Pub Date : 2018-01-01DOI: 10.4172/2329-6887.1000252
S. Najafi
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].
{"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}
Pub Date : 2018-01-01DOI: 10.4172/2329-6887.1000269
M. Azhar
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).
{"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}
Pub Date : 2018-01-01DOI: 10.4172/2329-6887.1000254
H. Hoummani
{"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}
Pub Date : 2018-01-01DOI: 10.4172/2329-6887.1000265
Aguilera Martinez Maria Elena, Villafan Rodriguez Rodrigo
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.
{"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}
Pub Date : 2018-01-01DOI: 10.4172/2329-6887.1000268
Kozulina Irina, Danilov Alexey, Andrianov Vladimir
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$. According to Wester et al. most often ADE are gastrointestinal bleeding, cerebrospinal bleeding, cardiovascular accidents, and other bleeding and renal disorders. Primary ADE rate among medicines belong to nonsteroidal antiinflammatory drug. According to meta-analysis prospective studies of Lazarou et al. as a result of ADE there were more than 100000 death cases. Makary determined that most commonly ADE was because of medical error.
{"title":"History, Epidemiology and Clinical Characteristic of Adverse Events","authors":"Kozulina Irina, Danilov Alexey, Andrianov Vladimir","doi":"10.4172/2329-6887.1000268","DOIUrl":"https://doi.org/10.4172/2329-6887.1000268","url":null,"abstract":"Rapid medicine and pharmacy progress bring new high-technology medical product to controlling and treating different diseases. Unfortunately, it does not correct a problem of drugs adverse events (ADE) from mild side effects till severe hyper sensitivity reactions, which can lead a new diseases and forming a temporary or total disability and death in some cases. There are about 17 thousand of different medicines in the world now, nearly 90% of them where done in last ten years. According to update data in last ten years mortality rate due to ADE takes 4-6 places in the world. In various ways the rate of hospitalization due to ADE is from 2%, 4% to 12%. As well as, ADE increases the volume of direct and indirect cost of patient treatment. In USA treatment of patients with ADE is about 30, 1 milliard dollars per year. According to Sultana, treatment cost for one person with one ADE averages about 2262$. 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}
Pub Date : 2018-01-01DOI: 10.4172/2329-6887.1000e172
Hiep X. Nguyen
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.
J Pharmacovigil，开放获取期刊，ISSN: 2329-6887透皮给药是一种很有吸引力的给药途径，它可以使药物绕过第一经肝代谢，最大限度地减少药物毒性，提高治疗效果，特别是对于那些在胃酸性环境中不稳定或引起胃肠道刺激的药物[13]。尽管有这些优点，但在皮肤输送中也存在一个缺点:由于皮肤最外层的亲脂性角质层，许多药物的皮肤渗透性极低。被动扩散通常局限于小分子(分子量小于500 Da)，具有低剂量(强效)和中等亲脂性(log P 1-3)[2-5]。可以通过优化药物配方或使用化学渗透增强剂或物理增强技术(包括微针、激光、声透、离子透和热能)破坏皮肤屏障功能来增强药物的传递[6,7]。微针的应用是一种微创、成本效益高且符合患者要求的技术，可显著增强药物进入和穿过皮肤的能力[8-10]。微针一插入皮肤，就会破坏角质层，穿透表皮层，在皮肤中形成充满液体的微型通道。这些微通道允许任何大小的治疗剂(单克隆抗体、疫苗、蛋白质和多肽、微粒和药妆品)渗透[8,11-13]，而不会对皮肤造成不可逆转的损伤、刺激或感染[14-16]。微针的安全性可以从孔隙闭合、潜在感染、出血风险、局部反应、针头断裂、针头材料的生物相容性、与微针重复使用有关的问题以及安全处置等多种因素进行评估。
{"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}
Pub Date : 2018-01-01DOI: 10.4172/2329-6887.1000266
Simona Brusco, M. Bertini, C. Scavone, R. Docimo, A. Bisecco, A. Capuano, A. Gallo
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.
{"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}
Pub Date : 2018-01-01DOI: 10.4172/2329-6887.1000267
M. Alemseged, Samuel Adugna, Ejigu Bayu
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.
{"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}
Pub Date : 2018-01-01DOI: 10.4172/2329-6887.1000257
Arlette G Delgado, J. Vera, M. A. Moyano, M. Serrano
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.
{"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}
Pub Date : 2018-01-01DOI: 10.4172/2329-6887.1000262
Ludmila Schneider, Isabelle Laugel
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”?
{"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}
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