Washington Multistate Pharmacy Jurisprudence MPJE Practice Exam

The main change in the Structured Professional Labeling and Prescribing Information for drugs approved after 2006 is:

1. The addition of a section called 'Highlights of Prescribing Information'

2. A reduction in the amount of clinical data required

3. The inclusion of international drug codes

4. A comprehensive list of all possible side effects

The correct answer is: The addition of a section called 'Highlights of Prescribing Information'

The addition of a section called 'Highlights of Prescribing Information' is the main change in the Structured Professional Labeling and Prescribing Information for drugs approved after 2006. This means that before 2006, this section did not exist and was not included in the labeling and prescribing information. This section provides a summary of important information about the drug, such as its approved indications, dosage and administration, and important safety information. Therefore, options B, C, and D are incorrect as they do not represent the main change in the labeling and prescribing information. Option B, a reduction in the amount of clinical data required, is also incorrect because there is no evidence to suggest that the amount of clinical data required has been reduced as a result of this change. Option C, the inclusion of international drug codes, is also incorrect as this information may already have been included in the labeling and prescribing information prior to 2006. Option D, a comprehensive list of all possible side effects, is also incorrect as this information may already have been included in the labeling and prescribing information prior to 2006 and is not the main change.