Within the framework of achieving Vision 2021, National Agenda Indicators in health and preventative services, transformation from E-Government to smart government, Agenda 2030 for sustainable development and in order to implement the initiative of strengthening the pharmacovigilance for the safety of society which has been approved by the cabinet in October 2017, the Ministry of Health and Prevention “MOHAP” launched the first-of-its-kind smart application about pharmacovigilance under the name “UAE RADR”.
The application has been developed in collaboration with Medicines and Healthcare products Regulatory Agency “MHRA”. UAE RADR is used for the complete management of pharmacovigilance including WHO’s UPPSALA monitoring center on the side effects of drugs, guideline on good pharmacovigilance practices which features the procedures required from the marketing authorization holders for drugs and medical products to ensure the safe use of its products in the country.
Through the implementation of this initiative, MOHAP looks forward to promote patients’ safety and drug safety as well, by using this smart application for regulating the reporting process about the side effects of drugs, in addition to fostering the capability of data analysis and consequently the acceleration of decisions taken and preventative measures, as well as curbing the phenomenon of fake drugs.
Also, this initiative aims to take benchmarks into account and to be acquainted with the international trends that can be leveraged in shaping policies, taking decisions, providing information and evidences which contribute to updating drug items in the drug formulary.
Transformation into smart government and achievement of Agenda 2030 for sustainable development to ensure healthy lifestyle habits
H.E Abdulrahman bin Mohamed Al Owais, Minister of Health and Prevention, said that UAE Vision 2021, UAE Centennial 2071, Agenda 2030 for Sustainable Development – Excellence in Implementation, form a fundamental guide for MOHAP’ business, since those initiatives feature lots of basic pillars such as consolidation of the preventative aspect, development of the healthcare systems, attainment of safe drug use, consequently accomplishing a health system with world-class standards. The strategic guidelines also include the general policies which have an impact on the work and activities of MOHAP such as the general policy for innovation.
UAE’s government believes in the importance of keeping pace with the latest technologies and its exploitation in government work. This initiative comes in accordance with the directives of the wise leadership of our country with regards to the smart government which complements the E-government and represents an extension for it, the matter that contributes in the happiness of our citizens.
“UAE has achieved the leadership in adopting pharmacovigilance system in collaboration with WHO. The initiative “strengthen the pharmacovigilance to achieve the safety of society” is consistent with the future directives of the country in the healthcare field and the Agenda 2030 for Sustainable Development – Excellence in implementation to ensure that all people enjoy healthy lifestyle habits and wellness. It also enhances the commitment to applying health legislations, provision of a national updated healthcare database, provision of open data and digital reports in order to take the decisions and to manage the healthcare services. The initiative is considered an important tool of strengthening the pharmacovigilance and drug safety in the country as the system provides data which could be used in analysis and studies on the reported drugs which facilitates and accelerates the process of taking decisions and the necessary preventative measures,” Dr. Abdulrahman added.
Strengthening quality, drug safety and reporting systems
The Minister of Health pointed out that building quality, curative, health and drug systems, in accordance with the international standards, are strategic goals for the ministry, thus the enhancement of pharmacovigilance and drug safety are a part and parcel of the ministry’s goals which strives to maintain patients’ safety and boosting the society prevention. Additionally, these programmes open the door to the communication with all society groups via simple, effective and smart online methods.
“We have formed an executive team for the initiative “strengthen the pharmacovigilance to achieve the safety of society” under the leadership of MOHAP and membership of all healthcare authorities with a view to carrying out the initiative, preparing an action plan including time frame, distribution of tasks and responsibilities, create periodic follow-up reports, hold regular meetings of the competent authorities and adopt the necessary measures to improve and ensure the efficiency and effectiveness of the initiative implementation,” H.E. the Minister said.
While the Undersecretary of the Ministry of Health and Prevention, said “the initiative of strengthening the pharmacovigilance to achieve the safety of society includes several activities and programmes to achieve the sought-after objectives, including preparation of national standards for pharmacovigilance, create database for the reportedly side effects, development of business models on the possible drug side-effects, in addition to establishing electronic and smart system for pharmacovigilance in order to report the possible drug side-effects and the cooperation with World Health Organization (WHO) to provide the new tools offered by the system as well as training of the staff on those tools.
Our goal is to reduce patients’ suffering and to achieve the goal of protecting patients from drug hazards, besides reducing the financial costs of healthcare systems
H.E. Dr. Amin Hussein Al Amiri, Assistant Undersecretary for Public Health Policy and Licensing of the Ministry of Health & Prevention and Chairman for Supreme Pharmacovigilance committee, emphasized the importance of launching UPPSALA monitoring center for online reporting, UAE RADR and guideline on good pharmacovigilance practices as part of the country’s efforts to enhance the awareness about the pharmacovigilance, particularly in the light of the growing and expansion of free trade and facilitating the communications across borders, as well as the illegal sale of drugs over the internet, manufacturing and selling fake medicines on a global scale and the increase of taking traditional and herbal medicine, the matter which is contradicted with the traditional culture of using medicines particularly with the rise of negative interactions and side-effects of those medicines.
Dr. Al Amiri added that the cabinet-approved initiative of strengthening the pharmacovigilance to achieve the safety of society aims to the early detection of drug safety issues, identify the risk factors as well as the rational and safe use of drugs. That contributes in reducing patients’ suffering and curbing the financial costs of healthcare systems and for patients as well. This initiative is one of the outcomes of the annual government meeting 2017.
Three pillars for pharmacovigilance initiative
“The initiative comprises 3 essential pillars, firstly, the link to WHO’s UPPSALA monitoring center which contributes to the automation of collecting data of drug side-effects reports through online reporting via the link available on the ministry’s portal. Furthermore, the automation of studying and analyzing data in order to identify which indicators are associated with drug safety. Also, the pharmacovigilance officers, at the ministry and local health authorities, are allowed to check the reportedly side-effects reports in more than 200 countries and to keep pace with safety indicators globally so as to take preventative measures to protect the society form drug hazards,” Dr. Al Amiri said.
Second pillar is the “UAE RADR” in collaboration with MHRA, UK. The application has a feature of reporting the drug side-effects in an easy way and with the involvement of society alongside healthcare professionals. The application, also, has brief statistics on the reportedly overall side-effects, which help ease the work of healthcare professionals. Dr. Al Amiri urged all people to download the application and use it in reporting the drug possible side-effects.
The third pillar identifies the national standards for pharmacovigilance and drug safety, duties and responsibilities of the marketing authorization holders for drugs and medical products to ensure the safe use of its products in the country. These standards have been tailored according to the best international practices (European Medicines Agency “EMA”, the International Coordination Conference and Arabic Pharmacovigilance Code).
Cooperation frameworks with WHO on strengthening pharmacovigilance
Dr. Al Amiri noted that the cooperation with WHO has several frameworks including facilitation of the process of reporting the drug side-effects through the online reporting application. The ministry or competent authorities’ pharmacovigilance team reviews and scrutinizes data. The confirmed cases are transferred to WHO’s database. This application allows pharmacovigilance officers to conduct studies and researches on the reports of the side-effects in an easy and automated way. Also, it gives them a chance to check the incoming reports from other countries, which help us take the precautionary measures when needed.
An overview of Ministry of Health and Prevention’s participation at Arab Health 2019
Ministry of Health and Prevention “MOHAP” will take part in the activities of the 44th edition of Arab Health 2019 which will take place from 28 – 31 January at the Dubai World Trade Centre.
MOHAP is planning to launch new and innovative package of advanced services and technologies including the first-of-its-kind healthcare systems and devices which will be unveiled at the ministry’s booth at Arab Health.
Arab Health 2019, which is considered the largest exhibition for healthcare professionals in Middle East and North Africa, will witness the participation of 4250 exhibiting companies and more than 84500 visitors from 160 countries are expected to visit the exhibition.
39 national booths have been dedicated for exhibiting companies and authorities, in addition to the increasing international representation to several booths and number of its exhibiting companies compared to the previous year.
Furthermore, Arab Health 2019 will witness the organization of 11 specialized and accredited medical conferences for Continuing Medical Education (CME) in various specialties including radiology, surgery, gastrointestinal diseases, diabetes, gynecology, obstetrics, pediatrics and others.
The upcoming edition, organized by Informa Exhibitions, will shed the light on the innovation in technology domains and business models alike as well as boosting the efficiency in dealing with patients. In this regard and in line with this trend, Arab Health 2019 will provide an innovation hub.