scholarly journals Pharmacovigilance in perspective: drug withdrawals, data mining and policy implications

F1000Research ◽  
2019 ◽  
Vol 8 ◽  
pp. 2109 ◽  
Author(s):  
Muaed Alomar ◽  
Subish Palaian ◽  
Moawia M. Al-tabakha
Keyword(s):  
Data Mining ◽  
Information Technology ◽  
Side Effects ◽  
Adverse Drug Reactions ◽  
Policy Implications ◽  
Policy Framework ◽  
Drug Reactions ◽  
Drug Withdrawals

Considering that marketed drugs are not free from side effects, many countries have initiated pharmacovigilance programs. These initiatives have provided countries with methods of detection and prevention of adverse drug reactions at an earlier stage, thus preventing harm occurring in the larger population. In this review, examples of drug withdrawals due to effective pharmacovigilance programs have been provided with details. In addition, information concerning data mining in pharmacovigilance, an effective method to assess pharmacoepidemiologic data and detecting signals for rare and uncommon side effects, is also examined, which is a method synchronized with information technology and advanced electronic tools. The importance of policy framework in relation to pharmacovigilance is discussed in detail, and country experiences upon implementation of pharmacovigilance policies is highlighted.

Monitoring adverse drug reactions across a nationwide health care system using information technology

2012 ◽  
Vol 69 (4) ◽  
pp. 321-328 ◽  
Author(s):  
Thomas Emmendorfer ◽  
Peter A. Glassman ◽  
Von Moore ◽  
Thomas C. Leadholm ◽  
Chester B. Good ◽  
...  
Keyword(s):  
Health Care ◽  
Information Technology ◽  
Health Care System ◽  
Adverse Drug Reactions ◽  
Drug Reactions ◽  
Care System

The role of advanced technologies supplemented with traditional methods in pharmacovigilance sciences

2020 ◽  
Vol 14 ◽  
Author(s):  
M Vijaya Satwika Naidu ◽  
Dudala Sai Sushma ◽  
Varun Jaiswal ◽  
S. Asha ◽  
Tarun Pal
Keyword(s):  
Data Mining ◽  
Social Media ◽  
Adverse Drug Reactions ◽  
Mobile Apps ◽  
Health Sector ◽  
Early Developmental Stage ◽  
Drug Reactions ◽  
Traditional Methods ◽  
Advanced Technologies

Background: The immediate automatic systemic monitoring and reporting of adverse drug reaction, improving the efficacy is the utmost need of medical informatics community. The venturing of advanced digital technologies into the health sector has opened new avenues for rapid monitoring. In recent years, data shared through social media, mobile apps and on other social websites has increased manifolds requiring data mining techniques. Objective: The objective of this report is to highlight the role of advanced technologies together with traditional methods to proactively aid in early detection of adverse drug reactions concerned with drug safety and pharmacovigilance. Methods: A thorough search was conducted for papers and patents regarding pharmacivigilance. All articles with respect to relevant subject were explored and mined from public repositories such as Pubmed, Google Scholar, Springer, ScienceDirect (Elsevier), Web of Science, etc. Results: The European Union’s Innovative Medicines Initiative WEB-RADR project emphasized the development of mobile applications and social media data for reporting adverse effects. Only relevant data has to be captured through the data mining algorithms (DMAs) playing an important role in timely prediction of risk with high accuracy using two popular approaches the frequentist and Bayesian approach. The pharmacovigilance at premarketing stage is useful for the prediction of the adverse drug reactions in early developmental stage of a drug. Later postmarketing safety reports and clinical data reports are important to be monitored through electronic health records, prescription-event monitoring, spontaneous reporting databases, etc approaches. Conclusion: The advanced technologies supplemented with traditional technologies is the need of hour for evaluating product’s risk profile and reducing risk in population esp. with comorbid conditions and on concomitant medications.

TOXICITIES OF TARGETED THERAPY AND IMMUNE-RELATED ADVERSE DRUG REACTIONS OF IMMUNOTHERAPY IN THE TREATMENT OF METASTATIC MELANOMA

2018 ◽  
Author(s):  
Lidija Kandolf Sekulović
Keyword(s):  
Overall Survival ◽  
Targeted Therapy ◽  
Side Effects ◽  
Adverse Effects ◽  
Metastatic Melanoma ◽  
Adverse Drug Reactions ◽  
Mek Inhibitor ◽  
Braf Inhibitors ◽  
Drug Reactions ◽  
Acneiform Eruption

Targeted therapy and immunotherapy changed the treatment landscape for metastatic melanoma, which is chemotherapy resistant cancer. In pre-innovation era, the overall survival of patients with metastatic melanoma was 6 months, while today 5-year overall survival rate of 34% (and 50% in good prognostic groups) is evident. However, both treatments have their side effects, and cutaneous are the most frequent. Treating physicians in oncology centres, but also primary care specialists, need to be aware of their spectrum which differs for each class of drug: BRAF inhibitors, MEK inhibitors and immunotherapy with anti-PD1 and anti-CTLA4. While BRAF inhibitors have the most prominent adverse effects which are class specific, there are also drug-specific adverse effects. For example, vemurafenib causes photosensitivity, which is not specific for dabrafenib, while dabrafenib induces pyrexia, that occurs much less frequently with other BRAF inhibitors. Cutaneous rash and cutaneous neoplasms which develop due to paradoxical activation of RAS signalling are described with BRAF inhibitor monotherapy. These side-effects are much less common in combination therapy with BRAF and MEK inhibitor, but MEK inhibitor itself causes characteristic acneiform eruption, and serous retinopathy. Immune related adverse drug reactions are a hallmark of the immune checkpoint inhibitor immunotherapy, which can affect every organ system, and most commonly skin, lungs and gastrointestinal system, with differential frequencies recorded with anti-CTLA4 therapy and anti PD-1 therapy. Skin reactions most frequently include pruritus and eczematous reactions, as well as vitiligo-like hypopigmentation, which is linked Melanom 45 to the better response to treatment. In this review, frequent and rare side effects are presented, as well as the current algorithms for their treatment.

scholarly journals Study of Adverse Drug Reactions Associated with Chemotherapy of Breast Cancer

2020 ◽  
Vol 5 (6) ◽  
pp. 1572-1578
Author(s):  
Barli Anvisha ◽  
Bonthu Sai Sireesha ◽  
Chilla Anitha ◽  
Sarvana Sravya ◽  
Dr. Shubham Babu Gupta ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Side Effects ◽  
Adverse Drug Reactions ◽  
Psychological Health ◽  
Close Monitoring ◽  
Drug Reactions ◽  
Weight Changes ◽  
Non Invasive ◽  
Study Population ◽  
Care Ward

Introduction/ Background Breast carcinoma is an important malignant tumor which occurs as non-invasive and invasive cancer with its various morphologic varieties. One of the treatments used for breast cancer is chemotherapy which has many side-effects. Aim and Objectives The aim of the present study is to assess the adverse drug reactions associated with chemotherapy of breast cancer. Methodology The study is observational, prospective study that includes all female patients admitted in day-care ward for chemotherapy cycles. Result The percentage of common side-effects were Nausea (75%), Alopecia (72%), Emesis (69%), Diarrhoea and Insomnia (64%), Asthenia (50%), Black nails (32%). There was a gradual reduction in weight of the study population. Conclusion The study emphasized the need to focus on management of other side-effects, for close monitoring over side-effects, muscle strength, weight changes, psychological health of the patient.

scholarly journals Psychotic Disorders, Definition, Sign and Symptoms, Antipsychotic Drugs, Mechanism of Action, Pharmacokinetics & Pharmacodynamics with Side Effects & Adverse Drug Reactions: Updated Systematic Review Article

2020 ◽  
Vol 10 (1) ◽  
pp. 163-172
Author(s):  
Rohit Bangwal ◽  
Shivam Bisht ◽  
Saurabh Saklani ◽  
Shobit Garg ◽  
Mohan Dhayani
Keyword(s):  
Adverse Drug Reaction ◽  
Drug Reaction ◽  
Side Effects ◽  
Adverse Drug Reactions ◽  
Common Property ◽  
Antipsychotic Drugs ◽  
Psychotic Disorders ◽  
World Health ◽  
Drug Reactions ◽  
Wide Range

Psychosis is a mental disorder characterized by a disconnection from reality. Psychosis is a group of disorder characterized by thought disorder, abnormal behaviour, defective cognition, delusion and hallucination. Adverse drug reaction is defined as any undesired or unintended effects of drugs treatment. According to the World Health Organization (WHO)- “adverse drug reaction (ADRs) has been defined one which is noxious and unintended, and which occurs at doses normally used in man for prophylaxis, diagnosis, or therapy of disease, or modification of physiological function”. Adverse drug reactions are the most important causes of the mortality and morbidity. Antipsychotics are the most effective drugs which are used in the psychiatry in the maintenance therapy of mania, psychoses and schizophrenia. The antipsychotics drugs are chemically disparate but have the common property of alleviating the symptoms of organic as well as functional psychosis. But they also have a capacity to cause a wide range of potential adverse drug reactions that can lead to non-compliance that can impair quality of life, may cause the extra pyramidal symptoms which can lead to discontinuation of therapy and in extreme cases it may be fatal. Knowledge of assessment of ADRs due to different antipsychotics is necessary. It helps to choose to safe treatment and reduce the risk of occurrence of ADRs by the clinicians. ADR are often poorly identified and reported in day to day medical practice. As we collect more and more information about ADRs, we need an active surveillance system regarding identification and reporting of ADRs with antipsychotic drugs.  On many review articles are read & ward round participation experiences we find that antipsychotic drugs can have shown a various kind of ADRs. Psychiatrist and clinical pharmacist are need to be made aware of these potentially fatal adverse effects associated with antipsychotic drugs via conduction of patients counseling regarding (drugs, disease, doses & side effects), quality-based seminars, published medical literature, conferences, learning programs and health care camps. Keywords: Antipsychotic Drugs, WHO, Adverse Drug Reactions, Pharmacovigilance, Psychiatrist.

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