Drug efficacy and safety research frontiers: soul of pharmaceutical care

To unveil more information about efficacy, safety and side effects of an approved new drug it is essential that all patients who are treated with such a drug are compulsorily supervised and monitored by prescribing physicians, dispensing pharmacists and nurses and duly documented for all major and minor events during the course of therapy to correlate real time safety and efficacy with clinical trial data, collected up to phase III. Mere dependence on spontaneous reporting is insufficient, because it suffers from the vice of poor-quality reports and underreporting. Moreover, it is difficult to estimate rates and frequencies of ADRs, on this basis. Drug’s effect on specific demographics should be specifically studied and documented to obtain real time data on safety and efficacy. Pregnant & lactating women and specially those taking other medications along with the new drug need to be studied as special populations to identify effects on the fetus, infants and interaction between the drugs. As a result of extensive treatment on large population, long-term and unique/rare events/effects may be identified, which may be instrumental in ensuring safety and efficacy of therapy. This also assists in finding new markets, new indications and product extension. Thus the research fields like post marketing surveillance (PMS) and Phase IV studies have vast opportunity and practice based research must focus on this. INTRODUCTION