Medical malpractice claims may be asserted against any healthcare provider, including nurse practitioners (NPs) as well as the practices that employ them. The insured in this case, presented by NSO and CNA, was a psychiatric nurse practitioner who held a Doctor of Nursing Practice (DNP) degree and also was the business owner of the behavioral health clinic. The clinic maintained a separate professional liability insurance policy that was in addition to the DNP’s individual policy.
Summary
This case involves a 29-year-old female patient who had a history of bipolar II disorder, Attention-Deficit/Hyperactivity Disorder (ADHD) and a generalized anxiety disorder for which she was prescribed antidepressants, anti-anxiety medications and an off-label mood stabilizer. The patient presented to the DNP for ongoing psychiatric care and reported a past history of discontinuing all of her medications, which resulted in the development of suicidal ideations. The DNP reviewed the patient’s psychiatric records and identified an ongoing pattern of non-adherence to the prescribed medication regime. The DNP counseled the patient about the importance of complying with the prescribed medication plan, but failed to document this discussion. Although the patient signed a consent form which listed the potential side effects of antipsychotics, including the risk of TD, there was no specific discussion of this risk, nor did the patient ask any questions about the side effects.
For approximately a year, the patient was treated by the DNP, vacillating between multiple medication changes and self-directed discontinuance of medications, with minimal improvement in symptoms. The patient’s non-adherence persisted, including an instance when she stopped taking all medications without consulting with the DNP. After approximately eleven months of treatment, the DNP notified the patient that he would be terminating the patient-provider relationship due to the ongoing non-adherence. The DNP followed the appropriate termination of care protocols, including providing the patient with proper notification, access to her healthcare information records and a referral for continuing care.
During the last month of treatment, the DNP prescribed new medications to treat depression and anxiety. Two weeks after prescribing these medications, the patient presented to the office complaining of neck stiffness. Based upon the patient’s complaints, the DNP again changed the medication. The following week, the patient was seen by the DNP for ongoing complaints of neck stiffness as well as other extrapyramidal symptoms, such as muscle spasms, akathisia and jerky movements. Medication was prescribed to treat the extrapyramidal symptoms. Following this office visit, the patient communicated with the DNP via the patient portal, reporting that she was unable to tolerate the new medication and that she had stopped taking it. In response to the patient’s continued symptoms, the DNP evaluated the patient in an office visit and diagnosed the patient with drug-induced tardive dyskinesia (TD). TD, a known side effect associated with dopamine-blocking antipsychotic medications, is
defined as “involuntary choreoathetoid movements usually associated with lower facial and distal extremity musculature.” The DNP provided the patient with medication samples for treatment of TD and referred the patient to a neurologist specializing in movement disorders. This was the last time that the DNP met with the patient.
Approximately three weeks later, the patient presented to the neurologist and reported that she had been having extrapyramidal symptoms for four months. The documentation in the DNP’s healthcare information record reflected a four-
week history, as opposed to four
months. During the medication reconciliation process, the neurologist identified that the patient had been taking an incorrect dosage of the sample medication provided to him by the DNP. Since the medication samples were not dispensed by a pharmacy, the patient had not received written instructions about the dosage. The neurologist provided the patient with a prescription for treatment of TD to be dispensed by a pharmacy, including detailed instructions for taking the medication. Over the course of the following year, the patient continued treatment with the neurologist with a moderate improvement in symptoms. However, the neurologist determined that the symptoms associated with the diagnosis of TD would be permanent.
Risk Management Comments
One year following the patient’s final visit with the DNP, a lawsuit was initiated against the DNP, the behavioral health clinic and the DNP’s supervising physician, asserting that the plaintiff (patient) developed permanent TD as a result of improper prescribing of mood stabilizing medications. The plaintiff further asserted that she was not informed of the risk of developing TD, and, if she had known, she would have sought alternative treatments. During her deposition, the plaintiff admitted that she signed a consent form stating that antipsychotic medications have the known side effect of TD, but testified that she did not understand the medical terminology in the consent form. In addition, there was an assertion that a delay in diagnosing and treating the TD caused this condition to be permanent. The plaintiff’s psychiatry expert opined that the DNP failed to monitor the patient for early signs of TD, and neglected to utilize the
Abnormal Involuntary Movement Scale (AIMS), developed by the National Institute of Mental Health , when the patient first reported symptoms. The plaintiff’s psychopharmacology expert testified that the DNP’s prescribed course of treatment was “chaotic”, reflecting multiple medication changes and omitting documentation to support the rationale for each of the changes.
Defense experts included a psychiatrist, a psychiatric nurse practitioner and a psychopharmacologist. Although they acknowledged that the plaintiff’s non-adherence to the treatment plan was probably a contributing factor to the development of TD, they were unable to support the DNP’s care and rendered the following opinions:
- There was a lack of documentation about the rationale for medication changes, including whether or not alternative, non-pharmacological types of treatment for medication-resistant depression were considered. A wide variety of potent antipsychotic drugs were prescribed without notable improvement in the patient’s symptoms.
- All of the DNP’s psychiatric assessments contained the same verbiage, giving the appearance that they were generated using the electronic medical record “copy and paste” function.
- The supervising physician was an orthopedic surgeon with no experience in psychiatry. There were no face-face discussions with the DNP regarding challenging patients, and the supervision was limited to “signing off” on the DNP’s documentation.
- There was a lack of concern for the severity of the risk related to the patient’s non-adherence/self-imposed “drug holidays.” Although the exact cause of the TD could not be determined, the experts believed that the repetitive “drug holidays” probably contributed to, or exacerbated, the TD.
The DNP asserted that the multiple medication changes were necessary due to the patient’s inability to tolerate certain side effects of the medication. The patient’s history of suicide attempts also was concerning to him, and, in his opinion, limited alternative treatment options. The DNP testified that he advised the patient to avoid abrupt discontinuation of the medications in order to limit the potential for unanticipated side effects. However, the patient failed to comply and would frequently stop taking the medication in an abrupt manner. Communication with the patient about the medications and warnings would often take place via the patient portal. The interactions in the portal were not accessible during litigation due to technical issues incurred during the transition to a different vendor. In retrospect, the DNP admitted that he should have documented all communications with the patient, as well as the rationale for medication changes, in the patient healthcare information record.
Resolution
Based upon the above-referenced defense challenges, the complex nature of the pharmacology and the sympathy factor associated with the plaintiff’s visible injury, defense attorneys concluded that there was a low likelihood for a successful defense of the DNP. Therefore, a settlement was negotiated in mediation on behalf of the DNP.
Total Incurred: More than
$500,000.
(Note: Figures represent the payments made on behalf of the insured and do not include any payments that may have been made from co-defendants.)
Risk Management Recommendations
- Remain current in knowledge of new and specialty medications, including but not limited to their pharmacology, side effects and drug-drug interactions. Consult with a pharmacist, as needed.
- Proactively monitor and assess patients on antipsychotic medications according to evidence-based industry standards, such as the American Psychiatric Association (APA) Guidelines, as early detection may increase the likelihood that complications will be transient and reversible.
- Utilize evidence-based clinical practice guidelines for treating TD and other side effects associated with antipsychotic medication use.
- Discuss the diagnosis, proposed treatment plan and reasonable expectations for outcomes with patients/families, in order to ensure their understanding of the plan of care and their responsibilities. Document this process, noting the patient’s responses.
- Conduct detailed informed consent discussions to ensure that patients understand the risks and benefits of the prescribed therapy.
- Discuss the following as part of the informed consent process when prescribing “off-label” medications and document the discussion with the patient:
- Details regarding the proposed off-label use and the use for which the medication received FDA approval.
- Known risks, complications, side effects and the potential for unknown risks related to the off-label use of the medication.
- Assess the patient’s health literacy level to ensure an adequate understanding of the information provided during the informed consent process and the patient’s role in the treatment plan. Consider using the “teach-back” method for communicating patient instructions about medications or other elements of the treatment plan.
- Educate the patient about the importance of adhering to treatment recommendations, medication regimens and screening procedures, and document these discussions.
- Capture advice rendered to patients via patient portals in the healthcare information record, as this information may not be accessible in the event that a lawsuit is filed.
- Ensure that supervisory relationships, when required, align with the specialty of the nurse practitioner and comply with state requirements. Execute contractual agreements outlining supervisory expectations through consultation with legal counsel.
- Document contemporaneously, factually, and comprehensively, and include the clinical decision-making process and rationale for the diagnosis and treatment plan. Limit the use of the “copy and paste” function when documenting in the electronic healthcare information record. Objective and concise documentation is integral both continuity of patient care, as well as for the defense of a potential malpractice claim. A comprehensive healthcare information record is the best legal defense.
- Manage sample medication dispensing, storage, access, tracking and documentation in conformity with state/federal pharmaceutical regulations. Consider the following guidelines among others:
- Maintain medication logs documenting lot numbers, patient name, dose, frequency and amount dispensed.
- Track drug recalls, maintain proper drug storage and monitor expiration dates.
- Provide patients with written instructions about the prescription using clear language, while avoiding medical terminology.
- Maintain proper security of medication storage area to avoid misuse.
- Ensure that all dispensed samples are accompanied by a prescription and detailed dosing instructions.
References
Disclaimers
These are illustrations of actual claims that were managed by the CNA insurance companies. However, every claim arises out of its own unique set of facts which must be considered within the context of applicable state and federal laws and regulations, as well as the specific terms, conditions and exclusions of each insurance policy, their forms, and optional coverages. The information contained herein is not intended to establish any standard of care, serve as professional advice or address the circumstances of any specific entity. These statements do not constitute a risk management directive from CNA. This material is for illustrative purposes and is not intended to constitute a contract. No organization or individual should act upon this information without appropriate professional advice, including advice of legal counsel, given after a thorough examination of the individual situation, encompassing a review of relevant facts, laws and regulations. CNA assumes no responsibility for the consequences of the use or nonuse of this information.
This publication is intended to inform Affinity Insurance Services, Inc., customers of potential liability in their practice. This information is provided for general informational purposes only and is not intended to provide individualized guidance. All descriptions, summaries or highlights of coverage are for general informational purposes only and do not amend, alter or modify the actual terms or conditions of any insurance policy. Coverage is governed only by the terms and conditions of the relevant policy. Any references to non-Aon, AIS, NSO, NSO websites are provided solely for convenience, and Aon, AIS, NSO and NSO disclaim any responsibility with respect to such websites. This information is not intended to offer legal advice or to establish appropriate or acceptable standards of professional conduct. Readers should consult with a lawyer if they have specific concerns. Neither Affinity Insurance Services, Inc., NSO, nor CNA assumes any liability for how this information is applied in practice or for the accuracy of this information.
Nurses Service Organization is a registered trade name of Affinity Insurance Services, Inc., a licensed producer in all states (TX 13695); (AR 100106022); in CA, MN, AIS Affinity Insurance Agency, Inc. (CA 0795465); in OK, AIS Affinity Insurance Services, Inc.; in CA, Aon Affinity Insurance Services, Inc., (CA 0G94493), Aon Direct Insurance Administrators and Berkely Insurance Agency and in NY, AIS Affinity Insurance Agency.