Patient Education and Counseling 99 (2016) 386–392
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Patient Education and Counseling journal homepage: www.elsevier.com/locate/pateducou
Medication adherence communications in community pharmacies: A naturalistic investigation Nathaniel M. Ricklesa,* , Gary J. Youngb , Judith A. Hallc , Carey Nolandd, Ayoung Kima , Conner Petersona , Mina Honga , John Halea a
Department of Pharmacy and Health Systems Sciences, Northeastern University, Boston, MA, USA Center for Health Policy and Healthcare Research, Northeastern University, Boston, MA, USA Department of Psychology, Northeastern University, Boston, MA, USA d Department of Communication Studies, Northeastern University College of Arts, Media, and Design, Boston, MA, USA b c
A R T I C L E I N F O
A B S T R A C T
Article history: Received 22 May 2015 Received in revised form 2 October 2015 Accepted 10 October 2015
Objective: To describe the extent of pharmacy detection and monitoring of medication non-adherence, and solutions offered to improve adherence. Methods: Participants were 60 residents of the Boston area who had a generic chronic medication with 30 day supplies from their usual pharmacy. Participants received a duplicate prescription which they filled at a different pharmacy. For 5 months, participants alternated between the two pharmacies, creating gaps in their refill records at both pharmacies but no gaps in their medication adherence. Participants followed a scripted protocol and after each pharmacy visit reported their own and the pharmacy staff’s behavior. Results: Across 78 unique community pharmacies and 260 pharmacy visits, pharmacies were inconsistent and inadequate in asking if participants had questions, discussing the importance of adherence, providing adequate consultations with new medication, and detecting and intervening on non-adherence. Insurers rarely contacted the participants about adherence concerns. Conclusion: There is a need for more structured intervention systems to ensure pharmacists are consistently and adequately educating patients and detecting/managing potential medication nonadherence. Practice Implications: The present study calls for more attention to building infrastructure in pharmacy practice that helps pharmacists more consistently identify, monitor, and intervene on medication adherence. ã 2015 Elsevier Ireland Ltd. All rights reserved.
Keywords: Medication adherence Pharmacies Pharmacists Pharmacist–patient communication Medication education Naturalistic design
1. Introduction Numerous studies indicate that patients adhere to only about 50% of medications as prescribed [1–4]. Poor adherence is associated with the unsafe use of medications and increased health costs [5–7]. Virtually all states in the U.S. have adopted some form of regulation requiring pharmacists to counsel patients about their medication use [8,9]. Pharmacist medication counseling can lead to improved medication adherence [10–13]. Beyond regulatory requirements, many community pharmacies have recognized the significance of medication adherence for clinical and commercial reasons by instituting automated refill
* Corresponding author at: Northeastern University School of Pharmacy, 140 The Fenway, 218TF 360 Huntington Ave., Boston, MA 02115, USA. Fax: +1 617 373 7655. E-mail address: [email protected] (N.M. Rickles). http://dx.doi.org/10.1016/j.pec.2015.10.003 0738-3991/ ã 2015 Elsevier Ireland Ltd. All rights reserved.
programs (refilling medications without patient initiation), sending telephone or text message reminders to pick up late medications, and, to a more limited extent, reaching out interpersonally to patients to explore reasons for non-adherence. Some insurance companies have instituted review procedures for prescription insurance claims to identify and manage nonadherence. The Health Collaboration Model (HCM) is a valuable framework for studying the role of pharmacy counseling in improving medication adherence [14]. HCM states two main paths between pharmacist communication and medication adherence: (1) improved quality of pharmacist medication instruction and support can lead to improved patient comprehension, motivation, and initial medication adherence, and (2) improved pharmacist feedback on medication and medication problem-solving can lead to improved patient satisfaction, sustained medication adherence, and clinical outcomes.
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Little data exist addressing the extent to which pharmacists engage patients on medication issues. The primary objective of the present study is to describe the nature and extent of pharmacy detection of medication non-adherence, monitoring of adherence, and solutions offered to improve adherence. We used a naturalistic observational design where participants filled the same prescription at either a new pharmacy or their usual pharmacy over a 5-month study period, creating refill gaps and making the participant appear less adherent to one of their medications. 2. Methods We recruited 74 participants from the Boston area through advertisements in newspapers and flyers posted in three primary care sites. We subsequently removed (see Analysis section) 14 participants for a final sample size of 60. Participants were eligible to participate if they (1) took a generic oral medication for a chronic illness with 30-day supplies, (2) picked up their medications regularly from a community pharmacy, (3) were willing to get one of their chronic medications from a new pharmacy via a duplicate prescription for part of the study period, and (4) were willing to be trained in the use of a structured observation tool and follow a script for each of 5 monthly pharmacy visits. As many participants were taking other medications in addition to the one that would be tracked for the study, they needed to return to their usual pharmacy during all study months to obtain these medications. When participants returned to the usual pharmacy to pick up these other medications, they might be asked why they are not picking up the one medication they were obtaining from the new pharmacy. Participants were instructed to tell their usual pharmacy that they had enough supplies of medication and did not need any more at the present time. We focused on generic medications since they are less expensive than brand medications and thus less costly to the study. Participants received an incentive of $175 for their time and efforts,
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reimbursement for transportation costs, and costs of obtaining medication at the new pharmacy since the purchase was made without prescription drug insurance. To document the nature and extent of medication adherence communications, we examined what pharmacists said and did when receiving cues that a participant might not be obtaining their medication. However, for ethical and clinical reasons, participants could not be asked to skip doses. Participants already on a medication never missed a monthly refill because they alternated getting refills at two different pharmacies without interruption. Participants selected a new pharmacy that was not connected organizationally to their usual pharmacy. The new pharmacy and the usual pharmacy did not have linked refill records; the staff at each pharmacy would not likely be aware that the participant had picked up the medication at a different pharmacy. By using this approach, we created artificial refill gaps to trigger suspicion that the participant may not be taking the medication as prescribed. Participants were instructed to go to the new pharmacy in months 1, 2, and 5 (creating a gap in the usual pharmacy’s refill records) and to the usual pharmacy in months 3 and 4 (creating a gap in the new pharmacy’s refill records). Participants were trained on how to follow the script, use monthly observation forms, and handle situations that have arisen when visiting the pharmacy or receiving communications about refilling medication. The observation forms contained yes/no questions to record observations in a manner that supported reliable measurement. Specifically, for each pharmacy visit, participants were instructed to indicate whether or not the pharmacy staff engaged in certain types of counseling-related communication regarding how the medication worked, how to take the medication, side effects, and precautions, and discussed the importance of medication adherence. Participants were instructed not to disclose to the pharmacists their involvement in the study, to self report whether they followed the protocol for each pharmacy visit, to complete observation forms immediately after visits, and return the forms
Study Montha New/Usual Pharmacy
Parcipant Behavior at Pharmacy
Parcipant Observaon at Pharmacy
1
New
Presents new prescripon to new pharmacy Tells pharmacy staff wants to speak to pharmacist Tells pharmacists they want to know more about medicaon
Asked if quesons for pharmacist Counseled on importance of adherence Counseled about medicaon purpose, direcons for use, side effects, and key precauons
2
New
Returns for refill at new pharmacy Reports no quesons for pharmacist
Asked if quesons for pharmacist
3
Usual
Presents refill at usual pharmacy Tells pharmacy staff wants to speak to pharmacist Tells pharmacist they are unsure medicaon is working If asked about adherence, report missing doses If asked why missed doses, report medicaon not working
Asked if they have quesons for pharmacist Counseled on importance of adherence Asked if they have missed doses Asked why they missed doses Provided an adherence soluon
4
Usual
Returns for refill at usual pharmacy
Asked if quesons for pharmacist
5
New
Returns for refill at new pharmacy Tells pharmacy staff wants to speak to pharmacist Tells pharmacist they are unsure medicaon is working If asked about adherence, report missing doses If asked why missed doses, report medicaon not working
Asked if quesons for pharmacist Counseled on importance of adherence Asked if they have missed doses Asked why they missed doses Provided an adherence soluon
a
For each month, the parcipant was also asked to indicate outside contact by new and/or usual pharmacy regarding late refill reminder and any adherence outreach efforts. Fig. 1. Study design of face-to-face encounters and observations.
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monthly in a pre-addressed, pre-stamped envelope to the researchers. A depiction of the study protocol can be seen in Fig. 1. For all visits, participants were asked to note any adherence outreach efforts (calls, emails, texts) made by the insurance company, new and/or usual pharmacy. The project was approved by the University Institutional Review Board. 2.1. Months 1 and 2 protocol: new pharmacy first and second visits We asked participants to get a new prescription from their physician and not transfer their existing prescription from their usual pharmacy to the new pharmacy. Transferring the prescription would reduce the suspicion of non-adherence at the usual pharmacy since there would be a valid reason for why the usual pharmacy was seeing a gap of medication use. Participants were instructed to present the prescription at the new pharmacy, pay in cash (to avoid insurance rejections for being filled too soon) and not to indicate they had used the medication previously. As such, the pharmacist would ideally be expected to counsel participants on how the new medication worked, how to take it, side effects, and precautions. Participants were to indicate that they did have questions for the pharmacist and instructed to note if the pharmacist covered topics about how the medication worked, how to take the medication, side effects, precautions, and mentioned the importance of medication adherence. During month 2, participants returned to the new pharmacy and were instructed to indicate not to present any questions for the pharmacist. 2.2. Months 3 and 4 protocol: usual pharmacy first and second study visits This visit was the first face-to-face opportunity for the pharmacist at the usual pharmacy to talk to the participant about suspected medication non-adherence. Participants were instructed to indicate they wanted to talk to the pharmacist. During the month 3 visit, participants were to indicate to the pharmacist they were unsure the medication was working since they did not feel any different (to trigger the pharmacist to think about non-adherence as a possible reason for lack of efficacy). If the pharmacist questioned them about missing doses, participants were to say they had missed doses “here and there” (participants were to note whether the pharmacist asked about missing doses and if they indicated missing doses). If pharmacists probed further about why they missed doses, participants were to indicate that they did not see any value in the medication since they did not feel any different. Participants were to note if pharmacists talked about the importance of medication adherence and offered any solutions to improve adherence. In month 4, participants returned again to the usual pharmacy and reported if the pharmacy staff asked if they had questions. The protocol for month 4 proceeded as for month 2.
3 and 5, participants were asked if they indicated to the pharmacist that they felt the medication was not working, and were considered violating protocol if they answered “no,” as this inhibited the planned interaction with the pharmacist. Fourteen participants had two or more such violations across months 1, 3, and 5 and these were removed, leaving N = 60. Sensitivity analyses revealed that responses for nearly all study items were quite similar among the sample of 74 vs. the sample of 60. Despite the removal of the 14 with two or more violations, the sample still included participants who violated the protocol. For example, in month 1, about 15% of the participants did not indicate they had a question for the pharmacist about their “new” medication. Likewise, about 15–18% did not indicate in months 3 and 5 that they had said they wanted to speak to the pharmacist when the protocol instructed them to. We do not know whether a protocol deviation was a real violation or just an omission on the part of the participant to report his/her behavior when completing the form. 2.4. Analysis Data were analyzed with SPSS 21.0. 3. Results The study was conducted from March 2013 to November 2013. Of the 60 participants for analysis, approximately 53% were females. One hundred eleven pharmacies were visited, but 33 were duplicate sites, making 78 the total number of unique pharmacies. Nineteen of these 78 pharmacies had 2 or more participants from our study, representing an approximate 24% overlap. Of these Table 1 New prescription consultation at new pharmacy, month 1 (n = 60). Pharmacy behaviors at pharmacy
n (%)
Did someone ask you if you had questions for the pharmacist? N: 27 (45.0) Y: 32 (53.3) Did the pharmacist talk to you about how adherence is important and that you will see more of a benefit from taking your medication regularly
N: 32 (53.3) Y: 26 (43.3)
Did the pharmacist initiate counseling about how the medication works?
N:32 (53.3) Y: 28 (46.7)
Did the pharmacist initiate counseling about the directions for use—when and how often to take medication?
N: 17 (28.3) Y: 43 (71.7)
Did the pharmacist initiate counseling about key side effects? N: 34 (56.7) Y: 26 (43.3) Did the pharmacist initiate counseling about key precautions?
N: 34 (56.7) Y: 26 (43.3)
Participant behaviors at pharmacy (protocol checks) Did you indicate that you had a question or wanted to speak N: 8 (13.3) with the pharmacist given new medication? Y: 52 (86.7)
2.3. Month 5 protocol: new pharmacy third visit In month 5, participants went for the third time to the new pharmacy and used the month 3 protocol. Data were analyzed with SPSS 21.0. Observation forms for months 1, 3, and 5 included questions that were used to assess whether a participant followed the study protocol. On month 1, participants were asked if they indicated that they wanted to speak with the pharmacist, and were considered violating protocol if they answered “no” and no conversation with the pharmacist occurred. If the participant answered “no” but a conversation did occur, the participant was retained in the analysis. On months
Outside pharmacy contact Did you receive contact reminding you of your refill at the end N: 42 (70.0) of the month from your usual pharmacy? Y: 17 (28.3) Did your usual pharmacy ask you why you were not picking N: 50 (83.3) up the particular medication? Y: 8 (13.3) Did your usual pharmacy ask you why you did not need the N: 50 (83.3) medication? Y: 6 (10.0) Did the insurance company contact you about your medication?
N: 57 (95.0) Y: 1 (1.7)
Y: Yes, N: No; Note: numbers may not add up to 100% due to missing data.
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78 pharmacies, 8 were independent or specialty pharmacies, 3 were located in a community health center or outpatient pharmacy in a hospital medical center, and the remaining 67 represented 8 different chain pharmacies. Due to attrition, results represent approximately 260 visits made to these pharmacies (representing 86.7% of the total potential number of visits). The mean number of visits per person was 4.33 visits, demonstrating a good retention of participants.
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Table 3 Non-adherence consultation at usual pharmacy, month 3 (n = 49). Pharmacy behaviors at pharmacy
n (%)
Did someone ask if you had questions for the pharmacist?
N: 18 (36.7) Y: 30 (61.2)
Did the pharmacist ask about why you had not picked up the N: 34 (69.4) medication last month? Y: 13 (26.5) Did the pharmacist talk to you on how adherence is important N: 24 (49.0) and will see more of a benefit if medication taken regularly? Y: 23 (46.9)
3.1. Month 1: new pharmacy first visit Table 1 highlights the month 1 visit by 60 participants to the new pharmacy. Approximately 45% indicated the pharmacy staff did not ask if they had any questions. Most participants (86.7%) followed the script by indicating they had a question for the pharmacist regardless of whether the pharmacist asked if they had questions. The most common counseling point from pharmacists that participants recorded was directions for use (71.7%). For more than half (57%) of the participants, directions of use was the only source of information presented during consultation. Only approximately 43–47% of the sample indicated the pharmacists discussed how the medication worked, key side effects, and precautions. Approximately 83% indicated that their usual pharmacy did not ask why they were not picking up the medication. 3.2. Month 2: new pharmacy second visit
Did the pharmacist offer you any solutions?
Participant behaviors at pharmacy (protocol checks) Did you indicate that you had a question or wanted to speak to N: 9 (18.4) the pharmacist? Y: 38 (77.6) Did you indicate being unsure the medication was working since you feel no different?
N: 10 (20.4) Y: 37 (75.5)
If asked about adherence, did you indicate you missed doses N: 2 (4.1) here or there? Y: 15 (30.6) Not asked: 30 (61.2) Outside pharmacy contact Did you ever receive contact from the new pharmacy concerning medication use? Did the new pharmacy offer to refill medication?
When participants returned to the new pharmacy for a refill, 54% of the participants reported that they were not asked if they had questions for the pharmacist (Table 2). The same percentage indicated not having a question for the pharmacist, thus following protocol. Over 70% indicated their usual pharmacy did not ask why they were not picking up the medication for the second consecutive month. More than half did not receive a call reminding them to refill the medication.
N: 26 (53.1) Y: 19 (38.8)
N: 35 (71.4) Y: 14 (28.6) N: 33 (67.3) Y: 14 (28.6)
Did the new pharmacy ask you why you were not picking up N: 45 (91.8) the particular medication? Y: 3 (6.1) Did the insurance company contact you about your medication?
N: 48 (98.0)
Y: Yes, N: No; Note: numbers may not up to 100% due to missing data.
3.3. Month 3: usual pharmacy first visit Table 2 Refill prescription consultation at new pharmacy, month 2 (n = 56). Pharmacy behaviors at pharmacy
n (%)
Did someone ask you if you had questions for the pharmacist?
N: 30 (53.6) Y: 26 (46.4)
Participant behaviors at pharmacy (protocol checks) Did you indicate that you had no questions for the pharmacist?
N: 30 (53.6) Y: 23 (41.1)
Outside pharmacy contact Did you receive contact reminding you of your refill at the end of the N: 33 month from the usual pharmacy? (58.9) Y: 19 (33.9) Did the usual pharmacy ask you why you were not picking up the N: 41 particular medication? (73.2) Y: 11 (19.6) Did the usual pharmacy ask you why you did not need the medication?
N: 42 (75.0) Y: 7 (12.5)
Did the insurance company contact you about your medication?
N: 55 (98.2)
Y: Yes, N: No; Note: numbers may not add up to 100% due to missing data.
Table 3 shows the results when participants returned to the usual pharmacy. Over 35% indicated that the pharmacy staff did not ask if they had questions. Approximately 70% indicated the pharmacist did not ask why they had not picked up the medication, almost half reported the pharmacist did not talk about the importance of adherence, and only about 40% reported the pharmacist offered solutions to improve adherence. A little over 77% requested, as per protocol, to speak to the pharmacist, and 75% of the sample indicated they said they were unsure the medication was working because they were not feeling any different. Most (61.2%) reported not being asked about adherence at the usual pharmacy. Approximately 31% indicated they had missed doses. Greater than 70% of the participants reported that the new pharmacy did not call about medication use. The new pharmacy only contacted 28% of the participants about refilling their medications. More than 90% indicated that the new pharmacy did not explore why they had not been picking up the medication. 3.4. Month 4: usual pharmacy second visit Table 4 shows that for month 4 only a little more than half the participants indicated someone asked if they had questions for the pharmacist and only 21.7% reported the pharmacist talked about adherence. Approximately 8% indicated that the new pharmacy asked why they were not picking up the medication.
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Table 4 Refill prescription consultation at usual pharmacy, month 4 (n = 46). Pharmacy behaviors at pharmacy
n (%)
Did someone ask you if you had questions for the pharmacist? N: 21 (45.7) Y: 24 (52.2) Did pharmacist talk about the importance of adherence?
N:35 (76.1) Y: 10 (21.7)
Outside pharmacy contact Did new pharmacy ask you why you were not picking up the N: 40 (87.0) particular medication? Y: 4 (8.7) Did you indicate to the new pharmacy that you did not need N: 31 (67.4) the medication? Y: 10 (21.7)
pharmacist, and approximately 81% indicated they were unsure the medication was working. Approximately 55% were not asked about missed doses, and about the same percentage reported the usual pharmacy did not contact them about refilling their medication and that the usual pharmacy did not offer to refill the medication. Approximately 75% indicated the usual pharmacy did not explore why they were not picking up the medication. Across the study months, nearly all participants reported no communication from their insurance company regarding medication adherence. 4. Discussion and conclusions 4.1. Discussion
Did the insurance company contact you about your medication?
N: 44 (95.7) Y:1 (2.2)
Y: Yes, N: No; Note: numbers may not up to 100% due to missing data.
3.5. Month 5: new pharmacy third visit In month 5 participants returned to the new pharmacy after a gap of two months (see Table 5). A little more than half reported that they were not asked if they had questions for the pharmacist. Almost 70% indicated that they were never asked why they had not picked up the medication in the past month. Approximately 55% reported the pharmacist did not discuss the importance and value of medication adherence. Nearly half the pharmacists reportedly did not offer any solutions to improve medication adherence. Approximately 85% indicated they wanted to speak to the Table 5 Non-adherence consultation at new pharmacy, month 5 (n = 47). Pharmacy behaviors at pharmacy
n (%)
Did someone ask if you had questions for pharmacist?
N: 25 (53.2) Y: 20 (42.6)
Did the pharmacist ask about why you hadn’t picked up the N: 32 (68.1) medication last month? Y: 14 (30.0) Did the pharmacist talk to you on how adherence is important N: 26 (55.3) and will see more of a benefit if medication taken regularly? Y: 19 (40.4) Did the pharmacist offer you any solutions?
N: 23 (48.9) Y: 21 (44.7)
Participant behaviors at pharmacy (protocol checks) Did you indicate that you had a question or wanted to speak to N: 7 (14.9) the pharmacist? Y: 40 (85.1) Did you indicate being unsure the medication was working since you feel no different?
N: 8 (17.0) Y: 38 (80.9)
If asked about adherence, did you indicate you missed doses N: 6 (12.8) here or there? Y: 14 (30.0) Not asked: 26 (55.3) Outside pharmacy contact Did you receive contact reminding you of your refill at the end N: 26 (55.3) of the month from the usual pharmacy? Y: 21 (44.7) Did usual pharmacy offer to refill the medication?
N: 24 (51.1) Y: 20 (42.6)
Did usual pharmacy ask you why you were not picking up the N: 35 (74.5) particular medication? Y: 10 (21.3) Did the insurance company contact you about your medication?
N: 44 (93.6) Y: 1 (2.1)
Y: Yes, N: No; Note: numbers may not add up to 100% due to missing data.
We documented pharmacy communications when patients appeared to be less adherent to a medication. The appearance of non-adherence was achieved by creating artificial gaps in medication refills that were intended to trigger suspicion among pharmacy staff that the patient may not be taking the medication as prescribed. Actual patients served as participants who observed and reported what happened in and outside of the pharmacy encounters to intervene on medication non-adherence (including any insurance company outreach). Across study months, approximately 37–54% of participants reported they were not asked if they had questions for the pharmacist as required by state law [8]. These numbers are better than previous reports in the literature [15,16]. Yet, the rates are lower than other prior reports of pharmacist counseling [17–20]. There are 28 other states like Massachusetts requiring the pharmacy to make an offer to counsel [21]. Comparisons to the present study are difficult since there are no known studies reporting pharmacist counseling rates for the Boston area. During month 1 when participants filled a prescription at a new pharmacy, more than half of the study participants indicated that directions of use were the only points of counseling they received. A Florida study, using trained observers, reported that directions of use (40%) and side effects (38%) were the most common points of consultations [16]. In most cases, the Florida pharmacists did not discuss side effects, key precautions, and how the medication worked. Months 3 and 5 were the two study months of particular interest to see if pharmacy staff recognized gaps in medication use when they came for a refill. During these months, only approximately 26–30% of participants reported that the pharmacist asked why they had not picked up the medication. In addition, across four months of the study (months 1, 3–5), 49–55% of participants reported that pharmacists did not talk about the importance of medication and the benefit of medication adherence. At months 3 and 5, when participants indicated that they felt as though the medication was not working, more than 70% reported the pharmacist did not ask why the medication was not picked up in the previous months (data not shown). One would hope that statements by participants that the medication is not working would trigger an adherence review and detection of possible nonadherence. When participants indicated missing doses, 61–73% reported the pharmacist provided solutions (data not shown). This highlights that solutions generally are provided when pharmacists learn of medication non-adherence. Many participants reported they did not receive from either pharmacy a reminder or offer to refill their late medication. The variability in contact and offer to refill may have to do with the differences in adherence outreach programs across pharmacies. Some pharmacies have software programs that (1) identify late refills and cue staff to contact patients to pick up medications, and
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(2) automatically prepare refills without patients prompting and call the patient to pick up medication. Of the 78% of the participants completing requested study information about automatic refills, over 80% indicated not being enrolled in their usual pharmacy’s automatic refill program. We instructed participants not to enroll in automatic refill programs with the new pharmacy since the pharmacy might assume an enrolled automatic refill participant does not need any adherence intervention to pick up a late refill as they are already receiving reinforcement to pick up their medication. Therefore, it is unlikely being involved in another adherence program like the automatic refill would explain the low percentage of participants reporting the usual and new pharmacy contacted them and/or offered to refill late medications during the study. More participants reported being reminded to pick up a late refill than being asked why they were not picking up the late medication. Outreach phone calls may be more likely to serve as computerized reminders to pick up a late fill than individual calls probing reasons for non-adherence and resolving those concerns. Nearly all participants indicated not receiving a phone call from their insurance company regarding gaps in their medication. As insurance plans are being held more accountable for adherence and other quality metrics, they may need to become more proactive in detecting and intervening in medication nonadherence [22]. The findings show a significant amount of communication default where the provider (and insurer) displays low engagement/ involvement in the medication adherence intervention process. Although patient engagement in the present study was experimentally manipulated, the pharmacist and insurer responses were not and the consequences of the default were therefore quite real and concerning. The actual frequencies of pharmacist engagement may be even lower than those reported because participants prompted conversations (months 1, 3 and 5) that may not have typically taken place. Pharmacists may not have asked about any gaps in medication use because they assumed individuals went to a different pharmacy or the physician made a change in medication instructions. However, because participants had prescription refills at both the new and usual pharmacy, any refill picked up from another pharmacy would have had to be transferred from the new/ usual pharmacy to the different pharmacy. Pharmacists should not have suspected that the prescription was filled elsewhere because participants were instructed not to have their refills transferred out to any of the pharmacies. Likewise, pharmacists should not have suspected prescription discontinuation because of the participants’ prompt during months 3 and 5 of “not feeling any different”; participants would know why they don't feel different if a medication was discontinued. Such communication defaults can result in medication nonadherence going undetected for some time resulting in significant negative patient outcomes. Automated refill systems and phone outreach to remind patients to pick up refills are current systems that are helpful in reducing memory-related barriers to adherence. However, other approaches should also be employed such as identifying times during the work day or evenings when it is feasible for pharmacists to have personalized interactions (phone or in-person visit) with patients to routinely probe barriers to adherence. Furthermore, pharmacies should consider developing tailored plans to improve medication adherence. The HCM framework presented earlier is a useful explanatory model for how pharmacists can interpersonally impact medication adherence and how team quality, quality of healthcare system, and insurance company practices can impact patient decision making about medication use [14]. Adherence interventions by both
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insurance plans and providers could be more effective than either component alone. The present study has several limitations. Some participants did not follow the protocol completely. To address this limitation, we restricted the analysis to only those participants who did not make repeated protocol violations across multiple months of the study. Reasons for apparent deviations from protocol may be participant discomfort in asking the pharmacist questions, discomfort over not being entirely honest about their experience, recording errors, confusion over protocol instructions, and memory lapses. Despite protocol violations, the method of using actual patients as research participants was beneficial in achieving the primary goals of our study. However, the method could be refined with more assessment of how well participants understand the protocol. The Institutional Review Board did not indicate any significant ethical issues associated with not informing pharmacies they were a part of a research study since they viewed participants’ prompts and pharmacists’ behaviors as typically found in many community pharmacy settings. They also noted that secret shoppers are often used as a course of practice by community pharmacies to evaluate the quality of their staff performance. The present study results are based on one metropolitan area, and there is the possibility that the pharmacies may not be representative of most pharmacies. However, the results are likely to be similar across other pharmacies in the U.S. because pharmacy workflow and practice patterns are similar across the nation. Finally, there was some attrition during the study despite multiple phone calls to remind participants to complete forms. Those who did not complete the study (primarily month 5 of the study) had findings similar to those participants completing the study. 4.2. Conclusion The present study was a description of what pharmacies in the Boston metropolitan area were doing regarding medication adherence detection, monitoring, and intervention. This report shows there were numerous missed opportunities for pharmacists (and insurers) to identify, monitor, and intervene on suspected medication non-adherence. These study results indicate a need for more infrastructure (tools, staffing, etc.) to support regular medication adherence monitoring and solutions. Given often tight resources, it might be best to begin with patients starting new medications for which early detection and intervention of nonadherence might help reduce continued behaviors leading to inconsistent medication use. Future research is needed to replicate findings and demonstrate the impact of pharmacy workflow systems that can facilitate detection, monitoring, and intervention to improve medication adherence. Such improved processes can help pharmacies and insurers reach target performance goals on national adherence quality measures. 4.3. Practice implications There are significant gaps in medication education and adherence communications between community pharmacists, insurers, and patients. The present study calls for more attention to building infrastructure in pharmacy practice that helps to more consistently identify, monitor, and intervene on medication adherence. More attention is needed regarding how patients might proactively engage pharmacists about their medication adherence. Conflicts of interest None.
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Acknowledgements We acknowledge the generous support of the Provost’s Office at Northeastern University for funding the present study. Funding source had no involvement in the development, implementation, evaluation, and any presentation of the current work. References [1] Compliance with Therapeutic Regimens, in: D. Sackett, R. Haynes (Eds.), John Hopkins University Press, Baltimore, MD, 1979. [2] J. Avorn, J. Monette, A. Lacour, et al., Persistence of use of lipid lowering medications- a cross-national study, J. Am. Med. Assoc. 279 (1979) 1458–1462. [3] J.S. Benner, R.J. Glynn, H. Mogun, P.J. Neumann, M.C. Weinstein, J. Avorn, Longterm persistence in use of statin therapy in elderly patients, J. Am. Med. Assoc. 288 (2002) 1455–1461. [4] D.H. Solomon, J. Avorn, J.N. Katz, et al., Compliance with osteoporosis medications, Arch. Intern. Med. 165 (2005) 2414–2419. [5] New England Healthcare Institute (NEHI), Thinking Outside of the Pillbox: A System-Wide Approach to Improving Patient Medication Adherence for Chronic Disease, New England Healthcare Institute, Cambridge, MA, 2009. [6] P.J. McDonell, M.R. Jacobs, Hospital admissions resulting from preventable adverse drug reactions, Ann. Pharmacother. 36 (2002) 1331–1336. [7] R. McCarthy, The price you pay for the drug not taken, Bus. Health 16 (1998) 27–33. [8] S.L. Spector, M. Youdelman, Analysis of State Pharmacy Laws: Impact of Pharmacy Laws on the Provision of Language Services, National Health Law Program, Washington, D.C, 2010. [9] D.M. Scott, M.J. Wessels, Impact of OBRA 90 on pharmacists' patient counseling practices, J. Am. Pharm. Assoc. 37 (1997) 410–416. [10] R. Berringer, M.C.H. Shibley, C.B. Pugh, et al., Outcomes of a community pharmacy-based diabetes monitoring program, J. Am. Pharm. Assoc. 39 (1999) 791–797.
[11] B.M. Bluml, J.M. McKenny, M.J. Cziraky, Pharmaceutical care services and results in Project ImPACT: hyperlipidemia, J. Am. Pharm. Assoc. 40 (2000) 157– 165. [12] P.R. Finley, H.R. Rens, J.T. Pont, et al., Impact of a collaborative pharmacy practice model on the treatment of depression in primary care, Am. J. Health Syst. Pharm. 59 (2002) 1518–1526. [13] N.M. Rickles, T.A. Brown, M.S. McGivney, et al., Adherence: a review of education, research, practice, and policy in the United States, Pharm. Pract. (Internet) 8 (2010) 1–17. [14] N.M. Rickles, B.L. Svarstad, The patient: behavioral determinants, in: L. Allen (Ed.), Remington: the Science and Practice of Pharmacy, 22nd ed., Pharmaceutical Press, London, 2012, pp. 1893–1902. [15] H.L. Mason, B.L. Svarstad, Medication counseling behaviors and attitudes of rural community pharmacists, Drug Intell. Clin. Pharm. 18 (1984) 409–414. [16] D.H. Berado, C.L. Kimberlin, C.W. Barnett, Observational research on patient education activities of community pharmacists, J. Soc. Adm. Pharm. 6 (1989) 21–30. [17] B. Sleath, Pharmacist question-asking in New Mexico community pharmacies, Am. J. Pharm. Educ. 59 (1995) 374–379. [18] R. Schatz, R.J. Belloto Jr, D.B. White, K. Bachmann, Provision of drug information to patients by pharmacists: the impact of the Omnibus Budget Reconciliation Act of 1990 a decade later, Am. J. Ther. 10 (2003) 93–103. [19] B.L. Svarstad, D.C. Bultman, J.K. Mount, Patient counseling provided in community pharmacies: effects of state regulation, pharmacist age, and busyness, J. Am. Pharm. Assoc. 44 (2004) 22–29. [20] M. DeYoung, A review of the research on pharmacists’ patient-communication views and practices, Am. J. Pharm. Educ. 60 (1996) 60–77. [21] S.L. Spector, M. Youdelman, Analysis of State Pharmacy Laws: Impact of Pharmacy Laws on the Provision of Language Services, National Health Law Program, Washington, D.C, 2010. [22] Centers for Medicare and Medicaid Services, Medicare Health and Drug Plan Quality and Performance Ratings: Part C and Part D Technical Notes, CMS, Baltimore (MD), 2012 (updated 2012 January 18).
Contents lists available at ScienceDirect
Patient Education and Counseling journal homepage: www.elsevier.com/locate/pateducou
Medication adherence communications in community pharmacies: A naturalistic investigation Nathaniel M. Ricklesa,* , Gary J. Youngb , Judith A. Hallc , Carey Nolandd, Ayoung Kima , Conner Petersona , Mina Honga , John Halea a
Department of Pharmacy and Health Systems Sciences, Northeastern University, Boston, MA, USA Center for Health Policy and Healthcare Research, Northeastern University, Boston, MA, USA Department of Psychology, Northeastern University, Boston, MA, USA d Department of Communication Studies, Northeastern University College of Arts, Media, and Design, Boston, MA, USA b c
A R T I C L E I N F O
A B S T R A C T
Article history: Received 22 May 2015 Received in revised form 2 October 2015 Accepted 10 October 2015
Objective: To describe the extent of pharmacy detection and monitoring of medication non-adherence, and solutions offered to improve adherence. Methods: Participants were 60 residents of the Boston area who had a generic chronic medication with 30 day supplies from their usual pharmacy. Participants received a duplicate prescription which they filled at a different pharmacy. For 5 months, participants alternated between the two pharmacies, creating gaps in their refill records at both pharmacies but no gaps in their medication adherence. Participants followed a scripted protocol and after each pharmacy visit reported their own and the pharmacy staff’s behavior. Results: Across 78 unique community pharmacies and 260 pharmacy visits, pharmacies were inconsistent and inadequate in asking if participants had questions, discussing the importance of adherence, providing adequate consultations with new medication, and detecting and intervening on non-adherence. Insurers rarely contacted the participants about adherence concerns. Conclusion: There is a need for more structured intervention systems to ensure pharmacists are consistently and adequately educating patients and detecting/managing potential medication nonadherence. Practice Implications: The present study calls for more attention to building infrastructure in pharmacy practice that helps pharmacists more consistently identify, monitor, and intervene on medication adherence. ã 2015 Elsevier Ireland Ltd. All rights reserved.
Keywords: Medication adherence Pharmacies Pharmacists Pharmacist–patient communication Medication education Naturalistic design
1. Introduction Numerous studies indicate that patients adhere to only about 50% of medications as prescribed [1–4]. Poor adherence is associated with the unsafe use of medications and increased health costs [5–7]. Virtually all states in the U.S. have adopted some form of regulation requiring pharmacists to counsel patients about their medication use [8,9]. Pharmacist medication counseling can lead to improved medication adherence [10–13]. Beyond regulatory requirements, many community pharmacies have recognized the significance of medication adherence for clinical and commercial reasons by instituting automated refill
* Corresponding author at: Northeastern University School of Pharmacy, 140 The Fenway, 218TF 360 Huntington Ave., Boston, MA 02115, USA. Fax: +1 617 373 7655. E-mail address: [email protected] (N.M. Rickles). http://dx.doi.org/10.1016/j.pec.2015.10.003 0738-3991/ ã 2015 Elsevier Ireland Ltd. All rights reserved.
programs (refilling medications without patient initiation), sending telephone or text message reminders to pick up late medications, and, to a more limited extent, reaching out interpersonally to patients to explore reasons for non-adherence. Some insurance companies have instituted review procedures for prescription insurance claims to identify and manage nonadherence. The Health Collaboration Model (HCM) is a valuable framework for studying the role of pharmacy counseling in improving medication adherence [14]. HCM states two main paths between pharmacist communication and medication adherence: (1) improved quality of pharmacist medication instruction and support can lead to improved patient comprehension, motivation, and initial medication adherence, and (2) improved pharmacist feedback on medication and medication problem-solving can lead to improved patient satisfaction, sustained medication adherence, and clinical outcomes.
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Little data exist addressing the extent to which pharmacists engage patients on medication issues. The primary objective of the present study is to describe the nature and extent of pharmacy detection of medication non-adherence, monitoring of adherence, and solutions offered to improve adherence. We used a naturalistic observational design where participants filled the same prescription at either a new pharmacy or their usual pharmacy over a 5-month study period, creating refill gaps and making the participant appear less adherent to one of their medications. 2. Methods We recruited 74 participants from the Boston area through advertisements in newspapers and flyers posted in three primary care sites. We subsequently removed (see Analysis section) 14 participants for a final sample size of 60. Participants were eligible to participate if they (1) took a generic oral medication for a chronic illness with 30-day supplies, (2) picked up their medications regularly from a community pharmacy, (3) were willing to get one of their chronic medications from a new pharmacy via a duplicate prescription for part of the study period, and (4) were willing to be trained in the use of a structured observation tool and follow a script for each of 5 monthly pharmacy visits. As many participants were taking other medications in addition to the one that would be tracked for the study, they needed to return to their usual pharmacy during all study months to obtain these medications. When participants returned to the usual pharmacy to pick up these other medications, they might be asked why they are not picking up the one medication they were obtaining from the new pharmacy. Participants were instructed to tell their usual pharmacy that they had enough supplies of medication and did not need any more at the present time. We focused on generic medications since they are less expensive than brand medications and thus less costly to the study. Participants received an incentive of $175 for their time and efforts,
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reimbursement for transportation costs, and costs of obtaining medication at the new pharmacy since the purchase was made without prescription drug insurance. To document the nature and extent of medication adherence communications, we examined what pharmacists said and did when receiving cues that a participant might not be obtaining their medication. However, for ethical and clinical reasons, participants could not be asked to skip doses. Participants already on a medication never missed a monthly refill because they alternated getting refills at two different pharmacies without interruption. Participants selected a new pharmacy that was not connected organizationally to their usual pharmacy. The new pharmacy and the usual pharmacy did not have linked refill records; the staff at each pharmacy would not likely be aware that the participant had picked up the medication at a different pharmacy. By using this approach, we created artificial refill gaps to trigger suspicion that the participant may not be taking the medication as prescribed. Participants were instructed to go to the new pharmacy in months 1, 2, and 5 (creating a gap in the usual pharmacy’s refill records) and to the usual pharmacy in months 3 and 4 (creating a gap in the new pharmacy’s refill records). Participants were trained on how to follow the script, use monthly observation forms, and handle situations that have arisen when visiting the pharmacy or receiving communications about refilling medication. The observation forms contained yes/no questions to record observations in a manner that supported reliable measurement. Specifically, for each pharmacy visit, participants were instructed to indicate whether or not the pharmacy staff engaged in certain types of counseling-related communication regarding how the medication worked, how to take the medication, side effects, and precautions, and discussed the importance of medication adherence. Participants were instructed not to disclose to the pharmacists their involvement in the study, to self report whether they followed the protocol for each pharmacy visit, to complete observation forms immediately after visits, and return the forms
Study Montha New/Usual Pharmacy
Parcipant Behavior at Pharmacy
Parcipant Observaon at Pharmacy
1
New
Presents new prescripon to new pharmacy Tells pharmacy staff wants to speak to pharmacist Tells pharmacists they want to know more about medicaon
Asked if quesons for pharmacist Counseled on importance of adherence Counseled about medicaon purpose, direcons for use, side effects, and key precauons
2
New
Returns for refill at new pharmacy Reports no quesons for pharmacist
Asked if quesons for pharmacist
3
Usual
Presents refill at usual pharmacy Tells pharmacy staff wants to speak to pharmacist Tells pharmacist they are unsure medicaon is working If asked about adherence, report missing doses If asked why missed doses, report medicaon not working
Asked if they have quesons for pharmacist Counseled on importance of adherence Asked if they have missed doses Asked why they missed doses Provided an adherence soluon
4
Usual
Returns for refill at usual pharmacy
Asked if quesons for pharmacist
5
New
Returns for refill at new pharmacy Tells pharmacy staff wants to speak to pharmacist Tells pharmacist they are unsure medicaon is working If asked about adherence, report missing doses If asked why missed doses, report medicaon not working
Asked if quesons for pharmacist Counseled on importance of adherence Asked if they have missed doses Asked why they missed doses Provided an adherence soluon
a
For each month, the parcipant was also asked to indicate outside contact by new and/or usual pharmacy regarding late refill reminder and any adherence outreach efforts. Fig. 1. Study design of face-to-face encounters and observations.
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monthly in a pre-addressed, pre-stamped envelope to the researchers. A depiction of the study protocol can be seen in Fig. 1. For all visits, participants were asked to note any adherence outreach efforts (calls, emails, texts) made by the insurance company, new and/or usual pharmacy. The project was approved by the University Institutional Review Board. 2.1. Months 1 and 2 protocol: new pharmacy first and second visits We asked participants to get a new prescription from their physician and not transfer their existing prescription from their usual pharmacy to the new pharmacy. Transferring the prescription would reduce the suspicion of non-adherence at the usual pharmacy since there would be a valid reason for why the usual pharmacy was seeing a gap of medication use. Participants were instructed to present the prescription at the new pharmacy, pay in cash (to avoid insurance rejections for being filled too soon) and not to indicate they had used the medication previously. As such, the pharmacist would ideally be expected to counsel participants on how the new medication worked, how to take it, side effects, and precautions. Participants were to indicate that they did have questions for the pharmacist and instructed to note if the pharmacist covered topics about how the medication worked, how to take the medication, side effects, precautions, and mentioned the importance of medication adherence. During month 2, participants returned to the new pharmacy and were instructed to indicate not to present any questions for the pharmacist. 2.2. Months 3 and 4 protocol: usual pharmacy first and second study visits This visit was the first face-to-face opportunity for the pharmacist at the usual pharmacy to talk to the participant about suspected medication non-adherence. Participants were instructed to indicate they wanted to talk to the pharmacist. During the month 3 visit, participants were to indicate to the pharmacist they were unsure the medication was working since they did not feel any different (to trigger the pharmacist to think about non-adherence as a possible reason for lack of efficacy). If the pharmacist questioned them about missing doses, participants were to say they had missed doses “here and there” (participants were to note whether the pharmacist asked about missing doses and if they indicated missing doses). If pharmacists probed further about why they missed doses, participants were to indicate that they did not see any value in the medication since they did not feel any different. Participants were to note if pharmacists talked about the importance of medication adherence and offered any solutions to improve adherence. In month 4, participants returned again to the usual pharmacy and reported if the pharmacy staff asked if they had questions. The protocol for month 4 proceeded as for month 2.
3 and 5, participants were asked if they indicated to the pharmacist that they felt the medication was not working, and were considered violating protocol if they answered “no,” as this inhibited the planned interaction with the pharmacist. Fourteen participants had two or more such violations across months 1, 3, and 5 and these were removed, leaving N = 60. Sensitivity analyses revealed that responses for nearly all study items were quite similar among the sample of 74 vs. the sample of 60. Despite the removal of the 14 with two or more violations, the sample still included participants who violated the protocol. For example, in month 1, about 15% of the participants did not indicate they had a question for the pharmacist about their “new” medication. Likewise, about 15–18% did not indicate in months 3 and 5 that they had said they wanted to speak to the pharmacist when the protocol instructed them to. We do not know whether a protocol deviation was a real violation or just an omission on the part of the participant to report his/her behavior when completing the form. 2.4. Analysis Data were analyzed with SPSS 21.0. 3. Results The study was conducted from March 2013 to November 2013. Of the 60 participants for analysis, approximately 53% were females. One hundred eleven pharmacies were visited, but 33 were duplicate sites, making 78 the total number of unique pharmacies. Nineteen of these 78 pharmacies had 2 or more participants from our study, representing an approximate 24% overlap. Of these Table 1 New prescription consultation at new pharmacy, month 1 (n = 60). Pharmacy behaviors at pharmacy
n (%)
Did someone ask you if you had questions for the pharmacist? N: 27 (45.0) Y: 32 (53.3) Did the pharmacist talk to you about how adherence is important and that you will see more of a benefit from taking your medication regularly
N: 32 (53.3) Y: 26 (43.3)
Did the pharmacist initiate counseling about how the medication works?
N:32 (53.3) Y: 28 (46.7)
Did the pharmacist initiate counseling about the directions for use—when and how often to take medication?
N: 17 (28.3) Y: 43 (71.7)
Did the pharmacist initiate counseling about key side effects? N: 34 (56.7) Y: 26 (43.3) Did the pharmacist initiate counseling about key precautions?
N: 34 (56.7) Y: 26 (43.3)
Participant behaviors at pharmacy (protocol checks) Did you indicate that you had a question or wanted to speak N: 8 (13.3) with the pharmacist given new medication? Y: 52 (86.7)
2.3. Month 5 protocol: new pharmacy third visit In month 5, participants went for the third time to the new pharmacy and used the month 3 protocol. Data were analyzed with SPSS 21.0. Observation forms for months 1, 3, and 5 included questions that were used to assess whether a participant followed the study protocol. On month 1, participants were asked if they indicated that they wanted to speak with the pharmacist, and were considered violating protocol if they answered “no” and no conversation with the pharmacist occurred. If the participant answered “no” but a conversation did occur, the participant was retained in the analysis. On months
Outside pharmacy contact Did you receive contact reminding you of your refill at the end N: 42 (70.0) of the month from your usual pharmacy? Y: 17 (28.3) Did your usual pharmacy ask you why you were not picking N: 50 (83.3) up the particular medication? Y: 8 (13.3) Did your usual pharmacy ask you why you did not need the N: 50 (83.3) medication? Y: 6 (10.0) Did the insurance company contact you about your medication?
N: 57 (95.0) Y: 1 (1.7)
Y: Yes, N: No; Note: numbers may not add up to 100% due to missing data.
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78 pharmacies, 8 were independent or specialty pharmacies, 3 were located in a community health center or outpatient pharmacy in a hospital medical center, and the remaining 67 represented 8 different chain pharmacies. Due to attrition, results represent approximately 260 visits made to these pharmacies (representing 86.7% of the total potential number of visits). The mean number of visits per person was 4.33 visits, demonstrating a good retention of participants.
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Table 3 Non-adherence consultation at usual pharmacy, month 3 (n = 49). Pharmacy behaviors at pharmacy
n (%)
Did someone ask if you had questions for the pharmacist?
N: 18 (36.7) Y: 30 (61.2)
Did the pharmacist ask about why you had not picked up the N: 34 (69.4) medication last month? Y: 13 (26.5) Did the pharmacist talk to you on how adherence is important N: 24 (49.0) and will see more of a benefit if medication taken regularly? Y: 23 (46.9)
3.1. Month 1: new pharmacy first visit Table 1 highlights the month 1 visit by 60 participants to the new pharmacy. Approximately 45% indicated the pharmacy staff did not ask if they had any questions. Most participants (86.7%) followed the script by indicating they had a question for the pharmacist regardless of whether the pharmacist asked if they had questions. The most common counseling point from pharmacists that participants recorded was directions for use (71.7%). For more than half (57%) of the participants, directions of use was the only source of information presented during consultation. Only approximately 43–47% of the sample indicated the pharmacists discussed how the medication worked, key side effects, and precautions. Approximately 83% indicated that their usual pharmacy did not ask why they were not picking up the medication. 3.2. Month 2: new pharmacy second visit
Did the pharmacist offer you any solutions?
Participant behaviors at pharmacy (protocol checks) Did you indicate that you had a question or wanted to speak to N: 9 (18.4) the pharmacist? Y: 38 (77.6) Did you indicate being unsure the medication was working since you feel no different?
N: 10 (20.4) Y: 37 (75.5)
If asked about adherence, did you indicate you missed doses N: 2 (4.1) here or there? Y: 15 (30.6) Not asked: 30 (61.2) Outside pharmacy contact Did you ever receive contact from the new pharmacy concerning medication use? Did the new pharmacy offer to refill medication?
When participants returned to the new pharmacy for a refill, 54% of the participants reported that they were not asked if they had questions for the pharmacist (Table 2). The same percentage indicated not having a question for the pharmacist, thus following protocol. Over 70% indicated their usual pharmacy did not ask why they were not picking up the medication for the second consecutive month. More than half did not receive a call reminding them to refill the medication.
N: 26 (53.1) Y: 19 (38.8)
N: 35 (71.4) Y: 14 (28.6) N: 33 (67.3) Y: 14 (28.6)
Did the new pharmacy ask you why you were not picking up N: 45 (91.8) the particular medication? Y: 3 (6.1) Did the insurance company contact you about your medication?
N: 48 (98.0)
Y: Yes, N: No; Note: numbers may not up to 100% due to missing data.
3.3. Month 3: usual pharmacy first visit Table 2 Refill prescription consultation at new pharmacy, month 2 (n = 56). Pharmacy behaviors at pharmacy
n (%)
Did someone ask you if you had questions for the pharmacist?
N: 30 (53.6) Y: 26 (46.4)
Participant behaviors at pharmacy (protocol checks) Did you indicate that you had no questions for the pharmacist?
N: 30 (53.6) Y: 23 (41.1)
Outside pharmacy contact Did you receive contact reminding you of your refill at the end of the N: 33 month from the usual pharmacy? (58.9) Y: 19 (33.9) Did the usual pharmacy ask you why you were not picking up the N: 41 particular medication? (73.2) Y: 11 (19.6) Did the usual pharmacy ask you why you did not need the medication?
N: 42 (75.0) Y: 7 (12.5)
Did the insurance company contact you about your medication?
N: 55 (98.2)
Y: Yes, N: No; Note: numbers may not add up to 100% due to missing data.
Table 3 shows the results when participants returned to the usual pharmacy. Over 35% indicated that the pharmacy staff did not ask if they had questions. Approximately 70% indicated the pharmacist did not ask why they had not picked up the medication, almost half reported the pharmacist did not talk about the importance of adherence, and only about 40% reported the pharmacist offered solutions to improve adherence. A little over 77% requested, as per protocol, to speak to the pharmacist, and 75% of the sample indicated they said they were unsure the medication was working because they were not feeling any different. Most (61.2%) reported not being asked about adherence at the usual pharmacy. Approximately 31% indicated they had missed doses. Greater than 70% of the participants reported that the new pharmacy did not call about medication use. The new pharmacy only contacted 28% of the participants about refilling their medications. More than 90% indicated that the new pharmacy did not explore why they had not been picking up the medication. 3.4. Month 4: usual pharmacy second visit Table 4 shows that for month 4 only a little more than half the participants indicated someone asked if they had questions for the pharmacist and only 21.7% reported the pharmacist talked about adherence. Approximately 8% indicated that the new pharmacy asked why they were not picking up the medication.
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Table 4 Refill prescription consultation at usual pharmacy, month 4 (n = 46). Pharmacy behaviors at pharmacy
n (%)
Did someone ask you if you had questions for the pharmacist? N: 21 (45.7) Y: 24 (52.2) Did pharmacist talk about the importance of adherence?
N:35 (76.1) Y: 10 (21.7)
Outside pharmacy contact Did new pharmacy ask you why you were not picking up the N: 40 (87.0) particular medication? Y: 4 (8.7) Did you indicate to the new pharmacy that you did not need N: 31 (67.4) the medication? Y: 10 (21.7)
pharmacist, and approximately 81% indicated they were unsure the medication was working. Approximately 55% were not asked about missed doses, and about the same percentage reported the usual pharmacy did not contact them about refilling their medication and that the usual pharmacy did not offer to refill the medication. Approximately 75% indicated the usual pharmacy did not explore why they were not picking up the medication. Across the study months, nearly all participants reported no communication from their insurance company regarding medication adherence. 4. Discussion and conclusions 4.1. Discussion
Did the insurance company contact you about your medication?
N: 44 (95.7) Y:1 (2.2)
Y: Yes, N: No; Note: numbers may not up to 100% due to missing data.
3.5. Month 5: new pharmacy third visit In month 5 participants returned to the new pharmacy after a gap of two months (see Table 5). A little more than half reported that they were not asked if they had questions for the pharmacist. Almost 70% indicated that they were never asked why they had not picked up the medication in the past month. Approximately 55% reported the pharmacist did not discuss the importance and value of medication adherence. Nearly half the pharmacists reportedly did not offer any solutions to improve medication adherence. Approximately 85% indicated they wanted to speak to the Table 5 Non-adherence consultation at new pharmacy, month 5 (n = 47). Pharmacy behaviors at pharmacy
n (%)
Did someone ask if you had questions for pharmacist?
N: 25 (53.2) Y: 20 (42.6)
Did the pharmacist ask about why you hadn’t picked up the N: 32 (68.1) medication last month? Y: 14 (30.0) Did the pharmacist talk to you on how adherence is important N: 26 (55.3) and will see more of a benefit if medication taken regularly? Y: 19 (40.4) Did the pharmacist offer you any solutions?
N: 23 (48.9) Y: 21 (44.7)
Participant behaviors at pharmacy (protocol checks) Did you indicate that you had a question or wanted to speak to N: 7 (14.9) the pharmacist? Y: 40 (85.1) Did you indicate being unsure the medication was working since you feel no different?
N: 8 (17.0) Y: 38 (80.9)
If asked about adherence, did you indicate you missed doses N: 6 (12.8) here or there? Y: 14 (30.0) Not asked: 26 (55.3) Outside pharmacy contact Did you receive contact reminding you of your refill at the end N: 26 (55.3) of the month from the usual pharmacy? Y: 21 (44.7) Did usual pharmacy offer to refill the medication?
N: 24 (51.1) Y: 20 (42.6)
Did usual pharmacy ask you why you were not picking up the N: 35 (74.5) particular medication? Y: 10 (21.3) Did the insurance company contact you about your medication?
N: 44 (93.6) Y: 1 (2.1)
Y: Yes, N: No; Note: numbers may not add up to 100% due to missing data.
We documented pharmacy communications when patients appeared to be less adherent to a medication. The appearance of non-adherence was achieved by creating artificial gaps in medication refills that were intended to trigger suspicion among pharmacy staff that the patient may not be taking the medication as prescribed. Actual patients served as participants who observed and reported what happened in and outside of the pharmacy encounters to intervene on medication non-adherence (including any insurance company outreach). Across study months, approximately 37–54% of participants reported they were not asked if they had questions for the pharmacist as required by state law [8]. These numbers are better than previous reports in the literature [15,16]. Yet, the rates are lower than other prior reports of pharmacist counseling [17–20]. There are 28 other states like Massachusetts requiring the pharmacy to make an offer to counsel [21]. Comparisons to the present study are difficult since there are no known studies reporting pharmacist counseling rates for the Boston area. During month 1 when participants filled a prescription at a new pharmacy, more than half of the study participants indicated that directions of use were the only points of counseling they received. A Florida study, using trained observers, reported that directions of use (40%) and side effects (38%) were the most common points of consultations [16]. In most cases, the Florida pharmacists did not discuss side effects, key precautions, and how the medication worked. Months 3 and 5 were the two study months of particular interest to see if pharmacy staff recognized gaps in medication use when they came for a refill. During these months, only approximately 26–30% of participants reported that the pharmacist asked why they had not picked up the medication. In addition, across four months of the study (months 1, 3–5), 49–55% of participants reported that pharmacists did not talk about the importance of medication and the benefit of medication adherence. At months 3 and 5, when participants indicated that they felt as though the medication was not working, more than 70% reported the pharmacist did not ask why the medication was not picked up in the previous months (data not shown). One would hope that statements by participants that the medication is not working would trigger an adherence review and detection of possible nonadherence. When participants indicated missing doses, 61–73% reported the pharmacist provided solutions (data not shown). This highlights that solutions generally are provided when pharmacists learn of medication non-adherence. Many participants reported they did not receive from either pharmacy a reminder or offer to refill their late medication. The variability in contact and offer to refill may have to do with the differences in adherence outreach programs across pharmacies. Some pharmacies have software programs that (1) identify late refills and cue staff to contact patients to pick up medications, and
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(2) automatically prepare refills without patients prompting and call the patient to pick up medication. Of the 78% of the participants completing requested study information about automatic refills, over 80% indicated not being enrolled in their usual pharmacy’s automatic refill program. We instructed participants not to enroll in automatic refill programs with the new pharmacy since the pharmacy might assume an enrolled automatic refill participant does not need any adherence intervention to pick up a late refill as they are already receiving reinforcement to pick up their medication. Therefore, it is unlikely being involved in another adherence program like the automatic refill would explain the low percentage of participants reporting the usual and new pharmacy contacted them and/or offered to refill late medications during the study. More participants reported being reminded to pick up a late refill than being asked why they were not picking up the late medication. Outreach phone calls may be more likely to serve as computerized reminders to pick up a late fill than individual calls probing reasons for non-adherence and resolving those concerns. Nearly all participants indicated not receiving a phone call from their insurance company regarding gaps in their medication. As insurance plans are being held more accountable for adherence and other quality metrics, they may need to become more proactive in detecting and intervening in medication nonadherence [22]. The findings show a significant amount of communication default where the provider (and insurer) displays low engagement/ involvement in the medication adherence intervention process. Although patient engagement in the present study was experimentally manipulated, the pharmacist and insurer responses were not and the consequences of the default were therefore quite real and concerning. The actual frequencies of pharmacist engagement may be even lower than those reported because participants prompted conversations (months 1, 3 and 5) that may not have typically taken place. Pharmacists may not have asked about any gaps in medication use because they assumed individuals went to a different pharmacy or the physician made a change in medication instructions. However, because participants had prescription refills at both the new and usual pharmacy, any refill picked up from another pharmacy would have had to be transferred from the new/ usual pharmacy to the different pharmacy. Pharmacists should not have suspected that the prescription was filled elsewhere because participants were instructed not to have their refills transferred out to any of the pharmacies. Likewise, pharmacists should not have suspected prescription discontinuation because of the participants’ prompt during months 3 and 5 of “not feeling any different”; participants would know why they don't feel different if a medication was discontinued. Such communication defaults can result in medication nonadherence going undetected for some time resulting in significant negative patient outcomes. Automated refill systems and phone outreach to remind patients to pick up refills are current systems that are helpful in reducing memory-related barriers to adherence. However, other approaches should also be employed such as identifying times during the work day or evenings when it is feasible for pharmacists to have personalized interactions (phone or in-person visit) with patients to routinely probe barriers to adherence. Furthermore, pharmacies should consider developing tailored plans to improve medication adherence. The HCM framework presented earlier is a useful explanatory model for how pharmacists can interpersonally impact medication adherence and how team quality, quality of healthcare system, and insurance company practices can impact patient decision making about medication use [14]. Adherence interventions by both
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insurance plans and providers could be more effective than either component alone. The present study has several limitations. Some participants did not follow the protocol completely. To address this limitation, we restricted the analysis to only those participants who did not make repeated protocol violations across multiple months of the study. Reasons for apparent deviations from protocol may be participant discomfort in asking the pharmacist questions, discomfort over not being entirely honest about their experience, recording errors, confusion over protocol instructions, and memory lapses. Despite protocol violations, the method of using actual patients as research participants was beneficial in achieving the primary goals of our study. However, the method could be refined with more assessment of how well participants understand the protocol. The Institutional Review Board did not indicate any significant ethical issues associated with not informing pharmacies they were a part of a research study since they viewed participants’ prompts and pharmacists’ behaviors as typically found in many community pharmacy settings. They also noted that secret shoppers are often used as a course of practice by community pharmacies to evaluate the quality of their staff performance. The present study results are based on one metropolitan area, and there is the possibility that the pharmacies may not be representative of most pharmacies. However, the results are likely to be similar across other pharmacies in the U.S. because pharmacy workflow and practice patterns are similar across the nation. Finally, there was some attrition during the study despite multiple phone calls to remind participants to complete forms. Those who did not complete the study (primarily month 5 of the study) had findings similar to those participants completing the study. 4.2. Conclusion The present study was a description of what pharmacies in the Boston metropolitan area were doing regarding medication adherence detection, monitoring, and intervention. This report shows there were numerous missed opportunities for pharmacists (and insurers) to identify, monitor, and intervene on suspected medication non-adherence. These study results indicate a need for more infrastructure (tools, staffing, etc.) to support regular medication adherence monitoring and solutions. Given often tight resources, it might be best to begin with patients starting new medications for which early detection and intervention of nonadherence might help reduce continued behaviors leading to inconsistent medication use. Future research is needed to replicate findings and demonstrate the impact of pharmacy workflow systems that can facilitate detection, monitoring, and intervention to improve medication adherence. Such improved processes can help pharmacies and insurers reach target performance goals on national adherence quality measures. 4.3. Practice implications There are significant gaps in medication education and adherence communications between community pharmacists, insurers, and patients. The present study calls for more attention to building infrastructure in pharmacy practice that helps to more consistently identify, monitor, and intervene on medication adherence. More attention is needed regarding how patients might proactively engage pharmacists about their medication adherence. Conflicts of interest None.
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