Some obstacles to implementation have been identified. During the implementation, the laboratory that carried out the urine screens introduced new software that required staff training and made it more difficult to create custom laboratory panels for drug testing. Three patients expressed data protection concerns regarding urine screens. Concerns did not arise when the agreement was signed, but at the time of urine collection. Patients were reminded that the tests were specific to prescribed drugs only and that they did not contain any other results or information. No patient refused to provide a urine sample for screening or refused to sign the agreement. Three patients did not agree to the file because the nurse forgot to offer the opportunity to review and sign the contract. Our project is subject to several restrictions. The project was carried out in a single private practice with only two suppliers and a specific local culture. Both suppliers were highly motivated and committed to the project. Results are not generalized for broader practices with multiple vendors that may be more difficult to implement. Our experience can be translated into the many small primary care practices that want to comply with the current Schedule II prescribing guidelines.
Patients who had prescribed Chedule II medications were predominantly Caucasian (96%) and at the age of < 60 (44%) and may not apply to patients with different demographic characteristics. Compliance was not monitored beyond 7 months after implementation. Individual practices should actively monitor compliance with guidelines until the practice model is integrated into daily life. No data were collected on the patient`s or physician`s perception of the policy. Although we did not collect this data, patients repeatedly expressed a clear understanding of the purpose of the agreement and seemed to view the treatment as positive. Suppliers supported the agreement by striving to comply with the elements of the contract. We did not record substance abuse or other risk factors for opioid dependence or abuse. These data would be useful in determining whether or not the study population is at high risk of opioid abuse. Finally, no data have been collected on patient outcomes, so we do not know whether the pain will continue to be adequately managed.
Despite these restrictions, the project demonstrated the ability to introduce a patient agreement on Schedule II-controlled substances in a small primary care practice, with excellent compliance with the required contractual elements. Future studies should replicate this project in different procedures, with different practical characteristics, and monitor compliance for a longer period of time. The use of controlled substances has increased significantly in North Carolina and across the country. The result is a public health crisis with epidemic amounts of drug rejections, abuse, abuse, involuntary overdoses and deaths. [1,2,3,4,5,6,77] Schedule II drugs are controlled substances in two distinct categories: opioid painkillers for pain treatment and non-narcotic stimulants, which are popular for treating attention deficit hyperactivity disorder (ADHD). U.S. consumption of Chedule II drugs, especially opiates, is higher than in another country in the world.