{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,9,4]],"date-time":"2026-09-04T05:16:31Z","timestamp":1788498991275,"version":"build-2803163510"},"reference-count":25,"publisher":"Springer Science and Business Media LLC","issue":"5","license":[{"start":{"date-parts":[[2025,2,12]],"date-time":"2025-02-12T00:00:00Z","timestamp":1739318400000},"content-version":"tdm","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0"},{"start":{"date-parts":[[2025,2,12]],"date-time":"2025-02-12T00:00:00Z","timestamp":1739318400000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0"}],"funder":[{"DOI":"10.13039\/100000030","name":"Centers for Disease Control and Prevention","doi-asserted-by":"publisher","award":["NU51IP000942-01-00"],"award-info":[{"award-number":["NU51IP000942-01-00"]}],"id":[{"id":"10.13039\/100000030","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":["link.springer.com"],"crossmark-restriction":false},"short-container-title":["Drug Saf"],"published-print":{"date-parts":[[2025,5]]},"abstract":"<jats:title>Abstract<\/jats:title>\n          <jats:sec>\n            <jats:title>Introduction<\/jats:title>\n            <jats:p>Despite the increased scrutiny on vaccine safety following the coronavirus disease 2019 (COVID-19) pandemic, Morocco\u2019s Centre of Antipoison and Pharmacovigilance (CAPM) remained concerned that the pharmacovigilance system in Morocco was insufficiently implemented, including limited adverse event (AE) reporting, poor data use, and inconsistent training nationwide.<\/jats:p>\n          <\/jats:sec>\n          <jats:sec>\n            <jats:title>Objectives<\/jats:title>\n            <jats:p>We sought to assess the status of pharmacovigilance activities (PAs) prior to formally institutionalizing them across university hospital centers (UHCs), given their position as the main providers of healthcare in Morocco and key sources for reporting serious AEs.<\/jats:p>\n          <\/jats:sec>\n          <jats:sec>\n            <jats:title>Methods<\/jats:title>\n            <jats:p>We assessed seven UHCs (housing 30 hospitals) in 2023 using a structured questionnaire with pharmacovigilance focal points developed from the World Health Organization\u2019s indicators of pharmacovigilance and the Global Benchmarking Tool. Data were grouped into 28 PAs and scored from 0 (not implemented) to 3 (fully implemented). We then calculated an implementation rate for each site on the basis of percent of PAs fully implemented (\u2265 70%, well established; &gt; 40% to &lt; 70%, partially implemented; and \u2264 40%, not implemented). A desk review was also performed at the sites. Using the results of the assessment, three working groups of pharmacovigilance stakeholders developed recommendations to be formally adopted by UHCs.<\/jats:p>\n          <\/jats:sec>\n          <jats:sec>\n            <jats:title>Results<\/jats:title>\n            <jats:p>Basic elements of pharmacovigilance (notification forms and VigiFlow<jats:sup>\u00ae<\/jats:sup> or Excel databases) were present at all the UHCs assessed. In total, 14 hospitals (47%) had well-established PAs, including advanced activities such as signal detection of adverse events following the use of medicines and vaccines, as well as causality assessment; 9 hospitals (30%) were partially implementing pharmacovigilance, and 7 hospitals (23%) had no established activities or very basic activities. Within four UHCs, activities had not been implemented at the same level from one hospital to another and vaccine vigilance was largely deprioritized. The working groups made recommendations for improving collaboration, standardizing procedures, and outlining a new organizational structure for pharmacovigilance, which was institutionalized by a formal agreement among UHCs in July 2023.<\/jats:p>\n          <\/jats:sec>\n          <jats:sec>\n            <jats:title>Conclusions<\/jats:title>\n            <jats:p>The assessment revealed a subgroup of centers with well-established AE signal detection and causality assessment abilities, which could play a leading role in the country. After the site assessment, our collaborative approach of bringing together focal points to identify next steps and generate buy-in helped to formalize pharmacovigilance across centers.<\/jats:p>\n          <\/jats:sec>","DOI":"10.1007\/s40264-025-01517-w","type":"journal-article","created":{"date-parts":[[2025,2,12]],"date-time":"2025-02-12T17:37:43Z","timestamp":1739381863000},"page":"527-539","update-policy":"https:\/\/doi.org\/10.1007\/springer_crossmark_policy","source":"Crossref","is-referenced-by-count":2,"title":["Assessment of Pharmacovigilance Across University Hospitals in Morocco"],"prefix":"10.1007","volume":"48","author":[{"given":"Hind","family":"Hamzaoui","sequence":"first","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Anna","family":"Shaum","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Imad","family":"Cherkaoui","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Latifa Ait","family":"Moussa","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Houda","family":"Sefiani","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Ismail","family":"Talibi","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Ghita","family":"Benabdallah","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Omar","family":"Salman","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Seth","family":"Ferrey","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Rachida","family":"Soulaymani Bencheikh","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"297","published-online":{"date-parts":[[2025,2,12]]},"reference":[{"key":"1517_CR1","unstructured":"World Health Organization. The importance of pharmacovigilance. Safety monitoring of medicinal products. 2002. https:\/\/www.who.int\/publications\/i\/item\/10665-42493. Accessed 26 Oct 2024."},{"key":"1517_CR2","unstructured":"World Health Organization. WHO pharmacovigilance indicators. A practical manual for the assessment of pharmacovigilance systems. 2015. https:\/\/www.who.int\/publications\/i\/item\/9789241508254. Accessed 26 Oct 2024."},{"key":"1517_CR3","unstructured":"World Health Organization website. The WHO Programme for International Drug Monitoring. https:\/\/www.who.int\/teams\/regulation-prequalification\/regulation-and-safety\/pharmacovigilance\/networks\/pidm. Accessed 26 Oct 2024."},{"key":"1517_CR4","unstructured":"Uppsala Monitoring Center. UR 48. Uppsala Reports. 2010. https:\/\/who-umc.org\/media\/164352\/ur48_06.pdf. Accessed 26 Oct 2024."},{"key":"1517_CR5","unstructured":"World Health Organization. Regulatory system strengthening for medical products. The Sixty-seventh World Health Assembly.WHA67.20. 2014. https:\/\/apps.who.int\/gb\/ebwha\/pdf_files\/WHA67\/A67_R20-en.pdf. Accessed 26 Oct 2024."},{"key":"1517_CR6","unstructured":"World Health Organization. WHO Global Benchmarking Tool (GBT) for evaluation of national regulatory systems of medicines and vaccines. 2021. https:\/\/www.who.int\/tools\/global-benchmarking-tools\/VI. Accessed 26 Oct 2024."},{"key":"1517_CR7","unstructured":"World Health Organization. Manual for the performance evaluation of regulatory authorities seeking the designation as WHO-listed authorities. 2023. https:\/\/www.who.int\/publications\/i\/item\/9789240076969. Accessed 26 Oct 2024."},{"key":"1517_CR8","unstructured":"Minister of Health of Morocco. Good pharmacovigilance practices (in French). https:\/\/pharmacie.ma\/uploads\/pdfs\/bonnes_pratiques_de_pharmacovigilance.pdf. Accessed 26 Oct 2024."},{"key":"1517_CR9","unstructured":"Minister of Health of Morocco. The Ministerial Circular no. 2 DR\/10 (1992) on the national organization for poison control and pharmacovigilance. Internal document (in French)."},{"key":"1517_CR10","unstructured":"Minister of Health of Morocco. The Ministerial Circular of the Minister of Health no. 003 (2016) on the organization of the national system of pharmacovigilance. Internal document (in French)."},{"key":"1517_CR11","unstructured":"Poison and Pharmacovigilance Center of Morocco website. Pharmacovigilance of vaccines (in French). https:\/\/www.capm-sante.ma\/vsn. Accessed 26 Oct 2024."},{"key":"1517_CR12","unstructured":"Minister of Health of Morocco. The Ministerial Circulars of the Minister of Health no. 91, 92, 96 and 98 CAPM\/00 (2020) concerning the improved organization of the vaccine vigilance following the COVID-19 immunization. Internal documents (in French)."},{"key":"1517_CR13","unstructured":"Minister of Health of Morocco. Health in numbers 2022 (in French). Direction of Planning and Financial Resources. https:\/\/www.sante.gov.ma\/Documents\/2024\/04\/Sante%20en%20chiffre%202022%20VF.pdf."},{"key":"1517_CR14","unstructured":"The Poison and Pharmacovigilance Center of Morocco. Pharmacovigilance annual report of 2022. Internal document (in French)."},{"key":"1517_CR15","unstructured":"The Poison and Pharmacovigilance Center of Morocco. The partnership convention between the Poison and Pharmacovigilance Center of Morocco (CAPM) and the university hospital centers (2018) - Internal document (in French)."},{"key":"1517_CR16","unstructured":"The Poison and Pharmacovigilance Center of Morocco. The partnership convention between the Poison and Pharmacovigilance Center of Morocco (CAPM) and the university hospital centers (2023). 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No identifiable information about individuals was disclosed in the manuscript and all findings are reported in aggregated form. The project was determined to be non-research by both the Moroccan Ministry of Health and the US Centers for Disease Control and Prevention (US CDC).","order":5,"name":"Ethics","group":{"name":"EthicsHeading","label":"Ethics approval"}},{"value":"Not applicable.","order":6,"name":"Ethics","group":{"name":"EthicsHeading","label":"Consent to participate"}},{"value":"Not applicable.","order":7,"name":"Ethics","group":{"name":"EthicsHeading","label":"Consent for publication"}},{"value":"Not applicable.","order":8,"name":"Ethics","group":{"name":"EthicsHeading","label":"Availability of data and materials"}},{"value":"Not applicable.","order":9,"name":"Ethics","group":{"name":"EthicsHeading","label":"Code availability"}},{"value":"R.S.B., H.H., and I.C. designed the assessment study. R.S.B., H.H., H.S., G.B., I.T., L.A.M., A.S., O.S., and S.F. developed the benchmarking questionnaire. R.S.B., H.H., I.C., H.S., G.B., I.T., L.A.M., and A.S. assisted with study implementation and\/or provided oversight of study personnel. H.H., H.S., G.B., I.T., and L.A.M. helped with data collection. I.C. performed data analysis and interpretation of results. I.C. and A.S. drafted the manuscript. R.S.B., H.H., H.S., G.B., I.T., and L.A.M. helped with drafting the manuscript. All authors have read and approved the manuscript.","order":10,"name":"Ethics","group":{"name":"EthicsHeading","label":"Author contributions"}}]}}