Maresa D. Glass, PharmD, BCPS, BCCCP
In November 2017, The Society of Critical Care Medicine (SCCM) participated in a meeting of healthcare professional organizations, the American Hospital Association (AHA), the U.S. Food and Drug Administration (FDA), and the Department of Health and Human Services (HHS) to address the ongoing patient care challenges associated with drug product shortages. Held at the American Society of Health-System Pharmacists’ headquarters, the groups represented in large part the clinician community, but also included the AHA, the Pew Charitable Trusts, and the University of Utah Drug Information Services. Representatives of the American Society of Anesthesiologists, American Society of Clinical Oncology, American Medical Association, American Society for Parenteral and Enteral Nutrition, Institute for Safe Medication Practices, and SCCM discussed the ongoing challenges of drug shortages and their impact on patient care.
The group discussion focused on answering the following three questions:
- What has worked in the past four years and what has changed?
- Have new trends, new causes, or new factors emerged?
- What recommendations, including policy options, may be needed?
After a full day of discussion, the group came up with the following recommendations to further mitigate the impact drug shortages have on our patients. These recommendations will be evaluated for legislative consideration.
1. Improving reporting of manufacturing delays to the FDA.
Manufacturers need to provide the FDA with more information on the cause and duration of shortages. Current law requires manufacturers to notify the FDA when there is a production interruption, but companies are not required to disclose what the problem is or provide a timeline for resolution. Title X should be strengthened to require notification that includes the problem causing the interruption and the expected timeline to address it.
2. Establish best practices for high-alert drugs.
Best practices should be established for utilizing certain drugs before they are in short supply. This will not only assist during a shortage but will also lead to a reduction in waste throughout the healthcare system. Specific focus should be placed on limiting IV fluid waste.
3. Require manufacturers to establish contingency plans.
It is understood that manufacturers cannot predict when a shortage will take place. Therefore, it is recommended that manufacturers establish contingency plans in the event of a shortage, specifically when there are fewer than three manufacturers producing a drug.
4. Establish incentives to encourage manufacturers to produce drugs in shortage.
Often when a drug is in shortage it is difficult to find a manufacturer who is willing to increase or begin production of the drug. Therefore, it is recommended that the FDA explore incentive options to encourage other manufactures to begin producing drugs that are in shortage.
5. Provide more information on compounding outsourcers’ quality.
Although outsourcers registered with the FDA under Section 503B are able to compound drugs that are in shortage, it is difficult for pharmacies to evaluate the quality of a 503B facility. This is especially true for an outsourcer who has been issued a form 483 citation by the FDA. More disclosure is recommended of the reasons for 483 citations, and timely removal of the 483 citation is recommended when the issue has been resolved.
6. Reconsider the purchasing process of saline.
As saline is used more widely than most drugs, the group discussed having saline unbundled from the purchasing of other supplies. Additionally, the group proposes that an authoritative body investigate the purchasing process to determine whether the process is stifling competition.
7. Increase manufacturing transparency. Title X could be strengthened to require more transparency.
The recommendation is for manufacturers to disclose location of production, including situations in which a contract manufacturer is used.
8. Examine drug shortages as a national security initiative.
When a drug is in shortage, it impacts all forms of medical care from public and private hospitals to the U.S. military and VA medical centers. The group recommends that the Department of Homeland Security conduct a modeling and risk assessment to determine whether manufacturing facilities should be considered critical infrastructure and assess the vulnerabilities of that infrastructure. To date, risk assessment has largely focused on cybersecurity, but geographic location should also be a consideration. As part of the assessment, funding opportunities to support products needed during emergency situations should be examined.
9. Craft a statement on ease of use regarding electronic health records (EHR).
In recent years, changes have been implemented across the healthcare system to improve patient safety, such as establishing more standardized practices. However, when a shortage occurs, it takes countless staff hours to change the EHR system. The group recommends crafting a statement requesting that changes be made to the systems to ease the process.
10. Establish a quality manufacturing initiative.
It is recommended that the FDA establish a manufacturing rating system in which higher quality manufacturers receive higher ratings. The FDA should consider incentives to participate in the program and should also consider higher ratings for companies who have redundancy or backup plans.
11. The Federal Trade Commission should include in drug company merger proposals the potential risk for drug shortages.
This discussion largely focused on examining drug shortages over the past five years and assessing what has worked and what could be improved in terms of preventing and mitigating shortages, changes in causes of shortages, and dynamics that impact supply. In addition, the meeting provided an opportunity to hear from new potential stakeholders within HHS on how the healthcare community can plan for future disasters and threats to critical infrastructure in order to minimize their impact on the supply of drugs. While SCCM has no formal advocacy program, these types of meetings help the leadership stay informed and take action on matters of patient safety. SCCM leadership has been provided this information and will be considering next steps.