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.
















Comments

Popular posts from this blog

Eritrea ranked top by UMC- WHO in ADR reporting

Eritrea an African country located in the north east region on the red coast sea bordering Ethiopia and Sudan, has been reported as the top country in reporting adverse drug reaction through safety reports submitted to global database by the Uppsala Monitoring Centre (Sweden), the collaborating centre for WHO as part of their international drug monitoring programme.
The Pharmacovigilance programme of Eritrea was carried out at maturity LEVEL THREE as per UMC with the assistance of local strength engaged in providing harmonization. Eritrea has identified 11 safety concerns on their medicinal products, which were also published in international peer reviewed journals. The Eritrean work on Pharmacovigilance has been globally acknowledged with insights on revising the policy of Eritrean Healthcare system.
Recognizing the significant contribution made in pharmacovigilance,Eritrea along with Netherlands and Peru has been invited for the upcoming 40th Anniversary of UMC on May 18 to share the…

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 adverse event. 
For mor…

What is a ‘backward forward convertor’ ?

Did you know that ICH has a backward forward conversion (BFC) tool which was build using eXtensible Stylesheet Language Transformation (XSLTs) ? This language basically transforms a XML file of a given format into another XML file of a different format. The BFC tool requires a program that understands XSLT language to make conversion of E2B (R2) to E2B (R3) and vice versa. Now considering this, the European medical agency has improvised the BFC tool with additional fields as per the EU implementation guide. The EU version of the amended BFC tool has been published on the EMA website.
The key files in the BFC package includes downgrade-icsr.xsl; which downgrades E2B (R3) file into E2B (R2) and upgrade-icsr.xsl; which upgrades E2B (R2) file into an E2B (R3) file. The acknowledgement convertors include downgrade-ack.xsl and upgrade-ack.xsl What are the technical limitations of BFC tools?
However, the conversion using BFC has some major limitations.
When converting ICSR from E2B (R2) i…