Objective: Lamotrigine is a new generation anticonvulsant, also used in bipolar type 1 disorders ... more Objective: Lamotrigine is a new generation anticonvulsant, also used in bipolar type 1 disorders to prevent occurrence of mood episodes not responding to traditional antidepressant, which is an increasing indication worldwide. Skin adverse events occur in 5-10% of patients, but are usually mild and self-limiting. The occurrence of drug-induced lupus erythematosus is an uncommon, but severe condition, usually requiring discontinuation of the drug. Methods: A spontaneous pharmacovigilance case reporting is presented, following the causality assessment criteria, including temporal association with drug exposure, exclusion of other etiologies, dechallenge and rechallenge. Skin biopsy for normal histopathology and direct immunofluorescence wasperformed to assess the diagnosis of lupus erythematosus. Results: A 77 years old woman was hospitalized in the Dermatology Clinic of Cagliari University for a lamotrigine Induced Subacute Cutaneous Lupus Erythematosus, confirmed by improvement after drug dismission, and immediate recurrence at re-exposure. The last measure was performed on request of the neurologist with the consent of the patient, because of a high suicidal risk, not responding to traditional antidepressants, and well controlled by lamotrigine. Another peculiarity of our observation is a potential dose-related effects, as the patients was assuming lamotrigine from 2 years, and skin manifestations actually began 3 weeks after the dosage was doubled to 100 mg daily. Conclusion: If confirmed by other observation, drug-induced subacute cutaneous lupus erythematosus might be dose-dependent, and careful clinician’s dosage monitoring might prevent occurrence, preserving the lamotrigine use for the many patients who need it. Dermatologist referral is warrant in front of any suspect cutaneous adverse reaction due to psychotropic medications, to provide prompt recognition, adequate assessment and supportive management of such difficult and delicate patients.
Pharmacovigilance is a critical factor in today’s healthcare practice. Education, awareness and t... more Pharmacovigilance is a critical factor in today’s healthcare practice. Education, awareness and training, ensure its proper implementation and achievement of its goals. The need for this mainly focuses on four relevant stakeholders: healthcare sciences students, healthcare professional, pharmaceutical industry employees and patients. Although a lot of progress has taken place, there is still the need of a more structured approach, improvement and optimization; this has to focus on patients, which are the end users of healthcare services and the most important stakeholder in the life cycle of medicinal products
Internal clustering validation indexes (CVIs) which can be assumed as the objective function of c... more Internal clustering validation indexes (CVIs) which can be assumed as the objective function of clustering algorithms is usually relied upon to assess the quality of different clustered partitions with the intention of ascertaining the local clustering outputs in an unsupervised way [1]. The researchers started by investigating numerous popular internal clustering validation indexes used for categorical data clustering [2]. In addition, they validated the ineffectiveness of assessing the partitions of diverse sets of clusters while disregarding any inter-cluster assumptions or separation measures [3]. The correctness of separation as well as how it coordinates with the intra-cluster compactness measures negatively impact performance. Consequently, the researcher suggested a new internal clustering validation index known as CUBAGE which could assess both the partition's separation and the compactness [4]. The study results proved that the CUBAGE performed excellently as compared to other internal clustering validation indexes whether in the presence or absence of the number of clusters [5]. Clustering analysis involves subdividing a set of data into clusters with the aim of grouping similar and dissimilar objects into their respective clusters. There are two types of clustering methods namely the hard and soft techniques [6]. In this case, the researchers adopted the hard former where all the objects belonged to a single cluster. The partitions obtained after clustering largely varied with the criteria of dissimilarity or similarity, clustering methods, and the parameter settings [7]. For instance, the clustering technique's mechanism such as the random initialization also lead to variations in the clustering outcome or output. The researchers sought to determine the final result from several likely partitions by performing numerous clustering processes with diverse schemes correspondingly before they chose the highest quality partition [8]. For the researchers, they focused on exploring the use of internal and external clustering validation indexes to help in defining and measuring the quality of partitions [9]. The internal CVIs can be relied on to assess the compliance of the clustered and prior partitions. Alternatively, the external CVIs rely on information obtained from outside sources to measure the quality of the clustering output. For example, in the case of the presence of prior knowledge, it can be utilized to analyze the compliance of the previous and clustered partitions. Since the unsupervised scenario lacks prior knowledge, the external CVIs cannot be applied [10]. The internal clustering validation indexes do not need previous experience, and usually, they can be applied in different areas or discipline such as data mining, biological engineering, image and text analysis, as well as information retrieval [11]. The inter-cluster isolation or separation and intra-cluster compactness are relied upon to test the quality of clustering results internally [12]. The isolation indicates how the data sets in a single cluster are dissimilar to others while the compactness signifies the level of equivalence or uniformity of data sets in the same cluster [13].
According to the article, the NCI-DREAM Drug Sensitivity Prediction problem has been persistent f... more According to the article, the NCI-DREAM Drug Sensitivity Prediction problem has been persistent for long; nonetheless, several models and algorithms have developed to tackle its two major sub-challenges [1]. The model includes a weighted Euclidean distance technique that is used to make a prediction as well as ranking the combination of drug especially their ability to neutralize the capability of a diffuse large B-cell lymphoma (DLBCL) cell line [2]. Similarly, the other technique is a bidirectional search algorithm that uses a nonlinear support vector machine (SVM) and a common scheme to predict how the drug compounds can impact the breast cancer cell lines [3]. The bidirectional search algorithm or greedy search algorithm usually makes a combination of the advantages of the support vector machine or kernel techniques as well as the ensemble modeling to correctly make a prediction of the sensitivity of the breast cancer cell lines to drug compounds which were formerly not tested [4]. Current composite models used to predict drug sensitivity use basic algorithms to extract traits from one type of data set [5]. Alternatively, the researcher created an ensemble model (as shown in figure 1 below) that was used in extracting features from different kind of datasets such as DNA copy number disparity, DNA methylation, RNA-seq, gene expression, proteomic data) as opposed to the use of diverse base algorithms on one form of datasets [6]. The researchers used similar base learning algorithms on the five different kinds of datasets [7]. Cancer is regarded as the causative factor of death globally, the development of drug compounds to target cancer cell and provide treatment has highly been prioritized [8]. Nonetheless, the discovery of cancer therapies is regarded as challenging, costly, and time consuming pharmaceutical venture since it entails various clinical evaluations and developmental phases [9]. Currently, simulation and computational models are increasingly preferred to make prediction of the reaction of the cancer cell lines to drug compounds to drug development or discovery process [10]. Such models are significantly helpful in improving the process of designing drugs as well as tackle several problems experienced throughout the process that assists in establishing the drug variations [11]. Furthermore, the researchers argue that the process of determining successful lead drug candidates used in treating cancer can greatly capitalize from such methods used to make prediction of how cancer cell lines are sensitive to drug compounds [12]. Time-series in addition to static conditional gene expression data are widely used to build the silicon models or predictors [13]. Statistical methods, for instance, a combination or integration of random forest and regression analysis have been used to manipulate gene expression data obtained from cancer cells which have treated with diverse drug compounds to predict of the capacity of the drugs to effectively stop cancer cell lines' proliferation [14]. Additionally, researchers have exploited gene expression datasets using the Naïve Bayes classifiers the sequencing data and chromosomal copy number difference obtained from human cancer lines which undergo treatment using twenty-four anticancer drugs to make a prediction of the capacity of the drugs to constrain their propagation [15]. Equally, gene expression data of sixty human cancer cell lines have been examined using a weighted voting classification model to foresee the drug reactions [16]. Moreover, the researchers combined random forest and nearest neighbor methodology to manipulate proteomic data to predict of the drug response of the cell lines [17]. In addition, a weighted voting algorithm which is created through the use of a set of genes which have been expressed differentially was used to accurately group 80 percent of the twenty-six samples to assess the effectiveness of the Docetaxel (an anticancer drug) in treating breast cancer [18, 19]. Majority of the statistical methods are variedly applied to the sequencing, gene expression, and proteomic data to determine how the cancer cell lines usually react to medication [20]. Therefore, review of the article reveal that current practice of making prediction about the cancer cell lines' sensitivity to the drugs can greatly be enhanced by using the ensemble models [21]. The researchers wanted to determine how the diverse forms of data can be relied on more correct prediction of the reaction of cancer cell lines to the drug compounds [22]. The research has greatly added new knowledge especially with how the ensemble methods can be used in capturing and extracting significant features from the diverse kinds of biological data [23, 24].
The researchers performed an assessment of the molecular structure
and numerical evaluation of mo... more The researchers performed an assessment of the molecular structure and numerical evaluation of molecular properties to examine the interrelationships that are prevalent in anticancer pharmacotherapies relied on to medically treat the lung cancer. In these cases, the researcher examined almost sixteen cancer medications focusing on their bioactivity scores, molecular properties, as well as their structures
The challenge for customize drug is to choose the right medicine for the individual patient. Drug... more The challenge for customize drug is to choose the right medicine for the individual patient. Drug testing of patients in large clinical trials is a way of assessing their efficacy and toxicity, but testing hundreds of drugs currently under development is impractical. Therefore, preclinical prediction models are highly desirable because of their capability is to know drug acknowledgement to hundreds of cell lines. In this paper, we presents, the classification technique is used to differentiate the drugs. Initially pre-processing is used on the true data that removes the noise, then the features are extracted which are saved into the database along with the information related to drug response. Then the performance parameters such as precision, recall, accuracy and f-measures are determined. The approximate accuracy observed come out to be 0.9315.
In the current study, we have experimentally and comparatively investigated and compared malignan... more In the current study, we have experimentally and comparatively investigated and compared malignant human cancer cells and tissues before and after irradiating of synchrotron radiation using Time–Resolved Spectroscopy and Time–Stretch Spectroscopy. It is clear that malignant human cancer cells and tissues have gradually transformed to benign human cancer cells and tissues under synchrotron radiation with the passage of time (Figures 1 and 2) [1-101].
Pharmacovigilance (PhV) was initiated to prevent adverse drug reactions and other adverse drug ev... more Pharmacovigilance (PhV) was initiated to prevent adverse drug reactions and other adverse drug events, in response to drug use tragedies such asphocomelia. As such, PhV has been long in existence in North America and Europe. However, in some countries the practice of PhV is relatively new. For example: In Namibia the Therapeutics Information and PhV Centre (TIPC) was established in 2008 by the Ministry of Health and Social Services (MoHSS), with technical support from Management Sciences for Health. Following the establishment of TIPC the MoHSS embarked on training in-service health care workers as a strategy to promote PhV. Training in-service HCW is a costly venture, and its continuous implementation may be interrupted. The training of medical, pharmacy, and nursing students is a more sustainable strategy for promoting PhV, by virtue of its long-term nature. In cognizance of the importance of PhV and the need to promote it, the School of Pharmacy (SoP), Faculty of Health Sciences at the University of Namibia included a module on PhV as part of the curriculum to train Bachelor of Pharmacy students. While didactic face to face training has been used to train PhV, the SoP utilised Self-Directed Learning. This report contains the aims of pharmacovigilance training at the SoP; how the module was structured; how the sessions were conducted; recommendations on how to make PhV training practical; and how to broaden student coverage on PhV training.
The control of blood glucose is critical in prevention of complication of diabetes and to improve... more The control of blood glucose is critical in prevention of complication of diabetes and to improve the quality of life of these patients. However in a setting of patients attending care from a private setting, the access to inexpensive care may be a critical control of diabetes, a lifelong chronic illness that requires optimal adherence to nutritional and medication. Such practices may ultimately heighten the financial burden associate with management of diabetes of complications such as hypertension and diabetic foot. In spite of this, the Glycaemic control practices in private health care settings in Uganda have not been well described and thus may negatively impact on the health outcomes. The study aimed to describe the practices among diabetic patients attending the Rubaga hospital, determine the level of Glycaemic control and identify the factors associated with diabetics' patients monitoring indicators (Hb1Ac levels, blood glucose levels). This is a Cross-sectional analytical study. Patients were randomly selected during the period of April and May 2012. The laboratory determination of the blood glucose levels (RBG) and Glycosylated hemoglobin (HB1AC) was done using the COBAS 6000 clinical chemistry analyser. Analysis was done using the student T-test and Chi-square test with a level of significance of 0.05. There was a significant statistical relationship between fasting plasma glucose and HbA1c (p-value = 0.000). Factors influencing high HBA1C levels in diabetic patients at Rubaga hospital were high cost of diabetes mellitus treatment (p-value = 0.019), duration the study participant had had the disease (P = 0.003) and having another chronic illness alongside diabetes mellitus (p-value = 0.045). The Republic of Uganda should make treatment of diabetes mellitus universally accessible and free. It should also put sensitization measures in place geared towards minimizing occurrence of some chronic disease conditions like hypertension which lead to co-treatment that lowers drug compliance.
Prior to defining pharmacopolitics, one may wonder about this odd associations and relevancy of t... more Prior to defining pharmacopolitics, one may wonder about this odd associations and relevancy of terminology. The word politics denotes articulating and resolving conflicts within society without recourse to physical violence [1]. Pharmaco stems from the Greek name Pharmakon/ Pharmacon which entail active ingredients/drug or medicine and is pertaining to pharmaceuticals and pharmacy sciences. Hence, the word pharmacopolitics joined the politics to medicines-drugs-pharmaceuticals to clarify the study of drug safety and efficacy (difficulties and solutions) in relation to societal priorities, controversies, health budgets and associated costs. This juxtaposition of the two words emphasizes the significance and impact of pharmaceuticals on health decisions, health political conflicts and societal health needs and priorities.
Background
Nevirapine’s (NVP) pharmaceutical manufacturer recommended the avoidance of NVP in fem... more Background Nevirapine’s (NVP) pharmaceutical manufacturer recommended the avoidance of NVP in females and males with baseline CD4 counts >250 and >400, respectively. This safety measure was challenged by research results that showed similar proportions of adverse events in high and low baseline CD4 count patients. WHO’s antiretroviral therapy guidelines recommended the use of NVP in patients with CD4 counts <350. Whether this recommendation would result in increase of NVP-related adverse reaction reports in Namibia was not known. Consequently, the pharmacovigilance centre monitored the NVP-related reaction reports for change in number and severity. Methods We accessed adverse reaction reports in VigiFlow®. NVP-related skin and liver adverse reaction reports received in 2011 were compared with those received in the Previous Years. Also, NVP-related reaction reports were compared with the same reactions associated with other medicines. The comparisons were made by using reporting ratio, proportional reporting ratio, and the Students T-Test. Results 1,074 adverse reaction reports were accessed. NVP-related liver and skin reactions were 208 (2011) and 99 (Previous Years). The proportions of reports related to ARV in 2011 and Previous Years were comparable (RR=1; p=0.87). The NVP-related reactions were greater in 2011 than in the Previous Years (43.2% vs. 16.7%: RR = 2.6; p <0.0001). Grade3 and 4 reactions related to NVP were greater in 2011 than in the Previous Years (SKIN: 22.7% vs. 5.6%: RR = 4.1; p <0.0001; LIVER: 8.5% vs. 2.2%: RR = 3.9; p <0.0001), but not for grade1 & 2 reactions (SKIN: 8.5% vs. 6.2%; RR = 1.4; p =0.16; LIVER: 2.7% vs. 2.4%; RR = 1.1; p = 0.73).The increase in reports was observed for both female and male patients (p<0.01). The increase ingrade 3 and 4 reactions were unique to NVP. Conclusion The significant increase in proportions of grade3 and 4 liver and skin reaction reports in patients on NVP was detected as a safety signal after shifting ART initiation to higher CD4 counts. The Ministry of Health halted the plan of initiating NVP-based ART in pregnant females, and recommended the avoidance of NVP in ART-naïve patients with high baseline CD4 counts. Through locally derived data, pharmacovigilance centres can protect patients from drug-induced harm.
Psychiatric disorders, like anxiety and depression, are risk factors for drug abuse and smoking b... more Psychiatric disorders, like anxiety and depression, are risk factors for drug abuse and smoking behavior. The purpose of this survey was to determine the prevalence of smoking, depression and anxiety and their relationship among school age students. This cross-sectional survey was done on 1020 high school students (male and female) recruited randomly and DSM-IV interview was done by researchers. A psychiatry resident accompanied by 3 last year medical students interviewed with students and a questionnaire containing demographic , anxiety and depression questions was filled simultaneously. The obtained data were analyzed using SPSS16. 50% of the students were female and the remainder male. 277 students (27.2%) were in the first year, 242 (23.7%) in the second year and 501 (49.1%) in the third year of high school. 55 students (5.4%) were smoker and used cigarette , water pipe (hobble bobble) and pipe.183 students (18%) had anxiety and stress symptoms (mild, moderate , sever). The 29 smoker students (2.84%) had anxiety. 144 students (14.1%) had depression (mild, moderate, sever) and 23 smoker students (2.25%) had depression symptoms. There was no significant correlation between smoking and anxiety and depression symptoms among school age students. As conclusion, we hypothesized that smoking may increase the tendency to depression and anxiety in high school students. Although the above results didn’t demonstrate any significant correlation between these three issues, school counselors and teachers need to be informed about the prevalence of problematic behaviors associated with smoking and it would be necessary to develop smoking prevention programs for adolescents, while taking the psychological factors such as depression and anxiety and school and family atmosphere into account.
Background
The Namibia Standard Treatment Guidelines (STGs) recommends empirical antibiotic treat... more Background The Namibia Standard Treatment Guidelines (STGs) recommends empirical antibiotic treatment in patients with signs and symptoms of Urinary tract infections (UTIs). The goal of UTI treatment is to eliminate the bacteria from the urinary tract. Efficacy of empirical antimicrobial treatment of UTI depends on the sensitivity of common microorganisms, the level of the antimicrobial load in the urine and the duration of treatment. The objective of this study was to identify the common uropathogens that cause UTI, describe the sensitivity pattern of common isolates to antibiotics that are used in the treatment of UTI and recommend appropriate antibiotics for the empirical treatment of UTI in Namibia. Methods This was a cross-sectional descriptive analysis of antibiotic susceptibility of isolates from urine using routinely collected data from the Namibia Institute of Pathology (NIP) database. Urine culture and sensitivity results from health facilities throughout Namibia from January 1, 2009 to June 30, 2013 were analysed. A total of 94, 682 urine samples were tested during the study period. Results The most common pathogens isolated were Escherichia coli (n = 18668, 34.1 %), Proteus mirabilis (n = 3520, 6.8%), and Klebsiella pneumoniae (n = 3266, 6.4%). E. coli showed very high resistance rate to amoxicillin and co-trimoxazol (79.6%, 78.64%) respectively. About one third (28%) of E. coli were resistant to Cephalothin and Nalidixic Acid. However, E. coli remained highly sensitive to ceftriaxone, amikacin, cefuroxime, gentamycin, nitrofurantoin, ofloxacin, norfloxacin, ciprofloxacin, and amoxicillin/ clavulanic acid its resistance ranging from 2.2% -16.82%. Proteus was found to be highly resistant to amoxicillin (55.91%), co-trimoxazole (57.85%) and nitrofurantoin (77.37%). However, it is less resistant to cephalothin (15.51%) and nalidixic acid (11.14%). Klebsiella, on the other hand, was found to be more resistant to Amoxicillin (96.72%) but less resistant to nitrofurantoin ( 23.87). It also demonstrated resistance to co-trimoxazole (56.52%) and cephalothin (35.79%).
Background
Few studies have reported rates of adverse drug reactions (ADRs) within low-income cou... more Background Few studies have reported rates of adverse drug reactions (ADRs) within low-income countries, and the resulting rates are extremely variable. Limited information exists about patterns of ADRs within African countries. Objective To identify the incidence and describe the types of ADRs for adult admissions to the Kamuzu Central Hospital in Lilongwe, Malawi. Methods In this retrospective chart review, baseline descriptive information for all patients and details surrounding any identified potential ADR were documented. Only medical charts that included both laboratory results and a medication administration record were included. An expert panel reviewed all potential ADRs for study inclusion. Results 263 charts were reviewed and only 16% (42) met inclusion criteria. Of those 42 charts, 4 ADRs were identified. A cumulative ADR occurrence of 9.5% was observed. Conclusions The preliminary incidence of ADRs in Malawi appears high and requires further evaluation to identify potential causes and solutions.
The World Health Organization (WHO) defines pharmacovigilance as “the science and activities rela... more The World Health Organization (WHO) defines pharmacovigilance as “the science and activities relating to the detection, assessment, understanding and prevention of adverse affects or any other possible drug-related problems.” The safety monitoring of pharmaceuticals is a fundamental component of daily clinical practice. Providing high eminence medical care, ongoing safety monitoring and evaluation of effectiveness are essential to the perpetual use of pharmaceuticals. Pharmacovigilance is recognized as a clinical discipline and it serves as an indicator of the standards of clinical care practiced within a country.
The healthcare facilities must have a system incorporated in order to detect, monitor, prevent an... more The healthcare facilities must have a system incorporated in order to detect, monitor, prevent and report any unsafe use of pharmaceuticals and to track the launch of newer ones. This tracking system can be achieved via the pharmacy and therapeutics committee (PTC) that represents the governing body of pharmaceuticals within any healthcare facility.
Pharmacovigilance (PV) is the science and activities relating to the detection, assessment, under... more Pharmacovigilance (PV) is the science and activities relating to the detection, assessment, understanding and prevention of adverse effects or any other drug related problem. PV collects, records, codes ADEs/ADRs analyses and assesses the reports, promotes the safe use of drugs, creates appropriate structures and means of communication needed to perform its tasks. The aims of PV are to improve patient care and safety, improve public health and safety, contribute to the assessment of benefit, harm, effectiveness and risk of medicines, promote education and clinical training, promote effective communication to public and promote rational and safe use of medicines.
This is both challenging and exciting to write an editorial for the journal Pharmacovigilance and... more This is both challenging and exciting to write an editorial for the journal Pharmacovigilance and Drug Safety. The number of medicines in the market has increased dramatically over the last few years, bringing some real innovations, but also considerable challenges in controlling the quality and rational use of medicines. Safety of medicines is an important issue. Due to intense competition among pharmaceutical manufacturers, products may be registered and marketed in many countries simultaneously. As a result adverse effect may go unnoticed and so are not monitored systematically. Pharmacovigilance is a structured process for the monitoring and detection of adverse drug reactions in the given context.
Since rofecoxib was withdrawn from the market in 2005, the controversy keeps going on about the c... more Since rofecoxib was withdrawn from the market in 2005, the controversy keeps going on about the cardiovascular risk of Non Steroidal Anti-Inflammatory Drugs (NSAIDs). With their analgesic, anti-inflammatory, antipyretic and anti-thrombotic properties, NSAIDs are among the most widely used therapeutic agents. They are also known for their side effects: dyspepsia, peptic ulcerations, fluid retention, high blood pressure ... The recent revelation of thrombotic events due to the use of coxibs (selective COX-2 inhibitors) has led to a thorough study of this risk with every NSAID. The results have shown that the vascular risks of diclofenac were comparable to coxibs. In 2013, new recommandations have been announced to warn patients and healthcare professionals about the safe use of diclofenac. Beyond these European recommendations, the use of diclofenac should be revised on a worldwide scale since its use is very common in countries such as China and India.
Objective: Lamotrigine is a new generation anticonvulsant, also used in bipolar type 1 disorders ... more Objective: Lamotrigine is a new generation anticonvulsant, also used in bipolar type 1 disorders to prevent occurrence of mood episodes not responding to traditional antidepressant, which is an increasing indication worldwide. Skin adverse events occur in 5-10% of patients, but are usually mild and self-limiting. The occurrence of drug-induced lupus erythematosus is an uncommon, but severe condition, usually requiring discontinuation of the drug. Methods: A spontaneous pharmacovigilance case reporting is presented, following the causality assessment criteria, including temporal association with drug exposure, exclusion of other etiologies, dechallenge and rechallenge. Skin biopsy for normal histopathology and direct immunofluorescence wasperformed to assess the diagnosis of lupus erythematosus. Results: A 77 years old woman was hospitalized in the Dermatology Clinic of Cagliari University for a lamotrigine Induced Subacute Cutaneous Lupus Erythematosus, confirmed by improvement after drug dismission, and immediate recurrence at re-exposure. The last measure was performed on request of the neurologist with the consent of the patient, because of a high suicidal risk, not responding to traditional antidepressants, and well controlled by lamotrigine. Another peculiarity of our observation is a potential dose-related effects, as the patients was assuming lamotrigine from 2 years, and skin manifestations actually began 3 weeks after the dosage was doubled to 100 mg daily. Conclusion: If confirmed by other observation, drug-induced subacute cutaneous lupus erythematosus might be dose-dependent, and careful clinician’s dosage monitoring might prevent occurrence, preserving the lamotrigine use for the many patients who need it. Dermatologist referral is warrant in front of any suspect cutaneous adverse reaction due to psychotropic medications, to provide prompt recognition, adequate assessment and supportive management of such difficult and delicate patients.
Pharmacovigilance is a critical factor in today’s healthcare practice. Education, awareness and t... more Pharmacovigilance is a critical factor in today’s healthcare practice. Education, awareness and training, ensure its proper implementation and achievement of its goals. The need for this mainly focuses on four relevant stakeholders: healthcare sciences students, healthcare professional, pharmaceutical industry employees and patients. Although a lot of progress has taken place, there is still the need of a more structured approach, improvement and optimization; this has to focus on patients, which are the end users of healthcare services and the most important stakeholder in the life cycle of medicinal products
Internal clustering validation indexes (CVIs) which can be assumed as the objective function of c... more Internal clustering validation indexes (CVIs) which can be assumed as the objective function of clustering algorithms is usually relied upon to assess the quality of different clustered partitions with the intention of ascertaining the local clustering outputs in an unsupervised way [1]. The researchers started by investigating numerous popular internal clustering validation indexes used for categorical data clustering [2]. In addition, they validated the ineffectiveness of assessing the partitions of diverse sets of clusters while disregarding any inter-cluster assumptions or separation measures [3]. The correctness of separation as well as how it coordinates with the intra-cluster compactness measures negatively impact performance. Consequently, the researcher suggested a new internal clustering validation index known as CUBAGE which could assess both the partition's separation and the compactness [4]. The study results proved that the CUBAGE performed excellently as compared to other internal clustering validation indexes whether in the presence or absence of the number of clusters [5]. Clustering analysis involves subdividing a set of data into clusters with the aim of grouping similar and dissimilar objects into their respective clusters. There are two types of clustering methods namely the hard and soft techniques [6]. In this case, the researchers adopted the hard former where all the objects belonged to a single cluster. The partitions obtained after clustering largely varied with the criteria of dissimilarity or similarity, clustering methods, and the parameter settings [7]. For instance, the clustering technique's mechanism such as the random initialization also lead to variations in the clustering outcome or output. The researchers sought to determine the final result from several likely partitions by performing numerous clustering processes with diverse schemes correspondingly before they chose the highest quality partition [8]. For the researchers, they focused on exploring the use of internal and external clustering validation indexes to help in defining and measuring the quality of partitions [9]. The internal CVIs can be relied on to assess the compliance of the clustered and prior partitions. Alternatively, the external CVIs rely on information obtained from outside sources to measure the quality of the clustering output. For example, in the case of the presence of prior knowledge, it can be utilized to analyze the compliance of the previous and clustered partitions. Since the unsupervised scenario lacks prior knowledge, the external CVIs cannot be applied [10]. The internal clustering validation indexes do not need previous experience, and usually, they can be applied in different areas or discipline such as data mining, biological engineering, image and text analysis, as well as information retrieval [11]. The inter-cluster isolation or separation and intra-cluster compactness are relied upon to test the quality of clustering results internally [12]. The isolation indicates how the data sets in a single cluster are dissimilar to others while the compactness signifies the level of equivalence or uniformity of data sets in the same cluster [13].
According to the article, the NCI-DREAM Drug Sensitivity Prediction problem has been persistent f... more According to the article, the NCI-DREAM Drug Sensitivity Prediction problem has been persistent for long; nonetheless, several models and algorithms have developed to tackle its two major sub-challenges [1]. The model includes a weighted Euclidean distance technique that is used to make a prediction as well as ranking the combination of drug especially their ability to neutralize the capability of a diffuse large B-cell lymphoma (DLBCL) cell line [2]. Similarly, the other technique is a bidirectional search algorithm that uses a nonlinear support vector machine (SVM) and a common scheme to predict how the drug compounds can impact the breast cancer cell lines [3]. The bidirectional search algorithm or greedy search algorithm usually makes a combination of the advantages of the support vector machine or kernel techniques as well as the ensemble modeling to correctly make a prediction of the sensitivity of the breast cancer cell lines to drug compounds which were formerly not tested [4]. Current composite models used to predict drug sensitivity use basic algorithms to extract traits from one type of data set [5]. Alternatively, the researcher created an ensemble model (as shown in figure 1 below) that was used in extracting features from different kind of datasets such as DNA copy number disparity, DNA methylation, RNA-seq, gene expression, proteomic data) as opposed to the use of diverse base algorithms on one form of datasets [6]. The researchers used similar base learning algorithms on the five different kinds of datasets [7]. Cancer is regarded as the causative factor of death globally, the development of drug compounds to target cancer cell and provide treatment has highly been prioritized [8]. Nonetheless, the discovery of cancer therapies is regarded as challenging, costly, and time consuming pharmaceutical venture since it entails various clinical evaluations and developmental phases [9]. Currently, simulation and computational models are increasingly preferred to make prediction of the reaction of the cancer cell lines to drug compounds to drug development or discovery process [10]. Such models are significantly helpful in improving the process of designing drugs as well as tackle several problems experienced throughout the process that assists in establishing the drug variations [11]. Furthermore, the researchers argue that the process of determining successful lead drug candidates used in treating cancer can greatly capitalize from such methods used to make prediction of how cancer cell lines are sensitive to drug compounds [12]. Time-series in addition to static conditional gene expression data are widely used to build the silicon models or predictors [13]. Statistical methods, for instance, a combination or integration of random forest and regression analysis have been used to manipulate gene expression data obtained from cancer cells which have treated with diverse drug compounds to predict of the capacity of the drugs to effectively stop cancer cell lines' proliferation [14]. Additionally, researchers have exploited gene expression datasets using the Naïve Bayes classifiers the sequencing data and chromosomal copy number difference obtained from human cancer lines which undergo treatment using twenty-four anticancer drugs to make a prediction of the capacity of the drugs to constrain their propagation [15]. Equally, gene expression data of sixty human cancer cell lines have been examined using a weighted voting classification model to foresee the drug reactions [16]. Moreover, the researchers combined random forest and nearest neighbor methodology to manipulate proteomic data to predict of the drug response of the cell lines [17]. In addition, a weighted voting algorithm which is created through the use of a set of genes which have been expressed differentially was used to accurately group 80 percent of the twenty-six samples to assess the effectiveness of the Docetaxel (an anticancer drug) in treating breast cancer [18, 19]. Majority of the statistical methods are variedly applied to the sequencing, gene expression, and proteomic data to determine how the cancer cell lines usually react to medication [20]. Therefore, review of the article reveal that current practice of making prediction about the cancer cell lines' sensitivity to the drugs can greatly be enhanced by using the ensemble models [21]. The researchers wanted to determine how the diverse forms of data can be relied on more correct prediction of the reaction of cancer cell lines to the drug compounds [22]. The research has greatly added new knowledge especially with how the ensemble methods can be used in capturing and extracting significant features from the diverse kinds of biological data [23, 24].
The researchers performed an assessment of the molecular structure
and numerical evaluation of mo... more The researchers performed an assessment of the molecular structure and numerical evaluation of molecular properties to examine the interrelationships that are prevalent in anticancer pharmacotherapies relied on to medically treat the lung cancer. In these cases, the researcher examined almost sixteen cancer medications focusing on their bioactivity scores, molecular properties, as well as their structures
The challenge for customize drug is to choose the right medicine for the individual patient. Drug... more The challenge for customize drug is to choose the right medicine for the individual patient. Drug testing of patients in large clinical trials is a way of assessing their efficacy and toxicity, but testing hundreds of drugs currently under development is impractical. Therefore, preclinical prediction models are highly desirable because of their capability is to know drug acknowledgement to hundreds of cell lines. In this paper, we presents, the classification technique is used to differentiate the drugs. Initially pre-processing is used on the true data that removes the noise, then the features are extracted which are saved into the database along with the information related to drug response. Then the performance parameters such as precision, recall, accuracy and f-measures are determined. The approximate accuracy observed come out to be 0.9315.
In the current study, we have experimentally and comparatively investigated and compared malignan... more In the current study, we have experimentally and comparatively investigated and compared malignant human cancer cells and tissues before and after irradiating of synchrotron radiation using Time–Resolved Spectroscopy and Time–Stretch Spectroscopy. It is clear that malignant human cancer cells and tissues have gradually transformed to benign human cancer cells and tissues under synchrotron radiation with the passage of time (Figures 1 and 2) [1-101].
Pharmacovigilance (PhV) was initiated to prevent adverse drug reactions and other adverse drug ev... more Pharmacovigilance (PhV) was initiated to prevent adverse drug reactions and other adverse drug events, in response to drug use tragedies such asphocomelia. As such, PhV has been long in existence in North America and Europe. However, in some countries the practice of PhV is relatively new. For example: In Namibia the Therapeutics Information and PhV Centre (TIPC) was established in 2008 by the Ministry of Health and Social Services (MoHSS), with technical support from Management Sciences for Health. Following the establishment of TIPC the MoHSS embarked on training in-service health care workers as a strategy to promote PhV. Training in-service HCW is a costly venture, and its continuous implementation may be interrupted. The training of medical, pharmacy, and nursing students is a more sustainable strategy for promoting PhV, by virtue of its long-term nature. In cognizance of the importance of PhV and the need to promote it, the School of Pharmacy (SoP), Faculty of Health Sciences at the University of Namibia included a module on PhV as part of the curriculum to train Bachelor of Pharmacy students. While didactic face to face training has been used to train PhV, the SoP utilised Self-Directed Learning. This report contains the aims of pharmacovigilance training at the SoP; how the module was structured; how the sessions were conducted; recommendations on how to make PhV training practical; and how to broaden student coverage on PhV training.
The control of blood glucose is critical in prevention of complication of diabetes and to improve... more The control of blood glucose is critical in prevention of complication of diabetes and to improve the quality of life of these patients. However in a setting of patients attending care from a private setting, the access to inexpensive care may be a critical control of diabetes, a lifelong chronic illness that requires optimal adherence to nutritional and medication. Such practices may ultimately heighten the financial burden associate with management of diabetes of complications such as hypertension and diabetic foot. In spite of this, the Glycaemic control practices in private health care settings in Uganda have not been well described and thus may negatively impact on the health outcomes. The study aimed to describe the practices among diabetic patients attending the Rubaga hospital, determine the level of Glycaemic control and identify the factors associated with diabetics' patients monitoring indicators (Hb1Ac levels, blood glucose levels). This is a Cross-sectional analytical study. Patients were randomly selected during the period of April and May 2012. The laboratory determination of the blood glucose levels (RBG) and Glycosylated hemoglobin (HB1AC) was done using the COBAS 6000 clinical chemistry analyser. Analysis was done using the student T-test and Chi-square test with a level of significance of 0.05. There was a significant statistical relationship between fasting plasma glucose and HbA1c (p-value = 0.000). Factors influencing high HBA1C levels in diabetic patients at Rubaga hospital were high cost of diabetes mellitus treatment (p-value = 0.019), duration the study participant had had the disease (P = 0.003) and having another chronic illness alongside diabetes mellitus (p-value = 0.045). The Republic of Uganda should make treatment of diabetes mellitus universally accessible and free. It should also put sensitization measures in place geared towards minimizing occurrence of some chronic disease conditions like hypertension which lead to co-treatment that lowers drug compliance.
Prior to defining pharmacopolitics, one may wonder about this odd associations and relevancy of t... more Prior to defining pharmacopolitics, one may wonder about this odd associations and relevancy of terminology. The word politics denotes articulating and resolving conflicts within society without recourse to physical violence [1]. Pharmaco stems from the Greek name Pharmakon/ Pharmacon which entail active ingredients/drug or medicine and is pertaining to pharmaceuticals and pharmacy sciences. Hence, the word pharmacopolitics joined the politics to medicines-drugs-pharmaceuticals to clarify the study of drug safety and efficacy (difficulties and solutions) in relation to societal priorities, controversies, health budgets and associated costs. This juxtaposition of the two words emphasizes the significance and impact of pharmaceuticals on health decisions, health political conflicts and societal health needs and priorities.
Background
Nevirapine’s (NVP) pharmaceutical manufacturer recommended the avoidance of NVP in fem... more Background Nevirapine’s (NVP) pharmaceutical manufacturer recommended the avoidance of NVP in females and males with baseline CD4 counts >250 and >400, respectively. This safety measure was challenged by research results that showed similar proportions of adverse events in high and low baseline CD4 count patients. WHO’s antiretroviral therapy guidelines recommended the use of NVP in patients with CD4 counts <350. Whether this recommendation would result in increase of NVP-related adverse reaction reports in Namibia was not known. Consequently, the pharmacovigilance centre monitored the NVP-related reaction reports for change in number and severity. Methods We accessed adverse reaction reports in VigiFlow®. NVP-related skin and liver adverse reaction reports received in 2011 were compared with those received in the Previous Years. Also, NVP-related reaction reports were compared with the same reactions associated with other medicines. The comparisons were made by using reporting ratio, proportional reporting ratio, and the Students T-Test. Results 1,074 adverse reaction reports were accessed. NVP-related liver and skin reactions were 208 (2011) and 99 (Previous Years). The proportions of reports related to ARV in 2011 and Previous Years were comparable (RR=1; p=0.87). The NVP-related reactions were greater in 2011 than in the Previous Years (43.2% vs. 16.7%: RR = 2.6; p <0.0001). Grade3 and 4 reactions related to NVP were greater in 2011 than in the Previous Years (SKIN: 22.7% vs. 5.6%: RR = 4.1; p <0.0001; LIVER: 8.5% vs. 2.2%: RR = 3.9; p <0.0001), but not for grade1 & 2 reactions (SKIN: 8.5% vs. 6.2%; RR = 1.4; p =0.16; LIVER: 2.7% vs. 2.4%; RR = 1.1; p = 0.73).The increase in reports was observed for both female and male patients (p<0.01). The increase ingrade 3 and 4 reactions were unique to NVP. Conclusion The significant increase in proportions of grade3 and 4 liver and skin reaction reports in patients on NVP was detected as a safety signal after shifting ART initiation to higher CD4 counts. The Ministry of Health halted the plan of initiating NVP-based ART in pregnant females, and recommended the avoidance of NVP in ART-naïve patients with high baseline CD4 counts. Through locally derived data, pharmacovigilance centres can protect patients from drug-induced harm.
Psychiatric disorders, like anxiety and depression, are risk factors for drug abuse and smoking b... more Psychiatric disorders, like anxiety and depression, are risk factors for drug abuse and smoking behavior. The purpose of this survey was to determine the prevalence of smoking, depression and anxiety and their relationship among school age students. This cross-sectional survey was done on 1020 high school students (male and female) recruited randomly and DSM-IV interview was done by researchers. A psychiatry resident accompanied by 3 last year medical students interviewed with students and a questionnaire containing demographic , anxiety and depression questions was filled simultaneously. The obtained data were analyzed using SPSS16. 50% of the students were female and the remainder male. 277 students (27.2%) were in the first year, 242 (23.7%) in the second year and 501 (49.1%) in the third year of high school. 55 students (5.4%) were smoker and used cigarette , water pipe (hobble bobble) and pipe.183 students (18%) had anxiety and stress symptoms (mild, moderate , sever). The 29 smoker students (2.84%) had anxiety. 144 students (14.1%) had depression (mild, moderate, sever) and 23 smoker students (2.25%) had depression symptoms. There was no significant correlation between smoking and anxiety and depression symptoms among school age students. As conclusion, we hypothesized that smoking may increase the tendency to depression and anxiety in high school students. Although the above results didn’t demonstrate any significant correlation between these three issues, school counselors and teachers need to be informed about the prevalence of problematic behaviors associated with smoking and it would be necessary to develop smoking prevention programs for adolescents, while taking the psychological factors such as depression and anxiety and school and family atmosphere into account.
Background
The Namibia Standard Treatment Guidelines (STGs) recommends empirical antibiotic treat... more Background The Namibia Standard Treatment Guidelines (STGs) recommends empirical antibiotic treatment in patients with signs and symptoms of Urinary tract infections (UTIs). The goal of UTI treatment is to eliminate the bacteria from the urinary tract. Efficacy of empirical antimicrobial treatment of UTI depends on the sensitivity of common microorganisms, the level of the antimicrobial load in the urine and the duration of treatment. The objective of this study was to identify the common uropathogens that cause UTI, describe the sensitivity pattern of common isolates to antibiotics that are used in the treatment of UTI and recommend appropriate antibiotics for the empirical treatment of UTI in Namibia. Methods This was a cross-sectional descriptive analysis of antibiotic susceptibility of isolates from urine using routinely collected data from the Namibia Institute of Pathology (NIP) database. Urine culture and sensitivity results from health facilities throughout Namibia from January 1, 2009 to June 30, 2013 were analysed. A total of 94, 682 urine samples were tested during the study period. Results The most common pathogens isolated were Escherichia coli (n = 18668, 34.1 %), Proteus mirabilis (n = 3520, 6.8%), and Klebsiella pneumoniae (n = 3266, 6.4%). E. coli showed very high resistance rate to amoxicillin and co-trimoxazol (79.6%, 78.64%) respectively. About one third (28%) of E. coli were resistant to Cephalothin and Nalidixic Acid. However, E. coli remained highly sensitive to ceftriaxone, amikacin, cefuroxime, gentamycin, nitrofurantoin, ofloxacin, norfloxacin, ciprofloxacin, and amoxicillin/ clavulanic acid its resistance ranging from 2.2% -16.82%. Proteus was found to be highly resistant to amoxicillin (55.91%), co-trimoxazole (57.85%) and nitrofurantoin (77.37%). However, it is less resistant to cephalothin (15.51%) and nalidixic acid (11.14%). Klebsiella, on the other hand, was found to be more resistant to Amoxicillin (96.72%) but less resistant to nitrofurantoin ( 23.87). It also demonstrated resistance to co-trimoxazole (56.52%) and cephalothin (35.79%).
Background
Few studies have reported rates of adverse drug reactions (ADRs) within low-income cou... more Background Few studies have reported rates of adverse drug reactions (ADRs) within low-income countries, and the resulting rates are extremely variable. Limited information exists about patterns of ADRs within African countries. Objective To identify the incidence and describe the types of ADRs for adult admissions to the Kamuzu Central Hospital in Lilongwe, Malawi. Methods In this retrospective chart review, baseline descriptive information for all patients and details surrounding any identified potential ADR were documented. Only medical charts that included both laboratory results and a medication administration record were included. An expert panel reviewed all potential ADRs for study inclusion. Results 263 charts were reviewed and only 16% (42) met inclusion criteria. Of those 42 charts, 4 ADRs were identified. A cumulative ADR occurrence of 9.5% was observed. Conclusions The preliminary incidence of ADRs in Malawi appears high and requires further evaluation to identify potential causes and solutions.
The World Health Organization (WHO) defines pharmacovigilance as “the science and activities rela... more The World Health Organization (WHO) defines pharmacovigilance as “the science and activities relating to the detection, assessment, understanding and prevention of adverse affects or any other possible drug-related problems.” The safety monitoring of pharmaceuticals is a fundamental component of daily clinical practice. Providing high eminence medical care, ongoing safety monitoring and evaluation of effectiveness are essential to the perpetual use of pharmaceuticals. Pharmacovigilance is recognized as a clinical discipline and it serves as an indicator of the standards of clinical care practiced within a country.
The healthcare facilities must have a system incorporated in order to detect, monitor, prevent an... more The healthcare facilities must have a system incorporated in order to detect, monitor, prevent and report any unsafe use of pharmaceuticals and to track the launch of newer ones. This tracking system can be achieved via the pharmacy and therapeutics committee (PTC) that represents the governing body of pharmaceuticals within any healthcare facility.
Pharmacovigilance (PV) is the science and activities relating to the detection, assessment, under... more Pharmacovigilance (PV) is the science and activities relating to the detection, assessment, understanding and prevention of adverse effects or any other drug related problem. PV collects, records, codes ADEs/ADRs analyses and assesses the reports, promotes the safe use of drugs, creates appropriate structures and means of communication needed to perform its tasks. The aims of PV are to improve patient care and safety, improve public health and safety, contribute to the assessment of benefit, harm, effectiveness and risk of medicines, promote education and clinical training, promote effective communication to public and promote rational and safe use of medicines.
This is both challenging and exciting to write an editorial for the journal Pharmacovigilance and... more This is both challenging and exciting to write an editorial for the journal Pharmacovigilance and Drug Safety. The number of medicines in the market has increased dramatically over the last few years, bringing some real innovations, but also considerable challenges in controlling the quality and rational use of medicines. Safety of medicines is an important issue. Due to intense competition among pharmaceutical manufacturers, products may be registered and marketed in many countries simultaneously. As a result adverse effect may go unnoticed and so are not monitored systematically. Pharmacovigilance is a structured process for the monitoring and detection of adverse drug reactions in the given context.
Since rofecoxib was withdrawn from the market in 2005, the controversy keeps going on about the c... more Since rofecoxib was withdrawn from the market in 2005, the controversy keeps going on about the cardiovascular risk of Non Steroidal Anti-Inflammatory Drugs (NSAIDs). With their analgesic, anti-inflammatory, antipyretic and anti-thrombotic properties, NSAIDs are among the most widely used therapeutic agents. They are also known for their side effects: dyspepsia, peptic ulcerations, fluid retention, high blood pressure ... The recent revelation of thrombotic events due to the use of coxibs (selective COX-2 inhibitors) has led to a thorough study of this risk with every NSAID. The results have shown that the vascular risks of diclofenac were comparable to coxibs. In 2013, new recommandations have been announced to warn patients and healthcare professionals about the safe use of diclofenac. Beyond these European recommendations, the use of diclofenac should be revised on a worldwide scale since its use is very common in countries such as China and India.
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Methods: A spontaneous pharmacovigilance case reporting is presented, following the causality assessment criteria, including temporal association with drug exposure, exclusion of other etiologies, dechallenge and rechallenge. Skin biopsy for normal histopathology and direct immunofluorescence wasperformed to assess the diagnosis of lupus erythematosus.
Results: A 77 years old woman was hospitalized in the Dermatology Clinic of Cagliari University for a lamotrigine Induced Subacute Cutaneous Lupus Erythematosus, confirmed by improvement after drug dismission, and immediate recurrence at re-exposure. The last measure was performed on request of the neurologist with the consent of the patient, because of a high suicidal risk, not responding to traditional antidepressants, and well controlled by lamotrigine. Another peculiarity of our observation is a potential dose-related effects, as the patients was assuming lamotrigine from 2 years, and skin manifestations actually began 3 weeks after the dosage was doubled to 100 mg daily.
Conclusion: If confirmed by other observation, drug-induced subacute cutaneous lupus erythematosus might be dose-dependent, and careful clinician’s dosage monitoring might prevent occurrence, preserving the lamotrigine use for the many patients who need it. Dermatologist referral is warrant in front of any suspect cutaneous adverse reaction due to psychotropic medications, to provide prompt recognition, adequate assessment and supportive management of such difficult and delicate patients.
of its goals. The need for this mainly focuses on four relevant stakeholders: healthcare sciences students, healthcare professional, pharmaceutical industry
employees and patients. Although a lot of progress has taken place, there is still the need of a more structured approach, improvement and optimization;
this has to focus on patients, which are the end users of healthcare services and the most important stakeholder in the life cycle of medicinal products
and numerical evaluation of molecular properties to examine the
interrelationships that are prevalent in anticancer pharmacotherapies relied on to medically treat the lung cancer. In these cases, the researcher examined almost sixteen cancer medications focusing on their bioactivity scores, molecular properties, as well as their structures
Nevirapine’s (NVP) pharmaceutical manufacturer recommended the avoidance of NVP in females and males with baseline CD4 counts >250 and >400, respectively. This safety measure was challenged by research results that showed similar proportions of adverse events in high and low baseline CD4 count patients. WHO’s antiretroviral therapy guidelines recommended the use of NVP in patients with CD4 counts <350. Whether this recommendation would result in increase of NVP-related adverse reaction reports in Namibia was not known. Consequently, the pharmacovigilance centre monitored the NVP-related reaction reports for change in number and severity.
Methods
We accessed adverse reaction reports in VigiFlow®. NVP-related skin and liver adverse reaction reports received in 2011 were compared with those received in the Previous Years. Also, NVP-related reaction reports were compared with the same reactions associated with other medicines. The comparisons were made by using reporting ratio, proportional reporting ratio, and the Students T-Test.
Results
1,074 adverse reaction reports were accessed. NVP-related liver and skin reactions were 208 (2011) and 99 (Previous Years). The proportions of reports related to ARV in 2011 and Previous Years were comparable (RR=1; p=0.87). The NVP-related reactions were greater in 2011 than in the Previous Years (43.2% vs. 16.7%: RR = 2.6; p <0.0001). Grade3 and 4 reactions related to NVP were greater in 2011 than in the Previous Years (SKIN: 22.7% vs. 5.6%: RR = 4.1; p <0.0001; LIVER: 8.5% vs. 2.2%: RR = 3.9; p <0.0001), but not for grade1 & 2 reactions (SKIN: 8.5% vs. 6.2%; RR = 1.4; p =0.16; LIVER: 2.7% vs. 2.4%; RR = 1.1; p = 0.73).The increase in reports was observed for both female and male patients (p<0.01). The increase ingrade 3 and 4 reactions were unique to NVP.
Conclusion
The significant increase in proportions of grade3 and 4 liver and skin reaction reports in patients on NVP was detected as a safety signal after shifting ART initiation to higher CD4 counts. The Ministry of Health halted the plan of initiating NVP-based ART in pregnant females, and recommended the avoidance of NVP in ART-naïve patients with high baseline CD4 counts. Through locally derived data, pharmacovigilance centres can protect patients from drug-induced harm.
The Namibia Standard Treatment Guidelines (STGs) recommends empirical antibiotic treatment in patients with signs and symptoms of Urinary tract infections (UTIs). The goal of UTI treatment is to eliminate the bacteria from the urinary tract. Efficacy of empirical antimicrobial treatment of UTI depends on the sensitivity of common microorganisms, the level of the antimicrobial load in the urine and the duration of treatment. The objective of this study was to identify the common uropathogens that cause UTI, describe the sensitivity pattern of common isolates to antibiotics that are used in the treatment of UTI and recommend appropriate antibiotics for the empirical treatment of UTI in Namibia.
Methods
This was a cross-sectional descriptive analysis of antibiotic susceptibility of isolates from urine using routinely collected data from the Namibia Institute of Pathology (NIP) database. Urine culture and sensitivity results from health facilities throughout Namibia from January 1, 2009 to June 30, 2013 were analysed. A total of 94, 682 urine samples were tested during the study period.
Results
The most common pathogens isolated were Escherichia coli (n = 18668, 34.1 %), Proteus mirabilis (n = 3520, 6.8%), and Klebsiella pneumoniae (n = 3266, 6.4%). E. coli showed very high resistance rate to amoxicillin and co-trimoxazol (79.6%, 78.64%) respectively. About one third (28%) of E. coli were resistant to Cephalothin and Nalidixic Acid. However, E. coli remained highly sensitive to ceftriaxone, amikacin, cefuroxime, gentamycin, nitrofurantoin, ofloxacin, norfloxacin, ciprofloxacin, and amoxicillin/ clavulanic acid its resistance ranging from 2.2% -16.82%. Proteus was found to be highly resistant to amoxicillin (55.91%), co-trimoxazole (57.85%) and nitrofurantoin (77.37%). However, it is less resistant to cephalothin (15.51%) and nalidixic acid (11.14%). Klebsiella, on the other hand, was found to be more resistant to Amoxicillin (96.72%) but less resistant to nitrofurantoin ( 23.87). It also demonstrated resistance to co-trimoxazole (56.52%) and cephalothin (35.79%).
Few studies have reported rates of adverse drug reactions (ADRs) within low-income countries, and the resulting rates are extremely variable. Limited information exists about patterns of ADRs within African countries.
Objective
To identify the incidence and describe the types of ADRs for adult admissions to the Kamuzu Central Hospital in Lilongwe, Malawi.
Methods
In this retrospective chart review, baseline descriptive information for all patients and details surrounding any identified potential ADR were documented. Only medical charts that included both laboratory results and a medication administration record were included. An expert panel reviewed all potential ADRs for study inclusion.
Results
263 charts were reviewed and only 16% (42) met inclusion criteria. Of those 42 charts, 4 ADRs were identified. A cumulative ADR occurrence of 9.5% was observed.
Conclusions
The preliminary incidence of ADRs in Malawi appears high and requires further evaluation to identify potential causes and solutions.
The safety monitoring of pharmaceuticals is a fundamental component of daily clinical practice. Providing high eminence medical care, ongoing safety monitoring and evaluation of effectiveness are essential to the perpetual use of pharmaceuticals. Pharmacovigilance is recognized as a clinical discipline and it serves as an indicator of the standards of clinical care practiced within a country.
Methods: A spontaneous pharmacovigilance case reporting is presented, following the causality assessment criteria, including temporal association with drug exposure, exclusion of other etiologies, dechallenge and rechallenge. Skin biopsy for normal histopathology and direct immunofluorescence wasperformed to assess the diagnosis of lupus erythematosus.
Results: A 77 years old woman was hospitalized in the Dermatology Clinic of Cagliari University for a lamotrigine Induced Subacute Cutaneous Lupus Erythematosus, confirmed by improvement after drug dismission, and immediate recurrence at re-exposure. The last measure was performed on request of the neurologist with the consent of the patient, because of a high suicidal risk, not responding to traditional antidepressants, and well controlled by lamotrigine. Another peculiarity of our observation is a potential dose-related effects, as the patients was assuming lamotrigine from 2 years, and skin manifestations actually began 3 weeks after the dosage was doubled to 100 mg daily.
Conclusion: If confirmed by other observation, drug-induced subacute cutaneous lupus erythematosus might be dose-dependent, and careful clinician’s dosage monitoring might prevent occurrence, preserving the lamotrigine use for the many patients who need it. Dermatologist referral is warrant in front of any suspect cutaneous adverse reaction due to psychotropic medications, to provide prompt recognition, adequate assessment and supportive management of such difficult and delicate patients.
of its goals. The need for this mainly focuses on four relevant stakeholders: healthcare sciences students, healthcare professional, pharmaceutical industry
employees and patients. Although a lot of progress has taken place, there is still the need of a more structured approach, improvement and optimization;
this has to focus on patients, which are the end users of healthcare services and the most important stakeholder in the life cycle of medicinal products
and numerical evaluation of molecular properties to examine the
interrelationships that are prevalent in anticancer pharmacotherapies relied on to medically treat the lung cancer. In these cases, the researcher examined almost sixteen cancer medications focusing on their bioactivity scores, molecular properties, as well as their structures
Nevirapine’s (NVP) pharmaceutical manufacturer recommended the avoidance of NVP in females and males with baseline CD4 counts >250 and >400, respectively. This safety measure was challenged by research results that showed similar proportions of adverse events in high and low baseline CD4 count patients. WHO’s antiretroviral therapy guidelines recommended the use of NVP in patients with CD4 counts <350. Whether this recommendation would result in increase of NVP-related adverse reaction reports in Namibia was not known. Consequently, the pharmacovigilance centre monitored the NVP-related reaction reports for change in number and severity.
Methods
We accessed adverse reaction reports in VigiFlow®. NVP-related skin and liver adverse reaction reports received in 2011 were compared with those received in the Previous Years. Also, NVP-related reaction reports were compared with the same reactions associated with other medicines. The comparisons were made by using reporting ratio, proportional reporting ratio, and the Students T-Test.
Results
1,074 adverse reaction reports were accessed. NVP-related liver and skin reactions were 208 (2011) and 99 (Previous Years). The proportions of reports related to ARV in 2011 and Previous Years were comparable (RR=1; p=0.87). The NVP-related reactions were greater in 2011 than in the Previous Years (43.2% vs. 16.7%: RR = 2.6; p <0.0001). Grade3 and 4 reactions related to NVP were greater in 2011 than in the Previous Years (SKIN: 22.7% vs. 5.6%: RR = 4.1; p <0.0001; LIVER: 8.5% vs. 2.2%: RR = 3.9; p <0.0001), but not for grade1 & 2 reactions (SKIN: 8.5% vs. 6.2%; RR = 1.4; p =0.16; LIVER: 2.7% vs. 2.4%; RR = 1.1; p = 0.73).The increase in reports was observed for both female and male patients (p<0.01). The increase ingrade 3 and 4 reactions were unique to NVP.
Conclusion
The significant increase in proportions of grade3 and 4 liver and skin reaction reports in patients on NVP was detected as a safety signal after shifting ART initiation to higher CD4 counts. The Ministry of Health halted the plan of initiating NVP-based ART in pregnant females, and recommended the avoidance of NVP in ART-naïve patients with high baseline CD4 counts. Through locally derived data, pharmacovigilance centres can protect patients from drug-induced harm.
The Namibia Standard Treatment Guidelines (STGs) recommends empirical antibiotic treatment in patients with signs and symptoms of Urinary tract infections (UTIs). The goal of UTI treatment is to eliminate the bacteria from the urinary tract. Efficacy of empirical antimicrobial treatment of UTI depends on the sensitivity of common microorganisms, the level of the antimicrobial load in the urine and the duration of treatment. The objective of this study was to identify the common uropathogens that cause UTI, describe the sensitivity pattern of common isolates to antibiotics that are used in the treatment of UTI and recommend appropriate antibiotics for the empirical treatment of UTI in Namibia.
Methods
This was a cross-sectional descriptive analysis of antibiotic susceptibility of isolates from urine using routinely collected data from the Namibia Institute of Pathology (NIP) database. Urine culture and sensitivity results from health facilities throughout Namibia from January 1, 2009 to June 30, 2013 were analysed. A total of 94, 682 urine samples were tested during the study period.
Results
The most common pathogens isolated were Escherichia coli (n = 18668, 34.1 %), Proteus mirabilis (n = 3520, 6.8%), and Klebsiella pneumoniae (n = 3266, 6.4%). E. coli showed very high resistance rate to amoxicillin and co-trimoxazol (79.6%, 78.64%) respectively. About one third (28%) of E. coli were resistant to Cephalothin and Nalidixic Acid. However, E. coli remained highly sensitive to ceftriaxone, amikacin, cefuroxime, gentamycin, nitrofurantoin, ofloxacin, norfloxacin, ciprofloxacin, and amoxicillin/ clavulanic acid its resistance ranging from 2.2% -16.82%. Proteus was found to be highly resistant to amoxicillin (55.91%), co-trimoxazole (57.85%) and nitrofurantoin (77.37%). However, it is less resistant to cephalothin (15.51%) and nalidixic acid (11.14%). Klebsiella, on the other hand, was found to be more resistant to Amoxicillin (96.72%) but less resistant to nitrofurantoin ( 23.87). It also demonstrated resistance to co-trimoxazole (56.52%) and cephalothin (35.79%).
Few studies have reported rates of adverse drug reactions (ADRs) within low-income countries, and the resulting rates are extremely variable. Limited information exists about patterns of ADRs within African countries.
Objective
To identify the incidence and describe the types of ADRs for adult admissions to the Kamuzu Central Hospital in Lilongwe, Malawi.
Methods
In this retrospective chart review, baseline descriptive information for all patients and details surrounding any identified potential ADR were documented. Only medical charts that included both laboratory results and a medication administration record were included. An expert panel reviewed all potential ADRs for study inclusion.
Results
263 charts were reviewed and only 16% (42) met inclusion criteria. Of those 42 charts, 4 ADRs were identified. A cumulative ADR occurrence of 9.5% was observed.
Conclusions
The preliminary incidence of ADRs in Malawi appears high and requires further evaluation to identify potential causes and solutions.
The safety monitoring of pharmaceuticals is a fundamental component of daily clinical practice. Providing high eminence medical care, ongoing safety monitoring and evaluation of effectiveness are essential to the perpetual use of pharmaceuticals. Pharmacovigilance is recognized as a clinical discipline and it serves as an indicator of the standards of clinical care practiced within a country.