“Every Report Counts: Vigilance Saves Lives” – An Inside Look at the Fifth Annual Pharmacovigilance Conference

Increasing awareness about the safety of drugs, sharing information about the adverse effects of medicines, and ensuring health through the appropriate use of medicines is the main mandate of the Eritrean National Pharmacovigilance Center (NPC).

The initiation of Pharmacovigilance (PV) in Eritrea in 2012 heralded a new era of healthcare advancement in the country. The achievements registered since then are highly impressive. Eritrea’s progress in PV has attracted the attention of international observers, including the Uppsala Monitoring Center (UMC). In fact, Eritrea was invited to share its experiences, along with the Netherlands and Peru, during events held to celebrate the UMC’s 40th anniversary on May 17-18 in Uppsala, Sweden. Despite its considerable progress in PV, Eritrea remains committed to improvement and it recently held its Fifth Annual Pharmacovigilence Conference. The conference featured an array of activities, including the presenting of research papers on various topics, “rapid-fire” talks, and panel and group discussions.

Discussions were about a range of topics, including critical issues that may pose a threat to the country’s provision of healthcare. The “rapid-fire” talks, which were a series of five minute long presentations, dealt with steps that need to be considered in the future and strategic planning. Other important topics raised during the discussions and talks include: the use and potentially adverse effects of medicine; TB, malaria, and various infections; and challenges associated with the provision of healthcare and potential remedies.

The Fifth Annual PV Conference, which was conducted under the theme “Every Report Counts: Vigilance Saves Lives”, sheds light on the need for timely and complete ADRs reports and the significant role played by reporters in detecting and addressing ADRs. As has become tradition during the annual PV conferences, awards were also presented to vigilant reporters who were able to bring suspected cases of ADRs to the NPC. Notably, Dr. Abiel Abrham from Agordat Hospital received the award for the “best promoter.”

Mr. Eyasu Bahta, Director of the National Medicines and Food Administration in the Ministry of Health, helped to officially open the conference. During his opening remarks, he commended all healthcare professionals for their commitment and dedication to improving PV in the country. Subsequently, he highlighted some of the strategies that Eritrea has employed as it has made impressive progress in PV. He also discussed how annual vigilance awards can motivate reporters on Adverse Drug Reactions (ADRs), the importance of a collaborative approach to addressing ADRs, possible mechanisms to enhance drug safety monitoring, and how to build on past success in PV. Mr. Mulugeta Russom, head of Eritrea’s NPC, also addressed the conference participants, which numbered over 210 people from across the country. Mr. Mulugeta’s comments broadly outlined the main objectives of the conference.

Notably, most conference participants are positive community role models and very successful in their line of work. They are expected to share their research findings and experiences with their colleagues and help improve healthcare in the country.

Eritrea’s progress in PV during the past six years has made it one of the top performing countries in Africa. Although Eritrea started PV relatively late (in 2012, to be specific), it has been able to register impressive progress due to the multifaceted efforts of the NPC. As well, it has integrated PV into its national public health framework. Mr. Mulugeta mentioned that Eritrea’s regulatory framework for ADRs is in a relatively good state and that the country has been able to considerably improve due to a number of factors, including the diligence and commitment of healthcare workers and important research that has been conducted by the NPC. “We are now better able to prevent ADRs and related challenges,” Mr. Mulugeta asserted.

The “rapid-fire” talks were highly insightful. They included important information about ADRs and how to build upon past PV success. Another highlight of the conference was the research presentations. Over the years, the quantity and quality of reports sent to the NPC has noticeably increased.

Some interesting research papers presented at the conference include: “Risk management of Artesunate/ Amodiaquine(ASAQ)”, by Ms. Selam Mihreteab, National Malaria Control Program Manager; “Rantitidine and Cardiac Arrest”, by Amon Solomon, MD, Ghindae Regional Referral Hospital; “Pharmacovigilance in Pediatrics”, by Ariam Mebrahtu, MD, Ghindae Regional Referral Hospital; “PV Training and Education in the Curriculum”, by Dawit Tesfai, Orotta College of Medicines and Health Sciences; “The Value of Single-case Reports in PV”, by Mulugeta Russom, head of the Eritrean NPC; and “Future Strategic Direction of PV in Eritrea”, by Eyasu Bahta, Director of National Medicines and Food Administration.

Mr. Mulugeta indicated that single-case reports are very important for risk identification, particularly when well-documented and adequately assessed. He also went on to say that many of the safety signals identified in the NPC are triggered by a single report and that they have saved many lives.

Mr. Eyasu Bahta revealed that since the establishment of the NPC in 2012, several issues regarding safety have been identified. Notably, these issues led to a number of regulatory actions, including product labeling changes, market withdrawals, dosage amendments, risk minimization strategies, and post-authorization safety studies, among other important steps.

While Eritrea has made considerable progress in a short time period, questions remain about its future direction in terms of PV. According to Mr. Eyasu, a series of key steps will be taken in the future to maintain Eritrea’s momentum and help it to continue to improve PV in the country.

An important part of the conference was the group discussions. These discussions led to a number of significant recommendations, including the need to strengthen communications between physicians and the drug administration branch, the need for greater accountability from drug manufacturing companies, reinforcing actions by regulators to reduce the risks associated with ADRs.

The Fifth Annual Pharmacovigilence Conference, conducted under the theme, “Every Report Counts: Vigilance Saves Lives”, was a remarkable success. Over the years, Eritrea has proven that even a single report of an ADR is important. As put by many participants of the conference, “Working together we can make a difference,” collaborative efforts of healthcare professionals, communities and policy makers will take the country’s success to new heights of achievement.