Inappropriate Drug Use in Elderly Indian Patients

Inappropriate drug use in hospitalized elderly
patients of medicine and cardiology departments at
a tertiary care hospital of Northeast India

Research Article
Inappropriate drug use in hospitalized elderly
patients of medicine and cardiology departments at
a tertiary care hospital of Northeast India
Ratan J. Lihite a,b,
*, Mangala Lahkar b
a
Department of Pharmacy Practice, National Institute of Pharmaceutical Education & Research (NIPER),
Guwahati, India
b
ADR Monitoring Centre (Pharmacovigilance Program of India) and Department of Pharmacology,
Gauhati Medical College, Guwahati, India
a r t i c l e i n f o
Article history:
Received 17 April 2013
Accepted 22 June 2013
Available online 10 July 2013
Keywords:
HEDIS
Inappropriate
Drug
Hospitalized
Elderly
a b s t r a c t
Background: National committee on quality assurance, USA convened an expert consensus
panel and identiﬁed the list of drugs which should be avoided in the elderly people. This
resulting list of drugs after 2003 beers criteria were added to the 2006 Health Plan Employer
Data and Information Set (HEDIS) to assess the drug prescribing in elderly people.
Methods: The objective of this study was to determine the prevalence of inappropriate drug
use and assess their predictors in the hospitalized elderly patients of tertiary care hospital by
using HEDIS 2006 criteria. A 6-month prospective study was conducted in medicine & cardi-
ology inpatient department of tertiary care hospital by reviewing prescriptions of 502 elderly
patients. The patients of either sex having age more than 60 year were included in this study.
Results: It is found that (2.39%) 12 patients received at least 1 inappropriate drug by 2006
HEDIS measure. Out of 12 inappropriate drugs, short acting nifedipine was prescribed to 4
elderly patients followed by dicyclomine to 2 patients and ketorolac to 2 patients each.
Increased number (!11) of concurrent medications use during hospital stay (OR: 0.015, CI:
0.001e0.199, P ¼ 0.001) and prolonged (!5 days) length of stay (OR: 0.039, CI: 0.005e0.291,
P ¼ 0.002) were found as a predictors of inappropriate medication use.
Conclusion: In this study, low prevalence (2.39%) of inappropriate drug prescribing was
found. Multiple medications and long duration of hospital stay were the risk factors for
inappropriate medication use.
Copyright ª 2013, Indraprastha Medical Corporation Ltd. All rights reserved.
1. Introduction
Inappropriate multiple medications use is a major patient
safety concern, as this irrational symptomatic prescribing
practice not only add to the cost and complexity of therapeutic
regimens, but also place patients especially vulnerable geri-
atric patient population at greater risk for adverse drug re-
actions and drugedrug interactions and jeopardize positive
* Corresponding author. Tel.: þ91 9706143510.
E-mail address: r.lihite@yahoo.com (R.J. Lihite).
Available online at www.sciencedirect.com
journal homepage: www.elsevier.com/locate/apme
a p o l l o m e d i c i n e 1 0 ( 2 0 1 3 ) 3 1 8 e3 2 3
0976-0016/$ e see front matter Copyright ª 2013, Indraprastha Medical Corporation Ltd. All rights reserved.
http://dx.doi.org/10.1016/j.apme.2013.06.002

therapeutic outcome e including patient experience, health
outcomes, overall performance, and with estimates of the
financial consequences of the healthcare services.1
Although, Beers criteria is the foundation of 2006 HEDIS
quality measures, clinicians contend that Beers criteria is too
broad and sometimes drugs may be appropriate for specific
patients in certain circumstances. The Beers criteria were
derived from expert consensus, some experts and clinicians
argue that they are not strictly evidence based.2
In some cases;
patients may be in the process of being treated successfully
with a potentially inappropriate drug. Thus, Beers criteria
have been controversial since their original publication in
1991.3
Despite controversy about which explicit criteria
should be used, there is a strong body of evidence showing
that suboptimal prescribing is disturbingly common in elderly
patients.4
Based on Beers criteria, National Committee on
Quality Assurance, USA have developed a 2006 Healthcare
Effectiveness Data and Information Set (HEDIS) criteria by
using modified Delphi process to identify rates of inappro-
priate prescribing in the elderly.5
To assess the healthcare
quality for elderly people, this measures included the drugs
that should usually avoided in the elderly.6
HEDIS is the most
widely reported set of performance measures in the industry,
used by health plans, medical groups, federal and state gov-
ernments.7
Thus, we have used 2006 HEDIS measures to
determine the prevalence of inappropriate drugs and assessed
the predictors in hospitalized elderly patient of medicine and
cardiology department of the tertiary care hospital in North-
east region of India.
2. Patients and methods
2.1. Study design and setting
The Institutional Ethic Committee approval was taken prior
the initiation of study. The prospective study was carried out
in an inpatient setting of medicine and cardiology department
of the Gauhati Medical College and Hospital (GMCH), Guwa-
hati, Assam. GMCH is the largest and major tertiary care
government hospital of the entire northeast region of India,
catering to millions of people in this region. This hospital has
geriatric clinical setting in medicine department and more-
over; elderly patients are more prevalent to cardiovascular
diseases; therefore to comprise maximum number of elderly
hospitalized patients in this study we have conducted our
study in medicine and cardiology departments.
The study data was collected for the period of 6 months
from July to December 2010. The elderly patients of either sex
were included in the study and written informed consent was
taken at the time of enrollment. Each prescription was
checked individually from the wards of medicine and cardi-
ology department of hospital for inappropriate drug by 2006
HEDIS Criteria. The inappropriate drugs were collected from
the prescriptions of elderly patients and it includes all the
medications prescribed, right from admission to discharge of
the patient. At the time of data collection the study form was
completed with regards to patient’s age, diagnosis, all the
drugs prescribed during hospital stay, length of hospitaliza-
tion and study form was updated daily until the patient was
discharged. Patients were also interviewed to get the infor-
mation regarding any self medication and past history of
illness. A prescription was said to be inappropriate if it con-
tained one or more drugs included in 2006 HEDIS drug list of
inappropriateness. The patients having incomplete informa-
tion were excluded from the study. The results were repre-
sented as average Æ standard deviation (SD) and percentages
as applicable; age, sex, diagnosis, number of medications and
duration of treatments were the variables for determination of
predictors. Odds ratio was calculated to assess the most
common predictors for inappropriate drug prescribing. Sta-
tistical significance (P < 0.05) was determined at 95% level of
confidence. The data were analyzed using Statistical Package
for Social Science (SPSS) Ver. 16.0.
2.2. Modifications
The criteria used in this study required certain modifications
which were necessary in the Indian setting. The life expec-
tancy at birth for Indian males and females corresponding to
the mid year 2003 was 62.3 and 63.9 years respectively, giving
an overall life expectancy as 63.2 years.8
Thus the modifications were:
1) The cut off age considered in this study was 60 years or
more instead of age 65 years or more and 2) the following
drugs were not considered in this study as they were excluded
from the drug list of 2006 HEDIS criteria (Table 3). These drugs
were Amitriptyline, Doxepin, Indomethacin, Ticlopidine,
Methyldopa, Reserpine, Disopyramide, Oxybutynin, Nap-
roxen, Oxaprozin, Piroxicam, Fluoxetine, Amiodarone, Dox-
azosin, Clonidine, Mineral Oil, Cimetidine, Ethacrynic acid and
long term use of stimulant laxatives except with opiate use.
3. Results
3.1. Population characteristics
Out of the 502 patients, 308 (61.35%) were males and 194
(38.64%) were females. The average age of the patients was
66.87 Æ 4.71 years, the overall age range being 60e84 years.
More than half of the 386 (76.89%) patients belonged to the age
group 60e69 years while 105 (20.91%) of the patients belonged
to the age group 70e79 years and the remaining 11 (2.19%)
patients were more than 80 years of age.
Table 1 e Inappropriate drug use identified by 2006
HEDIS.
Sr. no. Name of drugs Severity No. of patients
(n ¼ 12)
1 Short acting
nifedipine
High 4
2 Dicyclomine High 2
3 Ketorolac High 2
4 Nitrofurantoin High 2
5 Promethazine High 1
6 Chlorpheniramine High 1
a p o l l o m e d i c i n e 1 0 ( 2 0 1 3 ) 3 1 8 e3 2 3 319

3.2. General distribution of disease
The average disease per patient was found to be 3.20 Æ 1.26.
The total number of diagnosis was 1604 in 502 prescriptions.
Out of 502 prescriptions, 74 (14.74%) patient were diagnosed to
have 1 disease followed by 153 (30.47%) patients were having 2
diseases and 275 (54.78%) patients were found to have more
than 3 diseases. On the system wise analysis of 1604 disorders,
it was found that circulatory system disorders (26.43%) were in
the first rank followed by the endocrine system disorders
(17.14%), Infection & parasitic disorder (16.70%) and digestive
system disorders (9.28%). This finding can be attributed to the
fact that cardiovascular diseases are most prevalent among
the elderly patients.
3.3. General prescription pattern
The average number of medicine per prescription was
9.29 Æ 3.29 and the average duration of prescribed medication
in hospitalized elderly patient was 6.97 Æ 3.65 days. The total
numbers of prescribed drugs were 4664 in 502 prescriptions.
On the category-wise distribution of prescribed drugs, it was
found that antimicrobials drugs (18.84%) were most
frequently prescribed drugs, followed by drugs acting on car-
diovascular system (15.45%), endocrine system (9.60%),
gastrointestinal system (9.47%), analgesic & anti-
inflammatory drugs (9.06%) and vitamin, minerals & dietary
supplements (7.69%). Among the different drug classes, anti-
biotics were the most widely prescribed class of drugs;
approximately 2 antibiotics were prescribed to each patient.
Among the cephalosporin, ceftriaxone was the most widely
prescribed antibiotic followed by quinolones like ciprofloxacin
and ofloxacin. Among drugs acting on central nervous system
(5.93%), benzodiazepines, comprising of alprazolam and lor-
azepam were commonly prescribed anti-anxiety and seda-
tives in recommended daily dose.
3.4. Analysis of inappropriate drug use by 2006 HEDIS
measures
The overall 502 elderly patients aged over 60 year were
admitted during the study period in the medicine and
cardiology department of tertiary care hospital. Of the 502
elderly patients, 288 (57.37%) were from medicine department
and 214 (42.62%) were from cardiology department. In medi-
cine department 8 elderly patients had inappropriate pre-
scription while in cardiology department 4 elderly patients
having inappropriate prescription.
In our study, 12 (2.39%) each patient had received only 1
inappropriate drug identified by 2006 HEDIS measure and
severity of an adverse outcome due to exposure of this
medication (high vs. low) were ranked and shown in Table 1.
Of the 12 inappropriate drugs, short acting nifedipine having
high severity was prescribed to 4 elderly patients each.
3.5. Predictors of inappropriate drug use
In this study, elderly patients’ age of range 60e69 received
maximum number of inappropriate drugs. It is also
observed that patient with !11 number of medication and
stay !11 number of days along with !3 number of diagnosis
were received high number of inappropriate drugs (Table 2).
Using logistic regression analysis, identified that increased
number (!11) of concurrent medications use during hospital
stay (OR: 0.015, CI: 0.001e0.199, P ¼ 0.001) and prolonged (!5
days) length of stay (OR: 0.039, CI: 0.005e0.291, P ¼ 0.002)
were the predictors of inappropriate medication use. There
wasn’t any statistical significance in inappropriate drug
prescribing to male and female patients (OR ¼ 4.538;
CI ¼ 0.940e21.918, P ¼ 0.060). Different age groups and
number of diseases does not predict any inappropriate drug
use (Table 2).
4. Discussion
In this study antimicrobial drugs and drug acting on cardio-
vascular system were highly prescribed to the elderly patients.
Overall2 antibiotics per patientwereprescribed to hospitalized
elderly patients. Among the different classes of antibiotic; 3rd
generation cephalosporin i.e., ceftriaxone was most widely
prescribed drug to the elderly hospitalized patients and have
long half life as compared to other parenteral cephalosporin,
which permit once-daily dosing. Whereas, quinolones
Table 2 e Analysis of predictors associated with inappropriate drug use.
Predictors Total
(n ¼ 502)
Patients with inappropriate
drug use (n ¼ 12)
Significance
(P < 0.05)
Odd ratio 95% confidence
interval
1 Age 60e69 386 9 0.032 1 e
70e79 105 2 0.009 0.014 0.001e0.339
!80 11 1 0.021 0.019 0.001e0.546
2 Sex Female 194 6 1 e
Male 308 6 0.060 4.538 0.940e21.918
3 No. of medication 5 137 0 0.006 1 e
5e10 192 1 0.997 <0.001 0.000e>0.001
!11 173 11 0.001 0.015 0.001e0.199
4 Length of stay 5 209 2 0.002 1 e
5e10 219 4 0.002 0.039 0.005e0.291
!11 74 6 0.002 0.067 0.012e0.372
5 No. of diagnosis 1 74 1 0.706 1 e
2 153 1 0.701 1.564 0.159e15.344
!3 275 10 0.486 0.442 0.044e4.409

comprised of ciprofloxacinandofloxacin were2ndmostwidely
prescribed antibiotic in this study. Moreover, this quinolones
are well absorbed and had a considerable spectrum of anti-
bacterial activity. The excessive use of antibiotics has led to the
emergence of bacterial resistance. The inappropriate and ir-
rational use of antibiotic in the clinical medicine is widespread,
sometime at inadequate dosages and often, for non-bacterial
diseases.9
Thus, the antimicrobials drug must be consider
while preparing such quality tools in elderly patient to avoid
the drug resistance and inappropriate prescribing.
In our study, alprazolam and lorazepam were prescribed in
recommended daily dose i.e., 1e2 mg/day and 1e3 mg/day
respectively. Benzodiazepines should be prescribed to the
elderly, only with caution and for a short period at recom-
mended doses.10
While prescribing benzodiazepines, daily
doses should not exceed 2 mg for alprazolam, 3 mg for lor-
azepam, 60 mg oxazepam and 15 mg for temazepam.
4.1. Inappropriate medication use
The prevalence of potentially inappropriate drug in our study
was low (2.39%) by 2006 HEDIS criteria as compared to Pugh
et al study as they have reported prevalence of about 19.6% of
potentially inappropriate drugs by HEDIS 2006 drug list.11
Several commonly used drugs from the 1997 Beers criteria
were not included in 2006 HEDIS measure. The low prevalence
of inappropriate drug use in our study may be due to less
number of drugs being enlisted in HEDIS criteria and our study
was limited to inpatient setting of medicine and cardiology
department which may exclude inappropriate drugs pre-
scribed to elderly patients attending in outpatient setting and
other departments of hospital. Moreover, geographical varia-
tion among physicians in the awareness of the existence of
list of inappropriate drugs might also account for low preva-
lence in this study. Therefore, our prevalence rate may un-
derestimate the true level of potential inappropriate drug use.
Prescriptions of drugs that are considered to be inappro-
priate are deemed to be an important cause of adverse drug
reactions in the elderly population.12
In this study, we haven’t
considered the inappropriate drug induced adverse events
therefore our finding lack the reporting of adverse drug
reactions.
In our study, short acting nifedipine was prescribed to 4
elderly patients likewise of the 114 inappropriate drugs; the 4
drugs were nifedipine detected in Portuguese elderly
outpatient.13
In 11 European countries the study was con-
ducted and it is found that 0.7% (19 patients) of patients had
received nifedipine14
whereas, 2% of patients were received
nifedifine in the study conducted in 17 long term care facil-
ities of Japan.15
Similarly, The French consensus panel ex-
perts also, considered nitrofurantoin, short acting nifedipine
and stimulant laxatives as inappropriate in the elderly pa-
tients.16
Thus, short acting nifedipine is frequently pre-
scribed in elderly hypertensive patients, despite warnings of
possible harmful cardiovascular effects. It is also reported
that short acting nifedipine increased the risk of stroke
within 7 days in the newly diagnosed elderly hypertensive
patient.17
Because of the potential to cause hypotension and
constipation, short acting nifedipine was considered as a
potentially inappropriate drug in the beers and HEDIS
criteria. Cardiovascular system disorder like hypertension
and angina was more prevalent in our study thus short
acting nifedipine was prescribed in the elderly hospitalized
patients.
In our study, 2 elderly patients had received dicyclomine as
an inappropriate drug. In United States, the study was con-
ducted in outpatient prescription claims database and it was
found that 4.2% of the beneficiaries and 4% claims patients
had received dicyclomine.18
Similarly, study conducted in U.S.
health maintenance organization; reported that at least 1% of
elderly members received belladonna alkaloids (2.3%), dicy-
clomine (1.1%), and hyoscyamine (1.2%).19
Gastrointestinal
antispasmodic drugs are highly anticholinergic and have un-
certain effectiveness. The elderly appear to be more prone to
the anticholinergic effects of dicyclomine on the central
Table 3 e 2006 HEDIS drug list.
Sl. no. Drugs list Severity of adverse
effects
1 Barbiturates High
2 Flurazepam High
3 Meprobamate High
4 Chlorpropamide High
5 Meperidine High
6 Pentazocine High
7 Trimethobenzamide High
8 Belladonna alkaloids High
9 Dicyclomine High
10 Hyoscyamine High
11 Propantheline High
12 Chlordiazepoxide High
13 Diazepam High
14 Quazepam, halazepam,
chlorazepate
High
15 Propoxyphene Low
16 Carisoprodol High
17 Chlorzoxazone High
18 Cyclobenzaprine High
19 Metaxalone High
20 Methocarbamol High
21 Dipyridamole Low
22 Chlorpheniramine High
23 Cyproheptadine High
24 Diphenhydramine High
25 Hydroxyzine High
26 Promethazine High
27 Tripelennamine High
28 Dexchlorpheniramine High
29 Ketorolac High
30 Orphenadrine High
31 Guanethidine High
32 Guanadrel High
33 Cyclandelate Low
34 Isoxsuprine Low
35 Nitrofurantoin High
36 Methyltestosterone High
37 Thioridazine High
38 Mesoridazine High
39 Short acting nifedipine High
40 Desiccated thyroid High
41 Amphetamines High
42 Estrogens Low

nervous system. In the study Page JG et al has reported ma-
jority of adverse effects which were related to the anticho-
linergic activity of the dicyclomine.20
Thus, the dicycloamine
prescribing should be avoided especially in elderly patients to
prevent anticholinergic effects.
In our study, nitrofurantoin was prescribed to 2 elderly
hospitalized patients. Nitrofurantoins are potential for renal
and hepatic impairment. Forty-four cases of nitrofurantoin
associated hepatic injury were reported to the Danish Center
for Monitoring of Adverse Drug reactions from 1968 to 1998.
Forty-one were women with a median age of 69 years.21
In our study, ketorolac was prescribed to 2 elderly hospi-
talized patients. Ketorolac on immediate and long term use
should be avoided in older persons, since a significant
number have asymptomatic gastrointestinal pathologic
conditions.
4.2. Predictors of inappropriate medication use
In our study, elderly women and men were not having any
significant difference to receive inappropriate medication and
different age groups of elderly patients don’t predict any
inappropriate drug prescribing. Polypharmacy is the common
and is significantly associated with inappropriate prescrib-
ing.22
The clinical relevance of polypharmacy is always
questionable. This is especially pertinent in the case of elderly
patients, who are particularly vulnerable to adverse drug
events due to their compromised physiological function. In
this study, patients prescribed with !11 medications were
having more prevalence of inappropriate drug use and high-
level of polypharmacy was observed with 52.78% of patients
receiving ! 6 medications. Similarly, in Singapore nursing
homes study significantly higher (70.04%) inappropriate drug
use along with the high (58.59%) prevalence of polypharmacy
was observed.23
In our study, it was also observed that if the patients
hospitalized for !11 days then they are more likely to
receive inappropriate drugs. It is also shown by Mandavi
et al in Indian elderly hospitalized patient that age over 70
years, number of medications prescribed more than 5 and
longer length of stay in the hospital are the three important
predictors for inappropriate prescribing in elderly
patients.24
Number of diagnoses also has significant impact on the
inappropriate prescribing. It was observed that as the num-
ber of diagnosis increases, number of medications to treat
each particular disease condition also increases which may
leads to polypharmacy and more likely to receive inappro-
priate medication.25
In our study, 54.78% of the patients
suffered from !3 diseases. The majority of the diagnoses in
our study pertained to cardiovascular system (26.43%) which
denoted the higher occurrence of cardiovascular diseases
world-wide.
In conclusion, elderly hospitalized patients those having
multiple medications and long duration of hospital stay were
more likely to receive inappropriate drugs. The finding of this
study also suggests that antimicrobial agents should be
included in drug list of such quality measures to avoid irra-
tional and inappropriate use of antibiotic in elderly patients.
Moreover, the drug list included in such criteria should be
updated periodically and implemented in clinical practice to
avoid inappropriate drug use.
Conflicts of interest
All authors have none to declare.
Acknowledgments
Authors would like to acknowledge the Principal and HODs of
Medicine & Cardiology Department of GMCH, Guwahati for
providing permission to collect the data from elderly patients
in the wards.
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