Pharmacovigilance in Middle East & North Africa Region
The importance of countries to support their own national pharmacovigilance cannot be understated. While adverse drug reaction (ADR) data from other countries is helpful in making medication safety decisions, information may not be relevant or applicable to domestic populations.Pharmacovigilance has received much attention in Middle East & North Africa (MENA) countries recently due to the development of new regulations
The principal reasons which are fueling the growth of this market are increase in drug consumption and drug development, growing rate of ADRs &drug toxicity, and rapidly increasing trend of outsourcing pharmacovigilance services. The increasing prevalence of lifestyle diseases, such as hypertension, diabetes, and cardiac disorders, as a result of sedentary lifestyles, lack of physical activities, changing lifestyle patterns, and poor diet lead to increasing consumption of drugs, which, in turn, indicates the high demand for drug safety monitoring and further fuels the growth of the pharmacovigilance market. With the growing drug consumption, the need for the regular monitoring of drugs has also increased, leading to growth of pharmacovigilance market. Infectious diseases are also on rise due to the changing climate, pervasive poverty, and increasing urbanization, which also surge the drug consumption and drive the drug development process. Furthermore, new drug developments needs to be further regulated and stimulate the overall pharmacovigilance market.
Only 45% of Arab countries are official members of the World Health Organization (WHO) Collaborating Centre for International Drug Monitoring. Countries such as Morocco, Tunisia, Saudi Arabia, Egypt, and Jordan are considered to be advanced pharmacovigilance countries, whereas other countries such as Libya, Yemen, and Palestine remain in the very early stages of implementing and developing pharmacovigilance systems. Countries such as Somalia, Djibouti, Mauritania, and Comoros Island have no pharmacovigilance system or culture. Asian Arab countries have some advantages over those in Africa because 50% of them are a part of the Gulf Cooperation Council (GCC), meaning that most of them can utilize similar approaches for the application of the majority of activities related to the healthcare system, including pharmacovigilance. Thus, participating in the GCC enables increased connections among these countries. However, one of the strengths in Africa is that Morocco is partnering with the WHO through the WHO Collaborating Center to enhance and strengthen pharmacovigilance across the Eastern Mediterranean Region and the Francophone and Arab countries.
Several countries including Saudi Arabia, UAE, Kuwait, Turkey, Egypt Iran and Jordan have adopted new pharmacovigilance guidelines which require marketing authorization holders and pharma manufacturers to be compliant and need skilled/trained workforce. UAE adopted MOH
Guidelines in Good Vigilance Practice (GVP) For Marketing Authorization Holders / Pharmaceutical Manufacturers in UAE in 2017.
In1992, the first African country joined the Pharmacovigilance International Network, but it was not until 2006 that the majority of African countries integrate this programme. Despite this integration, Pharmacovigilance is still at the early stages. Pharmacovigilance is primarily dependent on the leadership and advocacy in the country, but this activity cannot play its role to enhance patient safety if the environment is not in favourable.
National pharmacovigilance centres (national centres) are gradually gaining visibility as part of the healthcare delivery system in MENA region. As does happen in high-income countries, it is assumed that national centres can play a central coordinating role in their national pharmacovigilance (PV) systems. National centres in Africa are faced with 3 core challenges:
1. Over-reliance on development partners,
2. Seeming indifference of national governments to provide support after national centres have gained membership of the World Health Organization (WHO) Programme for International Drug Monitoring (PIDM)
3. Engaging public health programmes in a sustainable way.
There is also evidence that the development of PV systems has become a key priority in certain countries which has led to successes. For instance, the Ghana Food and Drugs Authority has implemented legal provisions mandating Marketing Authorisation Holders (MAHs) to have a Qualified Person for Pharmacovigilance (QPPV) in line with the Public Health Act of Ghana (Act 851, 2012; Part Seven). The Pharmacy and Poisons Board of Kenya has been designated as a Regional Centre of Regulatory Excellence (RCORE) in pharmacovigilance by the African Union through the African Medicines Regulatory Harmonization (AMRH) programme. Despite this attention, our knowledge on the role and experiences of national centres in Africa is limited especially as it relates to the organizational capacity (resources and relationships) they need to deliver on their mandate
The first challenge is over-reliance on development partners. Pharmacovigilance in most countries started and/or have been facilitated by technical and financial support from development partners, usually the Global Fund, MSH through USAID or the Bill and Melinda Gates Foundation. This has led to a situation whereby national centres align their planning activities with those of the funding partners. Whilst this has been useful in several cases, it has also left national centres vulnerable.
The second challenge is the seeming indifference of national governments
to provide support after national centres have gained membership of the PIDM.
National governments tend to provide some political and modest technical support
by designating national centres and launching them publicly. Occasionally,
national governments have passed subsidiary legislation to help the work of the
national centre. However, in several cases this support seems to evaporate once
countries become members of the PIDM leaving national centres bereft of
The third core challenge facing national centres is how to engage all
public health programmes (PHPs) in a sustainable way.
Pharmacovigilance training need in MENA region is high as several
countries have only recently developed national PV systems, in most cases, PV is
yet to fully incorporated in national regulatory authorities work, experts and
training institutions. There is a need to build BASIC capacity for the 20
countries with no formal PV system. There is the need to build capacity for
national PV centres. There is the need to build ADVANCED capacity for existing
national PV centres like Pharmaco-epidemiology, Statistics etc.
Cliniminds offers wide range of pharmacovigilance programs for professionals. These programs would equip professionals with case processing / ISCSR on safety database (Oracle Clinical); medical review; aggregate reporting (PSUR; PADER; PBRERs; and DSUR); signal detection and evaluation; risk management; audits & inspections and several other aspects of pharmacovigilance.
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