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Immunologic and biologic evaluation of insulin degradation following prolonged storage in plastic syringes.

Insulin potency during storage in plastic disposable syringes for short periods of time is a concern of diabetics as well as syringe manufacturers. Previous studies have indicated that leaching of organic materials from rubber gaskets may have cytotoxic effects. The purpose of this study was to evaluate the immunologic and radioreceptor degradation of insulin storage in commercial plastic syringes. Insulin syringes were filled with insulin and stored at 4 degrees C for 2 weeks. Immunologic potency was assessed by radioimmunoassay while biologic potency was evaluated by binding to hepatic insulin receptors. Recoverable insulin was measured on days 1, 3, 7, and 14 and compared with highly purified porcine insulin. Insulin content of samples stored in all three plastic syringes showed no statistically significant (p less than 0.05) loss of immunologic or biologic potency for 2 weeks compared with stock controls. Lente insulin gave more variability in storage in the radioimmunoassay, possibly due to settling, and was less effective in displacing labeled insulin in the radioreceptor assay. We conclude that premeasured insulin may safely be stored in plastic disposable syringes under selected conditions, especially in blind and handicapped diabetic patients, for 2 weeks.

Drug Stability↗

Survival of HIV-1 in syringes.

We performed a study to determine the duration of survival of HIV-1 in syringes typically used by injectors of illicit drugs (IDUs). We describe the effectiveness of a microculture assay in detecting viable virus in volumes of blood typical of those commonly found inside used syringes. Using this assay and modeling the worse-case situation for syringe sharing, we have recovered viable, proliferating HIV-1 from syringes that have been maintained at room temperature for periods in excess of 4 weeks. The percentage of syringes with viable virus varied with the volume of residual blood and the titer of HIV-1 in the blood. These experiments provide a scientific basis for needle exchange schemes, harm reduction, and other interventions among IDUs that support the nonsharing and removal of used syringes from circulation.

Acquired Immunodeficiency Syndrome↗

Can HIV-1-contaminated syringes be disinfected? Implications for transmission among injection drug users.

Bleaching of syringes has been advocated to prevent HIV-1 transmission among injection drug users (IDUs). Bleach is frequently distributed by needle exchange, outreach, and educational programs targeting IDUs. We applied a sensitive HIV-1 microculture assay to determine the effectiveness of bleach in disinfecting syringes contaminated with HIV-1. This study demonstrates that in a laboratory environment designed to replicate injection behaviors, undiluted bleach is highly effective in reducing the viability of HIV-1 even after minimal contact time. However, it did not reduce the HIV-1 recovery to zero. Furthermore, three washes with water were nearly as effective as a single rinse with undiluted bleach in reducing the likelihood that contaminated syringes harbored viable HIV-1. Given the reality that IDUs share syringes and may not have access to a new, sterile syringe for each injection, the results suggest that they should be encouraged through harm reduction interventions to clean their syringes, preferably with undiluted bleach.

Disinfectants↗

Six-month stability of bevacizumab (Avastin) binding to vascular endothelial growth factor after withdrawal into a syringe and refrigeration or freezing.

PURPOSE: To determine the change in anti-vascular endothelial growth factor (VEGF) activity of bevacizumab (Avastin, Genentech, Inc., San Francisco, CA) after refrigeration or freezing. METHODS: Samples of bevacizumab were drawn up from new vials into plastic tuberculin syringes and refrigerated at 4 degrees C for 1 week, 3 weeks, 1 month, 3 months, and 6 months. The vials and syringes were stored at 4 degrees C, and the syringes were capped with a needle. One syringe was frozen at -10 degrees C. The bevacizumab concentration was measured, via its binding to VEGF-165. RESULTS: The percentage of degradation of bevacizumab in the previously pierced vials stored at 4 degrees C compared with that in the unpierced vial was 9.6% at 3 months and 12.7% at 6 months. The bevacizumab drawn into the syringe and stored at 4 degrees C was degraded by 1.6% at 1 week, 0% at 3 weeks, 8.8% at 3 months, and 15.9% at 6 months. The bevacizumab frozen in a syringe at -10 degrees C was degraded by 12.0% at 6 months. CONCLUSION: The anti-VEGF activity of bevacizumab may degrade minimally over time, with storage.

Angiogenesis Inhibitors↗

National survey of syringe exchange schemes in England.

This report gives information from an England wide survey of syringe exchange carried out in early 1989. A postal questionnaire was sent to 74 agencies, responses received from 65 (88%), of which 55 were agencies operating syringe exchanges. The development of syringe exchanges has been marked by lack of central coordination, supervision and direction, allowing for local autonomy sensitivity to local conditions and a resulting diversity of practices. Four service models were identified: schemes run by drug agencies; pharmacy-based schemes; specialist stand-alone schemes; and schemes based in non-drug agencies. The average number of different clients per week was 21 and it is estimated that they distributed about one million syringes in the year 1988/89. Pharmacy based schemes presented fewer barriers in terms of access but offered limited services on site, while drug agency schemes presented more barriers in terms of access, but offered more services. The significance of these differences is related to the aims of syringe exchange. In a public health orientation, ease of access to sterile injecting equipment would be the priority and the question of individual help in other areas less important. From a drug problems orientation, the ability to offer clients more services to respond to their wider needs would be a priority. It is estimated that by the end of 1989 there were approximately 120 syringe exchange schemes in England.

England↗

The effect of a needle and syringe exchange on a methadone maintenance unit.

In November 1986, a pilot needle and syringe exchange was established in Sydney adjacent to a methadone maintenance unit. A retrospective study was carried out to determine the effect of increasing the availability of sterile needles and syringes on the treatment outcome of the methadone maintenance unit. In this study, an increase in availability of sterile needles and syringes was not found to be associated with an increase in the presence of illicit injectable drugs in the urine specimens of clients of the methadone programme compared to a control methadone unit where there was no known change in needle and syringe availability. This study suggests that an increase in the availability of sterile needles and syringes does not appear to lead to an increase in the frequency of intravenous drug use. The possibility of drug and alcohol treatment centres acting as needle and syringe exchange or distribution outlets therefore requires consideration.

Australia↗

Immunogenicity and safety of Haemophilus influenzae type b capsular polysaccharide tetanus conjugate vaccine (PRP-T) presented in a dual-chamber syringe with DTP.

Separate injections of Haemophilus influenzae type b capsular polysaccharide-tetanus conjugate (PRP-T) vaccine and diphtheria-tetanus-pertussis (DTP) reconstitution of freeze-dried PRP-T vaccine with liquid DTP vaccine have been shown to be safe and immunogenic in infants. The present study was conducted to test the safety and immunogenicity of the liquid combination vaccine administered to young infants in the dual-chamber syringe. The study was a monocenter, open clinical trial of 3 month-old infants receiving PRP-T and DTP vaccines in the dual-chamber syringe reconstituted prior to injection. Healthy infants were immunized according to a 3, 4 and 5 months-of-age schedule. The vaccine was administered in a dual-chamber syringe, ready to use with two chambers. The proximal chamber contained freeze-dried PRP-T and the distal chamber contained liquid combination-vaccine DTP. The freeze-dried PRP-T vaccine was reconstituted with the liquid DTP vaccine in the same unidose dual-chamber syringe (0.5 mL) and was injected intramuscularly into the deltoid region. Blood sampling was performed prior to vaccination at 3 months of age and after the third vaccination at 6 months. The primary end-point was the serological response to PRP-T vaccine as expressed by the percentage of infants with an antibody titer greater than or equal to 1 microgram/mL. The reactogenicity was expressed as the percentage of reported local and systemic reactions. A total of 108 infants were included in the study and received the dual-chamber syringe vaccine. After the third injection, all the infants had a PRP antibody titer greater than or equal to 0.15 microgram/mL and 94.4% of infants had a PRP antibody titer greater than or equal to 1 microgram/mL; the pertussis agglutinin titers were over the threshold 40 and 80 in all infants and 98.1% were over the threshold 320. After the third injection, all the infants had diphtheria antibody titers greater than 0.1 IU/mL and 83.3% had titers greater than 1 IU/mL; all the infants had tetanus antibody titers greater than 0.1 IU/mL and 97.2% had results over 1 IU/mL. Thirty-seven infants (34.6%) had local reactions and 64.5% had systemic reactions. The dual-chamber syringe may reduce the cost of vaccine delivery, as well as the workload, and increase the vaccine acceptability and coverage rate of vaccines.

Antibodies, Viral↗

A prospective study of the hazards of multiple use of disposable syringes and needles in intensified insulin therapy.

The aim of the present study was to evaluate the potential hazards of multiple use of disposable syringes and needles for insulin injections over a long period of time. A special syringe container (pen-case) was developed to carry the syringe with insulin. In the microbial trial 24 patients, each injecting insulin for 1 week with one disposable needle, were studied for 201 patient-weeks with 5829 injections. Cultures of 154 needles, 155 syringe rinses, 154 pen-case rinses and the remains of insulin in 201 vials revealed no relevant contamination. In the clinical trial 100 diabetic patients were followed up for up to 7 years. Each syringe was reused for 1 to 12 weeks and each needle for 1 to 40 days (4 to 200 injections). Only sporadic redness not exceeding 4 mm2 was seen at sites of about 560,000 insulin injections. Thus, the repeated use of syringes and needles in one diabetic patient may be recommended as a convenient and safe approach in insulin administration.

Bacteria↗

Use of an electric ear syringe in the emergency department.

OBJECTIVES: To introduce an electric ear syringe into an emergency department and evaluate its use in the removal of foreign bodies from the external auditory canal. METHODS: Report of the use of a new device (the Propulse electric ear syringe) in an emergency department with a retrospective audit of the management of all cases of aural foreign bodies during one year. RESULTS: Almost 60% of the 84 patients who presented with foreign bodies in the auditory canal were children. Staff chose to treat over half of all patients with aural foreign bodies with the electric ear syringe. The overall success rates for the removal of the foreign bodies were: electric syringe, 93% in adults and 88% in children and instrumentation, 68% in adults and 50% in children. CONCLUSIONS: Irrigation with an electric ear syringe is an effective method of removing foreign bodies from the external auditory canal. The device tested was safe, inexpensive, easy to use, and readily acceptable to both adults and children. The availability of an electric ear syringe in an emergency department can avoid the need for specialist referral and the subsequent removal of foreign bodies under general anaesthesia.

Adult↗

Drug injectors and the cleaning of needles and syringes.

When people share needles and syringes they risk transmitting human immunodeficiency virus (HIV) and other infections including hepatitis B virus (HBV) and hepatitis C virus (HCV). Cleaning needles and syringes can help to reduce, although not eliminate, these risks. This article begins by engaging with some of the literature on the cleaning of needles and syringes. Drawing on qualitative research conducted with drug injectors in England, the article then goes on to explore drug injectors' perceptions and experiences of cleaning needles and syringes inside and outside prison. The article concludes by highlighting the implications for future research and policy making. Ultimately there should be a stronger policy response to reduce the risks associated with sharing needles and syringes inside prison, which should include the piloting of prison needle and syringe exchange schemes.

HIV Infections↗

Syringe injection pressure: a neglected factor in blood PO2 determination.

The mean arterial blood PO2 values of 20 patients' samples taken into Sarstedt 2 mL Monovette syringes were found to be initially 0.43 kPa higher and after 15 min storage 0.93 kPa higher than the mean values using Corning 3 mL Blood Gas Kit syringes. The Sarstedt syringe allowed entry of small air bubbles and the plunger was noted to be stiff. We speculated that high injection pressures might increase measured PO2. Using each type of syringe, 20 ITU staff injected saline into a Corning 178 pH/blood analyser linked to a pressure transducer via a three-way connector. Mean injection pressures for Sarstedt and Corning syringes were 17.15 and 6.42 kPa, respectively (P less than 0.005). Following injection at pressures between 2.8 and 26.6 kPa, the mean PO2 of equilibrated saline containing an air bubble was 0.80 kPa higher than the mean value obtained at injection pressures of less than 2.8 kPa. However, with no air bubble the mean PO2 of equilibrated saline was still 0.45 kPa higher when injected at pressures between 2.8 and 26.6 kPa than the mean value obtained with injection pressures of 2.8 kPa. We suggest that for optimal PO2 determinations syringes should not only allow minimal air contamination but also have plungers that reduce injection pressure to a minimum.

Adult↗

Sterility of filgrastim (G-CSF) in syringes.

OBJECTIVE: To determine if the sterility of filgrastim (G-CSF) is maintained for up to 7 days when aseptically transferred from the vial to tuberculin syringes in a laminar air flow environment. DESIGN: The study was conducted in two phases: a validation and an experimental phase. The method was validated by inoculating samples of sterile filgrastim solution with common bacterial and fungal skin contaminants. Samples were aseptically drawn into syringes in a class 100 horizontal laminar air flow hood and refrigerated. The samples were equally divided and transferred to microbiology culture media at times 0, 24 hours, 48 hours, and 7 days; incubated; and the organisms identified and quantitated. In the experimental phase, samples of filgrastim were aseptically drawn into syringes, separated into three groups, and refrigerated. At 24 hours, 48 hours, and 7 days, the samples were transferred to broth, incubated, and observed for the development of turbidity. SETTING: A class 100 laminar air flow hood in a pediatric hospital pharmacy and a home-infusion pharmacy class 100,000 clean room. MAIN OUTCOME MEASURES: The sterility of filgrastim in syringes was determined by comparing experimental broth culture tubes to a control tube and observing for the development of turbidity. RESULTS: Filgrastim demonstrated the ability to support the growth of intentionally inoculated skin contaminants, both qualitatively and quantitatively. However, when aseptically transferred to syringes and refrigerated, all tested filgrastim samples remained sterile for at least 7 days. CONCLUSIONS: Syringes of filgrastim remain sterile for 7 days when prepared in a class 100 laminar air flow hood, using aseptic technique, and stored under refrigeration. This change in practice can result in significant cost savings.

Drug Contamination↗

Syringe access for the prevention of blood borne infections among injection drug users.

BACKGROUND: Approximately one-third of acquired immunodeficiency syndrome cases in the United States are associated with the practice of sharing of injection equipment and are preventable through the once-only use of syringes, needles and other injection equipment. DISCUSSION: Sterile syringes may be obtained legally by 4 methods depending on the state. They may be purchased over the counter, prescribed, obtained at syringe exchange programs or furnished by authorized agencies. Each of these avenues has advantages and disadvantages; therefore, legal access through all means is the most likely way to promote the use of sterile syringes. SUMMARY: By assisting illicit drug injectors to obtain sterile syringes the primary care provider is able to reduce the incidence of blood borne infections, and educate patients about safe syringe disposal. The provider is also able to initiate discussion about drug use in a nonjudgmental manner and to offer care to patients who are not yet ready to consider drug treatment.

Acquired Immunodeficiency Syndrome↗

Syringe-actuated metered dose inhalers: a quantitative laboratory evaluation of albuterol delivery through nozzle extensions.

The metered dose inhaler (MDI) is a device that can be used to supply aerosolized bronchodilators to the tracheobronchial tree of patients requiring endotracheal intubation. Because direct actuation of the MDI into the breathing circuit is inefficient, a technique of extending the MDI nozzle with small-bore, long, intravenous catheters has been devised. To facilitate connecting the MDI to the extension and actuating the release of aerosol, insertion of the MDI cannister into the barrel of a large syringe attached to the Luer hub of the extension has been proposed but not quantitatively evaluated. The purpose of this study was to test, in a laboratory model, the performance of syringe-actuated MDIs attached to nozzle extensions. The deposition of the bronchodilator albuterol in the delivery device and distal to the extension was quantified spectrophotometrically. Maximum distal delivery of drug from nozzle extensions fashioned from small-bore (19-gauge) catheters was 80% of the actuated release. Loss of drug to the inner surface of the syringe plus extension varied inversely with the number of successive actuations. Syringes from two manufacturers in two sizes were compared and found to perform comparably. Syringes could be attached to the Luer connector of the secondary sampling channel of special pediatric-sized endotracheal tubes (ETTs) and the channels were evaluated as nozzle extensions, with distal delivery > 80% as efficient as the 19-gauge intravenous catheter. We conclude that syringe actuation of MDIs through nozzle extensions is an efficient method for supplying the aerosol distal to the tip of the ETT.(ABSTRACT TRUNCATED AT 250 WORDS)

Albuterol↗

Legal syringe purchases by injection drug users, Brooklyn and Queens, New York City, 2000-2001.

OBJECTIVE: To assess preliminary results of the Expanded Syringe Access Demonstration Program (ESAP) in New York City. DESIGN: Temporal trends of pharmacy use among injection drug users (IDUs) in Brooklyn and Queens were analyzed from December 2000 through December 2001. SETTING: Brooklyn and Queens, New York City. PARTIPANTS: IDUs. MAIN OUTCOME MEASURES: Attempts to purchase syringes from pharmacies and success in doing so. RESULTS: Of the 1,072 IDUs interviewed from December 2000 through December 2001, the majority were daily heroin injectors, but there was also substantial speedball and cocaine injection. There was a clear increase over time in both the percentage of subjects who attempted to purchase syringes in pharmacies and in the percentage who successfully purchased syringes. Among IDUs interviewed 4 or more months after ESAP began, large majorities of those who attempted to purchase syringes were successful in doing so. No differences in use of ESAP by IDUs were identified in Brooklyn versus Queens: 27% of IDUs interviewed in Queens reported that they had attempted to purchase syringes in pharmacies versus 28% in Brooklyn. Persons who reported injecting on a daily or more frequent basis were more likely to have attempted pharmacy purchases than persons who reported injecting less frequently, 32% versus 21%. CONCLUSIONS: The ESAP program has led to an increase in the use of pharmacies as sources of sterile injection equipment among IDUs in New York City. The extent to which pharmacies become an important source of sterile injection equipment and the effect of legal pharmacy sales on risk behaviors for human immunodeficiency virus (HIV) infection remain to be determined.

Data Collection↗

Stability of pO2, pCO2 and pH in heparinized whole blood samples: influence of storage temperature with regard to leukocyte count and syringe material.

Influences of storage temperature and blood cell metabolism in different types of syringes were investigated. Experiments were performed on blood samples with normal and elevated leukocyte counts. After equilibration with gas mixtures at normal pO2 (86 mm Hg/11.5 kPa) and elevated pO2 (140 mm Hg/18.7 kPa), sequential blood gas analyses were done within one hour. Storage temperatures were 4 degrees C or 22 degrees C. In the first group of experiments we compared glass samplers with plastic syringes at different storage temperatures with regard to deviations of blood gas concentrations. The analysed samples had a normal cell count. Blood stored in glass syringes in ice water served as the reference, and it displayed virtually no changes. The deviations of pCO2 and pH were relatively small. In plastic syringes the greatest increases for pO2 occurred after storage at 4 degrees C, which can be explained by the increased solubility of oxygen and the higher O2 affinity of haemoglobin at 4 degrees C. When stored at room temperature, the deviations in plastic syringes were smaller. In a second group of experiments, the influence of cell metabolism was studied. Blood gases were analysed in samples with elevated leukocyte counts (20 x 10(9)/l, 40 x 10(9)/l, 60 x 10(9)/l), and only glass syringes were used. It was demonstrated that after storage at 22 degrees C considerable losses in pO2 occurred, while at 4 degrees C there was virtually no change. Deviations of pO2, pCO2 and pH are described in detail.(ABSTRACT TRUNCATED AT 250 WORDS)

Blood Cells↗

Increased access to unrestricted pharmacy sales of syringes in Seattle-King County, Washington: structural and individual-level changes, 1996 versus 2003.

We examined pharmacists' attitudes and practices related to syringe sales to injection drug users before and after legal reform and local programming to enhance sterile syringe access. We replicated a 1996 study by conducting pharmacist phone surveys and syringe test-buys in randomly selected pharmacies. Test-buy success increased from 48% in 1996 to 65% in 2003 (P=.04). Pharmacists agreeing that syringes should be available to injection drug users through pharmacy purchase increased from 49% to 71% (P<.01). Pharmacy policies and pharmacist attitudes were strongly associated with syringe access. Structural changes, including policy reform and pharmacy outreach, appear to increase syringe access. Interventions should address pharmacy policies and pharmacist attitudes and policies.

Attitude of Health Personnel↗

Premixed insulin preparations in pen syringes maintain glycemic control and are preferred by patients.

OBJECTIVE: To examine the impact on glycemic control of substituting a range of premixed insulins for the standard treatment with patient-mixed insulin combinations. In addition, a pen-type syringe was substituted for the conventional insulin syringe, and the patients' preference was ascertained at the end of the study. RESEARCH DESIGN AND METHODS: Before the study, all patients had maintained a constant insulin dosage for 2 months. For the first month of the study, all patients were encouraged to make any adjustment in insulin dosage required to optimize control. Twenty-seven patients participated in the study. At the end of the first month, patients were randomized either to change to premixed insulins or to continue with self-mixed insulins for 2 months. At the end of the 2-month period, participants changed to the alternative regime for a further 2 months. Glycemic control was measured by assessment of glycosylated hemoglobin levels at the start of the study and after each 2-month period of the study. In addition, during the 1-month run-in period and during both 2-month study periods, a seven-point blood glucose profile was obtained extending from before breakfast to just before retiring for sleep. RESULTS: Glycosylated hemoglobin levels were unchanged throughout the duration of the study. Similarly, there were no systematic changes in individual seven-point blood glucose profiles. The frequency of hypoglycemic reactions was similar on patient-mixed and premixed insulin programs. However, 83% of patients expressed a preference for premixed insulins. A similar percentage regarded pen-type insulin syringes to be preferable to the conventional syringe. CONCLUSIONS: Glycemic control was similar on patient-mixed and premixed insulins, and patients had a marked preference for premixed insulins delivered in a pen-type syringe over conventional insulin therapy. Premixed insulin delivered by a pen-type syringe promises to ease the burden of daily injections for many diabetic patients.

Adolescent↗