A Cross-sectional, Descriptive Study of Medication Use Among Persons With a Gastrointestinal Stoma
Research on the use of medications in people with intestinal stomas is lacking, creating gaps in knowledge of pharmacoepidemiology in these patients. A cross-sectional, descriptive study was conducted over a period of 4 months in Divinópolis, Brazil to describe the profile of medication use among people enrolled in the Health Support Service for People with Stoma - Level II (SSPS II) of a municipality in the state of Minas Gerais, Brazil.
All patients from SSPS II with a colostomy or ileostomy were invited by phone to participate; those with incomplete registration data and/or who were <18 years old, hospitalized for any reason, or had their stoma reversed were excluded from participation. During home interviews, researchers obtained sociodemographic profiles (age, gender, education, occupation, and family income) and information on comorbidities, medication use, adherence to medication protocols (per the Morisky Green Levine test), polypharmacy, and adult/pharmaceutical care (medication description and indication, expiration date, self-medication). Drug storage was assessed by visual evaluation. The information was entered onto individual data sheets, numbered to ensure patient anonymity. The data then were entered into and analyzed using SSPS II statistical software using frequency measurements, measures of central tendency, and dispersion of demographic variables, health conditions, and medicine use. The study population included 59 persons (average age 66.9 ± 13.27 years), 36 (61.0%) women, 38 (64.4%) with an incomplete/primary level education, and 44 (74.5%) retired. Forty-nine (49) patients had a colostomy and 10 had an ileostomy; cancer was the main reason for stoma creation (61.1%). Half of the survey participants reported having 1 or 2 comorbidities (average 2.3); the most prevalent (52) was circulatory system disease among which hypertension (38, 64.4%) was most common. Analysis of the pharmacotherapeutic profile (prescribed and used) showed 89.8% of the study population used medication, and 52.8% were prescribed >5 medications (polypharmacy). Low and medium level adherence with prescriptions was noted (37.7%); 39.6% reported receiving no guidance on the use of the medication associated with their condition. Improper storage was observed in 33.9% of participants. In this population, persons with a stoma had complex pharmacotherapy, a high rate of polypharmacy, and deficiency in guidance on the use of medication. Further research into determining whether investments in both inclusion of a pharmacist on the team and more pharmacoepidemiological studies would improve patient care and medication safety in patients with a stoma is warranted.
An intestinal stoma is precipitated by or related to various underlying diseases, including agenesis and anorectal atresia, neoplasia, colorectal trauma, diverticular disease, inflammatory bowel disease, and fistulas.1 In Brazil, colorectal cancer is the leading reason for stoma creation2; surgical resection of the affected site and creation of a permanent colostomy are considered the most effective approaches.3
Having a stoma typically does not involve the use of specific medications, but underlying or concomittant disease may require treatment involving medication.4-6 The major consequence of extensive bowel resection is the loss of absorptive area; this may result in malabsorption of macro- and micronutrients, electrolytes, and water, which may interfere with the absorption of medications. Most macronutrient absorption occurs in the first 100 cm to 150 cm of the proximal intestines and specific micronutrients are absorbed in certain areas of the small intestine. Therefore, the length of the remaining intestine is a determining prognostic factor for ostomy patients.7
Absorption processes are related to the permeation of compounds through the biological membranes and are influenced by the physiochemical characteristics of both the large and small intestines. Thus, the anatomical and physiological parameters of the gastrointestinal tract drastically affect the speed and extent of oral drug absorption. For example, although the highest amount of absorption occurs in the duodenum and the proximal part of the jejunum, acidic drugs also are absorbed in the stomach, because the acidic pH hinders their dissociation, promoting their passive diffusion through the lipophilic portion of the membrane bilayer. An in vitro study8 has shown that commonly used drugs such as popranolol, acetaminophen, morphine, and hidrochlorothiazide drugs are absorbed mainly in the first part of the intestine.
Pharmacoepidemiology aims to study and describe the use of medication and its effect in a given population. It is extremely important to know the medication usage profile of the population in order to develop strategies aimed at optimal medication use.5 Pharmacoepidemiological data for ostomy patients are scarce. According to a descriptive study by Barbosa et al5 and an integrative review study by Luz et al,2 medication, nutrient, and electrolyte absorption among this population may be compromised,2,5 so gastroresistant medications and prolonged release of pharmaceutical substances can be affected by a decrease of the intestinal portion, leading to a reduction of the absorbed drug concentration and possible ineffectiveness of treatment.5,9,10
Knowing the profile of medication use in these patients is essential to understanding the frequency and distribution of medication use (prescribed and over-the-counter) in this population and in consequently ensuring its effectiveness and correct use. The purpose of this cross-sectional study was to describe the medication profile of persons with an intestinal stoma.
Data were collected after institutional approvals authorized the research; permission from the Brazilian Ethics Committee was obtained through opinion no. 862,133 (CAAE: 37653514.4.0000.5545). The study respected the ethical precepts determined by the Brazilian ethical criteria in agreement with the Declaration of Helsinki. All participants in the study signed the Free and Informed Consent Term Form and anonymity was ensured.
The cross-sectional study was conducted at the Health Support Service for People with Stoma - Level II (SSPS II) of a municipality in the state of Minas Gerais, Brazil. This type of service encompasses a multidisciplinary team including a physician, nurse, social worker, psychologist, and nutritionist. This team provides specialized and interdisciplinary assistance to people with a stoma, including instruction in the care and use of ostomy collection devices, prevention and treatment of stoma complications, health care professional training, and ostomy supplies and adjuvant equipment.11
All patients from SSPS II were eligible for the study. A total of 98 persons with a colostomy or ileostomy who were registered with the service were invited by phone call to participate via the local public health service. For sampling purposes, a 95% confidence interval, an error of 5%, and hypothetical population frequency of 90% were considered, with a sample of 59 ostomy patients being calculated (49 patients with colostomy and 10 patients with ileostomy). Persons with incomplete registration data, <18 years old, and/or who were hospitalized for any reason or who had their stoma reversed were not invited to participate.
Data were collected through home interviews set up by phone and conducted from February to May 2015. Trained interviewers administered the questionnaires. Sociodemographic variables (gender, age, marital status, education, occupation, family income) and health information (disease reported, medication use, and comorbidities) were collected. Family income was calculated using the Brazilian minimum wage of 2015 as a base (US $180/month). Information regarding patient history and health conditions, the type of stoma, the underlying disease requiring the creation of the stoma, and self-reported health status (classified according to the International Statistical Classification System of Diseases and Related Health Problems12) were extracted from medical records at SSPS II.
In addition, a questionnaire on adult/pharmaceutical care, developed and validated by Ribeiro et al13 was used to collect information on medications, including the medication description and indication, verification of its expiration date, and whether the medication was used without the indication of a health professional (self-medication). One (1) open-ended question was added to this questionnaire: “What disease led to making your stoma?”
To evaluate adherence to treatment, the Morisky Green Levine14 test was used in which the following questions were asked: 1) Do you sometimes have trouble remembering to take your medication? 2) Do you sometimes neglect to take your medicine? 3) When you are feeling better, do you sometimes stop taking your medicine? 4) Sometimes, if you feel worse while taking the medication, do you stop taking it? Questions had dichotomous answer categories (Yes or No); no was the expected answer for good adherence.
Patient prescription data from the past 3 months and medication packaging information was used to obtain a description of medication. This information was acquired during the home interviews. The medications used were classified according to Anatomical-Therapeutic-Chemical (ATC) Classification System15 levels: the first level included medications for a main anatomical group (eg, for the alimentary tract or for metabolism) and the second level addressed therapeutic subgroups, such as drug use in diabetes.
Polypharmacy was evaluated and defined as 5 or more different medications in continuous use.16 Medications were acquired through public and private pharmacies of the public pharmacy program of Brazil; other means of access such as neighborhood and donation also were identified as well as whether a medication was included in the Municipal Register of Medicinal Products 2015 (REMUME - 2015) of Divinópolis, Minas Gerais.
Drug storage was assessed by evaluating room of storage and whether the primary package (box) or secondary pack (blister) was intact. Researchers recorded their observations as 1) medication stored in the package (blister and box) in the bedroom or in the living room; 2) medication stored in the package (blister) in the bedroom or in the living room; 3) medication stored in the package (blister and box) in the kitchen (on top of the refrigerator or cabinet); 4) medication stored only in the blister pack in the kitchen (on top of the refrigerator or cabinet); or 5) medication stored outside the package (blister) in a container. Items 3, 4, and 5 were considered inadequate storage because medication stored out of the blister package or in the kitchen (a humid and warm place) can be compromised.
To evaluate the perception of the instruction received by the patient on the use of their medication, each patient answered an 8-item questionnaire created by the researchers related to guidance on the use of medications as presented in the adult pharmaceutical care survey.13 Yes responses = 1 point, No responses = 0 (see Figure 1). A final score <3 was considered unsatisfactory guidance, between 3 and 6 satisfactory guidance, and >6 excellent guidance.
Data collection and analyses. Data were initially collected on an individual spreadsheet for each patient and subsequently collated into an Excel (Microsoft Corp, Redmond, WA) spreadsheet that included all patients, which was entered into SPSS, version 19 (SPSS Inc, Chicago, IL). Descriptive data were analyzed using frequency measurements, measurements of central tendency, and dispersion of the demographic variables, health conditions, and use of medications. Subsequently, bivariate analysis was performed to compare patients who reported receiving guidance to those who did not receive guidance on the use of their medication for the following characteristics; information compared included demographic and socioeconomic data, type of stoma, polypharmacy, and adherence to treatment. For these analyses, data from 6 patients who did not use medication were excluded.
From a total of 98 persons with a colostomy or ileostomy registered at SSPS II and eligible to the study, 59 participants were included: 38 (61%) women, mean age 66.9 ± 13 years (range 40–96 years), of whom 49 (83.05%) were colostomy patients and 10 (16.95%) were ileostomy patients. The majority of participants (39, 66.10%) were >60 years of age, with an incomplete primary education (29, 49.15%) and an income ranging from 2 to 3 minimum salaries (42, 71.19%) (see Table 1).
The 59 participants reported a total of 135 diseases and health problems, with an average of 2.3 health conditions/patient (range 0–6); these included predominantly circulatory diseases (52, 88.13%) and nutritional and metabolic endocrine disorders (30, 50.84%) (see Table 2). Specific health problems included hypertension (38, 64.41%) and cardiac and coronary insufficiency (14, 23.71%) as part of 52 circulatory diseases, cancer (13, 22.03%), and depression (13, 22.03%).
In the majority of cases, stoma construction was due to malignant neoplasm of the digestive organs (36, 61.01%), unspecified malignant neoplasms (5, 8.47%), and other digestive diseases such as diverticulitis, obstruction, and intestinal polyp (8, 13.55%).
Of the 59 participants, 6 (10.16%) reported not using any medication (see Table 3); 53 patients used a total of 254 medications, averaging 4.3 ± 3 medications/patient (range 0–11). From patients who used medication, 29 (54.71%) were classified as utilizing polypharmacy (range 5–11 medications).The largest number of registered medications among patients taking any medication according to the first level of ATC were for cardiovascular system indications (95), followed by nervous system (64) and food and metabolic tract (55). For the second level of ATC, 29 (54.71%) were diuretics, 23 (43.39%) were agents acting on the renin-angiotensin system, 17 (32.07%) were psychoanaleptics, and 16 (30.18%) were medications for digestive disorders (see Table 4).
A medical professional was found to have recently prescribed 96.46% of the medications; 3.54% of medications were reported as self-medication or taken at the suggestion of a friend, relative, or neighbor. Of the 254 medications used, 87 (34.25%) were acquired from a municipal public pharmacy, 136 (53.54%) from retail chain pharmacies, 18 (7.09%) from the popular pharmacy program, and 13 (5.12%) from other unspecified places. Among the medications used, 61.81% appear in the Municipal Register of Medications (REMUME).
Twenty (20, 33.9%) participants improperly stored medications and 7 (11.86%) did not check the expiration date of the drugs.
Of the 53 patients using medications, 16 (30.19%) needed help taking them and 20 (37.73 %) had low or average adherence as indicated by the Morisky Green Levine test. Nine (9, 16.98%) participants reported discontinuing use of 42 medications. Twenty-one (21, 39.62%) said they had not received guidance from any health professional on the use of their medication. Of those who reported receiving some guidance (32), 2 (6.25%) received unsatisfactory guidance, 25 (78.13%) satisfactory guidance, and 5 (15.62%) excellent guidance.
In international studies, the incidence of intestinal stomas is reported to be higher in men than in women.17,18 In Brazil, as in this study, more women had a stoma.19,20 This may be explained by the fact that Brazilian women seek health services more often than men and/or have a higher rate of colorectal cancer.21
Increasing age is a factor in the oncogenic process owing to increased exposure to risk factors over the years. Consequently, the number of ostomy patients increases in this population according to descriptive study by Da Paz et al.22 In addition, a descriptive study by Skeps et al23 (2012) has shown health professionals must understand the implications of age-related changes for persons with a stoma and how they can affect their self-care.
International, demographic, and cross-sectional multicenter studies18,24 conducted in developed countries reveal a population with a high school education. According to a review,25 the illiteracy rate is high (51.6%) in Brazil, especially among the elderly who had no access to school.
The population of Brazilian patients with a stoma includes the most vulnerable economic classes, with family incomes below 3 minimum salaries (<$540 US) and dependent on public health services, which are precarious in the country.26 Pharmacoepidemiological demographic and descriptive studies of persons with a stoma that include a comorbidity profile are scarce.5 A pharmacoepidemiological study27 among persons with a stoma that includes a comorbidity profile showed from 0 to 8 comorbidities, with a high prevalence of cardiovascular, gastrointestinal, endocrine, and neoplastic diseases — conditions commonly found in the elderly. Therefore, in most cases having a stoma does not necessarily imply a limiting condition or poorer quality of health than the general population.
In their qualitative research, Barros et al28 and Silveira et al29 showed chronic degenerative diseases were predominantly found in older populations, making this age group more dependent on health services. Barros et al28 found the elderly with a stoma generally have more difficulties implementing daily care when compared to younger people and often depend on the care provided by other persons or professionals. The health care of this population should focus on disease specificity, the complication risks, and how to live with an ostomy. As such, the current authors believe training of care professionals must be continuous and policies that stimulate their implementation of good practice must be in place.
Polypharmacy and lack of a pharmacist. Chronic degenerative diseases are the factors most associated with polypharmacy.29 Descriptive studies30,31 conducted in different regions of Brazil among patients with chronic degenerative diseases found an average use of 3.6 to 4.67 medications per patient. Polypharmacy also was noted in the study population and contributes to the use of inappropriate and nonessential medication for treatment, which increases the risk of adverse reactions.29 In this study, according to the ATC classification level, persons with a stoma had a medication profile similar to that of the elderly population in general; the most commonly used drugs are agents acting on the renin-angiotensin system, diuretics, calcium channel blockers, psychoanaleptics, and drugs used for diabetes and digestive disorders.31,32
Although the stoma does not typically require use of specific medications, patients will need to use medication for their comorbidities.4 As such, the potential contribution of a pharmacist on a health team should be a considered.32,33 Without proper guidance and monitoring by a professional, intestinal motility, for example, can be affected by medication and interfere with the absorption, effectiveness, and safety of other drugs used concomitantly1,6,34; a pharmacist can provide recommendations on sustained-release medications as well as gastroresistant forms or coated tablets in capsules that can prevent release of the active ingredient at the gastric level in persons with a stoma and advise patients on the use of liquid forms, gelatin capsules, and noncoated tablets.1,4
In this study, the medications used were acquired from retail chain pharmacies, even though 61.81% of the medications referred belong to REMUME. Study data revealed medication is not available through the municipal public health system. One of the factors contributing to this access deficit may be related to the fact that the actions of the pharmacist in drugstores, pharmacies, and basic health units in Brazil are focused on administrative and logistic activities instead of patient care.8,35
Storage. The correct storage of drugs was also a potential problem found among the study population. Proper use of a drug begins with the condition of the product administered; an epidemiological study36 found some people do not observe the drug’s expiration date. Maintaining the quality of the medication, which includes proper storage, is fundamental for maintaining drug effectiveness, and recommended measures always should be taken related to medicine care and stability, along with the dose.36,37
Adherence to treatment. Adherence to treatment was another important factor and current study results corroborated a descriptive study38 conducted among elderly persons with a stoma in which 35.4% were nonadherent to treatment. However, it should be noted that a previous descriptive study14 that used the Morisky Green Levine methodology showed lower scores in identifying low adherence to treatment compared to other methods. As such, reported nonadherence to treatment may be related to the use of a particular questionnaire and whether the interviewer had an expected response bias. Other adherence measurement options such as pill count or therapeutic drug monitoring were not available.
It is worth remembering that treatment adherence is a factor of the guidance received. Potential and urgent problems can arise when the patient does not accept or refuses to follow the treatment regimen. A descriptive study by Oenning et al39 has shown this directly impacts patient safety because the correct medication and its proper administration is a strategic component in the treatment and maintenance of improved quality of life.
From 70% to 98% of patients reported receiving guidance on how to use their medication during their consultation or while the medication was dispensed. Because a method developed in this study to assess the use of medication is a new score created to assess self-reported guidance (see Figure 1), further studies are needed to evaluate the efficacy and reproducibility of the method.
Among patients in the current study who reported receiving (60.4%) and not receiving some guidance (39.6 %), 37% were elderly and 22% had not completed their elementary school education or were illiterate. Therefore, these data must be interpreted with caution because level of education and age could interfere with understanding and processing the instructions received. Information from health professionals promotes the appropriate use of medication, ensuring patient safety. Studies32,39 have shown providing professional guidance is a simple, low-cost strategy for the health system. The level of education is a determining factor in adherence to pharmacological treatment; according to a review study in Ireland,40 data demonstrating a low level of education can contribute to an insufficient degree of adherence with treatment.
Among the limiting factors of this research is that data collection did not include documentation of adverse drug events or efficacy. Results also are limited by the evaluation of self-reported patient perceptions and to this specific demographic and/or potential sampling limitations.
Ostomy patients in this study presented with complex pharmacotherapy needs, a high incidence of polypharmacy, and less-than-satisfactory guidance on medication use. The study population also presented a morbidity and medication use profile similar to that found in elderly persons without an intestinal stoma. Thus, it is of extreme importance to include a pharmaceutical professional on the interdisciplinary health team to guide and monitor the patient with an ostomy. Additional pharmacoepidemiological studies involving patients with a stoma would shed additional light on this concern and facilitate the development of health care guidance documents and recommendations. n
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Potential Conflicts of Interest: none disclosed
Ms. Pereira de Paula is a clinical pharmacist; Ms. da Silva Alves is a nurse; Mr. Percinio is a medical student; and Dr. Pereira, Dr. Moraes, and Dr. Sanches are adjunct professors, Federal University of São João Del Rei, Bairro Chanadour, Divinópolis, Brazil. Please address correspondence to: Geisa Cristina da Silva Alves, Federal University of São João Del Rei – Rua Sebastião Gonçalves Coelho, 400 – Bairro Chanadour, Divinópolis, Brazil; email: firstname.lastname@example.org.