The Drug Safety and Risk Management Advisory Committee: a case study of meeting frequency, content, and outcomes before and after FDAAA.

BACKGROUND: The Food and Drug Administration Amendments Act (FDAAA) of 2007 granted FDA-expanded drug safety authority. We hypothesized that meetings involving the FDA Drug Safety and Risk Management (DSaRM) Advisory Committee might serve as a barometer for the impact of FDAAA on drug safety regulatory decision making. RESEARCH DESIGN: We conducted a case study analysis of 42 DSaRM advisory committee meetings held between 2002 and 2011. Publicly available sources (FDA meeting minutes and materials, safety alerts, and drug manufacturer Web sites) were reviewed to describe and compare DSaRM meeting frequency, content and outcomes between the pre-FDAAA (2002-2007) and post-FDAAA (2008-2011) periods. RESULTS: DSaRM meeting frequency increased after FDAAA (from 2.7 to 6.5 meetings per year). DSaRM meetings were more likely to be held jointly with other drug advisory committees after FDAAA (from 68% to 92% of meetings). DSaRM members were invited participants in 35 additional meetings of other drug advisory committees (2007-2011). DSaRM meetings were more likely to review issues of approvability (eg, new drugs, new indications, and new product formulations) after FDAAA. FDA questions to the committee were more likely to request an explicit drug safety assessment after FDAAA (from 31% to 76% of meetings). Content analysis of meeting outcomes and subsequent FDA regulatory decisions did not suggest a more or less risk aversive climate after FDAAA. CONCLUSIONS: Increased DSaRM advisory committee activity indicates its advice was being sought more broadly for drug regulatory decision making and at earlier stages of drug development after FDAAA was enacted.

Evaluating a web-based test results system at an urban STI clinic.

BACKGROUND: Notifying patients of gonorrhea and chlamydia test results using online services may improve clinic efficiency and increase receipt of test results. This study evaluated the implementation of an online results system in an urban sexually transmitted infections clinic. METHODS: Using the clinic's electronic medical records system to assess if and how gonorrhea and chlamydia test results were obtained, 3 time periods were examined between December 2007 and April 2009: period 1, six months before initiation of the online results system; Period 2, six months when patients could opt in for online results by creating their own access codes; and Period 3, four months when access codes were assigned. In addition, a survey was conducted to assess reasons for accepting or declining the online results system. RESULTS: A total of 9056 new patient visits were evaluated. During periods 1, 2, and 3, respectively 67%, 67%, and 70% patients received results either online or by telephone (NS). The proportion of patients calling the clinic for results decreased from 67% in period 1, to 51% in period 2, and 36% in period 3 (P < 0.0001). Survey results indicated that patients accepted online results primarily because of the ability to check results anytime of day. Reasons for not accepting results online included lack of Internet access or a preference to receive results via the telephone. CONCLUSIONS: The online results system decreased the number of phone calls to the clinic pertaining to STI test results, but had no effect on the overall proportion of patients receiving results.

Impact of an interprofessional oral health education program on health care professional and practice behaviors: a RE-AIM analysis.

BACKGROUND: Early childhood caries is the most common chronic childhood condition and largely preventable. Access to oral health preventive services (OHPS) for children at risk for caries is suboptimal and could be expanded if they were provided by non-dental professionals. Many state Medicaid programs in the USA now reimburse non-dental professionals for OHPS but require that they receive oral health education (OHE) to be reimbursed. Few OHE programs have been evaluated. METHODS: We evaluated the impact of Colorado's OHE program on professional- and practice-level behaviors regarding the provision of OHPS to children by measuring its reach, effectiveness, adoption, implementation, and maintenance (ie, using the Reach Effectiveness Adoption Implementation Maintenance [RE-AIM] framework) with Medicaid claims data, online surveys, and key informant interviews. RESULTS: From 2009 to 2012, the proportion of young, low-income children receiving OHPS from a medical professional increased 16-fold. We surveyed 703 OHE participants; post-OHE response rates were 61% at 12 months, 34% at 24 months (2009 participants), and 39% at 12 months (2011 participants). Respondents reported confidence in providing OHPS; favorable oral health knowledge, attitudes, and beliefs; and were providing OHPS to most eligible children. Approximately half of the practices had initiated practice-level changes to support program implementation and maintenance. Few barriers were reported to care. Eighteen interviewees reported factors facilitating program diffusion, which included quality materials, community need, and reimbursement; barriers included lack of time to provide services, resources to purchase supplies, and referral dentists. CONCLUSION: This evaluation of a state interprofessional OHE program shows evidence of program diffusion and identifies facilitating factors and barriers to having medical professionals provide OHPS.