INTRODUCTION

There is a negative effect linked to every medication currently in use. One definition of an
adverse medication reaction is a noticeably unpleasant or dangerous side effect.
Reaction that happens as a result of a medication-related intervention and that indicates a risk
associated with continued usage and calls for prevention, targeted therapy, changing the
dosage, or stopping the product altogether. (1)
One of the main causes of morbidity and death is adverse drug reactions (ADRs), which
constitute a significant public health concern. (2)
A projected active pharmacovigilance initiative called FORWARD has been carried out in
Sicily since 2014. Its goal is to enhance ADRs surveillance in hospital wards. This study was
conducted as a component of the FORWARD initiative with the goal of describing ADRs
that happened in internal medicine wards during hospital stays. ADRs associated with
hospital admissions, as well as their traits and avoidability, were assessed. (2)

ADVERSE DRUG REACTION

An unpleasant, unintentional damage resulting from drug-related causes is called an adverse

drug reaction (ADR). (2)
Additional definition of ADR: "an intervention related to the use of a medicinal product that
results in an appreciably harmful or unpleasant reaction" which forecasts potential risks from
further administration and orders against prevention, particular treatment, changing the
dosage, or stopping the substance (3). ADR detection has grown in importance as a result of
the introduction of numerous strong hazardous substances as medications throughout the last
two or thirty years. Monitoring the recognized as well as unknown side effects of medications
became vital. (3)

ADR reporting initiatives support ADR reporting, enhance ADR surveillance, and advance
health professionals' knowledge of potential ADRs. (4)

An effective hospital-based reporting scheme can play a crucial role in offering important
insights into possible drug use issues within an organization. These initiatives identify and fix
issues, which leads to ongoing improvements in patient care. (4)
ADR REPORTING AND PHARMACOVIGILANCE

The World Health Organization defines pharmacovigilance as the science and activities relating to the
detection, assessment, understanding and prevention of adverse effects or any other possible drug
related problems (5)

Pharmacovigilance, the scientific study of medication safety, is one area in which

pharmacists are highly influential in the realm of medicinal pharmaceuticals. (6)

International Drug Monitoring Program of the World Health Organization is coordinated

from Geneva by the Quality Assurance and The Department of Essential Drugs and
Medicines Policy's Safety of Medicines Team (6)
A nationwide Pharmacovigilance Program of India (PvPI) is being run by the Central Drugs
Standard Control Organization (CDSCO), Directorate General of Health Services, under the
auspices of the Ministry of Health and Family Welfare, Government of India, in partnership
with the Indian Pharmacopeia Commission (IPC), Ghaziabad, to safeguard patient health
through ensuring drug safety. As a National Coordinating Center (NCC), the IPC oversees
the program. (7)
The goal of PvPI is to protect the health of the Indian populace by making sure that the
advantages of using pharmaceuticals exceed the hazards. The goal of PvPI is to decrease the
risk related to medication use by improving patient safety. (7)
Early ADR detection, risk factor identification, and comprehension of the mechanisms
underlying the ADR are all made possible with the aid of pharmacovigilance. (7)

The Government of India's Ministry of Health and Family Welfare introduced PvPI in 2010
with the goal of monitoring drug safety and lowering the risk that comes with using
medications among the populace of India. (8)
ADR Monitoring Centers (AMCs) have been put up throughout India to track ADRs and
report them to the NCC. These AMCs include medical colleges and hospitals,
medical/central/autonomous institutes, and public health
initiatives as well as corporate medical facilities. Qualified pharmacy degree holders, dentists,
and other professionals are assigned to each of these centers as Technical Associates (TAs).
(8)
TUBERCULOSIS
One of the biggest causes of sickness and death in the world's health is still tuberculosis (TB).
Mycobacterium tuberculosis (M. tuberculosis) is known to infect one in three people
worldwide, or 2.3 billion people, of whom 5–15% are expected to experience active TB
disease at some point in their lives. (9)
People who have pulmonary or laryngeal tuberculosis cough, sneeze, shout, or sing, releasing
droplet nuclei into the air that can infect others. Inhaling these droplet nuclei causes
transmission, which then proceeds through the upper respiratory tract, bronchi, mouth or
nasal cavities, and lung alveoli. (9)

PATHOGENESIS

Alveolar macrophages consume the tubercle bacilli when they enter the alveoli, which causes
the inhaled tubercle bacilli to be destroyed and inhibited. (10) Within macrophages, the small
unaffected proportion multiplies. Released tubercle bacilli can travel through lymphatic or
blood vessels to affect any region of the body, including the organs, tissues, and spine. Other
areas that are particularly vulnerable to tubercle bacilli infection include the kidney, larynx,
lymph nodes, spine, and lungs. The bulk of the tubercle bacilli can be encapsulated or
destroyed by white blood cells when an immunological response is triggered, which occurs in
roughly two to eight weeks. The tubercle bacilli are encapsulated by the white blood cells,
creating a barrier that surrounds them and forms a granuloma. The tubercle bacilli are
considered to be under control once they are inside the barrier shell. resulting in the
establishment of latent tuberculosis infection (LTBI). At this point, a person does not exhibit
any TB-related symptoms, is not spreading the infection, and is not regarded as a case of TB.
On the other hand, LTBI can develop into a case of tuberculosis (TB) if the immune system is
unable to suppress the tubercle bacilli and they multiply quickly. Patients with tuberculosis
are highly contagious and can infect others with the bacteria. (10)
DOTS REGIMEN

The RNTCP recommends Directly Observed Treatment Short Course (DOTS) chemotherapy
as the treatment for tuberculosis. This internationally accepted technique ensures cure by
prescribing the most effective medication and ensuring its use. (11)
The most successful way to encourage treatment adherence is to use DOT, which involves
seeing the patient swallow each prescribed dose at the appropriate times and amounts. This
not only provides each TB patient the best chance of recovery but also prevents the
development of drug resistance [11].

To ensure that patients are taking all of the recommended medications under DOT under this
new regimen, the entire course of treatment should be administered. This means that for the
full six months of treatment, patients should be monitored by TB Treatment Supporters (TTS)
while taking their medications on a daily basis. This is in contrast to the previous regimen,
which only monitored TB patients during the intensive phase of their treatment during the
first two months. This approach has not been tried before and may have some unintended
consequences because it may be challenging to monitor every TB patient while they are
taking their medications every day for the entirety of their treatment.
Thus, the purpose of this study was to investigate how patients and healthcare professionals
(HCPs) experienced using DOT during the entire course of tuberculosis therapy at a few
Addis public health institutions. (12)

Under the Revised National Tuberculosis Control Programme (RNTCP) in India, patients
with tuberculosis (TB) are treated with Directly Observed Treatment Short-course (DOTS)
regimens. The DOTS center is recommended for antituberculosis therapy (ATT), which
includes isoniazid (H), rifampicin (R), pyrazinamide (Z), and ethambutol (E). Pulmonary
tuberculosis treatment consists of a six-month course of treatment divided into two phases:
the 56-day Intensive Phase (IP) and the 112-day Continuous Phase (CP). Extrapulmonary TB,
including miliary TB, bone or joint TB, and tubercular meningitis, also has a 6-month
treatment plan, and can last up to 9–10 months, depending on the diagnosis. (13)

Intensive Phase (IP):

In a normal adult, the dose of HRZE is given daily in fixed-dose combination according to the
bodyweight of the patient for 56 days.
TABLE- INTENSIVE PHASE DRUGS

Weight category Number of tablets (in FDC)

HRZE (75/150/400/275 mg)
25-39 kg 2
40-54 kg 3
55-69 kg 4
>=70 kg 5

Table- continuous phase drugs

Weight category Number of tablets (in FDC)

HRE (75/150/400/275 mg)
25-39 kg 2
40-54 kg 3
55-69 kg 4
>=70 kg 5

LITERATURE REVIEW
• Gashaw workalemahu et al., (2021), studied and evaluated adverse drug reactions associated with
chemotherapy and related factors in hospitalized paediatric cancer patients in Ethiopia’s north-west
hospitals. Adverse drug reactions were developed in a significant proportion of the study patients (2
out of 5 patients). Therefore, for paediatric cancer patients on concomitant medications and for
patients on etoposide, mercaptopurine and doxorubicin drug regimens, efficient prevention and
management of adverse drug reactions was sighted (14)

• Muhammad Abdul Hadi et al., (2017), highlighted the role of pharmacists in pharmacovigilance and
identified barriers and facilitators toward ADR reporting document in the literature. The perspective
of pharmacy students on pharmacovigilance and ADR reporting was discussed with an aim to
highlight the need to improve content related to ADR reporting and pharmacovigilance in
undergraduate pharmacy curriculum. (15)