With increased globalization, medical products are constantly moving across borders, making information sharing at an international level even more vital. It’s a new age of pharmacovigilance.
Pharmacovigilance | Global Transparency
Information sharing and transparency can make all the difference if a medical product causes serious adverse reactions. Until recently, there was no one way to access this information. In mid-April of 2015, the World Health Organization (WHO) launched a new open access pharmacovigilance database system called VigiAccess (www.vigiaccess.org) hence providing global public access to critical information regarding adverse drug reactions or ADRs.
Pharmacovigilance | What is VigiAccess?
During clinical trials, it is difficult to determine every possible side effect or reaction to a drug or vaccine. By monitoring and collecting reports of suspected adverse drug reactions (ADRs), bio-pharmaceutical companies and healthcare providers can continue to evaluate product safety.
The system is set up in statistical data sets that are broken down by category and frequency. The data is composed of reports of suspected ADRs, called Individual Case Safety Reports (ICSRs), collected by national drug authorities in over 110 countries and for more than 100,000 medical products. Within the first weeks of availability, VigiAccess received reports of over 10 million ADRs related to 150,000 medicines and vaccines from around the world. According to WHO, VigiAccess is the “largest and most comprehensive [pharmacovigilance] database in the world,” and is “the only global database that contains safety reports from both high- and low-income countries.”
Pharmacovigilance | The Limitations
Many factors influence the number of ICSRs associated with a particular product, including the extent of use of the product and the nature of the reactions. Also there are a number of limitations associated with the new database that should be noted: 1) There is no information regarding the number of patients exposed to a particular product, therefore, it is not possible to calculate the frequency of a particular ADR. 2) Due to lack of standardized national legislation and policies in each country, the data itself is not homogeneous. 3) Only a limited number of the actual spontaneous ADRs are reported, indicating the need for better implementation. 4) A report of a suspected ADR does not definitively mean that the product in question is unsafe. Any conclusions regarding the benefits and risks of a specific product require evaluation of all available data, and must be considered specifically for the individual patient undergoing treatment. 5) Finally, there is the issue of language: If the preferred language is English, when the data entered in the user’s native language is other than English, it must be translated so that it can be understood universally.
Using the Database
The VigiAccess database is accessible on all computers, mobile phones and tabular devices. To use the website, one must enter the trade name of the specific medical product drug to access the active pharmaceutical ingredient (API) contained in the product and consequently the total number of ADR records related to that API. These reports include the types of reactions that have been reported for the product which have been broken down by category and frequency, including geographical distribution (by continent not country), age group, patient sex and the number of ADRs per year.
Learn more about our Translation Services and our Life Sciences Translation services!
About Language Connections:
Language Connections is one of the top language service companies in the US. Over the last 30 years, we’ve focused on providing the best business translation services, interpreting services, as well as interpreter training and customized language training programs. In addition to top-tier corporate language training, we offer certified corporate interpreters and professional business translation services in 200+ languages. Our network includes linguists with backgrounds in all major industries. They’re ready to meet your needs, whether they’re for technical translation services, legal translation, government translation services, international development translation services, education translation services, life sciences translation, or something else. Reach out to us today for a free quote on our cost-efficient and timely translation services, interpreters, or other linguistic services.
Language Connections Inc.
2001 Beacon Street, Suite 105,
Boston, MA 02135
Phone: +1-617-731-3510
Email: service@languageconnections.com