A Conversation with ASRA about Analgesic Drug Shortages: What Did We Learn?By Edward R. Mariano, MD, MAS Apr 30, 2018
Presenting at the late-breaking session are (left to right) ASRA President Dr. Asokumar Buvanendran, Dr. Ruth Landau, Dr. Jim Grant, and Paul Pomerantz.
The American Society of Regional Anesthesia and Pain Medicine (ASRA) convened a late-breaking session on April 21, 2018, at the World Congress of Regional Anesthesia and Pain Medicine in New York City to address the continuing problem of analgesic drug shortages.
We posted a blog on this topic on April 2, 2018, and this session was announced as a press release on April 16, 2018. Journalist John Commins published this story on Health Leaders Media on April 19, 2018 to help raise public awareness: “Patient Risk Rises with Local Anesthetics Shortage” after the ASRA press release.
Dr. Jim Grant, president of the American Society of Anesthesiologists (ASA), returned to New York to participate in the live session. Other special guests included Paul Pomerantz, chief executive officer of ASA, and Dr. Ruth Landau, 2nd vice president of the Society for Obstetric Anesthesia and Perinatology (SOAP) and author of the SOAP Advisory in Response to Shortages of Local Anesthetics in North America.
The meeting room was full with attendees representing academic and private practices from the United States, Canada, and Europe. Dr. Grant opened with an update of ASA efforts to advocate for a long-term solution to drug shortages, specifically mentioning the lifting of production quotas through the Drug Enforcement Agency, decreasing delays at the Food and Drug Administration (FDA) in the processing of generic drug application approvals and imports of pharmaceuticals produced outside North America. He emphasized that this is ASA’s number one priority. There are multiple contributing factors to the present shortages, but big ones included Pfizer’s acquisition of Hospira with subsequent closing of a major Hospira facility due to quality issues and the slow recovery of manufacturing facilities based in Puerto Rico. Dr. Grant also pointed out important collaborators in this fight: the American Hospital Association, American Society of Health-System Pharmacists, American Association of Clinical Oncology, and Institute for Safe Medication Practices. In my research, I discovered a letter sent to the FDA specifically about local anesthetic shortages from multiple societies representing dentists, dermatologists, and head and neck surgeons.
ASA recently surveyed members to gather stories about drug shortages affecting clinical care, receiving approximately 2500 responses, and will soon launch a new online registry that ASA members can use to report new and ongoing drug shortages affecting their practices.
Dr. Ruth Landau of Columbia University Medical Center
Dr. Landau shared Columbia University Medical Center’s experience, which has been suffering from shortages of hyperbaric 0.75% bupivacaine and other local anesthetic solutions since February 2018. She and the central hospital pharmacy decided to stockpile remaining 0.75% hyperbaric bupivacaine for emergency cesarean deliveries, and these cases have taken priority over all other surgical cases for access to hyperbaric bupivacaine. For other non-urgent cesarean deliveries, Dr. Landau and her team are using other preservative-free local anesthetic solutions as alternatives. Conservation strategies have included dividing large single-use vials in the pharmacy under sterile conditions into multiple syringes good for 24 hours which are delivered to labor and delivery and exchanged with new syringes daily. While implementing these local practice guidelines, Dr. Landau spearheaded the SOAP Advisory with the SOAP Board of Directors, which is the first societal statement to be released nationally, with careful consideration for potential liability and ongoing review and revision based on member feedback.
The attendees, both residents and practicing anesthesiologists, were actively involved in the discussion with questions for Drs. Grant and Landau and shared their own experiences dealing with ongoing drug shortages which have been remarkably similar around the world. Examples of alternative dosing strategies and techniques, using other available medications, and improving communication between anesthesiology and pharmacy were presented. Dr. Grant referred to this session as the “first real think tank” on this topic that he has participated in.
Here are some take-home points raised by attendees that should be considered by anesthesiologists facing analgesic drug shortages:
- Always have up-to-date information from your pharmacy department regarding inventory of local anesthetics and other medications affecting anesthesia care and perioperative pain management. One suggested best practice is to have a daily update (e.g., conference call, email, dashboard) on current drug shortages to facilitate communication between anesthesiology and pharmacy and among networked facilities within the same health system. During times of crisis, the FDA has decreased application processing times for generic drug applications and increased importation of the same medications produced abroad.
- Avoid excessive medication waste and identify opportunities for pharmacy to split commercially-available large vials into multiple single-dose syringes. Many single-use vials contain excessive amounts of medication. When done under proper sterile conditions, a pharmacy can divide these vials into syringes to decrease medication waste during this crisis of drug shortages and actually save a significant amount of money.
- Consider the ethics of practicing anesthesiology and surgery during this era of drug shortages. By their nature, anesthesiologists readily adapt to change, but a line has to be drawn somewhere. The ASA has a statement on the ethical considerations with drug shortages. This includes two key points:
“2. Anesthesiologists, as well as surgeons and other proceduralists, should consider postponing an elective procedure when the risks of proceeding might outweigh the risks of using medications that are alternative to those in short supply or unavailable.”
“3. If the anesthesiologist judges the risk of increased morbidity or mortality by using alternative medications to be negligible, then there is no need to discuss this issue when obtaining informed consent. However, if the anesthesiologist judges the added risk to be significant, then the discussion of alternative plans should be part of the informed consent process.”
- Keep working toward a longer term solution to drug shortages through improvements in supply chain. There are examples of health systems establishing partnerships with existing pharmaceutical manufacturers in an attempt to provide more stability in drug availability in the future. Recently a few major health systems have announced the creation of a new nonprofit generic drug company.
- Raise awareness in the community about the potential impact of analgesic drug shortages on quality and safety. If the general public sufficiently concerned, legislators and regulators may be more likely to take action.
ASA is currently working on multiple levels within the government on behalf of patients and the anesthesiologists who care for them. ASRA leaders will be working closely with ASA during this continuing crisis to provide guidance to members on how to deal with ongoing and ever-changing drug shortages and continue to provide the safest high quality care to patients.
Edward R. Mariano, MD, MAS (Clinical Research) is the chief of the Anesthesiology and Perioperative Care Service and associate chief of staff for inpatient surgical services at VA Palo Alto Health Care System and a professor of anesthesiology, perioperative, and pain medicine at Stanford University School of Medicine.