Anesthesiologists face an unprecedented number of drug shortages. For physician anesthesiologists, drug shortages directly impact patient safety and care. Having a diminished supply, or no supply of critical drugs at all, can cause suboptimal pain control or sedation for patients, in addition to creating complex workarounds for healthcare staff, leading to potential errors. Shortages have also resulted in delays and even cancellation of care.
ASA is a leader in the medical community on the drug shortages issue and works with other stakeholders, including federal agencies and Congress to ensure the appropriate parties are aware of the impact shortages have on patient care.
Read more about how drug shortages are impacting patient care.
The American Society of Health-System Pharmacists (ASHP) and the U.S. Food and Drug Administration (FDA) are important resources to stay informed of the most current drug shortages. ASA works with both to track and monitor issues related to drug shortages.
ASA supports Congressional action to reexamine the issue of drug shortages and requests the U.S. Department of Health and Human Services convene key stakeholders such as the Food and Drug Administration, the Drug Enforcement Administration, the Department of Homeland Security, manufacturers and organizations that represent end users such as the American Society of Anesthesiologists for the purpose of developing long-lasting solutions to the drug shortage crisis.
Current Drug Shortages
American Society of Hospital Pharmacists (ASHP) Real Time Drug Shortages:
ASHP lists every drug shortage reported through their online report form as soon as it is investigated and confirmed, usually within 24-72 hours.
FDA Drug Shortages Database:
The FDA focuses only on shortages of medically necessary drugs, as these have the potential to impact public health. A medically necessary drug is a product that prevents a serious disease or medical condition and for which there is no drug or alternative drug, available in adequate quantity that is judged by FDA’s medical staff to be an acceptable substitute. The FDA Drug Shortage Program Staff designates some drugs as medically necessary when the preferred therapy is in shortage.
What ASA is Doing
ASA shares drug shortage survey of its membership to FDA
The Society received more than 2000 responses in a recent, informal survey it conducted allowing members to share their personal stories about how their hospitals and practices have been affected by the drug shortages.
ASA 2018 Drug Shortage Summit planning
ASA is in the process of planning the next drug shortages stakeholder summit with ASHP, to take place mid 2018.
ASA urges Congress' transparency regarding drug shortages
ASA and others sent a formal communication to Congress expressing concern the shortage of small-volume parenteral solutions (SVPs). The letter urged increased transparency regarding drug shortages, as well as improvements to manufacturing infrastructure. In the letter to Reps. Morgan Griffith (R-VA) and Diana DeGette (D-CO) — the Vice Chairman and Ranking Member, respectively, of the House Energy and Commerce Subcommittee on Oversight and Investigations, signatories asked Congress to examine several questions to address the underlying causes of shortages.
- Staff from the drug shortage stakeholder organizations have continued to meet with Congressional staff from the Senate HELP Committee and the House Energy and Commerce Committee to express concern about these ongoing shortages and share our recommendations from the November meeting.
- In January 2018, FDA provided an update regarding ongoing IV saline shortages that resulted from, or were worsened by, the impact of the hurricane in Puerto Rico.The agency continued to allow imports and was working to identify new additional potential import sites for both small and larger volume IV saline bags.
ASA requests the DEA adjust aggregate production quotas (APQ)
As injectable opioid shortages became prevalent in February 2018, ASA, ASHP and others sent a communication to the DEA requesting the agency adjust aggregate production quotas (APQ) for certain opioids in order to mitigate ongoing drug shortages. Shortages of these injectable medications are largely attributable to manufacturing delays affecting Pfizer, the primary maker of these products, following its acquisition of Hospira’s manufacturing facilities of generic sterile injectable drugs. These manufacturing plants have been under FDA quality review and re-inspection escalating since May 2017. In a letter to customers, Pfizer indicated that the “anticipated full recovery dates for prioritized prefilled syringes have moved to 2Q19 and deprioritized syringes have moved to 2Q19.”
On January 31, 2018, Pfizer sent customers a further update informing them that, due to a third‐party supplier issue, none of these prefilled syringes of injectable opioids are currently being produced or released. There are ampoules or vials of fentanyl from 3 manufacturers with limited availability on allocation.
- The DEA scheduled a conference call with ASA and the other to discuss these concerns further.
- The DEA raised production quotas for two drug manufacturers (Fresenius Kabi and West-Ward Pharmaceuticals) to mitigate the shortage of opioid injectables.
- ASA's President Grant conducted a telephone call with Pfizer and the FDA Office of Drug Shortages at that time to encourage sharing of information and coordination.
ASA discusses ongoing challenges with American Society of Hospital Pharmacists (ASHP) in the wake of Hurricane Maria
In light of ongoing and new drug shortages, ASA re-convened with ASHP and other stakeholders in November 2017 to discuss ongoing challenges and new recommendations for Congress.
Around the same time, there were severe IV fluid shortages caused by production interruption in Puerto Rico due to hurricane related damage to pharmaceutical plants. ASA was concerned about the patient care implications of the shortage of small volume parenteral solutions (SVPs) that are widely used to further dilute common medications. Some of these products were FDA’s drug shortages list prior to Hurricane Maria, but the storm exacerbated the situation.
In mid-November of 2017, FDA announced they were actively working with drug manufacturers to address the critical shortages of IV fluids aggravated by Hurricane Maria’s impact on Puerto Rican drug manufacturing facilities. The agency allowed temporary import from Baxter facilities in Ireland, Australia, Mexico and Canada and from B. Braun in Germany.
ASA has a long history of working with Congress and the FDA Office of Drug Shortages
- In 2012, Congress took bipartisan action to address drug shortages by passing the Food and Drug Administration Safety and Innovation Act (FDASIA), a legislative package of important FDA provisions that includes Title X, a section dedicated solely to preventing and mitigating national drug shortages. With the endorsement of ASA and other stakeholders, FDASIA requires manufacturers to report to the FDA significant interruption or permanent discontinuance of the manufacture of many critical drugs. ASA was a leader in securing language to include those drugs used by anesthesiologists, in emergency medical care or during surgery and by physicians who treat patients with chronic pain. The FDA subsequently reported that the manufacturer notification requirement has helped the Agency become more proactive and successful in its efforts.
- In the FDA’s “Strategic Plan for Preventing and Mitigating Drug Shortages,” which was released in October 2013, the FDA recognized ASA’s ongoing work on drug shortages and sated that the FDA would “join with other stakeholder groups, such as groups convened by the American Society of Anesthesiologists…” to develop long-term prevention strategies on shortages.