2007-12-03-世界卫生组织-2005_ACSoMP_recommendations_5页_165kb

WHO Advisory Committee on Safety of Medicinal Products: Third Meeting Summary (December 2005)

The ACSoMP meeting addressed various issues in pharmacovigilance, including financial sustainability, specific drug safety, and patient safety initiatives. Below is a key summary:

Overall Meeting Summary

• The committee discussed challenges related to the Uppsala Monitoring Centre (UMC), notably its funding and commercial activities. It recommended improving budget allocation at the WHO level to ensure long-term sustainability.
• For antiretroviral drugs in HIV/AIDS programs, a small working group is tasked with developing a pharmacovigilance action plan for a pilot project in African countries, focusing on adverse drug reaction reporting and monitoring.

Pharmaceutical Safety and Pharmacovigilance

• UMC Issues: 90% of UMC's budget comes from sales, raising concerns about over-commercialization. Action: Seek better funding mechanisms.
• Antiretrovirals (ARVs): Encouragement for ADR collection; action plan includes strengthening spontaneous reporting, monitoring toxicities, and using pregnancy registers.
• Patient Safety: Support for a four-year pilot project integrating medication error reporting into pharmacovigilance; principles include strengthening national centers' objectives and focusing on developing countries.

Document and Policy Updates

• Patient Safety Guidelines: Drafts and comments on adverse event reporting and learning systems need refinement to include contributions from WHO/QSM and the UMC.
• Advocacy: Plan to promote pharmacovigilance through networks, integrate into WHO initiatives, and discuss events like a global Pharmacovigilance day.

Classification and Specific Drug Safety

• WHO International Classification: Collaboration needed with WHO teams to harmonize terminologies for ICD updates, focusing on drug safety sections.
• Medicines in Children: WHO advised preparing a guideline on child medication safety, with ongoing development by the Karolinska Institute.
• Specific Products: Recommendations include:
  • Oseltamivir: Active surveillance and safety data review for influenza use.
  • Amodiaquine/Artemesunate: Further investigation of dystonic reactions in malaria treatment.
  • Moxifloxacin: Long-term safety data needed before risk/benefit decisions.
  • Tenofovir/Emtricitabine: Ongoing monitoring due to potential renal effects.
  • Levamisole: Communication to WHO Essential Medicines Programme about toxicity, with possible de-listing considerations.

Kava Safety Study

• The committee endorsed research on kava hepatotoxicity; additional time for review and a position paper drafting follow up is required.

Key findings emphasize the need for enhanced resource allocation, greater collaboration, and targeted actions to strengthen global drug safety measures.