Sinette Goosen A look at the supply chain implications of TB regimen changes

Even though tuberculosis (TB) is a curable disease, it is still, according to the World Health Organization (WHO), responsible for 4,500 deaths a day.

The reasons behind this are complex and interwoven, ranging from educational and social issues, to a lack of early detection and missed detection opportunities, combined with long diagnostic processes and increasing drug resistance, among others.

Massive global endeavors to address the ever-evolving challenges through research, development, and investment are ongoing. One area of focus for the WHO and global stakeholders is the development of simpler-to-use drugs and treatment regimens that will encourage higher treatment adherence and simplify logistics, while reducing drug resistance.

In 2018, the WHO has already released some new recommendations and treatment guidelines for drug-resistant tuberculosis. These will be incorporated into the Consolidated Guidelines for Treatment and Care of Drug-resistant TB later this year.

Commitment and accountability to manage transition of the TB supply chain

The Partnership for Supply Chain Management (PFSCM)’s Global Supply Chain Director Wesley Kreft says public health supply chains can lead in the fight to end TB through commitment to — and accountability for — effective regimen transitions.

“It is normal for health programs to change — in fact, it is essential to ensuring successful outcomes in changing global markets and environments. The problem is that public health supply chains face unique challenges that often make quick implementation of changes difficult.”

Two such challenges are:

  • The time it takes to make and implement decisions in the public health supply chain; and
  • The operational and logistical weaknesses that hamper flexibility.

According to a report co-authored by PFSCM partner organization Management Sciences for Health (MSH) and entitled Tuberculosis regimen change in high-burden countries, countries committed to considering a change spend about one year on decision making and about two years to roll out or implement changes.

The report — which was compiled after conducting 166 interviews with country stakeholders in 21 of the 22 TB high-burden countries — also found that stakeholders are more often concerned with the program-based implications (logistics and cost) of the change than they are with the patient-focused implications (side effects).

Kreft explains that several logistics and cost factors — such as accurate forecasting, proper phasing out of old and excess products, availability of quality local sources, and uncertainties about future product pricing — need to be addressed during a transition.

He adds that these factors can be difficult for public health supply chains to manage when working with limited resources.

However, Kreft stresses that there are key principles that can be followed to aid in efficient transitions.

1. Preparing and closely monitoring the supply chain

To successfully implement new regimens, the supply chain must align with program changes to ensure proper budgeting, demand forecasting, supply planning, and procurement.

“Regular small orders need to be placed in the introduction phase, and stock and consumption need to be closely monitored to ensure all patients on old regimens can complete their treatment, while enough stock is already available for those newly diagnosed patients. The overlap of these activities should also be finely tuned to ensure as little stock destruction as possible. It is a sensitive process that has both advantages and disadvantages tied to the nature of the TB regimen.”

2. Minimizing risks through vendor pre-qualification and engagement, accurate forecasting, demand planning

Further, Kreft adds that there is also a risk that countries may return to old regimens if new products cannot be produced locally at reasonable prices, local product quality does not meet international standards, or global supply cannot meet demand.

To minimize these complications, it is important for countries to assess the suitability of local sources early in the transition and to determine how national and international guidelines can be harmonized to ensure local economic growth and regulatory compliance.

The challenge is balancing the need for “buying local” with the obligation toward international quality standards.

Countries are always battling the cost-quality dilemma, but pre-qualification groundwork can help governments to bridge the gap between in-country and international regulatory commitments, notes Kreft.

Further, accurate forecasting, demand planning, and vendor engagement is essential to ensure suppliers keep up with demand.

3. Supporting countries that will transition from donor support

In addition, in cases where countries are receiving highly subsidized or free products, there is a risk that the products may become too expensive when countries graduate from donor-funded programs.

“It is important that clear stakeholder engagement is maintained and that agreements or contingency plans are in place for countries with limited budgets or expected future financial constraints.”

Kreft concludes that bringing together multi-sectoral expertise may help countries respond faster to treatment guideline and regimen changes, thereby increasing commitment and accountability in the fight to end TB.