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To develop an evidence-based guideline on contraception, assisted reproductive technologies (ART), fertility preservation with gonadotoxic therapy, use of menopausal hormone replacement therapy (HRT), pregnancyassessment and management, and medication use in patients with rheumatic and musculoskeletal disease (RMD). We conducted a systematic review of evidence relating to contraception, ART, fertility preservation,HRT, pregnancy and lactation, and medication use in RMD populations, using Grading of Recommendations Assessment, Development and Evaluation methodology to rate the quality of evidence and a group consensus process todetermine final recommendations and grade their strength (conditional or strong). Good practice statements wereagreed upon when indirect evidence was sufficiently compelling that a formal vote was unnecessary.. This American College of Rheumatology guideline provides 12 ungraded good practice statements and131 graded recommendations for reproductive health care in RMD patients. These recommendations are intended toguide care for all patients with RMD, except where indicated as being specific for patients with systemic lupus erythematosus, those positive for antiphospholipid antibody, and/or those positive for anti-Ro/SSA and/or anti-La/SSBantibodies. Recommendations and good practice statements support several guiding principles: use of safe andeffective contraception to prevent unplanned pregnancy, pre-pregnancy counseling to encourage conception during periods of disease quiescence and while receiving pregnancy-compatible medications, and ongoing physicianpatient discussion with obstetrics/gynecology collaboration for all reproductive health issues, given the overall low level of available evidence that relates specifically to RMD. Guidelines and recommendations developed and/or endorsed by the American College of Rheumatology (ACR) are intended to provide guidance for patterns of practice and not to dictate the care of a particular patient. The ACR considers adherence to the recommendations within this guideline to be voluntary, with the ultimate determination regarding their application to be made by the clinician in light of each patient's individual circumstances. Guidelines and recommendations are intended to promote beneficial or desirable outcomes, but cannot guarantee any specific outcome. Guidelines and recommendations developed and endorsed by the ACR are subject to periodic revision, as warranted by the evolution of medical knowledge, technology, and practice. ACR recommendations are not intended to dictate payment or insurance decisions. These recommendations cannot adequately convey all uncertainties and nuances of patient care. The American College of Rheumatology is an independent, professional, medical and scientific society that does not guarantee, warrant, or endorse any commercial product or service. This guideline provides evidence-based recommendations developed and reviewed by panels of experts and RMD patients. Many recommendations are conditional, reflecting a lack of data or low-level data. We intend that this guideline be used to inform a shared decision-making process between patients and their physicians on issues related to reproductive health that incorporates patients' values, preferences, and comorbidities.

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OBJECTIVE: To develop an evidence-based guideline on contraception, assisted reproductive technologies (ART), fertility preservation with gonadotoxic therapy, use of menopausal hormone replacement therapy (HRT), pregnancy assessment and management, and medication use in patients with rheumatic and musculoskeletal disease (RMD). METHODS: We conducted a systematic review of evidence relating to contraception, ART, fertility preservation, HRT, pregnancy and lactation, and medication use in RMD populations, using Grading of Recommendations Assessment, Development and Evaluation methodology to rate the quality of evidence and a group consensus process to determine final recommendations and grade their strength (conditional or strong). Good practice statements were agreed upon when indirect evidence was sufficiently compelling that a formal vote was unnecessary. RESULTS: This American College of Rheumatology guideline provides 12 ungraded good practice statements and 131 graded recommendations for reproductive health care in RMD patients. These recommendations are intended to guide care for all patients with RMD, except where indicated as being specific for patients with systemic lupus erythematosus, those positive for antiphospholipid antibody, and/or those positive for anti-Ro/SSA and/or anti-La/SSB antibodies. Recommendations and good practice statements support several guiding principles: use of safe and effective contraception to prevent unplanned pregnancy, pre-pregnancy counseling to encourage conception during periods of disease quiescence and while receiving pregnancy-compatible medications, and ongoing physician-patient discussion with obstetrics/gynecology collaboration for all reproductive health issues, given the overall low level of available evidence that relates specifically to RMD. CONCLUSION: This guideline provides evidence-based recommendations developed and reviewed by panels of experts and RMD patients. Many recommendations are conditional, reflecting a lack of data or low-level data. We intend that this guideline be used to inform a shared decision-making process between patients and their physicians on issues related to reproductive health that incorporates patients' values, preferences, and comorbidities.

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RESUMEN

OBJECTIVE: To develop an evidence-based guideline on contraception, assisted reproductive technologies (ART), fertility preservation with gonadotoxic therapy, use of menopausal hormone replacement therapy (HRT), pregnancy assessment and management, and medication use in patients with rheumatic and musculoskeletal disease (RMD). METHODS: We conducted a systematic review of evidence relating to contraception, ART, fertility preservation, HRT, pregnancy and lactation, and medication use in RMD populations, using Grading of Recommendations Assessment, Development and Evaluation methodology to rate the quality of evidence and a group consensus process to determine final recommendations and grade their strength (conditional or strong). Good practice statements were agreed upon when indirect evidence was sufficiently compelling that a formal vote was unnecessary. RESULTS: This American College of Rheumatology guideline provides 12 ungraded good practice statements and 131 graded recommendations for reproductive health care in RMD patients. These recommendations are intended to guide care for all patients with RMD, except where indicated as being specific for patients with systemic lupus erythematosus, those positive for antiphospholipid antibody, and/or those positive for anti-Ro/SSA and/or anti-La/SSB antibodies. Recommendations and good practice statements support several guiding principles: use of safe and effective contraception to prevent unplanned pregnancy, pre-pregnancy counseling to encourage conception during periods of disease quiescence and while receiving pregnancy-compatible medications, and ongoing physician-patient discussion with obstetrics/gynecology collaboration for all reproductive health issues, given the overall low level of available evidence that relates specifically to RMD. CONCLUSION: This guideline provides evidence-based recommendations developed and reviewed by panels of experts and RMD patients. Many recommendations are conditional, reflecting a lack of data or low-level data. We intend that this guideline be used to inform a shared decision-making process between patients and their physicians on issues related to reproductive health that incorporates patients' values, preferences, and comorbidities.

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OBJECTIVE: Women with inflammatory arthritis appear to have fewer children as compared with healthy women, but few studies have assessed how patients' attitudes and decision making influence their family sizes. Little is also known about how patients experience other aspects of their reproductive lives, such as menstruation and contraception. METHODS: We partnered with ArthritisPower, a patient-powered research network, and its associated online patient community, CreakyJoints, to create and disseminate a survey among female members aged 18-50 years with inflammatory arthritis. RESULTS: Women in the final sample (n = 267) were 40 years old on average; most had rheumatoid arthritis (79%) and were predominantly white and college educated. Many women chose to limit childbearing because of their arthritis (58%); they feared that their arthritis was heritable, their diseases and medications could directly harm a fetus, they would be incapable of physically caring for a child, and arthritis could cause premature death, preventing them from raising their children. Infertility affected 40% of the sample. Half of women experienced subjective arthritis flares around the time of menstruation. Oral contraceptive pills (OCPs) did not worsen disease activity for most women and even prevented menstrual-associated arthritis flares for a subset of women. CONCLUSION: Our findings suggest that infertility, but also potentially outsized fear and anxiety related to their diagnoses, may affect the family sizes of women with inflammatory arthritis. The observation that menstruation worsens disease activity for some women requires additional study, and OCP use should be explored as a possible treatment for menstrual-associated arthritis. Clinicians may wish to consider how they communicate patients' individual pregnancy-associated risks, reassure patients when appropriate, and help to guide and support patients to make well-informed reproductive decisions.

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OBJECTIVES: Urinary tract infections (UTIs) caused by extended-spectrum ß-lactamase (ESBL)-producing Enterobacteriaceae are resistant to many conventional therapies, including third-generation cephalosporins. Carbapenems are considered first-line agents for ESBL infections, but their use is associated with increased multidrug resistance and should be reserved when absolutely necessary. Because of the increased rates of UTIs caused by ESBL-producing organisms and incidence of carbapenem resistance, safe and effective alternatives to carbapenems are needed. This study was conducted to evaluate the outcomes associated with the treatment of ESBL UTIs with noncarbapenem antibiotics. METHODS: A retrospective cohort study of adults with ESBL UTIs was conducted at a community hospital. Patients were categorized as those receiving definitive carbapenem therapy and those receiving definitive noncarbapenem therapy. Calculated measurements included infection-related mortality, length of hospital stay, and duration of definitive antibiotic therapy. Microbiological failure was assessed as a secondary outcome. Data on the safety of antibiotic therapy were not collected. P < 0.05 was considered significant. RESULTS: Fifty patients met inclusion criteria for the study, divided evenly between the two cohorts. No statistical differences were observed for length of hospital stay (P = 0.601), duration of therapy (P = 0.398), or rate of microbiological failure between the groups (P = 0.115). CONCLUSIONS: Noncarbapenems did not demonstrate significant differences compared with carbapenems in the treatment of adults with ESBL UTIs. In certain patient populations, noncarbapenems that demonstrate in vitro activity may be appropriate for UTIs caused by ESBL-producing organisms.

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Patients with reported penicillin allergies have been proven to experience negative health consequences, such as increased cost, suboptimal antimicrobial therapy, and adverse reactions. Though skin testing has been proposed as a method to clarify penicillin allergies, many institutions may lack the resources to perform skin testing on a wide scale. This literature review describes the current literature surrounding the use of penicillin allergy interviews when skin testing is not an option. Specifically, the review highlights the steps in carrying out a successful antibiotic allergy patient interview, summarizes the clinical evidence surrounding antibiotic allergy clarifications, and addresses key advantages and disadvantages of clarifying antibiotic allergies without the availability of skin testing.

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PURPOSE: Drug allergy documentation in the patient medical record varies in level of detail, and drug intolerances are often inappropriately documented as an allergy in the medical record. A pilot study was conducted to determine the impact of a pharmacy-led drug allergy clarification service. METHODS: The pilot quality improvement service was implemented in Fall 2016. General medicine patients were identified through daily census reporting and the electronic medical record (EMR) was reviewed within 72 hours of admission for documented drug allergies and/or intolerances. Patients were interviewed by a clinical pharmacist or a fourth year pharmacy student to determine a complete drug allergy and intolerance history. RESULTS: A total of 55 patients were interviewed and received the pilot service. A drug allergy/intolerance was documented in EMR for 54.5% (n=30) of patients interviewed. Of those 30 patients, 96.6% (n=29) were noted to have at least one discrepancy between EMR documentation and patient interview. The primary discrepancy noted was drug allergies or intolerances documented in the EMR without a description of the reaction. CONCLUSION: A pharmacy-led drug allergy clarification service was effective in identifying and clarifying EMR documentation of patients' drug allergies and intolerances. Patients with incorrect or incomplete allergy documentation may receive alternative therapy, which could increase costs and lead to unwanted adverse effects or less effective treatment. As a result of the pilot study, the program has remained in effect and is being expanded to other units within the institution.

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To review the use of the direct oral anticoagulant (DOAC) agents in inherited thrombophilia based on the literature. MEDLINE, International Pharmaceutical Abstracts, and Google Scholar searches (1970-May 2016) were conducted for case reports, case series, retrospective cohorts, or clinical trials using the key words: protein C deficiency, protein S deficiency, antithrombin deficiency, activated protein C resistance, Factor V Leiden, hypercoagulable, NOACs, dabigatran, apixaban, rivaroxaban, betrixaban, edoxaban, Xa inhibitor, direct thrombin inhibitor. Results were limited to English-only articles. Clinical studies evaluating the use of DOACs for hypercoagulable states related to inherited thrombophilia were selected and evaluated. Thrombophilia, a predisposition to thrombosis, manifests predominantly as venous thromboembolism. Causes of inherited thrombophilia include antithrombin deficiency, deficiencies of proteins C and S, and Factor V Leiden mutation. Many patients with thrombophilia receive anticoagulant therapy for primary or secondary prevention of VTE, historically either warfarin or a heparin product. DOAC's have been considered as potential alternatives to traditional agents based on their pharmacologic activity. Case reports and a post-hoc analysis of a clinical trial have indicated positive results in patients with inherited thrombophilia and VTE. Positive results have been reported for the use of DOACs in inherited thrombophilia. Further robust studies are needed for definitive decision making by clinicians.

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Background: Antiphospholipid syndrome (APS) is an autoimmune disease characterized by thrombosis or pregnancy loss with persistent positive antibodies. Standard treatment for APS with history of thromboembolism is heparin or low-molecular-weight heparin followed by a vitamin K antagonist (VKA). Novel oral anticoagulants (NOACs) could be effective in patients with APS, but none carry indications for treatment related to APS. Clinical Evidence: Five case reports or series with rivaroxaban and dabigatran suggest thrombotic events occur most often in the higher risk population (arterial thrombosis and/or triple positive antibodies) or in patients who had recurrent VTEs on warfarin therapy. An observational cohort in 26 APS patients using dabigatran or rivaroxaban described a recurrent thrombotic event in only 1 patient after 8 months of treatment. The event-free survival rate was 87.9% at 12 months. Three controlled clinical trials are underway to evaluate the thrombotic risk of NOACs (RAPS, TRAPS, and ASTRO-APS). Discussion: There are no completed studies that evaluate the use of NOACs in APS compared to VKAs. One major disadvantage of the NOACs is the limited availability of reversal agents for patients with a major bleeding episode. An increased risk of thrombotic events is associated with arterial occlusions and triple antibody positivity APS with both warfarin and NOACs; this is currently being researched in the TRAPS study. Conclusion: Based on current available evidence, VKAs remain the standard of care in the treatment of APS. Results of ongoing trials may offer more guidance on how to appropriately use NOACs for patients with APS.

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OBJECTIVE: To report a patient case identifying risk for recurrent venous thromboembolism (VTE) associated with heterozygous Factor V Leiden mutation. CASE SUMMARY: A 54-year-old Caucasian male was diagnosed with heterozygous Factor V Leiden mutation in 2008 after experiencing a deep vein thrombosis (DVT) and bilateral pulmonary embolism. The patient was treated appropriately and started on anticoagulation therapy with warfarin through an anticoagulation management clinic. After approximately 17 months of warfarin therapy without incident, warfarin was discontinued. Within 2 months after discontinuation of anticoagulation therapy, the patient experienced his second DVT and left pulmonary artery embolus. DISCUSSION: The risk of recurrent venous thromboembolism (VTE) in patients with heterozygous Factor V Leiden mutation is documented as an approximate 1.4-fold increase compared to patients without thrombophilia. However, the risk increases dramatically when nonreversible (age) or reversible risk factors (obesity, smoking, and long air flights) are present in this population. CONCLUSION: Based on recent literature, heterozygous Factor V Leiden mutation exponentially increases the risk of recurrent VTE, especially in the presence of other risk factors. Health care providers should complete a comprehensive review of the patients' other risk factors when deciding on duration of anticoagulation therapy for patients with positive heterozygous Factor V Leiden mutation.