Answer from Ready for REMS advisor Patricia Bruckenthal, PhD, RN, ANP-C

I commend you for your attention to implementing a system in your practice to facilitate safe and appropriate monitoring for patients receiving chronic opioid therapy. As of today, there is no single algorithm, but guidelines have been recommended for care of this population of patients.

As you know, in April 2011, the federal government mandated that a class-wide Risk Evaluation and Mitigation Strategy (REMS) be put into place for all long-acting opioids (LAOs). While not yet developed, REMS components will include medication guides, patient package inserts, elements to ensure safe use (including requirements for those who prescribe, dispense, or use the drug), and a timetable for REMS submission on the part of industry. As prescribers in practices managing patients on chronic opioid therapy, we will be responsible to have systems in place that meet the requirements of REMS and balance optimal care for patients in pain while mitigating abuse and diversion. The new REMS plan focuses primarily on: educating prescribers about patient selection and other requirements, and improving patient awareness about how to use these drugs safely.

It will be essential that you have good records and systems in place to ensure you are supporting the goals of the REMS programs. You might approach this in two ways in your practice. One is patient-based and the other office/practice-based.

For patients, ensure:

1. A thorough history and physical examination has been conducted and recorded in the medical record. This will include both subjective and objective assessments. Prior history of successful and unsuccessful medication use, history of substance abuse, and family history of substance abuse should be included. This will assist in patient selection for opioid therapy and frequency of monitoring.
2. There are several reliable and valid instruments to assess for risk of misuse of opioid analgesics. These are to be used as a guide to decisions on management. The Opioid Risk Tool (ORT), the revised Screener and Opioid Assessment for Patients with Pain (SOAPP-R), and the Current Opioid Misuse Measure (COMM) are commonly used for this population. Find one that works for your practice and put it in your “tool kit” for patients on chronic opioid therapy.
3. Institute a patient “Opioid Use Agreement” prior to initiating opioid therapy. These delineate office policy regarding practices such as single prescriber, single pharmacy, taking medications as prescribed, refill frequency instructions, and the need for intermittent urine drug screening. There are many good examples that can be downloaded from reputable Web sites. These are great teaching tools. Keep a signed copy in the patient medical record.
4. Initial urine drug screen prior to initiating opioid therapy. These need to be sent to a laboratory that specializes in screening for pain management. Once therapy is initiated, it is suggested that at a minimum, one or two intermittent urine screens be conducted annually for patients on chronic opioid therapy. These can be done more frequently if patients are at higher risk for abuse, misuse, or diversion. Make sure you know how to interpret the results. Most reputable laboratories have toxicologists able to help with this. If possible in your area, find a specialist in addiction as a referral source for the most at-risk patients.
5. When initiating opioid therapy include directions and documentation for proper use. This should include that patients have been counseled about the risks and benefits of the drug including the risk of overdose if given to someone for whom it has not been prescribed. As part of the REMS plans, the Food and Drug Administration (FDA) wants companies to provide patient education materials, including a medication guide that uses consumer-friendly language to explain safe use and disposal. Review the medication guide specific to the drug. The risk of addiction and dependence from exposure to opioid analgesics should be discussed. The risk of overdose due to chewing, crushing, or dissolving an extended-release formulation should be included. Also, discuss exit strategies for discontinuance of the medication if it is not effective, or if the patient is not compliant with safe use. You might want to develop a patient teaching guide and include it in your “toolkit” as well.
6. Finally, on subsequent patient follow-up, evaluate analgesic control, patient function, any adverse drug related side effects, and aberrant drug-related behaviors.
   

The other part of your plan should include office practice strategies.

1. Maintain a file for each prescriber that will include evidence of opioid prescribing training. Specifics of this will emerge, but you can certainly get ahead by starting now.
2. Have any pain management specific continuing education documentation included in each practitioner’s file. Prescribers will be required to obtain periodic training.
3. You may want to institute a separate file of all patients prescribed opioids that require REMS. This should include the rationale for prescribing the opioid and any adverse events associated with the drug. Currently only patients on transmucosal immediate-release fentanyl products are required to enroll in REMS programs, but the recent FDA announcements suggest that patients requiring LAOs are likely to have to do the same sometime in the future.
4. If your state has a state-based prescription drug monitoring program, make sure each prescriber is trained or registered with the state for its use. There is also legislation to enhance the use of these systems.
   

While this looks daunting, once your system is in place, the process will flow much more smoothly. Staff, administrators, and healthcare providers need to be proactive to make this happen. By instituting these strategies, you will help patients to safely use chronic opioid therapy and be in compliance with REMS. Check back with the Ready For REMS Web site periodically. It will be updated as this new REMS legislation evolves.

No, opioid medications have not been singled out as requiring REMS. In fact, as of October 2010 over 140 REMS from across a range of therapeutic areas have been approved by the FDA [View approved REMS here]. Other REMS, including those for additional opioids, are being prepared and/or are under review by the FDA.

There are concerns that REMS may limit the availability of appropriate medications to patients that need them. This is certainly not the intent: the goal of opioid REMS is to curb abuse, misuse, addiction, and overdose while maintaining access to opioid medications for appropriate patients. There are practical implications associated with the implementation of REMS that may impact the availability of medications for particular patients. Whilst the details will vary between different product REMS, it is clear that there will be an increased emphasis on patient education – with associated time implications for both healthcare professionals (HCPs) and patients. Regardless of what is involved with each particular REMS program, patients should continue to receive the most appropriate treatment for the management of their pain, and it is important that the demands of REMS do not negatively impact the HCP’s prescribing decisions.

No, REMS documentation may add to, but will not replace, existing state and federal regulations. REMS documentation may be more specific and may help improve procedures to ensure that appropriate patients have been selected for treatment, and that they have been fully instructed regarding informed consent, risk–benefit, treatment alternatives, and special issues. REMS documentation will also provide a framework to educate patients on the safe, appropriate, and responsible use and care of their opioid medications.