protecting the health of the patients by assuring drug safety with well-defined goals to ensure its future growth and progress. Initially its National Coordinating Centre was at AIIMS, New Delhi but now it has been shifted to IPC Ghaziabad, UP. The prime activity of the Pharmacovigilance Program of India (PvPI) is to collect, collate and analyse data on adverse drug Studies have revealed that ADRs are a leading cause of hospitalization among the population and constitutes a significant economic burden on patients in our country (2). The World Health Organisation (WHO)defined theAdverse 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 fro overdose, misuse or abuse of a medicine (1). The foundation of pharmacovigilance was laid on the following aims as specified by the WHO such as,the detection of increase in frequency of reported reactions, identification and quantification of risk factors and preventing the patients from being affected unnecessarily.
The term off label prescribing refers to use of a drug in a manner not approved by the regulatory authorities. The term also applies to the use of a marketed medication in a patient population, dosage, or dosage form that does not have regulatory approval. The practice of off label prescribing is widespread and is seen in almost all branches of medicine. The usage may be supported by strong scientific evidence and research but it does not guarantee the safety of the drug in a large population. Therefore this review focusses on usage of off label medications in different fields of medicine, the possible reason for the use and possible benefits and harms of off label prescribing
Objective: Spontaneous voluntary reporting of Adverse Drug Reactions (ADR) is of paramount importance to the Pharmacovigilance Programme of India, as well as for the benefit of mankind. There has however been minimal and sporadic voluntary reporting of ADRs by the patients at the various ADR Monitoring Centres (AMCs) across Northern India. Knowledge, perception, attitude, and awareness of patients are determinants of reporting practices. This questionnaire based study aims to evaluating these indicators in a tertiary care hospital and determines methods to improve existing reporting practices. This is a cross-sectional questionnaire-based Materials and Methods: observational study carried out in a tertiary care hospital over a period of 2 months. The questionnaires were filled by patients attending the OPD and returned to us. Data obtained from filled questionnaires were thereby analyzed. Results: While 74.4% respondents were aware that medicines can cause side effects, only 51.7% patients aptly feel the urgent need to report an ADR to a physician and receive prompt treatment. A majority of the respondents felt that it was the duty of the attending physician to warn the patients about the potential ADRs of medications while prescribing them, while newspaper reports and awareness campaigns could also be conducted to educate the community towards drug reactions and methods of reporting them to health care associates and receiving prompt treatment. Conclusion: The study indicates that although the respondents have an average knowledge and positive attitude towards ADR reporting and pharmacovigilance, there remains a lack of awareness and poor ADR reporting practices. Efforts are therefore required to enhance awareness and attitude towards pharmacovigilance and ADR reporting.
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