Ekwueme DU, Weniger BG, Chen RTModel-based estimates of risks of disease transmission and economic costs of seven injection devices in sub-Saharan Africa. Bull World Health Organ 80:859-870

National Immunization Program, Centers for Disease Control and Prevention, Atlanta, GA, USA.
Bulletin of the World Health Organisation (Impact Factor: 5.09). 02/2002; 80(11):859-70. DOI: 10.1590/S0042-96862002001100005
Source: PubMed


To investigate and compare seven types of injection devices for their risks of iatrogenic transmission of bloodborne pathogens and their economic costs in sub-Saharan Africa.
Risk assumptions for each device and cost models were constructed to estimate the number of new hepatitis B virus (HBV) and human immunodeficiency virus (HIV) infections resulting from patient-to-patient, patient-to-health care worker, and patient-to-community transmission. Costs of device purchase and usage were derived from the literature, while costs of direct medical care and lost productivity from HBV and HIV disease were based on data collected in 1999 in Côte d'Ivoire, Ghana, and Uganda. Multivariate sensitivity analyses using Monte Carlo simulation characterized uncertainties in model parameters. Costs were summed from both the societal and health care system payer's perspectives.
Resterilizable and disposable needles and syringes had the highest overall costs for device purchase, usage, and iatrogenic disease: median US dollars 26.77 and US dollars 25.29, respectively, per injection from the societal perspective. Disposable-cartridge jet injectors and automatic needle-shielding syringes had the lowest costs, US dollars 0.36 and US dollars 0.80, respectively. Reusable-nozzle jet injectors and auto-disable needle and syringes were intermediate, at US dollars 0.80 and US dollars 0.91, respectively, per injection.
Despite their nominal purchase and usage costs, conventional needles and syringes carry a hidden but huge burden of iatrogenic disease. Alternative injection devices for the millions of injections administered annually in sub-Saharan Africa would be of value and should be considered by policy-makers in procurement decisions.

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    • "However, difficulties exist in effectively and consistently delivering vaccines into the skin. Therefore, new cutaneous vaccine delivery devices such as microneedles and the Nanopatch (NP) have been developed (Kim et al., 2012a; Koutsonanos et al., 2013;Chen et al, 2009), which may also reduce needle-stick injuries, disease transmission of blood-borne diseases (Ekwueme et al., 2002) and could allow for self-administration (Prausnitz et al., 2009). In our previous work, delivery of a conventional influenza vaccine by NP to skin with antigen alone has achieved ~100-fold dose-sparing compared to i.m. delivery (Fernando et al., 2010), while co-delivery of adjuvant generated synergistically-improved antibody and T-cell immune responses (Fernando et al., 2012; Ng et al., 2012). "
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    ABSTRACT: Vaccines delivered to the skin by microneedles - with and without adjuvants - have increased immunogenicity with lower doses than standard vaccine delivery techniques such as intramuscular (i.m.) or intradermal (i.d.) injection. However, the mechanisms behind this skin-mediated 'adjuvant' effect are not clear. Here, we show that the dynamic application of a microprojection array (the Nanopatch) to skin generates localized transient stresses invoking cell death around each projection. Nanopatch application caused significantly higher levels (~65-fold) of cell death in murine ear skin than i.d. injection using a hypodermic needle. Measured skin cell death is associated with modeled stresses ~1-10 MPa. Nanopatch-immunized groups also yielded consistently higher anti-IgG endpoint titers (up to 50-fold higher) than i.d. groups after delivery of a split virion influenza vaccine. Importantly, co-localization of cell death with nearby live skin cells and delivered antigen was necessary for immunogenicity enhancement. These results suggest a correlation between cell death caused by the Nanopatch with increased immunogenicity. We propose that the localized cell death serves as a 'physical immune enhancer' for the adjacent viable skin cells, which also receive antigen from the projections. This natural immune enhancer effect has the potential to mitigate or replace chemical-based adjuvants in vaccines.Journal of Investigative Dermatology accepted article peview online, 08 April 2014; doi:10.1038/jid.2014.174.
    Full-text · Article · Apr 2014 · Journal of Investigative Dermatology
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    • "Compared to more traditional routes such as oral administration and hypodermic injection, transcutaneous drug delivery through chemical permeation of the skin, iontophoresis, ultrasound, microneedle treatment, or various other strategies has the potential to provide many practical and clinical advantages.1 Relative to parenteral injection, transcutaneous delivery is non-invasive, potentially allowing for rapid, pain-free administration either by minimally trained health care providers, or through self-administration.2, 3 Transcutaneous delivery systems may reduce the generation of dangerous medical waste and inhibit the spread of disease known to occur through needle-reuse and needle-based injury.4, 5 Further, dry storage of systems designed for topical application may also provide enhanced drug stability, enabling transport of environmentally sensitive biological therapeutics without the need for refrigeration. This is a key issue as the requirement of “cold chain” distribution increases costs and inherently limits the availability of therapies throughout the developing world.2 "
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    ABSTRACT: Transcutaneous administration has the potential to improve therapeutics delivery, providing an approach that is safer and more convenient than traditional alternatives, while offering the opportunity for improved therapeutic efficacy through sustained/controlled drug release. To this end, we demonstrate a microneedle materials platform for rapid implantation of controlled-release polymer depots into the cutaneous tissue. Arrays of microneedles comprised of drug-loaded poly(lactide-co-glycolide) (PLGA) microparticles or solid PLGA tips were prepared with a supporting and rapidly water-soluble poly(acrylic acid) (PAA) matrix. Upon application of microneedle patches to the skin of mice, the microneedles perforated the stratum corneum and epidermis. Penetration of the outer skin layers was followed by rapid dissolution of the PAA binder on contact with the interstitial fluid of the epidermis, implanting the microparticles or solid polymer microneedles in the tissue, which were retained following patch removal. These polymer depots remained in the skin for weeks following application and sustained the release of encapsulated cargos for systemic delivery. To show the utility of this approach we demonstrated the ability of these composite microneedle arrays to deliver a subunit vaccine formulation. In comparison to traditional needle-based vaccination, microneedle delivery gave improved cellular immunity and equivalent generation of serum antibodies, suggesting the potential of this approach for vaccine delivery. However, the flexibility of this system should allow for improved therapeutic delivery in a variety of diverse contexts.
    Full-text · Article · Jan 2013 · Advanced Functional Materials
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    • "While the purchase cost of the syringe is in itself low, there is an associated risk of iatrogenic disease (Giudice and Campbell 2006). When the societal cost of spread of blood-borne pathogens (for example, HIV and hepatitis B) through the reuse or inappropriate disposal of needles is included into the analysis, the cost of needle delivery through standard disposable syringes escalates from 0.10 to 25.29 USD per delivery (Ekwueme et al. 2002). Auto-disabling (AD) needles are now the most common delivery system and have a total cost of only 0.91 USD, although the cost of the device is originally more expensive at 0.14 USD each (Ekwueme et al. 2002). "
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    ABSTRACT: Vaccines are one of the most successful public health achievements of the last century. Systematic immunisation programs have reduced the burden of infectious diseases on a global scale. However, there are limitations to the current technology, which often requires costly infrastructure and long lead times for production. Furthermore, the requirement to keep vaccines within the cold-chain throughout manufacture, transport and storage is often impractical and prohibitively expensive in developing countries-the very regions where vaccines are most needed. In contrast, plant-made vaccines (PMVs) can be produced at a lower cost using basic greenhouse agricultural methods, and do not need to be kept within such narrow temperature ranges. This increases the feasibility of developing countries producing vaccines locally at a small-scale to target the specific needs of the region. Additionally, the ability of plant-production technologies to rapidly produce large quantities of strain-specific vaccine demonstrates their potential use in combating pandemics. PMVs are a proven technology that has the potential to play an important role in increasing global health, both in the context of the 2015 Millennium Development Goals and beyond.
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