Pharm World Sci (2006) 28:239–247 DOI 10.1007/s11096-006-9023-9
R E S E A R C H A RT I C L E
Drug-related problems in patients with angina pectoris, type 2 diabetes and asthma – interviewing patients at home Lotte Stig Haugbølle Æ Ellen Westh Sørensen
Received: 12 January 2006 / Accepted: 12 April 2006 / Published online: 26 October 2006 Springer Science+Business Media B.V. 2006
Abstract Objective of the study The objective of the overall study was to create a foundation for improving the quality of counselling practice in pharmacies. The research question addressed in this sub-study was to describe drug-related problems (DRPs) in terms of frequency as well as type in people with angina pectoris, type 2 diabetes and asthma, as the problems were identified through medication reviews and home interviews. Setting and method During their pharmacy internships, fourth-year pharmacy students collected data for the study in 1999, 2000 and 2001 by carrying out medication reviews, conducting home interviews and registering DRPs for 414 patients. Data were collected from the following patient groups in the years indicated: in 1999, 123 angina pectoris patients; in 2000, 192 type 2 diabetes patients, and in 2001, 99 asthma patients. The interviews dealt with the patient’s drug-related experiences, knowledge, perceptions, problems and actions. The DRPs were registered according to the so-called PIDoc system. Results A medication review was supplemented by qualitative interviews with the three patient groups, which revealed a relatively high number of DRPs compared to other studies. An average of 2.8 DRPs were identified per angina pectoris patient; 4.1 DRPs per type 2 diabetes patient and 4.0 DRPs per asthma patient. ‘‘Inappropriate use of medicines by the patient’’ and L. S. Haugbølle (&) Æ E. W. Sørensen Department of Pharmacology and Pharmacotherapy, Section for Social Pharmacy and Research Centre for Quality in Medicine Use, The Danish University of Pharmaceutical Sciences, Universitetsparken 2, DK-2100, Copenhagen, Denmark e-mail:
[email protected]
‘‘Other problems’’ (such as limited knowledge of the illness, inappropriate lifestyle, fear of medication, lack of information, etc.) were the two most common DRP subcategories identified in all three patient groups. Conclusion The study provided a profile of a pharmacy-based population of 414 patients visiting the pharmacy, all of whom are at high risk of experiencing drug-related problems. Pharmacy staff needs to take this high rate of DRPs in people with angina pectoris, asthma and type 2 diabetes into account when dispensing medicines to and advising patients from the three groups, especially when explaining how to use medicines appropriately. Keywords Angina pectoris Æ Asthma Æ Type 2 diabetes Æ Drug-related problems Æ Home interviews Æ Medication review Æ Patient perspective Æ Diabetes Æ DRP Short statements on the impact of the article on practice • The results of the study can be used to provide pharmacy staff with concrete information on the type and frequency of drug-related problems (DRPs) experienced by angina pectoris patients, asthma patients and type 2 diabetes patients. • Study results can be used to increase the awareness of pharmacy staff, so that whenever they meet a patient with angina pectoris, asthma or type 2 diabetes, they will be alert to the fact that these patients are likely candidates for DRPs, problems that pharmacy staff can often solve. • A Danish website based on the major results from the study has been developed and is used widely by pharmacists and pharmacy students.
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Introduction Documenting drug-related problems (DRPs) plays an important role in the quality assurance of the pharmaceutical care process and the quality development of pharmacy practice. Furthermore, documentation of DRPs can be used when negotiating reimbursement of pharmacy services, discussing health policy or as a process indicator of pharmacy practice [1–4]. Numerous pieces of research have suggested that the patient’s perspective should be an important prerequisite for describing and prioritizing the patient counselling practices of health professionals [5–11], the reason being that patients’ perspectives on illness and medicine use often differ from those of health professionals [8, 12–17]. This study differs from most other studies in the following way: We considered that interviewing patients in their homes would provide a useful method of collecting data to supplement medication reviews with regard to identifying DRPs. In their own homes, patients feel more relaxed as they describe and elaborate on their medication- and illness-related experiences, considerations, actions and problems, meanwhile displaying the specific contents of their medicine chest. Home interviews between pharmacists and patients have only been used in a few other studies to identify DRPs [18–21]. In this study, we also deal with specific pharmacy-based patient groups. Besides, neither of the other studies in the area were carried out by pharmacy students as part of a larger study, aiming at contributing to quality development of pharmacy practice and pharmacy practice research like out study did.
development of pharmacy practice and pharmacy practice research in the pharmaceutical care area. This article will focus on a description of the DRPs (frequency and type) of people with angina pectoris, asthma and type 2 diabetes as they were identified through medication reviews and home interviews with patients. Results on other study parts can be found elsewhere [17, 22, 23]. Method Design Internship pharmacies Fourth-year pharmacy students serving their pharmacy internships produced data for the study [23]. At present 60% of all 288 Danish pharmacies have the status of internship pharmacies. Selection as an internship pharmacy is based on willingness, a professional assessment of each pharmacy and the supervisor’s professional qualifications. For other aspects of Danish pharmacy context see in Table 1. The study was conducted as an action research study. The aim of action research is to initiate action in the local setting and create learning, in this case for students as well as pharmacies and pharmacy practice researchers [24–26]. A project group consisting of community and hospital pharmacists, pharmacy students and pharmacy practice researchers planned the study, and developed a study protocol containing the necessary data collection tools. Patient groups
Aim of the study The study on which this article is based was part of a more extensive Danish study aiming at contributing to quality Table 1 The Danish pharmacy context in 2000
Number of pharmacies in Denmark Served population per pharmacy Average pharmacy staff per pharmacy Prescription control Staff counselling Pharmacists’ training
Pharmacy technicians’ training
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Angina pectoris patients were chosen as the study’s first patient focus group in 1999, since with only one exception at the time [27], this patient group had lar288 18,450 inhabitants 1 pharmacy proprietor (a trained pharmacist), 2.2 community pharmacists and 8.6 pharmacy technicians (converted into full-time employees) Typically the pharmacist. About 70% of pharmacy technicians are authorized to control prescriptions though Pharmacy proprietor, community pharmacists, pharmacy technicians, pharmacy technician students Takes 5 years. In their fourth year, pharmacy students complete a 6month pharmacy internship in either a community or a hospital pharmacy Takes 3 years (20 weeks at college, the rest in a pharmacy)
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gely been neglected by community pharmacy. In addition, since the Danish Pharmaceutical Association (DPA) had designated 1999 a campaign year for cardiovascular diseases, pharmacies were already expected to meet the requirements for participating in a study on angina pectoris patients, due to their presumed increased knowledge of the patient group that year. The year 2000 was labelled a campaign year for diabetes by the DPA, and 2001 was a campaign year for asthma. Thus the next two patient groups to be included in the study were type 2 diabetes patients in 2000 and asthma patients in 2001. Involving the pharmacy students Prior to data collection, the students were given educational study materials and a test to complete to prepare them for conducting patient interviews, performing medication reviews and documenting DRPs. The students filled in medication profiles and conducted the patient interviews on the basis of data from the pharmacy and the patients. See Table 2. Interviews Qualitative interviews were chosen as the method of collecting patient data, since the students were to gain in-depth knowledge about each patient’s medicineand illness-related knowledge, perception, problems and actions. A non-random self-selecting sampling Table 2 Information about data collection
technique was used to select patients during one specific week [28]. For further details on inclusion and exclusion criteria see Table 3. The study thus provided a profile of a pharmacybased population of angina pectoris patients, type 2 diabetics and asthma patients. The patient interviews were carried out in patient’s homes on the basis of a semi-structured interview guide. Theories on the self-regulation of medicine [7, 29], coping with illness [7, 30, 31], user perspectives [5, 8, 9, 32] and DRPs [33, 34] were used as frames for developing the interview guide. The interviews lasted 1 h on average per interview (ranging from 20 min–2 h), were recorded and subsequently transcribed into the interview guide, either verbatim or in the student’s own words. See Table 4 for an example of an interview guide. Protocol for documenting DRPs As stated by van Mil et al. [1], as many as 14 systems for classifying DRPs are described in the international literature, although well-constructed and validated systems are still lacking. To ensure reliable and consistent documentation of the DRPs identified, the project group developed a DRP documentation protocol outlining when and how to code a DRP, based on the PI-Doc (Problem Intervention Documentation) coding form [33–35]. Developed in 1995, the PI-Doc is a hierarchical system for problem-intervention documentation, and the system has been used in several
Year
Patient group
No. of pharmacies involved
No. of patient interviews
No. of patients with medication profiles
1999 2000 2001
Angina pectoris Type 2 diabetes Asthma
70 107 52
123 192 99
118 191 97
Table 3 Patient inclusion and exclusion criteria
Patient inclusion criteria
Patient exclusion criteria
1999
2000
2001
Patients with angina pectoris who had been prescribed fast relief or sustained release glyceryl nitrates From two to four patients were included from each pharmacy. The first patients contacted by phone or at the counter who were interested in participating were enrolled
Patients with type 2 diabetes who had been prescribed oral antidiabetic agents or insulin
Patients with asthma who had been prescribed any kind of asthma medication
From two to four patients were included from each pharmacy. The first patients contacted by phone or at the counter who were interested in participating were enrolled
From two to four patients were included from each pharmacy. The first patients contacted by phone or at the counter who were interested in participating were enrolled
Patients in residential care, patients with senile dementia, patients who did not speak Danish and psychotic patients
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242 Table 4 Content of interview guide for angina pectoris patients
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Main themes
Sub-themes
Everyday life with angina pectoris and medicine Knowledge and behaviour in relation to angina pectoris and medicine
Course of illness, symptoms, living with angina pectoris (family, work, daily life) Use of medicines (dosage, storage, knowledge of effect of medicine), perception of medicine use, side effects (experienced, fear of side effects, speculation about side effects), other problems with medicine use, self-regulation of medicine use (rationale, arguments) Preventing angina pectoris (smoking cessation, exercise, food, etc.), strategies for staying healthy, ways of solving illness- and medicine-related problems, current condition of health, use of social network Content and form of information (from pharmacy, GP, hospital, others) expectations of health care personnel Meaningfulness, comprehensibility and manageability of angina pectoris
Ill-health perceptions and strategies
Satisfaction with information and needs Coping
pharmaceutical studies to pinpoint the exact nature of a DRP. The protocol was developed along with all three sub-studies, based on feedback from pharmacy students, pharmacies and researchers. For instance, based on experiences from the first sub-study (on angina pectoris), a number of sub-groups matching the relevant disease were set up for the second and third sub-studies to enhance documentation reliability. The protocol contained among other things general information about DRPs, concise guidelines for when and what to document as a DRP, and instructions on how to use the documentation form. The protocol also contained a documentation form with examples clarifying when to use the different sub-groups.
was used [37]. For further details see Haugbølle et al. [17, 22].
Results Described below are the most common DRPs found in the three patient groups in sub-categories A–E in the coding system for the project. Sub-category F ‘other problems’, which includes aspects of medicine use other than purely technical problem is described in the results section as well, since it shows a high number of DRPs for all three diseases. Examples come from interviews regarding specific DRPs. See Tables 5 and 6. Angina pectoris
Data analysis The students returned interview transcripts, medication profiles and completed DRP documentation forms to the project group. Two community pharmacists in the group with substantial experience in identifying and documenting DRPs analysed all interview transcripts and medication profiles for DRPs according to suggestions by Schaefer [34]. In addition, the two pharmacists systematically reached consensus on their documentation by each year crosschecking the first 5–10 cases, plus all other cases involving any doubt or where new sub-groups were to be added. Pharmacy students in the project group entered all data into the data-processing program NSDStat [36]; the resulting data were checked and analysed by members of the project group. Two other researchers/pharmacists from the project group groupcoded and analysed the interview transcripts using specific theoretical frames of references [5, 7, 29, 30, 32, 34]. A coding strategy of meaning condensation
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A total of 329 DRPs were identified for 118 patients with angina pectoris, corresponding to the identification of an average of 2.8 DRPs per patient. The most common DRP is the inappropriate use of medicines by the patient (72 cases). The patients said they didn’t know enough about their medicines (28 cases); for example in terms of how fast relief medicine affected their body. Another important problem area is that 23 patients made a conscious decision not to take their prescription medicine; for example, they don’t take statins because they cannot see that they work, or they do not take anti-seizure medicine or use a smaller amount than prescribed because it causes headaches. Inappropriate dosage is the second most common DRP (52 cases). In 31 cases, reports on a dosage interval that deviates from the one prescribed are seen; for example, no nitrate-free period and/or underdosage (11 cases). Side effects are registered in 47 cases, fore instance bradycardia (due to beta blockers), nausea (due to Emconor), and problems with stomach acid.
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Table 5 Results for DRPs identified in the three substudies A: Inappropriate choice of medicines B: Inappropriate use of medicines by the patient C: Inappropriate dosage D: Drug interactions E: Side effects F: Other Total number of DRPs Total number of patients Number of patients with DRPs Average number of DRPs per patient identified with a DRP
Table 6 Demographic data for patient groups
Angina pectoris number (percentage)
Type 2 diabetes number (percentage)
Asthma number (percentage)
23 (7.0) 72 (21.9)
57 (9.1) 171 (26.9)
66 (19.2) 167 (47.9)
52 (15.8) 8 (2.4) 47 (14.3) 127 (38.6) 329 123 118 2.8
52 (8.2) 4 (0.6) 55 (8.7) 296 (46.6) 635 192 155 4.1
16 (4.6) 2 (0.6) 52 (14.9) 46 (13.2) 349 99 88 4.0
Men/womena
Distribution of age (years)b
Angina pectoris (N = 123)
71/47
Type 2 diabetes (N = 192)
95/90
Asthma (N = 99)
30/68
–40 41–50 51–60 61–70 71–80 81– –40 41–50 51–60 61–70 71–80 81– –40 41–50 51–60 61–70 71–80 81–
a
No information on sex for 5 angina pectoris patients, 7 type 2 diabetes patients and 1 asthma patient
b
No information on age for 7 angina pectoris patients, 8 type 2 diabetes patients and 1 asthma patient
In the sub-category ‘other problems’, 127 cases of DRPs were registered, for instance related to patients themselves (81 cases) in the form of inappropriate lifestyle choices (21 cases) such as smoking and/or BMI above 25, and/or fear of medicine (11 cases). Thirty (30) patients experienced doctor-related DRPs; for example, in the form of lack of or incomplete information about prescription medicine. Type 2 diabetes For the group of patients with type 2 diabetes, a total of 635 DRPs in 155 patients were identified, which corresponds to 4.1 DRPs identified per patient. Inappropriate use of medicines by the patient was the most common DRP (171 cases, corresponding to more than one DRP per patient in this sub-category), for instance no or insufficient medicine monitoring (95 cases). Inappropriate choice of medicine is the second
1 – 14 40 47 14 5 21 47 68 36 7 29 15 21 17 16 –
most commonly registered category of DRPs (57 cases). Problems here can be inappropriate choice of medicine with regard to indication (29 cases), such as patients being prescribed insulin instead of tablet treatment. Another problem can be if a physiological contraindication is not taken into consideration when the medicine is prescribed (27 cases); for example, elderly patients were prescribed Metformin, which does not follow the recommendation that this product should not be prescribed to people over the age of 70. Side-effects is the third most common DRP (55 cases). In the sub-category ‘other problems’, 296 cases were registered. Here the most commonly registered DRPs are related to patients themselves (268 cases); for example, in the form of inappropriate lifestyle choices (130 cases), which include smoking, having a BMI value over 25, lack of exercise, lack of regular visits to the podiatrist or eye doctor. Similarly, the interviewees
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had limited knowledge about the nature of their disease (103 cases); some did not know about the negative influence of alcohol or chocolate on blood glucose level, the affect of the medicine on the disease and/or complications, what causes hypoglycaemic episodes, and ways to adjust the blood glucose level by eating. Asthma A total of 349 DRPs were identified for 88 patients with asthma, corresponding to 4.0 DRPs per patient. Inappropriate use of medicines by the patient is the most common DRP (167 cases). Lack of monitoring medicine treatment is the most common problem in this sub-category (58 cases), while practical problems, in particular, problems with using the inhalator, affected 51 patients. Some patients do not carry fast relief medicine around with them, they store powdered medicine in wet rooms, crush Bricanyl Retard tablets before use, do not shake inhalation sprays before use, and do not turn turbohalers as recommended. Insufficient knowledge about medicine use was found in 18 cases; for example, some patients confuse the steroid inhalator with the inhalator for use in asthma attacks. The second most common DRP is inappropriate choice of medicine, which was found in 66 cases, primarily with regard to indication (44 cases). Some patients were not being treated with inhalation steroids despite the use of beta-2 agonist. Side effects were registered in 52 cases, primarily in the form of tremor and heart palpitations. A total of 46 DRPs were registered in the sub-category ‘other problems’, the most commonly registered DRPs are related to patients themselves (26 cases); for example, in the form of inappropriate lifestyle choices. Several patients do not know about the connection between asthma, smoking and indoor climate. In 13 cases, patients experienced doctor-related DRPs; for example, in the form of lack of or incomplete information about prescription medicine.
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study throughout the 3 years, which leads us to believe that the results were useful in a pharmacy practice setting. Predicting about the external validity is more difficult, because of the sampling strategy used for selecting patients and pharmacies. As mentioned earlier, Danish internship pharmacies have to live up to certain professional and educational standards, thus the results might not be generalized to all Danish pharmacies, let alone pharmacies internationally. Choice of coding system A concern with the choice of the PI-Doc coding system was the possible risk of inconsistent documentation of DRPs due to possible confusion and misinterpretation arising from the split of DRPs into a large range of sub-groups. Nevertheless, the project group decided that the advantages of the detailed PI-Doc coding system clearly outweighed the concerns, and that the risk of inconsistent coding could be minimized by modifying sub-groups, developing a thorough documentation protocol and evaluating the pharmacy students’ application of the codes. That the same two pharmacists did the final identification and coding of DRPs all 3 years, including crosschecking one another, contributed heavily to increased reliability of the study. Not all documentation systems incorporate documentation of both actual and potential DRPs like the PI-Doc system does. However, we found that a very important part of pharmacy practice is to prevent DRPs from becoming manifest and thereby harmful to patients, and therefore find documentation of potential DRPs is a useful source of knowledge when the objective is to improve patient counselling. Many data collectors
Discussion
One disadvantage of the study design is related to the large number of data collectors, which could present a reason to question the reliability of the data collecting part of the study. However, all participating students had been trained to collect data and had been tested prior to data collection.
Study strengths and limitations
Discussion of results
Validity
A fair number of studies identifying and documenting DRPs in patient groups resembling those included in our study have been carried out over the past decade [18–21, 38–44], with only a few studies including home interviews though [18–21]. One study showed an average of 5.9 potential DRPs per patient [18], another study identified DRPs in 63.7% of the patients included
We consider the internal validity of the study to be fairly high. The results have been presented to staff in all participating pharmacies without their questioning the findings of the study. A large number of the Danish internship pharmacies volunteered to participate in the
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[19]. Our data document an average of 2.8–4.1 DRPs per patient, fewer than the number identified by Paulino et al. [18]. In contrast, 96% of the angina pectoris patients included in our study, 81% of the type 2 diabetes patients and 89% of the asthma patients had at least one DRP, which is more than the number of DRPs identified by Titley-Lake and Barber [19]. Thus, the results of our study in Danish internship pharmacies document that among a pharmacy-based population of 414 angina pectoris patients, asthma patients and type 2 diabetes patients, DRPs are more likely to occur in all patients than previously described in the literature, while the individual patient is likely to experience fewer DRPs than previously described. ‘‘Inappropriate use of medicines by the patient’’ and ‘‘other problems’’ (such as limited knowledge of the illness, inappropriate lifestyle, fear of medication and lack of information) were the two most common DRP sub-categories identified (see Table 5). These two subcategories constituted 61% of all DRPs identified in angina pectoris patients, 73% of those identified in type 2 diabetes patients and 61% of DRPs in asthma patients. The number of DRPs due to side effects was 14.3% for angina pectoris patients, 8.7% for type 2 diabetes patients and 14.9% for asthma patients. In two of the other DRP studies using home interviews, the percentage of DRPs due to side effects/ADR was higher than in our study, namely 29.5% in Paulino et al. [18], and 84% for ADRs in Titley-Lake and Barber [19]. The explanation for the high number of ADRs in the Titley-Lake and Barber study [19] could be related to the fact that the likelihood of a patient experiencing an ADR increases as the number of possible offending agents increase, which is not the case in our study. The prevalence of DRPs in all the studies mentioned [18–21, 38–44] varies a great deal for many reasons, such as the use of different coding systems, different data collection methods and, as described in Westerlund et al. [44], educational level and other characteristics of pharmacy staff and pharmacies. For instance, previous studies on DRPs and a high level of staff training have been shown to correspond with a higher DRP identification rate [44]. This may partly explain the high number of DRPs identified in our study. Convenience sampling among the presumed ‘best’ pharmacies in Denmark, and the fact that the two pharmacists who carried out the final identification and coding of DRPs were specially trained probably led to a higher identification rate of DRPs. Another explanation of the high numbers could be that the method of carrying out long qualitative interviews with patients in their own homes reveals more
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‘truths’ about patients’ drug utilization, since a safe and trusting relationship is established between interviewer and interviewee. This assumption is supported by a recently published evaluation report on home medicines reviews [45]. Research [8, 12–15, 17, 46] has shown that the advice and information given in pharmacies is usually unsolicited by patients and therefore not necessarily related to their problems or lack of knowledge. Instead, it is more likely to reflect the pharmacy staff’s perception of what patients need to know. But if pharmacy staff has insufficient knowledge of patients’ DRPs, how can they possibly base their counselling on the patient’s perspective? Study results can thus be used to increase the awareness of pharmacy staff, so that whenever they meet a patient from one of the three patient groups, they will be alert to the fact that these patients are likely candidates for DRPs. Identifying DRPs in only the first step in providing pharmaceutical care, and the process must be continued by working to resolve or prevent undesirable patient outcomes [47].
Conclusion The study provided a profile of a pharmacy-based population of 414 patients visiting the pharmacy, all at high risk of experiencing DRPs (angina pectoris patients, type 2 diabetes patients and asthma patients). Out of this population 361 patients (87%) experienced one or more DRP(s). Pharmacy staff needs to take into account the high incidence of DRPs when counselling patients from these three groups. Inappropriate use of medicines by the patient and other problems related to the patient constitute the sub-categories of DRPs that occur most often in all three patient groups. Acknowledgements The authors are very grateful to the entire project group, the 229 pharmacy students, the 414 patients interviewed and pharmacy staffs for their contribution to this study. We would also like to thank the Pharmacy Foundation of 1991 for their financial support, and the members of the Research Centre for Quality in Medicine Use, which provided professional support and under whose auspices the study was organised.
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