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Patient Recall of Health Care Provider Counseling for Opioid-Acetaminophen Prescriptions

Danielle M. McCarthy MD, MS, Kenzie A. Cameron PhD, MPH, Jennifer P. King MPH, Rebecca J. Mullen BS, Stacy Cooper Bailey PhD, MPH, Kara L. Jacobson MPH, Lorenzo Di Francesco MD, Terry C. Davis PhD, Ruth M. Parker MD, Mike S. Wolf PhD, MPH
DOI: http://dx.doi.org/10.1111/pme.12499 1750-1756 First published online: 1 October 2014

Abstract

Objective The aim of this study was to determine the frequency and nature of physician, nurse, and pharmacist verbal counseling at the time of a new prescription for an opioid-acetaminophen containing medication as recalled by patients.

Design A mixed methods approach with data from cross sectional, structured interviews was used.

Setting The settings were one academic emergency department in Chicago, IL and one outpatient pharmacy at a public hospital in Atlanta, GA.

Patients One hundred forty-nine patients receiving a new prescription for an opioid-acetaminophen medication were enrolled.

Methods Interviews assessed patient recall of counseling they received from their physician, nurse, and pharmacist upon receiving the new prescription. Their responses were unitized and assigned to categories.

Results One hundred forty-nine patients were enrolled; 61.1% African American and 58.4% female. Seven major categories of responses were noted; frequencies of patient recall for counseling in these categories were reported. Four categories related to the content of the counseling discussion were 1) details of administration (patient recall counseling from: physician/nurse only 44.3%, pharmacist only 5.4%, both providers 12.8%); 2) activities to avoid and side effects (36.2%, 4.7%, 8.7%); 3) medication indication (32.9%, 4%, 4%); and 4) addictive potential (9.3%, 1.3%, 0%). Three categories describe patients' recall of the interaction in broad terms: 5) being referred to print informational material accompanying the prescription (MD/RN only 7.4%, pharmacist only 20.1%, both providers 2.7%); 6) having questions solicited (0%, 11.4%, 0%); 7) having no interaction relating to medication counseling (3.4%, 32.2%, 1.3%).

Conclusions Patients infrequently recall counseling from providers on topics that are important to prevent harm from opioid-acetaminophen prescriptions. Future patient-centered clinical research should target identifying optimal strategies to convey these critical messages.

  • Opioids
  • Hydrocodone
  • Medication Counseling
  • Acetaminophen

Introduction

Opioid-acetaminophen prescription drugs are among the most commonly prescribed medications in the United States. In 2010, over 122 million prescriptions were written for hydrocodone-acetaminophen, more than three times the number of prescriptions for the leading brand name medication, Lipitor® [1,2]. The opioid-acetaminophen combination prescriptions have received recent attention due to the growing number of adverse events related to both the acetaminophen and opioid active ingredients. Opioid pain relievers were involved in 74% of all overdose deaths from prescription medications in the year 2008 and account for more annual deaths than from heroin and cocaine combined [3]. Although some of these deaths were related to long-acting and extended release opioids, opioid-acetaminophen combinations drugs were also a contributor. The acetaminophen component of these medications represents a particularly serious concern. In the United States, acetaminophen toxicity has become the leading cause of acute liver failure, surpassing viral hepatitis and resulting in more than 30,000 hospitalizations per year [4–6]. The majority of the acetaminophen overdoses are unintentional and not the result of suicidal intent [5,6].

In an effort to decrease the morbidity and mortality associated with these analgesics, national agencies such as the Food and Drug Administration (FDA) and the Drug Enforcement Agency have developed initiatives to improve prescription bottle labeling, implemented risk evaluation and mitigation strategies, and initiated prescription drug take-back programs [7,8]. Although these strategies are promising for addressing the problem from a systematic viewpoint, the individual physician prescribing and the pharmacist dispensing the medication also play an important role in counseling the patient to safeguard against inappropriate medication use.

Few studies to date have examined how opioid-naïve patients are verbally counseled when receiving a prescription for opioids for the first time. A small number of studies have assessed physician-counseling practices regarding acetaminophen. One study by Hornsby and colleagues found the majority of physicians (72%) self-reported providing some counseling when prescribing acetaminophen-containing medications; however, the information provided to patients was limited [9]. A study by Osborne and Bryant assessed patients' receipt of written emergency department (ED) discharge instructions and found none of the 108 patients receiving opioid-acetaminophen medications were given written information advising them to discontinue other acetaminophen-containing medications once they began taking opioid-acetaminophen medications [10].

The literature on pharmacist counseling about opioid-acetaminophen medications primarily focuses on harm reduction for abusers of these medications [11–13]. A review of counseling practices in community pharmacies documented highly variable rates of pharmacist counseling (range 8% to 100%), with pharmacists most likely to counsel patients on directions for medication use and less likely to counsel on side effects, safe storage, and precautions [14]. To add to this limited body of literature, we sought a patients' perspective on the nature of physician, nurse, and pharmacist verbal counseling at the time of receipt of a new prescription for an opioid-acetaminophen-containing medications as recalled by patients only days after receiving the prescription.

Methods

We conducted a cross-sectional study utilizing a mixed-methods approach with data from one-on-one interviews among adult patients receiving a new prescription for an opioid-acetaminophen analgesic in Atlanta, GA and Chicago, IL.

English-speaking adults were recruited to the study between April and August 2011. In Chicago, potential subjects were recruited upon discharge from the ED of an academic medical center. In Atlanta, potential subjects were recruited while waiting to have a prescription filled at a large pharmacy within a public, teaching hospital. The ED setting in Chicago has >85,000 annual patient visits and is staffed by approximately 40 attending physicians, 50 resident physicians, and a pool of 140 nurses; patients filled their prescriptions at community pharmacies. In Atlanta, the prescription may have come from any type of provider (e.g., emergency physician, dentist, orthopedic surgeon) in the health care system, but were all filled at a central, hospital-based pharmacy. Patients were deemed eligible to participate if they were ages 18 to 80, and without psychological impairment or intoxication (as judged by research staff member) and were prescribed an analgesic containing acetaminophen. Patients were excluded if they were admitted to the hospital or were receiving a refill of an analgesic medication they took chronically at home. The institutional review boards at Northwestern University (Chicago) and Grady Memorial Hospital (Atlanta) approved this study.

Research assistants (RAs) at both sites had brief, initial contact with the potential subjects to verify eligibility and obtain participants' consent. Those consenting to participate were scheduled to return to the same site 4–7 days later where they completed a structured interview, assessing their use of the opioid-acetaminophen prescription and additional prescription and over-the-counter medications as well as what information the participant recalled the prescribing physician or pharmacist provided about their prescription. The interview also included questions pertaining to basic demographic information (age, sex, race/ethnicity), socioeconomic information (education, household income), and health status (self-reported overall health, number of prescription medications, number of over-the-counter medications). Patients' literacy skills were measured using the Rapid Estimate of Adult Literacy in Medicine (REALM). The REALM is highly correlated with the Test of Functional Health Literacy in Adults and is an indicator of functional health literacy. Raw REALM scores (0–66) can be converted into reading grade levels that correlate with literacy skills. Raw scores of ≤60 indicate a reading grade level of eighth grade or below or limited literacy and scores >61 indicate at least a ninth grade reading level or adequate literacy. Subjects were compensated $50 for their time at the conclusion of their interview.

This analysis utilizes a subset of patients (mid-point of enrollment N = 149) that were part of a larger study (N ∼ 300) assessing patients' safe use of acetaminophen combination analgesic medications. The total interview lasted approximately 25 minutes (results reported separately), but the data presented herein is derived from four questions specific to counseling (two questions related to physician/nurse counseling and two related to pharmacist counseling). Experts in health literacy and safe medication use developed interview questions that would elicit free-recall of the patients experience. To assess the information patients recalled their physician or pharmacist discussing at the time of prescribing, the RA asked “Did your doctor or nurse (pharmacist) tell you about any medications that you should NOT take while taking this medicine?” Responses to this question were coded: Yes, No, “I don't know” or patient refused to answer. The RA then asked, “Please tell me everything you remember your doctor or nurse (pharmacist) telling you about this medicine.” Responses were recorded verbatim. The pair of questions was then repeated asking about pharmacist counseling, which allowed capture of counseling occurring during the medical encounter separate from counseling occurring when picking up the prescription. The interview guide did not change during the study period.

Descriptive statistics (percentage, mean and standard deviation [SD]) were calculated for demographic variables and for patient report of warnings to avoid other medications. All statistical analyses were performed using STATA software version 10.0 (StataCorp, College Station, TX, USA).

Two coders reviewed the open-ended responses and assigned them to categories. The open-ended responses were first unitized to ensure the coders would be applying the category to the same unit of speech. A list of both detailed and overarching categories was created. The coders then returned to the data independently to apply the categorization to all open-ended responses. Any discrepancy was resolved through discussion, and coders were able to reach consensus on the category in all cases.

Results

The sample is described in Table . In total, 318 patients were approached; 45 patients declined to participate and 12 were ineligible. Of the remaining 261 patients who were consented, 149 patients scheduled and completed their follow-up interview. Sixty-seven patients in the sample were from the Atlanta site and the remaining 82 patients were from the Chicago site. The mean age of participants was 43.3 years (SD = 12.37, range 18 to 72 years). Two-thirds of participants were African American (61.1%) and over half were female (58.4%). Forty percent of the sample had limited literacy skills, which correlates with reading at less than a ninth grade level according to the REALM (score ≤ 60). Participants were socioeconomically diverse by education and household income. The majority (70.5%) of participants took prescription medications on a daily basis and over half (55.7%) also used over-the-counter medications on a daily basis. In answer to the specific question regarding medications to avoid, only a quarter (24.8%) of participants were able to recall a physician or nurse counseling them about medications to avoid at the time of prescribing and even fewer (5.4%) could recall these instructions from the pharmacist.

View this table:
Table 1

Sample characteristics (N = 149)

Variable%
Age, mean (SD)42.33 (12.4)
Female58.4
Race
 African American61.1
 White29.5
 Other 9.4
Health literacy
 Limited40.5
 Adequate59.5
Education
 High school or less49.0
 Some college23.5
 College graduate27.5
Income level
 <20,00056.5
 20,000–50,00019.7
 >50,00023.8
Self-reported overall health
 Excellent 8.7
 Very good30.2
 Good39.6
 Fair17.5
 Poor 4.0
Number of daily prescriptions
 029.5
 117.5
 216.1
 310.1
 4 8.1
 5 or more 8.1
 Don't know 0.7
Number of daily over-the-counter (OTC) medications
 044.3
 132.2
 212.1
 3 or more10.7
 Don't know 0.7
  • Health literacy assessed using REALM; adequate (score > 60 correlates to approximately ninth grade reading level).

  • OTC medications for any indication, not exclusively for pain.

  • REALM = Rapid Estimate of Adult Literacy in Medicine; SD = standard deviation.

Following unitizing the open-ended responses, the 149 patients had a total of 388 unique comments regarding physician and nurse communication and 233 unique comments for pharmacist communication. These 621 comments were each assigned a single category within a framework of 20 categories. Several of the categories were related and upon completion of the coding, seven core categories emerged (encompassing 12 of the 20 total categories). Although sampling was not aimed toward saturation of the categories, saturation was reached when approximately half of the sample had been analyzed and no additional categories were created. The major categories, corresponding examples, and frequencies are found in Table . Inter-coder reliability was high with a Cohen's kappa of 0.90.

View this table:
Table 2

Categorization of open-ended responses

Category% of Patients Recalling CounselingExamples
%%%
MD/RN ONLY CounselingPharmacist ONLY CounselingBOTH MD/RN and Pharmacist Counseling
Specific categories related to content of the medication counseling discussion
Details of prescription: (e.g., active ingredient, medicines to avoid, or dosing related instructions)44.3%5.4%12.8%“Just simply that it has Tylenol in it.”
“It was ok to take with Ibuprofen.”
“Take it every four hours, or as needed.”
“Said not to take anything with Tylenol in it.”
“Take with food.”
Activities to avoid and side effects36.2%4.7%8.7%“It might make you drowsy, can't drive, no alcohol.”
“They told me … not to drive within 24 hours of taking it, and not to drink any alcohol.”
“She told me … it may make me drowsy and it's not something I want to take in the morning before going to work because it might make me a little loopy.”
Indication for medication32.9%4.0%4.0%“Only thing I remember is that it will help the pain.”
“All they said is they were going to give me something for the pain.”
“That it's really for breakthrough pain.”
Discussed addictive potential, abuse, or identified as a opioid/narcotic9.4%1.3%0%“Gave me the warning that it is highly addictive medication.”
“Don't abuse it.”
“This medicine is a narcotic.”
Broad categories related to description of the discussion
Follow the written instructions7.4%20.1%2.7%“He gave me that paper with the directions on how to take it, but he didn't explain it.”
“They just said there was paperwork explaining what to do and what not to do.”
“They gave me the piece of paper. I didn't read it.”
Solicited questions0%11.4%0%“If you have any other questions don't be bashful, call and let us know.”
“Do you have any questions?”
No communication about medication from physician or no interaction with pharmacist3.4%32.2%1.3%“They didn't really tell me much of anything.”
“My son picked it up for me, so I don't know.”
“She didn't tell me anything. Usually they did in the past, but Friday …”
  • MD/RN = physician/nurse.

The seven core categories are 1) details of the prescription; 2) activities to avoid and side effects; 3) indication for the medication; 4) addictive potential of the medication; 5) being referred to the written document; 6) having questions solicited; and 7) having no interaction relating to medication counseling.

The remaining of the 20 categories is not reported, as the individual frequencies were less than 6%. These categories include verification of existing medication, verification of allergies, discussing other therapeutic options, patient expressing concern with medication, patient citing previous experience with opioid-acetaminophen combination drugs, discussing follow-up instructions, patient lack of recall of any discussion, and general comments (lack of specificity).

For each of the seven core categories, the frequency is reported for recall of physician/nurse counseling, pharmacist counseling, and counseling by both sets of providers. For the first four categories that relate specifically to the content of the discussion, the patients recalled more physician than pharmacist counseling. Conversely, patients were more likely to describe the interaction with their pharmacists via the broad themes found in the last three categories. The specific categories patients recalled reinforced through both physician and pharmacist counseling were related to the details of administration. Of note, some categories (e.g., warning of addictive potential) were never recalled as being reinforced at two time points for the patient.

Patients reported recalling different things from the physician and nurse discussions than from the pharmacist discussion. The category patients recalled with the highest frequency for physician and nurse counseling was related to dosing the medication and active ingredients. Responses in this category differed in the amount of detail the patient recalled, ranging from specific counseling on the frequency and duration of medication use to broad statements about the general medication class. In the analysis of the pharmacist-related responses, many patients recalled being told to read the information sheet accompanying the bottle and to follow the instructions. Patients also recalled that pharmacists solicited questions (e.g., not offering counseling, but asking “Do you have any questions about the medication?”). In some cases, patients reported they had another family member pick up the prescription or the pharmacist “didn't say anything.”

Discussion

Our data show that among patients receiving new prescriptions for opioid-acetaminophen combination analgesics, the majority did not recall much about spoken counseling for the medication when interviewed only days after the prescription was filled. A universal pattern identified across all seven core categories was that even if the counseling occurred at one point of contact (physician or pharmacist), it was rarely reinforced at both points of contact. We know from cognitive factors and health literacy research that in order to maximize patients' recall of important health information, counseling with understandable and actionable content information should be provided in multiple modalities (written and spoken) and should be repeated or reinforced at different points in time [15–17]. The natural sequence of events of receiving a prescription (with physician and pharmacist separated in time and place, each with the opportunity to counsel on the same topic) represents an ideal situation for both health professionals to counsel patients about high-risk medications. However, our data show that patients do not recall any evidence of such repeated counseling occurring.

Only a third of our sample recalled counseling by a physician or nurse about medications to avoid while taking an opioid-acetaminophen prescription, and less than 5% remembered receiving this information from their pharmacist. That counseling about avoiding simultaneous use of two acetaminophen-containing products (a.k.a., “double-dipping”) is rarely occurring in this sample is in line with findings from a previous survey by Hornsby and colleagues [9]. In that study, primary care faculty and residents at three residency programs in Alabama (N = 76) were given a seven-item questionnaire assessing their knowledge of issues related to acetaminophen use and prescribing. Approximately half (53%) of the physicians surveyed said they discuss dosing and only 16% self-reported that they counsel patients about avoiding double-dipping when providing an acetaminophen-combination prescription. Our findings that when acetaminophen counseling is occurring, it is focused on medication dosing, activities to avoid, and side effects, are also concordant with the few prior studies investigating counseling about other classes of medications [18–20].

Counseling about the potential risks of addiction or abuse of the opioid-active ingredient in the opioid-acetaminophen drugs also rarely occurred among our patient sample. Only 10% of individuals recalled their providers mentioning that the medication was a narcotic or had addictive potential. No patient volunteered recall regarding safe storage or disposal of the medication. In light of the recently published data on the flood of opioids into the marketplace and the accompanying rise in mortality, the topic of opioid abuse and misuse deserves a more prominent place in patient education and counseling.

Although counseling patients on harm reduction is important, there are many potential barriers to counseling at both the patient and system level that may impact patient recall (both in the context of this study and in practice). From a systems viewpoint, time is limited, particularly in the ED; research has shown that in the ED, discharge instructions typically last only 1.5 minutes [21]. However, time is not necessarily more abundant in the outpatient setting, where demands on productivity have shortened visits and providers spend an average of only 23 seconds discussing new prescription medications with patients [19]. Patient level factors may also impact the retention of such information (e.g., information overload, psychological distress). Given these barriers, it is not surprising that recall of counseling is low. Many of the system and patient level factors are not easily modifiable; however, the futility of these circumstances should not discourage counseling, but rather encourage redesign of the factors that are controllable (e.g., reinforcing counseling at a time when psychological distress may be decreased, providing health literacy-appropriate print documents to reinforce counseling).

Omnibus Budget Reconciliation Act of 1990 requires pharmacists to counsel patients and at a minimum to “offer to discuss” the medication [22]. However, only about 1 in 10 patients recalled the pharmacist soliciting questions, or offering to discuss the medication, a percentage well below the targeted, and federally required, goals for counseling. Although the requirements vary by state and “offer to discuss” might be made by a non-pharmacist or may be in writing (on a pen-pad device), the low rates of patient recall for pharmacists' soliciting questions raise concerns that these federal guidelines are not being closely followed [22,23]. Patients (of all literacy levels) may not be aware that they are waiving their right to counseling when signing on the pen-pad.

The second most frequent categories identified from the pharmacist data was patient recall of being referred to read the written instructions. This finding is worrisome because it is well documented that patients have difficulty understanding written materials including prescription drug labels, auxiliary warnings on labels, and even the FDA-approved medication guides that accompany dispensed medications [24–26]. Leaving patients to discover the information on their own, without the help of a learned intermediary (i.e., physician or pharmacist), puts patients at potential risk for decreased comprehension and for medication misuse.

Study limitations should be noted. These data represent patient recall and not the actual counseling that occurred. Although recall might not be an accurate representation of what was said, it is an accurate representation of what was remembered and the information that the patient is acting upon. Hence, despite the use of a recall assessment, we believe that the assessment provides critical and valuable information and fills a gap in the literature. Recall bias is generally considered to increase as more time elapses from the event in question; other sources of bias can be introduced with look-back methods including selective recall. To minimize these biases, our assessment took place within 1 week of the initial visit and open-ended questions were asked to avoid influencing answers. We have ongoing research utilizing audio recordings of patient encounters to further assess actual counseling.

A further limitation is that some of the patients' recall regarding pharmacist counseling might be related to the workplace structure of current commercial pharmacies in which patients often interact with pharmacy technicians rather than pharmacists themselves. Finally, the data collection occurred at two sites and among English-speaking patients only.

Conclusions

With the high volume of opioid-acetaminophen combination products available to patients and the growing awareness of the consequences of prescription misuse through both unintentional acetaminophen double-dipping and opioid overdose, provider counseling about these medications is a potentially valuable tool to slow the tide of deaths and unintended adverse outcomes associated with misuse of this medication. Patients recall infrequent and inadequate counseling from their providers on the topics that are most important to prevent morbidity and mortality from opioid-acetaminophen combination prescriptions, namely, information on double-dipping, abuse, and overdose potential.

Footnotes

  • Disclosures: KAC, JPK, RJM, LDF, and KLJ have worked on projects funded by unrestricted research grants from McNeil Consumer Healthcare. DMM has received unrestricted grant funding from Emergency Medicine Foundation (EMF) foundation in conjunction with Purdue Pharma and has worked on projects funded by unrestricted research grants from McNeil Consumer Healthcare. TCD received unrestricted research grant funding from McNeil Consumer Healthcare and Abbott Foundation, and has served as a paid consultant to McNeil Consumer Healthcare. She owns stock in Abbott and Johnson & Johnson. SCB has worked on an unrestricted research grant funded by McNeil Consumer Healthcare and has served as a paid consultant to Abbott Laboratories. RMP has received unrestricted research grant support from McNeil Consumer Health, Johnson & Johnson, Abbott Foundation, and McKing Consulting. MSW has received unrestricted research grant funding from McNeil Consumer Healthcare and Abbott Foundation, and has served as a paid consultant to McNeil Consumer Healthcare, Abbott Laboratories, and Earthbound LLC.

  • Funding sources: This project was funded by an unrestricted research grant from McNeil Consumer Healthcare.

References

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