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BACKGROUND: The U.S. Food and Drug Administration has published new pregnancy and lactation labelling rules that set standards on the presentation of information with regard to drug usage during pregnancy and breastfeeding, as well as the effects on fertility. These guidelines became effective June 30, 2015, and classified the risks of using prescription drugs during pregnancy in three detailed subsections: Pregnancy, Lactation, and Females and Males of Reproductive Potential. These sections describe the risks within a real-world context of caring for these patients. OBJECTIVE: In this study, we reclassified and categorized drugs and treatments commonly used in dermatology according to these new guidelines. METHODS: We performed a search of the medical literature about the use of relevant prescription drugs during pregnancy and breastfeeding and their effect on fertility. The search included prospective and retrospective studies, review articles from PubMed-indexed journals (from inception to November 2018), U.S. Food and Drug Administration records, pregnancy exposure registries, relevant information and studies provided in drug labeling by companies, and updated pharmacologic texts and guidelines up to 2018. RESULTS: Topical immunomodulators, systemic immunomodulators (including biologics), systemic antipruritic agents, antimicrobials, as well as acne, hair, and cosmetic agents were included. We have made best attempts to review and consolidate existing and new data and include them in our guide. CONCLUSION: This new narrative format facilitates prescribing by considering a variety of factors. One previously overlooked aspect was the impact on the reproductive potential of both male and female patients. Rather than depending on overly simplistic letter risk categories, dermatologists will now need to make prescribing decisions based on each patient and the information provided, which will allow for better decision making and patient care.

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BACKGROUND: Dapsone is a commonly prescribed medication in dermatological practice. Its use is associated with a broad spectrum of adverse effects. Careful selection and monitoring of patients on dapsone are paramount in the prevention and early recognition of adverse effects. OBJECTIVE AND METHODS: We designed a risk-management program for dapsone at National Skin Centre, Singapore, enhancing an existing electronic medical records system and harnessing a team approach involving the nurses. This includes the performance of key laboratory tests before and after starting dapsone, ensuring adequate counseling before starting dapsone and screening for adverse effects using a questionnaire every visit. RESULTS: This system of dapsone prescription efficiently improved the adherence to safe prescription and monitoring guidelines. Average adherence rates for key safety parameters improved from 61.4% pre-implementation to 95.3% at six months and were sustained at 12 months at 91.3%. Percentage of follow-up cases in which all three key monitoring parameters were fulfilled increased from 9.5% to 79.6% (p=0.0001) after 12months. The percentage of new patients in which all four key monitoring parameters were met increased from 50% to 80%. It was not statistically significant possibly because of small patient numbers. This project has also translated into enhanced patient safety with dapsone dosages adjusted in 17 patients who experienced mild adverse effects. No severe adverse effects to dapsone were observed in the 12-month period. CONCLUSION: This example of risk management for dapsone may serve as a model for institutions looking at harnessing information technology and a team approach for safer prescription of high-alert medications.

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Oral isotretinoin is a highly effective treatment for refractory nodulocystic acne. However, it can be associated with serious adverse effects such as teratogenicity and hepatitis. Inadequate cumulative dosing may also result in reduced therapeutic efficacy and higher disease relapse. A preliminary audit had previously revealed a poor and inconsistent adherence to local isotretinoin prescribing guidelines by physicians. To achieve greater than 90% adherence to isotretinoin guidelines for all acne patients prescribed systemic isotretinoin at the National Skin Centre, Singapore, key areas and the reasons for non-adherence were identified. A specifically designed 'one-stop' electronic isotretinoin chart was launched within the electronic medical records (EMR) system to address important safety areas; namely, informed patient consent, pregnancy testing, baseline laboratory tests, and automatic calculation of cumulative and target doses of isotretinoin. Physician adherence to prescribing guidelines improved from a baseline of 50-60% to greater than 90% (range 95-100%) for 30 consecutive months post intervention. The e-isotretinoin chart has resulted in significant improvement in physicians' adherence to isotretinoin prescription guidelines and highlights the utility of EMR technology in influencing safe prescribing behaviour among doctors.

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