The World Health Organisation defines pharmacovigilance as a science with the aim of detecting, assessing, understanding and preventing adverse effects caused by or related to medical drugs. This article helps you understand the definitions of key events within the science with reference to the ICH guidelines for industry professionals and physicians widely used throughout Europe today.
What Are Adverse Events & Adverse Reactions?
The ICH guidelines characterise Adverse Events as Pharmacovigilance course medical occurrences of an adverse nature – in layman’s terms, something which isn’t medically desirable that occurs as a result of taking the medicine. They occur when a patient (or sometimes a healthy volunteer participating in a clinical trial) has had a medicine administered and include laboratory findings outside normal accepted values or ranges of values. It could be that there is no known causal relationship between the medicine and the Adverse Event to date. It could be that symptoms or diseases are temporarily associated with the medicinal product without a precedent.
In the testing stages before a product is allowed to go on general sale, Adverse Events are unwanted medical responses to a drug which were not described in the literature made available by the team responsible for the testing. Later in the product life cycle, once a drug has entered the market, they include unwanted medical events which take place at routine dosages that doctors would prescribe to treat disease or modify physical function. Some contemporary definitions also now include unwanted effects (or potential effects) that occur at dosages and/or when the drug is administered for a use which is not routinely recommended.
What Are Serious Adverse Events (SAEs)?
These are events which pose a serious threat to life or quality of life for patients (or healthy trial participants)
The definition also includes any event for which medical intervention is needed to protect the patient (or trial participant) from any of the events on the above list An event is also classed as serious if it jeopardises the patient in some other way; and within the EU, if it involves suspected transmission of infection