factors associated with potentially inappropriate medications use by the elderly according to beers...

RESEARCH ARTICLE

Factors associated with potentially inappropriate medications useby the elderly according to Beers criteria 2003 and 2012

Andre de Oliveira Baldoni • Lorena Rocha Ayres •

Edson Zangiacomi Martinez • Nathalie de Lourdes Souza Dewulf •

Vania dos Santos • Leonardo Regis Leira Pereira

Received: 23 January 2013 / Accepted: 7 November 2013

� Koninklijke Nederlandse Maatschappij ter bevordering der Pharmacie 2013

Abstract Background Potentially inappropriate medica-

tions (PIMs) should be avoided by the elderly because they

possess a significant high risk for this population when a safer

alternative is available. Therefore, the identification of prev-

alence and factors associated with PIMs should be considered

as they provide valuable information that can be used to

develop strategies to ensure patients’ safety. Objective To

identify the prevalence and the clinical and socioeconomic–

demographic factors that may be associated with PIMs use in

the elderly, according to Beers criteria 2003 and its updated

version 2012. And, as a secondary objective, a comparison

between both criteria was performed. Setting Pharmacy of the

Basic Health District Unit of the western district of Ribeirao

Preto. Methods This cross-sectional observational study was

conducted with the elderly, assisted by the Brazilian public

health system. Data from patients were collected through a

structured interview form. Beers criteria 2003 and 2012 were

used to classify PIMs. The association between PIMs used and

independent variables were analyzed by odds ratios. The

differences between PIMs use according to Beers criteria 2003

and 2012 were analyzed by McNemar’s test and the agree-

ment by kappa coefficient. Main outcome measure Prevalence

and factors associated with PIMs use in Brazilian elderly

outpatients. Results One thousand elderly patients were

interviewed. High prevalence of PIMs use was observed, 48.0

and 59.2 % according to Beers criteria 2003 and 2012,

respectively. The factors associated with PIMs use, common

for both criteria, are female gender, self-medication, use of

over the counter drugs, complaints related to adverse drug

event, psychotropic medication, polypharmacy and some

categories of drugs. PIMs use is different between Beers cri-

teria 2003 and 2012 (McNemar’s test, p \ 0.01), although a

substantial agreement between these classifications was

observed (kappa coefficient 0.635, 95% confidence intervals

(0.588, 0.681). Conclusions Our study showed a high preva-

lence of PIMs use, which is associated with various clinical

and social–demographic factors. When comparing both cri-

teria through McNemar’s test, PIMs use was considered dif-

ferent. The differences may have occurred because

medications with high prevalence of use in Brazil were

included in Beers criteria 2012.

Keywords Beers criteria � Brazil � Elderly �Pharmacoepidemiology � Potentially inappropriate

medications

Impact of findings on practice

• The prevalence of potentially inappropriate medica-

tions (PIMs) use seems to be higher in Brazil than in

other countries.

A. O. Baldoni (&) � L. R. Ayres � L. R. L. Pereira

Pharmaceutical Services and Clinical Pharmacy Research Center

(CPAFF), Department of Pharmaceutical Sciences, School of

Pharmaceutical Science of Ribeirao Preto, University of Sao

Paulo (FCFRP-USP), Avenida do Cafe, s/no., Campus

Universitario da USP, Ribeirao Preto, SP 14040-903, Brazil

e-mail: [email protected]

E. Z. Martinez

Department of Social Medicine, School of Medicine of Ribeirao

Preto, University of Sao Paulo (FMRP-USP), Ribeirao Preto,

Brazil

N. L. S. Dewulf

School of Pharmacy, Federal University of Goias (UFG),

Goiania, Brazil

V. dos Santos

Department of Clinical Analysis, Toxicology and Bromatology,

School of Pharmaceutical Science of Ribeirao Preto, University

of Sao Paulo (FCFRP-USP), Ribeirao Preto, Brazil

123

Int J Clin Pharm

DOI 10.1007/s11096-013-9880-y

• PIMs use is associated with multi-factorial character-

istics: gender, not having a partner, self-medication, use

of over the counter drugs, complaints related to adverse

drug event (ADE), use of psychotropic medication,

more than five medications, and some categories of

drugs.

• According to McNemar’s test, PIMs use is considered

different between Beers criteria 2003 and 2012,

although there seems to be a moderate agreement

between these classifications through kappa coefficient.

• Five out of ten medications with higher prevalence of

self-reported complaints about ADE’s in Brazil were

classified as PIMs.

Introduction

According to the World Health Organization, the elderly is

defined as a population that is 60 years and older in devel-

oping countries [1]. Currently the Brazilian population is 190

million, with about 20 million elderly people, representing

10.8 % of the population [2]. Since the 1960s, there has been

an increase in the percentage of the elderly, and the popu-

lation aged 60 years and older has grown faster than in

previous decades [2]. This increase in the percentage of the

elderly can be justified by better health conditions offered to

the population in recent decades, which generated a signifi-

cant reduction in overall mortality rates [3].

This percentage increase demands improvements in the

health care system as this population presents a high

prevalence of chronic diseases and/or conditions, needing

several medications to treat co-morbidities [4]. Medication

is one of the most important items of health care for the

elderly and the risks of inappropriate use are higher in this

age group. When compared to the rest of the population

these users become more vulnerable to adverse drug events

(ADEs) due to their physiological particularities [5, 6].

There is concern in the literature in relation to medica-

tions considered inappropriate for the elderly and ADEs,

polypharmacy, therapeutic redundancy and potentially

dangerous medication interactions. These factors, when

combined with self-medication and inappropriate pre-

scribing, contribute to therapeutic failure and generate

unnecessary costs [5, 7–9].

Potentially inappropriate medications (PIMs) have been

defined as medications that should be avoided by the

elderly because they possess a significant high risk for this

population when a safer alternative is available [10]. In

order to identify PIMs for the elderly, various criteria have

been employed. One of the most widely used is Beers

criteria, which was developed in 1991 for the elderly in

nursing homes to improve the quality of geriatric services

[11]. A newer version that also included community-

dwelling elderly patients was developed in 1997, and later

two updates incorporated new information from scientific

literature, one in 2003 and another in 2012 [10, 12, 13].

Given the increase in the number of elderly in the

Brazilian population and the clinical, humanistic and eco-

nomic consequences that the use of PIMs generates for the

patient and for the health system, the analysis of the

prevalence of use, and factors that are associated with the

use of these drugs, become essential for health planning,

providing valuable information that can be used to develop

strategies to ensure patients’ safety.

Aim of the study

The main objective of the study was to identify the preva-

lence and factors associated with PIMs used by elderly out-

patients according to Beers criteria 2003 and 2012. The

secondary objective was to perform a comparison of both

criteria.

Method

Study design and data collection

This is a cross-sectional study conducted in the Brazilian

city of Ribeirao Preto in the state of Sao Paulo. Information

was collected through a structured interview questionnaire

about medication used by elderly patients who are assisted

by the Brazilian public health system in the outpatient

pharmacy of the Basic Health District Unit of western

Ribeirao Preto. The interviews took place at the Health

Center School of the Faculty of Medicine of Ribeirao Preto

at the University of Sao Paulo (CSE-FMRP-USP) from

November 20th 2008 to May 20th 2009. The population of

Ribeirao Preto is approximately 605,000 inhabitants and

the unit studied covers a population of 184,000 inhabitants

[2].

Socioeconomic and demographic data from patients as

well as data related to the pharmacotherapy used were col-

lected. In order to analyze the pharmacotherapeutic profile,

the medications being used at the time of the interview were

considered, plus those consumed in the previous 30 days.

Self-medication and complaints about ADEs were identified

by self-report. In Brazil it is common to perform self-med-

ication with over-the-counter (OTC) and prescribed drugs

because of the lack of control of the regulatory agency.

All interviews were conducted by one pharmacist who used

a structured interview form previously developed by four

researchers, all with broad experience in pharmacoepidemi-

ology. A pilot study was performed with 20 elderly patients.

Int J Clin Pharm

123

The inclusion criteria were patients aged 60 years or

older of both genders who obtained their medications at the

public pharmacy during the study period. Exclusion criteria

were patients unable to express themselves or who went to

the pharmacy to collect the medication for another person.

This study was approved by the Ethics Committee of

CSE-FMRP-USP, protocol n. 285.

Medications classification

The medications were classified as PIMs or not, using

Beers criteria 2003 classification and the updated Beers

criteria 2012 as tools [10, 13].

Beers criteria 2003 is divided into two lists. The first

contains 48 medications or medication classes which

should be avoided by the elderly, their potential risks, and

some of their dosages. The second contains 20 medications

that should be avoided, considering the diagnosis of the

diseases or medical conditions [10]. Beers criteria 2012 is

divided into three lists. The first contains 34 medications or

medication classes which should be avoided by the elderly,

their potential risks, and some of their dosages. The second

contains the medications that should be avoided consider-

ing the diagnosis, and the third contains 14 medications or

medication classes that should be used with caution [13].

In order to classify PIMs according to both sets of criteria,

the classification of medication and/or medication classes

irrespective of diagnosis was considered. Doses were assessed

when necessary. The diagnosis was not considered due to lack

of information since only the patients were interviewed.

The medications were also classified using the first level

of anatomical therapeutical chemical (ATC) classification

[14]. Over-the-counter and psychotropic medications were

identified by Resolution no 138/2003 and Decree 344/98

and their updates according to the National Health Sur-

veillance Agency (Anvisa), respectively [15, 16].

Data analysis

The information was compiled in the Epi Info� version

3.4.3 database (www.cdc.gov/epiinfo). The use of PIMs

was considered as a dependent variable and was associated

with clinical and socioeconomic variables. All cut-offs of

quantitative variables were defined based on the median of

the results obtained, except for the number of medications,

where more than five medications were classified as pol-

ypharmacy. This definition was chosen because the use of

five or more drugs is associated with the occurrence of

ADEs caused by PIMs use [17].

The association between PIMs use and a set of indepen-

dent variables was analyzed for odds ratios (ORs) with their

respective 95 % confidence intervals (CIs). Multiple logistic

regression was used to obtain adjusted ORs, controlling for

age, gender, education level, partnership, per capita income,

and occupation. Statistical analysis software SASTM, version

9.2, was used to obtain estimates of interest [18].

The differences between PIMs use according to Beers

criteria 2003 and 2012 were analyzed by McNemar’s test

and the agreement between these classifications by kappa

coefficient. The levels assigned to the corresponding ranges

of kappa are\0.00 (poor strength of agreement), 0.00–0.20

(slight), 0.21–0.40 (fair), 0.41–0.60 (moderate), 0.61–0.80

(substantial) and 0.81–1.00 (almost perfect strength agree-

ment) [19].

Results

From November 20th 2008 to May 20th 2009, 1227 elderly

patients were invited to the study while they were at the

pharmacy waiting to obtain their medication. Of these, 116

patients refused to participate and 111 did not meet the

inclusion criteria; therefore, 1,000 patients were included

for the interview. The district where the study was con-

ducted has an estimated population of 17,664 elderly

people who depend exclusively on the Brazilian public

health system; therefore, patients included in this study

represent 5.67 % of the elderly who use the public health

service in this district [20, 21].

The mean age was 69.8 years with a standard deviation

(SD) of 6.5, the range being from 60 to 94 years, with the

female population being 66.1 %. It was observed that the

number of married men was almost twice that of the

number of married women (80.2 vs. 42.2 %). The char-

acteristics of this group are presented in Table 1.

A total of 6,856 medications were used in the previous

30 days, with 5,475 being prescribed medications and

1,381 being self-medications. The prevalence of patients

who used self-medication was 30.9 %. A mean of 6.9 drugs

per patient/day, ranging from one to 21, were administered.

About 60 % of the population studied used more than five

medications. According to the ATC classification, the most

commonly used medications were for the cardiovascular

system, which were used by the majority of patients

(83.4 %), and the second were for the alimentary tract and

metabolism, which were used by 64.3 % of the studied

group. The use of psychotropic medication was observed in

35.9 % of the patients. Moreover, 44 % of women used

these medications, which is more than twice the percentage

of men (20.1 %).

PIMs according Beers criteria 2003

According to Beers criteria 2003, 480 (48.0 %) participants

used at least one PIM, the mean being 1.38 (SD = 0.65)

PIMs/person, ranging from one to five. The factors that are

Int J Clin Pharm

123

http://www.cdc.gov/epiinfo

associated with PIMs use were female gender, self-medi-

cation, use of OTC medications, complaints related to

ADEs, psychotropic medication, more than five medica-

tions, and some ATC groups (musculoskeletal system,

antineoplastic and immunomodulating agents, nervous

system, respiratory system). Their ORs and the corre-

sponding CIs are presented in Table 2.

These PIMs were used mostly by women (77.5 %).

Medications with a high prevalence of prescription and

considered inappropriate were dexchlorpheniramine

(9.6 %), fluoxetine (9.1 %), diazepam (7.6 %), amitripty-

line (7.3 %), clonidine (5.6 %), and orphenadrine (5.6 %).

PIMs according Beers criteria 2012

According to Beers criteria 2012, 592 (59.2 %) participants

used at least one PIM, the mean being 1.56 (SD = 0.81)

PIMs/person, ranging from one to six. The factors associated

with PIMs use were female gender, not having a partner,

self-medication, use of OTC medications, complaints related

to ADEs, psychotropic medication, more than five medica-

tions, and some ATC groups (musculoskeletal system;

respiratory system; nervous system; genitourinary system

and sex hormones) (Table 3).

Factors such as education level, per capita income,

occupation, number of medical appointments, community

health care agent visits, and health insurance were not

associated with PIMs use in either tool.

Medications with a high prevalence of prescription and

considered inappropriate were diclofenac (20.3 %), dex-

chlorpheniramine (9.6 %), diazepam (7.6 %), amitriptyline

(7.3 %), clonazepam (6.1 %), clonidine (5.6 %), and

orphenadrine (5.6 %).

During the interview 45.5 % of participants reported

complaints related to ADEs; 94.5 % of these were caused

by prescribed medication. In Table 4, the ten medications

with the highest prevalence of self-reported ADEs com-

plaints can be observed. Among them, five were considered

PIMs according to Beers criteria, of which clonidine,

amitriptyline and dexchlorpheniramine are listed in both

criteria, while fluoxetine is listed only in Beers criteria

2003 and diclofenac is listed only in Beers criteria 2012.

The results presented in Table 5 show that PIMs use

differs between Beers criteria 2003 and 2012 (McNemar’s

Table 1 Sociodemographic

characteristics of the studied

population (n = 1,000)

OTC medications over-the-

counter medications, ADEs

adverse drug events, PIMs

potentially inappropriate

medications

Men

(n = 339)

Women

(n = 661)

Total

(n = 1,000)

Age group (years)

60–64 71 (20.9 %) 176 (26.6 %) 247 (24.7 %)

65–75 193 (56.9 %) 370 (56.0 %) 563 (56.3 %)

[75 75 (22.1 %) 115 (17.4 %) 190 (19.0 %)

Partner

With 272 (80.2 %) 279 (42.2 %) 551 (55.1 %)

Without 67 (19.8 %) 382 (57.8 %) 449 (49.9 %)

Per capita income

\$ 240,00 171 (50.4 %) 385 (58.2 %) 556 (5.6 %)

C$ 240,00 168 (49.6 %) 276 (41.8 %) 444 (44.4 %)

With occupation 23 (6.8 %) 28 (4.2 %) 51 (5.1 %)

Health insurance 59 (17.4 %) 108 (16.3 %) 167 (16.7 %)

Community Healthcare Agents Visits 147 (43.4 %) 279 (42.2 %) 426 (42.6 %)

Annual medical appointments

B3 179 (52.8 %) 282 (42.7 %) 461 (6.1 %)

[3 160 (47.2 %) 379 (57.3 %) 539 (53.9 %)

Self-medication 79 (23.3 %) 230 (34.8 %) 309 (30.9 %)

Use of OTC medications 233 (68.7 %) 569 (86.1 %) 802 (80.2 %)

Complaints related to ADEs 132 (38.9 %) 323 (48.9 %) 455 (45.5 %)

Psychotropic medication 68 (20.1 %) 291 (44.0 %) 359 (35.9 %)

Number of Medications items

5 or fewer 182 (53.7 %) 176 (32.8 %) 399 (39.9 %)

More than 5 157 (46.3 %) 370 (67.2 %) 601 (60.1 %)

Use of PIMs according to Beers Criteria (2003) 108 (31.9 %) 372 (56.3 %) 480 (48.0 %)

Use of PIMs according to Beers Criteria (2012) 157 (46.3 %) 435 (65.8 %) 592 (59.2 %)

Int J Clin Pharm

123

test, p \ 0.01), although a substantial agreement between

these classifications is observed (kappa coefficient 0.635,

95 % CI (0.588, 0.681).

Discussion

High rates of PIMs use were identified with both tools—

Beers Criteria 2003 and 2012, 48.0 and 59.2 %

respectively. To our knowledge, this is the first study to

compare the prevalence of PIMs use through both criteria.

The prevalence of PIMs use in this study conducted in

Brazil is one of the highest compared to other countries

[22–27]. One study performed in New Zealand found a

similar prevalence of PIMs use (42.7 %) [28]. Several

factors might be related to this finding. Among them, the

high rate of self-medication in this population (30.9 %) can

be highlighted. Another Brazilian study found 8.9 % of

Table 2 Factors associated

with potentially inappropriate

medications use according to

2003 Beers criteria (n = 1,000)

Adjusted by age, gender,

education level, partnership, per

capita income and occupation

ORs odds ratios, CIs confidence

intervals, OTC medications

over-the-counter medications,

ADEs adverse drug events, ATC

anatomical-therapeutical-

chemical classification system,

L antineoplastic and

immunomodulating agents,

R respiratory system,

M musculo-skeletal system,

N nervous system

2003 Beers criteria

Potentially inappropriate medication use

Crude ORs

(95 % CIs)

Adjusted ORs

(95 % CIs)

Yes (n = 480) No (n = 520)

Age group (years)

60–64 124 (25.8 %) 123 (23.7 %) Reference Reference

65–75 271 (56.5 %) 292 (56.1 %) 0.9 (0.6, 1.2) 0.9 (0.6, 1.2)

[75 85 (17.7 %) 105 (20.2 %) 0.8 (0.5, 1.2) 0.8 (0.5, 1.2)

Gender

Male 108 (22.5 %) 231 (44.4 %) Reference Reference

Female 372 (77.5 %) 289 (55.6 %) 2.7 (2.0, 3.6) 2.5 (1.9, 3.5)

Partner

With 237 (49.4 %) 314 (60.4 %) Reference Reference

Without 243 (50.6 %) 206 (39.6 %) 1.6 (1.2, 2.0) 1.2 (0.8, 1.5)

Self-medication

No 363 (61.3 %) 328 (80.4 %) Reference Reference

Yes 229 (38.7 %) 80 (19.6 %) 2.3 (1.7, 3.0) 2.1 (1.5, 2.8)

Use of OTC medications


Yes 425 (88.5 %) 377 (72.5 %) 2.9 (2.0, 4.1) 2.5 (1.7, 3.6)

Complaints related to ADEs


Yes 265 (55.3 %) 190 (36.5 %) 2.1 (1.6, 2.8) 2.0 (1.5, 2.6)

Psychotropic medication


Yes 275 (57.3 %) 84 (16.1 %) 7.0 (5.1, 9.4) 6.3 (4.6, 8.6)


5 or fewer 124 (25.8 %) 275 (52.9 %) Reference Reference

More than 5 356 (74.2 %) 245 (47.1 %) 3.2 (2.4, 4.2) 2.9 (2.1, 3.8)

ATC code L


Yes 36 (7.5 %) 23 (4.4 %) 1.8 (1.02, 3.00) 1.9 (1.08, 3.31)

ATC code R


Yes 133 (27.7 %) 41 (7.9 %) 4.5 (3.07, 6.52) 4.2 (2.94, 6.35)

ATC code M


Yes 271 (56.5 %) 200 (38.5 %) 2.1 (1.61, 2.67) 1.8 (1.40, 2.36)

ATC code N


Yes 383 (79.8 %) 238 (45.8 %) 4.7 (3.53, 6.20) 4.1 (3.07, 5.50)

Int J Clin Pharm

123

1,222 elderly patients on self-medication [29]. However,

the study analyzed the previous 3 days of self-medication

consumption while the present study analyzed self-medi-

cation over the previous 30 days which may lead to recall

bias since some patients might forget which medication

they had consumed previously. Unfortunately in Brazil, the

population can acquire prescription medication without

presenting a prescription in many commercial pharmacies.

This fact is probably due to poor inspection from

regulatory agencies. Only psychotropic drugs, antibiotics

and COX-2 selective inhibitor anti-inflammatory drugs

have stricter controls.

A high consumption of diclofenac was observed

(20.3 %), with almost half (9.9 %) of this consumption

considered self-medication. Brazilian law requires the

presentation of a prescription for the acquisition of dic-

lofenac; in practice this is not requested by the pharmacies,

hence contributing to self-medication.

Table 3 Factors associated

with potentially inappropriate

medications use according to

2012 Beers criteria (n = 1,000)

Adjusted by age, gender,

education level, partnership, per

capita income and occupation

ORs odds ratios, CIs confidence

intervals, OTC medications

over-the-counter medications,

ADEs adverse drug events, ATC

anatomical-therapeutical-

chemical classification system,

R respiratory system,

M musculo-skeletal system,

G genito urinary system and sex

hormones, N nervous system

2012 Beers criteria

Potentially inappropriate medication use

Crude ORs

(95 % CIs)

Adjusted ORs

(95 % CIs)

Yes (n = 592) No (n = 408)

Age group (years)

60–64 158 (26.7 %) 89 (21.8 %) Reference Reference

65–75 338 (57.1 %) 225 (55.2 %) 0.8 (0.6, 1.2) 0.8 (0.5, 1.1)

[75 96 (16.2 %) 94 (23.0 %) 0.6 (0.3, 0.9) 0.5 (0.3, 0.8)

Gender

Male 157 (26.5 %) 182 (44.6 %) Reference Reference

Female 435 (73.5 %) 226 (55.4 %) 2.2 (1.7, 2.9) 1.8 (1.3, 2.5)

Partner

With 293 (49.5 %) 258 (63.2 %) Reference Reference

Without 299 (50.5 %) 150 (36.8 %) 1.8 (1.3, 2.3) 1.5 (1.1, 2.1)

Self-medication


Yes 229 (38.7 %) 80 (19.6 %) 2.6 (1.9, 3.5) 2.4 (1.7, 3.3)

Use of OTC medications


Yes 501 (84.6 %) 301 (73.8 %) 1.9 (1.4, 2.7) 1.8 (1.2, 2.5)

Complaints related to ADE


Yes 307 (52.0 %) 148 (36.3 %) 1.9 (1.4, 2.5) 1.8 (1.3, 2.3)

Psychotropic medication


Yes 291 (49.2 %) 68 (16.7 %) 4.8 (3.5, 6.6) 4.5 (3.2, 6.2)


5 or fewer 176 (29.7 %) 223 (54.7 %) Reference Reference

More than 5 416 (70.3 %) 185 (45.3 %) 2.9 (2.1, 3.7) 2.7 (2.0, 3.6)

ATC code R


Yes 142 (24.0 %) 32 (7.8 %) 3.71 (2.46, 5.57) 3.53 (2.33, 5.35)

ATC code M


Yes 371 (62.7 %) 100 (24.5 %) 5.17 (3.90, 6.84) 4.71 (3.54, 6.26)

ATC code G


Yes 25 (4.2 %) 7 (1.7 %) 2.53 (1.08, 5.90) 2.76 (1.15, 6.59)

ATC code N


Yes 436 (73.7 %) 185 (45.3 %) 3.37 (2.57, 4.40) 3.07 (2.31, 4.06)

Int J Clin Pharm

123

In this context it is important to highlight that based on

the results of this study, the inclusion of diclofenac in

Beers criteria 2012 is of great relevance, since it is related

to high prevalence (19.2 %) of reported problems regard-

ing ADEs in the studied population (Table 4). Therefore,

the inclusion of diclofenac in Beers Criteria 2012 can be

considered one of the main causes of different rates

between both criteria and of the result obtained in McNe-

mar’s test. The inclusion of clonazepam and the exclusion

of fluoxetine from Beers criteria 2012, which are used by

6.1 and 9.1 % of the patients respectively, may also have

contributed to the difference found. The substantial

agreement between these classifications probably occurred

because most of the PIMs used by this population were

included in both criteria (Table 5).

The use of PIMs was related to the use of OTC medica-

tions. More than 80 % of the patients taking PIMs also use

OTC medication. Over-the-counter is considered an eco-

nomical treatment option and its use is increasing as more

OTC medications are becoming available [30]. Another

factor that contributes to this fact is the accessibility of OTC

medications which are often seen by patients as drugs

without serious side effects [30]. According to the findings in

the present study, the most used OTC medication considered

a PIM according to both criteria is orphenadrine, which is

used with a combination of other drugs as a painkiller.

The use of PIMs has been considered a frequent cause of

ADEs, which are responsible for many of the geriatric

hospital admissions [31]; furthermore, 40 % of ADEs lead

to hospitalization that could be avoided [32]. In addition to

the negative clinical and humanistic aspects that PIMs use

might cause, the use also increases the demand on financial

resources for the health system [33]. In this study, most

drugs that were possibly related to ADEs are also consid-

ered inappropriate for the elderly (Table 4). Fluoxetine,

which was considered a PIM in Beers criteria 2003, is

related to 27 % (24/89) of patient complaints about ADEs.

Although fluoxetine was removed from the PIMs list in

Beers criteria 2012, it was placed on a list of medications

that should be used with caution together with the other

selective serotonin reuptake inhibitors because they may

exacerbate or cause inappropriate antidiuretic hormone

secretion syndrome or hyponatremia [13].

When comparing the complaints related to drugs

reported by the elderly in this study with the ADEs already

described in the literature, a concordance between patients’

perception and the events relayed in pharmacotherapeutic

textbooks can be observed [34]. Besides, when analyzing

quantitatively the prevalence of ADEs, it can be observed

that some of the ADEs cited in this study are more pre-

valent among the elderly.

Table 4 Medication with higher prevalence of self-related complaints about adverse drug events by elderly (n = 1,000)

Medication (n/N; %) Complaints related to adverse drug events (n)

Clonidinea (42/57) 73.7 Xerostomy (30), somnolence (5); others (6)

Amitriptylinea (41/70) 58.6 Xerostomy (22), constipation (4) sleep (4); uneasiness (3); weakness (2) nightmare (2); others (4)

Metformin (63/178) 35.4 Diarrhea (33), nausea (9); heartburn (3); abdominal cramp (3); stomachache (3) flatulence (3) others (12)

Fluoxetineb (24/89) 27 Somnolence (6); xerostomy (5); heartburn (4); bitter mouth (2); stomachache (2), others (5)

Dexchlorpheniraminea (24/97)

24.7

Somnolence (24)

Diclofenacc (39/203) 19.2 Stomachache (21); tachycardia (2); edema (2); other (14)

Captopril (34/188) 18.1 Dry cough (23), xerostomia (3), stomachache (2), nausea (2), othes (4),

Acetyl salicylic acid (46/372) 12.3 Stomach ache (30), skin hematoma (8), nosebleed (3), gastrointestinal bleeding (2), others (3)

Simvastatin (40/362) 11.05 Muscle pain (5), insomnia (5), nausea (5), gastric pain (2), gastric pain (2), muscle weakness (2), others

(19).

Hydrochlorothiazide (30/377)

7.95

Cramp (17), somnolence (3), muscle weakness (2), urinary incontinence (2), others (6)

n number of patient that had complaints about adverse drug events, N number of patients that use the druga PIMs according to Beers criteria 2003 and 2012b PIMs according to Beers criteria 2003c PIMs according to Beers criteria 2012

Table 5 Agreement between prevalence of potentially inappropriate

medications use by elderly according Beers Criteria 2003 and 2012

(n = 1,000)

Beers 2012 Total

Yes No

Beers 2003 Yes 444 36 480 (48.0 %)

No 148 372 520 (52.0 %)

Total 592 (59.2 %) 408 (40.8 %) 1,000 (100 %)

Int J Clin Pharm

123

Regarding the higher prevalence of PIMs use among

women, it can also be observed in other studies which

concluded that elderly women are more likely to use these

medications, even if they receive the same healthcare

provided to men [35, 36]. This difference may occur since

women are more likely to see a physician and talk about

their problems. Furthermore, they tend to live longer than

men and are in a greater number [37].

In cases where the elderly (both male and female) are

older than 75 years they seem to use less PIMs than those

aged between 60 and 75. This can be due to a higher

concern by physicians in prescribing these medications to

this population.

Polypharmacy is an important factor associated with

PIMs. This study showed that the elderly who use more

than five different medications have 2.9 and 2.7 times more

chances of using at least one PIM according to Beers cri-

teria 2003 and 2012, respectively. In accordance with data

in the present study, Gallagher [38] showed that poly-

pharmacy in the elderly increases the chances of PIMs use

by 3.3 times. What is more, Johnell and Fastbom [39]

found significant association between polypharmacy and

anticholinergic medication use and the use of three or more

psychotropic medications.

In this study, the prevalence of the elderly taking psy-

chotropic medication accounts for 35.9 % and the preva-

lence of patients taking at least one psychotropic medication

that is considered a PIM according to Beers criteria 2003

and 2012 were 27.5 and 29.1 % respectively. The similari-

ties are probably because some psychotropic medications

such as fluoxetine, considered a PIM in Beers criteria 2003,

was removed from Beers criteria 2012, while others such as

clonazepam and chlorpromazine, were added to this updated

criteria. Prudent and colleagues [40] concluded that elderly

patients receiving polypharmacy with the concomitant use

of psychotropic medication have an increased risk of ADEs.

Although there are similarities between both criteria,

Beers criteria 2012 seems to be stricter than the previous

version since medications that are widely used should now

be avoided or used with caution. However, given the rel-

evance of the inappropriate use of drugs, it is necessary to

combine several strategies such as pharmacists’ interven-

tions and electronic prescribing with alerts for PIMs. A

review evaluated the impact of pharmacists’ interventions

to reduce inappropriate prescribing in the elderly and all

interventions showed positive outcomes [41]. Smith and

colleagues [42] found that the use of electronic prescribing

with alerts for PIMs for the elderly was an effective method

to reduce the use of these drugs. Therefore, training for

health professionals, combined with the incorporation of

Beers criteria 2012 into electronic prescribing systems

should improve clinical and humanistic results and provide

safer treatment for elderly patients.

Conclusion

Our study showed a higher prevalence of PIMs use when

compared with other studies. These high rates were identified

with both tools—Beers Criteria 2003 and 2012, 48.0 and

59.2 % respectively. When comparing Beers criteria 2003 and

2012 according to McNemar0s test, PIMs use was considered

different but a substantial agreement between them through

kappa coefficient was found. The differences may have

occurred because medications with high prevalence of use in

Brazil, such as diclofenac (20.3 %), were included in Beers

criteria 2012. The factors associated with PIMs use according

to both criteria were female gender, self-medication, use of

OTC medication, complaints related to ADEs, psychotropic

medication, polypharmacy and some categories of drugs.

Acknowledgments The authors would like to thank School of

Pharmaceutical Sciences of Ribeirao Preto—University of Sao Paulo

for its support during the research.

Funding The study was supported by Coordenacao de Aperfei-

coamento de Pessoal de Nıvel Superior (CAPES).

Conflicts of interest None.

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