Pharmacovigilance Saves Lives

Articles

Medicines, medical products, and vaccines represent essential components of any healthcare delivery system. Their use ensures benefits for patients, the general public, and the healthcare system. While modern medicines and vaccines are considered relatively safe, the thalidomide incident in the early 1960s brought to light the need to continuously monitor medical products so as to detect rare adverse effects early.

A rigorous safety monitoring system also helps to identify increases in the frequency of known unwanted effects, patient groups at risk of specified events from particular medications, specific effects due to genetics, prescription errors, and the circulation of substandard or counterfeit products. The effect of diet, culture, delivery systems, and the use of traditional or alternative remedies on the safety of registered medicines can also be known through safety monitoring of all medicines.

 

The Eritrean National Pharmacovigilance Centre (NPC) was established in 2003 and became a full member of the World Health Organisation (WHO) Programme for International Drug Monitoring in April 2012. Since 2012, the NPC has made significant strides and progress. It is encouraging to see the NPC ranked among the top four African countries in terms of number of adverse drug reaction reports and their completeness grading. The NPC, housed within the National Medicines and Food Administration, has the responsibility to monitor medicinal products and ensure their safety for the general public.

In order to carry out its mandate, the Ministry of Health (MOH) developed a National Policy on Pharmacovigilance, which will also be a guide to action. The MOH recognizes the importance of ensuring the health, safety, and well-being of the Eritrean population. This is clearly expressed within the new National Pharmacovigilance Policy. This policy covers a range of topic areas, including the use of medicines, vaccines, cosmetics, blood and blood products, alternative remedies, and other antibiotics.

Modern medicines, vaccines, and biological products are registered and offered for use only when they are considered safe and effective. However, inherently no medicine or vaccine can be regarded as safe for all people or under all conditions of use. The testing processes that provide the data required for the registration of medicines, vaccines, and biological products often are very short, exclude vulnerable populations like children and the elderly, and are carried out in people without co-morbidities. Nonetheless, in clinical practice, such registered products are used by several categories of people, including vulnerable populations like children and pregnant women, and people with co-morbid conditions. It is, therefore, extremely essential that after a product is approved for use, its safety is continuously monitored in order to ensure that it is safe for the general population and that rare occurrences of adverse reactions that may have been missed during the pre-approval process are picked up and managed appropriately.

In addition to these, prescription errors, inappropriate use of medicines, and the proliferation of substandard or counterfeit medical products can also have a harmful impact on the public. This is the basis of pharmacovigilance, which is defined by the WHO as “the science and activities relating to the detection, monitoring, assessment, understanding, and prevention of adverse effects or any other drug-related problems.” Pharmacovigilance also includes vaccine pharmacovigilance, which is defined as “the science and activities relating to the detection, assessment, understanding, prevention, and communication of AEFIs, or of other vaccine or immunization related issues.”

The ultimate aim of pharmacovigilance is patient safety. The pharmacovigilance activities of Eritrea’s NPC aim to ensure the rational and safe use of medicines, vaccines, and other health-related products. Since its revitalization in 2012, the NPC has made tremendous strides. One of its most notable achievements has been fulfilling the WHO benchmark (maturity level 3) quicker than any other African country.

A number of factors contributed to this important achievement. One of the most significant was the massive sensitization of local healthcare professionals. Specifically, around 90% of the healthcare professionals in Eritrea are aware of pharmacovigilance and a significant percentage are involved in reporting adverse drug reactions. As a result, in 2018, the NPC has been able to submit approximately 1000 individual case safety reports per million inhabitants to the global database. It has also led to some important safety signals.

Eritrea’s NPC shared the story of its experiences and successes during the Uppsala Monitoring Center’s (UMC) 40th anniversary celebrations, held earlier this year in Uppsala, Sweden. The UMC, established to support the WHO’s Programme for International Drug Monitoring, has recognized Eritrea for its strong record on pharmacovigilance. Eritrea, along with the Netherlands and Peru, was invited to share its pharmacovigilance experience. Mr. Mulugeta Russom, head of Eritrea’s NPC, gave a detailed presentation on Eritrea’s successes, strategies used, challenges encountered, solutions adopted, and lessons learned. Mr. Mulugeta also announced that Eritrea is working hard to integrate pharmacovigilance in public health and that the NPC has established an annual award to motivate people to report. The award is partly based on the idea that good or positive role models are important for the growth and continuity of successful vigilance.

It is quite clear that the success of the NPC is down to the efforts of its hard-working members. During its early days, it had only one member. However, now it has full-time staff members, three pharmacovigilance medical officers, and other professional volunteers. As noted, the Eritrean NPC falls under the umbrella of the Eritrean National Medicines and Food Administration. It has four main sections: data processing, data analysis and signal management, information control and publication, and training and education coordination. The NPC is also the recipient of considerable political backing and stable funding. These resources allow the NPC to carry out its various health-related activities. Furthermore, the NPC has provided support to members to attend pharmacovigilance fellowships, developed training manual, offered sensitization workshops, and established advanced courses and sensitization for higher officials and other institutions.

Despite its great progress and many successes, the NPC is confronted with several challenges. For example, there are no suitable patient reporting systems, there are some delays in the submission of reports, and there have been interruptions during pharmacovigilence harmonization initiatives. However, these are expected to be overcome with continued attention and effort. Moving forward, the NPC has plans to incorporate hemovigilance from the Eritrea’s National Blood Bank into the system of pharmacovigilance and to work closely with neighboring countries to develop an effective regional vigilance system.