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A research report submitted to faculty of health sciences in partial fulfillment of the requirement for the degree of Master of Science in Epidemiology in the field of implementation science University of the Witwatersrand, Johannesburg. November, 2017. / Background There is a dearth of information about how well this intervention is conducted in communities (implementation fidelity) as fidelity data are not included in routine program data. Therefore, this study measured the implementation fidelity of mass drug administration for onchocerciasis, lymphatic filariasis, and soil transmitted helminthiasis control, described factors affecting it, and determined the relationship between identified factors and implementation fidelity. Methodology A cross sectional survey was conducted in Nassarawa and Gezawa local government areas of Kano State, Nigeria, where a total 348 community directed distributors were interviewed. Scores were calculated by linearly combining responses obtained using Likert scales. Mean and median of implementation fidelity score were computed. Also, the mean of key determinants were calculated. Adjusted and unadjusted general linear regression models were then fitted to determine the relationship between implementation fidelity and identified determinants. Results The mean(SD) implementation fidelity score was 55.39(8.10) and median(IQR) was 56(60 - 49). Minimum implementation fidelity score obtained was 36 and maximum score was 72. The mean(SD) quality of delivery score, intervention complexity score, facilitation strategy score and participant responsiveness score were 16.77(2.74), 11.03(3.04), 8.83(0.99) and 4.62(0.52) respectively. Evidence of association between some factors and implementation fidelity score were found at p < 0.05. They include: intervention complexity (Adj Coef: -0.62(-0.93 to -0.30), iv facilitation strategies (Adj Coef:-1.68(-3.05 to -0.32), participants responsiveness (Adj Coef: 2.99(1.58 to 4.39), knowledge of NTD (Adj Coef: 0.75(0.36 to 1.13), CDD selection by local government staff (Adj Coef: 7.48(2.85 to 12.11), CDD who volunteered (Adj Coef: 8.38(4.59 to 12.16) CDD with formal training in a health-related field (Adj Coef: 7.34(2.61 to 12.07), and CDD participation in other public health activities (Adj Coef: -6.16(-9.49 to -2.83). Conclusion This study demonstrated the feasibility of measuring implementation fidelity of mass drug administration. In addition, key determinants such as intervention complexity and participant responsiveness were found to be important factors affecting implementation fidelity and could be the target of future implementation strategies. / LG2018

Thesis (Dr.P.H.)--Boston University / The recently classified neglected tropical diseases (NTD), -- onchocerciasis, lymphatic filariasis, schistosomiasis, and soil-transmitted helminthiasis -- are all coendemic in Nigeria. The World Health Organization recommended strategy for addressing these diseases is preventive chemotherapy through annual mass drug administration (MDA) with ivermectin, albendazole, and praziquantel. Integrated delivery of these medicines has become the de facto strategy advocated for in the literature as a means of reducing costs through shared resources. Little empirical evidence, however, exists to support this. This paper explores these diseases and the concept of integration in the context of the global strategies for their control. A literature review was conducted using PubMed to identify articles published containing any of the disease names and costs. Of the 2,028 articles returned, only 14 published between 1998 and 2011 met the criteria for review. All costs were adjusted for inflation. Overall, the mean cost of MDA by any means was 0.83 cents. No data comparing separate MDA to integrated MDA were found. To examine this, a model was created comparing MDA programs with similar distribution strategies and targeting similar diseases. Data from separate articles presenting stand alone MDA were combined to give a mean cost of 0.42 cents to deliver two medicines in two rounds. This was compared with articles showing integrated MDA, which gave a mean cost of 0.25 cents to deliver two medicines in a single round. This suggests a cost savings of 40 percent. To verify this, data from a NTD program in Nigeria that transitioned to integrated MDA was examined in detail. In 2008, eight districts received a single round of ivermectin with albendazole followed at least 1 week later by a single round of praziquantel to school-aged children. The following year, a single round of all three drugs was co-administered. The number of treated individuals was essentially unchanged during both years (1,301,864 in 2008 and 1,297,509 in 2009). The total programmatic costs for the MDA, not including drug and overhead costs, reduced by 41% from $123,624 to $72,870, similar to savings seen in the literature review. Cost savings were attributed largely to transportation and personnel costs. Integrated delivery of medicines is recommended for mature programs targeting these diseases.

No / Discussions between the children's services manager at an National Health Service trust, and a children's nursing lecturer from the trust's partnering university clarified that there was a need to establish a greater understanding of the local circumstances surrounding adverse events in drug administration - particularly when those events involved nurses. Indeed it is claimed that nurses spend up to 40% of their time administering drugs. It was agreed that a collaborative research study, specifically designed to explore the nature of drug administration errors, could inform future trust policies and procedures around both drug administration and error, as well as the various university curricula concerning drug administration. This study, supported by senior management in the trust, and the chair of the local research ethics committee, has commenced. The first part of this study -- an introductory literature review, is presented here. The work of O'Shea [J Clin Nurs (1999)8:496-504] is significant in structuring the review that bears a number of recurring themes. It is not the intention of this literature review to reappraise O'Shea's original critique but to expand on her work, offer a contemporaneous perspective in the light of studies and reports published since 1999, and reset the topic in the context of clinical governance. This literature review has already provided an underpinning framework for a pilot questionnaire to staff who have been involved in drug administration errors and is also the basis for curricular input to preregistration students on the subject of risk management and drug administration. In conclusion, several recommendations about the shape of future research are offered.

Class of 2010 Abstract / OBJECTIVES: The objective was to compare differences in weight loss data presented in published orlistat studies on orlistat to their corresponding studies submitted to the FDA. METHODS: This meta-­‐analysis compared one-­‐year weight loss data reported in six published orlistat 120 mg studies to data reviewed by the FDA in the New Drug Application (NDA). The primary dependent variables were the percentage of subjects achieving 5% and 10% weight loss. Prior to analysis, weight loss data was stratified into placebo and orlistat groups. Potential for bias was assessed with a funnel plot and by calculating Kendall’s tau. The a priori alpha level was 0.05. RESULTS: Corresponding FDA reviews were located for 6 published orlistat trials. The pooled odds ratio of published vs. FDA 5%weight loss data for the placebo arm was 2.18 (95% CI: 1.83 to 2.60; p < 0.001) and 1.95 (95% CI: 1.70 to 2.24; p < 0.001) for the orlistat arm. The pooled odds ratio of published vs. FDA for 10% weight loss data for the placebo arm was 2.25 (95% CI: 1.74 to 2.91; p < 0.001) and 2.20 (95% CI: 1.88 to 2.57; p < 0.001) for the orlistat arm. The p-­‐values for Kendall’s tau for the 5% and 10% weight loss data were 0.054 and 0.34, respectively. CONCLUSIONS: Published orlistat trials presented 5% and 10% weight loss data that were twice of that reported in the FDA-­‐reviewed trials, and there was potential for bias in the 5% weight loss data.

<p>Läkemedelshanteringen är ett av sjuksköterskans ansvarsområden inom hälso- och sjukvården. Utifrån kunskap och lagar skall den bedrivas på ett patientsäkert sätt men trots det sker läkemedelshanteringsfel vilket innebär risker i patientsäkerheten.</p><p>Syftet med studien var att beskriva faktorer som påverkar säkerheten i samband med sjuksköterskans läkemedelshantering. Studien genomfördes som en litteraturstudie. Resultatet visade att vanliga läkemedelshanteringsfel är utebliven dos, fel administreringstid, fel dos, fel administreringssätt, fel läkemedel och läkemedel till fel patient. Faktorer som påverkar sjuksköterskans läkemedelshantering är felaktiga och dåligt skrivna läkemedelsordinationer, distraktion under läkemedelshanteringen, bristande rutiner samt införande av ny teknologi. Sjuksköterskor upplever mer problem kring läkemedelsordinationer än läkarna. Annan vårdpersonal stod för den största orsaken till sjuksköterskans distraktion men vid införande av ett säkerhetssystem från flygindustrin reducerades distraktionen. Att följa rätt patient, rätt läkemedel, rätt dos, rätt administreringssätt och rätt tid (5 R) är en bra rutin för att läkemedelshanteringen kan bli säkrare. För att göra läkemedelshanteringen säkrare införs ny teknologi som datoriserade läkemedelsordinationer och då är rätt utbildning viktig för att det ska bli ett säkert hjälpmedel. Vidare forskning och utveckling bör bedrivas på sjukhusen i Sverige samt inom den teknologiska industrin med hjälp av sjuksköterskan för att utveckla säkrare läkemedelshantering och hjälpmedel till dem.</p><p>A central part of nursing is the drug administration. This administration is to be carried out in a manner which is conducive to patient safety. This science is the product both of knowledge and of legal provisions, yet errors still occur within the drug administration that create considerable risk for patient safety. </p><p>The purpose of this literary study has been to indicate factors that affect the safety of nurses’ drug administration. The results indicate that common errors in medicines administration are the result of the following: missed dosage, dosage at wrong time, wrong dosage, wrong method of administration, wrong medicine and giving medicine to the wrong patient. Factors contributing to these errors include erroneous or poorly written ordination, distraction during drug administration, poor routines as well as the introduction of new technology. Nurses’ consider the problems relating to ordination as being greater than doctors generally perceive them to be. Other healthcare personnel are seen to contribute to nurses’ distraction and this was greatly reduced in cases where security routines were adapted from the airline industry. The routine of right patient, right drug, right dosage, right administration and right time (5 R) is effective in creating greater safety in the drug administration. New technology is used to this end, computers being used, for example, for writing ordinations. In order for these methods truly to contribute to safety it is important that appropriate training is provided. In order to develop safer drug administration together with necessary tools and facilities it is recommended that more research is carried out, with the assistance of nurses, in hospitals here in Sweden as well as within the technology industries.</p>

Läkemedelshanteringen är ett av sjuksköterskans ansvarsområden inom hälso- och sjukvården. Utifrån kunskap och lagar skall den bedrivas på ett patientsäkert sätt men trots det sker läkemedelshanteringsfel vilket innebär risker i patientsäkerheten. Syftet med studien var att beskriva faktorer som påverkar säkerheten i samband med sjuksköterskans läkemedelshantering. Studien genomfördes som en litteraturstudie. Resultatet visade att vanliga läkemedelshanteringsfel är utebliven dos, fel administreringstid, fel dos, fel administreringssätt, fel läkemedel och läkemedel till fel patient. Faktorer som påverkar sjuksköterskans läkemedelshantering är felaktiga och dåligt skrivna läkemedelsordinationer, distraktion under läkemedelshanteringen, bristande rutiner samt införande av ny teknologi. Sjuksköterskor upplever mer problem kring läkemedelsordinationer än läkarna. Annan vårdpersonal stod för den största orsaken till sjuksköterskans distraktion men vid införande av ett säkerhetssystem från flygindustrin reducerades distraktionen. Att följa rätt patient, rätt läkemedel, rätt dos, rätt administreringssätt och rätt tid (5 R) är en bra rutin för att läkemedelshanteringen kan bli säkrare. För att göra läkemedelshanteringen säkrare införs ny teknologi som datoriserade läkemedelsordinationer och då är rätt utbildning viktig för att det ska bli ett säkert hjälpmedel. Vidare forskning och utveckling bör bedrivas på sjukhusen i Sverige samt inom den teknologiska industrin med hjälp av sjuksköterskan för att utveckla säkrare läkemedelshantering och hjälpmedel till dem. A central part of nursing is the drug administration. This administration is to be carried out in a manner which is conducive to patient safety. This science is the product both of knowledge and of legal provisions, yet errors still occur within the drug administration that create considerable risk for patient safety. The purpose of this literary study has been to indicate factors that affect the safety of nurses’ drug administration. The results indicate that common errors in medicines administration are the result of the following: missed dosage, dosage at wrong time, wrong dosage, wrong method of administration, wrong medicine and giving medicine to the wrong patient. Factors contributing to these errors include erroneous or poorly written ordination, distraction during drug administration, poor routines as well as the introduction of new technology. Nurses’ consider the problems relating to ordination as being greater than doctors generally perceive them to be. Other healthcare personnel are seen to contribute to nurses’ distraction and this was greatly reduced in cases where security routines were adapted from the airline industry. The routine of right patient, right drug, right dosage, right administration and right time (5 R) is effective in creating greater safety in the drug administration. New technology is used to this end, computers being used, for example, for writing ordinations. In order for these methods truly to contribute to safety it is important that appropriate training is provided. In order to develop safer drug administration together with necessary tools and facilities it is recommended that more research is carried out, with the assistance of nurses, in hospitals here in Sweden as well as within the technology industries.

Background: Drug administration is a main duty of a nurse’s clinical role. It involves great risk in patients’ lives and can potentially cause great harm. Despite many safeguards, preventable medication errors still occur. The aim of this descriptive quantitative study is to explore geriatric nurses’ perceptions of medication errors, perceived causes and their reporting behaviours. Methods: A self- report standardized survey was used to collect data from a purpose sample of nurses (n=17) working on geriatric wards at the Montfort hospital located in the province of Ontario. Data entry and analysis were done by using Statistical Package for the Social Sciences (SPSS) version 12 and presented using frequencies, number and percentage. Results: The most frequently identified causes of medication errors were failure to check patient’s name band with the patient’s medication administration record (MAR), nurses' tiredness, illegible physician handwriting, and nurses’ miscalculations of medication doses. In general, nurses were usually sure of constitutes a medication error and when to report it. However, only 30% of errors were perceived by nurses to be reported to the nurse manager. More than half (64.7%) of participants perceived that, some errors are not reported because nurses are afraid of the reaction they will receive from the nurse manager and the majority of them will notify the physician than to complete an incident report. Conclusion: Recognizing a medication error is the first step to reduce report and eliminate them, especially in acute care settings. Finding suggests that nurses need more educational reenforcement as to various issues related to medication errors, particularly defining and reporting these errors. Furthermore, the introduction of hospital policies and the development of structured protocols on drug administration may decrease medication errors. The hospital administration system needs to stress the importance of reporting errors and adopt a non-punitive approach to safeguard patient safety.

Drug development in the United States has undergone many changes in the past 25 years, but relatively few fully realize the complexities involved in developing a new drug. Once a promising compound is identified, it must undergo preclinical testing, have an Investigational New Drug Application filed with the U.S. Food and Drug Administration (FDA), and proceed through clinical testing. When sufficient information is gained, a marketing application is filed with the FDA, who identifies it as a New Drug Application for drugs or a Biologics License Application for biologics. After FDA review and approval, postmarketing studies are frequently performed. The FDA and Congress have undertaken several initiatives to expand access and to accelerate drug development and review of investigational drugs for life-threatening and/or serious illnesses. Although the ultimate goal is to bring safer and more effective medical products to patients in a timely manner, multiple challenges face those who participate in drug development.

Syfte: Syftet med studien var att beskriva vilka faktorer som kan orsaka risk för fel i samband med sjuksköterskans läkemedelshantering samt vad sjuksköterskan kan göra för att förebygga att fel uppstår inom den somatiska slutenvården. Syftet var också att granska artiklarnas kvalité utifrån urval och bortfall. Metod: En beskrivande litteraturstudie som baseras på 13 vetenskapliga artiklar med både kvalitativ och kvantitativ ansats. Litteratursökningen genomfördes i databaserna PubMed, Cinahl och Academic Search Elite. Resultat: Faktorer som orsakade att sjuksköterskan begick fel i läkemedelshanteringen var hög arbetsbelastning, bristande kunskaper inom farmakologi, mindre erfarenhet av sjuksköterskeyrket och avbrott i arbetet. Förebyggande åtgärder för att minimera risken att ett fel uppstod i samband med läkemedelshanteringen var att sjuksköterskan ökade sina kunskaper i farmakologi, bidrog till förbättrad arbetsmiljö och kommunikation med annan vårdpersonal samt var nogrannare vid kontroller. Slutsats: Flera förekommande faktorer som orsakade fel i samband med sjuksköterskans läkemedelshantering som hög arbetsbelastning och bristande kunskaper inom farmakologi borde inte vara svåra att förebygga. Det stora förebyggande arbetet bör ske inom verksamheten för att förbättra arbetsmiljön för sjuksköterskorna och på så vis minska att fel uppstår i samband med läkemedelshanteringen. / Aim: The purpose of this study was to describe the factors that could cause errors associated with the nurse's medication and what the nurse can do to prevent errors from occurring in somatic inpatient care. The aim was also to examine the quality of the articles in relation to sample size and disappearance. Method: A descriptive literature study based on 13 scientific articles with both qualitative and quantitative approach. The literature research was made in the databases PubMed, Cinahl and Academic Search Elite. Results: Factors that caused the nurse to made ​​errors in the handling of drugs was high workload, lack of knowledge in pharmacology, less experience in the nursing profession and working interruptions. Preventive measures to minimize the risk that an error occurred during the drug treatment were that the nurse increased her knowledge of pharmacology, contributed to a better working environment and the communication with other healthcare professionals and was accurate at the controls. Conclusion: Several common factors that caused the errors associated with the nurse's medication as high workload and insufficient of knowledge in pharmacology should not be difficult to prevent. The major preventive measures should be done within the hospital management to improve the working environment for nurses and prevent the error associated with medication management.