While this is a prerequisite for the prescription of controlled substances, consent requirements vary from state to state. Michigan, for example, will have a new law on June 1, 2018, containing specific guidelines for a state-imposed form. However, in discussions with our customers, we have found that there are differences between the information contained in these contracts and the consequences of non-compliance. What happens if a patient violates an agreement? Depending on the criteria set by the doctor or practice, a patient can be stripped of his controlled substances, or even released from the office. In the context of the national challenges of opioid abuse, informed consent has often become the document used to draw particular attention to personal and public health risks when practitioners prescribe planned drugs. The activities covered by a patient agreement may vary, but may include: explicit limitation of the sale of its medicines to other parties, obligation for patients to use a single pharmacy, to take medicines exactly as prescribed, to make all appointments, to provide a urine sample on request, to declare themselves ready not to drink alcohol or to take illicit drugs or medicines subject to medical prescription, that have not been prescribed to the patient, and the agreement to keep opioid medications in a safe place. Additional provisions may include necessary reporting activities in the event of loss or theft of the medicinal product subject to medical prescription. In summary, a treatment agreement can be seen as a conversation about how patients and doctors interact, the rules of the street. Informed consent recognizes the risks and clearly shows that a patient is aware of the possible consequences. Both are crucial steps towards a sensible patient-doctor relationship. In addition, both are an integral part of the medical literature, both from a regulatory and cost perspective. Rhode Island provides the following instructions: “Remember that each patient is unique and that, as with other serious illnesses, your clinical judgment is critical and your decision-making process should be documented in the medical record.

If you look at an algorithm, some offenses are more serious than others and warrant an interpreted reaction. Hold your emotions in check. A violation of a pain agreement should never be sacrificed as a personal attack. Keep your thoughts professional, objective and neutral and treat the issue like any other clinical situation by making a history and reviewing the facts. Violating a pain agreement could be a mistake, a misunderstanding, a symptom of addiction, or something else. “The language of informed consent may be included in a treatment agreement or as a separate document. The risks and benefits of TOC, potential side effects, the purpose of treatment, and the ability to facilitate ongoing communication about treatment goals are part of the basic standard framework. Each of them refers to the same contractual document: an agreement signed between a prescribing physician and a patient, which clearly defines the policies and responsibilities between these two parties with respect to behaviors and expectations regarding the prescription of opioid drugs.

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