subject:(drug safety)

Queens University

1. Boyes, Randall. Patterns of Use and Comparative Safety of New and Old Anticholinergic Medications in Older Adults: a Population-Based Study .

Degree: Community Health and Epidemiology, 2015, Queens University

URL: http://hdl.handle.net/1974/13495

► Overactive bladder (OAB) and urge urinary incontinence (UUI) are conditions that affect 12 – 18% of Canadians and that grow increasingly common with age. Patterns… (more)

▼ Overactive bladder (OAB) and urge urinary incontinence (UUI) are conditions that affect 12 – 18% of Canadians and that grow increasingly common with age. Patterns of use and comparative safety of six anticholinergic medications used to treat OAB and UUI were examined. Two of these medications (oxybutynin, tolterodine) have been included for many years on the provincial drug formulary, while the other four (solifenacin, darifenacin, trospium chloride, fesoterodine) have only recently been listed with conditions as “limited use” (LU) products. Acute urinary retention is a possible adverse outcome associated with these medications and was the outcome selected for the analysis of comparative safety. Participants were patients from Ontario between 66 and 105 years of age who received a new prescription for one of the bladder anticholinergic medications listed on the formulary between December 15, 2011 and December 31, 2013. A retrospective cohort design was used. Patients who were new users of any of the six bladder anticholinergic medications were identified from ODB program data. Descriptive statistics were used to assess physician adherence to the LU criteria. These patients were assigned to groups based on the bladder anticholinergic medication they received and the risk of acute urinary retention in new users of each medication was compared. Cox Proportional Hazards models were used to calculate hazard ratios to compare the risk of acute urinary retention among new users of each of the newer medications as compared to new users of oxybutynin. Analyses were stratified by sex, as men are known to be at greater risk of urinary retention than women. Only 10% of patients met the LU criteria for a prior trial of oxybutynin. Among men (but not women), new use of solifenacin, darifenacin, or tolterodine was associated with a reduced risk of acute urinary retention as compared to oxybutynin. The LU criteria for newer bladder anticholinergic medications do not appear to serve as an effective means of regulating their prescription. Exposure to these medications appears to confer a lower risk of acute urinary retention than oxybutynin in male patients. Further research into other potential adverse effects of these medication is needed.

Subjects/Keywords: Pharmacoepidemiology ; Drug Safety

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APA (6^th Edition):

Boyes, R. (2015). Patterns of Use and Comparative Safety of New and Old Anticholinergic Medications in Older Adults: a Population-Based Study . (Thesis). Queens University. Retrieved from http://hdl.handle.net/1974/13495

Note: this citation may be lacking information needed for this citation format:
Not specified: Masters Thesis or Doctoral Dissertation

Chicago Manual of Style (16^th Edition):

Boyes, Randall. “Patterns of Use and Comparative Safety of New and Old Anticholinergic Medications in Older Adults: a Population-Based Study .” 2015. Thesis, Queens University. Accessed March 05, 2021. http://hdl.handle.net/1974/13495.

Note: this citation may be lacking information needed for this citation format:
Not specified: Masters Thesis or Doctoral Dissertation

MLA Handbook (7^th Edition):

Boyes, Randall. “Patterns of Use and Comparative Safety of New and Old Anticholinergic Medications in Older Adults: a Population-Based Study .” 2015. Web. 05 Mar 2021.

Vancouver:

Boyes R. Patterns of Use and Comparative Safety of New and Old Anticholinergic Medications in Older Adults: a Population-Based Study . [Internet] [Thesis]. Queens University; 2015. [cited 2021 Mar 05]. Available from: http://hdl.handle.net/1974/13495.

Note: this citation may be lacking information needed for this citation format:
Not specified: Masters Thesis or Doctoral Dissertation

Council of Science Editors:

Boyes R. Patterns of Use and Comparative Safety of New and Old Anticholinergic Medications in Older Adults: a Population-Based Study . [Thesis]. Queens University; 2015. Available from: http://hdl.handle.net/1974/13495

Note: this citation may be lacking information needed for this citation format:
Not specified: Masters Thesis or Doctoral Dissertation

University of Maryland

2. Zafft, Kathryn Marie. Can Drug Courts Improve Public Safety? Exploring the Impacts of Drug Court on Crime.

Degree: Criminology and Criminal Justice, 2014, University of Maryland

URL: http://hdl.handle.net/1903/16267

► Drug courts represent one of the largest and most widespread criminal justice programs specifically developed to provide treatment and intensive supervision to drug-involved offenders. Most… (more)

Subjects/Keywords: Criminology; drug court; public safety

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APA (6^th Edition):

Zafft, K. M. (2014). Can Drug Courts Improve Public Safety? Exploring the Impacts of Drug Court on Crime. (Thesis). University of Maryland. Retrieved from http://hdl.handle.net/1903/16267

Note: this citation may be lacking information needed for this citation format:
Not specified: Masters Thesis or Doctoral Dissertation

Chicago Manual of Style (16^th Edition):

Zafft, Kathryn Marie. “Can Drug Courts Improve Public Safety? Exploring the Impacts of Drug Court on Crime.” 2014. Thesis, University of Maryland. Accessed March 05, 2021. http://hdl.handle.net/1903/16267.

Note: this citation may be lacking information needed for this citation format:
Not specified: Masters Thesis or Doctoral Dissertation

MLA Handbook (7^th Edition):

Zafft, Kathryn Marie. “Can Drug Courts Improve Public Safety? Exploring the Impacts of Drug Court on Crime.” 2014. Web. 05 Mar 2021.

Vancouver:

Zafft KM. Can Drug Courts Improve Public Safety? Exploring the Impacts of Drug Court on Crime. [Internet] [Thesis]. University of Maryland; 2014. [cited 2021 Mar 05]. Available from: http://hdl.handle.net/1903/16267.

Note: this citation may be lacking information needed for this citation format:
Not specified: Masters Thesis or Doctoral Dissertation

Council of Science Editors:

Zafft KM. Can Drug Courts Improve Public Safety? Exploring the Impacts of Drug Court on Crime. [Thesis]. University of Maryland; 2014. Available from: http://hdl.handle.net/1903/16267

Note: this citation may be lacking information needed for this citation format:
Not specified: Masters Thesis or Doctoral Dissertation

University of Georgia

3. Magazu, Samantha. Harmonized pharmacovigilance practices.

Degree: 2014, University of Georgia

URL: http://hdl.handle.net/10724/29914

► Pharmacovigilance practices have focused on the reporting of adverse drug reactions to medicinal products. In an increasingly global industry, attempts have been made to harmonize… (more)

Subjects/Keywords: Pharmacovigilance; Drug safety; Harmonization

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APA (6^th Edition):

Magazu, S. (2014). Harmonized pharmacovigilance practices. (Thesis). University of Georgia. Retrieved from http://hdl.handle.net/10724/29914

Note: this citation may be lacking information needed for this citation format:
Not specified: Masters Thesis or Doctoral Dissertation

Chicago Manual of Style (16^th Edition):

Magazu, Samantha. “Harmonized pharmacovigilance practices.” 2014. Thesis, University of Georgia. Accessed March 05, 2021. http://hdl.handle.net/10724/29914.

Note: this citation may be lacking information needed for this citation format:
Not specified: Masters Thesis or Doctoral Dissertation

MLA Handbook (7^th Edition):

Magazu, Samantha. “Harmonized pharmacovigilance practices.” 2014. Web. 05 Mar 2021.

Vancouver:

Magazu S. Harmonized pharmacovigilance practices. [Internet] [Thesis]. University of Georgia; 2014. [cited 2021 Mar 05]. Available from: http://hdl.handle.net/10724/29914.

Note: this citation may be lacking information needed for this citation format:
Not specified: Masters Thesis or Doctoral Dissertation

Council of Science Editors:

Magazu S. Harmonized pharmacovigilance practices. [Thesis]. University of Georgia; 2014. Available from: http://hdl.handle.net/10724/29914

Note: this citation may be lacking information needed for this citation format:
Not specified: Masters Thesis or Doctoral Dissertation

NSYSU

4. Dong, Yu-chi. Drug Education and Prevention-the case of National Army Troops in Tainan.

Degree: Master, Political Science, 2018, NSYSU

URL: http://etd.lib.nsysu.edu.tw/ETD-db/ETD-search/view_etd?URN=etd-0722118-151436

► In terms of development, the use of drugs is a problem-oriented issue for countries in the world.Given that the drug-using population has been going to… (more)

Subjects/Keywords: human safety; Drug abuse; drug prevention; drug use

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APA (6^th Edition):

Dong, Y. (2018). Drug Education and Prevention-the case of National Army Troops in Tainan. (Thesis). NSYSU. Retrieved from http://etd.lib.nsysu.edu.tw/ETD-db/ETD-search/view_etd?URN=etd-0722118-151436

Note: this citation may be lacking information needed for this citation format:
Not specified: Masters Thesis or Doctoral Dissertation

Chicago Manual of Style (16^th Edition):

Dong, Yu-chi. “Drug Education and Prevention-the case of National Army Troops in Tainan.” 2018. Thesis, NSYSU. Accessed March 05, 2021. http://etd.lib.nsysu.edu.tw/ETD-db/ETD-search/view_etd?URN=etd-0722118-151436.

Note: this citation may be lacking information needed for this citation format:
Not specified: Masters Thesis or Doctoral Dissertation

MLA Handbook (7^th Edition):

Dong, Yu-chi. “Drug Education and Prevention-the case of National Army Troops in Tainan.” 2018. Web. 05 Mar 2021.

Vancouver:

Dong Y. Drug Education and Prevention-the case of National Army Troops in Tainan. [Internet] [Thesis]. NSYSU; 2018. [cited 2021 Mar 05]. Available from: http://etd.lib.nsysu.edu.tw/ETD-db/ETD-search/view_etd?URN=etd-0722118-151436.

Note: this citation may be lacking information needed for this citation format:
Not specified: Masters Thesis or Doctoral Dissertation

Council of Science Editors:

Dong Y. Drug Education and Prevention-the case of National Army Troops in Tainan. [Thesis]. NSYSU; 2018. Available from: http://etd.lib.nsysu.edu.tw/ETD-db/ETD-search/view_etd?URN=etd-0722118-151436

Note: this citation may be lacking information needed for this citation format:
Not specified: Masters Thesis or Doctoral Dissertation

University of Toronto

5. Ho, Joanne. Adverse Cardiac Events Among Older Patients on Venlafaxine: A Population-based Study.

Degree: 2015, University of Toronto

URL: http://hdl.handle.net/1807/71445

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Background: It is unknown whether the common antidepressant, venlafaxine, is associated with increased cardiovascular risk. Objective: To examine the cardiac safety of venlafaxine in older… (more)

Subjects/Keywords: Adverse Drug Safety; Cardiovascular; Venlafaxine; 0564

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APA (6^th Edition):

Ho, J. (2015). Adverse Cardiac Events Among Older Patients on Venlafaxine: A Population-based Study. (Masters Thesis). University of Toronto. Retrieved from http://hdl.handle.net/1807/71445

Chicago Manual of Style (16^th Edition):

Ho, Joanne. “Adverse Cardiac Events Among Older Patients on Venlafaxine: A Population-based Study.” 2015. Masters Thesis, University of Toronto. Accessed March 05, 2021. http://hdl.handle.net/1807/71445.

MLA Handbook (7^th Edition):

Ho, Joanne. “Adverse Cardiac Events Among Older Patients on Venlafaxine: A Population-based Study.” 2015. Web. 05 Mar 2021.

Vancouver:

Ho J. Adverse Cardiac Events Among Older Patients on Venlafaxine: A Population-based Study. [Internet] [Masters thesis]. University of Toronto; 2015. [cited 2021 Mar 05]. Available from: http://hdl.handle.net/1807/71445.

Council of Science Editors:

Ho J. Adverse Cardiac Events Among Older Patients on Venlafaxine: A Population-based Study. [Masters Thesis]. University of Toronto; 2015. Available from: http://hdl.handle.net/1807/71445

University of Toronto

6. Carey, Nathalie. The Long-term Neurocognitive Development of Children Exposed to Above Manufacturer Recommended Doses of Diclectin In Utero.

Degree: 2012, University of Toronto

URL: http://hdl.handle.net/1807/33349

►

Nausea and vomiting of pregnancy (NVP) affects up to 90% of pregnancies. Diclectin (doxylamine/pyridoxine) is the only anti-emetic approved in Canada for NVP, at a… (more)

Subjects/Keywords: pharmacology; neuropharmacology; neurocognition; drug safety; 0419

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APA (6^th Edition):

Carey, N. (2012). The Long-term Neurocognitive Development of Children Exposed to Above Manufacturer Recommended Doses of Diclectin In Utero. (Masters Thesis). University of Toronto. Retrieved from http://hdl.handle.net/1807/33349

Chicago Manual of Style (16^th Edition):

Carey, Nathalie. “The Long-term Neurocognitive Development of Children Exposed to Above Manufacturer Recommended Doses of Diclectin In Utero.” 2012. Masters Thesis, University of Toronto. Accessed March 05, 2021. http://hdl.handle.net/1807/33349.

MLA Handbook (7^th Edition):

Carey, Nathalie. “The Long-term Neurocognitive Development of Children Exposed to Above Manufacturer Recommended Doses of Diclectin In Utero.” 2012. Web. 05 Mar 2021.

Vancouver:

Carey N. The Long-term Neurocognitive Development of Children Exposed to Above Manufacturer Recommended Doses of Diclectin In Utero. [Internet] [Masters thesis]. University of Toronto; 2012. [cited 2021 Mar 05]. Available from: http://hdl.handle.net/1807/33349.

Council of Science Editors:

Carey N. The Long-term Neurocognitive Development of Children Exposed to Above Manufacturer Recommended Doses of Diclectin In Utero. [Masters Thesis]. University of Toronto; 2012. Available from: http://hdl.handle.net/1807/33349

University of Toronto

7. Hutson, Janine Rose. Evaluation of Transplacental Pharmacology and Toxicology from Bench to Bedside.

Degree: PhD, 2014, University of Toronto

URL: http://hdl.handle.net/1807/68198

► Many women require pharmacologic treatment during pregnancy. Clinical studies of drug safety in human pregnancy are often limited because of ethical considerations and thus a… (more)

Subjects/Keywords: drug safety; pharmacokinetics; placenta; pregnancy; teratogen; 0419

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APA (6^th Edition):

Hutson, J. R. (2014). Evaluation of Transplacental Pharmacology and Toxicology from Bench to Bedside. (Doctoral Dissertation). University of Toronto. Retrieved from http://hdl.handle.net/1807/68198

Chicago Manual of Style (16^th Edition):

Hutson, Janine Rose. “Evaluation of Transplacental Pharmacology and Toxicology from Bench to Bedside.” 2014. Doctoral Dissertation, University of Toronto. Accessed March 05, 2021. http://hdl.handle.net/1807/68198.

MLA Handbook (7^th Edition):

Hutson, Janine Rose. “Evaluation of Transplacental Pharmacology and Toxicology from Bench to Bedside.” 2014. Web. 05 Mar 2021.

Vancouver:

Hutson JR. Evaluation of Transplacental Pharmacology and Toxicology from Bench to Bedside. [Internet] [Doctoral dissertation]. University of Toronto; 2014. [cited 2021 Mar 05]. Available from: http://hdl.handle.net/1807/68198.

Council of Science Editors:

Hutson JR. Evaluation of Transplacental Pharmacology and Toxicology from Bench to Bedside. [Doctoral Dissertation]. University of Toronto; 2014. Available from: http://hdl.handle.net/1807/68198

University of Toronto

8. Bapat, Priya. Placental Pharmacology – Implications for Therapy in Pregnancy.

Degree: PhD, 2016, University of Toronto

URL: http://hdl.handle.net/1807/76299

► Medication use during pregnancy requires a balance between treating a condition in the mother, and minimizing potential risks in the fetus. In recent years, it… (more)

▼ Medication use during pregnancy requires a balance between treating a condition in the mother, and minimizing potential risks in the fetus. In recent years, it has been estimated that between 50 and 70% of pregnant women in North America will take at least one prescription medication during their pregnancy. The decision to begin or continue treatment during pregnancy relies heavily on evaluating the risk-benefit ratio, and an important determinant in this risk assessment is estimating fetal drug exposure. The use of medications in pregnant women can be especially challenging, as there is very limited safety data in pregnancy. Recently, novel oral anticoagulants have been developed and approved for clinical use. However, the information regarding their fetal safety and placental transfer in humans is unknown. We used the ex vivo placenta perfusion model to investigate anticoagulant (dabigatran, rivaroxaban, apixaban) transfer across the human placenta. Rivaroxaban and apixaban rapidly crossed the term human placenta, while dabigatran crossed the placenta to a lesser extent. The placenta perfusion results were adjusted to account for protein binding and pH differences between the mother and fetus. We also developed a pharmacokinetic model that adequately described the transplacental transfer of anticoagulants by using data from our experiments. While the placenta perfusion model can be technically challenging, its results strongly correlate with in vivo placental transfer data. By evaluating the success rate of the perfusion model in our laboratory, we determined that establishing the fetal circulation is an important stage of the protocol. This information can be used to create a focused training program to help increase the overall success rate of this model and productivity of the lab. Drug use in pregnancy is multifactorial, and placental transfer data is important in assessing which drugs can be used to treat the mother while protecting the unborn. Advisors/Committee Members: Ito, Shinya, Pharmacology.

Subjects/Keywords: anticoagulants; drug safety; placenta; pregnancy; 0419

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APA (6^th Edition):

Bapat, P. (2016). Placental Pharmacology – Implications for Therapy in Pregnancy. (Doctoral Dissertation). University of Toronto. Retrieved from http://hdl.handle.net/1807/76299

Chicago Manual of Style (16^th Edition):

Bapat, Priya. “Placental Pharmacology – Implications for Therapy in Pregnancy.” 2016. Doctoral Dissertation, University of Toronto. Accessed March 05, 2021. http://hdl.handle.net/1807/76299.

MLA Handbook (7^th Edition):

Bapat, Priya. “Placental Pharmacology – Implications for Therapy in Pregnancy.” 2016. Web. 05 Mar 2021.

Vancouver:

Bapat P. Placental Pharmacology – Implications for Therapy in Pregnancy. [Internet] [Doctoral dissertation]. University of Toronto; 2016. [cited 2021 Mar 05]. Available from: http://hdl.handle.net/1807/76299.

Council of Science Editors:

Bapat P. Placental Pharmacology – Implications for Therapy in Pregnancy. [Doctoral Dissertation]. University of Toronto; 2016. Available from: http://hdl.handle.net/1807/76299

University of Illinois – Chicago

9. Qiu, Xi. Chemoprevention Study of Botanical Dietary Supplements by Mass Spectrometry.

Degree: 2012, University of Illinois – Chicago

URL: http://hdl.handle.net/10027/9309

► Botanical dietary supplements have the potential to maintain and or even improve health. In particular, some botanical dietary supplements have the potential to prevent cancer.… (more)

▼ Botanical dietary supplements have the potential to maintain and or even improve health. In particular, some botanical dietary supplements have the potential to prevent cancer. The iTRAQ quantitative proteomics approach described in this dissertation illustrates how lycopene exerts multiple chemoprotective effects on normal human prostatic epithelial cells which are probably the origin of most prostatic adenocarcinomas. Several proteins were up or down-regulated by lycopene in directions that are consistent with reduction of oxidative stress in these cells. Lycopene was found to inhibit proliferation of prostate epithelial cells by down regulating the AKT/mTOR pathway and by up regulating genes that have growth inhibitory effects. Lycopene was shown to induce caspase dependant apoptosis and down regulate several proteins involved in anti-apoptosis process. Lycopene was also found to alter several signaling pathways including decreased androgen receptor signaling by down regulating protein DJ 1 and HSP90; enhance TNFα signaling induced apoptosis by down regulating TXNDC17; deactivating MAPK pathway and reducing inflammation by down regulating MIF; and down regulation of the AKT/mTOR pathway to slow down cell proliferation and induce apoptosis. Humulus lupulus L. (hops) is well-known as a raw material in the brewing industry to give beer the signature aroma and flavor. In recent years prenylated flavonoids in hops attracted major attention because of their diverse activities. Xanthohumol, the most abundant chalcone from hops, emerged as a potential chemoprevention agent because of its broad activities against different cancer cell lines. However, little is known about the safety of whether xanthohumol or hops extract will cause drug-herb interactions in the human body. we evaluated a hop standardized extract for possible induction of human metabolizing enzymes cytochrome P450 1A2 and 3A4. We found that the hop extract will not induce either enzyme or its corresponding mRNA level at average physiological plasma concentrations. We further evaluated the inhibition potential of the hop extract or xanthohumol in combination with other major prenylated flavonoids on drug metabolizing enzymes. Our results indicate that xanthohumol or hop extract could inhibit cytochrome P450 2C family enzymes which may affect the efficacy and safety of some CYP 2C substrate drugs when co-administere. Advisors/Committee Members: van Breemen, Richard B. (advisor), Murphy, Brian T. (committee member), Orjala, Jimmy (committee member), Franzblau, Scott G. (committee member), Bosland, Maarten C. (committee member).

Subjects/Keywords: Chemoprevention; dietary supplement; quantitative proteomics; drug-drug interaction; botanical safety evaluation

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APA (6^th Edition):

Qiu, X. (2012). Chemoprevention Study of Botanical Dietary Supplements by Mass Spectrometry. (Thesis). University of Illinois – Chicago. Retrieved from http://hdl.handle.net/10027/9309

Note: this citation may be lacking information needed for this citation format:
Not specified: Masters Thesis or Doctoral Dissertation

Chicago Manual of Style (16^th Edition):

Qiu, Xi. “Chemoprevention Study of Botanical Dietary Supplements by Mass Spectrometry.” 2012. Thesis, University of Illinois – Chicago. Accessed March 05, 2021. http://hdl.handle.net/10027/9309.

Note: this citation may be lacking information needed for this citation format:
Not specified: Masters Thesis or Doctoral Dissertation

MLA Handbook (7^th Edition):

Qiu, Xi. “Chemoprevention Study of Botanical Dietary Supplements by Mass Spectrometry.” 2012. Web. 05 Mar 2021.

Vancouver:

Qiu X. Chemoprevention Study of Botanical Dietary Supplements by Mass Spectrometry. [Internet] [Thesis]. University of Illinois – Chicago; 2012. [cited 2021 Mar 05]. Available from: http://hdl.handle.net/10027/9309.

Note: this citation may be lacking information needed for this citation format:
Not specified: Masters Thesis or Doctoral Dissertation

Council of Science Editors:

Qiu X. Chemoprevention Study of Botanical Dietary Supplements by Mass Spectrometry. [Thesis]. University of Illinois – Chicago; 2012. Available from: http://hdl.handle.net/10027/9309

Note: this citation may be lacking information needed for this citation format:
Not specified: Masters Thesis or Doctoral Dissertation

University of Guelph

10. Lyster, Samantha. Evaluating the Clearance of Common Extra-label Drug Combinations by Turkey Hepatocytes in Primary Culture.

Degree: MS, Department of Biomedical Sciences, 2020, University of Guelph

URL: https://atrium.lib.uoguelph.ca/xmlui/handle/10214/20732

► Although common in the commercial turkey industry, concurrent use of two or more drugs in the same feed can result in drug-drug interactions that may… (more)

Subjects/Keywords: Food safety; drug clearance; in vitro; drug residue; LC-MS/MS

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APA (6^th Edition):

Lyster, S. (2020). Evaluating the Clearance of Common Extra-label Drug Combinations by Turkey Hepatocytes in Primary Culture. (Masters Thesis). University of Guelph. Retrieved from https://atrium.lib.uoguelph.ca/xmlui/handle/10214/20732

Chicago Manual of Style (16^th Edition):

Lyster, Samantha. “Evaluating the Clearance of Common Extra-label Drug Combinations by Turkey Hepatocytes in Primary Culture.” 2020. Masters Thesis, University of Guelph. Accessed March 05, 2021. https://atrium.lib.uoguelph.ca/xmlui/handle/10214/20732.

MLA Handbook (7^th Edition):

Lyster, Samantha. “Evaluating the Clearance of Common Extra-label Drug Combinations by Turkey Hepatocytes in Primary Culture.” 2020. Web. 05 Mar 2021.

Vancouver:

Lyster S. Evaluating the Clearance of Common Extra-label Drug Combinations by Turkey Hepatocytes in Primary Culture. [Internet] [Masters thesis]. University of Guelph; 2020. [cited 2021 Mar 05]. Available from: https://atrium.lib.uoguelph.ca/xmlui/handle/10214/20732.

Council of Science Editors:

Lyster S. Evaluating the Clearance of Common Extra-label Drug Combinations by Turkey Hepatocytes in Primary Culture. [Masters Thesis]. University of Guelph; 2020. Available from: https://atrium.lib.uoguelph.ca/xmlui/handle/10214/20732

Univerzitet u Beogradu

11. Kovačević, Milena, 1988-, 22718311. Procena učestalosti i prediktora klinički značajnih lek-lek interakcija i njihov uticaj na ishode terapije pacijenata sa kardiovaskularnim oboljenjima.

Degree: Farmaceutski fakultet, 2020, Univerzitet u Beogradu

URL: https://fedorabg.bg.ac.rs/fedora/get/o:22401/bdef:Content/get

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Farmacija - Farmakokinetika i klinička farmacija / Pharmacy - Pharmacokinetics and Clinical Pharmacy

Lek-lek interakcije (LLI) su čest uzrok pojave neželjenih ishoda terapije kroz izmenu… (more)

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Farmacija - Farmakokinetika i klinička farmacija / Pharmacy - Pharmacokinetics and Clinical Pharmacy

Lek-lek interakcije (LLI) su čest uzrok pojave neželjenih ishoda terapije kroz izmenu u efikasnosti ili bezbednosti terapije, a koji se može prevenirati. Posledice LLI nisu dovoljno istražene zbog njihovog neprepoznavanja. Lekovi u terapiji bolesti kardiovaskularnog sistema imaju veliki potencijal za stupanje u LLI, zbog svojih farmakokinetičkih i/ili farmakodinamskih karakteristika. Cilj istraživanja bila je identifikacija potencijalnih i klinički značajnih LLI, procena prevalence, karakteristika i prediktora u populaciji pacijenata sa kardiovaskularnim bolestima, kao i njihov uticaj na ishode terapije. Podaci o pacijentima su prikupljeni retrospektivno iz medicinske dokumentacije. Za identifikaciju LLI korišćena je baza Lexi-Interact, dok je statistička obrada podataka izvršena u programu PASW Statistics. Određena je visoka prevalenca potencijalno relevantnih LLI u populaciji pacijenata sa kardiovaskularnim bolestima, kako u trenutku prijema pacijenata na odeljenje kardiologije (60,7%), tako i tokom bolničkog lečenja (83,9%). Identifikovane su vrste, mehanizam, nivo rizika i stepen ozbiljnosti potencijalnih i ispoljenih LLI, identifikovani su prediktori za njihovu pojavu, izdvojene su subpopulacije pacijenata sa većom prevalencom, i ispitano je prisustvo dodatnih faktora rizika koji povećavaju rizik od manifestacije LLI. Procenjena je primena Lexi-Interact baze kao alata za identifikaciju LLI i optimizaciju terapije izborom alternativnog leka, a razmotrene su i mogućnosti unapređenja alerta uključivanjem karakteristika pacijenata kao modifikatora rizika. Prevalenca klinički značajnih LLI koje su bile povezane sa pojavom neželjenih reakcija na lek u trenutku hospitalizacije pacijenta iznosila je 9,7%. Razvijen je skor koji predviđa verovatnoću budućeg neželjenog događaja usled prisustva kumulativnog rizika od većeg broja potencijalnih LLI. Identifikacija pacijenata sa većim rizikom od pojave neželjenog događaja može olakšati prepoznavanje LLI i unaprediti primenu elektronskih baza podataka u kliničkoj praksi.

Advisors/Committee Members: Miljković, Branislava, 1963-, 12631399.

Subjects/Keywords: adverse drug event; adverse drug reactions; clinical significance; drug-drug interactions; cardiology; patient safety; cardiovascular disease; Lexi-Interact

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APA · Chicago · MLA · Vancouver · CSE | Export to Zotero / EndNote / Reference Manager

APA (6^th Edition):

Kovačević, Milena, 1988-, 2. (2020). Procena učestalosti i prediktora klinički značajnih lek-lek interakcija i njihov uticaj na ishode terapije pacijenata sa kardiovaskularnim oboljenjima. (Thesis). Univerzitet u Beogradu. Retrieved from https://fedorabg.bg.ac.rs/fedora/get/o:22401/bdef:Content/get

Note: this citation may be lacking information needed for this citation format:
Not specified: Masters Thesis or Doctoral Dissertation

Chicago Manual of Style (16^th Edition):

Kovačević, Milena, 1988-, 22718311. “Procena učestalosti i prediktora klinički značajnih lek-lek interakcija i njihov uticaj na ishode terapije pacijenata sa kardiovaskularnim oboljenjima.” 2020. Thesis, Univerzitet u Beogradu. Accessed March 05, 2021. https://fedorabg.bg.ac.rs/fedora/get/o:22401/bdef:Content/get.

Note: this citation may be lacking information needed for this citation format:
Not specified: Masters Thesis or Doctoral Dissertation

MLA Handbook (7^th Edition):

Kovačević, Milena, 1988-, 22718311. “Procena učestalosti i prediktora klinički značajnih lek-lek interakcija i njihov uticaj na ishode terapije pacijenata sa kardiovaskularnim oboljenjima.” 2020. Web. 05 Mar 2021.

Vancouver:

Kovačević, Milena, 1988- 2. Procena učestalosti i prediktora klinički značajnih lek-lek interakcija i njihov uticaj na ishode terapije pacijenata sa kardiovaskularnim oboljenjima. [Internet] [Thesis]. Univerzitet u Beogradu; 2020. [cited 2021 Mar 05]. Available from: https://fedorabg.bg.ac.rs/fedora/get/o:22401/bdef:Content/get.

Note: this citation may be lacking information needed for this citation format:
Not specified: Masters Thesis or Doctoral Dissertation

Council of Science Editors:

Kovačević, Milena, 1988- 2. Procena učestalosti i prediktora klinički značajnih lek-lek interakcija i njihov uticaj na ishode terapije pacijenata sa kardiovaskularnim oboljenjima. [Thesis]. Univerzitet u Beogradu; 2020. Available from: https://fedorabg.bg.ac.rs/fedora/get/o:22401/bdef:Content/get

Note: this citation may be lacking information needed for this citation format:
Not specified: Masters Thesis or Doctoral Dissertation

University of Ottawa

12. Crispo, James Alexander George. Pharmacotherapies in Parkinson Disease: Investigating Trends and Adverse Health Outcomes .

Degree: 2016, University of Ottawa

URL: http://hdl.handle.net/10393/35065

► Parkinson disease (PD) is the second most common neurodegenerative disease worldwide, with estimates suggesting that PD prevalence and incidence will increase with aging populations. Therapeutic… (more)

▼ Parkinson disease (PD) is the second most common neurodegenerative disease worldwide, with estimates suggesting that PD prevalence and incidence will increase with aging populations. Therapeutic options and clinical guidelines for PD have significantly changed over the past 15 years; however, pharmacoepidemiology data in PD are lacking, especially regarding adverse effects of non-ergot dopamine agonists (DAs) and outcomes associated with anticholinergic burden. The objectives of this doctoral research are threefold: 1) examine patterns of antiparkinson drug use in relation to clinical guideline publication, drug availability, and emerging safety concerns; 2) determine whether PD patients treated with non-ergot DAs are at increased risk of adverse cardiovascular or cerebrovascular outcomes; and 3) determine whether anticholinergic burden is associated with adverse outcomes in PD. Specific research questions were investigated using epidemiological methods and electronic health data from Cerner Health Facts®, an electronic medical record database that stores time-stamped patient records for more than 300 Cerner subscribing facilities across the United States. Findings from this work are reported in a series of manuscripts, all of which have been published. Key findings include: 1) DA use began declining in 2007, from 34% to 27% in 2012. The decline followed publication of the American Academy of Neurology’s practice parameter refuting levodopa toxicity, pergolide withdrawal, and pramipexole label revisions; 2) heart failure was the only adverse cardiovascular or cerebrovascular outcome that demonstrated a significant association with non-ergot DA use, mainly pramipexole; and 3) anticholinergic burden in PD was associated with the diagnosis of fracture and delirium, and significantly increased the risk of emergency department visit and readmission post inpatient discharge. Reported antiparkinson prescribing trends suggest that safety and best practice information may be communicated effectively in PD. Although findings warrant replication, individuals with PD and independent risk factors for or a history of heart failure may benefit from limited use of pramipexole. Similarly, individuals with PD may benefit from substituting non-PD medications with anticholinergic effects for equally effective non-anticholinergic agents. Additional pharmacovigilance studies are needed to better understand health risks and the impact of population health interventions in PD.

Subjects/Keywords: Parkinson disease; drug utilization; drug safety; dopamine agonist; adverse health outcomes; adverse cardiovascular outcomes

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APA · Chicago · MLA · Vancouver · CSE | Export to Zotero / EndNote / Reference Manager

APA (6^th Edition):

Crispo, J. A. G. (2016). Pharmacotherapies in Parkinson Disease: Investigating Trends and Adverse Health Outcomes . (Thesis). University of Ottawa. Retrieved from http://hdl.handle.net/10393/35065

Note: this citation may be lacking information needed for this citation format:
Not specified: Masters Thesis or Doctoral Dissertation

Chicago Manual of Style (16^th Edition):

Crispo, James Alexander George. “Pharmacotherapies in Parkinson Disease: Investigating Trends and Adverse Health Outcomes .” 2016. Thesis, University of Ottawa. Accessed March 05, 2021. http://hdl.handle.net/10393/35065.

Note: this citation may be lacking information needed for this citation format:
Not specified: Masters Thesis or Doctoral Dissertation

MLA Handbook (7^th Edition):

Crispo, James Alexander George. “Pharmacotherapies in Parkinson Disease: Investigating Trends and Adverse Health Outcomes .” 2016. Web. 05 Mar 2021.

Vancouver:

Crispo JAG. Pharmacotherapies in Parkinson Disease: Investigating Trends and Adverse Health Outcomes . [Internet] [Thesis]. University of Ottawa; 2016. [cited 2021 Mar 05]. Available from: http://hdl.handle.net/10393/35065.

Note: this citation may be lacking information needed for this citation format:
Not specified: Masters Thesis or Doctoral Dissertation

Council of Science Editors:

Crispo JAG. Pharmacotherapies in Parkinson Disease: Investigating Trends and Adverse Health Outcomes . [Thesis]. University of Ottawa; 2016. Available from: http://hdl.handle.net/10393/35065

Note: this citation may be lacking information needed for this citation format:
Not specified: Masters Thesis or Doctoral Dissertation

Linnaeus University

13. Floricica, Elisabeta. Läkarens syn på läkemedelsinteraktioner : en intervjustudie.

Degree: Natural Sciences, 2011, Linnaeus University

URL: http://urn.kb.se/resolve?urn=urn:nbn:se:lnu:diva-11696

► Syftet med detta arbete är att undersöka hur ett antal läkare ser på problematiken kring läkemedelinteraktioner samt om läkarna anser att ett utvidgat samarbete… (more)

Subjects/Keywords: medication; drug interactions; drug safety; läkemedel; läkemedelsinteraktioner; läkemedelssäkerhet; Pharmaceutical Sciences; Farmaceutiska vetenskaper

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APA · Chicago · MLA · Vancouver · CSE | Export to Zotero / EndNote / Reference Manager

APA (6^th Edition):

Floricica, E. (2011). Läkarens syn på läkemedelsinteraktioner : en intervjustudie. (Thesis). Linnaeus University. Retrieved from http://urn.kb.se/resolve?urn=urn:nbn:se:lnu:diva-11696

Note: this citation may be lacking information needed for this citation format:
Not specified: Masters Thesis or Doctoral Dissertation

Chicago Manual of Style (16^th Edition):

Floricica, Elisabeta. “Läkarens syn på läkemedelsinteraktioner : en intervjustudie.” 2011. Thesis, Linnaeus University. Accessed March 05, 2021. http://urn.kb.se/resolve?urn=urn:nbn:se:lnu:diva-11696.

Note: this citation may be lacking information needed for this citation format:
Not specified: Masters Thesis or Doctoral Dissertation

MLA Handbook (7^th Edition):

Floricica, Elisabeta. “Läkarens syn på läkemedelsinteraktioner : en intervjustudie.” 2011. Web. 05 Mar 2021.

Vancouver:

Floricica E. Läkarens syn på läkemedelsinteraktioner : en intervjustudie. [Internet] [Thesis]. Linnaeus University; 2011. [cited 2021 Mar 05]. Available from: http://urn.kb.se/resolve?urn=urn:nbn:se:lnu:diva-11696.

Note: this citation may be lacking information needed for this citation format:
Not specified: Masters Thesis or Doctoral Dissertation

Council of Science Editors:

Floricica E. Läkarens syn på läkemedelsinteraktioner : en intervjustudie. [Thesis]. Linnaeus University; 2011. Available from: http://urn.kb.se/resolve?urn=urn:nbn:se:lnu:diva-11696

Note: this citation may be lacking information needed for this citation format:
Not specified: Masters Thesis or Doctoral Dissertation

University of KwaZulu-Natal

14. Ndlovu, Garnet. Awareness and knowledge of doctors, pharmacists and nurses on adverse drug reaction reporting systems in Namibia.

Degree: 2020, University of KwaZulu-Natal

URL: https://researchspace.ukzn.ac.za/handle/10413/19015

► Objective Reporting of adverse drug reactions (ADRs) in Namibian public health facilities is routinely done through safety yellow forms which are forwarded to the Therapeutics… (more)

▼ Objective Reporting of adverse drug reactions (ADRs) in Namibian public health facilities is routinely done through safety yellow forms which are forwarded to the Therapeutics Information and Pharmacovigilance Centre (TIPC) for further assessment and possible interventions. This study investigated the awareness and knowledge of healthcare practitioners (HCPs) regarding the ADR reporting system in the country. Methods A cross-sectional study was conducted via a self-administered questionnaire at two state hospitals in Namibia; one located in the Khomas region and the other located in the Hardap region. The questionnaire was distributed to HCPs in current practice dealing directly with medication and it included a combination of open-ended, closed-ended and multiple-choice questions. Questionnaires were distributed in hard copy form during the period of 1 October 2019 up until 15 December 2019. Data was coded and transcribed into Microsoft® Excel® 2016 and analysed with SPSS® for IOS version 24. Results One-hundred and three completed questionnaires were received. Sixty-eight percent of the respondents were nurses, 24.3% were medical doctors and 7.8% were pharmacists. The majority of HCPs (73.8% and 56.3% respectively) were able to define the terms “adverse drug reaction” and “pharmacovigilance” correctly while only 41.7% correctly defined “spontaneous reporting”. The majority of HCPs (60.2%) have identified an ADR in practice; however only 36.9% reported this following the approved process. Only 48.5% of HCPs were aware of the safety yellow form for ADRs and 63.1% of HCPs did not know where to obtain the form. Furthermore only 37.9% of HCPs knew the name of the drug regulatory authority in Namibia. Conclusion Awareness and knowledge of ADR reporting systems by HCPs in Namibia is insufficient. While HCPs deem it necessary to report ADRs, reporting is unacceptably low leading to serious concerns regarding continuous monitoring of drug safety. Pharmacists showed better awareness compared to other HCPs and can, therefore, be best utilised as focal points in pharmacovigilance protraction. Mass awareness programs by the TIPC and other stakeholders need to be established to expand pharmacovigilance among HCPs. Advisors/Committee Members: Oosthuizen, Frasia. (advisor), Bangalee, Varsha. (advisor).

Subjects/Keywords: Adverse drug reactions - awareness and reporting - healthcare professionals - Namibia.; Pharmacovigilance - Namibia.; Adverse drug reactions - knowledge - healthcare professionals - Namibia.; Drug safety - Namibia.

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APA · Chicago · MLA · Vancouver · CSE | Export to Zotero / EndNote / Reference Manager

APA (6^th Edition):

Ndlovu, G. (2020). Awareness and knowledge of doctors, pharmacists and nurses on adverse drug reaction reporting systems in Namibia. (Thesis). University of KwaZulu-Natal. Retrieved from https://researchspace.ukzn.ac.za/handle/10413/19015

Note: this citation may be lacking information needed for this citation format:
Not specified: Masters Thesis or Doctoral Dissertation

Chicago Manual of Style (16^th Edition):

Ndlovu, Garnet. “Awareness and knowledge of doctors, pharmacists and nurses on adverse drug reaction reporting systems in Namibia.” 2020. Thesis, University of KwaZulu-Natal. Accessed March 05, 2021. https://researchspace.ukzn.ac.za/handle/10413/19015.

Note: this citation may be lacking information needed for this citation format:
Not specified: Masters Thesis or Doctoral Dissertation

MLA Handbook (7^th Edition):

Ndlovu, Garnet. “Awareness and knowledge of doctors, pharmacists and nurses on adverse drug reaction reporting systems in Namibia.” 2020. Web. 05 Mar 2021.

Vancouver:

Ndlovu G. Awareness and knowledge of doctors, pharmacists and nurses on adverse drug reaction reporting systems in Namibia. [Internet] [Thesis]. University of KwaZulu-Natal; 2020. [cited 2021 Mar 05]. Available from: https://researchspace.ukzn.ac.za/handle/10413/19015.

Note: this citation may be lacking information needed for this citation format:
Not specified: Masters Thesis or Doctoral Dissertation

Council of Science Editors:

Ndlovu G. Awareness and knowledge of doctors, pharmacists and nurses on adverse drug reaction reporting systems in Namibia. [Thesis]. University of KwaZulu-Natal; 2020. Available from: https://researchspace.ukzn.ac.za/handle/10413/19015

Note: this citation may be lacking information needed for this citation format:
Not specified: Masters Thesis or Doctoral Dissertation

15. Faria, Leila Márcia Pereira de. Interação medicamentosa: conhecimento de enfermeiros das unidades de terapia intensiva de três hospitais públicos de Goiânia - GO.

Degree: Mestrado, Enfermagem Fundamental, 2010, University of São Paulo

URL: http://www.teses.usp.br/teses/disponiveis/22/22132/tde-27092010-164203/ ;

►

Atualmente, é uma preocupação a exposição dos pacientes de unidade de terapia intensiva (UTI) a situações da prática clínica que colocam suas vidas em risco.… (more)

▼

Atualmente, é uma preocupação a exposição dos pacientes de unidade de terapia intensiva (UTI) a situações da prática clínica que colocam suas vidas em risco. Um agravante para essa exposição são os múltiplos agentes farmacológicos que esses pacientes recebem, aliado ao seu desequilíbrio fisiológico. Entre os principais problemas relacionados à utilização de medicamentos na UTI, estão as interações medicamentosas (IM), que quando não prevenidas ou tratadas prontamente podem provocar danos irreparáveis no paciente. Considerando que o conhecimento sobre IM é uma importante ferramenta para otimização no cuidado em enfermagem, desenvolveu-se este estudo com o propósito de analisar o conhecimento sobre interações medicamentosas de enfermeiros que atuam em unidades de terapia intensiva de adultos de três hospitais públicos de Goiânia - GO. Trata-se de um estudo descritivo, não experimental, com delineamento transversal. A população foi composta por 64 profissionais e a amostra constituiu-se de 51 enfermeiros que aceitaram participar do estudo. Para a coleta de dados construiu-se um instrumento com perguntas de múltipla escolha sobre IM. As alternativas desse instrumento foram extraídas da base de dados do MICROMEDEX® Healthcare Series (1974- 2009). Os dados foram organizados e analisados usando Microsoft Excel 2002. A faixa etária dos enfermeiros variou de 25 a 55 anos, com média de 38,9 anos. O tempo de atuação na enfermagem variou entre 2 e 31 anos, com média de 12 anos. Sobre a formação em farmacologia, 29 (56,9%) enfermeiros informaram ter tido uma formação regular na graduação e 49 (96,1%) expressaram necessidade de capacitação em farmacologia. Quanto ao conhecimento sobre interações medicamentosas na UTI, houve uma relação de acertos e erros praticamente de 50%. Os itens que alcançaram maior número de respostas corretas foram os que abordaram as interações relativas a medicamentos com ação sedativa e analgésica como o caso da dupla fentanila + morfina (86,3%). Os itens que apresentaram maior número de respostas incorretas foram os que abordaram medicamentos de ação antiinfecciosa e anti-hipertensiva. Quanto ao conhecimento do manejo clínico sobre IM, observou-se que metade dos profissionais responderam corretamente em mais de 50% dos itens se destacando, também, os medicamentos de ação sedativa e analgésica. Os resultados evidenciaram a necessidade de melhorar as práticas de cuidados na utilização de medicamentos e chamam a atenção para a importância de atualização dos enfermeiros a respeito dos medicamentos comumente administrados na UTI. Por sua vez, é necessário fornecer apoio aos profissionais para que busquem conhecimentos que sustente a qualidade da prática. Espera-se que as universidades e demais instituições de saúde se sensibilizem quanto à necessidade de difundir e promover um conhecimento farmacológico, adequado aos profissionais de enfermagem tendo em vista que a segurança do paciente na terapia medicamentosa deve ser uma prioridade no contexto da saúde.

Nowadays there is a hard concern on the…

Advisors/Committee Members: Cassiani, Silvia Helena De Bortoli.

Subjects/Keywords: drug Interaction; enfermagem; interação medicamentosa; nursing; patient safety; segurança do paciente

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APA · Chicago · MLA · Vancouver · CSE | Export to Zotero / EndNote / Reference Manager

APA (6^th Edition):

Faria, L. M. P. d. (2010). Interação medicamentosa: conhecimento de enfermeiros das unidades de terapia intensiva de três hospitais públicos de Goiânia - GO. (Masters Thesis). University of São Paulo. Retrieved from http://www.teses.usp.br/teses/disponiveis/22/22132/tde-27092010-164203/ ;

Chicago Manual of Style (16^th Edition):

Faria, Leila Márcia Pereira de. “Interação medicamentosa: conhecimento de enfermeiros das unidades de terapia intensiva de três hospitais públicos de Goiânia - GO.” 2010. Masters Thesis, University of São Paulo. Accessed March 05, 2021. http://www.teses.usp.br/teses/disponiveis/22/22132/tde-27092010-164203/ ;.

MLA Handbook (7^th Edition):

Faria, Leila Márcia Pereira de. “Interação medicamentosa: conhecimento de enfermeiros das unidades de terapia intensiva de três hospitais públicos de Goiânia - GO.” 2010. Web. 05 Mar 2021.

Vancouver:

Faria LMPd. Interação medicamentosa: conhecimento de enfermeiros das unidades de terapia intensiva de três hospitais públicos de Goiânia - GO. [Internet] [Masters thesis]. University of São Paulo; 2010. [cited 2021 Mar 05]. Available from: http://www.teses.usp.br/teses/disponiveis/22/22132/tde-27092010-164203/ ;.

Council of Science Editors:

Faria LMPd. Interação medicamentosa: conhecimento de enfermeiros das unidades de terapia intensiva de três hospitais públicos de Goiânia - GO. [Masters Thesis]. University of São Paulo; 2010. Available from: http://www.teses.usp.br/teses/disponiveis/22/22132/tde-27092010-164203/ ;

Boston University

16. Shea, Corey Matthew. Evaluation of the efficacy and long-term safety outcomes of first generation drug-eluting stents in off-label indications.

Degree: MS, Medical Sciences, 2014, Boston University

URL: http://hdl.handle.net/2144/15044

► FDA approval of drug-eluting stents (DES) in 2002, was based on data obtained from several pivotal, short-term (< one year) randomized control trials that evaluated… (more)

▼ FDA approval of drug-eluting stents (DES) in 2002, was based on data obtained from several pivotal, short-term (< one year) randomized control trials that evaluated their efficacy in reducing in-stent restenosis when used in treatment of coronary artery lesions compared with bare metal stents (BMS). These trials excluded patients with complex coronary lesions. When the FDA approved use of DES in treatment of coronary artery lesions, the on-label indications only applied to a very limited subset of simple lesions. Immediate advantages of DES were observed in clinical practice for on-label indications, specifically in their ability to significantly reduce in-stent restenosis after PCI. The increased short-term safety and efficacy seen in on-label clinical cases soon led clinicians to expand the use DES to more complex lesions. These complex indications, not included in the pivotal FDA trials, are considered off-label. Off-label indications include bifurcation lesions, ostial lesions, lesions greater in length and diameter than those approved by the FDA, implantation in saphenous vein grafts, and lesions in the left main coronary artery. Currently, DES use for treatment of lesions presenting off-label indications may comprise as much as 60% of clinical cases. However, early evidence that DES may play a role in adverse safety outcomes, has led many to question the use of DES outside their on-label indications. This paper sought to evaluate some of the current research investigating first generation DES use in four different off-label indications: coronary artery bypass graft lesions, saphenous vein graft lesions, ostial lesions, and chronic total coronary occlusions. In particular, it looked at studies, which compared the efficacy and clinical outcomes of DES and BMS treatment of each of the different lesion types. The results of this evaluation were very promising in that of the four specific off-label indications evaluated, all of them showed to be superior in reduction of neointimal growth and subsequent in-stent restenosis. Additionally, DES treatment of left main coronary artery lesions, saphenous vein graft lesions, and chronic total coronary occlusions showed to be superior in reducing the incidence rate of major adverse cardiac events and target vessel revascularization over various follow-up durations. The only scenario that DES did not prove to be superior to BMSs was the treatment of ostial lesions. Long-term randomized control trials with large study populations should be performed to further elucidate the effects of DES treatment of specific off-label lesions.

Subjects/Keywords: Medicine; Coronary artery disease; Drug-eIuting stent; Off-label; Safety outcomes

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APA · Chicago · MLA · Vancouver · CSE | Export to Zotero / EndNote / Reference Manager

APA (6^th Edition):

Shea, C. M. (2014). Evaluation of the efficacy and long-term safety outcomes of first generation drug-eluting stents in off-label indications. (Masters Thesis). Boston University. Retrieved from http://hdl.handle.net/2144/15044

Chicago Manual of Style (16^th Edition):

Shea, Corey Matthew. “Evaluation of the efficacy and long-term safety outcomes of first generation drug-eluting stents in off-label indications.” 2014. Masters Thesis, Boston University. Accessed March 05, 2021. http://hdl.handle.net/2144/15044.

MLA Handbook (7^th Edition):

Shea, Corey Matthew. “Evaluation of the efficacy and long-term safety outcomes of first generation drug-eluting stents in off-label indications.” 2014. Web. 05 Mar 2021.

Vancouver:

Shea CM. Evaluation of the efficacy and long-term safety outcomes of first generation drug-eluting stents in off-label indications. [Internet] [Masters thesis]. Boston University; 2014. [cited 2021 Mar 05]. Available from: http://hdl.handle.net/2144/15044.

Council of Science Editors:

Shea CM. Evaluation of the efficacy and long-term safety outcomes of first generation drug-eluting stents in off-label indications. [Masters Thesis]. Boston University; 2014. Available from: http://hdl.handle.net/2144/15044

University of Illinois – Chicago

17. Adimadhyam, Sruthi. Risk of Arrhythmias Associated with Inhaled Anticholinergics in Young Individuals with Asthma.

Degree: 2012, University of Illinois – Chicago

URL: http://hdl.handle.net/10027/9266

► Context: Asthma is a common chronic condition with significant morbidity. Inhaled anticholinergics (IACs) are being investigated for maintenance therapy in asthma. However, little is known… (more)

▼ Context: Asthma is a common chronic condition with significant morbidity. Inhaled anticholinergics (IACs) are being investigated for maintenance therapy in asthma. However, little is known about the cardiovascular safety of these drugs in asthma. Objective: To evaluate the risk of arrhythmias associated with IAC use in young individuals with asthma. Design, Setting, and Patients: A population-based, nested case-control study of new users of asthma controller medications was conducted. Patients aged 5 to 24 years were identified between July 1997 and April 2010 in the IMS LifeLink™ Health Plan Claims Database for inclusion in the study. Cases were newly diagnosed with arrhythmia and were matched with up to 10 controls based on age, gender, geographic region, and quarter and year of first controller medication dispensing. Active use of anticholinergics was defined as days supply for a prescription extending through the event date. Main Outcome Measure: New arrhythmia diagnoses Results: Among 283,429 individuals with asthma, there were 7,656 cases matched to 76,304 controls. The majority of those included were female (58.8%) and older than 12 years (73.3%). Active exposure of IACs was observed in 0.69% of cases and 0.18% of controls. Active use was associated with a 1.56-fold increase in arrhythmia risk compared with non-active/nonusers (Adjusted Odds Ratio (ORadj), 1.56; 95% CI, [1.08–2.25]). Risk was highest among active users of ipratropium (ORadj, 1.59 [1.08–2.33]) compared with tiotropium (ORadj, 1.20 [0.29–4.89]) and combination ipratropium and short-acting beta-agonists (ORadj, 1.20 [0.74–1.94]). Active high dose users of IACs (>0.114mg ipratropium equivalents) had a 69% increase in risk (ORadj, 1.69 [1.10–2.59]) whereas the added risk for active users on low dose (≤ 0.114mg ipratropium equivalents) (ORadj, 1.22 [0.53–2.65]) was not statistically significant. Conclusion: IAC use was associated with an increased risk of arrhythmias in young individuals with asthma Advisors/Committee Members: Schumock, Glen (advisor).

Subjects/Keywords: Asthma; Arrhythmia; Inhaled anticholinergics; Nested case-control study; Pharmacoepidemiology; Drug safety

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APA · Chicago · MLA · Vancouver · CSE | Export to Zotero / EndNote / Reference Manager

APA (6^th Edition):

Adimadhyam, S. (2012). Risk of Arrhythmias Associated with Inhaled Anticholinergics in Young Individuals with Asthma. (Thesis). University of Illinois – Chicago. Retrieved from http://hdl.handle.net/10027/9266

Note: this citation may be lacking information needed for this citation format:
Not specified: Masters Thesis or Doctoral Dissertation

Chicago Manual of Style (16^th Edition):

Adimadhyam, Sruthi. “Risk of Arrhythmias Associated with Inhaled Anticholinergics in Young Individuals with Asthma.” 2012. Thesis, University of Illinois – Chicago. Accessed March 05, 2021. http://hdl.handle.net/10027/9266.

Note: this citation may be lacking information needed for this citation format:
Not specified: Masters Thesis or Doctoral Dissertation

MLA Handbook (7^th Edition):

Adimadhyam, Sruthi. “Risk of Arrhythmias Associated with Inhaled Anticholinergics in Young Individuals with Asthma.” 2012. Web. 05 Mar 2021.

Vancouver:

Adimadhyam S. Risk of Arrhythmias Associated with Inhaled Anticholinergics in Young Individuals with Asthma. [Internet] [Thesis]. University of Illinois – Chicago; 2012. [cited 2021 Mar 05]. Available from: http://hdl.handle.net/10027/9266.

Note: this citation may be lacking information needed for this citation format:
Not specified: Masters Thesis or Doctoral Dissertation

Council of Science Editors:

Adimadhyam S. Risk of Arrhythmias Associated with Inhaled Anticholinergics in Young Individuals with Asthma. [Thesis]. University of Illinois – Chicago; 2012. Available from: http://hdl.handle.net/10027/9266

Note: this citation may be lacking information needed for this citation format:
Not specified: Masters Thesis or Doctoral Dissertation

18. Coloma, Preciosa. Mining Electronic Healthcare Record Databases to Augment Drug Safety Surveillance.

Degree: 2012, Erasmus University Medical Center

URL: http://hdl.handle.net/1765/41031

► textabstractIt is perhaps a fundamental truth in medicine that there is no intervention – be it a drug, a medical device or a procedure –… (more)

▼ textabstractIt is perhaps a fundamental truth in medicine that there is no intervention – be it a drug, a medical device or a procedure – that is without risks. Even with the most rigorous eff orts in drug approval and regulation, there is not a drug out there that is 100% safe under all conditions. Randomized controlled trials (RCTs) are considered to be the most stringent approach to determining cause-and-eff ect relationship between an intervention and an outcome, but such trials are rarely designed or powered to detect uncommon or unexpected adverse events.1-4 Once drugs are marketed, they are used in a more diverse group of people, oft en for much longer periods, and sometimes with a wider range of therapeutic indications. While monitoring the risks associated with drug use has come a long way since the thalidomide disaster in the 1960s and the institution of spontaneous reporting systems (SRS), it has become evident that adverse eff ects of drugs may be detected - and acted upon – too late, when millions of persons have already been exposed.5-6 Th ere has been a growing clamor for improving the current passive-reactive paradigm of drug safety surveillance. Prominent issues in the last few years have emphasized the importance of a life-cycle approach to drug safety monitoring and the need to explore new methods to improve surveillance of drugs post-marketing.7-8 It has been posited that electronic healthcare record (EHR) databases represent an important resource for proactive surveillance and can augment existing pharmacovigilance systems. Various public-private initiatives worldwide have been launched, and great investments have been made, to explore the secondary use of EHR for this purpose.9-10 In this thesis, we draw on the experience of the EU-ADR network (Exploring and Understanding Adverse Drug Reactions by Integrative Mining of Clinical Records and Biomedical Knowledge, http://www.euadr-project.org/), a federation of eight EHR databases in four countries in Europe, to demonstrate the feasibility of combining diverse and diff erently structured data and pave the way for large-scale drug safety monitoring. We describe the opportunities and challenges that come with heterogeneity in database structure, with diff erences in language and coding of both drugs and diseases, and with the diversity in the organization of European healthcare systems.

Subjects/Keywords: drug safety; medical databases

…of drug safety surveillance. Prominent issues in the last few years have emphasized the… …importance of a life-cycle approach to drug safety monitoring and the need to explore new methods… …diverse and differently structured data and pave the way for large-scale drug safety monitoring… …value of EHR-based signal detection systems to the current practice of drug safety… …preliminary results of combining data from eight European EHR databases for drug safety signal…

10 more images…

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APA · Chicago · MLA · Vancouver · CSE | Export to Zotero / EndNote / Reference Manager

APA (6^th Edition):

Coloma, P. (2012). Mining Electronic Healthcare Record Databases to Augment Drug Safety Surveillance. (Doctoral Dissertation). Erasmus University Medical Center. Retrieved from http://hdl.handle.net/1765/41031

Chicago Manual of Style (16^th Edition):

Coloma, Preciosa. “Mining Electronic Healthcare Record Databases to Augment Drug Safety Surveillance.” 2012. Doctoral Dissertation, Erasmus University Medical Center. Accessed March 05, 2021. http://hdl.handle.net/1765/41031.

MLA Handbook (7^th Edition):

Coloma, Preciosa. “Mining Electronic Healthcare Record Databases to Augment Drug Safety Surveillance.” 2012. Web. 05 Mar 2021.

Vancouver:

Coloma P. Mining Electronic Healthcare Record Databases to Augment Drug Safety Surveillance. [Internet] [Doctoral dissertation]. Erasmus University Medical Center; 2012. [cited 2021 Mar 05]. Available from: http://hdl.handle.net/1765/41031.

Council of Science Editors:

Coloma P. Mining Electronic Healthcare Record Databases to Augment Drug Safety Surveillance. [Doctoral Dissertation]. Erasmus University Medical Center; 2012. Available from: http://hdl.handle.net/1765/41031

Georgia State University

19. Lind, Jennifer N. Maternal Medication Use and Risk of Hypospadias- An Exposure Spectrum Approach.

Degree: MPH, Public Health, 2012, Georgia State University

URL: https://scholarworks.gsu.edu/iph_theses/207

► Purpose To investigate associations between maternal use of selected medications during early pregnancy and the risk of hypospadias in male infants. Methods We used… (more)

Subjects/Keywords: medications during pregnancy; hypospadias; birth defects; drug safety

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APA (6^th Edition):

Lind, J. N. (2012). Maternal Medication Use and Risk of Hypospadias- An Exposure Spectrum Approach. (Thesis). Georgia State University. Retrieved from https://scholarworks.gsu.edu/iph_theses/207

Note: this citation may be lacking information needed for this citation format:
Not specified: Masters Thesis or Doctoral Dissertation

Chicago Manual of Style (16^th Edition):

Lind, Jennifer N. “Maternal Medication Use and Risk of Hypospadias- An Exposure Spectrum Approach.” 2012. Thesis, Georgia State University. Accessed March 05, 2021. https://scholarworks.gsu.edu/iph_theses/207.

Note: this citation may be lacking information needed for this citation format:
Not specified: Masters Thesis or Doctoral Dissertation

MLA Handbook (7^th Edition):

Lind, Jennifer N. “Maternal Medication Use and Risk of Hypospadias- An Exposure Spectrum Approach.” 2012. Web. 05 Mar 2021.

Vancouver:

Lind JN. Maternal Medication Use and Risk of Hypospadias- An Exposure Spectrum Approach. [Internet] [Thesis]. Georgia State University; 2012. [cited 2021 Mar 05]. Available from: https://scholarworks.gsu.edu/iph_theses/207.

Note: this citation may be lacking information needed for this citation format:
Not specified: Masters Thesis or Doctoral Dissertation

Council of Science Editors:

Lind JN. Maternal Medication Use and Risk of Hypospadias- An Exposure Spectrum Approach. [Thesis]. Georgia State University; 2012. Available from: https://scholarworks.gsu.edu/iph_theses/207

Note: this citation may be lacking information needed for this citation format:
Not specified: Masters Thesis or Doctoral Dissertation

University of Oulu

20. Laatikainen, O. (Outi). Medication-related adverse events in health care.

Degree: 2020, University of Oulu

URL: http://urn.fi/urn:isbn:9789526225135

►

Abstract Medication-related adverse events include adverse drug events either directly or indirectly related to the drug’s pharmacology, as well as medication errors, i.e. errors in… (more)

▼

Abstract Medication-related adverse events include adverse drug events either directly or indirectly related to the drug’s pharmacology, as well as medication errors, i.e. errors in the medication process. Medication-related adverse events are common issue in both the inpatient and outpatient setting affecting approximately 20% of hospitalized patients and causing 3–5% of unplanned hospital admissions in the adult population. Although medication-related adverse events are common in all age groups, geriatric patients have been found especially susceptible to them. With the estimates of increased life expectancy and higher consumption of medicines in the future, there has been a growing pressure for more efficient detection and prevention of medication-related adverse events. The objective of this study was to form a comprehensive overview of medication-related adverse events around the Finnish tertiary care by describing both adverse drug events and medication errors occurring in this setting. The results of this research project demonstrated that adverse drug events affect approximately every fifth patient during hospital admission and that one third of these events are preventable. Most of adverse drug events and medication errors occur with medicines from commonly used ATC groups, the largest group being the N (Nervous class) medicines. Medication-related adverse events were also identified as a burdening factor to the health care organizations, as it was estimated that 23% of the unplanned geriatric hospital admissions resulted from adverse drug events. This research project was the first to describe the overall situation of medication-related adverse events in the Finnish tertiary care by utilizing the national medication safety incident report (Haipro) data. It emphasized the importance of medication safety research in the development of adverse event detection and prevention methods. The results of this research project create opportunities for further development of both national medication safety and patient safety.

Tiivistelmä Lääkkeisiin liittyviin haittatapahtumiin luetaan sekä lääkkeen farmakologiaan suorasti tai epäsuorasti liittyvät lääkehaitat, että lääkehoidon prosessin virheinä ilmenevät lääkityspoikkeamat. Lääkehaitat ja lääkityspoikkeamat ovat yleinen ongelma niin sairaaloissa kuin avohoidon puolellakin koskettaen arviolta 20 % sairaalassa hoidetuista potilaista ja aiheuttaen arviolta 3–5 % kaikista aikuisväestön päivystyskäynneistä. Vaikka lääkehaittoja esiintyy yleisesti koko väestön tasolla, ovat iäkkäät potilaat niille erityisen alttiita. Väestön ikärakenteen muutos sekä lääkkeiden kasvava kulutus luovat paineita lääkkeisiin liittyvien haittatapahtumien entistä tehokkaammalle tunnistamiselle ja ennaltaehkäisylle tulevaisuudessa. Tämän työn tarkoituksena oli muodostaa kokonaiskäsitys lääkkeisiin liittyvistä haittatapahtumista kuvaamalla sekä lääkehaittojen että lääkityspoikkeamien ilmenemistä erikoissairaanhoidon ympärillä. Työssä lääkehaittoja havaittiin arviolta joka viidennellä…

Advisors/Committee Members: Turpeinen, M. (Miia), Sneck, S. (Sami).

Subjects/Keywords: adverse drug event; health care; medication error; medication safety; patient safety; pharmacoepidemiology; tertiary care; erikoissairaanhoito; lääkehaitta; lääkityspoikkeama; lääkitysturvallisuus; potilasturvallisuus; terveydenhuolto

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APA · Chicago · MLA · Vancouver · CSE | Export to Zotero / EndNote / Reference Manager

APA (6^th Edition):

Laatikainen, O. (. (2020). Medication-related adverse events in health care. (Doctoral Dissertation). University of Oulu. Retrieved from http://urn.fi/urn:isbn:9789526225135

Chicago Manual of Style (16^th Edition):

Laatikainen, O (Outi). “Medication-related adverse events in health care.” 2020. Doctoral Dissertation, University of Oulu. Accessed March 05, 2021. http://urn.fi/urn:isbn:9789526225135.

MLA Handbook (7^th Edition):

Laatikainen, O (Outi). “Medication-related adverse events in health care.” 2020. Web. 05 Mar 2021.

Vancouver:

Laatikainen O(. Medication-related adverse events in health care. [Internet] [Doctoral dissertation]. University of Oulu; 2020. [cited 2021 Mar 05]. Available from: http://urn.fi/urn:isbn:9789526225135.

Council of Science Editors:

Laatikainen O(. Medication-related adverse events in health care. [Doctoral Dissertation]. University of Oulu; 2020. Available from: http://urn.fi/urn:isbn:9789526225135

University of Oulu

21. Sneck, S. (Sami). Sairaanhoitajien lääkehoidon osaaminen ja osaamisen varmistaminen.

Degree: 2016, University of Oulu

URL: http://urn.fi/urn:isbn:9789526210667

►

Abstract According to the law patients have a right to good care and the care has to be of a high level, safe and evidence… (more)

▼

Abstract According to the law patients have a right to good care and the care has to be of a high level, safe and evidence based. Medication has been found to be a nursing procedure that is associated with many risks. It has been documented that mistakes occur even in every fifth medication event. All Finnish nurses have been trained to carry out advanced medication and iv-therapy, and it is the nurses who are the main administrators of medication in the health care units. For these reasons nurses' medication competence is important. The constant development of medical treatment increases the demands of nurses' competence in medication. The aim of the study was to describe and to explain the medication competence of nurses assessed by themselves and according to theoretical and online exams. The aim was to describe the nurses' perceptions of the verification process of medication competence and e-learning as the method for verification. The quantitative data of the study consisted of 692 nurses´ self-assessment of medication competence and of 2479 nurses' results on theoretical and drug calculation exams. The qualitative data consisted of 342 nurses' perceptions of the verification and e-learning. In the theoretical exam the nurses had 84,9% correct answers while the required level to pass was 75%. The nurses themselves considered their medication competence to be good. Challenges were found most in the areas of anatomy, physiology and pharmacology, and in reading of professional and scholarly literature. About 5% of the nurses had persistent problems in the drug calculations. Diluting and solution calculations were the most challenging ones. The nurses who had taken the online course considered their medication competence better than the other nurses. The ones who regularly administer advanced medication and iv-therapy in their daily work considered their medication competence better than the other nurses. The nurses accepted the verification process of medication competence, and e-learning was considered a sound teaching method. Some of the nurses criticised the present model of verification and they wished for verification that is better targeted to their daily duties. In addition to e-learning they wished for other teaching methods. A nationally and even internationally standardised model needs to be developed for verification of nurses’ medication competence.

Tiivistelmä Potilailla on lain mukaan oikeus hyvään hoitoon, ja hoidon tulee olla korkeatasoista, turvallista ja näyttöön perustuvaa. Lääkehoito on todettu riskialttiiksi tehtäväksi. Jopa joka viidennessä lääkitystapahtumassa on havaittu tapahtuvan virheitä. Kaikki suomalaiset sairaanhoitajat ovat saaneet koulutuksen vaativan neste- ja lääkehoidon toteuttamiseen, ja sairaanhoitajat ovatkin terveydenhuollon toimintayksiköissä keskeisiä lääkehoidon toteuttajia. Näistä syistä sairaanhoitajien lääkehoidon osaaminen on tärkeää. Lääkehoidon jatkuva kehittyminen lisää sairaanhoitajien osaamisen vaatimuksia. Tämän tutkimuksen tarkoituksena oli kuvata ja…

Advisors/Committee Members: Isola, A. (Arja), Saarnio, R. (Reetta).

Subjects/Keywords: competence; drug calculations; drug therapy; iv-therapy; medication safety; nurses; lääkehoito; lääkelaskenta; lääkitysturvallisuus; nestehoito; osaaminen; sairaanhoitajat

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APA · Chicago · MLA · Vancouver · CSE | Export to Zotero / EndNote / Reference Manager

APA (6^th Edition):

Sneck, S. (. (2016). Sairaanhoitajien lääkehoidon osaaminen ja osaamisen varmistaminen. (Doctoral Dissertation). University of Oulu. Retrieved from http://urn.fi/urn:isbn:9789526210667

Chicago Manual of Style (16^th Edition):

Sneck, S (Sami). “Sairaanhoitajien lääkehoidon osaaminen ja osaamisen varmistaminen.” 2016. Doctoral Dissertation, University of Oulu. Accessed March 05, 2021. http://urn.fi/urn:isbn:9789526210667.

MLA Handbook (7^th Edition):

Sneck, S (Sami). “Sairaanhoitajien lääkehoidon osaaminen ja osaamisen varmistaminen.” 2016. Web. 05 Mar 2021.

Vancouver:

Sneck S(. Sairaanhoitajien lääkehoidon osaaminen ja osaamisen varmistaminen. [Internet] [Doctoral dissertation]. University of Oulu; 2016. [cited 2021 Mar 05]. Available from: http://urn.fi/urn:isbn:9789526210667.

Council of Science Editors:

Sneck S(. Sairaanhoitajien lääkehoidon osaaminen ja osaamisen varmistaminen. [Doctoral Dissertation]. University of Oulu; 2016. Available from: http://urn.fi/urn:isbn:9789526210667

Freie Universität Berlin

22. Andersohn, Frank. Post-marketing identification of adverse drug effects.

Degree: 2011, Freie Universität Berlin

URL: http://dx.doi.org/10.17169/refubium-5065

► Despite availability of drug safety information from pre-marketing studies, important adverse drug reactions are often identified or characterized only after drug approval. Reasons include the… (more)

▼ Despite availability of drug safety information from pre-marketing studies, important adverse drug reactions are often identified or characterized only after drug approval. Reasons include the rather low number of exposed subjects in pre-marketing trials; the exclusion of special patient populations (e.g. patients with comorbidities; children; elderly); the limited duration of the studies; and the strictly controlled and thus rather artificial environment in which these studies were performed. For these reasons, there is a clear need for pharmacovigilance methods allowing monitoring the safety of newly marketed drugs as well as identification of new risks. Analyses of individual case reports of adverse drug reactions using causality assessment; quantitative signal detection; and observational pharmacoepidemiological studies are the most important methods for post-marketing identification of adverse drug reactions. Aims of the presented studies were to identify important adverse drug reactions using these different methods. Published case reports and case series were used to identify potential causes of non-chemotherapy drug induced agranulocytosis after performing a systematic causality re-assessment. In addition, mean latency periods between start of drug exposure and disease onset; patient characteristics; use of specific therapeutic interventions; and the typical course of agranulocytosis were analyzed. There were 36 drugs with at least one case reports classified as definitely related to occurrence of agranulocytosis; and 89 drugs with at least one report classified as probably related. For 24 drugs, available data allowed calculating the duration of drug exposure before onset of agranulocytosis. The duration ranged between 2 days for metamizole (dipyrone) and 60 days for levamisole. A time-trend analysis indicated that case fatality decreased substantially over time. Case fatality was 17% during 1966-1980, 11% during 1981-1990, and 6% during 1991-2006. Case fatality in patients with and without treatment with G-CSF did not differ, but the composite endpoint of infectious complications or fatality occurred less often in patients treated with G-CSF. Another important risk factor for infectious complications or death was a low nadir of neutrophils (<100/µl). Signal detection with dysproportionality analyses of the database of adverse drug reactions of the US Food and Drug Administration (FDA AERS database) were used to study the relationship between dopamine agonists and occurrence of fibrotic reactions and the relationship between antipsychotics and priapism. For fibrotic reactions, there were signals for ergot-derived dopamine agonists as a group, as well as for the individual drugs bromocriptine, cabergoline and pergolide. In contrast, no signals were identified for non-ergot derived dopamine agonists (pramipexole, ropinirol, rotigotine). The analysis of reports of priapism revealed a strong signal for antipsychotics with high affinity to alpha-1 adrenoceptors, while only a week signal was present for… Advisors/Committee Members: m (gender), Prof. Dr. Petra Thürmann (firstReferee), Prof. Dr. Joerg Hasford (furtherReferee).

Subjects/Keywords: pharmacoepidemiology; pharmacovigilance; drug safety; post marketing surveillance; adverse drug effects; 600 Technik, Medizin, angewandte Wissenschaften::610 Medizin und Gesundheit

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APA · Chicago · MLA · Vancouver · CSE | Export to Zotero / EndNote / Reference Manager

APA (6^th Edition):

Andersohn, F. (2011). Post-marketing identification of adverse drug effects. (Thesis). Freie Universität Berlin. Retrieved from http://dx.doi.org/10.17169/refubium-5065

Note: this citation may be lacking information needed for this citation format:
Not specified: Masters Thesis or Doctoral Dissertation

Chicago Manual of Style (16^th Edition):

Andersohn, Frank. “Post-marketing identification of adverse drug effects.” 2011. Thesis, Freie Universität Berlin. Accessed March 05, 2021. http://dx.doi.org/10.17169/refubium-5065.

Note: this citation may be lacking information needed for this citation format:
Not specified: Masters Thesis or Doctoral Dissertation

MLA Handbook (7^th Edition):

Andersohn, Frank. “Post-marketing identification of adverse drug effects.” 2011. Web. 05 Mar 2021.

Vancouver:

Andersohn F. Post-marketing identification of adverse drug effects. [Internet] [Thesis]. Freie Universität Berlin; 2011. [cited 2021 Mar 05]. Available from: http://dx.doi.org/10.17169/refubium-5065.

Note: this citation may be lacking information needed for this citation format:
Not specified: Masters Thesis or Doctoral Dissertation

Council of Science Editors:

Andersohn F. Post-marketing identification of adverse drug effects. [Thesis]. Freie Universität Berlin; 2011. Available from: http://dx.doi.org/10.17169/refubium-5065

Note: this citation may be lacking information needed for this citation format:
Not specified: Masters Thesis or Doctoral Dissertation

Freie Universität Berlin

23. Matthes, Harald. Assessment of drug indications, safety, effectiveness and benefits in conventional and complementary medicine with specific attention to anthroposophic medicine facilitated by an electronic network of medical practitioners (EvaMed).

Degree: 2011, Freie Universität Berlin

URL: https://refubium.fu-berlin.de/handle/fub188/10679

► A network dealing with the topic of anthroposophic medicine and encompassing general practitioners, specialists and clinics has been set up on a specially developed web-based… (more)

▼ A network dealing with the topic of anthroposophic medicine and encompassing general practitioners, specialists and clinics has been set up on a specially developed web-based internet platform. The EvaMed network was able to record the largest cohorts actually using complementary and integrative medicine in Germany. It consequently succeeded in ascertaining the indications of a wide range of drugs with no indications (so-called registered drugs), recording the structure of therapy concepts and drawing comparisons with regular treatment regimes. The actual provision of AM in specific age groups such as children, adults, seniors and the very old compared to cohorts treated by conventional medicine was determined by means of special subgroup analyses and compared with average cohorts in Germany. One significant finding of these analyses was that the actual provision of AM corresponds to an integrative medicine model, i.e. conventional and complementary therapies are used to obtain a form of “best practice”. At the same time, conventional drug therapy largely conforms with current guidelines (e.g. as regards infections of the respiratory tract, hypertension etc.) and is usually supplemented by drugs prescribed in specific forms of therapy (anthroposophic, homeopathic and herbal remedies). Establishing a drug vigilance network made it possible to ascertain the safety of a wide range of drug groups in certain forms of therapy, particularly anthroposophic medicine. The number of reports increased markedly after the doctors underwent a special training programme. The effectiveness and sustainability of such training programmes for drug vigilance networks was evaluated. The Oncology Network (ON) keeps records of anthroposophical clinics and practices focusing on oncology which actually provide anthroposophical therapies. Here it was established that the oncological services actually provided make up an integrative model of treatment encompassing standard conventional cancer therapies supplemented with complementary or anthroposophical treatments. The complementary treatment most frequently used in the field of oncology is mistletoe therapy. Preliminary analyses indicated that mistletoe therapy has a positive effect on the patient’s quality of life and survival period. Comparisons of cohorts made it possible to determine drug use and the indications, effectiveness, safety and side-effects of various treatment concepts customarily used in children, adults, seniors and the very old in anthroposophic medicine and to compare them with average cohorts in Germany. The EvaMed project, comprising a network recording the actual provisions of one of the three special forms of therapy. has confirmed the feasibility of such a project in the field of supply research, with the result that this structure is also to be applied to homeopathic and naturopathic or alternative medicine (in the place of phytotherapy) and expanded accordingly. Homeopathy in particular largely uses registered drugs with no special indications, which means that… Advisors/Committee Members: [email protected] (contact), m (gender), Prof. Dr. med. Gustav Dobosch, Essen (firstReferee), Prof. Dr. med. Petra Thürmann, Witten/Herdecke (furtherReferee).

Subjects/Keywords: public health; electronic network; pharmacovigilance; drug safety; drug vigilance network; anthroposophic medicine; 600 Technik, Medizin, angewandte Wissenschaften::610 Medizin und Gesundheit

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APA · Chicago · MLA · Vancouver · CSE | Export to Zotero / EndNote / Reference Manager

APA (6^th Edition):

Matthes, H. (2011). Assessment of drug indications, safety, effectiveness and benefits in conventional and complementary medicine with specific attention to anthroposophic medicine facilitated by an electronic network of medical practitioners (EvaMed). (Thesis). Freie Universität Berlin. Retrieved from https://refubium.fu-berlin.de/handle/fub188/10679

Note: this citation may be lacking information needed for this citation format:
Not specified: Masters Thesis or Doctoral Dissertation

Chicago Manual of Style (16^th Edition):

Matthes, Harald. “Assessment of drug indications, safety, effectiveness and benefits in conventional and complementary medicine with specific attention to anthroposophic medicine facilitated by an electronic network of medical practitioners (EvaMed).” 2011. Thesis, Freie Universität Berlin. Accessed March 05, 2021. https://refubium.fu-berlin.de/handle/fub188/10679.

Note: this citation may be lacking information needed for this citation format:
Not specified: Masters Thesis or Doctoral Dissertation

MLA Handbook (7^th Edition):

Matthes, Harald. “Assessment of drug indications, safety, effectiveness and benefits in conventional and complementary medicine with specific attention to anthroposophic medicine facilitated by an electronic network of medical practitioners (EvaMed).” 2011. Web. 05 Mar 2021.

Vancouver:

Matthes H. Assessment of drug indications, safety, effectiveness and benefits in conventional and complementary medicine with specific attention to anthroposophic medicine facilitated by an electronic network of medical practitioners (EvaMed). [Internet] [Thesis]. Freie Universität Berlin; 2011. [cited 2021 Mar 05]. Available from: https://refubium.fu-berlin.de/handle/fub188/10679.

Note: this citation may be lacking information needed for this citation format:
Not specified: Masters Thesis or Doctoral Dissertation

Council of Science Editors:

Matthes H. Assessment of drug indications, safety, effectiveness and benefits in conventional and complementary medicine with specific attention to anthroposophic medicine facilitated by an electronic network of medical practitioners (EvaMed). [Thesis]. Freie Universität Berlin; 2011. Available from: https://refubium.fu-berlin.de/handle/fub188/10679

Note: this citation may be lacking information needed for this citation format:
Not specified: Masters Thesis or Doctoral Dissertation

University of Florida

24. Liu, Wei. Phosphodiesterase Type 5 Inhibitors and Risk of Sudden Sensorineural Hearing Loss a Post-Marketing Safety Study.

Degree: PhD, Pharmaceutical Sciences - Pharmaceutical Outcomes and Policy, 2014, University of Florida

URL: https://ufdc.ufl.edu/UFE0047028

► Several case reports published around 2007 suggest that phosphodiesterase type 5 (PDE5) inhibitor use might increase the risk of sudden sensorineural hearing loss (SSHL). We… (more)

Subjects/Keywords: Databases; Disease risks; Diseases; Dosage; Drug prescriptions; Hearing loss; Impotence; Insurance risks; Medications; Population estimates; drug – pde5 – pharmacoepidemiology – safety

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APA · Chicago · MLA · Vancouver · CSE | Export to Zotero / EndNote / Reference Manager

APA (6^th Edition):

Liu, W. (2014). Phosphodiesterase Type 5 Inhibitors and Risk of Sudden Sensorineural Hearing Loss a Post-Marketing Safety Study. (Doctoral Dissertation). University of Florida. Retrieved from https://ufdc.ufl.edu/UFE0047028

Chicago Manual of Style (16^th Edition):

Liu, Wei. “Phosphodiesterase Type 5 Inhibitors and Risk of Sudden Sensorineural Hearing Loss a Post-Marketing Safety Study.” 2014. Doctoral Dissertation, University of Florida. Accessed March 05, 2021. https://ufdc.ufl.edu/UFE0047028.

MLA Handbook (7^th Edition):

Liu, Wei. “Phosphodiesterase Type 5 Inhibitors and Risk of Sudden Sensorineural Hearing Loss a Post-Marketing Safety Study.” 2014. Web. 05 Mar 2021.

Vancouver:

Liu W. Phosphodiesterase Type 5 Inhibitors and Risk of Sudden Sensorineural Hearing Loss a Post-Marketing Safety Study. [Internet] [Doctoral dissertation]. University of Florida; 2014. [cited 2021 Mar 05]. Available from: https://ufdc.ufl.edu/UFE0047028.

Council of Science Editors:

Liu W. Phosphodiesterase Type 5 Inhibitors and Risk of Sudden Sensorineural Hearing Loss a Post-Marketing Safety Study. [Doctoral Dissertation]. University of Florida; 2014. Available from: https://ufdc.ufl.edu/UFE0047028

25. Magnusson, Otto. Investigating flow-related effects of Chronic Kidney Disease on renal drug toxicity in a human-derived proximal tubule microphysiological system .

Degree: Chalmers tekniska högskola / Institutionen för fysik, 2020, Chalmers University of Technology

URL: http://hdl.handle.net/20.500.12380/301122

► The kidney proximal tubule is responsible for the active expulsion of drugs from the blood to the urine and is, therefore, of great importance when… (more)

▼ The kidney proximal tubule is responsible for the active expulsion of drugs from the blood to the urine and is, therefore, of great importance when evaluating drug safety. Chronic kidney disease (CKD) is a major cause of reduced renal filtration function, reducing the fluid forces experienced by human renal proximal tubule eptihelial cells (HRPTEC). Developing a physiologically representative in vitro model for drug toxicity studies in both healthy and diseased HRPTEC would therefore be highly valuable. As CKD is a major cause of reduced renal function and may affect the function of proximal tubule cells, this thesis focused on the investigation of how flow-related aspects of chronic kidney disease affects drug transport and toxicity in HRPTEC cultured in 3D in the Nortis microphysiological system. qPCR was used to evaluate differential gene expression of drug transporters, proximal tubule and stress markers in response to flow exposure and nutrient deprivation in 3D and 2D cultured HRPTEC, alongside LDH in the supernatant and Live/Dead stain to evaluate cell viability. Phenotype by gene expression remained unchanged in the 3D proximal tubule model when exposed to a 5 week 2-fold increase to fluid shear stress (FSS) from 0.9 to 1.7 dyne/cm2, as well as in 2D cultures exposed to orbital flow (1.9 or 5.3 dyne/cm2) for 1 week compared to static cultures. 2D cultured cells also displayed no change to transport (P-gp) function in response to orbital flow when evaluated with Calcein-AM. Interestingly, gene expression of several drug transporters was increased in 3D HRPTEC cultures (1, 5 weeks) compared to 2D, including regained expression of OAT1 and OAT3 and upregulation of OCT2 (SLC22A2, 3.6 ± 1.1 fold [5 weeks]), MATE1 (SLC47A1, 41.3 ± 3.4 fold, 33.2 ± 13.2 fold), MATE2-K (SLC47A2, 71.9 ± 8.9 fold , 99.6 ± 61.7 fold) and the endocytosis receptor Megalin (LRP2, 46.7 ± 13.1 fold, 67.5 ± 34.1 fold). Moreover, this phenotype remained stable from 1 to 5 weeks in culture. The antibiotic polymyxin B (50 μM, 48 h) showing reduced viability to 83 ± 7.0% as evaluated by Live/Dead stain, demonstrating sensitivity to know nephrotoxicants in 3D cultured HRPTEC. Phenotype by gene expression was unaffected by nutrient and flow deprivation for 3 days. Although the aim of replicating flow related aspects of chronic kidney disease in the 3D proximal tubule model used in this study was not achieved, it was established that the 3D model displayed stable phenotype for up to five weeks with regained and significantly increased expression of drug transporter and endocytosis receptor genes when compared to 2D cultured cells. This suggests that the 3D proximal tubule model used in this study is a more physiologically relevant model for future long-term drug toxicity studies.

Subjects/Keywords: chronic kidney disease; 3D in vitro model; drug safety; drug toxicity and transport; primary human proximal tubule cells; microfluidics; microphysiological system

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APA (6^th Edition):

Magnusson, O. (2020). Investigating flow-related effects of Chronic Kidney Disease on renal drug toxicity in a human-derived proximal tubule microphysiological system . (Thesis). Chalmers University of Technology. Retrieved from http://hdl.handle.net/20.500.12380/301122

Note: this citation may be lacking information needed for this citation format:
Not specified: Masters Thesis or Doctoral Dissertation

Chicago Manual of Style (16^th Edition):

Magnusson, Otto. “Investigating flow-related effects of Chronic Kidney Disease on renal drug toxicity in a human-derived proximal tubule microphysiological system .” 2020. Thesis, Chalmers University of Technology. Accessed March 05, 2021. http://hdl.handle.net/20.500.12380/301122.

Note: this citation may be lacking information needed for this citation format:
Not specified: Masters Thesis or Doctoral Dissertation

MLA Handbook (7^th Edition):

Magnusson, Otto. “Investigating flow-related effects of Chronic Kidney Disease on renal drug toxicity in a human-derived proximal tubule microphysiological system .” 2020. Web. 05 Mar 2021.

Vancouver:

Magnusson O. Investigating flow-related effects of Chronic Kidney Disease on renal drug toxicity in a human-derived proximal tubule microphysiological system . [Internet] [Thesis]. Chalmers University of Technology; 2020. [cited 2021 Mar 05]. Available from: http://hdl.handle.net/20.500.12380/301122.

Note: this citation may be lacking information needed for this citation format:
Not specified: Masters Thesis or Doctoral Dissertation

Council of Science Editors:

Magnusson O. Investigating flow-related effects of Chronic Kidney Disease on renal drug toxicity in a human-derived proximal tubule microphysiological system . [Thesis]. Chalmers University of Technology; 2020. Available from: http://hdl.handle.net/20.500.12380/301122

Note: this citation may be lacking information needed for this citation format:
Not specified: Masters Thesis or Doctoral Dissertation

University of Georgia

26. Fuhrman, Shane Allen. Stereotypes and medical marijuana in the workplace.

Degree: 2014, University of Georgia

URL: http://hdl.handle.net/10724/28522

► Marijuana is growing in acceptance as a legitimate form of treatment for many disorders, injuries, and illnesses. However, due in large part to Federal law… (more)

Subjects/Keywords: policy capturing; medicinal marijuana; marijuana; drug-use; job performance; workplace safety; stereotype; recreational; co-worker

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APA · Chicago · MLA · Vancouver · CSE | Export to Zotero / EndNote / Reference Manager

APA (6^th Edition):

Fuhrman, S. A. (2014). Stereotypes and medical marijuana in the workplace. (Thesis). University of Georgia. Retrieved from http://hdl.handle.net/10724/28522

Note: this citation may be lacking information needed for this citation format:
Not specified: Masters Thesis or Doctoral Dissertation

Chicago Manual of Style (16^th Edition):

Fuhrman, Shane Allen. “Stereotypes and medical marijuana in the workplace.” 2014. Thesis, University of Georgia. Accessed March 05, 2021. http://hdl.handle.net/10724/28522.

Note: this citation may be lacking information needed for this citation format:
Not specified: Masters Thesis or Doctoral Dissertation

MLA Handbook (7^th Edition):

Fuhrman, Shane Allen. “Stereotypes and medical marijuana in the workplace.” 2014. Web. 05 Mar 2021.

Vancouver:

Fuhrman SA. Stereotypes and medical marijuana in the workplace. [Internet] [Thesis]. University of Georgia; 2014. [cited 2021 Mar 05]. Available from: http://hdl.handle.net/10724/28522.

Note: this citation may be lacking information needed for this citation format:
Not specified: Masters Thesis or Doctoral Dissertation

Council of Science Editors:

Fuhrman SA. Stereotypes and medical marijuana in the workplace. [Thesis]. University of Georgia; 2014. Available from: http://hdl.handle.net/10724/28522

Note: this citation may be lacking information needed for this citation format:
Not specified: Masters Thesis or Doctoral Dissertation

University of Waterloo

27. Whaley, Colin. Perspectives from Pharmacists, Prescribers and Patients on Sharing Medication Reason for Use.

Degree: 2020, University of Waterloo

URL: http://hdl.handle.net/10012/15817

► Pharmacists rarely receive the reason a medication was prescribed, often referred to as reason for use (RFU). Pharmacists can use this information to better counsel… (more)

Subjects/Keywords: reason for use; medication; drug safety; pharmacy services; primary care; medication therapy management; medication adherence

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APA (6^th Edition):

Whaley, C. (2020). Perspectives from Pharmacists, Prescribers and Patients on Sharing Medication Reason for Use. (Thesis). University of Waterloo. Retrieved from http://hdl.handle.net/10012/15817

Note: this citation may be lacking information needed for this citation format:
Not specified: Masters Thesis or Doctoral Dissertation

Chicago Manual of Style (16^th Edition):

Whaley, Colin. “Perspectives from Pharmacists, Prescribers and Patients on Sharing Medication Reason for Use.” 2020. Thesis, University of Waterloo. Accessed March 05, 2021. http://hdl.handle.net/10012/15817.

Note: this citation may be lacking information needed for this citation format:
Not specified: Masters Thesis or Doctoral Dissertation

MLA Handbook (7^th Edition):

Whaley, Colin. “Perspectives from Pharmacists, Prescribers and Patients on Sharing Medication Reason for Use.” 2020. Web. 05 Mar 2021.

Vancouver:

Whaley C. Perspectives from Pharmacists, Prescribers and Patients on Sharing Medication Reason for Use. [Internet] [Thesis]. University of Waterloo; 2020. [cited 2021 Mar 05]. Available from: http://hdl.handle.net/10012/15817.

Note: this citation may be lacking information needed for this citation format:
Not specified: Masters Thesis or Doctoral Dissertation

Council of Science Editors:

Whaley C. Perspectives from Pharmacists, Prescribers and Patients on Sharing Medication Reason for Use. [Thesis]. University of Waterloo; 2020. Available from: http://hdl.handle.net/10012/15817

Note: this citation may be lacking information needed for this citation format:
Not specified: Masters Thesis or Doctoral Dissertation

University of KwaZulu-Natal

28. Misra, Reshma. Proliferation of klebsiella pneumoniae in medication containing vials for multiple dose medication and intravenous fluids.

Degree: 2019, University of KwaZulu-Natal

URL: https://researchspace.ukzn.ac.za/handle/10413/17367

► Background and objectives: Klebsiella pneumoniae is frequently implicated in healthcare associated infections. This organism is non–fastidious and easily transmitted in a healthcare environment. Medication fluids… (more)

Subjects/Keywords: Infection prevention.; Multiple vials.; Healthcare infections.; Patient safety.; Drug shortages.; Medication vials.

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APA (6^th Edition):

Misra, R. (2019). Proliferation of klebsiella pneumoniae in medication containing vials for multiple dose medication and intravenous fluids. (Thesis). University of KwaZulu-Natal. Retrieved from https://researchspace.ukzn.ac.za/handle/10413/17367

Note: this citation may be lacking information needed for this citation format:
Not specified: Masters Thesis or Doctoral Dissertation

Chicago Manual of Style (16^th Edition):

Misra, Reshma. “Proliferation of klebsiella pneumoniae in medication containing vials for multiple dose medication and intravenous fluids.” 2019. Thesis, University of KwaZulu-Natal. Accessed March 05, 2021. https://researchspace.ukzn.ac.za/handle/10413/17367.

Note: this citation may be lacking information needed for this citation format:
Not specified: Masters Thesis or Doctoral Dissertation

MLA Handbook (7^th Edition):

Misra, Reshma. “Proliferation of klebsiella pneumoniae in medication containing vials for multiple dose medication and intravenous fluids.” 2019. Web. 05 Mar 2021.

Vancouver:

Misra R. Proliferation of klebsiella pneumoniae in medication containing vials for multiple dose medication and intravenous fluids. [Internet] [Thesis]. University of KwaZulu-Natal; 2019. [cited 2021 Mar 05]. Available from: https://researchspace.ukzn.ac.za/handle/10413/17367.

Note: this citation may be lacking information needed for this citation format:
Not specified: Masters Thesis or Doctoral Dissertation

Council of Science Editors:

Misra R. Proliferation of klebsiella pneumoniae in medication containing vials for multiple dose medication and intravenous fluids. [Thesis]. University of KwaZulu-Natal; 2019. Available from: https://researchspace.ukzn.ac.za/handle/10413/17367

Note: this citation may be lacking information needed for this citation format:
Not specified: Masters Thesis or Doctoral Dissertation

University of Illinois – Chicago

29. Adimadhyam, Sruthi. Comparative Safety of Sodium-Glucose Co-Transporter 2 Inhibitors.

Degree: 2018, University of Illinois – Chicago

URL: http://hdl.handle.net/10027/23328

► More than 30 million people living in the US have diabetes. Over time, increased concentrations of glucose in the blood lead to cellular damage and… (more)

▼ More than 30 million people living in the US have diabetes. Over time, increased concentrations of glucose in the blood lead to cellular damage and cause a variety of serious complications in these individuals. Sodium-Glucose Co-Transporter 2 Inhibitors (SGLT2i) are the latest class of oral antidiabetic medications approved for use in the US. They work by blocking the resorption of glucose in the kidney thereby increasing urinary glucose excretion. Due to their distinct mechanism of action, these drugs demonstrate cardio- and reno-protective effects in addition to their antihyperglycemic effect. However, clinical trials report an increased risk for adverse events such as amputations, fractures, and mycotic infections raising concerns about their safety. The objective of this dissertation was to evaluate the comparative safety of these drugs in a real-world setting outside of clinical trials. Three observational studies were conducted using prescription and medical insurance data from Truven Health MarketScan Databases (2009-2015). The first study investigated the association between SGLT2i and amputations and concluded that the potential for harm cannot be ruled out. While there was a 38% increase in risk for amputations following initiation of treatment with SGLT2i, the 95% confidence interval included the null. The second study investigated the association between SGLT2i and fractures. There was an 82% increase in risk for fractures early in treatment with SGLT2i. Beyond the initial 2-week treatment period, there was no apparent effect on fracture risk. The third study investigated the association between SGLT2i and mycotic infections. There was a 53% increase in risk for mycotic infections within the first 90 days of treatment with SGLT2i. This dissertation evaluated the post-marketing safety of this new class of antidiabetic medications in a real-world setting. Evidence from such observational studies can supplement that from clinical trials to more thoroughly inform decision-making. Findings from this research can help clinicians understand patients at high-risk for experiencing these events and devise remedial measures in anticipation. Advisors/Committee Members: Schumock, Glen T (advisor), Lee, Todd A (committee member), Calip, Gregory S (committee member), Smith Marsh, Daphne E (committee member), Layden, Brian T (committee member), Schumock, Glen T (chair).

Subjects/Keywords: pharmacoepidemiology; drug safety; SGLT2 inhibitors; type 2 diabetes; amputations; fractures; mycotic infections

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APA · Chicago · MLA · Vancouver · CSE | Export to Zotero / EndNote / Reference Manager

APA (6^th Edition):

Adimadhyam, S. (2018). Comparative Safety of Sodium-Glucose Co-Transporter 2 Inhibitors. (Thesis). University of Illinois – Chicago. Retrieved from http://hdl.handle.net/10027/23328

Note: this citation may be lacking information needed for this citation format:
Not specified: Masters Thesis or Doctoral Dissertation

Chicago Manual of Style (16^th Edition):

Adimadhyam, Sruthi. “Comparative Safety of Sodium-Glucose Co-Transporter 2 Inhibitors.” 2018. Thesis, University of Illinois – Chicago. Accessed March 05, 2021. http://hdl.handle.net/10027/23328.

Note: this citation may be lacking information needed for this citation format:
Not specified: Masters Thesis or Doctoral Dissertation

MLA Handbook (7^th Edition):

Adimadhyam, Sruthi. “Comparative Safety of Sodium-Glucose Co-Transporter 2 Inhibitors.” 2018. Web. 05 Mar 2021.

Vancouver:

Adimadhyam S. Comparative Safety of Sodium-Glucose Co-Transporter 2 Inhibitors. [Internet] [Thesis]. University of Illinois – Chicago; 2018. [cited 2021 Mar 05]. Available from: http://hdl.handle.net/10027/23328.

Note: this citation may be lacking information needed for this citation format:
Not specified: Masters Thesis or Doctoral Dissertation

Council of Science Editors:

Adimadhyam S. Comparative Safety of Sodium-Glucose Co-Transporter 2 Inhibitors. [Thesis]. University of Illinois – Chicago; 2018. Available from: http://hdl.handle.net/10027/23328

Note: this citation may be lacking information needed for this citation format:
Not specified: Masters Thesis or Doctoral Dissertation

30. Kovacs, Stephanie Diane. Assessing the Association between Receipt of Antimalarial Drugs and Adverse Pregnancy Outcomes using Pooled Data.

Degree: PhD, 2016, University of Washington

URL: http://hdl.handle.net/1773/37119

► Malaria is a major cause of maternal morbidity and mortality and neonatal death in areas of malaria transmission. Worldwide, it is responsible for up to… (more)

▼ Malaria is a major cause of maternal morbidity and mortality and neonatal death in areas of malaria transmission. Worldwide, it is responsible for up to 100,000 neonatal deaths and 10,000 maternal deaths annually. There is a need for better information on the safety of antimalarial drugs for women and their fetuses. Artemisinin-based combination therapies (ACT) are the most effective antimalarials, but are associated with teratogenic and embryotoxic effects in animal models when administered in early pregnancy. The limited observational studies in humans reported to-date have been reassuring. We conducted a systematic review and meta-analysis of the occurrence of adverse pregnancy outcomes among women treated with artemisinin monotherapy or artemisinin-based combination therapy during the 2nd or 3rd trimester relative to pregnant women who received non-artemisinin antimalarials or no antimalarial treatments in pregnancy. Pooled odds ratios (POR) were calculated using Mantel-Haenszel fixed effects models with a 0.5 continuity correction for zero events. To assess the risk of congenital malformations after receipt of an ACT during pregnancy, we pooled data from five recently completed randomized-controlled trials (RCT) and one multi-site, observational cohort study from the Malaria in Pregnancy Consortium (MIPc). We calculated prevalence risk ratios (PRR) comparing ACT exposed infants to ACT unexposed infants. From the meta-analysis, the pooled odds ratios (POR) (95% confidence interval (CI)) for stillbirth, fetal loss, and congenital anomalies when comparing artemisinin versus quinine were 0.49 (95% CI 0.24-0.97, I2=0%, 3 studies); 0.58 (95% CI 0.31-1.16, I2=0%, 6 studies); and 1.00 (95% CI 0.27-3.75, I2=0%, 3 studies), respectively. From the pooled analysis, there was no increased risk of congenital anomalies associated with receipt of an ACT during pregnancy compared to no such use (PRR 0.91, 95%CI 0.52-1.58). The PRR for congenital anomalies among the infants of women who received an ACT in the 1st, 2nd, and 3rd trimester compared to infants with no exposure to an ACT were 1.54 (95% CI 0.55-4.34), 0.79 (95%CI 0.47-1.34) and 1.08 (95%CI 0.57-2.07), respectively. Evidence from these studies supports the current WHO guidelines that call for the use of ACTs in 2nd and 3rd trimester to treat malaria. The findings from the analysis of the first trimester exposures and the risk of congenital anomalies are inconclusive due to the small number of malformations observed. Additional pharmacovigilance is recommended to obtain more reassurance of safety. Advisors/Committee Members: Stergachis, Andy (advisor).

Subjects/Keywords: Adverse pregnancy outcome; Artemisinin; Congenital Anomalies; Drug safety; Malaria; Pregnancy; Epidemiology; Public health; epidemiology

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APA · Chicago · MLA · Vancouver · CSE | Export to Zotero / EndNote / Reference Manager

APA (6^th Edition):

Kovacs, S. D. (2016). Assessing the Association between Receipt of Antimalarial Drugs and Adverse Pregnancy Outcomes using Pooled Data. (Doctoral Dissertation). University of Washington. Retrieved from http://hdl.handle.net/1773/37119

Chicago Manual of Style (16^th Edition):

Kovacs, Stephanie Diane. “Assessing the Association between Receipt of Antimalarial Drugs and Adverse Pregnancy Outcomes using Pooled Data.” 2016. Doctoral Dissertation, University of Washington. Accessed March 05, 2021. http://hdl.handle.net/1773/37119.

MLA Handbook (7^th Edition):

Kovacs, Stephanie Diane. “Assessing the Association between Receipt of Antimalarial Drugs and Adverse Pregnancy Outcomes using Pooled Data.” 2016. Web. 05 Mar 2021.

Vancouver:

Kovacs SD. Assessing the Association between Receipt of Antimalarial Drugs and Adverse Pregnancy Outcomes using Pooled Data. [Internet] [Doctoral dissertation]. University of Washington; 2016. [cited 2021 Mar 05]. Available from: http://hdl.handle.net/1773/37119.

Council of Science Editors:

Kovacs SD. Assessing the Association between Receipt of Antimalarial Drugs and Adverse Pregnancy Outcomes using Pooled Data. [Doctoral Dissertation]. University of Washington; 2016. Available from: http://hdl.handle.net/1773/37119

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Open Access Theses and Dissertations