Together with researchers from five universities and the Norwegian Institute of Public Health, we embarked on a four-year study* of drug shortages in Belgium, France, Norway, Sweden, the Netherlands and the UK. As part of the study, we developed the Risk/Criticality Matrix (RCM) which consists of two dimensions: supply chain risk and medical criticality. Our matrix provides a pragmatic framework for classifying drugs and guiding decision-making.
Medical criticality refers to the clinical value of a drug. Life-saving drugs should always be considered high criticality (e.g. insulin, blood thinners, antibiotics for the treatment of sepsis, etc.), while drugs that improve lifestyle tend to be low in medical criticality. Other criticality factors include the number of people dependent on the drug and whether good substitutes exist.
The other dimension, supply chain risk, captures the likelihood of mismatches between supply and demand. The probability of demand shocks, the connectedness and agility of the supply chain, as well as the availability of information and coordination are the deciding factors.
Our matrix invites relevant stakeholders – particularly governments and international organisations responsible for securing access to drugs – to consider how medical criticality and supply chain risk interact dynamically. In practice, it takes a multidisciplinary team with the relevant skills and training to evaluate where each drug stands.
Even when a drug is accurately characterised and placed in the most relevant quadrant, the interdisciplinary team needs to consider the context, regulations and costs to determine the most appropriate intervention – one that is not too expensive nor jeopardises patient care.
Tackling the shortage of drugs classified as high in medical criticality requires effective, full control, which may involve continuous scans of the entire supply chain, and acting pre-emptively with speed. On the other hand, strategies to address shortage of low criticality drugs such as erectile dysfunction medications are focused on efficiency. Occasional shortages would be acceptable in exchange for substantial cost savings.
For drugs with low supply chain risks, the supply chains should be monitored, prioritising preparedness for unlikely shortages and having responsive mechanisms to address shortages should they occur. As for drugs with high supply chain risks, mitigation is the priority. This should focus on reducing the risk of shortages through measures such as stockpiling or reshoring production, while monitoring the supply chains and having reactive systems in place at the same time.