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SIGNpost 00691

*SAFE INJECTION GLOBAL NETWORK* SIGNPOST *

Post00691 Medical Behavior? + Labor Risk + Abstracts + News 27 March 2013

CONTENTS
1. 10 years later: Continuing unethical and incompetent behavior by medical
professionals coincides with conflict of interest, leading to millions
of unexplained HIV infections
2. Abstract: Injections during labor and intrapartum-related hypoxic injury
and mortality in rural southern Nepal
3. Abstract:Survey of syringe and needle safety among student registered
nurse anesthetists: are we making any progress?
4. Abstract: An update from the AANA practice committee: application of the
evidence-based process
5. Abstract: Prevalence and factors associated with percutaneous injuries
and splash exposures among health-care workers in a provincial hospital,
Kenya, 2010
6. Abstract: Comparison of low- and higher-fidelity simulation to train and
assess pharmacy students’ injection technique
7. Abstract: Potential Risks of Pharmacy Compounding
8. Abstract: Strengthening the Expanded Programme on Immunization in
Africa: Looking beyond 2015
9. Abstract: The incidence and prevalence of hepatitis C in prisons and
other closed settings: Results of a systematic review and meta-analysis
10. Abstract: Pharmacists and harm reduction: A review of current practices
and attitudes
11. Abstract: Opioid overdose rates and implementation of overdose
education and nasal naloxone distribution in Massachusetts: interrupted
time series analysis
12. Abstract: Prevalence and predictors of hepatitis B virus co-infection
in a united states cohort of hepatitis C virus-infected patients
13. Abstract: Measures of knowledge about standard precautions: A
literature review in nursing
14. Abstract: Improved hand hygiene technique and compliance in healthcare
workers using gaming technology
15. Abstract: Microneedles for drug and vaccine delivery
16. Abstract: Keratoacanthoma arising after site injection infection of
cosmetic collagen filler
17. Abstract: Incidence of Adverse Events Among Healthcare Workers
Following H1N1 Mass Immunization in Ghana : A Prospective Study
18. No Abstract: Safer sharps in a dangerous world
19. No Abstract: Surface safety. Part 4. Best practices in surface and
medical device disinfection
20. No Abstract: Sustainable commitment. Advice on establishing a plastics
recycling program
21. No Abstract: Top 10 health technology hazards for 2013 are named
22. News
– USA: Inspection yields another compound pharmacy recall
– USA: Nurse spotted mold-tainted drugs right away, hospital says
– USA: 5 eye infections prompt Avastin injection recall
– USA: Visible mold forces recall of N.J. pharmacy injection d

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1. 10 years later: Continuing unethical and incompetent behavior by medical
professionals coincides with conflict of interest, leading to millions
of unexplained HIV infections

Crossposted with thanks from from “Don’t Get Stuck With HIV How to protect
yourself during health & cosmetic procedures”
http://dontgetstuck.wordpress.com
__________________________________________________________________

http://tinyurl.com/bwfezjq

10 years later: Continuing unethical and incompetent behavior by medical
professionals coincides with conflict of interest, leading to millions of
unexplained HIV infections

By David Gisselquist, Don’t Get Stuck With HIV (15.03.13)

Health care professionals in African ministries of health, the World Health
Organization (WHO), donor organizations, and foreign universities
participating in HIV-related research in Africa know the proper response to
unexpected HIV infections (eg, in children with HIV-negative mothers, in
spouses with one lifetime HIV-negative sex partner). That response is to
find the source of the infection by tracing and testing others who attended
suspected hospitals and clinics, and thereby to identify and correct unsafe
practices to protect other patients. There have been no such investigations
of unexpected HIV infections in any country in sub-Saharan Africa.

Health care professionals are ethically obligated to give patients accurate
information about risks. The World Medical Association’s Declaration of
Lisbon on the Rights of the Patient[1] states: “A mentally competent adult
patient has the right to give or withhold consent to any diagnostic
procedure or therapy. The patient has the right to the information
necessary to make his/her decisions…” and “Every person has the right to
health education that will assist him/her in making informed choices about
personal health and about the available health services.”

Medical researchers trying to find what is different about HIV transmission
in Africa that could explain the world’s worst HIV epidemics know that the
best way to do so is to trace and test sex and blood contacts when someone
shows up with a new or unexplained infection. Unfortunately, medical
researchers (who are also health care professionals) have been reticent to
find their colleagues’ contribution to Africa’s HIV epidemics. For example,
44 studies[2] that followed more than 120,000 adults in Africa and observed
more than 4,000 new HIV infections linked only 186 (4.6%) of those
infections to HIV-positive sex partners, all of which were spouses the
study had been following all along. No study traced and tested any sex
partner (spouse or other) not already included and followed in the study.
No study traced blood contacts, and few studies reported any information
about blood risks. Despite lack of evidence (avoided and ignored evidence)
all studies assumed infections came from sex. (These 44 studies were
randomized controlled trials of interventions to prevent HIV in African
adults.)

For 30 years, medical professionals have accused HIV-positive Africans of
careless or immoral sexual behavior. But if one looks for what is different
in Africa vs. the US and Europe, what jumps out is not sexual misbehavior
but rather unethical, immoral, and incompetent behavior by health care
professionals: not investigating unexpected HIV infections; not warning the
public about unsafe health care; and mismanaging research so as not to find
risks for HIV.

Ten years ago, on 14 March 2003, WHO held a one-day meeting to discuss the
role of unsafe medical injections in Africa’s HIV/AIDS epidemics. WHO staff
arranged the meeting after a series of articles[3][4][5] in the
International Journal of STD & AIDS during 2002-03 called attention to
decades of overlooked evidence that unsafe health care infected Africans
with HIV. The 20 invited attendees[6] included three co-authors of these
articles (Brody, Gisselquist, and Potterat).

WHO staff managed the meeting as part of a continuing cover-up of
hospitals’ and clinics’ contribution to Africa’s HIV epidemics. The meeting
was closed to the public. A first press release, prepared by WHO staff in
the days before the meeting and released before it ended, misleadingly
claimed:[7] “An expert group has reaffirmed that unsafe sexual practices
are responsible for the vast majority of HIV infections in sub-Saharan
Africa…”

Later that year, WHO’s meeting summary[8] acknowledged that “No consensus
emerged from the conference” on whether “sexual transmission was
responsible for the large majority of HIV infections.” The summary also
noted “universal agreement…that better data on the possible role of unsafe
injections, and other health care practices, in HIV transmission are needed
to more definitively determine their role in HIV transmission in sub-
Saharan Africa.”

Unfortunately, the events of the last 10 years show a continuing
unwillingness on the part of too many health care professionals to do what
is needed to find and stop HIV transmission through unsafe health care in
Africa.
—————————————————————————

[1] World Medical Association. 2005. Declaration of Lisbon on the Rights of
the Patient. Ferney-Voltaire, France: WMA. Available at:
http://www.wma.net/en/30publications/10policies/l4/ (accessed 18 August
2012).

[2] Gisselquist D. Randomized controlled trials for HIV/AIDS prevention
among men and women in Africa: untraced infections, unasked questions,
unreported data. Social Sciences Research Network, 2011. Available at:
http://papers.ssrn.com/sol3/papers.cfm?abstract_id=1940999.

[3] Gisselquist D, Rothenberg R, Potterat JJ, Drucker E. HIV infections in
sub-Saharan Africa not explained by sexual or vertical transmission. By:
Int J STD AIDS 2002; 13: 657-666. Available at:
http://www.robertogiraldo.com/reference/Gisselquist_TransmissionIsNotSexual
.pdf

[4] Gisselquist D, Potterat JJ. Heterosexual transmission of HIV in Africa:
an empiric estimate. Int J STD AIDS 2003; 14: 162-173. Available at:
http://contraception.fr/annexes/std162stats.pdf

[5] Gisselquist D, Potterat JJ, Brody S, Vachon F, Let it be sexual: how
health care transmission of AIDS in Africa was ignored. Int J STD AIDS
2003; 14: 148-161. Available at:
http://www.cirp.org/library/disease/HIV/gisselquist1/gisselquist1.pdf

[6] WHO. Unsafe injection practices and HIV Infection. Meeting summary (14
March 2003 meeting, undated summary posted by WHO later in 2003). Available
at: http://www.who.int/hiv/strategic/mt14303/en/index.html (accessed 6
January 2013).

[7] WHO. Expert group stresses that unsafe sex is primary mode of
transmission of HIV in Africa. Media Center statement 14 March 2003.
Available at:
http://www.who.int/mediacentre/news/statements/2003/statement5/en/index.htm
l (accessed 6 January 2013).

[8] WHO. Unsafe injection practices and HIV Infection. Meeting summary (14
March 2003 meeting, undated summary posted by WHO later in 2003). Available
at: http://www.who.int/hiv/strategic/mt14303/en/index.html (accessed 6
January 2013).
__________________________________________________________________
________________________________*_________________________________

2. Abstract: Injections during labor and intrapartum-related hypoxic injury
and mortality in rural southern Nepal
__________________________________________________________________
http://www.ncbi.nlm.nih.gov/pubmed/23523332

Int J Gynaecol Obstet. 2013 Mar 21. pii: S0020-7292(13)00130-6.

Injections during labor and intrapartum-related hypoxic injury and
mortality in rural southern Nepal.

Mullany LC, Khatry SK, Katz J, Stanton CK, Lee AC, Darmstadt GL, Leclerq
SC, Tielsch JM.

Department of International Health, Johns Hopkins Bloomberg School of
Public Health, Baltimore, USA. Electronic address: lmullany@jhsph.edu.

OBJECTIVE: To estimate the association between unmonitored use of
injections during labor and intrapartum-related neonatal mortality and
morbidity among home births.

METHODS: Recently delivered women in Sarlahi, Nepal, reported whether they
had received injections during labor. Data on breathing and crying status
at birth, time to first breath, respiratory rate, sucking ability, and
lethargy were gathered. Neonatal respiratory depression (NRD) and
encephalopathy (NE) were compared by injection receipt status using
multivariate regression models.

RESULTS: Injections during labor were frequently reported (7108 of 22352
[31.8%]) and were predominantly given by unqualified village “doctors.”
Multivariate analysis (excluding facility births and complicated
deliveries) revealed associations with intrapartum-related NRD (relative
risk [RR] 2.52; 95% CI, 2.29-2.78) and NE (RR 3.48; 95% CI, 2.46-4.93).

The risks of neonatal death associated with intrapartum-related NRD (RR
3.78; 95% CI, 2.53-5.66) or NE (RR 4.47; 95% CI, 2.78-7.19) were also
elevated.

CONCLUSION: Injection during labor was widespread at the community level.
This practice was associated with poor outcomes and possibly related to the
inappropriate use of uterotonics by unqualified providers. Interventions
are required to increase the safety of childbirth in the community and in
peripheral health facilities.

Parent trial registered at clinicaltrials.gov (NCT00 109616).

Copyright © 2013 International Federation of Gynecology and Obstetrics.
Published by Elsevier Ireland Ltd. All rights reserved.
__________________________________________________________________
________________________________*_________________________________

3. Abstract:Survey of syringe and needle safety among student registered
nurse anesthetists: are we making any progress?
__________________________________________________________________
http://www.ncbi.nlm.nih.gov/pubmed/23513322

AANA J. 2013 Feb;81(1):37-42.

Survey of syringe and needle safety among student registered nurse
anesthetists: are we making any progress?

Ford K.

Excela Health School of Anesthesia, Latrobe, Pennsylvania, USA.
jwford6@comcast.net

Anesthesia providers serve a vital role in preventing the transmission of
disease by following safe injection practices, yet violations of these
standards have occurred. The goal of this study was to determine the extent
of unsafe injection practices that exist among student anesthesia
providers.

An online survey containing 8 yes-no questions that assessed injection
practices as outlined by the American Association of Nurse Anesthetists was
sent to student registered nurse anesthetists with at least 3 months’
clinical experience. Three hundred twenty-five students completed the
survey.

Results showed that 14 (approximately 4%) have administered medications
from the same syringe to multiple patients, 59 (18%) have reused a needle
on the same patient, 266 (82%) have refilled used syringes, and 2 (0.6%)
have reused infusion sets for more than 1 patient. Furthermore, 71 (22%)
have reused a syringe or needle to withdraw medication from a multidose
vial, and 160 (49%) have reentered a single-use medication vial to prepare
doses for multiple patients. Students also were asked to report their
experiences with nurse anesthetists who engaged in these practices.

The results demonstrate that additional education on injection safety must
take place to improve practice, increase patient safety, and reduce
healthcare costs.
__________________________________________________________________
________________________________*_________________________________

4. Abstract: An update from the AANA practice committee: application of the
evidence-based process
__________________________________________________________________
http://www.ncbi.nlm.nih.gov/pubmed/23513315

AANA J. 2013 Feb;81(1):9-12.

An update from the AANA practice committee: application of the evidence-
based process.

Neft M, Greenier E.

The American Association of Nurse Anesthetists Practice Committee applies a
standardized evidence-based process to the development and revision of
practice-related documents and member resources.

This article highlights recent Practice Committee work related to the
revision and development of new materials for the Professional Practice
Manual for the Certified Registered Nurse Anesthetist.

Specific areas discussed include infection control, Certified Registered
Nurse Anesthetists and the interprofessional team, safe practices for
needle and syringe use, securing propofol, safe surgery and anesthesia,
patient safety and fatigue, and the use of mobile devices.
__________________________________________________________________
________________________________*_________________________________

5. Abstract: Prevalence and factors associated with percutaneous injuries
and splash exposures among health-care workers in a provincial hospital,
Kenya, 2010
__________________________________________________________________
http://www.ncbi.nlm.nih.gov/pubmed/23504245

Pan Afr Med J. 2013;14:10.

Prevalence and factors associated with percutaneous injuries and splash
exposures among health-care workers in a provincial hospital, Kenya, 2010.

Mbaisi EM, Ng’ang’a Z, Wanzala P, Omolo J.

Jomo Kenyatta University of Agriculture and Technology, Field Epidemiology
and Laboratory Training Programme and Ministry of Public Health and
Sanitation, Kenya.

INTRODUCTION: Accidental occupational exposure of healthcare workers to
blood and body fluids after skin injury or mucous membrane contact
constitutes a risk for transmission of blood-borne pathogens. Such
pathogens include Human Immunodeficiency Virus (HIV), Hepatitis B virus
(HBV) and Hepatitis C virus (HCV). We conducted a study to determine the
prevalence and associated factors for percutaneous injuries and splash
exposures among health-care workers in Rift Valley provincial hospital.

METHODS: A cross-sectional study was carried out from October to November
2010. Self reported incidents, circumstances surrounding occupational
exposure and post-exposure management were sought by use of interviewer
administered questionnaire. Descriptive, bivariate and multiple logistic
regression (forward stepwise procedure) analyses were performed. The level
of significance was set at 0.05.

RESULTS: Twenty five percent of health-care workers interviewed (N = 305)
reported having been exposed to blood and body fluids in the preceding 12
months. Percutaneous injuries were reported by 19% (n = 305) and splash to
mucous membrane by 7.2%. Higher rates of percutaneous injuries were
observed among nurses (50%), during stitching (30%), and in obstetric and
gynecologic department (22%). Health workers aged below 40 years were more
likely to experience percutaneous injuries (OR= 3.7; 95% CI = 1.08-9.13)
while previous training in infection prevention was protective (OR= 0.52;
95% CI = 0.03-0.90). Forty eight percent (n = 83) reported the incidents
with 20% (n = 83) taking PEP against HIV.

CONCLUSION: Percutaneous injuries and splashes are common in Rift Valley
Provincial hospital. Preventive measures remain inadequate. Health
institutions should have policies, institute surveillance for occupational
risks and enhance training of health care workers.

KEYWORDS: HIV, Health-care, blood, blood-borne pathogens, body fluids,
occupational exposure

Free Article
http://www.panafrican-med-journal.com/content/article/14/10/full/
__________________________________________________________________
________________________________*_________________________________

6. Abstract: Comparison of low- and higher-fidelity simulation to train and
assess pharmacy students’ injection technique
__________________________________________________________________
http://www.ncbi.nlm.nih.gov/pubmed/23518687

Am J Pharm Educ. 2013 Mar 12;77(2):33.

Comparison of low- and higher-fidelity simulation to train and assess
pharmacy students’ injection technique.

Skoy ET, Eukel HN, Frenzel JE.

College of Pharmacy, Nursing, and Allied Sciences, North Dakota State
University, Fargo, ND.

Objective. To evaluate 2 forms of simulation used to train and assess
third-year pharmacy students’ subcutaneous and intramuscular injection
techniques.

Design. A cross-over comparison was used to evaluate an injection pad vs a
patient simulator injection arm to train students in injection
administration.

Assessment. Students completed a survey instrument rating their
proficiency, confidence, and anxiety before and after each form of
simulated practice. All students demonstrated competence to administer an
injection to a peer after using both forms of simulation. Students’ self-
ratings of proficiency and confidence improved and anxiety decreased after
practicing injections with both forms of simulation.

The only significant difference in performance seen between students who
used the 2 types of simulations was in students who first practiced with
the injection pad followed by the injection arm.

Conclusion. Student ability to administer an injection and their self-
perceived levels of confidence, proficiency, and anxiety were not dependent
on the type of simulation training used.

KEYWORDS: immunization, injection, simulation, simulator, vaccination

Free full text: http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3602857/
__________________________________________________________________
________________________________*_________________________________

7. Abstract: Potential Risks of Pharmacy Compounding
__________________________________________________________________
http://www.ncbi.nlm.nih.gov/pubmed/23526368

Drugs R D. 2013 Mar 23.

Potential Risks of Pharmacy Compounding.

Gudeman J, Jozwiakowski M, Chollet J, Randell M.

Ther-Rx Corporation, 2280 Schuetz Road, St. Louis, MO, 63146, USA.

Pharmacy compounding involves the preparation of customized medications
that are not commercially available for individual patients with
specialized medical needs. Traditional pharmacy compounding is appropriate
when done on a small scale by pharmacists who prepare the medication based
on an individual prescription. However, the regulatory oversight of
pharmacy compounding is significantly less rigorous than that required for
Food and Drug Administration (FDA)-approved drugs; as such, compounded
drugs may pose additional risks to patients. FDA-approved drugs are made
and tested in accordance with good manufacturing practice regulations
(GMPs), which are federal statutes that govern the production and testing
of pharmaceutical products. In contrast, compounded drugs are exempt from
GMPs, and testing to assess product quality is inconsistent. Unlike FDA-
approved drugs, pharmacy-compounded products are not clinically evaluated
for safety or efficacy. In addition, compounded preparations do not have
standard product labeling or prescribing information with instructions for
safe use. Compounding pharmacies are not required to report adverse events
to the FDA, which is mandatory for manufacturers of FDA-regulated
medications.

Some pharmacies engage in activities that extend beyond the boundaries of
traditional pharmacy compounding, such as large-scale production of
compounded medications without individual patient prescriptions,
compounding drugs that have not been approved for use in the US, and
creating copies of FDA-approved drugs.

Compounding drugs in the absence of GMPs increases the potential for
preparation errors. When compounding is performed on a large scale, such
errors may adversely affect many patients. Published reports of independent
testing by the FDA, state agencies, and others consistently show that
compounded drugs fail to meet specifications at a considerably higher rate
than FDA-approved drugs.

Compounded sterile preparations pose the additional risk of microbial
contamination to patients. In the last 11 years, three separate meningitis
outbreaks have been traced to purportedly ‘sterile’ steroid injections
contaminated with fungus or bacteria, which were made by compounding
pharmacies. The most recent 2012 outbreak has resulted in intense scrutiny
of pharmacy compounding practices and increased recognition of the need to
ensure that compounding is limited to appropriate circumstances.

Patients and healthcare practitioners need to be aware that compounded
drugs are not the same as generic drugs, which are approved by the FDA.

The risk-benefit ratio of using traditionally compounded medicines is
favorable for patients who require specialized medications that are not
commercially available, as they would otherwise not have access to suitable
treatment. However, if an FDA-approved drug is commercially available, the
use of an unapproved compounded drug confers additional risk with no
commensurate benefit.
__________________________________________________________________
________________________________*_________________________________

8. Abstract: Strengthening the Expanded Programme on Immunization in
Africa: Looking beyond 2015
__________________________________________________________________
http://www.plosmedicine.org/article/info:doi/10.1371/journal.pmed.1001405

PLoS Med 10(3): e1001405. doi:10.1371/journal.pmed.1001405

OPEN ACCESS POLICY FORUM

Strengthening the Expanded Programme on Immunization in Africa: Looking
beyond 2015

Machingaidze S, Wiysonge CS, Hussey GD

Copyright: © 2013 Machingaidze et al. This is an open-access article
distributed under the terms of the Creative Commons Attribution License,
which permits unrestricted use, distribution, and reproduction in any
medium, provided the original author and source are credited.

Funding: No direct funding was received for this study. The authors were
personally salaried by their institutions during the period of writing
(though no specific salary was set aside or given for the writing of this
paper).

Competing interests: The authors have declared that no competing interests
exist.

Abbreviations: DTP3, diphtheria-tetanus-pertussis third dose; EPI, Expanded
Programme on Immunization; GAVI, Global Alliance for Vaccines and
Immunisation; HepB, hepatitis B; Hib, Haemophilus influenzae type B; LMIC,
low- and middle-income country; MCV, measles-containing vaccine; MDG,
Millennium Development Goal; MVP, Meningitis Vaccine Project; PCV,
pneumococcal conjugate vaccine; SIA, supplementary immunisation activity;
UNICEF, United Nations Children’s Fund; VPD, vaccine-preventable disease;
WHO, World Health Organization; WPV, wild polio virus

Provenance: Not commissioned; externally peer reviewed.

Summary Points

There have been significant improvements in the performance of the Expanded
Programme on Immunization (EPI) in Africa since its inception in 1974.
However, there exist wide inter- and intra-country differences.

Successes such as the introduction of hepatitis B (HepB), Haemophilus
influenzae type B (Hib), and meningococcal group A vaccines across the
continent are milestones indicating growth and development in the right
direction. Conversely polio and measles outbreaks, as well as high vaccine
drop-out rates across the continent, indicate failures within the EPI
system that require evidence-informed corrective interventions.

With the 2015 deadline for the Millennium Development Goals (MDGs)
approaching, it is necessary for Africa to take stock, critically assess
its position, take ownership of the regional and country-specific problems,
and develop precise strategies to overcome the challenges identified.

There is need for increased immunisation systems strengthening, as many are
plagued by weak infrastructure and shortage of skilled human resources.
More affordable and adapted vaccines need to be made available.

Increased political and financial commitments from African governments are
key factors for both maintaining current achievements and making additional
progress for EPI in Africa.

Complete open access article:
http://www.plosmedicine.org/article/info:doi/10.1371/journal.pmed.1001405
__________________________________________________________________
________________________________*_________________________________

9. Abstract: The incidence and prevalence of hepatitis C in prisons and
other closed settings: Results of a systematic review and meta-analysis
__________________________________________________________________
http://www.ncbi.nlm.nih.gov/pubmed/23504650

Hepatology. 2013 Mar 15.

The incidence and prevalence of hepatitis C in prisons and other closed
settings: Results of a systematic review and meta-analysis.

Larney S, Kopinski H, Beckwith CG, Zaller ND, Jarlais DD, Hagan H, Rich JD,
van den Bergh BJ, Degenhardt L.

National Drug and Alcohol Research Centre, University of New South Wales,
Sydney 2052, NSW, Australia; Alpert Medical School, Brown University,
Providence 02906, RI, USA. s.larney@unsw.edu.au.

People detained in prisons and other closed settings are at elevated risk
of infection with hepatitis C virus (HCV). We undertook a systematic review
and meta-analysis with the aim of determining the rate of incident HCV
infection and the prevalence of anti-HCV among detainees of closed
settings. We systematically searched databases of peer-reviewed literature
and widely distributed a call for unpublished data.

We calculated summary estimates of incidence and prevalence among general
population detainees and detainees with a history of injecting drug use
(IDU), and explored heterogeneity through stratification and meta-
regression. The summary prevalence estimates were used to estimate the
number of anti-HCV positive prisoners globally.

HCV incidence among general detainees was 1·4 per 100 person-years (py; 95%
CI: 0·1, 2·7; k=4), and 16·4 per 100py (95% CI: 0·8, 32·1; k=3) among
detainees with a history of IDU. The summary prevalence estimate of anti-
HCV in general detainees was 26% (95% CI: 23%, 29%; k=93), and in detainees
with a history of IDU, 64% (95% CI: 58%, 70%; k=51). The regions of highest
prevalence were Central Asia (38%; 95% CI 32%, 43%; k=1) and Australasia
(35%; 95% CI: 28%, 43%; k=9).

We estimate that 2·2 million (range: 1·4 million – 2·9 million) detainees
globally are anti-HCV positive, with the largest populations in North
America (668,500; range: 553,500-784,000) and East and Southeast Asia
(638,000; range: 332,000-970,000).

Conclusion: HCV is a significant concern in detained populations, with one
in four detainees anti-HCV positive. Epidemiological data on the extent of
HCV infection in detained populations is lacking in many countries. Greater
attention towards prevention, diagnosis and treatment of HCV infection
among detained populations is urgently required.

Copyright © 2013 American Association for the Study of Liver Diseases.
__________________________________________________________________
________________________________*_________________________________

10. Abstract: Pharmacists and harm reduction: A review of current practices
and attitudes
__________________________________________________________________
http://www.ncbi.nlm.nih.gov/pubmed/23509527

Can Pharm J (Ott). 2012 May;145(3):124-127.e2.

Pharmacists and harm reduction: A review of current practices and
attitudes.

Watson T, Hughes C.

Background: Injection drug use and other high-risk behaviours are the cause
of significant morbidity and mortality and thus have been the focus of many
health promotion strategies. Community pharmacists are considered
underutilized health providers and are often thought to be more accessible
than other health professionals.

The purpose of this review is to provide an overview of community
pharmacists’ practices as well as pharmacists’ attitudes and identified
barriers toward providing harm reduction services. We will highlight the
major harm reduction services being offered through community pharmacies,
as well as identify barriers to implementing these services.

Methods: A review of the literature from 1995 to 2011 was conducted using
the electronic databases MEDLINE, PubMed and Scopus, encompassing
pharmacists’ involvement in harm reduction services. Keywords included
pharmacist, harm reduction, disease prevention, health promotion,
attitudes, competence and barriers. References of included articles were
examined to identify further relevant literature.

Results: Pharmacists are primarily involved in providing clean needles to
injection drug users, as well as opioid substitution. Pharmacists generally
have a positive attitude toward providing health promotion and harm
reduction programs and express some interest in increasing their role in
this area. Common barriers to expanding harm reduction strategies in
community pharmacists’ practice include lack of time and training,
insufficient remuneration, fear of attracting unruly clientele and
inadequate communication between health providers.

Conclusion: As one of the most accessible health care providers, community
pharmacists are in an ideal position to provide meaningful services to
injection drug users. However, in order to do so, pharmacists require
additional support in the form of better health team and system
integration, as well as remuneration models.

Free PMC Article http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3567507/
__________________________________________________________________
________________________________*_________________________________

11. Abstract: Opioid overdose rates and implementation of overdose
education and nasal naloxone distribution in Massachusetts: interrupted
time series analysis
__________________________________________________________________
http://www.ncbi.nlm.nih.gov/pubmed/23372174

BMJ. 2013 Jan 30;346:f174.

Opioid overdose rates and implementation of overdose education and nasal
naloxone distribution in Massachusetts: interrupted time series analysis.

Walley AY, Xuan Z, Hackman HH, Quinn E, Doe-Simkins M, Sorensen-Alawad A,
Ruiz S, Ozonoff A.

Clinical Addiction Research Education Unit, Section of General Internal
Medicine, Boston University School of Medicine, Boston, MA 02118, USA.
awalley@bu.edu

OBJECTIVE: To evaluate the impact of state supported overdose education and
nasal naloxone distribution (OEND) programs on rates of opioid related
death from overdose and acute care utilization in Massachusetts.

DESIGN: Interrupted time series analysis of opioid related overdose death
and acute care utilization rates from 2002 to 2009 comparing community-year
strata with high and low rates of OEND implementation to those with no
implementation.

SETTING: 19 Massachusetts communities (geographically distinct cities and
towns) with at least five fatal opioid overdoses in each of the years 2004
to 2006.

PARTICIPANTS: OEND was implemented among opioid users at risk for overdose,
social service agency staff, family, and friends of opioid users.

INTERVENTION: OEND programs equipped people at risk for overdose and
bystanders with nasal naloxone rescue kits and trained them how to prevent,
recognize, and respond to an overdose by engaging emergency medical
services, providing rescue breathing, and delivering naloxone.

MAIN OUTCOME MEASURES: Adjusted rate ratios for annual deaths related to
opioid overdose and utilization of acute care hospitals.

RESULTS: Among these communities, OEND programs trained 2912 potential
bystanders who reported 327 rescues. Both community-year strata with 1-100
enrollments per 100,000 population (adjusted rate ratio 0.73, 95%
confidence interval 0.57 to 0.91) and community-year strata with greater
than 100 enrollments per 100,000 population (0.54, 0.39 to 0.76) had
significantly reduced adjusted rate ratios compared with communities with
no implementation. Differences in rates of acute care hospital utilization
were not significant.

CONCLUSIONS: Opioid overdose death rates were reduced in communities where
OEND was implemented. This study provides observational evidence that by
training potential bystanders to prevent, recognize, and respond to opioid
overdoses, OEND is an effective intervention.

Free full text http://www.bmj.com/content/346/bmj.f174?view=long
__________________________________________________________________
________________________________*_________________________________

12. Abstract: Prevalence and predictors of hepatitis B virus co-infection
in a united states cohort of hepatitis C virus-infected patients
__________________________________________________________________
http://www.ncbi.nlm.nih.gov/pubmed/23505059

Hepatology. 2013 Mar 16.

Prevalence and predictors of hepatitis B virus co-infection in a united
states cohort of hepatitis C virus-infected patients.

Tyson GL, Kramer JR, Duan Z, Davila JA, Richardson PA, El-Serag HB.

Houston VA Health Services Research and Development Center of Excellence,
Michael E. DeBakey Veterans Affairs Medical Center and Sections of Baylor
College of Medicine, Houston, TX; Gastroenterology and Hepatology, TX;
Health Services Research, Department of Medicine, Baylor College of
Medicine, Houston, TX. giatyson@hotmail.com.

BACKGROUND AND AIM: There is sparse epidemiologic data on co-infection of
hepatitis B (HBV) and hepatitis C (HCV) in the United States. Therefore,
the aim of this study was to determine the prevalence and predictors of HBV
co-infection in a large United States population of HCV patients.

METHODS: We used the National Veterans Affairs HCV Clinical Case Registry
to identify patients tested for HCV during 1997-2005. Patients were
categorized based on HCV exposure (any two +HCV tests or one test with a
diagnostic code), HCV infection (+RNA or genotype), HBV exposure (any +HBV
test, excluding +HBsAb only) and HBV infection (+HBsAg, HBV DNA, or HBeAg).
The prevalence of HBV exposure among patients with HCV exposure and that of
HBV infection among patients with HCV infection were determined.
Multivariable logistic regression evaluated potential demographic and
clinical predictors of HBV co-infection.

RESULTS: Among 168,239 patients with HCV exposure, 58,415 patients had HBV
exposure for a prevalence of 34.7% (95% CI 34.5-35.0). Among 102,971
patients with HCV infection, 1,431 patients had HBV co-infection for a
prevalence of 1.4% (95% CI 1.3-1.5). Independent associations with HBV co-
infection compared with HCV mono-infection were age = 50 years, male sex,
positive HIV status, history of hemophilia, sickle cell anemia or
thalassemia, history of blood transfusion, cocaine and other drug use;
there was decreased risk in patients of Hispanic ethnicity.

CONCLUSIONS: This is the largest cohort study in the United States on the
prevalence of HBV co-infection in HCV patients. Among veterans with HCV,
exposure to HBV is common (~35%), but HBV co-infection is relatively low
(1.4%). Several possible risk factors were identified. (HEPATOLOGY 2013.).

Copyright © 2013 American Association for the Study of Liver Diseases.
__________________________________________________________________
________________________________*_________________________________

13. Abstract: Measures of knowledge about standard precautions: A
literature review in nursing
__________________________________________________________________
http://www.ncbi.nlm.nih.gov/pubmed/23507075

Nurse Educ Pract. 2013 Mar 15. pii: S1471-5953(13)00039-5.

Measures of knowledge about standard precautions: A literature review in
nursing.

de Carvalho Nagliate P, Nogueira PC, de Godoy S, Mendes IA.

Fundamental Nursing Program at University of São Paulo at Ribeirão Preto
School of Nursing (EERP-USP), WHO Collaborating Centre for Nursing Research
Development, Brazil. Electronic address: patricianagliate@usp.br.

BACKGROUND: Standard precautions (SP) play an important role in hospital
infection control, as well as in issues related to biosafety and security
of patients, professionals and students active in direct or indirect health
care delivery.

OBJECTIVE: This research aimed to identify in the literature which
instruments nurse researchers have used to evaluate knowledge, attitudes
and compliance with SP for infection control.

METHODS: A literature review was undertaken in the databases Web of
Science, Bireme (Medline and Lilacs) and Scopus.

RESULTS: 91.66% of the studies were ranked as evidence level IV; 66.66% of
the instruments were structured questionnaires, 58.33% of which had been
validated and half of these instruments presented reliability and validity
scores for the instrument used. Publications were concentrated in 2009
(41.66%), mostly in English (75%), in nursing journals with impact factor
above 1.60 (83.33%).

CONCLUSIONS: The instruments nurse researchers most employed were
structured questionnaires associated with Likert-type rating scales.

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

14. Abstract: Improved hand hygiene technique and compliance in healthcare
workers using gaming technology
__________________________________________________________________
http://www.ncbi.nlm.nih.gov/pubmed/23498360

J Hosp Infect. 2013 Mar 13. pii: S0195-6701(13)00055-8.

Improved hand hygiene technique and compliance in healthcare workers using
gaming technology.

Higgins A, Hannan MM.

Infection Prevention and Control Department, Mater Private Hospital, Dublin
7, Ireland. Electronic address: ahiggins@materprivate.ie.

BACKGROUND: In 2009, the World Health Organization recommended the use of a
‘multi- faceted, multi-modal hand hygiene strategy’ (Five Moments for Hand
Hygiene) to improve hand hygiene compliance among healthcare workers. As
part of this initiative, a training programme was implemented using an
automated gaming technology training and audit tool to educate staff on
hand hygiene technique in an acute healthcare setting.

AIM: To determine whether using this automated training programme and audit
tool as part of a multi-modal strategy would improve hand hygiene
compliance and technique in an acute healthcare setting.

METHODS: A time-series quasi-experimental design was chosen to measure
compliance with the Five Moments for Hand Hygiene and handwashing
technique. The study was performed from November 2009 to April 2012. An
adenosine triphosphate monitoring system was used to measure handwashing
technique, and SureWash (Glanta Ltd, Dublin, Ireland), an automated
auditing and training unit, was used to provide assistance with staff
training and education.

FINDINGS: Hand hygiene technique and compliance improved significantly over
the study period (P < 0.0001).

CONCLUSION: Incorporation of new automated teaching technology into a hand
hygiene programme can encourage staff participation in learning, and
ultimately improve hand hygiene compliance and technique in the acute
healthcare
setting.

Copyright © 2013 The Healthcare Infection Society. Published by Elsevier
Ltd. All rights reserved.
__________________________________________________________________
________________________________*_________________________________

15. Abstract: Microneedles for drug and vaccine delivery
__________________________________________________________________
http://www.ncbi.nlm.nih.gov/pubmed/22575858

Adv Drug Deliv Rev. 2012 Nov;64(14):1547-68.

Microneedles for drug and vaccine delivery.

Kim YC, Park JH, Prausnitz MR.

Department of Chemical and Biomolecular Engineering, Korea Advanced
Institute of Science and Technology (KAIST), Daejeon, Republic of Korea.
dohnanyi@kaist.ac.kr

Microneedles were first conceptualized for drug delivery many decades ago,
but only became the subject of significant research starting in the
mid-1990’s when microfabrication technology enabled their manufacture as
(i) solid microneedles for skin pretreatment to increase skin permeability,
(ii) microneedles coated with drug that dissolves off in the skin, (iii)
polymer microneedles that encapsulate drug and fully dissolve in the skin
and (iv) hollow microneedles for drug infusion into the skin.

As shown in more than 350 papers now published in the field, microneedles
have been used to deliver a broad range of different low molecular weight
drugs, biotherapeutics and vaccines, including published human studies with
a number of small-molecule and protein drugs and vaccines. Influenza
vaccination using a hollow microneedle is in widespread clinical use and a
number of solid microneedle products are sold for cosmetic purposes. In
addition to applications in the skin, microneedles have also been adapted
for delivery of bioactives into the eye and into cells.

Successful application of microneedles depends on device function that
facilitates microneedle insertion and possible infusion into skin, skin
recovery after microneedle removal, and drug stability during
manufacturing, storage and delivery, and on patient outcomes, including
lack of pain, skin irritation and skin infection, in addition to drug
efficacy and safety.

Building off a strong technology base and multiple demonstrations of
successful drug delivery, microneedles are poised to advance further into
clinical practice to enable better pharmaceutical therapies, vaccination
and other applications.

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

16. Abstract: Keratoacanthoma arising after site injection infection of
cosmetic collagen filler
__________________________________________________________________
http://www.ncbi.nlm.nih.gov/pubmed/23500750

Int J Surg Case Rep. 2013;4(4):429-31.

Keratoacanthoma arising after site injection infection of cosmetic collagen
filler.

Brongo S, Moccia LS, Nunziata V, D’Andrea F.

Unit of Plastic Reconstructive Surgery, Department of Orthopaedic,
Traumatologic, Riabilitative and Plastic-Reconstructive Sciences,
Policlinico Hospital of Second University of Naples, Naples, Italy.

INTRODUCTION: Over one million treatments in more than 40 countries have
been administered Zyplast implants. Infections at collagen implant sites
have occurred in fewer than one per thousand treated patients.

PRESENTATION OF CASE: We present a case report of a 27-year-old man; he
developed a severe granulomatous reaction in the site of resolvable
collagen filler injection Zyplast, and one month later developed a
cutaneous nodular lesion. Histological examination of the lesion revealed
Keratoacanthoma (KA) with surgical margins free of tumor. We performed two
surgical corrections within a period of six months on multiple hypertrophic
skin scars of the face. Two years after the last excision, the patient
continued to be free of any recurrence.

DISCUSSION: Keratoacanthoma (KA) is a benign skin tumor with a quick growth
pattern but may regress spontaneously. Though the exact etiology of KA is
uncertain, it is found to be more frequent in elderly people, on photo-
exposed skin areas and cutaneous infection site. Bovine collagen
intradermal injections, though catabolized over the time in the patient,
can raise several complications already described in technical literature,
but we want underline that cutaneous infection near filler injection site
can develope KA as described in our case report.

CONCLUSION: KA must be considered as a new local unforeseeable complication
of bovine collagen injection to fill facial soft tissue when occurred a
face cutaneous infection. We believe that radical excision is the golden
standard.

Copyright © 2013 Surgical Associates Ltd. Published by Elsevier Ltd. All
rights reserved.

Free PMC Article http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3605485/
__________________________________________________________________
________________________________*_________________________________

17. Abstract: Incidence of Adverse Events Among Healthcare Workers
Following H1N1 Mass Immunization in Ghana : A Prospective Study
__________________________________________________________________
http://www.ncbi.nlm.nih.gov/pubmed/23508545

Drug Saf. 2013 Mar 19.

Incidence of Adverse Events Among Healthcare Workers Following H1N1 Mass
Immunization in Ghana : A Prospective Study.

Ankrah DN, Mantel-Teeuwisse AK, De Bruin ML, Amoo PK, Ofei-Palm CN,
Agyepong I, Leufkens HG.

Korle-Bu Teaching Hospital, P. O. Box 77, Korle-Bu, Accra, Ghana,
danielankrah45@hotmail.com.

BACKGROUND: Cases of the A(H1N1) 2009 influenza were first recorded in
Ghana in July 2009. In June 2010 when prioritized vaccination against the
novel A(H1N1) 2009 influenza virus started in the country, health workers
were among the selected groups to receive the vaccination.

OBJECTIVE: The aim of this study was to determine the distribution and
types of adverse events reported following immunization of healthcare
workers at the Korle-Bu Teaching Hospital from the day vaccination started
until 1 week after the end of vaccination.

METHODS: Safety data collected during the A(H1N1) 2009 influenza
vaccination of health workers at the Korle-Bu Teaching Hospital (Accra,
Ghana) were used for this study. All workers aged 18 years and over were
eligible for vaccination. For uniformity, 0.5 mL of Pandemrix® (equivalent
to 3.75 µg of hemagglutinin antigen) was administered intramuscularly into
the deltoid muscle of the left arm. Each vaccinee was issued with a card
and was advised to report any adverse events following immunization (AEFI)
to designated health workers for follow-up. Incidence rates of adverse
events were estimated and compared with the Pandemrix® Summary of Product
Characteristics (SPC) RESULTS: A total of 5870 people (64.9 % females) with
a mean age of 34.0 years were vaccinated. In total, 140 vaccinees reported
adverse events. The mean age among vaccinees reporting adverse events was
36.1 years. The overall incidence of vaccinees reporting adverse events and
the overall incidence of adverse events was 232 (95 % CI 199-320) per
10,000 people and 930 (95 % CI 820-1070) per 10,000 people, respectively.
In particular, we found no difference in the way males reported AEFI
compared with females (Chi-squared [?2] = 0.59; p > 0.2), and we did not
find any association between age as a categorical variable and vaccine
adverse event reporting (?2 = 5.24; p > 0.1). There were only three serious
cases that led to hospitalization. All three cases occurred within 24 hours
of receiving the vaccine. The incidence rates for the various reported
events were all lower compared with those in the Pandemrix® SPC, but while
injection-site pain was the most frequent in the SPC and other foreign
studies, we recorded headache as the most frequent. Even fatigue,
muscle/joint aches and fever had higher incidence rates compared with
injection-site pain. Tachycardia (n = 6), tinnitus (n = 1) and decreased
appetite (n = 4) were reported although were not included in the SPC.

CONCLUSION: The most prominent adverse events reported were headaches,
dizziness, muscle and joint aches, weakness, fever and injection-site pain.
Although similar events were reported in other studies, the incidence was
different and there were a few differences in the most frequently reported
events. More studies of a similar nature should be encouraged in low- and
medium-income countries to bridge the information gap with the developed
world.
__________________________________________________________________
________________________________*_________________________________

18. No Abstract: Safer sharps in a dangerous world
__________________________________________________________________
MLO Med Lab Obs. 2012 Dec;44(12):30, 32-3.

Safer sharps in a dangerous world.

Duesman KM, Duncan RJ.

Global Health for Retractable Technologies, Inc.

http://www.ncbi.nlm.nih.gov/pubmed/23330522
__________________________________________________________________
________________________________*_________________________________

19. No Abstract: Surface safety. Part 4. Best practices in surface and
medical device disinfection
__________________________________________________________________

http://www.ncbi.nlm.nih.gov/pubmed/23387104

Health Facil Manage. 2013 Jan;26(1):2p. preceding 39.

Surface safety. Part 4. Best practices in surface and medical device
disinfection.

Kehoe B.
__________________________________________________________________
________________________________*_________________________________

20. No Abstract: Sustainable commitment. Advice on establishing a plastics
recycling program
__________________________________________________________________
Health Facil Manage. 2013 Jan;26(1):36-8.

Sustainable commitment. Advice on establishing a plastics recycling
program.

Christenson TD.

Healthcare Plastics Recycling Council, USA. tod.christenson@anteagroup.com
__________________________________________________________________
________________________________*_________________________________

21. No Abstract: Top 10 health technology hazards for 2013 are named

See the press release here:
https://www.ecri.org/Press/Pages/2012_Top_Ten_Hazards.aspx
__________________________________________________________________
http://www.ncbi.nlm.nih.gov/pubmed/23424827

OR Manager. 2013 Feb;29(2):16-9.

Top 10 health technology hazards for 2013 are named.

[No authors listed]
__________________________________________________________________
________________________________*_________________________________

22. News

– USA: Inspection yields another compound pharmacy recall
– USA: Nurse spotted mold-tainted drugs right away, hospital says
– USA: 5 eye infections prompt Avastin injection recall
– USA: Visible mold forces recall of N.J. pharmacy injection drugs

Selected news items reprinted under the fair use doctrine of international
copyright law: http://www4.law.cornell.edu/uscode/17/107.html
__________________________________________________________________
USA: Inspection yields another compound pharmacy recall
Reuters (25.03.13)

BOSTON – The crackdown on specialty pharmacies that compound drugs into
customized doses on Monday yielded another recall after an inspection by
the Food and Drug Administration.

Pallimed Solutions Pharmacy, which specializes in treating erectile
dysfunction, said it issued a voluntary recall of 16 sterile compound
products, including injectable testosterone. Pallimed of Woburn,
Massachusetts, also said it agreed to stop all sterile compounding
activities.

“The company took this aggressive precautionary recall measure on the basis
of information observed during the course of an inspection conducted by the
Food and Drug Administration and the Massachusetts Board of Registration in
Pharmacy,” Pallimed said in a statement. The recall is limited to sterile
compounded products dispensed on or after January 1.

Authorities are coming to grips with how to oversee compounding pharmacies
in the wake of a deadly meningitis outbreak that has killed 50 and injured
more than 700 people.

FDA Commissioner Margaret Hamburg said in an official blog post on Friday
that serious problems continue to take place at compounding pharmacies and
she is hopeful that the Senate committee with jurisdiction over the issue
“will yield strong legislation for patients across the nation.”

(Reporting By Tim McLaughlin; Editing by Maureen Bavdek)
__________________________________________________________________
__________________________________________________________________
http://tinyurl.com/cz9g4zq

USA: Nurse spotted mold-tainted drugs right away, hospital says
By JoNel Aleccia, Senior Writer, NBC News, USA (20.03.13)

A sharp-eyed nurse at Yale-New Haven Hospital in Connecticut is being
credited with raising a warning last week about floating mold in vital
intravenous drugs, prompting a mass recall — and possibly averting serious
infections in patients in at least four states.

The nurse spotted the debris in a bag of magnesium sulfate IV solution as
part of a routine safety check, according to spokesman Rob Hutchison.
“This nurse pulled it and immediately called the pharmacy,” said Hutchison,
who didn’t identify the employee.

The hospital quickly quarantined about 40 different types of drugs produced
by Med Prep Consulting Inc., a Tinton Falls, N.J., compounding pharmacy
that has recalled all lots of all drugs and temporarily ceased operations
under a consent order imposed by the state pharmacy board.

Five bags with floating mold were found at Yale-New Haven Hospital; tests
showed the debris was a still-unidentified fungus. Eighty-eight orders of
the magnesium sulfate solution — in shipments ranging from 10 to 20 bags
up to 500 bags — were sent to 13 hospitals including Yale-New Haven,
according to Angelo J. Cifaldi, a lawyer for Med Prep.
Hospital officials are reaching out to doctors and patients who may have
received the contaminated drugs, Hutchison said. Health officials in
Connecticut, New Jersey, Pennsylvania and Delaware all said they are
working with federal investigators to determine what steps to take next.
The drugs were produced and delivered between Feb. 18 and March 13.
The worry is that patients may have been injected with tainted 50-
millileter doses of magnesium sulfate 2 gram in dextrose 5 percent solution
in water.

“Giving a patient a contaminated injectable drug could result in a life-
threatening infection,” Dr. Janet Woodcock, director of the Center for Drug
Evaluation and Research for the Food and Drug Administration, said in a
statement.

So far, no infections or other problems have been reported, FDA officials
said.

But it’s a worrisome — and very real — possibility six months after an
outbreak of fungal meningitis tied to contaminated pain shots that have
been tied to 722 illnesses and 50 deaths. The now-bankrupt compounding
pharmacy blamed in that outbreak, New England Compounding Center of
Framingham, Mass., had serious problems with contamination and sterility,
investigations showed.

In addition to the magnesium sulfate solution — which is used to replace
electrolytes in hospitalized patients — Med Prep also makes a wide variety
of sterile drugs, including antibiotics, anesthetics, cardiac, labor and
delivery and pain management medications, according to the FDA.
The firm received FDA warnings about its sterility practices in 2001 and
2010, agency records showed.

The 1,541-bed Yale-New Haven hospital has used drugs from compounding
pharmacies in order to meet the demand for the volume of vital medications,
Hutchison said. Drug shortages in recent years — particularly shortages of
sterile injectables — have sent many hospitals to compounding pharmacies,
experts say.

Of the 86 drugs affected by the Med Prep recall, 53 are in short supply,
according to Erin Fox, manager of the Drug Information Service at the
University of Utah, which tracks drug shortages.
After pulling the Med Prep products, the hospital is trying to find ways to
replace the drugs — and mixing many of the specialized products
themselves.

“We’re working very hard to source products from other vendors,” Hutchison
said.

Many of the drugs will be unavailable, however, Fox said. And it can be
very hard for a hospital to ramp up its own sterile drug production
quickly.

“I think it’s concerning anytime a hospital is completely starting from
scratch in a day or two.”
__________________________________________________________________
__________________________________________________________________
USA: 5 eye infections prompt Avastin injection recall
By JoNel Aleccia, Senior Writer, NBC News (20.03.13)

A Georgia compounding pharmacy is recalling 40 lots of Avastin injection
syringes after reports that at least five patients developed eye infections
from off-label use of the drug.

The injection drugs — typically used as a less-expensive way to treat wet
age-related macular degeneration — were distributed starting Dec. 18, 2012
to doctors’ offices in Georgia, Louisiana, South Carolina and Indiana by
Clinical Specialties Inc. of Augusta, Ga. Austin Gore, the pharmacist who
runs the firm, said all five infections appeared to be linked to a single
Georgia pharmacy, but Georgia health officials said one of those infections
actually occurred in Indiana. Indiana health officials said the situation
was under investigation.

The patients have developed bacterial endophthalmitis caused by
streptococcus bacteria, said Cherie Dreznek, Georgia’s state
epidemiologist. Food and Drug Administration officials warned health care
workers in August 2011 about the dangers of using repackaged eye injections
of Avastin, a cancer drug known generically as bevacizumab.

At least a dozen people developed eye infections, the FDA said, including
some who were blinded after receiving the tainted injections. Another four
patients developed eye infections in Tennessee, state officials said at the
time.

Clinical Specialties has notified doctors’ offices of the recall and urged
health workers to immediately stop using the Avastin injections.

Made by the firm Genentech, Avastin solution for IV injection is approved
to treat various cancers. It frequently is used off-label to treat macular
degeneration because Avastin costs about $50 per injection while Lucentis,
the Genentech drug approved for injection, costs about $2,000 per
injection.

Consumers should contact Clinical Specialties at 866-880-1915 if they have
experienced any eye problems after an injection of Avastin distributed by
the firm.
__________________________________________________________________
__________________________________________________________________
http://tinyurl.com/a4nmtla

USA: Visible mold forces recall of N.J. pharmacy injection drugs
By JoNel Aleccia, Senior Writer, NBC News, USA (19.03.13)

A New Jersey compounding pharmacy has temporarily shuttered operations
after Connecticut hospital officials reported finding visible mold in bags
of a vital injection drug.

Med Prep Consulting Inc., of Tinton Falls, agreed to stop making and
shipping medications after recalling all lots of all products — including
the magnesium sulfate intravenous solution that sparked concerns starting
last week, Food and Drug Administration officials said Monday.
The move followed a voluntary consent order enacted Friday that will remain
in effect until at least March 22, officials with the New Jersey State
Board of Pharmacy said. The recall potentially affects thousands of bags,
syringes and vials of premixed solution.

“This investigation is evolving. At this time, in an abundance of caution,
the Department of Health recommends that any health care facility that has
received products from Med Prep should inventory them and remove them from
use,” New Jersey Health Commissioner Mary E. O’Dowd said in a statement.
At least thirteen hospitals in Connecticut, Delaware, New Jersey and
Pennsylvania apparently received the firm’s 50-milliliter bags of magnesium
sulfate 2 grams in dextrose 5 percent in water, a solution commonly used to
replace vital electrolytes in hospitalized patients, according to agency
statements. Product packed in plastic syringes was also distributed
nationwide to doctors’ offices and clinics, FDA officials said.

The Connecticut officials last week identified “visible floating particles”
in the potentially contaminated drugs, New Jersey pharmacy board officials
said.

Mold was confirmed in five bags of the drugs after the Connecticut hospital
raised questions, the FDA said. There have been no reports of illness in
any patients who received the drugs, which was distributed between Feb. 18
and March 13 to regional hospitals.

Investigators from the state pharmacy board and the FDA were at the
pharmacy site over the weekend, said Angelo J. Cifaldi, a lawyer
representing Med Prep.

The affected drugs include 88 orders that could range from as few as 10 to
20 bags of magnesium sulfate solution per order to 500 bags per order,
Cifaldi said. He added that it is not clear how many patients may have
received the drugs.

“That doesn’t mean it all went to the patients,” he said. “It could be
sitting on the hospital shelves.”

The action comes six months after a deadly outbreak of fungal meningitis
tied to contaminated injection steroids manufactured by a Massachusetts
compounding pharmacy, the New England Compounding Center. Fifty people have
died among 722 sickened by contaminated epidural painkillers, the Centers
for Disease Control and Prevention said.

The NECC incident prompted Congress and others to call for an overhaul of
oversight of compounding pharmacies in the U.S.

FDA officials warned Med Prep Consulting president Gerald R. Tighe in 2001
and in 2010 about problems with sterility in certain repackaged drugs,
agency records show.

FDA and CDC officials are investigating the recall and any potential
patient harm. All facilities that received Med Prep compounded products
have been notified to remove and return the products to the pharmacy. The
firm’s products include antibiotics, local and general anesthetics,
cardiac, labor and delivery and pain medications.

The New Jersey board of pharmacy noted that the consent order is not a
disciplinary action and does not represent an admission of wrongdoing on
the part of the company.

“We don’t know where the contamination occurred,” said Cifaldi, noting that
the company used ingredients from several large manufacturers. “I’m not
pointing fingers, but who knows if something happened at the hospital?”
__________________________________________________________________
________________________________*_________________________________
* SAFETY OF INJECTIONS brief yourself at: www.injectionsafety.org

A fact sheet on injection safety is available at:
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* Visit the WHO injection safety website and the SIGN Alliance Secretariat
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Facsimile: +41 22 791 4836 E- mail: sign@who.int
__________________________________________________________________
________________________________*_________________________________

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

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

The SIGN 2010 meeting report pdf, 1.36Mb is available on line at:
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The report is navigable using bookmarks and is searchable. Viewing
requires the free Adobe Acrobat Reader at: http://get.adobe.com/reader/

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