Month: July 2019
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11. What is valid ICSR?
Sources of Adverse event reporting: Theinformation about adverse event collected from different sources. Below are types of reports – Spontaneous / Voluntary reports Clinical trials and Post marketing studies Regulatory reports License partner reports Literature reports Once report is received it is checked for following four parameters to consider it as a valid case; 1.…
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Giving Cough and Cold medications to Kids
The FDA issued public health advisory about children’s cold medicines. FDA stated children under 2 years of age should not be given any kind of cough and cold product that contains a decongestant or antihistamine because serious and possibly life-threatening side effects could occur. Reported side effects of these products included convulsions, rapid heart rates and…
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10. License partner and Regulatory authority reports
License partner reports: A Pharma company get into a licensing agreement with third party to produce or market a drug formulation that the other company has developed. Each license partners does have pharmacovigilance agreement to meet safety requirements in marketing country. Pharmacovigilance Agreement means an agreement entered into by the Pharma companies to set forth…
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9. Literature reports
“Scientific & medical literature is a significant source of information for the monitoring of the safety profile and of the risk benefit balance of medicinal products, particularly in relation to the detection of new safety signals or emerging safety issues.” Literature report is any adverse drug reactions reported in 1. Published abstracts or 2. Articles…
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8. Post-marketing study (PMS)
Post-marketing study (PMS): A study relating to an authorised medicinal product conducted with the aim of identifying, characterising or quantifying a safety hazard, confirming the safety profile of the medicinal product, or measuring the effectiveness of risk management measures. PMS studies are conducted to assure the quality, efficacy and safety of drugs after they go…
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7. Clinical Research
Clinical research is a process to find new and better ways to understand, detect, control and treat health conditions. The scientific method is used to find answers to difficult health-related questions. Types of clinical studies: Observational study: A type of study in which people are observed or certain outcomes are measured. No attempt is made…
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6. Spontaneous/voluntary Adverse event reporting:
Although drugs are passed through a series of trials to establish their efficacy and safety in human beings before they get marketing approval, not all the adverse effects caused by a drug can be detected in clinical trials, especially uncommon ones and those appear on long-term administration of that drug because clinical trial results are…
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5. Terms, Definitions and Examples for Adverse Event Reporting:
Pharmacovigilance has its own unique terminology that is important to understand. Most of the following terms are specific to drug safety, although some are used by other disciplines within the pharmaceutical sciences as well. Adverse event (AE): “Any untoward medical occurrence in a patient or clinical-trial subject administered a medicinal product and which does not…