The current COVID-19 pandemic presents unique challenges for pharmacovigilance. According to the CIOMS/WHO Working Group, Vaccine Pharmacovigilance is the science and activities relating to the: detection, assessment, understanding, communication of Adverse Event Following Immunization (AEFIs) and other Vaccine- or Immunization-related issues, and prevention of untoward effects of the Vaccine or Immunization
According to WHO, an Adverse Event Following Immunization (AEFI) is any untoward medical occurrence which follows immunization, and which does not necessarily have a causal relationship with the usage of the vaccine. The adverse event may be any unfavorable or unintended sign, abnormal laboratory finding, symptom or disease.
The PharmacoVigilance Program at the MoPH is currently in charge of handling and processing all reported AEFI with the COVID-19 vaccines
Dr. Rita Karam: Head of National Pharmacovigilance Program
Dr. Abeer Zeitoun: Senior Clinical and Technical Manager at the Pharmacovigilance Program
Dr. Myriam Watfa: Pharmacovigilance Program Consultant
Dr. Katia Iskandar, Pharmacovigilance Consultant
Carla Allam: National Pharmacovigilance Officer
Sarah Rida El Sayed: National Pharmacovigilance Officer
I- Pharmacovigilance System in Lebanon
One of the core functions of the Lebanese Ministry of Public Health (MoPH) is to safeguard the Quality, Safety and Efficacy of medical products (medicines, vaccines, biological and medical devices) at the national level. This task is carried out by the Quality Assurance of Pharmaceutical Products (QAPP) Program at MoPH, directed by Dr. Rita Karam which aims, in specific, to reinforce the implementation of quality standards relating to the safety of pharmaceutical products and to ensure that drugs reach the patient in a safe, effective and acceptable manner. The enhancement of patient safety is achieved by the project on the implementation of a National Pharmacovigilance (PV) System. Within the framework of the above mentioned project, the MoPH QAPP program developed a national system for spontaneous reporting of adverse events, and designated the PV Center at the Faculty of Pharmacy at the Lebanese University (LU). http://phcvg-lebanon.com/index.php/en/phcvg-n/
II- Pharmacovigilance Definition
PV is defined by the WHO as the science and activities relating to the detection, assessment, understanding and prevention of Adverse Events (AEs) or any other medicine related problem. Its aims are to enhance patient care and patient safety and to support public health programmes by providing reliable, balanced information for the effective assessment of the benefit-risk profile of medicines and vaccines. PV addresses AEs of medicines, medicine errors, counterfeit/substandard medicines, lack of efficacy, abuse and misuse of medicines, and interaction of medicines.
III- Importance of Pharmacovigilance
Medicines and vaccines have changed the way in which diseases are prevented and treated. In spite of their benefits, medical products have unexpected effects. Some of these effects are unfavorable, ranging in severity, seriousness and frequency within the intended population. While medicines and vaccines are studied in well controlled clinical trials and reviewed by regulatory authorities with the aim of ensuring benefits outweigh risks, some adverse effects (AEs) are observed only once the product is authorized by regulators and used by a larger population in ‘real world conditions’, including special populations such as children, pregnant women and elderly. It is therefore critical that medical products continue to be monitored for their effectiveness and safety post release. In practice this means having in place a well-functioning PV system.
Improper monitoring of medicines and vaccines can lead to catastrophic consequences. In some countries, the AEs are ranked 4th to 6th on the mortality scale. The total percentage of hospital admissions due to such events is an average between 10-20%. Some healthcare systems spend around 15-20% of their budget on medicine-related AEs which adds up to a high economic expenditure. In response to these figures, every country must strictly adhere to the application of PV.
What are the Advantages of Pharmacovigilance System? It:
Reduces medicine/vaccine-related problems leading to better treatment outcome
Improves the quality of care offered to patients
Improves patients confidence in professional practice
Is a cost effective method of monitoring the safety of medicinal products throughout its lifetime
Includes AEs reporting system which is the primary method of data collection used in most countries as it is an easy and fast way to submit an urgent health related issues
Provides feedback information on medicine/vaccine-related problems reported nationally and internationally
IV- About Pharmacovigilance
Pharmacovigilance System Mission
Detecting, assessing, understanding and preventing AEs
. Pharmacovigilance System Vision
Paddling in the same direction of the PV international community to achieve safer use of medicines worldwide
Pharmacovigilance System Values
Stakeholders of the Pharmacovigilance System in Lebanon
The PV System in Lebanon is comprehensive and includes many stakeholders:
The government is responsible for providing all the support needed for the national PV System through well-established national policy and action plan.
The QAPPP at the MoPH, that is responsible for the implementation of quality standards related to the safety of pharmaceutical products, aimed at ensuring that medicines reach the patient in a safe, effective and acceptable manner. The QAPPP oversees the implementation of the PV System.
The WHO-PIDM which is the forum where member states can collaborate in PV. The PIDM is responsible for policy issues, while the other partner, the Uppsala Monitoring Center (UMC) conducts operations.
Other parties (e.g., Marketing Authorization Holder, Health-Care Providers, Public Health Programs, Expanded Program for Immunization (EPI) and Primary Health Care Centers and patients/consumers) responsible for reporting AEs which collaborate as main stakeholder to the PV System through submitting Individual Case Study Reports (ICSRs) to the LNPVC.
V- Steps for the Implementation of Pharmacovigilance System in Lebanon: Regulations
Because of the seriousness of the situation, the MoPH decided to integrate strategies and regulations for medicines safety monitoring which included implementing the National PV System and the National Policy on the Safe and Rational Use of medicines and vaccines.
In this regard, the following chronological regulatory framework is considered to be the core building blocks related to the implementation of a PV system in Lebanon:
Ministerial Decree No.13370 (2004)
A Ministerial Decree No.13370 issued in 10/09/2004 from the Ministry of Education stated the creation of the Center for AEs of Drugs’ Monitoring in the Faculty of Pharmacy at the Lebanese University. Ministerial Decree No.13370 (2004)
Ministerial Resolution No. 1636 (2013)
The MoPH released several mandatory instruments including: Ministerial Resolution No. 1636 issued in 19/02/2013 to establish a committee at the QAPPP to examine AEs. Its responsibility covers the collection of AE-related data, review and evaluating this information, and communicating with the Center for AEs of Drugs’ Monitoring. Every AE collected and evaluated is then reported back to the Technical Committee (TC) of medicines at MoPH for decision making. Minister's Decision No.1636 of 9/10/2013
Collaborative Agreement (2016)
A collaborative agreement between the Lebanese University and MoPH dated 24/02/2016 authorized the Center for Drugs Monitoring of Advers Events at the Faculty of Pharmacy of the Lebanese University to function officially as National Pharmacovigilance Center.
A Strategic and Operational Plan (2016-2020)
A strategic and operational plan for a period of 5 years (2016-2020) was drafted for the MoPH in 2016. The main goals of the plan include upgrading the hospital accreditation and licensing systems as well as establishing Pharmacovigilance and post-marketing surveillance systems. Through the MoPH, QAPP applies for membership to the WHO-PIDM and Lebanon became an Associate Member in July 2018. Strategic Plan for the Medium Term (2016 to 2020)
PV Strategic Plan and Operational Plan (2020-2025)
A PV system strategic plan and an operational plan for the upcoming 5 years 2020-2025 was drafted and it details all the activities, objectives, regulations, departments, responsible personnel, partners, collaborators, timescale, and indicators.
Ministerial Resolution No. 1438/1 (2019)
Related to work mechanisms for the PV project in Lebanon and assigns Dr. Rita Karam as PV coordinator between the MoPH, WHO and LNPVC
The Regulation states the procedure for Reporting Adverse Drug Events related to the COVID-19 treatment by the responsible parties of Pharmaceutical Products and Drug Distributors Minister's Decision No.556 of 28/5/2020
The Pharmacovigilance training sessions, organized by Dr. Rita Karam and Dr. Myriam Watfa took place four times between the time period of 26 February 2021 until the 19th of March 2021. The presentations were run by Dr. Karam, Dr. Katia Iskandar, Dr. Jihane Howayek, Dr. Hanine Abbas and Dr. Watfa and moderated by both Dr. Karam and Dr. Issam Kassab. The webinars' participants were based on the selection of healthcare professionals who work in both public and private sectors.
Based on the organization, proceedings, outcome, and participants’ evaluation, it is judged that the webinars were a success.
The organizers wish to acknowledge WHO represented by Dr. Omar Al Rifai for its support, the PV team for its dedication, and the participants for their willingness and input.