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Pharmaceutical Manufacturing and Packing Sourcer
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Approximately 382 million people worldwide have diabetes, affecting 1 in
12 adults. By 2035, this figure is estimated to rise to 592 million.
Broken down, around 10% of people with diabetes suffer from the type 1
form, with 90% demonstrating type 2 (1,2). This does not even include
gestational diabetes, which affects up to 10 in every 100 women in
England and Wales during pregnancy (3).
As the prevalence of
diabetes continues to grow, so too does the strain on healthcare systems
and professionals. In response, healthcare providers, patients and
third sector organisations are working together to help manage, treat
and ultimately reduce the impact of this condition, through the
introduction of multiple novel initiatives.
Prevention and Support
The
increase in diabetes presents a challenge on a global scale – one that
governments around the world are responding to. The Dubai Health
Authority (DHA) has demonstrated its commitment to making changes with
the launch of ‘The Dubai Standards of Healthcare for Diabetes
Management’, in a move to ensure early detection and unified management
of diabetic and pre-diabetes cases. The DHA will also hold several
training workshops for more than 700 doctors in 2015, to ensure that all
healthcare providers in Dubai follow the same standards of diabetes
management.
The intensified focus on meeting the diabetes
challenge is evident in the UK too, with NHS England announcing the
launch of its new diabetes prevention strategy in March 2015. While the
full programme will be rolled out nationally from April next year, it
will be piloted in seven areas of England and will target up to 10,000
patients. The strategy aims to reduce England’s ever-growing spend on
diabetes treatment, which already stands at some £10 billion annually.
In
February of this year, Diabetes UK sought 16 healthcare workers across
the UK to become clinical champions to support and improve the care of
diabetics. Aided by a package of training materials, the roles are open
to anyone working in healthcare that has experience in handling the
condition. The success of a similar programme was first seen in 2014,
when Diabetes UK enlisted 10 clinical champions for the first time,
including several specialist nurses. These recruits have since
spearheaded a number of initiatives aimed at improving the care received
by people with diabetes.
Self-Management
However,
it is not just the healthcare professionals managing the disease that
need to be well trained and educated in diabetes management.
Self-management plays a critical part in diabetes, where the majority of
the treatment is in the hands of the patient. For example, studies show
that individualised management using care planning can significantly
improve glycaemic control (1). Research has also shown that
self-management can lower per patient costs and admissions (2), reducing
the pressure on professional time and improving clinical outcomes
which, in turn, should lead to positive behaviour, less stress and a
better quality of life for people with diabetes (4).
More and
more is being done to support and promote the benefits of good
self-management. Healthcare providers are offering free workshops and
classes to people with prediabetes and diabetes, and even to family and
friends of those living with the condition. These classes offer a wide
range of support services such as education on medication
administration, diet guidelines and blood sugar testing, as well as
promoting self-management – with the aim of helping to prevent or limit
long-term health complications.
A recent study, conducted by the
University of Kansas Work Group for Community Health and Development,
evaluated 173 patients from four patientcentred medical homes to
determine the effects of a multi-site coordinated care approach that
delivered diabetes self-management education (DSME) and diabetes
self-management support (DSMS). Results showed that patients with
diabetes had decreased glycated haemoglobin after the implementation of a
coordinated care approach, along with showing a significant decrease in
body mass index (5).
Case Study
The importance
of getting a device right for the end-user cannot be underestimated.
Once the patient needs have been identified during the design stages,
developers should utilise human factors engineering and prototyping to
ensure new devices meet these requirements, and are as comfortable and
straightforward to use as possible.
Research conducted during
the development stage allows companies to understand key design factors
of prototype devices that result in tangible patient benefits. For
example, experts agree that the most accurate routine when using
injection pens is the immediate removal of the pen needle after
injection, and replacement with a new needle just prior to the next use
(1,6,7). This information was used to drive the design of the Unifine® Pentips® Plus – a pen needle system with a built-in remover.
The
main goal of the device was to add incremental convenience when pen
needles are used, which supports good injection routine by encouraging
more frequent pen needle change. This, in turn, can help to reduce
adverse effects such as infection (8), lipodystrophy (9), trauma from
needle insertion (10), dose inaccuracy caused by air bubbles entering
the cartridge (11,12), needle breakage within the skin (13) and bruising
(14).
Guidance on a good injection routine is an important part
of diabetes selfmanagement education, and – by offering better devices
designed to support the required end-user outcomes – manufacturers can
play a valuable role in supporting adherence by healthcare professionals
and patients.
Smart Insulin
Along with the
developments in supporting self-management, there continue to be
technological and drug formulation advancements in diabetes therapy.
Introduced earlier this year, ‘smart insulin’ is currently undergoing
trials with scientists – it is hoped that it could revolutionise the way
diabetes is managed. Instead of repeated blood tests and injections
throughout the day to keep blood sugar in check, a single dose of smart
insulin would keep circulating in the body and ‘turn on’ when needed.
Smart
insulin would therefore enable people with type 1 diabetes to achieve
near-perfect glucose control, all from a single injection per day, or
even per week. This could greatly aid selftreatment for those living
with the condition; 57% of people with type 1 and type 2 diabetes
intentionally skip insulin injections, with the primary reason being
fear of pain when injecting (15). With the benefits smart insulin can
offer, this would dramatically reduce the amount of times end-users
would need to inject (16).
Greater Control
While
diabetes is placing an evergrowing strain on healthcare systems, it is
clear that this has in no way gone unnoticed, with the developments and
advancements in education, technology and drug formulations paving the
way to help manage the disease and, in turn, reduce its prevalence.
Guiding
healthcare professionals and end-users through education and training
on good self-management is key to treating diabetes worldwide.
References
1. What is the global economic burden of type 2 diabetes? Visit: www.medicalnewstoday.com/articles/290948.php
2.
Diabetes epidemic worldwide. Visit:
www.dailymail.co.uk/health/article-2997882/diabetes-epidemic-400-million-sufferers-worldwidenumber-condition-set-soar-55-20-years-unless-humans-change-wayeat-exercise.html
3. Gestational diabetes. Visit: www.nhs. uk/conditions/gestational-diabetes/pages/introduction.aspx
4.
Avoiding hospital admissions. Visit:
www.kingsfund.org.uk/sites/files/kf/Avoiding-Hospital-Admissions-Sarah-Purdy-December2010.pdf
5. Self-management education, support, improved clinical health
outcomes in patients with diabetes. Visit:
www.healio.com/endocrinology/diabetes-education/news/online/%7b4a04002f-9cbe-4975-9d97-7952cbb53b0e%7d/self-management-educationsupport-improved-clinicalhealth-outcomes-in-patientswith-
diabetes
6. Diabetes Care in the UK: The First UK Injection Technique Recommendations, 2nd edition
7. Evidence: Helping people help themselves. Visit: www.health.org.uk/publications/evidence-helpingpeople-help-themselves
8. Broadway CA, Prevention of injectable therapy leakage after subcutaneous injection, Diabetes Educator 17: p90, 1991
9. Insulin lipodystrophy and lipohypertrophy. Visit: www.ncbi.nlm.nih.gov/pmc/articles/pmc3743397
10. De Villiers FP, Lypohypertrophy – A complication of insulin injections, S Afr Med J 95: pp858-859, 2005
11. Dejgaard A and Murmann C, Air bubbles in injectable therapy pen devices, Lancet 334: p871, 1989
12. Chantelau E, Heinemann L and Ross D, Air bubbles in injectable therapy pen devices, Lancet 334: pp387-388, 1989
13. Annersten M and Frid A, Injectable therapy pen devices dribble from the tip of the needle after injection, Practical Diabetes International 17: pp109-111, 2000
14. Dolinar R et al, The importance of Good Insulin Injection Practices in diabetes management, US Endocrinology 5(1): pp49-52, 2009
15. Peyrot M, Rubin RR, Kruger DF and Travis LB, Correlates of insulin injection omission, Diabetes Care 33: pp240-245, 2010
16. 'Smart' insulin hope for diabetes. Visit: www.bbc.co.uk/news/health-31291722
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News and Press Releases |
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Softbox successfully supports Pfizer in the global cold chain distribution of Covid-19 vaccines
Long Crendon, Buckinghamshire, UK, 10 March 2021 – Softbox, a
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logistics industries, is proud to support Pfizer in the distribution of
Covid-19 vaccines through the supply of a high-performance
temperature-controlled parcel shipper developed specifically for
ultra-low temperature applications.
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Points to Consider When Developing a TMF (Trial Master File) Strategy
Phlexglobal Ltd
Many organizations are currently outsourcing clinical trial activities to one or more contract research organizations (CROs). This strategy enables companies to leverage specialized expertise and take advantage of flexible resourcing throughout the conduct of a clinical trial. Outsourcing minimizes the costs of recruiting experts, building a team and maintaining an infrastructure. However, it can also add complexity as the organization looks to meets its compliance obligations regarding clinical trial documentation.
The documentation referred to in Article 15(5) of Directive 2001/20/EC as the trial master file shall consist of essential documents, which enable both the conduct of a clinical trial and the quality of the data produced to be evaluated.1 This essential study specific documentation is also known as the TMF. As organizations try to minimize their reliance on paper files, the electronic TMF (eTMF) has emerged. A current industry initiative to standardize the organization of this content is known as the TMF Reference Model. This model is helping standardization efforts across paper and electronic systems.
As companies implement outsourcing strategies, CROs and sponsor organizations look for a common foundation on which to build their TMF capabilities. The following paper outlines some of the challenges organizations face when outsourcing clinical trial activities to multiple contract research organizations and a strategy to facilitate partnering and management of trial information between sponsors and CROs.
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