Restricted distribution program

Restricted distribution program requiring registered prescribers and pharmacists in the S TE PS, program (System for Thalidomide Education and Prescribing... 

Recently, restricted distribution programs have become common for drugs used in small populations or drugs with significant safety concerns. 

Thalidomide (thalomid) is best known for the severe birth defects it caused when administered to pregnant women. For this reason, it is available only under a restricted distribution program and can be prescribed only by specially licensed physicians who understand that thalidomide should never be taken by women who are pregnant or who could become pregnant while taking the drug. Nevertheless, it is indicated for the treatment of patients with erythema nodosum leprosum (see Chapter 47) and also is used in conditions such as multiple myeloma. Its mechanism of action is unclear. 

S.T.E.RS. 3.0 Celgene s Innovative Restricted Distribution Program. Thalomid Web site, www.thalomid.com/steps program.aspx. Accessed December 15, 2006. 

DOFETILIDE Dofetilide (ukosyn) is a potent and pure blocker that has virtually no extracardiac pharmacological effects. Dofetilide is effective in maintaining sinus rhythm in patients with atrial fibrillation. Dofetilide is available through a restricted distribution system that includes only physicians, hospitals, and other institutions that have received special educational programs covering proper dosing and treatment initiation. 

EPA s decision to register a pesticide is based in part on the risk of adverse elfects on endangered species as well as the environmental fate (how a pesticide will affect the habitat), Under FIFRA, EPA can issue emergency suspensions of certain pesticides to cancel, or restrict their use if an endangered species will be adversely affected. Under a new program, EPA, FWS, and USDA are distributing hundreds of county bulletins which include habitat maps, pe.sticide use limiiiiions,, md other actions required to protect listed species. 

In 1966 and 1967, when the use of endrin was not restricted, endrin was detected in 5 of 67 raw water samples from the Mississippi and Missouri Rivers (Schafer et al. 1969). At a later time when endrin use was substantially restricted, an Iowa study of 33 community water supplies using surface water found no detectable concentrations of endrin in the distribution systems (Wnuk et al. 1987). In an extensive water quality monitoring program conducted by the California Department of Health Services, endrin was detected (detection limit not specified) in only 2 of 5,109 public drinking water sources sampled from 1984 to 1992, at mean and maximum concentrations of 0.06 and 0.10 ppb, respectively (Storm 1994). Concentrations did not exceed the Maximum Concentration Level (MCL) of 0.2 ppb. In another recent study, endrin was not detected (detection limit not specified) in 32 samples each of raw water and highly treated reclaimed waste water undergoing evaluation as a possible supplement to raw water sources in San Diego, California (De Peyster et al. 1993). 

In the mid-nineties more highly correlated methods such as CCSD and QCISD became available through distribution of the ACES and Gaussian 94 programs. Geometry optimization with these more cpu intensive programs was restricted for the most part to six heavy atoms. About this time multiconfigurational self-consistent-field (MCSCF) or... 

The logic of the above form of gi(sttd) and additional details are available in advanced books on DLS, and the above description is meant only to illustrate the basic ideas and one data-analysis approach. The cumulant analysis is often used as a first step before more advanced analytical procedures (each of which has its own advantages and disadvantages) are attempted. Most DLS instruments come with computer programs for the analysis of the size distribution, but we should bear in mind that each analysis technique has specific, and often restrictive, assumptions and none is exact. As a consequence, the results of size distributions from DLS are best interpreted as semiquantitative indicators of polydispersity rather than a true representation of the distribution. 

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