Chronic use of diazepam in primary healthcare centers: user profile and usage pattern

ABSTRACT CONTEXT AND OBJECTIVE: Chronic use of benzodiazepines is frequent in general practice. The aim of this study was to describe the usage pattern and profile of chronic users of diazepam who had been consuming this drug for a minimum of thirty-six months continuously. DESIGN AND SETTING: This was a descriptive study (survey and clinical assessment) at five primary healthcare centers in Campinas, Brazil. METHODS: Psychotropic drug control books revealed 48 eligible patients. Among these, 41 were assessed by means of the Schedule for Clinical Assessment in Neuropsychiatry (SCAN), the Hospital Anxiety and Depression scale (HAD) and a questionnaire on usage pattern. RESULTS: Most patients were women (85.4%). The patients’ mean age was 57.6 years, and they were from the social strata C (39%), D (54%) and E (7%). The mean length of diazepam consumption was 10 years. The patients presented a lack of prescription compliance and had made frustrated attempts to stop using the drug. 55.5% said their doctor had never given any guidance on the effects of the drug. According to SCAN, 25 patients (61%) suffered from depressive disorders; only 12 cases of benzodiazepine dependence were detected by this instrument. CONCLUSION: There is a need to improve the detection and treatment of mental disorders, as well as to prevent inappropriate prescription and use of benzodiazepines. Diazepam dependence has distinctive characteristics that make it undetected by SCAN.


INTRODUCTION
Benzodiazepines are drugs with an anxiolytic effect, based on chlordiazepoxide synthesis, that started to be used in the 1960s.Their proven safety in comparison with barbiturates has contributed towards increased prescription rates since the 1970s. 1,2In the United States, 10-15% of adults take benzodiazepines at some time over a 12-month period and 2% use them chronically. 24][5] A fi gure of 10.2% has been found for the city of São Paulo, Brazil. 6A higher rate of 21.3% has been found in Porto Alegre, in southern Brazil. 7[10][11][12] One important matter to be considered regarding benzodiazepine consumption is physicians' prescription habits, in addition to the usage pattern adopted by patients and their clinical profi le.[20]

OBJECTIVE
The aim of this study was to describe the usage pattern for diazepam provided by pharmacies at primary healthcare centers (PHCCs) and evaluate the profi le of users who had been consuming this drug for a minimum of thirtysix months continuously.

Type of study Type of study
This was a descriptive study in which chronic users of diazepam were surveyed and assessed by means of a standardized psychiatric instrument.

Setting and subjects Setting and subjects
This study was conducted in the northeastern region of the city of Campinas (State of São Paulo) in 2001.This region had 152,438 residents at that time (15.7% of the population of the city), and was characterized by its poor economic status and high unemployment rates.It had eight PHCCs, four of which had a mental health team.Five PHCCs were included in this study because they were the fi rst to implement the use of psychotropic drug control books.These books revealed that 1,458 individuals had received diazepam at some time over the past three years.
The inclusion criteria for the present study were that the patients should be over 15 years old and among these 1,458 individuals, who had been using diazepam for a minimum of thirty-six months continuously, according to the monthly records in the books.These monthly records were, in turn, in accordance with the prescriptions made by the patients' doctors.Furthermore, the patients had to confi rm that they were the users of the benzodiazepines provided to them by the PHCC pharmacy.Accordingly, 48 individuals were eligible (the other 1410 had not taken diazepam for a minimum of thirty-six months continuously).It was possible to evaluate 41 of them (six patients did not respond to the three recall invitations made and one patient had moved to another town).

Instruments and variables Instruments and variables
The following data collected from the psychotropic drug control books were stored in an electronic fi le: total annual consumption of diazepam; average monthly consumption; mean duration of use; average daily dosage; and prescribing physician's specialty.
The clinical assessment of the patients involved: 1.A questionnaire to assess socioeconomic status based on ownership of items and the reported educational level of the head of the family.This instrument included fi ve social strata, A to E, defi ned by score ranges. 21hese strata were in accordance with the defi nitions of the Instituto Brasileiro de Geografi a e Estatística (IBGE).2. The Hospital Anxiety and Depression scale (HAD).This consisted of 14 multiple choice questions within two subscales: depression and anxiety.The overall score for each subscale ranged from 0 to 21. 22 Patients whose score was more than eight in the respective HAD subscales were considered to be possible cases of anxiety and depression, in accordance with the national validation study. 23

The Schedule for Clinical Assessment in
Neuropsychiatry (SCAN).This consisted of a sequence of tools that identifi ed, measured and classifi ed psychopathological conditions and also behavior associated with psychiatric disorders in adults. 24esides the formal psychiatric diagnosis, the second section of SCAN consisted of a list of physical symptoms that were not related to any specifi c physical condition but were to be ticked according to the interviewer's judgment.The SCAN system had two essential elements: a glossary of defi nitions and CATEGO (a data processing computer program).4. A questionnaire on the diazepam usage pattern was drawn up for this study, composed of open questions and questions with multiple-choice answers in two domains: the patient's habits and diffi culties regarding chronic use of the medication and the patient's opinion about the prescription and the physician's prescribing behavior.

Procedure Procedure
The patients received letters explaining the objectives and procedures of the study and recalling them to the PHCC.After they signed an informed consent form, the interview was carried out.A report on the patient's condition revealing diazepam dependence was discussed with the attending physician and attached to the respective fi le.The fi rst author of the present study (C.S.R), who underwent training on applying SCAN at a World Health Organization accredited center, conducted all the interviews.This research protocol was approved by the Ethics Committee of the Medical School of Universidade Estadual de Campinas.

Data analysis Data analysis
The data were organized in frequency tables with the respective percentages.Means and standard deviations were calculated for continuous variables.SCAN data were processed using the CATEGO system. 24

RESULTS
Most of the patients who had been using diazepam continuously for 36 months were women (85.4%) and white (85.4%).The patients' mean age was 57.6 years (standard deviation, SD = 12.5) and only four patients were below the age of 40 years; 43.9% were married and 70.8% were Catholics.The patients were from the social strata C (39%), D (54%) and E (7%).
The mean duration of diazepam consumption was 10 years (SD = 7.95).The patients began using diazepam at an average age of 43 years (SD = 14) and generally (73.2 %) took a single nocturnal dose of 10 mg.Thirty-seven (90.2%) out of the 41 patients used some other medication besides diazepam: mainly antihypertensives, antiarrhythmics and antidepressives (26, 8 and 7 patients, respectively).Ten patients (24.4%) used three or more drugs besides diazepam.
Table 1 demonstrates the percentages of affi rmative responses to the items in the questionnaire on usage patterns.When an attempt to stop using the drug was made, at least one withdrawal symptom was highlighted.Among the withdrawal symptoms remembered by the patients when answering the item "Report what you felt ……", the most common ones were insomnia (46.3%), agitation (9.7%), headaches or pain in the limbs (9.7%) and irritability (9.7%).Six of the seven patients who reported taking diazepam overdoses had needed urgent medical care.Ten of the 30 patients who tried to stop taking diazepam were motivated by their physicians to do so.The reasons reported for beginning and continuing to use diazepam can be seen in Table 2 (spontaneous answers to the open questions: "Why do you think your physician prescribed diazepam?"and "Why did you continue using diazepam?").
The specialty of the prescribing physician was: general clinician (44.4% of the cases), psychiatrist (41.7%), cardiologist (5.6%), neurologist (5.6%) and gynecologist (2.8%).With regard to the guidance given by the prescribing physician for the patient's health problem, 22.5% of the patients reported they had received guidelines but did not understand them, 55.5% affi rmed that they had never received any guidance and only 15% (eight patients) remembered some information received from the doctor.According to the HAD scale, 64.1% of the cases presented anxiety and 69.2% presented depression.Table 3 shows the ten most common physical and emotional symptoms verifi ed by SCAN.Table 4 presents a list of the psychiatric diagnoses based on the International Classification of Diseases, 10 th edition (ICD-10), that were obtained from SCAN.This only detected 12 cases of benzodiazepine dependence.

DISCUSSION
6][27] Our study provided an estimate of the diazepam usage pattern as well as the patients' clinical profi le.
Some methodological limitations should be taken into consideration.The first of these was the lack of a precise instrument for evaluating benzodiazepine dependence, since the SCAN criterion for benzodiazepine dependence has proved to have little sensitivity.Other studies 28,29 have already suggested that the operational criteria used in the diagnostic assessment of psychoactive substance dependence have proved to be useless with regard to benzodiazepines.The benzodiazepine dependence indicators suggested by a Canadian study were: self-identifi cation as a dependent, enumeration of multiple stressors to justify use, use based on anticipated stress, minimization of damage, storage of medication and failure to stop or diminish use. 29ur fi ndings reinforce the need for greater precision in establishing operational criteria for benzodiazepine dependence.
With regard to the patients' sociodemographic profi le, it is important to remember that our study comprised patients seen at PHCCs, within the public heath system.6][27][28][29][30] However, it should be borne in mind that our sample came from a region of the city of Campinas in which the residents are predominantly in lower middle and poor social classes, and are, therefore, public service users, and this impedes data generalization.
The overall trend was for individuals to use constant doses of benzodiazepine, with no progressive increases in dosage.][32] The patients' clear lack of understanding regarding the physician's instructions may be partly explained by their poor level of schooling.In addition to the specifi c maintenance prescription treatment, the physician ends up simply repeating previous prescriptions, thereby perpetuating a practice that is not always based on formal therapeutic criteria.][32][33][34] In the present study, 25 patients (61%) suffered from depression, according to the diagnoses produced by SCAN.The frequency with which depressive symptoms appear in the list of most reported emotional symptoms was also noticeable (it is worth clarifying that the patients were asked about each symptom in the SCAN list).On the other hand, there was no spontaneous report of depression as the main reason for having started using benzodiazepine.It is known that many patients suffering from depression who are seen by general practitioners are given only benzodiazepine for anxiety symptoms and insomnia, instead of the appropriate treatment for depression.Quality of care in cases of depression depends on good communication between the doctor and the patient, but patients who are depressed often have diffi culty in discussing their problems with doctors.They are also unlikely to be active in seeking care and have low expectations of what the treatment can provide. 31,32ccording to our fi ndings, the chronic benzodiazepine users at PHCCs did not have the required information and consequently did not have any preoccupations about the appropriateness of their treatment.When they did, they were unable to stop taking benzodiazepines without presenting withdrawal-related symptoms.
There is a need for guidance and follow-up for chronic users of benzodiazepine, especially in view of the low cost and effectiveness of the intervention programs for benzodiazepine-dependent patients.One very simple and straightforward program showed the positive economic implications of sending an educational letter to patients, aimed at reducing long-term benzodiazepine prescribing.After receiving the letter, 31% of those patients discussed their benzodiazepine usage with their general practitioner and 10% had their drug or drug strength changed.During the year following this intervention, a signifi cant reduction in benzodiazepine usage of 17% was observed in relation to baseline; 5% of the patients did not order any more benzodiazepine prescriptions after receiving the letter. 31There is also a need to improve medical students' and professionals' skills regarding the detection and management of anxiety and depressive disorders.

CONCLUSION
Chronic benzodiazepine users are frequently women over the age of 40 years, who began using the medication because of nervousness or insomnia.The usage pattern highlighted the patients' lack of prescription compliance, frustrated attempts to stop using this drug and frequent chronic concomitant use of one or more other drugs.SCAN proved to be inadequate for detecting benzodiazepine dependence syndrome.Most patients (61%) presented with depression.

Table 1 .
Pattern of benzodiazepine usage among patients in public primary healthcare centers *Negative answer to the question "Have you used diazepam according to your physician's prescription?"

Table 2 .
Reasons for starting to use diazepam and continuing with it, as reported by the patients of public primary healthcare centers

Table 3 .
Schedule for Clinical Assessment in Neuropsychiatry (SCAN) frequencies for physical and emotional symptoms among diazepam users

Table 4 .
Frequency of mental disorders according to the International Classifi cation of Diseases, 10 th edition (ICD-10), among diazepam users *More than one diagnostic category was given to some patients.