Pharmacovigilance of herbal medicines in Africa: Questionnaire study

Skalli, Souad; Soulaymani-Bencheikh, Rachida

doi:10.1016/j.jep.2015.05.033

Cited by 24 publications

(22 citation statements)

References 17 publications

(18 reference statements)

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“…A single reporting form covering all health products, including herbal medicines, is used in all countries. 35 This is important because a single form will facilitate reporting for health pro- Results of the present study identify several important issues. The key point is that the role of pharmacists in spontaneous ADRs reporting is crucial in the pharmacovigilance system since it helps monitor the patients' treatment in real-life conditions.…”

Section: Discussionmentioning

confidence: 94%

“…In spite of their perceived safety, however, it has become evident in the recent decades that natural medicines could cause adverse reactions, which is why the World Health Organization, recognizing the growing importance of the use of herbal medicines worldwide, developed guidelines for monitoring their safety within the existing pharmacovigilance framework . Inclusion of these products into pharmacovigilance systems is becoming increasingly important . Pharmacovigilance for herbal medicines is still a relatively new concept in most countries.…”

Section: Discussionmentioning

confidence: 99%

“…Pharmacovigilance for herbal medicines is still a relatively new concept in most countries. A single reporting form covering all health products, including herbal medicines, is used in all countries . This is important because a single form will facilitate reporting for health professionals and herbal medicines providers already included in national pharmacovigilance systems.…”

Section: Discussionmentioning

confidence: 99%

“…34 Inclusion of these products into pharmacovigilance systems is becoming increasingly important. 35 Pharmacovigilance for herbal medicines is still a relatively new concept in most countries. A single reporting form covering all health products, including herbal medicines, is used in all countries.…”

Section: Discussionmentioning

confidence: 99%

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Safety of medicines—Pharmacists' knowledge, practice, and attitudes toward pharmacovigilance and adverse drug reactions reporting process

Kopciuch

Zaprutko

Paczkowska

et al. 2019

Pharmacoepidemiology and Drug

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Purpose Patients' safety is a public concern in healthcare systems across the world and should be ensured, among others, by pharmacovigilance based on spontaneous reports of adverse drug reactions (ADRs). Spontaneous ADRs reporting is an important component of the pharmacovigilance system. The role of pharmacists in spontaneous ADRs reporting is crucial in the pharmacovigilance system since it helps to monitor the patients' treatment in real‐life conditions. The aim of the study was to evaluate the pharmacists' attitudes to and knowledge on spontaneous ADRs reporting in Poland and to identify the reasons for underreporting of ADRs. Methods The study was conducted between January 2016 and January 2018. A self‐administered questionnaire was designed and distributed to pharmacists. The pharmacists were randomly selected from the official database kept by the chief pharmaceutical inspectorate in Poland. Results Only 16% (n = 84) of the respondents have ever attended a training on pharmacovigilance. Eighty‐one percent (N = 422) of pharmacists believe that not all synthetic drugs available on the market were safe. Twenty‐eight percent (n = 146) of the respondents were certain about safety of drugs of natural origin, and 16% (n = 84) were of an opinion that adverse reactions following administration of such drugs should not be reported at all. Conclusions To conclude, there is an increasing awareness of the need to develop pharmacovigilance practices. The current (not fully adhered to in practice) model of pharmacovigilance and its associated tools have been developed for synthetic drugs, and applying these methods to monitor safety of herbal medicines presents unique challenges.

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Section: Discussionmentioning

confidence: 94%

Section: Discussionmentioning

confidence: 99%

Section: Discussionmentioning

confidence: 99%

Section: Discussionmentioning

confidence: 99%

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Safety of medicines—Pharmacists' knowledge, practice, and attitudes toward pharmacovigilance and adverse drug reactions reporting process

Kopciuch

Zaprutko

Paczkowska

et al. 2019

Pharmacoepidemiology and Drug

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“…In Africa, although herbal medicine pharmacovigilance programs covered suspected adverse reactions in 14 (87.5%) countries, medication errors in 5 (31.2%) countries, falsification and adulteration in 2 (each 12.5%) countries, and drug interactions in 1 (6.3%) country, particular attention to the development of surveillance of natural products is required [28] . Underreporting [18] and poor quality of information hinders causality association [29,30] .…”

Section: Discussionmentioning

confidence: 99%

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

Mastroianni

Varallo

COSTA

et al. 2017

Vitae

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Background: The use of herbal medicines is justified empirically using ethnopharmacological knowledge, which has limitations. Reports of adverse events (AE) may contribute for safety, quality, and effectiveness assessment. Objectives: This study aimed to develop an instrument to allow detection and evaluation of the causal likelihood of AE related to herbal medicines. Methods: A quantitative methodological development research intervention was performed with primary care health professionals. Two cases were distributed in an interval of one week in order to allow for completion of the proposal form. The within-rater reliability was calculated and classified into satisfactory, regular, and unsatisfactory, according to essential, necessary, and recommended items reported. Results: Fifty-seven professionals were enrolled. A high degree of the within-rater reliability was observed for the most essential, necessary, and recommended fields. The instrument contributed to assessment of definite causal association, once the duration of reactions including evolution, withdrawal, and reposition items showed high reliability. Most fields poor and weak filled were related to quality defects, such as popular name and appearance. Conclusions: Data suggest the instrument is adequate to report AE arising from herbal medicines. Owing to information regarding to organoleptic characteristics, the instrument is different from drug instruments. Therefore, it is intended to improve AE reports related to herbal medicines and contribute for appropriate use.

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Pharmacovigilance of Herbal and Traditional Medicines

Zhang

2018

Methods in Pharmacology and Toxicology

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Pharmacovigilance of herbal medicines in Africa: Questionnaire study

Cited by 24 publications

References 17 publications

Safety of medicines—Pharmacists' knowledge, practice, and attitudes toward pharmacovigilance and adverse drug reactions reporting process

Safety of medicines—Pharmacists' knowledge, practice, and attitudes toward pharmacovigilance and adverse drug reactions reporting process

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

Pharmacovigilance of Herbal and Traditional Medicines

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