Informal Trade of Psychoactive Herbal Products in the City of Diadema, SP, Brazil: Quality and Potential Risks

Abstract

The present study aimed to assess the quality and risks involved in the consumption of psychoactive herbal products (PHs) that are available through informal commerce in the city of Diadema, SP, Brazil. Methods of ethnography were used to conduct the fieldwork during which four dealers were selected to record the collection, handling, packaging, types of PHs marketed, and their therapeutic purposes. In addition, lots of the PHs selected were purchased from the dealers and analyzed using microbiology and pharmacognosy techniques. 217 PHs were recorded and categorized into two main groups: stimulants (67%) and depressants (27%) of the central nervous system; sixteen of them were selected, and their 52 lots were acquired. The deficiencies observed in handling and packaging these lots by dealers were confirmed by microbiological analysis; 80.8% of them presented risk according to the indicators defined by the Brazilian Pharmacopoeia. The pharmacognostic analysis confirmed the authenticity of only 9 to 16 PHs analyzed. In addition, descriptions of contraindications, adverse reactions, and drug interactions were found in the literature for the PHs. The results of this study allow the observation of the priorities for the sanitary adequacy of the popular trade of herbs.

Adverse Effects of Plant Food Supplements and Plants Consumed as Food: Results from the Poisons Centres-Based PlantLIBRA Study

“…The quality of the involved plant material is a general issue when it comes to the use of PFS. Lack of standardization and contamination with other plants during preparation, together with no or poor quality control may lead to adverse effects in case of consumption (Soares Neto, 2013) and could have also contributed to the adverse effects observed in our study.…”

“…The quality of the involved plant material is a general issue when it comes to the use of PFS. Lack of standardization and contamination with other plants during preparation, together with no or poor quality control, may lead to adverse effects in case of consumption (Soares Neto et al, 2013) and could have also contributed to the adverse effects observed in our study. Hepatotoxicity is an important issue when investigating the safety of medications, and many herbal medications do affect the liver (Bunchorntavakul and Reddy, 2013;Stickel et al, 2005;Teschke et al, 2012).…”

Development of Instrument to Report and Assess Causality of Adverse Events Related to Herbal Medicines

“…This finding can be justified based on the subjectivity associated to items "smell", "color", "appearance", and "texture". However, satisfactory filled fields "scientific name" may minimize bias related to description of organoleptic characteristics provided by health professionals, since it is possible to compare it with a description provided by official literature; however, this may increase quality deviations [15,34] . Moreover, the scientific name of herbal medicine is important for the standardization and harmonization of terminology within an international framework [17] in order to increase the effectiveness of post-marketing in regulation and supervision of natural products available in the market.…”

“…A pharmacovigilance system of herbal medicines also started in the same year by the publication of a notification form of adverse reactions related to herbal medicines (RAMP) by the institution. Therefore, the instrument form developed in this study will allow identification of other potential adverse events associated with the use of these products, such as handling and packaging [14,15] , improper storage and identification [15] , serious adverse reactions [38] , and medication errors [13] . This instrument is suitable for identification of adverse events related to herbal medicines, since it improves upon the previously available forms by ANVISA and CEBRID and expands the possibility of identification of events other than adverse reaction.…”

“…In addition, other factors may increase the risk of occurrence of adverse events, such as tampering, poor quality, lack of proper identification, contamination and inappropriate use [13] as well as improper storage and handling [14] and packaging [15] . However, there is an underestimation of causal association between adverse effects and the use herbal medicines, since users do not inform health professionals about their administration [2,14,16] , and since they are not able to correlate unwanted clinical manifestation with intake [17] .…”