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SIGNpost 00854

*SAFE INJECTION GLOBAL NETWORK* SIGNPOST

Post00854 New Listserv + Abstracts + News 25 May 2016

CONTENTS
1. Moderators Note: Moving to a new Listserv in the next week!
2. Abstract: Blood exposure accidents: Knowledge, attitudes and practices
of nursing and midwifery students at the Bobo-Dioulasso teaching
hospital (Burkina Faso)
3. Abstract: Seroprevalence of hepatitis B and C among domestic and
healthcare waste handlers in Belo Horizonte, Brazil
4. Abstract: APIC position paper: Safe injection, infusion, and medication
vial practices in health care
5. Abstract: Infectious Disease Risk Associated with Contaminated Propofol
Anesthesia, 1989-2014(1)
6. Abstract: Occupational Safety Precautions among Nurses at Four
Hospitals, Nablus District, Palestine
7. Abstract: Accidental blood exposures among emergency medicine residents
and young physicians in France: a national survey
8. Abstract: Hepatitis-C virus infection among injecting drug users in
Lahore, Pakistan: A cross sectional study
9. Abstract: Is the recent emergence of mephedrone injecting in the United
Kingdom associated with elevated risk behaviours and blood borne virus
infection?
10. Abstract: Evaluation of the Dual-Chamber Pen Design for the Injection
of Exenatide Once Weekly for the Treatment of Type 2 Diabetes
11. Abstract: Mixing Pens and the Future of Diabetes Drugs
12. Abstract: Science to Practice: What Causes Arterial Infarction in
Transforaminal Epidural Steroid Injections, and Which Steroid Is
Safest?
13. Abstract: Switching from subcutaneous insulin injection to oral
vildagliptin administration in hemodialysis patients with type 2
diabetes: a pilot study
14. Abstract: Hand hygiene using a new hand-cleansing formulation without
sanitizers: Effect on Staphylococcus aureus removal and recovery of
properties against skin damage
15. Abstract: Prions in dentistry: A need to be concerned and known
16. News
– China: China ‘Fake Vaccine’ Scandal: More Than A Hundred People Arrested
For Illegaly Buying, Selling Vaccines
– UK: London gangs fuel sharp rise in the number of dirty needles dumped
dangerously in Cambridge
– USA: B. Braun to pay $7.8 million for selling contaminated needles
– USA: B. Braun to pay up to $7.8M for selling contaminated needles
China: 4 detained over vaccine irregularities

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SIGNpost 00854

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1. Moderators Note: Moving to a new Listserv in the next week!
__________________________________________________________________
The SIGNpost listserv is moving to the cloud in the next week!

The SIGN list has been on the University of Queensland listserve since
October 1999. SIGNpost will have been the last traditional list on the
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2. Abstract: Blood exposure accidents: Knowledge, attitudes and practices
of nursing and midwifery students at the Bobo-Dioulasso teaching
hospital (Burkina Faso)
__________________________________________________________________

https://www.ncbi.nlm.nih.gov/pubmed/24922618

Med Sante Trop. 2014 Jul-Sep;24(3):258-62.
[Blood exposure accidents: Knowledge, attitudes and practices of nursing
and midwifery students at the Bobo-Dioulasso teaching hospital (Burkina
Faso)].

[Article in French]

Zoungrana J1, Yaméogo TM2, Kyelem CG2, Aba YT3, Sawadogo A4, Millogo A5.

1Service des maladies infectieuses et tropicales, CHU Sanou-Sourô de Bobo-
Dioulasso, 03 BP 4178 Bobo-Dioulasso, Burkina Faso.
2Service de médecine interne du CHU Sanou-Sourô de Bobo-Dioulasso.
3Service des maladies infectieuses et tropicales du CHU de Treichville,
Abidjan, Côte d’Ivoire.
4Service de gastroentérologie du CHU Sanou-Sourô de Bobo-Dioulasso,
Burkina Faso.
5Service de neurologie du CHU de Bobo-Dioulasso, Burkina Faso.

Blood exposure accidents are the source of major risks of contamination of
healthcare personnel. The objective of this study was to describe the
knowledge of standard precautions, and the attitudes and practices of
nursing and midwifery students in relation to this accidental exposure.
This cross-sectional survey, conducted in November 2011, was based on
voluntary anonymous questionnaires completed by students working in the
medical ward of the Bobo-Dioulasso teaching hospital.

Of the 275 students asked to participate, 219 (92.8%) completed the
questionnaire: 138 (63,0%) were student nurses and 81 (37.0%) student
midwives. Their mean age was 27.9 ± 5 years. Among them, 64 (29.1%)
acknowledged accidental exposure to blood during treatment performed as
part of their hospital work. Only 30 of these 64 cases were reported at
the time.

The standard precautions for the prevention of these accidents were known
to 131 students (59.8%); 58.4% always wore gloves for invasive procedures;
74.9% reported that the syringe container was “always” or “often” used.

The needles used were “always” or “often” recapped before disposal in only
39.1% of cases. Only 11.0% were fully vaccinated against hepatitis B.

Blood exposure accidents were not uncommon among these students and their
knowledge of the standard precautions and actions to take in case of an
accident is insufficient.

These data show the need for further training and awareness campaigns to
improve these hospital practices.

KEYWORDS: Burkina Faso; HIV; accidental exposure to blood; paramedic
students

Free Full Text https://tinyurl.com/jnfvjpv in French.
[Mod: The google Translate version looks OK]
__________________________________________________________________
________________________________*_________________________________

3. Abstract: Seroprevalence of hepatitis B and C among domestic and
healthcare waste handlers in Belo Horizonte, Brazil
__________________________________________________________________

https://www.ncbi.nlm.nih.gov/pubmed/27207769

Waste Manag Res. 2016 May 19. pii: 0734242X16649686.
Seroprevalence of hepatitis B and C among domestic and healthcare waste
handlers in Belo Horizonte, Brazil.

Mol MP1, Gonçalves JP2, Silva EA2, Scarponi CF2, Greco DB3, Cairncross S4,
Heller L5.

1Fundação Ezequiel Dias, Universidade Federal de Minas Gerais, Belo
Horizonte, Brasil marcos_mol@yahoo.com.br.
2Fundação Ezequiel Dias, Belo Horizonte, Brasil.
3Faculdade de Medicina, Universidade Federal de Minas Gerais, Belo
Horizonte, Brasil.
4London School of Hygiene and Tropical Medicine, London, UK.
5Centro de Pesquisas René Rachou, Fundação Oswaldo Cruz, Belo Horizonte,
Brasil.

Infection with the hepatitis B and C viruses may occur through contact
with infected body fluids, including injury with infected sharps.

Collectors of domestic or healthcare wastes are potentially exposed to
these infections.

The aim of this article is to investigate the risk factors associated with
the prevalence of hepatitis B and C viruses (HBV and HCV) infection among
domestic and healthcare waste workers in Belo Horizonte, Brazil.

A cross-sectional study of hepatitis B and C infection was conducted from
November 2014 to January 2015, through blood sample collection and
interviews about socio-demographic factors with 61 workers exposed to
healthcare waste (‘exposed’) and 461 exposed only to domestic wastes
(‘unexposed’).

The prevalence of antibodies to HCV (Anti-HCV) antibodies was 3.3% in
‘exposed’ workers and 0.9% in ‘unexposed’, and of antibody to hepatitis B
core antigen (Anti-HBc) was 9.8% and 5.6% in ‘exposed’ and ‘unexposed’
workers, respectively.

Only 207 (44.9%) of those exposed to domestic waste and 45 (73.8%) of
those handling healthcare waste were effectively immunised against
hepatitis B virus (HBV).

Exposures to domestic waste and to healthcare wastes were associated with
similar risks of infection with HBV. The risk of hepatitis C virus (HCV)
infection was marginally higher among healthcare waste workers compared
with domestic waste workers, probably because of needlestick accidents
owing to deficient sharps management systems.

Immunisation against hepatitis B and screening tests to ensure the success
of vaccination should be a condition for recruitment for both groups of
waste workers.

© The Author(s) 2016.

KEYWORDS: Hepatitis B; cross-section; domestic waste; healthcare waste;
hepatitis C
__________________________________________________________________
________________________________*_________________________________

4. Abstract: APIC position paper: Safe injection, infusion, and medication
vial practices in health care
__________________________________________________________________

https://www.ncbi.nlm.nih.gov/pubmed/27184207

Am J Infect Control. 2016 May 13. pii: S0196-6553(16)00283-2.
APIC position paper: Safe injection, infusion, and medication vial
practices in health care.

Dolan SA1, Arias KM2, Felizardo G3, Barnes S4, Kraska S5, Patrick M6,
Bumsted A7.

1Children’s Hospital Colorado. Electronic address:
Susan.Dolan@childrenscolorado.org.
2Arias Infection Control Consulting, LLC.
3Washington State Hospital Association.
4Kaiser Permanente.
5Memorial Hospital of South Bend Indiana.
6Infection Prevention Consultant, Washington, DC.
7Rush University Medical Center.

The transmission of bloodborne viruses and other microbial pathogens to
patients during routine health care procedures continues to occur because
of the use of improper injection, infusion, medication vial, and point-of-
care testing practices by health care personnel.

These unsafe practices occur in various clinical settings and result in
unacceptable and devastating events for patients. This document updates
the Association for Professionals in Infection Control and Epidemiology
2010 position paper on safe injection, infusion, and medication vial
practices in health care.

Copyright © 2016 Association for Professionals in Infection Control and
Epidemiology, Inc. Published by Elsevier Inc. All rights reserved.

KEYWORDS:
Contaminated; Endoscopy; HCV; Hepatitis C; Outbreak; Syringe; bloodborne

__________________________________________________________________
________________________________*_________________________________

5. Abstract: Infectious Disease Risk Associated with Contaminated Propofol
Anesthesia, 1989-2014(1)
__________________________________________________________________

http://wwwnc.cdc.gov/eid/article/22/6/15-0376_article

Emerg Infect Dis. 2016 Jun;22(6):981-92.
Infectious Disease Risk Associated with Contaminated Propofol Anesthesia,
1989-2014(1).

Zorrilla-Vaca A, Arevalo JJ, Escandón-Vargas K, Soltanifar D, Mirski MA.

Administration of propofol, the most frequently used intravenous
anesthetic worldwide, has been associated with several iatrogenic
infections despite its relative safety.

Little is known regarding the global epidemiology of propofol-related
outbreaks and the effectiveness of existing preventive strategies.

In this overview of the evidence of propofol as a source of infection and
appraisal of preventive strategies, we identified 58 studies through a
literature search in PubMed, Embase, and Lilacs for propofol-related
infections during 1989-2014.

Twenty propofol-related outbreaks have been reported, affecting 144
patients and resulting in 10 deaths.

Related factors included reuse of syringes for multiple patients and
prolonged exposure to the environment when vials were left open.

The addition of antimicrobial drugs to the emulsion has been instituted in
some countries, but outbreaks have still occurred.

There remains a lack of comprehensive information on the effectiveness of
measures to prevent future outbreaks.

KEYWORDS: 2,6-diisopropylphenol; EDTA; Propofol; anesthesia;
contamination; edetate disodium; fospropofol; glycerol; hospital
infection; iatrogenic; intravenous; lipidemulsion; lipophilic; nosocomial;
outbreak; phenol; phosphatide; safety; soybean

Free full text http://wwwnc.cdc.gov/eid/article/22/6/15-0376_article
__________________________________________________________________
________________________________*_________________________________

6. Abstract: Occupational Safety Precautions among Nurses at Four
Hospitals, Nablus District, Palestine
__________________________________________________________________

https://www.ncbi.nlm.nih.gov/pubmed/26498052

Int J Occup Environ Med. 2015 Oct;6(4):243-6.
Occupational Safety Precautions among Nurses at Four Hospitals, Nablus
District, Palestine.

Al-Khatib IA1, El Ansari W, Areqat TA, Darkhawaja RA, Mansour SH, Tucktuck
MA, Khatib JI.

1Institute of Community and Public Health, Birzeit University, West Bank,
Palestine Institute of Environmental and Water Studies, Birzeit
University, West Bank, Palestine. ikhatib@birzeit.edu.

Occupational hazards, exposure to blood and body fluids (BBF) accidents
and safety precautions constitute an important public health issue.

We assessed the prevalence and determinants of exposure to occupational
hazards among nurses, and their knowledge of occupational safety
precautions.

In a cross-sectional study, we surveyed 332 nurses working in 4 hospitals,
Nablus, West Bank, Palestine, by a questionnaire. Bivariate analysis
tested the associations between ever exposure and the high likelihood of
BBF exposure and the independent socio-demographic and occupational
variables. Binary logistic regression analysis was used to assess the
associations between the same two exposures and selected independent
variables (those significant in the bivariate analysis).

Prevalence of ever exposure to BBF was 51.7%, and was associated with
working in private and charitable hospitals (OR 2.62, 2.68, respectively),
having 4-6 family members (OR 0.52) and “nursing” being as one’s top
career choice at university (OR 0.48).

The prevalence of high likelihood of BBF exposure was 62.2%, and was
associated with working in charitable and private hospitals (OR 7.81,
2.43, respectively) and “nursing” being as one’s top career choice (OR
0.57).

Regarding knowledge, most respondents believed it is necessary to enact
laws and regulations regarding occupational safety precautions, reported
the use of sharps containers, immediate disinfection after an accident,
reporting an accident, and using personal protective equipment.

Nurses had adequate knowledge of the risks of their hospital work.
Nevertheless, they exhibited high prevalence of exposure to BBF accidents.

Future studies are needed to re-evaluate existing occupational safety
guidelines in hospitals, establish monitoring and evaluation protocols for
health care workers’ adherence to the guidelines, and institute well-
defined policies for reporting occupational injury incidents so these can
be handled appropriately.

Free full text
http://www.theijoem.com/ijoem/index.php/ijoem/article/view/581
__________________________________________________________________
________________________________*_________________________________

7. Abstract: Accidental blood exposures among emergency medicine residents
and young physicians in France: a national survey
__________________________________________________________________

https://www.ncbi.nlm.nih.gov/pubmed/27179649

Intern Emerg Med. 2016 May 14.
Accidental blood exposures among emergency medicine residents and young
physicians in France: a national survey.

Chauvin A1,2,3,4, Hutin A5,6,7, Leredu T5,8, Plaisance P9,10, Pateron
D11,12, Yordanov Y11,12,5.

1Emergency Département, Hôpital Lariboisière, Assistance Publique-Hôpitaux
de Paris, Paris, France. anthony.chauvin@lrb.aphp.fr.
2Faculté de Médecine, Université Diderot, Paris, France.
anthony.chauvin@lrb.aphp.fr.
3AJMU, Association des Jeunes Médecins Urgentistes, Paris, France.
anthony.chauvin@lrb.aphp.fr.
4Hospital Lariboisière, Service d’Accueil des Urgences, 2, rue Ambroise
Pare, 75010, Paris, France. anthony.chauvin@lrb.aphp.fr.
5AJMU, Association des Jeunes Médecins Urgentistes, Paris, France.
6Emergency Département, Hôpital Cochin, Assistance Publique-Hôpitaux de
Paris, Paris, France.
7Faculté de Médecine, Université Descartes, Paris, France.
8Emergency Département, Hôpital Mignot, Versailles, France.
9Emergency Département, Hôpital Lariboisière, Assistance Publique-Hôpitaux
de Paris, Paris, France.
10Faculté de Médecine, Université Diderot, Paris, France.
11Emergency Département, Hôpital Saint-Antoine, Assistance Publique-
Hôpitaux de Paris, Paris, France.
12Faculté de Médecine, Université Pierre et Marie Curie, Paris, France.

The aim of the present study was to investigate the epidemiological
characteristics of blood or fluid exposure (BFE) and occupational
infection risk among emergency medicine (EM) residents and young
physicians (<35 years old) in France.

We led a cross-sectional, anonymous, online survey. 1779 participants were
contacted with a response rate of 36 % (n = 633).

Among the respondents, 459 (72 %) reported at least one BFE. Among
participants with at least one BFE, 35 % (n = 163) never reported the
exposure to the relevant medical authorities or support. Among
participants who reported exposure, 63 % (n = 232) did it immediately.

Among participants who never or not systematically reported their BFE,
most of them (62 %, n = 181/289) did not do so because the procedure was
too long, and 28 % (n = 82/289) estimated the risk as low even if only
one-third (n = 166/458) checked their HIV status even though the BFE was
at a transmission risk. Circumstances in which the participants had the
most BFE were: suturing 57 % (n = 262/457) and when making precipitated
gestures 24 % (n = 111/457).

The latest exposures were caused by a solid needle in 42 % (n = 191/455)
or hollow-bore needle in 27 % (n = 123/455).

Post-exposure reporting rates were low. Reporting procedure itself and
self-management were the main reasons for BFE underreporting.

Simplifying procedures might increase BFE reporting, and allow appropriate
post-exposure counseling and/or prophylaxis.

KEYWORDS: Blood exposure; Emergency medicine; Post-exposure prophylaxis;
Residency; Survey
__________________________________________________________________
________________________________*_________________________________

8. Abstract: Hepatitis-C virus infection among injecting drug users in
Lahore, Pakistan: A cross sectional study
__________________________________________________________________

http://dx.doi.org/10.12669%2Fpjms.322.9038

Pak J Med Sci. 2016 Mar-Apr;32(2):373-8. Free Full Article
Hepatitis-C virus infection among injecting drug users in Lahore,
Pakistan: A cross sectional study.

Akhtar AM1, Majeed S2, Jamil M3, Rehman A4, Majeed S5.

1Dr. Abdul Majeed Akhtar, MBBS, DTCD, DPH, MCPS, Ph.D. Department of
Epidemiology and Public Health, University of Veterinary & Animal
Sciences, Lahore, Pakistan. Program Manager, Provincial TB Control
Program, Punjab, DGHS, 24 Cooper Road Lahore, Pakistan.
2Sadia Majeed, M.Phil. Foodand Nutrition Department, College of Home
Economics, Gulberg, Lahore, Pakistan.
3Muhammad Jamil, M.Phil. Out Patients Medical Laboratory, Mayo Hospital,
Lahore.
4Dr. Abdul Rehman, DVM, M.Phil, Ph.D Scholar. Department of Epidemiology
and Public Health, University of Veterinary & Animal Sciences, Lahore,
Pakistan.
5Sufia Majeed, Allama Iqbal Medical College, Lahore, Pakistan.

OBJECTIVES: To determine the prevalence and risk factors of hepatitis C
virus among injecting drugs users, furthermore different genotypes of HCV
infection and their effect on viral load were also found and subsequently
most prevalent subtype was predicted.

METHODS: All samples were processed for Anti-HCV antibody detection
through ELISA by using third generation ELISA Kit. The Anti-HCV positive
serum samples were stored for RT-PCR to estimate the viral load and
genotypes of HCV for study. Injecting drug users selected from in and
around Lahore Metropolitan from July 2012 to August 2013 was included. The
data analysis was completed by using SPSS version 16. A p-value of < 0.05
was considered to be significant.

RESULTS: A total of 241 Injecting drug users were enrolled and screened
for Anti HCV in the study. Prevalence of HCV infection in IDUs from Lahore
was found to be 36.09%. Education (p=0.000), low socioeconomic status
(p=0.011), Blood transfusion (0.003), any tattoo on the body (p=0.002),
use of injectable drugs with reused syringes (p=0.000) and sharing of
syringes (p=0.001) in groups was significantly associated with HCV
infection. Some utensils were also significantly associated with HCV
status. The most common subtype of HCV genotype was 3a (n=65) followed by
2a (n=15) and 1a (n=6).

CONCLUSION: The study reveals that IDUs with reused syringes status and
sharing of syringes in group had more chances to get HCV infection. The
viral load in IDUs infected with different subtypes of genotype was
significantly associated.

KEYWORDS: ELISA kits; HCV infection; Injecting drug users; Viral load

Free PMC Article https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4859026/
__________________________________________________________________
________________________________*_________________________________

9. Abstract: Is the recent emergence of mephedrone injecting in the United
Kingdom associated with elevated risk behaviours and blood borne virus
infection?
__________________________________________________________________

https://www.ncbi.nlm.nih.gov/pubmed/27195614

Euro Surveill. 2016 May 12;21(19).
Is the recent emergence of mephedrone injecting in the United Kingdom
associated with elevated risk behaviours and blood borne virus infection?

Hope VD1, Cullen KJ, Smith J, Jessop L, Parry J, Ncube F.

1Centre for Infectious Disease Surveillance and Control, Public Health
England, London, United Kingdom.

The recent, and rapid, emergence of injection of the short-acting
stimulant mephedrone (4-methylmethcathione) has resulted in concerns about
increased infection risks among people who inject drugs (PWID). Data from
the bio-behavioural surveillance of PWID in the United Kingdom were
analysed to examine the impact of mephedrone injection on infections among
PWID.

During the year preceding the survey, 8.0% of PWID (163/2,047) had
injected mephedrone.

In multivariable analyses, those injecting mephedrone were younger, less
likely to have injected opiates, and more likely to have injected cocaine
or amphetamines, used needle/syringe programmes or sexual health clinics,
been recruited in Wales and Northern Ireland or shared needles/syringes.

There were no differences in sexual risks.

Those injecting mephedrone more often had hepatitis C antibodies (adjusted
odds ratio (AOR)?=?1.51; 95% confidence interval (CI): 1.08-2.12), human
immunodeficiency virus (AOR?=?5.43; 95% CI: 1.90-15.5) and overdosed (AOR
=?1.70; 95% CI: 1.12-2.57).

There were no differences in the frequency of injecting site infections or
prevalence of hepatitis B.

The elevated levels of risk and infections are a concern considering its
recent emergence. Mephedrone injection may currently be focused among
higher-risk or more vulnerable groups. Targeted responses are needed to
prevent an increase in harm.

KEYWORDS: Hepatitis C; Mephedrone; People who inject drugs; human
immunodeficiency virus – HIV; risk behaviours
__________________________________________________________________
________________________________*_________________________________

10. Abstract: Evaluation of the Dual-Chamber Pen Design for the Injection
of Exenatide Once Weekly for the Treatment of Type 2 Diabetes
__________________________________________________________________

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4525643/

J Diabetes Sci Technol. 2015 Jul;9(4):815-21. Free PMC Article
Evaluation of the Dual-Chamber Pen Design for the Injection of Exenatide
Once Weekly for the Treatment of Type 2 Diabetes.

LaRue S1, Malloy J2.

1AstraZeneca, San Diego, CA, USA susan.larue@astrazeneca.com.
2Bristol-Myers Squibb, San Diego, CA, USA.

BACKGROUND: Exenatide once weekly, an injectable glucagon-like peptide-1
receptor agonist, has been shown to reduce A1C, fasting glucose, and body
weight in patients with type 2 diabetes. Exenatide 2.0 mg is dispersed in
poly-(D,L- lactide-co-glycolide) polymer microspheres, which require
resuspension in aqueous diluent before subcutaneous injection. A single-
use, dual-chamber pen was developed to improve the convenience of
exenatide once weekly delivery and tested following Food and Drug
Administration (FDA) guidance.

METHODS: Design development goals were established, and validation tests
(dose accuracy, torque/force requirements, usability, and ease-of-use)
were performed. Dose accuracy was tested under a variety of conditions.
After 10 exploratory studies in 329 patients, the final design’s usability
and ease-of-use were tested in untrained health care practitioners (HCPs;
n = 16) and untrained/trained patients (n = 30/17). Usability testing
evaluated completion of multiple setup, dose preparation, and injection
steps. Ease-of-use impression was assessed using a scale of 1-7 (1 = very
difficult, 7 = very easy).

RESULTS: The dual-chamber pen successfully met development goals and
delivered target volume (650 µL ± 10%) under tested conditions (mean
644.7-649.3 µL), with torque and force requirements below prespecified
maximum values. In the final user study, most participants (=87%)
correctly completed pen setup, dose preparation, and injection steps. Mean
ease-of-use scores were 5.8, 6.3, and 6.5 out of 7 in untrained HCPs,
untrained patients, and trained patients, respectively.

CONCLUSION: With self-education or minimal training, participants
accurately and precisely suspended, mixed, and delivered exenatide-
containing microspheres using the dual-chamber pen with high ease-of-use
scores. The dual-chamber pen was FDA-approved in February 2014.

© 2015 Diabetes Technology Society.

KEYWORDS: GLP-1 analogs; dual-chamber pen; noninsulin injectables; type 2
diabetes

Comment in Mixing Pens and the Future of Diabetes Drugs. [J Diabetes Sci
Technol. 2015] https://www.ncbi.nlm.nih.gov/pubmed/25944896

Free PMC Article https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4525643/
__________________________________________________________________
________________________________*_________________________________

11. Abstract: Mixing Pens and the Future of Diabetes Drugs
__________________________________________________________________

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4525653/

J Diabetes Sci Technol. 2015 Jul;9(4):822-3. Free Full Article
Mixing Pens and the Future of Diabetes Drugs.

Ginsberg BH1.

1Diabetes Technology Consultants, Wyckoff, NJ, USA
diabetes_consultants@yahoo.com.

With the availability of a smaller mixing pen, mass marketing of less
stable medications is possible. Bidureon is one such medication, and the
properties of its pen are discussed along with the prospects for future
mixing pens.

© 2015 Diabetes Technology Society.

KEYWORDS:
FDA; exenatide; mixing pen; pen

Comment on
Evaluation of the Dual-Chamber Pen Design for the Injection of Exenatide
Once Weekly for the Treatment of Type 2 Diabetes. [J Diabetes Sci Technol.
2015]

Free PMC Article https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4525653/
__________________________________________________________________
________________________________*_________________________________

12. Abstract: Science to Practice: What Causes Arterial Infarction in
Transforaminal Epidural Steroid Injections, and Which Steroid Is
Safest?
__________________________________________________________________

https://www.ncbi.nlm.nih.gov/pubmed/27183400

Radiology. 2016 Jun;279(3):657-9. Free Full Article
Science to Practice: What Causes Arterial Infarction in Transforaminal
Epidural Steroid Injections, and Which Steroid Is Safest?

Diehn FE1, Murthy NS1, Maus TP1.

1Department of Radiology Mayo Clinic 2001st Ave SW Rochester, MN 55905.

Transforaminal epidural steroid injections (TFESIs) are associated with
rare but devastating neurologic complications. Every published case has
been associated with a particulate steroid suspension, and the presumed
but not proven mechanism is embolization and occlusion of end arterioles.

Through an in vivo murine model and in vitro experiments on human red
blood cells (RBCs), the study by Laemmel et al (1) in this issue of
Radiology elucidates the potential mechanisms for steroid-induced vascular
compromise. Unlike dexamethasone (a nonparticulate steroid solution),
saline, and the particulate steroid cortivazol, other particulate steroids
(prednisolone, methylprednisolone, and triamcinolone) caused often
immediate and complete cessation of capillary blood flow, with RBC (not
steroid particle) aggregates and alteration of RBC morphologic structure
into spiculated RBCs.

Thus, the study strengthens evidence in support of the higher safety
profile in TFESI for dexamethasone, the nonparticulate and U.S. Food and
Drug Administration-recommended steroid of choice, compared with
particulate steroids.

The results should not be considered proof that cortivazol has not or
could not cause neurologic infarction during a TFESI. Rather, experiments
such as those by Laemmel et al should foster more research, particularly
in the arena of novel therapeutic agents (nonparticulate steroids and
nonsteroidal drugs alike).

http://dx.doi.org/10.1148/radiol.2016160171 Free Full Article
__________________________________________________________________
________________________________*_________________________________

13. Abstract: Switching from subcutaneous insulin injection to oral
vildagliptin administration in hemodialysis patients with type 2
diabetes: a pilot study
__________________________________________________________________

https://www.ncbi.nlm.nih.gov/pubmed/27193434

Int Urol Nephrol. 2016 May 18.
Switching from subcutaneous insulin injection to oral vildagliptin
administration in hemodialysis patients with type 2 diabetes: a pilot
study.

Yoshida N1, Babazono T2, Hanai K1, Uchigata Y1.

1Department of Medicine, Diabetes Center, Tokyo Women’s Medical University
School of Medicine, 8-1 Kawada-cho, Shinjuku-ku, Tokyo, 162-8666, Japan.
2Department of Medicine, Diabetes Center, Tokyo Women’s Medical University
School of Medicine, 8-1 Kawada-cho, Shinjuku-ku, Tokyo, 162-8666, Japan.
babazono.dmc@twmu.ac.jp.

We conducted this pilot study to examine efficacy and safety of switching
from subcutaneous injection of insulin to oral administration of a DPP-4
inhibitor, vildagliptin, in type 2 diabetic patients undergoing
hemodialysis. Consecutive type 2 diabetic patients on hemodialysis who
were switched from insulin to vildagliptin between August 2010 and April
2011 were extracted from the hospital database.

In patients whose post-switch increase in glycated albumin (GA) levels was
<1.5 % without resuming insulin at least 24 weeks, the switch was defined
as efficacious. In patients who resumed insulin therapy due to worsening
of glycemic control or in patients whose GA levels increased by 1.5 % or
more, the switch was considered inefficacious. To predict patients in whom
switch to vildagliptin proved efficacious, receiver-operating
characteristic (ROC) analysis and logistic regression analysis were
performed.

A total of 20 patients were extracted; insulin dose was 12 ± 4 units/day;
levels of GA and HbA1c was 21.0 ± 3.7 % and 6.5 ± 0.6 %, respectively.
Among them, 11 patients were efficaciously switched to vildagliptin.

ROC analysis and logistic analysis showed that patients with a shorter
duration of diabetes, as well as lower levels of GA and HbA1c, appeared to
have a higher likelihood of successful treatment switches.

None of the patients developed hypoglycemic symptoms, ketoacidosis, or
serious adverse events. In conclusion, efficacious change from insulin to
vildagliptin was possible in approximately a half of type 2 diabetic
dialysis patients. Long-term follow-up studies including large number of
patients are needed to confirm these results.

KEYWORDS: DPP-4 inhibitor; Glycated albumin; Glycated hemoglobin;
Hemodialysis
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________________________________*_________________________________

14. Abstract: Hand hygiene using a new hand-cleansing formulation without
sanitizers: Effect on Staphylococcus aureus removal and recovery of
properties against skin damage
__________________________________________________________________

http://www.ajicjournal.org/article/S0196-6553(16)30008-6/fulltext

Am J Infect Control. 2016 May 17. pii: S0196-6553(16)30008-6. Open Access
Hand hygiene using a new hand-cleansing formulation without sanitizers:
Effect on Staphylococcus aureus removal and recovery of properties against
skin damage.

Asaoka K1, Endo S2, Suzuki Y3, Komuro S4, Nemoto T5, Kaku M3.

1Department of Infection Control and Laboratory Diagnostics, Internal
Medicine, Tohoku University Graduate School of Medicine, Sendai City,
Miyagi, Japan; Department of Research and Development, Household
Laboratory, Kao Corporation, Wakayama City, Wakayama, Japan.
2Department of Infection Control and Laboratory Diagnostics, Internal
Medicine, Tohoku University Graduate School of Medicine, Sendai City,
Miyagi, Japan. Electronic address: ain@med.tohoku.ac.jp.
3Department of Infection Control and Laboratory Diagnostics, Internal
Medicine, Tohoku University Graduate School of Medicine, Sendai City,
Miyagi, Japan.
4Geriatric Health Services Facility “Cosmos”, Sendai City, Miyagi, Japan.
5Izumi Orthopedic Hospital, Sendai City, Miyagi, Japan.

BACKGROUND: Staphylococcus aureus is known to form a biofilm and colonize
on damaged skin of the hands. We investigated changes in the quantity of S
aureus on the hands and changes in skin damage when using a hand-cleansing
formulation with potassium oleate but without a sanitizer (formulation A),
which is highly effective in removing S aureus biofilm and causes minimal
skin damage.

MATERIAL AND METHODS: The participants (14 medical staff members) used 2
types of hand-cleansing formulations (formulations A and B), each for 4
weeks. S aureus of the hands was cultured from swab samples on agar
plates. Surface of hands was measured using an ultraviolet light
microscope.

RESULTS AND DISCUSSION: The quantity of S aureus after using formulation A
for 4 weeks was 101.08 ± 0.05 CFU/mL, a statistically significant decrease
from the quantity of S aureus (101.59 ± 0.19 CFU/mL) just before use (P =
.029). Also, dryness of hand surfaces decreased. With formulation B, the
quantity of S aureus did not significantly change from before to after use
(P > .05). This presumably occurs because formulation A gently removes S
aureus biofilm.

CONCLUSIONS: Formulation A removed S aureus from the hands of
participants, and skin damage on the hands improved.

Copyright © 2016 Association for Professionals in Infection Control and
Epidemiology, Inc. Published by Elsevier Inc. All rights reserved.

KEYWORDS: Biofilm; Potassium oleate; The surface evaluation of scaliness

Free full text
http://www.ajicjournal.org/article/S0196-6553(16)30008-6/fulltext
__________________________________________________________________
________________________________*_________________________________

15. Abstract: Prions in dentistry: A need to be concerned and known
__________________________________________________________________

Free Full Article http://dx.doi.org/10.4103%2F0973-029X.180961

J Oral Maxillofac Pathol. 2016 Jan-Apr;20(1):111-4.
Prions in dentistry: A need to be concerned and known.

Sushma B1, Gugwad S2, Pavaskar R3, Malik SA4.

1Department of Oral and Maxillofacial Pathology, School of Dental
Sciences, Krishna Institute of Medical Sciences Deemed University, Karad,
Maharastra, India.
2Department of Pedodontics and Preventive Dentistry, School of Dental
Sciences, Krishna Institute of Medical Sciences Deemed University, Karad,
Maharashtra, India.
3Department of Conservative Dentistry and Endodontics, Goa Dental College
and Hospital, Bambolim, Goa, India.
4Department of Prosthodontics and Crown and Bridge, School of Dental
Sciences, Krishna Institute of Medical Sciences Deemed University, Karad,
Maharastra, India.

Prion diseases were first discovered by Stanley B. Prusiner who defined
prions as infectious, transmissible proteinaceous particles that lack
nucleic acid and are composed exclusively of a modified isoform of the
noninfectious cellular prion protein (PrPC). These are incurable
neurodegenerative conditions affecting both animals and humans. They may
be sporadic, infectious or inherited in origin.

Human prion diseases include Creutzfeldt-Jakob desease (CJD), Gerstmann-
Straussler-Scheinker disease, Kuru and Fatal familial insomnia.

Prions resist the conventional sterilization procedures and hence the
dentists must be aware of such diseases so as to opt standard methods of
infection control and decontamination for such infectious agents.

This review article divulge the dentists with a brief overview of the
characteristics of prions, the risk of transmission and the implications
for infection control in dentist.

KEYWORDS: Prion; prion protein; transmissible spongiform encephalopathies

Free Full Article http://dx.doi.org/10.4103%2F0973-029X.180961
__________________________________________________________________
________________________________*_________________________________

16. News

– China: China ‘Fake Vaccine’ Scandal: More Than A Hundred People Arrested
For Illegaly Buying, Selling Vaccines

– UK: London gangs fuel sharp rise in the number of dirty needles dumped
dangerously in Cambridge

– USA: B. Braun to pay $7.8 million for selling contaminated needles

– USA: B. Braun to pay up to $7.8M for selling contaminated needles
China: 4 detained over vaccine irregularities

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

https://tinyurl.com/hmc99ux
China: China ‘Fake Vaccine’ Scandal: More Than A Hundred People Arrested
For Illegaly Buying, Selling Vaccines

By Alixandra Caole Vila, Nature World News (23.05.16(

China is under pressure with the “fake vaccine” scandal that has left the
public wondering whether vaccine in the country is still safe.

On May 21, 135 people in 22 provinces have been arrested for illegally
buying and selling vaccines. Fifteen of them have been indicted and two
have been convicted of illegal sale of vaccines. Ten health officials were
arrested for on-duty negligence, Associated Press reported.

In a statement, the national prosecuting office said the health officials
arrested worked at local public health centers.

According to State Media, police authorities in China started conducting
wide investigations few weeks after a mother and daughter in Shandong
Province were arrested for illegally selling $88 million worth of fake
vaccines across atleast 20 provinces since 2011. The authorities had
apparently responded to the issue later than expected, infuriating the
public even more.

At present, there have been 190 criminal cases, involving 341 suspects,
filed by the police nationwide.
The officers are looking at 25 kinds of fake vaccines sold across the
country.

The news has sparked anger among the community, blaming the government for
allowing such indecency to happen and questioning them how they were
unable to control the situation, with some two-thirds of the country
trading fake vaccines over the past five years.

China has a long history of unsafe products being sold in the market.
In 2008, a toxic chemical called melamine, found in children’s milk
powder, causing the deaths of at least six children and sickening another
300,000. In 2002, China was labeled unresponsive in spreading news about
an outbreak of Sars, leading to the deaths of hundreds of people.
The Shandong food and drug administration vowed to cooperate to bring
justice to the cases and halt the trade of the fake vaccines.
“We will thoroughly investigate all clues in the case and once we get to
the bottom of it then we will severely punish those found to have violated
the law,” it said in a statement posted on its website.
__________________________________________________________________
__________________________________________________________________

https://tinyurl.com/hvng5ng
UK: London gangs fuel sharp rise in the number of dirty needles dumped
dangerously in Cambridge

By Raymond Brown, , Cambridge U.K. (21.05.16)

[Photo: Dirty needles that have been found in Cambridge]

A sharp rise in the number of dirty needles dumped dangerously in
Cambridge linked to London gangs has prompted a police crackdown.

Police officers have hand out more than 150 leaflets to drug users on the
streets of the city advising them where to get support to kick the habit
and how to dispose of used syringes safely.

The move comes amid a wide sweeping bid to drive down drug use in the city
fulled by a rise in dealers sent to the city by London gangs.

Figures obtained by the News reveal that in 2014/15 there were 63 reports
of dirty needles, increasing to 103 in the last financial year to April –
and police are doing their bit to drive down the danger.

Det Inp Nick Skipworth said: “We have PCSOs who have given out more than
150 leaflets to suspected drug users about how they can access facilities
to be able to dispose of needles safely. The discarded needles are another
consequence of illegal drug use which impacts on the community along with
theft from shops and even burglaries which addicts commit to feed habits
that can cost them up to £150 a day.”

Cambridge City Council rapid response grime-busters are called out to
clean up dangerous needles ditched by drug users across the city.

The list of hotspots where the needles are found include church grounds,
alleyways, shopping streets and parks giving a picture of where addicts go
to inject drugs.

The leaflets police are handing out are printed by the counties Drug and
Alchol Action Team (DAAAT) which also published a list of where to safely
dispose of needles including at various pharmacies across the city.

They can also be disposed of in public toilet cubicles and even at
Christ’s Pieces’ gardeners’ shed.

Residents who find any discarded needles, either used or unused, or other
drug paraphernalia, call Cambridge City Council on 01223 458282.

The campaign by police is part of a new tactic is being used by detectives
in the war on London gangs to target dealers who take over homes in the
city to push drugs.

Call police on 101 with any information.
__________________________________________________________________
__________________________________________________________________
USA: B. Braun to pay $7.8 million for selling contaminated needles

By Joy Howe, Reporter, WFMZ Allentown, PA USA (18.05.16)

BETHLEHEM, Pa. – A medical company headquartered in Bethlehem has agreed
to pay $4.8 million in penalties and $3 million in restitution, after it
sold contaminated equipment that caused people to get sick. B. Braun
Medical Inc. reached an agreement Wednesday with the Department of Justice
that will resolve any criminal liability, but the company will have to
implement some new safeguards.

In a statement released to 69 News, B. Braun says the matter involved a
business relationship that ended over eight years ago, when B. Braun sold
saline syringes. The syringes in question weren’t made by B. Braun, but by
a third party company in North Carolina.

The Department of Justice says those syringes were contaminated, and even
though B. Braun didn’t actually make them, the company’s name was still on
them.

Deputy Assistant Attorney General Benjamin C. Mizer, head of the Justice
Department’s Civil Division said, “Companies must take reasonable steps to
ensure that their suppliers are making quality products that help rather
than harm patients. Today’s settlement shows that the government will
continue to hold companies accountable for failing to fulfill this
critically important responsibility.”

B. Braun, which has headquarters in Bethlehem and a primary manufacturing
facility in Allentown, began using the North Carolina facility to make its
saline syringes in 2006 and according to the DOJ, B. Braun was aware at
that time, that the third party company had manufacturing problems.
Eventually, bacteria-contaminated syringes led to infected patients in
California, Texas New York and Nebraska.

Three people at the North Carolina company were prosecuted and sentenced
to time in prison. Two are serving, but authorities say the President of
that North Carolina company fled the country and is currently wanted. The
resolution with B. Braun includes a non-prosecution agreement, along with
the financial penalty – but makes it clear – this can’t happen again.

In a statement, B. Braun said, “We are fully committed to ensuring patient
safety. In that regard, we have agreed to undertake additional compliance
measures related to the qualification and monitoring of third party
manufacturers of finished products distributed by B. Braun with the B.
Braun name on the label or logo.”

Copyright 2016 WFMZ. All rights reserved. This material may not be
published, broadcast, rewritten or redistributed.
__________________________________________________________________
__________________________________________________________________

https://tinyurl.com/gpanqgf
USA: B. Braun to pay up to $7.8M for selling contaminated needles

By Peter Hall, Allentown Morning Call, PA USA (18.05.16)

Medical device maker B. Braun will pay up to $7.8 million to resolve
criminal charges stemming from its sale of contaminated saline syringes
that prosecutors said caused an outbreak of bacterial infections and led
to at least five deaths, the U.S. Department of Justice announced
Wednesday.

The German company with U.S. corporate headquarters in Bethlehem faced
criminal liability for selling contaminated syringes manufactured by
another company under its brand. Under an agreement with the Justice
Department, the company will avoid prosecution in exchange for
implementing procedures to improve oversight of its suppliers.

B. Braun will pay $4.8 million in penalties and forfeited profit and up to
$3 million in restitution to victims of the outbreak as part of the
agreement, the Justice Department said.

B. Braun has about 2,000 employees in the Lehigh Valley. The company has
three local facilities: its Bethlehem headquarters, its operations plant
on Marcon Boulevard in Hanover Township, Lehigh County, and its
distribution center on Boulder Drive in Breinigsville.
__________________________________________________________________
__________________________________________________________________

https://tinyurl.com/zjm9qs9
China: 4 detained over vaccine irregularities

By Li Qian, Shanghai Daily PRINT EDITION, Shanghai China (17.05.16)

FOUR community health workers in southwest China’s Chongqing City have
been detained over alleged violations of immunization regulations that
came to light during an investigation into the suspected use of unsafe
vaccines.

The four, including a nurse surnamed Peng, at a community health service
center affiliated with Chongqing No. 6 People’s Hospital, were suspected
of lying about inventories and immunization records as well as their
failure to invoice patients, an initial investigation found.

Suspicions were aroused on May 13 when a mother surnamed Wu claimed she
took her baby to be vaccinated, but Peng replaced a blue glass syringe,
packaged along with vaccine vials, with a white plastic one. She suspected
the vials were also replaced, according to China National Radio.

Later, more parents who suspected their children had been given fake
vaccines came forward. They accused the center of forging their signatures
and not recording information such as the batch numbers and manufacturers’
names in the immunization records, CNR reported.

The vaccine, used on babies aged from 2 to 18 months, protects against
whooping cough, diphtheritis, tetanus, polio and Haemophilus influenzae
type B. It isn’t included in China’s compulsory immunization program and
must be paid for by the child’s parents.

An initial investigation concluded that Peng accidentally contaminated the
syringe and replaced it with a sterile one, local news portal
www.cqnews.net reported.

However, the four health workers were found to have violated immunization
policy by using their positions for personal profit.

No further details were given as an investigation is under way, it
reported.
__________________________________________________________________
________________________________*_________________________________

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 this link:
www.who.int/injection_safety/global-campaign/injection-safety_guidline.pdf

PDF Requires Adobe Acrobat Reader [620 KB]
__________________________________________________________________
________________________________*_________________________________
Making all injections safe brochure

This is an illustrated summary brochure for the general public.

pdf, 554kb [6 pages]

www.who.int/injection_safety/global-campaign/injection-safety_brochure.pdf
__________________________________________________________________
________________________________*_________________________________

SIGN Meeting 2015

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

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

A report of the meeting will be posted ASAP
__________________________________________________________________
________________________________*_________________________________
* 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
__________________________________________________________________
________________________________*_________________________________
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
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The comments made in this forum are the sole responsibility of the
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and does not in any way mean that they are endorsed by any of the
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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 SIGNpost website provides an archive of all SIGNposts, meeting
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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 Service Delivery and Safety (SDS)
Health Systems and Innovation (HIS) at WHO HQ, Geneva Switzerland.

The SIGN Forum is moderated by Allan Bass and is hosted on the University
of Queensland computer network. http://www.uq.edu.au
__________________________________________________________________

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