The role of data mining technology in the identification of signals of possible adverse drug reactions: value and limitations

2001 ◽  
Vol 62 (9) ◽  
pp. 664-672 ◽  
Author(s):  
Judith K. Jones
2020 ◽  
Vol 14 ◽  
Author(s):  
M Vijaya Satwika Naidu ◽  
Dudala Sai Sushma ◽  
Varun Jaiswal ◽  
S. Asha ◽  
Tarun Pal

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.


2017 ◽  
Vol 4 (suppl_1) ◽  
pp. S341-S341
Author(s):  
Vahini Chundi ◽  
Anh Eichholz ◽  
Onyeka Nwankwo ◽  
Alan Kinlaw ◽  
Wesley Kufel ◽  
...  

Abstract Background The UNC Medical Center OPAT program was started in 2015 to provide multidisciplinary monitoring and management of patients discharged on parenteral antimicrobials. We examined characteristics of incident adverse drug reactions (ADRs) observed in our initial cohort of OPAT patients. Methods We abstracted electronic health records for the first 250 patients enrolled in the OPAT program. 223 patients with sufficient recorded data for entire OPAT course were included in the analysis. ADRs meeting criteria as detailed in Table 1 were collected and further stratified by antimicrobial regimen. Results 57 patients (26%) experienced at least one ADR during OPAT therapy. The frequency of specific ADRs associated with OPAT therapies are provided in Figure 1. Β-lactam regimens were most frequently associated with liver dysfunction, while combinations of β-lactams and vancomycin were associated with kidney dysfunction. Median days on OPAT regimen was 19 days (IQR: 10–29) for patients who experienced an ADR compared with 39 (IQR: 30–44) for patients who did not experience an ADR. Conclusion ADRs were most commonly observed within the first three weeks of therapy, particularly for patients receiving vancomycin and a β-lactam antimicrobial in combination. These results underscore the critical role of a multidisciplinary team in providing laboratory monitoring and response to abnormal results for OPAT patients. In addition, closer monitoring within the first three weeks of therapy may provide opportunities for regimen changes or dose adjustment to avoid toxicities. Disclosures All authors: No reported disclosures.


2019 ◽  
Vol 12 (5) ◽  
pp. 407-442 ◽  
Author(s):  
Ramón Cacabelos ◽  
Natalia Cacabelos ◽  
Juan C. Carril

F1000Research ◽  
2019 ◽  
Vol 8 ◽  
pp. 2109 ◽  
Author(s):  
Muaed Alomar ◽  
Subish Palaian ◽  
Moawia M. Al-tabakha

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.


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