ABSTRACT. Objective. The Canadian Rheumatology Association (CRA) has developed recommendations for the pharmacological management of rheumatoid arthritis (RA) with traditional and biologic disease-modifying antirheumatic drugs (DMARD) in 2 parts. Part II, focusing on specific safety aspects of treatment with traditional and biologic DMARD in patients with RA, is reported here. Methods. Key questions were identified a priori based on results of a national needs-assessment survey. A systematic review of all clinical practice guidelines and consensus statements regarding treatment with traditional and biologic DMARD in patients with RA published between January 2000 and June 2010 was performed in Medline, Embase, and CINAHL databases, and was supplemented with a "grey literature" search including relevant public health guidelines. Systematic reviews of postmarketing surveillance and RA registry studies were performed to update included guideline literature reviews as appropriate. Guideline quality was independently assessed by 2 reviewers. Guideline characteristics, recommendations, and supporting evidence from observational studies and randomized trials were synthesized into evidence tables. The working group voted on recommendations using a modified Delphi technique.Results. Thirteen recommendations addressing perioperative care, screening for latent tuberculosis infection prior to the initiation of biologic DMARD, optimal vaccination practices, and treatment of RA patients with active or a history of malignancy were developed for rheumatologists, other primary prescribers of RA drug therapies, and RA patients. Conclusion. These recommendations were developed based on a synthesis of international RA and public health guidelines, supporting evidence, and expert consensus in the context of the Canadian health system. They are intended to help promote best practices and improve healthcare delivery for persons with RA. (First Release June 15 2012; J Rheumatol 2012;39:1583-602; doi:10.3899 Recommendations provided here are intended to be read in conjunction with the Canadian Rheumatology Association Recommendations for the Pharmacological Management of Rheumatoid Arthritis. These recommendations address specific safety questions that were identified a priori and are not intended to cover all safety aspects concerning treatment with traditional and biologic disease modifying antirheumatic drugs (DMARD).Traditional and biologic DMARD have greatly enhanced the care of persons with rheumatoid arthritis (RA); however, potential risks associated with their use need be considered. The Canadian Rheumatology Association (CRA) has developed recommendations for the pharmacological management of RA with traditional and biologic DMARD in 2 parts. Part I described the development process of CRA recommendations in detail and included 5 overarching RA care principles along with 26 treatment recommendations 1 . Part II, reported here, focuses on specific safety aspects of treatment with traditional and biologic DMARD in patients with ...