Compliance and acceptance problems with standardized extracts.
In summary, there are a number of segments of the allergy community that are affected by compliance and acceptance of allergen standardization: regulators, allergen products manufacturers, allergists and allergy patients. To maximize compliance and acceptance of new products, these different groups must be considered when making decisions that impact on standardization and utilization of allergens. In closing it is essential that the following issues are addressed: Units--The number of different units currently used in the same extracts during the transition and the different units used throughout the world are particularly troublesome, both for physicians and patients that they treat. Uniform units or at least a formula to calibrate different units to an international system will go a long way in enhancing the compliance and acceptance of standardized products among those who produce them, use them and are treated by them. Cost--Cost of standardization continues to be a concern. The good news is that the new standardized extracts probably will not cost that much more than the old unstandardized extracts. However, implementation of new extracts can be expensive and we need to find ways in which we can minimize such costs to the allergy patients. Support is needed to continue allergen characterization. We need to encourage traditional sources of funds such as the NIH and manufacturers to continue to provide support for the allergen characterization and the standardization process. Commitment--Is the allergy community really committed to allergen standardization? Are regulators committed to provide the resources to develop standardized extracts? Does the allergist want to use standardized extracts? Do allergy sufferers really want standardized extracts in their treatment?(ABSTRACT TRUNCATED AT 250 WORDS)
Lehrer
S B
SB
Tulane University, Dept. of Medicine, New Orleans, Louisana 70112.
D000485:Allergens; D004335:Drug and Narcotic Control; D006801:Humans
D000485:Allergens