Background
The investigative committee recommended the “establishment of a dedicated body in the Pharmaceutical Administration, to coordinate adverse event reports, integrated with pharmacovigilance, and to act in cooperation with and under the oversight of the Pharmaceutical Administration”.
The objective of the Department is to ensure the safety of drug treatment in Israel by means of the collection of safety information regarding medicines. Adverse event reports and safety information are received from pharmaceutical companies, from the general public and from healthcare practitioners.
Important information
Side effects of medicines are a significant cause of morbidity and mortality.
According to a number of studies that have been published, side effects of medicines lead to 5-10% of hospital admissions.
A study published in 2011 presented 1.9 million hospitalizations per year in the USA resulting from side effects. The FDA publicized data in the year 2000, indicating that some 2 million severe side effects led to hospitalization, incapacity or death.
These studies also indicate that 60%-70% of the side effects are preventable.
The field that deals with the identification, assessment, analysis and prevention of drug side effects and other problems connected to drug treatment is called Pharmacovigilance.
This pharmacovigilance is carried out after release of the medicine to the market, so that continual monitoring of the safety of medicines remains in place.
Prior to approval to market a medicine, controlled clinical trials are performed, usually with the participation of up to a maximum of 4,000 patients. Side effects that are rare or that develop after the elapse of a long period of time period are not always identified. Also, clinical trials differ from the “real world”, in which medicines are not always used correctly.
