Pharmacovigilance ( PV ) :  Pharmacovigilance can be  defined as the science and activities concerned with the detection, assessment, understanding and prevention of adverse reactions to medicines (i.e. adverse drug reactions or ADRs). The ultimate objective of this activity is to improve the safe and rational use of medicines, thereby improving patient care and public health. The {Drug Regulatory Authority} defines an Adverse Drug Reactions (ADR) or adverse reaction as a response to a medicine used in humans or animals, which is noxious and unintended, including lack of efficacy, and which occurs at any dosage and can also result from overdose, misuse or abuse of a medicine. The PV is important because when a medicine is released onto the market there is still a great deal that is unknown about the safety of the product. Once marketed the medicines are used by patients who have many different diseases, who are using several other drugs and who have different traditions and diets which may affect the way in which they react to a medicine. Different brands of medicines may differ in the manner in which they are produced and the ingredients that are used. The adverse drug reactions and poisonings associated with traditional and herbal remedies also need to be monitored in each country. The information we receive on the adverse effects of drugs in other countries 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 financial loss sustained by the patient due to the inappropriate or unsafe use of medicines, it is essential that a monitoring system for the safety of medicines in {Country} is supported by doctors, pharmacists, nurses and other health professionals in the country. Studies conducted in developed countries have consistently shown that approximately 5% of hospitalised patients are admitted into hospital as a result of an ADR and 6-10% of in-patients will experience a serious ADR during hospitalisation. Even these startling figures don’t represent the whole picture. These studies generally excluded ADRs caused by overdose, drug abuse, or therapeutic failures. The cost to most countries for managing adverse drug reactions is considerable. The information obtained from reported reactions promotes the safe use of medicines on a local and national level. A well completed adverse drug reaction/product quality form submitted by you could result in any of the following: • additional investigations into the use of the medication in {Country} • educational initiatives to improve the safe use of the medication. • appropriate package insert changes to include the potential for the reaction reported by you • changes in the scheduling or manufacture of the medicine to make the medicine safer Therefore, the purpose of ADR reporting is to reduce the risks associated with drug prescribing and administration and to ultimately improve patient care and safety

Parameters for  ADR

1. Take a Proper History and do a proper examination • A full drug and medical history should be done • Can this adverse be explained by other causes e.g. patient’s underlying disease, other drug/s, over-the-counter medicines or traditional medicines; toxins or foods 3 • It is essential that the patient is thoroughly investigated to decide what the actual cause of any new medical problem is. A drug-related cause should be considered, especially when other causes do not explain the patient’s condition 2. Establish time relationships • some reactions occur immediately after being given a medicine while other reactions take time to develop) • The time from the start of therapy to the time of onset of the suspected reaction must be logical. 3. Perform thorough physical examination with appropriate laboratory investigations • Few drug produce distinctive physical signs • Exceptions include fixed drug eruptions, steroid-induced dermal atrophy, acute extrapyramidal reactions • Lab tests are especially important if the drug is considered essential in improving patient care or of the lab test results will improve management of the patient • try to describe the reaction as clearly as possible and where possible provide an accurate diagnosis 4. Check pharmacology of the Medicine. • Is the reaction known to occur with the particular drug as stated in the package insert or other reference • If the reaction is not documented in the package insert, it does not mean that the reaction cannot occur with that particular medicine.)

Prevention Methods to avoid ADR’s

Some ADRs are unavoidable and cannot be prevented. However, most ADRs can be prevented by following the basic principles of rational use of medicines that are described as follows: Some ADRs are unavoidable and cannot be prevented. However, most ADRs can be prevented by following the basic principles of rational use of medicines as follows: 1. Use few drugs, whenever possible 2. Use drug that you know well 3. Do not change therapy from known drugs to unfamiliar one without good reasons. 4. Use text books and other reference material providing information on drug reactions and interactions. 5. Take extra care when you prescribe drugs known to exhibit a large variety of interactions and adverse reactions (anticoagulants, hypoglycemic, and drug affecting the CNS) with careful monitoring of patients with such reactions. 6. Beware of the interaction of drugs with certain food stuffs, alcohol and even with house hold chemicals. 7. Review all the drug used by your patients regularly, taking special notice with those bought without prescription .(Over the counter, herbal preparations). 8. Be particularly careful when prescribing to children, the elderly, the pregnant and nursing women, the seriously ill and patients with hepatic and renal diseases. Careful ongoing monitoring is also essential in these patients is essential. 9. If the patient  show signs or symptoms not clearly explained by the course of their illness, think of adverse drug reaction. 10. If an adverse reaction is suspected , consider stopping the drug or reduce the dosage as soon possible and please notify the adverse drug reaction to concerned authority.