The compliance trap

Pharmaceutical industry is a tightly regulated business, especially in the U.S. and in Europe. Before medicines reach the market, they must undergo extensive clinical testing. Upon reaching the market, approved drugs can be prescribed to any patient if the physician can reasonably expect therapeutic benefit for the specific patient. Clinical research on human subjects can be sponsored by the industry, academic institutions, hospitals and even by individuals. A sponsor is the organization or person who initiates the study and who

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The cost of patient harm

U.S. health care spending reached $3.5 trillion in 2017, of which hospital care was $1.1 trillion and physician and clinical services was $694 billion. Retail prescription drugs cost $333.4 billion [1]. The cost of drug-related patient injury, referred to adverse drug events (ADEs) in the U.S. is estimated at $528 billion in 2016 [2]. Costs associated with ADEs include new hospital admissions, readmissions, prolonged length of inpatient stay and additional therapeutic interventions. According to a decade old research published by

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Pharmacovigilance history, importance and current status

Pharmacovigilance, a science that studies the adverse effects of medicines, has come a long way since its inception in the 1960’s when the thalidomide disaster occurred. Manufacturers of medicinal products must prove the safety and efficacy of their products to obtain regulatory approval and place their product on the market. Side effects of medicines identified in clinical trials are now included in the drug label, along with indications, contraindications, interactions with other drugs and conditions of use. Specific population subgroups

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