1. Treatment Plan

2. 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
In addition to updating the registry to reflect the contents of the order, the legislation requires ordering physicians to create an initial treatment plan, to update it quarterly, and, then, to send it to the University of Florida College of Pharmacy. As required by the legislation, the information in the treatment plan will be used to conduct research concerning both the safety and effectiveness of low-THC cannabis. The College of Pharmacy’s research will focus on drug surveillance, which is commonly used by agencies such as the FDA, to identify safety signals, to learn about how drugs are used, and to discover information about their effectiveness under usual medical practice conditions. Safety, of course, is the most important purpose of drug surveillance. The information you provide will alert us to situations when physicians abruptly discontinue treatment and why. Further, this information will provide us with the basis for warning other physicians about adverse effects. One thing to keep in mind is that the conclusions drawn from drug surveillance studies are only as good as the quality of the data provided. Thus, it is vital that the information you include in the treatment plan are complete and clear.

3. 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
The initial treatment plan shall address the customary sections included in a treatment plan or patient work-up. The plan shall include information about the patient including social history, disease history, current medications, and indication(s) for cannabis treatment. Additionally, information is needed about the ordered dose, type of administration and planned duration. Finally, the initial treatment plan shall include your plan for monitoring the patient’s symptoms. Last, it is important to establish a baseline for comparing outcomes of treatment later by answering one question about the severity of the patient’s illness.
The legislation also requires the ordering physician to submit an updated treatment plan every three months to the University of Florida College of Pharmacy. The follow-up treatment plans will mainly focus on what has changed since the patient started using low-THC cannabis. This information includes how symptoms associated with the cannabis indication have changed, whether the dose changed and why, was low-THC cannabis discontinued and why, and were there potential safety concerns related to the use of cannabis. Finally, the clinician is asked to respond to a question about whether the patient’s condition has improved or worsened since the submission of the last treatment plan.

4. 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
The University of Florida has prepared two forms: one is marked “INITIAL,” which shall be used for preparing the first treatment plan for a patient for whom cannabis has been ordered. Three months later and for all subsequent treatment plans for each patient, the physician shall use the second form marked “FOLLOW-UP.” The forms are electronically fillable to ease in their preparation.

5. 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
The first three sections of the initial treatment plan form ask for information about the patient, the ordering physician and the cannabis order as entered into the registry. For the field called Race/Ethnicity, please report whether the person is Hispanic/Latino or not Hispanic/Latino. Then report whether she/he is either American Indian, Asian, Black/African American, Hawaiian/pacific Islander, White, or Mixed race.

6. 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, co- morbidities, and current medications
This section of the treatment plan focuses on the clinical history of the patient beginning with the chief complaint that led to the evaluation for cannabis treatment. Then, list each of the patient’s symptoms corresponding to the chief complaint and describe each symptom in terms of type, frequency of onset, severity and duration. Please be very clear yet concise when listing this information as this information is vital in drug surveillance research. Next, discuss prior treatments attempted including how long each treatment was employed and the outcome of each treatment. Describe the patient’s social history with a specific focus on the individual’s use of alcohol or illicit drugs and whether the patient smokes nicotine. The next section concerns the identification of the patient’s other medical conditions. Finally, the clinical history asks that you let us know which prescription medications has been prescribed for the patient and whether the patient is using any forms of self-medication such as herbals, OTCs.

7. 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
The last section of the initial treatment plan focuses on the physician’s plan and a measure of how ill the patient is at the time of the initial patient evaluation. Discuss your plan for managing the patent by stating the treatment goals you have established for the patient. Next, discuss your monitoring plan for the patient’s symptoms and when you plan to follow-up next with the patient. Finally, identify how ill the patient is by selecting one of the seven categories. This information will be used as a baseline against which the patient’s condition will be compared to later once the cannabis is being used. That’s all of the sections of the treatment plan and it is now complete. Please follow instructions at the bottom of the form to submit the form to the University of Florida.

8. 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, co- morbidities, and current medications
The legislation also requires physicians to update the treatment plan each quarter. After completing the patient and physician information of the form marked “Follow-Up,” indicate whether any change in the cannabis order was entered into the registry. If, for example, the dose was increased or decreased, describe the dosage adjustment and explain the reason for the change. Finally, update the clinical history by indicating any changes in the chief complaint, symptoms, co-morbidities, and current medications.

9. 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
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. Please be very clear in this section about what you observed or what was reported by the patient since this section provides important data about the safety of cannabis. If you suspect an ADR to cannabis, please note whether the adverse event appeared after cannabis was initiated. Further, please answer the following questions if appropriate. If cannabis was discontinued, did the adverse reaction improve following discontinuation? Did the adverse event appear if cannabis was re-initiated? Was the reaction more severe when the dose was increased or less severe when the dose was decreased?
Next, describe any changes to treatment goals and the monitoring plan. Finally, answer the following question “Compared to the patient’s condition at initiation of cannabis, did the patient’s condition improve or worsen?” This completes the form and its ready to be submitted to the University of Florida following the instructions at the end of the form.