Journal of Pharmacovigilance最新文献

{"title":"Pharmacovigilance Practices: Knowledge and Attitudes among theHealthcare Professionals at the Volta Regional Hospital of Ghana","authors":"Sedem Nunyuia Amedom, Dadson Ba","doi":"10.4172/2329-6887.1000229","DOIUrl":"https://doi.org/10.4172/2329-6887.1000229","url":null,"abstract":"Pharmacovigilance since its inception has been the global medicine safety monitoring tool by all World Health Organization member states. Ghana joined the program as the 65th member in 2001. Pharmacovigilance has mainly relied on spontaneous reports of adverse drug reactions from healthcare professionals. However, under reporting has been reported to be a major challenge. The success of the PV system in Ghana depends greatly on the understanding, active involvement and practices among the country’s healthcare professionals The study evaluated the pharmacovigilance practices among the healthcare professionals at the Volta Regional Hospital, Ho, by assessing their knowledge, attitudes and practices towards the program. A descriptive cross-sectional design was used and a 27-item pre-tested self-administered questionnaire as the research instrument. Convenient and judgmental sampling techniques were used to select an estimated sample of 145 representing, 68.1% of the targeted population. Data was processed and analyzed by the use of Statistical Package for Social Sciences (SPSS) version 20. Using descriptive statistics, frequencies were used to attain the individual and average percentages of responses. High level of awareness (doctors 88%, pharmacists 92.2% and nurses 78%) and positive attitude (doctors 72.4%, pharmacists 83.8% and nurses 68.2) among the respondents on pharmacovigilance was observed. The level of practice was observed to be relatively lower, especially among the doctors and the nurses. As low as 16.7% and 24% of the doctors and the nurses has ever reported ADRs by the use of the Blue form. Continual training on the essence and the use of the reporting forms with increased availability and accessibility of the reporting forms at all departments/units of the hospital coupled with regular public education on ADR reporting are recommended interventions.","PeriodicalId":16958,"journal":{"name":"Journal of Pharmacovigilance","volume":"17 1","pages":"1-5"},"PeriodicalIF":0.0,"publicationDate":"2017-06-27","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"87170518","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":"Analyzation and Understanding of Final Rule on Post-marketing Safety Reporting of Combination Products","authors":"A. Gill, Talla Vk","doi":"10.4172/2329-6887.1000230","DOIUrl":"https://doi.org/10.4172/2329-6887.1000230","url":null,"abstract":"","PeriodicalId":16958,"journal":{"name":"Journal of Pharmacovigilance","volume":"27 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2017-06-27","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"75721320","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":"Pharmaceutical Care Services: Indian Scenario","authors":"J. Patil","doi":"10.4172/2329-6887.1000E169","DOIUrl":"https://doi.org/10.4172/2329-6887.1000E169","url":null,"abstract":"The qualified pharmacist in coordination with other health care team works to prevent disease and to assess, monitor, initiate and modify use of medication in order to ensure safe and effective drug therapy regimens. This system is recognized as a patient focused, outcome based pharmaceutical care or pharmacy practice. This system is mainly aimed to optimize the patient health and to achieve positive clinical outcomes through the active involvement of clinical pharmacists in health care organizations. The active involvement of clinical pharmacists in India in this regard is not up to the expected mark in contrary to trends in developed countries. In present day health care trend usage of multiple drugs in drug therapy is common practice and raised the complexity of drug interactions and similar problems. To address such situations and solve the probable problems, existence of pharmaceutical care system in Indian health care organizations is of urgent need.","PeriodicalId":16958,"journal":{"name":"Journal of Pharmacovigilance","volume":"85 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2017-05-31","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"73619077","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":"A Five Years Surveillance on Use of Antimicrobial Therapies in Biella'sGeneral Hospital (Italy): Effective Management to Reduce AntibioticResistance and Improve Outcome","authors":"S. Ussai, F. D’Aloia, L. Laura, C. Frassati, S. Scarpetta, A. Penña, G. Bonelli","doi":"10.4172/2329-6887.1000227","DOIUrl":"https://doi.org/10.4172/2329-6887.1000227","url":null,"abstract":"Ussai S1,2*, D’Aloia F4, Lanzone L3, Frassati C4, Scarpetta S2, Penna A2 and Bonelli G2 1Bocconi School of Management, Bocconi University, 20100 Milano, Italy 2Office of the Director General, Biella General Hospital, 13875 Ponderano BI, Italy 3Division of Pharmacy, Biella General Hospital, 13875 Ponderano BI, Italy 4Infection Control Committee, Biella General Hospital, 13875 Ponderano BI, Italy *Corresponding author: Silvia Ussai, Bocconi School of Management, Bocconi University, 20100 Milano, Italy, Tel: +393451700980; E-mail: ussai.silvia@gmail.com","PeriodicalId":16958,"journal":{"name":"Journal of Pharmacovigilance","volume":"63 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2017-04-17","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"73993253","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":"A Case Report of ECT and Muscle Spasms","authors":"A. Turner, M. Gunther, M. Husain, Lawrence R. Faziola","doi":"10.4172/2329-6887.1000226","DOIUrl":"https://doi.org/10.4172/2329-6887.1000226","url":null,"abstract":"Major depressive disorder, a psychiatric condition whereby individuals experience at least one major depressive episode, is a significant health concern in the United States, with the World Health Organization estimating an affected 16 million adults in 2012. Many individuals who seek professional help are successfully treated with pharmacology and/or psychotherapy. For the subset of patients who experience refractory depression, alternative pharmacological treatments are often tried. After a trial of antidepressant medication (lasting at least four weeks and after dose escalation if appropriate) recommendations include atypical antipsychotics, anticonvulsants, and lithium augmentation [1]. Lithium has long been known to be efficacious for the treatment of bipolar disorder, and studies have confirmed its role in unipolar depression, as well as highlighted its anti-suicidal properties [2]. If thorough pharmacological treatment remains ineffective in these patients, Electroconvulsive Therapy (ECT) may be recommended [2]. By nature of this stepwise treatment protocol, a significant number of individuals who require ECT are being prescribed other medications, including lithium. The literature regarding the use of lithium in conjunction with ECT has mixed results, and no clear consensus has been reached [3-5]. This report aims to briefly review the literature regarding lithium use during ECT treatment, as well as present a case of muscle spasms occurring in a patient after receiving short-term lithium treatment with other medications, and co-administered ECT.","PeriodicalId":16958,"journal":{"name":"Journal of Pharmacovigilance","volume":"100 1","pages":"1-3"},"PeriodicalIF":0.0,"publicationDate":"2017-03-31","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"86775021","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":"Sterility Assurance of Parenteral Products Major Deficiency for Recall","authors":"L. Kolluru","doi":"10.4172/2329-6887.1000E168","DOIUrl":"https://doi.org/10.4172/2329-6887.1000E168","url":null,"abstract":"Lack of sterility assurance is a leading contributor to safety alerts and product recalls by Food and Drug Administration (FDA). Table 1 summarizes the safety alerts to parenteral products and drug manufacturers in 2016 [1]. Lack of sterility assurance can be product specific (probably caused by container closure integrity leakage) or manufacturing site specific (caused by poor facility and engineering or improper manufacturing practices) affecting all the drug products manufactured in the affected site. Such instances lead to major deficiencies during FDA facility inspections sometimes even leading to ceasing of all manufacturing operations until rectified [1-5].","PeriodicalId":16958,"journal":{"name":"Journal of Pharmacovigilance","volume":"64 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2017-03-24","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"77719420","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":"Oral Drug Delivery via Chronotherapy Approach: Need of the Day","authors":"J. Patil","doi":"10.4172/2329-6887.1000E167","DOIUrl":"https://doi.org/10.4172/2329-6887.1000E167","url":null,"abstract":"The drug delivery approach aimed to encounter the therapeutic requirements pertaining to particular pathological situations will be a newer research in formulation development area. Chronotherapy is a kind of treatment based on biological stimuli in drug therapy, and this has fetched a novel approach to the design of oral drug delivery systems. Several approaches are being exploited in the development of activated, pulsatile, controlled and programmed drug delivery strategies has exaggerated in recent years. Chronotherapeutics is the area related with drug delivery according to the intrinsic activities of a disease over a certain period of time. Chronotherapy deals with the treatment based on the human daily working cycle that corresponds to biological clock which the intention to enhance the therapeutic benefits and reduce the adverse effects. Chronotherapy mainly works by matching the timing of treatment with the intrinsic timing of illness. This method also refers to a kind of treatment approach in which in vivo drug availability is timed to match rhythms of disease, in order to improve therapeutic outcomes and reduce side effects. Optimal therapy can be achieved when the precise amount of drug is delivered to the correct target organ at the most suitable time. The drug release pattern will be varied based on the circadian rhythms and symptoms of a disease varied. The term chronothrapeutics is mainly novel in the field of drug delivery and in the treatment method. It is defined as an extensive term in which disease follow the circadian rhythm which undergoes the metabolic variations. Chronotehrapeutic strategies currently available control drug delivery by controlling the lag time independent environmental factors such as pH, gastric motility, and biological enzymes. These systems are available both multiple and single units. This delivery approach is considered as a future of oral drug delivery because these are self-programmed and designed to release a specific drug at a specified rate at a particular time. These drug delivery devices are able to maintain required plasma concentrations when placed in the oral cavity and enhance the patient compliances by circumventing frequency of drug administration.","PeriodicalId":16958,"journal":{"name":"Journal of Pharmacovigilance","volume":"52 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2017-03-16","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"83374826","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":"Oxidative Stress Levels in Buccal Cells Using MAWI Collection Tubes","authors":"y-Belle Tabbouny, E. Chamoun, N. Pavliuchenko, Marcel Bassil","doi":"10.4172/2329-6887.1000225","DOIUrl":"https://doi.org/10.4172/2329-6887.1000225","url":null,"abstract":"Background: Oxidative Stress (OS) is defined as an imbalance between oxidants and antioxidants, in favor of oxidants, potentially leading to DNA damage. Benzo[a] pyrene (B(a)P), a representative DNA-damaging mutagenic/ carcinogenic Polycyclic Aromatic Hydrocarbons (PAH), can lead to the final mutagen Benzo(a)Pyrene Diol Epoxide (BPDE). \u0000Methods: The extent of oxidative DNA damage is investigated in population studies using easily obtained cells. Buccal cell usage has been shown by many to be a cost effective, non-invasive and safe method to isolate DNA for various biological experiments. In this experimental research of 40 participants, equally divided between industry and academia, we compared the DNA concentration, purity, and associated levels of BPDE-DNA damage. Buccal cells were collected using ISWAB-DNA tubes, and DNA was then extracted to study the extent of DNA damage via ELISA Kit. \u0000Results: Results showed pure samples with no DNA degradation. DNA yields were as high as 35.657 μg/mL. In addition, none of the samples showed a presence of BPDE-DNA damage. \u0000Conclusions: MAWI collection tubes may not be able to detect BPDE-DNA damage. Other OS markers should be used to eradicate the previous statement.","PeriodicalId":16958,"journal":{"name":"Journal of Pharmacovigilance","volume":"382 1","pages":"1-6"},"PeriodicalIF":0.0,"publicationDate":"2017-02-28","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"74265523","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":"Need of Pharmacovigilance in AYUSH Drugs","authors":"Rajan, D. Chamundeeswari","doi":"10.4172/2329-6887.1000E166","DOIUrl":"https://doi.org/10.4172/2329-6887.1000E166","url":null,"abstract":"","PeriodicalId":16958,"journal":{"name":"Journal of Pharmacovigilance","volume":"238 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2017-01-20","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"75511821","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":"Regulation of Oncogene Expression via Targeting i-Motif in Nucleic Acids","authors":"Prashansa Agrawal","doi":"10.4172/2329-6887.1000E165","DOIUrl":"https://doi.org/10.4172/2329-6887.1000E165","url":null,"abstract":"The basic molecules required for sustaining life on earth include carbohydrates, lipids, proteins, and nucleic acids (DNA and RNA). DNA is considered to be the building block of life and can adopt various types of secondary structures. Gehring et al. revealed for the first time that DNA sequences having long cytosine stretch can form unconventional secondary structures called i-Motifs [1]. These i-Motifs are very dynamic intercalated, quadruple-helical structures and known to exist under acidic conditions. These cytosine stretches are not erratically located throughout the genome but enriched in the promoter regions of several oncogenes within the genome and in telomeres, the terminal regions of chromosomes. The formation and stabilization of i-motif may play a crucial role in gene expression [2-4], such as, the stabilization of the human telomeric i-motif by carboxylated single-walled carbon nanotubes inhibit telomerase that leads to telomere uncapping, DNA damage response and apoptosis [5].","PeriodicalId":16958,"journal":{"name":"Journal of Pharmacovigilance","volume":"11 1","pages":"1-2"},"PeriodicalIF":0.0,"publicationDate":"2017-01-05","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"81528454","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}