Managing Controlled Substance Agreements – The Ultimate PDF Understanding Controlled Substance Agreements Controlled substance agreements are contracts that govern the relationship between a healthcare provider and their patient in the context of prescribing controlled substances. Their use has become particularly important in the era of prescription drug addiction, providing a transparent mechanism for physicians to establish ground rules with their patients about the use of drugs that can lead to addiction, abuse, and even death. For many physicians , these agreements are included as part of a larger general consent document that patients are asked to sign before they can receive any prescription from the practice. Other providers use these agreements as a standalone document. For both groups, it is essential that the language in these agreements be crafted carefully to find the proper mix of legal protection and practicality of use. A poorly drafted agreement may not protect the provider if there is litigation over an adverse event, while a well-crafted agreement will help protect against the risk that favorable patients will avoid their use. Main Elements of a Controlled Substance Agreement Regardless of whether you use a controlled substance agreement or not in your practice, one of the best ways to understand what should be in the agreement is to understand each of the components. Like most things in life, you are generally fine if you follow the rules. However, those cases where you do not, are the cases when you get into trouble. Likely, there are many things that go into your controlled substance agreements, and many things that you do well in your practice, but if you do not use an agreement now it would be a good idea to consider some of the following components: Patient Responsibilities Opioid Monitoring Requirements Consent to Participate in Prescription Monitoring Programs Receipt of a Naloxone Rescue Drug Termination of the Physician/Patient Relationship Personal Responsibility for Controlled Substances Termination of Treatment No Refills Disciplinary Consequences No Unauthorized Referrals If You Change Physicians, Please Notify Us I Acknowledge That There Are No Guarantees In The Success Of Controlled Substances Unforeseeable Increase In Dosage May Lead to Referral to Addiction Center No Possession of Controlled Substances – Keep Safe in Home Non-Compliance with Testing I May Discontinue Your Opioids if No Evaluation is Conducted Falsehood Will Be Treated As Tampering with Health Care Provider I Cannot Assure That I Am Aware of All Controlled Substance Insurance Is Not Mandatory Repayment of Excess Payments No Change in Medications Created Without Consultation I Am Not Your Doctor I Will Keep You as a Patient Only if This Agreement Is Signed I Will Review the Necessity of Opioids if Other Treatment is Ineffective I May Charge for Missed Appointments Legal Requirements for Controlled Substance Agreements The legal implications of controlled substance agreements are profound, both for prescribers and for patients. Every state in the U.S. has its own version of the state medical board, and these boards have enacted legislation dealing with the prescribing of controlled substances. For example, in Ohio, the medical board has issued "Guidelines for the Use of Controlled Substances in the Treatment of Pain" as a 28-page pdf. There are two specific sections that are of interest to readers of controlled substance agreements. 9 Controlled substance use agreement. The use of a written controlled substance use agreement may be applicable for some patients based on their individual circumstances. Generally, a written controlled substance use agreement: A controlled substance use agreement is also an important tool for prescribers. A controlled substance use agreement: A few points should be made about these guidelines. First, the above language is quoted verbatim from a 28-page document. Second, neither the prescriber’s nor the patient’s ability to fulfill their obligations are absolute. In general, however, it is fair to say that a prescriber who has demonstrated that he or she has had previous experience with treating patients with chronic pain should not be penalized for deviating from the controlled substances use agreement. Additionally, a patient who continues to follow the terms of the controlled substance agreement can have greater leeway with regard to the dispensing of the medication. This could mean taking medication in slightly different amounts than prescribed or taking them at intervals contrary to the agreement. Such flexibility makes it difficult for either party to abide by a rigid set of rules. 1 Complaint reporting. Physicians have a responsibility to report to the medical board any violations of the agreement or evidence of drug diversion involving an employee or colleague. Failure to do so may result in adverse licensure action. 2 Non-compliance with the agreement. A physician who discovers non-compliance with the medication treatment plan, or that the patient has violated the controlled substance use agreement, and does not terminate the therapeutic relationship in a prompt and responsible manner, may face adverse licensure action, including license suspension, or revocation. 3 Loss of controlled substances. Loss of a controlled substance due to fire, theft, or other emergency can occur. The board does not penalize the prescriber if it can be shown that the physician took steps to reduce the risks associated with the loss. 4 Renewing controlled substances. For those controlled substances that are not listed in Appendix A of the Ohio Administrative Code, physicians will not be cited for renewing such a prescription if it meets the same criteria used to initiate the prescription for a controlled substance as set forth in the policy for the use of controlled substances in the treatment of pain. Prescribers should not be cited for simply refilling a prescription without further evaluation of the patient if that refilling is done in accordance with the policy. 5 Calls to a pharmacy. A board complaint cannot be filed simply because a doctor calls a pharmacy to determine if a patient has filled a controlled substance prescription. In cases where the physician uses this information to attempt to control the prescription use of the patient, then the physician may face board action. Doctors may see this as an advantage to the prescribing of controlled substances, as the misuse of controlled substances is then placed under the authority of the medical board, wherein the prescriber has more say about the fate of the patient. 6 Refills without consent. While the prescription of controlled substances must have patient consent, the refill of such a drug does not require patient consent if the physician has been granted permission by the patient to allow their pharmacy to provide that information to the physician. These legal implications of controlled substance agreements should always be exceeded and/or followed to the letter. A dispute between a provider and a patient can become a formal investigation of the provider by the state medical board, and the provider will always have to document a solid argument as to why the patient should be terminated from care, whether they have violated the controlled substances use agreement or not. Controlled Substance Agreement PDFs The widespread use of electronic agreements has made it necessary to rely more heavily on PDF formats to complete contracts. These electronic formats provide permanence, ease of sharing, and the ability to include electronic signature elements that allow the contract to be signed electronically, which can generally be done anywhere in the world . They also provide a way to avoid scanning paper forms that may forget to be created at the time of a patient’s appointment.Ultimately, the use of an electronic format should not affect the validity of the controlled substance agreement; even though some questions have arisen regarding the validity of e-signatures, the courts have upheld the validity of e-signatures in numerous cases. Creating and Utilizing a Controlled Substance Agreement PDF A controlled substance agreement (CSA) PDF typically includes terms and conditions for the prescribing of controlled substances, patient rights and responsibilities, and a list of potential consequences for their effects. Such an agreement helps ensure that patients are aware of the risks and benefits of taking controlled substances, along with encouraging them to take their medication as prescribed.Creating a CSA in PDF format is quite simple. You can use Microsoft Word, Google Docs or any word processing program to create your document, then "save as" a .pdf file.I highly recommend using a template. Google "controlled substance agreement template" and you will find a bevy of examples that you can modify to make your CSA. The important thing is to use it and make patients aware if they don’t want to sign.There are no laws stating that you must have a CSA. But if you don’t, when there are problems with your prescribing practices (which are out there) how will you be able to explain to the courts or physicians reviewing your record when there is an overdose (if it isn’t on the record but you verbally discussed it).I created my form using a Word Template but the one I use keeps changing as we learn more about these types of prescriptions and how doctors are required to have documentation. Common Inquiries Regarding Controlled Substance Agreements What is a controlled substance agreement (CSA)?A CSA is a contract between a prescribing provider and a patient that sets forth the patient’s responsibilities as a participant in the treatment of their pain condition. The agreement should be signed by prescriber and patient.The CSA will provide the framework for the provider-patient relationship and address several issues covered in the contract itself, including (1) the recognition of the risks associated with the use of these controlled substances (potential for addiction, diversion, adverse events, and overdose); (2) the rules relating to the receipt of controlled substances by the patient; and (3) the commitment to follow the doctor’s orders for their treatment.It is important for the patient, physician and staff to take the time to review the terms of the CSA with the patient so that he/she understands the importance of the agreement.Why is a patient required to enter into a CSA?A CSA allows a physician to provide appropriate treatment for patients with chronic pain in a way that balances risk to the provider and the patient. A CSA protects the physician and a valuable treatment modality for the patient. The agreement provides your patient with the opportunity to "opt out" of treatment if they are unable or unwilling to comply with the terms and conditions of the CSA. In addition, a properly executed CSA will strengthen your ability to terminate your relationship with the patient in compliance with the requirements of your state medical board.What happens if my patient refuses to sign the CSA?Refusal to sign the agreement should be documented in the patient’s medical record and the patient should be informed that you will not be able to continue treating them. The refusal to sign should be treated similarly to a missed appointment or unexpected termination of the relationship based on "no show" in that the patient is advised that you will no longer be able to participate in their care.Is it appropriate for a physician to ask a patient to sign a CSA if the patient is only taking NSAIDs?There are many treatment modalities for pain management. While the use of controlled substances in treating pain is common, there are non-controlled agents used in the treatment of patients with chronic pain. For example, analgesics such as NSAIDs, acetaminophen and topical anesthetics such as lidocaine patches, which do not have the abuse potential of controlled substances are used to treat pain in a non-addictive way. Nevertheless, the treatment of patients with chronic pain has been associated with the potential of liability for opioid prescribing. In addition, all classes of drugs have the potential for drug interactions that can be dangerous or even fatal. Manufacturers producing drugs, such as medications for the treatment of addiction, opioids, anesthetics, non-steroidal anti-inflammatory medications and antidepressants and other medications are providing a CSA for patients using their drug therapy, Warning Labels of these drugs carries language involving the "Risk of Fatal Interaction with Opioids." In short , all prescriptions for pain management carry some risk for abuse or liability that warrants attention to the safety of the therapy. Accordingly, having a CSA in place helps to ensure safety while avoiding liability.Is a CSA required under federal or state law?Neither federal nor state law requires a CSA. However, both federal and state guidelines address the need for contracts between physician and patient in the appropriately managed care of patients with chronic pain. For example, the Federation of State Medical Boards has endorsed the guidelines for the recommendation of the Federation and American Medical Association. In addition, the American Academy of Pain Management and the American Medical Association have published guidelines that address the appropriate use of a CSA.How can I utilize a CSA to limit opioid prescribing?The CSA should include language that acknowledges the risks associated with the prescription of opioids, the potential for addiction and overdose, and treatment alternatives (such as physical therapy, psychological therapy, or other interventional therapies where appropriate). The CSA will acknowledge your decision to taper or discontinue the use of the opioid if you develop or believe opioid therapy is no longer necessary or appropriate.Does the CSA cover only prescription controlled substances or can it cover over-the-counter medications?The CSA is an acknowledgement that the prescriber-patient relationship involves the use of controlled substances for pain management. In discussing the risks and benefits of opioid therapy, one would expect that the parties would address prescription medications that are controlled substances. However, as discussed above, as physician’s and prescriber’s knowledge of the risks associated with non-prescription medications continues to evolve, the CSA should be reviewed so that the provision in the agreement are sufficient to include all medications, prescription and over-the-counter, that may pose a risk.Do I have to have the patient re-sign the CSA each time the prescription is filled?In most cases, the CSA should only be signed when the patient presents for the first visit where the prescription for a controlled substance is given. Sometimes however, it is appropriate to have a new CSA acknowledged, for example, when a patient changes or substitutes a drug therapy from one pharmaceutical company to another under the same generic indication, or when the drug therapy is changed from one type of controlled substance to another (for example, if Oxycodone is substituted with Methadone). In the event the CSA needs to be re-signed, the CSA language should include the provision in Paragraph 33 above (which requires the acknowledgment and acceptance of the amendment within the contract). In other words, a new CSA is signed but the previous CSA remains in effect except for the new provisions.Is it acceptable to have the prescription drug monitoring program (PDMP) report attached to the CSA?Yes, the CSA should include the PDMP report as an exhibit to the contract. Except for the patient’s signature consenting to its inclusion, the report should be unchanged.