{"title":"Importance of Pharmacovigilance and the Role of Healthcare Professionals","authors":"S. Najafi","doi":"10.4172/2329-6887.1000252","DOIUrl":"https://doi.org/10.4172/2329-6887.1000252","url":null,"abstract":"According to the World Health Organization (WHO), pharmacovigilance also known as the “drug safety” is the science and activity relating to the detection, assessment, and prevention of adverse effects. The aim and scope of pharmacovigilance is broad and includes multiple components such as medication errors, counterfeit and unauthorized medicines, lack of efficacy, drug interactions, and rational prescription of medicines [1].","PeriodicalId":16958,"journal":{"name":"Journal of Pharmacovigilance","volume":"50 1","pages":"1-2"},"PeriodicalIF":0.0,"publicationDate":"2018-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"75366094","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":"Adverse Effect of Unani Pharmacopeial Formulation Habb-E-Shifa","authors":"M. Azhar","doi":"10.4172/2329-6887.1000269","DOIUrl":"https://doi.org/10.4172/2329-6887.1000269","url":null,"abstract":"India has a variety emporium of the medicinal and aromatic plants (MAPs) andhas well established local healthcare tradition still relevant in indigenous health care system; Unani Medical System is one of them. Unani System of Medicine based on Hippocratic theory of humours is well established in India. Simultaneously it is also believed that Unani dosage forms acts on human body in holistic way and do not exhibit the adverse effects. It is true up to some extent but not at all. Unani dosages forms are sometime exhibit adverse effects if not consumed in proper quantity or prepared in proper manner. Habb-e-Shia is a pharmacopoeial preparation and used as Daf-e- Humma (Antipyretic), Daf-e-Tashannuj (Anti-Spasmodic), Musakkin-e-Alam (Analgesic) agent in Unani System of Medicine. Habb-e-Shifa has shown some adverse reaction to a female patient suffering with Suda-e-Muzmin (Chronic headache due to rhino-sinusitis).","PeriodicalId":16958,"journal":{"name":"Journal of Pharmacovigilance","volume":"36 1","pages":"1-3"},"PeriodicalIF":0.0,"publicationDate":"2018-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"73924701","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":"Lichenoid Toxidermy with Antituberculosis","authors":"H. Hoummani","doi":"10.4172/2329-6887.1000254","DOIUrl":"https://doi.org/10.4172/2329-6887.1000254","url":null,"abstract":"","PeriodicalId":16958,"journal":{"name":"Journal of Pharmacovigilance","volume":"44 1","pages":"1-1"},"PeriodicalIF":0.0,"publicationDate":"2018-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"75619018","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}
Aguilera Martinez Maria Elena, Villafan Rodriguez Rodrigo
{"title":"Pharmacovigilance in the Long-Term use of Medications and the Alternative Based on the Combination of Drugs to Reduce Adverse Effects","authors":"Aguilera Martinez Maria Elena, Villafan Rodriguez Rodrigo","doi":"10.4172/2329-6887.1000265","DOIUrl":"https://doi.org/10.4172/2329-6887.1000265","url":null,"abstract":"Some demographic changes such as increased life expectancy and increased chronic degenerative diseases make pharmacovigilance is an important opportunity to clarify aspects of drug safety in patients with long-term treatment. A pharmacological alternative which seeks to improve these aspects of safety of using drugs, it is the combination of drugs with different mechanisms of action are analyzed through mathematical models to reduce the therapeutic doses but maintaining and even improving the therapeutic effect and thus reducing the adverse effects to avoid toxicity.","PeriodicalId":16958,"journal":{"name":"Journal of Pharmacovigilance","volume":"16 1","pages":"1-2"},"PeriodicalIF":0.0,"publicationDate":"2018-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"86161410","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}
Kozulina Irina, Danilov Alexey, Andrianov Vladimir
{"title":"History, Epidemiology and Clinical Characteristic of Adverse Events","authors":"Kozulina Irina, Danilov Alexey, Andrianov Vladimir","doi":"10.4172/2329-6887.1000268","DOIUrl":"https://doi.org/10.4172/2329-6887.1000268","url":null,"abstract":"Rapid medicine and pharmacy progress bring new high-technology medical product to controlling and treating different diseases. Unfortunately, it does not correct a problem of drugs adverse events (ADE) from mild side effects till severe hyper sensitivity reactions, which can lead a new diseases and forming a temporary or total disability and death in some cases. There are about 17 thousand of different medicines in the world now, nearly 90% of them where done in last ten years. According to update data in last ten years mortality rate due to ADE takes 4-6 places in the world. In various ways the rate of hospitalization due to ADE is from 2%, 4% to 12%. As well as, ADE increases the volume of direct and indirect cost of patient treatment. In USA treatment of patients with ADE is about 30, 1 milliard dollars per year. According to Sultana, treatment cost for one person with one ADE averages about 2262$. According to Wester et al. most often ADE are gastrointestinal bleeding, cerebrospinal bleeding, cardiovascular accidents, and other bleeding and renal disorders. Primary ADE rate among medicines belong to nonsteroidal antiinflammatory drug. According to meta-analysis prospective studies of Lazarou et al. as a result of ADE there were more than 100000 death cases. Makary determined that most commonly ADE was because of medical error.","PeriodicalId":16958,"journal":{"name":"Journal of Pharmacovigilance","volume":"89 1","pages":"1-3"},"PeriodicalIF":0.0,"publicationDate":"2018-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"72891595","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":"Safety of Microneedles for Transdermal Drug Delivery","authors":"Hiep X. Nguyen","doi":"10.4172/2329-6887.1000e172","DOIUrl":"https://doi.org/10.4172/2329-6887.1000e172","url":null,"abstract":"Volume 6 • Issue 2 • 1000e172 J Pharmacovigil, an open access journal ISSN: 2329-6887 Transdermal delivery is an attractive route of administration, allowing the therapeutic agents to bypass first pass-hepatic metabolism to minimize the drug toxicity and enhance the treatment efficacy, especially for drugs that are unstable in the acidic environment in the stomach or those cause irritation in the gastrointestinal tract [13]. Despite these advantages, a drawback is observed in skin delivery: numerous drugs have extremely low skin permeability due to the outermost lipophilic stratum corneum layer of skin. Passive diffusion is generally limited to small molecules (molecular weight less than 500 Da) with a low dose (highly potent), and moderate lipophilicity (log P 1-3) [2-5]. The drug delivery can be enhanced by optimizing the drug formulations or disrupting the skin barrier function using either chemical penetration enhancers or physical enhancement technologies including microneedles, laser, sonophoresis, iontophoresis, and thermal energy [6,7]. Microneedles application is a minimally invasive, cost-effective, and patient-compliant technique to significantly enhance the drug delivery into and across skin [8-10]. Upon being inserted into the skin, microneedles disrupt the stratum corneum and penetrate the epidermis layer to create interstitial fluid-filled and micronsized channels in skin. These microchannels allow the penetration of therapeutic agents of any size (monoclonal antibody, vaccines, proteins and peptides, microparticles, and cosmeceuticals) [8,11-13] without causing irreversible damage to skin, irritation, or infection [14-16]. The safety of microneedles could be evaluated on various factors including pore closure, potential infection, risk of bleeding, local reactions, needle breakage, biocompatibility of needle materials, concerns related to microneedles reuse, and safe disposal.","PeriodicalId":16958,"journal":{"name":"Journal of Pharmacovigilance","volume":"103 1","pages":"1-2"},"PeriodicalIF":0.0,"publicationDate":"2018-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"80925381","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}
Simona Brusco, M. Bertini, C. Scavone, R. Docimo, A. Bisecco, A. Capuano, A. Gallo
{"title":"Two Unexpected Cases of Rosacea during Fingolimod Therapy","authors":"Simona Brusco, M. Bertini, C. Scavone, R. Docimo, A. Bisecco, A. Capuano, A. Gallo","doi":"10.4172/2329-6887.1000266","DOIUrl":"https://doi.org/10.4172/2329-6887.1000266","url":null,"abstract":"Fingolimod is the first orally bioavailable disease modifying agent approved for the management of relapsingremitting multiple sclerosis (RRMS). Even though it is generally well tolerated, it requires a specific monitoring due to its first-dose and long-term toxicity. Although some of the skin adverse events drug-related may be severe, the most frequently reported are non-serious such as alopecia, eczema and pruritus. In this context, we describe two unexpected cases of fingolimod-induced rosacea occurred in two patients with MS in real life context. A 48-year-old Caucasian woman and a 27-year-old Caucasian male developed rosacea few days after starting treatment with fingolimod. After discontinuation of the treatment the lesions quickly resolved. Fingolimod represents one of the most commonly prescribed medications in patients with multiple sclerosis (MS), nevertheless its safety profile is still not completely known. Our cases contribute to the current knowledge on fingolimod safety profile. Further studies are needed to confirm the link between this drug and rosacea.","PeriodicalId":16958,"journal":{"name":"Journal of Pharmacovigilance","volume":"159 1","pages":"1-3"},"PeriodicalIF":0.0,"publicationDate":"2018-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"86385801","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 Properties of Mixture Honey and Garlic (Allium sativum) Extracts Against Respiratory Tract Infection Causing Bacteria","authors":"M. Alemseged, Samuel Adugna, Ejigu Bayu","doi":"10.4172/2329-6887.1000267","DOIUrl":"https://doi.org/10.4172/2329-6887.1000267","url":null,"abstract":"In Ethiopia, different local communities use mixture of honey and garlic to treat coughing and other respiratory tract infections by traditional methods. Objective of the present study was to assess the antibacterial properties of mixture of honey and garlic extract against respiratory tract infection causing bacteria. The antibacterial activity of mixture of garlic extract and honey was evaluated by methods such as agar well diffusion method to observe zone of inhibition around the well as well as broth dilution method to evaluate the minimum inhibitory concentration of the extracts against the tested organisms. Five respiratory tract infection causing bacteria such as Pseudomonas aeruginosa, Streptococcus pneumoniae, Klebsiella pneumoniae, Haemophilus influenza and Staphylococcus aureus were included in the study. Chloramphenicol was used as standard antibiotics. Mean inhibition zones of mixture of garlic extract and honey was significantly (P 0.05) greater than honey alone against the tested pathogens. The range of zone of inhibitions of mixture of garlic and honey against the tested bacteria was between 25 to 31 mm whereas the range of inhibition zone of chloramphenicol was from 9 to 30 mm. The inhibition capacity of mixture of garlic extract and honey was greater than the commercial antibiotics such as Co-trimoxazole, Cefoxitin and Erythromycin. Finally it may be possible to conclude that, mixture garlic extract and honey has the capacity to treat respiratory tract infection causing bacteria.","PeriodicalId":16958,"journal":{"name":"Journal of Pharmacovigilance","volume":"44 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":"81988741","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}
Arlette G Delgado, J. Vera, M. A. Moyano, M. Serrano
{"title":"The Clinical Importance of Drug Monitoring: Methotrexate-Induced Acute Renal Failure","authors":"Arlette G Delgado, J. Vera, M. A. Moyano, M. Serrano","doi":"10.4172/2329-6887.1000257","DOIUrl":"https://doi.org/10.4172/2329-6887.1000257","url":null,"abstract":"Plasma concentrations of methotrexate (MTX) represent the best predictive value of its toxicity. Monitoring of the MTX is a common practice that allows identifying patients with acute toxicity and adjusting the dose of folinic acid, and establishing immediate corrective actions. However, the main adverse effects that must be found after a patient treated with this drug are myelosuppression, mucositis of the entire gastrointestinal tract, renal failure and in some cases neurological alterations.","PeriodicalId":16958,"journal":{"name":"Journal of Pharmacovigilance","volume":"90 1","pages":"1-2"},"PeriodicalIF":0.0,"publicationDate":"2018-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"84527735","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 within Technic Solutions","authors":"Ludmila Schneider, Isabelle Laugel","doi":"10.4172/2329-6887.1000262","DOIUrl":"https://doi.org/10.4172/2329-6887.1000262","url":null,"abstract":"Inception of harmonised regulatory requirements revealed an important step toward high responsibility for human health safety. The process of regulatory harmonisation goes along with constant simultaneous developing of safe solutions for routine activities. Even though, there is still an empirical collection of various experiences, without sharing of best practices would be the current progress not possible. Similar development undergoes drug safety comprising strategic and operative activities to support pharmaceutical companies to fulfil the responsibility for own products, for public health and for being compliant with the current regulations. Nowadays, drug safety gains more and more significance within “traditional“ activities of pharmaceutical companies: safe data collection, safe processing of the data, safe evaluation and assessment of reports, safe submissions to authorities, safe overview of time frames for periodic reports, safe signal monitoring, safe management of risks of medicinal products. Summarizing, we can speak from safe pharmacovigilance. But what does mean “safe”?","PeriodicalId":16958,"journal":{"name":"Journal of Pharmacovigilance","volume":"2014 1","pages":"1-2"},"PeriodicalIF":0.0,"publicationDate":"2018-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"87748354","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}