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Accuracy and precision of low-dose insulin administration using syringes, pen injectors, and a pump.

We compared the accuracy and precision of low-dose insulin administration using various devices including, for the first time, an insulin pump. We dispensed 1, 2, and 5 unit(s) of soluble insulin (100 units/mL) 15 times each from a NovoPen (3.0 mL), a BD-Mini Pen (1.5 mL), a Humalog Pen (100 units/mL), 30G Precision Sure-Dose Insulin Syringes, 30G BD Ultra-Fine II Short Needle Syringes, and a H-TRON-plus V100 insulin pump. Each dose was weighed on an analytical scale, and the delivered and target doses were compared. Accuracy was defined by the absolute percent difference from the target dose. Precision was defined as the absolute percent difference from the group sample mean. Overall, we found that the pen and pump devices were more accurate, and the pump more precise, than the syringes at the 1- and 2-unit doses. Syringes were dangerously inaccurate, clinically, at the 1-unit dose. The use of pens and syringes with very fine increment markings (1/2 unit) did not improve accuracy or precision. Earlier researchers used multiple individuals to draw and weigh the samples. In an effort to eliminate the potential introduction of significant error; our study used only 2 investigators: 1 to draw up the doses and another to weigh them. The conclusions in our study were similar to prior studies.

Equipment Design↗

Pharmacokinetics and pharmacodynamics of a new formulation of recombinant human growth hormone administered by ZomaJet 2 Vision, a new needle-free device, compared to subcutaneous administration using a conventional syringe.

The objective of the present study was to investigate the applicability of a new human growth hormone (Zomacton) formulation, administered both by a conventional syringe and by a new needle-free device (ZomaJet 2 Vision). The study was performed according to a randomized, controlled, three-period crossover design. On 3 separate days, all subjects received in a random order a single subcutaneous injection of 1.67 mg hGH as follows: Zomacton 4 mg/ml conventional syringe administration (Treatment A), Zomacton 10 mg/ml conventional syringe administration (Treatment B), or Zomacton 10 mg/ml ZomaJet 2 Vision administration (Treatment C). The pharmacokinetic parameters were assessed for the individual subjects in each group by noncompartmental methods. Bioequivalence was assessed based on log-transformed AUC and C(max) values. To investigate the effectiveness of two formulations and the different administration methods, the pharmacodynamic parameters (insulin-like growth factor-1 [IGF-1] and free fatty acids [FFA]) were also evaluated. No subjects were withdrawn due to adverse events. The local tolerance assessment (assessed by inspection)revealed no differences between ZomaJet2 Vision application and conventional injections by syringe. Administration of the new hGH formulation by syringe was found to be bioequivalent with the reference treatment, both based on AUC and C(max) values; the new formulation administered by use of ZomaJet 2 Vision was found to be bioequivalent based on AUC values only. When using the ZomaJet 2 Vision, the absorption of hGH was faster, resulting in higher C(max) values. The maximum hGH serum concentration of around 20 ng/ml was observed 3.5 to 4 hours after drug administration. The terminal half-life was found to be around 2.5 hours. Comparison of the pharmacodynamic profiles (both IGF-1 and FFA) demonstrated bioequieffectiveness. These results support the use of jet injectors as a viable alternative to the traditional injection pens.

Adult↗

Contamination of syringe plungers during the sampling of cyclophosphamide solutions.

The presence of cytotoxic agents in the urine of operators and in their environment has been demonstrated. The pharmacokinetics of the urinary elimination of cyclophosphamide suggests that these drugs are absorbed cutaneously during handling. In the framework of a more general study on the contamination of hospital environment, the present study addresses the possible presence of cytotoxic agents on the plungers of syringes. The report is based on results indicating that the bacterial contamination of a plunger may result in the contamination of the solution being sampled. The study was divided into two phases. The first phase consisted in measuring the contamination of the plungers of eight syringes used for handling cyclophosphamide. Cyclophosphamide was analysed by gas chromatography-mass spectrometry with a detection limit of 0.1 ng/ml. The aim of the second phase was to localize the contamination on the plunger and thus determine the amount of drug that comes into contact with the gloves of the operators. The contamination was quantified by measuring the activity of metastable technetium. The results of the first phase showed that all the plungers were contaminated with cyclophosphamide amounts varying from 3.7 to 445.7 ng. The second phase showed that the infiltration of liquid onto the plunger depended on the solution being sampled. Almost no infiltration was seen with labelled water, but contamination appeared after the first sampling of a cyclophosphamide solution, then increased as a function of the number of times the plunger was pushed in and out. These results indicate that cyclophosphamide solutions infiltrate onto the plungers of syringes. They suggest that the general procedure for handling cytotoxic agents should be modified, and a regular replacement of syringes should be enforced. They also partly explain why the gloves of 50-90% operators are contaminated after a single preparation. The contamination seems to depend on the type of solution sampled and the number of samplings. Initial investigations by the manufacturer of the syringes had shown that the acid pH of cyclophosphamide solutions may affect the lubricant of the joint. Our study demonstrates that the contamination of plungers is one of the sources of environmental contamination for health workers handling antineoplastic agents, even in the absence of manipulation errors. More generally, these results demonstrate that the exposure of operators cannot be clearly described unless all existing sources of contamination in their environment are identified. The implementation of suitable procedures should thus take into account all possible sources of contamination, including technical facilities such as the use of a safety cabinet or an isolator.

Antineoplastic Agents↗

Stability of bortezomib 1-mg/mL solution in plastic syringe and glass vial.

BACKGROUND: The proteasome inhibitor bortezomib (BTZ), used in antineoplastic chemotherapy, must be diluted in NaCl 0.9% for injection and stored for no more than 3 hours in a syringe or 8 hours in a vial. Better information on its stability could improve storage. OBJECTIVE: To assess the stability of BTZ solution (1 mg/mL) in syringes and vials. METHODS: BTZ 1-mg/mL solutions were prepared by adding sterile NaCl 0.9% to Velcade vials containing 3.5 mg of lyophilized BTZ. Syringes were filled with 1 mL of solution and stored in the dark at 5 degrees C or 60 degrees C; others were not protected from light and stored at 22 degrees C. Velcade vials containing 1 mL of solution were stored at 5 degrees C in the dark. Samples were taken at various times over 23 days and assayed in duplicate. An HPLC method for assaying the stability of BTZ was validated. Appearance and pH were recorded. RESULTS: There was no color change or precipitation in the samples, and the pH was stable. Oxidation, light, and storage temperature all affected the chemical stability of BTZ. The mean concentrations of BTZ in syringes stored for 2, 3, and 5 days at 60, 22, and 5 degrees C were >95% of the initial concentration. The mean concentration of BTZ in vials stored for 5 days at 5 degrees C was >95% of the initial concentration. CONCLUSIONS: BTZ stored refrigerated in vials or syringes and protected from light is chemically stable for 5 days after reconstitution.

Antineoplastic Agents↗

Effectiveness and infant acceptance of the Rx medibottle versus the oral syringe.

STUDY OBJECTIVE: To compare the effectiveness and infant acceptance of drug delivery of the Rx medibottle with the standard oral syringe. DESIGN: Prospective open-label, randomized, crossover clinical study. SETTING: General pediatric outpatient clinic at an urban university. SUBJECTS: Thirty healthy, bottle-fed infants, aged 2-14 months, receiving routine vaccinations. INTERVENTION: Each infant received a single dose of acetaminophen (Tempra syrup), with one-half delivered by the Rx medibottle and one-half delivered with an oral syringe. MEASUREMENTS AND MAIN RESULTS: Three raters independently evaluated effectiveness and infant acceptance of each drug-delivery device. Effectiveness was based on the percentage of infants receiving 100% of the intended dose. Infant acceptance was scored using a validated infant medication acceptance scale (MAS, 10 = highest level). Significantly more infants received 100% of the intended dose with the Rx medibottle (93.3%) than with the oral syringe (56.7%, p=0.0074). Infants had a significantly higher mean MAS score when using the Rx medibottle (8.3+/-1.8 vs 7.3+/-1.7, p=0.002). In addition, a significantly higher percentage had ideal MAS scores of 9 or above with the Rx medibottle (73%) compared with the oral syringe (17%, p=0.0001). CONCLUSION: The Rx medibottle was more effective and had a higher level of infant acceptance than the oral syringe. Although further studies are necessary, this suggests that the Rx medibottle may be a better method of delivering liquid drug and may increase infant adherence.

Acetaminophen↗

Syringe prescription to prevent HIV infection in Rhode Island: a case study.

Injection drug users (IDUs) are a population at high risk for many diseases, including AIDS, and are clearly in need of medical and substance abuse treatment. Access to sterile syringes is critical for lowering the risk of transmission of HIV and other blood-borne pathogens among IDUs. Previously tried strategies include needle exchange programs and changing laws to allow the legal purchase and possession of syringes. An alternative strategy is to have physicians prescribe syringes to IDUs. To the best of our knowledge, this has previously been tried by only a few physicians in rare situations and never on a programmatic basis. This report describes the genesis of physician's syringe prescription in Rhode Island and some of the lessons learned to date. Because of the illicit nature of drug use, a tremendous amount of mistrust and fear on the part of IDUs often leads to poor interaction with the medical establishment. Prescription of syringes by a physician can serve as a tool for reaching out to a high-risk and often out-of-treatment population of drug users. It is a way for the health care community to tap into drug-using networks and bring those populations into a medical care system.

Adult↗

Comparison of bulb syringe and pulsed lavage irrigation with use of a bioluminescent musculoskeletal wound model.

BACKGROUND: Despite the fact that wound irrigation is a common surgical procedure, there are many variables, including delivery device, irrigant type, and fluid volume, that have yet to be optimized. The purpose of this study was to compare, with use of transgenic bioluminescent bacteria and standard quantitative microbiological methods, the efficacy of pulsed lavage and bulb syringe irrigation in reducing wound bacterial counts. METHODS: A caprine model of a complex, contaminated musculoskeletal wound was developed with use of a bioluminescent strain of Pseudomonas aeruginosa that can be quantified. Luminescent activity was recorded as relative luminescent units with use of a photon-counting camera six hours after the wound was created and inoculated. Twelve goats were randomly assigned to either the pulsed lavage group or the bulb syringe irrigation group. Each wound was irrigated with normal saline solution in 3-L increments for a total of 9 L and was imaged after each 3-L increment. In addition, quantitative culture samples were obtained from different tissues within the wound before and after irrigation. RESULTS: Pulsed lavage decreased the amount of relative luminescent units by 52%, 64%, and 70% at 3, 6, and 9 L, respectively. The bulb syringe irrigation reduced the amount of relative luminescent units by 33%, 44%, and 51% at these same time-points. Significant differences in luminescence were noted between the two groups after both 6 and 9 L of irrigation (p < or = 0.04). The correlation coefficients between relative luminescent units and quantitative cultures for the condition before irrigation and after irrigation were r = 0.96 and 0.83, respectively. CONCLUSIONS: Pulsed lavage was more effective than bulb syringe irrigation in reducing bacterial luminescence after both 6 and 9 L of irrigation. Both device and volume effects can be demonstrated with use of this model. Bioluminescent bacteria provide a method to visualize bacterial distribution and to quantify the bacteria in a wound. CLINICAL RELEVANCE: Pulsed lavage is a more effective and efficient method of irrigation to remove bacteria in a complex musculoskeletal wound. In the model we used, pulsed lavage irrigation with 3 L of saline solution resulted in a reduction of approximately the same amount of bacteria as did irrigation with 9 L with use of a bulb syringe.

Animals↗

Accuracy of pen injectors versus insulin syringes in children with type 1 diabetes.

OBJECTIVE: To compare the accuracy and precision of insulin syringes and pen devices used by children with type 1 diabetes and their parents. RESEARCH DESIGN AND METHODS: There were 48 subjects (32 patients, a parent of an additional 16 patients) instructed to measure out morning insulin doses three times from vials and/or cartridges containing saline mixed with small amounts of [14C]glucose (solution used as regular insulin) and [3H]glucose (solution used as NPH insulin) and to dispense the contents into a scintillation vial. Statistical analysis was used to determine the accuracy and precision of both methods of insulin delivery. RESULTS: The absolute error in measuring out doses of regular insulin < 5 U was greater with insulin syringes compared with pen injection devices (9.9 +/- 2.4 vs. 4.9 +/- 1.6%, respectively). Both were comparable for regular insulin doses > 5 U (3.2 +/- 0.6 vs. 2.2 +/- 0.4% for syringes and pens, respectively). The accuracy in drawing up NPH doses was similar for low and high insulin doses (mean percent error of 7.5 +/- 1.5 vs. 5.6 +/- 1.1%). CONCLUSIONS: Pen devices are more accurate than insulin syringes in measuring out insulin at low insulin doses. The accuracy of insulin syringes improves when higher doses of regular insulin are measured out and becomes comparable to pen devices.

Adolescent↗

Twice-daily mixed regular and NPH insulin injections with new jet injector versus conventional syringes: pharmacokinetics of insulin absorption.

The purpose of the present study was to evaluate the feasibility of using a jet injector in a split and mixed regular and NPH insulin regimen and to compare serum glucose and free-insulin profiles obtained with the injector and the conventional syringe and needle. Twelve insulin-dependent diabetic patients were hospitalized for 5 days. After a stabilization day, six patients received their insulin injection with the injector for 2 days and with the syringe and needle for the following 2 days; the regimen was reversed for the other six patients. Diet, exercise, and insulin dosage remained constant. The serum glucose levels with the injector were consistently lower than those obtained with the syringe at all times of the day except at 5:00 a.m. and 7:30 a.m., when mean values were similar for both treatments. Free-insulin levels were higher with the injector from 10:30 a.m. to 4:30 p.m. These findings suggest that insulin absorption is faster and possibly greater with the injector than with the syringe. When switching from a syringe to an injector insulin program, insulin dose adjustment may be necessary.

Adult↗

Reuse of disposable insulin syringes.

Seventeen insulin-dependent diabetics reused 111 disposable plastic syringes (Terumo 40/80-U; detachable needle) a total of 2363 times. Each syringe was used for an average of 12.2 days (range, one to 80 days), making an average of 21.3 injections each (range, two to 126 injections). There were no injection-related infections or local reactions. Six syringes from four patients were contaminated by non-pathogenic skin organisms (Staphylococcus albus and Bacillus spp.) without any detrimental effects. Contamination was independent of duration of syringe use or skin preparation technique. The reuse of plastic disposable insulin syringes appears to be a safe, cost-saving practice.

Adolescent↗

[Validation of the preparation of individual doses of 51Cr-EDTA in syringes].

The 51Cr-EDTA is one of the radiopharmaceuticals more used in the glomerular filtration rate determination. The necessity to prepare a daily reference dose every time that are prepared the patient's doses can go to a poor exploitation of the multidose vial. One way of improving its use consists on the preparation of individual doses in ready syringes to inject, for several days, employing only one of them as a standard. The aim of this study was to evaluate the storing of 51Cr-EDTA individual doses at room temperature and at 4 degrees C during 4 weeks, analyzing the radiochemical purity, the sterility and the radiopharmaceutical retention into the syringe. The results obtained showed that the radiochemical purity remains stable, always been greater than the value recommended for its use (> 95%). Likewise, there were not microorganism contamination nor 51Cr-EDTA appreciable retention into the syringes. We concluded that the preparation of individual doses of 51Cr-EDTA in syringes and their conservation at room temperature, or at 4 degrees C, during a period of 4 weeks, neither influence in the radiopharmaceutical quality nor increase its retention into the syringe.

Chromium Radioisotopes↗

Comparison of four 1-mL syringes for administering first-pass radionuclide angiography doses.

OBJECTIVE: For optimal imaging in first-pass radionuclide angiography (FPRNA) studies, 1.11 GBq (30 mCi) 99mTc-sestamibi doses are drawn up in volumes of 0.1-0.3 mL. A single bolus injection of this small volume is important to obtain accurate time-activity curves. Because of the small volume and concentrated radioactivity, it is undesirable for study effectiveness and image quality to have a significant amount of residual activity remaining in the syringe after injection. The purpose of this study was to compare the amount of residual activity in 4 different 1-mL syringes. METHODS: Each test syringe (n = 20) was filled with a volume (0.2 mL) of approximately 1.11 GBq (approximately 30 mCi) 99mTc-sestamibi. Initial activity was measured, and the dose was injected back into a vial only once, simulating bolus injection into a patient. The remaining activity was measured, followed by the calculation of percent residual activity. RESULTS: The two 25-G x 5/8-in. permanent needles had a low percent of residual activity, as well as a much sturdier needle for injection. However, one of these syringes is more expensive. CONCLUSION: The results of our comparison studies showed that the syringe with a 25-G x 5/8-in. permanent needle is ideal for FPRNA doses because of its sturdiness, low residual activity, and the quality of the bolus and resulting images.

Humans↗

Viability of HIV-1 in syringes: implications for interventions among injection drug users.

We have determined that the duration of survival of HIV-1 in syringes typically used by injectors of illicit drugs can exceed 6 weeks. The percentage of syringes with viable virus varied with the volume of blood remaining in the syringes and the temperature at which syringes were stored. These experiments underscore the need for needle exchange programs and other HIV prevention interventions that promote the availability of clean syringes and the removal of potentially infectious ones from circulation.

Acquired Immunodeficiency Syndrome↗

Is it safe to reuse a syringe of glutaraldehyde cross-linked collagen? A microbiological study.

PURPOSE: We evaluated the safety of saving partially used syringes of glutaraldehyde cross-linked collagen for subsequent treatment sessions in an individual. MATERIALS AND METHODS: After periurethral injection in an office setting 56 partially used syringes of glutaraldehyde cross-linked collagen were stored in a refrigerator for 1 to 61 weeks (mean 15). Collagen from all 56 syringes was then cultured qualitatively using a broth medium at 35C and semiquantitatively using a chocolate agar plate at 22 to 30C for 5 days each. RESULTS: A qualitative broth culture was positive for coagulase negative staphylococcus but the results of semiquantitative chocolate agar culture of material from the same syringe were negative. All cultures of the other 55 syringes were negative. CONCLUSIONS: The positive culture most likely resulted from contamination during periurethral injection or the culturing process. Minimal contamination from and the great potential cost savings of reusing glutaraldehyde cross-linked collagen for subsequent treatments in an individual indicate the need for an expanded study involving multiple centers.

Collagen↗

Supermarket tampering: cocaine detected in syringes and in fruit.

Product tampering, as detailed by the Federal Anti-Tampering Act of 1983 (1), is a felony punishable by both fine and imprisonment. The rationale for product tampering ranges from pranks and attention seeking acts to extortion, terrorism, and homicide. One such case submitted for analysis involved four medical syringes found in a supermarket and suspected of being used to tamper with various products. One of the syringes was found piercing a pear while the other three syringes were found with needles exposed in other parts of the supermarket. Microscopic analysis was used to collect residue from the syringe barrels and the pear. A multidiscipline approach involving SLM, PLM, including microchemical analysis, FTIR, and GC/MS analyses, performed on the residual liquid found in the syringe barrels and in the suspect pear, confirmed the presence of cocaine. This multidisciplinary approach is often necessary when there is a possible health risk to the public and rapid response is important. With this approach, it was quickly determined which drugs or poisons were used in this tampering.

Cocaine↗

Stability of ceftazidime (with arginine) stored in plastic syringes at three temperatures.

The stability of ceftazidime (with arginine) stored in plastic syringes at three temperatures was studied. Ceftazidime (with arginine) was reconstituted with sterile water for injection to a concentration of 100 mg/mL and transferred to plastic syringes. Syringes were stored at 22 degrees C for 24 hours; at 4 degrees C for 7 or 10 days, then at 22 degrees C for 24 hours; or at -20 degrees C for 91 days, then at 22 degrees C for 24 hours or at 4 degrees C for seven days followed by 22 degrees C for 24 hours. Ceftazidime concentration was measured at various times by using a stability-indicating high-performance liquid chromatographic method. At each sampling time, each syringe was visually inspected and the pH of each solution was measured. Mean ceftazidime concentration remained > 90% of initial concentration at all storage conditions. Although during storage the color of the solutions changed from light straw to dark yellow and the pH decreased, no precipitate was visually detected and no peaks for degradation products appeared on the chromatograms. Ceftazidime 100 mg/mL (with arginine) in sterile water for injection was stable when stored in plastic syringes for up to 24 hours at 22 degrees C, for 10 days at 4 degrees C followed by up to 24 hours at 22 degrees C, and for 91 days at -20 degrees C followed by up to 24 hours at 22 degrees C or by 7 days at 4 degrees C and up to 24 hours at 22 degrees C.

Arginine↗

A dual-chambered syringe that allows identification of the epidural space using the loss of resistance technique with air and with saline.

BACKGROUND AND OBJECTIVES: Each of the two most widely used techniques for identification of the epidural space, the loss of resistance technique with air and the loss of resistance technique with liquid, has certain advantages and disadvantages. A new syringe is described that has two chambers, one to contain air and the other to contain liquid, to combine the advantages of air with the advantages of liquid, and to prevent the disadvantages of each. METHODS: Twenty consecutive adult patients scheduled to receive epidural injections for surgery, obstetrics, or pain control were selected for study. This was an open study, and the EpIdent syringe was used as the only means of identifying the epidural space in every case. RESULTS: The EpIdent syringe easily and effectively identified the epidural space in all of the patients, with no adverse or unpleasant side effects. Successful identification of the space was documented by the production of adequate anesthesia after the injection of an appropriate volume or local anesthetic. There were no complications. CONCLUSIONS: The successful use of the EpIdent syringe in this preliminary study of 20 patients indicates that it provides a simple, safe, and effective means of identifying the epidural space. It allows the use of a plastic syringe (instead of glass) and avoids the unpleasant or untoward effects associated with currently used loss of resistance techniques.

Air↗

[Disposal of insulin syringes by diabetic patients. Report of 100 patients].

Elimination of syringes and needles is regulated in hospitals. However, the regulations remain unknown of diabetic patients who do not eliminate correctly their syringes of insulin. We propose to analyze the present situation concerning the management of used syringes of insulin by diabetic patients. This study was conducted in a clinic for diabetics and it involved 100 diabetic patients treated with insulin. The results of this study shaved an insufficiency in the management of syringes of insulin by diabetic patients. Thus, education and a conscionsness-raising of diabetic patients on management and correct use of syringes are necessary.

Adolescent↗