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SIGNpost 00790

*SAFE INJECTION GLOBAL NETWORK* SIGNPOST

Post00790 New Injection Safety Guidelines/Global Campaign 25 February 2015

Towards safe injections for all

CONTENTS

1. New WHO Injection Safety Guidelines
2. New injection safety policy and global campaign
3. WHO calls for worldwide use of “smart” syringes
4. HCWH to Present and Launch Database of Healthcare Waste Treatment
Technologies at WHO Meeting
5. Abstract: International governance structures for health-care waste
management: A systematic review of scientific literature
6. Abstract: Knowledge of Hepatitis B Virus Infection, Immunization with
Hepatitis B Vaccine, Risk Perception, and Challenges to Control
Hepatitis among Hospital Workers in a Nigerian Tertiary Hospital
7. Abstract: Taking care of themselves: how long-term injection drug users
remain HIV and Hepatitis C free
8. Abstract: A Community Care Model of Intravenous Antibiotic Therapy for
Injection Drug Users with Deep Tissue Infection for “Reduce Leaving
Against Medical Advice”
9. Abstract: Subcutaneous and intravenous ceftriaxone administration in
patients more than 75 years of age
10. Abstract: Long-term complications associated with permanent dermal
fillers
11. Abstract: A strategy for the prevention of protein oxidation by drug
product in polymer-based syringes
12. Abstract: Non-destructive vacuum decay method for pre-filled syringe
closure integrity testing compared with dye ingress testing and high-
voltage leak detection
13. Abstract: Factors influencing field testing of alcohol-based hand rubs
14. Abstract: Challenges in the delivery of peptide drugs: an industry
perspective
15. No Abstract: Gloves on, gloves off. Gloves don’t protect if they
aren’t removed at the proper times16. News
– Global: Why it took so long for the world to start using ‘smart,’ self-
destructing syringes
– Global: One man’s campaign to eradicate the dirty needles that kill 1.3
million a year
– Global: How Did A Celibate 82-Year-Old Buddhist Monk Contract HIV?
– Global: WHO urges shift to single-use smart syringes
– Cambodia: Healthy dose of hope for one-use syringes
– Africa: Drug abuse: ‘Injections fueling HIV infections’

The web edition of SIGNpost is online at:
http://signpostonline.info/archives/1814

More information follows at the end of this SIGNpost!

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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

Like SIGNpost on Facebook at: https://www.facebook.com/SIGN.Moderator
and get updates on your device!
__________________________________________________________________
________________________________*_________________________________

1. New WHO Injection Safety Guidelines
__________________________________________________________________
New WHO Injection Safety Guidelines

WHO is urging countries to transition, by 2020, to the exclusive use of
the new “smart” syringes, except in a few circumstances in which a syringe
that blocks after a single use would interfere with the procedure.

The new guideline is “Who guideline on the use of safety-engineered
syringes for intramuscular, intradermal and subcutaneous injections in
health care”.

It is available for free download or viewing at the link:
www.who.int/injection_safety/global-campaign/injection-safety_guidline.pdf

PDF Requires Adobe Acrobat Reader [620 KB]
__________________________________________________________________
________________________________*_________________________________

2. New injection safety policy and global campaign
__________________________________________________________________
New injection safety policy and global campaign

Each year, at least 16 billion injections are given worldwide. Reused
equipment poses a continued challenge, particularly in developing
countries. WHO and Safe Injection Global Network (SIGN) have a new
initiative to address this, promoting the rational and safe use of
injections.

Key initiative objectives are: (1) to prevent reuse and needle-stick
injuries through global communication campaigns and health- care worker
training; (2) to better ensure injection safety through the use of safety
engineered injection devices; and (3) to leverage past WHO SIGN network
findings.
__________________________________________________________________
Injection safety policy and global campaign

All of us, at some point in our lives, will have an injection to retain or
restore good health. But sometimes injections that are intended to promote
health do the opposite. This happens when they are given in an unsafe way
– using the same needle or syringe to give injections to more than one
person. Practices like this can lead to the transmission of life-
threatening infections.

According to a new study, unsafe injections are responsible for as many as
33 800 HIV infections, 1.7 million hepatitis B infections and 315 000
hepatitis C infections annually. Both patients and health workers are at
risk through needle injury.

Towards safe injections for all

WHO and close partners – including the Safe Injection Global Network
(SIGN), UNICEF and GAVI, the Vaccine Alliance – have been working actively
together for more than a decade to promote safe injection practices.
Educating policy makers and health workers on the critical importance of
sterile equipment is key. The group’s initial push in 1999 focused
strongly on spurring countries to use only auto-disable syringes for
vaccinating children. Now the spotlight is on the risks associated with
injections into muscle (intramuscular) or skin (subcutaneous or
intradermal) to treat medical conditions; and how to make them safer
through education on safe procedures, elimination of unnecessary
injections and better design of equipment.

Making all injections safe brochure
www.who.int/injection_safety/global-campaign/injection-safety_brochure.pdf
pdf, 554kb [6 pages]

Breakthrough: The new smart syringes

The surest way to protect against unsafe injections is to use injection
devices that have been engineered so they cannot be re-used and don’t lead
to accidental needle stick injuries among health workers.

Re-use prevention features are essentially the same as the auto-disable
features designed for immunization of a single child. The main difference
is that syringes designed for delivering medicines allow the health worker
to adjust the dose as needed and to move the plunger twice when it is
necessary to mix two different medicines in one syringe or for the
reconstitution of vaccines and medicines where appropriate. Some models
include a weak spot in the plunger that causes it to break if the user
attempts to pull back on the plunger after the injection. Others have a
metal clip that blocks the plunger so it cannot be moved back while in
others the needle retracts into the syringe barrel at the end of the
injection.

Syringes are also being engineered with features to protect health workers
from “needle stick” injuries and resulting infections. A sheath or hood
slides over the needle after the injection is completed to protect the
user from being injured accidentally by the needle. These syringes also
generally have a re-use prevention feature.

WHO guideline on the use of safety-engineered syringes for intramuscular,
intradermal and subcutaneous injections in health-care settings

www.who.int/injection_safety/global-campaign/injection-safety_guidline.pdf
pdf, 620kb [32 pages]

Stakeholder support: What needs to happen, who needs to do it

The injection safety policy and global campaign is a three to five year
initiative that engages many public and private sector stakeholders such
as Ministries of Health, international donor programmes, industry players
and umbrella organizations representing injection device manufacturers and
health care workers.

Some critical goals of the initiative include:

Governments

* By 2020 transition to the exclusive use, where appropriate, of safety-
engineered injection devices with re-use prevention and sharps (needle)
injury prevention. These devices should meet WHO quality standards.

* Set health-system-wide policies and standards for procurement, use and
safe disposal of disposable syringes in situations where they remain
necessary, including in syringe programmes for people who inject drugs.

* Develop an implementation strategy for safety syringes’ procurement,
training and education of health workers and sound waste management.
Establish a targeted communications programme and a framework for
evaluating overall progress.

Donors and development partners

* Only fund procurement of safety-engineered injection devices in all
projects that include administration of injectable medicines.

*Provide funding for ancillary needs, including appropriate quantities of
single-dose diluents and safety boxes, sharps waste management and health
worker training.

Manufacturers

* Begin or expand production as soon as possible of safety-engineered
injection devices while maintaining sufficient production of single-use
disposable syringes.

* Seek WHO Performance, Quality and Safety prequalification for their
products.

WHO is beginning to pilot test elements of the injection safety policy and
global campaign throughout 2015 and will announce and integrate lessons
learned.
__________________________________________________________________
________________________________*_________________________________

3. WHO calls for worldwide use of “smart” syringes
__________________________________________________________________
WHO calls for worldwide use of “smart” syringes

Press release

23 FEBRUARY 2015 | GENEVA – Use of the same syringe or needle to give
injections to more than one person is driving the spread of a number of
deadly infectious diseases worldwide. Millions of people could be
protected from infections acquired through unsafe injections if all
healthcare programmes switched to syringes that cannot be used more than
once. For these reasons, WHO is launching a new policy on injection safety
to help all countries tackle the pervasive issue of unsafe injections.*

A 2014 study sponsored by WHO, which focused on the most recent available
data, estimated that in 2010, up to 1.7 million people were infected with
hepatitis B virus, up to 315 000 with hepatitis C virus and as many as 33
800 with HIV through an unsafe injection. New WHO injection safety
guidelines and policy released today provide detailed recommendations
highlighting the value of safety features for syringes, including devices
that protect health workers against accidental needle injury and
consequent exposure to infection.

WHO also stresses the need to reduce the number of unnecessary injections
as a critical way of reducing risk. There are 16 billion injections
administered every year. Around 5% of these injections are for immunizing
children and adults, and 5% are for other procedures like blood
transfusions and injectable contraceptives. The remaining 90% of
injections are given into muscle (intramuscular route) or skin
(subcutaneous or intradermal route) to administer medicines. In many cases
these injections are unnecessary or could be replaced by oral medication.

“We know the reasons why this is happening,” says Dr Edward Kelley,
Director of the WHO Service Delivery and Safety Department. One reason is
that people in many countries expect to receive injections, believing they
represent the most effective treatment. Another is that for many health
workers in developing countries, giving injections in private practice
supplements salaries that may be inadequate to support their families.”

Transmission of infection through an unsafe injection occurs all over the
world. For example, a 2007 hepatitis C outbreak in the state of Nevada,
United States of America, was traced to the practices of a single
physician who injected an anaesthetic to a patient who had hepatitis C.
The doctor then used the same syringe to withdraw additional doses of the
anaesthetic from the same vial – which had become contaminated with
hepatitis C virus – and gave injections to a number of other patients. In
Cambodia, a group of more than 200 children and adults living near the
country’s second largest city, Battambang, tested positive for HIV in
December 2014. The outbreak has been since been attributed to unsafe
injection practices.

“Adoption of safety-engineered syringes is absolutely critical to
protecting people worldwide from becoming infected with HIV, hepatitis and
other diseases. This should be an urgent priority for all countries,” says
Dr Gottfried Hirnschall, Director of the WHO HIV/AIDS Department.

The new “smart” syringes WHO recommends for injections into the muscle or
skin have features that prevent re-use. Some models include a weak spot in
the plunger that causes it to break if the user attempts to pull back on
the plunger after the injection. Others have a metal clip that blocks the
plunger so it cannot be moved back, while in others the needle retracts
into the syringe barrel at the end of the injection.

Syringes are also being engineered with features to protect health workers
from “needle stick” injuries and resulting infections. A sheath or hood
slides over the needle after the injection is completed to protect the
user from being injured accidentally by the needle and potentially exposed
to an infection.

WHO is urging countries to transition, by 2020, to the exclusive use of
the new “smart” syringes, except in a few circumstances in which a syringe
that blocks after a single use would interfere with the procedure. One
example is when a person is on an intravenous pump that uses a syringe.

The Organization is also calling for policies and standards for
procurement, safe use and safe disposal of syringes that have the
potential for re-use in situations where they remain necessary, including
in syringe programmes for people who inject drugs. Continued training of
health workers on injection safety – which has been supported by WHO for
decades – is another key recommended strategy. WHO is calling on
manufacturers to begin or expand production as soon as possible of ”smart”
syringes that meet the Organization’s standards for performance, quality
and safety.

“The new policy represents a decisive step in a long-term strategy to
improve injection safety by working with countries worldwide. We have
already seen considerable progress,” Dr Kelley says. Between 2000 and
2010, as injection safety campaigns picked up speed, re-use of injection
devices in developing countries decreased by a factor of 7. Over the same
period, unnecessary injections also fell: the average number of injections
per person in developing countries decreased from 3.4 to 2.9. In addition,
since 1999, when WHO and its partner organizations urged developing
countries to vaccinate children only using syringes that are automatically
disabled after a single use, the vast majority have switched to this
method.

Syringes without safety features cost US$ 0.03 to 0.04 when procured by a
UN agency for a developing country. The new “smart” syringes cost at least
twice that much. WHO is calling on donors to support the transition to
these devices, anticipating that prices will decline over time as demand
increases.

Note:

The study cited in this news release, “Evolution of the Global Burden of
Viral Infections from Unsafe Medical Injections, 2000–2010”, was authored
by J Pépin et al and published in PLoS ONE 9(6): e99677.
doi:10.1371/journal.pone.0099677.

The title of the new guideline is “Who guideline on the use of safety-
engineered syringes for intramuscular, intradermal and subcutaneous
injections in health care”.

* Corrigenda: This sentence was updated on 24th February 2015.
__________________________________________________________________
________________________________*_________________________________

4. HCWH to Present and Launch Database of Healthcare Waste Treatment
Technologies at WHO Meeting
__________________________________________________________________
http://tinyurl.com/pqxn3kl

HCWH to Present and Launch Database of Healthcare Waste Treatment
Technologies at WHO Meeting

Geneva – On February 23-24, the World Health Organization’s (WHO) Safe
Injection Global Network (SIGN) will be meeting to launch the new WHO
policy on Injection Safety. Every year, SIGN meets to facilitate
collaboration and synergies among participants of the safe injection
global network. This year, the Director General of the WHO will be
presenting the new policy on Injection Safety, which calls for health
systems to use only injection devices with needlestick injury and reuse
prevention features in health services.

As part of this event, Ruth Stringer, Health Care Without Harm’s (HCWH)
International Science and Policy Coordinator will report on the waste
management implications of the new policy, and the starting of the
WHO/HCWH/UNDP/GEF Global Healthcare Waste Project in Africa that will
demonstrate model health-care waste management and best environmental
practices. These best practices will include non-incineration healthcare
waste treatment and mercury-free technologies and ensure the availability
and affordability of non-incineration waste treatment technologies in the
region.

Stringer will also present and demonstrate HCWH’s new global Healthcare
Waste Treatment Technologies Database.
http://www.medwastealternatives.org/

The database has been created to aid hospitals and health systems in the
procurement of appropriate technologies, and lists suppliers from around
the world of non- incineration technologies, such as autoclaves, different
steam and heat based technologies, and chemical based technologies to
treat infectious wastes and destroy pathological wastes and laboratory
cultures. It also includes equipment such as needle or syringe destroyers
that can help prevent needlestick injuries. Information about each vendor
includes contact details, countries where equipment is.

The database has been created to aid hospitals and health systems in the
procurement of appropriate technologies, and lists suppliers from around
the world of non-incineration technologies, such as autoclaves, different
steam and heat based technologies, and chemical based technologies to
treat infectious wastes and destroy pathological wastes and laboratory
cultures. It also includes equipment such as needle or syringe destroyers
that can help prevent needlestick injuries. Information about each vendor
includes contact details, countries where equipment is

The database aims to “reduce carbon emissions, particulate air pollution
and prevent releases of carcinogenic dioxins and furans as called for by
the Stockholm Convention”, said Stringer. The database can be found at:
www.medwastealternatives.org

Susan Wilburn, Sustainability Director of Global Green and Healthy
Hospitals – a project of HCWH – will also be chairing one of the panels.
She said: “HCWH celebrates this historic event which will support health
workers to do their job more safely and effectively for their patients and
their own health.”

Also attending the meeting are Mahesh Nakarmi, Director of the Healthcare
Waste Management program of HCWH’s Strategic Partner, Health Care
Foundation Nepal (HECAF) and Saraswoti Thakuri. HECAF has been
developing the medical waste management system at the country’s oldest
major hospital, the 460 bed Bir Hospital in Kathmandu, since 2010. Thanks
to their intervention, the hospital is now almost completely mercury free
and is autoclaving the infectious waste from the wards and chemically
deactivating cytotoxic pharmaceutical waste. While HECAF led the project,
HCWH has worked closely with them and provided technical expertise on
issues from validating the disinfection processes, reporting, biodigestion
and chemical disposal.
__________________________________________________________________
________________________________*_________________________________

5. Abstract: International governance structures for health-care waste
management: A systematic review of scientific literature
__________________________________________________________________
http://www.ncbi.nlm.nih.gov/pubmed/25687810

J Environ Manage. 2015 Feb 13;153C:93-107.

International governance structures for health-care waste management: A
systematic review of scientific literature.

Caniato M1, Tudor T2, Vaccari M3.

1Research Laboratory on Appropriate Technologies for Environmental
Management in Resource-Limited Countries (CeTAmb LAB), University of
Brescia, Brescia, Italy. Electronic address: marcocaniato@gmail.com.
2Centre for Sustainable Waste Management, School of Science and
Technology, University of Northampton, Northampton, UK.
3Research Laboratory on Appropriate Technologies for Environmental
Management in Resource-Limited Countries (CeTAmb LAB), University of
Brescia, Brescia, Italy.

Significant differences exist in the management of health-care waste
management, globally. This is particularly so between low, middle and
high-income countries.

A systematic review of scientific literature on global healthcare waste
management spanning the period 2000 – current was undertaken, in order to
identify key policies, practices, challenges and best practice.

The findings were analysed considering the Gross National Income and the
Human Development Index of each country. Effective regulation and
operative definitions of waste categories are key-factors requiring
improvement at the national level. The economic conditions in the country
are an important factor, especially regarding treatment and disposal.

Areas for improvement (e.g. the need for improved governance structures,
the development of regional clusters, as well as sharps waste segregation)
are suggested.

Copyright © 2015 Elsevier Ltd. All rights reserved.

KEYWORDS: Best practices; Challenges; Health-care waste management;
Infectious waste; Medical waste; Treatment and disposal
__________________________________________________________________
________________________________*_________________________________

6. Abstract: Knowledge of Hepatitis B Virus Infection, Immunization with
Hepatitis B Vaccine, Risk Perception, and Challenges to Control
Hepatitis among Hospital Workers in a Nigerian Tertiary Hospital
__________________________________________________________________
http://www.ncbi.nlm.nih.gov/pubmed/25685549

Hepat Res Treat. 2015;2015:439867.

Knowledge of Hepatitis B Virus Infection, Immunization with Hepatitis B
Vaccine, Risk Perception, and Challenges to Control Hepatitis among
Hospital Workers in a Nigerian Tertiary Hospital.

Adekanle O1, Ndububa DA1, Olowookere SA2, Ijarotimi O1, Ijadunola KT2.

1Department of Medicine, Obafemi Awolowo University/Obafemi Awolowo
University Teaching Hospitals Complex, Ile-Ife 220005, Osun State,
Nigeria.
2Department of Community Health, Obafemi Awolowo University/Obafemi
Awolowo University Teaching Hospitals Complex, Ile-Ife 220005, Osun State,
Nigeria.

Background. Studies had reported high rate of hepatitis B infection among
hospital workers with low participation in vaccination programmes,
especially those whose work exposes them to the risk of HBV infection. The
study assessed knowledge of hepatitis B virus infection, risk perception,
vaccination history, and challenges to control hepatitis among health
workers.

Methods. A descriptive cross-sectional study. Consenting health care
workers completed a self-administered questionnaire that assessed
respondents’ general knowledge of HBV, vaccination history and HBsAg
status, risk perception, and challenges to control hepatitis. Data was
analysed using descriptive and inferential statistics.

Results. Three hundred and eighty-two health care workers participated in
the study. There were 182 males and 200 females. The respondents comprised
94 (25%) medical doctors, 168 (44%) nurses, 68 (18%) medical laboratory
technologists, and 52 (14%) pharmacists.

Over 33% had poor knowledge with 35% not immunized against HBV. Predictors
of good knowledge include age less than 35 years, male sex, being a
medical doctor, previous HBsAg test, and complete HBV immunisation.

Identified challenges to control hepatitis include lack of hospital policy
(91.6%), poor orientation of newly employed health workers (75.9%), and
low risk perception (74.6%).

Conclusion. Hospital policy issues and low risk perception of HBV
transmission have grave implications for the control of HBV infection.

Free Full Article http://www.hindawi.com/journals/heprt/2015/439867/
__________________________________________________________________
________________________________*_________________________________

7. Abstract: Taking care of themselves: how long-term injection drug users
remain HIV and Hepatitis C free
__________________________________________________________________
http://www.ncbi.nlm.nih.gov/pubmed/25688570

Sociol Health Illn. 2015 Feb 16.

Taking care of themselves: how long-term injection drug users remain HIV
and Hepatitis C free.

Meylakhs P1, Friedman SR, Mateu-Gelabert P, Sandoval M, Meylakhs N.

1Laboratory for Comparative Social Research, National Research University
Higher School of Economics, St. Petersburg, Russia.

Though prevalence of HIV and especially Hepatitis C is high among people
who inject drugs (PWID) in New York, about a third of those who have
injected for 8-15 years have avoided infection by either virus despite
their long-term drug use.

Based on life history interviews with 35 long- term PWID in New York, this
article seeks to show how successful integration and performance of
various drug using and non-drug using roles may have contributed to some
of these PWID’s staying uninfected with either virus.

We argue that analysis of non-risk related aspects of the lives of the
risk-takers (PWID) is very important in understanding their risk-taking
behaviour and its outcomes (infection statuses). Drawing on work-related,
social and institutional resources, our double-negative informants
underwent both periods of stability and turmoil without getting infected.

© 2015 The Authors. Sociology of Health & Illness © 2015 Foundation for
the Sociology of Health & Illness/John Wiley & Sons Ltd.

KEYWORDS: HIV and HCV prevention; New York City; injection drug users;
qualitative study; role theory
__________________________________________________________________
________________________________*_________________________________

8. Abstract: A Community Care Model of Intravenous Antibiotic Therapy for
Injection Drug Users with Deep Tissue Infection for “Reduce Leaving
Against Medical Advice”
__________________________________________________________________
http://www.ncbi.nlm.nih.gov/pubmed/25685126

Int J Ment Health Addict. 2015;13:49-58.

A Community Care Model of Intravenous Antibiotic Therapy for Injection
Drug Users with Deep Tissue Infection for “Reduce Leaving Against Medical
Advice”

Jafari S1, Joe R1, Elliot D2, Nagji A1, Hayden S1, Marsh DC3.

1Addiction Medicine Program, Vancouver Coastal Health Authority,
Vancouver, BC Canada.
2Department of Social Sciences, York University, 4700 Keele Street,
Toronto, ON M3J 1P3 Canada.
3Community Engagement, Northern Ontario School of Medicine, 935 Ramsey
Lake Road, Sudbury, ON P3E 2C6 Canada.

Deep tissue infection is a serious sequela that often demands intravenous
(IV) antibiotic treatment.

With respect to IV drug users (IDU’s), research and lived experience
demonstrates a trend of failed treatment outcomes, most notably associated
with leaving hospital against medical advice (LAMA) prior to treatment
completion, increased adverse outcomes and patient hardship.

This paper examines an alternative model for delivering and completing IV
antibiotic treatment to IDU’s in a community care setting. A retrospective
study was designed to review client characteristics. A total of 33 in-
depth interviews were conducted with clients, clinicians and with staff.

The impact of treatment adherence and completion, as well as client
satisfaction of care was explored. A total of 165 patients were admitted
during the study period. Osteomyelitis was the primary cause for IV
antibiotics.

Risk of leaving AMA was significantly lower for community model (p value
<0.0000). Qualitative narrative analysis is also described with respect to
satisfaction, stigma and the need for better models of care.

With lower rates of LAMA a community model ought to be considered on a
wider scale for provision of comprehensive support for populations with
complex underlying health needs.

KEYWORDS: Antibiotic therapy; Deep tissue infection; Drug users; LAMA;
Leaving against medical advice

Free Article http://link.springer.com/article/10.1007%2Fs11469-014-9511-4
Free PMC Article http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4320270
__________________________________________________________________
________________________________*_________________________________

9. Abstract: Subcutaneous and intravenous ceftriaxone administration in
patients more than 75 years of age
__________________________________________________________________
http://www.ncbi.nlm.nih.gov/pubmed/24932703

Med Mal Infect. 2014 Jun;44(6):275-80.

Subcutaneous and intravenous ceftriaxone administration in patients more
than 75 years of age.

Gauthier D1, Schambach S1, Crouzet J1, Sirvain S1, Fraisse T2.

1Service de court séjour gériatrique, 811, avenue du Dr-Jean-Goubert,
30100 Ales, France.
2Service de court séjour gériatrique, 811, avenue du Dr-Jean-Goubert,
30100 Ales, France. Electronic address: dr.fraisse@ch-ales.fr.

OBJECTIVE: We wanted to compare the first line intravenous administration
of ceftriaxone to a subcutaneous administration in patients more than 75
years of age.

METHOD: We performed a retrospective monocentric study on all patients
more than 75 years of age admitted to the Ales hospital between January 1
and December 31, 2011, having received at least two doses of ceftriaxone
intravenously (IV) or subcutaneously (SC).

RESULTS: One hundred and forty-eight patients (70 females/78 males
patients) were included, 110 received ceftriaxone IV and 38 SC. They were
a mean age of 84.7 years, older in the SC group (86.9 years) than in the
IV group (83.9 years) (P = 0.0052). The SC group patients presented more
frequently with dementia (57% vs. 25% P = 0.001), were more often
bedridden (22% vs. 7% P = 0.023), had a higher mean World Health
Organization status (3.13 vs. 2.76, P = 0.0181), and higher ADL score
(7.79 vs. 5.76, P = 0.0056). There was no statistical difference for
isolated bacteria, site of infection, death rate, and patients cured.

CONCLUSION: Subcutaneous ceftriaxone administration seems to be preferred
for fragile elderly patients independently of disease severity. This
administration is not associated to an impaired effectiveness or to an
increased death rate. Copyright © 2014. Published by Elsevier SAS.

KEYWORDS: Ceftriaxone; Geriatric patients; Patients âgés; Subcutaneous
administration; Voie sous-cutanée
__________________________________________________________________
________________________________*_________________________________

10. Abstract: Long-term complications associated with permanent dermal
fillers
__________________________________________________________________
http://www.ncbi.nlm.nih.gov/pubmed/23962591

Br J Oral Maxillofac Surg. 2013 Dec;51(8):858-62.

Long-term complications associated with permanent dermal fillers.

Kunjur J1, Witherow H.

1ST4 in Oral and Maxillofacial Surgery, St George’s Healthcare NHS Trust,
Blackshaw Road, Tooting, London SW17 0QT, UK. Electronic address:
jkunjur@hotmail.com.

We report a case series of patients with serious long-term complications
associated with the injection of permanent dermal fillers.

Although such complications are relatively rare, the consequences are
potentially life- long, and the psychological and medical effects can
often have a profound impact on the patient.

The continued routine offering of these treatments will require doctors to
communicate effectively with patients about the nature of the
complications and the probability of risk compared with alternative
treatments.

Copyright © 2013 The British Association of Oral and Maxillofacial
Surgeons. Published by Elsevier Ltd. All rights reserved.

KEYWORDS: Late complications; Permanent dermal filler
__________________________________________________________________
________________________________*_________________________________

11. Abstract: A strategy for the prevention of protein oxidation by drug
product in polymer-based syringes
__________________________________________________________________
http://www.ncbi.nlm.nih.gov/pubmed/25691717

PDA J Pharm Sci Technol. 2015 Jan-Feb;69(1):88-95.

A strategy for the prevention of protein oxidation by drug product in
polymer-based syringes.

Nakamura K1, Abe Y2, Kiminami H2, Yamashita A2, Iwasaki K2, Suzuki S2,
Yoshino K2, Dierick W3, Constable K4.

1Terumo Corporation, R&D Center, Kanagawa, Japan;
Kouji2Nakamura@terumo.co.jp.
2Terumo Corporation, R&D Center, Kanagawa, Japan;
3Terumo Europe NV, Leuven, Belgium; and.
4Terumo Medical Corporation, Somerset, NJ, USA.

Recently, new and advanced ideas have been presented on the value of
polymer-based syringes for improved safety, better strength, reduced
aggregation, and the prevention of drug degradation. In this report, our
findings on drug degradation from protein oxidation will be presented and
discussed.

Commonly, dissolved oxygen is one of the factors for causing protein
degradation. Due to the nature of higher gas permeability in polymer-based
syringes, it was thought to be difficult to control the oxygen level
during storage. However, this report demonstrates the appropriateness of
combining the use of an oxygen absorber within the secondary packaging as
a deoxygenated packaging system.

In addition, this report suggests that another factor to enhance protein
oxidization is related to radicals on the syringe barrel from
sterilization by irradiation. We demonstrate that steam sterilization can
minimize protein oxidization, as the protein filled in steam sterilized
syringe is much more stable.

In conclusion, the main oxidation pathway of a protein has been identified
as dissolved oxygen and radical generation within a polymer container.
Possible solutions are herewith presented for controlling oxidation by
means of applying a deoxygenated packaging system as well as utilizing
steam sterilization as a method of sterilization for prefillable polymer
syringes.

LAY ABSTRACT:

There have been many presentations and discussions about the risks
associated with glass prefilled syringes. Advanced ideas are being
presented on the value of polymer-based syringes for improved safety,
better strength, reduced protein aggregation, and the prevention of drug
degradation.

Drug degradation based on protein oxidation is discussed in this report.
Identification of the main factors causing this degradation and possible
solutions available by using polymer-based syringes will be presented. The
causes of protein oxidation have been identified as dissolved oxygen and
radicals generated by the applied method of sterilization. The oxidation
reaction created by dissolved oxygen within the drug product can be
effectively inhibited by controlling the removal of the oxygen through the
use of a deoxygenated packaging system.

This packaging system can control the level or complete removal of oxygen
from the primary container and the secondary packaging system. Protein
oxidation induced by the formation of radicals from sterilization by
irradiation is another critical aspect where it was thought that various
sterilization methods were acceptable without loosing drug product
quality.

However, this report is first to demonstrate that gamma sterilized
polymer-based syringes accelerated protein oxidation by radical
generation; this effect can be prevented by means of steam sterilization.

© PDA, Inc. 2015.

KEYWORDS: Autoclave; COP; Oxidation; Protein; Radicals; Steam
sterilization; stability
__________________________________________________________________
________________________________*_________________________________

12. Abstract: Non-destructive vacuum decay method for pre-filled syringe
closure integrity testing compared with dye ingress testing and high-
voltage leak detection
__________________________________________________________________
http://www.ncbi.nlm.nih.gov/pubmed/25691719

PDA J Pharm Sci Technol. 2015 Jan-Feb;69(1):108-22.

Non-destructive vacuum decay method for pre-filled syringe closure
integrity testing compared with dye ingress testing and high-voltage leak
detection.

Simonetti A1, Amari F2.

1Senior Manager, Strategic Initiatives, Bonfiglioli Engineering S.r.l.,
TASI Group, Via Rondona, 33 – 44049 Vigarano Pieve (FE), Italy; Telephone
+39 0532 715631, a.simonetti@bonfiglioliengineering.com;
a.simonetti@bonfiglioliengineering.com.
2Continuous Improvement Manager, Novartis Vaccines, Località Bellaria
Rosia – 53018 Sovicille (SI), Italy; Telephone +39 0577 539613,
filippo.amari@novartis.com.

In reaction to the limitations of the traditional sterility test methods,
in 2008, the U.S. Food and Drug Administration issued the guidance
“Container and Closure System Integrity Testing in Lieu of Sterility
Testing as a Component of the Stability Protocol for Sterile Products”
encouraging sterile drug manufacturers to use properly validated physical
methods, apart from conventional microbial challenge testing, to confirm
container closure integrity as part of the stability protocol.

The case study presented in this article investigated the capability of
four container closure integrity testing methods to detect simulated
defects of different sizes and types on glass syringes, prefilled both
with drug product intended for parenteral administration and sterile
water. The drug product was a flu vaccine (Agrippal, Novartis Vaccines,
Siena, Italy). Vacuum decay, pharmacopoeial dye ingress test, Novartis
specific dye ingress test, and high-voltage leak detection were, in
succession, the methods involved in the comparative studies.

The case study execution was preceded by the preparation of two
independent sets of reference prefilled syringes, classified,
respectively, as examples of conforming to closure integrity requirements
(negative controls) and as defective (positive controls). Positive
controls were, in turn, split in six groups, three of with holes laser-
drilled through the prefilled syringe glass barrel, while the other three
with capillary tubes embedded in the prefilled syringe plunger. These
reference populations were then investigated by means of validated
equipment used for container closure integrity testing of prefilled
syringe commercial production; data were collected and analyzed to
determine the detection rate and the percentage of false results.

Results showed that the vacuum decay method had the highest performance in
terms of detection sensitivity and also ensured the best reliability and
repeatability of measurements.

An innovative technical solution, preventing possible prefilled syringe
plunger movement during container closure integrity testing execution, is
presented as well.

LAY ABSTRACT:

The growing need to meet sterile drug products’ regulatory, quality, and
safety expectations has progressively driven new developments and
improvements both in container closure integrity testing methods and in
the respective equipment, over the last years. Indeed, container closure
integrity testing establishes the container closure system capability to
provide required protection to the drug product and to demonstrate
maintenance of product sterility over its shelf life.

This article describes the development of four container closure integrity
testing approaches for the evaluation of glass prefilled syringe closure
integrity, including two destructive (pharmacopoeial and Novartis specific
dye ingress test) and two non-destructive (vacuum decay and high-voltage
leak detection) methods.

The important finding from the validation of comparative studies was that
the vacuum decay method resulted in the most effective, reliable and
repeatable detection of defective samples, whether the defect was exposed
to sterile water, to drug product, or to air.

Complete sets of known defects were created for this purpose (5 µm, 10 µm,
20 µm certified leakages by laser drilled holes and capillary tubes).

All investigations and studies were conducted at Bonfiglioli Engineering
S.r.l. (Vigarano Pieve, Ferrara, Italy) and at Novartis Vaccines
(Sovicille, Siena, Italy).

© PDA, Inc. 2015.

KEYWORDS: ASTM F2338; CCI; Defect; Dye ingress; High-voltage leak
detection; Integrity; Leak detection; Leak test; Leakage; Non-destructive;
Package integrity; Plunger movement; Prefilled syringes; Sterility;
Stopper movement; Vacuum decay
__________________________________________________________________
________________________________*_________________________________

13. Abstract: Factors influencing field testing of alcohol-based hand rubs
__________________________________________________________________
Free Full Text http://tinyurl.com/pxarw8g

Infect Control Hosp Epidemiol. 2015 Mar;36(3):302-10.

Factors influencing field testing of alcohol-based hand rubs.

Girard R1, Carre E2, Mermet V2, Adjide CC3, Blaise S4, Dagain M5, Debeuret
C6, Delande S7, Dubois V8, Fascia P9, Hadjadj C10, Honnart M5, Labrande
C6, Bauduin AL11, Martin A12, Petiteau Moreau F10, Roattino N13, Rougeot
E14, Shum Cheong Sing J15, Urban M16, Valdeyron ML1.
Author information
11Nosocomial Infection Department Hospices Civils de Lyon,Lyon,France.
22Pharmacy Hospices Civils de Lyon,Lyon,France.
33Nosocomial Infection Department CHU Amiens,Amiens,France.
44Nosocomial Infection Department CH Belfort Montbelliard,Belfort,France.
55Economic Department CHU Dijon,Dijon,France.
66Pharmacy Assistance Publique des Hopitaux de Marseille,Marseille,France.
77Economic Department CH Dieppe,Dieppe,France.
88Pharmacy CHU Saint Etienne,Saint Etienne,France.
99Nosocomial Infection Department CHU Saint Etienne,Saint Etienne,France.
1010Pharmacy CHU Bordeaux,Bordeaux,France.
1111Nosocomial Infection Department CHU Bordeaux,Bordeaux,France.
1212Economic Department CHU Amiens,Amiens,France.
1313Nosocomial Infection Department Assistance Publique des Hopitaux de
Marseille,Marseille,France.
1414Pharmacy CH Belfort Montbelliard,Belfort,France.
1515Nosocomial Infection Department CHU Grenoble,Grenoble,France.
1616Pharmacy CHU Angers,Angers,France.

BACKGROUND According to the World Health Organization guidelines, field
tests, in the context of a bid for the supply of alcohol-based hand rubs,
should take into account climatic region, test period, products already in
use, and type of use (hygienic or surgical) when assessing tolerance. This
laborious method is often contested.

OBJECTIVE To conduct a post hoc analysis of the data of a large bid,
including 5 factors, to validate the relevance of their inclusion.

METHODS For the purposes of the bid, products were compared in terms of
the 4 World Health Organization tolerance criteria (appearance,
intactness, moisture content, sensation) during product testing and were
separated into groups on the basis of the studied factors. The post hoc
analysis method included (1) comparison of the mean before-and-after
difference based on the self-evaluation of the skin with the 4 World
Health Organization tolerance criteria, between climatic regions, periods,
products in use, test product, and the type of use; (2) generalized linear
models, taking into account all studied factors.

RESULTS The analysis included data for 1,925 pairs of professionals. The
means of the differences observed were independently and significantly
associated with the test period (P<.001), the hygienic or surgical use
(P=.010 to .041, not significant for appearance), the product already in
use (significant for appearance P=.021), and the test product (P<.001).
The association with climatic region was found to be significant only in
the nonadjusted analysis.

CONCLUSION The type of use, the test period, and the product in use should
be taken into account when designing field tests of alcohol-based hand
rubs. Infect Control Hosp Epidemiol 2014;00(0): 1-9.

Free Full Text http://tinyurl.com/pxarw8g
__________________________________________________________________
________________________________*_________________________________

14. Abstract: Challenges in the delivery of peptide drugs: an industry
perspective
__________________________________________________________________
http://www.ncbi.nlm.nih.gov/pubmed/25690084

Ther Deliv. 2015 Feb;6(2):149-63.

Challenges in the delivery of peptide drugs: an industry perspective.

Lewis AL1, Richard J.

1Ipsen, 20 Rue Ethé Virton, 28109 Dreux, France.

Due mainly to their poor stability and short plasma half-life, peptides
are usually administered by injection, often several times daily.

Injectable sustained-release formulations of peptides based on
biodegradable polymer microparticles or implants early demonstrated the
power of drug delivery technologies to enhance patient adherence and
convenience, and increase safety and efficacy.

Injectable sustained-release formulations are likely to remain a
significant part of new peptide products. However, a new generation of
technologies that enable solvent-free formulations and manufacturing
processes, injection through narrow gauge needles and ready-to-use
presentations will be increasingly used.

In addition, the tremendous developments in noninvasive routes of delivery
are likely to result in more and more peptides being delivered by the
oral, transdermal, nasal or inhalation routes.
__________________________________________________________________
________________________________*_________________________________

15. No Abstract: Gloves on, gloves off. Gloves don’t protect if they
aren’t removed at the proper times
__________________________________________________________________
http://www.ncbi.nlm.nih.gov/pubmed/25630175

JEMS. 2014 Dec;39(12):21.

Gloves on, gloves off. Gloves don’t protect if they aren’t removed at the
proper times.

Edgerly D.
__________________________________________________________________
________________________________*_________________________________

16. News

– Global: Why it took so long for the world to start using ‘smart,’ self-
destructing syringes
– Global: One man’s campaign to eradicate the dirty needles that kill 1.3
million a year
– Global: How Did A Celibate 82-Year-Old Buddhist Monk Contract HIV?
– Global: WHO urges shift to single-use smart syringes
– Cambodia: Healthy dose of hope for one-use syringes
– Africa: Drug abuse: ‘Injections fueling HIV infections’

Selected news items reprinted under the fair use doctrine of international
copyright law: http://www4.law.cornell.edu/uscode/17/107.html
__________________________________________________________________
http://tinyurl.com/o87v9kj

Global: Why it took so long for the world to start using ‘smart,’ self-
destructing syringes

By Todd C. Frankel, Washington Post, USA (24.02.15)

The World Health Organization called Monday for the worldwide use of
needle syringes that self-destruct after a single injection.

These “smart” syringes are a response to a problem that medical
authorities have recognized for decades — the frequent reuse of
disposable shots. An estimated 25 percent of the 18 billion medical
injections performed worldwide each year are done with dirty needles.
Unsafe injections cause as many as 1.7 million new hepatitis B infections
annually, 315,000 hepatitis C infections and 33,800 HIV infections,
according to the World Health Organization. Stopping these infections
would be a boon for public health.

“This is a risk we don’t have to be taking,” the WHO’s Lisa Hedman said.

But changing the practice – especially in poor countries – has proven
difficult. In some places, syringes are scarce. Or the dangers are not
fully appreciated, despite education campaigns. And sometimes health-care
providers can just get lazy.

So how do you stop people from reusing syringes?

How do you remove the temptation?

The WHO has been hunting for solutions for nearly 25 years. Only recently
has the technology become feasible – cheap, easy to use, hard to break –
for an announcement like the WHO made Monday.

“It’s not simple,” WHO spokeswoman Judith Mandelbaum-Schmid said. “There
had to be quite a lot of engineering.”

The WHO’s quest began in 1987 – just as the spread of a disease called HIV
was beginning to cause alarm. At the same time, the widespread switch from
glass syringe tubes to plastic ones made reuse even more risky, since
glass containers could be disinfected with heat, while plastic melted and
warped.

The agency put out a call for syringe designs that automatically and
irrevocably stopping working after a single filling and injection. The
syringes essentially needed to break after one use.

The WHO wanted to use these shots to deliver vaccines.

One place that took up the challenge was Path, a small international
health technology nonprofit in Seattle. Staff already had begun playing
around with different designs two years earlier. They knew they had to
make their invention work with existing plastic syringes to keep costs
down, said Steve Brooke, the company’s commercialization adviser.

There were examples out there. Patents for single-use syringes dated back
to 1960s. But none seemed to fit the need.

Path came up with a plastic syringe with a metal clip inside it that
locked into place after the plunger was depressed. A syringe manufacturer
licensed the product.

In 1990, the Soloshot hit the market. Since then, it has been used to
deliver more than 6 billion vaccine shots.

Path developed the technology behind the SoloShot, a non-reusable syringe
that has delivered more than 6 billion vaccinations since 1992. Courtesy
of Path

But the Soloshot was limited to the vaccination market, which accounts for
only 5 to 10 percent of all injections worldwide. The product didn’t work
in syringes with varying dosages, where the plunger is pulled back to
different levels.

“People started to realize, what about the other 90 percent?” said Hedman,
who is the WHO’s technical officer for essential medicines and health
products.

Solving that problem would take several more years.

The effort received an unexpected boost in 2000 when the U.S. Congress
passed the Needlestick Safety and Prevention Act, which required steps to
reduce the risk of health-care workers accidentally stabbing themselves
with needles.

That led to inventions such as the spring-loaded needle, which retracts
after use “like a ballpoint pen,” Hedman said. And there are syringes with
plastic covers that can be slipped over a needle and locked into place.

Although these devices were designed to protect nurses and doctors, they
also rendered the syringes inoperative after a single use.

Other designs came on the market. A man named Marc Koska developed the K-1
syringe, with a plunger that breaks off if you try to reload it. He’s
delivered TED talks about the experience.

Today, there are more than 70 suppliers of non-reusable syringes.

“But it took a long time for industry to respond,” Hedman said.

The WHO’s call to use self-destructing syringes is seen as a step to
pushing for the widespread adoption of the devices. The technology works
and is priced on par with regular syringes. The need is greatest in the
developing world. But the reuse of syringes remains enough of a problem in
the United States that the U.S. Centers for Disease Control and Prevention
runs a One & Only campaign to reinforce the message.

Unsafe medical injections have affected at least 150,000 U.S. patients
since 2001, according to the CDC.

Preventing these exposures is as simple as a tiny flange that stops a
syringe from being reloaded “like going the wrong way out of a rental car
parking lot,” Hedman said.

She appreciated the simplicity of some of these solutions.

“They are elegant little things,” she said.
__________________________________________________________________
__________________________________________________________________
http://tinyurl.com/nunmsxo story with photos

Global: One man’s campaign to eradicate the dirty needles that kill 1.3
million a year

By Joe Sandler Clarke, The Guardian, Global Development Professionals
Network, UK (24.02.15)

It was 1984 and Marc Koska was working in the Caribbean, building forensic
models to support murder cases, when he read a newspaper article about
HIV/Aids that changed his life.

“All the media could talk about was this new killer disease that was going
to wipe out the planet,” the Briton recalls. The story predicted that
reusable needles would soon become a major way of spreading the infection,
and more than 30 years later, the prediction has come true: 260,000, or 5%
of all the world’s HIV infections, are caused by unsafe injections.

For Koska, that article was the beginning of a 30-year campaign to create
safe syringes. Now, finally the rest of the world seems to have caught up
with him.

Today the World Health Organisation (WHO) starts a global campaign to
eradicate the dirty needle, which is responsible for the deaths of 1.3
million people every year. New guidelines announced in Geneva today will
mean that every injection given in the world will have to come under
scrutiny and be safely engineered. If the programme is successful, it will
have dramatic consequences across the world, potentially wiping out more
than $1bn in Africa’s healthcare bills alone.

For many decades the reusable syringe was seen as the best option, and as
recently as 1998 WHO was still advocating that syringes and needles be
reused up to 200 times as part of vaccination programmes. But opinion
began to change, and a study by WHO in 2000 found that of the 16.7 billion
injections carried out worldwide that year, almost 40% were unsafe.

The figures associated with illnesses caused by using reusable syringes
are astonishing. According to WHO estimates, 21 million hepatitis B
infections are caused by unsafe injections, along with 2 million hepatitis
C infections, or 40% of all the documented cases in the world.

In Cambodia, a doctor currently faces murder charges after infecting more
than 100 people with HIV by reusing a syringe multiple times. And Peter
Piot, a microbiologist famous for discovering Ebola in the 1970s, stated
recently that the reuse of syringes in west African hospitals was a major
cause of the spread of the virus at the tail end of last year.

During our discussion, Koska repeatedly pauses to show me video clips shot
undercover of doctors and nurses in the developing world going around
their wards, shoving blunt needles into patients without pausing to change
syringe or to sterilise, even though sterilisation itself has long been
viewed as an ineffective means of stopping the spread of infection.

Using existing technology Koska came up with a syringe that falls apart
after one use, and sold his first one in 1997. Even though he’s sold more
than 4 billion auto-disable syringes since, he has been repeatedly
frustrated in his attempts to make the world aware of the problem caused
by reusable syringes. “It’s been a very frustrating journey. Thirty years
to get WHO turned around. Thirty years to get the manufacturers turned
around. You’ve got too many parts to expect it to be a three year
journey.”

“There is a very basic reason why it hasn’t happened and that is because
the manufacturers haven’t had a market,” he argues. “If the manufacturers
could sell a product and it was identified where they were going to sell
it and who was going to pay for it, they would make it.

“The core of it is that manufacturers have no incentive. Manufacturers
control all this, as they have all the money. Syringes are a commodity.
There is a very low margin on disposable medical products. So you say to
the manufacturer, ‘let’s all make better products’, and they say ‘why?’
because there’s no guarantee that anyone is going to buy them.”

Koska’s efforts to enter the market have been blighted by a series of
unfortunate events. His new invention was simple, used existing technology
and was cheap, costing the same as regular syringe at 5 cents. All this
meant it posed a threat to rival companies.

His first licensee in the developing world was bought out by another
company and then had its premises bulldozed. On another occasion, a
successful deal with a government fell through after the order was
mysteriously cancelled.

Now the delay from both the medical industry and global organisations in
embracing the single-use syringe not only means that millions of people
have died needlessly from injection-born infections; it also means that
Koska stands to lose out on making money from his invention.

With 30 syringe manufacturers around the world, earning $2m in revenue,
you would expect Koska to benefit from today’s announcement, but his
patent on the K1 runs out in 2017. “If this had happened 15 years ago we
would have been richer than God,” he says.

“But I don’t really care about the money, I care about whether we’re going
to solve the problem. The money will come later.”

Of medium build, with slightly greying hair and the natural confidence
that comes with an English public school education, Koska, 53, is a
determined man. He has needed to be.

After intense education efforts in the developing world through his
charity SafePoint, established in 2005, and years of lobbying WHO
director-general Margaret Chan for the introduction of guidelines
promoting auto-disable technology, Koska is well aware that today’s
announcement will only be the next step in efforts to make the single-use
syringe widely used across the globe.

WHO will embark on a global campaign to tell of the benefits of single-use
syringes, and the dangers of reusable needles, with the goal of using WHO-
approved syringes across the globe by 2018. Local and international
manufacturers will be encouraged to create safely engineered syringes.
Ministries of health and international donor programmes run by the likes
of Unicef and USAID will be targeted by the campaign.

“Today, Chan is a hero, but I think the next chapter might be just as
challenging as the first bit,” he says.

“My gut feeling is that the ministries of health will be most resistant,
because they’ve been saying for so long that they don’t have a problem of
reuse in their countries. They’re never going to say that ‘we’ve got a
terrible problem with hepatitis C because I can’t be bothered to buy
enough syringes’. So now ministers have got to change their position and
say, from Tuesday, we’re only going to buy auto-disable syringes.”

Even if takes another three decades, you would back Koska to win out in
the end. While working in the Caribbean, his team won every case.

“There is no excuse left,” he says of the impact of today’s announcement.
“That’s a nice way of explaining my feelings. It takes us over a bridge.
Up until now people could manipulate the story and come up with lots of
different excuses. Now, they won’t be able to.”
__________________________________________________________________
__________________________________________________________________
http://tinyurl.com/ka44jch

Global: How Did A Celibate 82-Year-Old Buddhist Monk Contract HIV?

Susan Brink, NPR USA (24.02.15)

An 82-year-old celibate Buddhist abbot from Cambodia has been diagnosed
with HIV. His doctor was the cause: He was reusing syringes and infected a
reported 272 individuals, including babies and children.

This horror story resonates around the world. More than 2 million people
were infected in 2010 alone, according to the most recent World Health
Organization research, with hepatitis B, hepatitis C and HIV because of
injections with previously used syringes or needles. While data are not
available for transmission of all diseases, unsafe needle practices could
also put people at risk for bloodborne illnesses, such as Ebola and
malaria, according to WHO.

And it happens in rich and poor countries alike.

This week, WHO launched a global campaign to tackle the problem of disease
spread because of the reuse of contaminated needles.

The organization is recommending that countries adopt the use of safety-
engineered syringes, or “smart” syringes, designed to prevent reuse. “With
one injection, the new-style syringes disable themselves,” says Dr. Selma
Khamassi, the head of the WHO team for injection safety. “Some have a
metal clip that blocks the plunger and you cannot pull it back to give
another injection. Some have a weak point, so if you try to pull it back,
it breaks.” And some have a device, like a spring, that automatically
retracts the needle after the plunger hits the bottom of the barrel.

About 70 manufacturers are beginning to make versions of the smart
syringes. In low-income countries, where the problem of reuse is greatest,
affordability is crucial. The cost of traditional syringes without safety
features is about 3 to 4 cents each; syringes that automatically disable
themselves when used range from 4 to 8 cents each. “They are moving toward
affordability. Once the demand increases, the price will decrease,” says
Khamassi.

Indeed, cost is one reason that health workers in poor countries reuse
needles or syringes. “When workers lack equipment, they feel obliged to
reuse the same syringe,” she says. Or some health care workers have the
misconception that changing the needle tip while keeping the same syringe
(which holds the medicine) is safe. “It is not,” says Khamassi.

A third reason in developing countries is that low-paid health workers can
reuse syringes to pick up extra income by giving injections outside their
clinics or hospitals in what might be called a private practice of sorts,
Khamassi said.

Reuse also happens in wealthy countries, including the United States,
because of ignorance of safety procedures, laziness, lack of equipment or
simple greed. “Please don’t think injection safety is an issue only in
poor countries,” says Khamassi.

The Centers for Disease Control and Prevention reported more than 50
outbreaks in the U.S. since 2001 of hepatitis B and C as well as
bloodborne diseases because health workers reused needles, syringes or
vials designed for single use. In other instances of reuse, there was no
transmission of disease but patients had to be notified for possible
testing. Examples include a urology clinic in Nevada using the same needle
for prostate biopsies on more than one patient; a pediatric clinic in
Denver reusing syringes to administer flu vaccines; a pain clinic in Los
Angeles reusing syringes that exposed patients to hepatitis C; and a
health fair in New Mexico that reused finger stick devices to test for
blood glucose levels.

Adding to the problem in some countries is a demand by patients for
injections when oral medications work as well. “Some patients believe
injections are more effective or work faster,” says Khamassi. “Some people
demand an injection for a fever or vitamin or antibiotic injections.” Part
of the WHO campaign is to educate communities and patients in order to
reduce the number of unnecessary injections.
__________________________________________________________________
__________________________________________________________________
http://www.bbc.com/news/health-31550817

Global: WHO urges shift to single-use smart syringes

By James Gallagher, BBC News, UK (23.02.15)

Smart syringes that break after one use should be used for injections by
2020, the World Health Organization has announced.

Reusing syringes leads to more than two million people being infected with
diseases including HIV and hepatitis each year.

The new needles are more expensive, but the WHO says the switch would be
cheaper than treating the diseases.

More than 16 billion injections are administered annually.

Normal syringes can be used again and again.

But the smart ones prevent the plunger being pulled back after an
injection or retract the needle so it cannot be used again.

Dr Selma Khamassi, the head of the WHO team for injection safety, told the
BBC News website: “This will hopefully help eliminate the 1.7 million new
hepatitis B cases, the 300,000 hepatitis C cases and the 35,000 HIV cases
every year, and all those we don’t have figures for, such as Ebola and
Marburg.”
__________________________________________________________________
__________________________________________________________________
http://www.bbc.com/news/science-environment-31537847

Cambodia: Healthy dose of hope for one-use syringes

by David Shuckman, BBC Science Editor, BBC News (23.02.15)

The people of the farming community of Roka in Cambodia are living through
exactly the nightmare scenario that the World Health Organisation wants to
stamp out with a new policy on syringes.

In wooden huts and farmhouses dotted among paddy fields, families are
struggling to cope with the bombshell of a sudden and frightening mass
infection of HIV.

To the astonishment and shock of this rural backwater, babies,
schoolchildren and even the 82-year-old abbot of the local Buddhist
temple, who is celibate, have all tested HIV-positive.

And there is one common factor that links them, directly or indirectly:
nearly all of them received injections from an unlicensed doctor suspected
of re-using his syringes.

The virus would have been spread from one patient to another, resulting in
an escalating tally of infections that now stands at 272, with further
rises expected as more tests are carried out.

Four of the victims – three elderly women and a baby – have since died.

Every year, millions of people around the world are infected when syringes
are used on more than one person, not only spreading HIV but also
Hepatitis B and C, and other diseases.

The WHO’s hope is to try to achieve a global switch to what are called
“auto-disable” syringes that are designed with a feature which effectively
breaks them once an injection has been given.

But for the people of Roka, all that is too late.

Looking tired and desperate, with her four-month-old daughter Tola on her
lap, Yong Sothom described to me how she became infected with HIV and then
unwittingly passed on the virus through her breast milk.

“I feel sad, very very sad,” she said, “because it’s a pity for my child –
she is innocent yet she is also infected.”

For her, the outbreak has become almost apocalyptic in that it has
stretched across four generations of her extended family, hitting no fewer
than 19 relations.

The family’s matriarch, 76-year-old Chay Yao, spoke with great dignity and
determination as she tried to convey the scale of the tragedy that has
struck an otherwise calm existence.

“It is not like a normal sadness, it’s so difficult, especially for these
small children.

“It’s no worry for me to die but I feel pity for the children about their
future, about how they will make a living, how they will get food, this is
what I am thinking about.”

So, amid the soaring temperatures and dust of the dry season here, a
sombre mood has descended over a community wholly unprepared for what has
developed into a national health crisis.

Most of the victims, including the abbot, Mom Heng, have now been
prescribed anti retroviral drugs but, in an effort to head off panic, he’s
been working with a local charity to persuade people not to worry.

We travelled with him to one particularly unfortunate family where the
mother and four of her five children are all infected with HIV.

The father, Sokhaa Vech, a local chief, recalled seeing the unlicensed
medic visiting a neighbouring family before coming to his, and he noticed
how the man handled his equipment.

“The syringe was in his bag,” he told me. “He pulled it out of its plastic
wrapping, gave an injection, put it back in its wrapping – and then I saw
him using it again on everyone else.”

The medic, Yem Chrin, was by all accounts a popular figure in the area,
dispensing injections at a far cheaper price than charged by the local
government clinic and prepared to make home visits.

We also heard that he offered his treatments on credit and was content to
be paid in commodities such as rice.

One charity worker described him as “uncle easy”, and the abbot and Chay
Yao, the matriarch of the family with 19 victims, are among those to
emphasise his attentiveness.

Since the crisis started, Chrin has been in custody and now faces an array
of charges including murder.

One striking feature of this outbreak is how the villagers are evidently
keen on injections, preferring them to pills, often receiving dozens of
jabs for ailments such as dysentery and fever.

This is a cultural phenomenon – not just in Cambodia but in many
developing countries – in which the technology of a highly visible
procedure is sought after, and the risks are probably not considered.

This is the reality facing campaigners who have long argued that the
safety of syringes is pivotal to cutting infection rates.

With us on the visit to Roka was Marc Koska, the British inventor of a
type of syringe that is disabled once used.

For years, through his charity SafePoint, he has argued – with health
authorities, at conferences and in the media – that the world needs to
ditch the standard kind of syringe because it carries too many dangers.

When we encountered a team of medics sent in from the capital Phnom Penh
to help cope with the outbreak, he had a chance to demonstrate how his
system works.

Marc unwrapped one of his syringes, depressed the plunger as if giving an
injection and then, when he tried to pull the plunger out, showed how it
snapped – making reuse impossible.

The medics, all specialists in HIV/Aids, were amazed and immediately saw
the benefit.

One of the team, Te Naisam, smiled at the sight and said: “I’ve never seen
this before. I’ve been a nurse for more than 20 years and I’ve just seen
today this modern syringe.

“If they are available, imported into my country, it would be very good to
help reduce the HIV/Aids infection.”

In fact these auto-disable syringes have been in use for international
immunisation programmes for the past decade and a growing number of
companies produce them.

But immunisations account for less than 10% of the estimated 16 billion
injections given globally every year – so the real challenge is to
persuade the manufacturers and national governments to agree to work
towards a total switch.

Marc Koska said: “What’s happening here in Roka should just never have
occurred.

“I’ve got a design and there are other designs for safety syringes that
you simply cannot use more than once. And they’re the same price as a
normal needle and syringe.

“We’ve just got to get on with this and then we can stop any similar
outbreak around the world.”

Our final stop was at the home of the man at the centre of the crisis. Yem
Chrin’s shop was closed up but his sister-in-law agreed to fetch a copy of
his driving licence so we could see his picture.

She then revealed something none of us had heard before: that she was
among those infected with HIV, along with Chrin’s mother-in-law and
grandson, presumably treated in the same way as all the others.

The plight of the grandson seems especially poignant: an innocent in a
crisis, infected in his own home, and all because of something as simple
as a dirty syringe.
__________________________________________________________________
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http://tinyurl.com/nvu42az

Africa: Drug abuse: ‘Injections fueling HIV infections’

By Carol Natukunda, NewVision, Uganda (24.02.15)

The use of injections among drug abusers is spreading HIV in sub-Saharan
Africa, a new research reveals

It notes that there is blood transfer, through the sharing of drug taking
equipment, particularly unsterilised needles, carries a high risk of HIV
transmission, with about five and ten percent of new HIV infections
resulting from sharing used needles.

The report on the emerging patterns of injecting drug use in sub-Saharan
countries such as Uganda, Tanzania, Senegal, Zanzibar and Kenya notes that
people who inject drugs into their bodies are sharing the syringes.

The most common injected drugs in Uganda include heroin and cocaine,
according to the report.

Titled, “The Global State of Harm Reduction 2014,” the report stresses the
need says that governments will require a further scaling up therapy such
as methadone and buprenorphine medicines and needle syringe safety
programmes in order to effectively respond to the growing HIV/ AIDS
epidemic.

The 2014 report, produced by UK based NGO Harm Reduction International
(HRI), says that prevalence of HIV among people who inject drugs in
Tanzania is an estimated 33.9 per cent, 16.7 per cent in Uganda and 9.1
per cent in Senegal.

“Moreover, because of the geographical location of countries such as
Tanzania and Zanzibar along key transit points for the trafficking of
heroin, cocaine and other drugs, there is increased availability of these
drugs in this part of the region.

“Further HIV infections in sub -Saharan Africa driven by drug use are as
concerning as they are avoidable,” said Rick Lines, Executive Director of
Harm Reduction International.

“It is reassuring then, to see the pioneering efforts of both Tanzania
(methadone and clean needle exchange services) and Kenya (methadone),
implementing programmes on the ground reducing harm but it is, at the same
time, critically important that these interventions are scaled up and
adopted across the region where similar patterns of drug use may be
emerging.”

New injecting drug practices in sub-Saharan Africa

The report points out that although services are generally lacking, the
initiation of research in the region will be vital in providing a basis
for policy responses in the future. It also calls for the need to document
of high- risk injecting practices.

Uganda’s health experts called for the need for parliament to pass the
anti-tobacco and narcotics bill which is before parliament.

“People are abusing drugs because they are everywhere.

Elsewhere in the world, injecting drugs for purposes not prescribed by a
doctor is illegal. We need a legislation that makes drug abuse completely
illegal,” says Dr. Sheila Ndyanabangyi, the principal medical officer at
the health ministry.

Drug user access to anti-retroviral therapy

In 2012 there were an estimated 6,991,492 adults receiving antiretroviral
therapy (ART) in sub-Saharan Africa, representing 60 per cent of those
living with HIV. However, the data on numbers of people who inject drugs
receiving ART within this region remain limited.

In 2008, the Reference Group to the United Nations on HIV and Injecting
Drug Use reported that just 38 people who inject drugs in Kenya and 138
people who inject drugs in Mauritius were receiving ART.

These estimates represented less than one per cent of HIV-positive people
who inject drugs in Kenya and 1.1 per cent of people who inject drugs in
Mauritius receiving ART.
__________________________________________________________________
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SIGN Meeting 2015

The Safe Injection Global Network SIGN meeting was 23-24 February 2015 at
WHO Headquarters in Geneva Switzerland

The main topic of the meeting will be the new injection safety policy
recommendation and developing the appropriate strategies for
implementation in countries worldwide.

The Keynote speaker will be Dr Margaret Chan, the Director-General of WHO.

Dr. Chan will launch the new IS policy which recommends the use of safety
engineered injection devices for reuse prevention and sharps injury
protection.
__________________________________________________________________
________________________________*_________________________________
* 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
__________________________________________________________________
________________________________*_________________________________

The 2010 annual Safe Injection Global Network meeting to aid collaboration
and synergy among SIGN network participants worldwide 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/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
__________________________________________________________________
________________________________*_________________________________
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any posting, or to use the forum to request technical information in
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The SIGN Forum welcomes new subscribers who are involved in injection
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* Subscribe or un-subscribe by email to: sign.moderator@gmail.com, or to
sign@who.int

The SIGNpost Website is http://SIGNpostOnline.info

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We would like your help in building this archive. Please send your old
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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 Secretariat home is the Department of Health Systems Policies and
Workforce, Geneva Switzerland.

The SIGN Forum is moderated by Allan Bass and is hosted on the University
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__________________________________________________________________

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