Improving the risk-benefit relationship and informed consent for patients treated with hydroxychloroquine.

PURPOSE To determine the prevalence of high-risk factors for hydroxychloroquine (HCQ) retinopathy and compliance with the American Academy of Ophthalmology (AAO) screening guidelines at the San Francisco Veterans Affairs Medical Center (VASF) and to develop an approach to improve the risk-benefit relationship and informed consent during HCQ treatment. METHODS All medical records of patients receiving HCQ were reviewed, with special attention to high-risk factors for retinopathy. The results were used to develop a method of enhancing the risk-benefit relationship and improving informed consent at the VASF. RESULTS Of the 109 patients taking HCQ at the VASF, 87% had at least one high-risk factor for retinal toxicity and 47% had two or more risk factors. Thirty-four percent had no evidence of an eye examination having been performed. An approach has been developed to improve the risk-benefit and informed consent for patients using HCQ at the VASF. CONCLUSIONS A significant number of veterans taking HCQ may be at an increased risk for retinal toxicity. More than one-third of these patients may not be managed as recommended by the AAO. Methods to minimize these risks and improve informed consent are outlined.