For PAs, Medication Risks Are Malpractice Risks: Safety Strategies

Ginger Biesbrock, DSc, PA-C, MPH, National Heart and Vascular Service Line Administrative Leader, Advocate Health and Member, TDC Group APC Advisory Board; Angela Jordan, RN, MHSc, CPHRM, Coding Manager, Patient Safety and Risk Management, The Doctors Company

Summary

Medication-related harm is a top malpractice allegation against physician assistants. PAs can protect their patients and their careers through proactive safety strategies.

Practitioners sometimes ask themselves: Do my patients’ records show a current list of all prescribed medications, over-the-counter medications, and supplements? Do my patients’ records prominently display allergy information? How confident am I that all high-risk medications are being managed and monitored? Am I certain that allergies and medications are getting updated at every visit?

When medication errors occur, they are likely to involve severe harm, including patient deaths. In U.S. healthcare overall, medication‑related malpractice allegations account for one in nine malpractice cases, and when litigation follows a medication-related adverse event, the financial costs are likely to be high. Medication issues have an outsized impact on both patient safety and practitioner liability.

To aid physician assistants (PAs) in mitigating their practice risks, The Doctors Company has analyzed 576 allegations of malpractice against PAs in cases that closed over a nearly 15-year period (2010 to 2024). Medication-related harm was among the top 4 allegations against PAs. Examining these closed medical malpractice claims using an evidence-based taxonomy1 reveals how routine medication decisions, workflows, and gaps in care can align to produce serious adverse outcomes—but it highlights potential solutions, too. Through steady commitment to patient safety habits at both the individual clinician level and the practice-wide level, PAs and their teams can help prevent medication-related adverse events.

The Swiss Cheese Model of Accident Prevention

Events that precede malpractice allegations typically have multiple contributing factors, which can be understood through the Swiss cheese model of human error and accident causation: Patient harm doesn’t usually result from a single mistake, because healthcare systems have multiple layers of defense, but there can be “holes” in those layers—and if those holes align, an error can reach the patient.

Our data analysis explores how overlapping gaps in healthcare’s safety systems can align to allow harm to reach PAs’ patients, and how PAs can prevent this from happening in their practice.

Injury Severity and Financial Severity

Among the studied medication-related claims, 34 percent involved a high-severity injury (as defined by the National Association of Insurance Commissioners Severity of Injury Scale) or death.

The average indemnity—meaning the compensation paid to a patient or family member related to a specified accident, incident, or event—for PA cases involving medications was $347,000, and 44 percent of medication-related claims against PAs closed with an indemnity paid.

More Medication Errors Occurred in Outpatient Settings

For PAs, it’s outpatient settings that represent higher‑risk environments for medication errors: 74 percent of the events that precipitated medication-related malpractice allegations occurred in the physician office or clinic. Anticoagulants and anti-infectives (such as antibiotics, antivirals, and antifungals) were the most commonly appearing medications in the claims studied.

Common Contributing Factors

Claims generally have more than one contributing factor. Our analysis found the top contributing factors in medication-related claims against PAs to be:

  • Clinical judgment (73 percent). Under the subcategory of selection and management of therapy, we saw alleged errors including prescribing medication dosages that are too high, failing to consider the risks of opioids relative to the patient’s comorbidities, prescribing excessive opioids for prolonged time periods, and failing to adjust or try different medications for patients with continued symptoms or no change in their symptoms.
  • Communication (65 percent). Gaps occurred among team members and/or between practitioners and the patient/family.
  • Behavior related (50 percent). Patient nonadherence to medications and/or treatment plans contributed to adverse events.
  • Documentation (33 percent). When documentation leaves apparent gaps in clinical reasoning, claims against PAs can be hard to defend.

Figure 1. Medication-Related Allegations Against PAs: Top Contributing Factors

PA Chart

Case Example: Patient Death

A patient diagnosed with colon cancer began a 12-week chemotherapy regimen. Halfway through, the patient came in for chemotherapy. Their labs showed white blood count (WBC) 3.3 × 10⁹/L (normal range is 4.0–11.0 × 10⁹/L), neutrophils 0.7 × 10⁹/L (normal range is 1.5–8.0 × 10⁹/L), and neutrophil differential percentage of 20.4 percent (normal range is 40 to 70 percent). The PA saw the labs but started the treatment. Nearing the end of the treatment, the patient was seen by another practitioner, who noticed the low counts and ordered Neulasta—but the Neulasta was never given. About a week later, the patient presented to the ED with weakness and vomiting. Their labs were as follows: WBC 0.5 x 10⁹/L (critically low), neutrophil differential percentage 20.7 percent (low), lactic acid 7.5 mmol/L (high).

The patient was diagnosed with severe neutropenia, consistent with chemotherapy treatment and neutropenic sepsis, and was admitted to the ICU, where they experienced multiple complications and died several days later.

This patient had been responding well to the chemotherapy, with an expectation of 40 to 50 percent chance for cure.

When objective lab values cross safety thresholds, continuing therapy becomes a clinical decision. In medication-related malpractice claims, often harm has occurred because labs were seen but not acted upon. Further, management doesn’t end with the order—it includes follow‑through, confirmation, and completion of the plan.

Case Example: Limited Mobility

A patient came into the office complaining of cough, weakness, and diarrhea for about a week. The patient had been on a Z-Pak with no improvement. The PA noted no rales or rhonchi but wanted to rule out pneumonia: A chest x-ray was negative. The PA ordered 500mg Levaquin daily. Four days later upon follow-up, the patient reported feeling better but still had fatigue and a cough. The patient’s gait was normal, no joint pain or swelling. Levaquin was continued.

Five days later, the patient had finished the Levaquin and saw the PA with a complaint of bilateral heel pain for two to three days. The impression was tendonitis, and topical gel was ordered. The next week, after a fall, the patient came to the office complaining of heel pain. The PA’s exam revealed a lump on the Achilles, with tenderness reported: An MRI showed a complete tear. The patient currently has problems walking.

Experts were not supportive of the decision to order Levaquin. First, the bronchitis was likely viral, so the need for any antibiotic was questionable. The choice of Levaquin, with its risk for tendon rupture and black box warning (which was not discussed with the patient), was also questionable, especially given the higher dose. Levaquin is a good choice for treating pneumonia, but in this case, Augmentin would have been a better option if an antibiotic was indicated at all. When the patient returned the first time with complaints of heel pain, there was little assessment or testing for a possible tendon rupture. There was limited documentation of any reassessment when new symptoms developed, and the PA continued the medication despite new musculoskeletal symptoms; this lack of focused monitoring is conspicuous, given Levaquin’s known adverse effects.

Reaping the Rewards of Risk Mitigation

Because personal vigilance can be depleted by stress or interruptions, it takes both safe personal practice habits and office-wide systems to prevent any of the “holes” in the “Swiss cheese” from lining up and letting hazards slip through. PAs are encouraged to embrace safety strategies that they can practice for themselves, including mindful medication reconciliation, thorough documentation, ensuring the diagnosis supports the medication use, educating patients about each medication’s purpose and benefits (as well as the risks of nonadherence), and engaging patients as safety partners. Practitioners are also encouraged to implement system-wide solutions with their teams, e.g., building in hard stops and integrating test tracking into office workflows. Attention devoted to medication safety will promote safer outcomes for patients and stronger careers for practitioners, with greater financial security for healthcare practices and organizations.


Reference

  1. Copyrighted by and used with permission of Candello a division of The Risk Management Foundation of the Harvard Medical Institutions Incorporated, all rights reserved.

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 considering the circumstances of the individual situation and in accordance with the laws of the jurisdiction in which the care is rendered.

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