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