As otolaryngologists, we prescribe many medications to our patients. The objective of this article is to review the potential side effects and medicolegal risks of the common medications used to treat chronic rhinosinusitis. The authors evaluate some of the common side effects as well as the published literature on the lawsuits associated with those medications. Finally, the authors review the informed consent discussion and opportunities to improve patient care and decrease the risk of litigation.
Key points
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Antibiotics, corticosteroids, and narcotics are classes of medications frequently associated with litigation.
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Allergic reactions to medications are a common complaint associated with lawsuits.
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Current medication lists and current allergies should be updated at each visit.
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Communication with patients is the key element to help minimize adverse events.
Introduction
As physicians, we have thousands of medications at our disposal; however, most rhinologists use a relatively limited number. Oral medications most commonly used include antibiotics, steroids, and narcotics in the postoperative period. Despite the common use of these medications, many providers are not familiar with the potential risks or the potential medicolegal ramifications of those risks.
The objectives of this review are to outline the existing data of the medicolegal implications of commonly used oral medications, including antibiotics, steroids, and narcotics. The authors discuss what is known about their specific risks and review the issues associated with lawsuits and how providers can educate patients and minimize the risk of litigation. Finally, the authors discuss informed consent for the use of medications.
Introduction
As physicians, we have thousands of medications at our disposal; however, most rhinologists use a relatively limited number. Oral medications most commonly used include antibiotics, steroids, and narcotics in the postoperative period. Despite the common use of these medications, many providers are not familiar with the potential risks or the potential medicolegal ramifications of those risks.
The objectives of this review are to outline the existing data of the medicolegal implications of commonly used oral medications, including antibiotics, steroids, and narcotics. The authors discuss what is known about their specific risks and review the issues associated with lawsuits and how providers can educate patients and minimize the risk of litigation. Finally, the authors discuss informed consent for the use of medications.
Antibiotics
The data supporting the use of antibiotics in acute rhinosinusitis and chronic rhinosinusitis are limited. There have been 2 Cochrane reviews evaluating the benefit of antibiotics for acute maxillary sinusitis, both of which reported statistical improvements in patients treated with antibiotics. They support the use of antibiotics in these patients. For chronic rhinosinusitis, an iterative review published in 2013 considered the use of antibiotics an option (level B evidence), given the balance of benefits to harm as well as the modest reduction in symptoms following antibiotic use.
Complications of Antibiotic Use
Allergy
Allergic reactions and anaphylaxis are always a concern when prescribing antibiotics. Penicillins and cephalosporins made up almost 60% of all antibacterial drugs sold in the United States in 2011 and were responsible for most of the allergic reactions. These reactions are type I, immunoglobulin E (IgE)–mediated hypersensitivity reactions. The reported incidence of an allergy to an antibiotic, such as penicillin, is much higher in the general population than the IgE testing shows. Studies in patients that have reported penicillin allergies have shown that only between 0.3% and 3.0% of them have positive testing for a type I hypersensitivity reaction.
Additionally, the cross reactivity between penicillin allergies and cephalosporin allergies are not as common as has been reported. Initial studies from the 1960s and 1970s report a cross reactivity rate of 8% to 18%. This rate may have been caused by minor contamination of cephalosporins by penicillin from the manufacturing process. More modern manufacturing involves synthetically synthesized cephalosporins rather than the earlier methods of using chemically modified penicillins to create cephalosporins. This process has essentially eliminated the risk of contamination. Current data suggest the true cross reactivity to be between 1.0% and 2.55%, with first- and second-generation cephalosporins having higher rates of cross reactivity with penicillins.
Antibiotic-associated diarrhea
Antibiotic-associated diarrhea (AAD) is a common side effect of antimicrobial therapy. Pseudomembranous colitis, a distinct subtype of AAD, is characterized by colonic mucosal necrosis and pseudomembrane formation. Clostridium difficile , an anaerobic, spore-forming, gram-positive bacillus, has been identified as the pathogen responsible for pseudomembranous colitis caused by disruption of the normal colonic flora caused by the antibiotic ingestion.
C difficile infection is defined as at least 3 unformed stools in 24 hours and a positive stool test for C difficile toxin or endoscopic evidence of pseudomembranous colitis. Disease severity can range dramatically from an asymptomatic colonization to fulminant colitis. The morbidity associated with infection is reported to be as high as 80%, with mortality rates up to 8%. The incidence of C difficile colitis has increased during the decade from 1990 to 2000, with the reported incidence increasing from 0% to 3.2%.
The most common risk factor for acquiring C difficile colitis is prior exposure to antibiotics. A recent meta-analysis reported that antibiotic usage led to a significantly higher risk of developing community-acquired C difficile infection compared with patients with no antibiotic exposure. When evaluating a specific antibiotic class, clindamycin had the greatest risk of a C difficile infection. Other antibiotics also increased the risk but at various frequencies. Fluoroquinolones were the next most commonly associated antibiotic, followed by cephalosporins, penicillins, and macrolides; sulfonamide/trimethoprim had the lowest risk. Tetracyclines were not associated with an increased risk of C difficile infection ( Table 1 ).
| Antibiotic | Odds Ratio for Developing a C difficile Infection | 95% Confidence Interval |
|---|---|---|
| Clindamycin | 20.43 | 8.50–49.09 |
| Fluoroquinolones | 5.65 | 4.38–7.28 |
| Cephalosporins | 4.47 | 1.60–12.50 |
| Penicillins | 3.25 | 1.89–5.57 |
| Macrolides | 2.55 | 1.91–3.39 |
| Sulfonamide/trimethoprim | 1.84 | 1.48–2.29 |
| Tetracyclines | 0.91 | 0.57–1.45 |
Probiotics role in preventing C difficile –associated diarrhea and infection has been extensively studied. Several studies have shown reduction in the incidence of C difficile infections in patients taking probiotics compared with placebo. A Cochrane review reported that probiotics reduced the risk of C difficile –associated diarrhea by 64%, a reduced the risk of developing antibiotic associated diarrhea, and a decreased risk of developing side effects from antibiotics such as abdominal cramping, nausea, flatulence, and taste disturbance. Although the study identified a reduction in C difficile –associated diarrhea, there was no difference in the incidence of C difficile infection. This finding may suggest the probiotics may be more effective at limiting the extent of infection or preventing the symptoms of infection rather than inhibiting the actual colonization. The investigators conclude that probiotics are safe and effective at reducing the rate of C difficile –associated diarrhea, AAD, and the side effects of antibiotics in immunocompetent patients.
Fluoroquinolone-induced tendon damage
In 2008, the US Food and Drug Administration issued a warning regarding the risk of tendonitis and tendon rupture with the use of fluoroquinolones. The purpose of this boxed warning was to draw providers’ attention to the continued report of tendon issues occurring in patients using fluoroquinolone antibiotics. All fluoroquinolone antibiotics were included. The Achilles tendon is the most commonly involved; but the rotator cuff, biceps, thumb, and hand tendons can also be affected. Patients older than 60 years, those taking corticosteroids, and those who have had solid organ transplants are at higher risk. There is debate regarding risk factors, such as obesity and sex; however, most of the studies consistently show increased age related to increased risk of tendon damage as well as concurrent corticosteroid use and renal impairment. The risk for injury does not end with the completion of the therapy. Patients can have problems months after the antibiotic was stopped. Of note, this warning only applied to systemic use of the fluoroquinolones, not eye or ear drops.
The exact incidence and cause of fluoroquinolone-associated tendon issues are not known. Reports estimate the incidence between 0.14% and 0.4% in healthy patients. Renal impairment and transplant have been associated with higher incidence, up to 15.6%. The mechanism of damage has been hypothesized to include degenerative lesions on the tendons, fissures, edema, and necrosis, whereas animal studies have demonstrated oxidative damage, edema, and alterations of the tenocytes.
Others
Additional risks include cardiac arrhythmias, gastritis, increased sun sensitivity, colitis, and so forth. The authors’ prior work on the subject has a more complete list of these risks in tabular form.
Corticosteroids
Corticosteroids are a mainstay of treatment in the management of sinonasal inflammatory disease and are commonly used and considered by many to constitute a key component of maximal medical therapy. Advocates of corticosteroids tout their antiinflammatory effects to treat the inflammation associated with rhinosinusitis as well as their antifibroblast effects to reduce postoperative scar tissue formation. The use and regimen vary greatly, but most rhinologists agree they play a role in management.
Complications of Steroid Use
The complications associated with steroid use can be extensive, affecting many different organ systems. These complications range from psychiatric reactions to changes in the skin, loss of bone density, and avascular necrosis (AVN) of the bone. Many of these effects are dose and/or duration dependent with an increased incidence in higher doses or longer courses. There seems to be significant individual variability in the dose required to see many of the complications. Additionally, the risk of multiple or repeated short courses of corticosteroids is not known.
AVN is the most common complication of corticosteroids leading to litigation. AVN has been seen primarily in the femoral head, although all other bones can be affected. The exact cause is not fully understood but is caused by impaired blood perfusion of the bone. Potential causes of the decreased perfusion include embolic events, a hyperviscous state of the blood, hypertrophy of marrow adipose cells that increase the pressure in the femoral head resulting in decreased blood flow, or generation of bone edema.
Corticosteroids are well known to increase the risk of AVN, but neither the pathophysiology nor the true risk is understood. Complicating factors include comorbidities that can be associated with nontraumatic AVN. These comorbidities include excessive alcohol use, connective tissue diseases (eg, lupus), hemoglobinopathies (eg, sickle cell disease), hyperlipidemia, liver disease, organ transplant, cancer, cerebral trauma, radiation treatment, chemotherapy, Crohn disease, Gaucher disease, and caisson disease.
Additionally, most of the data come from studies involving patients receiving long-term, high-dose steroids. Of the studies reporting AVN with short-term steroid use, the total dose of steroids is in excess of 290 mg of prednisone, with most studies reporting doses closer to 1000 mg of prednisone. The patient who presented after the lowest cumulative dose of prednisone, 290 mg in 7 days, also had a history of alcoholism, a separate risk factor for AVN. Another retrospective series of 1352 patients treated with corticosteroids for neurosurgical issues identified 4 cases of AVN, for a risk of 0.3%. The mean cumulative dose was equivalent to 673 mg of prednisone (range 389–990 mg), and the mean duration was 20 days (range 15–27 days).
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