Randomized controlled trials often suffer from two major complications, i.e., noncompliance and missing outcomes. One potential solution to this problem is a statistical concept called intention-to-treat (ITT) analysis. ITT analysis includes every subject who is randomized according to randomized treatment assignment. It ignores noncompliance, protocol deviations, withdrawal, and anything that happens after randomization. ITT analysis maintains prognostic balance generated from the original random treatment allocation. In ITT analysis, estimate of treatment effect is generally conservative. A better application of the ITT approach is possible if complete outcome data are available for all randomized subjects. Per-protocol population is defined as a subset of the ITT population who completed the study without any major protocol violations.

Objective:The primary objective of this study was to evaluate the knowledge, attitude, and practices (KAP) of the healthcare professionals about pharmacovigilance in Dhanalakshmi Srinivasan Medical College and Hospital (DSMCH), Perambalur (Tamil Nadu), a tertiary care teaching hospital. The second primary objective was to assess the causation of underreporting of adverse drug reactions (ADRs) as it needs to be well-assessed in India. The secondary objective was to compare the findings of this study with the results of the published studies from India on evaluation of the KAP of pharmacovigilance among healthcare professional.Materials and Methods:A cross-sectional study was carried out using a pretested questionnaire. The questionnaire was designed to assess the KAP regarding pharmacovigilance. The healthcare professionals (doctors, nurses, and pharmacists) working in the DSMCH, Perambalur (Tamil Nadu) during the study period were included. Only those who gave their consent to participate were included in the study. The data was analyzed by using the Statistical Package for Social Sciences (SPSS) statistical software, version 16.Results:One hundred and fifty pretested questionnaires were distributed among the healthcare professionals and 101 responded. 62.4% healthcare workers gave correct response regarding the definition of pharmacovigilance. 75.2% of healthcare workers were aware regarding the existence of a National Pharmacovigilance Program of India. 69.3% healthcare professional agreed that ADR reporting is a professional obligation for them. Among the participants, 64.4% have experienced ADRs in patients, but only 22.8% have ever reported ADR to pharmacovigilance center. Unfortunately only 53.5% healthcare workers have been trained for reporting adverse reactions. But, 97% healthcare professionals agreed that reporting of ADR is necessary and 92.1% were of the view that pharmacovigilance should be taught in detail to healthcare professional.Conclusion:This study demonstrated that knowledge and attitude towards pharmacovigilance is gradually improving among healthcare professionals, but unfortunately the actual practice of ADR reporting is still deficient among them.

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Off-label prescribing of medicines is prevalent worldwide because it gives freedom to physicians to apply new therapeutic options based on the latest evidence. Although physicians may lawfully prescribe approved drugs for any use consistent with available scientific data and proper medical practice, but unfortunately, usually this is done without adequate scientific data. Often, when the best available therapeutic option fails, patients demand new approach or new treatment which ultimately leads to off-label uses. Major concerns about efficacy and safety have been raised by inappropriate use of off-label drugs because it leads to drug being used without risk-benefit analysis by the regulatory agency. Although the regulatory approval process requires ample proof of efficacy and safety for granting approval for specific indications of prescription drugs but unfortunately, more clarity is required about regulations governing off-label use of medicine. Above all because of the financial aspects involved it is highly impractical to expect that pharmaceutical companies will restrict or stop off-label promotion. Off-label use might be compared to double-edged sword which might be very useful for some patients while it can also expose them to unrestricted experimentation, unknown health risks, or ineffective medicine. Hence, there is an urgent need for guidance to encourage proper off-label use of medicine by the distribution of scientifically valid and authentic information from the pharmaceutical companies. In fact, few countries such as the USA and France have taken an initiative and have come up with the regulations about off-label use of medicine.

Background: The assessment of doctor's perceptions and understanding about generic medicines may help in recognizing possible barriers to greater generic medicine usage. Aims & Objective: The primary objective of this study was to explore the knowledge, attitude, and practice (KAP) of doctors toward generic medicines. Materials and Methods: A cross-sectional study was carried out using a pretested questionnaire in a tertiary-care teaching hospital of Perambalur district of Tamil Nadu (India). The questionnaire was designed to assess the KAP about generic medicines. The doctors working in this institute during the study period were included. All data were analyzed with the Statistical Package for Social Science (SPSS, version 16.0). p-Values of <0.05 were considered to indicate statistical significance. Results: It was known to 76.7% doctors that a generic medicine contains the same active substance(s) as the innovator medicine, and it is used at the same dose(s) to treat the same disease(s) as the innovator medicine (p = 0.000). Among doctors, 79.5% were aware that generic drug manufacturers need to conduct bioequivalence studies to show equivalence between the generic medicine and the innovator medicine (p = 0.0000); 75.3% doctors did not agree that generics are not as safe as innovator drugs (p = 0.0000). Moreover, 64.4% doctor did not agree that generics are not as effective as brandname drugs (p = 0.0123); 71.2% doctors do not think that switching a patient from a brand-name to generic drug may change the outcome of the therapy (p = 0.0002). Sixty-three percent doctors said that they prescribe generic drugs (p = 0.0243). Conclusion: Good percentage of doctors had knowledge about generic medicines. They showed good attitude about the safety, efficacy and quality of generic medicines, and majority of them said that they prescribe generic drugs. But there was a meaningful proportion who expressed concerns about generic drugs. These beliefs could represent a significant hurdle to larger generic drug use and could lead to increased health-care expenses.