The core GLP-1 documentation package
Clinical protocol
Defines program scope, roles, evaluation, prescribing workflow, monitoring, continuation, referral, and escalation.
Orders and medication records
Capture the authorized prescriber, exact medication and formulation, directions, source, dispensing or administration, and changes.
Patient-facing forms
Intake, consent, medication education, administration guidance where applicable, follow-up questionnaire, and urgent contact instructions.
Clinic operations
Cover scheduling, communication, laboratory tracking, medication storage, temperature excursions, inventory, incident reporting, and document control.
Semaglutide, tirzepatide, liraglutide, and other products have different indications, labels, contraindications, dosing instructions, presentations, and warnings. The prescribing professional must use current product-specific information and individual clinical judgment.
An end-to-end clinic workflow
Inquiry and program information
Set accurate expectations about medical evaluation, approved and unapproved products, pricing, follow-up responsibilities, communication, and when the program may not be appropriate.
Clinical intake and evaluation
Collect the history and measurements the prescriber requires, verify identity and jurisdiction for telehealth when used, review contraindications and precautions, and document the assessment.
Medication decision and consent
The authorized prescriber selects the specific therapy and documents the rationale, order, patient discussion, alternatives, risks, expectations, and follow-up plan.
Access, dispensing, or administration
Document the exact medication, source, pharmacy where applicable, presentation, labeling, handling, delivery, education, and any clinic administration.
Monitoring and continuation
Track response, tolerability, adherence, relevant clinical findings and laboratory information, medication changes, communication, and the prescriber’s continuation or escalation decision.
Transition, referral, or discontinuation
Define how the team handles lack of response, adverse effects, contraindications, pregnancy considerations, access interruptions, transfer of care, and emergency symptoms.
What should the evaluation workflow address?
The approving prescriber should determine the required history, physical findings, measurements, testing, exclusion criteria, and follow-up plan. The protocol can organize these elements without replacing professional judgment.
- Identity, location, and contact information
- Goals and prior weight-management history
- Medical, surgical, and family history
- Current medications and allergies
- Pregnancy and reproductive considerations
- Contraindication and precaution review
- Relevant baseline findings and testing
- Behavioral health and eating-pattern considerations
- Medication access and administration readiness
- Urgent symptoms and referral criteria
Medication-specific documentation
The record should identify the exact FDA-approved or compounded medication, concentration and presentation, authorized prescriber, order, pharmacy or supplier, directions, education provided, changes, and disposition of any clinic-held stock. Avoid ambiguous entries such as “GLP-1 injection.”
Prescribing information
Link the protocol to the current label and medication guide for each FDA-approved product used.
Source and traceability
Document the authorized pharmacy or supplier, product identifiers, receipt, storage, and patient-level dispensing or administration details.
Patient education
Use product-specific instructions, expected effects, precautions, missed-dose guidance, storage information, and urgent contact directions approved by the prescriber.
Change control
Require review when the clinic adds a product, pharmacy, formulation, device presentation, or administration process.
Follow-up, monitoring, and escalation
The protocol should establish how the clinic collects follow-up information, routes it to the prescriber, documents clinical decisions, handles refills, and responds to adverse events or concerning symptoms. It should also define missed-visit outreach, medication interruptions, referral, and emergency instructions.
| Workflow area | Documentation question |
|---|---|
| Follow-up cadence | Who schedules, what information is collected, and when prescriber review occurs? |
| Response | How are clinical response, tolerability, adherence, and relevant findings recorded? |
| Medication changes | Who authorizes changes and where are the new order and education documented? |
| Escalation | Which symptoms require same-day review, urgent referral, emergency services, or discontinuation consideration? |
| Continuity | How are shortages, transfers, pharmacy problems, missed appointments, or program exit handled? |
Special attention for compounded or unapproved products
FDA states that compounded drugs are not FDA approved and does not review their safety, effectiveness, or quality before marketing. FDA has also reported dosing errors and adverse events associated with compounded injectable semaglutide, along with concerns involving fraudulent products, salt forms, shipping temperatures, and misleading claims.
If a clinic is considering compounded medication, its qualified prescriber and legal or pharmacy advisors should review current federal and state requirements, clinical need, source, formulation, labeling, quality information, dosing measurement, patient education, storage, adverse-event reporting, and the FDA’s current enforcement position. Marketing should not imply that a compounded product is an FDA-approved generic or the same as an approved drug.
Product availability, shortage status, compounding policy, warnings, and enforcement activity can change. Assign a document owner to verify current FDA information and update the clinic’s materials promptly.
Selected authoritative resources
Frequently asked questions
Can one protocol cover semaglutide and tirzepatide?
A shared program framework may be possible, but medication-specific evaluation, labeling, orders, directions, education, records, warnings, and monitoring must remain clearly separated and clinically approved.
Should the protocol include a dosing schedule?
Clinical dosing belongs under an authorized prescriber’s product-specific approval and patient-specific judgment. A template should not substitute for current labeling or establish treatment for an individual.
What forms should patients complete?
Common forms include a medical intake, medication and program consent, product-specific education acknowledgment, follow-up questionnaire, communication authorization, and any administration record applicable to the clinic’s workflow.
How often should the protocol be updated?
Use a defined review schedule and update sooner when labels, safety communications, laws, products, pharmacies, staffing, technology, or clinic processes change.
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