Pharmacovigilance

Introduction

The World Health Organisation (WHO) defines pharmacovigilance as “the science and activities relating to the detection, monitoring, assessment, understanding and prevention of adverse effects or any other drug related problems”. The goal of pharmacovigilance is the safer use of medicines and this is usually achieved by dissemination of accurate, timely and clinically relevant information. Communicating the potential harm of drug-use to physicians and patients is a matter of high priority and Julphar will carry out the responsibility or dynamically participate in the process.

Early detection of safety signals from clinical trials and postmarketing surveillance is necessary to identify the risks related with the products. Information collected during the pre-marketing phase of drug development might not detect rare Adverse Drug Reactions (ADRs). The use of a drug during a clinical trial is under controlled conditions, also, limited and selected numbers of patients are enrolled in the clinical trials. Drug use in special situations and population or drug interactions may not be studied. Therefore, the post-marketing surveillance of drugs is important.

Spontaneous ADR reporting, during post-marketing surveillance, has shown to detect adverse event signals resulting from drug use in the population.

The withdrawal from the market of certain medicines has focused attention on pharmacovigilance approaches, raised concerns about improving the existing pharmacovigilance structure; and highlighted the need to ensure consistency among regulations leading the reporting of side effects.

Patient safety is the fundamental principle for Julphar, ahead of commercial or other interests. With this awareness, Julphar is involved in continuously monitoring unwanted effects and other safety aspects of drugs that are already in the market apart from being vigilant in pre-marketing monitoring. Julphar believes that proactive monitoring of the risks helps to place risk management plans throughout the life cycle of the product.