A Bitter Pill

We’re accustomed to clinical information, studies and patient data compiled by the American Academy of Orthopaedic Surgeons that often serve to guide manufacturers’ decision making about product design, regulatory compliance issues or market demographics. A recent report by the Rosemont, Ill.-based association perhaps isn’t as “actionable” for orthopedic device makers, but it’s no less eye-opening. Though it is more pharmaceutical/clinical in focus, I nonetheless feel it is worth sharing with Orthopedic Design & Technology readers.

According to the authors of a new literature review in the May issue of The Journal of the American Academy of Orthopaedic Surgeons, there is a tie between the U.S. “opioid epidemic” and orthopedic care.

The United States makes up less than 5 percent of the world’s population but consumes 80 percent of the global opioid supply and approximately 99 percent of all hydrocodone—the most commonly prescribed opioid in the world. Authors of the Journal article claim that orthopedic surgeons are the third-highest prescribers of opioid prescriptions among physicians in the United States—
behind primary care physicians and internists.

“The past few decades have seen an alarming rise in opioid use in the United States, and the negative consequences are dramatically increasing,” said co-author Hassan R. Mir, M.D., associate professor of orthopedics and rehabilitation at Vanderbilt Orthopaedic Institute in Nashville, Tenn. “Management of pain is an important part of patient care; however, the increased usage of opioids for the treatment of pain has led to several unanticipated aftereffects for individual patients and for society at large.”

Opioids now also are prescribed by physicians more frequently to treat chronic conditions, including musculoskeletal pain of the spine and limbs, while prescriptions for non-opioids such as nonsteroidal anti-inflammatory drugs or acetaminophen have remained constant. The increased usage of opioids for pain management has led to unanticipated consequences, the authors noted:

• Patients building up tolerance to drugs;
• Worse treatment outcomes for conditions including work-related musculoskeletal disorders, joint replacements and spine surgery;
• Unlawful sale or sharing of opioid medications with others; and
• When used inappropriately, addiction and unintentional overdose deaths can result.

“Orthopedic patients can experience a tremendous amount of pain with acute injuries and chronic conditions, and the treatment plan may involve opioid prescriptions for relief of discomfort,” said Mir. “A significant number of orthopedic patients and their families are at risk for repercussions from opioid use. We must work together with all prescribers and patients to decrease the use of opioids for musculoskeletal pain.”

Article co-author Brent J. Morris, M.D., a shoulder and elbow surgeon with the Lexington Clinic Orthopedics—Sports Medicine Center, in Lexington, Ky., said,  “Physicians should aim to control pain and improve patient satisfaction while avoiding overprescribing opioids. A comprehensive strategy of risk assessment is needed to identify patients who may be at risk for opioid abuse. Objective measures including patient history, recognition of aberrant behavior, urine drug testing, state prescription drug—monitoring programs, and opioid risk-assessment screening tools may be necessary in select cases.”

Reasonable expectations should be established for pain management discussions and follow-up visits, and incorporate a protocol for a patient to be transitioned off of an opioid to acetaminophen or nonsteroidal anti-inflammatory drugs at a specific time following surgery, the authors wrote. According to Mir and Morris, the patient-physician relationship is built upon trust. Orthopedic surgeons trust that patients will accurately report their level of pain and only use opioids when appropriate. Patients trust their surgeons to assess and adequately treat the pain associated with their orthopedic conditions. Unfortunately, a small percentage of patients use opioids non-therapeutically and “doctor shop” for additional opioids, making this a delicate balancing act for physicians.

While perhaps not overt, there is a role here for device makers. Any processes, designs or ideas that help minimize post-operative pain could assist in alleviating this problem. Minimally invasive surgical technologies, imaging technology and patient-specific implants, to name a few, have gone a long way in reducing patients’ recovery time and trauma. Perhaps this is an opportunity for the industry to engage clinicians and explore device-related approaches to reducing pain and, thus, the need for strong painkillers. 

Christopher Delporte
Editorial Director, Medical Devices