Recognizing and educating about excipient-related side-effects from use of antiretroviral therapy in Mbeya, Tanzania

Service or Program: Pharmaceutical formulation is the process in which different chemical substances constituting Active Pharmaceutical Ingredient (API)  including excipients comprising of colours, flavors, emulsifiers, diluents, bulking agents, sweeteners, and preservatives are combined to produce a final medicinal product. Excipient-related reaction to certain ART formulations has been described in the literature, but is often overlooked and under-recognized by ART clinicians.

Justification/Documentation:  Having noted possibility of excipient-related side-effects for common adult and pediatric ART formulations used at Mbeya COE, we developed a presentation teaching on what excipients are and which pediatric ART could have excipient-related side-effects. During this session, we demonstrated solubility of dispersible tablets compared to non-dispersed tablets and passed formulations for viewing and smelling flavoring agents from available pediatric ART. We also discussed about future of ART formulations with regard to the new WHO recommendations and possibility of adaptation in Tanzania.  A unique case reports seen in Mbeya was discussed in which clients using blue colored AZT-3TC-NVP for adults in complained about feeling weaker during working hours as compared to when they used the white colored AZT-3TC-NVP for adults product from another company.

Transferability: Side-effects and drug interactions are usually attributed to API and little attention is paid to excipients which are regarded as inert/non-reactive ingredients. However, with changing formulations and availability of better palatable ART formulation in pediatric patients, it will become imperative for clinicians to be aware of excipient reactions in children using ART.  Many ART clinicians were unaware of these reactions, and benefited from the session.

Impact: As part of learning curriculum, we intend to integrate this topic into curriculum for pharmacy attachments at our center. We also shared this presentation with our counterpart adult CTC clinic at Mbeya Referral Hospital.