Pharmacovigilance

 

Pharmacovigilance

Nothing is an ideal drug; hence, no one can deny the risk of adverse drug reactions and toxicity in pharmacotherapy. So, it needs to record all adverse and unintended effects of a drug that is experienced by the patient or treating doctors. The adverse drug reactions (ADRs) are the pharmacological effect(s), other than known/ desired effects, at a particular dose. Pharmacovigilance is the observance of pharmacotherapy for the detection, assessment, understanding, and prevention of unintended effects, adverse drug side effects, or any other possible medication error, caused by a pharmaceutical product. Pharmacovigilance promotes systemic, rational use and assures confidence in the safety of drugs. It improves patient care and safety, public health, and safety. The adverse drug reactions (ADRs) may be of the following types –

1.     Adverse Event/Experience (AE): during treatment with a pharmaceutical product, the appearance of any drug induce untoward medical occurrence is called AE.

2.     Side Effect (SE) – This is a drug induce unintended effect taking place at a usual therapeutic dose that is related to the pharmacological properties of the drug.

3.     Serious Adverse Event (SAE) – Any fatal and life-threatening, adverse event of a pharmaceutical product that needs hospitalization or permanently disabling or death is called SAE.

4.     Expected adverse reaction – It is a known adverse effect of a pharmaceutical product that is noted in the brochure or labeling.

5.     Unexpected adverse reaction - The severity of adverse reaction that is not consistent with the domestic labeling or market authorization, or expected from characteristics of the drug.

To minimize the risk of adverse drug reactions, Unani scholars are advised to choose the drugs based on the temperament of the patient and the disease. They also established Darjat-e-Advia (degree of drugs) based on the severity of the effects. The option of substitution (Abdale-Advia) is also advised to avoid any suspected ADR.

 

National Pharmacovigilance Programme: First National Consultative meeting of the National Pharmacovigilance Programme for ASU Drugs was held at the Dept. of AYUSH, Ministry of Health & FW, and New Delhi on August 2008, supported by WHO. After that, National Pharmacovigilance Programme for ASU drugs was launched on 29th Sept 2008. The purpose of the program is to collect, collate, and analyze data to use the inferences to recommend informed regulatory interventions, besides communicating risks to healthcare professionals and the public. The National Institute of Unani Medicine, Bengaluru, is the National Pharmacovigilance Resource Centre for Ayurveda, Siddha, and Unani Drugs (NPRC-ASU) in India under the Central sector scheme for upgradation to Centre of Excellence since 2008-09. Under NPRC-ASU drugs, there are five Intermediary Pharmacovigilance Centres (IPvC) for ASU drugs. There are 74 Peripheral Pharmacovigilance Centres (PPvC) for ASU drugs, which are working under these Four IPvCs, across the country. Adverse drug reactions related to any ASU drugs are being reported to these PPvC, in a specially designed ADR reporting form. The program is intended to collect, collate and analyze data to establish evidence for the clinical safety of ASU & H drugs scientifically for documenting clinical evidence of safety and to undertake surveillance of misleading advertisements of ASU & H drugs and improper advertisements of ASU & H drugs for regulatory actions. Pharmacovigilance is dedicated to reducing the risk of drug-related harm to consumers.