Research needed to determine how often adverse events occur in dermatology

July 1, 2010

Adverse events (AEs) following dermatologic procedures are a real possibility. However, the frequency of these events in dermatologic practice remains an unknown. Only after establishing which AEs occur and how often they appear can dermatologists begin to put forth sound preventive strategies to keep these unwanted events to a minimum, improving surgical outcomes in patients.

Key Points

Winston-Salem, N.C. - Adverse events (AEs) following dermatologic procedures are a real possibility. However, the frequency of these events in dermatologic practice remains an unknown. Only after establishing which AEs occur and how often they appear can dermatologists begin to put forth sound preventive strategies to keep these unwanted events to a minimum, improving surgical outcomes in patients.

"We as dermatologists do not know how often adverse events occur in dermatologic surgery, because it is simply not being tracked. Not knowing how often a given AE occurs and lack of specific guidelines in preventing these AEs from occurring makes it challenging to prevent them in the future," says Steven R. Feldman, M.D., Ph.D., professor of dermatology, pathology and public health sciences, and director of the Center for Dermatology Research, Wake Forest University School of Medicine, Winston-Salem, N.C. "Without knowing the magnitude of the problem, it's difficult to find an effective solution, and this needs to change."

Compared to surgeries and procedures performed in other specialties, dermatologic surgery is usually minimally invasive. Therefore, the AEs that can occur are typically less severe. Furthermore, most dermatologic procedures require only local anesthesia, not general or intravenous sedation. Nevertheless, AEs do occur, and it is in the interest of the dermatologic surgeon and the patient to minimize them.

Types of AEs

According to Dr. Feldman, AEs associated with dermatologic procedures can range from contact dermatitis-type reactions to adhesive tapes or topical antibiotics to wrong-site surgery, wound infections and bleeding complications.

A more evidence-based approach regarding the administration of antibiotic prophylaxis in dermatologic surgeries, as well as other safety measures, needs to be developed by dermatologists, for dermatologists. Meanwhile, following standard safety protocols and guidelines used by other surgical specialties prior to performing dermatologic surgery is one good approach to help circumvent complications.

Paying meticulous attention to all aspects of the surgery to be performed is a positive step toward prevention of AEs. Prevention of intra- and postoperative AEs can begin with a standardized, thorough presurgical workup and a meticulous physical and history taking that includes information about medications a patient needs to be - or not be - taking prior to the procedure being performed.

Beware blood thinners

Patients taking medications such as aspirin, Coumadin (warfarin, Bristol-Myers Squibb) and Plavix (clopidogrel bisulfate, Bristol-Myers Squibb/Sanofi-Aventis) need to be identified, and managing their medications prior to surgery can be crucial to achieving positive surgical outcomes. These blood thinners can impact the amount of bleeding the surgeon will encounter, as well as the post-operative bruising seen in both excisional surgery and laser surgery procedures. A risk-benefit analysis involving the patient's other physicians is needed when considering holding such medications.

"One safety measure that is fairly uniform in the in-patient setting where the patient is asleep is the idea of a 'time out' before performing a dermatologic surgery. Prior to the procedure, physicians should run through a standardized check list and make sure that everybody is on the same page before proceeding with the procedure," Dr. Feldman says.

Dermatologists usually do not encounter the problem of operating on the wrong lesion, because of their interaction with the patient directly before the surgery is performed, Dr. Feldman says. Nevertheless, the frequency of such errors remains unknown, begging the need for safety protocols.

Expanding boundaries

The boundaries of dermatologic surgery are expanding and have come to be more than excisions, biopsies and Mohs. Dermatologists are performing more invasive procedures in the cosmetic surgery arena (such as minimally invasive facelifts), and these types of surgeries present a higher risk of AEs. Conceived guidelines should be appropriate for the level of the procedure performed. The more invasive the surgery, the more detailed the checklist should be, because there is a greater likelihood that something could potentially go wrong perioperatively.

"Rather than creating standards without any precedence, prospective studies are needed that evaluate the frequency of adverse events, in which scenarios they occur, and systems for tracking the adverse events that do occur," Dr. Feldman says. "Our AE rates may be very, very low. We need to see where we stand, determine where the appropriate targets are for improvement, and once we establish those targets, come up with interventions to address them and see if they really work."

AE research

Currently, Dr. Feldman is working under a grant provided to the Center for Dermatology Research at Wake Forest University by the American Society for Dermatologic Surgery (ASDS) to prospectively assess adverse events occurring from dermatologic surgery procedures. As part of this project, team members have developed a Web-based interface to prospectively track adverse events (AEs) in dermatologic surgery.

"All patients undergoing any procedure in our surgery clinic have demographic information entered at their first visit, and any patient who returns with an AE is logged," says Jenna L. O'Neill, M.D., clinical research fellow, Center for Dermatology Research, department of dermatology, Wake Forest University.

The abstract on the title page of the Web site reads:

"Patient safety has become a very important topic that is applicable to all medical specialties. Specifically in the field of dermatology, where the number of outpatient skin surgery procedures continues to increase, there is a need to characterize complications related to skin surgery. The objective of this study is to assess the incidence of adverse events in dermatological surgery by developing and implementing a Web-based, prospective tracking system. This tool will be utilized by dermatological surgeons and medical professionals to collect preoperative, intraoperative, postoperative data on each patient undergoing dermatological surgery. Possible risk factors and ways to improve patient safety will be studied as well."

According to Dr. O'Neill, the project has resulted in the logging of about 600 individual encounters thus far. "Our original goal was to log 2,000 encounters (per the grant application), but the project will likely be expanded to other sites to obtain numbers large enough to obtain valuable information about AEs after derm surgery," Dr. O'Neill says.

Disclosures: The Center for Dermatology Research is funded by a grant from Galderma.