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Healthcare provider opinions about a generic drug educational newsletter: A pilot cross-sectional survey
Research in Social and Administrative Pharmacy xxx (xxxx) xxx–xxx
Contents lists available at ScienceDirect
Research in Social and Administrative Pharmacy journal homepage: www.elsevier.com/locate/rsap
Healthcare provider opinions about a generic drug educational newsletter: A pilot cross-sectional survey Natalie S. Hohmanna, Kimberly B. Garzab, Daniel Surryb, Richard A. Hansenb, Ilene Harrisc, Zippora Kiptanuic, Oluwamurewa Oguntimeind, Mitchell M. Frostd, Jingjing Qianb,∗ a
Department of Pharmacy Practice, Auburn University Harrison School of Pharmacy, Auburn University, 4201 Walker Building, Auburn, AL, 36849, USA Department of Health Outcomes Research and Policy, Auburn University Harrison School of Pharmacy, Auburn University, 4306 Walker Building, Auburn, AL, 36849, USA c IMPAQ International LLC, IMPAQ Int., Columbia, MD, 21044, USA d U.S. Food and Drug Administration (FDA), Office of Generic Drugs (OGD), 10903 New Hampshire Avenue Bldg. 75, Silver Spring, MD, 20993-0002, USA b
ARTICLE INFO
ABSTRACT
Keywords: Provider education Educational materials Newsletter Health communication Generic drugs Prescribers and pharmacists
Background: Increasing the prescribing and dispensing of generic drugs, compared to branded drugs, may increase patient access to affordable drug treatments. Healthcare providers have information needs regarding generic drugs, but available, tailored education materials designed for provider use are lacking. Objectives: To examine healthcare provider opinions and receptivity regarding generic drug educational materials in content, format and design, delivery channel, and level of satisfaction. Methods: A national online survey was conducted in summer 2018 to gather practicing healthcare prescribers' (i.e., physicians, nurse practitioners, physician assistants) and pharmacists’ opinions on an educational newsletter developed through a collaboration between the investigators and the U.S. Food and Drug Administration (FDA). Survey data were analyzed using descriptive statistics. Quantitative analyses were performed using SPSS version 24 (IBM, Armonk, NY), while responses to open-ended questions were assessed using qualitative content analysis in Excel. Results: A total of 208 surveys were completed. Overall, participants expressed positive opinions about the newsletter's content and format/design. About 69% of prescribers and 60% of pharmacists stated the newsletter gave information that will help them better serve patients. While 15% of surveyed pharmacists stated that they did not have resources to help them get information on generic drug availability and cost, more prescribers (37%) responded similarly. Both prescribers and pharmacists preferred to receive this newsletter via email from the FDA or a professional association. Conclusions: Findings indicate the feasibility of educational outreach programs about generic drugs targeted towards healthcare providers. There is room for improvement in making prescribers and pharmacists aware of resources for learning about generic drug availability and cost. Future studies may test alternate versions of the newsletter that have been tailored to the needs of specific provider specialties or provider practices serving specific patient sub-groups, as well as preferred dissemination frequency.
Introduction As generics are 20–90% less expensive than their reference branded drug products, generics accounted for $90.3 billion in savings to Medicare and its beneficiaries in 2018 alone, and have saved the U.S. healthcare system over $2 trillion in the past 10 years.1,2
Pharmaceutical spending in global and emerging markets is also impacted by healthcare policies and systems that affect generic drug use.3–9 Evidence shows that generic drug use in the U.S. is largely impacted by certain key groups' (such as prescribers and pharmacists) behaviors and perceptions towards generic drugs.10 While believed to be influential, the extent of prescribers' and pharmacists' influence is
∗ Corresponding author. Auburn University Harrison School of Pharmacy, Department of Health Outcomes Research and Policy, 4306D Walker Building; Auburn, AL, 36849, USA E-mail addresses: [email protected] (N.S. Hohmann), [email protected] (K.B. Garza), [email protected] (D. Surry), [email protected] (R.A. Hansen), [email protected] (I. Harris), [email protected] (Z. Kiptanui), [email protected] (O. Oguntimein), [email protected] (M.M. Frost), [email protected] (J. Qian).
https://doi.org/10.1016/j.sapharm.2019.12.001 Received 23 April 2019; Received in revised form 5 October 2019; Accepted 1 December 2019 1551-7411/ © 2019 Elsevier Inc. All rights reserved.
Please cite this article as: Natalie S. Hohmann, et al., Research in Social and Administrative Pharmacy, https://doi.org/10.1016/j.sapharm.2019.12.001
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heterogeneous and dependent on factors such as experiences and perceptions with generic drugs and practice characteristics.10 For example, Segal et al. showed that patients filling prescriptions for certain drug classes at mail order pharmacies in the U.S. had significantly lower rates of generic drug substitution compared to those filling prescriptions at retail pharmacies.11 Further, misinformation about generic drugs among healthcare providers may be one barrier to patients' and caregivers’ generic drug use.12,13 In a systematic literature review, Colgan et al. found that a high proportion of physicians and pharmacists had negative perceptions of generic drugs in terms of effectiveness, quality, side effects, and safety.12 These negative perceptions may potentially influence prescription and dispensing of generic drugs. Many interventions targeted to healthcare providers have been shown to improve prescribing patterns, healthcare utilization, and/or economic outcomes, including educational outreach visits (academic detailing) to physicians,14 audit and feedback on prescribing patterns,15 and mailed information to physicians and pharmacists.16 However, such interventions are not always translated into clinical practice when it comes to generic drugs. For example, Slota et al. found that in a 2017 observational study of communication interactions between physicians and patients with glaucoma, only 41 (15%) of the patients discussed generic drug substitution options with their physician.17 This may indicate that providers lack point-of-care resources to learn about generic drug availability and cost, as well as tools and educational materials to facilitate conversations about generic drugs with patients. Patients who report talking to their healthcare providers about generic substitution are more likely to fill generic medications than those who do not have a discussion with their providers.18 Thus, developing accessible and engaging generic drug educational materials and resources for providers to utilize at the point-of-care may help to improve generic drug utilization. The U.S. Food and Drug Administration (FDA) offers a range of patient educational materials about generic drugs, including videos, graphics, fact sheets, and related resources available in both English and Spanish versions.19 These educational materials are targeted to patients and caregivers. However, generic drug educational materials targeted to healthcare providers such as prescribers and pharmacists are very limited, and the optimal content, format and design, and delivery channel of the educational materials are unclear. To address this information gap, one generic drug educational newsletter was developed through a collaborative effort between the investigators and the U.S. FDA to help provide prescribers and pharmacists with an educational resource related to generic drugs. This study reports the results of a survey conducted with U.S. prescribers and pharmacists to gauge their opinions about the developed newsletter in terms of content, format and design, delivery channel, and overall satisfaction. Since a single newsletter was developed in this preliminary study to target prescribers and pharmacists across specialties and practice sites, the survey collected feedback to ensure the newsletter adequately accounted for variations in target audience and provider specialty. Findings may be used to help develop generic drug communication messages and campaigns targeted to healthcare providers in order to improve their access to information about generic drugs and their engagement with this information, as well as increase generic drug utilization.
Sampling and recruitment Survey recruitment and participation took place in May–July 2018. Participants were recruited on a national level using a multi-modal recruitment strategy. Participants were: 1) prescribers who were clients of the University of Alabama at Birmingham (UAB) School of Medicine's continuing medical education (CME) program20 or prescribers within the CareHere LLC medical network21; and 2) pharmacists who were clients of Auburn University's continuing pharmacy education (CPE) program.22 Clients of UAB's CME program include physicians, nurse practitioners, and physician assistants throughout the U.S.; UAB's CME email list-serve contained contact information for approximately 1100 prescribers at the time of this study. CareHere LLC is a case management and health services firm that partners with employers to provide primary care, preventative care, and occupational health services to over 350,000 members and 200 wellness centers nationwide. CareHere LLC's network-provider email list-serve contained contact information for 150 prescribers at the time of this study. Clients of Auburn University's CPE program include pharmacists and pharmacy technicians throughout the U.S.; the CPE email list-serve included contact information for approximately 8743 pharmacists at the time of this study. Prescribers were eligible to participate if they: 1) were at least 19 years old; 2) were physicians, nurse practitioners, or physician assistants with U.S. prescribing authority; 3) actively participated in patient care at least 2 days per week; and 4) were able to read/write in the English language. Pharmacists were eligible to participate if they: 1) were at least 19 years old; 2) were licensed to practice pharmacy in the U.S.; 3) actively participated in patient care at least 2 days per week; and 4) were able to read/write in the English language. All 1250 prescribers in the UAB CME program and CareHere LLC provider network list-serves, as well as a random sample of 1500 pharmacists in the Auburn University CPE list-serve were sent a targeted and personalized recruitment email. Recruitment messages contained a link to the study information letter hosted on the Qualtrics survey platform (Qualtrics, Provo, UT, copyright version 2018), and participants who agreed to continue with the study were directed to the online survey. To increase response rate, survey invitations were sent from directors of the UAB CME program and CareHere LLC provider network. Similarly, survey invitations for pharmacist-clients of Auburn University's CPE program were sent directly from the investigators, who are affiliated with Auburn University. Response rate was also increased by sending an email reminder every 7–10 days (up to two reminders), for a maximum of three recruitment attempts per provider. A monetary incentive of $50 was provided to each participant who completed a survey. Recruitment continued until a quota of at least 100 completed surveys was received for each group (prescribers and pharmacists). Fig. 2 shows the recruitment process. Educational material development and pre-testing The newsletter was developed by the investigators through a fourstep process of qualitative feedback in interviews and focus groups with prescribers and pharmacists, followed by refinement of preliminary material in a collaborative development process between Auburn University investigators, IMPAQ International, the U.S. FDA, and graphic design experts in Auburn University's Office of Communications and Marketing. Steps in this development process are detailed below.
Methods
Step 1 – Needs investigation. Preliminary material was developed based on key informant interview findings (n = 24; n = 12 for prescribers and n = 12 for pharmacists). Key informants provided information about prescribers' and pharmacists' needs regarding generic drug educational materials targeted to healthcare providers.23 Needs were focused on material content and format. Based on findings from the needs investigation, a preliminary newsletter was developed by the investigators using a rapid development
Study design An online survey was conducted with prescribers and pharmacists. This study was approved by the Institutional Review Board (IRB) of the authors’ institution and the U.S. FDA Research Involving Human Subjects Committee (RIHSC). A broad overview of the study design is shown in Fig. 1. 2
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Fig. 1. Study design.
newsletter was accessed and downloaded by participants through an embedded pdf attachment in the online survey, and presented in the form of a two-page, 8x11 color newsletter titled, “Update from the FDA: Do you want to know how generic drugs can lower healthcare costs?” See the online supplemental material for the newsletter. Survey instrument development and process fidelity Survey questions were developed based on the four categories of interest for the educational material: content, format and design, delivery channel, and overall level of satisfaction. The preliminary survey instrument was finalized via discussion and consensus among the investigators (n = 5). The electronic survey was then pre-tested for content and face validity among a group of healthcare providers and researchers at Auburn University (n = 15) and results were used to modify survey wording and length. The final survey instrument included 3 eligibility questions, 2 attention filters to remove respondents who may not have fully read or engaged with the newsletter and/or survey, and 54 questions divided into 6 topic domains (Table 1). Wording of some questions differed between groups (prescribers and pharmacists). See the online supplemental material for both versions of the survey instrument.
Fig. 2. Recruitment process.
process. Step 2 – Preliminary testing. The preliminary newsletter was tested through a provider focus group (n = 5 prescribers and pharmacists). Preliminary testing was focused on material content, format and design, preferred delivery channel, and overall level of satisfaction. Testing was performed using printed 8x11 color copies of the preliminary newsletter and a condensed electronic, narrowscreen version of the newsletter projected onto a monitor. Step 3 – Material revision. The preliminary newsletter was revised according to focus group findings. Revisions were made by investigators with input from graphic design experts in Auburn University's Office of Communications and Marketing. Step 4 – Approval and testing. The prototype newsletter was approved by the FDA for quantitative testing in a larger audience of prescribers and pharmacists.
Data collection and analysis A total of 314 survey responses were received out of 2750 survey invitations sent, for an overall response rate of 11%. Of these, 106 surveys were ineligible or incomplete and were not included in analyses (65 respondents were ineligible; 37 respondents abandoned the survey for unknown reasons; 4 respondents incorrectly answered two attention filter questions). Overall, 208 eligible surveys were complete and usable (104 per group), for a usable response rate of 8%. Recruitment was
The educational newsletter was shown to each participant. The 3
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Table 1 Survey instrument description. Domains
Operationalization
Eligibility screening Attention filters Usual practices regarding generic drugs
1. Three multiple choice items. 1. Two multiple choice items. 1. Usual prescribing practices in regards to generic vs. branded drugs, via one 5-point Likert-type item. 2. Access and preferences for resources about generic drug availability and cost, via one 5-point Likerttype item and one multiple-response item. 1. Eleven 5-point Likert-type items addressing different elements of safety, effectiveness, cost, and novelty. 2. One 5-point Likert-type item addressing overall satisfaction with the newsletter's content. 3. One free-response item. 1. Seven 5-point Likert-type items addressing different elements of readability, visual appeal, and layout. 2. One 5-point Likert-type item addressing overall satisfaction with the newsletter's format and design. 3. One free-response item. 1. Two multiple-choice items. 2. One free-response item. 1. Five 5-point Likert-type items. 2. Three free-response items. 1. Eighteen multiple choice, multiple response, or numeric-entry items.
Opinions on the newsletter's content in terms of generic drug safety, effectiveness, and cost Opinions on the newsletter's format and design
Opinions on preferred delivery sources and delivery methods for the newsletter Overall satisfaction with the newsletter Demographics and practice characteristics
capped after a minimum of 200 usable surveys were received (an a priori cap of approximately 100 usable responses per group) for project and budget feasibility in this preliminary study. The survey took an average of 18 min for prescribers and 20 min for pharmacists to complete. When recruitment was complete, survey data were downloaded from the Qualtrics server (Qualtrics, Provo, UT, copyright version 2018) for data management and analysis. Data were analyzed using descriptive statistics, including frequencies, percentages, means, and standard deviations. Quantitative descriptive analyses were performed using SPSS version 24 (IBM, Armonk, NY). Responses to open-ended questions were assessed using qualitative content analysis in Excel. One investigator (NH) reviewed the responses to open-ended survey questions before coding these responses with an open coding approach. For each code, frequency counts were used to quantify the number of participants who mentioned a topic that aligned with the code. These frequency counts were reviewed for accuracy by a second investigator (JQ). A non-response bias investigation was performed by comparing responses of the first 25% (early responders) to the last 25% (late responders) to complete the survey.24 Characteristics and responses were similar between early and late responders in both the prescriber and pharmacist groups.
strongly disagreed that they had resources to help them get information on generic drug availability and cost, a relatively larger percentage of surveyed prescribers (37%) were neutral, disagreed, or strongly disagreed with this statement. Among those providers who did agree or strongly agree that they had resources to help them get information on generic drug availability and cost, most prescribers (82%) and pharmacists (61%) reported using a mix of resources for accessing this information, with Epocrates® (65%), UpToDate® (62%), and GoodRx.com (58%) being the most popular stand-alone drug information resources among surveyed prescribers who reported access to resources, and LexiComp® (40%) and Clinical Pharmacology Online® (28%) being the most popular stand-alone resources among surveyed pharmacists who reported access to resources. Among these surveyed pharmacists who reported having access to resources on generic drug availability and cost, 39% also reported via text entry that they used wholesaler tools and software (such as the wholesalers McKesson or Cardinal), and pharmacy dispensing software to access this information (Table 4). Participants' opinions regarding the newsletter's content, format and design, delivery channel, and overall level of satisfaction Participants expressed positive opinions about the newsletter's content (Table 5). The majority of prescribers and pharmacists agreed or strongly agreed that the newsletter gave adequate information about generic drug safety (80% and 77%), efficacy (83% and 82%), and resources about generic drug availability (79% and 80%). A majority also agreed or strongly agreed that the newsletter gave unbiased information (79% and 90%), gave interesting information (77% and 72%), and gave information they agree with (88% and 92%). Although still a majority, a relatively smaller percentage of participants agreed or strongly agreed that the newsletter gave adequate information on cost (71% and 67%) and FDA approval processes for generic drugs (65% and 66%). Similarly, 65% of prescribers and 66% of pharmacists agreed or strongly agreed that the newsletter gave just the right amount of information. While 56% and 66% of prescribers and pharmacists, respectively, were neutral, disagreed, or strongly disagreed that the newsletter provided information that was new to them, 69% of prescribers and 60% of pharmacists agreed or strongly agreed that the newsletter gave information that will help them better serve patients. Of note, more pharmacists compared to prescribers thought the newsletter gave unbiased information, but fewer pharmacists compared to prescribers thought the newsletter gave information that was new to them or that would help them better serve patients. Participants also expressed positive opinions about the newsletter's format and design (Table 5). The majority of prescribers and
Results Tables 2 and 3 show prescriber and pharmacist characteristics, respectively. The largest portion of prescribers and pharmacists were White (84% and 89%), female (63% and 61%), and self-reported nonHispanic or Latino(a) ethnicity (96% and 98%), with a mean age of 47 and 45 years, respectively. The largest portion of prescribers selfidentified as family medicine practitioners (44%), while the largest portion of pharmacists self-identified as community practice pharmacists (57%) or hospital pharmacists (21%). Also, the largest portion of both prescribers and pharmacists practiced in suburban (39% and 41%) or urban (36% and 33%) areas and were located in the Southeastern region of the U.S. (64% and 91%). Participants’ usual practices regarding generic drugs Most prescribers (90%) and pharmacists (91%) agreed or strongly agreed that they preferred to recommend generic drugs to patients instead of branded drugs. However, some prescribers (10%) and pharmacists (9%) were neutral, disagreed, or strongly disagreed with this statement. While 15% of surveyed pharmacists were neutral, disagreed, or 4
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Table 2 Prescriber characteristics (n = 104).
Table 3 Pharmacist characteristics (n = 104).
Characteristics
Statistics n (%)
Characteristics
Statistics n (%)
Mean Age (years) Sex Female Race White Black or African-American Asian Two or more races Ethnicity Hispanic or Latino(a) Not Hispanic/Latino(a) Primary practice setting Solo private practice Single-specialty group or partnership Multi-specialty group or partnership Hospital outpatient Hospital emergency department Multi-hospital system Urgent care center Academic medical center Federally Qualified Health Center Other Practice community Rural Suburban Urban Specialty Family medicine Internal medicine Psychiatry Cardiology Endocrinology Pulmonology Other More than one specialty Medical degree MD DO PA CNP or other advanced nursing degree Other Board certified Average number of patients seen per week Average number of years in practice Practice size Solo Small (2–10 physicians) Medium (11–50 physicians) Large (51 or more physicians) Geographic areaa West Midwest Southwest Southeast Northeast
46.9 (range 28–73, SD 10.62)
Mean Age (years)
65 (62.5%)
Sex Female Race White Black or African-American Asian Two or more races Ethnicity Hispanic or Latino(a) Not Hispanic/Latino(a) Primary practice setting Community pharmacy Hospital pharmacy Long-term care facility Ambulatory care clinic Academic pharmacy Consulting Other Practice community Rural Suburban Urban Specialtya Ambulatory care Critical care Geriatric pharmacy Managed care Oncology Pediatric pharmacy Pharmacotherapy Regulatory affairs/research/admin. Other More than one specialty Pharmacy degree PharmD BPharm Board certified Average number of prescriptions filled per weekb
44.7 (range 27–86, SD 12.19)
a
87 (83.7%) 6 (5.8%) 8 (7.7%) 3 (2.9%) 4 (3.8%) 100 (96.2%) 16 (15.4%) 28 (26.9%) 10 (9.6%) 1 (1.0%) 2 (1.9%) 1 (1.0%) 3 (2.9%) 14 (13.5%) 4 (3.8%) 25 (24.0%) 27 (26.0%) 40 (38.5%) 37 (35.6%) 46 (44.2%) 11 (10.6%) 1 (1.0%) 2 (2.0%) 1 (1.0%) 1 (1.0%) 13 (12.5%) 30 (28.8%) 40 (38.5%) 7 (6.7%) 19 (18.3%) 37 (35.6%) 1 (1.0%) 87 (83.7%) 73.4 (range 15–600, SD 61.78) 16.2 (range 1–45, SD 10.76) 17 55 15 17
Average number of years in practice Job Role Staff pharmacist Pharmacy manager Administration Consultant Other Geographic areac West Midwest Southwest Southeast Northeast
(16.3%) (52.9%) (14.4%) (16.3%)
12 (12.0%) 8 (8.0%) 5 (5.0%) 64 (64.0%) 11 (11.0%)
63 (60.6%) 93 (89.4%) 2 (1.9%) 7 (6.7%) 2 (1.9%) 2 (1.9%) 102 (98.1%) 59 (56.7%) 22 (21.2%) 5 (4.8%) 4 (3.8%) 2 (1.9%) 1 (1.0%) 11 (10.6%) 27 (26.0%) 43 (41.3%) 34 (32.7%) 16 (15.4%) 3 (2.9%) 4 (3.8%) 1 (1.0%) 1 (1.0%) 2 (1.9%) 2 (1.9%) 1 (1.0%) 50 (48.1%) 24 (23.1%) 58 (55.8%) 46 (44.2%) 29 (27.9%) 1192 (range 5–7000, SD 1095) 19.4 (range 2–60, SD 13.17) 52 (50.0%) 31 (29.8%) 3 (2.9%) 2 (1.9%) 16 (15.4%) 2 (2.0%) 2 (2.0%) 1 (1.0%) 93 (91.2%) 4 (3.9%)
a Among those self-identifying as “other” pharmacy specialists, 36 indicated (via text entry) that they were community practice specialists. b Not all pharmacists reported working in a dispensing role: average number of prescriptions filled per week n = 82. c There was some missing data: Geographic area n = 102.
There was some missing data: Geographic area n = 100.
pharmacists agreed or strongly agreed that the newsletter was easy to read and understand (89% and 89%), visually appealing (77% and 90%), well organized (89% and 89%), just the right length (77% and 81%), had a large enough font size (79% and 88%), loaded easily on their device (93% and 97%), and was presented in a convenient format (84% and 90%). Of note, more pharmacists compared to prescribers thought the newsletter was visually appealing and had a large enough font size. For both prescribers and pharmacists, the preferred source for the newsletter was the FDA (63% and 65%), followed by a professional association (27% and 24%). A newsletter provided by an employer was also preferred by some participants across both prescriber and pharmacist groups (1.9% and 6.7%). Surveyed prescribers and pharmacists most preferred to receive the newsletter from these sources via email
(64% and 66%). For prescribers, the second-most preferred delivery method was via postal mail (13%), followed by an online website (12%) or a mobile app (11%). Pharmacists reported a different preference order for these alternative delivery methods: their second-most preferred delivery method was an online website (14%), followed by postal mail (11%) or a mobile app (8%). Overall, while 88% of prescribers were satisfied or very satisfied with the newsletter's content, a relatively smaller percentage of pharmacists (71%) reported the same level of satisfaction with the newsletter's content (Table 5). Conversely, while 77% of surveyed prescribers were satisfied or very satisfied with the newsletter's format and 5
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thought that more specific examples were needed (such as thyroid medications, warfarin, or other narrow therapeutic index drugs); 5% would like more resources or URL links; and 3% would like to see information about how to deal with insurance formulary restrictions on dispensing branded vs. generic medications. In these free-response questions, 28% of prescribers mentioned they liked the format/design, including the graphics, charts, and call-out boxes, as well as the electronic delivery; 26% liked the concise nature of the newsletter; 14% stated the newsletter had good content, specifically information on bioequivalence, safety and efficacy, and differences between generic vs. branded medications; 9% appreciated the cost facts and pricing resources; and 9% could see themselves using this newsletter with patients as an educational resource. On the other hand, 15% of prescribers stated the newsletter was too busy or they generally disliked the format/design; and 14% thought the newsletter needed more detail, such as information about patent-protection of branded drugs, specific drug class examples, and anticipated timing of market entry for actual generic drugs in the pipeline. Further, 9% stated the newsletter contained information they already knew, and 4% stated that more resources and URL links were needed. Overall, these qualitative findings are consistent with the quantitative survey results. The rich information gained through these qualitative findings provides insight into both pharmacist and prescriber opinions and receptivity regarding generic drug educational materials, and highlights specific content and format/design elements that may be revised in future iterations of this newsletter. This may help to optimally engage providers and improve their timely access to the generic drug information and resources that they find most useful for personal education and interactive patient-provider discussions.
Table 4 Usual resources for generic drug availability and cost information among providers who reported access to resources (n = 154)a. Resource
Prescribers (n = 66) n (%) b
Pharmacists (n = 88) n (%) b
FDA Orange Book GoodRx.com Epocrates® Micromedex® Clinical Pharmacology Online® LexiComp® UpToDate® Other c
4 (6.1%) 38 (57.6%) 43 (65.2%) 7 (10.6%) 4 (6.1%)
17 (19.3%) 21 (23.9%) 3 (3.4%) 18 (20.5%) 25 (28.4%)
4 (6.1%) 41 (62.1%) 17 (25.8%)d
35 (39.8%) 8 (9.1%) 42 (47.7%)e
a Only 66 out of 104 prescribers (63%) and 88 out of 104 pharmacists (85%) agreed or strongly agreed that they had resources to help them find information on generic drug availability and cost. b Percentages do not add to 100 because participants marked all resources that applied. c Participants who responded “Other” were prompted to enter a free-text response. d Among surveyed prescribers who reported access to resources (n = 66), 8 (12.1%) reported via text entry that they looked up this information on community pharmacy websites or spoke directly with a pharmacist to access information about generic drug availability and cost, 2 (3.0%) used an electronic medical record (EMR) to find this information, 2 (3.0%) used Medscape, 2 (3.0%) used Monthly Prescribing Reference (MPR), 1 (1.5%) used Drugs.com, 1 (1.5%) reported looking up this information on the internet in general, 1 (1.5%) described receiving drug samples as a resource on generic drug information, and 1 (1.5%) looked at manufacturers' websites to find this information. e Among surveyed pharmacists who reported access to resources (n = 88), 34 (38.6%) reported via text entry that they used drug wholesaler resources/ software (such as websites or ordering portals) or internal pharmacy dispensing software to access information about generic drug availability and cost, 3 (3.4%) used Facts and Comparisons®, 2 (2.3%) reported calling other pharmacies to ask this information, 1 (1.1%) used Medscape, 1 (1.1%) used Drugs. com, 1 (1.1%) used Drug Topics®, 1 (1.1%) used Pharmacists Letter®, 1 (1.1%) used the FDA.gov website, 1 (1.1%) reported using Google in general, and 1 (1.1%) asked the inventory staff at the hospital where he/she worked to find this information.
Discussion A national online survey was conducted to gather healthcare providers' input on the optimal content, format and design, delivery channel, and level of satisfaction for an educational newsletter about generic drugs, targeted to the information needs of prescribers (physicians, nurse practitioners, and physician assistants) and pharmacists. Overall, participants expressed positive opinions about the newsletter's content and format/design. About 69% of prescribers and 60% of pharmacists stated the newsletter gave information that will help them better serve patients. While 15% of surveyed pharmacists stated they did not have resources to help them get information on generic drug availability and cost, more prescribers (37%) responded similarly. Surveyed prescribers and pharmacists most preferred to receive this newsletter via email from the FDA or professional associations. The finding that relatively fewer prescribers, compared to pharmacists, reported having resources to help them get information on generic drug availability and cost is not surprising considering pharmacists may be more likely to have access to prescription drug wholesaler and dispensing software. This finding is also consistent with previous literature showing that some providers lack confidence in the reliability of generic drug information.25 It was interesting that Epocrates®, UpToDate®, and GoodRx.com were the most popular standalone drug information resources among surveyed prescribers who reported access to resources, and LexiComp® and Clinical Pharmacology Online® were the most popular resources among surveyed pharmacists who reported access to resources. Further, 39% of these surveyed pharmacists who reported access to resources stated via text entry that they used other tools such as wholesaler software and pharmacy dispensing software to access information on generic drug availability and cost, while 12% of prescribers who reported access to resources stated via text entry that they asked pharmacist colleagues to share information on generic drug availability and cost or looked for this information on community pharmacy websites. This may reflect differences in drug information resources available to pharmacists and prescribers at the point-of-care, as well as differences in resources introduced to different
design, 85% of pharmacists expressed the same level of satisfaction with the newsletter's format and design. The majority of prescribers and pharmacists agreed or strongly agreed that they were satisfied with the quality of the newsletter (86% and 87%), the newsletter held their interest (75% and 81%), the newsletter had information that providers needed to know (86% and 88%), they could see themselves using the newsletter in practice if they had questions about brand and generic drugs (74% and 74%), and they would recommend the newsletter to other providers (69% and 78%). Of note, fewer of the surveyed prescribers, compared to pharmacists, reported the newsletter held their interest or that they would recommend the newsletter to other providers. Qualitative findings In a free-response question asking what participants liked most and least about the newsletter, 40% of pharmacists mentioned they liked the concise nature of the newsletter; and 28% liked the format/design, including the graphics, bolding, layout, and highlighted call-out boxes summarizing key points. Further, 21% of pharmacists mentioned they liked the content presented, including cost facts, bioequivalence information, how generics are rated (such as AB equivalency ratings), and what makes generics equivalent to branded drugs; 14% appreciated the cost and pricing resources; and 9% could see themselves using this newsletter with patients as an educational resource. On the other hand, 22% of pharmacists mentioned the newsletter contained information they already knew or that was too basic for pharmacists. Similarly, 7% 6
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Table 5 Participants' opinions on the newsletter's content, format and design, and level of satisfaction (n = 208). Content Questions
Provider Type
Strongly Disagree (1) n (%)
Disagree (2) n (%)
Neither Agree nor Disagree (3) n (%)
Agree (4) n (%)
Strongly Agree (5) n (%)
The newsletter gave adequate information about generic drug safety The newsletter gave adequate information about generic drug efficacy The newsletter gave adequate information about FDA approval processes for generic drugs The newsletter gave adequate information about generic drug cost The newsletter gave useful information on resources for generic drug availability The newsletter gave just the right amount of information about generic drugs The newsletter gave unbiased information
Prescribers Pharmacists Prescribers Pharmacists Prescribers Pharmacists Prescribers Pharmacists Prescribers Pharmacists Prescribers Pharmacists Prescribers Pharmacists Prescribers Pharmacists Prescribers Pharmacists Prescribers Pharmacists Prescribers Pharmacists
1 0 2 0 2 1 3 0 1 0 1 1 1 0 0 1 5 6 4 1 0 0
5 (4.8%) 7 (6.7%) 3 (2.9%) 5 (4.8%) 15 (14.4%) 11 (10.6%) 7 (6.7%) 12 (11.5%) 6 (5.8%) 7 (6.7%) 4 (3.8%) 10 (9.6%) 3 (2.9%) 1 (1.0%) 3 (2.9%) 6 (5.8%) 28 (26.9%) 39 (37.5%) 4 (3.8%) 14 (13.5%) 0 0
15 (14.4%) 17 (16.3%) 13 (12.5%) 14 (13.5%) 19 (18.3%) 23 (22.1%) 20 (19.2%) 22 (21.2%) 15 (14.4%) 14 (13.5%) 31 (29.8%) 24 (23.1%) 18 (17.3%) 9 (8.7%) 21 (20.2%) 22 (21.2%) 25 (24.0%) 24 (23.1%) 24 (23.1%) 27 (26.0%) 12 (11.5%) 8 (7.7%)
57 59 55 56 46 51 51 51 54 58 51 56 43 60 53 54 35 27 54 43 54 57
26 (25.0%) 21 (20.2%) 31 (29.8%) 29 (27.9%) 22 (21.2%) 18 (17.3%) 23 (22.1%) 19 (18.3%) 28 (26.9%) 25 (24.0%) 17 (16.3%) 13 (12.5%) 39 (37.5%) 34 (32.7%) 27 (26.0%) 21 (20.2%) 11 (10.6%) 8 (7.7%) 18 (17.3%) 19 (18.3%) 38 (36.5%) 39 (37.5%)
Format and Design Questions
Provider Type
Strongly Disagree (1) n (%)
Disagree (2) n (%)
Neither Agree nor Disagree (3) n (%)
Agree (4) n (%)
Strongly Agree (5) n (%)
The newsletter was easy to read and understand
Prescribers Pharmacists Prescribers Pharmacists Prescribers Pharmacists Prescribers Pharmacists Prescribers Pharmacists Prescribers Pharmacists Prescribers Pharmacists
1 1 0 1 0 1 0 1 1 0 1 1 1 1
2 (1.9%) 5 (4.8%) 7 (6.7%) 3 (2.9%) 4 (3.8%) 2 (1.9%) 14 (13.5%) 7 (6.7%) 13 (12.5%) 5 (4.8%) 1 (1.0%) 1 (1.0%) 6 (5.8%) 2 (1.9%)
8 (7.7%) 5 (4.8%) 17 (16.3%) 6 (5.8%) 7 (6.7%) 9 (8.7%) 10 (9.6%) 12 (11.5%) 8 (7.7%) 8 (7.7%) 5 (4.8%) 1 (1.0%) 10 (9.6%) 7 (6.7%)
56 41 46 40 55 45 41 43 51 50 41 36 42 43
37 52 34 54 38 47 39 41 31 41 56 65 45 51
Overall Satisfaction Questions
Provider Type
Not at all Satisfied (1) n (%)
Slightly Satisfied (2) n (%)
Fairly Satisfied (3) n (%)
Satisfied (4) n (%)
Very Satisfied (5) n (%)
Overall satisfaction with content
Prescribers Pharmacists Prescribers Pharmacists
0 3 (2.9%) 1 (1.0%) 1 (1.0%)
0 7 (6.7%) 3 (2.9%) 2 (1.9%)
12 20 20 13
54 56 39 37
38 18 41 51
Level of Satisfaction Questions
Provider Type
Strongly Disagree (1) n (%)
Disagree (2) n (%)
Neither Agree nor Disagree (3) n (%)
Agree (4) n (%)
Strongly Agree (5) n (%)
I am satisfied with the quality of the newsletter
Prescribers Pharmacists Prescribers Pharmacists Prescribers Pharmacists Prescribers Pharmacists Prescribers Pharmacists
0 2 0 1 1 1 2 1 2 1
2 (1.9%) 2 (1.9%) 7 (6.7%) 5 (4.8%) 2 (1.9%) 4 (3.8%) 9 (8.7%) 6 (5.8%) 13 (12.5%) 8 (7.7%)
13 (12.5%) 10 (9.6%) 19 (18.3%) 14 (13.5%) 12 (11.5%) 7 (6.7%) 16 (15.4%) 20 (19.2%) 17 (16.3%) 14 (13.5%)
54 50 46 42 50 51 47 46 43 44
35 40 32 42 39 41 30 31 29 37
The newsletter gave information that was interesting to me The newsletter gave information that was new to me The newsletter gave information that will help me better serve patients The newsletter gave information that I agree with
The newsletter was visually appealing The newsletter was well organized The newsletter was just the right length The newsletter had a good font size The newsletter loaded easily on my computer or phone The newsletter was convenient for me
Overall satisfaction with format and design
The newsletter was interesting to read The newsletter has information that prescribers/ pharmacists need to know I would use this newsletter in practice if I had questions about brand and generic drugs I would recommend this newsletter to other prescribers/pharmacists
(1.0%) (1.9%) (1.9%) (1.0%) (2.9%) (1.0%) (1.0%) (1.0%) (1.0%) (1.0%) (4.8%) (5.8%) (3.8%) (1.0%)
(1.0%) (1.0%) (1.0%) (1.0%) (1.0%) (1.0%) (1.0%) (1.0%) (1.0%) (1.0%)
(1.9%) (1.0%) (1.0%) (1.0%) (1.9%) (1.0%) (1.9%) (1.0%)
provider types during training. Future studies may expand on these findings by investigating differences in technology and point-of-care resources available to pharmacists and prescribers, and how pharmacists and prescribers interact and collaborate to share information related to generic drug availability and cost. To improve access to generic drug availability and cost resources, surveyed prescribers and pharmacists suggested the current newsletter could serve as a source of practical generic drug information that
(11.5%) (19.2%) (19.2%) (12.5%)
(54.8%) (56.7%) (52.9%) (53.8%) (44.2%) (49.0%) (49.0%) (49.0%) (51.9%) (55.8%) (49.0%) (53.8%) (41.3%) (57.7%) (51.0%) (51.9%) (33.7%) (26.0%) (51.9%) (41.3%) (51.9%) (54.8%)
(53.8%) (39.4%) (44.2%) (38.5%) (52.9%) (43.3%) (39.4%) (41.3%) (49.0%) (48.1%) (39.4%) (34.6%) (40.4%) (41.3%)
(51.9%) (53.8%) (37.5%) (35.6%)
(51.9%) (48.1%) (44.2%) (40.4%) (48.1%) (49.0%) (45.2%) (44.2%) (41.3%) (42.3%)
(35.6%) (50.0%) (32.7%) (51.9%) (36.5%) (45.2%) (37.5%) (39.4%) (29.8%) (39.4%) (53.8%) (62.5%) (43.3%) (49.0%)
(36.5%) (17.3%) (39.4%) (49.0%)
(33.7%) (38.5%) (30.8%) (40.4%) (37.5%) (39.4%) (28.8%) (29.8%) (27.9%) (35.6%)
providers could apply in real-life practice settings. Providers suggested the newsletter could be shortened, while simultaneously adding more detailed examples of specific drugs or drug classes, as well as anticipated market availability timelines for actual generic drugs entering the market. This may be accomplished by disseminating mini-newsletters or news blasts to providers on a more frequent basis, in both print and electronic form. Sending providers brief emails with generic drug availability updates may also help to disseminate information on 7
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generic drugs in a timely manner. Newsletters may also be tailored to fit the drug information needs of particular provider specialties, which may improve relevancy of the newsletter for different types of providers. Tailoring the format, design, and delivery method of generic drug educational materials to individual provider preferences may also help to improve providers’ access to and engagement with generic drug availability and cost information. Both prescribers and pharmacists expressed they would like to use this newsletter as a tool to discuss generic drug alternatives with patients and caregivers. Indeed, effective communication between patients and healthcare providers regarding generic drugs and generic substitution may play a critical role in reducing prescription spending and optimizing patient outcomes. Patients who report talking to their healthcare providers about generic drug substitution are more likely to fill generic medications than those who do not have a discussion with providers.18,26 Future expansions of this study may investigate the optimal content and format/design of shared decision-making tools for providers and patients/caregivers to use together when making joint decisions about generic drug substitution, across different types of provider specialties and patient populations. Also, it is important to note that some survey participants reported that they perceived the newsletter to be biased. One potential reason for this may be that the newsletter did not directly discuss narrow therapeutic index (NTI) drugs and does not account for patient-specific circumstances or insurance formulary or generic drug substitution restrictions that may influence whether a branded or generic medication is prescribed and dispensed to a patient. Future studies may investigate how to optimally incorporate this information into generic drug educational materials for providers.
Conclusion Findings indicate the feasibility of educational outreach programs about generic drugs targeted towards healthcare providers. Prescribers and pharmacists had an overall positive opinion of the newsletter's content and format/design. There is room for improvement in making prescribers and pharmacists aware of resources for learning about generic drug availability and cost. Future studies may test alternate versions of the newsletter that have been tailored to the needs of specific provider specialties or provider practices serving specific patient sub-groups, as well as preferred dissemination frequency. Implications for policy and practice Educational outreach programs about generic drugs can improve healthcare providers’ informational needs about generic drugs and further improve generic drug prescribing and dispensing. The survey methodology allows for scalable data for future development and dissemination of educational materials targeted to healthcare providers across a variety of health topics. Declaration of competing interest 1. Funding for this manuscript was made possible, in part, by the U.S. Food and Drug Administration (FDA) grant #U01FD005486. Views expressed in written materials or publications and by speakers and moderators do not necessarily reflect the official policies of the Department of Health and Human Services; nor does any mention of trade names, commercial practices, or organization imply endorsement by the United States Government. 2. In the past 3 years, an author has provided expert testimony for Daiichi Sankyo and Takeda. Two authors were employed with the U.S. FDA, Office of Generic Drugs. No other authors declare a potential conflict of interest. 3. All authors meet the criteria for authorship outlined by the Uniform Requirements for Manuscripts Submitted to Biomedical Journals. 4. The authors had access to all the study data, take responsibility for the accuracy of the analysis, and had authority over manuscript preparation and the decision to submit the manuscript for publication. The funder provided basic proof-reading suggestions for the manuscript. 5. All authors approve the manuscript and agree to adhere to all terms outlined in the Research in Social and Administrative Pharmacy information for authors, including terms for copyright. 6. This study has been approved by the institutional review boards (IRB) of the authors’ respective institutions, and informed consent was obtained from all study participants. 7. The U.S. FDA has approved publication of the newsletter included here as a Supplemental Online Material.
Limitations Recruitment for this cross-sectional survey was multi-modal; however, future studies may also include mail or fax recruitment as a means to reach more providers practicing in rural areas with less access to technology. Many survey participants identified as residing in the Southeastern U.S., which may affect generalizability of the results outside of this region. Since there are regional differences in prescribing patterns, future expansions of this study should gather additional feedback on generic drug educational materials from providers residing in different regions of the U.S. Additionally, the survey response rate was relatively low and participants sampled from the continuing medical and pharmacy education programs may have been self-motivated to seek out educational materials; thus, participants may have been predisposed to view the newsletter in a positive light. Results include both quantitative descriptive and qualitative data, but should be further tested in larger national samples, across different provider specialties and patient populations, and using additional recruitment mechanisms and sampling frames. Also, the Auburn University investigators are within a School of Pharmacy – the potential for social desirability bias exists for participants who were aware of the investigators' university affiliations. Further, although extensive survey development and recruitment monitoring took place, it is possible that participants may have misunderstood some survey questions or did not fully engage with the newsletter and/or survey. It should also be noted that the provision of generic drug information to providers may not necessarily result in changes to attitudes, intentions, or behaviors related to prescription and dispensing of generic drugs. Future experimental studies are needed to investigate how this or similar generic drug educational material might impact providers’ generic drug prescribing and dispensing behaviors. Despite these limitations, results offer formative, individualized insight into preferred educational material content, format and design, and delivery channel, as well as receptivity from prescribers and pharmacists, who are important stakeholders in the generic drug use process and serve as sources of generic drug information for patients and caregivers.
Acknowledgements All patient/personal identifiers have been removed or disguised so the patient/person(s) described are not identifiable and cannot be identified through the details of the article. Thank you to the University of Alabama at Birmingham (UAB) Medical School's continuing medical education (CME) program; the Auburn University Harrison School of Pharmacy's continuing pharmacy education (CPE) program; and CareHere LLC for recruitment assistance. Thank you to Dr. Sylvia E. Rogers at the Department of Teaching, Learning, and Assessment, Auburn University Harrison School of Pharmacy, for her support on the preliminary educational material development. 8
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Appendix A. Supplementary data 13.
Supplementary data to this article can be found online at https:// doi.org/10.1016/j.sapharm.2019.12.001.
14.
References
15. 16.
1. Babar ZU, Kan SW, Scahill S. Interventions promoting the acceptance and uptake of generic medicines: a narrative review of the literature. Health Policy. 2014;117(3):285–296. 2. Association for Accessible Medicines. Generic drug and biosimilars access and savings in the U.S. https://accessiblemeds.org/sites/default/files/2019-09/AAM-2019Generic-Biosimilars-Access-and-Savings-US-Report-WEB.pdf; 2019 Accessed 10.04.19. 3. Jakovljevic MB, Nakazono S, Ogura S. Contemporary generic market in Japan - key conditions to successful evolution. Expert Rev Pharmacoecon Outcomes Res. 2014;14(2):181–194. 4. Jakovljevic M, Verhaeghe N, Souliotis K. Editorial: challenges of pharmacoeconomics in global health arena. Front Public Health. 2018;6 368-368. 5. Jakovljevic M, Groot W, Souliotis K. Editorial: health care financing and affordability in the emerging global markets. Front Public Health. 2016;4:2. 6. Jakovljevic M, Yamada T. Editorial: role of health economic data in policy making and reimbursement of new medical technologies. Front Pharmacol. 2017;8 662-662. 7. Jakovljevic M, Lazarevic M, Milovanovic O, Kanjevac T. The new and old Europe: east-west split in pharmaceutical spending. Front Pharmacol. 2016;7 18-18. 8. Jakovljevic M, Souliotis K. Pharmaceutical expenditure changes in Serbia and Greece during the global economic recession. SEEJPH. 2016;5. 9. Jakovljević MB. Recent developments in the world's leading generic markets. Med Časopis. 2014;48(3):140–142. 10. Howard JN, Harris I, Frank G, Kiptanui Z, Qian J, Hansen R. Influencers of generic drug utilization: a systematic review. Res Soc Adm Pharm. 2018;14:619–627. 11. Segal JB, Onasanya O, Daubresse M, et al. Determinants of generic drug substitution in the United States. Ther Innov Regul Sci. 2019:2168479018820050. 12. Colgan S, Faasse K, Martin LR, Stephens MH, Grey A, Petrie KJ. Perceptions of
17. 18. 19. 20. 21. 22. 23. 24. 25. 26.
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generic medication in the general population, doctors and pharmacists: a systematic review. BMJ Open. 2015;5(12):e008915. Shrank WH, Liberman JN, Fischer MA, Girdish C, Brennan TA, Choudhry NK. Physician perceptions about generic drugs. Ann Pharmacother. 2011;45(1):31–38. O'Brien MA, Rogers S, Jamtvedt G, et al. Educational outreach visits: effects on professional practice and health care outcomes. Cochrane Database Syst Rev. 2007(4):Cd000409. Ivers N, Jamtvedt G, Flottorp S, et al. Audit and feedback: effects on professional practice and healthcare outcomes. Cochrane Database Syst Rev. 2012(6):Cd000259. Ho MJ, Venci J. Improving the success of mailed letter intervention programs to influence prescribing behaviors: a review. J Manag Care Pharm. 2012;18(8):627–649. Slota C, Davis SA, Blalock SJ, et al. Patient-physician communication on medication cost during glaucoma visits. Optom Vis Sci. 2017;94(12):1095–1101. Shrank WH, Cox ER, Fischer MA, Mehta J, Choudhry NK. Patients' perceptions of generic medications. Health Aff. 2009;28(2):546–556. U.S. Food and Drug Administration: Patient Education. 2018; 2018 https://www.fda.gov/ Drugs/ResourcesForYou/Consumers/BuyingUsingMedicineSafely/GenericDrugs/ ucm169209.htm Accessed 05.20.18. University of Alabama Birmingham School of Medicine Division of Continuing Medical Education. 2018; 2018 http://www.uab.edu/medicine/cme/ Accessed 04.04.18. CareHere, LLC. https://carehere.com/; 2018 Accessed 04.04.18. Auburn University Harrison School of Pharmacy Continuing Education. Auburn University; 2018 http://www.pharmacy.auburn.edu/ce/ Accessed on 04.04.18. Howard J, Frank G, Harris I, Kiptanui Z, Hansen R, Qian J. Key Groups Influencing Generic Drug Use in the U.S.: The Nature and Extent of Their Influence (Abstract). Atlanta, GA: American Public Health Association (APHA) Annual Meeting; 2017. Kypri K, Samaranayaka A, Connor J, Langley JD, Maclennan B. Non-response bias in a web-based health behaviour survey of New Zealand tertiary students. Prev Med. 2011;53(4):274–277. Toverud EL, Hartmann K, Hakonsen H. A systematic review of physicians' and pharmacists' perspectives on generic drug use: what are the global challenges? Appl Health Econ Health Policy. 2015;13(Suppl 1):S35–S45. Shrank WH, Cadarette SM, Cox E, et al. Is there a relationship between patient beliefs or communication about generic drugs and medication utilization? Med Care. 2009;47(3):319–325.
Contents lists available at ScienceDirect
Research in Social and Administrative Pharmacy journal homepage: www.elsevier.com/locate/rsap
Healthcare provider opinions about a generic drug educational newsletter: A pilot cross-sectional survey Natalie S. Hohmanna, Kimberly B. Garzab, Daniel Surryb, Richard A. Hansenb, Ilene Harrisc, Zippora Kiptanuic, Oluwamurewa Oguntimeind, Mitchell M. Frostd, Jingjing Qianb,∗ a
Department of Pharmacy Practice, Auburn University Harrison School of Pharmacy, Auburn University, 4201 Walker Building, Auburn, AL, 36849, USA Department of Health Outcomes Research and Policy, Auburn University Harrison School of Pharmacy, Auburn University, 4306 Walker Building, Auburn, AL, 36849, USA c IMPAQ International LLC, IMPAQ Int., Columbia, MD, 21044, USA d U.S. Food and Drug Administration (FDA), Office of Generic Drugs (OGD), 10903 New Hampshire Avenue Bldg. 75, Silver Spring, MD, 20993-0002, USA b
ARTICLE INFO
ABSTRACT
Keywords: Provider education Educational materials Newsletter Health communication Generic drugs Prescribers and pharmacists
Background: Increasing the prescribing and dispensing of generic drugs, compared to branded drugs, may increase patient access to affordable drug treatments. Healthcare providers have information needs regarding generic drugs, but available, tailored education materials designed for provider use are lacking. Objectives: To examine healthcare provider opinions and receptivity regarding generic drug educational materials in content, format and design, delivery channel, and level of satisfaction. Methods: A national online survey was conducted in summer 2018 to gather practicing healthcare prescribers' (i.e., physicians, nurse practitioners, physician assistants) and pharmacists’ opinions on an educational newsletter developed through a collaboration between the investigators and the U.S. Food and Drug Administration (FDA). Survey data were analyzed using descriptive statistics. Quantitative analyses were performed using SPSS version 24 (IBM, Armonk, NY), while responses to open-ended questions were assessed using qualitative content analysis in Excel. Results: A total of 208 surveys were completed. Overall, participants expressed positive opinions about the newsletter's content and format/design. About 69% of prescribers and 60% of pharmacists stated the newsletter gave information that will help them better serve patients. While 15% of surveyed pharmacists stated that they did not have resources to help them get information on generic drug availability and cost, more prescribers (37%) responded similarly. Both prescribers and pharmacists preferred to receive this newsletter via email from the FDA or a professional association. Conclusions: Findings indicate the feasibility of educational outreach programs about generic drugs targeted towards healthcare providers. There is room for improvement in making prescribers and pharmacists aware of resources for learning about generic drug availability and cost. Future studies may test alternate versions of the newsletter that have been tailored to the needs of specific provider specialties or provider practices serving specific patient sub-groups, as well as preferred dissemination frequency.
Introduction As generics are 20–90% less expensive than their reference branded drug products, generics accounted for $90.3 billion in savings to Medicare and its beneficiaries in 2018 alone, and have saved the U.S. healthcare system over $2 trillion in the past 10 years.1,2
Pharmaceutical spending in global and emerging markets is also impacted by healthcare policies and systems that affect generic drug use.3–9 Evidence shows that generic drug use in the U.S. is largely impacted by certain key groups' (such as prescribers and pharmacists) behaviors and perceptions towards generic drugs.10 While believed to be influential, the extent of prescribers' and pharmacists' influence is
∗ Corresponding author. Auburn University Harrison School of Pharmacy, Department of Health Outcomes Research and Policy, 4306D Walker Building; Auburn, AL, 36849, USA E-mail addresses: [email protected] (N.S. Hohmann), [email protected] (K.B. Garza), [email protected] (D. Surry), [email protected] (R.A. Hansen), [email protected] (I. Harris), [email protected] (Z. Kiptanui), [email protected] (O. Oguntimein), [email protected] (M.M. Frost), [email protected] (J. Qian).
https://doi.org/10.1016/j.sapharm.2019.12.001 Received 23 April 2019; Received in revised form 5 October 2019; Accepted 1 December 2019 1551-7411/ © 2019 Elsevier Inc. All rights reserved.
Please cite this article as: Natalie S. Hohmann, et al., Research in Social and Administrative Pharmacy, https://doi.org/10.1016/j.sapharm.2019.12.001
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heterogeneous and dependent on factors such as experiences and perceptions with generic drugs and practice characteristics.10 For example, Segal et al. showed that patients filling prescriptions for certain drug classes at mail order pharmacies in the U.S. had significantly lower rates of generic drug substitution compared to those filling prescriptions at retail pharmacies.11 Further, misinformation about generic drugs among healthcare providers may be one barrier to patients' and caregivers’ generic drug use.12,13 In a systematic literature review, Colgan et al. found that a high proportion of physicians and pharmacists had negative perceptions of generic drugs in terms of effectiveness, quality, side effects, and safety.12 These negative perceptions may potentially influence prescription and dispensing of generic drugs. Many interventions targeted to healthcare providers have been shown to improve prescribing patterns, healthcare utilization, and/or economic outcomes, including educational outreach visits (academic detailing) to physicians,14 audit and feedback on prescribing patterns,15 and mailed information to physicians and pharmacists.16 However, such interventions are not always translated into clinical practice when it comes to generic drugs. For example, Slota et al. found that in a 2017 observational study of communication interactions between physicians and patients with glaucoma, only 41 (15%) of the patients discussed generic drug substitution options with their physician.17 This may indicate that providers lack point-of-care resources to learn about generic drug availability and cost, as well as tools and educational materials to facilitate conversations about generic drugs with patients. Patients who report talking to their healthcare providers about generic substitution are more likely to fill generic medications than those who do not have a discussion with their providers.18 Thus, developing accessible and engaging generic drug educational materials and resources for providers to utilize at the point-of-care may help to improve generic drug utilization. The U.S. Food and Drug Administration (FDA) offers a range of patient educational materials about generic drugs, including videos, graphics, fact sheets, and related resources available in both English and Spanish versions.19 These educational materials are targeted to patients and caregivers. However, generic drug educational materials targeted to healthcare providers such as prescribers and pharmacists are very limited, and the optimal content, format and design, and delivery channel of the educational materials are unclear. To address this information gap, one generic drug educational newsletter was developed through a collaborative effort between the investigators and the U.S. FDA to help provide prescribers and pharmacists with an educational resource related to generic drugs. This study reports the results of a survey conducted with U.S. prescribers and pharmacists to gauge their opinions about the developed newsletter in terms of content, format and design, delivery channel, and overall satisfaction. Since a single newsletter was developed in this preliminary study to target prescribers and pharmacists across specialties and practice sites, the survey collected feedback to ensure the newsletter adequately accounted for variations in target audience and provider specialty. Findings may be used to help develop generic drug communication messages and campaigns targeted to healthcare providers in order to improve their access to information about generic drugs and their engagement with this information, as well as increase generic drug utilization.
Sampling and recruitment Survey recruitment and participation took place in May–July 2018. Participants were recruited on a national level using a multi-modal recruitment strategy. Participants were: 1) prescribers who were clients of the University of Alabama at Birmingham (UAB) School of Medicine's continuing medical education (CME) program20 or prescribers within the CareHere LLC medical network21; and 2) pharmacists who were clients of Auburn University's continuing pharmacy education (CPE) program.22 Clients of UAB's CME program include physicians, nurse practitioners, and physician assistants throughout the U.S.; UAB's CME email list-serve contained contact information for approximately 1100 prescribers at the time of this study. CareHere LLC is a case management and health services firm that partners with employers to provide primary care, preventative care, and occupational health services to over 350,000 members and 200 wellness centers nationwide. CareHere LLC's network-provider email list-serve contained contact information for 150 prescribers at the time of this study. Clients of Auburn University's CPE program include pharmacists and pharmacy technicians throughout the U.S.; the CPE email list-serve included contact information for approximately 8743 pharmacists at the time of this study. Prescribers were eligible to participate if they: 1) were at least 19 years old; 2) were physicians, nurse practitioners, or physician assistants with U.S. prescribing authority; 3) actively participated in patient care at least 2 days per week; and 4) were able to read/write in the English language. Pharmacists were eligible to participate if they: 1) were at least 19 years old; 2) were licensed to practice pharmacy in the U.S.; 3) actively participated in patient care at least 2 days per week; and 4) were able to read/write in the English language. All 1250 prescribers in the UAB CME program and CareHere LLC provider network list-serves, as well as a random sample of 1500 pharmacists in the Auburn University CPE list-serve were sent a targeted and personalized recruitment email. Recruitment messages contained a link to the study information letter hosted on the Qualtrics survey platform (Qualtrics, Provo, UT, copyright version 2018), and participants who agreed to continue with the study were directed to the online survey. To increase response rate, survey invitations were sent from directors of the UAB CME program and CareHere LLC provider network. Similarly, survey invitations for pharmacist-clients of Auburn University's CPE program were sent directly from the investigators, who are affiliated with Auburn University. Response rate was also increased by sending an email reminder every 7–10 days (up to two reminders), for a maximum of three recruitment attempts per provider. A monetary incentive of $50 was provided to each participant who completed a survey. Recruitment continued until a quota of at least 100 completed surveys was received for each group (prescribers and pharmacists). Fig. 2 shows the recruitment process. Educational material development and pre-testing The newsletter was developed by the investigators through a fourstep process of qualitative feedback in interviews and focus groups with prescribers and pharmacists, followed by refinement of preliminary material in a collaborative development process between Auburn University investigators, IMPAQ International, the U.S. FDA, and graphic design experts in Auburn University's Office of Communications and Marketing. Steps in this development process are detailed below.
Methods
Step 1 – Needs investigation. Preliminary material was developed based on key informant interview findings (n = 24; n = 12 for prescribers and n = 12 for pharmacists). Key informants provided information about prescribers' and pharmacists' needs regarding generic drug educational materials targeted to healthcare providers.23 Needs were focused on material content and format. Based on findings from the needs investigation, a preliminary newsletter was developed by the investigators using a rapid development
Study design An online survey was conducted with prescribers and pharmacists. This study was approved by the Institutional Review Board (IRB) of the authors’ institution and the U.S. FDA Research Involving Human Subjects Committee (RIHSC). A broad overview of the study design is shown in Fig. 1. 2
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Fig. 1. Study design.
newsletter was accessed and downloaded by participants through an embedded pdf attachment in the online survey, and presented in the form of a two-page, 8x11 color newsletter titled, “Update from the FDA: Do you want to know how generic drugs can lower healthcare costs?” See the online supplemental material for the newsletter. Survey instrument development and process fidelity Survey questions were developed based on the four categories of interest for the educational material: content, format and design, delivery channel, and overall level of satisfaction. The preliminary survey instrument was finalized via discussion and consensus among the investigators (n = 5). The electronic survey was then pre-tested for content and face validity among a group of healthcare providers and researchers at Auburn University (n = 15) and results were used to modify survey wording and length. The final survey instrument included 3 eligibility questions, 2 attention filters to remove respondents who may not have fully read or engaged with the newsletter and/or survey, and 54 questions divided into 6 topic domains (Table 1). Wording of some questions differed between groups (prescribers and pharmacists). See the online supplemental material for both versions of the survey instrument.
Fig. 2. Recruitment process.
process. Step 2 – Preliminary testing. The preliminary newsletter was tested through a provider focus group (n = 5 prescribers and pharmacists). Preliminary testing was focused on material content, format and design, preferred delivery channel, and overall level of satisfaction. Testing was performed using printed 8x11 color copies of the preliminary newsletter and a condensed electronic, narrowscreen version of the newsletter projected onto a monitor. Step 3 – Material revision. The preliminary newsletter was revised according to focus group findings. Revisions were made by investigators with input from graphic design experts in Auburn University's Office of Communications and Marketing. Step 4 – Approval and testing. The prototype newsletter was approved by the FDA for quantitative testing in a larger audience of prescribers and pharmacists.
Data collection and analysis A total of 314 survey responses were received out of 2750 survey invitations sent, for an overall response rate of 11%. Of these, 106 surveys were ineligible or incomplete and were not included in analyses (65 respondents were ineligible; 37 respondents abandoned the survey for unknown reasons; 4 respondents incorrectly answered two attention filter questions). Overall, 208 eligible surveys were complete and usable (104 per group), for a usable response rate of 8%. Recruitment was
The educational newsletter was shown to each participant. The 3
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Table 1 Survey instrument description. Domains
Operationalization
Eligibility screening Attention filters Usual practices regarding generic drugs
1. Three multiple choice items. 1. Two multiple choice items. 1. Usual prescribing practices in regards to generic vs. branded drugs, via one 5-point Likert-type item. 2. Access and preferences for resources about generic drug availability and cost, via one 5-point Likerttype item and one multiple-response item. 1. Eleven 5-point Likert-type items addressing different elements of safety, effectiveness, cost, and novelty. 2. One 5-point Likert-type item addressing overall satisfaction with the newsletter's content. 3. One free-response item. 1. Seven 5-point Likert-type items addressing different elements of readability, visual appeal, and layout. 2. One 5-point Likert-type item addressing overall satisfaction with the newsletter's format and design. 3. One free-response item. 1. Two multiple-choice items. 2. One free-response item. 1. Five 5-point Likert-type items. 2. Three free-response items. 1. Eighteen multiple choice, multiple response, or numeric-entry items.
Opinions on the newsletter's content in terms of generic drug safety, effectiveness, and cost Opinions on the newsletter's format and design
Opinions on preferred delivery sources and delivery methods for the newsletter Overall satisfaction with the newsletter Demographics and practice characteristics
capped after a minimum of 200 usable surveys were received (an a priori cap of approximately 100 usable responses per group) for project and budget feasibility in this preliminary study. The survey took an average of 18 min for prescribers and 20 min for pharmacists to complete. When recruitment was complete, survey data were downloaded from the Qualtrics server (Qualtrics, Provo, UT, copyright version 2018) for data management and analysis. Data were analyzed using descriptive statistics, including frequencies, percentages, means, and standard deviations. Quantitative descriptive analyses were performed using SPSS version 24 (IBM, Armonk, NY). Responses to open-ended questions were assessed using qualitative content analysis in Excel. One investigator (NH) reviewed the responses to open-ended survey questions before coding these responses with an open coding approach. For each code, frequency counts were used to quantify the number of participants who mentioned a topic that aligned with the code. These frequency counts were reviewed for accuracy by a second investigator (JQ). A non-response bias investigation was performed by comparing responses of the first 25% (early responders) to the last 25% (late responders) to complete the survey.24 Characteristics and responses were similar between early and late responders in both the prescriber and pharmacist groups.
strongly disagreed that they had resources to help them get information on generic drug availability and cost, a relatively larger percentage of surveyed prescribers (37%) were neutral, disagreed, or strongly disagreed with this statement. Among those providers who did agree or strongly agree that they had resources to help them get information on generic drug availability and cost, most prescribers (82%) and pharmacists (61%) reported using a mix of resources for accessing this information, with Epocrates® (65%), UpToDate® (62%), and GoodRx.com (58%) being the most popular stand-alone drug information resources among surveyed prescribers who reported access to resources, and LexiComp® (40%) and Clinical Pharmacology Online® (28%) being the most popular stand-alone resources among surveyed pharmacists who reported access to resources. Among these surveyed pharmacists who reported having access to resources on generic drug availability and cost, 39% also reported via text entry that they used wholesaler tools and software (such as the wholesalers McKesson or Cardinal), and pharmacy dispensing software to access this information (Table 4). Participants' opinions regarding the newsletter's content, format and design, delivery channel, and overall level of satisfaction Participants expressed positive opinions about the newsletter's content (Table 5). The majority of prescribers and pharmacists agreed or strongly agreed that the newsletter gave adequate information about generic drug safety (80% and 77%), efficacy (83% and 82%), and resources about generic drug availability (79% and 80%). A majority also agreed or strongly agreed that the newsletter gave unbiased information (79% and 90%), gave interesting information (77% and 72%), and gave information they agree with (88% and 92%). Although still a majority, a relatively smaller percentage of participants agreed or strongly agreed that the newsletter gave adequate information on cost (71% and 67%) and FDA approval processes for generic drugs (65% and 66%). Similarly, 65% of prescribers and 66% of pharmacists agreed or strongly agreed that the newsletter gave just the right amount of information. While 56% and 66% of prescribers and pharmacists, respectively, were neutral, disagreed, or strongly disagreed that the newsletter provided information that was new to them, 69% of prescribers and 60% of pharmacists agreed or strongly agreed that the newsletter gave information that will help them better serve patients. Of note, more pharmacists compared to prescribers thought the newsletter gave unbiased information, but fewer pharmacists compared to prescribers thought the newsletter gave information that was new to them or that would help them better serve patients. Participants also expressed positive opinions about the newsletter's format and design (Table 5). The majority of prescribers and
Results Tables 2 and 3 show prescriber and pharmacist characteristics, respectively. The largest portion of prescribers and pharmacists were White (84% and 89%), female (63% and 61%), and self-reported nonHispanic or Latino(a) ethnicity (96% and 98%), with a mean age of 47 and 45 years, respectively. The largest portion of prescribers selfidentified as family medicine practitioners (44%), while the largest portion of pharmacists self-identified as community practice pharmacists (57%) or hospital pharmacists (21%). Also, the largest portion of both prescribers and pharmacists practiced in suburban (39% and 41%) or urban (36% and 33%) areas and were located in the Southeastern region of the U.S. (64% and 91%). Participants’ usual practices regarding generic drugs Most prescribers (90%) and pharmacists (91%) agreed or strongly agreed that they preferred to recommend generic drugs to patients instead of branded drugs. However, some prescribers (10%) and pharmacists (9%) were neutral, disagreed, or strongly disagreed with this statement. While 15% of surveyed pharmacists were neutral, disagreed, or 4
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Table 2 Prescriber characteristics (n = 104).
Table 3 Pharmacist characteristics (n = 104).
Characteristics
Statistics n (%)
Characteristics
Statistics n (%)
Mean Age (years) Sex Female Race White Black or African-American Asian Two or more races Ethnicity Hispanic or Latino(a) Not Hispanic/Latino(a) Primary practice setting Solo private practice Single-specialty group or partnership Multi-specialty group or partnership Hospital outpatient Hospital emergency department Multi-hospital system Urgent care center Academic medical center Federally Qualified Health Center Other Practice community Rural Suburban Urban Specialty Family medicine Internal medicine Psychiatry Cardiology Endocrinology Pulmonology Other More than one specialty Medical degree MD DO PA CNP or other advanced nursing degree Other Board certified Average number of patients seen per week Average number of years in practice Practice size Solo Small (2–10 physicians) Medium (11–50 physicians) Large (51 or more physicians) Geographic areaa West Midwest Southwest Southeast Northeast
46.9 (range 28–73, SD 10.62)
Mean Age (years)
65 (62.5%)
Sex Female Race White Black or African-American Asian Two or more races Ethnicity Hispanic or Latino(a) Not Hispanic/Latino(a) Primary practice setting Community pharmacy Hospital pharmacy Long-term care facility Ambulatory care clinic Academic pharmacy Consulting Other Practice community Rural Suburban Urban Specialtya Ambulatory care Critical care Geriatric pharmacy Managed care Oncology Pediatric pharmacy Pharmacotherapy Regulatory affairs/research/admin. Other More than one specialty Pharmacy degree PharmD BPharm Board certified Average number of prescriptions filled per weekb
44.7 (range 27–86, SD 12.19)
a
87 (83.7%) 6 (5.8%) 8 (7.7%) 3 (2.9%) 4 (3.8%) 100 (96.2%) 16 (15.4%) 28 (26.9%) 10 (9.6%) 1 (1.0%) 2 (1.9%) 1 (1.0%) 3 (2.9%) 14 (13.5%) 4 (3.8%) 25 (24.0%) 27 (26.0%) 40 (38.5%) 37 (35.6%) 46 (44.2%) 11 (10.6%) 1 (1.0%) 2 (2.0%) 1 (1.0%) 1 (1.0%) 13 (12.5%) 30 (28.8%) 40 (38.5%) 7 (6.7%) 19 (18.3%) 37 (35.6%) 1 (1.0%) 87 (83.7%) 73.4 (range 15–600, SD 61.78) 16.2 (range 1–45, SD 10.76) 17 55 15 17
Average number of years in practice Job Role Staff pharmacist Pharmacy manager Administration Consultant Other Geographic areac West Midwest Southwest Southeast Northeast
(16.3%) (52.9%) (14.4%) (16.3%)
12 (12.0%) 8 (8.0%) 5 (5.0%) 64 (64.0%) 11 (11.0%)
63 (60.6%) 93 (89.4%) 2 (1.9%) 7 (6.7%) 2 (1.9%) 2 (1.9%) 102 (98.1%) 59 (56.7%) 22 (21.2%) 5 (4.8%) 4 (3.8%) 2 (1.9%) 1 (1.0%) 11 (10.6%) 27 (26.0%) 43 (41.3%) 34 (32.7%) 16 (15.4%) 3 (2.9%) 4 (3.8%) 1 (1.0%) 1 (1.0%) 2 (1.9%) 2 (1.9%) 1 (1.0%) 50 (48.1%) 24 (23.1%) 58 (55.8%) 46 (44.2%) 29 (27.9%) 1192 (range 5–7000, SD 1095) 19.4 (range 2–60, SD 13.17) 52 (50.0%) 31 (29.8%) 3 (2.9%) 2 (1.9%) 16 (15.4%) 2 (2.0%) 2 (2.0%) 1 (1.0%) 93 (91.2%) 4 (3.9%)
a Among those self-identifying as “other” pharmacy specialists, 36 indicated (via text entry) that they were community practice specialists. b Not all pharmacists reported working in a dispensing role: average number of prescriptions filled per week n = 82. c There was some missing data: Geographic area n = 102.
There was some missing data: Geographic area n = 100.
pharmacists agreed or strongly agreed that the newsletter was easy to read and understand (89% and 89%), visually appealing (77% and 90%), well organized (89% and 89%), just the right length (77% and 81%), had a large enough font size (79% and 88%), loaded easily on their device (93% and 97%), and was presented in a convenient format (84% and 90%). Of note, more pharmacists compared to prescribers thought the newsletter was visually appealing and had a large enough font size. For both prescribers and pharmacists, the preferred source for the newsletter was the FDA (63% and 65%), followed by a professional association (27% and 24%). A newsletter provided by an employer was also preferred by some participants across both prescriber and pharmacist groups (1.9% and 6.7%). Surveyed prescribers and pharmacists most preferred to receive the newsletter from these sources via email
(64% and 66%). For prescribers, the second-most preferred delivery method was via postal mail (13%), followed by an online website (12%) or a mobile app (11%). Pharmacists reported a different preference order for these alternative delivery methods: their second-most preferred delivery method was an online website (14%), followed by postal mail (11%) or a mobile app (8%). Overall, while 88% of prescribers were satisfied or very satisfied with the newsletter's content, a relatively smaller percentage of pharmacists (71%) reported the same level of satisfaction with the newsletter's content (Table 5). Conversely, while 77% of surveyed prescribers were satisfied or very satisfied with the newsletter's format and 5
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thought that more specific examples were needed (such as thyroid medications, warfarin, or other narrow therapeutic index drugs); 5% would like more resources or URL links; and 3% would like to see information about how to deal with insurance formulary restrictions on dispensing branded vs. generic medications. In these free-response questions, 28% of prescribers mentioned they liked the format/design, including the graphics, charts, and call-out boxes, as well as the electronic delivery; 26% liked the concise nature of the newsletter; 14% stated the newsletter had good content, specifically information on bioequivalence, safety and efficacy, and differences between generic vs. branded medications; 9% appreciated the cost facts and pricing resources; and 9% could see themselves using this newsletter with patients as an educational resource. On the other hand, 15% of prescribers stated the newsletter was too busy or they generally disliked the format/design; and 14% thought the newsletter needed more detail, such as information about patent-protection of branded drugs, specific drug class examples, and anticipated timing of market entry for actual generic drugs in the pipeline. Further, 9% stated the newsletter contained information they already knew, and 4% stated that more resources and URL links were needed. Overall, these qualitative findings are consistent with the quantitative survey results. The rich information gained through these qualitative findings provides insight into both pharmacist and prescriber opinions and receptivity regarding generic drug educational materials, and highlights specific content and format/design elements that may be revised in future iterations of this newsletter. This may help to optimally engage providers and improve their timely access to the generic drug information and resources that they find most useful for personal education and interactive patient-provider discussions.
Table 4 Usual resources for generic drug availability and cost information among providers who reported access to resources (n = 154)a. Resource
Prescribers (n = 66) n (%) b
Pharmacists (n = 88) n (%) b
FDA Orange Book GoodRx.com Epocrates® Micromedex® Clinical Pharmacology Online® LexiComp® UpToDate® Other c
4 (6.1%) 38 (57.6%) 43 (65.2%) 7 (10.6%) 4 (6.1%)
17 (19.3%) 21 (23.9%) 3 (3.4%) 18 (20.5%) 25 (28.4%)
4 (6.1%) 41 (62.1%) 17 (25.8%)d
35 (39.8%) 8 (9.1%) 42 (47.7%)e
a Only 66 out of 104 prescribers (63%) and 88 out of 104 pharmacists (85%) agreed or strongly agreed that they had resources to help them find information on generic drug availability and cost. b Percentages do not add to 100 because participants marked all resources that applied. c Participants who responded “Other” were prompted to enter a free-text response. d Among surveyed prescribers who reported access to resources (n = 66), 8 (12.1%) reported via text entry that they looked up this information on community pharmacy websites or spoke directly with a pharmacist to access information about generic drug availability and cost, 2 (3.0%) used an electronic medical record (EMR) to find this information, 2 (3.0%) used Medscape, 2 (3.0%) used Monthly Prescribing Reference (MPR), 1 (1.5%) used Drugs.com, 1 (1.5%) reported looking up this information on the internet in general, 1 (1.5%) described receiving drug samples as a resource on generic drug information, and 1 (1.5%) looked at manufacturers' websites to find this information. e Among surveyed pharmacists who reported access to resources (n = 88), 34 (38.6%) reported via text entry that they used drug wholesaler resources/ software (such as websites or ordering portals) or internal pharmacy dispensing software to access information about generic drug availability and cost, 3 (3.4%) used Facts and Comparisons®, 2 (2.3%) reported calling other pharmacies to ask this information, 1 (1.1%) used Medscape, 1 (1.1%) used Drugs. com, 1 (1.1%) used Drug Topics®, 1 (1.1%) used Pharmacists Letter®, 1 (1.1%) used the FDA.gov website, 1 (1.1%) reported using Google in general, and 1 (1.1%) asked the inventory staff at the hospital where he/she worked to find this information.
Discussion A national online survey was conducted to gather healthcare providers' input on the optimal content, format and design, delivery channel, and level of satisfaction for an educational newsletter about generic drugs, targeted to the information needs of prescribers (physicians, nurse practitioners, and physician assistants) and pharmacists. Overall, participants expressed positive opinions about the newsletter's content and format/design. About 69% of prescribers and 60% of pharmacists stated the newsletter gave information that will help them better serve patients. While 15% of surveyed pharmacists stated they did not have resources to help them get information on generic drug availability and cost, more prescribers (37%) responded similarly. Surveyed prescribers and pharmacists most preferred to receive this newsletter via email from the FDA or professional associations. The finding that relatively fewer prescribers, compared to pharmacists, reported having resources to help them get information on generic drug availability and cost is not surprising considering pharmacists may be more likely to have access to prescription drug wholesaler and dispensing software. This finding is also consistent with previous literature showing that some providers lack confidence in the reliability of generic drug information.25 It was interesting that Epocrates®, UpToDate®, and GoodRx.com were the most popular standalone drug information resources among surveyed prescribers who reported access to resources, and LexiComp® and Clinical Pharmacology Online® were the most popular resources among surveyed pharmacists who reported access to resources. Further, 39% of these surveyed pharmacists who reported access to resources stated via text entry that they used other tools such as wholesaler software and pharmacy dispensing software to access information on generic drug availability and cost, while 12% of prescribers who reported access to resources stated via text entry that they asked pharmacist colleagues to share information on generic drug availability and cost or looked for this information on community pharmacy websites. This may reflect differences in drug information resources available to pharmacists and prescribers at the point-of-care, as well as differences in resources introduced to different
design, 85% of pharmacists expressed the same level of satisfaction with the newsletter's format and design. The majority of prescribers and pharmacists agreed or strongly agreed that they were satisfied with the quality of the newsletter (86% and 87%), the newsletter held their interest (75% and 81%), the newsletter had information that providers needed to know (86% and 88%), they could see themselves using the newsletter in practice if they had questions about brand and generic drugs (74% and 74%), and they would recommend the newsletter to other providers (69% and 78%). Of note, fewer of the surveyed prescribers, compared to pharmacists, reported the newsletter held their interest or that they would recommend the newsletter to other providers. Qualitative findings In a free-response question asking what participants liked most and least about the newsletter, 40% of pharmacists mentioned they liked the concise nature of the newsletter; and 28% liked the format/design, including the graphics, bolding, layout, and highlighted call-out boxes summarizing key points. Further, 21% of pharmacists mentioned they liked the content presented, including cost facts, bioequivalence information, how generics are rated (such as AB equivalency ratings), and what makes generics equivalent to branded drugs; 14% appreciated the cost and pricing resources; and 9% could see themselves using this newsletter with patients as an educational resource. On the other hand, 22% of pharmacists mentioned the newsletter contained information they already knew or that was too basic for pharmacists. Similarly, 7% 6
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Table 5 Participants' opinions on the newsletter's content, format and design, and level of satisfaction (n = 208). Content Questions
Provider Type
Strongly Disagree (1) n (%)
Disagree (2) n (%)
Neither Agree nor Disagree (3) n (%)
Agree (4) n (%)
Strongly Agree (5) n (%)
The newsletter gave adequate information about generic drug safety The newsletter gave adequate information about generic drug efficacy The newsletter gave adequate information about FDA approval processes for generic drugs The newsletter gave adequate information about generic drug cost The newsletter gave useful information on resources for generic drug availability The newsletter gave just the right amount of information about generic drugs The newsletter gave unbiased information
Prescribers Pharmacists Prescribers Pharmacists Prescribers Pharmacists Prescribers Pharmacists Prescribers Pharmacists Prescribers Pharmacists Prescribers Pharmacists Prescribers Pharmacists Prescribers Pharmacists Prescribers Pharmacists Prescribers Pharmacists
1 0 2 0 2 1 3 0 1 0 1 1 1 0 0 1 5 6 4 1 0 0
5 (4.8%) 7 (6.7%) 3 (2.9%) 5 (4.8%) 15 (14.4%) 11 (10.6%) 7 (6.7%) 12 (11.5%) 6 (5.8%) 7 (6.7%) 4 (3.8%) 10 (9.6%) 3 (2.9%) 1 (1.0%) 3 (2.9%) 6 (5.8%) 28 (26.9%) 39 (37.5%) 4 (3.8%) 14 (13.5%) 0 0
15 (14.4%) 17 (16.3%) 13 (12.5%) 14 (13.5%) 19 (18.3%) 23 (22.1%) 20 (19.2%) 22 (21.2%) 15 (14.4%) 14 (13.5%) 31 (29.8%) 24 (23.1%) 18 (17.3%) 9 (8.7%) 21 (20.2%) 22 (21.2%) 25 (24.0%) 24 (23.1%) 24 (23.1%) 27 (26.0%) 12 (11.5%) 8 (7.7%)
57 59 55 56 46 51 51 51 54 58 51 56 43 60 53 54 35 27 54 43 54 57
26 (25.0%) 21 (20.2%) 31 (29.8%) 29 (27.9%) 22 (21.2%) 18 (17.3%) 23 (22.1%) 19 (18.3%) 28 (26.9%) 25 (24.0%) 17 (16.3%) 13 (12.5%) 39 (37.5%) 34 (32.7%) 27 (26.0%) 21 (20.2%) 11 (10.6%) 8 (7.7%) 18 (17.3%) 19 (18.3%) 38 (36.5%) 39 (37.5%)
Format and Design Questions
Provider Type
Strongly Disagree (1) n (%)
Disagree (2) n (%)
Neither Agree nor Disagree (3) n (%)
Agree (4) n (%)
Strongly Agree (5) n (%)
The newsletter was easy to read and understand
Prescribers Pharmacists Prescribers Pharmacists Prescribers Pharmacists Prescribers Pharmacists Prescribers Pharmacists Prescribers Pharmacists Prescribers Pharmacists
1 1 0 1 0 1 0 1 1 0 1 1 1 1
2 (1.9%) 5 (4.8%) 7 (6.7%) 3 (2.9%) 4 (3.8%) 2 (1.9%) 14 (13.5%) 7 (6.7%) 13 (12.5%) 5 (4.8%) 1 (1.0%) 1 (1.0%) 6 (5.8%) 2 (1.9%)
8 (7.7%) 5 (4.8%) 17 (16.3%) 6 (5.8%) 7 (6.7%) 9 (8.7%) 10 (9.6%) 12 (11.5%) 8 (7.7%) 8 (7.7%) 5 (4.8%) 1 (1.0%) 10 (9.6%) 7 (6.7%)
56 41 46 40 55 45 41 43 51 50 41 36 42 43
37 52 34 54 38 47 39 41 31 41 56 65 45 51
Overall Satisfaction Questions
Provider Type
Not at all Satisfied (1) n (%)
Slightly Satisfied (2) n (%)
Fairly Satisfied (3) n (%)
Satisfied (4) n (%)
Very Satisfied (5) n (%)
Overall satisfaction with content
Prescribers Pharmacists Prescribers Pharmacists
0 3 (2.9%) 1 (1.0%) 1 (1.0%)
0 7 (6.7%) 3 (2.9%) 2 (1.9%)
12 20 20 13
54 56 39 37
38 18 41 51
Level of Satisfaction Questions
Provider Type
Strongly Disagree (1) n (%)
Disagree (2) n (%)
Neither Agree nor Disagree (3) n (%)
Agree (4) n (%)
Strongly Agree (5) n (%)
I am satisfied with the quality of the newsletter
Prescribers Pharmacists Prescribers Pharmacists Prescribers Pharmacists Prescribers Pharmacists Prescribers Pharmacists
0 2 0 1 1 1 2 1 2 1
2 (1.9%) 2 (1.9%) 7 (6.7%) 5 (4.8%) 2 (1.9%) 4 (3.8%) 9 (8.7%) 6 (5.8%) 13 (12.5%) 8 (7.7%)
13 (12.5%) 10 (9.6%) 19 (18.3%) 14 (13.5%) 12 (11.5%) 7 (6.7%) 16 (15.4%) 20 (19.2%) 17 (16.3%) 14 (13.5%)
54 50 46 42 50 51 47 46 43 44
35 40 32 42 39 41 30 31 29 37
The newsletter gave information that was interesting to me The newsletter gave information that was new to me The newsletter gave information that will help me better serve patients The newsletter gave information that I agree with
The newsletter was visually appealing The newsletter was well organized The newsletter was just the right length The newsletter had a good font size The newsletter loaded easily on my computer or phone The newsletter was convenient for me
Overall satisfaction with format and design
The newsletter was interesting to read The newsletter has information that prescribers/ pharmacists need to know I would use this newsletter in practice if I had questions about brand and generic drugs I would recommend this newsletter to other prescribers/pharmacists
(1.0%) (1.9%) (1.9%) (1.0%) (2.9%) (1.0%) (1.0%) (1.0%) (1.0%) (1.0%) (4.8%) (5.8%) (3.8%) (1.0%)
(1.0%) (1.0%) (1.0%) (1.0%) (1.0%) (1.0%) (1.0%) (1.0%) (1.0%) (1.0%)
(1.9%) (1.0%) (1.0%) (1.0%) (1.9%) (1.0%) (1.9%) (1.0%)
provider types during training. Future studies may expand on these findings by investigating differences in technology and point-of-care resources available to pharmacists and prescribers, and how pharmacists and prescribers interact and collaborate to share information related to generic drug availability and cost. To improve access to generic drug availability and cost resources, surveyed prescribers and pharmacists suggested the current newsletter could serve as a source of practical generic drug information that
(11.5%) (19.2%) (19.2%) (12.5%)
(54.8%) (56.7%) (52.9%) (53.8%) (44.2%) (49.0%) (49.0%) (49.0%) (51.9%) (55.8%) (49.0%) (53.8%) (41.3%) (57.7%) (51.0%) (51.9%) (33.7%) (26.0%) (51.9%) (41.3%) (51.9%) (54.8%)
(53.8%) (39.4%) (44.2%) (38.5%) (52.9%) (43.3%) (39.4%) (41.3%) (49.0%) (48.1%) (39.4%) (34.6%) (40.4%) (41.3%)
(51.9%) (53.8%) (37.5%) (35.6%)
(51.9%) (48.1%) (44.2%) (40.4%) (48.1%) (49.0%) (45.2%) (44.2%) (41.3%) (42.3%)
(35.6%) (50.0%) (32.7%) (51.9%) (36.5%) (45.2%) (37.5%) (39.4%) (29.8%) (39.4%) (53.8%) (62.5%) (43.3%) (49.0%)
(36.5%) (17.3%) (39.4%) (49.0%)
(33.7%) (38.5%) (30.8%) (40.4%) (37.5%) (39.4%) (28.8%) (29.8%) (27.9%) (35.6%)
providers could apply in real-life practice settings. Providers suggested the newsletter could be shortened, while simultaneously adding more detailed examples of specific drugs or drug classes, as well as anticipated market availability timelines for actual generic drugs entering the market. This may be accomplished by disseminating mini-newsletters or news blasts to providers on a more frequent basis, in both print and electronic form. Sending providers brief emails with generic drug availability updates may also help to disseminate information on 7
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generic drugs in a timely manner. Newsletters may also be tailored to fit the drug information needs of particular provider specialties, which may improve relevancy of the newsletter for different types of providers. Tailoring the format, design, and delivery method of generic drug educational materials to individual provider preferences may also help to improve providers’ access to and engagement with generic drug availability and cost information. Both prescribers and pharmacists expressed they would like to use this newsletter as a tool to discuss generic drug alternatives with patients and caregivers. Indeed, effective communication between patients and healthcare providers regarding generic drugs and generic substitution may play a critical role in reducing prescription spending and optimizing patient outcomes. Patients who report talking to their healthcare providers about generic drug substitution are more likely to fill generic medications than those who do not have a discussion with providers.18,26 Future expansions of this study may investigate the optimal content and format/design of shared decision-making tools for providers and patients/caregivers to use together when making joint decisions about generic drug substitution, across different types of provider specialties and patient populations. Also, it is important to note that some survey participants reported that they perceived the newsletter to be biased. One potential reason for this may be that the newsletter did not directly discuss narrow therapeutic index (NTI) drugs and does not account for patient-specific circumstances or insurance formulary or generic drug substitution restrictions that may influence whether a branded or generic medication is prescribed and dispensed to a patient. Future studies may investigate how to optimally incorporate this information into generic drug educational materials for providers.
Conclusion Findings indicate the feasibility of educational outreach programs about generic drugs targeted towards healthcare providers. Prescribers and pharmacists had an overall positive opinion of the newsletter's content and format/design. There is room for improvement in making prescribers and pharmacists aware of resources for learning about generic drug availability and cost. Future studies may test alternate versions of the newsletter that have been tailored to the needs of specific provider specialties or provider practices serving specific patient sub-groups, as well as preferred dissemination frequency. Implications for policy and practice Educational outreach programs about generic drugs can improve healthcare providers’ informational needs about generic drugs and further improve generic drug prescribing and dispensing. The survey methodology allows for scalable data for future development and dissemination of educational materials targeted to healthcare providers across a variety of health topics. Declaration of competing interest 1. Funding for this manuscript was made possible, in part, by the U.S. Food and Drug Administration (FDA) grant #U01FD005486. Views expressed in written materials or publications and by speakers and moderators do not necessarily reflect the official policies of the Department of Health and Human Services; nor does any mention of trade names, commercial practices, or organization imply endorsement by the United States Government. 2. In the past 3 years, an author has provided expert testimony for Daiichi Sankyo and Takeda. Two authors were employed with the U.S. FDA, Office of Generic Drugs. No other authors declare a potential conflict of interest. 3. All authors meet the criteria for authorship outlined by the Uniform Requirements for Manuscripts Submitted to Biomedical Journals. 4. The authors had access to all the study data, take responsibility for the accuracy of the analysis, and had authority over manuscript preparation and the decision to submit the manuscript for publication. The funder provided basic proof-reading suggestions for the manuscript. 5. All authors approve the manuscript and agree to adhere to all terms outlined in the Research in Social and Administrative Pharmacy information for authors, including terms for copyright. 6. This study has been approved by the institutional review boards (IRB) of the authors’ respective institutions, and informed consent was obtained from all study participants. 7. The U.S. FDA has approved publication of the newsletter included here as a Supplemental Online Material.
Limitations Recruitment for this cross-sectional survey was multi-modal; however, future studies may also include mail or fax recruitment as a means to reach more providers practicing in rural areas with less access to technology. Many survey participants identified as residing in the Southeastern U.S., which may affect generalizability of the results outside of this region. Since there are regional differences in prescribing patterns, future expansions of this study should gather additional feedback on generic drug educational materials from providers residing in different regions of the U.S. Additionally, the survey response rate was relatively low and participants sampled from the continuing medical and pharmacy education programs may have been self-motivated to seek out educational materials; thus, participants may have been predisposed to view the newsletter in a positive light. Results include both quantitative descriptive and qualitative data, but should be further tested in larger national samples, across different provider specialties and patient populations, and using additional recruitment mechanisms and sampling frames. Also, the Auburn University investigators are within a School of Pharmacy – the potential for social desirability bias exists for participants who were aware of the investigators' university affiliations. Further, although extensive survey development and recruitment monitoring took place, it is possible that participants may have misunderstood some survey questions or did not fully engage with the newsletter and/or survey. It should also be noted that the provision of generic drug information to providers may not necessarily result in changes to attitudes, intentions, or behaviors related to prescription and dispensing of generic drugs. Future experimental studies are needed to investigate how this or similar generic drug educational material might impact providers’ generic drug prescribing and dispensing behaviors. Despite these limitations, results offer formative, individualized insight into preferred educational material content, format and design, and delivery channel, as well as receptivity from prescribers and pharmacists, who are important stakeholders in the generic drug use process and serve as sources of generic drug information for patients and caregivers.
Acknowledgements All patient/personal identifiers have been removed or disguised so the patient/person(s) described are not identifiable and cannot be identified through the details of the article. Thank you to the University of Alabama at Birmingham (UAB) Medical School's continuing medical education (CME) program; the Auburn University Harrison School of Pharmacy's continuing pharmacy education (CPE) program; and CareHere LLC for recruitment assistance. Thank you to Dr. Sylvia E. Rogers at the Department of Teaching, Learning, and Assessment, Auburn University Harrison School of Pharmacy, for her support on the preliminary educational material development. 8
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Appendix A. Supplementary data 13.
Supplementary data to this article can be found online at https:// doi.org/10.1016/j.sapharm.2019.12.001.
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