Defining pharmaceutical systems strengthening: concepts to enable measurement

Abstract

Pharmaceutical products are indispensable for improving health outcomes. An extensive body of work on access to and use of medicines has resulted in an assortment of tools measuring various elements of pharmaceutical systems. Until now however, there has been little attempt to conceptualize a pharmaceutical system as an entity and define its strengthening in a way that allows for measuring systems strengthening. The narrow focus of available tools limits their value in ascertaining which interventions result in stronger, more resilient systems. We sought to address this shortcoming by revisiting the current definitions, frameworks and assessment tools related to pharmaceutical systems. We conducted a comprehensive literature review and consulted with select pharmaceutical experts. On the basis of our review, we propose that a pharmaceutical system consists of all structures, people, resources, processes, and their interactions within the broader health system that aim to ensure equitable and timely access to safe, effective, quality pharmaceutical products and related services that promote their appropriate and cost-effective use to improve health outcomes. We further propose that pharmaceutical systems strengthening is the process of identifying and implementing strategies and actions that achieve coordinated and sustainable improvements in the critical components of a pharmaceutical system to make it more responsive and resilient and to enhance its performance for achieving better health outcomes. Finally, we established that, in addition to system performance and resilience, seven components of the pharmaceutical system are critical for measuring pharmaceutical systems strengthening: pharmaceutical products and related services; policy, laws and governance; regulatory systems; innovation, research and development, manufacturing, and trade; financing; human resources; and information. This work adds clarity to the concept of pharmaceutical systems and their strengthening by proposing holistic definitions on the basis of systems thinking. It provides a practical starting point for measuring the progress of pharmaceutical systems strengthening.

What makes health systems resilient against infectious disease outbreaks and natural hazards? Results from a scoping review

“…Infection Prevention and Control (IPC): A resilient health system has implemented strong IPC measures, including staff training, standardized protocols, a dedicated IPC focal point, and dedicated treatment units [4, 22, 39, 47, 51, 54, 81–86]. Commitment to Quality Improvement: A resilient health system requires a commitment to continuous quality improvement that promotes excellence and garners the trust of the community [15, 27, 39, 54, 69, 87, 88]. Plans for Post-Event Recovery: Resilient health systems have plans for post-event recovery that address a broad range of issues [24–26, 34, 40, 59, 73, 89–93].…”

“…Commitment to Quality Improvement: A resilient health system requires a commitment to continuous quality improvement that promotes excellence and garners the trust of the community [15, 27, 39, 54, 69, 87, 88].…”

Integrating pharmaceutical systems strengthening in the current global health scenario: three ‘uncomfortable truths’

“…This goes beyond the narrow focus of avoiding stockouts of a subset of health products. Pharmaceutical systems strengthening recognises the various structures, processes, and their interactions within the broader health system that help to ensure access to and appropriate use of safe, effective, quality medicines [7]. However, acknowledging the centrality of pharmaceutical systems strengthening and incorporating it into the current global health scenario require recognition of a few interrelated and 'uncomfortable truths'.…”

The importance of visual inspection in national quality assurance systems for medicines

“…In summary, these real-life cases indicate that a careful visual inspection, i.e., a simple and inexpensive technology, is of paramount importance in monitoring the quality of medicines not only in the field, but also at central level. In a pharmaceutical scenario characterized by a situation of multiple quality standards [ 7 – 10 ], complex distribution networks [ 11 , 12 ], and weaknesses of the pharmaceutical systems [ 13 , 14 ], it can provide additional important guidance to timely recall suspicious batches, to revoke marketing authorizations of unreliable suppliers, and to protect public health [ 15 ]. Central medical stores and regulatory agencies need to consider the visual inspection as part of their prequalification and ongoing requalification system.…”