By: Mark Schloneger, MD, PriMED Physicians and Karen Davis, RN, BSN, MBA, MediSync Inc.
Reprinted from the fall 2019 issue of The Ohio Family Physician.
The Rules Have Changed
Over the past few years, many changes have occurred in Ohio for primary care physicians who prescribe controlled substances. These changes require primary care physicians to document like pain management specialists, while also addressing the other needs of the patient that entail primary care. This can feel overwhelming. It also has a high likelihood of failure due to its complexity. In response, some physicians are choosing to stop prescribing controlled medications all together. PriMED Physicians took a different approach. We invested time to evaluate the new guidelines and developed plans to comply with the intent of the State Medical Board of Ohio. We feel that primary care physicians are well positioned to manage controlled medications. But we need help.
The Solution
The goal is to keep patients safe and to remain legally compliant, with minimal disruption to physician workflow. We standardized processes and created flowcharts and protocols for both staff and physicians. We also created electronic documentation check points so important steps are not missed when evaluating.
Many factors were considered in developing our processes. The most significant processes were: requiring office appointments to assess patients at specific intervals, creating a controlled substance agreement that includes an informed consent, initiating Ohio Automated Rx Reporting System (OARRS) report reminders at 80 days (to allow a 10-day buffer to complete), requiring patient self-assessments to be completed at each visit for which controlled substances are being reviewed, and creating specific appointment types for pain management related follow-up visits. Most of these processes are initiated by the staff. This reduces the impact on physicians and allows most of the processes to be completed prior to the patient being seen by the physician.
Aberrancy
In addition to these clinical and legal protocols, a significant amount of time was dedicated to aberrancy: misuse or suspected diversion. The team identified the points where aberrancy should be recognized. We determined a plan to fully evaluate the cause and implications of the aberrancy. Refer to the flow diagram.
- Perform and evaluate urine drug screen abnormalities
- Perform and evaluate pill counts of prescribed controlled substances
- Run fresh OARRS report and evaluate.
Drug screen
Urine drug screening should be a tenant of any diversion process. The urine drug screening process is primarily designed to determine if there is a presence of a controlled substance not prescribed and/or the presence of an illegal substance. (Note: confirmatory testing is necessary as false positives can occur). The other use of urine drug screening is to determine if the prescribed medication is present. (Note: confirmatory testing is necessary as false negatives can occur). A lack of prescribed medication on the drug screen raises concerns for diversion, misuse, or hoarding. The pill count and OARRS report can corroborate which of these is occurring.
Pill counts
Pill counts can reveal several concerns. Low pill counts may indicate poor pain control or diversion of medications. This must be fully assessed. If symptom control is inadequate, appropriate evaluation/assessment needs to occur so a plan can be developed that will better treat the patient. If medications are truly being diverted (stolen by a friend, family member, or sold, etc.), appropriate legal steps should be taken along with immediate discontinuation of therapy. Critical conversations with the patient are necessary to understand the problem and what actions will be most suitable.
OARRS reports
OARRS reports are evaluated to determine if there are other prescribers involved in the patient’s care and to monitor frequency of medication refills. Co-prescribing may identify drug dependency or inadequate symptom control. However, if the patient has already signed a controlled substance/informed consent agreement, failure to comply with the conditions of that document (which includes disclosure of other prescribers) would be a violation and require immediate action. Additionally, with the advent of legalized medical marijuana in Ohio, prescribers need to know if medical marijuana has been recommended and purchased. Interviews with the patient are extremely important in any of these aberrancy situations.
The PriMED process allows for fluid movement between these three areas on the flowchart to make sure all potential scenarios are captured. The flowchart adds the implications to each cause of aberrancy in compliance with current state law. We obtained legal counsel to clarify gray areas within the current state of Ohio medical guidelines.
Medical Marijuana
The legalization of medical marijuana in Ohio raises new questions for physicians and other healthcare professionals. Patients who have received a medical marijuana card may legally obtain it. It is important to account for the cumulative impact of legally obtained substances when prescribing controlled substances. Physicians will have to decide if they are comfortable co-prescribing controlled substances when medical marijuana is being used. If prescribing continues, clinicians need to treat the presence of this drug the same as co-prescribing other controlled substances, such as benzodiazepines. Attempting to understand the patient’s rationale for use is important. If inadequate symptom control is the problem, evaluation by a specialist may be warranted.
PriMED Physicians felt it was important to address legally prescribed substances (including marijuana) and illegally obtained substances in the process flow diagram. Physicians should attempt to help patients with substance addiction when identified. After an open and honest conversation, determine if changing or discontinuing the medication is necessary. Consider referrals to specialists to address patient’s needs.
Ongoing monitoring is critical with all patients, but especially for patients with aberrancy for which prescribing will continue. This will require patient buy-in. Discuss the need for monitoring with the patient and document agreement with the plan. If the patient does not commit to following the plan, dismissal from the practice should be considered. Again, the goal is to help patients remain safe and manage their medical needs.
Good documentation is legally required. PriMED created templates and prompts to ensure key areas are addressed during the visit. Templates remind and assist with the documentation process when making dose changes, performing periodic informed consent reviews, evaluating OARRS reports, Narcan prescribing at the appropriate MED level, determining clinical response to medications, assessing adverse effects of medications, and follow-up visits at required intervals.
Summary
Anyone receiving more than seven days of controlled medications in a six month period requires additional screening and documentation. When diversion or misuse is suspected, prescribers should perform drug screens, pill counts, and OARRS reports. Use the flowchart to guide required actions. The next step is to have a conversation with the patient about these findings and take the necessary actions.
Future
PriMED plans to monitor the effectiveness of its process to determine if the goals of compliance and patient safety are being achieved. PriMED will continue to adjust its process flows as state law changes. Finally, we acknowledge that despite our attempts to minimize the increased workload on our physicians, the new laws do add work. We are still considering whether specific controlled substance visits will be needed due to the additional requirements of evaluating and documenting controlled substances.
References available online.