• “We expect all companies marketing these products to work with us [to implement REMS] expeditiously. If not, we cannot guarantee that these products will remain on the market.” Bob A. Rappaport, MD, Director, Division of Anesthesia and Analgesia Products.
• “REMS are not specific to opioids or pain management, but rather to all products that have specific safety concerns…” Marsha K Millonig, MBA, RPh, pharmacist
• “There’s no question about it: Opioids are an essential component in the management of patients with moderate-to-severe pain.” Steven D Passik, PhD, prescriber
• “Physicians need REMS to be sentinels of public health, doing safe and effective prescribing.” Perry Fine, MD, anesthesiologist
• “We have a growing problem: it is imperative that we mitigate the risks associated with these medications while allowing appropriate use in appropriate patients.” Patricia Bruckenthal, PhD, RN, ANP-C, nurse practitioner
• “There is a possibility that some products could disappear if we cannot demonstrate that we can work with manufacturers to make sure REMS can be put in place to mitigate risks...” Steven D Passik, prescriber
• “Our responsibility is to be mindful that pain remains an undertreated phenomenon in our society.” Micke A Brown, BSN, RN, nurse
• “It’s key to work and coordinate with physicians to ensure seamless integration of each REMS into your pharmacy practice.” Marsha K Millonig, MBA, RPh, pharmacist
• “We are entering an era of more pharmacovigilence, more sophisticated risk management, more involvement of patients in treatment decisions, and more transparency.” Steven D Passik, prescriber
• “The intention of REMS to collectively work towards safe use of all opioids, not just LAO/ER opioid formulations, should be embraced.” Lynn Webster, MD, anesthesiologist
• “There has been a large increase over the past 10 years in prescription opioid use...With the exposure of more and more opioids there is a greater potential for problems including misuse of medications, abuse, and the real risk of overdose.” Patricia Bruckenthal, PhD, RN, ANP-C, nurse practitioner
• “REMS implementation involves a partnership between FDA, industry, and healthcare professionals…” Marsha K Millonig, MBA, RPh, pharmacist
• “I don’t see anything in the treatment pipeline in the near future that is likely to unseat opioids as an effective, flexible and mostly affordable option for treating moderate-to-severe pain.” Steven D Passik, prescriber
• “The abuse, misuse, and overdose data for opioids underlie the application of REMS to opioid prescribing…” Marsha K Millonig, MBA, RPh, pharmacist
• “REMS formalize responsibilities that have always been there.” Steven D Passik, prescriber
• “Planning and delegation of responsibilities can help pharmacists cope with the additional time that processes will take for implementing REMS in the pharmacy practice.” Marsha K Millonig, MBA, RPh, pharmacist
• “The problem is that there is still plenty of poorly or undertreated pain in this country...” Steven D Passik, PhD, prescriber
• “Having electronic support tools directing you to the appropriate REMS web site and having a notebook with step by step instructions is very helpful...” Marsha K Millonig, MBA, RPh, pharmacist
• “Staff training and monitoring of performance regarding REMS in your practice will be an investment...” Steven D Passik, prescriber
• “Healthcare professionals have a core role to work side by side with the FDA and the manufacturers of these important medications so that we can help manage risk at the same time as protecting access to those who need these medications in our society.” Micke A Brown, BSN, RN, nurse
• “Many pharmacies have trained a technician to be the expert on the various REMS programs, which is helpful going forward.” Marsha K Millonig, MBA, RPh, pharmacist
• “REMS programs involve medication that the FDA deems has a potential risk associated with it...” Patricia Bruckenthal, PhD, RN, ANP-C, nurse practitioner
• “Not all products will be subject to all five components of a REMS program: the risk of a particular product will deem which specific components are necessary.” Patricia Bruckenthal, PhD, RN, ANP-C, nurse practitioner
• “REMS are legally enforceable with monetary implications.” Marsha K Millonig, MBA, RPh, pharmacist
• “The two REMS components that are going to be most important to nurses and hospital administrators are the Medication Guide and Elements to Assure Safe Use.” Patricia Bruckenthal, PhD, RN, ANP-C, nurse practitioner
• “One part of the legislation from the FDA in 2007 says that these [REMS] strategies need to be used to mitigate risk but at the same time should not be used to put up barriers preventing access for patient use.” Micke A Brown, BSN, RN, nurse
• “If practitioners do not comply then this can lead to the medicine being withdrawn from the market, which will reduce treatment options for patients...” Marsha K Millonig, MBA, RPh, pharmacist
• “REMS programs have been requested for all rapid-onset opioids and long-acting opioids.” Patricia Bruckenthal, PhD, RN, ANP-C, nurse practitioner
• “We are seeing the emergence of more and more REMS in the opioid arena.” Patricia Bruckenthal, PhD, RN, ANP-C, nurse practitioner
• “More time will be needed for patient visits, REMS program assessments, and staff training and monitoring of performance.” Patricia Bruckenthal, PhD, RN, ANP-C, nurse practitioner
• “As of now, clinicians need to be aware that changes are coming. These will include an emphasis on clinician education regarding risks and benefits of opioids, pharmacists offering information to patients, and patients being provided details on safety and risks associated with opioids.” Michael J Brennan, MD, prescriber
• “REMS represent a more sophisticated part of the process of risk management.” Patricia Bruckenthal, PhD, RN, ANP-C, nurse practitioner
• “REMS stands for Risk Evaluation and Mitigation Strategies.” Micke A Brown, BSN, RN, nurse
• “The Nightingale Pledge of the 1800’s is as appropriate now as it was then, that we entered the field of nursing to first do no harm, and would not knowingly administer harmful medication. We do everything we can to maintain a high standard of care: REMS are here for that reason.” Patricia Bruckenthal, PhD, RN, ANP-C, nurse practitioner
• “REMS do not replace best practice – you need to continue to exercise professional judgement and follow best practice.” Marsha K Millonig, MBA, RPh, pharmacist
• “Society has a sense that medications that are prescribed are safer than those that are not prescribed or illegal. The truth is that prescribed medications can be safer as far as quality control and how they are manufactured, but any medication that is misused or not taken as prescribed can be dangerous.” Micke A Brown, BSN, RN, nurse
• “There are than 100 products that have a REMS program.” Patricia Bruckenthal, PhD, RN, ANP-C, nurse practitioner
• “REMS requirements are likely to impact current standard operating procedures in practice; this will soon become the new routine for the prescribing of opioid analgesics.” Patricia Bruckenthal, PhD, RN, ANP-C, nurse practitioner
• “Is your environment one that leans towards keeping the practice safe, or is it one that is compatible with patient understanding and a patient-centered approach that maintains a non-adversarial relationship?” Micke A Brown, BSN, RN, nurse
• “Pain in our nation is undertreated, untreated, or inappropriately treated.” James Campbell, past-President of the American Pain Society.
• “In the long run, while REMS implementation is likely to add more time to our practice, it will also put us more in line with appropriate strategies for safe prescribing of particular opioid medications.” Patricia Bruckenthal, PhD, RN, ANP-C, nurse practitioner
• “The whole point of REMS is to assure that risks are minimized and benefits are maximized.” David Brushwood, RPh, JD, pharmacist
• “What will require thought is how the lessons learned are utilized in practice, particularly with respect to discussion of risk stratification, tailoring of delivery of opioid therapy to correspond to the assessed level of risk, and inclusion of more patient education and management of overdose risk.” Steven D Passik, PhD, prescriber

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