Pharmaceuticals Policy and Law - Volume 10, issue 1-4
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The new international review,
Pharmaceuticals Policy and Law, appears with the aim of studying and evaluating the
legal status of medicinal products in the European Union, and its implications in other markets such as the USA and Japan, without neglecting the specific problems of developing countries.
Pharmaceuticals Policy and Law intends to participate in the process of world convergence of pharmaceutical legislation helped by a network of academic centers specializing in pharmaceutical law, without omitting a scientific, economic and social approach to medicinal products.
The specificity of medicinal products conditions their legal status. Legislation regulating other goods cannot be applied to them. To begin with, they are the result of scientific and technical innovation. Research policies determine their progress. The pharmaceutical industry is, by nature, multinational. But, next to these global trends, different traditions still remain at a national level. Within the EU, barriers to free trade in medicinal products still remain despite more than thirty years of harmonisation. The social dimension of medicinal products is complex and very significant in the preoccupations of our societies. Patenting is essential but not sufficient. The life-cycle of medicinal products is protected by professional responsibility, required in the general concept of health safety. It is important to remember their ethical dimension, including research and innovation in new fields such as genetic manipulation and biotechnology, which requires social consent to preserve human dignity and fundamental rights.
Abstract: The care of adults and children with primary immunodeficiencies is very much a multi-disciplinary and multi-professional responsibility. Amongst many of the health, and other, professionals whose input can make all the difference to the quality of life of these patients, the nurse stands out as the one person who probably has the most contact with the patients and their families. This chapter looks at the multi-dimensional role of the nurse who is working with these patients…and their families. These roles encompass the recognition of PIDs, the physical, psychosocial and emotional care of the patients and families, the prevention of complications, educational, and research. Of particular importance is the nurse's role in fostering, and working within, partnerships – partnerships with other health professionals, with families, and above all, with patients.
Keywords: Holistic care, partnership, support and care, education
Abstract: This chapter on the EU regulatory perspective of the intravenous immunoglobulins (IVIGs) encompasses the following topics: – Regulatory framework for IVIGs; – Current EMEA initiatives: revision of the core SPC/IVIG Guideline; – Paediatric Regulation: impacts/outcomes; – Patient involvement and consultation in the EMEA activities.
Abstract: Rationale: Although health surveys are routinely used to estimate the population incidence and prevalence of many chronic and acute conditions in the US population, they have infrequently been used for "rare" conditions such as primary immunodeficiency diseases (PID). Accurate prevalence measures are needed to separate the truly rare condition from those that primary care doctors are likely to see in their practices today, if early diagnosis and treatment are to be achieved. Methods: A…national probability sample of 10,000 households was sampled by random digit dialing and screened by telephone to identify how many of the nearly 27,000 household members had been diagnosed with a PID. Results: A total of 23 household members in 18 households were reported with a specific diagnosis for PID (CVID, IgA, IgG, XLA, SCID, CGD), whereas additional cases were reported as a PID without a confirmatory diagnosis. These findings suggest a population prevalence of diagnosed PID in the United States at approximately 1 in 1,200 persons. Conclusions: Diagnoses of PID in the United States are far more common than suggested in the literature.
Keywords: Primary immunodeficiency diseases, incidence, prevalence in the United States, Schulman, Ronca & Bucuvalas Inc. (SRBI) for the Immune Deficiency
Abstract: The primary antibody deficiency syndromes are a rare group of disorders that can present at any age and for which delay in diagnosis remains common. Replacement therapy with immunoglobulin in primary antibody deficiencies increases life expectancy and reduces infection frequency and severity. Higher doses of immunoglobulin are associated with reduced infection frequency. Late diagnosis and delayed institution of immunoglobulin replacement therapy results in increased morbidity with a wide variety of organ-specific complications…and increased mortality. Therapy with immunoglobulin leads to improvements in overall quality of life, and many of the improvements relate to reduced infection rates and fear of future infections, strongly suggesting that the immunoglobulin therapy itself is the major factor in this improvement. There is limited data on the economic benefits of immunoglobulin therapy, with the fluctuating costs of immunoglobulin making comparison between different studies difficult. However, estimates suggest that early intervention with immunoglobulin replacement compares favourably with prolonged therapy for other more common chronic diseases.
Keywords: Antibody deficiency, immunoglobulin therapy, common variable immunodeficiency