Journal of Pharmacovigilance最新文献

{"title":"Chelating Complex Micelles for Delivering Cytoprotectant Amifostine and its Application in Radiation Protection","authors":"Chau-Hui Wang, Chia-Yi Cheng, Chia-Hung Chen, W. Liao, Johnson Lin","doi":"10.4172/2329-6887.1000263","DOIUrl":"https://doi.org/10.4172/2329-6887.1000263","url":null,"abstract":"A new nano-size drug carrier was proposed to overcome the shortcomings of conventional drug delivery systems. Amifsotine, a hydrophilic and extremely short half-life cytoprotective agent, was loaded based on chelating complex micelles (CCM) in order to provide the protection from radiation exposure. The preparation of amifostine-loaded CCM (CCM-Ami) was simply mixing ferrous chloride, poly(ethylene glycol)-block-poly (glutamic acid) (PEG-b-PGA) and amifostine in an aqueous solution without using any organic solvent. The resulting CCM-Ami monodispersed with a mean particle size 25 nm and showed a slow release behavior as compared to amifostine. Furthermore, CCM-Ami pretreatment improved survival rates and median survival in C57BL/6 mice than did treatment with a corresponding dose of amifostine. These results point to a potential use of CCM as a novel drug carrier. Drug molecules that may act as ligands can be considered delivering by this platform technology.","PeriodicalId":16958,"journal":{"name":"Journal of Pharmacovigilance","volume":"238 1","pages":"1-6"},"PeriodicalIF":0.0,"publicationDate":"2018-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"79421242","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Knowledge and Awareness Regarding Safe Drug Disposal System among General Population of India","authors":"S. N., Ateendra Jha","doi":"10.4172/2329-6887.1000256","DOIUrl":"https://doi.org/10.4172/2329-6887.1000256","url":null,"abstract":"Thousands of drugs are releasing into the market day by day in order to treat various diseases and to promote the health of growing population of India. But when they no longer needed their disposal become necessary because drug is a chemical and once it expires it will become a toxic agent. The people may have expired drugs, unused or unwanted medicines which may occur as a result of non-adherence, excessive storage of OTC medication or disuse of drugs. The USFDA initiated ‘drug take back programme’ to prevent the entry of these medication into environment. But in India drug take back programmer is not functional. The country is now facing the numerous problems due to improper drug disposal methods such as burning, flushing into toilet and throwing somewhere or into waste-basket which may lead to environmental contamination and pollution, contamination of water supplies and other local sources used by community and wildlife which will results in serious environmental and health hazards like toxicity, accidental poisoning and drug abuse, development of drug resistance problems and even death. Since the drug take back programme is not functional in the developing countries like India several cases of toxicity and accidental exposure are seen day by day. So an online survey was conducted in general population in order to check the knowledge of people regarding safe drug disposal system. From the data, 73% of 214 people are not aware of safe and effective disposal of drugs without causing any harmful effect to nature and public.","PeriodicalId":16958,"journal":{"name":"Journal of Pharmacovigilance","volume":"9 1","pages":"1-4"},"PeriodicalIF":0.0,"publicationDate":"2018-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"79095287","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Secondary Middle-ear Damages in Patients with Head and Neck Cancerafter Radiotherapy","authors":"Huong Ld, Ng Lp, Nguyen Hx","doi":"10.4172/2329-6887.1000271","DOIUrl":"https://doi.org/10.4172/2329-6887.1000271","url":null,"abstract":"Objective: This study aimed to evaluate the relationship between radiotherapy and Eustachian tube dysfunction, and to investigate the efficacy of treatments by tympanostomy and grommet insertion. Methods: Patients with head and neck cancer (148 patients) were treated by three–dimensional radiotherapy in the Center of Oncology and Nuclear Medicine, Military Medical 103 Hospital from February 2014 to April 2016. All patients underwent an ear examination (otoscopy), audiometry, and tympanometry test. Those who developed otitis media with effusion and tympanosclerosis were then treated by tympanostomy or myringotomy. Results: The most common complication after the radiotherapy was found to be Eustachian tube dysfunction, especially otitis media with effusion and tympanosclerosis. Thus, carefully examining and closely monitoring need to be performed to detect patients with secondary middle-ear damages, to successfully cure post-radiotherapy otitis media with effusion, and to minimize possible injury to the middle ear and Eustachian tube. Also, tympanostomy and myringotomy were reported to be the preferable treatments due to their simplicity, high quality, and patients’ compliance. Conclusion: Eustachian tube dysfunction after radiotherapy treatment was the cause for otitis media with effusion and tympanosclerosis. Furthermore, tympanostomy and grommet insertion were convenient, efficient, and desirable treatments for secondary middle-ear damages in patients with head and neck cancer.","PeriodicalId":16958,"journal":{"name":"Journal of Pharmacovigilance","volume":"46 1","pages":"1-4"},"PeriodicalIF":0.0,"publicationDate":"2018-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"84065326","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Polymorphisms of CYP3A5 Affect Serum Levels and Maintenance Doses of Tacrolimus in Myasthenia Gravis Patients","authors":"N. Kawaguchi, K. Nakatani, A. Uzawa, Y. Nemoto, K. Himuro, S. Kuwabara","doi":"10.4172/2329-6887.1000258","DOIUrl":"https://doi.org/10.4172/2329-6887.1000258","url":null,"abstract":"Objectives: To evaluate the influences of polymorphisms of cytochrome P450 (CYP) 3A5 (A6986G, CYP3A5*3) on serum levels of tacrolimus and cyclosporine (CyA) in patients with myasthenia gravis (MG). Methods: This study included 74 MG patients treated with tacrolimus (n=65) or CyA (n=22). Genomic DNA was extracted and amplified with specific primers, and CYP3A5 alleles were confirmed by direct sequencing of PCR products on an automated AB13100 DNA sequencer. We measured blood trough level (C0) of tacrolimus and CyA. Clinical disabilities were evaluated with the MG-ADL scale. Results: For tacrolimus C0, the CYP3A5*3/*3 genotype was associated with higher levels than the CYP3A5*1/*3 genotypes (7.1 ng/ml versus 2.9 ng/ml; P<0.0001) and CYP3A*1/*1 (7.1 ng/ml versus 1.3 ng/ml; P<0.0004). The improvement in the mean MG-ADL scores tended to be better in MG patients with the CYP3A5*3/*3 or CYP3A5*1/*3 than those with CYP3A5*1/*1. For the CyA concentrations, CYP3A5 genotypes did not have significant effects. Conclusion: In MG patients, CYP3A5 polymorphism significantly affects serum levels of tacrolimus and thereby treatment effects, but not those of CyA. The maintenance dose of tacrolimus should be determined considering CYP3A5 polymorphism.","PeriodicalId":16958,"journal":{"name":"Journal of Pharmacovigilance","volume":"8 1","pages":"1-4"},"PeriodicalIF":0.0,"publicationDate":"2018-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"84195231","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Pharmacovigilance Process in India: An overview","authors":"Prashant N. Amale, S. Deshpande, Nakhate Yd, Arsod Na","doi":"10.4172/2329-6887.1000259","DOIUrl":"https://doi.org/10.4172/2329-6887.1000259","url":null,"abstract":"Clinical trial study of drug generally detects common Adverse Drug Reaction (ADR) but, the reaction which occurs after long duration in a specific person or population remains undetected. Pharmacovigilance (PV) is a scientific activity which keeps constant watch on the drug throughout its life cycle. In India, Indian Pharmacopoeia Commission (IPC) and National Coordination Committee (NCC) through the Central Drug Standard Control Organization (CDSCO) cordially regulate the PV activity. To build a potential PV system in India, Pharmacovilance Program of India (PvPI) have been proposed and implemented by the Indian government in 2010. The accurate detection and reporting of ADR is a heart of this system. Hence various regional, zonal and peripheral centres have been proposed for the smooth and effective reporting of ADR. Anyone can report ADR by filling the suspect ADR reporting form available online or offline to the nearest centre in suitable language. Considering Indian geographical distribution, huge population and mobile network connectivity, a toll free number and the mobile app is also provided for timely and effective reporting of ADR. The reported ADRs are collected and processed at the centres in Vigi-flow software. These centres detect signal which are reported to CDSCO and World Health Organisation (WHO) for the further regulatory action. CDSCO-WHO communicates their decision through a suitable media for the betterment of public health.","PeriodicalId":16958,"journal":{"name":"Journal of Pharmacovigilance","volume":"28 1","pages":"1-7"},"PeriodicalIF":0.0,"publicationDate":"2018-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"84513543","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Pharmacovigilance of Neuroleptics and Benzodiazepines in the Psychiatric Teaching Hospital of Benin Republic","authors":"A. Allabi, E. Klikpo, Lonmandon Sc, Tognide Cm","doi":"10.4172/2329-6887.1000249","DOIUrl":"https://doi.org/10.4172/2329-6887.1000249","url":null,"abstract":"Background: Data on adverse drug reactions (ADRs) related to neuroleptics and benzodiazepines in sub- Saharan Africa psychiatry setting are few indicating the need for psychotropic drugs safety surveillance in clinical care.Objective: To determine profile of the drugs prescribed, incidence, type and risk factors associated with adverse drug reactions (ADRs) among patients on neuroleptics and benzodiazepines.Methods: Patients initiated on neuroleptics and/or benzodiazepines between March 2014 and September 2014 were evaluated in a prospective cohort analysis. Prospective study of active pharmacovigilance during six months was performed. Each patient was followed for two months. The French method was used to determine the causality assessment.Results: 86 inpatients or outpatients were enrolled. 65.12% experienced a side event (SE). Among them, 22.09% had insomnia, 17.44%, drowsiness; 5.81%, dyskinesia; 4.65%, an appetite increase and 4.65%, headaches. The percentages of patients with 1, 2, 3, 4 and 5 side events were 39.28%, 41.07%, 8.92%, 7.14% and 3.57% of the 65.12% respectively. The average number of side events per patient was similar in hospitalized patients and in those treated ambulatory (1.97 vs. 1.92). The causality assessment of the side events to the drugs prescribed to each patient is predominantly doubtful (52.29%). It is likely in 44.95%, very likely in only 1.83% of the cases and plausible in 0.92% of the patients. All SEs occurred during the first month, most during the first week. The management of adverse drugs reactions led to drug doses reduction only in 23% of the cases while responsible drugs were stopped in 5.77% of the cases.Conclusion: The relatively high frequency of typical antipsychotics of use and low daily dose of benzodiazepine among our patients merit further investigation and systematic efficacy and safety monitoring. Typical antipsychotics should be made more available and monotherapies should be encouraged. The pharmacovigilance should be developed in the country by installing a National Center and by training health professionals.","PeriodicalId":16958,"journal":{"name":"Journal of Pharmacovigilance","volume":"32 1","pages":"1-5"},"PeriodicalIF":0.0,"publicationDate":"2017-12-09","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"87333710","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Evaluation of the Use of Granulocyte Colony-Stimulating Factors (G-CSFs) for Neutropenia Primary Prophylaxis in Solid Tumors at a Tertiary Care Hospital, Retrospective Study","authors":"A. af, A. Alnatsheh, M. Aseeri, T. Alfayea","doi":"10.4172/2329-6887.1000248","DOIUrl":"https://doi.org/10.4172/2329-6887.1000248","url":null,"abstract":"Objective: First, to determine the appropriate prescribing of granulocyte colony-stimulating factors (G-CSFs) for febrile neutropenia (FN) as primary prophylaxis during the first cycle of chemotherapy in breast, lung, gastric, esophageal, nasopharyngeal or colorectal cancer patients. Second, to compare the incidence of FN between patients who received G-CSF appropriately and inappropriately. \u0000Methods: This was a retrospective cohort study conducted at the Princess Norah bint Abdulrahman Al Faisal Oncology Center. We used cancer registry report which included adult patients with newly diagnosed solid tumors, such as breast, lung, gastric, esophageal, nasopharyngeal and colorectal cancer between January 2013 and December 2013. Patients were excluded if they did not receive chemotherapy after diagnosis and had renal or liver impairment. The appropriate indication of G-CSFs for FN primary prophylaxis was evaluated based on the National Comprehensive Cancer Network (NCCN) guidelines and published data. \u0000Results: G-CSFs were appropriately prescribed as primary prophylaxis in 85% of patients. The incidence of FN between the appropriate and inappropriate groups were not statistically significant (p=0.315). However, G-CSF use was inappropriate in 28 of the 29 patients who received chemotherapy regimens with high risk of developing FN; among these patients only three patients developed FN. \u0000Conclusion: The prescribing of G-CSFs for FN primary prophylaxis at our institution was found to be inappropriate on some occasions; mostly when G-CSFs were not prescribed with regimens associated with high risk of FN.","PeriodicalId":16958,"journal":{"name":"Journal of Pharmacovigilance","volume":"5 1","pages":"1-5"},"PeriodicalIF":0.0,"publicationDate":"2017-12-06","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"91142613","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Antibacterial Evaluation and Phytochemical Analysis of Selected Medicinal Plants against Some Pathogenic Enteric Bacteria in Gozamin District, Ethiopia","authors":"M. Fentahun, B. AyeleYilkal, N. Amsalu, A. Alemayehu, G. Amsalu","doi":"10.4172/2329-6887.1000244","DOIUrl":"https://doi.org/10.4172/2329-6887.1000244","url":null,"abstract":"Antibacterial activity evaluation and Phytochemical Analysis of aqueous, chloroform, methanol and ethanol crude extracts of thirteen medicinal plants species that were selected based on ethno botanical information on their traditional use were tested for treatment of enteric disease in Gozamin District. The study has been carried out from January 5, 2014 to February 15, 2015. All of these plants were extracted following standard methods (Soaking extraction method and agar-well diffusion) to screen of potential anti-microbial substance. All crude extracts of those medicinal plants were tested against standard reference strains including Escherichia coli, Staphylococcus aureus, Shigella sonnei, Pseudomonas aeruginosa and Salmonella typhimurium. The highest antibacterial activity (17 mm) was observed from chloroform leaf extract of Eucalyptus globules against E. coli and leaf extract of Verbena officinalis (13.6 mm) extract against Shigella sonnei, followed by methanol leaf extract of Cordia africana (12.8 mm) against E. coli. More over Eucalyptus globules was positive for all bioactive compounds tested except saponins and Verbena officinalis was positive for all bioactive ingredients tested except alkaloids. In general extracts of Eucalyptus globules leaves exhibited the highest potency against E. coli and extract Verbena officinalis showed highest potency against Shigella sonnei. Thus, this study confirmed the alternative sources of medicine for pathogenic enteric bacteria tested.","PeriodicalId":16958,"journal":{"name":"Journal of Pharmacovigilance","volume":"35 1","pages":"1-6"},"PeriodicalIF":0.0,"publicationDate":"2017-10-27","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"74802677","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Audit on medicine information centre queries and adverse drug reaction reporting","authors":"Ahmed Al Harthi","doi":"10.4172/2329-6887-C1-030","DOIUrl":"https://doi.org/10.4172/2329-6887-C1-030","url":null,"abstract":"","PeriodicalId":16958,"journal":{"name":"Journal of Pharmacovigilance","volume":"24 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2017-10-18","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"89128786","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Sudanese Clays for Heterogenous Methanolysis of Castor Oil","authors":"A. R. Yacob, A. Mohmedahmed","doi":"10.4172/2329-6887.1000241","DOIUrl":"https://doi.org/10.4172/2329-6887.1000241","url":null,"abstract":"Objective: To modify two Sudanese clays, called Jourdiqua and Jabbalmarra, with different loading of HCl, 0.1 M, 0.2 M, 0.3 M, 0.4 M, 0.5 M and 1.00 M in order to increase their catalytic activities and then used in methanolysis of castor oil. Methods/Statistical analysis: Both raw and modified clay samples were used as catalysts under reaction conditions; 5wt% of catalyst to oil, molar ratio of methanol to oil of 27:1, 4 h reaction time and temperature of 67°C. The unmodified and modified clay samples were characterized by, thermogravimetric analysis-differential thermogravimetric (TGA-DTG), Brunauer-Emmett-Teller (BET), inductively coupled plasma-emission spectroscopy (ICP-ES), atomic absorption spectroscopy (AAS), X-ray powder diffraction (XRD), Fourier transform infra-red (FTIR) and field electron scanning emission microscopy (FESEM). Finding: Application/Improvement: BET analysis showed increase in specific surface area for both Jourdiqua and Jabbalmarra clays. Elemental analysis by ICP-ES showed decrease content in elements of Al, Mg, Na and K for both clays, due to the acid leaching. The biodiesel conversion was monitored using nuclear magnetic resonance (NMR) spectroscopy. An increase in conversion was observed for Jourdiqua clay from 51% to 90% when treated with 0.5 M HCl, the optimized concentration for the modification, while for Jabbalmarra 22.5% conversion was obtained with raw clay and after modification gave conversion of 82% in reaction conditions of temperature 65°C, reaction time of 4 h, molar ratio of methanol to oil of 18:1 and catalyst loading of 9%. It was observed that acid modification with 0.5 M HCl have improved tremendously the catalytic capability of the raw clays.","PeriodicalId":16958,"journal":{"name":"Journal of Pharmacovigilance","volume":"2 1","pages":"1-6"},"PeriodicalIF":0.0,"publicationDate":"2017-10-05","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"78685534","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}