A framework to support new product introduction in national health systems
Monitoring & Uptake
Robust monitoring to ensure uninterrupted access to optimal products for patients
Monitoring uptake is critical as there are often disconnects between procurement and consumption, especially in the early phases of introducing a new product. If uptake occurs at a different pace than planned, it could lead to wastage or stock-outs. Therefore, early detection of consumption irregularities and risk mitigation can contribute to more rapid treatment and product uptake.
Monitoring & Uptake Checklist
Develop a comprehensive monitoring plan factoring in the number of patients, facilities dispensing product, and stock availability
Consider using a tool to track uptake trends on a more frequent basis than regular reporting in the early stages of rollout to monitor uptake against planned usage and available supply
Monitor consumption patterns and support adjustment of supply plan accordingly (closely monitor high-volume facilities as these greatly impact stock availability) (e.g. CHAI Rapid Consumption Monitoring Tool)
In the event of slower uptake than planned, consider strategies listed in the toolkit below to drive uptake and avoid expiries and waste
Monitor supplier performance to ensure suppliers are delivering according to their contractual obligations
Develop and implement a robust pharmacovigilance system to monitor adverse drug reactions, drug resistance, toxicities, and treatment failure, in line with World Health Organization (WHO) guidance
Monitoring & Uptake Resources
To ensure that product uptake is well monitored and relevant data is collected, both electronic and paper-based tools used to collect essential supply chain logistics and patient information should be updated to incorporate new products. These tools include facility ordering forms, stock cards, pharmacy registers, dispensing registers, warehouse registers, inventory management systems, and patient registers, which track which regimens each patient is on.
CHAI Rapid Consumption Monitoring Tool
As national programs continue to roll out new generic ARVs, there is a need for routine, careful monitoring of product uptake to ensure the smooth and sustained adoption of optimal formulations. During new product introduction, there are two common issues that may arise: over consumption (i.e., actual demand exceeds anticipated demand) and under consumption. (i.e., actual demand lags anticipated demand).
The CHAI Rapid Consumption Monitoring Tool is a simple tool for programs that have begun to roll out new ARVs to compare the actual consumption of a new product at the facility-level against forecasted uptake trends in the hopes of identifying any potential issues of under consumption or over consumption.
CHAI National Stock Status Dashboard
Keeping an adequate stock of ARVs on hand is important for multiple reasons. Too much stock and programs run the risk of products expiring before they can be used. Too little stock and programs run the risk of a stock-out and patients going without vital medicines. Monitoring the stock on hand (SOH) of ARVs is an exercise that programs should conduct on an ongoing basis to ensure that resources are being used wisely.
The CHAI National ARV Stock Status Dashboard is a simple tool designed for programs to monitor the SOH of ARVs at the national level. The tool shows, over a two year period, when stocks are likely to exceed maximum stock levels (i.e., potential wastage) and when stocks will dip below minimum required levels (i.e., an impending stock-out), based on current SOH, expected deliveries, and average monthly consumption (AMC).
Adverse Event Monitoring Tools
Prescribers should be provided with clear guidance on the national recommendations for use of new products in special populations, including TB co-infected patients and pregnant women, during rollout trainings and mentorship activities. Training should include guidance on when and how to use adverse event reports or other monitoring and pharmacovigilance reports.
Country Highlights: Improving Pharmacy Practices
As part of product rollout and monitoring activities, it is important to ensure that ordering and management practices at the facility-level support appropriate prescribing and uptake objectives. This link can be key to ensure patients are given accurate information, medicines are appropriately dispensed, and sufficient stock is maintained at the facility level to meet uptake targets.
ARV Procurement Working Group
The ARV Procurement Working Group (APWG) is a body that supports the ARV market in low- and middle-income countries via coordinated procurement, strategically managed demand, and reduced fragmentation. The APWG plays a key role in stabilizing supply for low-volume and transitional products and promoting uptake of new optimal products. When introducing new ARVs, country programs are encouraged to liaise with the APWG members, such as CHAI or the Global Fund, to communicate scale-up plans and to contribute efforts towards promoting global supply security during new product transitions. Additionally, the APWG publishes a number of useful resources including a quarterly rolling ARV demand forecast based on anticipated procurement plans of member organizations and regular newsletters with updates on key topics and issues facing the ARV and advanced HIV disease markets.
