The Accelerated Recovery Initiative (ARI) – an FDA/industry partnership being coordinated by pharma data manager IMS – is gaining momentum in its effort to forecast, prevent, and mitigate the impact of drug shortages, and a pilot program is now underway.
At a mid-March supply chain conference in Cincinnati, Ohio cosponsored by Xavier University and FDA, IMS Commercial Effective Services Senior Principle Michael Barnes noted that the pilot program is “in the early stages” and is now “getting to the point at which FDA, IMS and a select number of manufacturers are beginning to test the process.”
The process involves FDA identifying a subset of products on the drug shortage list based on criteria recently established by all of the participants to this initiative and providing this list of drugs to IMS. The Generic Pharmaceutical Association (GPhA) will contact the manufacturers to encourage their participation in the voluntary ARI program.
Participating manufacturers will send their production forecasts to IMS, who will develop demand forecasts and compare them to the production forecasts to “determine a risk probability associated with a drug either going into shortage or coming out of shortage and the associated time frame,” Barnes explained. Once the blinded integrated information is sent to FDA, the agency will use the information to develop mitigation and accelerated recovery strategies.
In his presentation at the FDA/Xavier conference, IMS’ Barnes provided insights into: ● the common complaints from stakeholders on how drug shortages are currently handled ● why drug shortages occur ● the formation, purpose and function of ARI, and ● the ARI pilot and the respective roles being played by FDA, GPhA and IMS (see box below).
During the Q&A, Barnes commented further on how the ARI will help in situations where drug shortages happen rapidly and unpredictably and how IMS hopes to be able to predict shortages. MHRA Expert GMP Inspector David Churchward – also a presenter at the session (IPQ “The News in Depth” March 20, 2013) – weighed in on possible reasons why drug shortages have increased in the last few years.
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See related IPQ stories:
FDA and ISPE Seek Stakeholder Input to Improve Drug Shortage Prevention and Mitigation Strategies
CDER Officials Shed Light on Forces Impacting Generic Injectable GMP Compliance and Drug Shortages
Hospira Takes QbD Approach to Compliance Remediation Efforts While Production Continues
