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Treatment Plan Treatment Plan Introduction • A treatment plan must be submitted quarterly to the University of Florida College of Pharmacy for research on the safety and efficacy of low-THC cannabis • The research to be performed by the University of Florida College of Pharmacy focuses on drug safety surveillance of low-THC cannabis, with a particular emphasis on the examination of treatment patterns, effectiveness, and safety • Drug safety surveillance is as good as the strength and integrity of the data provided in the treatment plan Key Parts of Treatment Plan • Once the low-THC cannabis has been ordered, the physician must maintain a treatment plan that includes at least the following: Patient identifier Clinical history and condition Dose and Type of administration (oil, injection, edibles, other) Planned duration Monitoring of the patients symptoms Other indicators of tolerance or reaction to the low-THC cannabis Initial vs Follow-up Treatment Plan 3 Treatment Plan • Paper-based forms available; may be completed on a fillable form • Complete the form marked “INITIAL” for the submission of the treatment plan when ordering cannabis for the first time for each patient • For all subsequent treatment plans, use the form marked “FOLLOW-UP” • Each form is two pages in length 4 Initial Treatment Plan • Indicate when the treatment plan was prepared • Identify the registry ID number for the patient for whom cannabis was ordered and provide the other requested information about the patient • Information about the ordering physician is requested. In instances when the patient is younger than 18 years old, include the name of the concurring physician. • Next, provide information about the contents of the cannabis order entered into the registry 5 Initial Treatment Plan Clinical History and Condition • Document the patient’s chief complaint that led to the evaluation of the patient for cannabis treatment • List symptoms observed or reported to you and describe each symptom in terms of its type, frequency, severity, and duration • Identify the prior treatment(s) employed, how long each was used and the outcomes • Describe the patient’s social history, comorbidities, and current medications 6 Initial Treatment Plan Monitoring Plan and Severity of Illness • Describe your plan for managing the patent by stating the treatment goals • Discuss your monitoring plan for the patient’s symptoms and when you plan to follow-up next with the patient • Based on your examination of the patient, describe how ill the patient is at this time by selecting one of the seven categories • Submit the treatment plan to the University of Florida College of Pharmacy per instructions at the bottom of form 7 Follow-Up Treatment Plan • Each quarter after submitting the initial treatment plan, a follow-up treatment plan must be prepared and submitted to the University of Florida • After completing the patient and physician information, indicate whether any change in the cannabis order was entered into the registry and why • Update the planned duration for treatment • Update the clinical history by indicating any changes in the chief complaint, symptoms, comorbidities, and current medications 8 Follow-Up Treatment Plan Reactions to Cannabis and Outcomes • Describe whether the patient is experiencing problems associated with the use of low-THC cannabis by describing any indicators of tolerance or reaction to the cannabis during the last quarter • Indicate any instances where the patient discontinued cannabis during the past quarter • Provide any changes to the treatment goals and the monitoring plan • Compared to the patient’s condition at initiation of cannabis treatment, indicate whether the patient’s condition has worsened or improved by selecting one of the seven categories • Submit the Follow-Up treatment plan to the University of Florida 9