- Keywords > active pharmacovigilance surveillance
- Keywords > adverse drug reactions (ADRs)
- Keywords > adverse event (AE)
- Keywords > anti-tuberculosis medicines
- Keywords > efficacy and safety of medicines
- Keywords > Multidrug-resistant Tuberculosis (MDR-TB)
- Keywords > new medicines - efficacy and safety
- Keywords > pharmacovigilance
- Keywords > reporting system
- Keywords > Standards Operating Procedures (SOP)
(2015; 21 pages)
Management Sciences for Health (MSH). Standard Operating Procedures. Active Pharmacovigilance Surveillance: Drug Safety Monitoring for New Medicines and Novel Regimens of the National TB Program in the Philippines. Manila, Philippines: MSH; 2015.
The purpose of this standard operating procedure is to outline a step-by-step approach for undertaking active drug safety monitoring for the 9-month MDR-TB treatment regimen and other novel medications and regimens for TB and MDR-TB.
The Philippines is committed to introducing evidence-based novel medicines and treatment strategies that are likely to benefit TB and MDR-TB patients. . The National TB Control Program will do this in a comprehensive way that reinforces the principles of World Health Organization (WHO) guidelines for the programmatic management of drug-resistant tuberculosis, ensuring that the introduction of the novel medicines and regimens in the Philippines maximizes the benefits and minimizes the risks to patients and communities.