Download Initial Treatment Plan - College of Pharmacy

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
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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
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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
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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
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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
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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
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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
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