title: Pharmacovigilance of herbal medicines in Africa: Questionnaire study.
abstract: In order to describe and evaluate Herbal Medicine (HM) pharmacovigilance in African countries who are members of the WHO International Programme for Drug Monitoring a survey questionnaire was sent to the national centres and national drug regulatory agencies of these countries. Data collection was carried out from October 1st to 31st December, 2014. Among the total of 39 African countries, 34 (87.2%) answered the questionnaire and 25 (64.1%) accepted to share their data in this publication. Spontaneous adverse reaction reporting for HM is voluntary in 7 (43.7%) countries. HM pharmacovigilance programmes covered suspected adverse HM reactions in 14 (87.5%) countries; HM information in 7 (43.7%) countries; HM dependence or abuse in 6 (37.5%) countries; medication errors in 5 (31.2%) countries; falsification and adulteration in 2 (each 12.5%) countries and HM-drug interactions in 1 (6.3%) country. Groups in countries encouraged to submit herbal reports were pharmacists and physicians (both n=15); nurses (n=13); herbal therapists (n=12); patients (n=11) and local manufacturers (n=8). The number of herbal reports received by most countries was very low or even insignificant. VigiFlow is used by 10 countries. Information from pharmacovigilance activities is disseminated using many means. Only five countries have regulatory status and quality control of their HM products. The participants identified a need for HM regulation, technical and training assistance, and funding as being major challenges to HM pharmacovigilance in countries. Particular attention to the development of pharmacovigilance of HM is required in Africa.
authors.affiliation: Moroccan Pharmacovigilance Centre, Rue Lamfedel Cherkaoui Rabat-Instituts-Madinate Al Irfane, BP: 6671, Rabat 10100, Morocco. Electronic address: sophieskalli@gmail.com.
authors.forename: Souad
authors.initials: S
authors.lastname: Skalli
authors.affiliation: Moroccan Pharmacovigilance Centre, Rue Lamfedel Cherkaoui Rabat-Instituts-Madinate Al Irfane, BP: 6671, Rabat 10100, Morocco.
authors.forename: Rachida Soulaymani
authors.initials: RS
authors.lastname: Bencheikh
mesh_terms: D000349:Africa; D006801:Humans; D008519:Medicine, Traditional / Q000009:adverse effects*; D060735:Pharmacovigilance; D008517:Phytotherapy / Q000009:adverse effects*; D010946:Plants, Medicinal / Q000009:adverse effects*; D011795:Surveys and Questionnaires
keywords: African WHO member countries; Pharmacovigilance of herbal medicines; Questionnaire study; WHO International Monitoring Programme