ORIGINAL RESEARCH

Vanessa Pereira Silva^I; Nadja Cristiane Lappann Botti ^II; Valéria Conceição de Oliveira^III; Eliete Albano de Azevedo Guimarães^IV

^INurse. Professor at the University of the State of Minas Gerais. Divinópolis, Minas Gerais, Brazil. Email: vanessanurse22@yahoo.com.br
^IIPhD in nursing. Professor at the Federal University of São João Del Rei - Dona Lindu Campus. Divinópolis, Minas Gerais, Brazil. E-mail: nadjaclb@terra.com.br
^IIIPhD in nursing. Professor at the Federal University of São João Del Rei - Dona Lindu Campus. Divinópolis, Minas Gerais, Brazil. Email: valeria.oli.enf@gmail.com
^IV. PhD in health sciences. Professor at the Federal University of São João Del Rei - Dona Lindu Campus. Divinópolis, Minas Gerais, Brazil. Email: elietealbano@hotmail.com

DOI: http://dx.doi.org/10.12957/reuerj.2016.8783

ABSTRACT

Objective: to analyze benzodiazepine users' socio-demographic characteristics, use history and dependence. Method: in this cross-sectional study of an intentional sample of 219 benzodiazepine users enrolled with four family health teams in the western Minas Gerais State, data was collected between January and May 2013 by applying an adapted questionnaire. Epidata 3.1 and EPINFO 6.04 software were used for data tabulation and descriptive analysis. Results: most of the benzodiazepine users were female, and 53 to 60 years old. Clonazepam was the benzodiazepine most commonly used, and 181 individuals (82.6%) were found to be chemically dependent on benzodiazepines. Conclusion: factors such as the positive image, low cost and swapping of benzodiazepines, medicalization of personal, social, family and professional problems, and treatment inadequacies contributed to benzodiazepine dependence.

Keywords: Benzodiazepines; primary care; substance dependence; mental health.

INTRODUCTION

Primary healthcare (PHC) aims to enable the first access of people to the health system, including those who demand attention in mental health¹. This care is facilitated by the possibility of access of users and vice versa, since family health (FH) teams work with a defined area and rely on the work of community health agents. Due to these characteristics, it is part of the daily life of FH professionals to handle all the time users in mental distress situation, as well as with other elements of their contexts of life².

People suffering with mental conditions in general present a significant reduction in quality of life, with lower productivity, higher morbidity and mortality, and higher rates of comorbidity. Parts of these enormous direct and indirect social costs can be aggravated because this is a group with undiagnosed, understated and often inappropriately handled disorders³.

Among the psychiatric disorders that affect the population currently, great mood and anxiety disorders are the most common and are identified more frequently in units of AP. For the treatment of mood and anxiety disorders it is common in units of the family health strategy (FHS) prescribing benzodiazepines (BZD), which are among the most prescribed psychotropics, characterized as anxiolytics, sedatives, hypnotics, anticonvulsants, anesthetics and muscle relaxant and supporting anesthetics³. When correctly indicated, BZD shows useful for presenting fast onset of action, few side effects and good safety margin⁴.

However, the big problem of the misuse and indiscriminate use of BZD arises from the time there is the medicalization of life or personal, socio-family and professional problems; the continuous use of these medications can cause the phenomenon of tolerance, being increasingly higher doses necessary to maintain the desired therapeutic effects⁵.

Thus, chemical dependence becomes a worrying and common phenomenon in primary healthcare units (UAPS). And, often, dependent users are reluctant to withdraw gradually the medication, stating changes in the pattern of sleep and rest such as insomnia and anxiety^6.7. Based on the above considerations, this study sought to characterize sociodemographic aspects, history of use and dependency of benzodiazepines among users in primary healthcare.

LITERATURE REVIEW

BDZs are drugs with anxiolytic activity that began to be used in the 60's. Chlordiazepoxide was the first BDZ released on the market (1960), 5 years after the discovery of its anxiolytic, hypnotics and myorelaxant effects. Because they present high therapeutic efficacy, BDZs presented low intoxication risk and dependence, factors that led to the rapid acceptance of medical professionals to its prescription⁷.

However, later identified the first cases of abuse, in addition to development of tolerance, dependence and withdrawal syndrome by chronic users of BDZ^8.9.

To give theoretical support to the study, there were used criteria established by the Diagnostic and Statistical Manual of Mental Disorders (DSM IV) which is a guideline for mental health professionals, with definitions of different categories of mental disorders and criteria to diagnose them, according to the American Association of Psychiatry ( American Psychiatric Association -APA)¹⁰.

Thus, it was set the term of substance dependence such as the presence of a cluster of cognitive, behavioral and physiological symptoms indicating that an individual continues to use a substance even if this causes significant problems. Which leads to a pattern of auto repeated administration that results in tolerance, withdrawal and compulsive use of the substance.

Tolerance and withdrawal symptoms may be associated with a greater risk of immediate clinical problems and with higher relapse rate¹¹. The definition of specifiers according

to DSM IV were also used for physiological dependence of substance which is when dependence is accompanied by evidence of tolerance and withdrawal and without physiological dependence which is when there is no evidence of tolerance or withdrawal, however there are compulsive symptoms.

METHODOLOGY

Descriptive and cross-sectional study performed in a medium-sized municipality of the Western region of the State of Minas Gerais. The intentional sample was composed of BZD users of both genders, aged over 18 years old enrolled in the municipal pharmacy of four reference FH teams of Western Minas Gerais, who received drugs in the last 12 months, according to what regulates the Ordinance n° 344¹². The registered population of the four FHS makes the total of 10,050 inhabitants.

The list of BZD medicines dispensed by the pharmacy, in the APS of that municipality, includes Diazepam 10mg, Clonazepam 2mg and Clonazepam 2.5mg/mL Alprazolam 0.5 mg and Nitrazepam 5.0mg dismissed upon notification of prescription B, in accordance with the legislation that approves the technical regulation on substances and medicinal products subject to special control¹².

There are, registered in the pharmacy of reference of the four municipal units of FH, 295 users of BDZ. Out of these, 76 users were excluded from the survey because they do not wish to participate, or due to death or change of address. Therefore, the sample comprised 219 users who have agreed to participate in the research.

The data were collected through the application of an adapted questionnaire⁶ plus issues related to diagnostic criteria for dependence on substances¹⁰. The questionnaire was applied by home visit by the researcher in charge of the project, from January to May, 2013.

The data were entered into EPIDATA 3.01 program and analyzed in theStatístical Pacckage for the Social Sciences (SPSS ®) 17.0 software. Descriptive analysis of the data, the issues have been categorized as demographic profile, profile of health condition and characteristics of chemical dependence.

In this study, the dependence was set to a default of wrong use of Adaptive benzodiazepines, manifested by three or more criteria, occurred in the last 12 months.

In addition to the tolerance criteria (criterion 1) and abstinence (criterion 2) for identification of physiological dependence, were the criteria of compulsive symptoms to chemical dependence without physiological dependence that are: Presence of frequent consumption and in greater quantity for a longer period than intended (criterion 3). Persistent desire or unsuccessful efforts to reduce or stop using the medication (criterion 4). If too much time is spent to obtain BZD (criterion 5). If important activities are abandoned or reduced due to the use of BZD (criterion 6) and if there are reports of any health problems due to the use of BZD (criterion 7).

Given the resolution No. 466/2012 of the National Council on ethics in research with Human Beings-CONEP, which deals with the rules on research involving human beings, was elaborated an informed consent form containing the objectives and purpose of the research, the voluntary participation and maintaining the anonymity of the subjects. The project was approved by the Municipal Health Secretariat and by the Committee of ethics in research (CEP) at the Federal University of São João Del Rei (UFSJ), through CAE 09751212.5.0000.5545.

RESULTS AND DISCUSSION

Characterization of the Subjects

Among the 219 subjects included in the survey, it was found that 98 (44.6%) individuals are aged 46 to 60 years old and 71 (32.1%) in the group above 60 years old. The average age was 53.6 ± 12.2 years old. When it comes to gender, 164 individuals (74.9%) were female and 55 (25.1%) male. In examining the marital status, it was observed that more than half of respondents were married or were in a stable relationship 152 (69.5%). See Table 1

The results showed that most of the BZD users are female, between the ages of 50 to 69 years, with low education and income, corroborating other studies^13-17. On APS using BZD presents a dysfunctional pattern repetitive, in which women-housewives, married, with three children or more, lower educational level and therefore with less information, less income, role of caregiver and family conflicts-are subject to greater use of medicines causing dependence, potentially with organic and mental side effects is important.

The largest use of BZD was reported by women who reported not be acting in the job market. Previous study identified similar results, users who do not have a job showed higher prevalence of mental suffering ¹⁵. However, another study points out that professionals who have a job, who are exposed to factors such as stress in the occupational environment, poor remuneration, lack of motivation and long journeys to work, also use BZD¹⁸.

Studies claim that beyond gender, cultural and social issues, the representative image of women in advertising of pharmaceutical industry, ends up being decisive and interferes with the clinical approach to making medical professionals to become more susceptible to the diagnosis of diseases such as anxiety and depression in female gender^13,19-22 . Besides, there are studies with women in the menopausal period, which estimates a significant prevalence of depression and anxiety in patients; 36.8 and 53.7%, respectively, since some of the signs and symptoms of this phase such as insomnia, irritability are being treated with BZD ^23-25.

Health conditions of the subjects

On the characterization of health conditions, it was observed that 153 (69.9%) subjects reported having disease. Among the diseases mentioned we highlight hypertension 68 (44.4%), 32 (20.5%), diabetes, hypertension and diabetes 25 (16.3%) and other diseases such as depression, heart diseases and musculoskeletal disorders - 28 (18.3%). It was also found that 79.5% respondents had a medical appointment last year; 92.7% reported owning the prescription with prescribing BZD, being the general practitioner/FH doctor the professional who prescribed the most (71.2% of prescriptions).

About the use of the BZD, 131 individuals (59.8%) reported using according to the prescription. The time of prolonged use has been observed since, 126 (57.5%) subjects reported being using BZD for over three years. The main reason to use this study was insomnia reported by 107 individuals (49.1%), followed due to anxiety with 72 individuals (33.0%) as shown in Table 2.

TABLE 2: Characteristics of health conditions of registered users at the municipal pharmacy. Municipality of West region of Minas Gerais, 2013 (N = 219)

(*) BZD = benzodiazepine

Several studies indicate the Diazepam as the most prescribed psych medicines, however, in this research, the most widely used BZD was Clonazepam, followed by users of Diazepam^17-19. A research carried out in Brazil has shown that, in 2004, Clonazepam was the sixth among the 10 best-selling drugs, taking the second position in 2008 ²⁰. Bromazepam, Nitrazepam and Alprazolam are also used by users, however, outnumbered. There was no report of using Midazolam, Lorazepam and Flurazepam.

Among the factors that comprise the misuse of BZD, prolonged treatment as one of the most often reported, corroborating other authors ^{13, 15, 17}. The daily dose and the time of use of the BZD are factors for determining a dependence framework. The use of up to 3 months presents a low risk. Between 3 and 12 months of use, the risk increases between 10% to 15%, and for more than 12 months the risk is 25% to 40%²⁰.

The results of this study showed that most users used the medication for more than three years and continuously, with reports of some customers who have already used it for over 30 years.

The motivation to use was reported mainly for insomnia and anxiety problems (for example, symptoms of panic, stressful situations, such as family squabbles, work-related issues), or escape from the family or personal problems; there have been also situations involving grief or pain. Many users have reported the use of BZD mostly for depression treatment and not as an adjuvant, which demonstrates ignorance on the part of the clients in relation to the consumption of BZD and the professionals about the prescriptions²⁶.

The use of BZD on clients that self-reported morbidities was described in other studies^{4, 6, 24, 27-29}, and brings concerns about the possibility of drug interactions. Especially among hypertensive and elderly, for damages caused using central depressor effect BZD and orthostatic hypotension common to antihypertensive drugs, increasing the risk of falls among users particularly among elderly^18.29. In addition, there is a study¹⁵ that shows that BZDs are being used as an important feature in the treatment of hypertension, aiming to control a user's emotional state, thus avoiding peaks of elevation of blood pressure.

The use of BZD has several factors as influence, such as the positive image of anxiolytic, going through the fact that it is easy to the doctors to prescribe them, self-medication, until the popularity among peers, through the loan and/or indication among family or friends. In this study, it was observed that most of the BZD prescriptions was performed by general practitioners/FH doctors, which confirms other studies^{15, 26-31}. This fact may be related to the search; however, studies show that medical specialties as Neurology and Psychiatry restrict and prescribe less BZD for better know its effects^30-33.

Prescription of BZD by general practitioners/FH doctors can be related to their unpreparedness for prescribing BZD, ignorance of the percentage of dependents of BZD, the gravity of this use and side effects of drugs. Other factors may also be involved such as: medical consultation only to get one more BZD prescription without specialized monitoring, lack of time for a detailed guidance or indication of other therapeutic practices ^30-32.

On the high consumption of BZD between users, appointments of doctors who are not experts, there is a study that questions that fact and points out that it would be ideal if the prescription was given by a neurologist or psychiatrist, for the absence of these professionals may compromise the quality of prescription³³. In addition, the mentioned study claims that the prescription by other professionals contributes to a possible mistake in the diagnosis and unnecessary use of central action medications, and favors the irrational use and unmonitored use of antidepressant drugs and psychotropic substances in general, which can lead to Iatrogenesis and even death.

However, this issue is contrary to the guidelines established for the APS that prioritizes prevention and promotion at primary level, as well as the interdisciplinary team work, based on a network of psychosocial care, focusing on individual/family and their needs and that interacts with other sectors of society.

Study shows that users of BZD go more to FH units for medical appointments, once the BZD prescription is generally standardized and in general it is good for 2 months^12,31. However, it should be noted that many users attend the medical consultation only for revalidation or to obtain a new prescription, primary source of BZD supply by individuals who use abusively this type of drug.

Use of BZD and dependence

In the analysis of consumption of BZD by registered users in the pharmacy, according to diagnostic criteria for chemical dependence, 181 (82.65%) subjects are considered addicts. Of these, 157 (86.7%) have physiological chemical dependence. It was also verified that among the chemical dependents, 125 (69.0%) presented signs of tolerance (criterion 1) and 163 (90.0%) withdrawal symptoms (criterion 2).

In examining the criteria for compulsive symptoms, it was found that the criterion 3 affects 152 (69.4%), criterion 4 was informed by 145 (66.2%) and 120 (54.8%) reported that they do not have difficulty in getting the medication (criterion 5). About criterion 6, 160 (73.1%) reported not having ceased to carry out important activities and 198 (90.4%) stated that they had no problem when using BZD (criterion 7) see table 3.

TABLE 3: The use of benzodiazepines according to diagnostic criteria for chemical dependency, according to the DSM IV. Minas Gerais - 2013. (N = 219)

In this study, it was found that most users failed in suspending the use of the BZD, what characterizes this medication dependence. Therefore, the suspension of treatment could lead to the installation of the undesirable symptoms of withdrawal syndrome or another acute manifestation of the disease.

The failure of the attempt of stopping the use of BZD can be related to difficulty in distinguishing symptoms of withdrawal of the reappearance of symptoms from anxiety¹⁰.

When asked whether the use of BZD caused or worsened health problems, most denied such a result. However, the few users who reported having any side effects when using BZD reported the feeling of dry mouth, which led to high amount of water intake, feel dizzy, headache and drowsiness. Such symptoms observed match what is expected and notified in the package inserts of pharmacologically active drugs.

CONCLUSION

This study presented the sociodemographic aspects, history of use and dependency of benzodiazepines among users in primary healthcare. The results revealed that the profile of users of BZD, present women aged between 50 and 69 years, vulnerable to addiction, with low education and income, without employment links, with a history of chronic diseases. In addition, he noted that these drug dependent women are being medicated with BZD for the treatment of menopausal symptoms, depression and blood pressure control.

Saying that the prescription should be made by psychiatrists or neurologists is contradictory to proposal of the FHS which should solve the problems in most cases of mild mental disorders. Discussion of cases are needed, considering risk and vulnerability. In addition, the support of Family Health Support Center, consisting of a multidisciplinary team, needs to promote work processes in conjunction with APS professionals, thereby enhancing the completeness of care through expanded clinic, and assisting in strengthening the capacity for analysis of health problems and health needs for appropriate interventions.

The limitation of this study refers to the location where the research was conducted, family health teams located in neighborhoods considered economically or socially disadvantaged, which may have contributed to the characteristics, i.e. the profile of the sample studied. The contribution lies in the field of public health policies, because it points to necessary changes in prescribing, dispensing and use of benzodiazepines in primary health care.

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