Diabetes Core Update – Special Edition

Compounded Medication in Diabetes Care: Perspectives from Patients, Physicians, and Pharmacists

Release Date: February 12, 2025
Host: Dr. Neil Skolnick
Guests: Dr. Susan Cuciera, Dr. John Hertig, Lisa Kessler (Patient)

Episode Overview

This special edition of Diabetes Core Update focuses on the proliferation of compounded and counterfeit medications in diabetes care, particularly regarding GLP-1 receptor agonists like semaglutide and tirzepatide. Host Dr. Neil Skolnick is joined by guest experts and a patient to dissect the challenges, safety issues, clinical implications, regulatory clarity, and patient perspectives surrounding the use of these medications amid increasing shortages, online sales, and public confusion.

Key Discussion Points & Insights

Understanding the Medication Landscape [00:02–03:42]

• Differentiation: FDA-approved vs. compounded vs. counterfeit medications.
• Rising Trend: Increased use of compounded and counterfeit GLP-1s due to drug shortages and skyrocketing public demand.
• Safety & Regulation:
  • Compounded medications aren't FDA approved; their manufacturing lacks rigorous FDA safety, quality, and efficacy oversight.
  • Counterfeit products may not contain the promised ingredients and present even greater risks.
• Recent Warnings:
  • The FDA (July 2024) and ADA have issued alerts about dosing errors and risks from compounded GLP-1 products.
• Quote:

  “…compounded medications are not FDA approved and the process for manufacturing these products does not undergo FDA review for safety, quality or effectiveness.” — Dr. Neil Skolnick [00:45]

Patient Perspective: Lisa’s Decision-Making Journey [04:48–13:53]

• Personal Health Context:
  • Lisa Kessler decided to consider weight loss medications after seeing elevated A1C and liver enzymes, despite a long-standing effort with diet and exercise.
  • Fears of developing type 2 diabetes, family history, and unmet health goals were motivating factors.
• The Doctor-Patient Dynamic:
  • Lisa appreciated her physician’s proactive approach, countering past experience where doctors were dismissive (“just keep working”).
• Exploring Online and Alternative Avenues:
  • Lisa consulted friends who obtained medications through various online routes—with little to no medical oversight—and noted common use of a compounding pharmacy in Florida.
  • Her skepticism about the legitimacy of these sources and lack of oversight led her to prefer her trusted physician for advice and guidance.
• Cost Considerations:
  • Online/compounded medications appeared significantly more affordable than branded GLP-1s, a critical factor for Lisa, especially as she transitioned to Medicare.
• Memorable Quote:

  “…I trusted you. I didn't trust all of these other relationships.” — Lisa Kessler on her decision to consult her doctor rather than internet providers [11:31]

Clinician and Pharmacist Insights: Decision-Making, Patient Engagement & Risks [09:00–22:30]

Dr. Susan Cuciera (Physician)

• Clinical Realities:
  • Unprecedented social awareness and patient inquiry distinguish GLP-1s from most medications.
  • Patients frequently seek out compounded medications for reasons ranging from cost, access, insurance coverage gaps, to joining weight loss programs.
• Ethical & Practical Guidance:
  • She does not recommend compounded medications due to dose unreliability and safety concerns, but acknowledges patient autonomy in shared decision-making.
  • Emphasizes exploring formal insurance and medical rationale for coverage (e.g., other FDA-indicated conditions).
• Real-World Experiences:
  • Shares practical stories of patients harmed by improper dosing with compounded meds.
• Quote:

  “…I don't recommend compounded products. I'm just not comfortable enough that the safety is there.” — Dr. Susan Cuciera [16:23]

Dr. John Hertig (Pharmacist)

• Regulatory Nuances:
  • Distinguishes “compounded” (customized for legitimate patient needs, often during shortages) vs. “counterfeit” (substandard or falsified, criminally fraudulent).
  • Many online “pharmacies” are unregulated, selling unsafe or fake products.
  • Regulatory frameworks: Brick-and-mortar compounders follow state oversight; bulk compounders for shortages must meet federal CGMP but are not FDA approved.
• Patient Safety Message:
  • Urges transparent conversations with patients about the risks—clinical and financial—of non-FDA-approved sources.
• Quote:

  “There are many safe sources that do provide effective medication. And we as clinicians need to ensure that we're directing our patients to those trusted and verified sources.” — Dr. John Hertig [28:15]

The Value of the Ongoing Clinical Relationship [13:53–20:10]

• Integrated Care: Patients benefit not solely from the medication, but from ongoing physician engagement, tailored diet and exercise advice, and regular monitoring that internet/online compounded sources cannot provide.
• Community Learning: Lisa reports sharing her physician’s nutrition/exercise advice with friends who lacked guidance from online prescribers—highlighting the educational void outside clinical care.
• Quote:

  “…without going to a physician for this and going online, I would not have gotten any of that information.” — Lisa Kessler [19:27]

Compounding vs. Counterfeiting – Core Distinctions [22:30–26:20]

• Compounded Medications:
  • Legitimate purpose in rare, specific circumstances (e.g., patient allergies, swallowing issues, or true shortage).
  • Lack FDA review, can vary in potency, purity, and effectiveness.
• Counterfeit Medications:
  • Categorized by WHO as “substandard” (wrong amount of drug/ingredients) or “falsified” (deliberately misrepresented).
  • Pose severe safety and financial risks; often associated with online “pharmacies.”
• Sterility Concerns:
  • Particularly critical for injectable diabetes therapies, as manufacturing missteps (common in unregulated operations) can cause infections and harm.
• Quote:

  “Compounded medicines do serve a niche…but they are not FDA approved. And I think that’s the crux of our conversation here.” — Dr. John Hertig [25:31]

Final Reflections & Action Points [26:44–29:40]

Lisa’s Perspective

• Grateful for physician guidance and education.
• Emphasizes outcome: healthy, sustained weight loss achieved through evidence-based, ethical care.

Expert Recommendations

• Dr. Hertig: Advocates for continual, open communication between patients and clinicians regarding safe medication procurement.
• Dr. Cuciera: Encourages clinicians’ embracing patient engagement, but warns against sacrificing diligence for expediency with these therapies.
• Dr. Skolnick: Reiterates the necessity of shared decision-making and trust in the patient-provider relationship for optimal outcomes.

ADA Position Statement Recap [29:51]

• Non-FDA approved compounded and counterfeit GLP-1 and GIP/GLP-1 agonists are not recommended for use due to uncertainty about content and safety concerns.
• Directs listeners to ADA guidelines and FDA alerts for further details.

Notable Quotes by Timestamp

• “Compounded medications are not FDA approved and…do not undergo FDA review for safety, quality, or effectiveness.” — Dr. Neil Skolnick [00:45]
• "I trusted you. I didn't trust all of these other relationships." — Lisa Kessler [11:31]
• “I don't recommend compounded products. I'm just not comfortable enough that the safety is there.” — Dr. Susan Cuciera [16:23]
• “There are many safe sources that do provide effective medication. And we as clinicians need to ensure that we're directing our patients to those trusted and verified sources.” — Dr. John Hertig [28:15]

Timestamps for Key Segments

| Time | Segment Description | |----------|----------------------------------------------------------------------------| | 00:02 | Introduction to compounded vs. counterfeit medications | | 04:48 | Patient Lisa Kessler details her decision-making journey | | 09:00 | Social/cultural changes in patient inquiry for GLP-1s | | 12:35 | Financial factors driving online/compounded drug use | | 14:19 | Dr. Hertig: Online pharmacy & compounding safety concerns | | 15:43 | Dr. Cuciera: Broader context of patient requests and insurance roles | | 17:48 | Navigating patient reactions and partnership in shared decision-making | | 19:27 | Patient education gaps with online-only medication sources | | 21:27 | Pharmacist’s role in patient counseling and medication safety | | 22:47 | Clear distinction: Compounding vs. Counterfeiting | | 25:31 | Regulatory summary and current overdose risks | | 26:44 | Patient gratitude and outcome report | | 27:50 | Calls to action for clinicians and pharmacists | | 29:51 | ADA statement reiterating safety concerns and official recommendations |

Takeaway Messages

• Physicians and pharmacists must guide patients on the risks, regulations, and proper sourcing of GLP-1 medications.
• Patients benefit vastly from the clinical relationship—expertise, personalized education, and ongoing support—not just prescriptions.
• Compounded medications have a narrow, legitimate role but lack FDA vetting; most online products are unsafe or outright counterfeit.
• Clinicians should leverage insurance processes and shared decision-making, prioritizing patient safety over convenience or cost.
• Continued education and dialogue are crucial as medication sourcing becomes more complex in the digital age.

References and further reading are linked in the show notes.