Importance of pharmacovigilance in the Middle East countries
This article briefly analyses Pharmaco vigilance and its relevance and implementation in the Middle East countries.
What is Pharmacovigilance?
According to WHO, Pharmacovigilance (PV) is characterized as the science and events that are related with the identification, appraisal, comprehension and avoidance of unfriendly impacts or whatever other effects that are related to the issues of medicines. WHO implemented a Program for International Drug Monitoring in light of the thalidomide catastrophe identified in 1961, together with the WHO Collaborating Center for International Drug Monitoring, Uppsala. WHO started collaborative pharmacovigilance programs at the national level of majority of countries. Toward the end of 2010, 134 nations were collaborators of the WHO Pharmacovigilance Program (WHO, 2015). Pharmacovigilance is also defined as the methodology of assessing and enhancing the quality and effective of medications. It assumes a crucial part in the early identification of drug related adverse reactions. Each medicine is trialed on a moderately little number of individuals before it is approved for utilization by the more extensive populace. Every patient is an exceptional user of medicine with a unique way of life and circumstances. Solutions that cause genuine Adverse Drug Reactions (ADRs) need to be re-assessed or expelled from the business sector to secure general health related issues (The European Commission, 2015).
Relevance of Pharmacovigilance in the Middle East countries
Pharmacovigilance program is related to Middle East countries due to various reasons. These reasons are related to the healthcare system, public awareness as well as the environmental conditions of the Middle East countries that can affect the quality of medicines. According to a recent survey report of 11 Middle East countries, Pharmacovigilance program was implemented practically in only 6 Middle East countries. Those 6 countries were Iraq, Egypt, Jordan, Saudi Arabia, Oman and the United Arab Emirates. While, there was no active Pharmacovigilance program in five countries. Those five countries were Palestine, Qatar, Kuwait, Yemen and Bahrain. Majority of these Pharmacovigilance programs were government funded. This study highlighted that; still there is more room for improvement of ADR reporting system and implementation of Pharmacovigilance program in the Middle East region (Wilbur, 2013). Pharmacovigilance is required in every nation as every nation has its own disparities in the event of antagonistic medication responses and other medication related issues (HAAD, 2015). However a website has been launched that act as a central point for providing reference for medicine information and Pharmacovigilance services that are currently being offered throughout the Middle East Region (ME-MI, 2015).
Importance of Cold Chain Management in Pharmacovigilance
Cold Chain Management is a key component of the Pharmacovigilance and in the globalization of the pharmaceutical supply chain management with an expanding concentrate on dealing with the cold chain dispersion of temperature delicate items; to guarantee quality, viability and agreeability are kept up. Approximately 10% of the pharmaceuticals sold all over the world are biotechnological temperature sensitive products and their revenue is equating up to $41 billion. This expanded venture implies the business is ceaselessly looking to create and deal with an intelligible and effective supply chain to guarantee quality and safe distribution of pharmaceutical items that are temperature monitored. Storage conditions of these shipments must be observed and mapped amid travel to guarantee agreeability with the principals of Good Distribution Practice (GDP) to ensure quality use of medicines (SMI, 2015). The cold chain management is an element process, and guaranteeing a viable cold chain supply from maker to patient is not an easy task. Temperature controlled logistics displays an assortment of complex difficulties from administrative consistence to entering developing markets; today’s pharmaceutical makers and their logistics suppliers must stay informed concerning the most recent arrangements and advancements to ensure their supply chains. Keeping up supply chain trustworthiness and patient security remains the most obvious need for pharmaceutical manufacturers, and all things considered they depend on innovation to guarantee an agreeable temperature-controlled production and supply network. With the latest increment in the quantity of items obliging cold room temperature products and solidified temperature conditions, the pharmaceutical industries are confronted with embracing particular conventions to guarantee these items are secured all through appropriation. The temperature prerequisites of the different items that are currently being acquainted with the business have postured extraordinary difficulties which have constrained drug manufacturers to direct the vital danger appraisal needed to recognize and see the greater part of the exposures that exist that is not only related to temperature but also along a given supply chain pathway.
Challenges in Cold Chain Management in climatic conditions of Middle East countries
While globalization has made the relative separation between districts of the world much littler, the physical division of these same areas is still a vital reality. The more prominent the physical partition, the higher chances items can be harmed. The major factor that affect the quality of medicines are the extensive high temperatures and humidity and the Middle East is famous due to these two characteristics; 1) high temperature and 2) high humidity. There are more chances of drug related adverse effects that may become troublesome for both the users of medicines as well as the manufacturers of medicines. It requires significant investment and coordination to proficiently move a shipment and each deferral can have negative effects on items. Minimizing hazard and guaranteeing compelling control over cold chain management techniques are getting to be progressively vital. To keep away from this harm or traded off all through this methodology, organizations in pharmaceutical, restorative, human services and sustenance commercial enterprises are progressively depending on powerful cold chains. Arranging the numerous aspects of capacity and dispersion of temperature controlled items may be a testing errand. A lot is on the line particularly when managing items that holds noteworthy fiscal esteem and are additionally critical segments to the nature of human life.
References
HAAD. (2015, Feburary 19). HAAD Pharmacovigilance Launching Programme. Retrieved from https://www.haad.ae/HAADDeps/Portals/7/Educational%20Material/Toxi%20Info%20Sept.pdf
ME-MI. (2015, 19 02). Middle East Medicine Information & Pharmacovigilance. Retrieved from http://www.middleeastmedinfo.com/default.aspx
SMI. (2015, Feburary 19). Cold Chain Distribution North America. Retrieved from http://www.smi-online.co.uk/pharmaceuticals/northamerica/conference/Cold-Chain-North-America
The European Commission. (2015, Feburary 19). What is Pharmacovigilance? – Health Action International. Retrieved from http://www.haiweb.org/19072009/19July2009FactsheetTheEuropeanCommission’sProposalforaPharmacovigilanceDirective.pdf.
WHO. (2015, Feburary 19). Pharmacovigilance. Retrieved from http://www.who.int/medicines/areas/quality_safety/safety_efficacy/pharmvigi/en/
Wilbur, K. (2013). Pharmacovigilance in the Middle East. Drug Safety, 25-30.