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Opening Address By Professor Mojisola Christianah Adeyeye Adeyeye At The Virtual Launch Of The Med Safety Mobile App For Adverse Drug Reactions Reporting In Nigeria

November 6, 2020,

Keynote Speech By Prof. Adeyeye C. M

Director General NAFDAC

Virtual Launch Of The Med Safety Mobile App For Adverse Drug Reactions Reporting In Nigeria

NAFDAC Head Quarters, Abuja.

4th November, 2020.

The Honourable Minister of Health, Federal Republic of Nigeria,

The Permanent Secretary, Federal Ministry of Health

The Chairman, National Drug Safety Advisory Committee

The Representatives of:

  • WHO Geneva
  • WHO Representative Nigeria
  • WHO Collaborating Centre for International Drug Monitoring (Uppsala Monitoring Centre) Sweden
  • Medicines and Health Care Products Regulatory Agency (MHRA) United Kingdom
  • United Nations Children’s Fund (UNICEF)
  • Pharmaceutical Society of Nigeria (PSN)
  • Nigerian Medical Association (NMA)
  • Other Pharmacovigilance Stakeholders
  • Members of the Press
  • Ladies and Gentlemen

I am very delighted to address you at this virtual launch of the Med Safety Mobile Application for reporting of Adverse Drug Reactions (ADRs) in Nigeria during the 2020 Med Safety Week organized by the UMC.

Almost three years ago speaking with the recently retired Director of PV/PMS, Alhaji Ibrahim Ali, I told him part of my administration’s goals in strengthening the regulatory framework in NAFDAC will include re-tooling of PV/PMS.  The launching is part of strengthening PV, therefore, I am delighted about this occasion.

In the course of this week, NAFDAC will link up with the WHO Collaborating Centre for International Drug Monitoring (Uppsala Monitoring Centre) as well as other National Medicines Regulatory Authorities, National Pharmacovigilance Centres across the world in web-based and social media campaigns that raises awareness on reporting of adverse drug reactions and other medicines-related problems.

There is no better time to officially launch the Med Safety App than now when the focus of the world is on the safety of medications used in healthcare delivery as the whole world battle with the unfortunate Covid-19 pandemic. The App will be one of the tools that will be used for Covid-19 vaccines in collaboration with other sister agencies in Nigeria whenever the vaccines are available and deemed fit on quality, safety and efficacy by NAFDAC.

The journey towards the adoption of the Med Safety App by Nigeria commenced in August 2019 when NAFDAC officially submitted an expression of interest to the WHO. The adoption process was cemented at the 42nd annual meeting of Pharmacovigilance centres held at Bogota Colombia in October 2019. The technical development of the app commenced in January 2020 when Nigeria provided country-specific information and a list of all NAFDAC registered medicines.

Several testing processes and demonstrations were done to determine its suitability and adaptability in Nigeria. I am glad that, we are here today to witness the official launch of the Med Safety App in Nigeria.

The National Pharmacovigilance Centre (NPC) domiciled in NAFDAC is charged with the responsibility of coordination of all pharmacovigilance activities in Nigeria.

Since its inception, the NPC has continually deployed the hard copy ADR triplicate forms (NAFDAC Yellow Forms), e-reporting platforms (which can be downloaded free from NAFDAC website) and the Pharmacovigilance Rapid Alert System for Consumer Reporting (PRASCOR) to collect and collate reports of ADRs which are then uploaded manually into WHO ADR database platforms (VigiFlow, VigiBase etc.).

Despite the availability of these pharmacovigilance reporting tools, it is worrisome that ADRs and other drug-related problems remain under-reported in Nigeria and generally within the WHO region of Africa. Nigeria is still a far cry from the WHO recommendation of 200 ADR reports per million of the population.

The provision of the Med Safety App which is available to download for free on android or apple smartphone devices provides a medium for users to seamlessly report incidences of ADRs from the comfort of their mobile phone devices. Reports can be created offline without internet connectivity and submitted once connection is established. Since it is directly linked to WHO database platforms, a lot of man hours are saved from manual input of the information on Individual Case Safety Reports (ICSRs) using the hard copy ADR forms.

In order to effectively harness the benefits of the Med Safety App, NAFDAC will intensify efforts on sensitization campaigns for the general public leveraging on conventional and social media platforms, organize quarterly zonal and state level trainings for healthcare providers and health professionals and make provision of internet-enabled tablets for Zonal Pharmacovigilance Centres and selected health facilities in Nigeria.

At this juncture I wish to passionately call on all Healthcare providers and everyone in Nigeria to support NAFDAC to achieve the mandate of safeguarding the health of the nation.

NAFDAC is very grateful to the WHO for supporting the procurement of the app; UMC for providing administration and technical support to NAFDAC and the Medicines and Health Care Products Regulatory Agency of the United Kingdom for their technical support and more especially for coordinating the Web Recognizing Adverse Drug Reactions (WEB-RADR) project which has led to the development of this novel app.

It is our expectation that the use of the Med Safety App will;

  • Promote awareness and increased reporting of ADRs amongst healthcare professionals, healthcare providers and members of the general public.
  • Ensure safety of the end-users of medicines and improve on health outcomes of the patients.
  • Directly reach out to over 10,000,000 pharmacovigilance stakeholders with the use of conventional and social media platforms
  • Leave a memorable experience in the minds of the stakeholders through exciting campaigns during this Med Safety Week and beyond.

Happy Med Safety Week

Thank you all.

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