Table 2.

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

Optimal program implementation feature	Implementation science best practices	Pharmaceutical risk-minimization programs: actual practice	Gap?
Organization and delivery	Formal collaborations and governance structures are specified between a central planning group and the local teams charged with implementing the program. Organizational readiness-to-change is assessed to inform local implementation adaptation. Champions are identified and engaged within the local organization and/or target audience (e.g., specialty or provider group) to facilitate implementation. Training and technical assistance is provided at program initiation and throughout implementation.	Risk-minimization programs are designed and approved by regulatory agencies at the national level. Programs are either implemented at the local level by individuals who have multiple competing priorities with varying levels of skills, commitment, and resources, or at the national level by individuals who do not have an understanding of local organizational challenges and barriers.	Yes
Process measures	Implementation is systematically evaluated for: Reach: absolute number, proportion, and representativeness of participants; Adoption: absolute number, proportion, and representativeness of participating settings and providers; Fidelity: extent to which key program components were delivered as designed; Cost and adaptations: time and resources required, and extent to which program activities were modified.	In general, process measures are not pre-specified at the time a risk-minimization program is approved. During program implementation, process measures are generally not reported in real-time; therefore, there is limited early assessment of how well the program is being implemented under real-world conditions. The exception is products with distribution restrictions (e.g., patient, provider, pharmacy registries) that have greater ability to monitor implementation progress than products without such distribution systems.	Partial
Sustainability	Promising practices, solutions, and results among implementing teams are shared across sites to increase the likelihood of program sustainability. Ongoing training and technical assistance to sites are provided periodically to minimize intervention drift and minimize impact of staff turnover.	Typically, risk-minimization programs must be delivered over the lifetime of product marketing. The need for assessing patient and healthcare system burden has been identified, but methods have not been established. Local learning on how best to adapt a program is not included in program evaluations presented to regulatory agencies. Re-training (or re-certification) has not been discussed for healthcare providers.

Optimal program implementation feature

Implementation science best practices

Pharmaceutical risk-minimization programs: actual practice

Gap?

Organization and delivery

Formal collaborations and governance structures are specified between a central planning group and the local teams charged with implementing the program.

Organizational readiness-to-change is assessed to inform local implementation adaptation.

Champions are identified and engaged within the local organization and/or target audience (e.g., specialty or provider group) to facilitate implementation.

Training and technical assistance is provided at program initiation and throughout implementation.

Risk-minimization programs are designed and approved by regulatory agencies at the national level.

Programs are either implemented at the local level by individuals who have multiple competing priorities with varying levels of skills, commitment, and resources, or at the national level by individuals who do not have an understanding of local organizational challenges and barriers.

Yes

Process measures

Implementation is systematically evaluated for:

Reach: absolute number, proportion, and representativeness of participants;

Adoption: absolute number, proportion, and representativeness of participating settings and providers;

Fidelity: extent to which key program components were delivered as designed;

Cost and adaptations: time and resources required, and extent to which program activities were modified.

In general, process measures are not pre-specified at the time a risk-minimization program is approved.

During program implementation, process measures are generally not reported in real-time; therefore, there is limited early assessment of how well the program is being implemented under real-world conditions. The exception is products with distribution restrictions (e.g., patient, provider, pharmacy registries) that have greater ability to monitor implementation progress than products without such distribution systems.

Partial

Sustainability

Promising practices, solutions, and results among implementing teams are shared across sites to increase the likelihood of program sustainability.

Ongoing training and technical assistance to sites are provided periodically to minimize intervention drift and minimize impact of staff turnover.

Typically, risk-minimization programs must be delivered over the lifetime of product marketing. The need for assessing patient and healthcare system burden has been identified, but methods have not been established.

Local learning on how best to adapt a program is not included in program evaluations presented to regulatory agencies.

Re-training (or re-certification) has not been discussed for healthcare providers.