Table 1.

Optimal design features, best practices in implementation science, and current practices in risk-minimization program design

Optimal program design feature	Implementation science best practices	Pharmaceutical risk-minimization programs: actual practice	Gap?
Use of models and frameworks	Theoretical models guide conceptualization of risk-minimization intervention and hypothesis generation. Intervention models and frameworks guide program planning to increase the likelihood of effectiveness by focusing on the essential strategies for successful translation. Evaluation models and frameworks guide the types of questions that should be asked to assess the success of the risk-minimization program.	Current risk-minimization strategies are generally atheoretical and developed without benefit of comprehensive and well-tested models and frameworks that guide intervention planning and implementation, dissemination, and evaluation assessment [8].	Yes
Evidence-based	Intervention components are selected and designed based on prior learning and empirical evidence.	Justification for intervention components and implementation design is generally absent, design elements are largely derived from regulatory precedent.	Yes
Patient and stakeholder centered	Formative evaluation is conducted with stakeholders as part of the design process, including patients and staff. Implementation interventions should ideally be compatible with existing patterns of care and workflows to facilitate adoption. Implementation interventions should be designed for sustainability given the context of the program.	Varies by program. Some consideration for compatibility with clinical and patient workflows is given (i.e., considerations of patient and healthcare burden). However, formative research is typically not conducted and/or presented at the time a risk-minimization program is approved. Program costs and sustainability are not addressed.	Partial
Multi-faceted and multi-level	Multiple, integrated intervention elements are delivered in unison for increased effectiveness. Implementation program components are integrated across patient, provider, and system levels using a social ecological framework of healthcare delivery.	Varies by program; some are more developed than others. Some over-reliance on single element to achieve desired goal. Programs are usually directed at multiple levels (e.g., patient, physician, hospital, and/or pharmacy).	Partial
Dissemination and communication strategies	Target audience(s) are segmented according to their level of knowledge, attitudes, and beliefs. Implementation messaging should be appropriately targeted and/or tailored to the audience. Active dissemination strategies are used involving multiple communication channels of the appropriate scale (e.g., reach and frequency) given the target audience(s).	Communication strategies and examples of targeted messaging are typically not presented at the time a risk-minimization program is approved. Communication campaign metrics are not specified.	Yes
Adaptable	Core (non-mutable) program elements are identified. Implementation flexibility is allowed for non-core elements to accommodate for differences in and allow adaptation for contextual factors across sites and areas.	Regulatory precedence is that programs must be implemented uniformly within a nation; however, programs often vary between nations that are under different regulatory authorities.	Partial