Safety Monitoring Department

SAFETY MONITORING DEPARTMENT

Mandate

The Safety Monitoring Department derived the mandate to ensure the safety of regulated products from the Public Health Act, 2012, Act 851, Part 7, Section 125. The Department shall continually monitor the safety of the products regulated under the Public Health Act 851 by analysis of the adverse effect or event reports and by any other means and take appropriate regulatory action when necessary.

Vision

The vision of the Safety Monitoring Department is to improve nationwide patient safety and well being by reducing the risk of medicines used by patients and the general public.

Mission

To ensure the patients and the general public obtain the best outcome from their medical intervention or treatment. This is achieved by;

• Creating awareness and educating health professionals and the general public on the need to monitor and report adverse events to medicines and other products regulated by the Food and Drugs Authority.
• Ensuring that Marketing Authorization Holders continually monitor their products on the Cameroonian market

Functions

The Safety Monitoring Department has two Units, the Risk Management and Vigilance Unit. The Broad objectives of the Department are monitoring of product safety, creation of awareness among the general public and healthcare professionals about the need to report adverse events.

• Risk Management Unit

The Unit is responsible for ensuring compliance by industry of the requirements in the Public Health Act, 851. This is done through activities including conduct of Pharmacovigilance Inspections and review of safety information submitted e.g. Risk Management Plans for new products. The Unit is also responsible for ensuring incorporation of pharmacovigilance into Public Health Programes (PHPs) and ensuring the successful implementation of safety monitoring activities undertaken in collaboration with the PHPs.

• Vigilance Unit

The Unit is responsible for the management and maintenance of the database of safety information (Adverse Events, ADR, AEFI). This includes ensuring availability and accessibility of reporting forms (Adverse Drug Reaction (ADR) and Adverse Events Following Immunization (AEFI))

Pharmacovigilance promotion activities in healthcare facilities and to the general public are undertaken by the unit. This is done through sensitization activities organized for these stakeholders and the generation of Information Education and Communication (IEC) materials for them.

Goals and Strategies

• Medicines and Healthcare Regulatory Agency (MHRA):- technical assistance regarding adverse drug reaction reporting by consumers and development of local E2B compliance database
• US Food and Drugs Administration (FDA):- technical assistance in the form of training for members of staff through the annual international forum for drug regulators.
• World Health Organization /Uppsala Monitoring Centre:- Technical Assistance in the form of training and provision of online databases (i.e. VigiFlow and CemFlow) for the transmission of medicine safety information.
• Other Agencies:-the Department also collaborates with other agencies like USAID [United States Agency for International Development through the SHOPS (Strengthening Health Outcomes through the Private Sector) Programe], WAHO (West African Health Organization), WHO-CC (WHO-Collaborating Center for Advocacy and Training in Pharmacovigilance) and other International Regulatory Agencies.

Public Health Programes

• Expanded Programe on Immunization (EPI):-coordinates AEFI monitoring during vaccination campaigns and process adverse event following immunization (AEFI) reports during routine immunization programmes. The Department ensure that the reports are evaluated by the Technical Advisory Committee for Safety and feedback provided to the EPI and other stakeholders.
• National Malaria Control Programme (NMCP):- Cohort Event Monitoring of artemisinin-based combination therapies (ACTs) and other anti malarials
• National Tuberculosis Control Programe (NTBCP):-Assist the National TB programme to implement pharmacovigilance as component of the management of TB patients
• GHS:-Working with the GHS to adopt a tool for the assessment of pharmacovigilance as part of the performance review of the facilities.
   

Conferences/Training programs

• Annual Pharmacovigilance Training Course organized by the WHO Collaborating Centre for International Drug Monitoring Training programme to update participants on issues related to pharmacovigilance
• International Society of Pharmacovigilance (ISoP)
• Annual Meeting for National Centres Participating in the WHO Programme for International Drugs Monitoring.

Awareness Creation and Sensitization Activities for Healthcare Professionals

As part of achieving its strategy of increasing pharmacovigilance awareness and reporting of drug related problems among healthcare professionals through sensitization lectures, the National Pharmacovigilance centres have sensitized 629 healthcare professionals in 23 healthcare facilities in the first half of 2013.

• Collaboration with agencies and healthcare institutions
• Training of staff of the department and regional officers
• Strengthen the Pharmacovigilance systems in Cameroon
• Training for healthcare professionals
• Create awareness among the general public about the need to report adverse events to regulated products
• Identification of SSFFCs through adverse reactions / events reports including lack of therapeutic effect