Prescription Opioids and Pain Management: The Tennessee Guidelines _ ______________________________
Mental Health Screening Tool The Mental Health Screening Tool is a five-item screen that asks about a patient’s feelings of happiness, calmness, peacefulness, nervousness, and depression in the past month [22]. A lower score on this tool is an indicator that the patient should be referred to a specialist for pain management. The Tennessee Controlled Substance Monitoring Database The Tennessee CSMD is a prescription-monitoring program designed to provide healthcare practitioners with a cumulative record of a patient’s prior controlled substance prescription history [94]. Information sent to, contained in, and reported from the database is confidential and password protected. The data are available to a prescriber or dispenser (pharmacist) of a controlled substance to the extent the information relates to a current or bona fide prospective patient. The CSMD contains prescription information from all dispensers of controlled substances in Tennessee and also those dispensers who ship to patients residing in Tennessee, including from mail-order pharmacies and some Veterans Affairs pharmacies [94]. The information that is required to be submitted includes prescriber U.S. Drug Enforcement Administration (DEA) number, patient identifier, dispensing date, controlled substance national drug code number, quantity dispensed, strength, estimated day supply, and dispenser DEA number. All data in the CSMD are reported as submitted to the data collection website by the dispenser. Therefore, if there are any questions about the data, a practitioner should contact the dispenser identified in the report. All prescribers and dispensers of controlled substances in Tennessee must register for access to the CSMD [94]. Healthcare practitioners wishing to register with the CSMD to access prescription information are required to register at https://www.tncsmd.com. A prompt will appear requesting information used to validate the provider’s statutory authority to access CSMD data. A detailed discussion of the CSMD, including access, patient report content, and prescriber self- lookup reports, is available in the Tennessee Chronic Pain Guidelines [94]. Additional information about the CSMD as well as the Data Collection Manual can be obtained at the Tennessee CSMD website at https://www.tn.gov/health/ health-program-areas/health-professional-boards/csmd-board. html. When prescribing or dispensing a controlled substance, all healthcare providers must check the CSMD at each of the following stages of treatment [94]: • Prior to prescribing an opioid, benzodiazepine, or Schedule II amphetamine to a patient at the beginning of a new episode of treatment • Prior to the issuance of each new prescription for the opioid or other controlled substance during the first 90 days of a new episode of treatment • At least every six months when opioid/controlled substances are continued for chronic care
AGREEMENTS The initial opioid prescription is preceded by a written informed consent or “treatment agreement” [1]. This agreement should address the rationale for and appropriate use of a controlled medication and the mechanism of action, expected benefit, and limitations of therapy. It should also provide information regarding potential negative effects of controlled medication, including side effects, tolerance and/or physical dependence, drug interactions, motor skill impairment, limited evidence of long-term benefit, misuse, addiction, and drug diversion. Informed consent documents should include information regarding the risk/benefit profile for the drug(s) being prescribed and common-sense rules for using controlled medications safely. The prescribing policies should be clearly delineated, including the number/ frequency of refills, early refills, and procedures for lost or stolen medications. The treatment agreement also outlines joint physician and patient responsibilities. The prescriber’s responsibility is to address unforeseen problems and prescribe scheduled refills. The patient agrees to using medications safely, refraining from “doctor shopping,” and consenting to routine UDTs. Included is the expectation that a patient will inform the provider if she wishes to avoid unintended pregnancy and if she becomes pregnant. The Tennessee practice guidelines recommend that the practitioner obtain a signature indicating that any woman who wishes to become or is at risk to become pregnant has been educated about the risks and benefits of opioid treatment during her pregnancy [94]. The provider should discuss a method to prevent unintended pregnancy with every woman of child-bearing age who has reproductive capacity before opioids are prescribed. When there is a change or discontinuation of opioid treatment, the reasons should be documented. Agreements may also include sections related to follow-up visits, monitoring, and safe storage and disposal of unused drugs. The Tennessee Department of Health provides a sample Informed Consent/Controlled Substance Agreement and Patient Agreement/Treatment Attestation form in the Appendix of the Chronic Pain Management Guidelines [94]. THE TREATMENT PLAN AND INITIATING OPIOID THERAPY The use of opioids for treatment of chronic pain should be presented as a trial approach for a pre-defined period (e.g., ≤30 days). The goals of treatment should be established with all patients prior to initiation of opioid therapy, including reasonable improvements in pain, function, depression, anxiety, and avoidance of unnecessary or excessive medication use [1; 10]. It should be emphasized to the patient that the primary goal is to reduce pain and improve functioning ability, not necessarily to alleviate pain entirely. Pain management plans should describe the selected treatment, progress measures, and other diagnostic evaluations, consultations, and therapies. The plan should establish realistic goals and expectations that will
INFORMED CONSENT AND TREATMENT
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