Introduction:
The widespread inappropriate use of
antibiotics is considered as one of the important causes of the development of
antibiotic resistance [1-4]. It is estimated that 20-50% of all antibiotics use is
inappropriate, resulting in an increased risk of side effects, higher costs and
higher rates of AMR in community pathogens [5]. Around 25 percent of ADRs are
caused by antimicrobial medicines. Antimicrobials
constitute about 20 to 40 percent of a hospital’s medicine budget and can lead
to significant, unnecessary health care costs if not carefully managed. A
crucial strategy to control antibiotic resistance is to reduce the excessive and
inappropriate use of antibiotics in practice. One such strategy involves the
detailed surveillance of antibiotic use in both hospitals as well as community
to guide and control antibiotic overuse and misuse.
However, the antibiotic usage
patterns and the problem of AMR has received relatively little recognition in
developing countries like India and the ability to undertake extensive
surveillance is lacking in resource-constrained settings [5].There is acute
paucity of literature on antibiotic utilization patterns in developing
countries like India where antibiotics can be obtained easily from private
retail pharmacies without prescriptions and pharmacists also advise and
dispense antibiotics to patients [6]. This tri-centric study is an attempt to
analyze the situation on ground vis-a-vis antibiotic prescribing and
utilization patterns in out-patient departments of government hospitals,
private clinics and community households with an aim of identifying the gaps,
barriers, prospects and challenges towards enhancing their rational use and
minimizing emergence of antibiotic resistance.
Novelty:
There is dearth of literature
published on DUE of anti-microbials from India as a whole. In the state of
J&K, barring a couple of hospital based DUE studies by Jan et al [1] and
Tandon et al [2], no community or hospital-based DUE studies have been conducted
at all. However newspaper reports suggest large scale use of medicines
including anti-microbials by the locals. Self-medication and over-the-counter
dispensing of prescription drugs by mostly unqualified retail pharmacists seem
to be rampant. There is acute paucity of literature about DUE studies from
J&K. Therefore there is need to conduct a study which can reveal the
picture of how anti-microbials are being prescribed, dispensed and used at
primary, secondary and tertiary care hospitals. Christian Medical College
(CMC), Vellore and Post Graduate Institute of Medical Education and Research
(PGIMER), Chandigarh have already been designated as nodal centres in the
ICMR’s antimicrobial surveillance programme launched in early 2014 to work on
antibiotic resistance and its mechanization for developing a policy to minimize
microbial resistance due to Gram +ve and Gram -ve bacteria. Through the
present study they will be able to scale up and further evaluate drug
utilization patterns in their affiliate hospitals and catchment areas and
substantiate the antimicrobial resistance data.
Applicability:
Aim of
this study is to determine the prescribing practices and utilization patterns
of antimicrobials in private retail pharmacy outlets and out-patient
departments at all the three levels of healthcare viz., primary, secondary and
tertiary care and assess rationality of treatment for Upper Respiratory Tract
Infections (URTI). This tri-centric study on antimicrobial utilization patterns
will evolve a holistic picture about the overall utilization patterns of
antimicrobials and identify gaps in literature, stumbling blocks in rational
prescribing and barriers in appropriate use of antibiotics. This study will
assess and document statutory frameworks required for equitable access and
rational use of antibiotics at state level and tertiary care level hospitals.
It will identify the problem areas vis-a-vis utilization of anti-microbials and
thereby help in devising suitable strategies for necessary interventions
required to enhance their rational use.
Methodology:
The study shall be conducted in
catchment areas and affiliated hospitals of three study centers namely
University of Kashmir, Srinagar, Christian Medical College (CMC), Vellore and
Post Graduate Institute of Medical Education and Research (PGIMER), Chandigarh.
Healthcare facilities at all the three level of care viz., primary, secondary
and tertiary care shall be selected on PPS (Probability proportional to size)
based approach alongside private pharmacy retail outlets.
Phase-I of the study shall include
drug utilization evaluation in ambulatory care of government hospitals and in
private retail pharmacy outlets. Data collection will make use of a
pre-validated, self-administered structured questionnaire. The study design
will be a cross sectional baseline study based on the methods contained in WHO
manual "How to investigate the use of medicines by consumers”[7] and WHO
methodology on Drug Utilization Research as outlined in WHO guide “Introduction
to drug utilization research”[8].
Objectives of the study are as
follows:
- To determine
the extent and nature of antibiotic use, including FDCs, in prescriptions at
retail dispensing pharmacist for community and OPD setting of primary,
secondary and tertiary care in J&K, Chandigarh and Vellore (TN).
- Evaluation of
prescriptions for rationality of the antibiotic use in URTIs with pharmacist
collecting additional patient data.
- To see the availability
and extent of adherence to standard treatment guidelines (STG) for URTIs.
- To determine
the proportion of cost of a prescription attributed to antimicrobials.
- Determine
availability of antibiotic policy in the tertiary care and district hospitals
and assess the level of adherence to the same.
- To correlate
the patterns of DDDs of antibiotics with antibiograms wherever available.
- To formulate effective
intervention strategies to address antimicrobial use related problems.
Selection
of districts, health facilities and community households:
Sampling of districts and health
facilities from within the states shall be done in a systematic manner in
accordance with PPS (probability proportional to size) approach so as to ensure
that the findings are representative of the entire state. Selection of
districts shall be done using economic and geographical criteria to capture
maximum diversity. Steps in selection of districts involve ranking of districts
on the bases of per capita Gross District Domestic Product (GDDP). Districts
with equal intervals shall be selected taking first, last and the state
capital. All levels of health facilities within India’s 3 tier public health
system will be sampled, i.e., medical colleges (MC) at tertiary care level,
district (DH) and sub-district hospitals (SDH) at secondary care level,
community health centres (CHCs) and primary health centres (PHCs) at primary
level. From each district one DH, 2 CHCs or SDHs (whichever are available) and
3 PHCs shall be randomly chosen for the study on the basis of capture diversity
and geographical distribution intact. One Medical College or tertiary care
hospital and one private hospital shall also be included from each study
centre. Additionally ten community household and ten private clinicians
practicing at a clinic willing to participate in the study would also be
included randomly from each district.
Training of Field Workers
Data collectors/field
workers/pharmacists would be trained over 1-2 days for collection of relevant
data and addressing issues of confidentiality. Specifically, necessary skills
would be imparted for the aspect of determination of rationality of
antimicrobials prescribed/used for upper respiratory tract infections. Wherever
possible algorithms will be made available for URTIs in order to help them
determine the need and rationale of antimicrobials.
Data collection:
Trained data collectors (pharmacy
practitioners or clinical pharmacologists) shall collect antibiotic use data by
conducting exiting interviews with all patients receiving an antibiotic on
leaving the medical facility. The patients will be interviewed at the attending
pharmacy after they fill their prescription without the knowledge of
prescribing physicians. This would avoid any bias on part of the prescribing
physicians regarding their prescribing habits in relation to anti-microbials.
However in hospitals where all prescriptions are filled within hospital
premises and only negligible or none of the prescriptions go to retailers for
dispensing, prescriptions will be audited within OPDs adjacent to consultation
chambers of the prescribers. A pre-designed proforma shall be used to collect
data regarding the diagnosis, name of the prescribed antibiotic/s, dose, dosage
form, duration of treatment, number of units of antibiotic dispensed or
purchased etc. The prescriptions will also be analyzed for various WHO drug use
indicators. All the data collected shall be entered either into MS-Excel
spreadsheets or any other suitable software that can also be used to process,
code, clean and analyze the data.
Prescription audit:
In order
to study prescription practices of anti-infectives in public health facilities,
a prescription audit will also be undertaken at the healthcare facilities. Data
from a random sample of prescription slips will be captured on the days of the
facility visit as per WHO recommendation of 600 encounters (20 facilities and
30 patients/prescriptions per facility) for each survey. Prior consent of the
respective medical heads of the facilities shall be sought as well as oral
consent of the patients. Analysis of prescription slips would contribute to
understanding the level and patterns of prescribing of anti-microbials.
Consumption of antimicrobial drugs would be determined in terms of total number
of DDDs using the WHO ATC/DDD system [13]. The Anatomical Therapeutic Chemical
(ATC) classification and the Defined Daily Dose (DDD), ATC/DDD measurement
units shall be assigned to the data.
Assessing rational use of
Anti-microbials:
The rationality behind antibiotic
use would be assessed by collecting information on availability of a hospital
Essential Medicines list or formulary system; existence of a hospital drugs and
therapeutics committee and infection control committee; availability, updation
and dissemination of any standard treatment guidelines (STGs) related to the
use of antibiotics in the hospital; whether doctors consult STGs available;
availability of suitable diagnostic methods for diagnosing infectious diseases;
magnitude of patient load in the hospital (high patient load can decrease
consultation time resulting in erratic diagnosis and treatment); percentage of
patients sent for microbial lab investigations; percentage of patients to whom
antibiotics are prescribed empirically and reasons for empirical treatment.
Reasons for non-adherence to STGs and recommendations on improving antibiotic
use shall be sought from prescribing doctors. A suitable questionnaire would
obtain relevant information from the prescribers.
Workshop for dissemination of
results and devising intervention strategies
At the end of first year, workshop
for dissemination of results to the practitioners involved in providing the
information will be undertaken for creating awareness among stakeholders and
devising suitable interventional strategies in consultation with all
stakeholders towards ensuring rational use of antimicrobials that in turn shall
be implemented during second phase of the study.
Feasibility:
Two of the study centres namely
PGIMER, Chandigarh and CMC, Vellore are already part of a national study on
estimation of Drug Resistance Index of antimicrobials. This study would scale
up the national programme further and supplement data obtained on drug
resistance surveillance programme. Furthermore, the health sector in Jammu and
Kashmir is unique Indian state beset by many challenges. A combination of weak
institutional capacity, limited access to modern equipment and infrastructure,
and shortage of healthcare personnel has limited the effectiveness of health
service delivery in the State. The healthcare system in J&K is primarily
run by the state government.
The private sector plays a smaller part in health service delivery. The
non-governmental sector is largely absent.We don’t have qualified and trained
pharmacy graduates working as pharmacists either in government or in private
sector. In government hospitals Medical Assistants with one year multi-purpose
health worker type diploma in their hands are employed as pharmacists whereas in
private sector matriculates with some experience in sale of medicines at a
retail counter have been registered as pharmacists and granted drug sale
licenses. Consequently patients are deprived of good counseling services on the
use of medicines. On top of that patients largely prefer to consult these very
Medical Assistants or so-called pharmacists over registered medical
practitioners for choosing medicines and curing their ailments. However the
reasons for and consequences of such a drug utilization pattern have not been
documented anywhere in the literature.
Outcome:
This study shall be able to
generate baseline data on the nature, magnitude and extent of antibiotic
prescribing, choice of the antibiotics, their dosage, frequency, duration,
cost, disease conditions for which they have been prescribed, availability of
Standard Treatment Guidelines, any deviations from the standard treatment
guidelines etc across three study centres, one each in Srinagar (J&K),
Chandigarh and Vellore (TN). This study will explore various policy options in
accordance with the findings. Governments at the central and state level,
hospital administrators, policy makers and ministries of health can use the
research data for devising policies and strategies for enhancing rational use
of antibiotics and for curbing the menace of antimicrobial resistance that is
seriously limiting their effectiveness and use. In the second phase of the
study interventions devised after due consultation with all stakeholders shall
be implemented and their effectiveness evaluated for their subsequent
translation into policy and practice.
References:
1. Jan A et al.
Drug Utilization At SKIMS–A Tertiary Care Hospital.JK- Practitioner 2013;18(1-2):35-40.
2. Tandon R et
al. Antihypertensive drug prescription patterns, rationality, and adherence to
Joint National Committee-7 hypertension treatment guidelines among Indian
postmenopausal women. J Midlife Health. 2014; 5(2): 78–83.
3. Chetley A,
Hardon A, Hodgkin A, Haaland A, Fresle D. How to investigate the use of
medicines by consumers.(WHO/PSM/PAR/2007.2) Geneva: World Health Organization,
2007.
4. WHO.
Introduction to drug utilization research/WHO International Working Group for
Drug Statistics Methodology, WHO Collaborating Centre for Drug Statistics
Methodology, WHO Collaborating Centre for Drug Utilization Research and
Clinical Pharmacological Services 2003.
5. WHO (2002).
Promoting rational use of medicines: core components. WHO Policy Perspectives
on Medicines, No.5. Geneva, World Health Organization.
6. Potter M.
Medication compliance - a factor in the drug wastage problem. Nurs times. 1981;
77 (suppl 5):17-20.
7. Nasser AN.
Prescribing patterns in primary health care in Saudi Arabia. DICP. 1991;
25:90-93.
8. Serradell J, Bjornson DC
&Hartzema AG. Drug Utilization Study Methodologies: National and
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