What is Pharmacovigilance?
Pharmacovigilance is defined as the science and activities concerned with thedetection, assessment, understanding and prevention of adverse reactions tomedicines (i.e. adverse drug reactions or ADRs). The ultimate goal of this activity isto improve the safe and rational use of medicines, thereby improving patient care andpublic health.

What is an Adverse Drug Reaction (ADR)?
The {Drug Regulatory Authority} defines an Adverse Drug Reactions (ADR) oradverse reaction as a response to a medicine used in humans or animals, which isnoxious and unintended, including lack of efficacy, and which occurs at any dosageand can also result from overdose, misuse or abuse of a medicine.

Why is Pharmacovigilance important?
When a medicine is released onto the market there is still a great deal that isunknown about the safety of the product. Once marketed the medicines are used bypatients who have many different diseases, who are using several other drugs andwho have different traditions and diets which may affect the way in which they reactto a medicine. Different brands of medicines may differ in the manner in which theyare produced and the ingredients that are used. The adverse drug reactions andpoisonings associated with traditional and herbal remedies also need to be monitoredin each country. The information we receive on the adverse effects of drugs in othercountries may not be relevant or applicable to {Country}’s citizens. In some cases,adverse effects to certain drugs may only occur in {Country}’s citizens.In order to prevent unnecessary suffering by patients and to decrease the financialloss sustained by the patient due to the inappropriate or unsafe use of medicines, it isessential that a monitoring system for the safety of medicines in {Country} issupported by doctors, pharmacists, nurses and other health professionals in the country.
The {Drug Regulatory Authority} and the Department of Health’s Essential DrugProgramme are committed to improving drug safety through adverse drug reactionmonitoring in {Country}. Through the {Drug Regulatory Authority}’s nationalpharmacovigilance programme, adverse reactions should be reported on a dailybasis.

What is the Size or Severity of the ADR Problem in {Country}?
While no studies have comprehensively assessed the burden of adverse drugreactions on health care, it is likely that the problem is considerable in {Country}.Studies conducted in developed countries have consistently shown thatapproximately 5% of hospitalised patients are admitted into hospital as a result of anADR and 6-10% of in-patients will experience a serious ADR during hospitalisation.Even these startling figures don’t represent the whole picture. These studiesgenerally excluded ADRs caused by overdose, drug abuse, or therapeutic failures.The cost to most countries for managing adverse drug reactions is considerable.

Who should report Adverse Drug Reactions?
All health care workers, including doctors, dentists, pharmacists, nurses and otherhealth professionals are requested to report all suspected adverse reactions to drugs