Drug utilization evaluation of anti-microbials in ambulatory care and community households - a multicentric study

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:

1. 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).
2. Evaluation of prescriptions for rationality of the antibiotic use in URTIs with pharmacist collecting additional patient data.
3. To see the availability and extent of adherence to standard treatment guidelines (STG) for URTIs.
4. To determine the proportion of cost of a prescription attributed to antimicrobials.
5. Determine availability of antibiotic policy in the tertiary care and district hospitals and assess the level of adherence to the same.
6. To correlate the patterns of DDDs of antibiotics with antibiograms wherever available.
7. 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 International Perspectives. Drug Intelligence and Clinical Pharmacy. 1987; 21(12, December):994-1001.