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 elderlypatients of medicine and cardiology departments ata tertiary care hospital of Northeast India

Ratan J. Lihite a,b,*, Mangala Lahkar b

aDepartment of Pharmacy Practice, National Institute of Pharmaceutical Education & Research (NIPER),

Guwahati, IndiabADR 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 8e3 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 ofmedicine 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 � standard deviation (SD) and percentages

as applicable; age, sex, diagnosis, number of medications and

duration of treatmentswere 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 � 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 2006HEDIS.

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 8e3 2 3 319

3.2. General distribution of disease

The average disease per patient was found to be 3.20 � 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 systemwise analysis of 1604 disorders,

it was found that circulatory systemdisorders (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 � 3.29 and the average duration of prescribed medication

in hospitalized elderly patient was 6.97 � 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 HEDISmeasures

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 frommedicine 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 systemwere highly prescribed to the elderly patients.

Overall 2 antibioticsperpatientwereprescribed tohospitalized

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 inappropriatedrug use (n ¼ 12)

Significance(P < 0.05)

Odd ratio 95% confidenceinterval

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

a p o l l o m e d i c i n e 1 0 ( 2 0 1 3 ) 3 1 8e3 2 3320

comprisedof ciprofloxacinandofloxacinwere2ndmostwidely

prescribed antibiotic in this study. Moreover, this quinolones

are well absorbed and had a considerable spectrum of anti-

bacterial activity. Theexcessiveuseof antibioticshas led to the

emergence of bacterial resistance. The inappropriate and ir-

rationaluseof antibiotic in theclinicalmedicine iswidespread,

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 lorazepamwere 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 HEDISmeasure. 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 adverseeffects

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

a p o l l o m e d i c i n e 1 0 ( 2 0 1 3 ) 3 1 8e3 2 3 321

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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