July 8, 2013
Teresa Shook, MS, RT
This paper will address different types of communication methods for a national drug manufacturer who has reports of significant negative effects caused by one of the medications that is used by a significant population. This paper will identify the advantages and disadvantages of using traditional, electronic, and social media for health care communication and the effects of HIPAA and other regulations on the use of these media for health care communication.
As the Communications Coordinator for this nationwide pharmaceutical company, we will need to brainstorm and talk about how we will address the negative consequences that our medications are initating to the public. There are different types of healthcare communication that we can use for this type of crisis. Labeling. FDA-approved drug product labeling is the primary source of information about a drug’s safety and effectiveness, and it summarizes the essential scientific information needed for the safe and effective use of the drug. Compliance with the recently issued physician labeling rule for prescription drugs is expected to further enhance the usefulness of product labeling and further facilitate the safe and optimal use of prescription drugs (Seligman, 2009). Early Communications about Ongoing Safety Reviews. Since August 2007, FDA has issued Early Communications about Ongoing Safety Reviews (ECs) to keep health care professionals and the general public informed of postmarket safety issues that are currently being evaluated by FDA. ECs are issued at the beginning of FDA’s assessment, prior to conclusive determination of the clinical or public health significance of the information under evaluation and before a decision has been made about what regulatory actions, if any, should be taken. Rather, they reflect FDA’s current analysis of available data concerning these drugs, but posting the...
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