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AAPS PharmSciTech Mar 2021Intravitreal (IVT) administration of therapeutics is the standard of care for treatment of back-of-eye disorders. Although a common procedure performed by retinal... (Review)
Review
Intravitreal (IVT) administration of therapeutics is the standard of care for treatment of back-of-eye disorders. Although a common procedure performed by retinal specialists, IVT administration is associated with unique challenges related to drug product, device and the procedure, which may result in adverse events. Container closure configuration plays a crucial role in maintaining product stability, safety, and efficacy for the intended shelf-life. Careful design of primary container configuration is also important to accurately deliver small volumes (10-100 μL). Over- or under-dosing may lead to undesired adverse events or lack of efficacy resulting in unpredictable and variable clinical responses. IVT drug products have been traditionally presented in glass vials. However, pre-filled syringes offer a more convenient administration option by reducing the number of steps required for dose preparation there by potentially reducing the time demand on the healthcare providers. In addition to primary container selection, product development studies should focus on, among other things, primary container component characterization, material compatibility with the formulation, formulation stability, fill volume determination, extractables/leachables, and terminal sterilization. Ancillary components such as disposable syringes and needles must be carefully selected, and a detailed administration procedure that includes dosing instructions is required to ensure successful administration of the product. Despite significant efforts in improving the drug product and administration procedures, ocular safety concerns such as endophthalmitis, increased intraocular pressure, and presence of silicone floaters have been reported. A systematic review of available literature on container closure and devices for IVT administration can help guide successful product development.
Topics: Drug Delivery Systems; Drug Packaging; Humans; Intravitreal Injections; Needles; Pharmaceutical Preparations; Sterilization; Syringes
PubMed: 33709236
DOI: 10.1208/s12249-021-01949-4 -
Journal of Pharmaceutical Sciences May 2014The functionality of a newly developed silicone oil-free (SOF) syringe system, of which the plunger stopper is coated by a novel coating technology (i-coating™), was...
The functionality of a newly developed silicone oil-free (SOF) syringe system, of which the plunger stopper is coated by a novel coating technology (i-coating™), was assessed. By scanning electron microscopy observations and other analysis, it was confirmed that the plunger stopper surface was uniformly covered with the designed chemical composition. A microflow imaging analysis showed that the SOF system drastically reduced both silicone oil (SO) doplets and oil-induced aggregations in a model protein formulation, whereas a large number of subvisible particles and protein aggregations were formed when a SO system was used. Satisfactory container closure integrity (CCI) was confirmed by means of dye and microorganism penetration studies. Furthermore, no significant difference between the break loose and gliding forces was observed in the former, and stability studies revealed that the SOF system could perfectly show the aging independence in break loose force observed in the SO system. The results suggest that the introduced novel SOF system has a great potential and represents an alternative that can achieve very low subvisible particles, secure CCI, and the absence of a break loose force. In particular, no risk of SO-induced aggregation can bring additional value in the highly sensitive biotech drug market.
Topics: Chemistry, Pharmaceutical; Drug Stability; Proteins; Silicone Oils; Syringes
PubMed: 24643749
DOI: 10.1002/jps.23945 -
Harm Reduction Journal Jul 2021Increasing rates of injection drug use (IDU) associated-infections suggest significant syringe service program (SSP) underutilization. Our study objective was to assess...
BACKGROUND
Increasing rates of injection drug use (IDU) associated-infections suggest significant syringe service program (SSP) underutilization. Our study objective was to assess practices of safe injection techniques and to determine predictors of SSP utilization in a rural state.
PATIENTS AND METHODS
This was a fifteen-month cross-sectional study of participants hospitalized with IDU-associated infections in Maine. Data were collected through Audio Computer-Assisted Self-Interview survey and medical record review. Descriptive analyses were performed to characterize demographics, health characteristics, and injection practices. The primary outcome was SSP utilization, and the main independent variable was self-reported distance to SSP. Logistic regression analyses were performed to identify factors associated SSP utilization, controlling for gender, homelessness, history of overdose, having a primary care physician and distance to SSP.
RESULTS
Of the 101 study participants, 65 participants (64%) reported past 3 month SSP utilization, though only 33% used SSPs frequently. Many participants (57%) lived more than 10 miles from an SSP. Participants who lived less than 10 miles of an SSP were more likely to use an SSP (adjusted odds ratio 5.4; 95% CI 1.9-15.7).
CONCLUSIONS
Our study highlights unsafe injection practices and lack of frequent SSP utilization among people admitted with IDU-associated infections in a rural state. Especially given increasing stimulant use, these results also highlight the need for SSP access. Particularly in rural areas where patients may live more than 10 miles from an SSP, expansion of harm reduction services, including mobile units, should be a priority.
Topics: Cross-Sectional Studies; Harm Reduction; Humans; Needle-Exchange Programs; Substance Abuse, Intravenous; Syringes
PubMed: 34273986
DOI: 10.1186/s12954-021-00524-1 -
Journal of Oral Science 2016Ultrasonic irrigation and syringe irrigation were compared for their efficacy at cleaning root canal in vivo and in vitro. The in vivo study used 60 anterior teeth or... (Comparative Study)
Comparative Study
Ultrasonic irrigation and syringe irrigation were compared for their efficacy at cleaning root canal in vivo and in vitro. The in vivo study used 60 anterior teeth or premolars from 60 patients with periapical periodontitis who were randomly assigned to a syringe irrigation group (group S) or an ultrasonic irrigation group (group U). After instrumentation with a K-file using the step-back technique, the two groups received ultrasonic or syringe irrigation using 40 mL of 2.5% NaOCl respectively, followed by conventional lateral compaction. The in vitro study used 60 extracted single-canal premolars, which were also divided into U and S groups, and underwent the same irrigation and compaction. Forty of them were evaluated histologically by light microscopy, and the remaining 20 by scanning electron microscopy. No difference in main root canal filling was observed between the U and S groups. Notably, group U had a larger number of obturated lateral canals than group S. Moreover, a smaller amount of organic debris and more open dentinal tubules were observed in the root canal in group U than in group S. Our findings suggest that ultrasonic irrigation has a greater capacity to clean instrumented root canals than syringe irrigation. (J Oral Sci 58, 373-378, 2016).
Topics: Female; Humans; Male; Radiography, Dental; Syringes; Therapeutic Irrigation; Ultrasonics
PubMed: 27665977
DOI: 10.2334/josnusd.15-0550 -
British Journal of Anaesthesia Oct 2019
Review
Topics: Anesthesiology; Anesthetists; Humans; Hygiene; Practice Guidelines as Topic; Syringes
PubMed: 31248642
DOI: 10.1016/j.bja.2019.05.036 -
The International Journal on Drug Policy Jun 2018Pharmacies have much to contribute to the health of people who inject drugs (PWID) and to community efforts in HIV and hepatitis C (HCV) prevention through syringe...
BACKGROUND
Pharmacies have much to contribute to the health of people who inject drugs (PWID) and to community efforts in HIV and hepatitis C (HCV) prevention through syringe access. However, little is known about what predicts pharmacy syringe sales without a prescription.
OBJECTIVE
To identify factors predicting pharmacy syringes sales to PWID.
METHODS
A hybrid staggered online survey of 298 Indiana community pharmacists occurred from July-September 2016 measuring pharmacy policy, practice, and pharmacist perceptions about syringe sales to PWID. Separate bivariate logistical regressions were followed by multivariable logistic regression to predict pharmacy syringe sales and pharmacist comfort dispensing syringes to PWID.
RESULTS
Half (50.5%) of Indiana pharmacies sold syringes without a prescription to PWID. Pharmacy syringe sales was strongly associated with pharmacist supportive beliefs about syringe access by PWID and their comfort level selling syringes to PWID. Notably, pharmacies located in communities with high rates of opioid overdose mortality were 56% less likely to sell syringes without a prescription than those in communities with lower rates. Pharmacist comfort dispensing syringes was associated with being male, working at a pharmacy that sold syringes to PWID and one that stocked naloxone, having been asked about syringe access by medical providers, and agreement that PWID should be able to buy syringes without a prescription.
CONCLUSIONS
As communities with high rates of opioid overdose mortality were less likely to have pharmacies that dispensed syringes to PWID, a concerted effort with these communities and their pharmacies should be made to understand opportunities to increase syringe access. Future studies should explore nuances between theoretical support for syringe access by PWID without a prescription and actual dispensing behaviors. Addressing potential policy conflicts and offering continuing education on non-prescription syringe distribution for pharmacists may improve comfort distributing syringes to PWID, and therefore increase pharmacy syringe sales.
Topics: Adult; Aged; Attitude of Health Personnel; Commerce; Community Pharmacy Services; Female; Humans; Male; Middle Aged; Pharmacists; Syringes
PubMed: 29558701
DOI: 10.1016/j.drugpo.2018.02.024 -
Harm Reduction Journal Nov 2021Syringe services programs (SSPs) remain highly effective, cost-saving interventions for the prevention of blood-borne infections among people who inject drugs. However,...
BACKGROUND
Syringe services programs (SSPs) remain highly effective, cost-saving interventions for the prevention of blood-borne infections among people who inject drugs. However, there have been restrictions regarding financial resources allocated to these programs, particularly in the US South. This study aimed to provide cost data regarding the implementation and first-year operations of an academic-based SSP utilizing fixed and mobile strategies, including the integration of onsite wound care.
METHODS
We conducted a micro-costing study that retrospectively collected detailed resource utilization and unit cost data for both the fixed and mobile SSP strategies, including onsite wound care, from both healthcare and societal perspectives. A three-step approach was used to identify, measure, and value intervention costs, and cost components were categorized into implementation, variable program, and time-dependent costs. Sensitivity analysis was performed to examine the impact of SSP operational changes (i.e., needs-based distribution and opt-out HIV/HCV testing) on the cost-per-participant. Cost data we presented as overall cost and cost-per-participant adjusted to 2017 US dollars.
RESULTS
A total of 452 and 129 participants enrolled in fixed and mobile SSP services, respectively. The total cost associated with implementation and first year operations for the fixed site was $407,217.22 or $729.72 per participant and $311,625.52 or $2415.70 per participant for the mobile unit. The largest cost component for both modalities was time-dependent costs (personnel and overhead), while intervention materials (syringes, injection equipment, naloxone) were less than 15% of the total program cost.
DISCUSSION/CONCLUSION
Implementation and operation of new SSP models continue to be low cost compared to treatment for the multitude of harms PWID face without access to evidence-based prevention. Future cost-effectiveness and cost-benefit analyses integrating a comprehensive SSP model within an academic institution, including onsite wound care and other medical services, will provide a more comprehensive understanding of this model, and state-level policy action must be taken to lift the prohibition of state and local funds for the implementation, sustainability, and maintenance of these programs in Florida.
Topics: Academic Medical Centers; HIV Infections; Humans; Needle-Exchange Programs; Retrospective Studies; Substance Abuse, Intravenous; Syringes
PubMed: 34798887
DOI: 10.1186/s12954-021-00563-8 -
AJNR. American Journal of Neuroradiology May 2018Blood flow should be interrupted during mechanical thrombectomy to prevent embolization of clot fragments. The purpose of our study was to provide a handy overview of... (Comparative Study)
Comparative Study
BACKGROUND AND PURPOSE
Blood flow should be interrupted during mechanical thrombectomy to prevent embolization of clot fragments. The purpose of our study was to provide a handy overview of the most common aspiration devices and to quantify their flow characteristics.
MATERIALS AND METHODS
We assessed volumetric flow rates generated by a 60-mL VacLok vacuum pressure syringe, a Pump MAX aspiration pump, and a Dominant Flex suction pump connected to the following: 1) an 8F long sheath, 2) an 8F balloon-guide catheter, 3) an ACE 64 distal aspiration catheter, and 4) an AXS Catalyst 6 Distal Access Catheter. We used a water/glycerol solution, which was kept at a constant temperature of 20°C (viscosity, 3.7 mPa · s).
RESULTS
Aspiration with the syringe and the Dominant Flex suction pump achieved the highest flows, whereas aspiration with the Pump MAX was significantly lower ( < .001). Resistors in the aspiration system (tubing, connectors, and so forth) restricted flows, especially when the resistance of the catheter was small (due to its large diameter) and the connected resistors became the predominant resistance ( < .001). The syringe achieved an average vacuum pressure of -90 kPa, and the resulting flow was constant during almost the entire procedure of filling the syringe.
CONCLUSIONS
Sixty-milliliter VacLok vacuum pressure syringes and the Dominant Flex suction pump achieved high and constant flows likely sufficient to reverse blood flow during thrombectomy with an 8F sheath or balloon-guide catheter in the ICA and modern distal aspiration catheters in the MCA. The Pump MAX aspiration pump is dedicated for use with distal aspiration catheters and is unlikely to reverse blood flow in the ICA and MCA without balloon protection.
Topics: Catheters; Endovascular Procedures; Humans; Models, Biological; Suction; Syringes; Thrombectomy
PubMed: 29650784
DOI: 10.3174/ajnr.A5605 -
Harm Reduction Journal Sep 2022Vaccine-hesitant persons who inject drugs are at increased risk for several vaccine-preventable diseases. However, vaccination rates among this population remain low....
BACKGROUND
Vaccine-hesitant persons who inject drugs are at increased risk for several vaccine-preventable diseases. However, vaccination rates among this population remain low. While syringe services programs (SSPs) are places where persons who inject drugs feel comfortable accessing services, few offer vaccination services. This study describes facilitators and barriers to vaccination at SSPs.
METHODS
We used convenience sampling to conduct semi-structured, qualitative in-depth interviews with 21 SSPs in the USA from June to August 2021. Interview questions asked SSPs about their perceptions, priorities, barriers, facilitators, and the effects of partnerships and policies on vaccine administration. We used deductive thematic analysis to identify the main themes.
RESULTS
Eight (n = 8) SSPs offered vaccinations, and thirteen (n = 13) did not offer vaccinations. Most SSPs believed offering vaccination services was important, although addressing SSP participants' immediate needs often took precedence. Staffing, physical space, and logistical issues were the most common barriers to vaccine administration reported by SSPs, followed by SSP participant-related barriers. Facilitators of vaccine administration included access to a tracking system, partnering with agencies or other organizations providing vaccines, and having a licensed vaccination provider on-site. Partnerships provided SSPs opportunities to expand capacity but could also restrict how SSPs operate. Recommended policy changes to facilitate vaccine administration included subsidizing the cost of vaccinations and addressing restrictions around who could administer vaccinations.
CONCLUSIONS
Increasing the availability of vaccination services at SSPs requires addressing the varying capacity needs of SSPs, such as tracking systems, licensed vaccinators, and free or low-cost vaccination supplies. While these needs can be met through partnerships and supportive policies, both must consider and reflect cultural competence around the lived experiences of persons who inject drugs.
Topics: Drug Users; Humans; Needle-Exchange Programs; Substance Abuse, Intravenous; Syringes; Vaccination; Vaccines
PubMed: 36050735
DOI: 10.1186/s12954-022-00681-x -
Bulletin of the World Health... 1999In recent years, many poorer countries have chosen to use disposable instead of sterilizable syringes. Unfortunately, the infrastructure and management systems that are... (Review)
Review
In recent years, many poorer countries have chosen to use disposable instead of sterilizable syringes. Unfortunately, the infrastructure and management systems that are vital if disposables are to be used safely do not exist. WHO estimates that up to 30% of injections administered are unsafe. The traditional sterilizable syringe had many disadvantages, some of which have been minimized through better design and the use of modern materials; others have been overcome because staff are able to demonstrate that they have performed safely. For example, the time-steam saturation-temperature (TST) indicator has enabled staff to demonstrate that a sterilizing cycle has been successfully completed. Health facility staff must be able to sterilize equipment, and the sterilizable syringe remains the least costly means of administering an injection. Data from countries that have acceptable systems for processing clinical waste indicate that safe and environmentally acceptable disposal, destruction and final containment cost nearly as much as the original cost of a disposable syringe. By careful supervision of staff behaviour and good management, some countries have demonstrated that they are able to administer safe injections with sterilizable syringes at a price they can afford.
Topics: Cost-Benefit Analysis; Developing Countries; Disposable Equipment; Humans; Medical Waste Disposal; Risk Factors; Safety; Sterilization; Syringes
PubMed: 10593029
DOI: No ID Found