My Trip to Washington: Speaking Out Against Drug Shortages

UPDATE: The MEDS Act was incorporated into the Coronavirus Aid, Relief, and Economic Security (CARES) Act and passed into law on March 27, 2020. I commented on the COVID-19 pandemic’s exacerbation of ongoing drug shortages in this interview with CBS news.

On November 5, 2019, I had the opportunity to participate in a Congressional briefing related to drug shortages at the Capitol in Washington, DC. Senator Susan Collins (R-ME) opened the session and co-sponsored the Mitigating Emergency Drug Shortages (MEDS) Act with Senator Tina Smith (D-MN). I was one of only two physicians on the panel and tried to represent the voice of clinicians involved in perioperative care and the patients we care for (video). Below are the notes from my presentation.

As a physician specializing in anesthesiology, this ongoing crisis of drug shortages in the United States is frankly terrifying.

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Anesthesiology is a unique specialty within medicine. Our patients are the most vulnerable in the hospital. Patients under general anesthesia cannot advocate for themselves and trust us with their lives.

We do not know what the next drug shortage will be or how long it will last. This week it is prefilled syringes of lidocaine, a life-saving emergency medication we give in case of a dangerous heart rhythm. Two weeks ago it was phenylephrine, a routine medication we use to increase blood pressure when it goes down after inducing anesthesia.

Last year, we had complete shortages of common injectable opioids and local anesthetics used for numbing injections. This directly affected surgical patients in terms of anesthesia and pain management. For 3 months in 2018, we did not have the local anesthetic indicated for spinal anesthesia. We know this is the safest anesthetic for patients having certain surgeries. During this shortage, we used an alternative anesthetic in order to continue providing spinal anesthesia, but our patients experienced more side effects. The reasons for this shortage were complex and involved a limited number of manufacturers and quality issues.

Thankfully, the shortage of spinal local anesthetic ended. We do not know when or if the rest of our current drug shortages will end. All we know for sure is that there will be another one.

The predictably unpredictable cycle of drug shortages puts physicians in an impossible position. Medicine is a calling, and we physicians have sworn an oath to support the well-being of our community and humanity in general.

Not having access to the right drugs at the right time for every patient and being forced to use less acceptable alternatives, if any exist at all, represents a form of moral injury. Moral injury “is being unable to provide high-quality care and healing in the context of health care” and is now recognized as a contributor to the epidemic of physician burnout.

Listen to my interview with Paul Costello on SoundCloud.

From left to right: Daniel Teich (Fairview Pharmacy Services), Dr. Peter Adamson (Children’s Hospital of Philadelphia), Senator Susan Collins, me, and Brian Marden (MaineHealth Pharmacy)

The crisis of prescription opioid overuse and abuse has affected countries around the world, and anesthesiologists are well-positioned to make positive changes (1). Even minor outpatient surgical procedures, and their associated anesthesia and analgesia techniques, can lead to long-term opioid use (2,3). Patients who present for surgery with an active opioid prescription are very likely to still be on opioids after a year (4).

Anesthesiologists have been working to set up regional anesthesiology and acute pain medicine programs with careful coordination of inpatient and outpatient pain management to improve patient outcomes. Regional anesthesia, especially with continuous peripheral nerve block (CPNB) techniques, has been shown repeatedly to reduce patients’ need for opioid analgesia (5).

Today, the crisis of drug shortages threatens to reverse many advances in acute pain management.

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Today, the crisis of drug shortages threatens to reverse the many advances in perioperative pain control that have been achieved. Local anesthetics or “numbing medications” represent a class of drugs that is our strongest weapon against opioids. These drugs (e.g., bupivacaine, lidocaine, ropivacaine) are currently in shortage. Targeted injections of local anesthetic in the form of regional anesthesia eliminate sensation at the site of surgery and can obviate the need for injectable opioids (e.g., fentanyl, hydromorphone, morphine) which also happen to be in short supply. Local anesthetics are also the critical ingredient in providing epidural pain relief and spinal anesthesia for childbirth. Without them, new moms will miss the first moments of their babies’ lives.

The following are potential ramifications of the current drug shortages affecting anesthesia and pain management on patient care:

Decreased Quality of Acute Pain Management

Regional anesthesia techniques, which include spinal, epidural, and peripheral nerve blocks, offer patients many potential advantages in the perioperative and peripartum period. Human studies have demonstrated the following benefits: decreased pain, nausea and vomiting, and time spent in the recovery room (6,7). Long-acting local anesthetics (e.g., bupivacaine, levobupivacaine, and ropivacaine) generally provide analgesia of similar duration for 24 hours or less (8-11). These clinical effects of nerve blocks typically last long enough for patients to meet discharge eligibility from recovery and avoid unnecessary hospitalization for pain control (12). CPNB techniques (also known as perineural catheters) permit delivery of local anesthetic solutions to the site of a peripheral nerve on an ongoing basis (13). Portable infusion devices can deliver a solution of plain local anesthetic for days after surgery, often with the ability to titrate the dose up and down or even stop the infusion temporarily when patients feel too numb (14,15). In a meta-analysis comparing CPNB to single-injection peripheral nerve blocks in humans, CPNB results in lower patient-reported worst pain scores and pain scores at rest on postoperative day (POD) 0, 1, and 2 (16). Patients who receive CPNB also experience less nausea, consume less opioids, sleep better, and are more satisfied with pain management (16). By using local anesthetic medication to interrupt nerve transmission along peripheral nerves, patients continue to experience decreased sensation as long as the infusion is running. A shortage of local anesthetic medications makes it impossible for anesthesiologists to provide this potent form of opioid-sparing pain control for all surgical patients. This also means that local anesthetics cannot be administered by surgeons as wound infiltration to help patients with incisional pain, and epidural analgesia for laboring women may not be universally available.

Increased Incidence of Postoperative Complications

Based on the study by Memtsoudis and colleagues, overall 30-day mortality for total knee arthroplasty patients is lower for patients who receive regional anesthesia, either neuraxial and combined neuraxial-general anesthesia, compared to general anesthesia alone (17). In most categories, the rates of occurrence of in-hospital complications (e.g. all-cause infections, pulmonary, cardiovascular, acute renal failure) are also lower for the neuraxial and combined neuraxial-general anesthesia groups vs. the general anesthesia only group, and transfusion requirements are lowest for neuraxial anesthesia patients compared to all other groups (17). The inability to offer regional anesthesia (e.g., spinal or epidural) to all patients due to lack of local anesthetics therefore represents a threat to patient safety.

Increased Risk of Persistent Postsurgical Pain

Chronic pain may develop after many common operations including breast surgery, cesarean delivery, hernia repair, thoracic surgery, and amputation and is associated with severe acute pain in the postoperative period (18). A Cochrane systematic review and meta-analysis reviewed published studies on this subject, and the results favor epidural analgesia for prevention of persistent postsurgical pain (PPSP) after thoracotomy and favor paravertebral block for prevention of PPSP after breast cancer surgery at 6 months (19). Only regional blockade with local anesthetics can block patients’ sensation during and after surgery. Without local anesthetics for nerve blocks, spinals, and epidurals, patients will experience greater than expected acute pain, require additional opioid treatment, and potentially be at higher risk of developing chronic pain.

Increased Health Care Costs

Approximately 31% of costs related to inpatient perioperative care is attributable to the ward admission (20). Anesthesiologists as perioperative physicians have an opportunity to influence the cost of surgical care by decreasing hospital length of stay through effective pain management and by developing coordinated multi-disciplinary clinical pathways (21,22). Regional anesthesia and analgesia can improve outcomes through integration into clinical pathways that involve a multipronged approach to streamlining surgical care (23,24). Inadequate pain control can delay rehabilitation, prolong hospital admissions, increase the rate of readmissions (25), and increase the costs of hospitalization for surgical patients.

In summary, regional anesthesia and analgesia has been shown in multiple studies to improve outcomes for obstetric and surgical patients. The current shortage of local anesthetics and other analgesic medications negatively affects quality of care and pain management and is a threat to patient safety.

References

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