Factors associated with adverse drug reactions in community-dwelling older adults

Abstract

Objective  To evaluate the factors associated with adverse drug reactions (ADR) in older adults in the context of primary health care (PHC).

Method  An epidemiological, cross-sectional, analytical study was conducted in Basic Health Units in the cities of Caicó and Currais Novos, Rio Grande do Norte state, Brazil. Sociodemographic variables, behavioral habits, presence of comorbidities, medication use, perceived health, and occurrence of ADRs were investigated. The exposure variables investigated were: polypharmacy (use of five or more medications), and use of PIM; the outcome variable was the occurrence of potentially life-threatening or disabling adverse reactions (delirium, sedation, gastrointestinal hemorrhages, falls, fractures). Data analysis entailed descriptive statistics followed by bivariate analysis (chi-square) to investigate the association of variables, and multivariate analysis (binary logistic regression).

Results  Overall, 100 participants aged 60 or older were included in the study. Polypharmacy was identified in 44% of the interviewees, PIM use in 28%, while 41% reported ADR, with falls being the most prevalent adverse event (26%). Bivariate analysis revealed ADR was associated with comorbidity, polypharmacy, and PIM (p < 0.001). On the multivariate analysis model, polypharmacy remained the only associated independent risk factor (p < 0.01).

Conclusion  Polypharmacy constituted the main factor associated with ADRs in the community-dwelling older adults. The strengthening of rational prescribing practices, clinical protocols, and interprofessional work (physician-pharmacist) are essential to mitigate risks and ensure therapeutic safety in PHC.

Keywords
Primary Health Care; Older Adult; Potentially Inappropriate Medication List; Drug Prescriptions; Polypharmacy.

Resumo

Objetivo  Avaliar os fatores associados às reações adversas a medicamentos (RAM) em pessoas idosas no contexto da Atenção Primária à Saúde (APS).

Método  Estudo epidemiológico, transversal e analítico, realizado em Unidades Básicas de Saúde dos municípios de Caicó e Currais Novos, Rio Grande do Norte, Brasil. Foram investigadas variáveis sociodemográficas, hábitos comportamentais, presença de comorbidades, uso de medicamentos, percepção de saúde, ocorrência de reações adversas aos medicamentos. As variáveis de exposição foram: polifarmácia (uso de cinco ou mais medicamentos), uso de medicamentos potencialmente inapropriados; a variável de desfecho foi ocorrência de reações adversas potencialmente ameaçadoras à vida ou incapacitantes (delirium, sedação, hemorragias gastrintestinais, quedas, fraturas). Para análise dos dados, foi empregada a estatística descritiva seguida de análise bivariada (qui-quadrado) para investigar variáveis de associação e análise multivariada (regressão logística binária).

Resultados  No total, 100 pessoas com 60 anos ou mais de idade foram incluídas no estudo. A polifarmácia foi identificada em 44% dos entrevistados, o uso de MPI em 28%, e 41% relataram alguma RAM, sendo a queda o evento adverso mais prevalente (26%). A análise bivariada associou RAM com comorbidade, polifarmácia e MPI (p < 0,001). Na análise multivariada, a polifarmácia manteve-se como fator de risco independente associado (p < 0,01) para RAM.

Conclusão  A polifarmácia constitui o principal fator associado às RAM em pessoas idosas. O fortalecimento de práticas de prescrição racional, protocolos clínicos e a atuação interprofissional (médico-farmacêutico) são essenciais para mitigar riscos e garantir a segurança terapêutica na APS.

Palavras-chave
Atenção Primária à Saúde; Idoso; Lista de Medicamentos Potencialmente Inapropriados; Prescrições de Medicamentos; Polimedicação.

INTRODUCTION

Rapid population aging and the consequent changes in the demographic and epidemiological profiles of Brazilian society call for a new vision of care to address the increased prevalence of noncommunicable chronic diseases (NCDs), especially in the older adult population¹,².

In older adults, the prevalence of polypharmacy and use of potentially inappropriate medications (PIMs) is high². Polypharmacy is characterized by the concomitant use of five or more medications¹,³. PIMs, in turn, are drugs whose risks outweigh the benefits of their use when there are therapeutically equivalent alternatives with safer scientific evidence³.

Both polypharmacy and PIM use are risk factors for the occurrence of negative outcomes, which may result from adverse drug reactions (ADRs) and/or drug-drug interactions¹,⁴,⁵.

In this context, the American Geriatrics Society (AGS) established the Beers Criteria in 2012 as a list of PIMs for older adults⁶. These criteria were created by specialists with the aim of increasing prescription safety by identifying drugs to avoid in specific situations⁷. In Brazil, the Beers Criteria formed the basis for the creation of the Brazilian Consensus on Potentially Inappropriate Medications (CBMPI)⁸ as an essential tool for classifying medications, rationalizing prescriptions, and reducing ADRs³.

The Brazilian National Health System (SUS) promotes the rational use of medications through the formulation of an action plan to reduce polypharmacy⁹. The role of the multidisciplinary team in Primary Health Care (PHC), specifically the work of pharmacists, can have positive impacts in the prevention and resolution of medication-related problems, resulting in greater adherence to pharmacotherapy and improved control of chronic diseases¹⁰.

The scenario of high prevalence of polypharmacy and PIMs in older adults prompted the present study, considering PHC as the organizer of care and comprehensive assistance to older adults. The objective of this study was to evaluate the factors associated with ADRs in older adults within the PHC setting.

METHOD

An epidemiological, cross-sectional, analytical study was conducted. The target population of the study was individuals aged 60 years or older, registered and attended at Basic Health Units (BHUs), with medication dispensing or basic pharmacy in the cities of Caicó and Currais Novos – Rio Grande do Norte (RN) state. According to data from the Brazilian Institute of Geography and Statistics (IBGE), the city of Caicó - RN, has approximately 61,146 inhabitants, of which 17.22% are aged 60 years or older¹¹; and has 24 BHUs, five of which offer a medication dispensing service. The city of Currais Novos - RN has approximately 41,313 inhabitants, of which 18.36% are aged 60 or older¹¹. The city has 18 BHUs, and medication dispensing is performed via basic pharmacy services.

The study participants were selected at time of picking up prescribed medications at BHU pharmacies. These units should make available resident professionals from the Family and Community Medicine Program and the Basic Care Residency Program of the Multicampus School of Medical Sciences of Rio Grande do Norte (EMCM/UFRN). The sample size was obtained by convenience. A total of 100 interviews were planned, considering the constraints for implementing the study within an appropriate timeframe.

Thus, the inclusion criteria were being aged 60 years or older and holding a document with a record of medications used (medical prescription, SUS user card, or Older Adult Health Booklet). None of the participants were subsequently excluded. Data were collected from March to August 2025 by medical students/EMCM (Caicó) and by the resident pharmacist in Basic Care/EMCM (Currais Novos), duly trained to apply the semi-structured data collection questionnaire. All participants were invited to take part in the study and sign the Informed Consent Form (TCLE).

The information for the following variables was collected: sociodemographic characteristics, behavioral habits, presence of comorbidities, medication use, perceived health, and occurrence of adverse drug reactions.

The exposure variables were: polypharmacy (use of five or more medications) and use of potentially inappropriate medications; the outcome variable was the occurrence of potentially life-threatening or disabling adverse reactions (delirium, sedation, gastrointestinal hemorrhages, falls, fractures).

The sociodemographic information collected included: sex, age, race/ethnicity, marital status, education, religious practice, and monthly income. Behavioral habits were investigated by asking whether the individual consumed alcohol and/or tobacco, whereas physical activity (PA) was investigated by asking about engagement in physical exercise in the last three months. The presence of comorbidities was assessed based on clinical diagnosis of the following chronic diseases: heart diseases, arterial hypertension, diabetes mellitus, malignant tumor, arthritis or rheumatism, pulmonary diseases, depression, osteoporosis, and stroke.

Perceived health was assessed using a Likert-type scale with response options very good, good, fair, poor, or very poor.

Regarding the presence of polypharmacy and PIMs, medication use was investigated by collecting name and dosage of the prescribed medication. Each medication reported was classified according to the Anatomical Therapeutic Chemical classification system (ATC), recommended by WHO, at levels 1 (anatomical group) and 2 (therapeutic subgroup). Also, medications were checked for inclusion in the National List of Essential Medicines (RENAME)⁵.

The occurrence of polypharmacy was defined as reported concomitant use of five or more medications¹. The occurrence of PIMs was characterized, regardless of clinical condition, according to the CBMPI, which consists of 118 criteria: 43 to be avoided regardless of clinical condition; and 75 depending on specific health conditions³..

ADRs were investigated by asking the participant about the occurrence (within last year) of falls, fractures, hospitalizations, constipation, heart failure, depression, cognitive deficit, and renal dysfunction³.

Data were stored and processed using statistical software. Descriptive analysis (absolute and relative frequency, measures of central tendency, and measures of dispersion) was performed to characterize the sample, and the confidence interval [95% CI] of the proportions observed among the categories analyzed was calculated. Bivariate analysis (Pearson's chi-square test) was then performed to investigate the association of variables. Finally, multivariate analysis (binary logistic regression) was conducted to adjust for possible confounding variables and identify factors associated with ADR occurrence. The 95% CI and significance level α=5% were estimated.

For the regression model, variables were grouped into blocks: 1) sociodemographic characteristics (sex and age group); 2) health conditions (presence of comorbidities, use of polypharmacy, and use of PIMs). Sociodemographic variables were included in the binary logistic regression regardless of the p-value from bivariate analysis, given their importance for adjusting the analysis. The remaining variables were selected according to the statistical significance on bivariate analysis, adopting inclusion criterion of p-value < 0.20.

The present study was approved by the Research Ethics Committee of the Faculty of Applied Social Sciences (CEP FACISA—UFRN), in accordance with the determinations of Resolution No. 466/12 of the National Health Council (CNS), which defines the regulatory guidelines and norms governing research involving humans, and Resolution No. 510/2016 of the National Health Council (CNS). CAAE: 85766424.0.0000.5568 / Approval no.: 7.392.508.

DATA AVAILABILITY

The full data set underpinning the study results is available from figshare at https://doi.org/10.6084/m9.figshare.31231507.

RESULTS

A total of 100 participants aged 60 years or older were interviewed (50 in Caicó and 50 in Currais Novos), registered and attended under the Family Health Strategy of these cities.

The characteristics of the sample, according to sociodemographic variables, behavioral habits, and health conditions, together with the 95% CI of the proportions in each category analyzed, are given in Table 1. The mean age was 71.41 ± 7.88 years. Participants were predominantly female, aged 70 years or older, married or in a stable union, brown, practicing a religion, with educational level below complete elementary school, and income less than two minimum wages. Regarding behavioral habits, only regular physical activity was reported by the majority of respondents. With regard to health conditions, most participants reported having comorbidities and a perceived health status of fair.

Table 1
Sample characterization according to sociodemographic variables, behavioral habits, and clinical and health conditions. Caicó and Currais Novos, Rio Grande do Norte, 2024.

Variables	Relative Frequency (%) N= 100	Confidence Interval [95%] of proportions observed
Sociodemographics
Age: µ = 71.41 ± 7.88 years [Min = 60; Max = 97]
Age Group (years)
60-69	44	[35.0 – 54.0]
≥70	56	[46.0 – 65.0]
Sex
Female	79	[70.0 – 87.0]
Male	21	[13.0 – 30.0]
Education
Incomplete primary	71	[63.3 – 80.6]
Complete primary	12	[5.1 – 17.3]
Complete secondary or greater	15	[8.2 – 21.4]
Not known or no response given	2	[1.1 – 3.1]
Income (minimum wages)
≤ 1	40	[28.0 – 47.0]
>1 and ≤2	31	[22.0 – 41.0]
> 2	29	[17.0 – 33.0]
Marital Status
Single	16	[9.0 – 24.0]
Married/Stable union	48	[38.0 – 58.0]
Separated/Divorced	10	[5.0 – 16.0]
Widowed	26	[17.0 – 35.0]
Race/Ethnicity
Yellow / Asian	2	[0 – 5.0]
White	39	[29.0 – 48.0]
Brown / Mixed	47	[37.0 – 58.0]
Black	12	[6.0 – 19.0]
Religion
Yes	98	[95.0 – 100.0]
No	2	[0 – 5.0]
Behavioral Habits
Alcohol use
Yes	6	[2.0 – 11.0]
No	94	[89.0 – 98.0]
Tobacco use
Yes	7	[2.0 – 12.0]
No	93	[88.0 – 98.0]
Physical activity
Yes	52	[43.0 – 62.0]
No	48	[38.0 – 57.0]
Clinical characteristics
Presence of comorbidities
Yes	70	[61.0 – 79.0]
No	30	[21.0 – 29.0]
Perceived health
Very good/Good	40	[21.2 – 50.6]
Fair	52	[42.4 – 61.0]
Poor / Very poor	8	[2.0 – 11.1]
Polypharmacy use (≥5 medications)
Yes	44	[34.0 – 53.0]
No	56	[47.0 – 66.0]
Potentially Inappropriate Medications use
Yes	28	[20.0 – 38.9]
No	67	[61.1 – 90.0]
Missing data	5	-
Adverse Reactions reported
Yes	41	[50.0 – 69.0]
No	59	[28.0 – 47.0]

The main diseases and adverse reactions reported are presented in Table 2. The most prevalent main comorbidities were systemic arterial hypertension, arthritis, and diabetes. The most prevalent adverse effects were falls.

Table 2
Comorbidities and adverse drug reactions in community-dwelling older adults. Caicó and Currais Novos, Rio Grande do Norte, 2024.

Variables	Relative Frequency (%) N= 100	Confidence Interval [95%] of proportions observed
Comorbidities
Arterial Hypertension
Yes	84	[77.0 – 91.0]
No	16	[9.0 – 23.0]
Heart Disease
Yes	30	[21.0 – 39.0]
No	70	[61.0 – 79.0]
Diabetes Mellitus
Yes	41	[31.0 – 51.0]
No	59	[49.0 – 69.0]
Tumor
Yes	3	[0.0 – 7.0]
No	97	[93.0 – 100.0]
Arthritis
Yes	42	[32.0 – 52.0]
No	58	[48.0 – 68.0]
Pulmonary Disease
Yes	8	[3.0 – 14.0]
No	92	[86.0 – 97.0]
Depression
Yes	18	[11.0 – 26.0]
No	82	[74.0 – 89.0]
Osteoporosis
Yes	23	[15.0 – 32.0]
No	77	[68.0 – 85.0]
Stroke
Yes	1	[0 – 3.0]
No	99	[97.0 – 100.0]
Adverse Reactions
Falls
Yes	26	[18.0 – 34.0]
No	74	[66.0 – 82.0]
Hospitalization
Yes	6	[2.0 – 11.0]
No	94	[89.0 – 98.0]
Fractures
Yes	5	[1.0 – 10.0]
No	95	[90.0 – 99.0]
Constipation
Yes	14	[8.0 – 22.0]
No	86	[78.0 – 92.0]
Heart Failure
Yes	4	[1.0 – 8.0]
No	96	[92.0 – 99.0]
Depression
Yes	7	[2.0 – 12.0]
No	93	[88.0 – 98.0]
Cognitive Deficit
Yes	5	[1.0 – 10.0]
No	95	[90.0 – 99.0]
Renal Dysfunction
Yes	8	[3.0 – 13.0]
No	92	[87.0 – 97.0]

The results of the bivariate analysis of presence of adverse reactions and age group, sex, physical activity, presence of comorbidities, use of polypharmacy, and PIMs are presented in Table 3. Pearson's chi-square test revealed a significant association between adverse reactions and comorbidity (p < 0.001), polypharmacy (p < 0.001), and PIMs (p < 0.001).

Table 3
Bivariate analysis of the presence of adverse reactions and sociodemographic variables, behavioral habits, and clinical and health conditions. Caicó and Currais Novos, Rio Grande do Norte, 2024.

Variables	Adverse Reactions		p-value
	Yes	No
Age Group (years)
60-69	14	30	0.09
≥70	27	29
Sex
Female	34	45	0.42
Male	07	14
Physical Activity
Yes	19	33	0.34
No	22	26
Presence of Comorbidity
Yes	36	34	< 0.001
No	05	25
Polypharmacy
Yes	30	14	< 0.001
No	11	45
Potentially Inappropriate Medication
Yes	17	11	0.01
No	21	46

Following bivariate analysis, multivariate analysis was performed using binary logistic regression to control for possible confounding variables and to evaluate factors associated with ADRs (Table 4). Only polypharmacy remained as an associated factor, independently of age, sex, presence of comorbidities, or use of PIMs.

Table 4
Binary logistic regression model to identify factors associated with adverse drug reactions in community-dwelling older adults. Caicó and Currais Novos, Rio Grande do Norte, 2024.

Variables	Odds Ratio [95%CI]	p-value
Model 1: Health Conditions
Presence of Comorbidity
No	1.00	0.23
Yes	2.15 [0.62 – 7.51]
Polypharmacy
No	1.00	0.004
Yes	4.69 [1.63 – 13.52]
Potentially Inappropriate Medication
No	1.00	0.09
Yes	2.46 [0.87 – 6.98]
Model 2: Health Conditions adjusted for age group and sex
Presence of Comorbidity
No	1.00	0.23
Yes	2.19 [0.62 – 7.71]
Polypharmacy
No	1.00	0.01
Yes	4.31 [1.42 – 13.10]
Potentially Inappropriate Medication
No	1.00	0.07
Yes	2.63 [0.90 – 7.71]
Age Group (years)
60-69	1.00	0.57
≥70	1.35 [0.48 – 3.77]
Sex
Male	1.00	0.76
Female	0.83 [0.26 – 2.70]

DISCUSSION

The main finding of this study revealed that polypharmacy was an independent risk factor for ADR occurrence, even after adjusting the model for confounding variables such as age, sex, presence of comorbidities, and use of PIMs. This result confirms the premise that the number of drugs used may be a determining factor for the occurrence of adverse events that, taken alone, exerts a greater influence than age or specific therapeutic classes. The finding corroborates robust evidence in the literature showing that concomitant use of multiple drugs plays a key role in drug interactions and negative clinical outcomes, especially among older adults⁷,¹⁵,²².

Although the adjusted multivariate analysis identified polypharmacy as a factor contributing to ADRs, the findings on bivariate analysis are noteworthy showing that ADR occurrence was also associated with the presence of comorbidities and use of PIMs. This result suggests a triad of clinical vulnerability: comorbidities, PIM use, and polypharmacy, which should not be overlooked, especially given the high prevalence of these conditions in PHC³,¹⁹,²⁰.

In the present study, findings regarding health conditions reaffirm the high burden of chronic diseases in the older adult population. The majority of participants (70%) had comorbidities, a finding similar to that observed in other studies involving PHC users¹⁵,¹⁶. Polypharmacy was identified in 44% and PIM use in 28% of respondents, corroborating the international panorama where polypharmacy ranges from 13.9% to 64.⁵%¹,⁴,⁷,¹⁴,¹⁷,¹⁸, and PIM use mirrors studies that applied both the Beers criteria and the CBMPI, reporting rates from 27.6% to 32.⁹%³,²¹. Adverse reactions were reported by 41%, with falls being the most reported event.

This scenario highlights the complexity of clinical management in PHC. Although some medications are classified as inappropriate for older adults, in many cases they are essential for the appropriate management of chronic conditions, given that each condition may require one or more medications for treatment and control⁷,¹⁵,²⁰.

Placing these results in context, the profile of the study sample (low educational level, low income, and high prevalence of chronic diseases) mirrors that of other investigations conducted in the Brazilian Northeast and within PHC in general¹,¹²,¹³,¹⁴, where unfavorable socioeconomic factors compromise self-care and therapeutic adherence, exacerbating the risk associated with polypharmacy¹⁴.

It should be reiterated that polypharmacy played a key role in ADR occurrence, having a greater influence than the other factors assessed, representing a priority risk marker. This points to the need for policies and protocols defining periodic review of prescriptions in PHC, as well as the adoption of non-pharmacological measures for the treatment and control of chronic diseases. Studies show that interventions centering on medication review, based on shared decision-making, and professional training, are effective in reducing medication burden²³.

In this context, quaternary prevention serves as a vital tool for mitigating excessive medicalization²⁴, in which the pharmacist is key in carrying out medication reconciliation, identifying problems related to prescribing, and potentially preventing readmissions and avoidable costs to the health system¹,²⁵.

However, these results should be interpreted within the constraints of the study limitations: cross-sectional design precluding the establishment of direct causality between variables; selection bias due to convenience sampling; and measurement bias from self-reports.

Of these limitations, self-reports of ADRs are of most note, given they are susceptible to both recall bias (forgetting past events or medication names) and information bias (lack of knowledge on the patient´s clinical condition). Hence, these factors may have led to an underestimation of the actual prevalences of ADRs.

Despite its cross-sectional design, relatively small sample size, and non-probabilistic selection, the study has several strengths, including the methodological rigor applied (use of validated instruments and standardization in data collection) and adjusted statistical analysis.

Therefore, given the importance of this topic and exploratory nature of the present investigation, future studies with probabilistic, representative sampling, longitudinal designs, and both quantitative and qualitative data should be conducted. Additionally, studies evaluating interventions, such as systematic review of prescriptions, multiprofessional integration, and health education, can help inform effective strategies for safe care.

CONCLUSION

In summary, polypharmacy constituted the main factor associated with adverse drug reactions in the community-dwelling older adults, representing a priority challenge for Primary Health Care. The strengthening of rational prescribing practices and clinical protocols, coupled with interdisciplinarity, is fundamental to mitigate risks and ensure greater therapeutic safety for the older adult population.

Although some medications classified as inappropriate are necessary for the management of chronic conditions, their prescription should be accompanied by periodic review, considering number of drugs, administration times, and potential interactions.

Interprofessional work (physician-pharmacist) and patient-centered care are essential to promote rational prescribing and reduce adverse events associated with medication use.

ACKNOWLEDGEMENTS

The authors extend thanks to the Graduate Studies Office of the Federal University of Rio Grande do Norte (UFRN) for institutional and academic support in the conducting of this study.

• Funding
  Funding: Coordenação de Aperfeiçoamento de Pessoal de Nível Superior - Brasil (CAPES). Funding Code 001.

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Edited by

• Edited by
  Camila Alves dos Santos

Publication Dates

• Publication in this collection
  11 May 2026
• Date of issue
  2026

History

• Received
  17 Nov 2025
• Accepted
  06 Feb 2026