Affiliation:
1. Riggs Pharmaceuticals Karachi, Department of Pharmacy, University of Karachi - Pakistan.
Abstract
Medicine are a core part of health-care services and their use has grown enormously during the last century with the advent of effective Antibiotics, Anesthetics, Analgesics, Anti-retroviral and many other medicines, they can cure diseases, relieve symptoms and prevent future ill health. Appropriate medicine use means providing the right medicine at the right dose, when it is needed and avoiding medicine that are unnecessary or are unlikely to result in health benefits it means choosing the treatment with the best effectiveness and safety profile among available alternatives and the least costly of equivalent treatments. The international pharmaceutical industry plays an important role in the development, production and distribution of medicines. In many countries it has also become the major funder of continuing medical education (CME) and research. However, a tension exists between pressure to expand products sales within a competitive market and patient care. The World Health Organization (WHO) describe" an inherent conflict of interest between the legitimate business goals of manufacturers and the social, medical and economic needs of providers and the public to select and use drugs in the most rational way"( WHO Europe 1993)1 The Global Medicine Market: In 2007, global pharmaceutical sales amounted to US $ 712 billion (IMS 2008)2 The top product in term of sales, was the cholesterol lowering medicine, Lipitor (Atorvastatin), which had sales of US $ 13.6 billion (scrip.2007)3. This is more than the gross national income of over half of the world’s countries (World Bank, 2008)4. The effects of promotion in fueling sales of specific brands should not be underestimated e.g. sales of Lipitor (Atorvastatin) were higher than sales of simvastatin and Provaststin, two medicine in the same class that have similar effectiveness and are less costly (Preserire, 2006) 5. Newer Medicine are not necessarily better: To get a new medicine to market, a company must provide evidence of effectiveness, safety and manufacturing quality. Effectiveness and safety evidence includes laboratory animal and clinical studies. The largest are phase III randomized controlled trials in patient with the disease the medicine aims to treat. Most of these studies compare a new medicine to a placebo. Many people are unaware that manufacturers do not need to show that a new medicine is better than existing compound with placebo and be acceptably safe. To test the medicine 's efficacy, the manufacturers carried out the randomized, controlled trials involving patients with the condition to be treated by the new medicine. These are usually relatively short-term studies and many last a few weeks to a few months, even when the treatment for a chronic disease. For some serious disease for which placebo treatment would be unethical, a new medicine is compared with existing treatments. However, these studies aim to show that a new medicine is as effective as alternatives, or no less effective, it does not need to be better, when a new medicine comes to the market.it has only been tested on highly selected groups of clinical trials participants. e.g. the elderly and those with co-morbid, chronic conditions are usually excluded. To few people have been exposed to asses’ rare harmful effects, generally 3, 000 to 5, 000 peoples. Because of this inevitably incomplete safety assessment, there is a rational from a public health perspective and an individual patient Care perspective for a slow, cautious approach to the introduction of new medicines.
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