Effective Management to Standardize Quality Services in Pharmaceutical Industry, GlaxoSmithKline - Research Proposal Example

Effective Management to Standardize Quality Services in Pharmaceutical Industry Literature Review 1. The Pharmaceutical Industry in the United Kingdom In the United Kingdom the pharmaceutical industry is of critical importance to the economy, as it is one of the fast-growing and dynamic industries. This feature of the pharmaceutical industry is derived from its grounding in research for the development of new products. The South-East, North-West and North-East of England are where a large proportion of the pharmaceutical industry is located (Department of Health, 2009). The importance of the pharmaceutical industry to the economic health of the United Kingdom can be seen from the size and its contributions to the economy. The direct contribution to employment is in the form of 83,000 employees, with many more benefiting indirectly. It is the third most profitable industry sector in the United Kingdom, ranked only behind the tourism and financial sectors. It is one of the critical contributors to the healthy balance of trade position of the United Kingdom (The Stationery Office Limited, 2005, p.7). Estimates for the year 2005, show that international trade of pharmaceutical products from the United Kingdom were of the value of 12.1 billion pounds as exports and #8.7 billion pounds as imports, leading to a positive trade balance of 3.4 billion pounds. The major trading partners are the Western Europe, North America, and Japan (Department of Health, 2009). The domestic consumption of products of the pharmaceutical industry is also large and growing at a fast rate. The NHS spends nearly twelve percent of its budget on the purchase of pharmaceutical products. In 2003 the average prescription rate for every citizen for pharmaceutical products was 13.1. Pharmaceutical products dispensed through prescriptions have shown a steep rate of increase. In 1993 the cost of prescriptions dispensed was 3.4 billion pounds, while in 2003 it climbed to 7.5 billion pounds. This is besides the cost of over the counter drugs dispensed at 1.8 billion pounds (The Stationery Office Limited, 2005, p.7) The pharmaceutical industry in the United Kingdom is responsible for many new pharmaceutical products being made available for the treatment of diseases and conditions. It ranks only behind the United States in research and development of medicines that have good markets all around the world. It is responsible for the development of eighteen of the seventy-five most popular medicines in the world. These pioneering developments include the powerful antibiotics semi-synthetic penicillin and cephalosporin, and therapeutics for ulcers, asthma, arthritis, meningitis C, cancer, migraine, HIV/AIDS, coronary heart disease, hypertension, fungal infections, erectile dysfunction and schizophrenia covering a wide range of branches of medicine (Department of Health, 2009). The pharmaceutical industry in the United Kingdom through its service of making pharmaceutical products available for use in the health sector of the United Kingdom, for the treatment of diseases and condition, makes a large contribution to maintaining the health of the citizens of the nation. This contribution is also an ingredient to improving the quality of life of the citizens of the United Kingdom, reducing the requirement for costly surgical interventions and the duration of stay in hospitals and saving the lives of many citizens (The Stationery Office Limited, 2005, p.3). 1.2. Issues Relating to the Service Provided by the Pharmaceutical Industry The House of Commons Health Committee in its fourth report of session 2004-2005 highlights the first issue regarding the service provided by the pharmaceutical industry as “the increasing use of and reliance on medicines” (The Stationery Office Limited, 2005, p.3). This inappropriate and over use of medicines, instead of improving the quality of life of the citizens of the United Kingdom, is leading to discomfort, illness, hospitalisation and mortality. Evidence of increased hospitalization due to inappropriate use of medications can be evinced from the figures of hospitalization due to adverse drug reactions, which stand at five percent of hospital admissions in the United Kingdom (The Stationery Office Limited, 2005, p.3). It may be argued that the pharmaceutical industry only makes the drugs available. A very large percentage of drug usage is through prescriptions of the medical practitioners and if there is over use of drugs, then the blame should fall at the doors of the medical practitioners. This is a difficult line to toe totally, for there are factors that need to be considered in the over use of drugs, which stems largely from the influence that the pharmaceutical companies have in the health sector. According to the House of Commons Health Committee fourth report of session 2004-2005, p.4, “while the pharmaceutical industry cannot be blamed for creating unhealthy reliance on, and over-use of, medicines, it has certainly exacerbated it. There has been a trend towards categorising more and more individuals as ‘abnormal’ or in need of drug treatment.” To understand the manner in which the pharmaceutical industry aggravates the over use of pharmaceuticals we have to go back to the development of new drugs and the applications that it is meant for. Research and development bring out new formulations that may be useful as therapeutics for the treatment of diseases and conditions. Clinical trials provide the evidence of the utility and safety of the formulations, as well as the applications of the formulations. This is a key issue in the use of drugs and medications. In the United Kingdom it is the Medical Health Regulatory Agency (MHRA) that is responsible for giving the license for new medications to be marketed. Its evaluation of new medicines is influenced strongly by the evidence that comes from the clinical trials designed to test the efficacy, utility and safety of the new medications. The license is provided by MHRA for a new medication only when the evidence suggests that the benefits are more than any possible risks (MHRA, 2007). However, the supervision of MHRA on the entry of new formulations is no inadequate in scrutinizing the evidence and surveillance post market entry of the new formulations. This may be put down to the closeness that has developed between the MHRA and the pharmaceutical industry and the influence of the pharmaceutical industry, the trust that it reposes in the pharmaceutical industry and the competition it faces from the other similar regulatory bodies in Europe (The Stationery Office Limited, 2005, p.4). The National Institute of Health and Clinical Excellence (NICE) is the body that lays down the standards for health care provided to health care seekers. It provides the guidance on when and how drugs and medical technology should be prescribed, through what is known as technology appraisal guidelines. NICE relies on clinical evidence for setting its guidelines (National Institute of Health and Clinical Excellence, 2008). The key operative words in the decisions of when and how drugs should be prescribed are “clinical evidence”. This clinical evidence comes from the results of clinical research. Clinical research requires funding and the pharmaceutical industry is responsible for a large share of the funding required for clinical research. Lexchin et al 2003 investigated the influence of funding of drug studies by the pharmaceutical industry on the finding of outcomes that favour the pharmaceutical industry. From its investigations into thirty studies that included both studies that received funding from the pharmaceutical industry and studies that received funding from other sources, it found that findings of studies funded by the pharmaceutical industry were more likely to produce results in favour of the pharmaceutical industry than the studies funded by other. This led the investigators to conclude that there is systematic bias in favour of the drugs, when the clinical studies are funded by the pharmaceutical industry (Lexchin et al, 2003, p.1167). The clinical evidence is thus influenced by the pharmaceutical industry in its favour allowing drugs to not only enter the market, but also influences its over use. The influence of the pharmaceutical companies in over use of drugs does not merely end there. Medicines allowed into the market are strongly promoted through various means by the pharmaceutical industry to recover as quickly as possible the money spent on research and development and then subsequently to boost profits. These promotional activities include sponsorship of information in medical journals, medical information materials circulated to the medical professionals, workshops and other promotional events. The general practitioners are the main target of such activity, as they have greater freedom in prescribing than the medical profession specialists in hospitals, resulting in over use of drugs by general practitioners. Patients are also the target of promotional activities of the pharmaceutical companies, which results in their demand for the drugs from their doctors and over use of these drugs. In this manner the pharmaceutical industry distorts the prescription practice in its favour, with dire consequences, as can be seen from the over prescription of the COX-2 inhibitors Vioxx and Celebrex, leading to many deaths (The Stationery Office Limited, 2005, p.4). This is despite the prescribed self-regulatory stand of the Association of British Pharmaceutical Industry (ABPI), through its Prescription Medicines Code of Practice, wherein it requires its members to function in a manner that is committed to “benefiting patients by operating in a professional, ethical and transparent manner to ensure the appropriate use of medicines and support the provision of high quality healthcare” (ABPI, 2008, p.4). For confidence in the services of the pharmaceutical industry to be retained, ABPI understands the need for transparency in the promotional activities of the pharmaceutical. Hence transparency of promotional activities is a key provision in the code (ABPI, 2008, p.5). Yet, continuing experiences suggest that this is observed more in breach (The Stationery Office Limited, 2005, p.4). The question then arises as to why such a situation has arisen with the pharmaceutical industry in the United Kingdom. It has been wrongly assumed that the interests of the health of the nation and the pharmaceutical industry are one and the same (The Stationery Office Limited, 2005, p.3). This assumption has sprung from the belief that many of the pharmaceutical companies in the pharmaceutical industry were started incorporating a philanthropic goal also in the form of enhancing human life through the services that it provides (Stancich, 2009). That the pharmaceutical industry needs to recover its costs involved in research and development and making its services available to the citizens of the United Kingdom for continuing its service to the populace is understandable (The Stationery Office Limited, 2005, p.3). Yet, in the current scenario the pharmaceutical industry has gone beyond this basic and ethical requirement to becoming like any other business enterprise, focussing its attention on increased revenue generation. This slip in ethics is the root cause of the deficiencies found in the services provided by the pharmaceutical industry and can be traced to drop in standards of corporate governance of the pharmaceutical industry (Stancich, 2009). 1.3. GlaxoSmithKline (GSK) GlaxoSmithKline (GSK) is the leading pharmaceutical company headquartered in the United Kingdom. Among the pharmaceutical companies around the world, GSK is the second largest in terms of revenue generation and the largest pharmaceutical company in the United Kingdom. It offers a range of services, which include prescription medicines, vaccines, over-the-counter drugs, oral care products, and nutritional care products (Stancich, 2009). The mission of GSK is to “to improve the quality of human life by enabling people to do more, feel better and live longer.” GSK believes that it is this mission that provides them with the function of developing new medicines and products, as a part of its service, to provide assistance to the population of the world to combat diseases and conditions they may be afflicted with (GSK, 2009). Being a leader in the pharmaceutical industry, GSK believes that it has a social responsibility in leading the way in corporate responsibility and attempts this, by being transparent in its operations and delivery of service. As a part of its corporate social responsibility GSK tries to dispel the perception of extra profit generation through these transparency efforts and also preferential pricing policies and community development programmes. In its transparency efforts the company has published two social reports that provide an outline of its research and development efforts and how this would enable improving healthcare. In addition to this along with this, GSK works along with many governmental and non-governmental agencies to address the concerns on many dreaded diseases in the world. This activity also involves taking into consideration key issues impacting on its service in terms of clinical drug trials, pricing of the drugs and making the drugs available (Stancich, 2009). Literary References ABPI. 2008, ‘CODE OF PRACTICE for the PHARMACEUTICAL INDUSTRY’, Prescription Medicines Code of Practice Authority [Online} Available at: http://www.pmcpa.org.uk/files/sitecontent/ABPI_Code_of_Practice_2008.pdf (Accessed June 14, 2009). Department of Health. 2009, ‘Pharmaceutical industry’, [Online} Available at: http://www.dh.gov.uk/en/Healthcare/Medicinespharmacyandindustry/Industrybranch/DH_4000038 (Accessed June 14, 2009). GSK. 2009, ‘Our company’, [Online} Available at: http://www.gsk.com/about/company.htm (Accessed June 14, 2009). Lexchin, J., Bero, L. A., Djulbegovic, B. & Clark, O. 2003, ‘Pharmaceutical industry sponsorship and research outcome and quality: systematic review’, BMJ, vol.326, pp.1167-1170. MHRA. 2007, ‘Making Regulatory Decisions about Medicines and Medical Devices’, [Online} Available at: http://www.mhra.gov.uk/Howweregulate/index.htm (Accessed June 14, 2009). National Institute of Health and Clinical Excellence. 2008, ‘NICE: our guidance sets the standard for good healthcare’ [Online} Available at: http://www.nice.org.uk/media/888/38/ourguidancesetsstandard.pdf (Accessed June 14, 2009). Stancich, R. 2009, ‘The pharmaceutical industry: a cross-section of CR practice’, Ethical Corporation. [Online} Available at: http://www.ethicalcorp.com/content.asp?ContentID=1340 (Accessed June 14, 2009). The Stationery Office Limited. 2005, ‘The Influence of the Pharmaceutical Industry’, House of Commons Health Committee’, Fourth Report of Session 2004-2005, Vol.1 [Online], Available at: http://www.publications.parliament.uk/pa/cm200405/cmselect/cmhealth/42/42.pdf (Accessed June 14, 2009). Read More