RESUMO
STERIS and W.L. GORE collaborated on a case study testing the compatibility of a new prefilled syringe plunger design with VHP terminal sterilization. VHP chamber conditions require deep vacuum pulsing, which may represent challenges to prefilled syringe container integrity. The growing industry trend toward VHP sterilization is driven by the FDA search for alternative sterilization methods to EO and the recent publication of a VHP specific process standard. The purpose of the study is to test and report compatibility of the new 0.5 mL GORE IMPROJECT plunger, a silicone free syringe solution for ophthalmic application, with VHP sterilization. Various challenges have been reported when using conventional, siliconized, prefilled syringe systems for intravitreal injections such as subvisible particles, inflammation, silicone floaters, and intraocular pressure increases. The GORE plunger eliminates the need for silicone oil as a lubricant on the plunger and barrel, while meeting strict container closure and terminal sterilization requirements of ophthalmic applications. This case study presents successful results of deep vacuum VHP terminal sterilization process compatibility with the GORE plunger design and material composition. Test results include primary container integrity, stopper off-gassing/ingress, and visual inspection. Principles of VHP vacuum sterilization process, test cycle configuration, and its main parameters are presented.
Assuntos
Peróxido de Hidrogênio , Esterilização , Seringas , Esterilização/métodos , Seringas/normas , Peróxido de Hidrogênio/química , Desenho de Equipamento , Vácuo , Volatilização , Embalagem de Medicamentos/normas , Tecnologia Farmacêutica/métodos , Tecnologia Farmacêutica/instrumentação , Tecnologia Farmacêutica/normas , Óleos de Silicone/química , Injeções Intravítreas/instrumentaçãoRESUMO
In 2017, a severe shortage of infusion bags resulted in a paradigm change in medication administration practice from intermittent infusion to intravenous push. The Institute for Safe Medication Practices proposed safe practice guidelines for adult intravenous push medications. A different study showed that ready-to-administer medication prepared in the sterile area of a pharmacy reduces the risk of harm, nurses' time for medication administration and the cost of medications. Based on the recommendation of the Institute for Safe Medication Practices, we decided to conduct a pilot study on the implementation of sterile compounding and administration of intravenous push medication in adult patients admitted to the hospital. In the study, the stability of five intravenous push antibiotic syringes was also determined in the syringes.
Assuntos
Antibacterianos , Seringas , Centros de Atenção Terciária , Humanos , Seringas/normas , Antibacterianos/administração & dosagem , Antibacterianos/uso terapêutico , Centros de Atenção Terciária/organização & administração , Centros de Atenção Terciária/estatística & dados numéricos , Projetos Piloto , Adulto , Administração Intravenosa/métodos , Estabilidade de Medicamentos , Infusões Intravenosas/métodos , Infusões Intravenosas/instrumentação , Infusões Intravenosas/normasRESUMO
Some needleless Luer-activated valve connectors with internal pins are not compatible with certain prefilled glass syringes. The internal pin can block the glass syringe tip and prevent drug administration.Nurses should be aware of this risk and assist in evaluating the Luer-activated valve connectors used in their organization.
Assuntos
Equipamentos e Provisões , Seringas , Seringas/normas , Equipamentos e Provisões/normasRESUMO
The formation of particulates in post-manufacture biopharmaceuticals continues to be a major concern in medical treatment. This study was designed to evaluate the content of micro-sized particles using flow imaging of antibodies in intravenous infusion bags. Intravenous immunoglobulin (IVIG) and Avastin® were selected as model drugs and plastic syringes with and without silicone oil (SO) were used to transfer the drugs into the bags (0.9% saline or 5% dextrose). Antibodies exposed to SO had significantly increased levels of microparticles in both diluents, suggesting SO accelerates particle formation, especially at a higher antibody concentration. Even before the drop stress, their count exceeded the USP guideline. Dropping the bags in the presence of SO produced larger microparticles. Meanwhile, air bubbles were retained longer in saline suggesting more protein film formation on its air-water interface. Overall, both drugs were conformationally stable and produced less particles in dextrose than in saline.
Assuntos
Agregados Proteicos/imunologia , Óleos de Silicone/farmacologia , Seringas/normas , Biofarmácia/métodos , Química Farmacêutica/métodos , Composição de Medicamentos , Estabilidade de Medicamentos , Excipientes/farmacologia , Glucose/farmacologia , Imunoglobulinas Intravenosas/administração & dosagem , Imunoglobulinas Intravenosas/efeitos adversos , Fatores Imunológicos/administração & dosagem , Fatores Imunológicos/efeitos adversos , Infusões Intravenosas/efeitos adversos , Infusões Intravenosas/métodos , Uso Off-Label , Tamanho da Partícula , Solução Salina/farmacologiaRESUMO
Norepinephrine is a potent α-sympathomimetic drug which plays an important role in the acute treatment of hypotension and shock. Commercially available norepinephrine solutions contain sodium metabisulfite (Na2S2O5) as an antioxidant. However, prefilled cyclic olefin polymer syringes are not compatible with sodium metabisulfite. The aim of this study was to develop a new formulation of 0.1-mg/mL norepinephrine solution without sodium metabisulfite which is chemically stable and sterile and can be stored in prefilled polymer syringes. Formulation studies were performed with 0.1-mg/mL norepinephrine solution with 0, 0.05, or 0.1% ascorbic acid added as antioxidant. The syringes were filled under nitrogen gassing, stored at 20 ± 5°C, and protected from daylight. Based on the formulation test results, the final formulation was defined and stability testing at 20 ± 5°C was performed measuring norepinephrine concentration, pH, clarity, color of the solution, subvisible particles, and sterility at time intervals up to 12 months. The norepinephrine concentrations at t = 22 weeks were 100.4%, 95.4%, and 92.2% for the formulations with no ascorbic acid and with 0.05% and 0.10% ascorbic acid, respectively. Three batches for the stability study were produced containing norepinephrine, sodium edetate, sodium chloride, and water for injections filled under nitrogen gassing and stored at 20 ± 5°C. Norepinephrine concentrations were respectively 98.8%, 98.6%, and 99.3% for batches 1, 2, and 3 at t = 12 months. It can be concluded that norepinephrine (0.1 mg/mL) solution without metabisulfite is stable for at least 12 months at room temperature when protected from daylight.
Assuntos
Alcenos/química , Antioxidantes/química , Norepinefrina/química , Esterilização/métodos , Seringas , Alcenos/análise , Antioxidantes/análise , Estabilidade de Medicamentos , Armazenamento de Medicamentos/métodos , Armazenamento de Medicamentos/normas , Injeções , Norepinefrina/análise , Soluções Farmacêuticas/análise , Soluções Farmacêuticas/química , Seringas/normasRESUMO
BACKGROUND: Percutaneous vertebroplasty (PVP) has been demonstrated to be effective in the treatment of acute osteoporotic vertebral fracture (AOVF). However, bilateral puncture takes more time to accept more X-ray irradiation; some scholars apply unilateral puncture PVP, but the cement cannot be symmetrically distributed in the vertebral body, so we use a flexible cement injector that undergoes PVP through the unilateral pedicle puncture. This research aims to compare the clinical results of PVP for AOVF with unilateral pedicle puncture using a straight bone cement injector and a bendable cement injector, determine the value of a bendable cement injector. METHODS: We undertook a retrospective analysis of patients with thoracic and lumbar compression fracture treated with unilateral pedicle puncture percutaneous vertebroplasty from our institution from June 2013 to July 2015. Operation time, radiation exposure, bone cement injection amount, and the incidence of bone cement leakage were recorded on presentation, the cement leakage was measured by X-ray and computed tomography scan. The patients were followed up postoperatively and were assessed mainly with regard to clinical and radiological outcomes. RESULTS: There was no significant difference in the operation time, radiation exposure time and incidence of bone cement leakage between the two groups. There was significant difference in the amount of bone cement injection and the difference between the two groups. There were no significant differences in VAS and the relative height of the vertebral body and local Cobb angle and QUALEFFO between the two groups at 1 week after PVP, significant difference was observed only 12 months after operation. CONCLUSIONS: Application of flexible cement injector is safe and feasible, compared with the application of straight bone cement injector, without prolonging the operative time, radiation exposure time and the incidence of bone cement leakage; it has the advantages of good long-term effect and low incidence of vertebral fracture recurrence.
Assuntos
Cimentos Ósseos , Injeções Espinhais/métodos , Complicações Pós-Operatórias/epidemiologia , Seringas/efeitos adversos , Vertebroplastia/métodos , Idoso , Idoso de 80 Anos ou mais , Feminino , Fraturas por Compressão/cirurgia , Humanos , Injeções Espinhais/efeitos adversos , Injeções Espinhais/instrumentação , Vértebras Lombares/cirurgia , Masculino , Pessoa de Meia-Idade , Fraturas da Coluna Vertebral/cirurgia , Seringas/normas , Vértebras Torácicas/cirurgia , Vertebroplastia/efeitos adversos , Vertebroplastia/instrumentaçãoRESUMO
Prefilled syringes (PFS) are a container and delivery device of choice for storing and administering therapeutic protein products to patients. Addressing concerns and regulatory expectations related to the risk to biologic drug product quality and patient safety from PFS requires implementation of an extractable and leachable program based on understanding of materials, risk assessment, review of existing literature, and testing supported by a sound scientific foundation. Extractables and leachables data generated as part of a thorough and holistic program are presented for five PFS systems, including glass and plastic syringes filled with 12 biologic drug products encompassing the implementation of traditional and single-use biotechnology manufacturing processes. The comprehensive extractables and leachables data presented demonstrate and substantiate a holistic extractable and leachable program designed to ensure product quality and patient safety.
Assuntos
Produtos Biológicos/normas , Biotecnologia , Saúde Holística , Seringas/tendências , Produtos Biológicos/administração & dosagem , Cromatografia Líquida de Alta Pressão , Contaminação de Medicamentos , Sistemas de Liberação de Medicamentos , Embalagem de Medicamentos , Estabilidade de Medicamentos , Armazenamento de Medicamentos , Humanos , Espectrometria de Massas , Segurança do Paciente , Proteínas/administração & dosagem , Proteínas/uso terapêutico , Medição de Risco , Espectrofotometria Ultravioleta , Seringas/normasRESUMO
Introduction: Nefopam has been reported to be effective in postoperative pain control with an opioid-sparing effect, but the use of nefopam can lead to nausea and vomiting. To prevent these side effects, droperidol can be mixed with nefopam. In intensive care units, high concentrations of nefopam and droperidol in syringes can be used with a continuous flow. Objectives: The first objective of this work was to study the physicochemical stability of a nefopam solution 2.5 mg/mL diluted in NaCl 0.9% in polypropylene syringes immediately after preparation and after 6, 24 and 48 hours at room temperature. The second objective was to study the physicochemical stability of mixtures of nefopam 2.5 mg/mL and droperidol 52 µg/mL diluted in NaCl 0.9% in polypropylene syringes at room temperature over 48 hours. Materials and methods: Three syringes for each condition were prepared. For each time of analysis, three samples for each syringe were prepared and analysed by high performance liquid chromatography coupled to photodiode array detection. The method was validated according to the International Conference on Harmonisation Q2(R1). Physical stability was evaluated by visual and subvisual inspection (turbidimetry by UV spectrophotometry). pH values were measured at each time of analysis. Results: Solutions of nefopam at 2.5 mg/mL and the mixture of nefopam 2.5 mg/mL with droperidol 52 µg/mL, diluted in NaCl 0.9%, without protection from light, retained more than 90% of the initial concentration after 48 hours storage at 20-25°C. No modification in visual or subvisual evaluation and pH values were observed. Conclusion: Nefopam solutions at 2.5 mg/mL and the mixture of nefopam 2.5 mg/mL with droperidol 52 µg/mL diluted in NaCl 0.9% were stable over a period of 48 hours at room temperature. These stability data provide additional knowledge to assist intensive care services in daily practice.
Assuntos
Droperidol/química , Unidades de Terapia Intensiva/normas , Nefopam/química , Polipropilenos/química , Seringas/normas , Fenômenos Químicos , Cromatografia Líquida de Alta Pressão/métodos , Cromatografia Líquida de Alta Pressão/normas , Droperidol/análise , Humanos , Nefopam/análise , Soluções Farmacêuticas/análise , Soluções Farmacêuticas/química , Polipropilenos/análiseRESUMO
Objectives: Opioid-free anaesthesia is a treatment strategy of pain management based on the use of drugs such as lidocaine, ketamine and dexmedetomidine that do not interact significantly with opioid receptors. In particular, these drugs are used by anaesthesiologists to ensure adequate levels of analgesia during surgical procedures for burn patients such as daily wound dressings and graft surgeries. Furthermore, for hypothermia prevention and wound-healing purposes, ambient temperature must be kept high for these patients, usually between 27°C and 30°C. To facilitate the use of this technique, clinicians want to mix lidocaine and ketamine in the same syringe. No stability data is available to determine the feasibility of this admixture and at this temperature. The objective was to study the physicochemical stability of lidocaine 20 mg/mL with ketamine 2.5 mg/mL diluted with 0.9% sodium chloride (0.9% NaCl) stored at 28°C in polypropylene syringe for 48 hours. Methods: Physical stability was evaluated by visual examination and by measuring turbidity with a spectrophotometer. Chemical stability was determined after preparation and after 6, 24 and 48 hours of conservation with a high performance liquid chromatography and pH measurements. The method was validated according to International Conference on Harmonisation Q2(R1) guidelines. Results: Both lidocaine (99.98%±1.44%) and ketamine (100.70%±0.95%) retained more than 95% of their initial concentration after 48 hours storage. pH measurements remained stable over the course of the study (less than 0.21 point of variation). No signs of physical instability were observed after visual and subvisual inspections. Conclusions: The physicochemical stability of lidocaine 20 mg/mL and ketamine 2.5 mg/mL diluted with 0.9% NaCl in a polypropylene syringe stored at 28°C protected from light was demonstrated for 48 hours. This infusion technique is therefore feasible from a pharmaceutical point of view in burn-unit settings.
Assuntos
Anestesia/normas , Ketamina/química , Lidocaína/química , Polipropilenos/química , Polipropilenos/normas , Seringas/normas , Analgésicos/química , Analgésicos Opioides , Anestésicos Locais/química , Fenômenos Químicos , Cromatografia Líquida de Alta Pressão/métodos , Estabilidade de Medicamentos , Quimioterapia Combinada , HumanosAssuntos
Agonistas Adrenérgicos/administração & dosagem , Anafilaxia/tratamento farmacológico , Epinefrina/administração & dosagem , Segurança do Paciente/normas , Seringas/normas , Agonistas Adrenérgicos/uso terapêutico , Epinefrina/uso terapêutico , Humanos , Injeções Intramusculares , Educação de Pacientes como Assunto , Espanha , Fatores de TempoRESUMO
BACKGROUND/AIMS: To assess silicone oil (SO) release by different brands of syringes used for intravitreal injection under different handling conditions. METHODS: Eight syringes were analysed: from the USA, Terumo 0.5 mL, Becton-Dickinson (BD) Tuberculin 1 mL, BD Luer-lok 1 mL, BD Ultra-Fine 0.3 mL and Exel Insulin 0.3 mL; from Germany, Braun Omnifix-F 1 mL and Braun Injekt-F 1 mL and from Spain, BD Plastipak 1 mL. The impact of air, priming the plunger, agitation by flicking and fluid temperature on SO release were assessed by light microscopy. Fourier transform infrared spectroscopy (FTIR) was performed to identify the molecular compound in each syringe. RESULTS: Five hundred and sixty syringes were analysed. Terumo 0.5 mL and BD Ultra-Fine 0.3 mL released more SO than all others. BD Luer-lok 1 mL, BD Plastipak and Braun Omnifix-F 1 mL released little SO; BD Tuberculin 1 mL, Exel 0.3 mL and Braun Injekt-F 1 mL released the least SO. Priming the syringe and different temperatures did not significantly affect SO release. Agitation by flicking caused a significantly higher proportion of samples to have SO droplets and an increased number of oil droplets. Air had an additive effect on the release of oil in the agitation groups. FTIR identified polysiloxane in all syringes but Injekt-F. CONCLUSION: Syringes commonly used for intravitreal injections frequently release SO droplets, especially when agitated by flicking. To avoid unnecessary ocular risks, syringes should not be agitated before intravitreal injection. It is desirable that syringes be manufactured specifically for ophthalmic use.
Assuntos
Injeções Intravítreas/métodos , Óleos de Silicone/análise , Seringas/normas , Humanos , Modelos Logísticos , Uso Off-LabelRESUMO
BACKGROUND: Different international organizations recommend safety measures for the use of vincristine to prevent wrong route administrations. A central recommendation is to use infusion bags instead of syringes to prevent confusion with intrathecal chemotherapy. This study aimed to investigate the implementation of safety measures for vincristine and intrathecal chemotherapies in Switzerland. METHOD: We conducted a written survey among hospital pharmacies of all general care and pediatric hospitals in Switzerland (n = 102). A responsible person of each hospital pharmacy was invited by email to participate in the online survey in May 2018. RESULTS: Of 66 responding hospitals (response rate 65%), 27 have a hospital pharmacy preparing parenteral chemotherapy. All of these hospitals prepared vincristine in 2017, while 21 also prepared intrathecal chemotherapy. Of these 21, 16 hospitals prepared vincristine as syringes, with small volume syringes being the most widely distributed dosage form. A switch from syringes to infusion bags was discussed in seven hospitals, and discussions led to plans for switch in two. The most prevalent safety measures were labeling for vincristine and special delivery for intrathecal drugs. Of hospitals preparing both vincristine syringes and intrathecal chemotherapy, four reported to have no safety measures implemented neither for vincristine nor for intrathecal chemotherapy. CONCLUSION: International recommendations are not widely implemented in Swiss hospitals. Syringes are still in use and other safety measures are sparsely disseminated. Thus, Swiss vincristine patients are still at an increased risk for wrong route application. Recommendations have to be further disseminated and implementation could be enhanced.
Assuntos
Antineoplásicos Fitogênicos/administração & dosagem , Erros de Medicação/prevenção & controle , Serviço de Farmácia Hospitalar/normas , Inquéritos e Questionários , Vincristina/administração & dosagem , Antineoplásicos Fitogênicos/efeitos adversos , Vias de Administração de Medicamentos , Feminino , Humanos , Masculino , Serviço de Farmácia Hospitalar/métodos , Suíça/epidemiologia , Seringas/normas , Vincristina/efeitos adversosRESUMO
To ensure drug efficacy and patient safety, the importance of interaction between primary container and a biological drug product must not be ignored. The United States Food and Drug Administration guidance on development and manufacturing of combination products (e.g., the biologic and the primary container) encourages careful selection and stability testing of the drug and its performance in the marketed primary container. With various options available for primary container type (vials, prefilled syringes, and cartridges), material (e.g., glass or plastic), and lubricants/coatings, we designed a platform consisting of several bioanalytical methods that can simplify selection of a compatible primary container. We tested the stability of a commercially available monoclonal antibody (mAb) in 3 syringe types under 3 conditions: cold storage, high temperature, and agitation induced stress, respectively. Under each condition, dynamic fluid imaging was sensitive enough to differentiate mAb stability as measured by aggregate formation in different syringe systems, followed by size exclusion-high performance liquid chromatography and sodium dodecyl sulfate-polyacrylamide gel electrophoresis but only at high temperature. With this platform, we identified a primary container that provided higher mAb stability under cold storage as well as stress conditions. We recommend that such an approach should be applied early in drug development stage to identify a superior primary container system to maintain drug stability and quality.
Assuntos
Produtos Biológicos , Desenvolvimento de Medicamentos/métodos , Indústria Farmacêutica/métodos , Embalagem de Medicamentos/métodos , Seringas , Anticorpos Monoclonais/administração & dosagem , Produtos Biológicos/administração & dosagem , Produtos Biológicos/normas , Cromatografia em Gel/métodos , Cromatografia em Gel/normas , Desenvolvimento de Medicamentos/normas , Indústria Farmacêutica/normas , Embalagem de Medicamentos/normas , Humanos , Agregados Proteicos/fisiologia , Seringas/normasRESUMO
A model was developed that can be used to predict how hydrogen peroxide (H2O2) transfers into a liquid drug product that is exposed to vapor phase hydrogen peroxide (VPHP). This model accounts for fluid flow in both the gas and liquid phases as well as the diffusion and convection mechanisms of mass transfer using the first principles of engineering to predict the amount of H2O2 that will transfer from the gas to the liquid phase considering a given geometrical system and surrounding conditions. The model was used to investigate how much space is needed in a given container to eliminate convective mass transfer and to create a balance between mass transfer and the air/liquid interface for oxidation-sensitive products in cartridges or vials being filled in an isolator. Experimental results compared well with model predictions. A no-slip boundary condition between the gas and liquid phases was used for the model, which was especially important for the full syringes where convective mass transport predominated. This model may be used to evaluate isolator designs for filling oxidation-sensitive products utilizing the correlation between spiking studies and VPHP uptake to minimize the uptake studies required. It could also be used to inform the design of containers that would minimize the potential for VPHP uptake. For the geometry tested here, it was demonstrated that convection only occurs near the top few millimeters of the container. If the fill level is lower, as it would be for a syringe, the diffusion mechanism of transfer predominates and the rate of transfer of H2O2 is much slower. The balance between mass transfer by convection and diffusion should be a consideration in the design of the system to be filled.
Assuntos
Gases/análise , Peróxido de Hidrogênio/análise , Teste de Materiais/normas , Transição de Fase , Seringas/normas , Tecnologia Farmacêutica/normas , Teste de Materiais/métodos , Tecnologia Farmacêutica/métodosRESUMO
KIRO® Oncology (Kiro Grifols, Spain) is a robotic system for automated compounding of sterile injectable drugs including intravenous cytotoxic treatments. The present article describes the qualification procedure applied prior to production phases. Peristaltic pumps which ensure the reconstitution of drugs were tested with water and NaCl 0.9%. The performance of the robot (accuracy and precision) to prepare bags, syringes and elastomeric pumps was evaluated with three placebo solutions (aqueous, foaming and viscous) using gravimetric controls. Microbiological controls were also performed. The pumps met the requirements set for volumes ranging from 5 to 100 mL. A total of 274 preparations was compounded. For the bags, the filling accuracy was within the limit of ±10% from 1 to 48 mL with aqueous solution, from 0.6 to 48 mL with foaming solution and from 5 to 48 mL with viscous solution. For all syringes and elastomeric pumps, it was within the limit of ±10%. The precision was validated for all preparations, except for bags and syringes prepared with 0.6 and 0.25 mL, respectively. The samples of surfaces and air complied with ISO 5 class environment. Among the 24 gloves tests performed, two presented microbiological growth. All Media fill tests were validated. The qualification procedure led us to exclude injections of any active principle volume strictly lower than 1 mL. The microbiological contamination of operators' gloves remains a critical point. Our operators will be made aware of the issue during the training period.
Assuntos
Antineoplásicos/síntese química , Composição de Medicamentos/métodos , Contaminação de Medicamentos/prevenção & controle , Robótica/métodos , Seringas , Antineoplásicos/administração & dosagem , Composição de Medicamentos/instrumentação , Composição de Medicamentos/normas , Humanos , Infusões Intravenosas/normas , Injeções/normas , Robótica/instrumentação , Robótica/normas , Espanha , Seringas/microbiologia , Seringas/normasRESUMO
Individualized dosing is often required in pharmacotherapy, particularly for pediatric and geriatric patients and adjustment of drugs that demand dose adaptation. This study aimed to evaluate critical quality attributes (CQAs) of doses obtained by distinct approaches for achieving individual dosing. Approaches were evaluated as follows: subdivision of tablets by splitter and hand (haloperidol) and delivery by plastic dropper bottle (haloperidol), glass dropper bottle (clonazepam), dosing cup (sodium valproate), and dosing syringe (carbamazepine), including brand name, generic, and similar marketed products. Measuring devices were packaged with their respective product. Drug content uniformity was assessed to each substance according to pharmacopeial methods. Tablets subdivided by splitter had the poorest performance among all approaches, in which doses ranged around 60% of the labeled amount (Acceptance Value = 58.1 and RSD = 23.2%). The greatest performances were observed for the dosing syringe which fulfilled all the requirements for dose precision and for the glass dropper bottle. There were significant differences in dose delivery between manufacturers of the same medicine when measuring the same volume or number of drops. High drug content variability is extremely harmful to pharmacotherapy and may result in therapeutic failure or toxicity. It is crucial that measuring devices and scoring of tablets be checked for functionality and standardized for different manufacturers of the same medicine. Part of the approaches for achieving individual dosing did not meet the quality needs for drug content and uniformity. Yet, our findings show that more accurate and precise dosing can be accessed when using the dosing syringe and glass dropper bottle.
Assuntos
Anticonvulsivantes/administração & dosagem , Anticonvulsivantes/normas , Formas de Dosagem/normas , Sistemas de Liberação de Medicamentos/métodos , Controle de Qualidade , Seringas/normas , Administração Oral , Idoso , Criança , Relação Dose-Resposta a Droga , Humanos , ComprimidosRESUMO
OBJECTIVE: The objective of this review is to identify and map literature related to safe injection practices among anesthesia providers in developed nations. The mapped literature will be used to determine if there is sufficient literature available to pose specific questions that can be valuably addressed, through a future systematic review, to reduce the prevalence of unsafe injections. INTRODUCTION: A safe injection is one that does not harm the recipient, does not expose the healthcare worker to avoidable risk, and does not result in waste that is a danger to the community. The literature is replete with examples of disease outbreaks connected to unsafe injections via the misuse of syringes, needles and medications. Many such outbreaks involve unsafe injections by anesthesia providers. INCLUSION CRITERIA: This scoping review will consider any research article or policy document, including unpublished reports, that provides information related to safe injection practices by anesthesia providers in developed nations. METHODS: For studies published in English from 2000, the databases to be searched include Ovid MEDLINE, CINAHL and Google Scholar. The search for unpublished literature will include the websites of anesthesia organizations, the Centers for Disease Control and Prevention, and the National Institutes of Health. Results will be screened by two independent reviewers who will use a standardized tool to independently extract data from each included source. The results of the review will be presented as a map of the data extracted in a tabular form and in a narrative descriptive summary.