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 Electro...

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 availabl...

There would be an increase in fees upto 1.7 % from April 1 st 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...

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 40 th Anniversary of UMC o...

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 ?     ...

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 ...

Proactive pharmacovigilance through  Social media data Adverse drug events (ADEs) are a significant cause of morbidity and mortality worldwide. Clinical drug trials have limited ability to detect all ADRs due to various reasons: small sample sizes, relatively short durations, lack of diversity among participants usually excludes specific conditions: kids, elderly, pregnant women, patients with co-morbidities. Pharmacovigilance practice has evolved and grown more complex over the past 5 to 10 years due to higher data volumes, evolving regulations, increased influence of emerging markets and the emergence of social media and innovative technological advances. Social media is a promising source for new safety data and potential emergent safety signals. Social media may be a method by which pharmacovigilance could be strengthened given that approximately 72% of internet users search for health information online. Social media have significantly expanded recently with Twitte...

FOR HEALTHY US The ever changing environment and day to day stress starting from the childhood for securing higher grades leading up to the never ending demands of the boss pushing for more. Everyone today is either already been affected by some or the other type of medical condition or is at the high risk of developing one.  The major sufferer is the health of an individual, which affects the individual’s quality of life and hampers the growth of the nation too. But thanks to the professionals involved in the health services that we are constantly able to manage our health and stay fit. Clinical Research plays an important role in offering us the solutions to our health challenges with safe drugs and devices.  Scientists conduct Clinical trials, a research study that tests how well an intervention works in a group of people. It tests for new methods of screening, prevention, diagnosis or therapy. Clinical trials are conducted in different phases, ADR Reporting ...

Multiple sclerosis (MS) is condition in which the immune system attacks myelin sheath, which may eventually damage the neurons and leave scar tissue, relapsing multiple sclerosis is a type of sclerosis in which there is flare up following remission, which means during the relapsing phase, the symptoms of MS will partially or completely go away.  daclizumab is a type of Interleukin 2 receptor (IL2R) antagonist which is used in the treatment of MS. (Interleukin is a type of Cytokine which binds with IL2R to generate immune responses, a type cell signalling)  daclizumab was administered as an injection under brand ZINBRYTA, which was first approved by FDA on 27 th May 2016, however recently the Pharmacovigilance Risk Assessment committee (PRAC), a part of European Medical Agency recommended restrictions on using daclizumab, due to safety issues associated with serious liver damage (as reported in a clinical trial where 1.7 % subjects developed serious liver reaction, a su...

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...

Pharmacovigilance is Booming with its market size expected to expand at a CAGR of 14.2% through 2020. In 2014 the market was at 2,75 Mn $ which is now expected to reach 6,10 Mn $ by 2020. It is believed that the growth is attributed to CAGR of 15.5% in Phase III clinical trials, further needless to say that 57% of global pharmaceutical companies outsource their projects to contract research organization.                Outsourcing trend of pharmaceutical companies has projected increase the market size of Pharmacovigilance , which in turn benefits the not only the vendor (by creating more job opportunities) , it also benefits the Pharmaceutical giants by increasing their capitalization by working on shorter turn-around time and also avoiding operational cost in Talent acquisition and Infrastructure for carrying drug safety operations. Reference:  https://goo.gl/h3vc8i

European Medical Agency would be releasing a new version of EudraVigilance system, which is expected to go live in November 2017, EMA in their report mentioned that they would be publishing a checklist of readiness for all the stakeholders to prepare them for the changes which will come along with the launch of the revised version of EudraVigilance, for which EMA also intends to provide eLearning modules, support webinars and face to face training. The prototype of EudraVigilance test environment or XCOMP is already scheduled to be released June 2017 which will let all the National competent authorities to test Individual case safety reports in E2B R3 versions. 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 more details, contact us at +91 ...

There have been talks about what would happen once UK leaves EU which has put lot of QPPV (Qualified Persons Responsible for Pharmacovigilance) in UK in dilemma as the regulations say that the QPPV should be a part of the EU, with the impact Brexit it will hit the pharmacovigilance system in UK as EU would not be obliged to carry out Post marketing surveillance in UK. Currently June Raine who is chairing the Pharmacovigilance Risk Assessment Committee ( part of the European Medical Agency, in which there are two members from each member state) is from the Medicines and healthcare products regulatory agency (MHRA) of the UK. There have been discussions about QPPV who still want to be a part of EU which might eventually lead to a negotiation between EMA and UK to collaborate pharmacovigilance activities together, as pharmacovigilance is above politics. By Joseph Mathew Sr. Manager- Think i About us: We are an organization providing technological solutions ...