To help FDA, pharmacists and other stakeholders monitor drug shortages and identify new or worsening shortages the IMS Institute recommends that FDA, or the industry, create an early warning system for drug shortages.

This ‘early warning system’ should include:

1. Risk Identification
Systematically identify high-risk sectors of the generics market. Identify all the low-cost, technically challenging and critical medicines–whether they are currently on the shortage list or not.

2. Demand Forecasting
Continuously forecast the long-term demand for low-cost, technically challenging and critical medicines. Adjust forecasts based on such factors as demand trends, new medications, changes in clinical guidelines, practice patterns, care delivery changes and needs of clinical trials.

3. Volatility Index
A quantitative measure to systematically track and report month-to-month changes in the volume of drugs supplied to hospitals, clinics and retail pharmacies. Volatility in supply–whether national, regional, by individual supplier, or for specific drug molecules–is a signal of problems in meeting demand and instability or dramatic change in the supply chain. Volatility itself can seriously exacerbate problems in meeting demand, encourage overstocking, disrupt patient therapies and facilitate short-term price manipulation by a few suppliers.

4. Predictive Modelling
With the wealth of data available, predictive modelling techniques could be applied to anticipate shortages or supply disruptions for critically important medications at the national and regional levels. As data accumulate and measures are improved, the model can tightly focus interventions on those specific parts of the market and supply chain genuinely needing attention.

Other tools that would augment the ‘early warning system’ include self-reporting of demand and supply disruptions by pharmacies, wholesalers, group purchasing organisations and drug manufacturers.

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Related articles

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Suppliers of products on the drug shortages list in the US

Which drugs are affected by drug shortages in the US

Investigating drug shortages in the US

References

1.  GaBI Online - Generics and Biosimilars Initiative. Some relief from drug shortages in the US [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2012 Feb 17]. Available from: www.gabionline.net/Pharma-News/Some-relief-from-drug-shortages-in-the-US

2.  IMS Institute for Healthcare Informatics. Drug shortages: a closer look at products, suppliers and volume volatility. 2011 Nov.