FDA PROGRAMMES

Safety Monitoring

The Safety Monitoring Department of the Food and Drugs Authority hosts the National Pharmacovigilance Centre. 

LEARN MORE

The Safety Monitoring Department of the Food and Drugs Authority hosts the National Pharmacovigilance Centre. The Centre joined the WHO Programme for International Drug Monitoring (PIDM) in November 2001 as the 65th member of the Programme.
Staff of the Department are dedicated scientists with background in pharmacy, chemistry, biological science with most having Masters’ Degrees and several years’s experience in the area of pharmacovigilance with some of them involved in activities by the World Health Organization to promote patient safety in sub-Saharan Africa.

In 2020, the Safety Monitoring Department was adjudged Maturity Level 4 Regulatory function by the World Health Organization. This means that the safety monitoring function of the FDA is at an advanced level of performance with continuous improvement needed in monitoring the safety of medicines, vaccines and other health products. Maturity Level 4 is the highest level any regulatory function can attain.

The safety monitoring system is decentralized with FDA’s regional offices involved in coordination pharmacovigilance in all the 16 regions. There are also Institutional Contact Persons at the healthcare facilities with responsibility for safety monitoring of drugs, vaccines and other health products. In 2016, the FDA also embarked on an initiative to empower the general public to report safety issues of regulated products to the FDA.

The Safety Monitoring Department has had several years of experience in monitoring the safety of vaccines. The Department has effectively coordinated the introduction of new vaccines including the pneumococcal/rotavirus vaccines, measles rubella and the ongoing Malaria Vaccine Pilot Implementation Programme which has gone on for close to two years without major safety concerns.

The Safety Monitoring Department is also a Regional Centre of Regulatory Excellence (RCORE). The Department serves as a training centre for regulators from other African Countries.
The Safety Monitoring Department has two functional Units namely, the Vigilance Unit and Risk Management Unit.

Functions of The Safety Monitoring Department

The SMD has two Units, the Risk Management and Vigilance Units. The broad objectives of the Department are safety monitoring of products, awareness creation amongst patients, consumers and healthcare professionals on the need to report adverse events.

  • Vigilance Unit
  1. Ensure pharmaceutical industries comply with the requirements in Section 125, Subsection 1 and 2 of the Public Health 2012, Act, 851 and applicable guidelines.
  2. Carry out Good Pharmacovigilance Practice (GVP) Inspections
  3. Liaise with Public Health Programmes (PHPs) to ensure pharmacovigilance becomes an integral component of these programmes
  4. Create awareness on pharmacovigilance for healthcare professionals and to the general public.
  5. Organize training programmes for stakeholders
  6. Produce Drug Safety Newsletter (DrugLens) and Patient Safety Newsletter.
  7. Produce Information Education and Communication (IEC) materials to promote safety monitoring of products.
  • Risk Management Unit
  1. Ensure availability of Reporting Forms at user points and functioning of the electronic platforms for reporting adverse events.
  2. Maintain the FDA’s Safety Database (SafetyWatch System).
  3. Receive and Process of Individual Case Safety Reports (ICSRs)
  4. Coordinate Technical Advisory Committees Meetings
  5. Communicate alerts and safety issues to stakeholders
  6. Review safety information including but not limited to Risk Management Plans (RMPs) and Periodic Safety Update Reports (PSUR) /Periodic Benefit-Risk Evaluation Reports (PBRER) and Safety variations for regulated products submitted to the FDA.
  7. Follow up on the implementation of Risk minimization activities
  8. Ensure the Department’s commitment to the FDA’s quality management system.
  • Collaborating Agencies and Stakeholders

*Medicines and Healthcare Regulatory Agency (MHRA): Technical assistance with the development of consumer/patient reporting system for reporting safety issues and E2B compliance database (SafetyWatch System) for safety data management.
*World Health Organization/ Uppsala Monitoring Center: Technical assistance in the form of training.
*Ghana Health Service (GHS): Monitoring and evaluation of Pharmacovigilance performance within healthcare facilities using the pharmacovigilance assessment tool.

Other agencies the department collaborates with are:
*United States Agency for International Development (USAID) through the SHOPs-Strengthening Health Outcomes through the Private Sector)
*West African Health Organization (WAHO)
*African Collaborating Centre for Pharmacovigilance (ACC)

Public Health Programmes (PHPs)
PHPs involves the administration of medicines to large populations. Pharmacovigilance in PHPs plays a role in the successful implementation of PHPs. In view of this, the SMD coordinates pharmacovigilance activities in collaboration with the under-listed Public Health Programmes.

*Expanded Programme on Immunization (EPI): Coordinates adverse events following immunization (AEFI) monitoring during vaccination campaigns and routine immunization programmes. The Department ensures that the reports are evaluated by the Technical Advisory Committee on Safety of Vaccines and Biological Provides (TAC-VBP) and feedback is provided to the EPI and other stakeholders.
*National Malaria Control Programme (NMCP): Coordinates the monitoring of adverse events in the Seasonal Malaria Chemoprevention and other anti-malaria campaigns.
*National Tuberculosis Control Programme (NTBCP): coordinates the monitoring of adverse events in patients on anti-tuberculosis medicines.
*National AIDS Control Programme: coordinates the monitoring of adverse events in patients receiving antiretroviral therapy.
*Neglected Tropical Diseases Control Programme: coordinates the monitoring of adverse events in the patients receiving therapy for neglected tropical diseases such as Lymphatic Filariasis, Onchocerciasis, Trachoma, Schistosomiasis, Soil-transmitted helminthiasis, Buruli ulcer, Yaws, Leprosy, Guinea worm, Human African Trypanosomiasis (HAT), Cutaneous Leishmaniasis and Rabies.