The SSG/PM (Sodium Stibogluconate/Paromycin) Pharmacovigilance Plan aims to collect pharmacovigilance information during the early post-approval period of SSG/PM as soon as SSG/PM is in use by the Ministries of Health for treatment of Visceral Leishmaniasis.

During the early post-approval period, SSG/PM might be used in settings different from clinical trials and a much larger and diverse population might be exposed in a relatively short timeframe. The pharmacovigilance (PV) programme is crucial in order to continuously evaluate the risk-benefit ratio in different groups of patients and in different contexts

The Pharmacovigilance study in Kenya involves the key sentinel site of Kacheliba kala-azar treatment centre and Kimalel, (where MSF-OCG is based). A similar protocol is ongoing in Sudan and planned for Uganda. The Pharmacovigilance plan primary objectives are: a) to continuously monitor the safety profile of SSG/PM during the first 2 years that follow its authorization for use in East Africa; b) to identify additional risks that have not been reported in pre-approval clinical studies; c) to determine whether SSG/PM adverse reactions are of higher concern in specific groups of patients; d) to monitor the treatment failure rate of SSG/PM and e) to monitor any evidence in site variation in terms of SSG/PM effectiveness and safety.

The target population are all VL patients treated with SSG/PM in Kenya and other participating countries. A registry is used independently from clinical presentation and demographic characteristics. Diagnostic, treatment and discharge procedures should be consistent with the routine clinical practice in use in the health facility. A standard form is used to collect information. No blood/tissue samples or extra medical procedures are required for the PV plan.

Every 3 months, descriptive statistics are produced. In particular, the total number of SAE, the number of treatment-related SAE and the number of treatment failures are calculated. The Steering Committee is responsible for data review.

In Kenya Ethical and Regulatory approval is sought through KEMRI ERC and Pharmacy and Poisons Board. Informed consent document is distributed to each patient treated with SSG/PM. The aim of the PV plan is discussed, as well as the measures taken to ensure confidentiality of the data collected.

Ultimately, the information generated through PV plan will help refine VL management guidelines and assist physicians in choosing the best treatment. The PV plan also will be used as the risk management plan for introduction of the SSG/PM Combination for treatment of VL.