“Our Ultimate Goal: Ensuring the Safety of Our Patients”
Promoting good health for a healthy society is the essence of sustainable development, as Dr. Menghis Bairu, CEO and Founder of Serenus Biotherapeutics, expressed during an interview we conducted on May, the 13th. Indeed, the relation between patients and health professionals is a question of trust.
Thus, a patient who is advised to take certain medicines to improve his health, the trust he put, not only on the doctor, but also the pharmacist, is of utmost importance. Accordingly, the good use of drugs by patients as well as the assurance that the drug will do more good than harm is the challenge that drug regulators are working on in order to keep the standards high.
A week-long International Conference on Pharmacovigilance (PV) and Harmonization in East Africa was held in Asmara in April. This successful conference hosted health professionals as well as representatives of World Health Organization (WHO) among other institutions to discuss and assess drug quality control and the way forward in harmonizing the regulatory system in the continent and, in particular, East Africa. Many papers presented by young Eritrean physicians on adverse drug impact in their respective clinics or hospitals impressed the participants and demonstrate the great investment Eritrea put forth in ensuring control of drugs in its soil.
Hence, one of the main themes of discussion was regarding the training of professionals and continuous mentorship to ensure that professionals have sufficient knowledge on how to assess drugs and to be in line with international standards. Henceforth, the National PV Center has been working hard, particularly during the last four years, in guaranteeing safety in the use of drugs and medical devices. The center and the Ministry of Health (MOH) have, therefore, been engaged for the last 18 months, in the planning and implementation of courses and trainings to health professionals in Eritrea. With this in mind, a week-long training on PV and Risk Management was given in partnership between the MoH and Serenus Biotherapeutics in the premises of Orrota Referral Hospital from 6th to 13th of May, 2016. This training was a continuation of the previous conference and focused on monitoring and registering capacity of medicines produced in the country. Strengthening the human capacity, regulatory capacity and capability for the registration of technologies and medical products, which address the public health needs of the people of Eritrea were also other topics of the conference.
To strengthen this, a three module program was implemented in May 2015 starting by, a week-long visit at the Azel Pharmaceutical Share Company in Keren as well as in Orrota Referral Hospital in Asmara with a focus on drugs manufacturing control, and quality control. A gap analysis was provided highlighting areas to improve with the ultimate goal of ensuring WHO’ pre-qualified manufactured standards. The second model consisted of strengthening the PV department in terms of monitoring of drugs in the real market.
The second part has the primary goal of ensuring safety in the use of drug. Although, there is a long process before a medicine is placed on the market: passing the pre-clinical test (animal testing), followed by a testing of 15-25 patients. If there are no major safety issues, the trial will move to a second phase in which the drugis tested for safety and efficacy with about 50-70 patients, before it proceedes to a third phase with larger group of 400 to 2000 patients in which the safety, efficacy and doses are tested for a successful conclusion. Finally, an application to the regulatory agency for a new drug application (NDA) will be submitted. “We are minimizing the risk during the trial, it’s a controlled environment but when the drug is out in the market, there is a variety of people using it and that’s when you see its effect in real patient population”, Dr. Bairu explained. Surely, this is where the role of drug regulator comes into the picture which involves understanding how a drug is behaving in the real market and then documenting any adverse drug reaction.
The investments made on controlling falsified drug production is worth 80 million USD a year, Dr. Bairu stressed, and surely there is not enough focus on how to tackle such activity. Nonetheless, overcoming the distribution of falsified or substandard drugs into one’s market will depend on the efficency of a regulatory system in controlling what enters the country, the type of drug as well as strict inspection upon arrival by following WHO’ guidelines and authority.
These falsified drugs have an impact on patient’s health as well as the population as a whole and in addition to thier financial impact, “the patient, instead of getting better, his health will be undermined as well as his pocket”, Dr. Bairu added.
Certainly, with the importation of new drugs into Eritrea and as a relatively new sector in less developed countries (LDCs), it is important to ensure that there is a system in place to see signals and to educate professionals and citizens on how to proceed. Already, in Eritrea, a good system is in place and is being implemented by providing ongoing training to professionals in this field.
Accordingly, based on a Memorandum of Understanding (MoU) between the MoH and CEPAD in Accra, Ghana, Mr. Vincent Mensah, a clinical researcher and consultant gave extensive training by compressing a commonly two-week long training into three days. “I was impressed by the way students kept up the pace… it is commendable”, he said. The training given to 25 young health professionals was an occasion to exchange ideas, and also develop expertise in Eritrea. Further, this training on risk management gives the possibility to regulators to understand the work they do and understand the impact it has. “Regulators do not only protect the public but they act as a shield in the battlefront, and the only shield they have is the bulletproof vest… if that bulletproof vest is perforated, then, there isn’t any protection”, Mr. Mensah explained. Without a doubt, in ensuring that regulators complete their task accurately, it is important to look at the drug regulation standards. The world is now moving toward a Common Technical Document (CTD) adopted worldwide, and is aimed to see at assessing drug manufacturing standards, the expectation and how to proceed to inspection and what quality standards should be measured.
Drug regulation is, therefore, a question of public safety which Eritrea is surely putting a particular emphasis on. As health is one of the top priorities of Eritrea’s development policies, ensuring the safe use of drugs as well as the good quality of medical devices are key factors. On this matter, Dr. Bairu gave an extensive explanation during an interview we conducted at the end of the training. The eye opening discussion allowed anyone to understand the usual difficult medical jargon which is essential in raising awareness in our society. Dr. Bairu and his over 25 years of professional experience in this field as well as his multiple exposure and researches demonstrated that regulators have the role to protect the public. This huge responsibility is essential in implement ingoing trainings in Eritrea by adopting the CTD format but to also put a clear emphasis on: drugs, medical equipment and food and nutrition products in Eritrea to ensure that they are properly used.
As Mr. Iyassu Bahta, Senior Pharmacist at the Ministry of Health and Director of the Drug Regulatory Authority explained the accomplishment in consolidating three projects into one and working hand in hand with the international community while training our local professionals is “the ultimate goal aimed at safeguarding the health of our patients”.
Clearly, the commitment of Eritrea in the safe use of drugs through training and continual mentorship to young professionals is commendable. With the aim of ensuring an in-depth hands on training on regulatory dossier evaluation, looking at the way forward in accelerating the registration of essential and novel quality medicines and vaccines in Eritrea without ignoring the focus on human capacity building were greatly appreciated by participants of the course.
As a young professional in pharmacy, Ms. Elsa Mekonen said, “it is an eye opening and it shows us that we need to work together to reach our goals, and it’s good that we are from different departments in raising awareness in our respective place sof work”. Mrs. Emnet Kibrom, clinical pharmacist also stressed the need to provide guidelines and manuals for health practitioners while Mr. Tsehaye Gilay, teacher at the College of Health Sciences stressed the importance in including such program into the curriculum of the college. Surely, a comprehensive strategic plan is under revision for the next five years in keeping the momentum of the PV Center, Mr. Mulugeta Russom, and Head of the National PV Centre highlighted.
The numerous comments and enthusiasm to learn demonstrated by the participants as Dr. Bairu and Mr. Mensah expressed, “it motivates us to continue training these young professionals”. When I asked Dr. Bairu’s expectations in the long run, he answered, “the expectations from these trainings on a short and long term basis are to ensure the safety of our patients with the ultimate goal of providing the people with the best quality of health products and drugs because without health any sustainable development is impossible”.
Certainly, the great investment put in training professionals has to go in hand with raising the awareness of the population as it is key to effective drug regulation. In other words, it is essential to remind the public to report any side effect sor abnormal symptom after any drugs intake to their pharmacist or any health practitioners.