QUINOLONE QUAGMIRE
If you’ve had the opportunity recently to watch television, listen to the radio, or surf the web, you’re sure to have run across an attorney advertising their prowess in pursuing “unscrupulous” pharmaceutical companies. In a brief search of the web, I found attorneys filing lawsuits for adverse reactions with Actos, testosterone, Xarelto, and fleet phospho-soda! I even found one attorney that claimed to be a “qualified fluoroquinolones lawsuit attorney.” Most of these claims are against the deep pockets of the pharmaceutical industry for bringing a defectively designed or defectively manufactured medication/medical device into the stream of commerce. In the past 5-10 years, though, there has been a discernible escalation in the number of claims directed against individual physicians and cases being reported to The Texas Medical Board (TMB) concerning the injudicious prescribing of medications. Although the majority of the cases involve the prescribing of controlled substances, there are quite a few that involve the overutilization and injudicious prescribing of antibiotics in particular. The class of antibiotics most frequently at issue, and the ones we encounter most in emergency medicine, are the quinolones. Quinolones have been around since Nalidixic Acid was brought to the market in the early 1960’s. Newer generations of quinolones have expanded coverage against gram negatives (ciprofloxacin), gram positives (levofloxacin), and anaerobes (trovafloxacin). With the expanded coverage has come considerable use and experience with the medication’s expanding negative side-effect profile. Unfortunately, 30-40% of all the antibiotic prescriptions that are written in this country are for inappropriate indications. Whether it be for patient satisfaction, patient expectations, fear of missing an occult bacterial infection, or some other unjustifiable reason, this class of antibiotics now exposes patients to much more than the feared antibiotic resistance. The quinolones had already been implicated with a litany of serious adverse reactions such as: nonreversible peripheral neuropathy, tendon rupture, QT prolongation, toxic psychosis, depression, and suicidality. The FDA has now placed the quinolones under even closer scrutiny for their most recent association with aortic and valvular disease (i.e. mitral and aortic regurgitation, aortic dissection, aortic aneurysm). Physicians are not immune from personal injury claims when an adverse drug reaction occurs. The legal principle called “The learned intermediary doctrine” espouses that the pharmaceutical companies discharge their duty to the consumers (patients) by fully informing the prescribing provider (physician, PA, NP, etc.) of the risks and benefits of a particular medication or medical device. It then becomes incumbent upon the medical practitioner to adequately determine the appropriate medication for the patient’s particular condition, convey the risks and benefits to the patient, and document that informed consent for the medication was obtained. In a nutshell, you are responsible for knowing all of the nuances of any medication/antibiotic you prescribe. You must also be able to defend the rationale for prescribing any antibiotic, especially one that can have life altering side-effects like the quinolones. Attorneys and the TMB understand that not every clinical situation is clearly viral or bacterial. When there is ambiguity though, add a few sentences to your medical decision making section to clarify why you are prescribing antibiotics and why you chose one antibiotic over the other. In some cases, a quinolone may be the reasonable choice of antibiotic. Let the record reflect your decision making process so you are not named in a suit or called to Austin to convey this information in person (an ounce of prevention…). Lastly, have a convenient link to the FDA Adverse Event Reporting System (FAERS) public dashboard) or another commercial provider like Medscape or Epocrates that keeps track of relevant updates to medication side-effect profiles. Not only will this be clinically helpful, it may very well keep you out of the crosshairs of the TMB or a plaintiff’s attorney. As I have done in the past, I have included several recent examples of how Texas physicians have been disciplined by the TMB. This month’s theme has been injudicious use of antibiotics. Rao, Seshagiri, M.D., Lic. No. G0803, Plano On December 6, 2019, the Board and Seshagiri Rao, M.D., entered into a Mediated Agreed Order requiring him to have his practice monitored by another physician for four consecutive monitoring cycles; and within one year complete at least four hours of CME in identifying and treating pediatric fungal infections. The Board found Dr. Rao failed to meet the standard of care by using antimicrobial agents for inappropriate indications and in an excessive and undisciplined manner. This order resolves a formal complaint filed at the State Office of Administrative Hearings. Srivathanakul, Suraphandhu, M.D., Lic. No. E7288, Garland On June 10, 2016, the Board entered a Final Order against Suraphandhu Srivathanakul, M.D., which revoked his Texas medical license. The Board found Dr. Srivathanakul failed to meet the standard of care with respect to multiple patients by nontherapeutically prescribing antibiotics without adequately determining if the patients had a bacterial infection, nontherapeutically prescribing codeine to patients with chronic bronchitis, by failing to consider differential diagnoses, failing to maintain adequate medical records and was in violation of his 2011 Board order. The action was based on the findings of an administrative law judge at the State Office of Administrative Hearings. This order resolves a formal complaint filed at the State Office of Administrative Hearings. Dr. Srivathanakul has 20 days from the service of the order to file a motion for rehearing. Pham, Chi Manh, M.D., Lic. No. G1993, Houston On October 14, 2016, the Board and Chi Manh Pham, M.D., entered into an Agreed Order on Formal Filing Modifying Prior Mediated Agreed Order, modifying Dr. Pham’s June 2014 Order. The modification requires Dr. Pham to have his practice monitored for an additional eight consecutive chart monitoring cycles; within one year schedule an assessment with the Texas A&M Health Science Center Rural and Community Health Institute (KSTAR); within one year complete at least 18 hours of CME, divided as follows: four hours in professional communications, four hours in prescribing of antibiotics/resistance and 10 hours in medical recordkeeping; and within 60 days pay an administrative penalty of $1,000. The Board found Dr. Pham violated the 2014 Order by failing to implement any of the chart monitor’s recommendations. All other terms of the 2014 remain in full force and effect. This order resolves a formal complaint filed at the State Office of Administrative Hearings. Kenneth Alan Totz, DO, JD, FACEP No information within this report should be construed as medical or legal advice. Independent medical and/or legal advice should be sought based on each individual’s particular circumstances. |
