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Adverse reporting events in medication may be explained as: “Any one of the many untoward medical occurrences in a patient or either a clinical investigation subject administered to a pharmaceutical product which never necessarily has to possess a causal relationship with treatment. In clinical trials, there is always a distinction between adverse events as well as serious adverse events. In general terms, any event that causes death, or permanent damage, requires hospitalization or causes birth defects is considered a serious adverse event. The results of the trials are usually included in the labeling of the medication in order to provide basic information for the patients, as well as prescribing physicians.
Adverse effects are always required by law to be reported, and also researched in all clinical trials and also included into the patient information that accompanies medical devices or drugs for sale to the public. Investigators specializing in human clinical trials are usually obligated to report the events in clinical study reports. Research is of the opinion that the events are usually inadequately reported in all publicly available reports. This is because of the lack of the data and the uncertainty about methods of synthesizing them, the individuals conducting systematic reviews as well as meta-analyses of all therapeutic interventions who unknowingly overemphasize the health benefit. To balance off the overemphasis on benefit, doctors and researchers have called for complete reporting of harm from the clinical trials.
There is the lack of certainty that the reported event was due to the product. Thus, it is not required that a causal relationship between product and event be proven, as reports do not usually contain enough detail to properly evaluate a particular event.
References
Reducing and Preventing Adverse Drug Events to Decrease. Retrieved from
http://www.fda.gov/safety/medwatch/howtoreport/ucm053087.htmExpert working group (efficacy) of the international conference on harmonization of technical
Requirements for registration of pharmaceuticals for human use. (2007). “Guideline for Industry Structure and Content of Clinical Study Reports.” (PDF). FDA Center for Drug Evaluation and Research.Medication Administration Safety – Patient Safety and Quality – NCBIRetrieved from www.ncbi.nlm.nih.gov/
