Medication-Related Errors and Liability: What Can You Do?
Medications are increasingly complex and can be a source of errors resulting in patient injury and liability. This was clearly illustrated in a claim presented in The Doctor’s Advocate (“A Tragic Lesson in Drug Safety” in the third quarter 2011 issue) involving a physician who prescribed Tussionex (hydrocodone and chlorpheniramine) to a four-year-old for treatment of a cough.
The child died from respiratory depression. An FDA Alert indicating reports of life-threatening events in children taking Tussionex had been issued the week before the prescribing event occurred. The manufacturer’s “Dear Provider” letter advising that prescribing Tussionex to children under six was contraindicated had been released the following week. A new edition of the Physicians’ Desk Reference (PDR) in the physician’s office contained the warning. The pharmacist filling the prescription received an electronic Drug Utilization Review Alert requiring him to contact the physician regarding its safety. He overrode the Alert and filled the prescription.
Safe Use Initiative and Know the Label Campaign
The FDA introduced the Safe Use Initiative in 2009 to create and facilitate public and private collaborations within the healthcare community. Its goal is to identify specific, preventable medication risks and then develop and implement interventions to promote safe medication use.
In collaboration with the FDA’s Safe Use Initiative, PDR Network and medical professional liability carriers launched a national Know the Label campaign early in 2011. Because almost 25 percent of drugs have clinically relevant changes made to their FDA-approved labels annually, it is difficult for busy physicians to keep up with label changes for medications.
The campaign allows physicians to earn free continuing medical education (CME) credits for reviewing the FDA-approved labeling for drugs they most commonly prescribe. We encourage our members to join the PDR Alert Network to receive FDA Drug Alerts and label changes via e-mail. Physicians can earn free CME credits for reading Alerts and label changes and taking a short online test on their content. PDR Network hosts the CME programs, and The Doctors Company provides the CME credits.
While the tragic outcome in the case outlined above could have been prevented by receiving the FDA Alert (Boxed warning) on the PDR Alert Network, it would have been prevented by using PDR BRIEF on the electronic health record (EHR).
The critical information (date of last label update + Boxed warning) would have been brought to the physician’s attention at the point of care when Tussionex was e-prescribed.
PDR BRIEF provides drug information on four brief lines (as shown above) whenever a drug is e-prescribed or when the drug name is detected on the EHR screen or in any EHR application or website. The highlighted word(s) provide links to the information detail. PDR BRIEF serves as a companion to existing embedded drug database and drug interaction checking tools. It also provides access to the latest FDA-approved patient education and financial assistance information, which will improve medication adherence and patient satisfaction.
Adverse drug events have become a subject of considerable attention, both in the medical literature and lay press. A recent study1 conducted by researchers from the Centers for Disease Control and Prevention reported that adverse drug events account for nearly 100,000 hospital admissions each year for adults 65 years of age or older.
Approximately two-thirds of these admissions are related to unintentional overdoses involving a few commonly used medications. Roughly one-third involved warfarin, and another one-third involved insulins, oral hypoglycemic agents, and oral antiplatelet agents. In another report,2 the National Center for Injury Prevention and Control found that the number of overdose deaths from prescription painkillers (including hydrocodone, oxycodone, oxymorphone, and methadone) is greater than deaths from heroin and cocaine combined and accounted for nearly half a million emergency department visits (resulting from both misuse and abuse) in 2009.
Because malpractice claims involving prescription medications are common, and the FDA-approved labeling is often the standard to which physicians are held, The Doctors Company has performed several claims analyses to determine the incidence of medication-related errors and to identify the drugs most commonly involved. The results are summarized below.
We reviewed 363 consecutive claims from The Doctors Company that settled in an indemnity range of $100,000 to $500,000 between January 2004 and January 2006. These claims involved all medical specialties. Medication-related errors were present in 12 percent of these claims and accounted for 32 percent of total system errors. Overall, 48 percent of these medication-related errors occurred in internal medicine, psychiatry, and family practice claims.
- 43% were monitoring errors (one-third involved Coumadin)
- 26% were dosage errors
- 10% involved inappropriate medication
- 10% involved medication side effects
- 7% were medication reconciliation errors
- 4% involved medication allergic reactions
Since settlement requires concurrence of the patient (and his or her attorney) with the physician (and his or her insurance company) and generally requires the consent of the insured physician, settled claims contain a higher incidence of medical and/or system error than the universe of all medical professional liability claims.
Therefore, the 12 percent incidence of medication-related errors in this study is predictably higher than one would expect when looking at all closed claims.
We also reviewed 3,310 consecutive claims from The Doctors Company that closed in 2010. These involved all medical specialties. Medication-related errors were present in 6 percent of these claims.
- 31% were monitoring errors involving Coumadin, Lovenox, and gentamicin
- 19% involved giving the wrong medication
- 17% involved failure to follow a guideline or protocol
- 14% involved giving the wrong dosage
- 14% were drug administration errors
- 5% were ordering errors
Because of the large size of this sample that included all closed claims and all specialties, the 6 percent incidence of medication-related errors is probably an accurate estimate of their incidence in all medical professional liability claims.
We reviewed 369 internal medicine claims that closed between 2000 and 2007 from a subsidiary of The Doctors Company. Medication-related errors were present in 10 percent of these claims, and 58 percent of these errors involved improper medication management. The following medications appeared repeatedly in these claims:
- 59% involved anticoagulants, and 81% of these involved Coumadin; 46% of the Coumadin claims resulted from failure to monitor using the international normalized ratio (INR)
- 15% involved gentamicin ototoxicity and nephrotoxicity
- 15% involved improper antibiotics selected for pneumonia
- 11% involved injury related to steroids
Since nearly one-half of medication-related errors occur in internal medicine, psychiatry, and family practice claims, the 10 percent incidence of medication-related errors in this study confined to internal medicine claims is also predictably higher than one would expect when looking at closed claims from all medical specialties.
We reviewed 140 medication-related internal medicine claims that closed from 2000 through 2011 from The Doctors Company and a subsidiary. The following medications were most frequently involved:
- 24% involved anticoagulants (Coumadin 20%, Lovenox 4%)
- 18% involved opioids (oxycodone, hydrocodone)
- 7% involved gentamicin
- 10% involved steroids (Kenalog 5%, prednisone 5%)
The incidence of medication-related errors in medical professional liability claims is approximately 6 percent. The classes of drugs most frequently involved in medication-related errors are anticoagulants (chiefly Coumadin), antibiotics (particularly gentamicin), opioids, and steroids. Monitoring is the most common medication-related error—which accounts for the prevalence of Coumadin and gentamicin in these medication-related claims.
Strategies for mitigating medication-related errors include:
- Signing up for the free online PDR Drug Alert service at www.PDR.net.
- Reading the entire FDA-approved labeling for the drugs most commonly prescribed.
- Using an EHR that provides the full updated FDA Alerts and labeling from the PDR BRIEF service.
- Budnitz DS, Lovegrove MC, Shehab N, Richards CL. Emergency hospitalizations for adverse drug events in older Americans. N Engl J Med. 2011;365(21):2002-12.
- Centers for Disease Control and Prevention. Prescription painkiller overdoses in the U.S. Vital Signs. http://www.cdc.gov/vitalsigns/PainkillerOverdoses/. Published November 2011.
Dr. Troxel’s analysis of pathology claims from 2004 through 2010, “Trends in Pathology Malpractice Claims,” appears in the January 2012 online issue of the American Journal of Surgical Pathology.
By David B. Troxel, MD, Medical Director, Board of Governors.
This article originally appeared in The Doctor’s Advocate, first quarter 2012 (www.thedoctors.com/advocate).
The guidelines suggested here are not rules, do not constitute legal advice, and do not ensure a successful outcome. The ultimate decision regarding the appropriateness of any treatment must be made by each healthcare provider in light of all circumstances prevailing in the individual situation and in accordance with the laws of the jurisdiction in which the care is rendered.