online canadian pharmacy http://www.canadianpharmacy365.net/ pharmacy ratings phentermine no prescription

SIGNpost 00686

 

*SAFE INJECTION GLOBAL NETWORK* SIGNPOST *SAFE INJECTION GLOBAL NETWORK*

Post00686 Clean UR Hands + IOM Report + Abstracts + News 20 February 2013

CONTENTS
1. SAVE LIVES: Clean Your Hands – WHO’s global annual campaign 5 May 2013!
2. IOM Report: Countering the Problem of Falsified and Substandard Drugs
3. Abstract: The impact of new vaccine introduction on immunization and
health systems: a review of the published literature
4. Abstract: Biological risk and occupational health
5. Abstract: Time trends of incidence rates of work accident with blood
contamination in a North Italian teaching hospital
6. Abstract: The systems approach to error reduction: factors influencing
inoculation injury reporting in the operating theatre
7. Abstract: Best Practices in Newborn Injections
8. Abstract: The distribution of new HIV infections by mode of exposure in
Morocco
9. Abstract: Risks for HIV Infection Among Male Street Laborers in Urban
Vietnam
10. Abstract: High prevalence but low awareness of hepatitis C virus
infection among heroin users who received methadone maintenance therapy
in Taiwan
11. Abstract: Should North America’s first and only supervised injection
facility (InSite) be expanded in British Columbia, Canada?
12. Abstract: Evaluation of a new reusable insulin pen (ClikSTAR) in
Canadian patients with type 1 and type 2 diabetes mellitus receiving
insulin glargine
13. Abstract: Dose sparing intradermal trivalent influenza (2010/2011)
vaccination overcomes reduced immunogenicity of the 2009 H1N1 strain
14. Abstract: Immunity to hepatitis B virus infection two decades after
implementation of universal infant hepatitis B vaccination: the
association of detectable residual antibody and response to a single
hepatitis B vaccine challenge dose
15. No Abstract: Corticosteroid injections: serious infections and necrosis
16. Summary: Scaling Up mHealth: Where Is the Evidence?
17. News
– USA: Hepatitis C Bills Get First Airing
– Technology: Preventing Diseases May Soon Be As Simple As Applying A
Band-Aid
– Devices: PharmaJet`s StratisNeedle-free Injector Receives WHO PQS
Certification as a Pre-qualified Delivery Device for Vaccine
Administration

The web edition of SIGNpost is online at:
http://signpostonline.info/archives/1400

More information follows at the end of this SIGNpost!

Please send your requests, notes on progress and activities, articles,
news, and other items for posting to: sign.moderator@gmail.com

Normally, items received by Tuesday will be posted in the Wednesday
edition.

Subscribe or un-subscribe by email to: sign.moderator@gmail.com or to
sign@who.int

Visit the WHO injection safety website and the SIGN Alliance Secretariat
at: http://www.who.int/injection_safety/en/

Visit the SIGNpostOnline archives at: http://signpostonline.info

Selected updates and breaking news items on the SIGN Moderator Facebook
page at: http://facebook.com/SIGN.Moderator

Selected updates at: http://twitter.com/#!/signmoderator
__________________________________________________________________
________________________________*_________________________________

1. SAVE LIVES: Clean Your Hands – WHO’s global annual campaign 5 May 2013!

– Clean Care is Safer Care
__________________________________________________________________
http://www.who.int/gpsc/5may/en/index.html

Clean Care is Safer Care
SAVE LIVES: Clean Your Hands – WHO’s global annual campaign

Getting ready for 5 May 2013!

Celebrations for 5 May 2013 aim to be as inclusive of everyone as possible!
This time, the day actually falls on a Sunday, a rest day for most, but not
for all. Activities in support of 5 May have always been promoted as ‘on or
around 5 May’ to ensure all health-care workers have the opportunity to
take part in important hand hygiene awareness-raising activities.
Therefore, we encourage those working on Saturday and Sunday, to celebrate
hand hygiene promotion and improvement on 4 and 5 May 2013. Celebrations in
other parts of the world where these are not regular working days will take
place on 6 and 7 May 2013.

Our call to action for you in 2013 is two-fold:

Continue to focus on hand hygiene monitoring and feedback!

Evaluation and repeated monitoring of a range of indicators reflecting hand
hygiene infrastructures and practices, as well as health-care workers’ and
senior managers’ knowledge and perception of the problem of health care-
associated infection and the importance of hand hygiene at the health-care
facility, is a vital component of any successful hand hygiene campaign.

Visit our new page on monitoring and feedback
http://www.who.int/entity/gpsc/5may/monitoring_feedback/en/index.html

Patients have a voice too!

Patient participation is a powerful approach to achieving improvements in
health care by building and strengthening a strong patient safety climate.
Identify the best way to gather patient participation in hand hygiene
promotion and improvement, according to your local culture and facility’s
approach.

Take a look at the new page dedicated to this topic.
www.who.int/entity/gpsc/5may/5may2013_patient-participation/en/index.html

Registering for SAVE LIVES: Clean Your Hands

You can still register now and be part of this global movement to improve
hand hygiene! Heading to 5 May 2013, we aim to gather new health-care
settings joining especially from countries that have LOW or NO
registrations. See the list of these countries below. Please help us
achieve new registrations from at least 5 new countries!

If you have already registered, there is no need to register again.
http://www.who.int/entity/gpsc/5may/register/en/index.html
__________________________________________________________________
________________________________*_________________________________

2. IOM Report: Countering the Problem of Falsified and Substandard Drugs
__________________________________________________________________
IOM Report: Countering the Problem of Falsified and Substandard Drugs

Released:

February 13, 2013
Type: Consensus Report

Topic: Global Health

Activity: Understanding the Global Public Health Implications of
Substandard, Falsified, and Counterfeit Medical Products

Board: Board on Global Health

Falsified and substandard medicines provide little protection from disease
and, worse, can expose consumers to major harm. Bad drugs pose potential
threats around the world, but the nature of the risk varies by country,
with higher risk in countries with minimal or non-existent regulatory
oversight. While developed countries are not immune, – negligent production
at a Massachusetts compounding pharmacy killed 44 people from September
2012 to January 2013 – the vast majority of problems occur in developing
countries where underpowered and unsafe medicines affect millions.

It is difficult to measure the public health burden of falsified and
substandard drugs, the number of deaths they cause, or the amount of time
and money wasted using them. The FDA asked the IOM to assess the global
public health implications of falsified, substandard, and counterfeit
pharmaceuticals to help jumpstart international discourse about this
problem. At the international level, productive discussion relies on
cooperation and mutual trust. This report lays out a plan to invest in
quality to improve public health.

Read online at: http://books.nap.edu/openbook.php?record_id=18272
or download a PDF at: http://www.nap.edu/catalog.php?record_id=18272
__________________________________________________________________
________________________________*_________________________________

3. Abstract: The impact of new vaccine introduction on immunization and
health systems: a review of the published literature
__________________________________________________________________
http://www.ncbi.nlm.nih.gov/pubmed/22940378

Vaccine. 2012 Oct 5;30(45):6347-58.

The impact of new vaccine introduction on immunization and health systems:
a review of the published literature.

Hyde TB, Dentz H, Wang SA, Burchett HE, Mounier-Jack S, Mantel CF; New
Vaccine Introduction Impact Published Literature Working Group.

Collaborators (6) Gindler J, Goldstein ST, Gordon WS, Brenzel L, Shearer
JC, Favin M.

Centers for Disease Control and Prevention, Atlanta, GA 30333, USA.
thyde@cdc.gov

We conducted a systematic review of the published literature to examine the
impact of new vaccine introduction on countries’ immunization and broader
health systems. Six publication databases were searched using 104 vaccine
and health system-related search terms.

The search yielded 15,795 unique articles dating from December 31, 1911 to
September 29, 2010. Based on review of the title and abstract, 654 (4%) of
these articles were found to be potentially relevant and were referred for
full review. After full review, 130 articles were found to be relevant and
included in the analysis.

These articles represented vaccines introduced to protect against 10
different diseases (hepatitis A, hepatitis B, Haemophilus influenzae type b
disease, human papilloma virus infection, influenza, Japanese encephalitis,
meningococcal meningitis, Streptococcus pneumoniae disease, rotavirus
diarrhea and typhoid), in various formulations and combinations.

Most reviewed articles (97 [75%]) reported experiences in high-income
countries.

New vaccine introduction was most efficient when the vaccine was introduced
into an existing delivery platform and when introduced in combination with
a vaccine already in the routine childhood immunization schedule (i.e., as
a combination vaccine). New vaccine introduction did not impact coverage of
vaccines already included in the routine childhood immunization schedule.

The need for increased cold chain capacity was frequently reported.

New vaccines facilitated the introduction and widespread use of auto-
disable syringes into the immunization and the broader health systems.

The importance of training and education for health care workers and social
mobilization was frequently noted. There was evidence in high-income
countries that new vaccine introduction was associated with reduced health-
care costs.

Future evaluations of new vaccine introductions should include the
systematic and objective assessment of the impacts on a country’s
immunization system and broader health system, especially in lower-income
countries.

Published by Elsevier Ltd.
__________________________________________________________________
________________________________*_________________________________

4. Abstract: Biological risk and occupational health
__________________________________________________________________
http://www.ncbi.nlm.nih.gov/pubmed/22785422

Ind Health. 2012;50(4):326-37.

Biological risk and occupational health.

Corrao CR, Mazzotta A, La Torre G, De Giusti M.

Department of Public Health and Infectious Diaseases, “Sapienza” University
of Rome, Italy. carmela.corrao@uniroma1.it

Many work activities include hazards to workers, and among these biological
risk is particularly important, mostly because of different types of
exposure, contact with highly dangerous agents, lack of limit values able
to compare all exposures, presence of workers with defective immune systems
and therefore more susceptible to the risk.

Bioaerosols and dust are considered important vehicles of microganisms at
workplaces and interaction with other occupational agents is assumed.
Moreover, biological risk can be significant in countries with increasing
economic development or particular habits and some biological agents are
also classified as carcinogenic to human.

Specific emerging biological risks have been recently pointed out by Risk
Observatory of the European Agency for Safety and Health at work, and we
must consider the worker’s attitude and behaviour, influenced by his own
perception of risk more than his real knowledge, that could over-
underestimate the risk itself.

Therefore, biological risk at work requires a complex approach in relation
to risk assessment and risk management, made more difficult due to the wide
variety of biological agents, working environments and working techniques
that can determine the exposures.

Free full text
https://www.jstage.jst.go.jp/article/indhealth/50/4/50_MS1324/_article
__________________________________________________________________
________________________________*_________________________________

5. Abstract: Time trends of incidence rates of work accident with blood
contamination in a North Italian teaching hospital
__________________________________________________________________
http://www.ncbi.nlm.nih.gov/pubmed/23405640

G Ital Med Lav Ergon. 2012 Jul-Sep;34(3 Suppl):275-7.

[Time trends of incidence rates of work accident with blood contamination
in a North Italian teaching hospital].

[Article in Italian]

Ferrario MM, Landone S, De Biasi M, Tagliasacchi R, Riva R, Veronesi G,
Sassi M, Borchini R, Bonzini M.

Medicina del Lavoro e Preventiva, Ospedale di Circolo e Fondazione Macchi,
Varese, Italy. marco.ferrario@uninsubria.it

Unbiased estimates of incidence rates of accidents with blood
contaminations (ABC) and time trends is the milieu for assessing the
effectiveness of preventive interventions.

A standardised procedure for registration and follow-up of ABC was et up in
a North Italian hospital since 2002. Accurate estimates of rate
denominator, as full-time equivalent (FTE) person-years, was calculated,
for exposed workers only and excluding periods of prolonged absence. In the
observation period (2004-2011), training courses for head nurses on
security procedures were repeatedly carried out as well as the progressive
introduction of vacuum blood collection systems (since 2009).

1287 ABC have been reported, corresponding to an overall annual crude
incidence rate of 4.73 per 100 FTE. Temporal trends, calculated on the
biennial incidence, resulted in a reductions over the time period
considered, in particular for needlestick injuries.

Our results support the notions on the efficacy of the adopted prevention
measures.
__________________________________________________________________
________________________________*_________________________________

6. Abstract: The systems approach to error reduction: factors influencing
inoculation injury reporting in the operating theatre
__________________________________________________________________
http://www.ncbi.nlm.nih.gov/pubmed/23406338

J Nurs Manag. 2012 Jun 16.

The systems approach to error reduction: factors influencing inoculation
injury reporting in the operating theatre.

Cutter J, Jordan S.

Lecturer Reader, College of Human and Health Science, Swansea University,
Swansea, UK.

cutter j. & jordan s. (2012) Journal of Nursing Management

Aim To examine the frequency of, and factors influencing, reporting of
mucocutaneous and percutaneous injuries in operating theatres. Background
Surgeons and peri-operative nurses risk acquiring blood-borne viral
infections during surgical procedures.

Appropriate first-aid and prophylactic treatment after an injury can
significantly reduce the risk of infection. However, studies indicate that
injuries often go unreported.

The ‘systems approach’ to error reduction relies on reporting incidents and
near misses. Failure to report will compromise safety.

Methods A postal survey of all surgeons and peri- operative nurses engaged
in exposure prone procedures in nine Welsh hospitals, face-to-face
interviews with selected participants and telephone interviews with
Infection Control Nurses.

Results The response rate was 51.47% (315/612). Most respondents reported
one or more percutaneous (183/315, 58.1%) and/or mucocutaneous injuries
(68/315, 21.6%) in the 5 years preceding the study. Only 54.9% (112/204)
reported every injury. Surgeons were poorer at reporting: 70/133 (52.6%)
reported all or >50% of their injuries compared with 65/71 nurses (91.5%).

Conclusions Injuries are frequently under-reported, possibly compromising
safety in operating theatres. Implications for nursing management A
significant number of inoculation injuries are not reported. Factors
influencing under-reporting were identified. This knowledge can assist
managers in improving reporting and encouraging a robust safety culture
within operating departments.

© 2012 Blackwell Publishing Ltd.
__________________________________________________________________
________________________________*_________________________________

7. Abstract: Best Practices in Newborn Injections
__________________________________________________________________
http://www.ncbi.nlm.nih.gov/pubmed/23403493

MCN Am J Matern Child Nurs. 2013 Feb 11.

Best Practices in Newborn Injections.

Hensel D, Morson GL, Preuss EA.

Desiree Hensel, PhD, RNC-NIC, CNE, is an Assistant Professor at Indiana
University School of Nursing, Bloomington, IN. She can be reached via e-
mail at dehensel@indiana.edu Gwyndolen Leigh Morson, BSN, RN, is a
Registered Nurse, NICU at Community Health North Hospital, Indianapolis,
IN. Elizabeth A. Preuss, BSN, RN is a Clinical Nurse, Cardiac Step-Down
Unit at St Mary’s Hospital Richmond, VA.

Many long-held practices surrounding newborn injections lack evidence and
have unintended consequences. The choice of needles, injection techniques,
and pain control methods are all factors for decreasing pain and improving
the safety of intramuscular injections.

Using practices founded on the available best evidence, nurses can reduce
pain, improve the quality and safety of care, and set the stage for long-
term compliance with vaccination schedules.
__________________________________________________________________
________________________________*_________________________________

8. Abstract: The distribution of new HIV infections by mode of exposure in
Morocco
__________________________________________________________________
http://www.ncbi.nlm.nih.gov/pubmed/23413401

Sex Transm Infect. 2013 Feb 14.

The distribution of new HIV infections by mode of exposure in Morocco.

Mumtaz GR, Kouyoumjian SP, Hilmi N, Zidouh A, El Rhilani H, Alami K,
Bennani A, Gouws E, Ghys PD, Abu-Raddad LJ.

Infectious Disease Epidemiology Group, Weill Cornell Medical College-Qatar,
Cornell University, Qatar Foundation, Education City, Doha, Qatar.

OBJECTIVES: Building on a wealth of new empirical data, the objective of
this study was to estimate the distribution of new HIV infections in
Morocco by mode of exposure using the modes of transmission (MoT)
mathematical model.

METHODS: The MoT model was implemented within a collaboration with the
Morocco Ministry of Health and the Joint United Nations Programme on
HIV/AIDS. The model was parameterised through a comprehensive review and
synthesis of HIV and risk behaviour data in Morocco, mainly through the
Middle East and North Africa HIV/AIDS Synthesis Project. Uncertainty
analyses were used to assess the reliability of and uncertainty around our
calculated estimates.

RESULTS: Female sex workers (FSWs), clients of FSWs, men who have sex with
men (MSM) and injecting drug users (IDUs) contributed 14%, 24%, 14% and 7%
of new HIV infections, respectively. Two-thirds (67%) of new HIV infections
occurred among FSWs, clients of FSWs, MSM and IDUs, or among the stable
sexual partners of these populations. Casual heterosexual sex contributed
7% of HIV infections. More than half (52%) of HIV incidence is among
females, but 71% of these infections are due to an infected spouse. The
vast majority of HIV infections among men (89%) are due to high-risk
behaviour.

A very small HIV incidence is predicted to arise from medical injections or
blood transfusions (0.1%).

CONCLUSIONS: The HIV epidemic in Morocco is driven by HIV incidence in
high-risk population groups, with commercial heterosexual sex being the
largest contributor to incidence. There is a need to focus HIV response
more on these populations, mainly through proactive and sustainable HIV
surveillance, and the expansion and increased geographical coverage of
services such as condom promotion among FSWs, voluntary counselling and
testing, harm reduction and treatment.
__________________________________________________________________
________________________________*_________________________________

9. Abstract: Risks for HIV Infection Among Male Street Laborers in Urban
Vietnam
__________________________________________________________________
http://www.ncbi.nlm.nih.gov/pubmed/23413195

J Community Health. 2013 Feb 15.

Risks for HIV Infection Among Male Street Laborers in Urban Vietnam.

Van Nguyen H, Dunne MP, Debattista J.

Department of Health Management and Organization, Institute for Preventive
Medicine and Public Health, Hanoi Medical University, 01 Ton That Tung
Str., Dong Da Dist., Hanoi, Vietnam, nvanhuy@yahoo.com.

Risks for HIV infection remain unknown in male street laborers. This
research investigates patterns of self-reported risk behaviors among these
men in urban Vietnam. In a cross-sectional survey using a social mapping
technique, 450 men, mostly low-skilled and unregistered migrant laborers
across 13 districts in Hanoi were approached for interviews.

The study revealed that male street laborers were at high risk of acquiring
and transmitting HIV. One in every 12 men reported homosexual or bisexual
behavior. These men on average had three sexual partners within the
preceding year, and condom use was inconsistent. Close to 95 % of the men
had reported sexual encounters with regular partners. One-third with
commercial sex workers (CSW) and 24.2 % with casual partners, but just
under one-third had ever used condoms with regular partners and CSWs and
very few (17.6 %) with casual partners at their last sexual encounter.
17.11 % used illicit drugs sometimes, with 66.7 % of them frequently
sharing injecting equipment with peers.

These men had limited HIV knowledge; 51.4 % incorrectly believed that, once
you trust your partner, you no longer need to use condoms and 42.4 %
believed that you can tell by looking at someone if they have HIV. Access
to HIV prevention was also limited; only 19.8 % of men had been tested for
HIV during the previous 12 months, almost 10 % of whom neither returned for
the result nor knew their HIV status.

The study provides interesting directions for future research and suggests
ways to effectively design prevention strategies for these men.
__________________________________________________________________
________________________________*_________________________________

10. Abstract: High prevalence but low awareness of hepatitis C virus
infection among heroin users who received methadone maintenance therapy
in Taiwan
__________________________________________________________________
http://www.ncbi.nlm.nih.gov/pubmed/23403277

Addict Behav. 2013 Apr;38(4):2089-93.

High prevalence but low awareness of hepatitis C virus infection among
heroin users who received methadone maintenance therapy in Taiwan.

Ng MH, Chou JY, Chang TJ, Lee PC, Shao WC, Lin TY, Chen VC, Gossop M.

Tsaotun Psychiatric Center Department of Health, Nan-Tou 542, Taiwan.
Electronic address: eenniidd_ng@yahoo.com.tw.

BACKGROUND: This study investigates the prevalence and correlates of
hepatitis C virus (HCV) infections among heroin dependent individuals who
received methadone maintenance therapy in Taiwan. Also, we investigate
users’ awareness of HCV.

METHODS: Participants were 773 heroin users entering the methadone
maintenance treatment (MMT) program at Tsaotun Psychiatric Center in
Taiwan. The presence of HCV antibodies was detected. Multivariate logistic
regression was used to identify the relationship between HCV infection and
correlates.

RESULTS: The prevalence of HCV infection was 90.8%. All participants who
were HIV- positive were also infected with HCV. Multivariate logistic
regression analysis showed that the route of heroin administration
(injection), HIV- infection, and criminal records were significantly
related to HCV infection. Few (34.8%) HCV positive heroin users were aware
of their infection.

CONCLUSION: An extremely high prevalence of HCV infection but low awareness
of their infection status was found among MMT patients in Taiwan. These
findings highlight the importance of education regarding risky behaviors
and the necessity for HCV treatment for this population in Taiwan.

Copyright © 2013 Elsevier Ltd. All rights reserved.
__________________________________________________________________
________________________________*_________________________________

11. Abstract: Should North America’s first and only supervised injection
facility (InSite) be expanded in British Columbia, Canada?
__________________________________________________________________

Harm Reduct J. 2013 Feb 16;10(1):1. [Epub ahead of print]

Should North America’s first and only supervised injection facility
(InSite) be expanded in British Columbia, Canada?

Jozaghi EE, Andresen MM.

BACKGROUND: This article reports qualitative findings from a sample of 31
purposively chosen injection drug users (IDUs) from Vancouver, Surrey and
Victoria, British Columbia interviewed to examine the context of safe
injection site in transforming their lives. Further, the purpose is to
determine whether the first and only supervised injection facility (SIF) in
North America, InSite, needs to be expanded to other cities.

METHODS: Semi-structured qualitative interviews were conducted in a
classical anthropological strategy of conversational format as drug users
were actively involved in their routine activities. Purposive sampling
combined with snowball sampling techniques was employed to recruit the
participants. Audio recorded interviews were transcribed verbatim and
analyzed thematically using NVivo 9 software.

RESULTS: Attending InSite has numerous positive effects on the lives of
IDUs including: saving lives, reducing HIV and HCV risk behavior,
decreasing injection in public, reducing public syringe disposal, reducing
use of various medical resources and increasing access to nursing and other
primary health services.

CONCLUSIONS: There is an urgent need to expand the current facility to
cities where injection drug use is prevalent to reduce overdose deaths,
reduce needle sharing, reduce hospital emergency care, and increase safety.
In addition, InSite’s positive changes have contributed to a cultural
transformation in drug use within the Downtown Eastside and neighbouring
communities.

Free full text
http://www.harmreductionjournal.com/content/10/1/1/abstract
__________________________________________________________________
________________________________*_________________________________

12. Abstract: Evaluation of a new reusable insulin pen (ClikSTAR) in
Canadian patients with type 1 and type 2 diabetes mellitus receiving
insulin glargine
__________________________________________________________________
http://www.ncbi.nlm.nih.gov/pubmed/22775367

Diabetes Technol Ther. 2012 Oct;14(10):926-35.

Evaluation of a new reusable insulin pen (ClikSTAR) in Canadian patients
with type 1 and type 2 diabetes mellitus receiving insulin glargine.

Gottesman I, Perron P, Berard L, Stewart J, Basso N, Mettimano K, Elliott
T.

University of Toronto, Mississauga, Ontario, Canada.
irvgottesman@hotmail.com

BACKGROUND: The objective of this Canadian observational study was to
assess the safety and patient satisfaction with the ClikSTAR(®) (sanofi-
aventis, Frankfurt am Main, Germany) reusable insulin pen in clinical
practice.

SUBJECTS AND METHODS: Patients with diabetes (n=2,517) were recruited from
103 sites, provided with the ClikSTAR pen, and instructed to report product
technical complaints (PTCs), product technical failures (PTFs), and adverse
events (AEs) over 6-12 weeks of use. A patient subgroup (n = 301) completed
a pen use questionnaire at 12 weeks. The risk acceptance criterion was that
no validated PTF led to a serious AE (SAE). PTFs were PTCs having a
confirmed technical deficiency.

RESULTS: Patients (68.5% with type 2 diabetes) had a mean age of 56.2
years, and 92.5% were insulin pen users. In total, 84 PTCs were reported by
79 (3.1%) patients. Most PTCs were due to pen handling errors. PTCs from 12
patients were possibly related to AEs, three of which were SAEs; none was
confirmed to be due to a PTF. The single reported PTF was not related to an
AE/SAE. In the substudy, 97.0% and 95.3% of patients rated “ease of
learning” and “ease of use” of the ClikSTAR pen as excellent or good,
respectively. Mean scores for patient satisfaction, convenience,
flexibility, and recommendations of current treatment on the Diabetes
Treatment Satisfaction Questionnaire (change version) had positive changes
ranging from 1.0 to 1.8.

CONCLUSIONS: With ClikSTAR, PTCs were infrequent, and there were no PTFs
associated with AEs, demonstrating that the pen is reliable and safe with
high levels of patient acceptance and satisfaction.
__________________________________________________________________
________________________________*_________________________________

13. Abstract: Dose sparing intradermal trivalent influenza (2010/2011)
vaccination overcomes reduced immunogenicity of the 2009 H1N1 strain
__________________________________________________________________
http://www.ncbi.nlm.nih.gov/pubmed/22910287

Vaccine. 2012 Oct 5;30(45):6427-35.

Dose sparing intradermal trivalent influenza (2010/2011) vaccination
overcomes reduced immunogenicity of the 2009 H1N1 strain.

Hung IF, Levin Y, To KK, Chan KH, Zhang AJ, Li P, Li C, Xu T, Wong TY, Yuen
KY.

State Key Laboratory for Emerging Infectious Diseases, Carol Yu’s Centre
for Infection and Division of Infectious Diseases, The University of Hong
Kong, Queen Mary Hospital, Hong Kong Special Administrative Region, Hong
Kong. ivanfn@gmail.com

BACKGROUND: We hypothesized that low dose intradermal vaccination of the
trivalent influenza vaccine (TIV) delivered by the MicronJet600™ (NanoPass
Technologies, Israel) would be non-inferior to the full dose intramuscular
and mid dose Intanza(®) vaccination in the elderly and the chronically ill
adults.

METHODS: We performed a prospective randomized trial on elderly and
chronically ill adults. Subjects were randomly assigned into 4 groups.
Groups ID3 and ID9 received reduced dose ID TIV (3 µg and 9 µg of
hemagglutinin (HA) per strain respectively) delivered by MicronJet600™
(NanoPass Technologies, Israel). Group INT9 received reduced dose ID TIV (9
µg) delivered by Becton Dickinson’s Soluvia™ device (Intanza(®)9, Sanofi-
Pasteur, France). Control group IM15 received a full dose IM TIV (15 µg).
We measured antibody titers by hemagglutination inhibition (HAI) and
microneutralization (MN) assays at baseline and day 21.

RESULTS: Baseline characteristics for all groups were similar (group and
sample sizes: ID3=63; ID9=68; INT9=65; and IM15=66). At day 21 post
vaccination, the GMT ratio and the seroconversion rates difference for all
three strains of the ID vaccine groups were non-inferior to the IM vaccine
group. The seroconversion rate, seroprotection rate, and the GMT of the
H1N1 strains by HAI and MN assays were significantly higher in the ID
groups compared with the full dose IM vaccine group. The seroconversion
rates of the H3N2 strain by HAI assay were also significantly higher in the
ID groups when compared with the full dose IM group. Direct comparison
among the three ID groups showed no significant differences. No serious
adverse events related to vaccination were reported.

CONCLUSION: Dose-sparing ID TIV can overcome reduced immunogenicity of the
H1N1 strain, and according to some measures, for the H3N2 strain. At risk
subjects indicated for the TIV should be considered for intradermal
immunization to compensate for reduced immunogenicity.

Copyright © 2012 Elsevier Ltd. All rights reserved.
__________________________________________________________________
________________________________*_________________________________

14. Abstract: Immunity to hepatitis B virus infection two decades after
implementation of universal infant hepatitis B vaccination: the
association of detectable residual antibody and response to a single
hepatitis B vaccine challenge dose
__________________________________________________________________

http://www.ncbi.nlm.nih.gov/pubmed/23408522

Clin Vaccine Immunol. 2013 Feb 13.

Immunity to hepatitis B virus infection two decades after implementation of
universal infant hepatitis B vaccination: the association of detectable
residual antibody and response to a single hepatitis B vaccine challenge
dose.

Spradling PR, Xing J, Williams R, Masunu-Faleafaga Y, Dulski T, Mahamud A,
Drobeniuc J, Teshale EH.

Division of Viral Hepatitis, Centers for Disease Control and Prevention,
Atlanta, GA.

Most persons who receive hepatitis B vaccine during infancy will have a
level of antibody to hepatitis B surface antigen (anti-HBs) <10 IU/L if
measured 10-15 years later; however, most will demonstrate immune memory by
an anamnestic response to a vaccine challenge dose. To determine whether
there was a difference in anamnestic response among college students
vaccinated during infancy, we compared anti-HBs levels after a dose of
Engerix-B 20 µg between those with a residual anti-HBs level of 0 IU/L
versus those with a level of 1-9 IU/L.

Anti-HBs was measured before (baseline) and two weeks after a challenge
dose; response was defined as a level =10 IU/L after the dose among those
<10 IU/L at baseline. Among 153 students who completed the study, 130 (85%)
had an anti-HBs level <10 IU/L at baseline; 72 had a level of 0 IU/L and 58
had a level ranging from 1 to 9 IU/L. Students with a level from 1-9 IU/L
were more likely to respond to the challenge dose compared to those with a
baseline anti-HBs level of 0 IU/L (83% versus 50%; p<0.001).

The presence of any detectable anti-HBs among persons vaccinated in the
remote past may indicate the persistence of immune memory.
__________________________________________________________________
________________________________*_________________________________

15. No Abstract: Corticosteroid injections: serious infections and necrosis
__________________________________________________________________
http://www.ncbi.nlm.nih.gov/pubmed/23383409

Prescrire Int. 2013 Jan;22(134):17.

Corticosteroid injections: serious infections and necrosis.

[No authors listed]
__________________________________________________________________
________________________________*_________________________________

16. Summary: Scaling Up mHealth: Where Is the Evidence?
__________________________________________________________________
PLoS Med 10(2): e1001382

Scaling Up mHealth: Where Is the Evidence?

Mark Tomlinson, Mary Jane Rotheram-Borus, Leslie Swartz, Alexander C. Tsai

Published: February 12, 2013

Copyright: © 2013 Tomlinson et al.

Provenance: Not commissioned; externally peer reviewed.

Summary Points

Despite hundreds of mHealth pilot studies, there has been insufficient
programmatic evidence to inform implementation and scale-up of mHealth.

We discuss what constitutes appropriate research evidence to inform scale
up.

Potential innovative research designs such as multi-factorial strategies,
randomized controlled trials, and data farming may provide this evidence
base.

We make a number of recommendations about evidence, interoperability, and
the role of governments, private enterprise, and researchers in relation to
the scale up of mHealth.

This is an open-access article
http://www.plosmedicine.org/article/info:doi/10.1371/journal.pmed.1001382
__________________________________________________________________
________________________________*_________________________________

17. News

– USA: Hepatitis C Bills Get First Airing
– Technology: Preventing Diseases May Soon Be As Simple As Applying A
Band-Aid
– Devices: PharmaJet`s StratisNeedle-free Injector Receives WHO PQS
Certification as a Pre-qualified Delivery Device for Vaccine
Administration

Selected news items reprinted under the fair use doctrine of international
copyright law: http://www4.law.cornell.edu/uscode/17/107.html
__________________________________________________________________
USA: Hepatitis C Bills Get First Airing
Aaron Sanborn, Seacoastonline (19.02.13)

The New Hampshire state House will hold hearings this month on two bills
formulated in response to the hepatitis C outbreak at Exeter Hospital. The
outbreak was caused when a technician with the disease allegedly injected
himself with fentanyl meant for patients, then refilled the contaminated
syringes with another liquid and used them on patients.

On February 21, House Bill 658 will be heard. It seeks to establish a
“Medical Technician Registration Board” that would track individual
healthcare workers in the state and would build a database of those workers
not licensed or registered by the state. The database would maintain
records on registrants for 15 years, with a corresponding designation of
active, inactive, suspended, revoked, or retired. The board will accept
written complaints from the public against registrants, conduct necessary
investigations, and hold hearings. The board also will be required to share
information with appropriate in-state and out-of-state boards.

Rep. Tim Copeland (R-Stratham), the primary sponsor, is working on some
minor amendments to the bill. He said a section will be added to give
individuals the right to file civil action to recover damages if they are
injured by a medical technician who violates a provision of the law.

The second bill, House Bill 597, will be heard in the House Health, Human
Services, and Elderly Affairs Committee on February 26. This bill would
require health facilities to conduct random drug testing at least four
times a year on healthcare employees working at the facility. Local
lawmakers stated that they wanted to introduce a bill that would close
loopholes that allow traveling technicians to get jobs at hospitals after
being fired in another state.
__________________________________________________________________
__________________________________________________________________
http://tinyurl.com/b5t3rtj

Technology: Preventing Diseases May Soon Be As Simple As Applying A Band-
Aid
Jennifer Welsh, Business Insider(16.02.13)

This post is part of the Roadmap To The Future Series. Roadmap To The
Future explores innovative industry trends and breakthroughs in science,
entertainment, and technology. This series is sponsored by Verizon.

An innovative new way to deliver vaccines could drastically improve the
health of the third world, and even the first world, by making vaccines
cheaper and easier to distribute and use. The “vaccine patch” would be as
easy to apply as a Band-Aid, and would be stable for weeks at room
temperature.

“You could potentially get a vaccine patch over the counter from your
pharmacist, go home, and wear it for a couple minutes, then pull it off,
and that’s your vaccine,” researcher Peter DeMuth told Business Insider.
The patch differs from the nicotine and birth control patches currently in
use. It uses tiny “microneedles” coated in DNA, which is deposited into the
very outer layer of the skin. The needles are so small they are painless,
they don’t pierce down to the level of blood vessels so there’s no
bleeding, and no risk of infection.

“What we’ve shown in the paper is that we can make these coatings in the
right way we can apply the microneedle to the skin of the patient, for only
10 to 15 minutes, and then remove the needles and those coatings will be
deposited into the skin,” DeMuth said.

Acquiring immunity

Multiple groups are working to design these microneedle vaccination
patches. The most recent work was published in Jan. 27 in Nature Materials,
and came from DeMuth, a graduate student at M.I.T in the lab of Darrell
Irvine.

DNA vaccines work by inserting strands of DNA, the molecule that holds the
instructions that keep our bodies working, into the body’s cells. The DNA
holds the code for a protein — a protein from a virus or bacteria, for
example — which the body senses is foreign.

“We just deliver the DNA and allow the cells of your body, the patient’s
body, to produce those for us,” DeMuth said.

The body mounts an immune defense to this foreign protein, and this
response is what protects us from that disease when it tries to invade us
and sicken us — the immune system recognizes the foreign protein and is
able to vanquish the invading virus or bacteria before it gets a foothold
in the body.

Though they worked in small animals in the lab, previous attempts to make
DNA vaccines failed when they reached monkey trials, but those vaccines
were injected into the muscles, which isn’t the ideal place to mount an
immune defense. In theory DNA vaccines worked, but it seemed as if the idea
had hit an impasse.

A new approach

To make DNA vaccines work, researchers had to go back to the drawing board
and think up new ways to administer the DNA. “DNA vaccines could make a big
difference in the way we immunize people, but we are still kind of stuck at
this place where it’s difficult to get human cells to take up DNA and
express it as proteins in the same ways that small animal models do, ”
DeMuth said.

For the study, they tested a new way of applying vaccine — coating
microneedles in DNA and having them pierce the outer layer of the skin,
depositing the DNA package inside. They made these microneedles, which are
half a millimeter long, into patches and checked out how effective they
were in mice and monkeys.

The needles can be coated in different layers which would change the way
the vaccine is released into the skin — faster or slower, or even in a
certain sequence.

They tested mice and monkeys with a centimeter-wide circle of microneedles,
applied directly to the skin. The skin is where our body is fighting off
infections every day, so it’s full of disease fighting white blood cells
that are primed to react to these foreign proteins. They saw this skin-
based application really worked to improve the body’s reaction to the DNA
vaccination.

For the test, the needles were coated with the DNA that encodes a glowing
protein from fireflies. If the DNA got into the animal’s cells and was
expressed, then the skin should glow, which it did.

Then they had to check to see if the cells were making proteins that got
into the blood and activated the immune system, which they checked using a
protein from the monkey version of HIV, the virus that causes AIDS. They
then checked the animal’s blood for evidence that it had reacted to the
proteins, recognizing them as foreign, which they had.

“The good news is that all the studies up to now, in mice and in primates,
have looked very promising, so the next step would be to verify this more
robustly in primates,” DeMuth said.

There’s still a lot of work left to do to get the patch working in humans
and through clinical trials, but when approved, the patch vaccine will have
plenty of advantages.

A major improvement

First, DNA is easier to make in large quantities than proteins are.
Secondly, once created, the patches don’t need to be refrigerated — they
survive just fine for weeks on end at room temperature. This makes them
easier and cheaper to transport and administer, especially in third-world
countries where refrigeration is expensive and needles are incredibly
dangerous.

“DNA has the advantage that it could be potentially more stable for
transportation for distribution throughout the world as a vaccine,” DeMuth
said. That would drastically diminish the costs of immunizing against
disease in third-world countries.

“Those are the places you want vaccines to go and we need to find a way to
eliminate that necessity for refrigeration if we are going to vaccinate
those people who are most at risk,” DeMuth said.

Third, the patches would remove the need for needles for application of
vaccines. Needles spread disease because they are reused, are expensive,
and require training to use. Needle puncture wounds can also get infected.
Because the patch doesn’t breach the outer layers of the skin, it never
reaches the blood vessels and would be much less likely to become infected.
Also, using a DNA vaccine is much safer than vaccinating with a dead or
mutated virus, as most traditional vaccines do. These could contain small
amounts of live or healthy virus or bacteria that could cause infections.
“For example, HIV is a virus, and the risk is if you would give that virus
to a patient in a vaccine form, even if it is weakened, there is still the
potential that you could actually cause infection as opposed to just
eliciting the immunity you are looking for,” DeMuth told us.

Flexible technology

Another great thing about DNA vaccines? They can be made for almost any
thing, including many of the diseases we already have vaccines for. DNA can
be made that can create any protein — be it part of a virus, a bacteria,
fungus, or even tumor cells. Just about any current vaccine could be
changed into a DNA patch vaccine.

“Every vaccine, for the most part, is centered around proteins and every
protein can be generated from a piece of DNA,” DeMuth said. “DNA is a
starting place for everything that we would want to immunize against.” The
patch technology isn’t just for viruses and bacteria though, several
researchers are also developing “vaccines” for things like cancer. These
would train the body to recognize tumor cells by the kinds of proteins they
made (some of which are different from the proteins in our normal body
cells). “You can even develop a DNA vaccine that encoded a piece of protein
that distinguishes tumor cells from self or healthy cells, and you could
use that to immunize against cancer,” DeMuth said. As the technology
improves, we should start seeing microneedle patch vaccines in human trials
in about a decade.

* Copyright © 2013 Business Insider, Inc
__________________________________________________________________
__________________________________________________________________
Devices: PharmaJet`s StratisNeedle-free Injector Receives WHO PQS
Certification as a Pre-qualified Delivery Device for Vaccine Administration
Business Wire, Press Release, USA (11.02.13)

GOLDEN, Colo.–(Business Wire)– PharmaJet Inc. has become the first and
only needle-free injection company to receive Performance, Quality and
Safety (PQS) pre-qualified certification from the World Health Organization
(WHO).

The WHO uses its Department of Immunization, Vaccines and Biologicals to
pre-qualify vaccines and devices for safe immunizations. The Quality,
Safety and Standards Team pre-qualifies a comprehensive range of cold chain
equipment, injection devices and other products needed for safe and
effective immunization delivery. PQS certification allows purchase and use
of Stratis jet injectors for mass immunization campaigns by WHO, The Global
Alliance for Vaccines and Immunization (GAVI) and UNICEFworldwide.

Vaccine magazine`s July 2012 issue reported that 24% of adults and 63% of
children in the U.S. are fearful of needles and this has a direct impact on
immunization non-compliance.1 It is estimated that 7% to 17% of the U.S.
population choose to forego vaccinations due to fear of needles.2 Needle-
free jet injectors have been used in the U.S. and other countries to
deliver millions of vaccinations.3

The PharmaJet Stratis needle-free injection system received FDA 510(k)
clearance in July 2011 for delivery of various medications and vaccines and
also achieved CE Marking in 2012 allowing use in the European Economic
Area.

About PharmaJet Inc. and Needle-free Injection Technology:

PharmaJet`s innovative needle-free injection technology delivers drugs and
vaccines to intramuscular, subcutaneous and intradermal tissue depths.
PharmaJet injectors use pressure to create a fine stream of liquid that
penetrates the skin, delivering doses to the desired depth, while
eliminating risks of needle-stick injuries and the cost burden of “sharps”
waste management. Further benefits of PharmaJet injectors include the
potential for dose-sparing of vaccines, reducing the overall cost of
vaccine delivery. PharmaJet`s needle-free injectors have received FDA
510(k) marketing clearances for use to deliver various liquid medicines and
vaccines. The PharmaJet system has been well received in the developed
world, and is also advantageous in the developing world due to its
usability, affordability and inherent safety features. For more
information on PharmaJet`s needle-free injection technology, please visit
http://www.pharmajet.com/.

PharmaJet and Stratis are trademarks of PharmaJet Inc.

References

1.Vaccine, Volume 30, Issue 32, 6 July 2012, pp 4807-4812, “Survey of the
Prevalence of Immunization Non-compliance Due to Needle Fears in Children
and Adults”.

2. The American Journal of Medicine, Vol. 121, No. 7B, July 2008, Johnson
et al, “Barriers to Adult Immunization”, pp S28-S35.

3. Vaccines, 5th ed. Philadelphia, PA: Saunders (Elsevier); 2008;
1357-1392, Weniger BG, Papania MJ, “Alternative Vaccine Delivery Methods”
[Chapter 61].

PharmaJet Inc.
Shannon O’Reilly, 1.303.526.4278
support@pharmajet.com

Copyright Business Wire 2013
__________________________________________________________________
________________________________*_________________________________
* SAFETY OF INJECTIONS brief yourself at: www.injectionsafety.org

A fact sheet on injection safety is available at:
http://www.who.int/mediacentre/factsheets/fs231/en/index.html

* Visit the WHO injection safety website and the SIGN Alliance Secretariat
at: http://www.who.int/injection_safety/en/

* Download the WHO Best Practices for Injections and Related Procedures
Toolkit March 2010 [pdf 2.47Mb]:
http://whqlibdoc.who.int/publications/2010/9789241599252_eng.pdf

Use the Toolbox at: http://www.who.int/injection_safety/toolbox/en/

Get SIGN files on the web at: http://signpostonline.info/signfiles-2
get SIGNpost archives at: http://signpostonline.info/archives-by-year

Like on Facebook: http://facebook.com/SIGN.Moderator

The SIGN Secretariat, the Department of Health Systems Policies and
Workforce, WHO, Avenue Appia 20, CH-1211 Geneva 27, Switzerland.
Facsimile: +41 22 791 4836 E- mail: sign@who.int
__________________________________________________________________
________________________________*_________________________________

SIGN meets annually to aid collaboration and synergy among SIGN network
participants worldwide.

The 2010 annual Safe Injection Global Network meeting was held from 9
to 11 November 2010 in Dubai, The United Arab Emirates.

The SIGN 2010 meeting report pdf, 1.36Mb is available on line at:
http://www.who.int/entity/injection_safety/toolbox/sign2010_meeting.pdf

The report is navigable using bookmarks and is searchable. Viewing
requires the free Adobe Acrobat Reader at: http://get.adobe.com/reader/

Translation tools are available at: http://www.google.com/language_tools
or http://www.freetranslation.com
__________________________________________________________________
________________________________*_________________________________
All members of the SIGN Forum are invited to submit messages, comment on
any posting, or to use the forum to request technical information in
relation to injection safety.

The comments made in this forum are the sole responsibility of the writers
and does not in any way mean that they are endorsed by any of the
organizations and agencies to which the authors may belong.

Use of trade names and commercial sources is for identification only and
does not imply endorsement.

The SIGN Forum welcomes new subscribers who are involved in injection
safety.

* Subscribe or un-subscribe by email to: sign.moderator@gmail.com, or to
sign@who.int

The SIGNpost Website is http://SIGNpostOnline.info

The new website is a work in progress and will grow to provide an archive
of all SIGNposts, meeting reports, field reports, documents, images such as
photographs, posters, signs and symbols, and video.

We would like your help in building this archive. Please send your old
reports, studies, articles, photographs, tools, and resources for posting.

Email mailto:sign.moderator@gmail.com
__________________________________________________________________
________________________________*_________________________________

The SIGN Internet Forum was established at the initiative of the World
Health Organization’s Department of Essential Health Technologies. The
SIGN Forum is moderated by Allan Bass and is hosted on the University of
Queensland computer network. http://www.uq.edu.au
__________________________________________________________________

Comments are closed.