Drug shortages pose a significant threat to patient care in the United States, resulting in delayed treatment, increased risk of adverse reactions and medication errors, and additional unnecessary healthcare costs.
Limited inventories of critical medications place a tremendous strain on daily operations in most hospitals across the country. Shortages force healthcare providers to spend time and resources locating medications rather than focusing on direct patient care.
How to Protect Patients – ASHP is Working to:
- Encourage the Food and Drug Administration (FDA) to be required to provide ratings on the quality management processes of drug manufacturers in order to help predict drug supply chain and manufacturing vulnerabilities.
- Advocate that the FDA expand the Drug Supply Chain Security Act (DSCSA) to require manufacturers to provide transparency in active pharmaceutical ingredient (API) sources and manufacturing locations, including locations of contract manufacturers.
- Support Strategic National Stockpile (SNS) functionality improvements that involve:
- Finalizing and regularly updating a list of medicines necessary to respond to potential national-scale public health emergencies, which should be included in the SNS. These drugs may differ from those on the essential medicines list.
- Increasing transparency regarding the specific products and quantities of such products included in the SNS.
- Publishing a clear, nationally consistent process for making requests from the SNS, including publication of contact information for key personnel in each agency that has responsibility for managing requests and distributions from the SNS.
- Engaging pharmacists and other supply chain experts to develop process for maintaining and refreshing products in the SNS.
- Creating a standard distribution logistics process for medications and related supplies from the SNS that incorporates feedback from pharmacists and other supply chain experts, including clear expectations for how updates to these processes will be publicized, if needed, in the event of a national emergency.
- Publishing criteria that will be used to prioritize distribution of products from the SNS, including clear expectation for how updates to these criteria will be publicized, if needed, in the event of a national emergency.
- Incentivizing the creation of private sector reserves of essential medicines not adequately provided by the SNS.