Thursday 13 October 2016

Vank's disease: A compelling need to decrease Anti Tubercular (TB) drug resistance

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 says ‘Poor patients residing in rural areas faced the greatest difficulty in overcoming the barriers. They had to travel long distances every alternative day to reach a DOTS centre, had to put up with inconvenient timings’ and “unfavorable attitude” of the staff.

Lack of proximity to a DOTS center, inconvenient timings, and lack of patient awareness eventually leads to Multi-drug-resistant tuberculosis, specifically prominent in Patients from rural parts of country.

Multi-drug-resistant tuberculosis or Vank's disease is caused by bacteria that are resistant to treatment with at least two of the most powerful first-line anti-TB drugs.

Treatment to DOTS is now becoming difficult with increase in drug resistance, Pharmacovigilance plays a vital role in drug monitoring for Multi-drug-resistant anti-TB drugs. 

Drug resistance is caused when:

· Patients do not complete a full course of TB treatment

· Health care professional prescribe the wrong treatment (the wrong dose or length of time)

· Drugs for proper treatment are not available

· Drugs are of poor quality

· Further Drug-resistance is more common in people who

· Do not take their TB drugs regularly

· Do not take all of their TB drugs

· Develop TB disease again, after being treated for TB disease in the past

· Come from areas of the world where drug-resistant TB is common

· Have spent time with someone known to have drug-resistant TB disease

Apart from drug resistance patients also experience ADR from the DOTS drug regime ADRs could include hearing loss to dizziness, rashes, anorexia, abdominal pain, nausea, and vision loss. Immediate medical attention is required on a time-bound basis to stop the drug and control the reaction after which an alternate medication is prescribed.

Recently The Pharmacovigilance Programme of India (PvPI), which has identified the SDS TB Research Centre, Rajiv Gandhi Institute of Chest Diseases (RGICD) to monitor adverse drug reactions (ADRs), is now working to have a centre for research and training. The objective is to educate its nurses and doctors on early detection of ADR caused by TB and lung infection medications.


Joseph Mathew
Senior Manager- Pharmacovigilance
Cliniminds, Unit of Tenet Health Edutech Pvt. Ltd.
Mobile: +91 9971622264

Wednesday 12 October 2016

Think-i – offers end-to-end pharmacovigilance services

Think-i – offers end-to-end pharmacovigilance services – case processing, aggregate reports, RMP, signal detection, training, medical writing, clinical and non-clinical documents. For more information, please contact or +91 9810068241 for further discussion.

Why is E2B Validation important?

Date: 06Oct2016

Why is E2B Validation important?

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 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 E2B file in the regulatory database while doing the regulatory submission it will not accept the E2B file and prompt back with an error hence it is mandatory to always do an E2B validation.