One of the challenges facing the healthcare sector in the Eastern Cape Province, South Africa, has been the lack of proper recording of Adverse Drug Reaction (ADR) cases which contributes to increased patient morbidity and mortality.
PEPFAR-supported partner Beyond Zero has identified gaps to adverse drug reaction reporting and pharmacovigilance – and has responded by providing training and mentoring as well as tools required to assist with voluntary reporting of ADRs. At the beginning of the organisation’s support, a challenge existed where no ADR forms were being completed. Normally, ADR reporting is voluntary and this is one of the main challenges in reporting. Together with the mentoring, training and tools provided by Beyond Zero, the organisation has since witnessed a surge in ADR reporting with 10 percent of facilities religiously undertaking this exercise.
Ansuya Naraindas, Pharmacy Advisor at Beyond Zero, says “whilst this may seem like a small number, it is a significant figure compared to previous years.” This has not gone unnoticed as the National Department of Health Pharmacovigilance has recognised Beyond Zero’s efforts made in this field. “You cannot eat an elephant in one bite, but a little at a time. So for us, who have worked tirelessly on this programme have everything to celebrate this milestone because it shows that our work is impacting positively,” Ansuya said.
Notably, South Africa is currently witnessing growth in the pharmacovigilance arena. The antiretroviral and tuberculosis programmes recognise the importance of targeted monitoring of the safety of the medicines they use in patients and developing targeted pharmacovigilance systems to address particular problems with the medicines they commonly use. The Minister of Health in South Africa, Dr Aaron Motsoaledi notes that currently there are over 3 million people on Antiretroviral Treatment (ART) in the country. However, with ART patients still facing numerous challenges, one of the key risks is Adverse Drug Reactions (ADRs) which can increase morbidity and mortality. It is therefore essential to monitor the adverse drug reactions linked to ART so that clinicians can make informed decisions regarding patient treatment and ensure that they do not default on their treatment.
To support the Department of Health and address the low rate of ADR reporting, Beyond Zero’s programme of support, aimed at encouraging adverse drug reaction reporting entails:
Training 329 (and counting!) health care providers/workers including nurses, doctors, pharmacists, pharmacy assistants on pharmacovigilance, adverse drug reaction reporting and correctly and thoroughly completing ADR forms.
Mentoring staff at 321 primary health care facilities on how to complete the adverse drug reaction form.
Providing ADR forms and written clinical tools and guidelines for the Prevention and Management of Side Effects and Drug Interactions in Adults and Paediatrics to thes same facilities.
Locally, the challenge is the multi completion of ADR forms as this process demands that they be completed in triplicate. The lack of photocopy machines and unavailability of forms has also been reported as one of the challenges by facilities. To combat this, Beyond Zero has designed an innovative tool to improve adverse drug reaction reporting. The A4 booklet contains an adverse drug reaction form for the HIV and TB programme in triplicate form. This resource has been recognised and adopted for use by the National Department of Health Pharmacovigilance Department. The NDoH pharmacovigilance coordinator is set to continue rolling out the booklet in other provinces. Thus far, Beyond Zero has distributed this booklet to 430 supported facilities in the Eastern Cape and Kwa Zulu Natal Provinces.
Clinical management of patients with adverse drug reactions is also important to ensure better patient outcomes. To that effect, Beyond Zero has printed and made available the management of Adverse Drug Reactions and Drug Interaction book for Adults and Paediatrics. The organisation has also been assisting the NDoH in rolling out their Decentralised Pharmacovigilance model in the Eastern Cape Province and Harry Gwala District in KwaZulu Natal Province, in South Africa. To date, hundreds of health care providers/workers have been trained on the various tools and approaches in this increasing more comprehensive ADR and pharmacovigilance model with plans to intensify this activity in underperforming clinics in need of further support.