FDA launches patients safety programme

The Food and Drugs Authority (FDA), has launched the Patient Engagement in Medicine Safety programme to compliments its efforts in ensuring medicine safety.

The programme encourages the participation of patients in ensuring medicine safety by providing avenues for them to report side effects of drugs that they take.

Mr Hudu Mogtari, Chief Executive Officer of the FDA said information collected in post approval safety monitoring of medicines is important as it helps to ensure safe medical practice by preventing drug related harm to patients.

He was speaking at the launch of the programme, which employs the use of various tools to encourage patients to report adverse side effects of medicines as well as medical devices.

He noted that Ghana has been monitoring the safety of medicines since 2001 when it joined the World Health Organisation Programme for International Drug Monitoring.

Mr Mogtari said hitherto, the main source of reports on adverse reaction to drugs is healthcare professionals including doctors, pharmacists, nurses and other allied health professionals.

He said it is important to involve patients and consumers in the post approval safety monitoring of medicines to help reduce adverse drug reactions, and prevent unnecessary harm to patients, reduce healthcare cost such as hospital admission cost and ensure public confidence in medicines.

Mr Mogtari noted that although patient reporting has been encouraged during immunisation campaigns, there are no formal processes that allow the introduction of formal routine reporting, with only eight (0.3 per cent) direct reports received since 2001, out of the more than 3,000 spontaneous reports received by the FDA.

He said evidence from countries such as the United Kingdom and the Netherlands showed that patients’ engagement in post approval safety monitoring, not only provides regulatory authorities with a new source of information such as hitherto unknown side effects of medicines and the frequency of known side effects, but also gives direct, detailed and unambiguous information as it describes exactly what the patient feels.

“Spontaneous reporting by patients also has benefits beyond pharmacovigilance because patients play an active role in his or her treatment regimen instead of being a largely passive recipient of treatment,” he stated.

He said it helps them to manage their medicines and communicate more effectively with their healthcare professionals.

He urged patients to report undesirable side effects of medicines they take to the FDA through healthcare professionals and community pharmacies to be designated as Patient Safety Centres.

Mr George Sablah, Head of Safety Monitoring at the FDA, said the Authority has developed tools to enable patients to report their side effects.

These include forms that are available at community pharmacies. Dubbed the ‘blue form’, patients who report side effects to the pharmacies would be required to fill the form with details of the symptoms, medicines and other information that would be forwarded to the FDA for further action.

The Authority would also use various communication materials and channels such as posters, billboards, radio and television adverts in English and some local languages to sensitise the public on the need to report known and unknown side effects of medications.

Patients suffering side effects could also text the details of the effects to the short code 4015 and could also file reports online via the FDA’s website www.fdaghana.gov.gh or via email to drug.safety@fdaghana.gov.gh?

The FDA would provide appropriate and timely feedback on every report received, which may include recall of the medicine depending on the frequency and severity of the reports received on the medicine.

The Authority would also announce a toll-free number where those who cannot afford regular phone calls could report effects.

The Authority awarded selected pharmacies from the Greater Accra, Central, Upper East, Brong Ahafo and Northern regions which had performed well during the pilot phase of the project.

The Abibigroma drama group performed a sketch on the importance of patients’ engagement in post approval safety monitoring of medicines.