Eritrea: National Pharmacovigilance Center (NPVC)

The centre provides the utmost focus on studying the effectiveness and risk of medicines, and, hence encourages safe, rational and effective use of drugs.

The Eritrean National Pharmacovigilance Center (NPVC)
Drugs Safety. The Eritrean National Pharmacovigilance Center, transforming endeavors for better outcome.

BY KESETE GHEBREHIWET | SHABAIT

Saving lives by ensuring safety of drugs, controlling or minimizing and, if possible, eliminating adverse drugs reactions, and therefore delivering safe patient care is the primary objective of Eritrea’s Pharmacovigilance Center.

The Center which has been active since 2012 is gaining reputation for its commitment to encourage healthcare professionals to make timely report of adverse events, identify casualty and detect signals of first of their kind.

Five years of extensive efforts and an increasing number of reports for adverse reactions of drugs has enabled the Center to maintain an outstanding position in the African Continent.

“According to WHO-UMC report (January 2017), Eritrea is rated as the first country in Africa in completeness score of the adverse drugs reaction reports submitted to the international data base for the last three consecutive years.”

What is more,

“The Center is rated second in Africa following Cape-Verde in the number of reports submitted to the global database as per million populations per year.”

The National Pharmacovigilance Center (NPVC), like other centers in various countries, gives utmost focus to studying the effectiveness and risk of medicines, and, hence encourages safe, rational and effective use of medicines.



Promoting education and increasing awareness of healthcare professionals and the public as regards the importance of safety of drugs is also one of the major activities of the Center. Last year’s East African Advanced Course on Pharmacovigiliance and Risk Management held in Asmara Palace is a good example of the Center’s dedication to a wider regional and international integration.

As a continuation of the ongoing efforts to ensure safe provision of healthcare, the NPVC hosted its 4th conference from 29 – 30 September at the Hall of National Confederation of Eritrean Workers.

Mr. Eyassu Bahta, Director of the National Medicine and Food Administration (NMFD), opened the conference saying much has been done with remarkable achievement since the revitalization of the Eritrean National Pharmacovigiliance system in 2012.

Massive sensitization programs, operational research related to adverse drug reactions, development of pharmacovigiliance policy, integration of pharmacovigiliance with public health programs, acknowledging and awarding best reporters and the hosting of the 2016 East African Advance Course on Pharmacovigiliance and Risk Management are some of the key strategies implemented to strengthen the Eritrean Pharmacovigiliance, Mr. Iyassu elaborated.

Papers related to effective treatment as well as adverse drug reactions were presented in the conference. The topics that were discussed include: The prevalence and treatment of TB, Malaria and HIV/AIDS, and other communicable and non-communicable diseases and other Adverse Drugs Reactions with a higher risk potential that leads to blindness and deafness.

In his presentation about the Nature, Magnitude and Risk Factors of Adverse Drug Reactions in MDR-TB (Multidrug –resistance Tuberculosis) Patients in Eritrea, Mr. Mulugeta Russom, Head of Eritrean Pharmacovigiliance Center, said that most of the side effects of TB medicines are reversible.

Indicating that 98% of TB patients encounter at least one or two ADRs and 77% of the patients recover from the Adverse Drug Reactions (ADRs) after the completion and total stoppage of treatment, Mr. Mulegeta said “Treatment success rate in Eritrea is 64.1 % while the global rate is 52%.”



In a few years of its existence, the NPVC has managed to collect a number of reports related to adverse reactions of medicines and that of second-line drugs in particular. Mr. Mulugeta gives utmost credit to the vigilant healthcare professionals for their sustainable efforts in identifying and reporting possible risk factors and for being the reason behind the success so far registered in the healthcare system.

What the conference made clear is that most of the reported cases were very serious and new signals in the healthcare system. Such findings are playing decisive role in the withdrawal or change of drugs that are major causes of ARDs.

Societal well-being through the provision of safe drugs is the primary mandate of Parmacovigilance. Taking into account that ADRs have been the leading causes of morbidity and mortality. The NPVC considers any temporary illness caused by second-line drugs as a serious signal that needs to be addressed as early as possible.

The need to extend the scope of the national PV activities much beyond the present signals of drug safety concerns was among the issues that were extensively discussed. Emphasizing that PV should not be only confined to drug safety, the participants of the conference shared views as regards the inclusion of blood and blood products, safe treatment procedures and other healthcare issues that are not yet covered in the national PV program.

Caution in the intake of some drugs such as anti- inflammation and ant- pain drugs that could cause skin disease, cardiac problems that could also affect the other organs was another issue discussed at length.

Awareness of safety issues related to medical products has indeed led to an increase in the importance of pharmacovigilance. Prevention of potential risks of drugs is therefore the top concern of the NPVC.

Retinal disorder, blindness and generally visual disorder associated with Clomifence Citrate are very alarming signals with a sudden Adverse Reaction just after two days of the initiation of the medicine. The result was total blindness. Another ADR with an equal alarming status is the intake of an over dose of HCTZ 25 mg five times a day for three days. The adverse reaction was total deafness with the onset of just three days. These two cases presented in the conference are really instances of ADRs.

Anti-Maicrobiral resistance: Case report by Dr. Sharon Woldu from Orotta National Referral Hospital was a very touchy incident where a patient who suffers from drug resistance was finally cured by combination therapy.

Adverse reaction of Ciprofloxacin and cases of alopecia related to intake of second-line drugs were also discussed. For these reasons, the availability of an active pharmacovigiliance center becomes a prerequisite for an effective provision of healthcare and avoidance of ADRs.



As regards the situation of malaria in Eritrea, Dr. Araya Berhane, Director of Communicable Diseases Control at the Ministry of Helath, says that malaria mortality and morbidity rates have decreased over the past decade largely due to integrated vector management, early dialogistic and effective treatment.

Seventy percent of Plasmodium Faclicporum and 30% of Plasmodium Vivax are confirmed malaria cases in Eritrea, According to Dr. Araya.

“Even though the prevalence is shrinking, due to its unstable and seasonal nature and varying transmission pattern across the ecological zones, malaria is still a healthcare concern in Eritrea,” Dr. Araya said. “Through effective treatment and prevention mechanisms malaria will be totally eradicated from Eritrea by 2030.”

Effective treatment is what the NPVC strives to achieve. The envisaged goal of effective patient care will be achieved as early as possible through the integrated actions of the Eritrean medicine regulatory system, National Medicines and Food Administration, healthcare professionals and the reinforcement of the National Drug Quality Control Laboratory (NDQCL).

The NDQCL is now looking ahead for accreditation through the establishment of strong ties with accredited laboratory in the African continent. 
Some recommendations forwarded by the presenters of the papers include:

Introduction of new treatment regimen; provision of training to public health professionals on the appropriate management of ADRS and further observational studies; upgrading the lab set-ups of the hospitals and the need to recruit full-time internists; introduction of ADRs education to patients; strict checkup of patients drugs intake history and caution in prescribing ototoxic drugs concomitantly with HCTZ on the part of physicians as well as undertaking detailed Ophthalmic examination prior to the intake and regular monitoring after the intake of Clomifence Citrate.

The conference makes it clear that the intake of drugs not prescribed by physicians and intake of overdose and repetition are the major causes complicating the adverse drugs reaction.

After extensive deliberation the conference was closed in the evening hours of 30th December. Mr. Iyassu Bahta made this remarks during the closing event:

The success we have achieved up to this day is the product of combined efforts of the PV Center, vigilant reporters and all other partners. This combined effort was necessitated by the very nature of Pharmacovigiliance and the sustainability of integrated collaboration will make a difference.

Three healthcare professionals were awarded as exemplary pharmacovigilantee of the year. Sirak Debas for 67, Ghebremeskel Belay for 129 and Russom Oqbatsion for 257 ADR reports.