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FAQs: GLP-1 Agonists (Semaglutide)

  1. How can I get quick information on how to offer semaglutide/tirzepatide?
    A. You can view our previous webinar on semaglutide/tirzepatide, or visit this article for additional medical context.
  2. How do I order semaglutide/tirzepatide? 
    Please navigate to the Inventory Ordering page.
  3. How long does shipping typically take?
    Semaglutide/tirzepatide is usually shipped for overnight delivery on Mondays or Tuesdays after ordering. Depending on when you place your order, it can range anywhere from 2-7 business days.
  4. How do I start offering this to patients?
    Please see the template Policy and Procedure. You should customize this to your business and confirm with your Medical Director and medical malpractice prior to offering it.

For existing patients: 

  1. We recommend capturing the information in the provided consult template in writing. You may create your own template capturing the same information. We recommended printing copies to have in your studio for easy access. We’ve also created a follow-up note template to help you consistently and thoroughly document patient visits.
  2. Take a photo of the completed intake form and attach it to the patient’s chart in the EHR.
  3. If you use Portrait Clearing Services, the above steps are needed to complete the Good Faith Examination. Once the photo is attached to the patient’s chart:

For NP/PA providers: confirm the patient is a candidate. Then, the patient will review and sign the consent form. You'll administer the first injection, provide the patient with 1-3 months of product in pre-drawn syringes, and complete the semaglutide/tirzepatide procedure note (or make your own and enter it).

 

For new patients: 

There is an optional weight loss field that has been added to the new patient onboarding flow. Patients will see the following question when creating a medical profile: 

  • Are you interested in weight loss products?

This will help indicate their interest in semaglutide/tirzepatide and also streamline future medical clearances.

Ensure patient attests to the following during their visit (please note these are also included in the consent form provided to you):

  • BMI>25 to start treatment, BMI>21 for maintenance treatment
  • No personal or family history of multiple endocrine neoplasia syndrome type 2 (MEN 2)
  • Not type 1 diabetic or type 2 diabetic requiring medications
  • No history of thyroid cancer
  • No history of pancreatitis
  • Not pregnant or intending to become pregnant in the next two months
  • Not currently on another hypoglycemic agent (e.g. metformin) -- > these patients are not candidates and should be managed by their primary care provider
  1. What ancillaries should I have on hand to offer semaglutide/tirzepatide?

    A. You will need extra needles and syringes on hand to give to the patient and bacteriostatic water for reconstitution. These are available in your Medline account.
  2. What should I do when the patient arrives? How do I dispense semaglutide/tirzepatide?

    Once in office, be sure to document the patient’s relevant medical history as indicated above. When you go to dispense it, it’s recommended the patient sign a consent, particularly for their first visit and annually thereafter. 


You might administer the first injection as this is a great opportunity to increase patient confidence. Typically, providers provide the patient with at least 1 month of product in pre-drawn syringes, and complete a visit note. Draw each dose into a syringe and label it with 1) the patient's name or initials and 2) the dosage and frequency. At the bottom of this page you will see a complete recommended label (based on FDA guidelines). 

  1. What does this cost me? 

    Please review the Ordering page to see the current pricing.
  2. Do you have any marketing messages I can use with my existing patient base? 

    We recommend personalizing this, but here is a messaging starting point for communication with patients:

“I’ve got something truly amazing in store for you: XYZ business now proudly offers the game-changing weight loss solution semaglutide/tirzepatide, and it’s exclusively for loyal patients like you!

I’m thrilled to introduce semaglutide/tirzepatide, a fantastic addition to my lineup of services at XYZ business that is focused on weight loss. It’s the perfect complement to your existing beauty and wellness regimen.

I'm so excited to help develop a personalized plan just for you that covers skincare, aesthetic enhancements, and now: weight loss. I can’t wait to continue the holistic journey of helping you look and feel your absolute best as we step into 2024!

If you’re interested, please reply to me with your height and weight and we can get this started!”

What has worked well for providers to be successful with this? How do they coach patients to get the desired results?

Kristen Doezie has had a lot of success with GLP-1 (semaglutide/tirzepatide) and graciously shared this informational packet she shares with patients.


Specific to Pure RX product

How Do You Store Our Lyophilized (Freeze-Dried) Peptides?

  • Storage Conditions:
    • Peptides in their lyophilized state can be safely stored at room temperature.
    • For optimal stability, store peptides in a cool, dry place, away from direct sunlight, heat, or moisture.
  • Shelf Life:
    • Most peptides have a shelf life of up to 24 months under appropriate conditions.
    • Always refer to the expiration date on the vial for specific information.

 

Find more information regarding Pure RX Semaglutide/tirzepatide in the following documents

Understanding the Beyond Use Date (BUD) for Sterile Compounded Products

 

The beyond-use date (BUD) for a compounded sterile prescription after puncturing depends on several factors, including:

  1. Sterility Risk Level: How the prescription was compounded (e.g., low-risk, medium-risk, high-risk sterile compounding).
  2. Storage Conditions: Whether the punctured vial or container is stored at room temperature, refrigerated, or frozen.
  3. Type of Container: The integrity and type of the container (e.g., single-dose vial vs. multi-dose vial).
  4. Regulatory Standards: Compliance with USP <797> guidelines or any other applicable local regulations.

General Guidelines:

  • Single-Dose Vials (SDVs): Once punctured, an SDV must be used within 6 hours if maintained in an International Organization for Standardization (ISO) Class 5 or better environment. Otherwise, discard it after 1 hour if outside this environment.
  • Multi-Dose Vials (MDVs): Once punctured, MDVs may be used for up to 28 days, unless the manufacturer specifies a shorter duration or contamination occurs.
  • Compounded Sterile Products (CSPs): If CSPs are drawn into syringes or other containers, their BUD depends on compounding risk level, storage conditions, and stability data, as outlined in USP <797>. For example:
    • Low-risk CSPs: Up to 48 hours at room temperature, 14 days refrigerated, or 45 days frozen.
    • Medium-risk CSPs: Up to 30 hours at room temperature, 9 days refrigerated, or 45 days frozen.
    • High-risk CSPs: Shorter BUDs due to higher contamination risk.

Always refer to the specific instructions provided by the manufacturer, facility policies, and applicable regulations. If sterility or stability is ever in doubt, the product should be discarded. 

 

 

References:

1. United States Pharmacopeia (USP) <797>

  • Purpose: Outlines practices for compounding sterile preparations, including storage, beyond-use dating (BUD), and handling of single-dose and multi-dose vials.
  • Access: Available through the USP website or compounding compliance resources. Updated versions (e.g., 2022 revision) provide expanded information.

Link: USP <797>

2. Centers for Disease Control and Prevention (CDC) - Injection Safety

  • Purpose: Guidelines for safe injection practices, emphasizing proper handling of single-dose and multi-dose vials to prevent contamination.
  • Key Takeaway: Single-dose vials should be discarded after one use unless otherwise specified, while multi-dose vials may be used for up to 28 days unless contamination occurs.

Link: CDC Injection Safety

3. Institute for Safe Medication Practices (ISMP)

  • Purpose: Offers best practices for handling injectable medications, including sterile products and vials.
  • Key Takeaway: Reinforces the importance of adhering to manufacturer and regulatory guidelines for BUDs and storage.

Link: ISMP Guidelines

 

Example label:

Patient: John Doe

Semaglutide 5mg/ml

Generic for Ozempic

Manufacturer’s name

Inject 12 units once weekly x 4 weeks

Expiration date: 11/30/25

Lot#: 6621

RX# JD1

Prescribing physician: Jennifer Jones, MD

Office contact info: (123)456-7890

Patient contact info: (098)765-4321

Quantity: 2ml