To err is human, and therefore also part of being a doctor. At the 28th Further Education Week for Practical Dermatology and Venereology, held last month in Munich, Peter Elsner, MD, former director of the department of dermatology at University Hospital Jena in Switzerland, presented the most common dermatologic treatment failures and provided important tips on prevention and correct procedure.
Informative Case Report
“We have to take an active approach to patient safety and deal with the fact that mistakes can happen, even in medical practice,” said Elsner, who has been active at the SRH dermatology outpatient clinic in Gera, Germany, and as a member of the bar association in the field of medical law.
Elsner presented the case report of a patient treated at a clinic for acute arterial occlusion in the left leg. An allergy to Novalgin (metamizole) and penicillin had already been noted on the patient referral.
Despite this warning, the patient was given Novalgin and tramadol intravenously for pain treatment shortly after admission. The patient also received Gramaxin (amoxicillin-trihydrate and clavulanic acid) intravenously for prophylaxis following the arterial thrombectomy.
As one might expect, the patient developed a generalized exanthem. The dermatologic team diagnosed this as a fixed drug eruption using dermatohistology. The discharge report included diagnoses of an allergy to penicillin and Novalgin and a fixed drug eruption. It recommended an allergology work-up. This work-up was apparently never performed though, said Elsner. The patient also did not receive an allergy pass.
Warnings Ignored
Four years later, the patient was taken to the same hospital with severe upper abdominal pains, fever, chills, nausea, and diarrhea. The ambulance team had already noted a penicillin allergy on the documentation forms. Since the patient could not provide any information himself due to the pain, his wife was questioned. She emphatically and repeatedly mentioned the patient’s allergies to Novalgin and penicillin. The staff responded, “Yes, yes, we know. Everything’s on the computer.”
On the day of admission, the patient repeatedly received short-term infusions of Novalgin and buscopan, and these were administered four times daily from the following day. Skin redness developed, which the internal medicine specialists interpreted as sunburn due to the summer weather and treated with after-sun lotion. On the third day, he only received two more infusions of Novalgin and buscopan, then it was discontinued.
After five days, the patient was transferred to the dermatology clinic due to a severe skin reaction. The diagnosis read, “Toxic epidermal necrolysis (TEN) due to known metamizole allergy based on the typical clinical picture (bullous drug reaction over 70% of the surface of the body including genitals, but not oral mucosa) and the corresponding histology.”
A suspected disease pass was issued and presented to the panel of experts at the Documentation Center for Severe Skin Reactions (dZh) at the University Hospital Freiburg, Germany. They concluded that Novalgin was the likely trigger of the generalized, bullous, fixed drug eruption.
The Swiss Cheese Model
“Here’s an important maxim for you to remember: mistakes rarely come alone,” said Elsner. The so-called Swiss cheese model suggests that a hazard can only evolve into an incident or adverse event if the compensation mechanisms (such as people or technical precautions) fail, that is, if “holes” form.
These “holes” form through active (mistakes and violations by physicians, nurses, or caregivers) and latent human failure (through decisions that are made at higher levels of an organization), are influenced by contributing factors, and are otherwise “dynamic.” They open, close, or shift over time.
In the case presented, Elsner believes that the mistakes could have been avoided if the admission sheet had been read and acted on accordingly before the initial treatment commenced. The same applies for the medical report after discharge. In the second treatment, the secondhand medical history from the wife should have been taken seriously. It is also important to gather a panel of experts promptly when reactions develop and not wait for days before doing so, explained the dermatologist.
Legal Obligations
The physician is obliged to use the most up-to-date state of medical knowledge. There are numerous due-diligence obligations to comply with this, just as there are possible sources of error. These sources can be divided into the following categories:
Treatment Mistakes
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Treatment in contradiction of the “generally recognized specialist standard existing at the time of treatment.” This is not the gold standard, but rather the standard of treatment that could be provided by an average physician in the respective field (specialist standard).
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Guidelines are helpful, deviations are possible (they are not the ultimate wisdom).
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Experts must provide the expert standard!
Gross Treatment Mistakes
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If the physician clearly contradicts tried-and-tested medical treatment rules or proven medical knowledge, and an error occurs, then this no longer seems objectively understandable, because said knowledge absolutely must not be circumvented by a physician.
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The physician must prove that every injury alleged by the patient cannot be attributed to the physician or the treatment.
Medical Advice Mistakes
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Every single factor essential for consent must be explained orally, promptly (at least 1 day before, or ideally before admission in the case of inpatient treatment), and in an understandable manner.
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Describe the worst-case scenario for side effects.
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The burden of proof when explaining lies with the physician.
Mistakes When Collecting Findings
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Medically required findings are not collected promptly.
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A lack of dermatologic examination of an excised sample.
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Mistakes can place the burden of proof on the physician.
Safety Advice Mistakes
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The patient is not offered any therapeutically required advice about ways to ensure successful healing, protect against intolerance risks, or avoid other disadvantages.
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The patient or physicians providing follow-up treatment are not informed about collected findings to ensure proper follow-up treatment.
Documentation Mistakes
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All essential information and treatment results that are significant from a specialist’s perspective for current and future treatment must be documented. This information includes medical history, diagnoses, examinations, examination results, findings, therapies, and interventions, as well as their effects, consents, and explanations. Medical reports from previous and current practitioners also must be included.
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The patient file should also contain laboratory results, printouts from examinations with imaging procedures, X-ray images, surgical reports, anesthesia records, nursing forms, pharmacologic prescriptions, and work-incapacity certificates.
Mistakes from “Fully Controllable Risk”
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The practitioner must rule out the materialization of risk.
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Classical mistakes include a surgical tool forgotten in the abdominal cavity, positional damage during surgery, or mixed-up biopsies.
Most Common Mistakes
An analysis of treatment indications by 337 experts from the North German Arbitration Board suggests that treatment mistakes can occur in almost every diagnosis: from acne and psoriasis to lipoma. “But it is becoming more frequent in oncology,” Elsner added. He listed a failure to perform reflective microscopy, a failure to perform a biopsy, and a dermato-histologic misdiagnosis for melanoma among the most common mistakes in dermatologic oncology. For basal cell carcinoma, common mistakes are non–margin-controlled excision and a lack of follow-up excision, if the cancer is not excised in toto.
The expert analysis also revealed that only every third accusation of medical malpractice is confirmed in dermatology. A claim for compensation was made in more than 25% of cases. Most confirmed cases of dermatologic malpractice had mild to moderate permanent consequences, 7% had very severe permanent health consequences, and 5% resulted in death.
Responding to Mistakes
To avoid mistakes, a culture of safety should be established. This culture may include using checklists, guidelines, quality management, communication, teamwork, and a Critical Incident Reporting System (CIRS).
If a mistake occurs, the damage must first be minimized. Furthermore, the affected patient or patients must be informed as a matter of obligation. “However, one should think of a good situation and ideally conduct the discussion with witnesses, perhaps practice staff,” Elsner added.
The professional liability insurance company, as well as any superiors, must also be informed. Should any legal protection insurance be in place, it is recommended to contact the insurer.
Documentation should be secured. According to Elsner, it can be helpful to create a detailed report from memory and to add it to the files. He also advises securing witnesses and seeking legal advice.
This article was translated from Coliquio.
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