FDA launches Med Safety App; expected to improve patients’ safety

A tool, the ‘Med Safety App’ aimed at improving the safety of patients and consumers in Ghana, has been launched by the Food and Drugs Authority (FDA).

The app is also expected to improve communications about medicines between patients, healthcare professionals and the FDA.

“The Med Safety App is today our new, faster way to report safety issues of medical products, and to promote patient safety anytime and anywhere because you always have your phone with you,” CEO of the FDA, Delese A. Darko, said at the app’s launch.

According to the CEO of FDA, all medicines must be used correctly so they can remain safe: “If medicines are not used correctly they usually have adverse events; if they are used unwisely, they lead to major risks for the population”.

Speaking at the app’s launch in Accra, she maintained there is always a risk that a medicine may not be effective – or may even cause unwanted or dangerous side-effects.

The Med Safety App can be downloaded on Google play store or app store.

Since Ghana joined the World Health Organisation (WHO) programme for international drug monitoring in November 2001, the FDA has introduced a number of initiatives to improve patient safety.

These include institutional contact persons in most of the health facilities – who are responsible for the safety and use of medicines in these healthcare facilities.

FDA has also introduced the ‘qualified persons for pharmacovigilance programme’, which ensures the pharmaceutical industry that introduces medical products into the country will monitor the safety of those medicines.

They also launched the ‘patients’ engagement into medicines safety programme’, which is to promote and direct reporting of safety issues by patients to the authority through community pharmacists.

Also, the pharmacovigilance assessment tool – in collaboration with the Ghana Health Service – allows the FDA to peer-review the performance of health facilities based on pharmaceutical indicators.

“As you know, mobile apps are quicker than online reporting – we have an online reporting system already and we have added the mobile app to make it faster; as soon as you report to us on your mobile app then we can give you feedback. We assume everybody has a mobile phone, so if you have a smartphone you can easily download this app; go through the app, it gives you information on all medicines that have been registered by the FDA.

“It also has a portion where you can put your own medicine – say you are hypertensive, you take certain medicines; if you put the list of medicines you take on the watch-list part of the app, whenever there is an alert on any of your medicines you get it directly to your app. And you can get feedback on whether counterfeits in any medicines you are taking have been found; whether there have been any new adverse events for your medicines that have been found; and you can contact your pharmacy or healthcare professional with that information for them to help you, so that is what this app is all about.”

Health Minister Kweku Agyeman-Manu, who’s speech was read on his behalf, lauded the initiative and indicated that the ministry has embraced the use of technology to improve the well-being of Ghanaians.

“It is the right timing for the FDA to launch the mobile app for reporting side-effects of medicines by healthcare professionals and the general public, to further promote its mandate of ensuring safety.

“The introduction of the app will help the FDA to identify medicine safety issues faster, since it will make it easier for health care professional and the general public to report problems with their medicines to the Authority, at no extra cost, once the app is downloaded,” he said.

The FDA as a result of these innovations has improved reporting of adverse drug reactions, and increased reporting from 95 reports in 2005 to over 3,700 reports in 2008.

At the moment, the FDA has over 11,000 safety reports through the pharmacovigilance system database, which has led to a regulatory actions including withdrawal of substandard and counterfeit products from the markets.

There are mandatory fields in the app that will ask you to state the medicines you have taken, time you took it, and batch-number.

Information fed into the app goes to the National Pharmacovigilance Centre, with feedback received in less than a minute.

The app not only allows patients to report the safety of medicines or vaccines, but also provides patients with pertinent information on safety to improve well-being and health.

For clients, it is a positive intervention to actively involve patients in post-approval of medical products.

The app’s development was supported by the Access and Delivery Partnership (ADP) funded by the government of Japan, Web Radar project, UK Medicines and Health Products Regulatory Agency, World Health Organisation and the Ministry of Health.