The Importance Of Drug Safety

Drug safety is of key importance in today’s climate and in the past as without it the standard of patient healthcare would be low. Drug safety or more commonly known in the pharmaceutical industry as Pharmacovigilance, refers to the detection, assessment, collection, monitoring and prevention of the adverse effects caused by pharmaceutical products. The word Pharmacovigilance is a combination of the Greek word pharmakon meaning drug and the Latin word vigilare meaning to keep watch. Pharmacovigilance focuses heavily on adverse drug reactions, which can be defined as any response to a drug which is noxious and unintended, including the lack of efficacy. Overdose, misuse and abuse of a drug as well as drug exposure during pregnancy and breastfeeding,

Adverse event data received by the licence holder, normally a pharmaceutical company, has to have a prerequisite of tests sent to the local drug regulatory authority to market the medicine in most countries. The identification of hazards associated with pharmaceutical products and the minimizing of risk of any harm that may come to patients is a defining goal of pharmacovigilance. [1]

The international society of Pharmacovigilance (ISoP), previously the European Society of Pharmacovigilance (ESoP), is an international non-profit scientific organisation, which aims to foster Pharmacovigilance both scientifically and educationally, and to enhance all aspects of the safe and proper use of medicines, in all countries. [2]

Pharmacovigilance (PVG) is the on-going surveillance of product safety occurring throughout the product life cycle. It is the drug safety monitoring of pharmaceutical products and is practised in a highly regulated environment. New legislation amends the existing legislation; it is intended to further protect public health by strengthening the current European wide system for monitoring the safety of medicines.

These include:

1. Pharmacovigilance and their quality systems.

2. Pharmacovigilance system mater file.

3. Risk management systems.

4. Management and reporting of adverse reactions to medical products.

5. Periodic safety update reports.

6. Post-authorisation studies and signal management. [4]

The safety of all medicines on the European market is strictly monitored. The inverted triangle in the product information leaflet does not mean that a medicine is unsafe but rather that the medicine is new to the market or that further data is needed. The symbol notification is there to encourage both patients and healthcare professionals to report any suspected side effects observed with the pharmaceutical product. [4]

New European Union (EU) pharmacovigilance legislation was adopted by the European Parliament and Council of Ministers in December 2010. Many of the new provisions contained in the legislation have been effective since July 2012.

The legislation is outlined in

1. Regulation (EU) No 1235/2010

2. Directive (EU)