*SAFE INJECTION GLOBAL NETWORK* SIGNPOST *SAFE INJECTION GLOBAL NETWORK* SIGN 2009 30 November to 2 December 2009 at WHO HQ Geneva Post00514 Hands + Abstracts + HCWM Call + News 23 September 2009 CONTENTS O. Moderators note 1. WHO Guidelines on Hand Hygiene in Health Care 2. Abstract: Intranasal administration of a live non-pathogenic avian H5N1 influenza virus from a virus library confers protective immunity against H5N1 highly pathogenic avian influenza virus infection in mice: Comparison of formulations and administration routes of vaccines 3. Abstract: Perceptions and attitudes of the professional staff concerning infection surveillance and control programs in Brazilian hospitals 4. Abstract: Reducing HIV Risks Among Active Injection Drug and Crack Users: The Safety Counts Program 5. Abstract: Minimally invasive insulin delivery in subjects with type 1 diabetes using hollow microneedles 6. Abstract: Microneedle-based vaccines 7. Abstract: Microneedle Arrays Allow Lower Microbial Penetration Than Hypodermic Needles In Vitro 8. Abstract: Structural injury to the human sciatic nerve after intraneural needle insertion 9. Abstract: An orthopedic injection training instrument using flow impedance to indicate needle tip locations 10. Abstract: Oral transgenic plant-based vaccine for hepatitis B 11. Abstract: Prospects for control of emerging infectious diseases with plasmid DNA vaccines 12. Abstract: Persistence of antimicrobial activity through sustained release of triclosan from pegylated silicone elastomers 13. No Abstract: Is Europe falling behind the United States in the field of sharps safety? 14. No Abstract: Health care and the environment: hospitals take steps to reduce waste 15. HCWH HCWM: Global South Newsletter 16. Hubli-Dharwad Sustainable Healthcare Waste Management Project: A success story from South India 17. Global Waste Management Symposium: Call for Abstracts 18. News - Benefit and Doubt in Vaccine Additive - UK: Shoplifter in syringe attack gets 3 years - USA: EMERGENCY ACTION: Medical assistants feel pinch - Board reinforces rule limiting who can give Botox injections - UK addicts may be given free foil for 'safer' heroin smoking: UK authorities could give out free foil to protect heroin addicts' health - Inhalable swine flu vaccine to be ready soon - USA: PA allows over-the-counter syringe sales - USA: Restrictions lifted on sale of needles - USA: Dozens of syringes found in Clay Township channel - Australia: Patient risk after medical equipment bungle - USA: Tactic against DUI may go too far - Today's Topic: Police take blood in test program - USA: Guest editorial: Police blood draw is extreme violation - USA: You Gotta Wash Your Hands is the Word Out! - Merck, Wellcome Trust To Launch Vaccine Center In India To Produce Vaccines For Developing Countries - Study on respirators versus masks hailed as landmark - "Turbid syringes and drugs for the sick," a Spanish newspaper reports on counterfeit drugs scandal in Argentina - Drug delivery market report from Reportlinker - USA: American Scientific Resources acquires Safeguard Medical's home needle destruction device patent This edition of SIGNpost is located at: http://uqconnect.net/signfiles/Archives/SIGN-POST00514.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/ __________________________________________________________________________ _____________________________________*____________________________________ O. Moderators note __________________________________________________________________________ SIGNpost will not be posted on Wednesday 30 September. The next scheduled edition of SIGNpost will be in your mailboxes on Wednesday 7 October. due to travel. Thanks for your patience! regards, allan __________________________________________________________________________ _____________________________________*____________________________________ 1. WHO Guidelines on Hand Hygiene in Health Care __________________________________________________________________________ At 06:54 PM 10/09/2009, you wrote: From: ISINGOMA PATRICK Subject: Copy of the WHO Guidelines on Hand Hygiene in Health Care Allan, In the copy of SIGN you sent us yesterday,(09.09.09 - Post00512) there was mention of the WHO Guidelines on Hand Hygiene and I would like to share a copy with my other Health Workers. Can you email me a copy or Send the hard copy. Thank you for the continued effort to get us pertinent articles in SIGN. We are always following Patrick Waste Management Advisor, Injection Safety Project, P.O.BOX 40070, Kampala. Tel 077446747 .......................................................................... __________________________________________________________________________ Hi Patrick, Here it is! You can get hard copies from WHO. It can also be downloaded from the WHO website at: http://whqlibdoc.who.int/publications/2009/9789241597906_eng.pdf Glad you find SIGNpost useful. regards, allan .......................................................................... __________________________________________________________________________ Abstract: The World Health Organization Guidelines on Hand Hygiene in Health Care and their consensus recommendations Infect Control Hosp Epidemiol. 2009 Jul;30(7):611-22. Pittet D, Allegranzi B, Boyce J; World Health Organization World Alliance for Patient Safety First Global Patient Safety Challenge Core Group of Experts. Collaborators (16) Infection Control Program, University of Geneva Hospitals and Faculty of Medicine, Geneva, Switzerland. didier.pittet@hcuge.ch The World Health Organization's Guidelines on Hand Hygiene in Health Care have been issued by WHO Patient Safety on 5 May 2009 on the occasion of the launch of the Save Lives: Clean Your Hands initiative. The Guidelines represent the contribution of more than 100 international experts and provide a comprehensive overview of essential aspects of hand hygiene in health care, evidence- and consensus-based recommendations, and lessons learned from testing their Advanced Draft and related implementation tools. __________________________________________________________________________ _____________________________________*____________________________________ 2. Abstract: Intranasal administration of a live non-pathogenic avian H5N1 influenza virus from a virus library confers protective immunity against H5N1 highly pathogenic avian influenza virus infection in mice: Comparison of formulations and administration routes of vaccines __________________________________________________________________________ Vaccine. 2009 Sep 10. Intranasal administration of a live non-pathogenic avian H5N1 influenza virus from a virus library confers protective immunity against H5N1 highly pathogenic avian influenza virus infection in mice: Comparison of formulations and administration routes of vaccines. Kashima Y, Ikeda M, Itoh Y, Sakoda Y, Nagata T, Miyake T, Soda K, Ozaki H, Nakayama M, Shibuya H, Okamatsu M, Ishigaki H, Ishida H, Sawai T, Kawaoka Y, Kida H, Ogasawara K. Department of Pathology, Shiga University of Medical Science, 485 Setatsukinowa, Otsu, Shiga 520-2192, Japan; Department of Surgery, Shiga University of Medical Science, Otsu, Shiga 520-2192, Japan. Outbreaks of highly pathogenic avian influenza viruses (HPAIVs) would cause disasters worldwide. Various strategies against HPAIVs are required to control damage. It is thought that the use of non-pathogenic avian influenza viruses as live vaccines will be effective in an emergency, even though there might be some adverse effects, because small amounts of live vaccines will confer immunity to protect against HPAIV infection. Therefore, live vaccines have the advantage of being able to be distributed worldwide soon after an outbreak. In the present study, we found that intranasal administration of a live H5N1 subtype non-pathogenic virus induced antibody and cytotoxic T lymphocyte responses and protected mice against H5N1 HPAIV infection. In addition, it was found that a small amount (100PFU) of the live vaccine was as effective as 100mug (approximately 10(10-11)PFU of virus particles) of the inactivated whole particle vaccine in mice. Consequently, the use of live virus vaccines might be one strategy for preventing pandemics of HPAIVs in an emergency. __________________________________________________________________________ _____________________________________*____________________________________ 3. Abstract: Perceptions and attitudes of the professional staff concerning infection surveillance and control programs in Brazilian hospitals __________________________________________________________________________ Am J Infect Control. 2009 Sep 11. Perceptions and attitudes of the professional staff concerning infection surveillance and control programs in Brazilian hospitals. Guerra CM, Ramos MP, Penna VZ, Goto JM, Santi LQ, de Andrade Stempliuk V, Sallas J, Medeiros EA. Federal University of São Paulo, São Paulo, SP, Brazil. BACKGROUND: Several countries have conducted studies to assess the status of their infection control programs (ICP) with the objective of improving quality of infection control practices. METHODS: To assess the perceptions and attitudes of the health care workers (HCW) concerning ICP in Brazilian hospitals, we conducted a cross- sectional survey using a self-administered online questionnaire during a Web-based course (WBC) on infection control (IC) and antimicrobial resistance (AR). RESULTS: Of 6256 Brazilian HCW registered for the WBC, 1998 were members of infection control committees (ICC) and answered the survey. Eight hundred six (40.4%) respondents said that an ICP was established for more than 10 years in their institutions. Most professionals reported that their hospitals perform microbiologic surveillance targeted at epidemiologically important multidrug-resistant organisms, but the majority underestimated the prevalence of AR. CONCLUSION: Our survey highlights important information about the perceptions and attitudes of ICC members that may be used to tailor key interventions for implementing effective ICP. It suggests, additionally, that, to achieve countrywide standardized IC mechanisms in a developing country, authorities should consider the social, cultural, and economical disparities between regions and identify specific regional needs to make available the resources required to minimize such disparities. __________________________________________________________________________ _____________________________________*____________________________________ 4. Abstract: Reducing HIV Risks Among Active Injection Drug and Crack Users: The Safety Counts Program __________________________________________________________________________ AIDS Behav. 2009 Sep 11. Reducing HIV Risks Among Active Injection Drug and Crack Users: The Safety Counts Program. Rotheram-Borus MJ, Rhodes F, Desmond K, Weiss RE. Center for HIV Identification, Prevention, and Treatment Services, University of California, Los Angeles, CA, USA, Rotheram@ucla.edu. The efficacy of Safety Counts, a CDC-diffused intervention, was reanalyzed. In a quasi experimental, cross-over design, injection drug users (IDU) and crack users in two neighborhoods were assigned by neighborhood to receive individual Voluntary HIV Counseling and Testing or Safety Counts and 78% were reassessed at 5-9 months. Drug users in the Safety Counts program reported significantly greater reductions in risky sex, crack and hard drug use, and risky drug injection. The more sessions of Safety Counts attended, the greater were the reductions in risky acts. Different analytic decisions result in very different findings for the same intervention. Safety Counts is an effective intervention for IDU and crack users. Analytic decision of intervention outcomes is highly related to evaluations of an intervention's efficacy. __________________________________________________________________________ _____________________________________*____________________________________ 5. Abstract: Minimally invasive insulin delivery in subjects with type 1 diabetes using hollow microneedles __________________________________________________________________________ Diabetes Technol Ther. 2009 Jun;11(6):329-37. Minimally invasive insulin delivery in subjects with type 1 diabetes using hollow microneedles. Gupta J, Felner EI, Prausnitz MR. School of Chemical & Biomolecular Engineering, Georgia Institute of Technology, Atlanta, Georgia 30332-0100, USA. BACKGROUND: Microneedles have previously been used to deliver insulin to animal models, but not in human subjects. This study tested the hypothesis that hollow microneedles can deliver insulin to modulate blood glucose levels in subjects with type 1 diabetes in a minimally invasive manner. METHODS: This study was carried out in two adults with type 1 diabetes and evaluated bolus delivery of lispro insulin using a hollow microneedle compared to a catheter infusion set (9 mm). The study first determined the minimum insulin delivery depth by administering insulin from microneedles inserted 1, 3.5, and 5 mm into the skin of fasting subjects and then assessed the efficacy of insulin delivery from microneedles inserted 1 mm into the skin to reduce postprandial glucose levels. Blood samples were periodically assayed for plasma free insulin and plasma glucose levels for up to 3.5 h. RESULTS: The first phase of the study indicated that microneedles inserted at the shallowest depth of 1 mm within the skin led to rapid insulin absorption and reduction in glucose levels. Bolus insulin delivery followed by consumption of a standardized meal in the second phase revealed that microneedles were effective in reducing postprandial glucose levels. Subjects reported no pain from microneedle treatments, and there were no adverse events. CONCLUSIONS: This study provides the first proof of concept that hollow microneedles can effectively deliver bolus insulin to type 1 diabetes subjects in a minimally invasive manner. __________________________________________________________________________ _____________________________________*____________________________________ 6. Abstract: Microneedle-based vaccines __________________________________________________________________________ Curr Top Microbiol Immunol. 2009;333:369-93. Microneedle-based vaccines. Prausnitz MR, Mikszta JA, Cormier M, Andrianov AK. School of Chemical and Biomolecular Engineering, Georgia Institute of Technology, 311 Ferst Drive, Atlanta, GA, 30332-0100, USA, prausnitz@gatech.edu. The threat of pandemic influenza and other public health needs motivate the development of better vaccine delivery systems. To address this need, microneedles have been developed as micron-scale needles fabricated using low-cost manufacturing methods that administer vaccine into the skin using a simple device that may be suitable for self-administration. Delivery using solid or hollow microneedles can be accomplished by (1) piercing the skin and then applying a vaccine formulation or patch onto the permeabilized skin, (2) coating or encapsulating vaccine onto or within microneedles for rapid, or delayed, dissolution and release in the skin, and (3) injection into the skin using a modified syringe or pump. Extensive clinical experience with smallpox, TB, and other vaccines has shown that vaccine delivery into the skin using conventional intradermal injection is generally safe and effective and often elicits the same immune responses at lower doses compared to intramuscular injection. Animal experiments using microneedles have shown similar benefits. Microneedles have been used to deliver whole, inactivated virus; trivalent split antigen vaccines; and DNA plasmids encoding the influenza hemagglutinin to rodents, and strong antibody responses were elicited. In addition, ChimeriVax(TM)-JE against yellow fever was administered to nonhuman primates by microneedles and generated protective levels of neutralizing antibodies that were more than seven times greater than those obtained with subcutaneous delivery; DNA plasmids encoding hepatitis B surface antigen were administered to mice and antibody and T cell responses at least as strong as hypodermic injections were generated; recombinant protective antigen of Bacillus anthracis was administered to rabbits and provided complete protection from lethal aerosol anthrax spore challenge at a lower dose than intramuscular injection; and DNA plasmids encoding four vaccinia virus genes administered to mice in combination with electroporation generated neutralizing antibodies that apparently included both Th1 and Th2 responses. Dose sparing with microneedles was specifically studied in mice with the model vaccine ovalbumin. At low dose (1 mug), specific antibody titers from microneedles were one order of magnitude greater than subcutaneous injection and two orders of magnitude greater than intramuscular injection. At higher doses, antibody responses increased for all delivery methods. At the highest levels (20-80 mug), the route of administration had no significant effect on the immune response. Concerning safety, no infections or other serious adverse events have been observed in well over 1,000 microneedle insertions in human and animal subjects. Bleeding generally does not occur for short microneedles (<1 mm). Highly localized, mild, and transient erythema is often observed. Microneedle pain has been reported as nonexistent to mild, and always much less than a hypodermic needle control. Overall, these studies suggest that microneedles may provide a safe and effective method of delivering vaccines with the possible added attributes of requiring lower vaccine doses, permitting low-cost manufacturing, and enabling simple distribution and administration. __________________________________________________________________________ _____________________________________*____________________________________ 7. Abstract: Microneedle Arrays Allow Lower Microbial Penetration Than Hypodermic Needles In Vitro __________________________________________________________________________ Pharm Res. 2009 Sep 11. Microneedle Arrays Allow Lower Microbial Penetration Than Hypodermic Needles In Vitro. Donnelly RF, Singh TR, Tunney MM, Morrow DI, McCarron PA, O'Mahony C, Woolfson AD. School of Pharmacy, Queen's University Belfast, Medical Biology Centre, 97 Lisburn Road, Belfast, BT9 7BL, UK, r.donnelly@qub.ac.uk. METHODS: In this study we determined, for the first time, the ability of microorganisms to traverse microneedle-induced holes using two different in vitro models. RESULTS: When employing Silescol(R) membranes, the numbers of Candida albicans, Pseudomonas aeruginosa and Staphylococcus epidermidis crossing the membranes were an order of magnitude lower when the membranes were punctured by microneedles rather than a 21G hypodermic needle. Apart from the movement of C. albicans across hypodermic needle- punctured membranes, where 40.2% of the microbial load on control membranes permeated the barrier over 24 h, the numbers of permeating microorganisms was less than 5% of the original microbial load on control membranes. Experiments employing excised porcine skin and radiolabelled microorganisms showed that the numbers of microorganisms penetrating skin beyond the stratum corneum were approximately an order of magnitude greater than the numbers crossing Silescol(R) membranes in the corresponding experiments. Approximately 10(3) cfu of each microorganism adhered to hypodermic needles during insertion. The numbers of microorganisms adhering to MN arrays were an order of magnitude higher in each case. CONCLUSION: We have shown here that microneedle puncture resulted in significantly less microbial penetration than did hypodermic needle puncture and that no microorganisms crossed the viable epidermis in microneedle-punctured skin, in contrast to needle-punctured skin. Given the antimicrobial properties of skin, it is, therefore, likely that application of microneedle arrays to skin in an appropriate manner would not cause either local or systemic infection in normal circumstances in immune-competent patients. In supporting widespread clinical use of microneedle-based delivery systems, appropriate animal studies are now needed to conclusively demonstrate this in vivo. Safety in patients will be enhanced by aseptic or sterile manufacture and by fabricating microneedles from self-disabling materials (e.g. dissolving or biodegradable polymers) to prevent inappropriate or accidental reuse. __________________________________________________________________________ _____________________________________*____________________________________ 8. Abstract: Structural injury to the human sciatic nerve after intraneural needle insertion __________________________________________________________________________ Reg Anesth Pain Med. 2009 May-Jun;34(3):201-5. Structural injury to the human sciatic nerve after intraneural needle insertion. Sala-Blanch X, Ribalta T, Rivas E, Carrera A, Gaspa A, Reina MA, Hadzic A. Departments of Anesthesiology, Hospital Clínic of Barcelona, Spain. BACKGROUND: Recent clinical reports suggest that intraneural needle placement may not always lead to neurologic injury. To explain the absence of neurologic complications in these reports, we studied the risk and extent of nerve injury after intentional needle-nerve placement in a cryopreserved human sciatic nerve. METHODS: The sciatic nerve was dissected from a cryopreserved cadaver through partial exposure. Needles were inserted through the nerve, using blunt-tip (30 degrees beveled) (group A) and sharp-tip (15 degrees beveled) (group D) needles. Five needle insertions were made for each needle type. Subsequently, transverse nerve sections at 10 needle trajectories were processed. Nerve samples were stained with hematoxylin- eosin, Masson trichromic, and immunohistochemical stains. In each section, the following variables were quantified: total number of fascicles and vessels in the immediate vicinity of the needle trajectories and the number of injured fascicles and vessels. RESULTS: A total of 520 fascicles were quantified, of which 134 were in contact with the needle trajectories. The numbers of fascicles and vessels per section were 65 +/- 8 and 14 +/- 7, respectively. A mean of 16 +/- 5 fascicles were found in contact with the needle trajectory (group A: 17+/- 3, group D: 15 +/- 6). Of these, 4 fascicles (3.2%) and 1 intraneural vessel were found damaged in group D. No fascicular or vascular injuries were found in group A. CONCLUSIONS: Our findings suggest that intraneural needle insertion may more commonly result in interfascicular rather than intrafascicular needle placement. __________________________________________________________________________ _____________________________________*____________________________________ 9. Abstract: An orthopedic injection training instrument using flow impedance to indicate needle tip locations __________________________________________________________________________ J Clin Monit Comput. 2009 Sep 13. An orthopedic injection training instrument using flow impedance to indicate needle tip locations. Yao J, Sullivan ST, Eckert CA, Bartlett EC. East Carolina Unveristy, Greenville, NC, USA, yaoj@ecu.edu. OBJECTIVE: The project aimed to design an instrument that can provide visual, quantitative feedback to medical students and help them develop intuitive, tactile-based injection skills. METHODS: The instrument uses force and displacement sensors to find flow impedance, the ratio of the pressure applied to fluid in the syringe to the fluid flow rate, of different tissues. A software program utilizes these flow impedances to identify needle tip location-either joint or tendon. Injection experiments with pork feet were completed to collect flow impedance data when the needle tip was located in joint or tendon. Injections used deionized water and aqueous pullulan solutions to study the instrument's effectiveness when medical therapies of different viscosities are injected. For each solution, at least 13 injections were conducted. The mean and standard deviation of the flow impedances from injections with each solution were obtained. RESULTS: In all experimental cases, the flow impedance demonstrated by the tendon is a number of times higher than that of the joint cavity: the impedance ratios (tendon to joint cavity) for water, 3 w/w% pullulan, and 15 w/w% pullulan are 74, 62, and 6, respectively. CONCLUSIONS: The results confirmed the concept of using flow impedance to index the needle tip location-whether the tip is positioned in joint or tendon. This instrument's user interface can serve as a training aid for medical students and infrequent operators. __________________________________________________________________________ _____________________________________*____________________________________ 10. Abstract: Oral transgenic plant-based vaccine for hepatitis B __________________________________________________________________________ Immunol Res. 2009 Sep 16. Oral transgenic plant-based vaccine for hepatitis B. Thanavala Y, Lugade AA. Department of Immunology, Roswell Park Cancer Institute, Elm and Carlton Streets, Buffalo, NY, 14263, USA, yasmin.thanavala@roswellpark.org. In addition to improving vaccine formulations in order to elicit robust and long-lasting immune responses, there is also an increasing need for improving the manner in which these vaccines are delivered. As most current vaccines are administered by injection by a health care giver, there is the ever-present danger of needlestick injuries. Therefore, needle-free vaccinations are a viable option toward limiting needle- associated injuries and additionally increasing compliance with vaccination schedules, as both children and adults have an aversion to injections. Noninvasive methods of vaccination will also facilitate speed of vaccine delivery and likely also reduce cost, both important factors for health care in developing countries. One alternative to current injectable immunizations is orally delivered vaccines. A specific approach that we and others are evaluating is the use of transgenic plant tissue that expresses vaccine antigens for oral immunization. Herein, we review the development of an oral HBV vaccine expressed in transgenic potato tubers and the immune responses generated in human subjects given this novel vaccine. __________________________________________________________________________ _____________________________________*____________________________________ 11. Abstract: Prospects for control of emerging infectious diseases with plasmid DNA vaccines __________________________________________________________________________ J Immune Based Ther Vaccines. 2009 Sep 7;7:3. Prospects for control of emerging infectious diseases with plasmid DNA vaccines. Moss RB. Vical Inc, San Diego, CA, USA. shotdoc92130@yahoo.com. Experiments almost 20 years ago demonstrated that injections of a sequence of DNA encoding part of a pathogen could stimulate immunity. It was soon realized that "DNA vaccination" had numerous potential advantages over conventional vaccine approaches including inherent safety and a more rapid production time. These and other attributes make DNA vaccines ideal for development against emerging pathogens. Recent advances in optimizing various aspects of DNA vaccination have accelerated this approach from concept to reality in contemporary human trials. Although not yet licensed for human use, several DNA vaccines have now been approved for animal health indications. The rapid manufacturing capabilities of DNA vaccines may be particularly important for emerging infectious diseases including the current novel H1N1 Influenza A pandemic, where pre-existing immunity is limited. Because of recent advances in DNA vaccination, this approach has the potential to be a powerful new weapon in protecting against emerging and potentially pandemic human pathogens. __________________________________________________________________________ _____________________________________*____________________________________ 12. Abstract: Persistence of antimicrobial activity through sustained release of triclosan from pegylated silicone elastomers __________________________________________________________________________ Biomaterials. 2009 Sep 16. Persistence of antimicrobial activity through sustained release of triclosan from pegylated silicone elastomers. McBride MC, Karl Malcolm R, David Woolfson A, Gorman SP. McClay Research Centre, School of Pharmacy, Queen's University Belfast, 97 Lisburn Road, Belfast BT9 7BL, Northern Ireland, UK. Microbial adhesion to silicone elastomer biomaterials is a major problem often resulting in infection and medical device failure. Several strategies have been employed to modulate eukaryotic cell adhesion and to hamper bacterial adherence to polymeric biomaterials. Chemical modification of the surface by grafting of polyethylene glycol (PEG) chains or the incorporation of non-antibiotic antimicrobial agents such as triclosan into the biomaterial matrix may reduce bacterial adhesion. Here, such strategies are simultaneously applied to the preparation of both condensation-cure and addition-cure silicone elastomer systems, seeking a sustained release antimicrobial device biomaterial. The influence of triclosan incorporation and degree of pegylation on antimicrobial release, surface microbial adherence and persistence (Escherichia coli and Staphylococcus epidermidis) were evaluated in vitro. Non-pegylated silicone elastomers provided an increased percentage release of triclosan extending over a relatively short duration (99% release by day 64) compared with their pegylated (4% w/w) counterparts (65% and 72% release by day 64, for condensation and addition-cure systems respectively). Viable E. coli adherence to a non-pegylated silicone elastomer containing 1% w/w triclosan was reduced by over 99% after 24 h compared to the non- pegylated silicone elastomer containing no triclosan. No viable S. epidermidis adhered to any of the triclosan-loaded (>0.1% w/w) formulations other than the control. Persistence of the antimicrobial activity of the triclosan-loaded pegylated silicone elastomers continued for at least 70 days compared to the triclosan-loaded non-pegylated elastomers (at least 49 days). Understanding how PEG affects the release of triclosan from silicone elastomers may prove useful in the development of a biomaterial providing prolonged, effective antimicrobial activity. __________________________________________________________________________ _____________________________________*____________________________________ 13. No Abstract: Is Europe falling behind the United States in the field of sharps safety? __________________________________________________________________________ J Infus Nurs. 2009 May-Jun;32(3):128-9. Is Europe falling behind the United States in the field of sharps safety? Strauss K. Becton, Dickinson and Company, PO B 13, Erembodegem-Dorp 86, Erembodegem- Aalst B-9320, Belgium. Kenneth_Strauss@Europe.bd.com __________________________________________________________________________ _____________________________________*____________________________________ 14. No Abstract: Health care and the environment: hospitals take steps to reduce waste __________________________________________________________________________ ONS Connect. 2009 Jun;24(6):18. Health care and the environment: hospitals take steps to reduce waste. Becze E. __________________________________________________________________________ _____________________________________*____________________________________ 15. HCWH HCWM: Global South Newsletter HCWH Global South Newsletter - Asia, Africa and Latin America - in English __________________________________________________________________________ Interested in finding out more about environmental health issues and events, green healthcare, and the work of Health Care Without Harm? We provide a number of free information services to help you stay on top of developments in these areas. Sign up for one or more of our newsletters. http://72.32.87.20/global/newsletter/ Archive of Global South Newsletters Download the HCWH Global South Newsletter in PDF format. Issue No. 5, June 2009 Issue No. 3, Jan 2009 __________________________________________________________________________ _____________________________________*____________________________________ 16. Hubli-Dharwad Sustainable Healthcare Waste Management Project: A success story from South India __________________________________________________________________________ Hubli-Dharwad Sustainable Healthcare Waste Management Project: A success story from South India Dharwad Sustainable Healthcare Waste Management Project is being implemented in collaboration with Health Care Without Harm (HCWH) and supported by Deshpande Foundation. With an aim to help the hospitals and clinics of the district improve their practices in health care management. The project Hubli-Dhrawad healthcare waste management project is a milestone in the over a decade long activities of TL in waste management. The two year long project, the first one to be implemented with the support of municipal authorities in South India is intended to make a healthy change in the biomedical waste management practices in the twin city area. The attitude survey conducted prior to the project highlights the poor awareness on bio medical waste among the healthcare staff. This issue of TD looks in to the highlights of the survey and the details of the project: http://toxicslink.org/dn.php?section=1&id=198&atn=0 File Name: 06198_TD_32_33.PDF file size: 526Kb pdf __________________________________________________________________________ _____________________________________*____________________________________ 17. Global Waste Management Symposium: Call for Abstracts Deadline is 23 October 2009 __________________________________________________________________________ Global Waste Management Symposium www.wastesymposium.com http://tinyurl.com/l65jpj Call for Abstracts Deadline is October 23, 2009 The second Global Waste Management Symposium (GWMS) will serve as a forum for the presentation of applied and fundamental research, case studies, and policy analysis on waste and recyclables management. We invite the community of researchers, engineers, designers, educators, facility owners and operators, regulators, and policymakers to participate. The GWMS will be held in a setting where all participants can share ideas and will include oral and poster presentations as well as social events to provide opportunities for technical interaction and discussion. We invite abstracts in all areas related to the policy and management of solid waste, including: Waste minimization, reuse, recycling and management policy, regulation, economics, and planning Facility operation and design Global climate change Chemical and biological treatment and processes Life cycle analysis Conversion technologies and diversion strategies Waste containment Leachate treatment and management Bioreactors Air/gas emission quality, collection, control, utilization, and destruction Energy recovery and thermal treatment Equipment and safety Environmental characterization of waste Reuse of high-volume industrial waste materials Abstract Submission Guidelines and Instructions: An abstract template is available here http://tinyurl.com/lp86u5 This template must be used. The abstract should provide sufficient detail to show that the submission contains significant results of a case study, applied or fundamental research, or policy/regulatory/economic analysis. The inclusion of tables or figures that summarize selected results is encouraged. Abstract length is limited to two pages of single spaced text, tables, and figures. Abstracts describing plans for future work or that sell a product or service will not be accepted. An example of an acceptable abstract is available here http://tinyurl.com/l2ad7a Final decisions regarding presentations will be made by the symposium technical committee (listed on the web site). Authors of accepted abstracts will be expected to submit a short paper for peer review. Abstracts should be submitted electronically to Alice Jacobsohn, National Solid Wastes Management Association, at wastesymposium@nswma.org. The deadline for the submission of abstracts is October 23, 2009. Publication Schedule October 23, 2009 Abstract due (maximum length two pages) December 4, 2009 Notification to authors February 12, 2010 Accepted papers due for peer review April 16, 2010 Comments back to authors May 28, 2010 Submission of final paper ready for publication Conference Co-Chairs: Bryan Staley, Environmental Research and Education Foundation Morton Barlaz, North Carolina State University Craig Benson, University of Wisconsin __________________________________________________________________________ _____________________________________*____________________________________ 18. News - Benefit and Doubt in Vaccine Additive - UK: Shoplifter in syringe attack gets 3 years - USA: EMERGENCY ACTION: Medical assistants feel pinch - Board reinforces rule limiting who can give Botox injections - UK addicts may be given free foil for 'safer' heroin smoking: UK authorities could give out free foil to protect heroin addicts' health - Inhalable swine flu vaccine to be ready soon - USA: PA allows over-the-counter syringe sales - USA: Restrictions lifted on sale of needles - USA: Dozens of syringes found in Clay Township channel - Australia: Patient risk after medical equipment bungle - USA: Tactic against DUI may go too far - Today's Topic: Police take blood in test program - USA: Guest editorial: Police blood draw is extreme violation - USA: You Gotta Wash Your Hands is the Word Out! - Merck, Wellcome Trust To Launch Vaccine Center In India To Produce Vaccines For Developing Countries - Study on respirators versus masks hailed as landmark - "Turbid syringes and drugs for the sick," a Spanish newspaper reports on counterfeit drugs scandal in Argentina - Drug delivery market report from Reportlinker - USA: American Scientific Resources acquires Safeguard Medical's home needle destruction device patent Selected news items reprinted under the fair use doctrine of international copyright law: http://www4.law.cornell.edu/uscode/17/107.html __________________________________________________________________________ Benefit and Doubt in Vaccine Additive By Andrew Pollack, The New York Times, USA (22.09.09) Are Americans obligated to use an unproven vaccine to help protect people in other countries from the flu pandemic? That is the crux of a debate over adjuvants - a class of substances that somewhat mysteriously increase the potency of vaccines. Early studies suggest that adjuvants (pronounced AD-joo-vants) could allow four times as many people to be immunized against the H1N1 pandemic influenza with a given amount of vaccine. So with the world facing possibly severe shortages of vaccine, the World Health Organization and some health experts have been calling for the use of adjuvants to stretch the vaccine supply. -We have always argued that using adjuvanted vaccine would leave more vaccine for poor people,- said Marie-Paule Kieny, director of the World Health Organization’s initiative for vaccine research. Wealthy nations have contracted for much of the expected pandemic vaccine production, leaving little for poorer countries. But while Canada and some European nations will use vaccines containing adjuvants, American officials have decided against it for now. They say that they have enough vaccine and that the safety of the additives has not been proved. -These are products that potentially can be given to millions of healthy people,- said Dr. Jesse Goodman, chief scientist at the Food and Drug Administration. -There is not a known, specific safety danger or issue- with the adjuvants, Dr. Goodman acknowledged. -There’s just more uncertainty.- Officials also fear that using an adjuvant would raise public fears about vaccine safety at a time when their challenge might be about to shift from procuring enough vaccine to persuading people to use it. -If you add what the public would perceive as another unknown there, there’s a concern that people would be reluctant to get vaccinated,- said Dr. Anthony S. Fauci, director of the National Institute of Allergy and Infectious Diseases. Furthermore, officials say, one reason to use adjuvants is that they can increase a vaccine’s potency against a virus to which it is poorly matched. But the swine flu vaccine is well matched to the virus, which has not mutated. In the last two weeks, new data has lifted some of the pressure on the government to use adjuvants. Early studies suggest that even without an adjuvant, a single injection of swine flu vaccine - rather than the two anticipated - will confer adequate protection on adults and children at least 10 years old. That effectively doubles the number of people who can be immunized, and last week the government said it would make 10 percent of its roughly 200 million vaccine doses available to other countries. Eight other nations are also releasing some vaccine. Still, Dr. Tadataka Yamada, president of the global health program at the Bill and Melinda Gates Foundation, said that most of the world’s population of six billion people, mostly in poorer countries, would still be without vaccine, especially early in the pandemic. Less vaccine than expected has been produced so far because of manufacturing problems. -Over all, there is still clearly a shortage of vaccine supplies,- said Dr. Andrin Oswald, chief executive of the vaccine business at Novartis. Except for the United States, Dr. Oswald said, most countries ordering from Novartis have taken vaccine with adjuvant. Dr. Kieny, of the W.H.O., said as many as three billion doses of vaccine could be produced in a year. But she said governments that had ordered adjuvant vaccines should not abandon them. -There’s no reason to think these vaccines will not be safe,- she said. Even if adjuvants do not save the day in this pandemic, experts say they will become increasingly important for vaccines against all manner of diseases. That is because many vaccines now being developed -simply don’t work that well without an adjuvant,- said Dr. Thomas Monath, acting chief medical officer of Juvaris BioTherapeutics, a company developing adjuvants. Vaccines once typically contained a weakened or killed pathogen to spur an immune response. Some newer vaccines consist of only proteins or protein fragments from a pathogen, which makes them purer, safer and quicker to produce. But it turns out that the missing parts of the pathogens help to jolt the immune system; without them, an adjuvant is needed. Companies and academic laboratories are racing to develop adjuvants, -mainly because everyone recognizes the adjuvant could be the make-or-break component of a vaccine,- Dr. Monath said. Intercell, an Austrian company, is developing an adjuvant for flu shots in a patch worn on top of the injection site for a few hours. Scientists are also learning how adjuvants work and how to devise them rationally rather than by trial and error. -For the longest time, adjuvants were sort of a witch’s brew of substances, empirically designed,- said Bali Pulendran, a professor of pathology at Emory University. -What was once a black box is now being illuminated at the mechanistic level by new advances in immunology.- The term adjuvant, from a Latin word meaning -to help,- was coined in the 1920s by Gaston Ramon, a veterinarian at the Pasteur Institute in France, who observed that horses given diphtheria toxin had a stronger immune response if they had some inflammation at the injection site. Among his first adjuvants were bread crumbs and tapioca. Within a few years, scientists discovered that aluminum salts could prompt an immune response. Alum, as this adjuvant is often called, is now used in various vaccines, including those for tetanus and hepatitis B. It is a relatively weak adjuvant. But about 80 years after its discovery, it is still the only one used in vaccines the United States. That could soon change. An advisory committee to the F.D.A. recently recommended approval of Cervarix, a vaccine against the virus that causes cervical cancer. The vaccine, made by GlaxoSmithKline, uses an adjuvant containing a bacterial lipid. (Gardasil, the Merck cervical cancer vaccine already in use, has an aluminum adjuvant.) Alum is not used in flu shots because it has little effect. But Novartis and GlaxoSmithKline are selling pandemic flu vaccines containing newer adjuvants they have developed. They are oil-in-water emulsions of squalene, a lipid that is found in the body. Glaxo’s also contains vitamin E. A seasonal flu vaccine containing Novartis’s MF59 adjuvant has been used in Europe since 1997. Glaxo’s adjuvant, called AS03, is in a vaccine approved in Europe for use against the H5N1 bird flu, which spurred fears of a pandemic a few years ago. For the bird flu, an adjuvant was crucial because vaccines without adjuvants did not work well in tests and required huge doses. Glaxo’s vaccine required only one twenty-fourth as much antigen, the viral component of the vaccine, as another company’s vaccine that did not contain an adjuvant. Thinking the swine flu might pose the same problem, federal officials ordered $700 million worth of adjuvant from Novartis and Glaxo. If the adjuvants were used, they would have to be combined with the vaccine before the injection was given. And because the adjuvants have not been approved by the F.D.A., they would fall under a so-called emergency use authorization. But in the last two weeks it has been learned that the vaccines against the H1N1 virus stimulate a strong response on their own. A single shot containing 15 micrograms of antigen - the same amount used for each strain in a seasonal flu vaccine - should confer adequate protection for most people. Preliminary data from GlaxoSmithKline show that a vaccine with an adjuvant might use only one-fourth as much antigen. But federal officials say the savings are not large enough to offset the possible risks and extra complexity of using the adjuvants. While adjuvants tend to increase the temporary pain, swelling or fatigue caused by a vaccine, the main concern is whether they might cause an autoimmune disease, like rheumatoid arthritis, in which the immune system attacks the body’s own tissues. Some animal studies have suggested that possibility. Last year, the F.D.A. halted a clinical trial of a hepatitis B vaccine containing a novel adjuvant after one participant developed a type of blood-vessel inflammation that is considered an autoimmune disease. But the agency lifted its hold this month, apparently satisfied that the vaccine, made by Dynavax Technologies, was not the cause. Adjuvant makers say there is no cause for concern with the flu vaccines. Dr. Bruce Innis, head of the clinical flu vaccine team at GlaxoSmithKline, said the immune response spurred by his company’s adjuvant was directed only at the antigen in the vaccine. -There is not a general upregulation of immune responses across the body,- which would be needed for an autoimmune disease, Dr. Innis said. Novartis says more than 40 million doses of vaccine with its adjuvant have been used in Europe, with no signs of problems. But Dr. Fauci, of the National Institute of Allergy and Infectious Diseases, said Novartis’s adjuvant had been used mainly among the elderly, who tended to have weaker immune systems. There is less data, he said, on its use among children, younger adults and pregnant women. Copyright 2009 The New York Times Company .......................................................................... __________________________________________________________________________ UK: Shoplifter in syringe attack gets 3 years Yorkshire Post, UK (22.09.09) A syringe-wielding shoplifter has been jailed for three years after he stabbed a store security officer just days after being given bail. The victim, who worked at a store in Bramley, Leeds, had undergone medical tests after it emerged that heroin addict Michael Dale was infected with Hepatitis C, Bradford Crown Court heard yesterday. But the complainant, who was injured in June, faces an anxious six months wait before he will learn if he has contracted any infection as a result. Days before the incident in Bramley, homeless Dale, 34, had gone into the Somerfield store in Headingley, Leeds, to steal food. After he was challenged he produced a syringe and waved the hypodermic needle towards staff. Dale, who has an extensive record for shoplifting and violence, was given bail, but four days later used another syringe to stab a security officer in the groin at the Bramley store. Dale pleaded guilty to various offences including theft and affray in relation to the first incident and theft, possessing an offensive weapon and assault in respect of the stabbing. .......................................................................... __________________________________________________________________________ USA: EMERGENCY ACTION: Medical assistants feel pinch - Board reinforces rule limiting who can give Botox injections By Paul Harasim, Las Vegas Review-Journal, Nevada USA (20.09.09) Rebecca Luth couldn't believe it. One day she was making up to $300 an hour at The Body Spa injecting Botox into patients who wanted to hide their wrinkles. The next day all she could do was inject her opinion into a growing public debate on what medical assistants should be able to do. "It's not fair," the medical assistant said, weeping as she sat at a table outside a coffee shop in Henderson last week. "I've been injecting Botox and other (cosmetic) fillers for years. My patients love me. "They tell me I do it better than doctors. And now, just like that, the medical board said I can no longer do my job. Why this change?" The Nevada State Board of Medical Examiners has suddenly forced change in a big way to the delivery of vanity cosmetic procedures. Emergency regulations enacted Friday reinforce a long-ignored rule that prohibits medical assistants from injecting people with Botox and collagen drugs. These assistants have been working in salons operating under the license of medical doctors. The new regulations do allow medical assistants to provide flu shots and vaccinations, practices which it turns out also were prohibited under the 30-year-old law. Health officials called the emergency session because, without the changes, they feared long lines for seasonal and swine flu vaccines and because medical assistants were being laid off as a result of confusion and uncertainty about the law. Under Nevada law, no training or educational background is required for the position of medical assistant. Nevertheless, many medical assistants, including Luth, received certificates from vocational schools or community colleges such as the College of Southern Nevada. Others receive on-the-job training from physicians. The new directives are applauded by some as health care measures that keep Nevadans safer as they pursue the Fountain of Youth through a hypodermic needle. Others see the rules as perhaps the unintended result of a strategy by plastic surgeons, including board member Dr. Benjamin Rodriguez, who wanted to see more regulation of medical spas and their medical assistants. Critics say this increased regulation would end up benefiting plastic surgeons. Some health care professionals believe the recent hepatitis outbreak in Southern Nevada was the catalyst for the action. "Why did the medical board do this now?" Luth asks. The answer to that question, which has been asked by everyone from politicians to Botox users, depends on who you talk to. To Louis Ling, the medical board executive director who actually wrote the new regulations, the answer is simple: "We have to do the right thing when we find out something is wrong." How could it be that a law which made it illegal for medical assistants to give shots of any kind was either unknown to the medical community -- or ignored -- for 30 years? Ling won't even speculate. "I don't know," he said. But Dr. Leonard Kreisler, a former chief of staff at University Medical Center, said physicians long knew about the law but didn't want to pay a large number of registered nurses and physician assistants in their offices to do the work. "It was simple economics," Kreisler said. Larry Pinson, executive director of the Nevada State Board of Pharmacy, suggested that physicians decided they "could just deputize people to do these things." NOW WAS THE TIME Regardless of why the law was never enforced, Ling said now was the time to clarify what medical assistants could do. Ling said he learned in August from Rodriguez, who recently was reappointed to the board by Gov. Jim Gibbons, and other physicians that some doctors were allowing medical assistants to inject Botox and other cosmetic fillers under their licenses at spas with no supervision. "There was some abuse in this area by physicians," Ling said. Ling said he became convinced that something should be done soon, even though there had been no sentinel event in which a Nevadan was badly harmed by a cosmetic filler. "We can't let Nevadans be at risk," he said. "I know that there are some medical assistants who can probably do this well, but there are others we can't say that about. When you're a regulator, you have to make some tough calls when you're dealing with serious drugs like Botox." Botox carries such a serious risk of side effects, including breathing problems, that earlier this year the Food and Drug Administration issued an order to place black box warnings on the injectable toxin, a warning usually reserved for drugs that have caused fatal heart attacks or strokes. Ling said that because he was aware of the old law that made it illegal for medical assistants to administer potent drugs, he was able to call for a "clarification" of what medical assistants do. "I had been general counsel of the (Nevada State) Pharmacy Board, so I knew about the law. I had to act." Dr. Robert Feingold, a former Focus Medical Spa medical director who allowed medical assistants to do injections under his license, said it has long been common knowledge in the medical community that doctors at medical spas are not on premises "all the time." "I was there about four hours a day," he said. Feingold said he believes the focus on medical assistants by public health officials has come as a result of the hepatitis outbreak. "They don't want that kind of infection problem again." He said the mandatory use of small, single dose vials of Botox by Nevada health officials is a direct result of the outbreak, in which nine hepatitis cases were linked to the now-closed Endoscopy Center of Southern Nevada. SAFETY OR BOTTOM LINE? Rodriguez has previously voiced concerns about how medical spas work. Minutes of an open meeting of the board in May 2007 reported: "Dr. Rodriguez stated that the issue of non-physician spa personnel practicing medicine without a license by giving injections and using lasers without the physician seeing the patient before and after treatment and just signing off on the charts is something that should be brought before the legislature." Some in the Las Vegas health care community, such as Dr. Ivan Goldsmith, an internist who provides Botox to patients, and Tracy Hurst, owner of The Medical Spa at Summerlin, maintain that Rodriguez's chief concern is really the bottom line of plastic surgeons. Hurst has said it's not necessary for a doctor to be present for all the types of services spas provide, including skin care and anti-aging procedures. More regulation means more medical assistants at salons are out of business, she said. Goldsmith said the practices of plastic surgeons "are way down in the great recession. ... He's (Rodriguez) always allowed his medical assistants to give Botox." Rodriguez wouldn't comment. But his daughter and public relations manager, Noelle Rodriguez, said those criticisms don't reflect her father's reasons for pressing for change in how injections are delivered. "Dr. Rodriguez's position on the medical board has nothing to do with his personal potential net gain," Noelle Rodriguez wrote in a e-mail. "Fillers and Botox make up a minuscule part of his practice." But Hurst said the reason plastic surgeons want the cosmetic filler business is because it often leads to expensive procedures later on. Though refusing to name names, Hurst said plastic surgeons have told her about this business strategy. Although a $500 Botox treatment may seem like chump change in comparison to a $20,000 breast augmentation, Hurst said plastic surgeons and their representatives do all they can to talk patients into getting expensive elective surgery whenever they come in for a treatment. "They're good salesmen," she said. "They eventually wear them down." Dr. Tracy Hankins, a local plastic surgeon, said it is wrong to think that people in his profession only care about money when it comes to injections. "It's safety for patients that we care about," he said. Hankins said he has been surprised to learn that so much "unsupervised injecting" was done at spas. Rodriguez was a part owner of the Skin Care Institute on Sahara for years, according to former owner and now manager Amber Tsang. Rodriguez got out of the business in 2007, according to his daughter, but she couldn't remember how long he had been there. Tsang said Rodriguez brought a woman from his office, Monica de la Cruz, to teach medical assistants at the Skin Care Institute how to inject Botox and other fillers. Tsang said she is sure that Rodriguez's desire to have physicians more in control of injections did not mean he wanted to outlaw their administration by medical assistants. "He is very close to Monica and wouldn't do anything to hurt her," she said. "He just wanted all the Botox and filler business coming to him and other plastic surgeons instead of salons because it would benefit them." Noelle Rodriguez said de la Cruz enjoyed a sterling reputation for injecting. "I'm sure he (Rodriguez) didn't see all this coming," Tsang said. According to Noelle Rodriguez, her father had always thought it was legal for medical assistants to give injections, but he just wanted more physician involvement for safety purposes. Feingold said one of the medical assistants working under his license was Betty Guerra, who recently was charged by the state attorney general's office with practicing medicine without a license. Edie Cartwright, a spokeswoman for the office, said Guerra was charged after a complaint was forwarded by the medical board. Cartwright said she believes that arrest focused more attention on medical assistants, particularly in the salon community. Despite his reservations about Rodriguez, Goldsmith concedes that some accidental good may have come out of the plastic surgeon's call for more oversight in injections. "We shouldn't have medical assistants injecting something that dangerous," he said. "They won't know what to do if something goes wrong." Luth, a strong proponent of safety, says Goldsmith is wrong. "I've taken every class I can so I can do injections safely," she said. "I even have taught doctors." She fears that losing her livelihood will snowball into other problems. "I'm going to lose my house, everything," she said. Dion Frayle, one of Luth's longtime clients, wants her to continue giving him Botox injections. "She's so much better than a doctor," Frayle said. "She does a much better job and cares more than all the plastic surgeons I've ever gone to." Copyright © Las Vegas Review-Journal, 1997 - 2008 .......................................................................... __________________________________________________________________________ UK addicts may be given free foil for 'safer' heroin smoking: UK authorities could give out free foil to protect heroin addicts' health Denis Campbell, health correspondent The Observer, UK (20.09.09) Heroin addicts could be given free aluminium foil to encourage them to smoke rather than inject the class A drug under plans being considered by government advisers. Drug treatment experts say that inhaling heroin instead of injecting reduces a user's risk of contracting HIV and Hepatitis C. An addict heats a blob of heroin on the foil in a process known as "chasing the dragon". The Advisory Council on the Misuse of Drugs (ACMD) is examining whether the law should be changed to allow Britain's 300,000 problem drug users to receive foil as a way of protecting their health. Since last year, the ACMD's 31 members, who advise the Home Office, have been considering whether section 9A of the Misuse of Drugs act, governing "paraphernalia" or equipment used in the consumption of illicit substances, should be amended to allow the UK's network of needle exchanges to supply foil. At present, it prohibits the supply of "articles to be used for the preparation or consumption of illicit drugs". Critics say the ban endangers users' health because most drug workers are too afraid of being prosecuted to risk giving out something that many see as a sensible harm-reduction measure. An estimated 100 of England's 1,300 needle exchanges already defy the law by providing foil. Some have even had tacit support in the form of "letters of comfort" from their local police force, such as Avon and Somerset, which emphasises that it does not see the pursuit of section 9A as a priority. The ACMD's technical committee has held two private evidence-gathering sessions on the subject with with Jamie Bridge of the International Harm Reduction Association, which backs legalisation, and drugs treatment researchers Neil Hunt and Rachael Pizzey. It is due to hear on 29 October from veteran Dutch drugs worker John-Peter Kools, who has issued foil in the Netherlands. Both Holland and Spain issue foil through needle exchanges without any major problems. The full ACMD is to debate the issue in November and is expected to suggest setting up a pilot study on the effects of foil provision. It hopes to advise ministers of its views soon - possibly before the end of the year - on whether the law should be changed. Bridge said: "Smoking drugs is by no means safe, but is a great deal safer than injecting drugs - which is particularly associated with overdose, blood-borne viruses, drug-related litter, greater dependency, abscesses and vein damage. "The law has unintentionally put us in a strange position whereby we can give someone clean needles to inject with, but we face arrest for giving them aluminium foil to smoke with. Providing foil in this way is such a common-sense approach - with huge potential benefits and little opposition or potential costs - that we hope the law will change soon." Significantly, the Association of Chief Police Officers, which represents the country's most senior officers, is neutral on whether the law should be amended. But it would support a change if the ACMD recommended such a move on public health grounds, sources told the Observer. Harry Shapiro of Drugscope, which represents 800 drug projects, said: "It's important to do everything possible to discourage Britain's 300,000 problem drug users from injecting their drugs, and we should allow injecting heroin users to be provided with foil as part of a harm- reduction programme. As the law now stands users' health is being compromised and it would be better if section 9A was repealed." But James Brokenshire, the Conservative shadow home affairs minister, said: "I'm cautious about these sort of moves, which progress harm reduction rather than focus on getting people drug-free. In recent years there has been insufficient focus on getting people off drugs and too much on just maintaining people on drugs through methadone and other measures. "I would need to be swayed that there are clear and compelling public health arguments to make such a change [in the law]. I want to promote abstinence-based rehabilitation. There needs to be a greater emphasis in getting people off their drug habit rather than maintaining their addiction." Paul Hayes, the chief executive of the NHS's National Treatment Agency, which funds drug treatment, said: "Any way of using heroin is dangerous and likely to lead to addiction. However, injecting the drug is far more dangerous than other means of ingestion, such as smoking. Currently, the provision of foil is not legal. The NTA cannot advise drug treatment services to follow a course of action which is illegal and could have adverse consequences for provider services." guardian.co.uk © Guardian News and Media Limited 2009 .......................................................................... __________________________________________________________________________ Inhalable swine flu vaccine to be ready soon By Thomas H. Maugh II. Los Angeles Times (18.09.09) The mist will probably go mainly to healthcare workers, as it is not approved for children under 2, adults over 49 or pregnant women. It is expected to be available at the beginning of October. At least 3.4 million doses of vaccine against the pandemic H1N1 influenza virus will be available at the beginning of October, and about 20 million doses per week should become available soon after that, federal officials said Friday. The first vaccine available will be MedImmune's FluMist inhalable vaccine, but injectable vaccines should be distributed soon after that, Dr. Jay Butler, chief of the Centers for Disease Control and Prevention's 2009 H1N1 vaccine task force, said at a morning news conference. The inhalable vaccine has not been approved for children younger than 2, adults older than 49 or pregnant women, so it may go primarily to healthcare providers. Distribution of the vaccine will be complicated logistically, at least in part because the government is paying for both the vaccine supplies and most of the paraphernalia needed to give shots, such as needles, syringes and alcohol swabs. Patients may receive the vaccine free or may have to pay for administration, depending on where they receive it. Many insurance companies have agreed to pay for the shots Physicians, clinics and other providers will place their orders for the vaccine with state health departments, who will compile the orders every day and forward them to the CDC, which will ensure that the vaccine is distributed equitably. Allocations will be based primarily on state populations. Physical distribution of the vaccine will be handled by McKesson Corp. of San Francisco, which also handles distribution of vaccines for the government's Vaccines for Children program. That program normally ships vaccines to about 40,000 sites around the country from its 30 warehouses. The flu vaccine will go out to 90,000 separate sites, so McKesson has added an additional six distribution facilities, including two in California, to handle the increased demand. All five swine flu vaccine manufacturers will ship their product directly to McKesson. Each morning, the company will receive a list of orders from the CDC. Within three days, those orders will be processed and shipped overnight to the local providers, Butler said. No shipments will be made on Fridays and Saturdays to avoid having the vaccine arrive and sit unattended. Those 90,000 sites include physician's offices and clinics, but they also include distribution points such as the warehouses of chain pharmacies, which will then send the vaccine out to their own stores. Local health departments may also distribute it to clinics, schools and other sites. At the same news conference, Dr. Daniel Jernigan, deputy director of the CDC's influenza division, said that the flu season has begun early and that all 50 states are now reporting activity, with 21 reporting widespread activity. "It's very strange to see that kind of activity this time of year," he added. Most of the cases are swine flu, not seasonal flu, and the good news is that there has been no increase in virulence of the virus and no increase in resistance to antiviral drugs used to treat it. Copyright © 2009, The Los Angeles Times .......................................................................... __________________________________________________________________________ USA: PA allows over-the-counter syringe sales By: Taunya English, WHYY (18.09.09) Philadelphia health officials say a new pharmacy rule will help slow the spread of HIV among injection-drug users. Pennsylvania residents can now buy needles and syringes at the pharmacy without a prescription. Nan Feyler is chief of staff in the Philadelphia Department of Public Health. She says HIV can spread when people share needles. Feyler says over-the-counter sales will make clean needles more available, and she says studies from other states show that the prevention strategy works. Feyler: There's more privacy sometimes, there's much greater access than even with our needle exchange programs here in Philadelphia. You know, think about it pharmacies are open 24 hours a day, some of them, they're in many different neighborhoods, there's a trained health professional and pharmacists who's there if there's questions. Supporters say the change is also a convenience for diabetics who rely on insulin and need an at-home supply of syringes. Scott Burris is a health law professor at Temple University. Burris: This is also needed as a way of fighting HIV and hepatitis, particularly hepatitis C, which spreads from injection drug use. Injection drug use not just of heroin, but cocaine, amphetamines even steroids. Some people question whether addicts will go into a pharmacy to purchase clean needles. Burris thinks they will. Burris: One of the big myths that makes it hard to get policy changes like this, is the belief that drug users don't want to be saved and can't be saved, in fact the evidence is overwhelming that drug users will get out of the way to save their own lives if we get out of the way, and what Pennsylvania has done today is get the law out of the way. A prescription is no longer required, but pharmacists must supervise syringe sales and stock them behind the counter. .......................................................................... __________________________________________________________________________ USA: Restrictions lifted on sale of needles By Jeff Hawkes, Intelligencer Journal, Lancaster PA USA (18.09.09) Pennsylvanians can now buy hypodermic needles without a prescription, a change that research shows reduces the spread of AIDS and other viruses among users of illegal drugs. Public health activists hailed the state Board of Pharmacy's lifting of the restriction as a way to lessen risky sharing of needles by drug users, but not all pharmacists are happy about it. "I just don't agree with the rationale behind it: purposeful purchasing for illegal use," said John Hinkle of Hinkle's Pharmacy in Columbia. "I can't believe our pharmacy board would do something so foolish," said Velinda Pickel, a Royer Pharmacy manager. But pharmacist Herman Glassman at Queen Pharmacy said deregulating syringe sales makes sense. "When people are reusing needles, there's an opportunity to spread disease," said Glassman, who added that the change will also make access to needles more convenient for diabetics. The prescription requirement ended Sept. 12. A customer can now buy as many syringes as he wants, and there's no age restriction. The needles must be kept in a pharmacy's prescription area and be sold under a pharmacist's supervision. Pharmacists don't have to sell syringes to people lacking prescriptions if they don't want to, said Leslie Amoros of the Pennsylvania Department of State, which oversees regulatory boards. "This is not a mandate to pharmacists," Amoros said. "But based on scientific study, it's a good step forward to improve the public's health." In a letter to the Board of Pharmacy in 2007, the Pennsylvania Pharmacists Association endorsed syringe deregulation and called for prompt action. Before the Board of Pharmacy's action, Pennsylvania was one of only three states that had not deregulated the sale of hypodermic needles. Connecticut led the way in 1992, resulting in black-market syringe sales falling 74 percent to 28 percent, the Centers for Disease Control and Prevention reported. Because of positive results of over-the-counter syringe sales in some states, the National Association of Boards of Pharmacy in 2000 encouraged all states to revise their regulations. The CDC reports that about 20 percent of HIV infections and the majority of hepatitis C infections occur because of the virus being transmitted by addicts sharing needles. The sex partners of those drug users are then put at risk. In 2002, a group called Pennsylvania Coalition for Responsible Syringe Policy asked the Pennsylvania Pharmacy Board in a letter to consider deregulation. Then, in 2005, a separate group, Pennsylvanians for the Deregulation of Syringe Sales, hired an attorney and submitted a formal, 9-page petition asking the Pharmacy Board to make the change. That group is headed by Robert E. Field of Lancaster, an apartment industry executive and advocate of drug law reform. "Our job was to get the ball rolling," the group's attorney, Elizabeth Mullaugh of Harrisburg, said. Field said he sought the repeal of the prescription requirement after his advocacy for a needle-exchange program for drugs users in Reading met with opposition. Field said his group met in 2005 with state officials, including a high- ranking member of Gov. Ed Rendell's administration. That meeting was facilitated by Rep. Mike Sturla of Lancaster city, then chair of the House Professional Licensure Committee, facilitated. Field said state officials he met supported the change. "There's real evidence that this will save people's lives," Sturla said. "I think it needed somebody to give it a little push. I think (Field) deserves a whole lot of credit for pushing." The Pharmacy Board held hearings and sought written input from interested parties. Almost all of the input the board received supported deregulation. Dr. Jeffrey Kirchner, a physician who runs an AIDS treatment center at Lancaster General Hospital, supports the regulatory move. "The data speaks for itself," Kirchner said. Infection rates have been shown to be significantly impacted when people have clean syringes. It's a misconception that it promotes drug use." Ronda Goldfein of AIDS Law Project of Pennsylvania, one of many groups that urged the Board of Pharmacy to lift the prescription requirement, said research shows that allowing drug users to have easy access to sterile needles reduces the spread of HIV and hepatitis and does not increase the number of drug users. "People aren't going to say, 'Now that I can get a clean needle at Rite Aid, I'm going to start shooting heroin,' " Goldfein said. She said having access to needles at pharmacies is especially important to drug users in areas outside of Philadelphia and Pittsburgh. They are the only cities in Pennsylvania with special permission to operate needle exchanges that distribute needles at no cost and encourage addicts to enter treatment. Beyond those cities, distribution and possession of a syringe for injecting illegal drugs remains a crime under the drug paraphernalia law. "One of the terrible consequences of heroin addiction is that people hide their disease, they don't get proper medical care and they end up sharing needles," said Adam Kegley, head of Addiction Recovery Systems of Lancaster, a methadone clinic. "And Lancaster, I can tell you, has a very serious heroin problem. Since opening in May 2006, we have seen a steady stream of admissions. The admissions have not slowed down." Because deregulating needle sales doesn't solve the addiction problem, Kegley said more steps are needed, including the expansion of needle exchanges across the state. "We need to tear down the paraphernalia law and operate responsible needle exchanges that reach out to the addicts and, ultimately, get them to stop using," he said. Chris Runkle, program director of Manos House, a drug treatment facility for juveniles, said he has seen teen users who have contracted hepatitis C. "The percentage is small only because we're catching them early," he said, adding that allowing syringe sales makes sense as a disease-reduction tactic. "But I don't think it should be, 'Here's a needle. Thanks for shopping,' " Runkle said. He said community groups need to come together to create an outreach effort, such as a needle exchange, that focuses on disease prevention, education and treatment. Still, ending the prescription requirement is an important first step, advocates said. "I think we're going to be saving lives all around Pennsylvania" now that needles are being sold over the counter, said Scott Burris, a specialist in health law at Temple University School of Law. "Pharmacists can now enlist in the fight against AIDS." .......................................................................... __________________________________________________________________________ USA: Dozens of syringes found in Clay Township channel By Stephen Tait, Times Herald, Michigan USA (18.09.09) DEQ says user likely a diabetic CLAY TWP. -- The Michigan Department of Environmental Quality collected about five dozen syringes in a channel that runs next to Anchor Bay Drive, a collection they said is larger than most they see. "Once in a while we will get reports of one or two," said Andrew Shannon, of the DEQ's Medical Waste Regulatory Program, "but not this amount." John Gohlke, program specialist with the DEQ Medical Waste Regulatory Program, said the syringes were "undoubtedly" used by a diabetic. He said it is a cause of concern. "You don't know what bacteria or viruses it contains; it's an infectious disease problem we're dealing with," Gohlke said. Shannon said diseases such as hepatitis and HIV can be transmitted through such syringes if someone is stuck. Art Roberts, who lives at 8014 Anchor Bay Drive, said he found the collection of waste Monday and reported it to the Department of Natural Resources. Gohlke said his department was notified of the waste late Wednesday and was unsure why there was a delay. The waste was found in a boat bay where Roberts stores his boat -- a small jut off the channel that is about 8 feet deep. "I didn't know what to think," Roberts said of the waste. "Just throwing anything in the water is just not right." Most of the syringes found Thursday had small orange caps covering the needles. But at least one needle was exposed. The DEQ officials said it is unclear if the syringes were thrown into the boat bay or floated into the area from the channel. "They were just mixed in with all the weeds," Shannon said. There were no identifiable labels on the syringes or an empty vial of insulin, making identifying who the waste belonged to difficult. Furthermore, Gohlke said if it is an individual who dumped the waste, it would not fall under the punishments of the Medical Waste Regulatory Act, which regulates waste from commercial and professional establishments such as hospitals and tattoo parlors. Instead, the violator would be punishable under regular littering laws, Gohlke said, which is a $1,000 fine. Gohlke and Shannon said dumping is a problem because disposing of the syringes can be expensive. They said in some Michigan counties there are programs through hospitals, health departments and other organizations. But because of funding problems, many such organizations either are no longer pursuing those programs or cutting them. "It is a budgetary issue," Gohlke said. St. Clair County has no waste program through government or other health care-providers. Sue Amato, spokeswoman for the St. Clair County Health Department, said the department pays for a service to discard its own medical waste but not for others to drop it off there. "We just don't have the resources," she said. Residents still have at least three options for disposal that involves mailing medical waste. Specific information is available at www.michigan.gov/deqmedwaste. The problem of disposal is such a concern Gohlke sends out a news release at the beginning of each boating season to warn boaters of syringes. "That's infectious waste and can transmit infectious disease," he said, pointing toward the pile fished out of the water Thursday. Additional Facts INFORMATION ON HOW TO DISPOSE OF MEDICAL SYRINGES General Information: http://www.michigan.gov/deqmedwaste .......................................................................... __________________________________________________________________________ Australia: Patient risk after medical equipment bungle ABC Online (18.09.09) More than 200 patients at Inverell Hospital in northern New South Wales may have been exposed to infection risks after undergoing colonoscopy and gastroscopy procedures. Hunter New England Health says medical equipment that should have been disposed of after a single application, was re-used. Follow-up blood tests and counselling have been offered to 218 patients who had the operation between February and August. The service's Director of Operations, Scott McLachlan, says there is a small chance of cross-infection. "We're looking for typically some blood-borne viruses," he said. "They can be hepatitis B or C, or HIV. The blood testing that will go through will take a couple of days to provide the tests back to those people. "Wherever possible we'll provide them with their test results within 48 hours." .......................................................................... __________________________________________________________________________ USA: Tactic against DUI may go too far - Today's Topic: Police take blood in test program The Tennessean, Nashville Tennessee USA (18.09.09) Our View Imagine being pulled over for drunken driving. You refuse a breath test, so the police officer pulls out a syringe. That's what's happening under a pilot program in Idaho and Texas, where law enforcement officers can draw blood on the spot from DUI suspects who refuse to submit to a breath test. The aim of the pilot study is to determine whether blood draws by law enforcement officers can be an effective tool against drunken driving and help in the prosecution. Most legal experts say blood tests are a more accurate measure of blood alcohol than are breath tests. The study, conducted under the eyes of the National Highway Traffic Safety Administration, will surely only add to the problems of prosecuting DUI suspects. Earlier this week, The Associated Press reported that if the results of the study seem promising after a year or two, the safety administration will encourage police nationwide to undergo similar training. Under the pilot program, an officer will stop a DUI suspect and give them a field sobriety test. If the officer has probable cause, he or she can asked the driver to undergo a breath test. If the person refuses, a blood test can be ordered and the driver cannot decline. Officers are being trained to take blood generally under the same program as hospital or clinical phlebotomists but on a shorter schedule, according to the Associated Press. Officers don't need to know how to draw blood from a foot or other difficult sites but are trained on the elbow crease, the forearm and the back of the hand, the Associated Press reported. If none are accessible, they will take the suspect to a hospital for testing. In Tennessee, law enforcement officers can take DUI suspects to a medical facility for blood testing if they refuse a breath test. Anyone who refuses a breath or blood test is in violation of the state's implied consent law and loses their driver's license. EMTs, doctors, nurses, phlebotomists and officers who are EMT-certified can draw blood at the scene in the case of an auto accident. The pilot study is based on a program used in Arizona for a number of years that reportedly has reduced the number of DUI suspects who refuse a breath test. But some questions about the program cause concern, questions about physical intrusion, for example. Also, should the state or a municipality take on the added responsibility of law enforcement officers drawing blood instead of medical personnel? And what about liability? Medical personnel draw blood every day, but how often does a police officer stop someone suspected of driving drunk? Will they draw blood enough to be proficient? Drunken driving is a serious - and too often deadly - offense and should not be taken lightly. Alcohol kills 13,000 people a year on the nation's roads, including 327 people in Tennessee in 2008. While vigilance in preventing drunken driving is absolutely necessary, having law enforcement officers draw blood from suspects might add to problems for prosecutors. Already, DUI cases are one of the most litigated types of cases in our court systems. Would this plan add to that litigation? It may not be worth the risk and may be going too far. .......................................................................... __________________________________________________________________________ USA: Guest editorial: Police blood draw is extreme violation By Tommy Longaberger, The Tennessean, Nashville Tennessee USA (18.09.09) Other Views The latest proposal in the fight against drunken driving is to allow police officers to forcibly obtain blood samples from DUI suspects who refuse to submit to a breath test. In 1966, the U.S. Supreme Court ruled that law enforcement officers could forcibly withdraw blood without a warrant. The federal government, through the National Highway Traffic Safety Administration, is paying to train police officers in Texas and Idaho to forcibly obtain blood samples from motorists believed to be driving under the influence. If this program is seen to be successful it is intended to be encouraged throughout the nation. Arizona police officers have been forcibly drawing blood without a warrant since 1995. In Phoenix, 120 officers have received training certifying them to draw blood. These officers obtain samples from 400 to 500 suspects a month, many by force. Just two weeks ago the Arizona Court of Appeals ruled that forcibly withdrawing blood without consent is unconstitutional. Perhaps we could all learn a lot about this proposal from the experience in Arizona over the past 14 years. Get evidence with video cameras I was raised and taught that in our nation we live in a free society where the government has to follow certain procedures and rules in order to invade our lives. Allowing a police officer the right to forcibly restrain and invade a person's body without a warrant is, in my opinion, an extreme violation of what our society was founded on. No one favors treatment benefiting those who drive drunk. The fact is, innocent people die due to drunken driving. Politicians and the press find this issue one with great interest and no opposition. In spite of this we must look at the practical implications of the laws we live by. The officers in the pilot program in Texas and Idaho are undergoing an accelerated phlebotomy course lasting a week. They are given needles and hit the street after only 75 successful blood draws. Do you believe they are going to learn all they need to know about AIDS, hepatitis, blood thinners, hemophiliacs and other medical issues that are sure to arise? Can you imagine the trauma of being held down while someone forcefully inserts a needle into your arm? Why not get a warrant and take the suspect to a hospital or proper medical facility? On average, more than 100 motorists are arrested for DUI in Nashville each week. Over one-third of those arrested refuse to submit to a breath test. Most will tell you they refused due to advice they received from an attorney, police officer or friend. Few realize that if you fail a breath test you have a right to a blood test at your expense. My experience tells me that many who refuse the breath test would pass or help their case if they submitted a blood sample. Individually, we would all benefit by having a better understanding of the effects that consuming alcohol has on our ability to operate an automobile. Do you know how much it takes for you to reach the legal limit of .08 percent blood-alcohol content? The primary purpose of allowing police officers to forcefully withdraw blood is enhancing the evidence to convict those driving drunk. There are more humane and civil ways of accomplishing this. Only a few of Nashville's patrol cars are equipped with video equipment. Video evidence is quite compelling, and I suggest before we start providing medical training to officers we investigate other avenues. .......................................................................... __________________________________________________________________________ USA: You Gotta Wash Your Hands is the Word Out! Reuters (17.09.09) Foundation launches public service campaign with a premiere, billboards, an inflatable, and a message. PHILADELPHIA, Sept. 17 /PRNewswire-USNewswire/ -- The Word-OUT! Awareness Foundation, a member of the Congressional District Program 501(c) (3)-509(a)(1), will launch the third year of its You Gotta Wash Your Hands! A Public Service Campaign, on September 21, 2009. The press conference will start promptly at 1:30 p.m. and take place on the lawn of The Philadelphia High School For Creative and Performing Arts (CAPA), located at Broad and Christian Streets. Word-OUT!'s press conference coincides with the global launch of International Clean Hands Week, September 20-26, 2009, as sanctioned by the World Health Organization, The Center for Disease Control and Prevention, and the National Clean Hands Coalition. An additional campaign element and vital component this year will be the Foundation's new website: www.wordoutawareness.org. The website will be officially launched at the press conference. Once again, the Foundation welcomes the sponsorship of Jefferson University Hospital for the campaign's "aerial reminders:" PSA billboards and our giant inflatable helium balloon, which will soar above the gathering. Dr. Rachel Sorokin, Chief Patient Safety and Quality Officer, Thomas Jefferson University Hospitals will reinforce the necessity of practicing hand washing as the "first line of defense." The Foundation's first PSA billboard celebrity, "the Geator with the Heater," Jerry Blavat, will be joined by Clear Channel's Outdoor Representative, Barbara Bridge, to unveil the 2009 PSA billboard celebrities. The CAPA Dancers, along with the CAPA Choir, will perform the premiere of "Contamination" from the Foundation's You Gotta Wash Your Hands! The Musical, currently in development. The CAPA Dancers will also dance to the theme from the movie FAME, a tribute to all creative and performing arts students. Join us. SOURCE Word-OUT! Awareness Foundation © Thomson Reuters 2009. .......................................................................... __________________________________________________________________________ Merck, Wellcome Trust To Launch Vaccine Center In India To Produce Vaccines For Developing Countries Kaiser Daily Global Health Policy Report (17.09.09) Pharmaceutical company Merck and the Wellcome Trust have joined together to create a non-profit, £90-million (about $150 million) research center in India to facilitate the development of new vaccines, "including [those for] neglected diseases for which inadequate or no vaccines exist," Nature News reports. "The move marks the first time that a major medical-research charity and a pharmaceutical company have directly partnered to create vaccines aimed at low-income countries," according to the journal (Butler, 9/16). "There is a critical need to develop new ways for scientific innovation to be translated effectively into new vaccines that can save lives and protect the health of people living in low-income countries," Merck CEO Richard Clark said in a Wellcome Trust press release. "We believe that success in bringing forward these new vaccines can be best achieved through productive partnerships." Wellcome Trust Director Mark Walport said, "Linking the ingenuity of academic research with the know-how of industry is vital if we are to produce a new generation of vaccines to reduce the burden of infectious diseases in low-income countries" (9/17). "The joint venture has yet to decide which diseases it will tackle, but will base the decisions on criteria such as scientific and technical feasibility, affordability and whether vaccine formulations will meet the field and other needs of the large procurement agencies such as the WHO, the United Nations Children's Fund (UNICEF) and the GAVI Alliance," Nature News writes (9/16). Reuters adds that the center "will focus on fields relevant to low-income countries, such as the production of heat-stable vaccines that do not require refrigeration and the development of a vaccine against Group A streptococci," (Hirschler, 9/17) which causes more than 500,000 deaths per year worldwide. The non-profit "will be run as a business, and will be free beyond its ... seed funding to pursue partnerships with academics, companies, governments and philanthropic bodies," according to Nature News. The center plans to team up with local pharmaceutical companies to develop low-cost versions of the vaccines developed by the center. "That's novel, says [Marie-Paule] Kieny [of the WHO], and may well pave the way for Western vaccine makers to allow generic versions of vaccines, such as those against human papillomavirus or pneumonia, which are available in rich countries but too expensive for poorer ones," Nature News writes. "Affordability will be key in the technical and other choices all along the product design and development path," said Mark Feinberg, Merck's vice president of medical affairs and policy. "We really want to lower a lot of the barriers that exist for developing promising products." The center is expected to open by the end of the year (9/16). The Kaiser Daily Global Health Policy Report is published by the Kaiser Family Foundation. © 2009 Henry J. Kaiser Family Foundation .......................................................................... __________________________________________________________________________ Study on respirators versus masks hailed as landmark Robert Roos News Editor, CIDRAP News (17.09.09) Sep 17, 2009 (CIDRAP News) - A study in which N95 respirators strongly outperformed surgical masks in shielding hospital workers from influenza viruses and other microbes is being hailed as a landmark in research on respiratory protection for healthcare workers. The study, which involved close to 2,000 hospital staffers in Beijing, showed that N95 respirators reduced the risk of respiratory illness by a significant 60% and the risk of confirmed influenza by 75%, whereas surgical masks had no effect. The study was reported at an American Society for Microbiology meeting in San Francisco this week but has not yet been published in full form. It is described as the first randomized controlled trial comparing the effectiveness of N95 respirators and surgical masks. N95 respirators are designed to fit closely to the face and filter out 95% of airborne particles, whereas surgical masks are looser fitting and were originally designed to prevent the wearer from infecting others. But health workers say the tight-fitting N95s are uncomfortable and difficult to wear for long periods, and hospitals sometimes have trouble keeping them in supply. Surgical masks are more comfortable and cheaper, but scientists have not found much evidence that they protect wearers from respiratory pathogens. In the face of the H1N1 flu pandemic, respiratory protection for health workers has been a big issue. Two weeks ago, the National Academy of Sciences' Institute of Medicine (IOM) issued a report affirming the current Centers for Disease Control and Prevention (CDC) guidance on the topic. The CDC recommends use of N95s by all healthcare workers who enter the rooms of patients with confirmed or suspected H1N1 infection. The same advice goes for emergency medical personnel who come in close contact with such patients. But the CDC is expected to issue some new guidance on the issue soon. CDC spokesman Tom Skinner said today that the new recommendations will be issued "by next week at the latest." China chosen for good reason The IOM report said few studies have compared N95 respirators and surgical masks in clinical use. The new study, conducted by an international team led by Raina MacIntyre of the University of New South Wales in Australia, was designed to help fill that gap. The authors picked China as the study site because they wanted a place where hospital workers are used to wearing respiratory protection and thus would be likely to comply with the study protocol, MacIntyre told an IOM committee at a workshop in August. She said Asians are much more used to wearing face protection than their counterparts in the West. The researchers recruited 1,936 front-line workers at 24 Beijing hospitals, according to the study abstract from the Interscience Conference on Antimicrobials and Chemotherapy (ICAAC). They were assigned to one of four groups: surgical masks, fit-tested N95s, non-fit-tested N95s, or control (no respiratory protection). The volunteers wore their assigned form of protection for 4 weeks and were monitored for illness for 5 weeks. The authors found that surgical masks had no protective effect. In contrast, the N95s, compared with the controls, were linked with a 60% reduction in risk for any respiratory illness, a 75% reduction in flu-like illness, a 56% decrease in lab-confirmed respiratory illness, and a 75% reduction in confirmed flu, according to the report. The reductions met the test of statistical significance. However, the researchers found that fit-testing of the N95s-recommended by manufacturers to keep air from leaking around them-made no difference in protection. "These data are the first clinical data to confirm the superiority of N95 masks in preventing respiratory infections," the authors state in their abstract. "Front line health workers are key to an effective pandemic response, and should be protected with N95 masks." Concerning the finding that fit-testing doesn't improve the effectiveness of N95s, they also say, "Given the logistic difficulties of fit testing, particularly during an infectious diseases emergency, this is an advantage for public health control." Study wins praise Lisa Brosseau, a University of Minnesota researcher who has studied respiratory protection for years, agreed with the initial assessment by others, reported in the media, that the MacIntyre study is a major achievement in the field. "It is a landmark study," she said. "I was very excited to hear it, because doing a clinical study comparing surgical masks and respirators is not an easy thing to do," said Brosseau, an associate professor in the environmental sciences division of the university's School of Public Health. "China is one of the only places where people would be willing to wear a respirator all the way through the day." "It's hard to comment conclusively before reading the [full] paper, but based on her [MacIntyre's] presentation and the data she's given us, it's a pretty clear conclusion that surgical masks do not offer protection, which is not very surprising based on the literature I've seen," she said. Brosseau said that as the name suggests, surgical masks were originally designed to be worn by surgical teams to protect the surgical field from contamination. "But then they started being worn in many more settings," encouraging an impression that they protect wearers, she said. MacIntyre's study "illustrates how there is no protection from surgical masks, so I hope it'll discourage people from saying there is protection," Brosseau said. She said a few studies, particularly related to SARS (severe acute respiratory syndrome) in Asia and Canada, have seemed to show that surgical masks helped protect wearers from respiratory infections, but she called the findings questionable. "There's a really big problem with retrospective studies," she said. "How do you know that people really did wear those masks, and how much do you know about their exposure? Really in the end, what it's arguing is that putting anything on your face is an improvement over putting nothing on your face." As for the finding that fit-testing made no difference in benefits from the N95s, Brosseau suggested a possible explanation. She said MacIntyre told the IOM committee at the August workshop that her team used an N95 specially designed by 3M Co. for the Chinese face and that fewer than 5% of volunteers failed to pass the fit test. "Thus, this is a mask that is likely to fit most adults in the Chinese population very well, which is why fit testing did not make a significant difference in the rates of disease," Brosseau said. MacIntyre C, Wang Q, Cauchemez S, et al. The first randomized, controlled clinical trial of surgical masks compared to fit-tested and non-fit-tested N95 masks in prevention of respiratory virus infection in hospital health care workers in Beijing, China. Presented Sep 15, 200, at ICAAC meeting, San Francisco (Abstract accessible through ICAAC meeting search page) .......................................................................... __________________________________________________________________________ "Turbid syringes and drugs for the sick," a Spanish newspaper reports on counterfeit drugs scandal in Argentina Momento 24, Buenos Aires, Argentina (16.09.09) The Spanish newspaper El Pais said: -The anesthetist gently stirred the ampoule to inject the patient in the surgery room and froze: the hose was muddy and with a strange color. The operation was immediately stopped. The anesthesia was one of thousands of phony drugs (counterfeit) circulating in Argentina and constitute a formidable mafia business. -I’m telling a case occurred recently in the hospital over there, the Churruca, which, moreover, is the hospital of the Welfare of the police personnell,- says prosecutor Marcelo Munilla Lacasa in his office of the Buenos Aires City neighborhood of Pompeii. -Here in this office, we have fifty other similar cases,- he confirms. The fake drugs scandal and the involvement of known drugstores (suppliers) and some labor unions this week in Argentina reached a climax. The Government decided to intercede The Bank Workers union’s health services, for their ties with the pharmaceutical businessman Nestor Lorenzo, considered one of the leaders of that hateful mob. .......................................................................... __________________________________________________________________________ Drug delivery market report from Reportlinker News-Medical.Net (15.09.09) Reportlinker.com announces that a new market research report is available in its catalogue. http://tinyurl.com/m88jrb With pharmaceutical companies increasingly looking for ways to extend the revenue-earning lifetime of their biggest products, drug delivery has become an important focus of the industry. Kalorama’s Drug Delivery Markets: Implantable / Injectable and Needle-Free Delivery Systems provides detail for business planners on the market for implantable / injectable delivery system markets. Biopharmaceutical products are driving growth of needle-free systems; there will likely be significant increases in revenues in the vaccine arena. This report looks at that trend and reports current and forecasted revenues for the implantable/injectable drug delivery market, segmented into two main categories: Needle-free drug delivery Other Injectable/Implantable Kalorama's unique analysis offers segmentation of this market for: Drug Delivery Techology Revenues Pharmaceuticals Sold via Delivery Technology This breakout makes the report relevant to business plans of either device technology companies or pharmaceutical concerns. (This market analysis does not include drug-eluding stents or prefilled or regular syringes. Kalorama considers these seperate markets) With pharmaceutical companies increasingly turning to drug delivery to extend the revenue-earning lifetime of their biggest products, drug delivery has become an important focus of the pharmaceutical industry. Kalorama’s Drug Delivery Markets: Implantable / Injectable and Needle-Free Delivery Systems, the second volume of Kalorama’s popular series focusing on global drug delivery systems markets, provides the definitive break down of the market for implantable / injectable delivery system markets. The report covers both pharmaceuticals sold through implantable/injectable delivery systems and the technologies themselves including: This focused report provides information on the revenues for relevant companies and provides information critical to assessing the opportunities available in this market, including: Detailed Profiles of Key Companies in Implantable/Injectable Delivery and Brief Round-Up of smaller players Current Market Size and Forecasts to 2013 Needle-Free Cost Savings, Protein-Coated Microcrystal Technology, Nanotechnology, and Other Trends and Developments New Products in Development Kalorama’s trusted information-gathering process provides most accurate study of the implantable/injectable delivery drug market available today. Information and analysis presented in this report is based on extensive interviews with senior management of top companies in the industry. While major research literature and government information is culled, information is corroborated and key market insights originate from interviews with industry leaders. http://www.reportlinker.com/ .......................................................................... __________________________________________________________________________ USA: American Scientific Resources acquires Safeguard Medical's home needle destruction device patent News-Medical.Net (15.09.09) American Scientific Resources, Inc. (Pink Sheets: ASFX) (the Company), is excited to announce that it has acquired the intellectual property to the world's only FDA approved home needle destruction device (NDD), the Disintegrator(TM) and Disintegrator Plus(TM) (U.S. Patent No. 6,384,362 Patent Application No.: 09/500,504) (the "Device Technology"). A formerly owned property of Safeguard Medical Technologies, American Scientific Resources now holds the rights to the patent, which includes the Device Technology Patent and all present and future developed information, knowledge, experience and results. As part of the agreement, all current contracts and future sales and contracts pertaining to the Device Technology are the sole property of ASR. Rights to such sales are worldwide with the exception of a single licensing agreement covering the European Union region where Safeguard pays a consulting royalty on sales. Safeguard will receive stock, warrants, a convertible note and cash payments based on sales performance. They will also provide ongoing production engineering and quality control services to ASR for a fee. ASR's plan is to introduce the product commercially in the fall/winter of 2009. The Disintegrator enables patients who give themselves injections, including those suffering from multiple sclerosis or diabetes, to properly and safely dispose of needles at home. The EPA and the American Diabetes Association approve the device. Dr. Christopher F. Tirotta, CEO of American Scientific Resources, states, "We are overjoyed to have acquired the property rights to a product that we think has enormous potential to be a worldwide leader in home needle destruction. The product has already received a warm reception in the market." Safeguard delivered a purchase order for 5000 units to one of the world's leading healthcare enterprises in March of 2009; since then, the global enterprise has placed an additional order for 2000 units which American Scientific Resources will fill. Safeguard practices a form of just-in-time productivity, matching production to its needs based on order size. Production is planned to ramp up by year's end with full production capability exceeding 25,000 units per month. California State Senator Joe Simitian announced recently that his bill, SB 486, is headed to the Governor for review. The bill is designed to facilitate the safe disposal of syringes and needles (also known as "sharps") by requiring pharmaceutical manufacturers who sell specialty drug medications for home use to provide information on their websites on safe needle collection and disposal programs for their drugs. Over one million Californians who use specialty injection drugs don't have a safe, legal way to dispose of their sharps. Hence, approximately 386-million sharps are generated each year in California that need to be disposed of. "Given the need in the US for a safe way to dispose of sharps, we are hopeful that the Disintegrator will eventually become a trusted household name," continues Dr. Tirotta. Additionally, a congressional bill (S, 1312) is pending which would amend Title XVIII of the Social Security Act to provide for coverage, as supplies associated with the injection of insulin, of containment, removal, decontamination, and disposal of home-generated needles, syringes, and other sharps through a sharps decontamination/destruction device or similar program under part D of the Medicare program. Source: http://www.americansci.com __________________________________________________________________________ _____________________________________*____________________________________ __________________________________________________________________________ * SAFETY OF INJECTIONS brief yourself at: www.injectionsafety.org A fact sheet on injection safety is available at: http://www.who.int/mediacentre/factsheets/fs231/en/index.html * Visit the WHO injection safety website and the SIGN Alliance Secretariat at: http://www.who.int/injection_safety/en/ Download the latest injection safety Best Practices review at: http://www.uqconnect.net/signfiles/Files/BestPracticesJul2003.pdf Use the Toolbox at: http://www.who.int/injection_safety/toolbox/en/ Subscribe or un-subscribe by email to: sign@uq.net.au, sign@who.int or on subscribe online at: http://www.who.int/injection_safety/sign/en/ Get SIGN files on the web at: http://www.uqconnect.net/signfiles/Files/ get SIGNpost archives at: http://www.uqconnect.net/signfiles/Archives/?M=D The SIGN Secretariat, the Department of Essential Health Technologies, WHO, Avenue Appia 20, CH-1211 Geneva 27, Switzerland. Telephone: +41 22 791 3680, Facsimile: +41 22 791 4836, E- mail: sign@who.int _____________________________________*____________________________________ __________________________________________________________________________ SIGN meets annually to aid collaboration and synergy among SIGN network participants worldwide. The 2009 SIGN annual meeting will be held from 30 November to Wednesday 2 December 2009 at WHO Headquarters in Geneva Switzerland. The PQS (performance Quality and Safety) consultative meeting with the industry, will be held back to back with the SIGN meeting on 3rd and 4th December 2009. Get the final report of the SIGN Meeting 2008, Moscow, Russian Federation [2.36Mb] at: http://www.who.int/injection_safety/2008MeetingReport.pdf Many SIGN files can be opened in Acrobat Reader. To access all the features in Adobe Acrobat documents download the Acrobat Reader at: http://www.adobe.com/products/acrobat/readstep2.html Translation tools are available at: http://www.google.com/language_tools or http://www.freetranslation.com __________________________________________________________________________ All members of the SIGN Forum are invited to submit messages, comment on any posting, or to use the forum to request technical information in relation to injection safety. The comments made in this forum are the sole responsibility of the writers and does not in any way mean that they are endorsed by any of the organizations and agencies to which the authors may belong. Use of trade names and commercial sources is for identification only and does not imply endorsement. Contributions to: sign@uq.net.au or use your reply button! The SIGN Forum welcomes new subscribers who are involved in injection safety. Please subscribe by sending an email to: sign@who.int _____________________________________*____________________________________ The SIGN Internet Forum was established at the initiative of the World Health Organization's Department of Essential Health Technologies. The SIGN Forum is moderated by Allan Bass and is hosted on the University of Queensland computer network. http://www.uq.edu.au __________________________________________________________________________