BLEBEA Nicoleta Mirela1, NEGREȘ Simona²
1Pharmacology and Clinic Pharmacy Department, Faculty of Pharmacy, “Ovidius” University, 6, Căpitan Aviator Al.Șerbănescu Street, Constanța (ROMANIA)
²Pharmacology and Clinic Pharmacy Department, Faculty of Pharmacy, “Carol Davila” University of Medicine and Pharmacy, 6, Traian Vuia Street, 020956, Bucharest (ROMANIA)
The prevalence of diabetes mellitus differs significantly depending on the population studied, age, sex, socio-economic status and lifestyle. The treatment of patients with diabetes mellitus consists of three main parts: diet, exercise and drug treatment. Monitoring of therapy for patients with diabetes involves particular monitoring of efficacy based on biochemical parameters glycated hemoglobin HbA1c, (normal values 4.8-6.5% of total hemoglobin ), blood glucose. The CODE-2 study (The cost of diabetes in Europe – type 2) found that in Europe, in only 28% of patients, there is good glycemic control. Diabetes control requires more than the proper administration of medications. In the United States, less than 2% of adults with diabetes meet the full level of care recommended by the American Diabetes Association-ADA . Care is the main cause of the development of complications of diabetes and individual and economic costs.
Key words: compliance, diabetic patients, diabetes mellitus, HbA1, pharmaceutical care,
Diabetes mellitus is a metabolic disease, a pathology that, according to the World Health Organization (WHO), will affect approximately 4.3% of the population by 2025. The disease is detected late and affected patients develop comorbidities . If we take into account the Epidiab study, cardiovascular complications are present in the case of diabete type 2, in a percentage of 50% at the time of diagnosis of the disease . Unfortunately, the complications that occur decrease the quality of life, functional capacity, autonomy of patients, increase the number of days of hospitalization, medical consultations and implicitly the expenses related to the patient diabetes. There is also a doubling of the mortality rate, which in the percentage of 70-80% is determined by cardiovascular complications. For these reasons the management of diabetic patients is important and consists of:
- training on the correct administration of the treatment;
- clarification of administration issues, order of administration and the need for continuous administration, without interruption of medication;
- training the patient to self-monitor blood glucose at home using his own measuring device;
- detecting problems related to side effects (identifying the signs and symptoms related to medications) and maintaining contact with the specialist for their remedy;
- training patients on the proper storage of medicines at home;
- encouraging patients to use non-pharmacological methods, namely: nutritional measures such as low-sodium diet (about 2.4g / day NaCl), diet according to weight status (diet rich in fruits with low sugar content, vegetables, low consumption of fats, especially unsaturated, minimal use of processed foods that contain quite a lot of salt), quitting smoking, reducing excessive alcohol consumption, coffee;
- monitoring the changes in salty taste induced by some antihypertensives so that the low-sodium diet is accepted correctly, as well as the sweet taste in diabetics modified by antidiabetic treatment;
- implementation of strategies to increase adherence to patients’ drug therapy .
According to the WHO, there are 3 main types of diabetes, depending on the need for insulin: insulin-dependent diabetes mellitus (type 1), non-insulin-dependent diabetes mellitus (type2) and gestational diabetes (pregnancy). Approximately 10-20% of patients have type1, the remaining 80-90% of diabetic patients have type2.
The characteristics of the main types of diabetes
Type 1 diabetes is the consequence of an absolute deficiency of pancreatic insulin secretion due to the destruction of beta-secreting endocrine cells in the Langerhans Islands . Therapeutic goals are: prevention of life-threatening hyperglycemic diabetic coma, prevention of complications of diabetes resulting from damage to small and large blood vessels patient monitoring is essential to avoid even short-term increase in blood sugar, prevention of insulin overdose that may lead to hypoglycemic shock and may put the patient’s life in danger .
Type 2 diabetes is a consequence of the development of the insulin resistance of tissues. Most patients fall into this category. The causes are apparently genetic and not viral or autoimmune. Under these conditions, the physiological concentrations of insulin generate a lower than normal biological response. Type 2 diabetes is accompanied by hyperinsulinemia, which occurs as a compensatory response of the body. The metabolic alterations are milder than those described for type2, but the long-term complications can be just as devastating , which is why the management of diabetic patients is important.
The goal is to keep the biochemical parameters (blood sugar, glycated hemoglobin, lipid profile, blood pressure, anthropometric parameters) within normal limits .
The treatment consists of three main parts: diet, exercise and drug treatment. The diet involves an individualization of carbohydrate and caloric intake in each patient, depending on: age, physical activity and possible comorbidities.
Diet in diabetes is indispensable for treatment, so it is necessary to consider the three categories of food:
- forbidden foods (alcohol, sugar, cakes, jams, sweets, concentrated syrups, honey, juices sweetened with sugar, non-dietary chocolate, sweet fruits such as grapes, dates, figs, raisins)
- foods allowed, but weighed (bread, pasta, semolina, rice, potatoes)
- foods allowed without restriction (meat, cheese, vegetables, eggs).
Exercise should be mandatory, for 30-60 min / day, minimum 5 days / week.
Non-pharmacological, hygienic-dietary treatment is indispensable and aims to change the lifestyle based on medical education and consists of:
- combating risk factors (obesity, stress, excessive carbohydrate consumption, long-term consumption of thiazide diuretics and corticosteroids)
- low calorie and hypoglycemic diet distributed during the day in 4-5 meals;
- daily physical exercise in accordance with the caloric needs in the form of, walking for 30 minutes .
Clinical management of diabetes
Clinical management of diabetes is achieved through TEME programs (Therapy, Education, Monitoring, Evaluation) . Their purpose is to increase the quality of life of patients with diabetes, through the direct intervention of medical staff involved in initiating therapy, optimizing and monitoring it, monitoring the progress of the disease and educating patients. In these last stages, the pharmacist has the most important role.
Proper and complete prescription medication: the prescription is essential for the pharmacist to dispense the correct drug. The role of informing and training the patient by the pharmacist is meant to ensure optimal compliance with the treatment . The directions by which the pharmacist informs the patient refer to: the purpose of the treatment and its effects and what are the consequences of non-compliance regarding the treatment, the dose and the correct administration of the pharmaceutical form; optimal timing of meals and circadian biorhythm, precautions and contraindications, predictable side effects of medication.
The study is prospective, longitudinal, randomized, controlled and was performed on 2 groups of 35 diabetic patients who go to the same pharmacies in Constanța County.
- group of 35 patients with diabetes to whom a pharmaceutical assistance program was applied;
- control group of 35 patients with diabetes in whom the release of drugs was performed according to the usual, traditional model, with a minimum training of the patient in the pharmacy office offering standard pharmaceutical services.
The inclusion criteria in the analysis were:
- pacients with type 1 or type 2 diabetes;
- pacients with complications due to diabetes: retinopathy, neuropathy, diabetic nephropathy;
- comorbidities: cardiovascular, metabolic, respiratory, digestive, nervous, etc.
- age between 42-81 years;
- sex: men and women;
The aim of the study was to observe and quantify whether diabetic patients participating in the study have a better reduction in blood glucose and glycosylated hemoglobin levels as a result of the management of the communitary pharmacist providing pharmaceutical care to optimize the therapeutic effects within 3 months.
Pharmacists in the communitary pharmacy advise patients with diabetes who have comorbidities (hypertension, dyslipidemia, metabolic syndrome) on the importance of monitoring blood biochemical factors (blood glucose, glycated hemoglobin) at the beginning of the study and at the end of the study as and daily self-monitoring of blood glucose at home, using its own measuring device.
Results and discussions
The research results showed that in this study were included patients of both sexes: men (37.14%), women (62.86%) with a mean age of 62.97 ± 9.538 (M ± DS). The associated diseases of the patients included in the study are hypertension (62.85%), diabetic neuropathy (25.71%), dyslipidemia (20%), varicose ulcer (8.57%), depression (2.85% ). As a result of the pharmaceutical care provided by the pharmacist, blood glucose levels decreased from an average of 181.42 ± 31,967 (M ± DS) to an average of 161.94 ± 31,608 (M ± DS) after 3 months. and HbA1c values from 7.84%, ± 1.1298 (M ± DS) to 6.48% ± 1.1383 (M ± DS) after 3 months (%), values decreased to 88.5% of those 35 patients. Monitoring of biochemical parameters reflecting glycemic status, glycated hemoglobin (HbA1) and blood glucose value took place at the beginning and end of the study, respectively at 3 months in the same medical analysis laboratory, as well as daily self-monitoring of blood glucose at home, using a own measuring device The patient received a notebook from the pharmacist in which he passed irregularities in the administration of the drug. Adherence to medication was established by using the report in the notebook by the patient, how many times he took his medication regularly, daily, according to the treatment schedule during the 3 months, if there were days when the drugs were not administered. The glycemic control represented by HbA1c proved to be significantly related to the reports in the notebook, in which the low level of HbA1c (better glycemic control) was associated with higher adhesion scores in the study cohort.
The study highlights the influence of the pharmacist on the adherence of diabetic patients to treatment and recommendations on lifestyle changes. In conclusion, it is necessary to intensify the activity of management the diabetic patients in order to increase adherence to treatment, for all patients. Supporting the diabetes patient community is a complex and long-term mission. A good communication between the patient and the pharmacist is the way in which all these efforts can give best results  and the lives of patients with diabetes can be improved.
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