Integration of temperature-sensitive pharmaceuticals in the vaccine cold chain

In 2020, WHO and UNICEF issued a joint statement encouraging greater health commodity supply chain integration for temperature-sensitive pharmaceuticals where appropriate. The joint-statement reiterates the value of safe, feasible and cost-effective integration of temperature-sensitive health products into the Expanded Program on Immunization (EPI) cold chain system, highlights integration as a practical solution that can support rolling out a new product, expanding treatment of certain diseases, improving access to care in Primary Health Care centers, improving cold chain efficiency, etc…. The joint statement also provides reference to planning tools and other existing mechanisms to design and implement a safe and efficient integrated cold chain system. Lessons learned in cases that started with a low-performing system suggest that capacity building could be needed as a precursor.

Research and consultations established that the level of integration of heat-sensitive pharmaceuticals varies widely from country to country, that there is no "one size fits all" solution. Integration strategies vary based on different conditions/countries (infrastructure, system design, program priorities) and the different problems they are trying to solve. Strategies may require developing additional capacities as a precursor. For example, expansion of the physical infrastructure, health work force to implement in the cases of new products or scale ups, or even changes to where certain cold chain products can be administered are all variables. Several risks have been identified, including limited cold chain capacity despite investments made in recent years (GAVI CCEOP, COVID-19 pandemic response), and implementation risk - including coordination between programs and misuse of products requiring clear guidance and training, and work on product packaging and visual cues. 

A tailored approach will be needed on a country-by-country basis and certain pre-conditions prior to implementation ought to be required and monitored to gauge country-readiness for such a policy change. In those countries that are implementing, additional tools and methods are most certainly required.

Two life-saving products whose quality depends on cold storage (2-8°C) - oxytocin, used in the prevention of post-partum hemorrhage, and insulin, essential in the management of patients with type 1 diabetes - could be considered candidate products for segmented integration if they could be stored in the vaccine cold chain. A recent study indicates that around 17% of pharmaceutical products require cold storage, suggesting that cold chain expansion could be a strategic component within integration.

In order to define a roadmap to support countries to  develop and implement strategies for integrating heat-sensitive products into the vaccine cold chain, WHO is launching a consultation with TechNet members. The aim of this consultation is to contribute to defining the interventions to be carried out and the resources to be mobilized at country and global level.

Specifically, we would like to identify the lessons learned by countries that are already implementing a practice of Oxytocin or Insulin in the vaccine cold chain; identify the factors facilitating and limiting this integration and define at which segments of the supply chain integration should take place. Here are some of the questions we would like to pose to the TechNet21 community:

• What has been your experiences when integrating oxytocin and insulin (or other non-EPI vaccines product) in your country cold chain system? What were the key reasons for doing so, the decision-making process and what things worked and what didn’t?
• What are the most critical factors limiting the integration of Oxytocin or Insulin into the vaccine cold chain in countries that have not yet done so? And what are the top 3 factors that would facilitate this integration?
• Where integration is more appropriate: What segments of the supply chain could most benefit from integration? At what level of the supply chain should integration occur (national, sub-national and service levels)? For what function of the supply chain should integration occur (planning, storage, distribution, handling, and management, information, cold chain equipment temperature and performance monitoring, and management)?”