Legislation, media put spotlight on drug regimens
On June 30, 2009, a federal advisory panel voted 20 to 17 to recommend a ban on Percocet® and Vicodin®. If accepted and implemented by the U.S. Food and Drug Administration (FDA), the ban will have a profound effect on the way we treat patients with a variety of common orthopaedic conditions. Ironically, the narrow decision was based not on the addictive potential of the drugs, but on the dangers posed by acetaminophen, once thought to be among the safest medications in the world. (See “FDA tackles acetaminophen and liver toxicity”)
The day after the vote, The New York Times reported that acetaminophen-related liver damage was responsible for more than 400 deaths and 42,000 hospitalizations per year. In response, the stock prices of Johnson & Johnson (Tylenol), Abbott Laboratories (Vicodin), and Endo Pharmaceuticals (Percocet) dropped, acutely demonstrating the issue’s high economic stakes.
What can we learn from this potentially cataclysmic shift in the perception of the risk-benefit ratio of acetaminophen, the pain reliever and antipyretic that’s been a staple in medicine cabinets for a half century? What are the implications for other sectors of our practice?
Lessons for orthopaedics
Orthopaedic procedures are typically thought of as “high-risk” surgeries. In general, we have managed this perception well by providing our patients with the benefits of pain relief and functional improvement. Can that also be said for the medications that we routinely prescribe for our patients? How much tolerance does the public have for a medication that delivers a marginal advantage and a substantially increased risk over a less risky drug?
In a Jan. 15, 2009, article in The New York Review of Books, author Marcia Angell discusses a common technique used to expand pharmaceutical markets. “Instead of promoting drugs to treat diseases, they have begun to promote diseases to fit their drugs,” Angell wrote. Thus, a dangerous condition with a high probability of patient harm tends to carry with it the justification for using a potent and potentially dangerous drug.
An example of this approach can be seen in the efforts by manufacturers of anticoagulants to promote the aggressive use of their products routinely in hospitals for the prevention of thromboembolic disease. Although these drugs have many appropriate uses and the need for increased awareness of their indications is no doubt beneficial, the concerns of orthopaedic surgeons regarding their potential harms have been largely ignored by hospitals scrambling to comply with the perceived demands of guidelines and performance measures. A high-profile near-disaster in late 2007, however, may have started the pendulum swinging toward a more reasonable position.
The Quaid effect
In November 2007, actor Dennis Quaid’s newborn twins were mistakenly administered a nearly fatal overdose of heparin to flush their intravenous catheters, and the public spotlight shifted to the harmful side of anticoagulant treatment. The Joint Commission quickly moved to reduce the likelihood of patient harm associated with the use of anticoagulant therapy by making it a National Patient Safety Goal.
The seriousness of the risk reverberated in September 2008 when Mark R. Chassin, MD, president of the Joint Commission, announced the roll-out of a Sentinel Event Alert for anticoagulant use. Dr. Chassin warned the medical community by underscoring the potential dangers of anticoagulants. This was a fitting retort to the Surgeon General’s “Call to Action to Prevent Deep Vein Thrombosis and Pulmonary Embolism” released the previous week.
Much of the perceived risk of anticoagulation is attributed to medical error; that is, the improper dispensing of a medication that, if given as indicated by the proper route of administration in the appropriate patient, would lead to negligible adverse effects. But for routine orthopaedic procedures, such as primary hip and knee replacement, the dispensing of an aggressive thromboprophylactic agent as indicated may result in significantly increased bleeding, which carries the additional risk of a poor clinical outcome. This type of harm, therefore, should be considered an inherent risk in the prophylactic regimen itself, just as the well-known risk of liver damage with acetaminophen was accepted for many years without question.
The use of more potent and potentially harmful anticoagulation regimens have largely been justified by their ability to reduce the incidence of both symptomatic and asymptomatic thromboembolism, which are commonly considered together as if they belong in the same dangerous category. The AAOS questioned this assumption in its Clinical Practice Guideline on the Prevention of Symptomatic Pulmonary Embolism in Patients Undergoing Total Hip or Knee Arthroplasty (available online at www.aaos.org/guidelines). Viewed through the AAOS framework, the more aggressive regimens have not proven more effective in preventing symptomatic pulmonary embolism than other regimens, such as early mobilization, mechanical compression, and aspirin where the risk of surgical site bleeding is negligible. This view of the evidence supports the case for potentially unnecessary patient harm in a significant subset of hip and knee replacement patients.
Whatever the verdict of the FDA, this important review of medical dogma demonstrates that widely accepted drug regimens are always at risk of reinterpretation. Orthopaedic surgeons who are distressed by bleeding complications brought on by a possibly overaggressive prophylactic regimen in an otherwise healthy elective surgical patient should continue to call attention to the problem and do so with new and valid methods of attribution.
Norman A. Johanson, MD, is a member of the AAOS Evidence-Based Practice Committee and chaired the work group that developed the AAOS Clinical Practice Guideline on the Prevention of Symptomatic Pulmonary Embolism in Patients Undergoing Total Hip or Knee Arthroplasty. He can be reached at firstname.lastname@example.org
- Angell M: Drug companies & doctors: A story of corruption. The New York Review of Books. 2009;56(1):8-12.
- Jennings HR, Miller EC, Williams TS, Tichenor SS, Woods EA: Reducing anticoagulant medication adverse events and avoidable patient harm. Jt Comm J Qual Patient Saf 2008;34(4):196-200.
- Johanson NA, Lachiewicz PF, Lieberman JR, Lotke PA, et al: American Academy of Orthopaedic Surgeons Clinical Practice Guideline on Prevention of Symptomatic Pulmonary Embolism in Patients Undergoing Total Hip or Knee Arthroplasty. J Bone Joint Surg. 2009;91:1756-1757.
- Johanson NA, Lachiewicz PF, Lieberman JR, Lotke PA, et al: AAOS Clinical Practice Guideline Summary. J Am Acad Orthop Surg 2009;17(3):183-196.
- Rathbun S: The Surgeon General’s Call to Action to Prevent Deep Vein Thrombosis and Pulmonary Embolism. Circulation 2009;119:e480-e482.
- Sentinel Event Alert: Preventing errors relating to commonly used anticoagulants. The Joint Commission. Sept. 24, 2008; Issue 41.
- Wood D: Joint Commission Issues Anticoagulant Safety Alert. http://www.Nursezone.com/printarticle.aspx?articleID=27648