Innovation for drug safety monitoring in Malawi and Ghana

By Access and Delivery Partnership

Medsafe 360 is an innovative tool to improve the reporting of adverse drug reactions in Malawi. Photo: TDR

Advances in modern medicine have transformed the way in which diseases are controlled, extending life expectancy and improving health and well-being of all. However, adverse reactions do occur, and can be the cause of illness and disability, even death. This is especially the case for newly introduced health technologies, which must be closely monitored.

Systems are put in place to detect, assess and manage adverse reactions. Often referred to as ‘pharmacovigilance’, such systems are a critical component of effective national regulatory systems, clinical practice and overall public health programmes in countries.

Effective pharmacovigilance systems require, among other things, numerous and high-quality reports, and in many countries, underreporting and delays are common. To help address this, the Access and Delivery Partnership (ADP) is actively promoting the use of low-cost and easily accessible digital solutions.

In Malawi, ADP has supported the creation and installation of a digital solution for patients to report adverse reactions to medicines and vaccines—a process accelerated after the onset of the COVID-19 pandemic.

In 2021, with ADP’s support and funding, Malawi introduced Medsafe 360. With this tool, patients and health care workers can report suspected adverse drug events using a mobile phone with SMS capability. Medsafe 360 reduces delays in reporting, as it is quicker than using the traditional paper forms. Notably, it does not require smartphone capability or an internet connection to function. Users can simply dial or message *360# for free to submit reports.

The use of Medsafe 360 is timely, because the introduction of new health technologies, such as the new treatments for drug-resistant tuberculosis and the new vaccines for malaria and COVID-19, always requires close safety monitoring.

According to Cecilia Sambakunsi, a Medicine Inspection Officer at the Malawi Pharmacy and Medicines Regulatory Authority, ADP has been a key stakeholder in strengthening the pharmacovigilance system in Malawi.

“ADP has provided both technical and financial support towards building capacities of the key personnel at the national pharmacovigilance centre and also health care workers,” said Ms. Sambakunsi. “In terms of MedSafe 360, ADP has provided funding for development, introduction and evaluation of the tool.”

Innovation for drug safety monitoring in Malawi and Ghana

ADP has also supported the digitization of drug safety surveillance in Ghana, through the introduction of the Safety Watch System, a national electronic management system for individual case safety reports, and most recently, MedSafety, a mobile application that facilitates fast and direct community reporting of possible adverse drug reactions. Together, the systems increased related reporting by over 30 percent between 2016 and 2019.

The MedSafety app, which is implemented by the Ghana Food and Drugs Authority, is designed to encourage reporting by patients and health care professionals of harmful, unexpected side effects of health technologies, including medicines and vaccines. It includes safety information and allows users to receive personalized product-specific news and alerts.

It was developed with support from ADP, the WEB-RADR (Recognising Adverse Drug Reactions) project, the United Kingdom Medicines and Health Products Regulatory Agency and the Ghana Ministry of Health.[1]

Speaking at the launch of the app in June 2019, Delese Mimi Darko, Chief Executive Officer of the Ghana Food and Drugs Authority, said: “The Med Safety app today is our new, faster way to report safety issues of medical products, to promote patient safety anytime and anywhere—because you always have your phone with you.”

Delese Mimi Darko, Chief Executive Officer of the Ghana Food and Drugs Authority. Photo: Ghana Food and Drugs Authority

The MedSafety App has contributed to a reduction in the cost of monitoring and reporting adverse reactions and has improved communication between the Food and Drugs Authority and clients. An ADP-supported survey of users (mainly health workers) revealed an overwhelmingly positive response to the app, and identified key areas for improvement. The results will be published in a peer-reviewed journal in 2022, and findings will help with scaling up the app in Ghana. It will also provide information for the implementation of similar applications in other countries.

Further information:

Food and Drugs Authority Ghana, MedSafety app video walk-through, 21 February 2021

UNDP, ‘Med Safety App for reporting side effects of medicines and other health products in Ghana’, 17 August 2019

This is part of a collection of impact stories highlighting the work of the Access and Delivery Partnership in ensuring access to health technologies for those in need. For more information and to read additional impact stories, please visit the ADP website.