Pharmacovigilance in Multiple Myeloma Care in Sub-Saharan Africa: A Review of Immunomodulatory Anti-myeloma Guidelines Using Kenyan AMPATH Framework

Abstract

Background: Pharmacovigilance is a science that deals on the impact of therapeutic interventions (i.e., benefits and adverse effects) on the target body. In multiple myeloma treatment, it deals with the impact of anti-myeloma drugs on target patients through their risk assessment and risk management. This framework ensures safety and surveillance of anti-myeloma drugs administered to prospective multiple myeloma patients. Pharmacovigilance of anti-myeloma therapy is rarely instituted in the health institutions in sub-Saharan Africa due to late diagnosis and poor palliative care system in the region. The hallmarks are increased disability adjusted life-years, reduced quality adjusted life-years and average survival interval of people living with multiple myeloma in the region. Aim: This study highlighted the safety measures undertaken by the healthcare professionals and multiple myeloma patients who are on immunomodulatory (Thalidomide and Lenalidomide) anti myeloma drugs to prevent or minimize adverse drug reactions. Methodology: This study was a review of the guidelines for Pharmacovigilance using Kenyan AMPATH anti-myeloma pharmacovigilance brochures and other research database as literature sources. The paper was analysed and grouped according to the following categories namely the adverse drug reactions encountered with the use of anti-myeloma drugs and pharmacovigilance risk management programme (RMP) for immunomodulatory drugs (thalidomide and lenalidomide). Results: The three major identified safety tools for effective pharmacovigilance of the anti-myeloma patient population were the healthcare professional workforce, safety guidelines brochures and safety forms for registration and documentation of impact of therapeutic interventions. The healthcare professionals are key players in the formulation of pharmacovigilance risk management protocols. The risk management starts with education of the healthcare providers and myeloma patients using guidelines brochures designated for the respective groups. The prescriber registration-, pharmacy registration-, treatment initiation-, prescription authentication-, and adverse drug reaction forms are the essential safety working documents that are needed to be completed by the patient and healthcare professionals for effective monitoring and evaluation. Both the healthcare provider and the myeloma patient are expected to adhere strictly to the safety measures enshrined in the pharmacovigilance guideline brochures. The patient’s anti-myeloma safety measures are stratified into female of child bearing age, women above the child-bearing age and the male sub-population. Conclusion: In setting up a comprehensive multiple myeloma care centre, an effective pharmacovigilance program is paramount. This requires healthcare professional workforce, safety guidelines brochures and safety forms for registration and documentation of impact of therapeutic interventions. Policy formulation, sustainable drug availability and collaboration with support groups are vital tools to drive this operative framework in underserved settings of sub-Saharan Africa.