Thursday, 15 November 2012

Understanding Pharmacovigilance System & Processes

According to WHO “Pharmacovigilance is the science and activities relating to the detection, assessment, understanding and prevention of adverse effects or any other drug-related problem.” In other words the goal of pharmacovigilance is getting the best outcome of therapy by patient care and surveillance. Good pharmacovigilance will identify the risks and risk factors related to adverse drug reactions (ADRs) during the complete product life cycle. This information allows for intelligent, evidence-based prescription and has the potential for preventing ADRs.

The importance of Pharmacovigilance

The primary aim is to enhance patient safety and to provide reliable and balanced information for the effective use of medicines. The secondary aim is communication of new safety ?ndings to the national and international regulatory authority in a timely manner. Pharmacovigilance programmes promote the education and training in this field and its effective communication to the public. Pharmacovigilance identify adverse events and their rates with the possible risk factors. It assesses causality with respect to clinical relevance, frequency and distribution of ADRs, which helps to understand the benefit, harm, effectiveness and risk of medicines.

Good Pharmacovigilance Practice

The concept of pharmacovigilance is normally not well understood, either by health professionals, patients or the general population. Development of guidelines and standards are required for a coherent and good pharmacovigilance system, which describe the practical details of the intended information Now.

Good pharmacovigilance systems should have the capability for receiving and processing of reports with veri?cation, interpretation and case causality assessment. It should have databases and procedures for data analysis, review and signal detection. An effective coordination between health care settings, regulatory and public health activities is required. Also regular training of health care workers in reporting adverse reactions improves both active and passive reporting.

Spontaneous reporting is a system whereby case reports of adverse drug events are voluntarily submitted by health professionals, pharmaceutical companies or consumers to the national pharmacovigilance centre. It is basically the reporting of a suspected adverse reaction on the initiative of the health professional that becomes aware of the problem, or on the patient’s initiative. Cohort event monitoring refers to the use of prospective, observational cohort studies of patients to whom the medicine of interest has been administered with recording of all adverse events.

Pharmacovigilance system may be run by a person or group of persons with expert knowledge of drug safety and adverse events under the independent government setup. The Central Drugs Standard Control Organization (CDSCO), Directorate General of Health Services under the aegis of Ministry of Health & Family Welfare, Government of India in collaboration with Indian Pharmacopeia commission is initiating a nation-wide pharmacovigilance programme for protecting the health of the patients by assuring drug safety. The programme shall be coordinated by the Indian Pharmacopeia commission, Ghaziabad as a National Coordinating Centre (NCC). The centre will operate under the supervision of a Steering Committee.

We at WorkSure provide complete Pharmacovigilance system and Process solutions for signal detection, signal evaluation, medical review and causality assessment of safety data (AEs, SAEs, SUSARs etc). We also provide medical writing services for preparation of safety reports eg ICSRs, PSURs etc as per regulatory requirements, and resolving queries from regulatory authorities on safety issues.


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