Improving Healthcare Access in Botswana by Addressing Drug Registration Backlog

The Challenge

The Drug Regulatory Unit (DRU) of the Botswana Ministry of Health (MOH) is responsible for registering all drugs used in Botswana to ensure that they meet established standards of quality, safety and efficacy. At the end of 2007, the DRU had a backlog of 400 applications. This limited access to a narrow range of ARVs, preventing the introduction of alternatives available on the global markets. DRU’s small staff was overwhelmed with other regulatory activities and required greater registration to overcome this backlog. With weak process and outdated information management software, DRU registration activities had accumulated beyond manageable levels by the available DRU human resource. The MOH requested that SCMS, through collaboration with the Centers for Disease Control and Prevention, assist with improving DRU processes.

Program Implementation

SCMS and the DRU collaborated to reengineer processes, developing and implementing a “retreat plan” whereby staff went off-site to focus solely on working through the backlog and acquiring and installing WHO-recommended software for drug registration. The plan included SCMS capacity-building support through training DRU staff, reviewing guidelines, and providing short-term technical assistance that enabled mentoring of new staff while providing additional technical resources for evaluating applications.

The retreat approach. . . contributed to increasing individual evaluation output from one application in two days at the office to an average of eight dossiers per day during the retreat period.

Results and Outcomes

The six-month secondment of a technical consultant from Ghana strengthened DRU capacity, enabling the review of 400 applications up to the Drug Advisory Board approval level. The retreat approach also contributed to increasing individual evaluation output from one application in two days at the office to an average of eight dossiers per day during the retreat period. The acquisition of user-friendly WHO information management software was also essential to the success of these efforts by keeping track of product information and minimizing errors. The increased pool of generics and generic suppliers available for procurement supported an increase in central medical store (CMS) procurement of ARV generics versus brands ARVs from 65 percent (FY06/07) to 99 percent (FY07/08).

The DRU/SMS collaboration will continue retreats as part of their work processes to enable efficient approval of qualifying products, since continuous drug dossier review is critical to providing patients with access to quality products. Continuous review also enables the DRU to procure the newest cost-effective treatments, thereby maximizing their budgets to treat more people.