Department of Dermatology, Royal Hallamshire Hospital, Sheffield, UK.
Br J Dermatol. 2011 Mar;164(3):537-43. doi: 10.1111/j.1365-2133.2010.10173.x. Epub 2011 Feb 7.
The elimination or reduction of risk is a prime requirement of all healthcare workers. The matter has come to the fore in dermatological practice recently with the widespread use of effective drugs that have significant side-effects (e.g. retinoids, cytotoxic drugs, biologics), the increase in skin surgery, especially for skin cancer, and the extensive use of phototherapies.
To examine the available database from different agencies to which adverse events may be reported over at least a 5-year time frame, categorize the risks, look forward to where as yet unidentified risks might exist, and draw conclusions to improve the safety of dermatological practice. This work came about through a request from the National Patient Safety Agency [to the Joint Specialty Committee of the British Association of Dermatologists (BAD) and Royal College of Physicians] for information on risks to patients receiving treatment or investigation for skin disease.
Organizations in the U.K. that receive information about adverse events, whether caused by drugs or procedures in dermatological treatments, were approached for information about reported events over a 5-year (or, in one case, 10-year) time frame up to 2009. Data were received from the National Patient Safety Agency, the Medicines and Healthcare Products Regulatory Agency, the National Health Service Litigation Authority, the Medical Protection Society and the Medical Defence Union. In addition, the results of a survey conducted in 2010 by the BAD of its members concerning potential critical incident reporting were included. The received information was analysed according to category of event and conclusions drawn about how best to manage the risks that were identified.
Adverse events were divided into the following categories, listed in order of the number of reports received: drug side-effects (biologics and retinoids), phototherapy dosage, drug monitoring (including initial screening), pregnancy prevention programmes, skin cancer follow-up (including acting on reports), dermatopathological reporting and conduct of dermatological surgery (including management of complications, equipment problems, use of lasers, cosmetic procedures and cryotherapy). Critical incidents reported by BAD members often concerned follow-up failures, e.g. of patients receiving systemic drugs or of those with skin cancer.
Several of the reported adverse events concern systemic failures. Recommendations for risk reduction include the following points: better systems for drug monitoring (including regularity of attendance, provision of sufficient follow-up appointments, acting on results and adequacy of pregnancy prevention programmes); staff training and record keeping for phototherapy; acting on skin cancer multidisciplinary team meeting outcomes (including provision of sufficient follow-up appointments); and adequate training of staff in dermatological surgery including cryotherapy. Regular monitoring of the occurrence of such reports is needed to ensure safe practice and to identify early areas of new risk.
消除或减少风险是所有医疗保健工作者的首要要求。最近，随着有效药物的广泛使用，这些药物具有显著的副作用（例如类视黄醇、细胞毒性药物、生物制剂），皮肤手术的增加，尤其是皮肤癌的手术，以及光疗的广泛应用，这一问题在皮肤科实践中变得尤为突出。
检查不同机构的现有数据库，这些机构可能会在至少 5 年的时间内报告不良事件，对风险进行分类，展望尚未确定的风险可能存在的地方，并得出结论以提高皮肤科实践的安全性。这项工作是应英国国家患者安全局的要求（向英国皮肤病学会（BAD）和皇家内科医师学院联合专业委员会提出），以获取有关接受皮肤疾病治疗或检查的患者风险的信息。
联系了英国接收有关皮肤科治疗中药物或程序引起的不良事件信息的组织，以获取截至 2009 年的 5 年（或在一个案例中为 10 年）时间范围内的报告事件信息。从英国国家患者安全局、药品和医疗保健产品监管局、国家卫生服务诉讼管理局、医疗保护协会和医疗辩护联盟收到了数据。此外，还包括 2010 年 BAD 对其成员进行的潜在重大事件报告调查的结果。根据事件类别对收到的信息进行了分析，并得出了如何最好地管理已确定风险的结论。
不良事件分为以下几类，按收到报告的数量顺序列出：药物副作用（生物制剂和类视黄醇）、光疗剂量、药物监测（包括初始筛查）、妊娠预防计划、皮肤癌随访（包括对报告的处理）、皮肤科病理报告和皮肤科手术（包括并发症管理、设备问题、激光使用、美容程序和冷冻疗法）。BAD 成员报告的重大事件通常涉及随访失败，例如接受全身药物治疗的患者或患有皮肤癌的患者。
报告的一些不良事件涉及全身性失败。减少风险的建议包括以下几点：更好的药物监测系统（包括定期就诊、提供足够的随访预约、根据结果采取行动和妊娠预防计划的充分性）；光疗的员工培训和记录保存；皮肤癌多学科团队会议结果的实施（包括提供足够的随访预约）；以及对皮肤科手术（包括冷冻疗法）的员工进行充分培训。需要定期监测此类报告的发生情况，以确保安全实践并尽早发现新的风险领域。
