Objective: Use of ampicillin in outpatient parenteral antimicrobial therapy (OPAT) has historically been complicated by frequent dosing and limited stability. The purpose of this study was to evaluate stability of ampicillin using high-pressure liquid chromatography (HPLC) in an OPAT dosing model using continuous infusion at room temperature over 24 hours immediately following preparation compared with batches stored under refrigeration for 24 hours, 72 hours, and 7 days. Methods: An HPLC method was developed and validated as stability indicating using guidance in USP general Chapter <1225>. Four ampicillin batches were prepared for each experimental condition (immediate use and refrigerated storage for 24 hours, 72 hours, and 7 days). A pump was used to recirculate the solutions through medical-grade tubing for 24 hours. Triplicate 1-mL aliquots were removed from each batch at time 0, 4, 8, 12, and 24 hours and analyzed for ampicillin concentration. Results: Each batch was assayed for initial concentration (20.34-21.50 mg/mL), and percent recovery compared with that concentration thereafter. For the duration of infusion, the average recoveries were 96.4%, 95.8%, 94.6%, and 90.3% for immediate use, 24-hour storage, 72-hour storage, and 7-day storage, respectively. The recovery remained above 90% for all batches and time points, except for 7-day storage, which fell below 90% after 4 hours of circulation. Conclusion: Ampicillin can be prepared and stored in a refrigerator for up to 72 hours prior to continuously infusing at room temperature over 24 hours with less than a 10% loss of potency over the dosing period. This model supports twice weekly OPAT delivery of ampicillin.

Objective: Use of ampicillin in outpatient parenteral antimicrobial therapy (OPAT) has historically been complicated by frequent dosing and limited stability. The purpose of this study was to evaluate stability of ampicillin using high-pressure liquid chromatography (HPLC) in an OPAT dosing model using continuous infusion at room temperature over 24 hours immediately following preparation compared with batches stored under refrigeration for 24 hours, 72 hours, and 7 days. Methods: An HPLC method was developed and validated as stability indicating using guidance in USP general Chapter <1225>. Four ampicillin batches were prepared for each experimental condition (immediate use and refrigerated storage for 24 hours, 72 hours, and 7 days). A pump was used to recirculate the solutions through medical-grade tubing for 24 hours. Triplicate 1-mL aliquots were removed from each batch at time 0, 4, 8, 12, and 24 hours and analyzed for ampicillin concentration. Results: Each batch was assayed for initial concentration (20.34-21.50 mg/mL), and percent recovery compared with that concentration thereafter. For the duration of infusion, the average recoveries were 96.4%, 95.8%, 94.6%, and 90.3% for immediate use, 24-hour storage, 72-hour storage, and 7-day storage, respectively. The recovery remained above 90% for all batches and time points, except for 7-day storage, which fell below 90% after 4 hours of circulation. Conclusion: Ampicillin can be prepared and stored in a refrigerator for up to 72 hours prior to continuously infusing at room temperature over 24 hours with less than a 10% loss of potency over the dosing period. This model supports twice weekly OPAT delivery of ampicillin.

Thesis (Dr. P.H.)--University of Texas Health Science Center at Houston, School of Public Health, 1994. / Typescript. Includes bibliographical references (leaves 167-172).

Thesis (M.S.)--Brock University, 2009. / Includes bibliographical references (leaves 34-35).

A review of the literature on blood stream infections caused by contaminated intravenous infusates which are prepared in clinical care settings found that this common nursing procedure poses at times a significant and life-threatening risk to patients. The guidance and regulations surrounding the preparation of intravenous drugs in clinical care settings suggests that this procedure is extremely complex and poses many different potential hazards to patients. This thesis set out to determine how the infection risks are being addressed in practice by asking the questions: ‘What is the system of intravenous drug preparation in clinical care settings in NHS Scotland?’ and, ‘How does it work in practice?’ Several data sources were utilised: six locations, in specialities where the literature identified significant outbreaks had occurred, were examined for potential contamination risk. Observations (78) of infusate preparations were undertaken and, where available, written procedures were compared with observed practices. Finally, analyses were made of 71 questionnaires, completed by the nurses who prepare intravenous drugs, regarding their opinions of the procedures’ safety and when they perform redundancy checks. The conclusion of this study is that the system of preparing intravenous drugs in clinical care settings by nurses is, as a consequence of potential infusate contamination, error-prone and unreliable. The reasons for this conclusion are now detailed. o Due to a lack of mandatory environmental standards, and the provision of poor environments, there is a risk of infusate contamination from environmental sources and consequently, a risk to patients of infusate-related blood stream infections (IR-BSI). o Some in use equipment poses contamination risks to patients’ infusates. Equipment that could reduce the contamination risk is not always available and in some instances such safety-enhancing equipment has been removed. o There are no complete written procedures which mirror what is done in practice. At present, from a human-factors perspective, it is not easy for the nurse to do the right thing, or to be sure exactly what is the right thing to do. o The procedure, in practice, has the required elements of an aseptic procedure, but the execution of the procedure is more often not performed aseptically. o The procedure of intravenous drug preparation as observed is mainly an interrupted aseptic procedure and as such the recommencement of the aseptic procedure requires repeated hand hygiene. o The nurses’ opinions of safety vary, as did their assessment of the infection risk to their patients, but it is clear that intravenous drug preparation is not a much-loved nursing procedure and some nurses find it very stressful. o There is no asepsis quality control built into the system. Aseptic steps are the least likely to be performed as a redundancy check compared to the mandatory checks of ‘right patient, right drug and right dose’. o The information available to the nurses, from the drug companies, from the makers of equipment and from national agencies does not identify with sufficient clarity the infection risks, or detail how to negate them. Suggestions for improvement to the six procedures and environments are clear once the procedure steps are colour-coded as either aseptic or non-aseptic; validity testing of these improvements is however, still needed. The systems’ vulnerabilities observed in this research appear to stem from a chain of external influences including an underestimation of the problem size and the actions needed to prevent it in evidence-based guidelines and mandatory guidance. This leads to poor recognition of the risk of IR-BSI in clinical practice. The problem of infusate contamination causing IR-BSIs is further compounded by the fact that it is not caused by a single organism and does not always present as a disease in real time, that is, over the lifetime of the infusion. As a consequence, this presents surveillance difficulties in terms of definitions, data collection and analysis. Finally, although the diagnosis of a blood stream infection for an individual patient remains relatively easy, it is not easy to recognise a contaminated infusate as the origin of the problem. All these challenges make both the recognition of the problem and agreement on prevention strategies, extremely challenging. In summary, the main conclusion of this thesis is that the preparation of infusates in clinical care settings, which occurs approximately 3,000,000 times a year in NHSScotland, is from an aseptic perspective, error-prone and unreliable. Recommendations to optimise patient safety include, changing the procedure locally and, with the utmost urgency, the production of minimum environmental standards. The results of this study are relevant to all hospitals in Scotland and throughout the United Kingdom where the current regulations apply and similar procedures are performed.

Thesis (MNutr)--Stellenbosch University, 2013. / ENGLISH ABSTRACT: Objectives: The objectives of this study were to determine the nutritional content/ contribution of intravenous (IV) fluid and electrolyte administration on the total feeding prescription of intensive care unit (ICU) patients. Methods: Retrospective review of ICU charts of consecutive patients (>18 years) with APACHE II scores ≥10 and on ≥72 hours nutrition therapy (NT) admitted to a medical/surgical ICU. Total fluid, electrolyte, energy and macronutrient intake from nutritional and non-nutritional sources were reviewed from ICU admission until discharge, discontinuation of NT or death for ≤7 days. Energy and protein delivery were compared to calculated targets of 25.4 – 28.6kCal/kg and 1.3 – 1.5g/kg respectively. Summary statistics, correlation coefficients and appropriate analysis of variance were used to describe and analyse the data. Results: A total of 71 patients (49% male), average age 49.2 ± 17.1, average APACHE II score 21.0 ± 6.1, 68% medical and 32% surgical, were included. Fluid and nutrient intake were reviewed over a mean of 5.7 ± 1.1 days. Mean daily fluid delivery was 3.2 ± 0.6L. IV fluid therapy (IVFT) contributed 32.0 ± 12.0% to total fluid delivery (TFD), whereas IV drug administration, including fluids used for reconstitution and dilution purposes, contributed 20.7 ± 8.1% to TFD. Balanced electrolyte solutions (BES) were the crystalloid of choice, prescribed in 91.5% of patients with a mean daily volume (MDV) of 0.5 ± 0.4L. Hypertonic low molecular weight (LMW) 130/0.4kD hydroxyethyl starch (HES) was the colloid of choice, prescribed in 78.9% of patients with a MDV of 0.2 ± 0.1L. Potassium salts were the most frequently prescribed IV electrolyte supplement (IVES), prescribed in 91% of patients (±20 – 60mmol per administration). NT was initiated within 14.5 ± 14.1 hours. The majority (80%) received enteral nutrition (EN). The mean daily energy delivered was 1613 ± 380kCal (25.1kCal/kg), meeting 93.6 ± 17.7% of mean target range (MTR). Mean daily protein delivery (PD) was 72 ± 22g (1.1g/kg), meeting 82.8 ± 19.9% of MTR. Non-nutritional energy sources (NNES), mostly derived from carbohydrate-containing IV fluids, contributed 10.1 ± 7.5% to total energy delivered (156kCal/d). Mean cumulative energy and protein balance was -674.0 ± 1866.1kCal and -86.0 ± 106.9g respectively. The majority (73%) received >90% of the minimum energy target but only 49% >90% of minimum protein target; 59% of those with energy intake 90-110% of target had adequate protein intake. A significant negative correlation was found between cumulative energy/protein balance and the time to initiation of NT (energy: r=-0.28, p=0.02; protein: r=-0.32, p=0.01). Conclusion: In this ICU BES are the crystalloid of choice and hypertonic LMW 130/0.4kD HES the colloid of choice for IVFT. Potassium salts are the most frequently prescribed IVES. NNES added significantly to energy delivery and should be included in the calculation of feeding prescriptions to avoid the harmful effects of overfeeding. Early initiation of EN with conventional products which are energy rich is insufficient to achieve adequate PD. EN formulae with a more favorable nitrogen to non-protein energy ratio could help to optimise PD during the first week of ICU care. / AFRIKAANSE OPSOMMING: Doelwitte: Die doelwit van hierdie studie was om die voedingswaarde/ bydrae van intraveneuse (IV) vog en elektroliet toediening tot die totale voedings voorskrif van pasiënte in ‘n intensiewe sorg eenheid (ISE) te bepaal. Metodes: Retrospektiewe bestudering van die ISE kaarte van agtereenvolgende pasiënte (>18 jaar) opgeneem in ‘n mediese/chirurgie ISE en met APACHE II tellings ≥10 en ≥72 ure voedingsterapie (VT). Totale vog, elektroliet, energie en makronutriënt inname vanaf voedingsverwante en nie-voedingsverwante bronne is vanaf ISE opname tot en met ontslag, staking van VT of sterfte, vir ≤7 dae hersien. Energie en proteiën inname is vergelyk met berekende doelwitte van 25.4 – 28.6kKal/kg en 1.3 – 1.5g/kg onderskeidelik. Beskrywende statisitiek, korrelasie koeffisiënte en toepaslike analises van variansie is gebruik vir data analise. Resultate: 71 pasiënte (49% mans), gemiddelde ouderdom 49.2 ± 17.1, gemiddelde APACHE II telling 21.0 ± 6.1, 68% medies en 32% chirurgie, is ingesluit. Vog en voedingstof inname is hersien oor ‘n gemiddelde tydperk van 5.7 ± 1.1 dae. Gemiddelde vog inname was 3.2 ± 0.6L/dag. IV vog terapie (IVVT) het 32.0 ± 12.0% bygedra tot totale vog inname (TVI). IV medikasie toediening, insluitende die herkonstruksie en verwatering van medikasie, het 20.7 ± 8.1% bygedra tot TVI. Die mees voorgeskrewe kristalloiëd en kolloiëd vir IVVT was gebalanseerde elektroliet oplossings (GEO), voorgeskryf in 91.5% van pasiënte (gemiddeld 0.5 ± 0.4L/dag), en hipertoniese lae molekulêre gewig (LMG) 130/0.4kD hidroksie-etiel stysel (HES), voorgeskryf in 78.9% van pasiënte (gemiddeld 0.2 ± 0.1L/dag), onderskeidelik. Die mees voorgeskrewe IV elektroliet supplement was kalium soute, voorgeskryf in 91% van pasiënte (±20 – 60 mmol per toediening). VT is binne 14.5 ± 14.1 ure geinisieër. Die meerderheid (80%) het enterale voeding (EV) ontvang. Die gemiddelde daaglikse energie inname van 1613 ± 380kCal (25.1kKal/kg) het 93.6 ± 17.7% van die gemiddelde doelwit rykwydte (GDR) bereik. Die gemiddelde daaglikse proteiën inname van 72 ± 22g (1.1g/kg) het 82.8 ± 19.9% van die GDR bereik. Nie voedings-verwante energie bronne (NVEB), meestal vanaf koolhidraat-bevattende IV vloeistowwe, het 10.1 ± 7.5% tot totale energie inname (TEI) bygedra (156kKal/d). Die gemiddelde kumulatiewe energie en proteiën balans was -674.0 ± 1866.1kKal en -86.0 ± 106.9g onderskeidelik. Die meerderheid (73%) het >90% van die minimum energie doelwit (ED) bereik. Slegs 49% het >90% van die minimum proteiën doelwit (PD) bereik. Opsomming: Die kristalloiëd en kolloiëd van keuse vir IVT is GEO en hipertoniese LMG 130/0.4kD HES onderskeidelik. Kalium soute word mees algemeen voorgeskryf. NVEB dra beduidend by tot TEI en moet inaggeneem word tydens die berekening van voedingsvoorskrifte ten einde oorvoeding te voorkom. Vroeë inisiëring van EV met konvensionele energie-ryke EV produkte is onvoldoende om genoegsame proteiën inname te verseker. EV produkte met ‘n gunstiger stikstof tot nie-proteiën energie verhouding sal help om proteiën inname gedurende die eerste week van intensiewe sorg te optimaliseer.Slegs 59% van pasiënte met genoegsame energie inname (90-110% van ED) het hul minimum PD bereik. Daar was ‘n beduidende negatiewe korrelasie tussen kumulatiewe energie/proteiën balans en die tyd tot inisiëring van VT (energie: r=-0.28, p=0.02; proteiën: r=-0.32, p= 0.01).

Submitted by Anderson Silva (avargas@icict.fiocruz.br) on 2012-09-27T17:08:04Z No. of bitstreams: 1 debora_h_g_paula_ipec_pesquisaclinicadi_0007_2010.pdf: 1005728 bytes, checksum: b98fa20a9a16f91bb1e9a163dcd87107 (MD5) / Made available in DSpace on 2012-09-27T17:08:04Z (GMT). No. of bitstreams: 1 debora_h_g_paula_ipec_pesquisaclinicadi_0007_2010.pdf: 1005728 bytes, checksum: b98fa20a9a16f91bb1e9a163dcd87107 (MD5) Previous issue date: 2010 / Instituto Nacional de Cardiologia. Rio de Janeiro, RJ, Brasil / Eventos Adversos (EAs) são complicações indesejadas que podem decorrer durante os cuidados prestados ao paciente, não atribuídas à evolução natural da doença de base, podendo resultar em seqüela, prolongando a permanência no hospital ou mesmo levar ao óbito. A utilização do acesso intravenoso no tratamento medicamentoso da endocardite infecciosa (EI) pode trazer EAs ao paciente, com riscos de desfechos desfavoráveis. O objetivo deste estudo é identificar os EAs infecciosos e não infecciosos relacionados à utilização do acesso intravenoso no tratamento da EI no Instituto Nacional de Cardiologia (INC) nos anos de 2009 e 2010. Trata-se de estudo observacional, analítico, e prospectivo, a partir do diagnóstico possível e definitivo para EI, pelos critérios de Duke modificados, através do preenchimento de instrumentos de coleta de dados adaptados de outros estudos primários [International Collaboration on Endocarditis (ICE) e de um estudo piloto de terapia intravenosa (INC)] dos acessos intravenosos [periférico, profundo, hemodiálise, e catéter central de inserção periférica (PICC)]. Foram incluídos 37 episódios de EI, que ocorreram em 35 pacientes. A idade média foi 44,32 ± 15,32 anos; sendo 22 (63%) pacientes do sexo masculino e 13 (37%) do sexo feminino. A amostra estudada totalizou 253 acessos intravenosos sendo 148 acessos periféricos, 85 acessos intravenosos (21 de hemodiálise) profundos de curta permanência não tunelizado (CVP), e 20 cateteres centrais de inserção periférica (PICC). “Hiperemia” e “infiltração” foram os eventos mais frequentes nos acessos periféricos; “febre” foi o evento mais frequente nos acessos profundos; “obstrução” e “exteriorização” mais frequente no PICC. A análise estatística relacionando os EAs com cada tipo de acesso intravenoso mostrou significância estatística para febre (p<0,005), bacteremia (p<0,05), saída acidental e exteriorização (p<0,001), e obstrução (p<0,001). Com relação ao tempo de permanência dos cateteres, o número de cateteres-dia foi 360 para periféricos, 1156 para CVP e 420 para PICC. A construção de curvas de Kaplan Meyer para CVP e PICC mostrou diferença estatística para obstrução (p<0,001) e manuseio (saída acidental, mais exteriorização mais obstrução, p<0,001), sendo estes eventos mais comuns na PICC. Houve mais bacteremias no CVP, mas sem diferença estatística (p=0,23). Observa-se que os eventos descritos decorrem do manuseio inadequado e de possíveis falhas nas técnicas assépticas. Deste modo, é necessário implementação mais rigorosa de medidas efetivas de controle de infecções relacionadas a acessos e ações educativas para evitar complicações mecânicas. / Adverse events (AEs) are undesirable complications that may occur during patient care that cannot be attributed to the natural history of the underlying disease. They may result in incapacity, lengthening of hospital stay or even death. The use of intravenous access in the medical treatment of infective Endocarditis (IE) may result in AE to the patient, with unfavorable outcomes. The goal of the present study was to identify the infectious and non-infectious AEs related to the use of intravenous access sites for IE treatment at national Institute of Cardiology (INC) in the years from 2009 to 2010. This is an observational, analytic and prospective study based on cases of IE diagnosed as possible or definite by the modified Duke criteria. A case report form was created for data collection on intravenous lines (peripheral, central vascular, haemodyalisis and peripherally inserted central catheter/ PICC), based on data collection forms from other primary studies[International Collaboration on Endocarditis (ICE), and a pilot study on intravenous therapy (INC)].Thirty-seven episodes of IE in 35 patients were studied. Patients’ mean age was 44.32 ± 15.2 years; 22 patients (63%) were male, and 13 (37%) female. A total of 253 vascular catheters were studied, 148 were peripheral catheters, 85 were short term, non tunneled central venous catheters (21 of which were for haemodyalisis) and 20 were PICC. “Erythema” and “infiltration” were the most frequently observed AEs in the peripheral catheters, while “fever” was the most frequent AEs for CVPs, and “obstruction”, and “externalization” were more frequent in PICCs. Statistical analysis relating AEs with venous catheters type showed significance for fever (p<0.005), bacteraemia (p<0.05), accidental extrusion and externalization (p<0.001), and obstruction (p<0.001). As to the time catheters remained, the number of catheter-days was 360 for peripheral catheters, 1,156 for CVP and 420 for PICC. Kaplan Meyer curves for CVP and PICC showed statistical difference for obstruction (p<0.001) and “manipulation” (accidental extrusion, externalization, and obstruction, p<0.001), and these events were more common in PICC. More bacteraemia occurred in CVP, but this was of no statistical significance (p=0.23). The described adverse events resulted from inadequate handling and breakdown in aseptic techniques. Therefore, it is important that stricter implementation of infection control measures to prevent catheter related infections and educational measures to minimize mechanical complications are implemented.

Submitted in fulfillment of the requirements for the Degree of Master of Health Sciences in Radiography, Durban University of Technology, 2017. / Background The current scope of practice for diagnostic radiographers, does not allow them to administer intravenous contrast media (IVCM) since there are no formal training guidelines accredited by the Health Professions Council of South Africa (HPCSA) (Koch 2014: 26). In selected countries abroad, radiographers are allowed to administer IVCM and have thus received the necessary and accredited training to do so. In view of this, the South African radiographer’s scope of practice is not on par with the selected countries. The radiologists in South Africa (SA) who are currently responsible for the administration of IVCM have issued a position statement which supports, in principle, the idea of radiographers administering IVCM should they receive the necessary and appropriate training to do so (RSSA 2011: 1-2). The aim of this research study was, therefore, to investigate the radiologists’ perspectives regarding the theoretical knowledge, clinical competencies and medico legal responsibilities required by radiographers in order to effectively administer IVCM. This research study provides input for the development of national training guidelines for radiographers to administer IVCM. Research Methodology A quantitative, descriptive study was conducted by targeting qualified radiologists residing and practicing within the province of KwaZulu Natal (KZN). Ethical approval was obtained from the Durban University of Technology’s (DUT) Institutional Research and Ethics Committee (IREC). All the participants were contacted in their personal capacity. The research tool was an online survey administered through SurveyMonkey which included questions and statements relating to the administration of IVCM and was structured so as to meet the study objectives. The research tool was evaluated and amended by an expert focus group to ensure reliability and validity. Confidentiality was maintained and all the data obtained during this research study was password protected. Results and discussion Fifty-nine radiologists (60.8 percent) participated in this study. Twelve respondents, however, were excluded due to incomplete surveys. The final response rate, therefore, was 48.5 percent (n=47) of which 72.3 percent of the respondents were from the private sector. Results illustrated the radiologists’ agreement regarding the theoretical, clinical/practical and medico legal training components for inclusion in the further training of radiographers to administer IVCM. Most respondents supported the inclusion of three assessments: theoretical (87.2 percent), clinical (93.6 percent) and a record of clinical competencies (95.7 percent). The assessments were considered equally important in terms of percentage weighting. The overall results compared favorably to the current international trends and practice standards of radiographers administering IVCM. Conclusion and Recommendations The study, in providing key data for the development of training guidelines for radiographers to administer IVCM, has demonstrated the importance of higher education (HE) and training in addressing transformation in health services with particular reference to professional scopes of practice. Furthermore, it reinforces the need for local research that will inform HE and training and hence a scope of practice that meets local needs. It was recommended that future studies should include those HE institutions offering training in Radiography as well as their stakeholders for the design and transformation of a national curriculum for radiographers to administer IVCM. / M

MCur / Department of Advanced Nursing Science / See the attached abstract below