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Post00692 Immunization + Abstracts + eTraining + News 03 April 2013

1. World Immunization Week: Protect your world – get vaccinated
2. Editorial: The Risk of Autism Is Not Increased by “Too Many Vaccines Too
3. Abstract: Increasing Exposure to Antibody-Stimulating Proteins and
Polysaccharides in Vaccines Is Not Associated with Risk of Autism
4. Abstract: Patients for patient safety in China: A cross sectional study
5. Abstract: A 5-year surveillance of occupational exposure to bloodborne
pathogens in a university teaching hospital in Monterrey, Mexico
6. Abstract: Adverse events associated with botulinum toxin injection: A
multidepartment, retrospective study of 5310 treatments administered to
1819 patients
7. Abstract: Local complications after industrial liquid silicone
injection: case series
8. Abstract: Determinants of HIV Infection Among Female Sex Workers in Two
Cities in the Republic of Moldova: The Role of Injection Drug Use and
Sexual Risk
9. Abstract: Methods for administering subcutaneous heparin during
10. Abstract:Observational study of vaccine efficacy 24 years after the
start of hepatitis B vaccination in two gambian villages: no need for a
booster dose
11. Abstract: Sublingual immunotherapy for the treatment of allergic
rhinoconjunctivitis and asthma: a systematic review
12. Immunization Summary: New IPAD/IPHONE application (version 1.0) now
available on the app. store
13. New e-learning design: Global Learning Opportunities for Vaccine
Quality (GLO/VQ) goes virtual
14. Launch of AMP-WHO LOGIVAC Training Programme in Health Logistics
15. News
– VietNam: Street robbers use blood-stained needles as menace
– USA: Second chemist charged in Massachusetts drug lab scandal
– USA: New program allows drug users to safely dispose of needles
– USA: Dentist’s dirty practice shocks Oklahoma community

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1. World Immunization Week: Protect your world – get vaccinated
Protect your world – get vaccinated

World Immunization Week, beginning on 20 April, aims to promote one of the
world’s most powerful tools for health – the use of vaccines to protect, or
“immunize”, people of all ages against disease.

Under the global slogan “Protect your world – get vaccinated”, WHO
encourages individuals and organizations working at international,
regional, national, and community levels, in the public and private
sectors, to coordinate and engage in activities during World Immunization

World Immunization Week, April 2013

World Immunization Week – beginning on 20 April – aims to promote one of
the world’s most powerful tools for health – the use of vaccines to
protect, or “immunize”, people of all ages against disease.

Immunization is one of the most successful and cost-effective health
interventions and prevents between 2 and 3 million deaths every year. From
infants to senior citizens, immunization protects against diseases such as
diphtheria, measles, pertussis (whooping cough), pneumonia, polio,
rotavirus diarrhoea, rubella and tetanus. The benefits of immunization are
increasingly being extended to adolescents and adults, providing protection
against life-threatening diseases such as influenza, meningitis, and
cancers (cervical and liver cancers).

However, even now, an estimated 22 million infants are not fully immunized
with routine vaccines, and more than 1.5 million children under 5 die from
diseases that could be prevented by existing vaccines.

Goals: more awareness, access, and coverage

The ultimate goal of World Immunization Week is for more people – and their
communities – to be protected from vaccine-preventable diseases.
Specifically, during the week, WHO and partners work to:

– convince people that immunization saves lives;
– mobilize action to increase vaccination coverage with existing and newly
available vaccines in underserved and marginalized communities; and
– reinforce political support for global immunization goals.

WHO encourages individuals and organizations working at international,
regional, national, and community levels, in the public and private sectors
and civil society, to coordinate and engage in activities during World
Immunization Week. Working from the global slogan, “Protect your world –
get vaccinated”, participation can be tailored to regional and national
public health priorities. Activities may include vaccination campaigns,
training workshops, round-table discussions, public information campaigns,
and more.

Immunization Week initiatives began in the Region of the Americas in 2003.
The Week was observed simultaneously in WHO’s six regions for the first
time in 2012, with the participation of more than 180 countries,
territories and areas.

2. Editorial: The Risk of Autism Is Not Increased by “Too Many Vaccines Too

Crossposted from the Journal of Pediatrics with thanks.

Editorial: The Risk of Autism Is Not Increased by “Too Many Vaccines Too


Children’s Hospital Medical Center, MLC-3021 3333 Burnet Ave.
Cincinnati, OH 45229-3039, [513-636-7140 FAX: 513-636-7141]

Cincinnati, OH, March 29, 2013 — Although scientific evidence suggests
that vaccines do not cause autism, approximately one-third of parents
continue to express concern that they do; nearly 1 in 10 parents refuse or
delay vaccinations because they believe it is safer than following the
Centers for Disease Control and Prevention’s (CDC) schedule ( A
primary concern is the number of vaccines administered, both on a single
day and cumulatively over the first 2 years of life. In a new study
scheduled for publication in The Journal of Pediatrics, researchers
concluded that there is no association between receiving “too many vaccines
too soon” and autism.

Dr. Frank DeStefano and colleagues from the CDC and Abt Associates, Inc.
analyzed data from 256 children with autism spectrum disorder (ASD) and 752
children without ASD (born from 1994-1999) from 3 managed care
organizations. They looked at each child’s cumulative exposure to antigens,
the substances in vaccines that cause the body’s immune system to produce
antibodies to fight disease, and the maximum number of antigens each child
received in a single day of vaccination.

The researchers determined the total antigen numbers by adding the number
of different antigens in all vaccines each child received in one day, as
well as all vaccines each child received up to 2 years of age. The authors
found that the total antigens from vaccines received by age 2 years, or the
maximum number received on a single day, was the same between children with
and without ASD. Furthermore, when comparing antigen numbers, no
relationship was found when they evaluated the sub-categories of autistic
disorder and ASD with regression.

Although the current routine childhood vaccine schedule contains more
vaccines than the schedule in the late 1990s, the maximum number of
antigens that a child could be exposed to by 2 years of age in 2013 is 315,
compared with several thousand in the late 1990s. Because different types
of vaccines contain varying amounts of antigens, this research acknowledged
that merely counting the number of vaccines received does not adequately
account for how different vaccines and vaccine combinations stimulate the
immune system. For example, the older whole cell pertussis vaccine causes
the production of about 3000 different antibodies, whereas the newer
acellular pertussis vaccine causes the production of 6 or fewer different

An infant’s immune system is capable of responding to a large amount of
immunologic stimuli and, from time of birth, infants are exposed to
hundreds of viruses and countless antigens outside of vaccination.
According to the authors, “The possibility that immunological stimulation
from vaccines during the first 1 or 2 years of life could be related to the
development of ASD is not well-supported by what is known about the
neurobiology of ASDs.” In 2004, a comprehensive review by the Institute of
Medicine concluded that there is not a causal relationship between certain
vaccine types and autism, and this study supports that conclusion.


Open Access article:

“Increasing exposure to antibody-stimulating proteins and polysaccharides
in vaccines is not associated with risk of autism,” by Frank DeStefano, MD,
MPH, Cristofer S. Price, ScM, and Eric S. Weintraub, MPH, appears in The
Journal of Pediatrics (, DOI 10.1016/j.jpeds.2013.02.001,
published by Elsevier.

Copyright © 2013 Elsevier Inc. All rights reserved.

3. Abstract: Increasing Exposure to Antibody-Stimulating Proteins and
Polysaccharides in Vaccines Is Not Associated with Risk of Autism
Increasing Exposure to Antibody-Stimulating Proteins and Polysaccharides
in Vaccines Is Not Associated with Risk of Autism

Frank DeStefano, MD, MPH1
, Cristofer S. Price, ScM2
, and Eric S. Weintraub, MPH1

Objective To evaluate the association between autism and the level of
immunologic stimulation received from vaccines administered during the
first 2 years of life.

Study design We analyzed data from a case-control study conducted in 3
managed care organizations (MCOs) of 256 children with autism spectrum
disorder (ASD) and 752 control children matched on birth year, sex, and
MCO. In addition to the broader category of ASD, we also evaluated autistic
disorder and ASD with regression.

ASD diagnoses were validated through standardized in-person evaluations.

Exposure to total antibody-stimulating proteins and polysaccharides from
vaccines was determined by summing the antigen content of each vaccine
received, as obtained from immunization registries and medical records.

Potential confounding factors were ascertained from parent interviews and
medical charts. Conditional logistic regression was used to assess
associations between ASD outcomes and exposure to antigens in selected time

Results The aOR (95% CI) of ASD associated with each 25-unit increase in
total antigen exposure was 0.999 (0.994-1.003) for cumulative exposure to
age 3 months, 0.999 (0.997-1.001) for cumulative exposure to age 7 months,
and 0.999 (0.998-1.001) for cumulative exposure to age 2 years. Similarly,
no increased risk was found for autistic disorder or ASD with regression.

Conclusion In this study of MCO members, increasing exposure to antibody-
stimulating proteins and polysaccharides in vaccines during the first 2
years of life was not related to the risk of developing an ASD.

Open Access article:

4. Abstract: Patients for patient safety in China: A cross sectional study

J Evid Based Med. 2012 Feb;5(1):6-11.

Patients for patient safety in China: A cross sectional study.

Zhang Q, Li Y, Li J, Mao X, Zhang L, Ying Q, Wei X, Shang L, Zhang M.

West China Hospital/ School of Medicine, Sichuan University, Chengdu
610041, China Chinese Evidence-Based Medicine Centre, West China Hospital,
Sichuan University, Chengdu 610041, China Equal first author.

Objectives: To investigate the baseline status of patients’ awareness,
knowledge, and attitudes to patient safety in China, and to determine the
factors that influence patients’ involvement in patient safety.

Methods: We conducted a cross sectional survey using questionnaires adapted
from recent studies on patient safety from outside China. The items
included medical errors, infection, medication safety, and other aspects of
patient safety. The questionnaire included 17 items and 5 domains. The
survey was conducted between Jan. 2009 and Dec. 2010 involving 1000
patients from ten grade-A hospitals in seven provinces or cities in China.
Most patients from the surgery departments completed the questionnaires
voluntarily and anonymously. Five reviewers independently input the data
into Microsoft Excel 2003, and the data were double-checked. Data were
analyzed using SPSS 15.0 software for differences in the perceptions and
attitudes of patients toward patient safety among different genders, ages,
and regions.

Results: We distributed 1000 questionnaires and collected 959 completed
questionnaires (response rate: 96%). Among the respondents, 58% of patients
did not know what medical error is. Sixty-five percent of patients wanted
disclosure of all medical errors. After errors occurred, 58% of patients
wanted explanations of all possible harms that had resulted. Among 187
patients who had experienced medical errors, 83% of patients had sought
appropriate legal action. About 52% of patients understood hospital
infection, but 28% patients did not know that infections could occur in
hospital. Seventy-eight percent of patients thought that medical staff
should wash their hands before examining patients. More than half of the
patients (68%) were willing to remind the staff of hygiene if they saw
unsanitary conditions in a health clinic. Only 14% of patients knew the
side effects of medications that they took.

Conclusion: The majority of patients surveyed expressed willingness to
contribute to patient safety, but their knowledge about patient safety
practices was generally very limited.

© 2012 Blackwell Publishing Asia Pty Ltd and Chinese Cochrane Center, West
China Hospital of Sichuan University.

5. Abstract: A 5-year surveillance of occupational exposure to bloodborne
pathogens in a university teaching hospital in Monterrey, Mexico

Am J Infect Control. 2013 Mar 22. pii: S0196-6553(13)00108-9.

A 5-year surveillance of occupational exposure to bloodborne pathogens in a
university teaching hospital in Monterrey, Mexico.

Camacho-Ortiz A, Díaz-Rodríguez X, Rodríguez-López JM, Martínez-Palomares
M, Palomares-De la Rosa A, Garza-Gonzalez E.

Department of Hospital Epidemiology, Hospital Universitario “Dr. José
Eleuterio González” Universidad Autónoma de Nuevo León, Monterrey, Mexico.
Electronic address:

BACKGROUND: Occupational exposure to bloodborne pathogens (OEBPs) is a
serious health and safety concern for health care providers. Lack of
experience of medical personal in training could make them more susceptible
for acquiring infections by these infectious agents.

METHODS: We conducted a 5-year retrospective review of all reported
occupational exposures. Characteristics, risk factors, and management of
the accidents were obtained from OEBP database.

RESULTS: A total of 951 events were analyzed, and 94.3% occurred in medical
personnel in training; of those, 87.4% were percutaneous injuries. The
emergency room was the hospital ward with more events recorded (34.1%),
followed by the internal medicine and surgical wards. A hollow needle was
used in 59.1% of the events, a suture needle in 10.7%, and a lancet in
8.8%. Most of events were recorded in the morning shift (38.3%). The months
with fewer reports of events were January, July, and December, and the
months with the highest reports were the combined months of October 2006
through 2011.

CONCLUSION: A high incidence of OEBP in medical personnel in training was
detected; this high frequency correlates with the dynamics of the student
population during the year and the hands on practice that the nursing and
medical students receive.

Copyright © 2013 Association for Professionals in Infection Control and
Epidemiology, Inc. Published by Mosby, Inc. All rights reserved.

6. Abstract: Adverse events associated with botulinum toxin injection: A
multidepartment, retrospective study of 5310 treatments administered to
1819 patients

J Dermatolog Treat. 2013 Mar 28.

Adverse events associated with botulinum toxin injection: A
multidepartment, retrospective study of 5310 treatments administered to
1819 patients.

Kim B, Park GH, Yun WJ, Chang S, Won CH, Lee MW, Chung SJ, Rho NK, Jang KA.

University of Ulsan College of Medicine, Asan Medical Center, Dermatology,
Seoul, Korea, Republic of.

Abstract Background: The injection of botulinum toxin is now commonly used
for many therapeutic and cosmetic purposes but because of its increased use
more adverse events are being reported.

Objective: To evaluate and analyze the safety of botulinum toxin injections
in terms of purpose and the type of toxin administered. Materials and
Methods: Data were collected on 1819 patients who underwent a total of 5310
treatments between 2005 and 2011. A multivariable GEE with the logistic
link function was used to identify the factors associated with adverse

Results: Among the 5310 botulinum toxin treatments in our study cohort, 184
adverse events were recorded. The highest number of adverse events (8.29%)
was associated with the treatment of blepharospasm and the lowest (1.07%)
with masseter hyperplasia. By multivariate analysis, the odds ratio for
females was 1.577 (P = 0.027) and for the dose was (P = 0.005). When
compared with upper face wrinkles, the odds ratio was 2.510 (P = 0.002) for
blepharospasm, 0.375 (P = 0.002) for cervical dystonia, and 0.114 (P =
0.035) for masseter hyperplasia.

Conclusion: When injecting botulinum toxin for cosmetic purposes,
practitioners should be cautious, especially when targeting the areas
around the eyes.

7. Abstract: Local complications after industrial liquid silicone
injection: case series

Rev Col Bras Cir. 2013 Feb;40(1):37-43.

Local complications after industrial liquid silicone injection: case

[Article in English, Portuguese]

Mello DF, Gonçalves KC, Fraga MF, Perin LF, Helene Jr A.

Serviço de Cirurgia Plástica, Santa Casa de Misericórdia de São Paulo

OBJECTIVE: To analyze a case series of patients who underwent injection of
industrial liquid silicone in a clandestine manner and by unauthorized

METHODS: We conducted a retrospective analysis of medical records of
patients treated between September 2003 and December 2010. Data regarding
gender, age, location and volume of silicone injected, time between
application and clinical manifestations, complications, treatment and
outcome were collected. Early manifestations were defined as occurring
within 30 days of injection and late manifestations, the ones arising after
this period.

RESULTS: We treated 12 patients, eight were male, seven transsexuals. The
volume injected ranged from 5ml to 2000ml, being unknown in three cases.
The most often used injected sites were the thighs and buttocks. Eight
patients had early manifestations, with inflammation and/or infection.
Surgical debridement was necessary in five cases. Three patients with a
history of injection in the breast region underwent adenomastectomy. There
was one death due to refractory septic shock.

CONCLUSION: The use of industrial liquid silicone should be completely
contraindicated as a filling material and modification of body contouring,
and may have
serious complications, even death.

Free full text

8. Abstract: Determinants of HIV Infection Among Female Sex Workers in Two
Cities in the Republic of Moldova: The Role of Injection Drug Use and
Sexual Risk

AIDS Behav. 2013 Mar 29.

Determinants of HIV Infection Among Female Sex Workers in Two Cities in the
Republic of Moldova: The Role of Injection Drug Use and Sexual Risk.

Zohrabyan L, Johnston LG, Scutelniciuc O, Iovita A, Todirascu L, Costin T,
Plesca V, Cotelnic-Harea T, Ionascu G.

UNAIDS Regional Support Team, Moscow, Russia.

In 2009-2010, females who reported having vaginal, anal or oral sex in
exchange for money in the previous year, =16 years, and living in either
Chisinau (n = 299) or Balti (n = 359), Moldova, were recruited into a
respondent driven sampling survey.

One fifth reported ever injecting drugs and over 30 % ever had sexual
intercourse with men who inject drugs. In both cities, condom use with
permanent and casual partners was much lower than condom use with
commercial partners. In Chisinau, 6.9 % and in Balti, 24.7 % tested
positive for HIV; 18 and 23.7 % had antibodies to hepatitis C; 9.1 and 8.9
% had antibodies to HBV; and, 8.4 and 6.1 % tested positive for syphilis.

HIV seropositive FSW in either city were more likely to have ever injected
drugs and to be infected with HCV.

Limited government initiative and drastic reductions in international
funding will likely impact urgently needed HIV prevention and harm
reduction services targeting FSW in Moldova.

9. Abstract: Methods for administering subcutaneous heparin during

Cochrane Database Syst Rev. 2013 Mar 28;3:CD009136.

Methods for administering subcutaneous heparin during pregnancy.

Sasaki H, Yonemoto N, Hanada N, Mori R.

Department of Health Policy, National Center for Child Health and
Development, 2-10-1 Okura, Setagaya, Tokyo, Tokyo, Japan, 157-8535.

BACKGROUND: Pregnant women with a history of venous thromboembolism (VTE),
antithrombin deficiency, or other risk factors for VTE, need heparin
(unfractionated heparin (UFH) or low-molecular weight heparin (LMWH))
prophylaxis, mainly through administering subcutaneously. Several methods
of administering heparin (UFH or LMWH) subcutaneously have been introduced
to prevent adverse pregnant outcomes. The effectiveness and safety of
different methods administering subcutaneous heparin (UFH or LMWH) during
pregnancy have not been systematically evaluated.

OBJECTIVES: To compare the effectiveness and safety of different methods of
administering subcutaneous heparin (UFH or LMWH) to pregnant women.

SEARCH METHODS: We searched the Cochrane Pregnancy and Childbirth Group’s
Trials Register (31 January 2013) and reference lists of retrieved studies.

SELECTION CRITERIA: All randomised controlled trials (individual and
cluster) comparing the effectiveness and safety of different methods of
administering subcutaneous heparin (UFH or LMWH) during pregnancy. Studies
reported only as abstracts were eligible for inclusion and would have been
placed in studies awaiting assessment, pending the full publication of
their results. Quasi-randomised studies and cross-over trials were not
eligible for inclusion..Methods of administering subcutaneous heparin
include intermittent injections versus indwelling catheters or programmable
(auto) external infusion pumps, or any other devices to facilitate the
subcutaneous administration of heparin (UFH or LMWH) during pregnancy.

DATA COLLECTION AND ANALYSIS: If eligible trials had been identified, trial
quality would have been assessed and data extracted, unblinded by review
authors independently.

MAIN RESULTS: No trials met the inclusion criteria for the review.

AUTHORS’ CONCLUSIONS: There is no evidence from randomised controlled
trials to evaluate the effectiveness and safety of different methods of
administering subcutaneous heparin (UFH or LMWH) to pregnant women.

10. Abstract:Observational study of vaccine efficacy 24 years after the
start of hepatitis B vaccination in two gambian villages: no need for a
booster dose

PLoS One. 2013;8(3):e58029.

Observational study of vaccine efficacy 24 years after the start of
hepatitis B vaccination in two gambian villages: no need for a booster

Mendy M, Peterson I, Hossin S, Peto T, Jobarteh ML, Jeng-Barry A, Sidibeh
M, Jatta A, Moore SE, Hall AJ, Whittle H.

Medical Research Council Laboratories, The Gambia, Banjul, the Gambia, West

OBJECTIVES: To determine the duration of protection from hepatitis B
vaccine given in infancy and early childhood and asses risk factors for HBV
infection and chronic infection.

METHODS: In 1984 infant HBV vaccination was started in two Gambian
villages. Cross sectional serological surveys have been undertaken every 4
years to determine vaccine efficacy. In the current survey 84.6% of 1508
eligible participants aged 1-28 years were tested. A spouse study was
conducted in females (aged 14 years and above) and their male partners.

RESULTS: Vaccine efficacy against chronic infection with hepatitis B virus
was 95.1% (95% confidence interval 91.5% to 97.1%), which did not vary
significantly between age groups or village. Efficacy against infection was
85.4% (82.7% to 87.7%), falling significantly with age. Concentrations of
hepatitis B antibody fell exponentially with age varying according to peak
response: 20 years after vaccination only 17.8% (95% CI 10.1-25.6) of
persons with a low peak response (10-99 mIU/ml) had detectable HBs antibody
compared to 27% (21.9% to 32.2%) of those with a high peak response (>999
mIU/ml). Time since vaccination and a low peak response were the strongest
risk factors for HBV infections; males were more susceptible, marriage was
not a significant risk for females. Hepatitis B DNA was not detected after
infection, which tested soley core antibody positive. An undetectable peak
antibody response of <10 mIU/ml and a mother who was hepatitis B e antigen
positive were powerful risk factors for chronic infection.

CONCLUSIONS: Adolescents and young adults vaccinated in infancy are at
increased risk of hepatitis B infection, but not chronic infection. Married
women were not at increased risk. There is no compelling evidence for the
use of a booster dose of HBV vaccine in The Gambia.

Free PMC Article

11. Abstract: Sublingual immunotherapy for the treatment of allergic
rhinoconjunctivitis and asthma: a systematic review

JAMA. 2013 Mar 27;309(12):1278-88.

Sublingual immunotherapy for the treatment of allergic rhinoconjunctivitis
and asthma: a systematic review.

Lin SY, Erekosima N, Kim JM, Ramanathan M, Suarez-Cuervo C, Chelladurai Y,
Ward D, Segal JB.

Department of Otolaryngology-Head and Neck Surgery, Johns Hopkins
University School of Medicine, Baltimore, MD 21287, USA.

IMPORTANCE: Allergic rhinitis affects up to 40% of the US population. To
desensitize allergic individuals, subcutaneous injection immunotherapy or
sublingual immunotherapy may be administered. In the United States,
sublingual immunotherapy is not approved by the Food and Drug
Administration. However, some US physicians use aqueous allergens, off-
label, for sublingual desensitization.

OBJECTIVE: To systematically review the effectiveness and safety of aqueous
sublingual immunotherapy for allergic rhinoconjunctivitis and asthma.

Cochrane Central Register of Controlled Trials were searched through
December 22, 2012. English- language randomized controlled trials were
included if they compared sublingual immunotherapy with placebo,
pharmacotherapy, or other sublingual immunotherapy regimens and reported
clinical outcomes. Studies of sublingual immunotherapy that are unavailable
in the United States and for which a related immunotherapy is unavailable
in the United States were excluded. Paired reviewers selected articles and
extracted the data. The strength of the evidence for each comparison and
outcome was graded based on the risk of bias (scored on allocation,
concealment of intervention, incomplete data, sponsor company involvement,
and other bias), consistency, magnitude of effect, and the directness of
the evidence.

RESULTS: Sixty-three studies with 5131 participants met the inclusion
criteria. Participants’ ages ranged from 4 to 74 years. Twenty studies (n =
1814 patients) enrolled only children. The risk of bias was medium in 43
studies (68%). Strong evidence supports that sublingual immunotherapy
improves asthma symptoms, with 8 of 13 studies reporting greater than 40%
improvement vs the comparator. Moderate evidence supports that sublingual
immunotherapy use decreases rhinitis or rhinoconjunctivitis symptoms, with
9 of 36 studies demonstrating greater than 40% improvement vs the
comparator. Medication use for asthma and allergies decreased by more than
40% in 16 of 41 studies of sublingual immunotherapy with moderate grade
evidence. Moderate evidence supports that sublingual immunotherapy improves
conjunctivitis symptoms (13 studies), combined symptom and medication
scores (20 studies), and disease-specific quality of life (8 studies).
Local reactions were frequent, but anaphylaxis was not reported.

CONCLUSIONS AND RELEVANCE: The overall evidence provides a moderate grade
level of evidence to support the effectiveness of sublingual immunotherapy
for the treatment of allergic rhinitis and asthma, but high-quality studies
are still needed to answer questions regarding optimal dosing strategies.
There were limitations in the standardization of adverse events reporting,
but no life-threatening adverse events were noted in this review.

12. Immunization Summary: New IPAD/IPHONE application (version 1.0) now
available on the app. store

Crossposted from Technet21 with thanks.
Immunization Summary: New IPAD/IPHONE application (version 1.0) now
available on the app. store

Diana Chang Blanc, WHO

The Immunization Summary is an application for visualizing (tables, graphs,
maps) data on policies, activities and impact of national immunization
systems. The IPAD/IPHONE app can now be downloaded directly from the iTunes
app store by typing “immunization summary” in the search field, or by
clicking the immunization logo from the right column of our pages : which will load your iTunes app store
and allow you to download the app (The app size is 61.5 MB).

These data are reported by WHO & UNICEF member states annually for
incid.ence, coverage and immunization indicators. The WHO UNICEF estimates
of national immunization coverage constitute an independent technical
assessment of coverage. The population data are provided by the United
Nations’ “Population Division. The World Population Prospects – the 2010
revision. New York, 2011.” with the exception of the infant and child
mortality figures which are provided by WHO’s “World Health Statistics
2011, data for 2010.”

The Gross National Income (GNI) & the Gross Domestic product (GDP) data are
taken from “The 2011 World Bank Development Indicators Online”.

Data are available from 1980 to 2011 (as of October 2012) for 195 countries
or territories.

Direct link to Apple App store:

13. New e-learning design: Global Learning Opportunities for Vaccine
Quality (GLO/VQ) goes virtual

Crossposted from Technet21 with thanks.
New e-learning design: Global Learning Opportunities for Vaccine Quality
(GLO/VQ) goes virtual

Umit Kartoglu, WHO

Over a period of five years, learning groups, composed of fifteen
participants and three mentors, have travelled along the route of the cold
chain in Turkey. Public and private institutions hosted the learners and
allowed them to experience the real life of the cold chain (the video
Nothing Stands Still can be viewed at

The WHO-PDA Pharmaceutical Cold Chain Management On Wheels course has
proven a notably intense and successful if not unique learning experience.
However, a week-long course required an enormous amount of planning and
resources – the reason why it has been possible to arrange only one such
course a year. With the demand growing, we have been challenged to find
ways to provide a similar learning experience for the cold chain
practitioners around the world.

With the goal of increasing access to efficient learning opportunities, the
course design team was put together in late 2009. Besides providing
important and useful content, the design team was committed to create a
unique technology-supported learning experience where people could learn
with and from each other and where real-life situations and study cases
could be used to develop expertise. The team also wanted to include aspects
of “authentic learning” where the learners could address real, ill-defined
problems and create solutions that would be of a real public health

The e-Pharmaceutical Cold Chain Management course is the result of the work
of the talented and dedicated design team, including instructional
designers, illustrators, filmmakers, software engineers, programmers,
content experts, and formative evaluators who spent literally thousands of
hours on this project. Their motivation was driven by an aspiration to
create a high-quality learning programme that will help to assure using
time-temperature sensitive products that are safe, pure, and effective.

The platform EPELA (Extensio et Progressio: Authentic e-Learning) provides
all the necessary tools to participants. EPELA e-learning promotes
collaborative learning which is now well recognized as the vital aspects of
effective learning and professional development. EPELA e-learning enhances
quality and outcomes of the courses offered. As good as the other courses
are, EPELA e-learning provides unique affordances for supporting learning
that even best traditional face-to-face courses cannot match.

The EPELA e-learning platform can be visited at

You can also explore the very first example of this authentic e-learning
course e-Pharmaceutical Cold Chain Management course at The course takes participants
inside an enhanced, robust mental model of a pharmaceutical cold chain. For
11 weeks, we travel with participants virtually from one location to
another, through different levels of the supply chain. In addition to the
virtual visits to facilities, we offer short illustrated videos and
critical reference materials. Authentic tasks are arranged mainly as group
activities to promote collaborative learning and enhanced with peer-review.

The course site offers participants tools to help to easily connect with
other participants, discuss and produce as a team. Mentors provide timely
feedback to all participants whenever necessary and are always ready to
assist them whenever participants need them. Following 7 weeks of virtual
visits to facilities, participants are introduced as a group to a real
client so that together with their peers they could analyse, report and
give recommendations to the client regarding the client’s operation of the
time and temperature-sensitive pharmaceutical products.

Although developed to support the authentic context of the e-Pharmaceutical
Cold Chain Management course, we make all short video-lectures and limited
number of documents publicly available (more documents are available for
course participants as well as facility tour videos, 360 degree spherical
and cylindrical photography of the facilities and authentic task videos).

Both WHO and EPELA encourage others to widely use the videos and embed them
in other web sites. The following videos are now available publicly (

Documents, records and record management by James Vesper

James Vesper reviews the critical aspects of documents, records and record
management. Documents like procedures, protocols, methods, and
specifications provide instructions so people can perform tasks and make
decisions safely, effectively, compliantly, and consistently. Records,
such as batch manufacturing records, cleaning logs, and laboratory data
sheets and notebooks provide evidence that actions were taken and decisions
were (hopefully) made in keeping with procedures and GMP expectations.
Reports, another type of documentation, provide specific information on a
particular topic (like an investigation or one aspect of product
development) in a formal, standardized way.

Exploitation of stability data to reach the unreached by Umit Kartoglu

Umit Kartoglu presents the critical aspect of exploitation of stability
data to reach 8°c the unreached through overview of studies taking vaccines
beyond the 8°C, all published in peer-review journals as well as a new
concept of cool water packs by the WHO and Vaccine Vial Monitors. As he
indicates that vaccines have become more stable and there is a clear
prospect of increased or even complete heat stability, and concludes that
in these circumstances the dogmatic approach to the cold chain causes
resources to be wasted and places unnecessary restrictions on field

Global Perspectives in Regulatory Oversight by Rafik Bishara

Members of the pharmaceutical supply chain have various global requirements
to meet during the storage, transport and handling of time and temperature-
sensitive products. Changing product portfolios, requirements for good
storage and distribution practices, regulatory expectations, quality
management, and risk assessment factors bring many challenges to the
handling of drug products. Rafik Bishara reviews the global perspectives
in regulatory oversight on pharmaceutical time and temperature products.

How Best to Use Stability Data for Handling of Time and Temperature
Sensitive Products by Claude Ammann

Claude Ammann reviews the importance of understanding regulations related
to the stability testing to add value to evaluate temperature excursions.

Introduction to Quality Risk Management by James Vesper

Risk management involves a series of activities that are sequenced so that
one step informs or shapes those that follow. James Vesper provides a
high-level overview of the entire process.

Last Mile by Umit Kartoglu

Umit Kartoglu reviews the critical last mile between the service point and
the end user. He further discusses the best solutions for storage and
transport of products and best practices for temperature monitoring.

Packaging design by Kevin O’Donnell

Kevin O’Donnell reviews the peculiarities of five different packaging
technology: Nylon, EPS, EPP, Airliner and VIP.

Risk assessment methods by James Vesper

James Vesper goes into details of methods frequently used in risk
assessments and gives first hand advise on when and how best to them:
Preliminary risk assessment, failure mode effects analysis and fault tree

Storage Facility Design: Cold Storage by Andrew Garnett

Andrew Garnett reviews the cold storage aspects of storage facility design
and covers temperature controlled storage areas, order assembly areas and
materials handling.

Storage Facility Design: Site and Buildings by Andrew Garnett

Andrew Garnett reviews the storage facility design with a particular
emphasis on the site and buildings through analysing the reasons for
storing cold chain products, different types and functions of storage
facilities, location, access, security, general building design issues.

Thermodynamics by Kevin O’Donnell

Kevin O’Donnell discusses thermodynamics, the basis of heat transfer and
how we can use heat energy to our benefit in packaging.

In addition these illustrated video-lectures, EPELA also brings the
following videos on technical issues:

Five senses: Vaccine Vial Monitors by World Health Organization

A movie, produced for the 10th year anniversary of the introduction of
vaccine vial monitors (VVM). The movie focuses on how this simple tool
expands the horizon of the immunization programme and empowers health
workers serving people at the very periphery of the health system. The
theme and the goal are specific but there are scenes, human conditions,
different livings for everybody to see and think about them. Shot in
Niger, Vietnam and Indonesia in 2007.

Nothing stands still by World Health Organization

The video of the WHO-PDA Pharmaceutical cold chain management on wheels
course conducted during 2-7 June 2008 in Istanbul, Ankara, Konya, Eskisehir
and Bursa (1,400 km route) in Turkey.

Now is the time by Project Optimize …
This three-minute video examines the growing challenges of maintaining
reliable vaccine supply and logistics systems and offers potential
solutions toward achieving optimized, efficient systems that reach people
with the vaccines they need.

Shake and Tell (video article) by World Health Organization

This is the first ever video of a full-fledged scientific article on the
validity of the shake test. Shake test is the only test available to
diagnose whether a freeze-sensitive vaccine has been damaged by freezing.

Step-by-step how to conduct the shake test by World Health Organization

This educational video provides the steps of a standard validated way of
performing a shake test and interpreting the results.

WHO and EPELA, with the launch of their second course e-VVM Based Vaccine
Management, will make seven more illustrated-lecture videos publicly
available in coming months.

Stay tuned…

With warmest regards,

Umit Kartoglu
Global Learning Opportunities for Vaccine Management
Extensio et Progressio: Authentic e-Learning

14. Launch of AMP-WHO LOGIVAC Training Programme in Health Logistics

Crossposted from Global Immunization News with thanks

31/03/2013 from Sabrina Gaber, Philippe Jaillard and Benjamin Schreiber

An official ceremony was held at the Regional Institute of Public Health
(Institut Régional de Santé Publique, IRSP) in Ouidah, Benin on 26 March
2013 to mark the launch of the first edition of the LOGIVAC training degree
pro-gramme in health logistics. The event brought together representatives
of various ministries in Benin and other project stakeholders.

The first class consists of 24 students, of which five are women, who come
from various Francophone African countries (Seven from the Democratic
Republic of the Congo; five from Benin; four from Togo; two each from
Burkina Faso, Chad and Niger; and one each from Burundi and Madagascar).

They are part of various public health programmes (e.g. Expanded Programme
on Immunization, Essential Drugs) as well as national reference laborato-
ries. Students are partly self-funded or sponsored by the Agence de
Médecine Préventive (AMP), WHO, and GlaxoSmithKline.

The training curriculum was developed through a series of workshops with
experts from different organizations and includes courses on: health
logistics basics; logistics planning; coordination and administration;
logistics infor-mation systems; partnerships; supply chain management;
management of essential health products; management of technical equipment;
infrastructure management; and crisis management.

The programme features distance learning, classroom learning, and an
internship. This blended learning approach enables students to spend a
minimum amount of time away from their jobs, and to immediately apply
teachings in their field of work. Training is delivered by IRSP faculty,
Institut Bioforce, WHO, UNICEF, AMP, and other ex-perts.

Upon successful completion, participants receive a bachelor’s degree from
the University of Abomey-Calavi, which is recognized by other academic and
professional bodies in the region.

For more information, visit this website.

15. News

– VietNam: Street robbers use blood-stained needles as menace
– USA: Second chemist charged in Massachusetts drug lab scandal
– USA: New program allows drug users to safely dispose of needles
– USA: Dentist’s dirty practice shocks Oklahoma community

Selected news items reprinted under the fair use doctrine of international
copyright law:
VietNam: Street robbers use blood-stained needles as menace
TUOI TRE, Tuoitrenews, VietNam (02.04.13)

Bus commuters in Ho Chi Minh City and surrounding localities have been
threatened and robbed by gangs in recent months.

Their evil trick is simple: holding out a blood-stained syringe, hinting
that the needle is HIV/AIDS-infected and threatening to attack victims with
it in order to steal their money and assets.

This sometimes follows another common trick, in which thieves sell herbal
medicine on buses at dirt-cheap prices and then attack those who take out
big sums of money from their pockets for payment. The sale of the medicine
is meant to choose whom to rob.

Some victims who refuse to give the thieves money are physically attacked
by the gangsters in the absence of help from bus drivers and other
passengers for fear of injury.

Keeping watch on the gangs

Tuoi Tre journalists followed members of the mugging gangs on buses in the

On March 20, three robbers were prowling the Phu Lam Roundabout in District
6, which is the center of many different bus routes in the city.

A guy called Vinh ‘den’ (black) got on a bus numbered 62L-3082 plying the
Cho Lon – Long An route. He immediately took out a syringe with a blood-
stained needle and pointed at a passenger, who was a student. He muffled
his voice, “Hey, do you want a shot with this? Money.”

The student was embarrassed and mumbled in whiny voice, “I have only this.
I am on the way home from school. I don’t have money.” Vinh ‘den’ grabbed
it and stepped towards the front door to get out with an order, “Let me get
out, driver.” He quickly left the bus as it was speeding down and got on a
motorbike driven by one of the culprits in his gang. They rode back to the
bus stop for another theft.

Five minutes later, they got on the bus numbered 62L-3223 and Vinh ‘den’
told passengers that he was a sales agent of the herbal chemist Thien Chi
distributing medicine free of charge. After delivery, he begged each
recipient for 1,000 dong. Glancing at the passengers’ pockets to determine
who had the most money, he jutted out a syringe kept in his shirt pocket
and began robbing the passengers. Pointing at a woman, he scowled, “Are you
tired of living? Money.” She stuttered something and gave him VND200,000
(US$9.6). He took it and snatched another VND100,000 from her purse.

Then, he turned the syringe on another woman sitting next to the previous
victim and got 200,000 dong more with the same trick.

The following day, Vinh ‘den’ got on bus 62L-5128 and advertised a herb for
the treatment of malaria, diabetes and stomachaches for just 1,000 dong a
dose. Vinh ‘den’ and a culprit called Khang turned up as robbers, taking a
total of VND1.7 million ($82) from passengers on the bus.

Besides the gang of Vinh ‘den’, bus passengers have been threatened by a
gang in An Lac, Binh Chanh District, and the area near the Western Bus

The gangs may move to other bus routes if they feel they are traced. After
robbing five to ten buses a day, members of the gangs of Vinh ‘den’ and
Hung return to Hoang Phung Hotel in the area to share their loot. Fear

A bus driver assistant, Tran Dinh Long, told Tuoi Tre, “Most buses plying
this route are mugged by the gangs, but we drivers dare not to report or
resist them for fear of revenge. What we can do is warn passengers before
they get on.”.

They robbed passengers in broad daylight long ago, but few victims reported
the cases to local police.

Tuoi Tre reported the situation to the Binh Tan District police department
and Tran Van Hien, vice chief of an investigative police team in the
district said, “We have been collecting information about the gangs and
will raid them soon.”
USA: Second chemist charged in Massachusetts drug lab scandal
By Zach Howard, Reuters (01.04.13)

CONWAY, Massachusetts (Reuters) – A chemist who worked at a Massachusetts
state drug lab was indicted on Monday on state charges of tampering with
evidence and stealing cocaine held in evidence, in the second case against
a state chemist in recent months.

Sonja Farak, who has been suspended with pay from her position at a state
drug lab in western Massachusetts, was charged with theft of a controlled
substance from an authorized dispensary and tampering with evidence, and
possession of a Class B substance, Massachusetts Attorney General Martha
Coakley said in a statement.

Farak, 35, was arrested in January on charges related to her work at the
Amherst Drug Laboratory, about 90 miles west of Boston, and pleaded not
guilty to charges of tampering and drug possession.

Her arrest came a month after another state drug lab chemist, Annie
Dookhan, was indicted on charges of falsifying evidence in thousands of
drug cases, resulting in the release of hundreds of people who had been
convicted on related charges.

Last week, a state court judge ordered the suspension of the sentences of
eight imprisoned men due to the questions about Farak’s evidence handling,
according to local media.

Prosecutors charged Dookhan with inspecting samples only visually, a
pattern apparently intended to speed up evidence handling. Dookhan has
pleaded not guilty.

In Farak’s case, prosecutors said she had removed drug samples for her own
use and mixed drug evidence samples with counterfeit drugs to hide the

Her attorney did not immediately respond to a call seeking comment.

The Amherst lab where Farak worked stores and analyzes controlled
substances seized by local and state police. Lab supervisors in January
contacted State Police to report a discrepancy in the controlled substance
evidence inventory, and police and Coakley’s office began investigating.

Authorities said they found controlled substances believed to be cocaine
both in Farak’s workstation and in her vehicle, Coakley said. In addition,
they found Farak had materials consistent with the counterfeit material
allegedly added to two of the drug samples.

Farak began working as a state lab chemist at the Hinton lab in Boston in
2002 and moved to the Amherst lab in 2004, Coakley said. State police
assumed oversight of the Amherst lab and the Hinton lab from the Department
of Public Health in July after learning of Dookhan’s alleged activities.

(Editing by Scott Malone, Cynthia Johnston and Steve Orlofsky)
USA: New program allows drug users to safely dispose of needles
By Andrea Koskey, SF Examiner, San Francisco CA USA (01.04.13)

Two needle drop boxes, including one on the side of the Tom Waddell Health
Center near City Hall, will be available 24 hours a day.
When GK Callahan began working to transform a blighted plot of land into
the Please Touch Community Garden in 2010, he and his volunteers were
astounded at the volume of hypodermic needles piled up in the empty lot.

“When I started the garden project, it had been desolate for years,”
Callahan said of its Grove Street location. “I collected about 2,000
needles. That’s when it became apparent to me there was a need.”

Although San Francisco began needle-exchange programs in 1993, that didn’t
begin to take all the needles off The City’s streets.

Now, a bright-red box, roughly 1 foot long and 1 foot high, hangs on the
side of the Tom Waddell Health Center building, one block from City Hall
and just outside the garden’s gates. The box is part of a new pilot program
that will offer a place for needle users to drop empty syringes 24 hours a
day, seven days a week.

That location and one by Glide Memorial Church in the Tenderloin were
chosen carefully, according to Eileen Loughran, the Department of Public
Health’s health program coordinator in HIV prevention.

“No one wants syringes in their gardens or on the streets,” Loughran said.
“A couple of years ago, a study was done that interviewed drug users. They
said they wanted a place to put syringes. They didn’t want to just dump
them on the street.”

These boxes, Loughran hopes, will help. Disposing of needles safely helps
prevent the spread of HIV and Hepatitis C, among other diseases.

The pilot program was launched roughly one month ago, but it could take at
least six months before any talks of expansion begin. Loughran said the
boxes will be monitored to see if they are being used.

“Right now they’re emptied twice a week,” Loughran said, “to assess how
many syringes are there.” But Loughran said the needles are not counted due
to the danger of doing so.

According to Katie Bouche of the San Francisco AIDS Foundation, which
maintains the two boxes, 2.7 million needles are handed out throughout the
year in The City. While all syringe programs offer a way to disposed of
used needles, not all needles come back.

“Overnight, there is no place for folks to dispose of them,” said Bouche,
manager of the AIDS Foundation’s syringe-access services. “We have needle
exchanges throughout the week and we hand out sharp containers so the
needles can be carried back to us. But this is a safe way too.”

The founder of Please Touch Community Garden was one of those who pushed
for more access for needle drops. And Callahan reports that the red box at
the Tom Waddell Health Center has made a difference.

“There are a lot of people who wanted to see this happen for a long time,”
he said. “I think if they keep putting these containers where there are
high volumes (of users), it’s going to make a definite difference.”
USA: Dentist’s dirty practice shocks Oklahoma community, USA (29.03.13)

Thousands of patients of an Oklahoma dentist are being urged to get tested
for HIV and hepatitis after public health officials found evidence of
practices that could have exposed patients to the viruses.

The Oklahoma and Tulsa health departments said Thursday approximately 7,000
people who were treated at clinics operated by Dr. W. Scott Harrington
could have been exposed to Hepatitis B, hepatitis C, and HIV, the virus
that causes AIDS, calling the dentist “a menace to public health.”

State and county health inspectors went to Harrington’s practice after a
patient with no known risk factors tested positive for both hepatitis C and
the virus that causes AIDS.

After determining the patient had a dental procedure about the likely time
of exposure, investigators visited Harrington’s office and found a number
of unsafe practices, state epidemiologist Kristy Bradley said.

“I want to stress that this is not an outbreak. The investigation is still
very much in its early stages,” Bradley said.

‘Unprecedented event’

The agencies found “major violations” of the Oklahoma Dental Act and
numerous violations of health and safety laws during an investigation into
Harrington’s practice. These included employees using dirty equipment,
reusing needles and administering drugs without a license.

“This is an unprecedented event,” Susan Rogers, executive director of the
state Board of Dentistry, said in an interview. “To my knowledge, this has
never happened before as far as a public notification of a (hepatitis C)
case involving a dental office.”

The Oklahoma Board of Dentistry said the inspectors discovered multiple
sterilization issues at Harrington’s offices, including the use of a
separate, rusty, set of instruments for patients who were known to carry
infectious diseases.

The Board lodged a 17-count complaint against Harrington, saying he was a
“menace to the public health by reasons of practicing dentistry in an
unsafe or unsanitary manner.” Among the claims was one detailing the use of
rusty instruments in patients known to have infectious diseases.
“The CDC (Centers for Disease Control and Prevention) has determined that
rusted instruments are porous and cannot be properly sterilized,” the board
said in a 17-count complaint against the dentist.

‘He’s been practicing for 36 years’

Officials are sending letters to 7,000 people who are known to have been
patients of Harrington, but they noted that they do not have information
for patients before 2007. The letters urge the patients to be tested for
hepatitis B, hepatitis C and HIV. — viruses typically spread through
intravenous drug use or unprotected sexual contact, not occupational

“It’s uncertain how long those practices have been in place,” Snider said.
“He’s been practicing for 36 years.”

Harrington could not be reached for comment Thursday. A message at his
Tulsa office said it was closed and the doctor’s answering service referred
callers to the Tulsa Health Department. Phone numbers listed for Harrington
were disconnected. A message left with Harrington’s malpractice attorney in
Tulsa, Jim Secrest II, was not immediately returned.

Harrington’s practice in Tulsa is in a tony part of town, on a row of some
of the city’s most upscale medical practices. The white-and-green stucco,
two-story dental clinic has the doctor’s name in fancy letters on the

Inside, the Dentistry Board said, Harrington ran a clinic that paid little
attention to ensuring items were sterile. Dental assistants needing an
extra dose of an anesthetic would re-insert used needles into drug vials,
drug vials were used on multiple patients, the office had no written
infection-protection procedure and Harrington told officials he left
questions about sterilization and drug procedures to his employees.

“They take care of that, I don’t,” the board quoted him as saying.
The doctor is also accused of letting his assistants perform tasks only a
licensed dentist should have done. Also, the complaint says that the
doctor’s staff could not produce permits for the assistants when asked for

Rogers said that as an oral surgeon, Harrington routinely does invasive
procedures that involve “pulling teeth, open wounds, open blood vessels.”
The Dentistry Board complaint said Harrington and his staff told
investigators that a “high population of known infectious disease carrier
patients” received dental care from him.

According to the complaint, a device used to sterilize instruments wasn’t
working properly. A test is supposed to be performed monthly and sent to a
lab to determine that the equipment is successfully sterilizing
instruments, but “no such test had ever been performed in the 6 years one
dental assistant had been working at the office,” the complaint said.

The doctor also apparently used outdated drugs, as one vial found this year
had an expiration date of 1993, and didn’t properly keep track of drugs,
the complaint said. It noted that a drug cabinet was unlocked and
unattended during the day and that dental assistants administered IV
sedation for procedures without the doctor being present.

It also said that although U.S. Drug Enforcement Administration records
show Harrington had not received morphine from a distributor since 2009,
the drug logs kept by his assistants said morphine had been used on
patients intermittently throughout 2012.

Officials said patients will be offered free medical testing at the Tulsa
Health Department’s North Regional Health and Wellness Center.

Most people who become infected by hepatitis C get it by sharing needles or
other equipment to inject drugs, according to the CDC’s website. The
infection can last a lifetime and lead to scarring of the liver or liver

Most people who get hepatitis B have it for a short time, though it can
cause a long-term infection that can damage the liver. It can be
transmitted through unprotected sex and sharing needles.

The Associated Press contributed to this report.
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