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Step-by-step process for addressing potential shortages is outlined
The topic of drug shortages—especially those originating from manufacturing issues—continues to bedevil the pharma industry globally. The current count of ongoing shortages in the US is around 140—down from over 250 in 2011, but still elevated from the <100 level seen in prior years, according to the Univ. of Utah Drug Information Service. FDA, EMA, professional societies like ISPE International, and private consulting organizations have all looked at the topic, but the general drift of many of the reports tells industry, “Do better.”
Now, the Parenteral Drug Assn. (Bethesda, MD) has brought out its recommendations, in the form of Technical Report No. 68, Risk-Based Approach for Prevention and Management of Drug Shortages. Normally, PDA charges several hundred dollars for its technical reports, but is making this one available at no charge. And while PDA's main focus is on parenteral (injectable) drugs, the guidelines seem to apply to any product situation.
The report boils down a lot of the discussion to several fairly straightforward steps:
Rank drugs by their level of criticality to patients safety
Assess the risk of a shortage proactively by analyzing supply, manufacturing, quality and geographic issues
Manage those risks
Develop a prevention and response plan, including notifications to regulatory authorities (now mandated in the US by law).
Assessing and managing risks can be a highly complex process, and the report refers to a variety of “value stream mapping” and other techniques that can be used, without going into deep details on these methodologies. But for a management-level structuring of developing a risk-management plan, and for organizing priorities on which risks should be addressed first, the report is admirably straightforward.