Epidemiology of ADRs in Internal Medicine, HCC

Alba Delia Campaña S., Anthon Álvarez Arredondo, J. Alfredo Contreras G., S. Saúl Irizar S. and A. Miroslava Flores R. Faculty of Medicine, Autonomous University of Sinaloa, Center of Research and Teaching in Health Sciences (CIDOCS) UAS CA-285, México

Abstract: We aimed to characterize, and analyze the presence of factors such as polypharmacy and personal medical history that predispose to Adverse Drug Reactions (ADRs) and potential preventability of these. The Civil Hospital of Culiacan (HCC), in Sinaloa, where the study was conducted has 80 beds in total, in which the Department of Internal Medicine with 24 beds: 12 for men and 12 for women, we found the part of the share to contribute to the 200,000 cases of ADRs that according with the WHO each of the countries members report every year to the Uppsala Monitoring Centre. We have not only but also ordered frequency of drugs, pathologies, and analytical tests of the hospitalized patients.

Key words: ADRs, hospitalized patients, polypharmacy, pharmacovigilance, analytical tests.

1. Introduction  EU [4]. Historically, the main source of information on the occurrence of ADRs has been spontaneous

ADR: Some definitions specifically exclude minor reporting by healthcare professionals. However, the unwanted reactions (e.g., a slight dryness of the mouth, source population (the total number of patients using a

a harmful or significantly unpleasant effect caused by certain medicine) is generally not known in such

a drug at doses intended for therapeutic effect -or systems and the total number of patients experiencing prophylaxis or diagnosis- which warrants reduction of an ADR is also not known as reporting is usually dose or withdrawal of the drug and/or foretells hazard voluntary and underreporting of ADRs can be as high from future administration). However, these as 94% [5]. The Harvard Medical practice study found definitions (and others reviewed elsewhere) exclude that adverse events were more common among elderly error as a source of adverse effects [1, 2]. [4], and also Leavy reported high incidence of ADRs Polypharmacy (prescribing more than five drugs in children [7]. Historically, the main source of concurrently) is more common in elderly patients information on the occurrence of ADRs has been because of existences of one or more diseases [3]. But spontaneous reporting by healthcare professionals [8]. multiple medication increases the incidence of adverse This definition does not include the effects due to drug reactions. WHO promotes among 154 countries errors in dosage and administration, overdose or lack pharmacovigilance program starting in 2010. In of therapeutic effect. 80% of ADRs are predictable Europe, ADRs cause a considerable amount of and explainable by the pharmacological action morbidity and mortality [4]. It has been estimated that compared to 20% who are not. The difference approximately 5% of all hospital admissions are between ADRs and toxic effects is that these appear caused by ADRs that 5% of hospitalized patients will due to overdose, while ADRs occur with therapeutic experience an ADR during their hospital stay, and that

doses [9].

ADRs cause 197,000 deaths annually throughout the

2. Materials and Methods

Corresponding author: Anthon Álvarez Arredondo, Ph.D., professor, research fields: pharmacology and toxicology.

150 direct questionnaires were applied to

Epidemiology of ADRs in Internal Medicine, HCC

hospitalized patients of both genders of Internal average age was 53 years old, 60% W and 40% M. Medicine Service of the Civil Hospital of Culiacan, Determining polypharmacy and we often found the

150 direct questionnaires were applied to hospitalized most commonly used drugs and we recorded the signs, patients of both genders in a period of 10 months.

the doses and symptomatology (Table 2). The most Supplemented by medical record data using adverse

common laboratory tests: BQ, HB, Alb., UGT, T3, T4, drug reaction format detection, and the Naranjo’s

Na, and K. Antibiotic therapy was the group that Algorithm was applied to determine causality.

followed triggered for antidiabetics and antiarrhythmics (Fig. 1). The most frequent diseases

3. Results and Analysis

were: diabetes, septic shock, heart failure, COPD, H The ADRs reported were 40, the demographic data

cirrhosis, pneumonia and dengue (Fig. 2). The showed up a female predominance (Table 1), the

prevalence was similar to other authors [10].

Table 1 Demographic data of ADRs in patients.

Age Male Female ≤ 20 years 2 (3.08%)

20-40 years 17 (26.15%)

41-60 years 20 (30.77%)

61-80 years 24 (36.92%)

Table 2 Adverse drug reactions after treatment.

Drug

Doses

Sings & Sympotms

Ciprofloxacin

Maculopapular rash and seizures Amoxicilin/clavulante

400 mg c/12 h

120 mg / day

Diarreheal stools

Metronidazole

500 mg c/6 h

Dysuria, urinary orange

Vancomicyn 50 mg c/6 h Generalized rash Tenofovir

300 mg c/24 h

Vomiting, chills

Vancomycin 65 mg c/6 h Generalized rash L-asparaginasa

Diffuse abdominal pain and vomiting Sodium bicarbonate

400 mg c/24 h

Hypothiroidism

Insulin 250 U Hypoglycemia

(a) (b)

Fig. 1 Laboratory tests significantly altered. (A) Glucose levels and transaminase levels were the highest ones: (P < 0.0001). (B) Fluctuating glucose levels with insulin treated patients .

56 Epidemiology of ADRs in Internal Medicine, HCC

(a) (b)

Fig. 2 Percentages of diseases and drugs. (A) Order frequency percentages of diseases of hospitalized patients. (B) Percentage of drugs in order of class that most ADRs presented.

4. Discussion

medication errors, especially errors of prescription and tracing. Therefore, a prospective or retrospective

It is necessary characterize polypharmacy and observational study in which the total population at RAMs, emphasize the social role of risk of ADRs is included in the study is required to pharmacovigilance in the clinical field, identify estimate the epidemiology of ADRs as studies on medicines adverse experienced by patients during ADRs occurrence in the outpatient setting, are needed. their hospital stay, differentiated by their Addressing this problem is necessary to incorporate preventability. The actual incidence of ADRs may be the identification and prevention of RAMs to clinical even greater because some ADRs mimic natural practice. According with the findings, elderly and disease states and may thus go undetected and/or female patients seemed to be more susceptible to unreported [11]. It must raise awareness among

ADRs [14].

professionals and health authorities the significance of this problem in hospitals and implement security

Acknowledgments

practices effective in reducing medication errors, We would like to thank the Deputy Chief of especially errors of prescription and tracing. As other

Nursing Education and Medical Staffs of the HCC and authors, t he vast majority of preventable ADEs

CIDOCS for their cooperation for the success of the (36.3%) resulted from omitting a necessary study.

medication [12]. To evaluate the preventability of a RAM we propose questionnaire Schumock and

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