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A risk classification model for prioritising the management of quality issues relating to substandard medicines in Singapore.
Ang, Pei San; Teo, Desmond Chun Hwee; Toh, Yi Long; Ng, Michelle Sau Yuen; Choong, Chih Tzer; Phuah, Doris Sock Tin; Tan, Dorothy Hooi Myn; Tan, Filina Meixuan; Tan, Maggie Siok Hwee; Koh, Suan Tian; Thinn, Wint Maw; Poh, Jalene Wang Woon; Dorajoo, Sreemanee Raaj.
Afiliación
  • Ang PS; Vigilance and Compliance Branch, Health Products Regulation Group, Health Sciences Authority, Helios, Singapore.
  • Teo DCH; Vigilance and Compliance Branch, Health Products Regulation Group, Health Sciences Authority, Helios, Singapore.
  • Toh YL; Vigilance and Compliance Branch, Health Products Regulation Group, Health Sciences Authority, Helios, Singapore.
  • Ng MSY; Vigilance and Compliance Branch, Health Products Regulation Group, Health Sciences Authority, Helios, Singapore.
  • Choong CT; Vigilance and Compliance Branch, Health Products Regulation Group, Health Sciences Authority, Helios, Singapore.
  • Phuah DST; Vigilance and Compliance Branch, Health Products Regulation Group, Health Sciences Authority, Helios, Singapore.
  • Tan DHM; Vigilance and Compliance Branch, Health Products Regulation Group, Health Sciences Authority, Helios, Singapore.
  • Tan FM; Vigilance and Compliance Branch, Health Products Regulation Group, Health Sciences Authority, Helios, Singapore.
  • Tan MSH; Vigilance and Compliance Branch, Health Products Regulation Group, Health Sciences Authority, Helios, Singapore.
  • Koh ST; Vigilance and Compliance Branch, Health Products Regulation Group, Health Sciences Authority, Helios, Singapore.
  • Thinn WM; Vigilance and Compliance Branch, Health Products Regulation Group, Health Sciences Authority, Helios, Singapore.
  • Poh JWW; Vigilance and Compliance Branch, Health Products Regulation Group, Health Sciences Authority, Helios, Singapore.
  • Dorajoo SR; Vigilance and Compliance Branch, Health Products Regulation Group, Health Sciences Authority, Helios, Singapore.
Pharmacoepidemiol Drug Saf ; 31(7): 729-738, 2022 07.
Article en En | MEDLINE | ID: mdl-35366030
BACKGROUND: Monitoring for substandard medicines by regulatory agencies is a key post-market surveillance activity. It is important to prioritise critical product defects for review to ensure that prompt risk mitigation actions are taken. METHODS: A regulatory risk impact prioritisation model for product defects (RISMED) with 11 factors considering the seriousness and extent of impact of a defect was developed. The model generated an overall score that categorised cases into high, medium or low impact. The model was further developed into a statistical risk scoring model (stat-RISMED) using multivariate logistic regression that classified cases into high and non-high impact. Both models were evaluated against an expert-derived gold standard annotation corpus and tested on an independent dataset. RESULTS: Product defect cases received from January 2011 to June 2020 (n = 660) were used to train stat-RISMED and cases from July 2020 to June 2021 (n = 220) for validation. The stat-RISMED identified four factors associated with high impact cases, namely defect classification based on MedDRA-HSA terms, therapeutic indication of product, detectability of defect and whether any overseas regulatory actions were performed. Compared to RISMED, stat-RISMED achieved an improved sensitivity (94% vs 42%) and positive predictive value (47% vs 43%) for the identification of high impact cases, against the gold standard labels. CONCLUSIONS: This study reported characteristics that predicts cases with high impact, and the use of a statistical model to identify such cases. The model may potentially be applied to prioritise product defect issues and strengthen overall surveillance efforts of substandard medicines.
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Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Asunto principal: Medicamentos de Baja Calidad Tipo de estudio: Etiology_studies / Prognostic_studies / Risk_factors_studies Límite: Humans País/Región como asunto: Asia Idioma: En Revista: Pharmacoepidemiol Drug Saf Asunto de la revista: EPIDEMIOLOGIA / TERAPIA POR MEDICAMENTOS Año: 2022 Tipo del documento: Article País de afiliación: Singapur Pais de publicación: Reino Unido
Texto completo
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Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Asunto principal: Medicamentos de Baja Calidad Tipo de estudio: Etiology_studies / Prognostic_studies / Risk_factors_studies Límite: Humans País/Región como asunto: Asia Idioma: En Revista: Pharmacoepidemiol Drug Saf Asunto de la revista: EPIDEMIOLOGIA / TERAPIA POR MEDICAMENTOS Año: 2022 Tipo del documento: Article País de afiliación: Singapur Pais de publicación: Reino Unido