What questions should you ask before starting peptide therapy?

It can be frustrating that peptide protocols have credible science supporting their use, an uneven compounding supply chain, and a seemingly arbitrary designation as to whether a particular peptide is a medication or not and therefore subject to increasingly strict regulation. However, most of this can be navigated with appropriate consultation to clearly outline the treatment program’s corresponding questions and allow for intelligent and appropriate modification as needed along the way.

First, a list of the questions I use to guide my consulting for a working treatment plan with a client and within the boundaries of my lawful practice to ensure a good outcome for a client’s full treatment plan.

Who is prescribing, and what are they qualified to prescribe?

Check the credentials of your prescriber. In the world of peptide protocols, title is not as important as licensure. If your prescriber is an MD, NP, or PA practicing within their scope of practice and holding an active DEA license where required, you’re off to a good start. What percentage of their practice is endocrine and metabolic related as opposed to pure aesthetic?

What facility is compounding the peptides? Are they a 503A or 503B outsourcing facility (currently registered with the state’s pharmacy board)? Have they performed appropriate sterility and potency testing on the specific compounds that will be used? Is the peptide being offered for sale as ‘research grade’ or are patient-specific prescriptions being written for them?

Questions that separate clinical practice from product sales

• Which pharmacy compounds this, and can a certificate of analysis be provided for the current lot?
• Is the compound on the FDA bulk substances list, or has it been placed in a restricted category?
• Does the practice have a financial interest in the dispensing entity, and is that disclosed?
• Who covers after-hours questions about injection site reactions or dosing errors?

What exactly is the therapy meant to change?

Circumvent the temptation to agree to work with a client with very general goals like “more energy”. Define specific targets such as improving sleep efficiency, decreasing recovery time from resistance training or shifting body composition. Set up specific metrics that can be tracked and measured at regular timeframes, usually 8-12 weeks.

Set a stopping rule at the same time you set a goal. The stated outcome for the energy-hungry patient should not remain unchanged for more than the agreed time period for the specified goal (usually 8-12 weeks). If it does not move, then what?

Matching the compound class to the objective

Which parts of the medical history actually change the plan?

There are many cancer victims who have active and treated cancers. Secretagogues for growth hormone are particularly to be avoided by individuals with malignancy or cancer in their history as growth hormone can stimulate the IGF-1 pathway and promote tumor growth. A thorough history taking will seek information regarding untreated, active proliferative retinopathy, uncontrolled diabetes, recent major surgery and will utilize checkbox forms as inferior means of data collection.

Growth Hormone Secretagogues are contraindicated in patients with active or history of cancer and may affect individuals with proliferative retinopathy, diabetes, post-operative major surgery and other conditions that may impact the IGF-1 pathway. Moreover, the interactions with a variety of other medications (e.g. Insulin/sulfonylureas, oral hypoglycemics, corticosteroids, thyroid hormones and others) as well as their impact on pregnant or breastfeeding women and women of childbearing potential must be understood prior to use.

How will response and safety be tracked over time?

Draw a full set of baseline labs before starting a patient on a peptide, and not after. For growth hormone secretagogues, this would include a measurement of the patient’s IGF-1 level (measured age-adjusted) as well as his or her fasting glucose, HbA1c, CMP, and full lipid profile, as well as a measurement of thyroid function if his or her symptoms of fatigue suggest hypothyroidism. If you live on the First Coast, it is worth booking that baseline panel with a Jacksonville peptide doctor who will repeat the identical labs at your first review rather than a scaled-down version of them.

Agree in advance what will signal that a change to decrease the dose or stop therapy is warranted (e.g. Rising fasting glucose, an IGF-1 level that is above the age-specific reference range, persistent edema, new onset of carpal tunnel syndrome).

Practical items to confirm before the first injection

1. Reconstitution instructions, including diluent volume and resulting concentration per unit.
2. Cold chain requirements and the beyond-use date for the reconstituted vial.
3. Injection timing relative to meals and sleep, which materially affects several compounds.
4. Written guidance on missed doses and travel storage.

What should be settled about cost, consent, and continuity?

Additionally, most peptide therapies are not covered by insurance, and therefore, patients should be informed of the full cost of the treatment protocol (including blood work) and all of their follow-up visits in advance. Furthermore, practitioners should clearly inform patients in the informed consent documents as to which indications for specific peptides are off-label and that said peptides lack large-scale human trials.

Be sure to determine how the practitioner’s records will be shared with the patient’s primary care physician or with specialists treating the patient as well. The risk of unwise therapy in isolation of the patient’s total medical care is far greater than in most situations in medicine and a practice unwilling to share records with other treating clinicians has already told you something useful.