Post Market Data Collection (PMDC)

Rational

Insecticide treated nets (ITNs) have become the mainstay of malaria-control efforts for two decades, however, growing evidence shows that nets often do not perform for the expected three years cycle in the field. Post-market data collection (PMDC) is the collection of data on ITN performance, post-distribution and it includes physical durability, chemical durability, and behavioural (net use) practices.

Unlike medicines distributed in the field, which are routinely monitored for durability, the same structured approach is missing for bednets. This is due to limited funding, data underutilization post PMDC, and existing protocols proving difficult to adapt to local contexts.

The current main method of PMDC, Durability Monitoring, is resource intensive, and given present resource constraints, there is a need to understand better the value different stakeholders get from the data and issues around data collection.

Approach

A series of listening exercises were conducted with key stakeholders. Five quality control experts, three implementing partners, three manufacturers and five country programmes were included in eight listening sessions between March-May 2023. Each stakeholder group met together, while representatives from each country were included in a single session. Discussions were centered around four key questions around decisions that are relevant to post-market data, the types of data already being collected, and current challenges and gaps in post-market data.  A consolidation of notes taken during the listening exercises identified four areas of alignment between stakeholder groups, which were converted into four recommendations to re-think post-market data going forward, alongside potential adoption strategies. These were:

 

  1. Strategies should optimise post market data collection within budgetary constraints
    • Use a risk matrix approach to identify an optimal approaches.
    • Increase focus on minimal sample size calculations, which can be extrapolated to geographical areas, over a prolonged period.
  2. Approaches should be integrated and allow for data sharing
    • Increased transparency of collection processes and use of data.
  3. Country involvement should be prioritised
    • Inclusion of countries in developing and designing the strategy, collecting and owning data.
  4. ITN monitoring to always include net use practices data
    • Increase the importance/visibility of behavioural data.
    • Acceptability and awareness surveys to form a major aspect of durability monitoring.

Output: The PMDC Toolkit

To address this challenge, the PMDC working group developed a comprehensive toolkit, modelled after the ESPT, to streamline the PMDC process and consolidate all relevant resources in one central location. This framework aims to empower national control programs by offering clear, actionable guidance for conducting durability studies tailored to their unique contexts, while emphasizing their key role and responsibilities in the process. The goal is to support the need for effective, locally adapted, and sustainable vector control.

This PMDC toolkit aligns with and aims to distill WHO guidance into a decision-support tool for malaria programs to strengthen PMDC activities and support cost-effective, locally tailored, evidence-based vector control. This toolkit incorporates guidance from the President’s Malaria Initiative (PMI), the World Health Organization and other technical partners and resources.

  1. To determine the median LLIN life in a country and understand factors affecting attrition and LLIN durability;
  2. To inform improved procurement practices to ensure that LLINs bought provide as optimal durability as can be expected;
  3. To inform countries on how to develop their LLIN distribution strategies to ensure nets are available when needed, depending on median life;
  4. To inform countries to develop effective BCC messages on the care of LLINs;
  5. To provide information to WHO Prequalification and manufacturers on the durability of different LLINs under different conditions to improve products and their specifications.

Incorporated into the PMDC toolkit is a PMDC glossary.

A key step to promote understanding of performance and quality of ITNS  is to ensure all stakeholders agree on key terminology and in doing so have transparency in partners dialogue. Misalignment causes consternation and misunderstanding between stakeholders, has made it more challenging to identify and address issues. To overcome this, I2I has drafted a broad group of key terms (30) pertaining to the quality assurance of ITNs and will be shared with partners for their feedback.

The PMDC toolkit will be published on the AMP website in late 2025.

To learn more about the PMDC Toolkit

Resources

  1. Implementation guidance documents for ITN dossier compilation (2023)
  2. WHO malaria guidelines (2022)
  3. WHO malaria terminology (2021)
  4. Guide to Global Fund Policies on Procurement and Supply Management of Health Products (2021)
  5. Overview of the WHO Prequalification Assessment of Vector Control Products (2021)
  6. Amy Wheldrake , Estelle Guillemois , Vera Chetty , Albert Kilian , Stephen J Russell  Development of a single resistance to damage metric for mosquito nets related to physical integrity in the field Malar J. 2021 Jan 19;20(1):46.
  7. Guidance for post-market surveillance and market surveillance of medical devices, including in vitro diagnostics (2020) ISO 9001:2015
  8. WHO good manufacturing practices for pharmaceutical products: main principles (2014)
  9. WHO Guidelines for procuring public health pesticides (2012)
  10. Guidelines for monitoring the durability of long-lasting insecticidal mosquito nets under operational conditions (2011)

Partners