by Laura Hale Brockway, ELS, Vice President, Marketing, and
Emma Louise, Risk Management Representative
A 69-year-old woman came to see her family physician for hip pain on August 3. She reported the pain occurred constantly in her left posterior hip, radiating to her left knee. The pain was aggravated by movement and was described as aching, sharp, and stabbing. She also reported joint pain.
The patient’s medical history included diabetes, hypertension, coronary artery disease, GERD, elevated lipids, sleep apnea, and chronic pain.
The family physician’s assessment was chronic bilateral low back pain with sciatica, left anterior knee pain, and pain of the left hip. He prescribed exenatide, diphenoxylate/atropine, ropinirole, and nateglinide.
Labs were drawn and the results were normal, with the exception of elevated uric acid of 7.5 (range 2.6-7.2). On August 10 — after the lab values were returned — the family physician added allopurinol for the patient’s gout.
Five weeks after her visit to the family physician, the patient was transported to a local emergency department (ED) by ambulance. She reported general weakness and an inability to stand. She had a temperature of 102.8 degrees; nausea and vomiting; swelling over her eyes; and a rash on her chin and neck. The results of a chest x-ray and abdominal CT scan were normal.
The assessment in the ED was sepsis secondary to tonsilitis, suspected disseminated gonorrhea infection, hypertension, high cholesterol, diabetes, coronary artery disease, and congestive heart failure. The following medications were discontinued: allopurinol, lubiprostone, aspirin, folate, furosemide, glipizide, metformin, amlodipine, ropinirole, promethazine, and simvastatin.
An infectious disease physician was consulted. She noted that the patient had a number of medications — including allopurinol — that could cause a drug reaction. She also mentioned a possible bacterial infection, disseminated viral infection, as well as the patient’s other comorbidities.
The patient was admitted under the care of a hospitalist. Over the next two days, the patient developed painful, blistering lesions on her face and chest. The hospitalist diagnosed sepsis on multiple antibiotics, erythema multiform with impending Stevens-Johnson syndrome (SJS). He also noted that she had uncontrolled hypertension, diabetes with tachycardia, fever, and possible sepsis syndrome. The patient was transferred to the burn unit at a regional hospital.
The admitting diagnosis to the burn unit was severe SJS associated with allopurinol. The patient had skin lesions on her chest, back, arms, legs, face, and scalp, along with mucosal and ophthalmologic involvement. Her hospital stay was complicated by dysphagia and an ileus requiring placement of an NG tube. Her condition improved and she was discharged after five weeks.
After her discharge, the patient was diagnosed with SJS-related symblepharon, a condition in which the bulbar and palpebral conjunctiva form an adhesion to one another. Despite treatment from several ophthalmologists over a two-year period, the patient can see only hand motion in both eyes.
A lawsuit was filed against the family physician, alleging that he failed to properly examine the patient and prescribed an unnecessary medication, allopurinol. The allopurinol then caused the patient’s life-threatening illness and blindness. Further, the plaintiffs alleged that the family physician pursued an unreasonable workup for symptoms without documenting the rationale for his decision-making.
Through their experts, the plaintiffs argued that there was nothing in the patient’s clinical presentation or visit notes on August 3 to suggest a diagnosis of gout. The defendant did not document a focused exam or workup surrounding the gout diagnosis. The records mention hip pain radiating to the knee, but there was no assessment or plan to address these symptoms.
According to these reviewers, gout symptoms frequently include acute inflammation of the small joints. They felt the patient’s symptoms were more indicative of arthritic pain than gout. Further, her elevated uric acid levels could have been explained by some of the medications the patient was already taking.
Physicians who reviewed this case for the defense were mixed in their opinions of the family physician’s actions. From a causation perspective, several reviewers believed the patient had sepsis, not a reaction to allopurinol. Her labs showed 90% neutrophils, which indicated a bacterial infection. Further, given the patient’s elevated uric acid, prescribing allopurinol was appropriate. It was also possible that another medication the patient was taking caused her SJS.
The biggest challenge in the defense of this case was the family physician’s documentation. From the records, it looked as though he diagnosed the patient with gout without documenting a physical exam to corroborate the diagnosis. The records also did not include documentation of the allopurinol dose, how it was to be taken, risk/benefits of the medication, and when labs needed to be re-checked.
Three years after the patient’s hospitalization and while preparing to testify in this case, the family physician discovered an additional record entry dated August 10. This entry shows an electronic transaction record of the family physician’s review of labs, diagnosis of gout, and prescription of allopurinol. The family physician could not explain why this record had not been produced when the lawsuit was filed, other than his practice group used an outside entity to keep and manage records. The group’s custodian of records testified to the authenticity of the August 10 record entry.
This case was settled on behalf of the family physician.
Risk management considerations
The prominent issues affecting this case included multiple failures to document the physician’s examination and diagnosis of the patient’s gout and provide patient education on the prescribed medications and required follow-ups.
Another issue includes the physician’s failure to maintain patient records in an accessible manner to enable easier reference to the patient’s treatment timeline and allow timely continuity of care.
Insufficient documentation can lead to significant liability issues, as well as continuity of care and potential financial issues. Although rules will vary from state to state, documentation standards in the medical record are an important factor for quality patient care in all states. The Texas Medical Board (TMB) Rule 165.1 says, an adequate medical record should be “complete, contemporaneous, and legible.” 1 Well-organized and complete medical records are necessary to maintain the integrity of a patient’s care plan.
To ensure efficient accessibility of documentation, TMB rule 165 also states that “past and present diagnoses should be accessible to the treating and/or consulting physician.” 1 Providers should ensure that the patient records they maintain accurately reflect and support the diagnosis and recommended treatment at every patient encounter.
To avoid adverse drug reactions, it is critical to review, reconcile, and discuss the risks/benefits, dosage, and instructions for any medications prescribed with the patient and/or their caregivers. One study found that providers informed their patients of important medication information less than 60% of the time, and informed patients of adverse effects less than one third of the time. 2
Medications need to be reviewed at each appointment to monitor compliance, identify new medications or treatments since previous appointments, and determine the patient’s tolerance of these medications. Patients may be advised to complete repeat labs or contact the office for questions or concerns regarding new medications; however, it is best practice for the physician to have a follow-up system in place. Documentation of the physician’s instructions regarding follow up might have helped support the defensibility of this case.
According to the American Medical Association (AMA) Code of Medical Ethics, appropriate medical record management includes a physician’s obligation to “manage the records of current patients, but also retain old records against possible future need.” 3
Specific to this case, AMA states physicians should retain “information that another physician seeing the patient for the first time could reasonably be expected to need or want to know unless otherwise required by law” and should retain records of “significant health events or conditions and interventions that could be expected to have a bearing on the patient’s future health needs.” 3
Missing information in the patient record, such as a thorough assessment and diagnosis, education on new medications, and poor monitoring of patient follow up, created difficulty in defending this case.
In addition, this provider used an outside entity to manage patient records. Establishing a business associate agreement with electronic health record (EHR) vendors is critical for controlling and safeguarding EHR data (Mahler, 2016). It is recommended to regularly perform self-audits, back-ups, and recovery processes to maintain the integrity of your medical records.4
1. Texas Medical Board. Texas Medical Board Rules Chapter 165 Medical Records. Rule 165.1(6)(C)(D). Available at https://texreg.sos.state.tx.us/public/readtac$ext.TacPage?sl=R&app=9&p_dir=&p_rloc=&p_tloc=&p_ploc=&pg=1&p_tac=&ti=22&pt=9&ch=165&rl=1. Accessed March 11, 2022.
2. Tarn DM, Heritage J, Paterniti DA, et. al. Physician Communication When Prescribing New Medications. Archives of Internal Medicine. JAMA Network. September 25, 2006. Available at https://jamanetwork.com/journals/jamainternalmedicine/fullarticle/410942. Accessed March 24, 2022.
3. American Medical Association. Management of Medical Records. Code of Medical Ethics Code 3.3.1. (B) (ii). Available at https://www.ama-assn.org/delivering-care/ethics/management-medical-records. Accessed March 14, 2022.
4. EHR Contracts Untangled: Selecting Wisely, Negotiating Terms, and Understanding the Fine Print. The Office of the National Coordinator for Health Information Technology. September 2016, Available at https://www.healthit.gov/sites/default/files/EHR_Contracts_Untangled.pdf. Accessed March 24, 2022.
Laura Hale Brockway can be reached at email@example.com.
Emma Louise can be reached at firstname.lastname@example.org.