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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 Nation…
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Three deaths reported due to contaminated Penicillin injection

The Ghana FDA department dispatched a Pharmacovigilance team to investigate the death of 3 patients caused due to contaminated Benzathine Penicillin injection. The preliminary investigations revealed that due to contaminated 0.9 normal saline solution which was used in reconstituting Penicillin powder for injection had led to fatality of the patients.
The primary cause of death was determined to be injection site abscess, other serious adverse drug reaction included were skin necrosis and ulcers. The reason for contamination was stated as the re use of normal saline solution for several days at the Health Centre in the Asuogyaman District. In the statement regarding Benzathine Penicillin, it has been clearly indicated that sterile water should be used for reconstitution.
The healthcare professionals have been asked to be more vigilant and report any untoward medical occurrence through submitting adverse event forms to the FDA or even by direct contact through the available hotline numb…

European Medical Agency to increase fees upto 1.7 %

There would be an increase in fees upto 1.7 % from April 1st 2018 as mentioned in the notification of Commission Regulation (EU) No 2018/471 (amending Council Regulation (EC) No 297/95), the fees however would be implemented for all activities carried out by the agency except pharmacovigilance.
Apart from Pharmacovigilance the agency has also exempted fees of Micro Small or Medium Sized Enterprise, Orphan Medicinal Products, Medicinal Products for Paediatric Use, Advanced Therapy Medicinal Products etc… Detailed information on has been provided on an explanatory note. The agency every year revises its fees as per the statistical data from EUROSTAT (European Union’s statistical office), the current revision is made in accordance with the inflation rate for 2017.
Reference: 1.Explanatory note on general fees payable to the European Medicines Agency http://www.ema.europa.eu/docs/en_GB/document_library/Other/2018/03/WC500246428.pdf 2.COMMISSION REGULATION (EU) 2018/471 of 21 March 2018 htt…

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…

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. Pharmacovigilanceis 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 intelligence may be called as …

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…

Policy Paper published by ICMRA on Big Data Analytics; Experts from EMA, Health Canada & MHRA to examine the opportunities and limitations of Big Data and Analytics in Pharmacovigilance.

The International Coalition of Medicines Regulatory Authorities’ (ICMRA) has released a policy paper which examines strengths and limitations of big data and analytics in pharmacovigilance. The working group of the ICMRA comprising of subject matter experts from European Medical Agency (EMA), Health Canada and Medicines and Healthcare Product Regulatory Agency (MHRA) had developed the policy paper with a list of initiatives pertaining to the implementation of big data analytics in pharmacovigilance.
‘Big Data’ is a sub group of ICMRA working group. One of key areas in exploring the opportunities with big data and analytics would be in the spontaneous reporting system (SRS) which currently contains limited structured / unstructured data. Data collected through voluntary reporting, often has its own challenges with limited information available about patient’s demographics, medical history, past drug history, concomitant therapies, onset date and time of adverse event and it becomes …