Licensure

In the United States, there is no national qualifying or licensing body for pharmacists. Licensure requirements are promulgated by State boards of pharmacy that administer examinations, issue internship requirements, and oversee the practice of pharmacy. The National Association of Boards of Pharmacy serves the collective needs of the state boards. This organisation has no Hcensure authority. However, it has developed a standardized Hcensure examination (NABPLEX), which as of this writing (ca 1995) is used by 48 states (see Licensing). 

Schwamm LH, Smith EE, Abdullah AR, Palmeri G, Prvu J, Goyette L, McElligott C, Dreyer P. Hospital characteristics associated with successful state-hased licensure for acute stroke services The Massachusetts experience. Stroke. 2006 37 719. 

Stroke consultants may be deterred from providing telemedicine-based consultation by the requirement of securing licensure in all states in which they provide consultation. However, acute stroke consultation may be exempt from these rules in states that make exceptions for emergency situations, limited duration of clinical care, or consultation to patients in bordering states. Still, other states prohibit ongoing... 

The first large-scale process to circumvent these limitations was one developed by Genentech, Inc. (South San Francisco, CA) for production of recombinant tissue plasminogen activator (tPA). This protein dissolves blood clots and can be used to treat heart attacks and strokes. This process was developed in the mid-1980s, resulting in final product licensure in 1987. The process required both regulatory and technical breakthroughs. 

Vaccine development involves a substantial investment in time, effort, and resources. Any public or private research and producing facility should allocate huge financial and human rescues when development of vaccine is decided. The cost from research to licensure, the risks inherent in vaccine development (e.g. technological constraints, regulatory approval) and short- or long-term evaluations of scientific and financial results may constrain this activity. In the developing world, the price has been a major impediment to the introduction of new vaccines. 

Curriculum vitae and licensure for the principal investigator and each subinvestigator... 

Rotavirus — the most common cause of severe diarrhea in infanfs, with approximately 125 million cases worldwide per year and 600,000 deaths — vaccines have been linked with intussusceptions (a problem with the intestine in which one portion of the bowel slides into the next) at a rate of between 1 in 5000 and 1 in 11,000 infants. The only rotavirus vaccine approved in the United States, RotaShield (Wyeth-Ayerst), was withdrawn from market on October 22, 1999, about 1 year after licensure. 

In this context, judging the qualifications of an alternative medicine practitioner can be difficult— there are no universally accepted guidelines. Some states require licensing of alternative medicine practitioners (e.g., acupuncturists, naturopathic herbalists), and licensure is often used by courts to establish school-specific standards of care. In cases where no licensing exists, courts apply conventional medical or lay standards of care. Eisenberg (1997) has proposed strategies for physicians in guiding patients who seek alternative medical treatment. 

Continuing in-service medical education as a licensure requirement... 

III.b.1.6. Continuing in-service medical education as a licensure requirement. Continuing in-service medical education (CME) is a requirement for licensure of health professionals in many industrialized countries. In many developing countries opportunities for CME are limited and there is also no incentive since it is not required for continued licensure. CME is likely to be more effective if it is... 

To ensure safety, the FDA continues to oversee the production of vaccines after the vaccine and the manufacturing processes are approved. After licensure, monitoring of the product and of production activities, including periodic facility inspections, must continue as long as the manufacturer holds a license for the product. If requested by the FDA, manufacturers are required to submit the results Continued on next page)... 

For purification, scale-up considerations are important even in the earliest phases of development. It is important to avoid the use of purification techniques of limited scale-up potential even for early clinical production because thorough justification of process changes and demonstration of biochemical comparability are necessary prior to product licensure. For successful scale-up, it is important to understand the critical parameters affecting the performance of each purification step at each scale. Conversely, it is important to verify that the scaled-down process is an accurate representation of the scaled-up process, so that process validation studies, such as viral clearance and column lifetime studies, can be performed at the laboratory scale. 

Resnik, D. and K. DeVille. 2002. Bioterrorism and Patent Rights Compulsory Licensure and... 

Synthetic Heme. Synthetic compounds that bind or chelate 02 have been produced. These compounds are commercially attractive because manufacture and licensure might be developed as a drug, rather than as a biological product. It has been shown that synthetic hemes can be used to transfuse animals (53). Although synthetic 02 carriers would avoid the limited hemoglobin supply problem, the synthetic procedures are very tedious, and the possibility of scale up seems remote. 

Cross-links Unlike linear flow charts or outlines, concept maps may contain cross-links that allow the reader to visualize complex relationships between ideas represented in different parts of the map (Figure 1.13B), or between the map and other chapters in this book, or companion books in the series (Figure 1.13C). Cross-links can thus identify concepts that are central to more than one discipline, empowering students to be effective in clinical situations, and on the United States Medical Licensure Exam ination (USMLE) or other examinations, that bridge disciplinary boundaries. Students learn to visually perceive non-linear rela tionships between facts, in contrast to cross referencing within lin ear text. 

O Neill, R.T., Biostatistical considerations in pharmacovigilance and pharmacoepidemiology linking quantitative risk assessment in pre-market licensure application safety data, post-market alert reports and formal epidemiological studies, Stat. Med., 17, 1851, 1998. 

For firms that manufacture several products from one source (e.g., Chinese hamster ovary [CHO] cells), a generic approach may suffice. Regulatory authorities in some countries are accepting this approach [13]. There are also some generic kits on the market that can be used to study host cell protein clearance during development, and may be considered acceptable for licensure. 

Capabilities—solid dosage, sterile products, liquids/semisolids, potent compound, different licensure (DEA, etc.)... 

Computerized physician provider order entry (CPOE) is defined as the computer system that allows direct entry of medical orders by the physician or person with appropriate licensure and privileges to do so. Directly entering orders into a computer has the benefit of reducing errors by minimizing the errors caused by handwritten orders, but even a greater benefit is realized when the combination of CPOE and clinical decision-support tools is implemented together. 

Bachelor s degree (5-year program) or advanced pharmacy degree (Pharm.D. or M.S.) from an accredited college of pharmacy, hospital pharmacy experience preferred, licensure or eligibility for licensure. 

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