Mental health first aid training among pharmacy and other university students and its impact on stigma toward mental illness.

BACKGROUND AND PURPOSE: Information on effective and replicable methods employed in pharmacy and other college students to combat stigmatizing beliefs toward those with mental illness is limited. Mental Health First Aid (MHFA) is an international, standardized, eight-hour course focused on helping members of the general public triage a mental health crisis. The objective of this study was to determine the effect of MHFA training on stigmatizing attitudes toward those with mental illness among pharmacy and non-pharmacy students. EDUCATIONAL ACTIVITY AND SETTING: Pharmacy and non-pharmacy students were invited to voluntarily participate in one of two MHFA sessions. A survey utilizing the Social Distance Scale (SDS) and Attitudes to Mental Illness Questionnaire (AMIQ) was given to participants before and after the MHFA session to assess change in stigmatizing behavior. FINDINGS: Thirty-four pharmacy students and 21 non-pharmacy students participated in the study. Overall, stigma toward depression and schizophrenia decreased. For the SDS schizophrenia vignette, a statistically significant improvement (p < 0.05) was seen on six of the seven responses for pharmacy students and on four responses in non-pharmacy students. Both pharmacy and non-pharmacy students improved on one item in the SDS depression vignette. For the AMIQ, pharmacy students demonstrated statistically significant improvement on four items in the schizophrenia vignette and five items in the depression vignette. Non-pharmacy students showed improvement on two items for both the AMIQ schizophrenia and depression vignettes. DISCUSSION AND SUMMARY: MHFA was effective in decreasing stigmatizing beliefs among pharmacy and non-pharmacy students. These findings support the utilization of teaching methods that emphasize the patient experience and humanize mental illness.

United States Food and Drug Administration Advisory Committee outcomes and agency approval analysis from 2010 to 2015.

OBJECTIVES: This analysis sought to quantify voting behavior and other characteristics of advisory committee (AC) meetings and compare that with the U.S. Food and Drug Administration's (FDA) approval decisions from 2010 to 2015. METHODS: The analysis of the Center for Drug Evaluation and Research AC meetings was conducted using publicly available information from the FDA website and the sponsors' websites. RESULTS: There were 163 voting sessions, 207 votes, and 229 meetings. Voting questions assessed approval (63%), acceptable risk-benefit profile (19%), efficacy (8%), safety and efficacy (7%), and safety (3%). The AC voted in favor of approval 67% of the time and against approval 33% of the time, although it heavily favored one outcome when voting favorably or unfavorably. The FDA approval decision supported the committee's decision in 90% of cases. When such agreement did not occur, it was due to differences in clinical opinion (43%), manufacturing deficiencies (14%), lack of manufacturing data (14%), and a post-AC event (5%). There was insufficient information to determine why there was a differing opinion in 24% of cases. When FDA had a differing opinion, the agency typically did not approve a substance in which the committee recommended approval (81%). CONCLUSION: The results support past research examining the topic from 2001 to 2010. Voting patterns were relatively constant, and they generally heavily favored one outcome. The FDA's ultimate approval decision was in line with the AC vote the vast majority of cases. Any disagreement was usually due to FDA having a differing opinion regarding clinical importance, furthering the notion that AC insight is heavily considered but not the final determinant in agency action. This topic has importance in understanding pharmaceutical approval in the United States, and this has clinical practice implications.