Current drug safety最新文献

{"title":"Role and Responsibilities of Various Stakeholders in Pharmacovigilance (PV).","authors":"Pinki Phougat, Meenu Beniwal, Garima Kapoor, Navidha Aggarwal, Aanchal Kumari, Rashmi Sharma, Hitesh Chopra, Rohit Sharma, Mohammad Amjad Kamal","doi":"10.2174/0115748863277574240125045459","DOIUrl":"https://doi.org/10.2174/0115748863277574240125045459","url":null,"abstract":"<p><p>In this review paper, we have analyzed the potential and issues associated with Pharmacovigilance (PV). The analysis is divided into four sections: background, stakeholders, data sources, and medicinal chemistry. Each section discusses the current state, the future trends, and the best practices of Pharmacovigilance (PV). The main purpose, methods, results, and implications of our analysis are summarized.</p><p><strong>Background: </strong>Pharmacovigilance (PV) is the science and practice of monitoring, evaluating, understanding, and preventing adverse drug reactions. Pharmacovigilance (PV) was established by the World Health Organization in response to the thalidomide tragedy of 1961. The main purpose of Pharmacovigilance (PV) is to ensure the safety and efficacy of drugs in clinical practice. Stakeholders: Pharmacovigilance (PV) involves various stakeholders, such as patients, pharmacists, pharmaceutical companies, healthcare professionals, and regulatory authorities. Each stakeholder has a different role and responsibility in reporting, processing, analyzing, and communicating information about adverse drug reactions. Patient engagement is a key factor for enhancing Pharmacovigilance (PV) practices.</p><p><strong>Data sources: </strong>Pharmacovigilance (PV) relies on data from various sources, such as clinical trials, spontaneous reports, electronic medical records, biomedical literature, and patient-reported data in online health forums. These data sources can provide valuable insights into the real-world use and safety of drugs, as well as the preferences and needs of patients. However, these data sources also pose challenges in terms of quality, validity, reliability, and accessibility. Medicinal Chemistry: Medicinal chemistry is the branch of chemistry that deals with the design, synthesis, and evaluation of new drugs and their biological effects. Medicinal chemistry can enhance Pharmacovigilance (PV) practices by finding new therapeutic indications for existing drugs or compounds that have already been tested for safety and efficacy. Medicinal chemistry also requires careful design and evaluation of covalent inhibitors, bi-substrate inhibitors, stabilizers of protein non-effective conformations, and hydrophobic pocket modifiers to ensure their safety and efficacy.</p><p><strong>Implications: </strong>Pharmacovigilance (PV) is a dynamic and evolving discipline that requires collaboration, regulation, education, and innovation to improve patient safety and care. This review aims to provide a comprehensive overview of the potential and issues associated with Pharmacovigilance (PV) practices.</p>","PeriodicalId":10777,"journal":{"name":"Current drug safety","volume":null,"pages":null},"PeriodicalIF":1.5,"publicationDate":"2024-02-02","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"139691438","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":"Meet the Co-Editor","authors":"Anna Capasso","doi":"10.2174/157488631901230914111346","DOIUrl":"https://doi.org/10.2174/157488631901230914111346","url":null,"abstract":"<jats:sec>\u0000<jats:title />\u0000<jats:p />\u0000</jats:sec>","PeriodicalId":10777,"journal":{"name":"Current drug safety","volume":null,"pages":null},"PeriodicalIF":1.5,"publicationDate":"2024-02-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140464253","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":"Persistent Hiccups Shortly after Tramadol Intake: A Case Report and Literature Review.","authors":"Hossam Tharwat Ali, Ziad Emad Mohamed, Mohamed Mahmoud Shalaby, Ana Leticia Fornari Caprara, Jamir Pitton Rissardo","doi":"10.2174/0115748863290330240116094015","DOIUrl":"https://doi.org/10.2174/0115748863290330240116094015","url":null,"abstract":"<p><strong>Background and objective: </strong>Tramadol can inhibit serotonin and norepinephrine reuptake leading to stimulation of the central component of the hiccup reflex arc. We have found only two previous cases of tramadol-induced hiccups. Additionally, three pharmacovigilance studies have investigated the involvement of tramadol in cases who have developed hiccups as adverse effects. Herein, we have presented a case of a middle-aged male who has developed hiccups shortly after tramadol intake.</p><p><strong>Case presentation: </strong>A 35-year-old male complaining of chronic pain in the right knee was treated with tramadol. The individual developed hiccups within 10 hours of the first tramadol dose. The patient tried to stop the hiccups with non-pharmacological measures, such as stopping the air inside the lungs and drinking cold fluids. The patient appeared to concentrate on avoiding hiccups, which he could avoid for some time. However, then, the hiccups would come all at a unique time. The hiccups occurred at a frequency of one hiccup/5-10 seconds, interrupting the patient's nutrition and sleep pattern. Eventually, tramadol was suspected of inducing hiccups, and baclofen was started.</p><p><strong>Conclusion: </strong>Tramadol as well as opioids should be considered as a cause of hiccups. We aim to improve awareness about the safety of such drugs among physicians and the proper management of associated risks.</p>","PeriodicalId":10777,"journal":{"name":"Current drug safety","volume":null,"pages":null},"PeriodicalIF":1.5,"publicationDate":"2024-01-31","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"139650429","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":"Impact of Clinical Pharmacist-conducted Medication Reconciliation at Admission and Discharge on Medication Safety in Patients Hospitalized with Acute Decompensated Heart Failure.","authors":"Maryam Rangchian, Mana Makhdoumi, Maryam Zamanirafe, Erfan Parvaneh, Azadeh Eshraghi, Taher Entezari-Maleki, Maryam Mehrpooya","doi":"10.2174/0115748863284257231212063959","DOIUrl":"https://doi.org/10.2174/0115748863284257231212063959","url":null,"abstract":"<p><strong>Background: </strong>Most studies have focused on the impact of medication reconciliation on one of the points of hospital admission or discharge. In this study, we aimed to investigate the impact of medication reconciliation at both admission and discharge on medication safety in patients hospitalized with acute decompensated heart failure.</p><p><strong>Methods: </strong>This was a prospective, single-center, cohort study conducted in a tertiary care cardiovascular hospital from October 2022 to March 2023 on patients hospitalized with acute decompensated heart failure. Patients were considered eligible if they were taking at least five chronic medications prior to hospital admission. Medication reconciliation was carried out for the study patients by a clinical pharmacy team both at admission and discharge. Further, the study patients also received comprehensive discharge counseling as well as post-discharge follow-up and monitoring.</p><p><strong>Results: </strong>Medication reconciliation was applied for 129 patients at admission and 118 of them at discharge. The mean time needed for medication reconciliation presses was 32 min per patient on admission and 22min per patient on discharge. Unintentional medication discrepancies were relatively common both at admission and discharge in the study participants, but compared to admission, discrepancies were less frequent at discharge (178 versus 72). Based on the consensus review, about 30% of identified errors detected at both admission and discharge were judged to have the potential to cause moderate to severe harm to the patient, and most of the clinical pharmacists' recommendations on unintended discrepancies were accepted by physicians and resulted in changes in medication orders (more than 80%). Further, the majority of the participants were 'very satisfied' or 'satisfied' with the clinical pharmacy services provided to them during hospitalization and after hospital discharge (89.90%).</p><p><strong>Conclusions: </strong>Our results demonstrated that heart failure patients are vulnerable to medication discrepancies both at admission and discharge and implementing a comprehensive medication reconciliation by clinical pharmacists could be helpful in improving medication safety in these patients.</p>","PeriodicalId":10777,"journal":{"name":"Current drug safety","volume":null,"pages":null},"PeriodicalIF":1.5,"publicationDate":"2024-01-30","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"139650428","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 Systematic Review of the COVID Vaccine's Impact on the Nervous System.","authors":"Viswarupachari Tanguturi Yella, Sumit Pareek, Bhumika Meena, K S B S Krishna Sasanka, Pugazhenthan Thangaraju, Sree Sudha T Y","doi":"10.2174/0115748863273931231121072231","DOIUrl":"https://doi.org/10.2174/0115748863273931231121072231","url":null,"abstract":"<p><strong>Aims & objectives: </strong>The objective of this study was to conduct a systematic review of research pertaining to the COVID-19 vaccine and its association with neurological complications.</p><p><strong>Method: </strong>We performed a comprehensive search of the literature using Google Scholar, PubMed, and NCBI databases from December 2021 to December 2022. For Google Scholar, PubMed, and NCBI databases we used the following key search terms: \"neurological adverse effects\", \"COVID-19 vaccination\", \"SARS-CoV-2\", CNS complications, and CNS adverse effects. Two reviewer authors individually searched and assessed the titles and abstracts of all articles. The third reviewer resolved the disagreement between them. Data were documented regarding title, study location, type of study, type of COVID-19 vaccine, type of neurological complications/adverse effects, and sample size.</p><p><strong>Results: </strong>From our findings, it is confirmed that these neurological complications like GuillainBarre syndrome (23.6%), Neuromyelitis Optica spectrum disorder (5.5%), Neuropathy (6.9%), Transverse Myelitis (8.3%) and Acute disseminated Encephalomyelitis (4.1%) are majorly affected in most of the people. The increase in risks associated with SARS-CoV-2 infection far outweighs any previously reported associations with vaccination.</p><p><strong>Conclusion: </strong>We found no safety signal was observed between COVID-19 vaccines and the immune-mediated neurological events. Before assuming a causal relationship, the side effects of the COVID-19 vaccine should first be carefully examined to rule out known associated factors. Symptom onset was within two weeks of vaccination in the majority of cases; as such, this seems to be a high-risk period warranting vigilance.</p>","PeriodicalId":10777,"journal":{"name":"Current drug safety","volume":null,"pages":null},"PeriodicalIF":1.5,"publicationDate":"2024-01-24","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"139563860","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 Severe Case of Isotretinoin Induced Eosinophilic Pneumonia and Pericardial Effusion, a Case Report.","authors":"Anne Kampman, Laurien Keulers, Jan van der Maten, Jacqueline van der Meij, Carina Bethlehem","doi":"10.2174/0115748863274642231121072432","DOIUrl":"https://doi.org/10.2174/0115748863274642231121072432","url":null,"abstract":"<p><strong>Background: </strong>We report a case of a 25-year-old female who presented with fever, rash and general malaise.</p><p><strong>Case presentation: </strong>She was initially diagnosed and treated for peri-/myocarditis, but she deteriorated quickly with the development of extensive bilateral consolidations for which she was mechanically ventilated. Two weeks before admission, she took isotretinoin for less than a week for disfiguring acne. Diagnosis of drug-induced acute eosinophilic pneumoniae (EP) was made after excluding other causes of AEP. Even before starting steroid treatment, the patient improved significantly, which was in alignment with the elimination of the active metabolite of isotretinoin.</p><p><strong>Conclusion: </strong>The presented case underlines the importance of performing a thorough history and consider recently started drugs as the cause of eosinophilic pneumoniae, even if they have not yet been described as a known trigger of drug-induced EP.</p>","PeriodicalId":10777,"journal":{"name":"Current drug safety","volume":null,"pages":null},"PeriodicalIF":1.5,"publicationDate":"2024-01-24","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"139563857","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":"Azathioprine-induced Veno-occlusive Hepatotoxicity in a Patient with Myasthenia Gravis.","authors":"Nikhil Dongre, Jayantee Kalita, Usha K Misra","doi":"10.2174/0115748863272041231116104839","DOIUrl":"https://doi.org/10.2174/0115748863272041231116104839","url":null,"abstract":"<p><strong>Introduction: </strong>Myasthenia gravis (MG) is an autoimmune disorder of post-synaptic neuromuscular junction characterised by fatigable muscle weakness and is treated with prednisolone with or without other immunosuppressants, including azathioprine (AZA). Veno-occlusive hepatotoxicity of AZA is a rare complication in MG.</p><p><strong>Case report: </strong>We report a 35-year-old man with MG who was treated with pyridostigmine, prednisolone, and AZA for 5 years. He presented with abdominal pain and increased fatiguability for 7 days. His serum bilirubin and liver enzymes were elevated, and ultrasound revealed a dilated hepatic vein and portal vein suggestive of veno-occlusive liver disease. The clinical symptoms, liver functions, and ultrasound of the hepatobiliary system normalized after withdrawal of AZA.</p><p><strong>Conclusion: </strong>A possibility of AZA veno-occlusive hepatoxicity should be considered in an MG patient if presented with abdominal pain, elevated bilirubin and transaminases and ultrasound showing dilatation of hepatic veins. Physicians should be aware of this complication because this toxicity is reversible following dose reduction or withdrawal of AZA.</p>","PeriodicalId":10777,"journal":{"name":"Current drug safety","volume":null,"pages":null},"PeriodicalIF":1.5,"publicationDate":"2024-01-23","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"139541969","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":"Natural Flavonoids: Fortifying Renal Defence Mechanism.","authors":"Tanya Jain, Manish Pal Singh, Kashmira J Gohil","doi":"10.2174/0115748863277092231217142733","DOIUrl":"https://doi.org/10.2174/0115748863277092231217142733","url":null,"abstract":"<p><strong>Background: </strong>The kidneys, intricate organs responsible for maintaining fluid and electrolyte balance, are susceptible to damage from diverse nephrotoxic insults, including drugs, toxins, and metabolic disorders. In recent years, flavonoids, bioactive compounds abundant in fruits, vegetables, and herbal extracts, have emerged as promising candidates for renal protection due to their potent antioxidant and anti-inflammatory properties.</p><p><strong>Methods: </strong>We have collected the data that supported this idea to conduct a comprehensive review by using scientific databases, such as Pub Med ®, ScienceDirect ®, Google Scholar ®, and MEDLINE ®. An attempt was made to refer to all English-language articles published between 2000 to 2020 using keywords like flavonoids potential in nephrotoxicity and nephrotoxicity treatment approaches with herbal remedies.</p><p><strong>Conclusion: </strong>This comprehensive review delves into the molecular mechanisms underlying the reno-protective effects of flavonoids. By scavenging reactive oxygen species, inhibiting inflammatory mediators, and modulating intracellular signalling pathways, flavonoids can mitigate oxidative stress and inflammation, thereby preserving renal function and integrity. Preclinical studies have demonstrated the potential of specific flavonoids in ameliorating drug-induced nephrotoxicity, renal ischemia-reperfusion injury, diabetic nephropathy, and other kidney diseases. Furthermore, epidemiological evidence highlights the inverse relationship between flavonoid intake and the risk of developing kidney diseases. Nevertheless, understanding the molecular mechanisms of flavonoids in nephroprotection offers exciting prospects for developing novel therapeutic strategies to combat kidney diseases and promote kidney health.</p>","PeriodicalId":10777,"journal":{"name":"Current drug safety","volume":null,"pages":null},"PeriodicalIF":1.5,"publicationDate":"2024-01-09","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"139416594","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":"Current Scenario and Future Prospects of Adverse Drug Reactions (ADRs) Monitoring and Reporting Mechanisms in the Rural Areas of India.","authors":"Shalini Shukla, Priyanka Sharma, Priya Gupta, Shikha Pandey, Reshu Agrawal, Deepak Rathour, Dharmendra Kumar Kewat, Ramu Singh, Sunil Kumar Thakur, Rishi Paliwal, Kunjbihari Sulakhiya","doi":"10.2174/1574886318666230428144120","DOIUrl":"10.2174/1574886318666230428144120","url":null,"abstract":"<p><strong>Background: </strong>Pharmacovigilance (PV) deals with the detection, collection, assessment, understanding, and prevention of adverse effects associated with drugs. The objective of PV is to ensure the safety of the medicines and patients by monitoring and reporting all adverse drug reactions (ADRs) associated with prescribed medicine usage. Findings have indicated that about 0.2- 24% of hospitalization cases are due to ADRs, of which 3.7% of patients have lethal ADRs. The reasons include the number of prescribed drugs, an increased number of new medicines in the market, an inadequate PV system for ADR monitoring, and a need for more awareness and knowledge about ADR reporting. Severe ADRs lead to enhanced hospital stays, increased treatment costs, risk of death, and many medical and economic consequences. Therefore, ADR reporting at its first instance is essential to avoid further harmful effects of the prescribed drugs. In India, the rate of ADR reporting is less than 1%, whereas worldwide, it is 5% due to a need for more awareness about PV and ADR monitoring among healthcare providers and patients. The main objective of this review is to highlight the current scenario and possible futuristic ways of ADR reporting methods in rural areas of India. We have searched the literature using PubMed, Google scholar, Indian citation index to retrieve the resources related to ADR monitoring and reporting in India's urban and rural areas. Spontaneous reporting is the most commonly used PV method to report ADRs in India's urban and rural areas. Evidence revealed that no effective ADR reporting mechanisms developed in rural areas causing underreporting of ADR, thus increasing the threat to the rural population. Hence, PV and ADR reporting awareness among healthcare professionals and patients, telecommunication, telemedicine, use of social media and electronic medical records, and artificial intelligence are the potential approaches for prevention, monitoring, and reporting of ADRs in rural areas.</p>","PeriodicalId":10777,"journal":{"name":"Current drug safety","volume":null,"pages":null},"PeriodicalIF":1.5,"publicationDate":"2024-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"9399474","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":"Current Landscape on Development of Phenylalanine and Toxicity of its Metabolites - A Review.","authors":"Samrat Bose, Shirsendu Mandal, Rajesh Khan, Himangshu Sekhar Maji, Sumel Ashique","doi":"10.2174/1574886318666230331112800","DOIUrl":"10.2174/1574886318666230331112800","url":null,"abstract":"<p><p>Phenylalanine, an essential amino acid, is the \"building block\" of protein. It has a tremendous role in different aspects of metabolic events. The tyrosine pathway is the prime one and is typically used to degrade dietary phenylalanine. Phenylalanine exceeds its limit in bodily fluids and the brain when the enzyme, phenylalanine decarboxylase, phenylalanine transaminase, phenylalanine hydroxylase (PAH) or its cofactor tetrahydrobiopterin (BH4) is deficient causes phenylketonuria, schizophrenia, attentiondeficit/ hyperactivity disorder and another neuronal effect. Tyrosine, an amino acid necessary for synthesizing the pigments in melanin, is produced by its primary metabolic pathway. Deficiency/abnormality in metabolic enzymes responsible for the catabolism pathway of Phenylalanine causes an accumulation of the active intermediate metabolite, resulting in several abnormalities, such as developmental delay, tyrosinemias, alkaptonuria, albinism, hypotension and several other undesirable conditions. Dietary restriction of the amino acid(s) can be a therapeutic approach to avoid such undesirable conditions when the level of metabolic enzyme is unpredictable. After properly identifying the enzymatic level, specific pathophysiological conditions can be managed more efficiently.</p>","PeriodicalId":10777,"journal":{"name":"Current drug safety","volume":null,"pages":null},"PeriodicalIF":1.5,"publicationDate":"2024-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"9220636","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}