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Pharmacists’ discussions of medication side effects: a descriptive study
Patient Education and Counseling 56 (2005) 21–27
Pharmacists’ discussions of medication side effects: a descriptive study Andria Dyck, Michelle Deschamps∗ , Jeff Taylor Pharmacy EduLab Program, College of Pharmacy and Nutrition, University of Saskatchewan, Saskatoon, SK, Canada S7N 5C9 Received 6 January 2003; received in revised form 21 October 2003; accepted 31 October 2003
Abstract To improve efforts to assist patients in making informed decisions regarding medications, current methods of providing information, such as patient counseling by pharmacists, must be examined. This will require attention not only to what content is delivered, but also how it is phrased by this group. Ten community pharmacists were videotaped while providing their customary patient counseling to two standardized patients receiving new prescriptions within staged scenarios. All of the pharmacists discussed side effects and management strategies. Vague, verbal descriptors of frequency—rather than numerical indicators—were used which may inhibit accurate risk assessment by patients. Additionally, pharmacists focused on safety aspects of using medications and spent far less time discussing potential therapeutic benefits. Patient decision-making regarding medication may be affected by how pharmacists communicate such benefits and risks, meriting further investigation into patients’ interpretations of information received. © 2003 Elsevier Ireland Ltd. All rights reserved. Keywords: Patient counseling; Pharmacist; Side effects
1. Introduction Patients have become increasingly involved in their own medical care and are now recognized as key decision-makers in many aspects of personal health, from seeking medical attention to the ultimate (and often daily) choice of taking prescribed therapy. In order to facilitate effective decision-making, it is important to provide the patient with evidence-based information about medications and to assist him or her in weighing the potential risks and benefits. The expanded role of community pharmacists in today’s healthcare arena positions them well to fill this need. The standards of practice for Canadian pharmacists (as in many other countries) require educating patients on prescription drug therapy. Such communication includes but is not necessarily limited to: a confirmation of the identity of the patient; drug allergy status; name, general description of the drug dispensed, and directions for use; the intended therapeutic response; common or important side effects and appropriate management; and storage requirements [1]. Certainly, patients are interested in receiving this information, with side effect information ranked high in terms of im∗ Corresponding author. Tel.: +1-306-966-1997; fax: +1-306-966-1996. E-mail address: [email protected] (M. Deschamps).
portance, along with when and how to take the medication [2]. Research indicates that improvements are required and that patients are still somewhat dissatisfied with the quality and quantity of information received [3,4]. The situation, as it relates to pharmacists, may even be exacerbated during this time of pharmacist shortages. From a research perspective, one possible factor is that while what to say (the content) during patient exchanges regularly receives attention, how to convey such information to the public (the process) continues to be underrepresented. How to present information about adverse drug effects is a critical component of the counseling process and has been an issue of debate for health care professionals. On one hand, patients should have an accurate picture of a medication’s drawbacks while, on the other, maximum confidence that adhering to medical advice will achieve the desired results. Ziegler et al. surveyed 2500 adults for feedback on side effect information. Although the authors felt explaining every possible side effect would be too time consuming and of questionable advisability, the participants held a different view [5]. Most subjects (76%) would want to hear of any side effects, no matter how rare. When involving ‘serious’ adverse effects, 83% indicated they would want to be informed, regardless of rarity. Almost 75% of the sample felt
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that physicians were never justified in withholding any information. Other investigators have also reported that patients wish to be made aware of any potential adverse drug effects [2,6]. The United States Food and Drug Administration, however, has taken the position that long, exhaustive lists of side effects need not be included in patient information [7]. A Finnish study found that while patients definitely want to hear about side effects, the majority of pharmacists held the opinion that it is sometimes necessary to withhold such information [8]. General practitioners have rated side effects as the least important piece of information to include in a medication leaflet [9]. Health care practitioners’ reluctance to fully disclose potential side effects likely stems from concern that such information will predispose patients to experiencing problems with their medications. While it has been demonstrated that detailed risk information may make some patients more anxious about their treatment, side effects do not appear to occur any more frequently in patients informed about them than those who are not [10]. How to best express the potential for medications to cause adverse reactions has been the subject of several investigations. It appears that patients may prefer numerical (1.0, 0.1, 0.01%, etc.) rather than verbal (rare, infrequent, common, etc.) frequency descriptors and are able to use that informational format to make more accurate predictions of their personal likelihood of experiencing a particular reaction [11–13]. There is a tendency to overestimate side effect frequency when verbal descriptors are used [14], which has been shown (at least in hypothetical scenarios) to negatively impact patients’ intentions to comply with prescribed therapy [15]. How information is framed—in the context of a potential gain or loss—for a given patient will likely play a part in this decision process as well [16]. While considerable attention has been paid to medication counseling in the pharmacy arena, most have tended to focus on content and an implied assumption that more information is better than less. Yet, it has been demonstrated that too much information is also problematic for patients and has given rise to feelings of frustration or information overload [17]. Tailoring medication information to the individual patient (as much as possible) is likely the most important piece of the how to (process) puzzle. Such an approach has been shown to be of therapeutic value when compared to giving patients standardized medical facts and treatment rules [18]. A critical look at the process of pharmacist-conducted patient counseling may provide direction as to where current efforts to educate patients may be improved. One research tool available is the use of conversation analysis (CA), which examines the conventions or common understandings used to organize and interpret what is said during conversation. Investigators record, transcribe and scrutinize in detail “naturally occurring” conversations typical of the type of interaction of interest. Only three reports to date have documented CA studies involving pharmacists [19–21]. John and Housley published an abstract drawn from a community pharmacy setting [19], perhaps the first of its
kind for this segment of practice. The focus of the abstract, however, was more on the acceptability of the methodology rather than the reporting of data. Pilnick carried out CA of interactions from a pediatric oncology clinic [20]. She reported that pharmacy counseling is more on the order of a sequence of instructions rather than ‘counseling in its broader sense’ [21]. Accordingly, a set of instructions tend to be delivered over a series of turns with the recipient commonly repeating the instruction or uttering a response token such as “okay” or “mhmm”. Pharmacists rarely treated even these minimal acknowledgments as potentially problematic from the viewpoint of evidence for patient understanding. 1.1. Study objectives This study looked at staged counseling sessions involving two medications, one for a chronic condition and one for an acute illness. Areas of interest included topics discussed by pharmacists; question-asking behaviour; organization of information presented; and communication skills demonstrated by the pharmacists. A report of these results have been published [22]. For the purposes of this paper, pharmacists’ discussions of adverse effects including how the information was framed and their use of printed medication leaflets were considered. It is our plan to conduct conversation analyses of actual pharmacist–patient interactions in the future. To test and streamline the methodology, this pilot study was undertaken before the significant step of taking audiovisual equipment into places of business.
2. Methods and procedures 2.1. Participants and medications Pharmacists who participated in the study were recruited by telephone using the city Yellow Pages. Seventy pharmacies were operating in this Western Canadian city of approximately 210,000 citizens. Every fourth community pharmacy was phoned in the order of the listings in the directory until the appropriate number of pharmacists was recruited; 12 was deemed a workable number for this pilot. Only one pharmacist was taken per pharmacy. Pharmacists with a teaching role with the local pharmacy college were excluded. Twelve agreed to participate subsequent to the initial contacts. Four actors were hired to act as standardized patients under the guise of receiving new prescriptions from a community pharmacy, two patients for each of the two selected prescriptions. They were coached by a senior research member on how to act, what to say, and how to respond to various questions or statements from the pharmacists before the counseling sessions began. Scripts were provided as part of their training. The two scenarios in which the patient actors role-played were: (1) an elderly, regular patient of the pharmacy starting
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a new medication for a chronic condition (atenolol 50 mg once a day for 1 month with three refills); and (2) a young patient, new to the pharmacy, starting a new drug for an acute illness (amoxycillin 250 mg three times a day for 10 days). These particular situations were chosen to investigate whether age of the patient or perceived duration of therapy had an effect on the communication techniques used by the pharmacists. All actors were female as the addition of gender as another potential influencing factor was beyond the scope of this study. Patient familiarity with the mock pharmacy could be determined if the pharmacist asked the patient actor whether she had had ‘prescriptions filled here before’. A patient prescription record for each patient was provided for additional realism. These were kept fairly simple; there was little interest in testing pharmacists’ abilities to counsel multi-problematic patients, but rather to provide information on the basic techniques used in the communication process between community pharmacists and patients. Pharmacists were free to access this record as they saw fit. Volunteer pharmacists were given a monetary stipend. Approval from the university’s Behavioural Research Ethics Board was obtained before commencement. 2.2. Experimental procedure While electing to use patient actors rather than encounters in actual practice settings may run contrary to CA, steps were taken to duplicate reality as best as possible. The counseling sessions took place in the Professional Skills Development Laboratory at the University of Saskatchewan, a facility constructed to emulate the design of Canadian pharmacies. Under the guise of this study, the prescriptions had been previously filled for the volunteer pharmacists. Patient medication records were made available, as were relevant drug information sheets produced by the computer system normally used by each pharmacist in their practice sites. In most instances, two counseling sessions took place at the same time, each pharmacist counseling on a different drug with a different patient than his/her counterpart at another station in the laboratory. Background noise/activity was in place in an attempt to recreate the atmosphere of a community pharmacy setting (e.g., background music, computer printers, telephones ringing, customer traffic). Pharmacists waiting for their turn at counseling were kept in a different room. All participants were aware they were being recorded. Pharmacists were not given a priori knowledge of the drugs that would be used. They were given instructions when shown to their pharmacy station and a couple of minutes to familiarize themselves with the set-up before counseling began at their station. A patient actor then approached the pharmacy counter, asked for her prescription, and the counseling session proceeded. As soon as the first counseling session was completed, a second patient actor approached the pharmacist requesting her prescription.
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2.3. Data analysis While the methodological procedures of conversation analysis were adhered to, the scripted nature of the patients’ input obviously impeded ‘naturally occurring interaction’. Patient actors were guided by pre-determined scripts when responding to pharmacist directives in a manner that was as realistic as possible. The audio tracks of the recordings were transcribed verbatim using the convention of Psathas [23] and ten Have [24]. The video portion of the recordings allowed for assessment of non-verbal cues such as eye contact.
3. Results 3.1. Volunteer pharmacists While 12 agreed to participate, only 10 pharmacists reported to the study site. The convenience sample ranged in years of practice experience from <1 year to >15 years’ experience (see Table 1). Participants were asked to self-report the percentage of patients in their usual practice site they routinely counsel when receiving new prescriptions: 25% or less (three pharmacists); 26–50% (three pharmacists), 51–75% (one pharmacist), and 76–100% of the time (three pharmacists). 3.2. Number of side effects discussed and expression of probability The 20 encounters took an average of 3:20 min (S.D. = 1:25 min) to complete. Side effects were discussed by all of the pharmacists. An average of 4 ± 2 unique side effects were mentioned. One pharmacist mentioned 10 different side effects, while the minimum number of unique side effects Table 1 Demographic characteristics of participating pharmacists (n = 10) Demographic
N
Years of practice experience <5 4 6–10 2 11–15 1 >15 3 Location of primary pharmacy practice site Independent operation 5 Chain pharmacy 2 Grocery or mass merchandiser 3 Percentage of new prescriptions routinely counseled on (%) 0–25 3 26–50 3 51–75 1 76–100 3 Gender Male 4 Female 6
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mentioned was two, which occurred in four of the counseling sessions. In eight of the 20 counseling sessions, the last topics presented to the patient (before asking for any final questions) were the mention of potential side effects, followed by discussing how to manage the adverse drug reactions. In 16 of the 20 counseling sessions, the pharmacist suggested a technique to manage adverse drug reactions directly after mentioning what possible side effects may occur. All pharmacists used at least two different expressions in each of their counseling sessions to describe the likelihood of a side effect occurring (see Table 2). Rather than using numeric descriptions of frequency taken from clinical studies, pharmacists tended to use somewhat vague verbal descriptors. No differences in selection of terms was noted when the scenarios involving the elderly patient were compared to those involving the young patient. The type of prescription (chronic versus short-term treatment) impacted the qualifying information supplied in that pharmacists were much more likely to mention how long a side effect might persist for the atenolol case than for the amoxycillin. Table 2 Expressions of probability used by pharmacists when counseling on new prescriptions Examples of probability phrasing
Sessions in which the phrase was used (n = 20)
1. You might experience/might notice/may show up/may occur 2. Some people/some individuals/sometimes 3. Can increase your risk of/can work a little too good/some antibiotics can interfere/can leave you prone/can include/can cause/it could 4. Initially/when you first start this/for the first few days 5. Most commonly/not that common 6. It should be fine/that should only be a couple of days/it shouldn’t be a problem 7. Usually diminish with time/usually doesn’t 8. You’ll probably see/that’ll probably disappear 9. Fairly rare/very rare/rarely 10. Is a possibility 11. Most of my patients/most people 12. Will go away 13. I wouldn’t expect to see that/I don’t think you’re going to have/I don’t anticipate that problem 14. In extreme cases 15. Haven’t had too many people with that 16. Not everyone 17. Only in people that are pre-disposed 18. And just maybe 19. That’ll happen with a lot of blood pressure medications 20. Not that prone to it 21. Going to be 22. People tend to
17 14 11
9 6 6 5 4 3 3 2 2 2
1 1 1 1 1 1
3.3. Communication skills demonstrated by pharmacists Most of the information shared with patients was stated matter-of-factly by the pharmacists in an informing or directing manner. Topics discussed using this style of communication included the medication’s name, indication, pharmacology, directions for use, drug interactions and storage. When the pharmacist used an advising or reassuring style of communication, it was usually in the context of discussing adverse reactions, with the information presented often as opinion rather than fact. The following examples are typical of the way a single pharmacist presented information on pharmacology and on an adverse reaction: ph: Yeah, what it is, atenolol. It’s a- what is called a beta-blocker. pt: Ok. ph: And a beta-blocker affects your heart. And it’ll actually slow your heart rate down a little bit pt: Ohh: ph: and just like turning the pressure down on a pump. Turn the pressure down you slow the pump down the pressure’s gonna go down a little bit. Transcript 21b lines 29–36 ph: Um, for the first little while I would just watch because your blood pressure’s gonna be a little lower, um watch for any dizziness, especially when you get out up out of a chair quick, or say out of bed. pt: right pt: OK ph: Uh, just because your blood pressure’s gonna be a little normal when you get up that blood can drain down a little bit pt: Oh, ok ph: and make you a little faint at first. pt: Oh, ok. ph: That’s about the thing I’d be worried about. Transcript 21b lines 63–73 In the second passage, the pharmacist offers his opinion regarding what the patient should do, that is, be aware that she may experience some dizziness but that no action is required other than watching. Other side effects are also discussed during the conversation, but the pharmacist indicated here that the dizziness is the one that concerns him the most. While no indication is given of the incidence of atenolol causing dizziness, the pharmacist attempts to reassure the patient that this is a normal extension of how the drug works to lower her blood pressure, that it will be situational, and that this response should occur only initially (although no specific time frame is mentioned). 3.4. Use of the drug information leaflet
1 1 1
Community pharmacists commonly provide written information to patients during the medication dispensing process
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[25]. For this study, a computer-generated medication leaflet was offered to the patient in 19 of the 20 counseling sessions. However, it was only specifically referred to in 10 of them. The researchers considered “referring to the sheet” to include positioning the information sheet to enable the patient to read it, underlining or highlighting parts of the text, or pointing directly to specific information on the sheet with the patient looking towards it. One of the pharmacists reviewed the printed information almost entirely, while other pharmacists who used the sheet did so mainly while discussing adverse reactions. Pharmacists have at times been criticized for frightening patients into states of non-compliance through use of information sheets that list numerous adverse drug effects [26]. These leaflets do tend to list the negative, while failing to provide much context for the patient regarding their relative rarity or how they might be minimized or managed. Further, hypertensive patients have been found to have a negative attitude toward being given a pamphlet with no verbal information from the pharmacist [18]. In seven of the 19 sessions where an information sheet was provided, all side effects listed on the sheet were at least partially discussed by the pharmacist. For the remaining twelve consultations, one side effect that was on the print material was not discussed in four scenarios; two, three or four side effects were not discussed in two sessions each; and there were two instances where the patient received take-home information on seven or nine different side effects for which the pharmacist did not provide some degree of context. In the last two cases, the dispensing system (Simplicity Plus—MediSolution Ltd.) generated sheets containing quite comprehensive lists of adverse reactions compared to the other vendors. For example, atenolol is listed as possibly causing dizziness, lightheadedness, drowsiness, blurred vision, cold extremities, easy bruising or bleeding, swollen hands or feet, confusion, depression, sore throat, and allergy including rash, itching or trouble breathing. First DataBank Inc., on the other hand, lists only drowsiness, lightheadedness or dizziness, unusual tiredness or weakness, and difficulty breathing.
4. Discussion The ultimate aim pharmacists have for engaging in patient counseling is to equip patients with enough knowledge to enable them to use medicines safely and effectively to achieve their treatment goals. This pilot was carried out to examine how pharmacists couch side effect information within the overall context of a counseling encounter. Nuances of the exchange may have a significant impact on how patients weigh potential risks and benefits of any given medicine. Safety was indeed a large concern of the pharmacists observed here. All reviewed potential side effects and strategies to minimize them. Many reviewed potential drug interactions and sought information on possible contraindications.
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There was little attention devoted to the benefits that may be achieved, however, suggesting that the treatment goals of the patient have yet to achieve the priority that safety has for pharmacists. One possible explanation for this is that pharmacists may assume that the prescriber covers the rationale and therapeutic benefits for using a medicine and that a pharmacist’s job is simply to provide cautionary information. This may explain why pharmacists also hesitate to name all side effects, if they tend not to frame them within a balance that includes the hoped-for therapeutic effects. For the most part, pharmacists did not use the computergenerated medication information sheets as substitutes for providing verbal information. Pharmacists were supplied example documents used by their respective pharmacies and would therefore have been very familiar with their content and format. At times, a sheet was used to apparently provide more detail than that which was mentioned verbally. Pharmacists chose what items to raise and what items to leave for patients to read on their own. This situation was quite commonly seen when discussing a medication’s side effects. When pharmacists opted to not mention listed side effects, they tended to be those rare in nature (e.g., irritation of the mouth and throat with amoxycillin) or those more serious (e.g., difficulty breathing). It is not clear whether pharmacists chose not to mention serious adverse reactions due to their rarity or due to a wish not to alarm the patient. While it is understandable that rare reactions were not included in the discussion, patient surveys indicate that members of the public wish to be informed of side effects no matter how rare they might be, and even more so when the adverse effect is potentially serious [4,5]. Side effects appearing on the printed information that were unmentioned by the pharmacists may be difficult for patients to interpret as to personal relevancy. They may also give the appearance that the pharmacist is withholding information in a manipulative fashion. Conversely, it is unknown whether there is a threshold for the number of side effects that may be disclosed to patients before the medication is considered “too risky”. Berry et al., however, did find that it may be the severity of side effects, rather than the number presented, that is the determining factor in perceived likelihood of taking a medicine [27]. There are also questions on how to couch this material within the discussion for best effect. Further study of patients’ interpretations of side effect information received from pharmacists in actual counseling situations is warranted to determine how to balance consumer demand for complete disclosure with practicality and time constraints. Evidence suggests that numeric descriptors of a medication’s propensity for side effects promote more accurate personal risk predictions for patients when compared with use of verbal terms such as commonly, rarely or very rarely [11–13,28–30]. The pharmacists observed here used terms that may be even more imprecise, such as sometimes, possibly and might occur. It could be very difficult, for example, to predict personal risk of developing a side effect described as one some people get. The message seemingly
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being conveyed was that ‘it could happen to others, but hopefully (and likely) not you, so do not let that stop you from taking this medicine.’ It is unclear whether these terms were selected in an attempt not to alarm people, while at the same time mentioning that the effect could occur, or whether pharmacists’ attempts to use easily understood lay language precluded the use of incidence rates. A third possibility is that the pharmacists were themselves unfamiliar with the actual rates of the side effects’ occurrences. A complicating factor is the frequency that adverse effects are reported in patients receiving placebo in clinical trials. It would indeed be difficult to have the rates for all of the side effects for all of the medications dispensed in the course of a typical workday at one’s fingertips. Incorporating actual side effect frequencies into computer-generated medication leaflets may facilitate their use by pharmacists, especially since they have become commonplace with the dispensing of a new prescription. During the encounters, pharmacists relied quite heavily on the one-way transfer of information. Consistent with previous observation [21], the pharmacists participating in this study provided a sequence of informational items while the patients responded with utterances such as “oh” and “okay”. It is not known whether these responses indicated an understanding of the information received or merely an acknowledgement that the pharmacist was heard. The pharmacists sought further verification of understanding in relatively few of the recorded encounters. This suggests that regardless of how the patients were using these utterances, pharmacists likely were interpreting them as s/he (the pharmacist) continues to have the floor and that s/he is being heard (and perhaps even understood). Often, regardless of how patients answered a question, during the pharmacist’s next turn the conversation reverted to his/her own agenda rather than altering to a course based on what the patient had just said. For example, ph: pt: ph: pt: ph:
Uh, are you in a- on any other medications? Um, I’m just taking some Tylenol right now. Oh, mm-hmm I- I’ve had a fever, so Ok, great. (ph glances down at Rx bottle and back up at patient) And no problems with allergies to penicillin or anything like that?
Transcript 23a lines 14–19 Pharmacists appeared to be listening for a specific response and if the patient provided a different answer that did not raise any concerns, the pharmacist carried on with the consultation. This is evident above in the retort “ok, great” to the question about concurrent medication use. For this patient case (the antibiotic), the pharmacist was likely wondering if she was taking birth control pills and having heard she was not, was satisfied there would be no drug interaction. Responding with the utterance “great” to a patient’s revelation she had a fever, however, was rather misplaced. This may be perceived by the patient as insensitivity on the
part of the pharmacist, or at least, a failure to listen. Furthermore, the issue of the fever may have been an important clinical angle for the pharmacist to pursue at that moment. The small number of pharmacist–patient interactions and the pseudo-laboratory setting limits the ability to generalize the results of this study to the broad scope of community pharmacy practice. Further, the pharmacists may have displayed their best work due to the videotaping process and lack of time pressures seen in an ordinary working environment. For perspective, the 20 encounters took an average of 3:20 min to complete, likely more than what takes place in actual practice [31,32]. The volunteer pharmacists who were willing to be videotaped could also have been confident in their patient counseling skills and may represent those performing at the high end of the range of skill seen among community pharmacists. It is unlikely that the sampling process produced pharmacists representative of the whole. Another limitation was the use of standardized patients, which prohibited the careful examination of the patient’s contribution to the interaction.
5. Conclusions This is one of the few studies to date that has examined how community pharmacists approach dissemination of side effect information during patient counseling sessions. It is an area of concern for the profession given anecdotal reports suggesting the current approach may at times unduly scare patients into noncompliance. Discussion of potential adverse effects and strategies to minimize (or prevent) them was a topic of high priority for the participating pharmacists. However, disclosure of all possible reactions did not occur during these staged encounters; pharmacists (to varying degrees) chose to focus on specific ones. When the potential for experiencing a side effect was broached, pharmacists opted for verbal descriptors and leaned toward wording that might appear to encourage the taking of the drug. The use of computer-generated drug information sheets to supplement the information provided was very common. 5.1. Practice implications How pharmacists interact with patients is likely important to patient satisfaction and perhaps their decisions regarding treatment adherence. Strategies to communicate information on adverse drug effects in a manner that can be accurately interpreted by patients without causing them undue alarm merit further investigation.
Acknowledgements This research was funded by an Apotex/P.A.C.E. Undergraduate Pharmacy Practice Research Award. It was
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Pharmacists’ discussions of medication side effects: a descriptive study Andria Dyck, Michelle Deschamps∗ , Jeff Taylor Pharmacy EduLab Program, College of Pharmacy and Nutrition, University of Saskatchewan, Saskatoon, SK, Canada S7N 5C9 Received 6 January 2003; received in revised form 21 October 2003; accepted 31 October 2003
Abstract To improve efforts to assist patients in making informed decisions regarding medications, current methods of providing information, such as patient counseling by pharmacists, must be examined. This will require attention not only to what content is delivered, but also how it is phrased by this group. Ten community pharmacists were videotaped while providing their customary patient counseling to two standardized patients receiving new prescriptions within staged scenarios. All of the pharmacists discussed side effects and management strategies. Vague, verbal descriptors of frequency—rather than numerical indicators—were used which may inhibit accurate risk assessment by patients. Additionally, pharmacists focused on safety aspects of using medications and spent far less time discussing potential therapeutic benefits. Patient decision-making regarding medication may be affected by how pharmacists communicate such benefits and risks, meriting further investigation into patients’ interpretations of information received. © 2003 Elsevier Ireland Ltd. All rights reserved. Keywords: Patient counseling; Pharmacist; Side effects
1. Introduction Patients have become increasingly involved in their own medical care and are now recognized as key decision-makers in many aspects of personal health, from seeking medical attention to the ultimate (and often daily) choice of taking prescribed therapy. In order to facilitate effective decision-making, it is important to provide the patient with evidence-based information about medications and to assist him or her in weighing the potential risks and benefits. The expanded role of community pharmacists in today’s healthcare arena positions them well to fill this need. The standards of practice for Canadian pharmacists (as in many other countries) require educating patients on prescription drug therapy. Such communication includes but is not necessarily limited to: a confirmation of the identity of the patient; drug allergy status; name, general description of the drug dispensed, and directions for use; the intended therapeutic response; common or important side effects and appropriate management; and storage requirements [1]. Certainly, patients are interested in receiving this information, with side effect information ranked high in terms of im∗ Corresponding author. Tel.: +1-306-966-1997; fax: +1-306-966-1996. E-mail address: [email protected] (M. Deschamps).
portance, along with when and how to take the medication [2]. Research indicates that improvements are required and that patients are still somewhat dissatisfied with the quality and quantity of information received [3,4]. The situation, as it relates to pharmacists, may even be exacerbated during this time of pharmacist shortages. From a research perspective, one possible factor is that while what to say (the content) during patient exchanges regularly receives attention, how to convey such information to the public (the process) continues to be underrepresented. How to present information about adverse drug effects is a critical component of the counseling process and has been an issue of debate for health care professionals. On one hand, patients should have an accurate picture of a medication’s drawbacks while, on the other, maximum confidence that adhering to medical advice will achieve the desired results. Ziegler et al. surveyed 2500 adults for feedback on side effect information. Although the authors felt explaining every possible side effect would be too time consuming and of questionable advisability, the participants held a different view [5]. Most subjects (76%) would want to hear of any side effects, no matter how rare. When involving ‘serious’ adverse effects, 83% indicated they would want to be informed, regardless of rarity. Almost 75% of the sample felt
0738-3991/$ – see front matter © 2003 Elsevier Ireland Ltd. All rights reserved. doi:10.1016/j.pec.2003.10.006
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that physicians were never justified in withholding any information. Other investigators have also reported that patients wish to be made aware of any potential adverse drug effects [2,6]. The United States Food and Drug Administration, however, has taken the position that long, exhaustive lists of side effects need not be included in patient information [7]. A Finnish study found that while patients definitely want to hear about side effects, the majority of pharmacists held the opinion that it is sometimes necessary to withhold such information [8]. General practitioners have rated side effects as the least important piece of information to include in a medication leaflet [9]. Health care practitioners’ reluctance to fully disclose potential side effects likely stems from concern that such information will predispose patients to experiencing problems with their medications. While it has been demonstrated that detailed risk information may make some patients more anxious about their treatment, side effects do not appear to occur any more frequently in patients informed about them than those who are not [10]. How to best express the potential for medications to cause adverse reactions has been the subject of several investigations. It appears that patients may prefer numerical (1.0, 0.1, 0.01%, etc.) rather than verbal (rare, infrequent, common, etc.) frequency descriptors and are able to use that informational format to make more accurate predictions of their personal likelihood of experiencing a particular reaction [11–13]. There is a tendency to overestimate side effect frequency when verbal descriptors are used [14], which has been shown (at least in hypothetical scenarios) to negatively impact patients’ intentions to comply with prescribed therapy [15]. How information is framed—in the context of a potential gain or loss—for a given patient will likely play a part in this decision process as well [16]. While considerable attention has been paid to medication counseling in the pharmacy arena, most have tended to focus on content and an implied assumption that more information is better than less. Yet, it has been demonstrated that too much information is also problematic for patients and has given rise to feelings of frustration or information overload [17]. Tailoring medication information to the individual patient (as much as possible) is likely the most important piece of the how to (process) puzzle. Such an approach has been shown to be of therapeutic value when compared to giving patients standardized medical facts and treatment rules [18]. A critical look at the process of pharmacist-conducted patient counseling may provide direction as to where current efforts to educate patients may be improved. One research tool available is the use of conversation analysis (CA), which examines the conventions or common understandings used to organize and interpret what is said during conversation. Investigators record, transcribe and scrutinize in detail “naturally occurring” conversations typical of the type of interaction of interest. Only three reports to date have documented CA studies involving pharmacists [19–21]. John and Housley published an abstract drawn from a community pharmacy setting [19], perhaps the first of its
kind for this segment of practice. The focus of the abstract, however, was more on the acceptability of the methodology rather than the reporting of data. Pilnick carried out CA of interactions from a pediatric oncology clinic [20]. She reported that pharmacy counseling is more on the order of a sequence of instructions rather than ‘counseling in its broader sense’ [21]. Accordingly, a set of instructions tend to be delivered over a series of turns with the recipient commonly repeating the instruction or uttering a response token such as “okay” or “mhmm”. Pharmacists rarely treated even these minimal acknowledgments as potentially problematic from the viewpoint of evidence for patient understanding. 1.1. Study objectives This study looked at staged counseling sessions involving two medications, one for a chronic condition and one for an acute illness. Areas of interest included topics discussed by pharmacists; question-asking behaviour; organization of information presented; and communication skills demonstrated by the pharmacists. A report of these results have been published [22]. For the purposes of this paper, pharmacists’ discussions of adverse effects including how the information was framed and their use of printed medication leaflets were considered. It is our plan to conduct conversation analyses of actual pharmacist–patient interactions in the future. To test and streamline the methodology, this pilot study was undertaken before the significant step of taking audiovisual equipment into places of business.
2. Methods and procedures 2.1. Participants and medications Pharmacists who participated in the study were recruited by telephone using the city Yellow Pages. Seventy pharmacies were operating in this Western Canadian city of approximately 210,000 citizens. Every fourth community pharmacy was phoned in the order of the listings in the directory until the appropriate number of pharmacists was recruited; 12 was deemed a workable number for this pilot. Only one pharmacist was taken per pharmacy. Pharmacists with a teaching role with the local pharmacy college were excluded. Twelve agreed to participate subsequent to the initial contacts. Four actors were hired to act as standardized patients under the guise of receiving new prescriptions from a community pharmacy, two patients for each of the two selected prescriptions. They were coached by a senior research member on how to act, what to say, and how to respond to various questions or statements from the pharmacists before the counseling sessions began. Scripts were provided as part of their training. The two scenarios in which the patient actors role-played were: (1) an elderly, regular patient of the pharmacy starting
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a new medication for a chronic condition (atenolol 50 mg once a day for 1 month with three refills); and (2) a young patient, new to the pharmacy, starting a new drug for an acute illness (amoxycillin 250 mg three times a day for 10 days). These particular situations were chosen to investigate whether age of the patient or perceived duration of therapy had an effect on the communication techniques used by the pharmacists. All actors were female as the addition of gender as another potential influencing factor was beyond the scope of this study. Patient familiarity with the mock pharmacy could be determined if the pharmacist asked the patient actor whether she had had ‘prescriptions filled here before’. A patient prescription record for each patient was provided for additional realism. These were kept fairly simple; there was little interest in testing pharmacists’ abilities to counsel multi-problematic patients, but rather to provide information on the basic techniques used in the communication process between community pharmacists and patients. Pharmacists were free to access this record as they saw fit. Volunteer pharmacists were given a monetary stipend. Approval from the university’s Behavioural Research Ethics Board was obtained before commencement. 2.2. Experimental procedure While electing to use patient actors rather than encounters in actual practice settings may run contrary to CA, steps were taken to duplicate reality as best as possible. The counseling sessions took place in the Professional Skills Development Laboratory at the University of Saskatchewan, a facility constructed to emulate the design of Canadian pharmacies. Under the guise of this study, the prescriptions had been previously filled for the volunteer pharmacists. Patient medication records were made available, as were relevant drug information sheets produced by the computer system normally used by each pharmacist in their practice sites. In most instances, two counseling sessions took place at the same time, each pharmacist counseling on a different drug with a different patient than his/her counterpart at another station in the laboratory. Background noise/activity was in place in an attempt to recreate the atmosphere of a community pharmacy setting (e.g., background music, computer printers, telephones ringing, customer traffic). Pharmacists waiting for their turn at counseling were kept in a different room. All participants were aware they were being recorded. Pharmacists were not given a priori knowledge of the drugs that would be used. They were given instructions when shown to their pharmacy station and a couple of minutes to familiarize themselves with the set-up before counseling began at their station. A patient actor then approached the pharmacy counter, asked for her prescription, and the counseling session proceeded. As soon as the first counseling session was completed, a second patient actor approached the pharmacist requesting her prescription.
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2.3. Data analysis While the methodological procedures of conversation analysis were adhered to, the scripted nature of the patients’ input obviously impeded ‘naturally occurring interaction’. Patient actors were guided by pre-determined scripts when responding to pharmacist directives in a manner that was as realistic as possible. The audio tracks of the recordings were transcribed verbatim using the convention of Psathas [23] and ten Have [24]. The video portion of the recordings allowed for assessment of non-verbal cues such as eye contact.
3. Results 3.1. Volunteer pharmacists While 12 agreed to participate, only 10 pharmacists reported to the study site. The convenience sample ranged in years of practice experience from <1 year to >15 years’ experience (see Table 1). Participants were asked to self-report the percentage of patients in their usual practice site they routinely counsel when receiving new prescriptions: 25% or less (three pharmacists); 26–50% (three pharmacists), 51–75% (one pharmacist), and 76–100% of the time (three pharmacists). 3.2. Number of side effects discussed and expression of probability The 20 encounters took an average of 3:20 min (S.D. = 1:25 min) to complete. Side effects were discussed by all of the pharmacists. An average of 4 ± 2 unique side effects were mentioned. One pharmacist mentioned 10 different side effects, while the minimum number of unique side effects Table 1 Demographic characteristics of participating pharmacists (n = 10) Demographic
N
Years of practice experience <5 4 6–10 2 11–15 1 >15 3 Location of primary pharmacy practice site Independent operation 5 Chain pharmacy 2 Grocery or mass merchandiser 3 Percentage of new prescriptions routinely counseled on (%) 0–25 3 26–50 3 51–75 1 76–100 3 Gender Male 4 Female 6
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mentioned was two, which occurred in four of the counseling sessions. In eight of the 20 counseling sessions, the last topics presented to the patient (before asking for any final questions) were the mention of potential side effects, followed by discussing how to manage the adverse drug reactions. In 16 of the 20 counseling sessions, the pharmacist suggested a technique to manage adverse drug reactions directly after mentioning what possible side effects may occur. All pharmacists used at least two different expressions in each of their counseling sessions to describe the likelihood of a side effect occurring (see Table 2). Rather than using numeric descriptions of frequency taken from clinical studies, pharmacists tended to use somewhat vague verbal descriptors. No differences in selection of terms was noted when the scenarios involving the elderly patient were compared to those involving the young patient. The type of prescription (chronic versus short-term treatment) impacted the qualifying information supplied in that pharmacists were much more likely to mention how long a side effect might persist for the atenolol case than for the amoxycillin. Table 2 Expressions of probability used by pharmacists when counseling on new prescriptions Examples of probability phrasing
Sessions in which the phrase was used (n = 20)
1. You might experience/might notice/may show up/may occur 2. Some people/some individuals/sometimes 3. Can increase your risk of/can work a little too good/some antibiotics can interfere/can leave you prone/can include/can cause/it could 4. Initially/when you first start this/for the first few days 5. Most commonly/not that common 6. It should be fine/that should only be a couple of days/it shouldn’t be a problem 7. Usually diminish with time/usually doesn’t 8. You’ll probably see/that’ll probably disappear 9. Fairly rare/very rare/rarely 10. Is a possibility 11. Most of my patients/most people 12. Will go away 13. I wouldn’t expect to see that/I don’t think you’re going to have/I don’t anticipate that problem 14. In extreme cases 15. Haven’t had too many people with that 16. Not everyone 17. Only in people that are pre-disposed 18. And just maybe 19. That’ll happen with a lot of blood pressure medications 20. Not that prone to it 21. Going to be 22. People tend to
17 14 11
9 6 6 5 4 3 3 2 2 2
1 1 1 1 1 1
3.3. Communication skills demonstrated by pharmacists Most of the information shared with patients was stated matter-of-factly by the pharmacists in an informing or directing manner. Topics discussed using this style of communication included the medication’s name, indication, pharmacology, directions for use, drug interactions and storage. When the pharmacist used an advising or reassuring style of communication, it was usually in the context of discussing adverse reactions, with the information presented often as opinion rather than fact. The following examples are typical of the way a single pharmacist presented information on pharmacology and on an adverse reaction: ph: Yeah, what it is, atenolol. It’s a- what is called a beta-blocker. pt: Ok. ph: And a beta-blocker affects your heart. And it’ll actually slow your heart rate down a little bit pt: Ohh: ph: and just like turning the pressure down on a pump. Turn the pressure down you slow the pump down the pressure’s gonna go down a little bit. Transcript 21b lines 29–36 ph: Um, for the first little while I would just watch because your blood pressure’s gonna be a little lower, um watch for any dizziness, especially when you get out up out of a chair quick, or say out of bed. pt: right pt: OK ph: Uh, just because your blood pressure’s gonna be a little normal when you get up that blood can drain down a little bit pt: Oh, ok ph: and make you a little faint at first. pt: Oh, ok. ph: That’s about the thing I’d be worried about. Transcript 21b lines 63–73 In the second passage, the pharmacist offers his opinion regarding what the patient should do, that is, be aware that she may experience some dizziness but that no action is required other than watching. Other side effects are also discussed during the conversation, but the pharmacist indicated here that the dizziness is the one that concerns him the most. While no indication is given of the incidence of atenolol causing dizziness, the pharmacist attempts to reassure the patient that this is a normal extension of how the drug works to lower her blood pressure, that it will be situational, and that this response should occur only initially (although no specific time frame is mentioned). 3.4. Use of the drug information leaflet
1 1 1
Community pharmacists commonly provide written information to patients during the medication dispensing process
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[25]. For this study, a computer-generated medication leaflet was offered to the patient in 19 of the 20 counseling sessions. However, it was only specifically referred to in 10 of them. The researchers considered “referring to the sheet” to include positioning the information sheet to enable the patient to read it, underlining or highlighting parts of the text, or pointing directly to specific information on the sheet with the patient looking towards it. One of the pharmacists reviewed the printed information almost entirely, while other pharmacists who used the sheet did so mainly while discussing adverse reactions. Pharmacists have at times been criticized for frightening patients into states of non-compliance through use of information sheets that list numerous adverse drug effects [26]. These leaflets do tend to list the negative, while failing to provide much context for the patient regarding their relative rarity or how they might be minimized or managed. Further, hypertensive patients have been found to have a negative attitude toward being given a pamphlet with no verbal information from the pharmacist [18]. In seven of the 19 sessions where an information sheet was provided, all side effects listed on the sheet were at least partially discussed by the pharmacist. For the remaining twelve consultations, one side effect that was on the print material was not discussed in four scenarios; two, three or four side effects were not discussed in two sessions each; and there were two instances where the patient received take-home information on seven or nine different side effects for which the pharmacist did not provide some degree of context. In the last two cases, the dispensing system (Simplicity Plus—MediSolution Ltd.) generated sheets containing quite comprehensive lists of adverse reactions compared to the other vendors. For example, atenolol is listed as possibly causing dizziness, lightheadedness, drowsiness, blurred vision, cold extremities, easy bruising or bleeding, swollen hands or feet, confusion, depression, sore throat, and allergy including rash, itching or trouble breathing. First DataBank Inc., on the other hand, lists only drowsiness, lightheadedness or dizziness, unusual tiredness or weakness, and difficulty breathing.
4. Discussion The ultimate aim pharmacists have for engaging in patient counseling is to equip patients with enough knowledge to enable them to use medicines safely and effectively to achieve their treatment goals. This pilot was carried out to examine how pharmacists couch side effect information within the overall context of a counseling encounter. Nuances of the exchange may have a significant impact on how patients weigh potential risks and benefits of any given medicine. Safety was indeed a large concern of the pharmacists observed here. All reviewed potential side effects and strategies to minimize them. Many reviewed potential drug interactions and sought information on possible contraindications.
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There was little attention devoted to the benefits that may be achieved, however, suggesting that the treatment goals of the patient have yet to achieve the priority that safety has for pharmacists. One possible explanation for this is that pharmacists may assume that the prescriber covers the rationale and therapeutic benefits for using a medicine and that a pharmacist’s job is simply to provide cautionary information. This may explain why pharmacists also hesitate to name all side effects, if they tend not to frame them within a balance that includes the hoped-for therapeutic effects. For the most part, pharmacists did not use the computergenerated medication information sheets as substitutes for providing verbal information. Pharmacists were supplied example documents used by their respective pharmacies and would therefore have been very familiar with their content and format. At times, a sheet was used to apparently provide more detail than that which was mentioned verbally. Pharmacists chose what items to raise and what items to leave for patients to read on their own. This situation was quite commonly seen when discussing a medication’s side effects. When pharmacists opted to not mention listed side effects, they tended to be those rare in nature (e.g., irritation of the mouth and throat with amoxycillin) or those more serious (e.g., difficulty breathing). It is not clear whether pharmacists chose not to mention serious adverse reactions due to their rarity or due to a wish not to alarm the patient. While it is understandable that rare reactions were not included in the discussion, patient surveys indicate that members of the public wish to be informed of side effects no matter how rare they might be, and even more so when the adverse effect is potentially serious [4,5]. Side effects appearing on the printed information that were unmentioned by the pharmacists may be difficult for patients to interpret as to personal relevancy. They may also give the appearance that the pharmacist is withholding information in a manipulative fashion. Conversely, it is unknown whether there is a threshold for the number of side effects that may be disclosed to patients before the medication is considered “too risky”. Berry et al., however, did find that it may be the severity of side effects, rather than the number presented, that is the determining factor in perceived likelihood of taking a medicine [27]. There are also questions on how to couch this material within the discussion for best effect. Further study of patients’ interpretations of side effect information received from pharmacists in actual counseling situations is warranted to determine how to balance consumer demand for complete disclosure with practicality and time constraints. Evidence suggests that numeric descriptors of a medication’s propensity for side effects promote more accurate personal risk predictions for patients when compared with use of verbal terms such as commonly, rarely or very rarely [11–13,28–30]. The pharmacists observed here used terms that may be even more imprecise, such as sometimes, possibly and might occur. It could be very difficult, for example, to predict personal risk of developing a side effect described as one some people get. The message seemingly
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being conveyed was that ‘it could happen to others, but hopefully (and likely) not you, so do not let that stop you from taking this medicine.’ It is unclear whether these terms were selected in an attempt not to alarm people, while at the same time mentioning that the effect could occur, or whether pharmacists’ attempts to use easily understood lay language precluded the use of incidence rates. A third possibility is that the pharmacists were themselves unfamiliar with the actual rates of the side effects’ occurrences. A complicating factor is the frequency that adverse effects are reported in patients receiving placebo in clinical trials. It would indeed be difficult to have the rates for all of the side effects for all of the medications dispensed in the course of a typical workday at one’s fingertips. Incorporating actual side effect frequencies into computer-generated medication leaflets may facilitate their use by pharmacists, especially since they have become commonplace with the dispensing of a new prescription. During the encounters, pharmacists relied quite heavily on the one-way transfer of information. Consistent with previous observation [21], the pharmacists participating in this study provided a sequence of informational items while the patients responded with utterances such as “oh” and “okay”. It is not known whether these responses indicated an understanding of the information received or merely an acknowledgement that the pharmacist was heard. The pharmacists sought further verification of understanding in relatively few of the recorded encounters. This suggests that regardless of how the patients were using these utterances, pharmacists likely were interpreting them as s/he (the pharmacist) continues to have the floor and that s/he is being heard (and perhaps even understood). Often, regardless of how patients answered a question, during the pharmacist’s next turn the conversation reverted to his/her own agenda rather than altering to a course based on what the patient had just said. For example, ph: pt: ph: pt: ph:
Uh, are you in a- on any other medications? Um, I’m just taking some Tylenol right now. Oh, mm-hmm I- I’ve had a fever, so Ok, great. (ph glances down at Rx bottle and back up at patient) And no problems with allergies to penicillin or anything like that?
Transcript 23a lines 14–19 Pharmacists appeared to be listening for a specific response and if the patient provided a different answer that did not raise any concerns, the pharmacist carried on with the consultation. This is evident above in the retort “ok, great” to the question about concurrent medication use. For this patient case (the antibiotic), the pharmacist was likely wondering if she was taking birth control pills and having heard she was not, was satisfied there would be no drug interaction. Responding with the utterance “great” to a patient’s revelation she had a fever, however, was rather misplaced. This may be perceived by the patient as insensitivity on the
part of the pharmacist, or at least, a failure to listen. Furthermore, the issue of the fever may have been an important clinical angle for the pharmacist to pursue at that moment. The small number of pharmacist–patient interactions and the pseudo-laboratory setting limits the ability to generalize the results of this study to the broad scope of community pharmacy practice. Further, the pharmacists may have displayed their best work due to the videotaping process and lack of time pressures seen in an ordinary working environment. For perspective, the 20 encounters took an average of 3:20 min to complete, likely more than what takes place in actual practice [31,32]. The volunteer pharmacists who were willing to be videotaped could also have been confident in their patient counseling skills and may represent those performing at the high end of the range of skill seen among community pharmacists. It is unlikely that the sampling process produced pharmacists representative of the whole. Another limitation was the use of standardized patients, which prohibited the careful examination of the patient’s contribution to the interaction.
5. Conclusions This is one of the few studies to date that has examined how community pharmacists approach dissemination of side effect information during patient counseling sessions. It is an area of concern for the profession given anecdotal reports suggesting the current approach may at times unduly scare patients into noncompliance. Discussion of potential adverse effects and strategies to minimize (or prevent) them was a topic of high priority for the participating pharmacists. However, disclosure of all possible reactions did not occur during these staged encounters; pharmacists (to varying degrees) chose to focus on specific ones. When the potential for experiencing a side effect was broached, pharmacists opted for verbal descriptors and leaned toward wording that might appear to encourage the taking of the drug. The use of computer-generated drug information sheets to supplement the information provided was very common. 5.1. Practice implications How pharmacists interact with patients is likely important to patient satisfaction and perhaps their decisions regarding treatment adherence. Strategies to communicate information on adverse drug effects in a manner that can be accurately interpreted by patients without causing them undue alarm merit further investigation.
Acknowledgements This research was funded by an Apotex/P.A.C.E. Undergraduate Pharmacy Practice Research Award. It was
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