Pharmacovigilance

WHAT IS PHARMACOVIGILANCE?

Pharmacovigilance (PV) is defined by the World Health Organisation (WHO) as the science and activities relating to the detection, assessment, understanding and prevention of adverse effects or any other drug-related problem.

WHAT IS ADVERSE DRUG REACTION (ADR)?

ADR is defined as “a response to a medicine which is noxious and unintended, which occurs at doses normally used”. Occurrence of ADR can vary from individual to individual.

DO DRUGS CAUSE ADVERSE DRUG REACTIONS (ADRs)?

On the hypothetical side, all medications may cause some ADRs, but many people use drugs without causing them any ADRs. The benefit of taking a drug has generally outweigh the risk that may occur.

WHAT SHOULD I DO IF I THINK I MAY HAVE EXPERIENCED AN ADVERSE REACTION?

It is important that you contact your doctor or pharmacist if you think you may have experienced a side effect after using a medicine. They will tell you if you need any medical care or if you need to change your treatment.

WHAT IS THE BENEFIT OF REPORTING ADVERSE DRUG REACTION (ADR)?

By reporting adverse drug reaction, you provide to us a very important action that help Sahala Pharmaceutical Industries to apply appropriate measures to minimize the risk and reoccurrence of these ADRs and to ensure the safety of our products and our patients.

The information you provide will also help us to fulfill our reporting responsibilities to regulatory authorities and to undertake necessary investigations, which in turn will lead to improve the quality of health-care offered to the community. This requires that you provide information on any side effects that may be experienced by you while using our products, even in cases where a relationship between the product and the side effect had not been established.

HOW DOES Sahala PHARMACEUTICAL INDUSTRIES HANDLE THE PRIVACY OF REPORTED ADVERSE DRUG REACTION (ADR)?

Reporter’s and patient’s identity are fully held in strict confidence by us and protected of the law, information provided by the reporter will be strictly protected and will not be used in any way against him / her.

WHO CAN REPORT ADVERSE DRUG REACTION?

Sahala Pharmaceutical Industries encourages patients, carers and other members of the public to report suspected adverse reactions.

Anyone can report issues relating to the safety of medicines to Sahala Pharmaceutical Industries. This includes patients, carers, other members of the society and healthcare professionals.

HOW TO REPORT AN ADVERSE DRUG REACTION?

We realize that filling Adverse Drug Reaction (ADR) Reporting Form requires time to complete but reporting ADRs are crucial for safe use of medication.

Fill Adverse Drug Reaction (ADR) Reporting Form either handwritten or electronically and once you click “send”, it will go to the Pharmacovigilance Department in Sahala Pharmaceutical Industries