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Biologically active supplements: safety, efficacy, market review

https://doi.org/10.17749/2070-4909/farmakoekonomika.2024.269

Abstract

In October 2024, the Dietary Supplement Health and Education Act (DSHEA) of the United States celebrated its 30th anniversary, having established a new class of supplementary medical products. Over the 30-year period, the use of dietary supplements in the United States has evolved from a few hundred products primarily consisting of vitamins, minerals, and select herbal extracts to more than 75,000 items. Despite the popularity of biologically active supplements (BAS), their concurrent use alongside conventional prescription medications raises concerns regarding potential drug interactions, particularly among individuals with comorbidities. An increasing number of patients with chronic diseases use BAS; however, a global consensus regarding their safety remains elusive. The present paper reviews the efficacy and safety of BAS, as well as the market for such products. The presented data underscore the risks associated with the global proliferation of BAS, thus necessitating the development of an effective collaboration among consumers, practicing physicians, and government institutions, as well as the establishment of international criteria for assessing the risks of adverse events. This eventually enhances transparency and trust in the products. In order to ensure safety, a stricter regulation and an efficient control system are required to facilitate adequate monitoring and recording of complications that may arise due to the use of BAS.

About the Authors

A. M. Stepanova
Federal Scientific and Clinical Center of Medical Rehabilitation and Balneology, Federal Medical and Biological Agency
Russian Federation

Aleksandra M. Stepanova - PhD. Scopus Author ID: 57224723316. eLibrary SPIN-code: 7401-7038.

37А bldg 1 Altufyevskoe Shosse, Moscow 127410



А. N. Plutnitskiy
State Scientific Center of the Russian Federation – Burnazyan Federal Medical Biophysical Center; Ministry of Health of the Russian Federation
Russian Federation

Andrey N. Plutnitskiy - Dr. Sci. Med., Assoc. Prof.

23 Marshal Novikov Str., Moscow 123098; 3 Rakhmanovskiy Passage, Moscow 127994



E. V. Gameeva
Federal Scientific and Clinical Center of Medical Rehabilitation and Balneology, Federal Medical and Biological Agency
Russian Federation

Elena V. Gameeva - Dr. Sci. Med. Scopus Author ID: 6504612323. eLibrary SPIN-code: 9423-7155.

37А bldg 1 Altufyevskoe Shosse, Moscow 127410



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What is already known about thе subject?

 An increasing number of patients with chronic diseases use biologically active supplements (BAS); however, a global consensus regarding their legal regulation remains elusive

 In many countries, studies are still not required when registering BAS to confirm their safety and efficacy due to the alleged “low risk” of natural products

What are the new findings?

 The issues of BAS efficiency and safety were considered, the need for developing an effective strategy for cooperation between consumers, practicing physicians and government institutions, as well as for international criteria for assessing the risks of adverse events was demonstrated

 In Russia, it was proposed to establish a more comprehensive legal regulation of BAS market similar to the control over drugs and medical products, to legislate a mechanism for studying BAS therapeutic and preventive properties using scientific methods

 To harness the full potential of BAS, it is necessary to create a com-
prehensive system of preclinical and clinical studies, actively educate consumers and healthcare professionals about potential drug interactions, and ensure careful adherence to good manufacturing practices by industry representatives

How might it impact the clinical practice in the foreseeable future?

 Strict regulation and effective control system will allow for adequate monitoring and recording of complications that may arise from taking BAS, which will eventually increase their therapeutic effectiveness

 The implementation of the proposed measures will increase transparency and trust in BAS, the competence of healthcare professionals and consumer caution

 Due to the presented list of herbal ingredients with drug interactions doctors will be able to consider BAS when planning treatment strategy

Review

For citations:


Stepanova A.M., Plutnitskiy А.N., Gameeva E.V. Biologically active supplements: safety, efficacy, market review. FARMAKOEKONOMIKA. Modern Pharmacoeconomics and Pharmacoepidemiology. 2024;17(4):558-571. (In Russ.) https://doi.org/10.17749/2070-4909/farmakoekonomika.2024.269

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