Patient protection

The Food and Drug Administration relies on data that sponsors submit to decide whether a drug should be approved. To protect the rights and welfare of people in clinical trials, and to verily the quality and integrity of data submitted, the FDA s Division of Scientific Investigations (DSI) conducts inspections of clinical investigators study sites. DSI also reviews the records of institutional review boards to be sure they are fulfilling their role in patient protection. 

A medication should be considered falsified unless the label contains 1. Indications of adequate use and 2. Adequate warnings regarding the pathological indications in those it should not be used or not for children use, when its use can be dangerous for health, of dosages, methods or interval of administration, or unsafe application, of mode and in necessary form for patients protection. 

The setting is arranged in such manner that the patient is able to surrender to his experiences uninhibitedly. All authors recommend a darkened room and quiet music to subtly stimulate the experience. The continuous presence of the therapist or a specifically trained assistant offers the patient protective support during the sessions. Occasional visits by the treating physician complement the care. These professionals do not intervene with interpretation during the course of the experience. 

New Drugs are not always innovative, just formulas that mirror each other and have been tweaked to gain patient protection and turn big profits. 2005. (Accessed Feb 7,2007, at http //www.signonsandiego.com/news/business/20051120-9999-lzl b20meds. html. )... 

Pharmaceutical companies, individual regulatory authorities and the WHO have databases which facilitate this overview. The use of a standard coding dictionary of adverse event terms is essential for this sort of analysis, and one, MedDRA (Medical Dictionary for Regulatory Activities) has been accepted as the gold standard to be used. Nevertheless, routine review of individual cases by responsible, experienced reviewers is the most essential factor in identifying new signals and ensuring patient protection. 

Even insurance practices exhibit cross-cultural differences. The EU guidelines for patient protection lay down that there should be sufficient insurance provision. However, some countries have taken this requirement a step further by laying down the actual sums for which individual patients, or, in the case of Germany, the total number of patients, must be covered. In the United States, patients and volunteers are in general insured by the institution in which the study is conducted the fees for this are not directly reimbursed by the sponsor but form part of the overall study cost. 

With limited resources available, the major tasks of the BAS are to provide lifesaving care and to prepare the casualty for evacuation. By necessity these must be short, simple procedures. After receiving care in a low-echelon MTF, the casualty is evacuated in a clean vehicle to a higher echelon for further care. If clean vehicles are not available, the casualty may be placed in a patient protective wrap and evacuated in a dirty vehicle (see Figure 16-42 in Chapter 16, Chemical Defense Equipment). At higher echelons, the treatment area will be located in a collective protection shelter otherwise, this should be at least 100 m upwind from the receiving area. 

The patient protective wrap (PPW) is designed to protect a patient during evacuation after the BDO has been removed and the patient has received medical treatment (Figure 16-42). A patient can remain in the PPW for 6 hours. The protective mask is not needed inside the PPW, but it should be evacuated with the patient. 

A controversial area that safety professionals should be aware of is that of breast feeding when the mother returns to the job. Although not specifically addressed in the Pregnancy Discrimination Act, safety professionals should be aware of the break-time requirement that is now part of the Fair Labor Standards Act, specifically in Section 4207 of the Patient Protection and Affordable Care Act (also referred to as the Affordable Care Act ). Safety professionals should be aware that this provision requires companies and organizations to provide reasonable break time for an employee to express breast milk for her nursing child for 1 year after the child s birth each time such employee has need to express the milk. Additionally, safety professionals should be aware that this provision requires the company or organization to provide a place, other than a bathroom, that is shielded from view and free from intrusion from coworkers and the public, which may be used by an employee to express breast milk. This is relatively new, and safety professionals should be aware that this break-time requirement became effective when the Affordable Care Act was signed into law on March 23, 2010. 

In 2010, the Patient Protection and Affordable Care Act (PPACA) (commonly called Obamacare or the Affordable Care Act (ACA)) was signed into law. This new law, in general, is a major change in the U.S. health care system addressing affordability of health insurance, preexisting conditions, and a number of major... 

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