Skip to main content

Table 1 Content of training programme for healthcare workers at health facilities

From: Experience of safety monitoring in the context of a prospective observational study of artemether-lumefantrine in rural Tanzania: lessons learned for pharmacovigilance reporting

Topic

Content

Study drug (AL)

Indications and dosage

 

Contraindications

 

Drug interactions

 

Use in pregnancy/lactation

 

Common ADRs (frequency > 10%)

 

Special precautions

Study objectives

Primary and secondary objectives of the observational study (ALIVE)

ADRs, AEs & SAEs

Minimum reporting requirements

 

Definitions of ADRs, AEs & SAEs (including congenital abnormalities & birth defects)

 

Detection and recognition of ADRs, AEs & SAEs

Reporting of AEs & SAEs

Data collection requirements

 

TFDA reporting form

 

Novartis SAE reporting form

  1. ADR = adverse drug reaction; AE = adverse event; AL = artemether-lumefantrine; ALIVE = A rtemether-L umefantrine I n V ulnerable patients: E xploring health impact; SAE = serious adverse event; TFDA = Tanzanian Food and Drugs Authority. ADRs were defined as 'all noxious and unintended responses to a medicinal product related to any dose. The responses to a medicinal product means that a causal relationship between a medicinal product and an adverse event is at least a reasonable possibility i.e. the relationship cannot be ruled out'