Monoclonal antibodies: longitudinal prescribing information analysis of hypersensitivity reactions.

Monoclonal antibodies (mAbs) are known to cause hypersensitivity reactions (HSRs). The reactions pose a significant challenge to investigators, regulators, and health providers. Because HSRs cannot be predicted through the pharmacological basis of a therapy, clinical data are often relied upon to detect the reactions. Unfortunately, clinical studies are often unable to adequately characterize HSRs especially in therapies for orphan diseases. HSRs can go undetected until post-marketing safety surveillance when a large number of patients have been exposed to the therapy. The presented data demonstrates how hypersensitivity reaction warnings have changed over time in the prescribing information (PI), i.e., the drug package insert, through August 1, 2011 for 28 US-marketed mAbs. Tracking all PI revisions for each mAb over time revealed that hypersensitivity warning statements were expanded to include more severe manifestations. Over the course of a mAb therapy's life cycle, the hypersensitivity warning is twice more likely to be upgraded than downgraded in priority. Approximately 85% of hypersensitivity-associated fatality warnings were added in PI revisions as a result of post-marketing experience. Over 60% (20/33) of revisions to hypersensitivity warnings occurred within 3-4 y of product approval. While HSRs are generally recognized and described in the initial PI of mAbs, fatal HSRs are most commonly observed in post-marketing surveillance. Results of this study suggest that initial product labeling information may not describe rare but clinically significant occurrences of severe or fatal HSRs, but subsequent label revisions include rare events observed during post-marketed product use.

A qualitative study of herbal medicine use in the Ukraine: implications for US pharmacy practice.

INTRODUCTION: Half of nearly all new immigrants in the United States come from only 10 countries, including the Ukraine. Immigrants bring facets of their culture to their new country; therefore, it is important for health care providers to have an appreciation and understanding of cultural differences in regard to the use of herbal medicine. OBJECTIVES: To determine health care provider and patient preferences for herbal versus synthetic medications, health care provider didactic training in pharmacognosy and trends in herbal medication use in the Ukraine. METHODS: Ten health care providers, pharmacists and physicians, were interviewed to determine their views on herbal medicine use in Ukraine using semistructured in-depth face-to-face interviews. RESULTS: Ukrainian practitioners and patients viewed herbal medicines as safer than synthetic drugs, appropriate and preferable for use in chronic and preventative programs. Synthetic drugs were viewed as more desirable for use in the acute setting. Preference for synthetic versus herbal medication was not price driven. CONCLUSIONS: The inclusion of pharmacognosy training in the US pharmacy curricula is recommended to facilitate US health care professional's ability to provide pharmaceutical care both to new US immigrants and to the increasing number of US citizens utilizing herbal medications.