cover of episode What Is A Compounding Pharmacy? The Science Behind Medications Customized Just for You | Shaun Noorian

What Is A Compounding Pharmacy? The Science Behind Medications Customized Just for You | Shaun Noorian

2024/11/6
logo of podcast The Doctor's Farmacy with Mark Hyman, M.D.

The Doctor's Farmacy with Mark Hyman, M.D.

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Mark Hyman:作为功能医学从业者,我高度评价复方药房在提供个性化医疗服务方面的作用。它们可以解决药物短缺问题,并为患者提供无法通过常规渠道获得的定制药物,包括激素、肽类药物以及静脉注射疗法。 Shaun Noorian:复方药房的历史可以追溯到古代,在大型制药公司出现之前就已存在。如今,由于患者和医护人员对复方药房的认识提高,以及大型制药公司不断提高的药物价格,复方药房正在复兴。复方药房可以根据医生的处方,定制剂型、剂量和药物组合,解决药物短缺、停产或缺乏特定剂量的问题。它们还可以根据患者的生物标志物和合并症微调治疗方案,以获得最佳疗效。我本人也受益于复方药房提供的睾酮治疗,这促使我创立了Empower Pharmacy。我们生产600多种药物,包括激素、生长激素、促智药、利托品注射剂和B12注射剂等,以满足不同患者的需求。 我个人使用的复方药包括亚甲蓝、睾酮和一种含有米诺地尔、壬二酸、非那雄胺和酮康唑的局部护发产品。我们还生产针对痤疮、脱发等问题的复方药物,这些药物可以将多种成分组合成单一剂型,提高患者依从性并降低成本。Empower Pharmacy是一个垂直整合的供应链,直接与患者和医生合作,绕过保险公司和药品福利管理机构,降低药物成本。我们也生产一些非处方药物,例如针对女性性欲低下的局部睾酮滴剂。 关于肽类药物,复方药房只能生产符合特定条件的药物,包括曾是FDA批准药物的成分、具有USP或NF专著以及列在503B批量清单第一类中的药物。许多肽类药物从未获得批准,也不符合配方药房生产的条件,因此监管机构正在采取行动打击其生产。一些肽类药物的临床试验因患者死亡而终止,这凸显了其潜在风险。 关于静脉营养疗法,静脉注射的营养物质具有100%的生物利用度,可以解决口服药物吸收率低的问题。静脉营养疗法可以用于治疗各种疾病,包括过敏、癌症、感染和宿醉等。我们也提供免疫鸡尾酒疗法、宿醉鸡尾酒疗法、美容鸡尾酒疗法和运动恢复鸡尾酒疗法等。 Mark Hyman:我个人也使用复方药房提供的多种药物,包括NAD、谷胱甘肽和B族维生素等。我赞同复方药房在个性化医疗中的作用,以及它们在解决药物短缺问题方面的贡献。 关于非标签用药,医生可以根据自己的临床判断,将药物用于标签说明以外的用途,只要他们相信该药物对患者有临床疗效。复方药房可以为医生提供更多选择,帮助他们为患者制定更有效的治疗方案。 关于肽类药物,虽然有些肽类药物已经获得FDA批准,但许多肽类药物的安全性仍存在争议。FDA正在加强对复方药房生产肽类药物的监管,以确保患者安全。 关于静脉营养疗法,虽然缺乏大型随机对照试验的数据支持,但许多医生认为静脉营养疗法可以有效提高患者的健康水平。静脉营养疗法可以提供100%的生物利用度,并且可以根据患者的具体需求进行定制。

Deep Dive

Key Insights

Why are compounding pharmacies experiencing a resurgence?

Compounding pharmacies are seeing a resurgence due to increased awareness and the need for customized dosage forms that commercial products may not offer, addressing specific patient needs such as allergies, discontinued medications, or unique combinations.

How do compounding pharmacies address chronic illnesses?

Compounding pharmacies customize medications to fit individual patient needs, optimizing treatment for chronic conditions by fine-tuning dosages, forms, and combinations of drugs that may not be available commercially.

What role do compounding pharmacies play in hormone replacement therapy?

Compounding pharmacies provide personalized hormone replacement therapy by creating customized formulations tailored to individual hormone levels and symptoms, ensuring optimal dosages and delivery methods for better patient outcomes.

How does the FDA regulate compounding pharmacies?

The FDA regulates compounding pharmacies through strict guidelines, including CGMPs (Current Good Manufacturing Practices) for 503B outsourcing facilities, ensuring drugs are made under the same high standards as pharmaceutical companies, with regular inspections by state boards of pharmacy.

What are the benefits of using compounded medications over commercial drugs?

Compounded medications offer benefits such as personalized dosages, avoidance of unwanted ingredients, and access to unique combinations and delivery methods that may not be available through commercial drugs, often at lower costs.

How do compounding pharmacies handle off-label drug use?

Compounding pharmacies facilitate off-label drug use by creating customized formulations based on a prescriber's judgment, ensuring that medications are used in ways that may not be FDA-approved but are deemed clinically beneficial for specific patients.

What is the controversy surrounding peptides like semaglutide?

The controversy around peptides like semaglutide stems from their off-label use and the FDA's strict regulation, as some peptides have failed clinical trials or are not approved for certain indications, leading to regulatory actions against their use in compounding pharmacies.

How do compounding pharmacies address drug shortages?

Compounding pharmacies step in during drug shortages by producing necessary medications that are in short supply from commercial manufacturers, ensuring continued access for patients and prescribers.

What are the potential benefits of IV nutrient therapy?

IV nutrient therapy offers 100% bioavailability of nutrients, which can be crucial for patients who need high doses of vitamins, minerals, or amino acids that are not efficiently absorbed orally, providing rapid benefits for conditions like hangover recovery, immune support, and athletic performance.

How do compounding pharmacies contribute to personalized medicine?

Compounding pharmacies enable personalized medicine by creating customized medications that address individual patient needs, including unique dosages, combinations, and delivery methods, optimizing treatment outcomes beyond what standardized commercial drugs can offer.

Chapters
Introduction to compounding pharmacies and their role in providing customized medications, including a discussion on FDA approval processes and the personal story of Shaun Noorian.
  • Compounding pharmacies customize medications for individual patient needs.
  • FDA approval processes can be lengthy and costly, making compounding a viable option for small patient populations.
  • Shaun Noorian's personal health journey led him to found Empower Pharmacy.

Shownotes Transcript

Imagine a pharmacy that tailors medications specifically for your body. In this episode, Dr. Mark Hyman speaks with Shaun Noorian, founder of Empower Pharmacy, about the resurgence of compounding pharmacies and how they’re addressing critical health needs. Learn how compounded medications are offering solutions for chronic conditions, drug shortages, and even hormone and peptide therapies that help patients thrive.

In this episode, we discuss:

  • The Importance of Compounding Pharmacies

  • The Impact of Compounding on Chronic Illness

  • Hormone Replacement Therapy and Personalized Medicine

  • Compounded Testosterone Treatments

  • The Controversy Behind Semaglutides Like Ozempic

View Show Notes From This Episode)

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