for the branded Botox, which is the most popular cosmetic treatment in America. Doctors did more than 2.4 million Botox procedures in 2008, according to the American Society for Aesthetic Plastic Surgery. In recent years, the vast amounts of money spent on the treatment have attracted scams and knockoffs, which the FDA has had to crack down on. In May, the FDA also ruled the drug needed a tougher "black-box" warning label to reflect an increased understanding of the small, but real risks of the treatment. In the U.S., it is illegal for anyone but a doctor or nurse practitioner to prescribe drugs to patients and only pharmacists can dispense drugs to people. Yet drug sellers on the internet routinely flout the FDA’s regulations. A review published last month in the Annals of Family Medicine found more than 130 websites offering antibiotics without a prescription. The National Association of Boards of Pharmacy tracks thousands of sites that don’t meet its standards for brick-and-mortar shops. LegitScript, a private firm that works with the NABP, has database of 47,633 internet pharmacies; 46,570 of them aren’t up to snuff. These sites are brazenly circumventing regulations that protect consumers from bad or fake drugs and ensure that the chemicals are used correctly. The laws were designed precisely to prevent Americans with little to no medical training from doing things like buying a form of toxin, mixing it with saline and injecting it into their faces. Yet, precisely that appears to be possible with the help of discountmedspa.com. Wired.com was able to complete the ordering process on discountmedspa.com for the Freeze without being asked for a prescription. In fact, the word, "prescription" does not appear anywhere on the website. The domain’s registration details are private, but medspacanada.com, which refers back to discountmedspa.com, is registered to Cristie Stone, with the same phone number and e-mail address listed on discountmedspa’s website. The physical address listed for medspacanada.com is the home of the Manitoba Society of Pharmacists, which has no record of Stone. "Not only is Christie [sic] Stone not a member or the Society, I can honestly say that I have never heard her name before," wrote Jill Ell, executive director of the society, in an e-mail to Wired.com. Wired.com was unable to track down any trace of Stone anywhere, but did discover that D’Alleva’s maiden name is Stone. Wired.com reached D’Alleva’s assistant, but had not heard back from D’Alleva at publication time. The discountmedspa.com blog administrator, presumably D’Alleva posting under the handle Botox Queen, provided an explanation from a purported "long-time customer," Tamara Lesley, explaining how the site is able to offer a prescription product. "Laurie belongs to the Texas Medical Council and is licensed to sell these products to the women that want to use them and understand that it is their responsibility to use them safely," she wrote. Wired Science could not find an organization called the Texas Medical Council. It does not maintain a website and has not been mentioned in the press. A representative for the Texas Department of State Health Services had never heard of it. Barry DiBernardo, a plastic surgeon from Mont Clair, New Jersey, had not heard of people home-administering Botox or Dysport, but did not think it was a good idea. "I’m not aware of that," DiBernardo said. "You need to know where the muscles are, the depth, the dosage. That doesn’t seem good." Short of buying and testing it, there is no way to verify that the product sold on the site is the genuine article, but the site swears by it - and the legality of its practices. In a blog post response to a customer’s skeptical query, Laurie provided the following explanation for the legality of her site and the provenance of her products. I know there is much information out on the net about fillers and Botox ‘knock-offs’. This is not what I am selling! The products I have are from a company names Ipsen.. I have a connection that allows me to get products that are not usually available in the states because I purchase other products in their line. Now the trick is I have to market it and label it under my own brand, to keep them and myself from getting into any legal trouble. It does take a leap of faith, but I assure you I have over 2000 customers now who love the products and are saving literally hundreds of thousands of dollars between us! It’s unclear how D’Alleva obtains the drugs and then resells them. Ipsen did not immediately respond to a request for comment from Wired.com. Ipsen also sells Dysport in Mexico, so it’s possible the drugs are purchased there and illegally imported into the U.S. "If it’s prescription-only, it doesn’t matter whether it’s over the counter in Mexico or not," said Carmen Catizone, executive director of the National Association of Boards of Pharmacy. "Offering a prescription drug without a prescription is illegal any way you phrase it." Catizone also cautioned that the drugs might not actually be real, though his organization had picked up some buzz about purchasing Botox and its competitors without a prescription. "Sometimes, if the site offers Botox, they may not really be selling Botox," Catizone said. Users of the site, though, testify to a variety of experiences with the drugs that seem to indicate that the Freeze is actually a botulinum toxin- derivative, as discountmedspa.com’s proprietor claims. If the site’s comments are a con - it’s a very elaborate one. In comments on the discountmedspa blog, users testify to watching YouTube videos of doctors doing Botox injections to learn techniques for making themselves look the way they want. Dozens of cosmetic surgeons show off their Botox procedures in videos made to promote their services. Lesley offered a helpful hint on how to inject the Freeze to make the corners of the mouth turn up so you appear to be always smiling. "I watched a Doctor on YouTube.com do this to a patient and he warned people not to inject below the eyes however I had to put a smile on my face too," Lesley commented on a blog post. "The trick to this is to hold a pencil just at the corner of one side of your mouth and inject two units of Freeze at the very bottom of your chin. This will cause your [sic] very end of your mouth to turn up. Then do the other side the same way. If you don’t get it even you may have a crooked smile so be very careful that the injection is placed in exactly the same place as the other side." Her recommendation for another user is to "watch YouTube.com and you will learn a lot of some of the Doctors [sic] secrets to recreating your face the way you want to look." Other women describe mishaps with over-injecting the drug. "My Dr. would never inject the crows feet. I did and got GREAT results!" wrote a commenter named Pat. "Unfortunately, I can’t read those little hash marks on the syringe too well and over injected above the brow on one side. A week later I’m now sporting a half closed and swollen eye, and look ready for Halloween!" In January, Wired.com reported on other similar websites that sell Melanotan, a tanning drug that has not been approved by the FDA, which has cracked down on the drug’s manufacturers and distributors. In response to queries from Wired.com, the Texas Department of State Health Services released the following statement, but would not comment further. "The Texas Department of State Health Services is aware of discountmedspa.com through a complaint we received. That complaint status remains open and under review," the agency wrote. The complaint was made under the Texas Food, Drug and Cosmetic Act, which regulates the sale of prescription drugs like Dysport in the state. "Botox is a prescription drug that must be dispensed or sold by a licensee pharmacy and only with a prescription from a licensed practitioner. Any over-the-counter sale of Botox is illegal," the agency affirmed. The Food and Drug Administration did not immediately respond to a request for comment about the illegal sale of Dysport, but asked Wired.com for the web address of the offending site. Video: The original YouTube video was pulled by DiscountMedSpa on Wednesday, October 28. Wired.com had saved the source and has embedded that video in the story. .......................................................................... __________________________________________________________________________ Ghana: Health Access Network declares war against fake drugs Chris Twum - Ghanaian Chronicle, Accra Daily Mail Ghana (27.10.09) The Executive Director of Health Access Network (HAN), Mr. Charles Allotey, has indicated his preparedness to fight against the sales and patronage of fake drugs in the country. He has thus declared an open and unending war on the increasing spate of fake drugs in the Ghanaian society. According to him, this would ensure that a patient-centered regulatory and policymaking approach becomes the dominant way of addressing access and quality issues in Ghana, as far as medicine and healthcare is concerned. The Executive Director of HAN made this known in an interview with this paper in Accra. This comes in the wake of a high prevalence rate of fake and counterfeit medicines, found on the 'black market', with fraudulent and mislabeling packaging. To this end, a partnership between Health Access Network and mPedigree Network has been formed to coordinate various ongoing anti-counterfeiting efforts in order to ensure a harmonized approach towards dealing with the problem at all levels of the health ecosystem. This partnership would support the statutory authorities in their mandate to police existing standards, while contributing to the equally critical task of formulating emerging standards that are responsive to new trends in pharmaceutical quality assurance. Meanwhile, recent statistics from several reputable bodies have placed such high prevalence rate of counterfeit drugs between 15 and 25 per cent of all medicines which are being sold in sub-Saharan Africa. These incidents come in the wake of several studies which have found frightening levels of substandard medication in the national drug supply chain in Ghana. ?While it is true that not all substandard medicines come from counterfeit sources, and that poor handling of legitimate medicines can corrupt them, substandard medicines are just as dangerous to consumers and patients?, said Mr. Allotey. That notwithstanding, he said ?the increasing incidents of duplication and imitation, contents tampering, unlicensed repackaging, unauthorized parallel trading, or the sale of dummies masquerading as drugs. In all these situations, the consequences are largely the same and fatal to Ghana's public health system?. According to him, not all substandard medicines come from counterfeit sources, and that poor handling of legitimate medicines can be corrupted, adding that ?Substandard medicines are just as dangerous to consumers and patients?. Mr. Allotey has thus urged stakeholders in the industry to assist the country's Ministry of Health and the Food & Drugs Board to contain the crisis of counterfeit medicines. It would be recalled that a research report in 2008, conducted by Researchers at KNUST, namely Ofori Kwakye, Asantewaa and Gaye, found out that 82 per cent of sampled artesunate which were being sold in pharmacies in Kumasi were substandard as compared to European guidelines. They described the situation as intolerable for patients and consumers of health products, stressing that it should be unacceptable to regulators, policymakers, and concerned civil society actors. ?It threatens the growth of pharmaceutical industry and commerce in this country, undercutting any possibility of Ghana attaining security in the supply of quality medicines both through trade and local production. The proliferation of counterfeit medicines must clearly be stopped?, the report said. Health Access Network is a network of health professionals and consumer health advocates committed in using innovative ways through collaboration with wide range of stakeholders including government, non government and civil society organisations to promote access to essential medicines for the people of Ghana. 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