By Laura Hale Brockway, ELS, Assistant Vice President, Marketing, and
Anthony Passalacqua, Risk Management Representative
Presentation
A 16-year-old boy came with his mother to an appointment at a dermatology practice for treatment of acne. The patient had face and back acne that included redness, blemishes, scarring, and white and black heads.
Physician action
Dermatologist A’s physician’s assistant (PA) saw the patient, and they discussed the patient’s previous acne treatments. The patient had tried doxycycline, Skin ID, Proactiv, and green tea without success. The PA discussed treatment options and prescribed topical adapalene and benzoyl peroxide gel and doxycycline. The patient was told to follow up with the PA.
Two months later, the patient returned to see the PA. The patient appeared to have experienced good results and had fewer areas of acne on his neck and face. Treatment was continued and the patient was noted to be doing well at subsequent follow-up appointments.
About 15 months later (on July 28), the patient and his mother saw the PA for another follow-up visit. The PA evaluated the patient and counseled him on the importance of complying with the treatment and only using the gel and antibiotics during acne flare ups.
According to the PA (but not documented in the record for this visit), the patient mentioned he had scarring on his abdomen that began the previous year and was worsening. The patient’s mother reported that they had mentioned this concern to the patient’s pediatrician. The pediatrician informed them that the scarring was likely stretch marks associated with the patient being overweight. The patient’s mother insisted the diagnosis of stretch marks was incorrect, because her son was not overweight.
The PA examined the patient’s abdomen and noted areas of inflamed and depressed wrinkle-like thinning of the skin in a vertical formation in varying shades of red, pink, tan, and the patient’s skin color.
The PA voiced the same conclusion as the pediatrician: the marks were striae (stretch marks). He told the patient and his mother that the marks were caused by the patient’s obesity. The mother insisted that her son was not overweight and he could not have stretch marks. At the time of this visit, the patient weighed 225 pounds and was 5’10” tall with a BMI of 32.
The PA recommended an over-the-counter scar cream and told the patient that losing weight would prevent additional or worsening stretch marks. The patient’s mother asked about prescription-strength alternatives, and the PA discussed the available options of topical retinols or compound scar gel.
At the request of the patient’s mother, the PA wrote a prescription for a compound scar gel containing a steroid. While not charted or indicated on the prescription, the PA told the patient to use the medication for two weeks on, then two weeks off. He did not want the patient to use the steroid gel for long intervals. He also referred the patient to a cosmetic dermatologist to discuss alternatives.
The patient’s first prescription for the steroid gel was dispensed on July 28 for a 13-day supply. On September 9, the pharmacy sent a refill request for the steroid gel to the PA. After considering the amount of time that had elapsed between prescriptions, the PA believed the patient was compliant with the medication instructions. The patient also did not raise any concerns about the medication. The PA authorized four refills.
The patient did not refill the steroid gel until January 5, again for a 13-day supply.
On February 26, the patient and his mother returned for a follow-up visit with the PA. The patient had used one refilled 13-day supply. The PA noted the patient’s stretch marks were bigger. The patient said he had been using the steroid gel almost daily without breaks, contrary to the instructions he had received. The PA was concerned that all four prescription refills had been used.
He told the patient to stop using the steroid gel and wrote a prescription for a compounded scar cream that did not contain a steroid. The PA referred the patient to a cosmetic dermatologist for treatment of the striae. The prescription for the non-steroidal scar cream was filled on February 27 and refilled on April 14.
On April 15, the dermatology practice received a report about the patient from the cosmetic dermatologist. The report stated that the patient had large atrophic striae on his flanks and that the striae were attributable to the topical fluorinated steroid gel prescribed by the PA. The cosmetic dermatologist gave the patient a tretinoin cream and told the patient the striae would take months to heal. Dermatologist A, who never saw the patient, did not contact the cosmetic dermatologist about the report.
The patient later sought treatment for the stretch marks from another dermatology group. After two laser resurfacing procedures, he experienced some improvement.
Allegations
A lawsuit was filed against the PA and Dermatologist A (who supervised the PA). The allegations against the PA included failure to conduct a prudent, differential diagnosis to explain the patient’s condition; prescribing a contraindicated and dangerous medication that contained a steroid for repeated application over a protracted period of time; and failure to monitor the side effects of the medication.
The allegations against Dermatologist A included failure to supervise.
Legal implications
A weakness in this case — identified by the defense dermatology experts — was the prescription of the topical scar gel for the patient’s stretch marks. This was an off-label use, and two reviewers stated that this was not appropriate treatment. Another weakness was that the PA authorized four refills without seeing the patient in follow up. Consultants were also concerned that the patient never saw the supervising physician at any visit, even when the patient’s mother questioned the PA’s treatment.
Documentation was also an issue in this case, specifically the lack of detailed information about the reason the steroid gel was prescribed. There was no mention of the patient’s striae in the medical records and no justification for the prescription.
Regarding causation, though reviewers said the steroid gel was inappropriate, they also said that using it did not worsen the patient’s striae or have an impact on his outcome. The patient’s primary care physician prescribed a stronger steroid cream after the patient stopped using the gel prescribed by the PA. It was possible the subsequent scar cream caused the patient’s striae to worsen.
When it came to the actions of Dermatologist A, one consultant stated that he acted within the standard of care for the supervision of a PA. The Texas Medical Board does not require a physician to directly supervise a PA for all patient visits, and Dermatologist A was always available to the PA by phone.
Disposition
This case was settled on behalf of the PA and the dermatology practice.
Risk management considerations
During follow-up appointments, it is important to establish and document medication compliance and reconcile medications. Doing so allows a provider to check-in on the patient, monitor any changes to the patient’s health, and avoid adverse drug interactions.
In this case, the patient was provided with multiple refills for an off-label medication and there was a greater length of time between follow ups. These factors made it challenging for the PA to accurately assess compliance. If the PA had followed up more routinely with the patient, he may have discovered that the patient was not using the medication correctly and as prescribed.
When documenting prescriptions, remember “the rights for medication administration” to reduce medication error, which include: the right patient, drug, dose, route, and time. It is also important to include within your note any specific instructions, discussion of potential side effects, the rationale for the prescription, risks and benefits, patient education, and patient consent to proceed. Consent is especially important when prescribing any medication in an off-label manner.
Effective communication between a physician and the providers he or she supervises is critical in establishing and confirming that proper care is being given to a patient. When employing an advanced practice provider (APP), it is important to have written protocols regarding prescriptive authority agreements (PAA), responsibilities, scope of practice, and standing delegation orders.
The protocols should address conditions and/or circumstances that warrant a consultation between the APP and supervising physician. Physicians who enter into or are parties to a PAA should review rules set forth by their licensing board. In Texas, Occupations Code 157.0512-0514 outlines eligibility for entering into a PAA, the minimum requirements of a PAA, some exceptions, and any inspections or audits of medical records or activities relating to the implementation and operations of the agreement. 1
Written policies and procedures are helpful to ensure a standardized process is followed by both supervising physician and staff members and that each care team member understands their responsibilities. Whenever policies and procedures are updated or changed, communicate these changes within your organization or practice. Instruct all employees to sign and date the policies and procedures to acknowledge they have read and understand the changes.
If the dermatology practice was following its policies and procedures when treating this patient, then this case illustrates a need for the practice to revisit its guidelines to ensure complete, contemporaneous documentation and clear communication between physicians and employees.
Physicians who delegate duties are vicariously liable for the actions of their employees. The Texas Occupations Code 157.001 (b) states, “the delegating physician remains responsible for the medical acts of the person performing the delegated medical acts.” Physicians should consider maintaining employee records for each staff member that include any standing delegation orders, a written job description, signed confidentiality agreements, current licenses and verifications, signed acknowledgment of policies and procedures, and transcripts for all training obtained.
Source
1. Texas Occupations Code. Title 3. Health Professional. Subtitle B. Physicians. Chapter 157. Authority of Physicians to Delegate Certain Medical Acts. Subchapter A. General Provisions. Available at https://statutes.capitol.texas.gov/Docs/OC/htm/OC.157.htm. Accessed November 3, 2020.
Laura Brockway can be reached at laura-brockway@tmlt.org.
Anthony Passalacqua can be reached at anthony-passalacqua@tmlt.org.
