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Project work Submitted to
Submitted by
M.ARUMUGAVIGNESH (381610805)
P.JESSICA (381610809)
S.R.NANDHINI (381610814)
J.SOFFIA MARY (381610825) V-Pharm.D
Under the Guidance & Supervision of
Dr. J. JEYAANANTHI, M.Pharm., Ph.D.
Professor, Department of Pharmaceutics.
Arulmigu Kalasalingam College of Pharmacy,
Krishnankoil – 626126, Tamil Nadu.
A PROSPECTIVE STUDY OF DRUG UTILIZATION PATTERN AND
EVALUATION USING
WHO GUIDELINES AND PRESCRIBING INDICATORS IN A GOVERNMENT
HEADQUARTERS HOSPITAL
INTRODUCTION
 Drug utilization study is described by World Health Organization (WHO) as the
marketing, distribution, prescription, and use of drugs in a society, with special
emphasis on the medical, social and economic consequences.
 The main aim of drug utilization study in patients is to provide rational use of
medicines among public populations. Drug Use evaluation is defined as the
authorized structured, ongoing review of physician prescribing, pharmacist
dispensing and patient use of medication. Drug Use evaluation is ongoing,
systematic process designed to maintain the appropriate and effective use of drugs.
Prescribing too much of drugs can result in polypharmacy issue, drug-drug
interactions and adverse drug events.
 Hence our study aims to evaluate various issues using WHO prescribing indicators.
These prescribing indicators are used to measure the performance of healthcare
providers in several key dimensions related to appropriate use of drugs. Drug
Utilization Review programs differ from drug utilization studies, which are time-
limited investigations that measure drug use, but do not necessarily assess
appropriateness or attempt to change practice.
The pioneers of this research understood that a correct interpretation of data on drug
utilization requires investigations at the patient level. It became clear that we need to
know the answers to the following questions:
• Why drugs are prescribed?
• Who the prescribers are?
• For whom the prescribers prescribe?
• Whether patients take their medicines correctly or not?
• What are the benefits and risks of the drugs?
Together, drug utilization research and may provide insights into the following aspects of
drug use and drug prescribing. pharmacoepidemiology
• Pattern of use: This covers the extent and profiles of drug use and the trends in drug
use and costs over time.
• Quality of use: This is determined using audits to compare actual use to national
prescription guidelines or local drug formularies. Indices of quality of drug use may
include the choice of drug (compliance with recommended assortment), drug cost
(compliance with budgetary recommendations), drug dosage (awareness of inter-
individual variations in dose requirements and age-dependence), awareness of drug
interactions and adverse drug reactions, and the proportion of patients who are aware of
or unaware of the costs and benefits of the treatment.
• Determinants of use: These include user characteristics (e.g. sociodemographic
parameters and attitudes towards drugs), prescriber characteristics (e.g. speciality,
education and factors influencing therapeutic decisions) and drug characteristics (e.g.
therapeutic properties and affordability).
• Outcomes of use: These are the health outcomes (i.e. the benefits and adverse effects)
and the economic consequences.
TYPES OF DRUG UTILIZATION STUDIES
Drug utilization studies can be targeted towards any of the following links in the drug-use
chain:
 The systems and structures surrounding drug use (e.g. how drugs are ordered, delivered and
administered in a hospital or health care facility);
 The processes of drug use (e.g. what drugs are used and how they are used and does their
use comply with the relevant criteria, guidelines or restrictions);
 The outcomes of drug use (e.g. efficacy, adverse drug reactions and the use of resources
such as drugs, laboratory tests, hospital beds or procedures).
1. Cross-sectional studies
Cross-sectional data provide a «snapshot» of drug use at a particular time (e.g. over a
year, a month or a day). Such studies might be used for making comparisons with similar data
collected over the same period in a different country, health facility or ward, and could be
drug-, problem-, indication, prescriber- or patient-based. Alternatively, a cross-sectional study
can be carried out before and after an educational or other intervention. Studies can simply
measure drug use, or can be criterion-based to assess drug use in relation to guidelines or
restrictions.
2. Longitudinal studies
Public health authorities are often interested in trends in drug use, and longitudinal data
are required for this purpose. Drug-based longitudinal data can be on total drug use as
obtained through a claims database, or the data may be based on a statistically valid
sample of pharmacies or medical practices. Longitudinal data are often obtained from
repeated cross-sectional surveys (example, IMS (Intercontinental Medical Statistics)
practice-based data are of this type). Data collection is continuous, but the practitioners
surveyed, and therefore the patients, are continually changing. Such data give
information about overall trends, but not about prescribing trends for individual
practitioners or practices.
3. Continuous longitudinal studies
In some cases continuous longitudinal data at the individual practitioner and patient
level can be obtained. Claims databases are often able to follow individual patients using
a unique (but anonymous) identifier. These data can provide information about
concordance with treatment based on the period between prescriptions, co prescribing,
duration of treatment, Prescribed Daily Doses and soon. As electronic prescribing
becomes more common, databases are being developed to provide continuous
longitudinal data comprising full medical and prescribing information at the individual
patient level. Such databases are very powerful, and can address a range of issues
including reasons for changes in therapy, adverse effects and health outcomes.
PRESCRIBING INDICATORS AS DEFINED BY WORLD HEALTH
ORGANISATION
Prescribing indicators are recommended by the WHO in order to enhance the
quality of performance in prescribing medicines as appropriate to individuals need.
It has not been an empirical determination but with purposed significance in various
clinical conditions in different settings. In particular, indicators such as drugs per
prescription, drugs in generics, injectables and antibiotics usage might be
influencing various other clinical parameters. Yet this study has to expanded in
different dimension to enhance the rational use of medications
• Average number of drugs per prescription
This indicator measures the degree of polypharmacy. Polypharmacy is a
deviation to rational prescribing. In this study combination drugs are counted as single
count. Polypharmacy is concurrent use of multiple medications in a single prescription
of a patient. Generally Polypharmacy denotes use of five or more medications taken
daily by a patient.
Polypharmacy issue increases with increase in age of the patient. Polypharmacy is
often associated with a decreased quality of life, including decreased mobility and
cognition. Patient’s adherence to the therapy can be improved by avoiding
polypharmacy and prescribing less number of drugs. The average number of drugs
per prescription can be calculated by dividing (total number of drugs prescribed in
‘n’ prescriptions) by (total number of prescriptions sampled, ‘n’).
• Average number of antibiotics per prescription
Inappropriate use of antibiotics is a global public health challenge and has
been associated with antibiotic resistance. The assessment of this indicator helps to
avoid irrational use of antibiotics and to promote rational use of antibiotics.
Antibiotics should not be prescribed empirically. It should be prescribed after
obtaining the report of culture and sensitivity tests. The average number of
antibiotics per prescription can be calculated by dividing total number of antibiotics
prescribed by total number of prescriptions sampled.
• Percentage of drugs prescribed in generic name
Percentage of drugs prescribed by generic name is calculated to measure the
tendency of prescribing by generic name. It was calculated by dividing the number
of drugs prescribed by generic name by total number of drugs prescribed,
multiplied by 100. Generic medicines cost less when compared to medicines in
brand name. When drugs are prescribed in generic name, it promotes the cost
effective treatment.
• Percentage of drugs prescribed as injections
The purpose of this indicator is to measure the overall level of use of two
important dosage forms, (oral drugs and injections). Injections are often overused
and are expensive form of drug therapy. Decreasing the injectables and early
switch over to oral preparations will significantly reduce both the drug and non-
drug cost (cost of injection, surgical items and hospital & nursing charges). It was
calculated by dividing the number of drugs prescribed as injections by total number
of drugs prescribed, multiplied by 100.
PATIENT CARE INDICATORS AS DEFINED BY WORLD HEALTH
ORGANISATION
Patient care indicators are average consultation time, average dispensing time, the
percentage of medicines actually dispensed, the percentage of medicines adequately
labeled and patient’s knowledge of correct dosage.
1. Average consultation time was calculated by dividing the total time for a series of
consultations to the number of consultations.
2. Average dispensing time was calculated by dividing the total time for dispensing
medicines to a series of patients by the number of encounters.
3. Percentage of medicines actually dispensed was calculated by dividing the number
of medicines actually dispensed at the health care facility to the total number of
medicines prescribed and multiplied by 100.
4. Percentage of medicines adequately labeled was calculated by dividing the number
of medicine packages containing at least the medicine name, the strength and the
frequency and length of time/day the medicine should be taken to the total number of
medicine packages dispensed and multiplied by 100.
5. Patient’s knowledge of correct dosage was calculated by dividing the number of
patients who adequately reported the dosage schedules for all medicines to the total
number of patients interviewed and multiplied by 100.
HEALTH FACILITY INDICATORS AS DEFINED BY WORLD
HEALTH ORGANISATION
Facility indicators are availability of essential medicines (ELM), formulary
availability, standard treatment guideline availability (STG) and key medicines
availability. ELM or Formulary or STG availability was determined during the time of
the visit. Key medicines availability was calculated by dividing the number of
specified products actually in stock to the total number of medicines on the checklist
and multiplied by 100.
COMPLEMENTARY INDICATORS AS DEFINED BY WORLD
HEALTH ORGANISATION
This includes average medicine cost per encounter and percentage of prescriptions
in accordance with clinical guidelines.
APPLICATIONS OF DRUG UTILIZATION STUDY TO THE FIELD
OF PHARMACOEPIDEMIOLOGY
Drug utilization study is a field of pharmacoepidemiology.
Pharmacoepidemiological is described as the study to estimate the utilization
pattern and effect of drugs in any clinical populations and to understand the various
therapeutic outcomes like adverse drug reactions, drug effects like drug-drug
interactions, medication adherence. It is the study of drug oriented safety and its
effectiveness.
Rationalization is the approach of deprescribing inappropriate medications and
prescribing the most appropriate correct medication appropriate for the relevant
pathologic conditions as per the need of an individual. The following are some of
its applications,
• It can be used to estimate the numbers of patients exposed to specified drugs within
a given time period. Such estimates may either refer to all drug users, regardless of
when they started to use the drug (prevalence), or focus on patients who started to
use the drug within the selected period (incidence).
• It can describe the extent of use at a certain moment and/or in a certain area (e.g. in a
country, region, community or hospital).
• Researchers can estimate (e.g. on the basis of epidemiological data on a disease) to
what extent drugs are properly used, overused or underused.
• It can be used to compare the observed patterns of drug use for the treatment of a
certain disease with current recommendations or guidelines.
LITERATURE REVIEW
• Drug utilization pattern in South Indian pediatric population
Thiruthopu NS et al., (2014) - Patients who attended the pediatric unit with the age
newborn to 18 years were included in the study and patients who were not willing
to participate in the study were excluded and the data collected from the pediatric
unit were analyzed. Out of 209 patients, the average number of drugs per patient
was 4.56. Among 209 prescriptions 49.78% of the drugs were essential drugs.
Among the antibiotics 33.33% prescribed, cephalosporin group were the most
commonly prescribed followed by amino glycoside and penicillin.
• Prescribing pattern of analgesics in orthopedic in-patients at tertiary care
hospital in Northeast India
Choudhury DK et al., (2016) - The study was aimed to evaluate the prescribing pattern
of analgesics and analyze the rational use of analgesic in the orthopedic in-patient
department of tertiary care teaching hospital. Out of 200 patients’ case sheets
collected, 123 were male and 77 were female. The average number of analgesic per
prescription was found to be 1.46. In this study, 55.5% of patients had received
single analgesic. Diclofenac was the most commonly prescribed analgesic
(43.49%).
• Evaluation of polypharmacy and appropriateness of prescription
K. B. Rakesh, et al., (2016) - They conducted a study evaluation of polypharmacy and
appropriateness of prescription in geriatric patients: A cross-sectional study at a
tertiary care hospital. The study design is a cross sectional analysis which included
patients above 60 years of age. A total of 426 patients, 216 (50.7%) were males and
210 (49.3%) were females. Polypharmacy was present in 282 prescriptions
(66.2%). Highest prevalence of polypharmacy was seen in 70-79 years age group
compared to the other two groups and it was statistically significant. Out of 426
patients, 36 patients were receiving drugs which were to be avoided as per Beers
criteria. Around 66.19% patients were receiving polypharmacy.
• Assessment of drug use pattern
Shrestha B et al., (2018) - This was a prospective cross-sectional study carried out in
order to determine current prescribing trends at Kathmandu Medical College
Teaching Hospital. A total of 605 prescriptions were collected and analyzed in the
study. The average number of drugs per prescription was 5.85 . Furthermore,
assuming each prescription as an individual patient, 64.1% of patients received
antibiotics, and 71% of patients received injectable form of drugs. Among
antibiotics the most common antibiotics prescribed were Ceftriaxone,
Amoxicillin/Cloxacillin, Azithromycin, Cefixime, and Cloxacillin. The study
indicated the issue of polypharmacy and prescription writing using brand names.
They stressed the need to write prescriptions in generic name. They concluded that
there is a crucial need for the development of prescribing guidelines when it comes
to antibiotics.
AIM AND OBJECTIVES
AIM
• The main aim of this study was to evaluate the patterns of drug
prescribing using WHO core drug use and complementary indicators.
OBJECTIVES
• To promote rational use of drugs and antibiotics in various walks of
medical field.
• To avoid polypharmacy issue and hence enhance patients’
medication compliance
• To prevent the incidence of antibiotic resistance by encouraging
rational use of antibiotics.
• To rule out the prevalence of various diseases in several inpatient
departments of concern hospital.
• To estimate diseases versus antibiotic usage in various inpatient
departments of the concern hospital.
MATERIALS AND METHODOLOGY
• Prospective observational longitudinal
study .
• Sample size – 282.
• Study period – 6 months.
STUDY DESIGN
• Virudhunagar Government Headquarters
Hospital which is now upgraded into Medical
college and Teaching Hospital.
STUDY SITE
• Male and female inpatients irrespective of age at
various wards were included
• Pregnant women, unconscious patients, patients
who denied to participate were excluded.
INCLUSION AND
EXCLUSION
CRITERIA
Data collection
The data collected from the case sheets includes age, gender and economic status
of the patients, provisional diagnosis, final diagnosis, various laboratory parameters
like, serum creatinine, urea, and hemoglobin levels, dose, dosage and frequency of
prescribed drugs etc. These data were collected during regular ward round which
was conducted twice in a week. The samples were collected by systematic random
sampling method. Separate form was used for data collecting purpose.
• Prescribing indicators measurement
The WHO prescribing indicators like average number of drugs per prescription,
average number of antibiotics per prescription, percentage of drugs prescribed in
generic name were pre tested. The tests were done using the formulas given by
WHO in their prescription indicators manual.
• Patient care indicators measurement
Patient care indicators include average consultation time, average dispensing
time, percentage of drugs actually dispensed, patients’ knowledge about correct
dosage. Among these tests, average consultation time of physicians in the inpatient
setting was measured. The consultation time was divided into three categories as
follows; less than 5 minutes, 5-10 minutes, above 10 minutes. Longer consultation
time has been linked to better heath care outcomes.
• Health facility indicators measurement
It is the measurement of availability of key drugs in a hospital. The key drugs as
were oral rehydration salts, cotrimaxazole tablets, procaine penicillin injection,
pediatric paracetamol tablets, chloroquine tablets, ferrous sulfate + folic acid
tablets, mebendazole tablets, tetracycline eye ointment, iodine, gentian violet or
local alternative, benzoic acid + salicylic acid ointment, paracetamol tablets for
adults, retinol. Total number of the above mentioned key drugs was found to be 12.
These key drugs were selected according to the WHO’s model list of key drugs for
testing drug availability. We checked the availability of the above drugs in the
hospital.
• Complementary indicators measurement
It is the measurement of cost per prescription encounter. As Government hospital
provides treatment at free cost, this criteria was excluded from the study.
Data analysis
All the sources of data were collected from inpatients’ case sheets of the health
care hospital and were segregated. Then the data were analyzed using Microsoft
Excel 2007. The observed values of indicators are reported as means and
proportions. 282 prescriptions in 282 case sheets were analyzed.
RESULTS
1. Totally 282 inpatients were enrolled in this study. Socio demographic details like
age and gender were collected. Fifty patients were from 46-55 years of age. Male
patients outnumber women patients in this study. Out of 282 patients, 163 were
males and 119 were females. These details are mentioned in table 1 and in figures
1&2.
Table No: 1 Demographic details of study population
CHARACTERISTICS FREQUENCY (N) PERCENTAGE
AGE
Below five years 19 6.73%
6-15 years 30 10.63%
16 – 25 years 30 10.63%
26-35 years 35 12.41%
36-45 years 45 15.95%
46-55 years 50 17.73%
56-65 years 40 14.18%
66-75 years 28 9.92%
Above 75 years 5 1.82%
Total 282
GENDER
Male 163 57.8%
Female 119 42.2%
Total 282
19
30 30
35
45
50
40
28
5
0
10
20
30
40
50
60
Below 5
years
6-15
years
16-25
years
26-35
years
36-45
years
46-55
years
56-65
years
66-75
years
Above
75
years
Figure.1 Age wise distribution of study population
58%
42%
Male
Female
Figure.2 Percentage of Males and Females in study population
2. Eleven different antibiotics were found in 282 prescriptions. Cefotaxime; a third
generation cephalosporin was found in 118 prescriptions followed by ampicillin in
47 prescriptions. Ceftriaxone is also a third generation antibiotic and it was found in
31 prescriptions. Ciprofloxacin; a fluroquinolone was found in 27 prescriptions.
Cefixime is also a third generation cephalosporin and it was found in only two
prescriptions. These details are enlisted in table 2 and represented in figure 3.
Figure.3 Prescription frequency of eleven different antibiotics
118
47
31
27
23
14
13
7
5
2
1
0 20 40 60 80 100 120 140
Cefotaxime
Ampicillin
Ceftriaxone
Ciprofloxacin
Gentamicin
Amoxicillin
Amikacin
Doxycycline
Cloxacillin
Cefixime
Garamycin
Frequency
Table No: 2 Different antibiotics’ prescription pattern
NAME OF THE ANTIBIOTIC FREQUENCY PRESCRIBED PERCENTAGE
Cefotaxime 118 40.9%
Ampicillin 47 16.3%
Ceftriaxone 31 10.7%
Ciprofloxacin 27 9.4%
Gentamicin 23 7.9%
Amoxicillin 14 4.8%
Amikacin 13 4.5%
Doxycycline 7 2.4%
Cloxacillin 5 1.7%
Cefixime 2 0.6%
Garamycin 1 0.3%
TOTAL 288
3. Among WHO’s various prescribing indicators, number of drugs per prescription and
number of antibiotics per prescription were measured. Two prescriptions contain
only one drug. Fifty seven prescriptions contain five drugs and one fifty
prescriptions contain more than five drugs. Seventy prescriptions have no
antibiotics. Ten prescriptions have three antibiotics and three prescriptions have
more than three antibiotics. This is listed in table 3 and drugs prescription pattern is
represented as image in figure 4.
0
20
40
60
80
100
120
140
160
No.of
prescription
with 1 drug
No.of
prescription
with 2 drugs
No. of
prescriptions
with 3 drugs
No. of
prescriptions
with 4 drugs
No. of
prescriptions
with 5 drugs
No. of
prescriptions
with more
than 5 drugs
2 5 15
51 57
150
Figure.4 Prescribed pattern of drug
Table No: 3 Analysis of Prescription using prescription indicators
PRESCRIBING INDICATORS TOTAL NO. OF
PRESCRIPTIONS (N=282)
PERCENTAGE
Number of drugs per
prescription
1 2 0.70%
2 7 2.48%
3 15 5.31%
4 51 18.08%
5 57 20.21%
More than 5 150 53.19%
Number of antibiotics/Px
Nil 70 24.82%
1 151 53.54%
2 48 17.02%
3 10 3.54%
More than 3 3 1.06%
4. Four different classes of analgesics were found in 282 prescriptions. The four
different classes are antispasmodic, opioids, NSAIDs and corticosteroids.
Dicyclomine; an antispasmodic was mentioned in twenty four prescriptions.
Tramadol and pentazocine are opioids and they were found in fifteen and seven
prescriptions respectively. Diclofenac and ibuprofen are NSAIDs and mentioned in
thirteen and ten prescriptions respectively. Dexamethasone; a corticosteroid was
found in eleven prescriptions. Analgesics’ prescribing frequency is mentioned in
table 4.
5. Total number of prescriptions with three analgesics was found to be one. Twelve
prescriptions contain two analgesics. Fifty three prescriptions contain only one
analgesic. Two hundred and sixteen prescriptions contain no analgesic. Prescription
pattern of analgesics is represented in table 5.
Table No: 4 Prescription pattern of Analgesics with their frequency in
prescriptions
NAME OF ANALGESIC NO.OF TIMES PRESCRIBED
= X
PERCENTAGE
Antispasmodic
Dicyclomine 24 30%
Opioids
Tramadol 15 18.75%
Pentazocine 7 8.75%
NSAIDs
Diclofenac 13 16.25%
Ibuprofen 10 12.5%
Corticosteroids
Dexamethasone 11 13.75%
TOTAL 80
Table No: 5 Prescription pattern of analgesics
FREQUENCY PERCENTAGE
Number of prescriptions
with 3 analgesics
1 0.355%
Number of prescriptions
with 2 analgesics
12 4.255%
Number of prescriptions
with only one analgesic
53 18.794%
Number of prescriptions
with atleast 1 analgesic
66 23.4%
Number of prescriptions
with no analgesics
216 76.596%
6. Consultation time is measured among WHO’s patient care indicators. Eighty two
patients were consulted for 0-5 minutes. Seventy six patients were consulted for 11-
15 minutes. It is mentioned in table 6 and figure 5.
0
50
100
150
0-5 minutes 6-10 minutes 11-15
minutes
82
124
76
Number of patients
Figure.5 Measurement of patient care indicators using consultation time
Table No: 6 Assessment of prescription pattern using patient care indicators
PATIENT CARE INDICATORS TOTAL NUMBER OF
PRESCRIPTIONS
PERCENTAGE
Consultation time in
minutes
0-5 82 29.07%
6-10 124 43.97%
11-15 76 26.95%
7. Among 282 inpatients; 46 were pediatrics, 194 were adults and forty two were
geriatrics. Total number of drugs in 282 prescriptions was found to be 1654. Among
pediatric prescriptions, thirty one are recognized with polypharmacy issue. Among
adults, one hundred and forty prescriptions are with polypharmacy. Among
geriatrics, thirty six prescriptions are with polypharmacy issue. Polypharmacy is
high among geriatrics (81%). The pattern of drugs usage as per category of age is
presented in table 7.
Table 7 Pattern of drugs’ usage as per age category
Category No. of
patients
No. of
drugs
No. of
prescriptio
ns (5&more
than 5
drugs)
% of
Polypharm
acy
No. of
antibiotics
Pediatrics
(0-12years)
46 251 31 67.391% 43
Adults (13-
59)
194 1159 140 72.165% 200
Geriatrics
(>60)
42 244 36 80.952% 45
TOTAL 282 1654 207 288
8. Among eleven different antibiotics, cefotaxime was used for infectious conditions
like UTI, bronchopneumonia, diabetic foot ulcer and lipoma. Ampicillin was used
for treating purpura, acute bronchiolitis and foot ulcer. Ceftriaxone was used in the
treatment of acute peptic ulcer and foot ulcer. The most common indication of
ciprofloxacin was UTI. Gentamicin was used to treat bronchiolitis and appendicitis.
Amoxicillin’s indication was found to be umbilical hernia and diabetic foot ulcer.
Amikacin was used in the treatment of bronchopneumonia and acute gastroenteritis.
Enteric fever was treated with doxycycline. Cloxacillin is also used in the treatment
of diabetic foot ulcer. Cefixime is used to treat loose stools. Diseases versus
antibiotics’ usage is mentioned in table 8.
Table No: 8 Diseases vs. antibiotics usage
Name of antibiotics Diseases for which it is prescribed
Cefotaxime Alcoholic gastritis, Simple febrile seizures,
UTI, Lipoma, Bronchopneumonia, Diabetic
foot ulcer
Ampicillin Purpura, Diabetic foot ulcer,
Apppendicitis, Acute bronchiolitis
Ceftriaxone Acute peptic disease, Diabetic foot ulcer,
Appendicitis
Ciprofloxacin Fatty liver, UTI
Gentamicin Acute bronchiolitis, Appendicitis
Amoxicillin Umblical hernia, Diabetic foot ulcer
Doxycycline Enteric fever
Cloxacillin Diabetic foot ulcer
Cefixime Loose stools
Amikacin Broncho pneumonia, Acute gatroenteritis
Garamycin Simple febrile seizures
DISCUSSION
 Out of 282 patient encounters, 119 (42.2%) were females and 163 (57.8%) were
males. This includes both male and female children. The average age of patients is
39.5 years. These socio-demographic features are represented in the table 1. Age
wise distribution of study population is mentioned in figure 1. Gender wise
distribution of study population is represented in figure 2.
 As far as the prescription indicators are considered, the average number of drugs
per prescription is 5.8. The total number of drugs in 282 prescriptions was found to
be 1654.
 The average number of antibiotics per prescription is 1, whereas percentage of
patients encountered with at least 1 antibiotic was found to be 75.53%. The total
number of antibiotics in 282 prescriptions was found to be 288. It was observed that
11 different antibiotics were prescribed randomly in total of 282 prescriptions.
Among them, cefotaxime was more frequently prescribed i.e. 118 times (40.972%)
followed by ampicillin, prescribed 47 times (16.319%). Garamycin was the least
prescribed and it is the brand name for gentamicin. The antibiotics’ prescription
pattern is mentioned in table 2 & figure 3. The results were comparable with that
of studies carried out at the pediatric wards of Bishoftu hospital, East Ethiopia,
where Ceftriaxone accounted for 73 (43.50 %) followed by gentamicin 43 (25.60
%) out of 120 prescriptions.
 The percentage of patients encountered with at least one analgesic was found to be
23.4%. Since the data was collected from government hospital, almost all drugs were
prescribed in generic name.
 Among analgesics, tramadol (used in 15 patients, 18.75%), diclofenac (used in13
patients, 4.25%), dexamethasone (used in 11 patients, 3.9%), ibuprofen (used in 9
patients) and pentazocine (used in 7 patients) were used. The prescription indicators
measured according to WHO guidelines are represented in the table 3 & figure 4.
Analgesics’ prescribing pattern is represented in table 4 and 5.
 It is analogous to the study that was conducted at Federal Medical Centre, Lokoja; a
tertiary health care and a major referral centre in Kogi State of Nigeria. In that study
carried out in Nigeria, 624 prescriptions were analyzed out of which 784 analgesics were
prescribed. The number of analgesics encountered per prescription was only one with a
frequency of 479 (76.8%) while 130 (20.8%) prescriptions had two prescribed analgesics
and only 15 (2.4%) of the prescriptions had three analgesics per prescription. A total of
16 different analgesics were prescribed throughout the period of their study. Close to half
(46.6%) of the prescribed analgesics was Paracetamol. One hundred and twenty nine i.e.
(16.5%) of the prescribed analgesics was Diclofenac and 95 (12.1%) was Ibuprofen.
 Majority of prescriptions (73%) were prescribed with five and more than five drugs
indicating polypharmacy. Polypharmacy is associated with increased risk of adverse
outcomes.7.7% of population in India is geriatrics (> 60 years). Medication to treat
the adverse reaction with a drug caused by another drug can be also a cause of
polypharmacy. Inappropriate prescribing is also a cause of polypharmacy which is
most commonly seen in older people with age-related pharmacokinetic and
pharmacodynamics. In most of the observational studies, it is reported that
polypharmacy is associated with negative health outcomes like adverse events
hospitalizations and mortality.
 In overall prescription, antibiotics were not at all prescribed for 24.82% of patients
who were suffering from non infectious diseases and fever. This clearly indicates
that antibiotics are only prescribed wherever required. Among patients, prescribed
with antibiotics, majority (53.54%) of prescriptions contains single antibiotic
therapy, followed by dual therapy (17%).
 For the measurement of health facility indicators, we selected availability of key
drugs. Out of 12 key drugs; oral rehydration salts, pediatric paracetamol tablets,
ferrous sulfate + folic acid tablets, iodine, benzoic acid + salicylic acid ointment,
paracetamol tablets for adults were either mentioned in the prescription or seen
during dispensing. Hence out of 12 key drugs, 6 (50%) drugs were available with
hospital.
 Polypharmacy leads to decrease in medication adherence among patients.
Medications should be assessed for benefit –risk ratio and the final combination of
medications should be based on benefits outweighing the risks. 53.54% of
prescriptions contain at least one antibiotic. Rational use of antibiotics should be
promoted because WHO warns frequently about the development of antibiotic
resistance and about the formation of superbugs. Antibiotics should not be used
empirically for more than three days. Physicians should use sensitivity testing to
determine the appropriate antibiotic treatment for an infection and to monitor
changes in bacterial resistance to antibiotics.
 The most commonly used antibiotics were cefotaxime, ampicillin, amikacin,
ciprofloxacin, gentamicin, amoxicillin, ceftriaxone. The least commonly used
antibiotics were doxycycline, garamycin and cloxaciliin. Except garamycin, all the
other prescribed antibiotics are in WHO’s Essential Drug List. Amikacin and
gentamicin are most frequently used in pediatric ward for infections like fever,
bronchitis and bronchiolitis but these antibiotics are not the first line drug of choice.
Ciprofloxacin is most commonly prescribed to treat urinary tract infections in adult
females. Ceftriaxone and cefotaxime were most commonly used to treat diabetic
foot ulcer in adults.
 Antibiotics with broad-spectrum activity were most frequently prescribed.
However, patients admitted to hospital are often severely ill and need immediate
antibiotic therapy. Thus antibiotic therapy to treat broad spectrum of bacteria is
usually commenced as empirical treatment. Once the antibiogram is available, the
treatment is focused to eliminate the specific bacteria identified for a specific
patient. Polypharmacy among geriatric patients is 80.95 %. Moreover among adult
patients, 72.16% were having polypharmacy issues. Polypharmacy issues are more
associated with patients suffering from multiple co-morbid diseases, chronic illness
and increases with incremental age, especially geriatric patients.
SUMMARY
 In recent decades of drug explosion era, modern medicine has been blessed with
much more powerful armamentarium, but yet rational use of drugs in various walks
of medical field is still a dream. Promotion of a more stringent rational drug use
practice in India is much warranted. The main objective of this study was to
evaluate the patterns of drug prescribing using WHO core drug use and
complementary indicators.
 About 282 inpatients were randomly included and their prescriptions were
scrutinized for pharmacoepidemiological variances in comparisons with the WHO
guidelines. Case sheets collected from Government Headquarters Hospital,
Virudhunagar, TamilNadu were evaluated. A separate data collection form was used
to evaluate the WHO core drug use and complementary indicators. The result
deliberate from our data is based on the pattern of drug utilization measured using
the WHO prescribing indicators.
 The present study revealed that out of total drugs prescribed (1654), mean number
of drugs per encounter was 5.8. Prescriptions without a single antibiotic were found
to be 24.82%. Polpharmacy issue was recognized in 73% of prescriptions and the
percentage of drugs prescribed by generic name was found to be 99.8%.
 Eleven different antibiotics from five categories were prescribed. Among those
cefotaxime, ceftriaxone, cefixime were from Cephalosporins. Ampicillin,
amoxicillin, cloxacillin are penicillin derivatives. Gentamicin, amikacin, garamycin
(brand name of gentamicin) belongs to aminoglycosides. Ciprofloxacin is a
fluroquinolone and doxycycline is a tetracycline class antibiotic.
 Six different analgesics from four different classes were prescribed in this study.
CONCLUSION
• In India the healthcare is dominated by private practitioners at the primary level but
government sector also plays a crucial role. Prescription practices of the individual
community-based clinician needs consistent monitoring with respect to generic
name prescribing habits. The data collected by this study can be helpful to
policymakers to monitor and improve the prescribing pattern and drug use in
Southern India.
• The current study demonstrates that prescribing indicators have shown slight
deviation than that of expected norms as per WHO indicators. Slight
deviation/variation from WHO indicators might be due to various other clinical
reasons, comorbid diseases and depends on professional decision taken by
physicians. An established Standard therapeutic guideline should be followed for
the treatment of every disease. This study indicates that polypharmacy issue cannot
be addressed until or unless the therapeutic guidelines are strictly followed by the
physicians. There is a mandatory need to improve prescribing pattern, utilization of
dispensed drugs, judicious use of antibiotics and analgesics and availability of
essential guidelines and key drugs in the stock.
• Data gathered by this study can be used by researchers and policymakers to monitor
and improve pharmaceutical prescribing pattern and consumption practices in
southern part of Tamilnadu. It would be also conducive for further
Pharmacoepidemiological studies.
BIBLIOGRAPHY
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drugs in the south Eastern Nigeria. Int J Drug Dev Res 2009;1:27-36.
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department of a north indian university teaching hospital. Asian J Pharm Clin Res 2012;5:146-9.
• Al Shimemeri A, Al Ghadeer H, Memish Z. Antibiotic utilization pattern in a general medical ward of a
tertiary medical center in Saudi Arabia. Avicenna journal of medicine. 2011 Jul;1(1):8.
• Alam K, Mishra P, Prabhu M, Shankar PR, Palaian S, Bhandari RB, Bista D. A study on rational drug
prescribing and dispensing in outpatients in a tertiary care teaching hospital of Western Nepal. Kathmandu
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prescribing, patient care and health facility indicators in selected health facilities in Southwest Ethiopia.
Journal of Applied Pharmaceutical Science. 2011 Sep 1;1(7):62. Jun 27;2020.
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available than other medicines around the globe. PloS one. 2014 Feb 12;9(2):e87576.
• Bhagavathula AS, Vidyasagar K, Chhabra M, Rashid M, Sharma R, Bandari DK, Fialova D. Prevalence of
Polypharmacy, Hyperpolypharmacy and Potentially Inappropriate Medication Use in Older Adults in India:
A Systematic Review and Meta-Analysis. Frontiers in pharmacology. 2021;12.
• Bhargava A, et al., The crisis in access to essential medicines in India: key issues which call for action.
Indian J Med Ethics. 2013;10(2):86–95.
• Garnacho-Montero J, Garcia-Garmendia JL, Barrero-Almodovar A, Jimenez-Jimenez FJ, Perez-Paredes C,
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intensive care unit with sepsis. Critical care medicine. 2003 Dec 1;31(12):2742-51.
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a cross-sectional study. S Afr Fam Pract. 2013;55(1):78–84.
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DATA COLLECTION FORM
PUBLICATIONS
THE END
End means not end. It means Efforts Never Die
- Dr. A.P.J. Abdul Kalam
THANK YOU

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A PROSPECTIVE STUDY OF DRUG UTILIZATION PATTERN AND EVALUATION USING WHO GUIDELINES AND PRESCRIBING INDICATORS

  • 1. Project work Submitted to Submitted by M.ARUMUGAVIGNESH (381610805) P.JESSICA (381610809) S.R.NANDHINI (381610814) J.SOFFIA MARY (381610825) V-Pharm.D Under the Guidance & Supervision of Dr. J. JEYAANANTHI, M.Pharm., Ph.D. Professor, Department of Pharmaceutics. Arulmigu Kalasalingam College of Pharmacy, Krishnankoil – 626126, Tamil Nadu. A PROSPECTIVE STUDY OF DRUG UTILIZATION PATTERN AND EVALUATION USING WHO GUIDELINES AND PRESCRIBING INDICATORS IN A GOVERNMENT HEADQUARTERS HOSPITAL
  • 2. INTRODUCTION  Drug utilization study is described by World Health Organization (WHO) as the marketing, distribution, prescription, and use of drugs in a society, with special emphasis on the medical, social and economic consequences.  The main aim of drug utilization study in patients is to provide rational use of medicines among public populations. Drug Use evaluation is defined as the authorized structured, ongoing review of physician prescribing, pharmacist dispensing and patient use of medication. Drug Use evaluation is ongoing, systematic process designed to maintain the appropriate and effective use of drugs. Prescribing too much of drugs can result in polypharmacy issue, drug-drug interactions and adverse drug events.  Hence our study aims to evaluate various issues using WHO prescribing indicators. These prescribing indicators are used to measure the performance of healthcare providers in several key dimensions related to appropriate use of drugs. Drug Utilization Review programs differ from drug utilization studies, which are time- limited investigations that measure drug use, but do not necessarily assess appropriateness or attempt to change practice.
  • 3. The pioneers of this research understood that a correct interpretation of data on drug utilization requires investigations at the patient level. It became clear that we need to know the answers to the following questions: • Why drugs are prescribed? • Who the prescribers are? • For whom the prescribers prescribe? • Whether patients take their medicines correctly or not? • What are the benefits and risks of the drugs?
  • 4. Together, drug utilization research and may provide insights into the following aspects of drug use and drug prescribing. pharmacoepidemiology • Pattern of use: This covers the extent and profiles of drug use and the trends in drug use and costs over time. • Quality of use: This is determined using audits to compare actual use to national prescription guidelines or local drug formularies. Indices of quality of drug use may include the choice of drug (compliance with recommended assortment), drug cost (compliance with budgetary recommendations), drug dosage (awareness of inter- individual variations in dose requirements and age-dependence), awareness of drug interactions and adverse drug reactions, and the proportion of patients who are aware of or unaware of the costs and benefits of the treatment. • Determinants of use: These include user characteristics (e.g. sociodemographic parameters and attitudes towards drugs), prescriber characteristics (e.g. speciality, education and factors influencing therapeutic decisions) and drug characteristics (e.g. therapeutic properties and affordability). • Outcomes of use: These are the health outcomes (i.e. the benefits and adverse effects) and the economic consequences.
  • 5. TYPES OF DRUG UTILIZATION STUDIES Drug utilization studies can be targeted towards any of the following links in the drug-use chain:  The systems and structures surrounding drug use (e.g. how drugs are ordered, delivered and administered in a hospital or health care facility);  The processes of drug use (e.g. what drugs are used and how they are used and does their use comply with the relevant criteria, guidelines or restrictions);  The outcomes of drug use (e.g. efficacy, adverse drug reactions and the use of resources such as drugs, laboratory tests, hospital beds or procedures). 1. Cross-sectional studies Cross-sectional data provide a «snapshot» of drug use at a particular time (e.g. over a year, a month or a day). Such studies might be used for making comparisons with similar data collected over the same period in a different country, health facility or ward, and could be drug-, problem-, indication, prescriber- or patient-based. Alternatively, a cross-sectional study can be carried out before and after an educational or other intervention. Studies can simply measure drug use, or can be criterion-based to assess drug use in relation to guidelines or restrictions.
  • 6. 2. Longitudinal studies Public health authorities are often interested in trends in drug use, and longitudinal data are required for this purpose. Drug-based longitudinal data can be on total drug use as obtained through a claims database, or the data may be based on a statistically valid sample of pharmacies or medical practices. Longitudinal data are often obtained from repeated cross-sectional surveys (example, IMS (Intercontinental Medical Statistics) practice-based data are of this type). Data collection is continuous, but the practitioners surveyed, and therefore the patients, are continually changing. Such data give information about overall trends, but not about prescribing trends for individual practitioners or practices. 3. Continuous longitudinal studies In some cases continuous longitudinal data at the individual practitioner and patient level can be obtained. Claims databases are often able to follow individual patients using a unique (but anonymous) identifier. These data can provide information about concordance with treatment based on the period between prescriptions, co prescribing, duration of treatment, Prescribed Daily Doses and soon. As electronic prescribing becomes more common, databases are being developed to provide continuous longitudinal data comprising full medical and prescribing information at the individual patient level. Such databases are very powerful, and can address a range of issues including reasons for changes in therapy, adverse effects and health outcomes.
  • 7. PRESCRIBING INDICATORS AS DEFINED BY WORLD HEALTH ORGANISATION Prescribing indicators are recommended by the WHO in order to enhance the quality of performance in prescribing medicines as appropriate to individuals need. It has not been an empirical determination but with purposed significance in various clinical conditions in different settings. In particular, indicators such as drugs per prescription, drugs in generics, injectables and antibiotics usage might be influencing various other clinical parameters. Yet this study has to expanded in different dimension to enhance the rational use of medications • Average number of drugs per prescription This indicator measures the degree of polypharmacy. Polypharmacy is a deviation to rational prescribing. In this study combination drugs are counted as single count. Polypharmacy is concurrent use of multiple medications in a single prescription of a patient. Generally Polypharmacy denotes use of five or more medications taken daily by a patient.
  • 8. Polypharmacy issue increases with increase in age of the patient. Polypharmacy is often associated with a decreased quality of life, including decreased mobility and cognition. Patient’s adherence to the therapy can be improved by avoiding polypharmacy and prescribing less number of drugs. The average number of drugs per prescription can be calculated by dividing (total number of drugs prescribed in ‘n’ prescriptions) by (total number of prescriptions sampled, ‘n’). • Average number of antibiotics per prescription Inappropriate use of antibiotics is a global public health challenge and has been associated with antibiotic resistance. The assessment of this indicator helps to avoid irrational use of antibiotics and to promote rational use of antibiotics. Antibiotics should not be prescribed empirically. It should be prescribed after obtaining the report of culture and sensitivity tests. The average number of antibiotics per prescription can be calculated by dividing total number of antibiotics prescribed by total number of prescriptions sampled. • Percentage of drugs prescribed in generic name Percentage of drugs prescribed by generic name is calculated to measure the tendency of prescribing by generic name. It was calculated by dividing the number of drugs prescribed by generic name by total number of drugs prescribed, multiplied by 100. Generic medicines cost less when compared to medicines in brand name. When drugs are prescribed in generic name, it promotes the cost effective treatment.
  • 9. • Percentage of drugs prescribed as injections The purpose of this indicator is to measure the overall level of use of two important dosage forms, (oral drugs and injections). Injections are often overused and are expensive form of drug therapy. Decreasing the injectables and early switch over to oral preparations will significantly reduce both the drug and non- drug cost (cost of injection, surgical items and hospital & nursing charges). It was calculated by dividing the number of drugs prescribed as injections by total number of drugs prescribed, multiplied by 100. PATIENT CARE INDICATORS AS DEFINED BY WORLD HEALTH ORGANISATION Patient care indicators are average consultation time, average dispensing time, the percentage of medicines actually dispensed, the percentage of medicines adequately labeled and patient’s knowledge of correct dosage. 1. Average consultation time was calculated by dividing the total time for a series of consultations to the number of consultations. 2. Average dispensing time was calculated by dividing the total time for dispensing medicines to a series of patients by the number of encounters.
  • 10. 3. Percentage of medicines actually dispensed was calculated by dividing the number of medicines actually dispensed at the health care facility to the total number of medicines prescribed and multiplied by 100. 4. Percentage of medicines adequately labeled was calculated by dividing the number of medicine packages containing at least the medicine name, the strength and the frequency and length of time/day the medicine should be taken to the total number of medicine packages dispensed and multiplied by 100. 5. Patient’s knowledge of correct dosage was calculated by dividing the number of patients who adequately reported the dosage schedules for all medicines to the total number of patients interviewed and multiplied by 100. HEALTH FACILITY INDICATORS AS DEFINED BY WORLD HEALTH ORGANISATION Facility indicators are availability of essential medicines (ELM), formulary availability, standard treatment guideline availability (STG) and key medicines availability. ELM or Formulary or STG availability was determined during the time of the visit. Key medicines availability was calculated by dividing the number of specified products actually in stock to the total number of medicines on the checklist and multiplied by 100. COMPLEMENTARY INDICATORS AS DEFINED BY WORLD HEALTH ORGANISATION This includes average medicine cost per encounter and percentage of prescriptions in accordance with clinical guidelines.
  • 11. APPLICATIONS OF DRUG UTILIZATION STUDY TO THE FIELD OF PHARMACOEPIDEMIOLOGY Drug utilization study is a field of pharmacoepidemiology. Pharmacoepidemiological is described as the study to estimate the utilization pattern and effect of drugs in any clinical populations and to understand the various therapeutic outcomes like adverse drug reactions, drug effects like drug-drug interactions, medication adherence. It is the study of drug oriented safety and its effectiveness. Rationalization is the approach of deprescribing inappropriate medications and prescribing the most appropriate correct medication appropriate for the relevant pathologic conditions as per the need of an individual. The following are some of its applications, • It can be used to estimate the numbers of patients exposed to specified drugs within a given time period. Such estimates may either refer to all drug users, regardless of when they started to use the drug (prevalence), or focus on patients who started to use the drug within the selected period (incidence). • It can describe the extent of use at a certain moment and/or in a certain area (e.g. in a country, region, community or hospital). • Researchers can estimate (e.g. on the basis of epidemiological data on a disease) to what extent drugs are properly used, overused or underused. • It can be used to compare the observed patterns of drug use for the treatment of a certain disease with current recommendations or guidelines.
  • 12. LITERATURE REVIEW • Drug utilization pattern in South Indian pediatric population Thiruthopu NS et al., (2014) - Patients who attended the pediatric unit with the age newborn to 18 years were included in the study and patients who were not willing to participate in the study were excluded and the data collected from the pediatric unit were analyzed. Out of 209 patients, the average number of drugs per patient was 4.56. Among 209 prescriptions 49.78% of the drugs were essential drugs. Among the antibiotics 33.33% prescribed, cephalosporin group were the most commonly prescribed followed by amino glycoside and penicillin. • Prescribing pattern of analgesics in orthopedic in-patients at tertiary care hospital in Northeast India Choudhury DK et al., (2016) - The study was aimed to evaluate the prescribing pattern of analgesics and analyze the rational use of analgesic in the orthopedic in-patient department of tertiary care teaching hospital. Out of 200 patients’ case sheets collected, 123 were male and 77 were female. The average number of analgesic per prescription was found to be 1.46. In this study, 55.5% of patients had received single analgesic. Diclofenac was the most commonly prescribed analgesic (43.49%).
  • 13. • Evaluation of polypharmacy and appropriateness of prescription K. B. Rakesh, et al., (2016) - They conducted a study evaluation of polypharmacy and appropriateness of prescription in geriatric patients: A cross-sectional study at a tertiary care hospital. The study design is a cross sectional analysis which included patients above 60 years of age. A total of 426 patients, 216 (50.7%) were males and 210 (49.3%) were females. Polypharmacy was present in 282 prescriptions (66.2%). Highest prevalence of polypharmacy was seen in 70-79 years age group compared to the other two groups and it was statistically significant. Out of 426 patients, 36 patients were receiving drugs which were to be avoided as per Beers criteria. Around 66.19% patients were receiving polypharmacy. • Assessment of drug use pattern Shrestha B et al., (2018) - This was a prospective cross-sectional study carried out in order to determine current prescribing trends at Kathmandu Medical College Teaching Hospital. A total of 605 prescriptions were collected and analyzed in the study. The average number of drugs per prescription was 5.85 . Furthermore, assuming each prescription as an individual patient, 64.1% of patients received antibiotics, and 71% of patients received injectable form of drugs. Among antibiotics the most common antibiotics prescribed were Ceftriaxone, Amoxicillin/Cloxacillin, Azithromycin, Cefixime, and Cloxacillin. The study indicated the issue of polypharmacy and prescription writing using brand names. They stressed the need to write prescriptions in generic name. They concluded that there is a crucial need for the development of prescribing guidelines when it comes to antibiotics.
  • 14. AIM AND OBJECTIVES AIM • The main aim of this study was to evaluate the patterns of drug prescribing using WHO core drug use and complementary indicators. OBJECTIVES • To promote rational use of drugs and antibiotics in various walks of medical field. • To avoid polypharmacy issue and hence enhance patients’ medication compliance • To prevent the incidence of antibiotic resistance by encouraging rational use of antibiotics. • To rule out the prevalence of various diseases in several inpatient departments of concern hospital. • To estimate diseases versus antibiotic usage in various inpatient departments of the concern hospital.
  • 15. MATERIALS AND METHODOLOGY • Prospective observational longitudinal study . • Sample size – 282. • Study period – 6 months. STUDY DESIGN • Virudhunagar Government Headquarters Hospital which is now upgraded into Medical college and Teaching Hospital. STUDY SITE • Male and female inpatients irrespective of age at various wards were included • Pregnant women, unconscious patients, patients who denied to participate were excluded. INCLUSION AND EXCLUSION CRITERIA
  • 16. Data collection The data collected from the case sheets includes age, gender and economic status of the patients, provisional diagnosis, final diagnosis, various laboratory parameters like, serum creatinine, urea, and hemoglobin levels, dose, dosage and frequency of prescribed drugs etc. These data were collected during regular ward round which was conducted twice in a week. The samples were collected by systematic random sampling method. Separate form was used for data collecting purpose. • Prescribing indicators measurement The WHO prescribing indicators like average number of drugs per prescription, average number of antibiotics per prescription, percentage of drugs prescribed in generic name were pre tested. The tests were done using the formulas given by WHO in their prescription indicators manual. • Patient care indicators measurement Patient care indicators include average consultation time, average dispensing time, percentage of drugs actually dispensed, patients’ knowledge about correct dosage. Among these tests, average consultation time of physicians in the inpatient setting was measured. The consultation time was divided into three categories as follows; less than 5 minutes, 5-10 minutes, above 10 minutes. Longer consultation time has been linked to better heath care outcomes.
  • 17. • Health facility indicators measurement It is the measurement of availability of key drugs in a hospital. The key drugs as were oral rehydration salts, cotrimaxazole tablets, procaine penicillin injection, pediatric paracetamol tablets, chloroquine tablets, ferrous sulfate + folic acid tablets, mebendazole tablets, tetracycline eye ointment, iodine, gentian violet or local alternative, benzoic acid + salicylic acid ointment, paracetamol tablets for adults, retinol. Total number of the above mentioned key drugs was found to be 12. These key drugs were selected according to the WHO’s model list of key drugs for testing drug availability. We checked the availability of the above drugs in the hospital. • Complementary indicators measurement It is the measurement of cost per prescription encounter. As Government hospital provides treatment at free cost, this criteria was excluded from the study. Data analysis All the sources of data were collected from inpatients’ case sheets of the health care hospital and were segregated. Then the data were analyzed using Microsoft Excel 2007. The observed values of indicators are reported as means and proportions. 282 prescriptions in 282 case sheets were analyzed.
  • 18. RESULTS 1. Totally 282 inpatients were enrolled in this study. Socio demographic details like age and gender were collected. Fifty patients were from 46-55 years of age. Male patients outnumber women patients in this study. Out of 282 patients, 163 were males and 119 were females. These details are mentioned in table 1 and in figures 1&2. Table No: 1 Demographic details of study population
  • 19. CHARACTERISTICS FREQUENCY (N) PERCENTAGE AGE Below five years 19 6.73% 6-15 years 30 10.63% 16 – 25 years 30 10.63% 26-35 years 35 12.41% 36-45 years 45 15.95% 46-55 years 50 17.73% 56-65 years 40 14.18% 66-75 years 28 9.92% Above 75 years 5 1.82% Total 282 GENDER Male 163 57.8% Female 119 42.2% Total 282
  • 21. 58% 42% Male Female Figure.2 Percentage of Males and Females in study population
  • 22. 2. Eleven different antibiotics were found in 282 prescriptions. Cefotaxime; a third generation cephalosporin was found in 118 prescriptions followed by ampicillin in 47 prescriptions. Ceftriaxone is also a third generation antibiotic and it was found in 31 prescriptions. Ciprofloxacin; a fluroquinolone was found in 27 prescriptions. Cefixime is also a third generation cephalosporin and it was found in only two prescriptions. These details are enlisted in table 2 and represented in figure 3. Figure.3 Prescription frequency of eleven different antibiotics 118 47 31 27 23 14 13 7 5 2 1 0 20 40 60 80 100 120 140 Cefotaxime Ampicillin Ceftriaxone Ciprofloxacin Gentamicin Amoxicillin Amikacin Doxycycline Cloxacillin Cefixime Garamycin Frequency
  • 23. Table No: 2 Different antibiotics’ prescription pattern NAME OF THE ANTIBIOTIC FREQUENCY PRESCRIBED PERCENTAGE Cefotaxime 118 40.9% Ampicillin 47 16.3% Ceftriaxone 31 10.7% Ciprofloxacin 27 9.4% Gentamicin 23 7.9% Amoxicillin 14 4.8% Amikacin 13 4.5% Doxycycline 7 2.4% Cloxacillin 5 1.7% Cefixime 2 0.6% Garamycin 1 0.3% TOTAL 288
  • 24. 3. Among WHO’s various prescribing indicators, number of drugs per prescription and number of antibiotics per prescription were measured. Two prescriptions contain only one drug. Fifty seven prescriptions contain five drugs and one fifty prescriptions contain more than five drugs. Seventy prescriptions have no antibiotics. Ten prescriptions have three antibiotics and three prescriptions have more than three antibiotics. This is listed in table 3 and drugs prescription pattern is represented as image in figure 4. 0 20 40 60 80 100 120 140 160 No.of prescription with 1 drug No.of prescription with 2 drugs No. of prescriptions with 3 drugs No. of prescriptions with 4 drugs No. of prescriptions with 5 drugs No. of prescriptions with more than 5 drugs 2 5 15 51 57 150 Figure.4 Prescribed pattern of drug
  • 25. Table No: 3 Analysis of Prescription using prescription indicators PRESCRIBING INDICATORS TOTAL NO. OF PRESCRIPTIONS (N=282) PERCENTAGE Number of drugs per prescription 1 2 0.70% 2 7 2.48% 3 15 5.31% 4 51 18.08% 5 57 20.21% More than 5 150 53.19% Number of antibiotics/Px Nil 70 24.82% 1 151 53.54% 2 48 17.02% 3 10 3.54% More than 3 3 1.06%
  • 26. 4. Four different classes of analgesics were found in 282 prescriptions. The four different classes are antispasmodic, opioids, NSAIDs and corticosteroids. Dicyclomine; an antispasmodic was mentioned in twenty four prescriptions. Tramadol and pentazocine are opioids and they were found in fifteen and seven prescriptions respectively. Diclofenac and ibuprofen are NSAIDs and mentioned in thirteen and ten prescriptions respectively. Dexamethasone; a corticosteroid was found in eleven prescriptions. Analgesics’ prescribing frequency is mentioned in table 4. 5. Total number of prescriptions with three analgesics was found to be one. Twelve prescriptions contain two analgesics. Fifty three prescriptions contain only one analgesic. Two hundred and sixteen prescriptions contain no analgesic. Prescription pattern of analgesics is represented in table 5.
  • 27. Table No: 4 Prescription pattern of Analgesics with their frequency in prescriptions NAME OF ANALGESIC NO.OF TIMES PRESCRIBED = X PERCENTAGE Antispasmodic Dicyclomine 24 30% Opioids Tramadol 15 18.75% Pentazocine 7 8.75% NSAIDs Diclofenac 13 16.25% Ibuprofen 10 12.5% Corticosteroids Dexamethasone 11 13.75% TOTAL 80
  • 28. Table No: 5 Prescription pattern of analgesics FREQUENCY PERCENTAGE Number of prescriptions with 3 analgesics 1 0.355% Number of prescriptions with 2 analgesics 12 4.255% Number of prescriptions with only one analgesic 53 18.794% Number of prescriptions with atleast 1 analgesic 66 23.4% Number of prescriptions with no analgesics 216 76.596%
  • 29. 6. Consultation time is measured among WHO’s patient care indicators. Eighty two patients were consulted for 0-5 minutes. Seventy six patients were consulted for 11- 15 minutes. It is mentioned in table 6 and figure 5. 0 50 100 150 0-5 minutes 6-10 minutes 11-15 minutes 82 124 76 Number of patients Figure.5 Measurement of patient care indicators using consultation time
  • 30. Table No: 6 Assessment of prescription pattern using patient care indicators PATIENT CARE INDICATORS TOTAL NUMBER OF PRESCRIPTIONS PERCENTAGE Consultation time in minutes 0-5 82 29.07% 6-10 124 43.97% 11-15 76 26.95%
  • 31. 7. Among 282 inpatients; 46 were pediatrics, 194 were adults and forty two were geriatrics. Total number of drugs in 282 prescriptions was found to be 1654. Among pediatric prescriptions, thirty one are recognized with polypharmacy issue. Among adults, one hundred and forty prescriptions are with polypharmacy. Among geriatrics, thirty six prescriptions are with polypharmacy issue. Polypharmacy is high among geriatrics (81%). The pattern of drugs usage as per category of age is presented in table 7. Table 7 Pattern of drugs’ usage as per age category Category No. of patients No. of drugs No. of prescriptio ns (5&more than 5 drugs) % of Polypharm acy No. of antibiotics Pediatrics (0-12years) 46 251 31 67.391% 43 Adults (13- 59) 194 1159 140 72.165% 200 Geriatrics (>60) 42 244 36 80.952% 45 TOTAL 282 1654 207 288
  • 32. 8. Among eleven different antibiotics, cefotaxime was used for infectious conditions like UTI, bronchopneumonia, diabetic foot ulcer and lipoma. Ampicillin was used for treating purpura, acute bronchiolitis and foot ulcer. Ceftriaxone was used in the treatment of acute peptic ulcer and foot ulcer. The most common indication of ciprofloxacin was UTI. Gentamicin was used to treat bronchiolitis and appendicitis. Amoxicillin’s indication was found to be umbilical hernia and diabetic foot ulcer. Amikacin was used in the treatment of bronchopneumonia and acute gastroenteritis. Enteric fever was treated with doxycycline. Cloxacillin is also used in the treatment of diabetic foot ulcer. Cefixime is used to treat loose stools. Diseases versus antibiotics’ usage is mentioned in table 8.
  • 33. Table No: 8 Diseases vs. antibiotics usage Name of antibiotics Diseases for which it is prescribed Cefotaxime Alcoholic gastritis, Simple febrile seizures, UTI, Lipoma, Bronchopneumonia, Diabetic foot ulcer Ampicillin Purpura, Diabetic foot ulcer, Apppendicitis, Acute bronchiolitis Ceftriaxone Acute peptic disease, Diabetic foot ulcer, Appendicitis Ciprofloxacin Fatty liver, UTI Gentamicin Acute bronchiolitis, Appendicitis Amoxicillin Umblical hernia, Diabetic foot ulcer Doxycycline Enteric fever Cloxacillin Diabetic foot ulcer Cefixime Loose stools Amikacin Broncho pneumonia, Acute gatroenteritis Garamycin Simple febrile seizures
  • 34. DISCUSSION  Out of 282 patient encounters, 119 (42.2%) were females and 163 (57.8%) were males. This includes both male and female children. The average age of patients is 39.5 years. These socio-demographic features are represented in the table 1. Age wise distribution of study population is mentioned in figure 1. Gender wise distribution of study population is represented in figure 2.  As far as the prescription indicators are considered, the average number of drugs per prescription is 5.8. The total number of drugs in 282 prescriptions was found to be 1654.  The average number of antibiotics per prescription is 1, whereas percentage of patients encountered with at least 1 antibiotic was found to be 75.53%. The total number of antibiotics in 282 prescriptions was found to be 288. It was observed that 11 different antibiotics were prescribed randomly in total of 282 prescriptions. Among them, cefotaxime was more frequently prescribed i.e. 118 times (40.972%) followed by ampicillin, prescribed 47 times (16.319%). Garamycin was the least prescribed and it is the brand name for gentamicin. The antibiotics’ prescription pattern is mentioned in table 2 & figure 3. The results were comparable with that of studies carried out at the pediatric wards of Bishoftu hospital, East Ethiopia, where Ceftriaxone accounted for 73 (43.50 %) followed by gentamicin 43 (25.60 %) out of 120 prescriptions.
  • 35.  The percentage of patients encountered with at least one analgesic was found to be 23.4%. Since the data was collected from government hospital, almost all drugs were prescribed in generic name.  Among analgesics, tramadol (used in 15 patients, 18.75%), diclofenac (used in13 patients, 4.25%), dexamethasone (used in 11 patients, 3.9%), ibuprofen (used in 9 patients) and pentazocine (used in 7 patients) were used. The prescription indicators measured according to WHO guidelines are represented in the table 3 & figure 4. Analgesics’ prescribing pattern is represented in table 4 and 5.  It is analogous to the study that was conducted at Federal Medical Centre, Lokoja; a tertiary health care and a major referral centre in Kogi State of Nigeria. In that study carried out in Nigeria, 624 prescriptions were analyzed out of which 784 analgesics were prescribed. The number of analgesics encountered per prescription was only one with a frequency of 479 (76.8%) while 130 (20.8%) prescriptions had two prescribed analgesics and only 15 (2.4%) of the prescriptions had three analgesics per prescription. A total of 16 different analgesics were prescribed throughout the period of their study. Close to half (46.6%) of the prescribed analgesics was Paracetamol. One hundred and twenty nine i.e. (16.5%) of the prescribed analgesics was Diclofenac and 95 (12.1%) was Ibuprofen.
  • 36.  Majority of prescriptions (73%) were prescribed with five and more than five drugs indicating polypharmacy. Polypharmacy is associated with increased risk of adverse outcomes.7.7% of population in India is geriatrics (> 60 years). Medication to treat the adverse reaction with a drug caused by another drug can be also a cause of polypharmacy. Inappropriate prescribing is also a cause of polypharmacy which is most commonly seen in older people with age-related pharmacokinetic and pharmacodynamics. In most of the observational studies, it is reported that polypharmacy is associated with negative health outcomes like adverse events hospitalizations and mortality.  In overall prescription, antibiotics were not at all prescribed for 24.82% of patients who were suffering from non infectious diseases and fever. This clearly indicates that antibiotics are only prescribed wherever required. Among patients, prescribed with antibiotics, majority (53.54%) of prescriptions contains single antibiotic therapy, followed by dual therapy (17%).
  • 37.  For the measurement of health facility indicators, we selected availability of key drugs. Out of 12 key drugs; oral rehydration salts, pediatric paracetamol tablets, ferrous sulfate + folic acid tablets, iodine, benzoic acid + salicylic acid ointment, paracetamol tablets for adults were either mentioned in the prescription or seen during dispensing. Hence out of 12 key drugs, 6 (50%) drugs were available with hospital.  Polypharmacy leads to decrease in medication adherence among patients. Medications should be assessed for benefit –risk ratio and the final combination of medications should be based on benefits outweighing the risks. 53.54% of prescriptions contain at least one antibiotic. Rational use of antibiotics should be promoted because WHO warns frequently about the development of antibiotic resistance and about the formation of superbugs. Antibiotics should not be used empirically for more than three days. Physicians should use sensitivity testing to determine the appropriate antibiotic treatment for an infection and to monitor changes in bacterial resistance to antibiotics.
  • 38.  The most commonly used antibiotics were cefotaxime, ampicillin, amikacin, ciprofloxacin, gentamicin, amoxicillin, ceftriaxone. The least commonly used antibiotics were doxycycline, garamycin and cloxaciliin. Except garamycin, all the other prescribed antibiotics are in WHO’s Essential Drug List. Amikacin and gentamicin are most frequently used in pediatric ward for infections like fever, bronchitis and bronchiolitis but these antibiotics are not the first line drug of choice. Ciprofloxacin is most commonly prescribed to treat urinary tract infections in adult females. Ceftriaxone and cefotaxime were most commonly used to treat diabetic foot ulcer in adults.  Antibiotics with broad-spectrum activity were most frequently prescribed. However, patients admitted to hospital are often severely ill and need immediate antibiotic therapy. Thus antibiotic therapy to treat broad spectrum of bacteria is usually commenced as empirical treatment. Once the antibiogram is available, the treatment is focused to eliminate the specific bacteria identified for a specific patient. Polypharmacy among geriatric patients is 80.95 %. Moreover among adult patients, 72.16% were having polypharmacy issues. Polypharmacy issues are more associated with patients suffering from multiple co-morbid diseases, chronic illness and increases with incremental age, especially geriatric patients.
  • 39. SUMMARY  In recent decades of drug explosion era, modern medicine has been blessed with much more powerful armamentarium, but yet rational use of drugs in various walks of medical field is still a dream. Promotion of a more stringent rational drug use practice in India is much warranted. The main objective of this study was to evaluate the patterns of drug prescribing using WHO core drug use and complementary indicators.  About 282 inpatients were randomly included and their prescriptions were scrutinized for pharmacoepidemiological variances in comparisons with the WHO guidelines. Case sheets collected from Government Headquarters Hospital, Virudhunagar, TamilNadu were evaluated. A separate data collection form was used to evaluate the WHO core drug use and complementary indicators. The result deliberate from our data is based on the pattern of drug utilization measured using the WHO prescribing indicators.
  • 40.  The present study revealed that out of total drugs prescribed (1654), mean number of drugs per encounter was 5.8. Prescriptions without a single antibiotic were found to be 24.82%. Polpharmacy issue was recognized in 73% of prescriptions and the percentage of drugs prescribed by generic name was found to be 99.8%.  Eleven different antibiotics from five categories were prescribed. Among those cefotaxime, ceftriaxone, cefixime were from Cephalosporins. Ampicillin, amoxicillin, cloxacillin are penicillin derivatives. Gentamicin, amikacin, garamycin (brand name of gentamicin) belongs to aminoglycosides. Ciprofloxacin is a fluroquinolone and doxycycline is a tetracycline class antibiotic.  Six different analgesics from four different classes were prescribed in this study.
  • 41. CONCLUSION • In India the healthcare is dominated by private practitioners at the primary level but government sector also plays a crucial role. Prescription practices of the individual community-based clinician needs consistent monitoring with respect to generic name prescribing habits. The data collected by this study can be helpful to policymakers to monitor and improve the prescribing pattern and drug use in Southern India. • The current study demonstrates that prescribing indicators have shown slight deviation than that of expected norms as per WHO indicators. Slight deviation/variation from WHO indicators might be due to various other clinical reasons, comorbid diseases and depends on professional decision taken by physicians. An established Standard therapeutic guideline should be followed for the treatment of every disease. This study indicates that polypharmacy issue cannot be addressed until or unless the therapeutic guidelines are strictly followed by the physicians. There is a mandatory need to improve prescribing pattern, utilization of dispensed drugs, judicious use of antibiotics and analgesics and availability of essential guidelines and key drugs in the stock. • Data gathered by this study can be used by researchers and policymakers to monitor and improve pharmaceutical prescribing pattern and consumption practices in southern part of Tamilnadu. It would be also conducive for further Pharmacoepidemiological studies.
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  • 52. THE END End means not end. It means Efforts Never Die - Dr. A.P.J. Abdul Kalam THANK YOU