In response to the demand for internationally harmonized detail of medicinal products, the IDMP which comprises of a set of five ISO norms provides the basis of identifying medicinal products. IDMP standard readily facilitates ICSR (Individual Case Safety Report) submission to regulatory agencies. The message specification in IDMP protects the integrity of medicinal product information when submitting cases to the regulatory agency. HL-7 transmissions are within the IDMP standards Health Level 7- is an international standard for facilitating data exchange between the safety/ clinical database and the regulatory agency. The five ISO norms comprise of ISO 11238 pertains to general characteristics of regulated medicinal products specifying where the product is an active pharmaceutical ingredient or an adjuvant. ISO 11238 also describes the grade of product used (purity, manufacturing information etc.…) ISO 11239 pertains to regulated information on packaging, dosage form, route ...

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 ?     ...

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 I...

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 ...

Case Study: A top pharmaceutical company was interested to develop a medicine for diabetes, and for which it wanted to asses and identify attractive patient segments. Approach: Secondary research was undertaken to understand current diabetes treatment guidelines and therapy landscape, to identify patient segments. Following this trial analysis was undertaken to identify upcoming trends and molecules in different patient segments of diabetes. The molecules and trends were further analyzed to ascertain their expected relevance on the diabetes landscape through clinical data and benchmark analysis. Key trends analyzed during the study were related to epidemiology, pricing, regulatory activities, and market access regulations across geographies. These findings were further validated through an intense primary research involving key opinion leaders, payers, physicians and regulatory bodies. The all inputs from primary and secondary research with collated together and analytical tool...

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...

In Pharmacovigilance -Case processing after completing the data entry process and before routing the case to the next workflow (Medical Review), it is mandatory for everyone to do a Validation check called as E2B validation, E2B validation error could also be an error associated with a special character in case study narrative or in adverse event, further if an error is reported on Validation check which cannot be rectified, a comment stating ‘E2B validation was noted and bypassed’ should be used contact log Every wondered why? Every ICSR (Individual case safety report) as per 21 CFR 314.80 in US and Schedule Y appendix XI in India, should be transmitted from the reporting sources to the regulatory authority and this process is also known as E2B submission (as we submitting E2B files) and because one of the mode of transmission is via XML format, if a special character found in the ICSR which is not rectified after the ICSR is converted into an XML file and upload as an...

Tuberculosis is an infectious and contagious disease caused by a bacteria called Mycobacterium tuberculosis. Tuberculosis primarily affects the lungs, symptoms include: chronic cough with blood in Phlegm, fever. Pharmacovigilance imparts a vital role in monitoring serious Adverse drug reactions (ADRs) in TB patients who are on treatment in national TB program. ADRs could lead to a tuberculosis (TB) patient interrupting treatment before completion, and can thus contribute to avoidable morbidity, drug-resistance, treatment failure, reduced quality of life, or death. Tuberculosis is completely curable using short term chemotherapy called DOTS or Directly Observed Treatment Short course. However, there are several challenges encountered by patient to get DOTS treatment in India. Some of the challenges include coping up with DOTS strategy. In a recent research paper published by (research, team name), it had a study which in which TB patients were interviewed, the paper ...

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...