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PubMed1998

Enough sterile syringes to prevent HIV transmission among injection drug users in Montreal?

The HIV epidemic among injection drugs users in Montreal continues unabated. We wished to know whether sufficient syringes were being distributed to provide for the needs of injection drug users (IDUs) in Montreal. Using data from several sources, including the estimated number of active IDUs in 1994 and the injection frequency according to the drug consumed, we calculated the number of syringes required by IDUs. The number of syringes estimated was compared with the number of syringes distributed by needle exchange programs or sold in private pharmacies. Overall, we estimated that in 1994 about 10,683,000 syringes were required by the 10,000 IDUs in Montreal. Because about 338,000 syringes were distributed, <5% of the need was being met. The parameters in our analysis, particularly the number of IDUs in Montreal, drug use, and the frequency of injection, are subject to uncertainty. Nevertheless, because of the disparity between the small proportion of syringes distributed and the number required, it is unlikely that sufficient syringes are available to ensure access to clean needles and prevent HIV transmission. Measures should be taken to expand syringe distribution to Montreal IDUs.

Cocaine↗
PubMed2005

Syringe pumps take too long to give occlusion alarm.

BACKGROUND: The aim of this study was to assess the time needed to trigger an occlusion alarm, and the influence of the type of infusion pump, type and size of the syringe, and the set infusion rate. METHODS: Forty syringe pumps (20 JMS SP-100 and 20 JMS SP-500 machines) were tested using two types (JMS and Hayat) and two sizes (20 and 50 ml) of syringes at four infusion rates (0.5, 1, 2 and 5 ml x h(-1)). Syringes filled with saline were occluded with a stopcock, and times to activation of the occlusion alarm were recorded. Statistical analysis was performed with Wilcoxon and Mann-Whitney U-tests, P < 0.05 was considered significant. RESULTS: The mean time to alarm activation was longer with lower infusion rates and larger syringes (P < 0.05). We recorded delays up to 117.3 +/- 9.4 min with 50 ml syringe at 0.5 ml x h(-1) and 15.0 +/- 7.1 min at 5 ml x h(-1). Syringe type had no effect on time to alarm activation (P > 0.05). The alarm on the JMS SP-500 pump was activated faster than the JMS SP-100 pump (P < 0.05). CONCLUSION: Our results showed that activation of occlusion alarms on both pumps takes a considerable time, and that the mean time to alarm activation was longer with low infusion rates and larger syringes. To reduce occlusion alarm delays smaller sized syringes with low compliance should be used and staff be alerted when using low flow rates with highly concentrated potent drugs.

Equipment Failure↗
PubMed1998

Accuracy and reproducibility of low dose insulin administration using pen-injectors and syringes.

Many children with diabetes require small doses of insulin administered with syringes or pen-injector devices (at the Booth Hall Paediatric Diabetic Clinic, 20% of children aged 0-5 years receive 1-2 U insulin doses). To determine how accurately and reproducibly small doses are delivered, 1, 2, 5, and 10 U doses of soluble insulin (100 U/ml) were dispensed in random order 15 times from five new NovoPens (1.5 ml), five BD-Pens (1.5 ml), and by five nurses using 30 U syringes. Each dose was weighed, and intended and actual doses compared. The two pen-injectors delivered less insulin than syringes, differences being inversely proportional to dose. For 1 U (mean (SD)): 0.89 (0.04) U (NovoPen), 0.92 (0.03) U (BD-Pen), 1.23 (0.09) U (syringe); and for 10 U: 9.8 (0.1) U (NovoPen), 9.9 (0.1) U (BD-Pen), 10.1 (0.1) U (syringe). The accuracy (percentage errors) of the pen-injectors was similar and more accurate than syringes delivering 1, 2, and 5 U of insulin. Errors for 1 U: 11(4)% (NovoPen), 8(3)% (BD-Pen), 23(9)% (syringe). The reproducibility (coefficient of variation) of actual doses was similar (< 7%) for all three devices, which were equally consistent at underdosing (pen-injectors) or overdosing (syringes) insulin. All three devices, especially syringes, are unacceptably inaccurate when delivering 1 U doses of insulin. Patients on low doses need to be educated that their dose may alter when they transfer from one device to another.

Adult↗
PubMedDate not supplied

Syringe disposal practices and gender differences.

PURPOSE: The purpose of this study was to describe syringe disposal practices of individuals with diabetes who take insulin and to investigate the attitude toward and effect of previous information on proper syringe disposal. METHODS: Adult men and women who injected insulin were recruited from an endocrinology practice and given 2 questionnaires concerning syringe disposal practices and attitude toward proper syringe disposal. Completed questionnaires were returned by mail to the investigator. Nonparametric statistical procedures were used to analyze the data. RESULTS: Men with higher income tended to use the trash for syringe disposal more often than lower income men, and older women exhibited a higher positive attitude score than younger women. A positive attitude significantly correlated with the likelihood of proper syringe disposal, and those who had received previous information were more likely to dispose of syringes properly. Healthcare providers were identified as the main source of information. CONCLUSIONS: Diabetes educators can improve the syringe disposal practices of their patients through education at each office visit. Knowing more about the environmental and social problems that may ensue from improper syringe disposal may influence patients to practice better disposal methods.

Adult↗
PubMed1997

Is direct collection of pleural fluid into a heparinized syringe important for determination of pleural pH? A brief report.

INTRODUCTION: It has long been believed that pleural fluid must be directly aspirated into a heparinized syringe to obtain an accurate value. Many operators aspirate 30 to 60 mL of pleural fluid into a syringe without heparin, and then place 1 mL into a heparinized syringe from which the pH is determined. We postulated that this technique does not cause a clinically significant difference in pleural pH values. METHODS: Patients undergoing thoracentesis in the outpatient clinic, general ward, and medical ICU were eligible. After the initial entry of the needle into the pleural space, a heparinized syringe was used to obtain pleural fluid for pH determination. A 60-mL syringe was then used to aspirate additional pleural fluid for biochemical analysis and culture. At the end of the procedure, a second aliquot of pleural fluid was placed into a heparinized syringe for pH determination. A difference of 0.1 in pH was taken as clinically important. RESULTS: Twenty-one pleural fluid samples were obtained from 20 patients. Pleural fluid pH determinations were within 0.1 in all but one patient. The mean pH for the directly collected group was 7.39 (25%: 7.35; 75%: 7.45). The mean for the indirectly collected group was 7.41 (25%: 7.35; 75%: 7.45). The difference between the two means (0.02; 95% confidence interval, 0.0368 to 0.00131) was statistically significant but clinically unimportant (p=0.037). CONCLUSIONS: Pleural fluid can be collected in a large syringe and then placed into a heparinized syringe to assess pH. This is useful information because the use of just one syringe saves time and reduces the risk of iatrogenic complications.

Aged↗
PubMed1992

Stability of blood gases, electrolytes and haemoglobin in heparinized whole blood samples: influence of the type of syringe.

The alterations of blood gases, pH, electrolytes and haemoglobin during 45 min storage in ice-water were measured in 6 types of syringes (1 glass and 5 plastic syringes, among these 3 "blood gas samplers"). It was confirmed that pO2 generally is not stable in plastic syringes. However, considerable differences among plastic syringes were found in this respect, the smallest increase occurring in an ordinary 2 ml syringe for injections and the greatest in one of the special blood gas samplers. Due to the "buffering effect" of deoxyhaemoglobin, the alterations of pO2 are smaller in the hypoxaemic than in the normoxaemic range. Relevant pO2 alterations in plastic syringes are demonstrable after 20 minutes. It is concluded that blood collected in plastic syringes must be analysed within 15 min after sampling, otherwise glass syringes should be used for blood collection. Deviations of pCO2, pH and electrolytes are described in detail. In general, they are due to sampling rather than to storage, and can be effectively minimized by a small dead space of the syringe and by use of an electrolyte-balanced heparin solution. The danger of erroneous haemoglobin measurements due to unequal resuspension of the red cells after storage is pointed out.

Blood Chemical Analysis↗
PubMed1999

Effect of in-line bacteriological filters on numbers of heterotrophic bacteria in water emitted from non-autoclavable dental air-water syringes.

PURPOSE: To determine the effect of in-line bacteriological filters on the heterotrophic bacterial count of water from non-autoclavable dental air-water syringes. MATERIALS AND METHODS: In-line bacteriological filters were placed in the waterlines of non-autoclavable dental air-water syringes. Filters were placed either as close as possible to the air-water syringe or at a distance of approximately 6 feet (1.8 meters) from the air-water syringe. After routine flushing of water lines and air-water syringes, water samples were collected aseptically. Samples were diluted, plated on NWRI agar, and incubated, and numbers of heterotrophic bacteria per ml were determined. RESULTS: Filtration substantially reduced heterotrophic contamination of air-water syringe water when the filter was placed immediately adjacent to the air-water syringe. However, there was no beneficial effect when the filter was at a distance from the air-water syringe. Furthermore, filtered water containing no detectable heterotrophic bacteria was re-contaminated upon passage through the non-autoclavable air-water syringe.

Colony Count, Microbial↗
PubMed1999

The use of a new mechanically advantaged syringe for performing coronary intervention.

OBJECTIVE: To determine the utility of a new mechanically advantaged syringe in the performance of percutaneous coronary intervention. BACKGROUND: A new mechanically advantaged syringe has been developed to perform cardiovascular imaging. We wanted to assess the utility of this device in the performance of small catheter percutaneous coronary intervention. Data from coronary interventions performed with the standard technique at our institution, using a 10 ml manual syringe, were compared to the use of a new mechanically advantaged syringe. Contrast utilization during the standard technique was assessed by obtaining data from fifty consecutive successful single-vessel coronary interventions (angioplasty with or without stenting). After an initial learning experience with the mechanically advantaged syringe, fifty consecutive successful single-vessel coronary interventions were assessed. Most interventions performed using the mechanically advantaged syringe were with 6 French catheters. Detailed contrast utilization information was gathered. RESULTS: During the standard method of performing coronary intervention, 216 +/- 114 ml of contrast were used. Utilizing the mechanically advantaged OZ Power Syringe (Cardiovascular Innovations Inc., Athens, Texas), the contrast use was reduced to 66 +/- 39 ml (p < 0.0001) per case. The syringe also allowed excellent visualization despite using a smaller guide catheter system. CONCLUSION: The OZ Power Syringe can be utilized effectively in percutaneous coronary intervention. Our preliminary data suggest that there may be reduced contrast use without sacrificing image quality.

Angioplasty, Balloon, Coronary↗
PubMed1990

Sterility of insulin in prefilled disposable syringes.

The sterility of insulin in prefilled syringes that had been prepared by visiting nurses in patients' homes and stored in their refrigerators for one month was studied. Twenty elderly diabetic patients requiring weekly home-nursing visits were enrolled in the study. At the initial study visit, a nurse filled 15 syringes with the type and amount of insulin being used by the patient. Seven syringes constituted the patient's supply for the coming week; the remaining eight syringes were appropriately labeled and placed in a separate part of the refrigerator. Upon returning to replenish the patient's insulin supply during each of the following four weeks, the nurse removed two of the stored syringes for subsequent culturing. The culture medium used was appropriate for bacteria that are usual skin flora and therefore are most likely to cause touch contamination during the syringe-filling process. Control-positive cultures were prepared by intentionally contaminating two vials of 0.9% sodium chloride injection and two vials of NPH insulin with Staph. aureus and Staph. epidermidis. Insulin from 159 syringes was tested, and no bacterial growth was detected by daily readings of cultures for one week. Of the contaminated control syringes, those containing sodium chloride injection produced positive cultures at each of the study weeks; the contaminated insulin samples, although positive at week 0, had become negative by week 3, confirming the bactericidal activity of one or more of the components of this insulin product. Prefilled insulin syringes that are prepared by nurses using good aseptic technique and are stored in the patient's refrigerator appear to remain sterile for up to one month after preparation.

Aged↗
PubMed2001

Infusion pump performance with vertical displacement: effect of syringe pump and assembly type.

OBJECTIVE: To evaluate the effect of different infusion pump models on continuity of drug delivery during vertical displacement of syringe pumps. DESIGN: Zero-drug delivery time (ZDDT), retrograde aspiration volume, and infusion bolus were recorded using the same syringe in three different models of syringe pump after lowering and elevating the pump. Compliance of each infusion assembly was measured using the occlusion release technique at 38 mmHg. RESULTS: Lowering the pump by 50 cm at an infusion rate of 1 ml/h resulted in ZDDT values ranging from 2.78 +/- 0.29 to 5.99 +/- 1.09 min. Elevating the syringe pump to its original position caused infusion boluses between 44.1 +/- 3.2 and 77.1 +/- 5.1 microl. The results demonstrated that there are large differences between syringe pump models (F = 66.8, df = 2/33, p < 0.0001) and between pumps of the same model (F = 21.3, df = 1/34, p < 0.0001). A similar pattern was found in retrograde aspiration volume and infusion bolus. CONCLUSION: All tested pumps led to clinically relevant flow irregularities during vertical displacement of the syringe pump. Thus, vertical displacement of any syringe pump connected to an infusion line delivering highly potent drugs at low infusion rates should be avoided. The variability across syringe pumps indicates that syringe pump design remains an area of potential further improvement for reducing the risk of adverse patient events.

Analysis of Variance↗
PubMedDate not supplied

[Risk behaviors for HIV transmission among the recent clients of a syringe-exchange program in Madrid, 1993].

OBJECTIVE: To determine the prevalence of the major risk behavior in HIV transmission (syringe sharing and failure to use condoms) and associated factors among drug injectors recruited for a syringe exchange program (PIJ) in the city of Madrid. METHODS: Cross-section study. All the information was obtained in 1993 through structured interviews with 441 users who had injected drugs during the previous month and had resorted to the PIJ five times, at most. The reference period for drug use and risk behaviour was the month prior to the interview. The statistical analysis included bivariate methods and logistical regression techniques. RESULTS: 29.2% shared syringes (18% passing and 21.7% taking used syringes) and of those that had sexual intercourse (49.4%), 42.5% always used a condom. 89.5% had an HIV antibody test and of those that knew the results, 48.6% were HIV-positive. Multivariate analysis showed that the association between certain behaviour patterns was significant; i.e., taking used syringes and: passing used syringes (odds ratio -OR- = 6.1; 95% confidence interval -CI- = 3.0-12.5), being HIV-positive (OR = 4.1; CI = 1.8-9.1), being unaware of HIV antibody test status (OR = 4.2; CI = 1.7-10.2) and having used intravenous drugs for 5-9 years (OR = 2.9; CI = 1.1-7.9); the association was significant between passing used syringes and: using a mixture of heroin and cocaine (OR = 2.7; CI = 1.1-6.4) and being unaware of HIV antibody test status (OR = 2.5; CI = 1.1-6.0). In the sample as a whole, the association between not using condoms ever and consuming cocaine (OR = 1.7; CI = 1.1-2.9) or crack (OR = 3.0; CI = 1.5-5.9) was significant; furthermore, among those that had sexual intercourse, the association was significant between not using condoms ever and: having been in jail (OR = 2.9; CI = 1.3-6.4), injecting drugs 2-4 times a day (OR = 2.4; CI = 1.0-5.8), having sexual intercourse with drug injectors (OR = 2.6; CI = 1.2-5.9) and having intercourse with two or more partners (OR = 0.4; CI = 0.2-0.9). CONCLUSIONS: The prevalence of HIV infection and risk behavior in the transmission of this virus remain high among drug injectors in Madrid. The habit of sharing syringes is still common, especially among HIV-positive drug injectors (a high percentage take used syringe) and among those who are unaware of their HIV antibody test status. The use of condoms is less frequent among those who have sexual intercourse with other drug injectors or with only one partner.

Adult↗
PubMed2002

Direct observation of syringeal muscle function in songbirds and a parrot.

The role of syringeal muscles in controlling the aperture of the avian vocal organ, the syrinx, was evaluated directly for the first time by observing and filming through an endoscope while electrically stimulating different muscle groups of anaesthetised birds. In songbirds (brown thrashers, Toxostoma rufum, and cardinals, Cardinalis cardinalis), direct observations of the biomechanical effects of contraction largely confirm the functions of the intrinsic syringeal muscles proposed from indirect studies. Contraction of the dorsal muscles, m. syringealis dorsalis (dS) and m. tracheobronchialis dorsalis, constricts the syringeal lumen and thus reduces airflow by adducting connective tissue masses, the medial (ML) and lateral (LL) labia. Activity of the medial portion of the dS appears to affect the position of the ML and, consequently, plays a previously undescribed role in aperture control. Under the experimental conditions used in this study, full constriction of the syringeal lumen could not be achieved by stimulating adductor muscles. Full closure may require simultaneous activation of extrinsic syringeal muscles or the supine positioning of the bird may have exerted excessive tension on the syrinx. Contraction of m. tracheobronchialis ventralis enlarges the syringeal lumen and thus increases airflow by abducting the LL but does not affect the ML. The largest syringeal muscle, m. syringealis ventralis, plays a minor role, if any, in direct aperture control and thus in gating airflow. In parrots (cockatiels, Nymphicus hollandicus), direct observations show that even during quiet respiration the lateral tympaniform membranes (LTMs) are partially adducted into the tracheal lumen to form a narrow slot. Contraction of the superficial intrinsic muscle, m. syringealis superficialis, adducts the LTMs further into the tracheal lumen but does not close the syringeal aperture fully. The intrinsic deep muscle, m. syringealis profundus, abducts the LTMs through cranio-lateral movement of a paired, protruding half-ring. The weakly developed extrinsic m. sternotrachealis seems to increase tension in the ipsilateral LTM but does not move it in or out of the syringeal lumen.

Animals↗
PubMed1999

Syringe exchange in the United States, 1996: a national profile.

OBJECTIVES: This paper provides 1996 information on the status of US syringe exchange programs and compares these findings with data from our 1994 survey. METHODS: In November 1996, questionnaires were mailed to 101 syringe exchange programs. Program directors were contacted to conduct telephone interviews based on the mailed questionnaires. Data collected included number of syringes exchanged, syringe exchange program operations, legal status, and services offered. RESULTS: Eighty-seven programs participated in the survey. A total of 46 (53%) were legal, 20 (23%) were illegal but tolerated, and 21 (24%) were illegal-underground. Since 1994, there has been a 54% increase in the number of cities and a 38% increase in the number of states with syringe exchange programs. Eighty-four programs reported exchanging approximately 14 million syringes, a 75% increase from 1994. Syringe exchange programs also provided a variety of other services and supplies, and legal programs were more likely than illegal ones to provide these services. CONCLUSION: Despite continued lack of federal funding, syringe exchange programs expanded in terms of the number of syringes exchanged, the geographic distribution of programs, and the range of services offered.

Health Care Surveys↗
PubMedDate not supplied

Tumescent and syringe liposculpture: a logical partnership.

Liposuction has been traditionally performed under general anesthesia. Standard instrumentation for the procedure has included blunt-tipped suction cannulae connected to an electric vacuum pump by noncollapsible tubing. A subcutaneous injection of Lidocaine with Epinephrine is routinely employed to minimize blood loss during the procedure. This infiltration has been described as the "wet technique," but it is not a method to supplant general anesthesia. The tumescent technique, a method of infusing very large volumes of dilute lidocaine with epinephrine solutions, has been advocated as a satisfactory means for providing conscious anesthesia for liposuction procedures, avoiding the need for general anesthesia. The syringe technique employs blunt-tipped suction cannulae connected to a syringe. Drawing back the syringe plunger generates the negative pressures needed to remove fat during liposuction and replaces the electric vacuum pump and connecting tubing traditionally used for this procedure. This study evaluates the combined tumescent and syringe techniques for liposuction. One hundred consecutive patients were treated with the tumescent technique as the sole means of anesthesia and the syringe technique as the sole means of performing liposuction. A modified tumescent formula is presented. A comparison of liposuction aspirates using this modified tumescent technique is compared and contrasted to liposuction aspirates obtained using the "dry technique" and the "wet technique." A historical review of the syringe technique and its perceived attributes is also presented. Technical descriptions of the tumescent infusion method, tumescent fluid formulation, and suggested patient sedation and monitoring is presented. Photographic documentation of patients who underwent the combined tumescent and syringe liposculpture treating various body areas is shown. A critical analysis of the limitations of this combined technique is also described noting added time requirements, difficulties with under-correction of deformities, and need for reoperation, methods for determining the "end-point" for the procedure, as well as addressing large-volume liposuction problems. The conclusion reached by this study is that combining the tumescent technique and the syringe technique is a logical partnership. Each method complements the other, allowing liposuction to be performed with considerable advantage over traditional methods. These advantages include eliminating the need for general anesthesia, lessening blood loss and postoperative bruising, greater accuracy, precision, and overall high patient satisfaction.

Adolescent↗
PubMed1988

A microbiological study of the contamination of the syringes used in anaesthesia practice.

In many operating theatres, it is common practice to reuse disposable plastic syringes with the same needles for several injections to different patients during the same day. This practice could lead to bacterial contamination of these syringes, making them an infection hazard to patients. We did a microbiologic survey of 100 of the most frequently reused syringes in our operating rooms and a control group of 100 single-use syringes. Only three of the syringes were contaminated in each group. None of the patients exposed to the syringes having a positive culture showed any sign of sepsis. Our data suggest that reusing plastic syringes is not associated with an increase in the incidence of bacterial contamination. However, contamination of the syringes by patients' blood, with the risk of cross-infections, remains a possibility and further studies are needed to evaluate this potential hazard.

Anesthesiology↗
PubMed2003

Performance of a device to minimise radiation dose to the hands during radioactive syringe calibration.

The preparation of syringes for routine applications in nuclear medicine, and in particular the calibration procedure, is associated with high radiation exposure to the hands. To reduce this radiation burden, our group developed a modified calibration procedure based on a device that we refer to as the ActivoFix, which allows syringes to be drawn up inside the dose calibrator. This study investigated the performance of the new device as compared to the usual procedure of syringe calibration with regard to the absorbed radiation dose to the hands (fingertips and middle finger bases), the precision of the calibration procedure and the time required to calibrate syringes. Fourteen experienced nuclear medicine technologists drew up syringes from an initial eluate of 8.2 GBq using the conventional technique and the new calibration procedure. All technologists had to calibrate syringes with 50 MBq, 250 MBq and 650 MBq. This sequence was repeated four times using the conventional technique and then the new procedure. The equivalent dose to the hands was measured with thermoluminescent dosimeters. The exact amount of radioactivity in the syringe and the time needed for the calibration procedure were also recorded. The reduction in equivalent dose using the new device compared with the routine procedure ranged from 8.3- to 19.6-fold (mean 14.3-fold) for the fingers of the dominant hand and from 13.6- to 40.3-fold (mean 27-fold) for those of the non-dominant hand (total mean 21.3-fold). For small volumes, time could be saved with the ActivoFix, whereas for greater volumes time was lost. The device produced less variability in calibrating doses at 250 MBq and 650 MBq. Following the ALARA principle, the new device can be recommended for syringe calibration in nuclear medicine because the use of the ActivoFix-based procedure reduces finger dose by an average factor of 21, improves the precision of calibration and reduces the filling time for small volumes.

Calibration↗
PubMedDate not supplied

Syringe calibration factors for the NPL Secondary Standard Radionuclide Calibrator for selected medical radionuclides.

Before a radiopharmaceutical is administered to a patient, its activity needs to be accurately assayed. This is normally done via a radionuclide calibrator, using a glass vial as the calibration device. The radionuclide is then transferred to a syringe and it is now becoming common practice to re-measure the syringe and use this value as the activity administered to the patient. Due to elemental composition and geometrical differences, etc. between the glass vial and the syringe, the calibration factors are different for the two containers and this can lead to an incorrect activity being given to the patient unless a correction is applied for these differences. To reduce the uncertainty on syringe measurements, syringe calibration factors and volume correction factors for the NPL Secondary Standard Radionuclide Calibrator have been derived by NPL for several medically important radionuclides. It was found that the differences between the calibration factors for the syringes and glass vials depend on the energies of the photon emissions from the decay of the radionuclides; the lower the energy, the greater the difference. As expected, large differences were observed for 125I (70%) and only small differences for 131I. However, for radionuclides such as 99mTc and 67Ga, differences of up to 30% have been observed. This work has shown the need for the use of specifically derived syringe calibration factors as well as highlighting the complexity of the problem with regard to syringe types, procurement, etc.

Calibration↗
PubMed2006

Clinical assessment of pain, tolerability, and preference of an autoinjection pen versus a prefilled syringe for patient self-administration of the fully human, monoclonal antibody adalimumab: the TOUCH trial.

BACKGROUND: Adalimumab is a therapeutic monoclonal antibody for SC administration by 2 single-use injection devices providing bioequivalent amounts of adalimumab: a ready-to-use, prefilled syringe and an integrated, disposable delivery system, the autoinjection Pen. Although pens have been shown to be preferred over syringes by patients requiring long-term SC administration of medications, there are no data on preference and pain in the use of biologics in patients with chronic inflammatory diseases. OBJECTIVE: The aim of this study was to assess injection-site pain, tolerability, and patient preference of 2 delivery systems of adalimumab. METHODS: Patients with rheumatoid arthritis were enrolled in a Phase II, multicenter, open-label, single-arm, sequential trial. Patients self-administered a standard dose of adalimumab 40 mg SC every other week at each of 3 monitored clinical visits: visit 1 (syringe), visits 2 and 3 (Pen). At each visit, patients rated their pain on an 11-point scale (0 = none to 10 = pain as bad as it could be) immediately after injection and 15-30 minutes after injection and provided their impressions of and preferences for each delivery system. Safety events were recorded throughout the study and 70 days after final study dose. RESULTS: Fifty-two patients were enrolled in the trial and completed all 3 visits (32 women, 20 men; mean [SD] age, 53.8 [12.1] years). Forty (76.9%) patients reported that the Pen was less painful than the syringe, 4 (7.7%) patients found the syringe to be less painful, and 8 (15.4%) patients had no preference. Patients had statistically significant reductions in injection-pain scores from visit 1 to visit 2 and from visit 1 to visit 3. No new safety signals or apparent differences regarding tolerability between the syringe and Pen were observed. In addition, 46 (88.5%) patients preferred the Pen, 3 (5.8%) preferred the syringe, and 3 (5.8%) had no preference. Overall, patients evaluated the Pen as easier to use (94.2%), more convenient (92.3%), requiring less time to inject (82.7%), and safer (88.5%). CONCLUSIONS: Patients experienced less pain self-administering adalimumab via the Pen and preferred it versus the syringe. Further, patients perceived the Pen to be easier to use and more convenient. Both delivery systems were generally well tolerated.

Adalimumab↗