Skip to main content

MHRA’s Black Triangle Report



In United Kingdom, there are certain drugs in which although they were granted marketing approval by the Medicines and healthcare product regulatory agency (MHRA), they need to be closely monitored, since limited information were available about these drugs. 

One of the key reasons attributed to this may be, less subjects being enrolled in the clinical trials, short therapy duration etc.…thus, in order to identify rare adverse reactions, effect of the drug in different populations or effect of the drug under different co-morbidities, such drugs are tagged with an inverted black triangle (▼) on their package insert, to ensure that these drugs are intensively monitored.

The Commission on Human Medicines (CHM) and MHRA encourages expedited reporting within 15 calendar days of all such drugs with an inverted black triangle symbol if, found to have caused serious or non-serious adverse drug reaction.

You may find the black triangle drugs at the Electronic Medicines Compendium, British National Formulary, Nurse Prescribers’ Formulary etc.… A black triangle symbol may be assigned to any new active drug / vaccine or even a Biosimilar (Biosimilar are similar biological therapeutic products). Black triangle is not restricted to only drugs, it may also include new route of administration, new drug delivery systems or even new patient population.

Black triangle drugs are reviewed every 2 years by the MHRA and monitoring black triangles reports helps in identifying benefit risk profile of drug and unrecognized adverse effects.

Reference:
·         List of medicines under additional monitoring, European Medical Agency (url: http://www.ema.europa.eu/ema/index.jsp?curl=pages/regulation/document_listing/document_listing_000366.jsp&mid=WC0b01ac058067c852 )
·         EMC (https://www.medicines.org.uk/emc/ )



   Brought to you by: 

 Think-i (www.thinki.in)  , Quality driven Solution providers in Clinical research and Pharmacovigilance 

We at Think I are committed to provide cost effective & robust pharmacovigilance solutions. Think I partners with AB Cube, France to provide SafetyEasy PV™ pharmacovigilance database which is fully evolutive and pre-validated, hosted through cloud based technology and delivered through software as a solution (SaaS) in a web based access.
















Labels:

Comments

Post a Comment

Popular posts from this blog

Chat Bot- the first artificial intelligence bot in Pharmacovigilance

Merck Sharp & Dohme (MSD) Corp., a subsidiary of Merck & Co., Inc has developed an Artificial Intelligence (AI) chat bot. The MSD Salute chat bot is designed to aid physicians in providing product information and pathology.  The Physicians who are registered with MSD would use the Chat bot using facebook messenger.  Chat bot is derived from the social media and uses machine learning and implements feedback to develop interactions.  Currently MSD is monitoring and not filtering the communication between Chat bot and users, as they want to analyse the open ended exchanges between the AI and the users. Chat bot currently in the testing phase, is said augment patient safety through proactive pharmacovigilance .  We at Think I are also driven to produce Pharmacovigilance safety database solutions using cloud based technology which are not only cost effective and user friendly but also fully validated for quick, easy import, entry and electronic submissions of adve
11 comments
Read more

Pharmacovigilance system- Industry perspective, Market size and Operations

Monitoring adverse drug reaction is an essential component in patient safety. In the last decade we have seen how technology has influenced the entire healthcare system, leading to patient awareness, thus making the pharmaceutical companies and regulatory authorities to invest more time and resource in monitoring adverse events. Pharmacovigilance as per WHO is defined as the science and activities relating to the detection, assessment, understanding and prevention of adverse effects or any other drug-related problem Pharmacovigilance is the study of adverse events taking into account all the plausible relationship or untoward medical occurrence which the patent experienced after taking the drug and then using standard set of coordinated activities which involves first collecting adverse event reports either via telephone, email, social network, lay press , media. After adverse event reports are filed we then process and assess these reports in database to determine if indee
3 comments
Read more

Artificial Intelligence Seeing through the lens of Pharmacovigilance

Pharmacovigilance as we know is a science with a set of pre defined functions to collect, analyse, monitor adverse event reports in understanding the safety profile of drug. The set pre defined functions would include case processing through data entry of adverse event forms into safety database, medical review, aggregate reporting, signal detection, risk evaluation and mitigation strategies. With patients awareness and regulatory compliance we may have seen a surge of adverse event data over last few years , resulting in the urgent need for the application of automation. Pharmacovigilance is the only discipline where in which timelines and quality data are evaluated on a benchmark of 100 % and a compromise in these two parameters are considered to be a zero tolerance. Automation of above pre defined function is possible through machine learning, which is an integral components of Artificial Intelligence. What is Artificial Intelligence ?        Artificial intellig
2 comments
Read more