IMMUNIZE AND PROTECT YOUR FAMILY IN THIS ISSUE:

1 Sustaining National Programs PAN AMERICAN HEALTH ORGANIZATION 1 in the Event of an Infl uenza Pandemic 4 Update on Thimerosal and Autism 4 2005 Vaccination Week in the Americas 5 Regional Plan for Control and Safety of Syringes 7 Guidelines for Use of AD Syringes

Volume XXVII, Number 5 October 2005 Sustaining National Immunization Programs Vaccination in the Context of Introducing New and Considerations in the Event of an Impending Achieving the Millennium Development Goals Infl uenza Pandemic A Briefi ng Session on Sustaining National Immunization Programs in the Context of Introducing New Vaccines and Achieving the Millennium Development Goals (MDGs) was held as part of the 46th PAHO’s Directing Background Council Meeting in Washington D.C. on 28 September 2005. The objectives of this meeting were: Infl uenza is an infectious dis- • To promote the strengthening of partnerships between Ministries of Health and Finance; ease associated with seasonal • To reaffi rm PAHO’s role and responsibility for negotiating affordable prices for new vaccines with epidemics each year. Moreover, manufacturers; infl uenza can also generate pan- • To foster a deeper understanding of fi scal issues; and demics, understood as epidemics • To strengthen regional capacity for existing production as well as research and development of that spread to several countries. new vaccines. These pandemics are associated Dr. Carissa Etienne, PAHO Assistant Director, opened the session on behalf of PAHO Director. Dr. Etienne with high morbidity, increased emphasized the importance of immunization as essential to reducing child mortality. She also stressed mortality, major social disruption, that, to ensure that new technologies are accessible to all in an equitable manner, Pan Americanism will be and substantial economic losses. critical. The Spanish fl u pandemic of 1918 Dr. Pilar Mazzetti Soler, Minister of Health of Peru acted as Chair. Other panelists included Dr. Jon Andrus, was responsible for some 40 to 50 Chief, Immunization Unit (IM), PAHO; Mr. John Fitzsimmons, Technical Offi cer, IM; Dr. Peter Heller, Deputy million deaths worldwide, killing Director, Fiscal Affairs Department, International Monetary Fund; Dr. Steve Landry, Senior Health Advisor, Bill more people than World War I. and Melinda Gates Foundation; and Dr. John Wecker, Director, Program, PATH. Epidemiological models forecast The fi ve key topics covered were: that an infl uenza pandemic is im- 1. The Unfi nished Agenda and Achieving the MDGs with Immunization pending. It could result in 57 to Dr. Andrus presented a regional policy framework for addressing the unfi nished immunization agenda, as 132 million medical consultations, 1 to 3.23 million hospital admis- sions, and 280,000 to 650,000 deaths in less than two years in the industrialized countries alone. In 2004 and 2005, outbreaks of the highly pathogenic avian fl u caused by the H5N1 virus in birds occurred throughout much of Asia. This virus has crossed the species bar- rier and infected humans, raising concerns regarding its pandemic potential. However, the capacity for person-to-person transmission is currently very limited.

J. Fitzsimmons (PAHO) addressing the audience. At the Head Table, from left to right, are Dr. S. Landry (Bill and Melinda Gates Foundation), Dr. J. Andrus (PAHO), Dr. P. Mazzetti Soler (Minister of Health, Peru), Dr. C. Etienne (PAHO), and Dr. P. Heller (International Monetary Fund). Not seen on the picture is Dr. J. Wecker (PATH). See INFLUENZA page 2 2 IMMUNIZATION NEWSLETTER Volume XXVII, Number 5 October 2005 PAN AMERICAN HEALTH ORGANIZATION

related to the achievement of the MDGs. The expensive vaccines, the additional fi scal space for securing and enhancing fl ow of funds. In evidence presented indicated that, even in the needed will be very modest when compared addition, the promotion and maintenance of context of spectacular child mortality reduc- with the overall size of a national economy. partnerships between Ministries of Health tion results, signifi cant immunization access However, in assessing the fi scal sustainability and Finance through shared understanding and equity issues remain. Further progress of interventions, issues including likely future of issues and an enhanced inter-ministerial communication vocabulary was presented toward achieving the MDGs would require competition for funds from interventions of as a key factor to the success of sustainable different approaches including improving the similar merit would need to be carefully ana- lyzed. immunization funding negotiations. uptake of under utilized vaccines for priority The discussion between Ministers attending the diseases outside the traditional vaccine-pre- 4. Promoting and Strengthening Partnerships session was focused around a reaffi rmation of ventable childhood diseases, expanding the The Partnerships presentation was shared between Dr. Landry and Dr. Wecker. The the need for solidarity in negotiating supply use of vaccine legislation as tools for sustain- presentation by Dr. Landry focused on GAVI contracts, by acting as a regional block through ing programs, and continuing to forge new (Global Alliance for Vaccines and Immuni- the PAHO Revolving Fund; the need to explore partnerships to deliver basic health services, zation) and its current activities related to new modalities of RF operation, as a means of including immunization, to those currently vaccine demand, supply, and fi nancing. This addressing constraints to wider participation by underserved by the health system. included support for Accelerated Develop- some countries; and the need for support for 2. Positioning the Revolving Fund for the Future ment and Introduction Plan (ADIPs) for vac- pandemic preparedness, including contingency Mr. Fitzsimmons presented the lessons learned cines against rotavirus and pneumococcus, as planning and operational response, especially in view of the emergence of avian infl uenza and in managing vaccine supply and demand in well as signifi cant investment in the evidence the risks of a human pandemic. the Americas in the context of improving op- base for decision-making on the introduction erations and reducing costs of the PAHO EPI of vaccines against Haemophilus infl uenzae Following the discussion, the Chairperson sum- Revolving Fund (RF). Drawing on evidence of type b (Hib). The presentation by Dr. Wecker marized the recommendations as follows: effective performance in achieving improved focused on the Rotavirus Vaccine Project as 1. The Directing Council 2006 should include an uptake of under-utilized and new vaccines an example of an international partnership agenda item to follow-up on the sustainability and an increasing gap between fund capital- focused on the accelerated introduction of of national immunization programs. ization and regional vaccine expenditure, the vaccines against this priority disease for Latin 2. Member States should reaffi rm their commit- case was made for an expanded role for the America and the Caribbean. Further exam- ment to maintain their strong solidarity and RF. It was stressed that participation in the ples of vaccine supply partnerships within the use of the RF. Fund by all PAHO Member States within the Region included public-private technology 3. With PAHO support, the countries’ top principle of Pan Americanism is fundamental transfer agreements and public-public vac- priority should be to complete the unfi nished for maintaining the benefi ts that can accrue cine research and development initiatives in immunization agenda and achieve the by its use. Brazil. Technical partnerships will obviously MDGs. 3. Policy Development and Creating Fiscal Space be critical to the future of vaccine research, 4. Policy on introduction of new and Dr. Heller presented the policy options open development, and production in the Region. underutilized vaccines should be evidence- to national decision-makers for creating and based and consistent with overall health 5. Country Perspectives: Cross-Sectorial Coor- budget priorities and country characteristics. accessing fi scal space to sustainably fund dination with Finance meritorious interventions such as immuniza- 5. Sustainable immunization programs through Dr. Mazzetti Soler discussed lessons learned in the study of fi scal space should be a top tion. The presentation addressed three key the dialogue between Ministries of Health and questions: How is fi scal space created? How priority for all countries. Finance. The lessons included the prioritization 6. PAHO should continue to engage global much fi scal space is needed for new vaccine of interventions within the Ministry of Health introduction? How can this fi scal space be ac- partnerships to enhance the likelihood that and the demonstration of optimal use of new vaccines become available to those who cessed by immunization planners? Even for resources as the major points in a dialogue need them most

INFLUENZA from page 1 drafting preparedness plans should be a top prior- plan; National Preparedness Plans for an ity in all countries. These plans will not prevent • Clinical management and control a pandemic, but rather aim to make the best use protocols; Infl uenza Pandemic of available resources to curb the spread of the • Strategies for vaccination and the use of The World Health Organization (WHO) has issued disease, mitigate the impact of secondary catas- antivirals in different scenarios; technical guidelines for national preparedness trophes, and prevent panic in the population. • A plan to supply drugs, vaccines, other supplies, plans for an infl uenza pandemic since 1999. In A pandemic preparedness plan should include and the necessary logistics; and March 2005, WHO published a checklist to assist the following: • A risk communication plan. countries with their preparedness plans for such • Strengthening of the epidemiological surveil- WHO has also recommended the creation of a pandemic. lance system; national pandemic preparedness committees Given the imminence of an infl uenza pandemic, • A hospital and health services contingency to devise appropriate strategies for their PAN AMERICAN HEALTH ORGANIZATION IMMUNIZATION NEWSLETTER Volume XXVII, Number 5 October 2005 3 countries. The national committee should be a with children aged 0-5 months; permanent body with responsibilities varying Increasing production and use 4. Preschool and elementary schoolchildren, according to the global and national infl uenza of seasonal vaccine in considered frequent transmitters of the disease in the community; and situation. Its composition should be fl exible developing countries will help and depend on each country’s institutional 5. People without risk factors for complications: This is the largest population group and and political framework. It is suggested that the boost production capacity includes healthy adults and children. The main following types of organizations or experts be to respond to a pandemic. objective is to lower the demand for medical represented on, or consulted by, the committee: services and enable individuals to continue National and regional public health authorities; since measures of this type can slow transmission their daily activities and avoid greater social medical, nursing, and pharmacists’ associations; at the start of the pandemic. Nevertheless, these disruption. This decision depends on vaccine virologists and epidemiologists; personnel measures cannot stop the pandemic altogether. availability and the epidemiological situation. in charge of vaccination; ethics committees; veterinary authorities and experts in animal Vaccination in a Pandemic Final Considerations infl uenza viruses; pharmaceutical producers and During a pandemic, vaccination is one of the An infl uenza pandemic can affect a very distributors; emergency response teams, whether most effective interventions for infl uenza control. high proportion of the population and have military or governmental; nongovernmental National pandemic preparedness plans should a tremendous socioeconomic impact. Thus, organizations; and the media, among others. clearly defi ne which high-risk populations should all countries should launch or strengthen be given priority for vaccination. This should be preparedness activities. Vaccination is the best Vaccine Production done before the crisis hits, not in the midst of it, tool for the prevention and control of a pandemic, since supplies of the vaccine will be extremely but vaccines will be in very short supply during Infl uenza vaccine is produced in fertilized chicken limited during the fi rst wave of the pandemic, the initial phase of the pandemic. eggs, with the full production cycle taking 6 to 9 especially in countries that do not produce In various political and scientifi c forums in months once the circulating viruses are identifi ed. vaccine. The plan should also specify how to the Region of the Americas, PAHO has urged The production of vaccines to fi ght seasonal distribute the vaccine and how to monitor its Member States to develop national preparedness infl uenza is very limited, with approximately 300 safety and effi cacy. plans for an infl uenza pandemic. PAHO is also million doses currently produced worldwide, Setting goals and priorities involves logistical, working with potential producers to bolster mainly in Australia, Europe, Japan, and North ethical, moral, cultural, and legal considerations, vaccine production capacity in Latin America. America. In a pandemic, two doses of vaccine as well as continuous analysis of the Infl uenza pandemic preparedness plans are only will be required to protect each individual. Thus, epidemiological situation to target measures in the preliminary phase in some countries and only a small proportion of the world population, to the most affected groups. Based on these much remains to be done. Political and fi nancial concentrated in vaccine-producing countries, considerations, countries should prioritize the priority must be given to the prompt preparation would have access to a monovalent vaccine in vaccination of population groups according to and validation of these plans the following: the early months of a pandemic. 1. Essential services personnel (to prevent Bibliography: Country pandemic preparedness plans should interruption of services during the pandemic): 1. PAHO. Infl uenza Pandemic: Preparation in the Western state the amount of vaccine required, the groups Clinical health workers; personnel essential Hemisphere. 44th Directing Council of the Pan Ameri- to vaccinate, the strategies to deploy, and how the can Health Organization 2005. Available at: http://www. for vaccine and drug production; staff of paho.org/English/AD/DPC/CD/vir-fl u-pandemic.htm vaccine will be distributed. This information will nursing homes and long-term care facilities; 2. WHO. Infl uenza surveillance and control. Weekly Epide- provide the data and incentives needed to boost the police; fi refi ghters; the armed forces; and miological Record. 2005; 80 (34): 289-296. Available at: global production. To this end, PAHO is working http://www.who.int/wer/2005/wer8034/en/index.html the staff responsible for the operations of 3. WHO. WHO checklist for infl uenza pandemic prepared- with potential manufacturers of fl u vaccine in other public utilities; ness planning 2005. WHO/CDS/CSR/GIP/2005.4. Avail- the Region of the Americas to determine the 2. People at higher risk of mortality from able at: http://www.who.int/csr/resources/publications/ availability of the production infrastructure. infl uenza: Residents of nursing homes or infl uenza/WHO_CDS_CSR_GIP_2005_4/en/ long-term care facilities; people aged 65 with 4. WHO. WHO global infl uenza preparedness plan 2005. Given the limitations of vaccine production, WHO/CDS/CSR/GIP/2005.5. Available at: http://www. chronic heart and lung disease; pregnant national authorities should adopt a wide range who.int/csr/resources/publications/influenza/WHO_ women in the second and third trimester; CDS_CSR_GIP_2005_4/en/ of non-medical interventions early on in a children aged 6-23 months; children aged 6 pandemic, especially interventions related to months to 18 years under a chronic aspirin public gatherings (school and movie theater regimen; and other vulnerable groups, closures; curtailment of public transportation) such as indigenous people living in isolated and interpersonal contact (hand washing, communities. personal hygiene, covering the mouth when 3. Individuals in close contact with people at coughing, quarantine in specifi c situations, and high risk: Health workers and nursing home travel restrictions). This information should be staff; family members in daily contact with part of each country’s risk communication plan, people at risk; and people in daily contact 4 IMMUNIZATION NEWSLETTER Volume XXVII, Number 5 October 2005 PAN AMERICAN HEALTH ORGANIZATION

pointed the Global Advisory Committee on Vac- Update on Thimerosal and Autism cine Safety (GACVS) to evaluate safety concerns regarding the use of thimerosal. In 2003, GACVS Thimerosal or , a mercury-contain- histopathology show that the specifi c sites of in- concluded that there was no need to change ing preservative, is found in many biologics and volvement in the brain and the brain cell types immunization practices regarding thimerosal- vaccines that are routinely recommended for affected are different in the two disorders. containing vaccines. In 2005, GACVS restated children. Since the 1930’s thimerosal has been A number of epidemiological studies were con- its view that there is no evidence supporting a proven especially effective when added to multi- ducted to determine the potential effects of ex- causal association between neurobehavioral dis- dose containers, preventing bacterial and fungal posure to thimerosal during routine pediatric orders and thimerosal-containing vaccines. contamination. However, a number of consumer vaccination. No evidence to support a correla- groups have recently became concerned about The Pan American Health Organization (PAHO) tion between thimerosal-containing vaccines genuinely supports the discovery of the cause the cumulative levels of mercury to which infants and the occurrence of autism was found in Den- were being exposed as a result of receiving the and cure for autism. However, due to lack of mark, where the incidence of autism continued evidence proving a correlation between expo- recommended series of childhood immuniza- to increase from 1991 to 2000 after the removal tions. Parents were also becoming increasingly sure to thimerosal and neurodevelopmental dis- of thimerosal-containing vaccines. Similarly, in orders, PAHO recommends the continued use of concerned that autism might be an expression Sweden, autism rates continued to increase after of mercury poisoning. However, thimerosal is thimerosal-containing vaccines and adherence the removal of thimerosal from vaccines in 1992. to current childhood immunization schedules composed of ethyl mercury, which is very differ- A retrospective cohort study performed in Eng- ent from the neurotoxic methyl mercury. It is land dispelled concerns about the possible toxic- Acknowledgement: The Immunization Unit methyl mercury, not ethyl mercury, that causes ity of thimerosal exposure levels via DTP/DT vac- wishes to thank Ms. Rebecca Reingold, UC histopathological lesions of the brain. In addi- cines in children born between 1988 and 1997, Berkeley Student, for her lead role in preparing tion, these lesions are distinct from the lesions concluding that there was no evidence to link the preliminary draft of this update. present in autistic children. thimerosal exposure to neurodevelopmental dis- Recommended Bibliography: It is important to clarify that MMR vaccine does orders. In summary, these experiences showed 1. Institute of Medicine (IOM). Immunization Safety. Available not contain thimerosal. It was a temporal asso- that even when thimerosal was removed, autism at: http://www.iom.edu/focuson.asp?id=4189. Washington ciation of MMR vaccines given in many countries continued increasing, suggesting that a causal DC: The National Academy of Sciences, 2005. Viewed Sept at 15 months of age and the onset of autism’s relationship does not exist. 30, 2005. 2. Global Advisory Committee on Vaccine Safety (GACVS) early symptoms after one year of life that gen- In 2000 the U.S. Centers for Disease Control and http://www.who.int/vaccine_safety/topics/thiomersal/en/ erated suspicion of a causal relationship. This Prevention (CDC) and the National Institute of 3. Global Advisory Committee on Vaccine Safety (GACVS). relationship has been rejected on the basis of Health asked the Institute of Medicine (IOM) to Statement on Thimerosal. Available at: http://www.who. epidemiological evidence. int/vaccine_safety/topics/thiomersal/statement200308/ evaluate newly released scientifi c evidence con- en/index.html. World Health Organization (WHO): Concerned parents of autistic children are partic- cerning the safety of the current recommended August, 2003. ularly driven to determine the cause and develop childhood immunization schedule. In May 2004, 4. Weekly Epidemiological Record. Global Advisory a cure for autism. Mercury poisoning and autism the IOM concluded that current epidemiological Committee on Vaccine Safety, 11–12 June 2003. 8 August 2003, vol. 78, 32 (pp 277-284) both affect the central nervous system and share evidence fails to support “a causal relationship 5. Weekly Epidemiological Record. Global Advisory a number of nonspecifi c symptoms. However, between thimerosal-containing vaccines and au- Committee on Vaccine Safety, 9–10 June 2005. 15 July upon closer investigation, the clinical signs and tism.” In 2000 the World Health Organization ap- 2005, vol. 80, 28 (pp 241–248).

CEF, Head Start, country governments, the Red Vaccination Week in the Americas 2005: de Municipios de Latinoamérica (Latin Ameri- Achievements and Recommendations can Municipality Network), and other regional, national, and local agencies joined forces to achieve country goals and a higher visibility for The third Vaccination Week in the Americas At the United States–Mexico border, a immunization programs throughout the Region. (VWA) took place from 24-30 April 2005. To large awareness campaign targeted health adequatly prepare for this activity, managers of practitioners and communities in four border Selected Achievements the Region’s immunization programs met in late states: Texas, California, New Mexico, and 2004 to defi ne objectives and priorities (Table Arizona. Meetings and workshops were planned During VWA 2005, 38 million children, women of 1). to discuss the benefi ts of vaccination and how childbearing age, older adults, and other groups VWA 2005 was regionally launched in Washing- important it is for children to be up-to-date at-risk were vaccinated, representing 92% of the ton, D.C. on 25 April. Throughout the Americas, with their vaccination schedules. VWA was the goal targeted for vaccination. In Haiti, Honduras, countries launched their own campaigns at offi - occasion to initiate bi- and multi-national efforts Mexico, and Panama, over 17,000 children aged cial events attended by national and local leaders, that include two follow-up campaigns (in August 1-4 years were vaccinated for the fi rst time with ministers of health, fi rst ladies, and representa- and October) to encourage the completion of pentavalent vaccine. In Colombia, Honduras, tives of international institutions. The presidents schedules. Mexico, and Panama, over 480,000 women of of Bolivia, Nicaragua, and Paraguay, and the First Strategic alliances were essential for organizing childbearing age were vaccinated with a fi rst Ladies of Colombia and the Dominican Republic and implementing VWA 2005. PAHO, the U.S. dose of Td. attended national and local launching events. Centers for Disease Control and Prevention, UNI- see VACCINATION page 8 PAN AMERICAN HEALTH ORGANIZATION IMMUNIZATION NEWSLETTER Volume XXVII, Number 5 October 2005 5

tests; and establish indicators to monitor quality Regional Plan for Quality Control and Safety and impact. of Syringes Safety In 2004, PAHO developed a Regional Plan through a bid solicitation process considering for Quality Control and Safety of Syringes to the following technical requirements: As part of the safety component of the plan, an incident reporting system and a procedure guarantee the quality and safety of the syringes • Compliance with either ISO1 quality regulations to investigate and follow up those incidents purchased through its Revolving Fund (RF). This or with Good Manufacturing Practices (GMP); have been developed. To allow for easy access plan is comprehensive and aims to cover the • Compliance with ISO regulations specifi c for to the reports, an Internet-based system entire life cycle of the syringes, from purchase syringes and needles (design, manufacturing, using “SharePoint” has been introduced. The to fi nal disposal. It emphasizes compliance with packaging, labeling, and sterilization); and objectives of the incident reporting system are international quality and safety standards, and • Evaluation of syringe samples. the following: promotes capacity-building within National Regulatory Authorities in the area of syringe Quality assurance • Provide a forum to report quality or safety quality and safety testing. The plan represents problems of syringes in use; Quality assurance testing for manufacturing, a collaborative activity between the Essential • Facilitate investigating and following the design, and quality standards of syringes incidents reported; Medicines, Vaccines, and Health Technology purchased through the RF is currently conducted • Publish the fi ndings of incident investigations; Unit and the Immunization Unit to ensure that 2 in a reference laboratory. The reference • Generate alerts based on the investigations experiences and knowledge in the areas of laboratory is in charge of developing protocols conducted; immunization safety, injection safety, patient for laboratory procedures, validation tests, safety, regulation of medical devices, and laboratory design, and equipment requirements. 1 ISO: International Standard Organization. ISO dictates technology management are integrated and The collaboration aims to offer support to fi ve international standards of quality to certify processes applied to the specifi c needs of immunization of manufacturing, design, and management systems, countries to set up national laboratories for thus contributing to ensure that the development, programs. quality assurance, as well as provide training of manufacturing, and supply of products are safe and The Regional Plan for Quality Control and Safety the personnel conducting the validation tests. effi cient. ISO is the leading organization setting standards of Syringes is divided into three stages. The fi rst Selection of the 5 countries is underway. The worldwide. ISO-quality standards are accepted globally. personnel is trained on how to organize the 2 A reference laboratory is a laboratory with the capacity stage, which is underway, aims to strengthen to serve as center of expertise and standardization of PAHO’s capacity to establish mechanisms ensur- testing laboratory; verify the quality and safety techniques; it is charged with resolving all scientifi c and ing the quality and safety of syringes purchased of the syringes; perform the actual laboratory technical problems. through the RF. The second stage aims to build capacity at national level, decentralizing the Table 1. PAHO-WHO Recommendations for Vaccine Administration: Route of Administration, Anatomical Area, Dose, and Type of Syringe quality assurance procedures and strengthen- Route of Administration/ Type of Syringe* for ing national immunization programs. The last Antigen Dose stage, aims to transfer all the knowledge and Anatomical Area vaccine administration Intradermal/deltoid region in the know-how on syringe management to National BCG 0.1 ml 1cc – 26G x 3/8” upper third of the right arm Regulatory Authorities. Deep intramuscular/external 0.5 ml 1cc – 23G x 1” The Regional Plan for Quality Control and Safety anterolateral mid-third of the thigh of Syringes has the following objectives: Pentavalent (DPT + Hep B + Hib)(, Deep intramuscular/external • To guarantee the quality, safety, and effi cacy 0.5 ml 1cc – 23G x 1” of syringes procured through the RF; Pertussis, , Hepatitis B, and anterolateral mid-third of the thigh Haemophilus infl uenzae type b) • To strengthen the acquisition, storage, distri- bution, and use of syringes; Tetravalent (DPT + Hib)(Diphtheria, Pertussis, Deep intramuscular/external • To develop and strengthen national capacity 0.5 ml 1cc – 23G x 1” to verify syringe quality and compliance with Tetanus, and Haemophilus anterolateral mid-third of the thigh infl uenzae type b) international standards; Subcutaneous/deltoid region in the • To train health care workers on the use of Yellow Fever 0.5 ml 1cc – 25G x 5/8” upper third of the right or left arm auto-disable (AD) syringes and safe injection MMR Subcutaneous/deltoid region in the 0.5 ml 1cc – 25G x 5/8” practices, including syringe disposal and fi nal (Measles, Mumps and Rubella) upper third of the right or left arm waste management; Adult Intramuscular/deltoid region in the 0.5 ml 1cc – 22G x 1 ½” • To promote syringe standardization; dT(Diphtheria and Tetanus ) upper third of the right or left arm • To promote safe injection practices; and MR Subcutaneous/deltoid region in the 0.5 ml 1cc – 25G x 5/8” • To contribute to safe immunization and (Measles, Rubella) upper third of the right or left arm Pediatric DT Intramuscular/deltoid region in the patient safety. 0.5 ml 1cc – 23G x 1” (Diphtheria and Tetanus Toxoids) upper third of the right or left arm

Syringe Acquisition *WHO exclusively recommends AD syringes for vaccine administration The RF initiates the syringe procurement process Source: Pan American Health Organization. Immunization Safety Modules. Module III: Safe Injection Practices. Immunization Unit, Washington, D.C., USA 6 IMMUNIZATION NEWSLETTER Volume XXVII, Number 5 October 2005 PAN AMERICAN HEALTH ORGANIZATION

• Provide a forum to exchange information Table 2. Distribution of Syringes Purchased by the Revolving Fund, 2002-2004 among network members; • Create an information record on products, Syringe Type/Total Syringes Purchased (%) documents, and services for immunization Syringe Type Needle Gauge 2002 2003 2004 program managers; and N = 47,122,100 N = 52,631,090 N = 94,277,500 • Post news and a list of upcoming events 22G x 1/2 0% 0% 0% ½cc relevant to immunization programs. 23 G x 1 4.4% 11.4% 6% Auto-disable 25G x 5/8 16.6% 13.3% 9% Syringes Syringe Disposal 27G x 1/2 1.7% 0% 0% 22G x 1 ¼ 9.9% 13.1% 8% The plan also highlights the need to include 22G x 1 ½ * 6.5% 12.5% 12% the disposal and management of sharps and 23G x 1* 18% 22.70% 25% 1cc hazardous biological waste in accordance 23G x 1 1/4 0% 0% 0% Disposable 25G x 5/8 * 20.7% 17.9% 33% with national regulations. The plan promotes Syringes the use of safety boxes (also known as sharps 26G x 3/8 * 1.3% 2.8% 3% containers), training of health care workers, and 27G x 1/2 0% 0.9% 1% coordination between the Ministries of Health 27G x 3/8 0.6% 2.1% 0% and Environment regarding the fi nal disposal of 3cc Disposable 25G x 5/8 17.8% 0% 0% sharps and biological waste. Syringes 20G x 1 0.6% 1.1% 1% Syringe Standardization 5cc 21G x 1 1.2% 0% 0% Disposable 22G x 1 ¼ 0% 1.2% 1% Syringes are standardized based on their pre- Syringes 22G x 1 ½ 0% 1% 1% sentation and the gauge (caliber) of the needle, 23G x 1 0.7% 0% 1% which relates to the type of vaccine and vaccine * Recommended by WHO (as AD syringes) dose. Source: PAHO Revolving Fund The standardization component of the Plan complies with the recommendations from the 1999 Technical Advisory Figure 1. Revolving Fund Syringes: Group (TAG) on Vaccine-preventable Diseases regarding syringe type Forecast Versus Purchases, 2002-2004 and needle gauge (caliber) for each vaccine and dose. Table 1 presents 100 a summary of the types of syringes recommended according to injectable antigens. 80

Data from the RF for the purchase of AD and disposable syringes for 60 the period 2002-2004 are presented in Table 2. The Plan promotes AD syringe use in the Region, as recommended by WHO. AD syringes prevent 40 reusing syringes, thus ensuring the safety of patients, health workers, and Units (Millions) 20 the community. AD syringes use has increased slowly in the Region, from 10.7 million in 2002 to 13.9 million in 2004. Eleven countries purchased AD 0 syringes from the RF in 2004 compared to 9 in 2002. 2002 2003 2004 Years Standardization will facilitate procurement and quality control of syringes purchased through the RF and will contribute to a more effi cient procurement Estimated Demand Actual Purchases process. The economies of scale achieved should, in turn, allow for better Source: PAHO Revolving Fund prices. Standardization will allow the RF to produce a more reliable forecast (Figure 1). management, safe injection practices, proper disposal, and fi nal waste Final Considerations management. The Plan should be instrumental in broadening the knowledge about The expected results of the Plan are as follows: syringe quality, safety, and use, and creating a pool of human resources • To strengthen the process of syringe acquisition and management properly trained in the areas of safe injections and immunization safety, through the entire syringe life cycle, until fi nal disposal; with patient safety as the ultimate goal • To build capacity for syringe quality assessment within the National Regulatory Authorities of fi ve countries, emphasizing the training of personnel. Ultimately, it is expected that this knowledge can be transferred to the rest of the countries in the Region; • To set up a dynamic incident reporting system for sharing data on incidents, posting alerts, research fi ndings, and other relevant documents; and • To promote and train on the proper use of AD syringes, risk PAN AMERICAN HEALTH ORGANIZATION IMMUNIZATION NEWSLETTER Volume XXVII, Number 5 October 2005 7 U N S A F E ¾ FULL Insert needle in clean rubber cap of inverted vaccine vial and draw up a dose. Do not overfi ll the safety box Do not overfi 4 8 S A F E in a safety box at the point of use. The health worker should discard the used, uncapped syringe with its needle piston forward before fi lling the piston forward before fi nology in Health (PATH). All rights reserved; and World Organization. “First, do no harm” Introducing of the Human Environment and Vaccines Biologicals. WHO/V&B/02.26. Geneva, Switzerland ¾ FULL Do not push syringe Do not recap the needle. Immediately discard in the safety box. needle remains in the vial. 3 7 7. Remove the protective caps on piston and needle, if present. 8. Remove the needle cap. 9. uid until a complete dose is drawn up. Insert needle into the vial, keeping in fl 10. Remove air bubbles by tapping the barrel and pushing piston to correct dose mark, while 11. Check that the dose is correct. 12. Select the injection area indicated for vaccine. 13. Inject the entire dose. 14. After injection, place the syringe with its needle immediately in a safety box When administering an injection, always: Guidelines for Use of Auto-disable (AD) Syringes Remove needle cap, without touching the needle. Inject vaccine. 2 6 set the needle down before disposal. carry the syringe from area where immunization was administered recap the needle. NEVER NEVER NEVER 1. 2. 3. auto-disable syringes and ensuring injection safety in immunization systems of developing countries. Departments Protection Giving Safe Injections: Using Auto-disposable Syringes for Immunization. Copyright © 2000, 2001, Program Appropriate Tech Peel open sterile wrapper. Expel air or excess vaccine, adjusting piston to the indicated vaccine dose. discarded. needle hub or syringe tip. 1 5 After use, the syringe should be handled safely. The health worker should: 1. Verify the medication, dose, patient, site, and route of administration. 2. Check the sterile pack expiry date; if date has passed, it should be discarded. 3. Check whether the sterile pack is damaged or punctured. If punctured, it should be 4. For syringes wrapped in sterile (blister) paper packaging, peel open the package without touching 5. rmly to the needle and twist. If the syringe has a detachable needle, attach fi 6. Activate the syringe, if necessary. Adapted from: 8 IMMUNIZATION NEWSLETTER Volume XXVII, Number 5 October 2005 PAN AMERICAN HEALTH ORGANIZATION

VACCINATION from page 4 Table 1. VWA 2005: Objectives and Priorities Guatemala introduced the pentavalent vaccine, Objectives Priorities immunizing 55,000 children against fi ve diseases (diphtheria, pertussis, tetanus, Haemophilus • Vaccinate children <5 years of age and WCBAs • Municipalities with low coverage; infl uenzae type b, and hepatitis B) with a single with 0-dose or incomplete schedule; • Urban fringe areas, in particular those with poor biological during VWA 2005. Paraguay launched • Vaccinate other groups such as adults and people peri-urban neighborhoods; a rubella vaccination campaign targeting over >60; • Border areas with high level of migration; 3 million people and the elimination of rubella • Maintain the region free of and measles; • Indigenous groups; and congenital rubella syndrome. El Salvador • Support the implementation of plans to eliminate • Ethnic minorities; worked on a critical vaccination law to ensure rubella and congenital rubella syndrome; and sustainability of the immunization program in • Remote areas; and • Strengthen epidemiological surveillance the context of new vaccine introduction. Bolivia, • Other populations, based on each country’s priorities. Ecuador, and Nicaragua continued to give priority to their underserved populations by trying to their leading role during vaccination activities. for the completion of vaccination schedules. improve routine immunization coverage. • Educational activities for community aware- More countries need to report on rapid ness must continue. coverage monitoring results and plan Selected Recommendations: • Coordination of border launching activities additional activities to complete schedules must remain an essential component of accordingly. Countries made several recommendations to VWA events as these activities help with • National and local level launchings have improve future VWA efforts while strengthening establishing relationships among local leaders provided the critical political commitment national immunization programs. Selected and promoting Pan Americanism. for national immunization programs. These recommendations included: • Efforts must be focused on reaching isolated events should become a priority for countries • VWA must be used as a tool to strengthen populations and promoting greater awareness and be included in their plan of action for inter-agency cooperation, which will facilitate among local authorities and health workers national immunization programs the distribution of fi nancial resources and toward groups who usually do not have information material. regular access to public health services. • Community health workers must continue • Rapid coverage monitoring is instrumental

The Immunization Newsletter is published every two months, in English, Spanish, and French by the Immunization Unit of the Pan American Health Organization (PAHO), Regional Offi ce for the Americas of the World Health Organization (WHO). The purpose of the Immunization Newsletter is to facilitate the exchange of ideas and information concerning immunization programs in the Region, in order to promote greater knowledge of the problems faced and possible solutions to those problems.

References to commercial products and the publication of signed articles in this Newsletter do not constitute endorsement by PAHO/WHO, nor do they necessarily represent the policy of the Organization.

ISSN 1814-6244

Volume XXVII, Number 5 • October 2005

Editor: Jon Andrus Associate Editors: Béatrice Carpano and Carolina Danovaro

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