Search results for: Abdulrahman Al Lily
Commenced in January 2007
Frequency: Monthly
Edition: International
Paper Count: 130

Search results for: Abdulrahman Al Lily

10 The Impact of Bilateral Investment Treaties on Health-Related Intellectual Property Rights in the Agreement on Trade-Related Aspects of Intellectual Property Rights in the Kingdom of Saudi Arabia and Australia

Authors: Abdulrahman Fahim M. Alsulami

Abstract:

This paper is dedicated to a detailed investigation of the interaction between the agreement on trade-related aspects of intellectual property rights (TRIPS) and bilateral investment treaties (BITs) in the regulation of health-related intellectual property rights in Australia and the Kingdom of Saudi Arabia. The chosen research object is complex and requires a thorough examination of a set of factors influencing the problem under investigation. At the moment, to the author’s best knowledge’ there is no academic research that would conceptualize and critically compare the regulation of health-related intellectual property rights in these two countries. While there is a substantial amount of information in the literature on certain aspects of the problem, the existing knowledge about certain aspects of the health-related regulatory frameworks in Australia and Saudi Arabia barely explains in detail the specifics of the ways in which the TRIPS agreement interacts with (BITs) in the regulation of health-related intellectual property rights. Therefore, this paper will address an evident research gap by studying an intriguing yet under-researched problem. The paper comprises five subsections. The first subsection provides an overview of the investment climate in Saudi Arabia and Australia with an emphasis on the health care industry. It will cover political, economic, and social factors influencing the investment climate in these countries, the systems of intellectual property rights protection, recent patterns relevant to the investment climate’s development, and key characteristics of the investment climate in the health care industry. The second subsection analyses BITs in Saudi Arabia and Australia in light of the countries’ responsibilities under the TRIPS Agreement. The third subsection provides a critical examination of the interaction between the TRIPS Agreement and BITs in Saudi Arabia on the basis of data collected and analyzed in previous subsections. It will investigate key discrepancies concerning the regulation of health-related intellectual property rights in Saudi Arabia and Australia from the position of BITs’ interaction with the TRIPS Agreement and explore the existing procedures for clarifying priorities between them in regulating health-related intellectual property rights. The fourth subsection of the paper provides recommendations concerning the transformation of BITS into a TRIPS+ dimension in regulating health-related intellectual property rights in Saudi Arabia and Australia. The final subsection provides a summary of differences between the Australian and Saudi BITs from the perspective of the regulation of health-related intellectual property rights under the TRIPS agreement and bilateral investment treaties.

Keywords: Australia, bilateral investment treaties, IP law, public health sector, Saudi Arabia

Procedia PDF Downloads 112
9 Empirical Modeling and Spatial Analysis of Heat-Related Morbidity in Maricopa County, Arizona

Authors: Chuyuan Wang, Nayan Khare, Lily Villa, Patricia Solis, Elizabeth A. Wentz

Abstract:

Maricopa County, Arizona, has a semi-arid hot desert climate that is one of the hottest regions in the United States. The exacerbated urban heat island (UHI) effect caused by rapid urbanization has made the urban area even hotter than the rural surroundings. The Phoenix metropolitan area experiences extremely high temperatures in the summer from June to September that can reach the daily highest of 120 °F (48.9 °C). Morbidity and mortality due to the environmental heat is, therefore, a significant public health issue in Maricopa County, especially because it is largely preventable. Public records from the Maricopa County Department of Public Health (MCDPH) revealed that between 2012 and 2016, there were 10,825 incidents of heat-related morbidity incidents, 267 outdoor environmental heat deaths, and 173 indoor heat-related deaths. A lot of research has examined heat-related death and its contributing factors around the world, but little has been done regarding heat-related morbidity issues, especially for regions that are naturally hot in the summer. The objective of this study is to examine the demographic, socio-economic, housing, and environmental factors that contribute to heat-related morbidity in Maricopa County. We obtained heat-related morbidity data between 2012 and 2016 at census tract level from MCDPH. Demographic, socio-economic, and housing variables were derived using 2012-2016 American Community Survey 5-year estimate from the U.S. Census. Remotely sensed Landsat 7 ETM+ and Landsat 8 OLI satellite images and Level-1 products were acquired for all the summer months (June to September) from 2012 and 2016. The National Land Cover Database (NLCD) 2016 percent tree canopy and percent developed imperviousness data were obtained from the U.S. Geological Survey (USGS). We used ordinary least squares (OLS) regression analysis to examine the empirical relationship between all the independent variables and heat-related morbidity rate. Results showed that higher morbidity rates are found in census tracts with higher values in population aged 65 and older, population under poverty, disability, no vehicle ownership, white non-Hispanic, population with less than high school degree, land surface temperature, and surface reflectance, but lower values in normalized difference vegetation index (NDVI) and housing occupancy. The regression model can be used to explain up to 59.4% of total variation of heat-related morbidity in Maricopa County. The multiscale geographically weighted regression (MGWR) technique was then used to examine the spatially varying relationships between heat-related morbidity rate and all the significant independent variables. The R-squared value of the MGWR model increased to 0.691, that shows a significant improvement in goodness-of-fit than the global OLS model, which means that spatial heterogeneity of some independent variables is another important factor that influences the relationship with heat-related morbidity in Maricopa County. Among these variables, population aged 65 and older, the Hispanic population, disability, vehicle ownership, and housing occupancy have much stronger local effects than other variables.

Keywords: census, empirical modeling, heat-related morbidity, spatial analysis

Procedia PDF Downloads 100
8 Development of Advanced Virtual Radiation Detection and Measurement Laboratory (AVR-DML) for Nuclear Science and Engineering Students

Authors: Lily Ranjbar, Haori Yang

Abstract:

Online education has been around for several decades, but the importance of online education became evident after the COVID-19 pandemic. Eventhough the online delivery approach works well for knowledge building through delivering content and oversight processes, it has limitations in developing hands-on laboratory skills, especially in the STEM field. During the pandemic, many education institutions faced numerous challenges in delivering lab-based courses, especially in the STEM field. Also, many students worldwide were unable to practice working with lab equipment due to social distancing or the significant cost of highly specialized equipment. The laboratory plays a crucial role in nuclear science and engineering education. It can engage students and improve their learning outcomes. In addition, online education and virtual labs have gained substantial popularity in engineering and science education. Therefore, developing virtual labs is vital for institutions to deliver high-class education to their students, including their online students. The School of Nuclear Science and Engineering (NSE) at Oregon State University, in partnership with SpectralLabs company, has developed an Advanced Virtual Radiation Detection and Measurement Lab (AVR-DML) to offer a fully online Master of Health Physics program. It was essential for us to use a system that could simulate nuclear modules that accurately replicate the underlying physics, the nature of radiation and radiation transport, and the mechanics of the instrumentations used in the real radiation detection lab. It was all accomplished using a Realistic, Adaptive, Interactive Learning System (RAILS). RAILS is a comprehensive software simulation-based learning system for use in training. It is comprised of a web-based learning management system that is located on a central server, as well as a 3D-simulation package that is downloaded locally to user machines. Users will find that the graphics, animations, and sounds in RAILS create a realistic, immersive environment to practice detecting different radiation sources. These features allow students to coexist, interact and engage with a real STEM lab in all its dimensions. It enables them to feel like they are in a real lab environment and to see the same system they would in a lab. Unique interactive interfaces were designed and developed by integrating all the tools and equipment needed to run each lab. These interfaces provide students full functionality for data collection, changing the experimental setup, and live data collection with real-time updates for each experiment. Students can manually do all experimental setups and parameter changes in this lab. Experimental results can then be tracked and analyzed in an oscilloscope, a multi-channel analyzer, or a single-channel analyzer (SCA). The advanced virtual radiation detection and measurement laboratory developed in this study enabled the NSE school to offer a fully online MHP program. This flexibility of course modality helped us to attract more non-traditional students, including international students. It is a valuable educational tool as students can walk around the virtual lab, make mistakes, and learn from them. They have an unlimited amount of time to repeat and engage in experiments. This lab will also help us speed up training in nuclear science and engineering.

Keywords: advanced radiation detection and measurement, virtual laboratory, realistic adaptive interactive learning system (rails), online education in stem fields, student engagement, stem online education, stem laboratory, online engineering education

Procedia PDF Downloads 61
7 The Role of High-Intensity Focused Ultrasound (HIFU) in the Treatment of Fibroadenomas: A Systematic Review

Authors: Ahmed Gonnah, Omar Masoud, Mohamed Abdel-Wahab, Ahmed ElMosalamy, Abdulrahman Al-Naseem

Abstract:

Introduction: Fibroadenomas are solid, mobile, and non-tender benign breast lumps, with the highest prevalence amongst young women aged between 15 and 35. Symptoms can include discomfort, and they can become problematic, particularly when they enlarge, resulting in many referrals for biopsies, with fibroadenomas accounting for 30-75% of the cases. Diagnosis is based on triple assessment that involves a clinical examination, ultrasound imaging and mammography, as well as core needle biopsies. Current management includes observation for 6-12 months, with the indication of definitive surgery, in cases that are older than 35 years or with fibroadenoma persistence. Serious adverse effects of surgery might include nipple-areolar distortion, scarring and damage to the breast tissue, as well as the risks associated with surgery and anesthesia, making it a non-feasible option. Methods: A literature search was performed on the databases EMBASE. MEDLINE/PubMed, Google scholar and Ovid, for English language papers published between 1st of January 2000 and 17th of March 2021. A structured protocol was employed to devise a comprehensive search strategy with keywords and Boolean operators defined by the research question. The keywords used for the search were ‘HIFU’, ‘High-Intensity Focused Ultrasound’, ‘Fibroadenoma’, ‘Breast’, ‘Lesion’. This review was carried out in accordance with the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines. Results: Recently, a thermal ablative technique, High Intensity Focused Ultrasound (HIFU), was found to be a safe, non-invasive, and technically successful alternative, having displayed promising outcomes in reducing the volume of fibroadenomas, pain experienced by patients, and the length of hospitalization. Quality of life improvement was also evidenced, exhibited by the disappearance of symptoms, and enhanced physical activity post-intervention, in addition to patients’ satisfaction with the cosmetic results and future recommendation of the procedure to other patients. Conclusion: Overall, HIFU is a well-tolerated treatment associated with a low risk of complications that can potentially include erythema, skin discoloration and bruising, with the majority of this self-resolving shortly after the procedure.

Keywords: ultrasound, HIFU, breast, efficacy, side effects, fibroadenoma

Procedia PDF Downloads 183
6 Correlation between Sleeping Disturbance and Academic Achievement in University Female Students

Authors: Amel Fayed, Shaden AlSubaih, Nouf Al-Qahtani, Asmaa Gosty, Asma Aljuhaimi

Abstract:

Introduction: Sleep difficulties are vastly predominant among adults and affect different aspects of their life. Many literatures found out that females are more liable to suffer from sleeping problems. College students are typical example of people dealing with daily pressure and stress to fulfill the daily tasks and responsibilities. In addition to their ultimate goal of achieving excellent academic records which require their full concentration and effort. Consequently, many of them start complaining of sleep deprivations which can undesirably affect their academic achievements. This study was aiming to investigate how prevalent is sleeping disorders among different colleges in the university and its relation their academic achievements. Methods: A cross-sectional study of female university students at Princess Norah Bint Abdulrahman University using self-administered questionnaire was conducted. Insomnia Severity Index (ISI) was used to assess different grades of insomnia. Students were requested to answer the questions evaluating their sleeping habits over the last two weeks. Participants reported their latest Grade Point Average (GPA). According to ISI, insomnia severity is reported as ‘No clinically significant’, ‘Subthreshold ‘,’ Clinical moderate insomnia’ and ‘Clinical severe’. Results: In the current study, 228 students participated; 172(75.4%) from medical colleges and 56 (24.6%) from non-medical colleges. About 80% of them claimed to have never taken any medications to help them sleep while only three students confirmed their regular use of sleep-inducing medications. About 16% of the students drink milk or other hot drinks to help them fall asleep. None of the students was suspected of having obstructive sleep apnea or apparent psychiatric disorder. According to ISI, 182 (79.8%) students suffered from subthreshold insomnia, 37 (16.2%) had clinical insomnia (moderate severity) and 9 (3.9%) of students had sleeping problems of non-clinically significance level. However, none of students was found to have severe clinical insomnia. Clinical moderate insomnia was reported in 15.1% of medical students and 19.6% of non-medical students. Moreover, about 82% of medical students suffered from subthreshold insomnia compared to 73.2% of non-medical students. This difference was not statistically significant (P=0.24). About 63% of medical students and 48% of non-medical students believed that high percentage of their colleagues are suffering from insomnias (p-value 0.08) The association between GPA and insomnia revealed that; 19.5% of low GPA group compared to 9.3% of high GPA group had clinical moderate insomnia. This association was not statistically significant (p=0.15). The correlation between the GPA and the ISI score was negative but not conclusive (r=-0.08, p-value = 0.29). More than 92% of all students agreed that sleeping problems affect their academic achievement to varying degrees. Conclusion: our results suggest that insomnia is commonly prevalent among female university students and might affect the students’ achievement. This study provides preliminary data about the quality of sleep among medical and non-medical university students which may be used to promote the healthy sleeping habits among female students.

Keywords: academic achievement, females, insomnia, university student

Procedia PDF Downloads 310
5 An Exploratory Study in Nursing Education: Factors Influencing Nursing Students’ Acceptance of Mobile Learning

Authors: R. Abdulrahman, A. Eardley, A. Soliman

Abstract:

The proliferation in the development of mobile learning (m-learning) has played a vital role in the rapidly growing electronic learning market. This relatively new technology can help to encourage the development of in learning and to aid knowledge transfer a number of areas, by familiarizing students with innovative information and communications technologies (ICT). M-learning plays a substantial role in the deployment of learning methods for nursing students by using the Internet and portable devices to access learning resources ‘anytime and anywhere’. However, acceptance of m-learning by students is critical to the successful use of m-learning systems. Thus, there is a need to study the factors that influence student’s intention to use m-learning. This paper addresses this issue. It outlines the outcomes of a study that evaluates the unified theory of acceptance and use of technology (UTAUT) model as applied to the subject of user acceptance in relation to m-learning activity in nurse education. The model integrates the significant components across eight prominent user acceptance models. Therefore, a standard measure is introduced with core determinants of user behavioural intention. The research model extends the UTAUT in the context of m-learning acceptance by modifying and adding individual innovativeness (II) and quality of service (QoS) to the original structure of UTAUT. The paper goes on to add the factors of previous experience (of using mobile devices in similar applications) and the nursing students’ readiness (to use the technology) to influence their behavioural intentions to use m-learning. This study uses a technique called ‘convenience sampling’ which involves student volunteers as participants in order to collect numerical data. A quantitative method of data collection was selected and involves an online survey using a questionnaire form. This form contains 33 questions to measure the six constructs, using a 5-point Likert scale. A total of 42 respondents participated, all from the Nursing Institute at the Armed Forces Hospital in Saudi Arabia. The gathered data were then tested using a research model that employs the structural equation modelling (SEM), including confirmatory factor analysis (CFA). The results of the CFA show that the UTAUT model has the ability to predict student behavioural intention and to adapt m-learning activity to the specific learning activities. It also demonstrates satisfactory, dependable and valid scales of the model constructs. This suggests further analysis to confirm the model as a valuable instrument in order to evaluate the user acceptance of m-learning activity.

Keywords: mobile learning, nursing institute students’ acceptance of m-learning activity in Saudi Arabia, unified theory of acceptance and use of technology model (UTAUT), structural equation modelling (SEM)

Procedia PDF Downloads 162
4 Ibrutinib and the Potential Risk of Cardiac Failure: A Review of Pharmacovigilance Data

Authors: Abdulaziz Alakeel, Roaa Alamri, Abdulrahman Alomair, Mohammed Fouda

Abstract:

Introduction: Ibrutinib is a selective, potent, and irreversible small-molecule inhibitor of Bruton's tyrosine kinase (BTK). It forms a covalent bond with a cysteine residue (CYS-481) at the active site of Btk, leading to inhibition of Btk enzymatic activity. The drug is indicated to treat certain type of cancers such as mantle cell lymphoma (MCL), chronic lymphocytic leukaemia and Waldenström's macroglobulinaemia (WM). Cardiac failure is a condition referred to inability of heart muscle to pump adequate blood to human body organs. There are multiple types of cardiac failure including left and right-sided heart failure, systolic and diastolic heart failures. The aim of this review is to evaluate the risk of cardiac failure associated with the use of ibrutinib and to suggest regulatory recommendations if required. Methodology: Signal Detection team at the National Pharmacovigilance Center (NPC) of Saudi Food and Drug Authority (SFDA) performed a comprehensive signal review using its national database as well as the World Health Organization (WHO) database (VigiBase), to retrieve related information for assessing the causality between cardiac failure and ibrutinib. We used the WHO- Uppsala Monitoring Centre (UMC) criteria as standard for assessing the causality of the reported cases. Results: Case Review: The number of resulted cases for the combined drug/adverse drug reaction are 212 global ICSRs as of July 2020. The reviewers have selected and assessed the causality for the well-documented ICSRs with completeness scores of 0.9 and above (35 ICSRs); the value 1.0 presents the highest score for best-written ICSRs. Among the reviewed cases, more than half of them provides supportive association (four probable and 15 possible cases). Data Mining: The disproportionality of the observed and the expected reporting rate for drug/adverse drug reaction pair is estimated using information component (IC), a tool developed by WHO-UMC to measure the reporting ratio. Positive IC reflects higher statistical association while negative values indicates less statistical association, considering the null value equal to zero. The results of (IC=1.5) revealed a positive statistical association for the drug/ADR combination, which means “Ibrutinib” with “Cardiac Failure” have been observed more than expected when compared to other medications available in WHO database. Conclusion: Health regulators and health care professionals must be aware for the potential risk of cardiac failure associated with ibrutinib and the monitoring of any signs or symptoms in treated patients is essential. The weighted cumulative evidences identified from causality assessment of the reported cases and data mining are sufficient to support a causal association between ibrutinib and cardiac failure.

Keywords: cardiac failure, drug safety, ibrutinib, pharmacovigilance, signal detection

Procedia PDF Downloads 102
3 The Impact of Non State Actor’s to Protect Refugees in Kurdistan Region of Iraq

Authors: Rozh Abdulrahman Kareem

Abstract:

The displacement of individuals has become a common interest for international players. Mostly occurs in Islamic states, as religion is considered the most common cause of this form of displacement. Therefore, this thesis aims to depict the reality of the situations of the refugees, particularly in KRI, illustrating how they are treated and protected and if the treatment merits the protection clause as envisaged in the 1951 Refugee Convention. Overall, the aim is to touch on the issue of protection by non-governmental organizations and government towards the refugees here. In light of this, it focused on the adequate protection of refugees in relation to the refugee law. In the Middle East, including Iraq, there have been multiple reports on violations of these refugee laws and human rights. Protection involves providing physical security to the concerned parties, functional administration with legal structures, and infrastructural setup that could help citizens exercise rights. The KRI has provided the refugees with various benefits, including education, access to residency, and employment. It also provided transitionary in various social dimensions like gender-based violence. The Convention on Status of Refugees 1951 tried to resolve this problem, whereby the principle of ‘nonrefoulement’ under Article 33 was passed. The ‘nonrefoulement’, an exceptional reference, was enacted to protect refugees from forcible return to their countries of the original. However, the convention never addressed an unusual scenario regarding the application of this principle, ‘Extradition Treaties.’ Even though some scholarly article exists regarding the problems of refugees, the topic of interplay between Nonrefoulement and Extradition Treaties has never been explained in detail in the available books on refugee laws and practices. Each year, millions of refugees seek protection from foreign countries for fear of being tortured, victimized, or executed. People seeking international protection are susceptible and insecure. The main objective of the prevention is to provide security to citizens susceptible to inhuman treatment, distress, oppression, or other human rights defilements when they arrive back in their own countries. The refugee situation may get worse in the near future. Just like several nations within the Middle East, Iraq is not a signatory to the globally acknowledged legal structure for the protection of refugees. The first law of 1971 in Iraq was issued only for military or political causes. This law also establishes benefits such as the right to education and health services and the right to acquire employment just as the Iraqi nationals. The other legislative instrument is the 21st law from the ministry of migration of Iraq widened the description of an immigrant to incorporate the definition from the refugee resolution. Nonetheless, there is a lack of overall consistency in the protection provided under these legislations regarding rights and entitlement. A Memorandum of Understanding was signed in October 2016 by the UNHCR and the Iraq government to develop the protection of refugees. Under the term of this MoU, the Iraqi Government is obligated to provide identity documents to asylum seekers beside that UNHCR provides more guidance.

Keywords: law, refugee, protection, Kurdistan

Procedia PDF Downloads 47
2 Isolation and Structural Elucidation of 20 Hydroxyecdystone from Vitex doniana Sweet Stem Bark

Authors: Mustapha A. Tijjani, Fanna I. Abdulrahman, Irfan Z. Khan, Umar K. Sandabe, Cong Li

Abstract:

Air dried sample V. doniana after collection and identification was extracted with ethanol and further partition with chloroform, ethyl acetate and n-butanol. Ethanolic extract (11.9g) was fractionated on a silica gel accelerated column chromatography using solvents such as n-hexane, ethyl acetate and methanol. Each eluent fractions (150ml aliquots) were collected and monitored with thin layer chromatography. Fractions with similar Rf values from same solvents system were pooled together. Phytochemical test of all the fractions were performed using standard procedure. Complete elution yielded 48 fractions (150ml/fraction) which were pooled to 24 fractions base on the Rf values. It was further recombined and 12 fractions were obtained on the basis on Rf values and coded Vd1 to Vd12 fractions. Vd8 was further eluted with ethylacetate and methanol and gave fourteen sub fractions Vd8-a, -Vd8-m. Fraction Vd8-a (56mg) gave a white crystal compound coded V1. It was further checked on TLC and observed under ultraviolet lamp and was found to give a single spot. The Rf values were calculated to be 0.433. The melting point was determined using Gallenkamp capillary melting point apparatus and found to be 241-243°C uncorrected. Characterization of the isolated compound coded V1 was done using FT-infra-red spectroscopy, HNMR, 13CNMR(1and 2D) and HRESI-MS. The IR spectrum of compound V1 shows prominent peaks that corresponds to OHstr (3365cm-1) and C=0 (1652cm-1) etc. This spectrum suggests that among the functional moiety in compound V1 are the carbonyl and hydroxyl group. The 1H NMR (400 MHz) spectrum of compound V1 in DMSO-d6 displayed five singlet signals at δ 0.72 (3H, s, H-18), 0.79 (3H, s, H-19), 1.03 (3H, s, H-21), 1.04 (3H, s, H-26), 1.06 (3H, s, H-27) each integrating for three protons indicating the five methyl functional groups present in the compound. It further showed a broad singlet at δ 5.58 integrated for 1 H due to an olefinic H-atom adjacent to the carbonyl carbon atom. Three signals at δ 3.10 (d, J = 9.0 Hz, H-22), 3.59 (m, 1H, 2H-a) and 3.72 (m, 1H, 3H-e), each integrating for one proton is due to oxymethine protons indicating that three oxymethine H-atoms are present in the compound. These all signals are characteristic to the ecdysteroid skeletons. The 13C-NMR spectrum showed the presence of 27 carbon atoms, suggesting that may be steroid skeleton. The DEPT-135 experiment showed the presence of five CH3, eight CH2, and seven CH groups, and seven quaternary C-atoms. The molecular formula was established as C27H44O7 by high resolution electron spray ionization-mass spectroscopy (HRESI-MS) positive ion mode m/z 481.3179. The signals in mass spectrum are 463, 445, and 427 peaks corresponding to losses of one, two, three, or four water molecules characteristic for ecdysterone skeleton reported in the literature. Based on the spectral analysis (HNMR, 13CNMR, DEPT, HMQC, IR, HRESI-MS) the compound V1 is thus concluded to have ecdysteriod skeleton and conclusively conforms with 2β, 3β 14α, 20R, 22R, 25-hexahydroxy-5 β cholest-7-ene-6- one, or 2, 3, 14, 20, 22, 25 hexahydroxy cholest-7-ene-6-one commonly known as 20-hydroxyecdysone.

Keywords: vitex, phytochemical, purification, isolation, chromatography, spectroscopy

Procedia PDF Downloads 325
1 Methotrexate Associated Skin Cancer: A Signal Review of Pharmacovigilance Center

Authors: Abdulaziz Alakeel, Abdulrahman Alomair, Mohammed Fouda

Abstract:

Introduction: Methotrexate (MTX) is an antimetabolite used to treat multiple conditions, including neoplastic diseases, severe psoriasis, and rheumatoid arthritis. Skin cancer is the out-of-control growth of abnormal cells in the epidermis, the outermost skin layer, caused by unrepaired DNA damage that triggers mutations. These mutations lead the skin cells to multiply rapidly and form malignant tumors. The aim of this review is to evaluate the risk of skin cancer associated with the use of methotrexate and to suggest regulatory recommendations if required. Methodology: Signal Detection team at Saudi Food and Drug Authority (SFDA) performed a safety review using National Pharmacovigilance Center (NPC) database as well as the World Health Organization (WHO) VigiBase, alongside with literature screening to retrieve related information for assessing the causality between skin cancer and methotrexate. The search conducted in July 2020. Results: Four published articles support the association seen while searching in literature, a recent randomized control trial published in 2020 revealed a statistically significant increase in skin cancer among MTX users. Another study mentioned methotrexate increases the risk of non-melanoma skin cancer when used in combination with immunosuppressant and biologic agents. In addition, the incidence of melanoma for methotrexate users was 3-fold more than the general population in a cohort study of rheumatoid arthritis patients. The last article estimated the risk of cutaneous malignant melanoma (CMM) in a cohort study shows a statistically significant risk increase for CMM was observed in MTX exposed patients. The WHO database (VigiBase) searched for individual case safety reports (ICSRs) reported for “Skin Cancer” and 'Methotrexate' use, which yielded 121 ICSRs. The initial review revealed that 106 cases are insufficiently documented for proper medical assessment. However, the remaining fifteen cases have extensively evaluated by applying the WHO criteria of causality assessment. As a result, 30 percent of the cases showed that MTX could possibly cause skin cancer; five cases provide unlikely association and five un-assessable cases due to lack of information. The Saudi NPC database searched to retrieve any reported cases for the combined terms methotrexate/skin cancer; however, no local cases reported up to date. The data mining of the observed and the expected reporting rate for drug/adverse drug reaction pair is estimated using information component (IC), a tool developed by the WHO Uppsala Monitoring Centre to measure the reporting ratio. Positive IC reflects higher statistical association, while negative values translated as a less statistical association, considering the null value equal to zero. Results showed that a combination of 'Methotrexate' and 'Skin cancer' observed more than expected when compared to other medications in the WHO database (IC value is 1.2). Conclusion: The weighted cumulative pieces of evidence identified from global cases, data mining, and published literature are sufficient to support a causal association between the risk of skin cancer and methotrexate. Therefore, health care professionals should be aware of this possible risk and may consider monitoring any signs or symptoms of skin cancer in patients treated with methotrexate.

Keywords: methotrexate, skin cancer, signal detection, pharmacovigilance

Procedia PDF Downloads 91