Implementation fidelity of patient-centered prescription label to promote opioid safe use

Danielle M. McCarthy; Andrea M. Russell; Morgan R. Eifler; Lauren A. Opsasnick; Abigail E. Lyden; Stephanie J. Gravenor; Enid Montague; Scott I. Hur; Kenzie A. Cameron; Laura M. Curtis; Michael S. Wolf

doi:10.1002/pds.4795

Implementation fidelity of patient-centered prescription label to promote opioid safe use

Danielle M. McCarthy^*, Andrea M. Russell, Morgan R. Eifler, Lauren A. Opsasnick, Abigail E. Lyden, Stephanie J. Gravenor, Enid Montague, Scott I. Hur, Kenzie A. Cameron, Laura M. Curtis, Michael S. Wolf

^*Corresponding author for this work

Research output: Contribution to journal › Article › peer-review

5 Scopus citations

Abstract

Purpose: Patient-centered labels may improve safe medication use, but implementation challenges limit use. We assessed implementation of a patient-centered “PRN” (as needed) label entitled “Take-Wait-Stop” (TWS) with three deconstructed steps replacing traditional wording. Methods: As part of a larger investigation, patients received TWS prescriptions (eg, Take: 1 pill if you have pain; Wait: at least 4 h before taking again; Stop: do not take more than 6 pills in 24 h). Prescriptions labels recorded at follow-up were classified into three categories: (1) one-step wording (Take 1 pill every 4 h [without daily limits]), (2) two-step wording (Take 1 pill every 4 h; do not exceed 6 pills/day), and (3) three-step wording. There were three subtypes of three-step wording: (3a) three-step, not TWS (three deconstructed steps, not necessarily TWS wording), (3b) TWS format, employing three steps with leading verbs, but “with additions or replacements” (eg, replaced “do not take” with “do not exceed”), and (3c) verbatim TWS. Results: Two hundred eleven participants completed follow-up. Mean age was 44.3 years (SD 14.3); 44% were male. One-step bottles represented 12% (n = 25) of the sample, whereas 26% (n = 55) had two-step wording. The majority (44%, n = 93) had three-deconstructed steps, not TWS (3a); 16% (n = 34) retained TWS structure, but not verbatim (3b). Only 2% (n = 4) displayed verbatim TWS wording (3c). All category three labels (utilizing deconstructed instructions) were considered adequate implementation (62%). Conclusions: Exact intervention adherence was not achieved in the majority of cases, limiting impact. Nonetheless, community pharmacies were responsive to new instructions, but higher implementation reliability requires additional supports.

Original language	English (US)
Pages (from-to)	1251-1257
Number of pages	7
Journal	Pharmacoepidemiology and Drug Safety
Volume	28
Issue number	9
DOIs	https://doi.org/10.1002/pds.4795
State	Published - Sep 1 2019

Funding

We would like to acknowledge the additional study coinvestigators for the larger project from which these data are derived including Kim KY, Lank PM, Kim HS, Courtney DM, and Walton S. We would additionally like to acknowledge the research assistants and project coordinators who assisted with data collection and Deesha Patel who assisted with preliminary analysis. This project was supported by grant number R18HS023459 (PI: McCarthy) from the Agency for Healthcare Research and Quality. The content is solely the responsibility of the authors and does not necessarily represent the official views of the Agency for Healthcare Research and Quality. REDCap is supported at FSM by the Northwestern University Clinical and Translational Science (NUCATS) Institute. Research reported in this publication was supported, in part, by the National Institutes of Health's National Center for Advancing Translational Sciences, grant number UL1TR001422. The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Institutes of Health.

Keywords

acetaminophen-hydrocodone drug combination
drug labeling
health literacy
pharmacies
pharmacoepidemiology

ASJC Scopus subject areas

Pharmacology (medical)
Epidemiology

Access to Document

10.1002/pds.4795

Cite this

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title = "Implementation fidelity of patient-centered prescription label to promote opioid safe use",

abstract = "Purpose: Patient-centered labels may improve safe medication use, but implementation challenges limit use. We assessed implementation of a patient-centered “PRN” (as needed) label entitled “Take-Wait-Stop” (TWS) with three deconstructed steps replacing traditional wording. Methods: As part of a larger investigation, patients received TWS prescriptions (eg, Take: 1 pill if you have pain; Wait: at least 4 h before taking again; Stop: do not take more than 6 pills in 24 h). Prescriptions labels recorded at follow-up were classified into three categories: (1) one-step wording (Take 1 pill every 4 h [without daily limits]), (2) two-step wording (Take 1 pill every 4 h; do not exceed 6 pills/day), and (3) three-step wording. There were three subtypes of three-step wording: (3a) three-step, not TWS (three deconstructed steps, not necessarily TWS wording), (3b) TWS format, employing three steps with leading verbs, but “with additions or replacements” (eg, replaced “do not take” with “do not exceed”), and (3c) verbatim TWS. Results: Two hundred eleven participants completed follow-up. Mean age was 44.3 years (SD 14.3); 44% were male. One-step bottles represented 12% (n = 25) of the sample, whereas 26% (n = 55) had two-step wording. The majority (44%, n = 93) had three-deconstructed steps, not TWS (3a); 16% (n = 34) retained TWS structure, but not verbatim (3b). Only 2% (n = 4) displayed verbatim TWS wording (3c). All category three labels (utilizing deconstructed instructions) were considered adequate implementation (62%). Conclusions: Exact intervention adherence was not achieved in the majority of cases, limiting impact. Nonetheless, community pharmacies were responsive to new instructions, but higher implementation reliability requires additional supports.",

keywords = "acetaminophen-hydrocodone drug combination, drug labeling, health literacy, pharmacies, pharmacoepidemiology",

author = "McCarthy, {Danielle M.} and Russell, {Andrea M.} and Eifler, {Morgan R.} and Opsasnick, {Lauren A.} and Lyden, {Abigail E.} and Gravenor, {Stephanie J.} and Enid Montague and Hur, {Scott I.} and Cameron, {Kenzie A.} and Curtis, {Laura M.} and Wolf, {Michael S.}",

note = "Funding Information: We would like to acknowledge the additional study coinvestigators for the larger project from which these data are derived including Kim KY, Lank PM, Kim HS, Courtney DM, and Walton S. We would additionally like to acknowledge the research assistants and project coordinators who assisted with data collection and Deesha Patel who assisted with preliminary analysis. This project was supported by grant number R18HS023459 (PI: McCarthy) from the Agency for Healthcare Research and Quality. The content is solely the responsibility of the authors and does not necessarily represent the official views of the Agency for Healthcare Research and Quality. REDCap is supported at FSM by the Northwestern University Clinical and Translational Science (NUCATS) Institute. Research reported in this publication was supported, in part, by the National Institutes of Health's National Center for Advancing Translational Sciences, grant number UL1TR001422. The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Institutes of Health. Publisher Copyright: {\textcopyright} 2019 John Wiley & Sons, Ltd.",

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doi = "10.1002/pds.4795",

language = "English (US)",

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T1 - Implementation fidelity of patient-centered prescription label to promote opioid safe use

AU - McCarthy, Danielle M.

AU - Russell, Andrea M.

AU - Eifler, Morgan R.

AU - Opsasnick, Lauren A.

AU - Lyden, Abigail E.

AU - Gravenor, Stephanie J.

AU - Montague, Enid

AU - Hur, Scott I.

AU - Cameron, Kenzie A.

AU - Curtis, Laura M.

AU - Wolf, Michael S.

N1 - Funding Information: We would like to acknowledge the additional study coinvestigators for the larger project from which these data are derived including Kim KY, Lank PM, Kim HS, Courtney DM, and Walton S. We would additionally like to acknowledge the research assistants and project coordinators who assisted with data collection and Deesha Patel who assisted with preliminary analysis. This project was supported by grant number R18HS023459 (PI: McCarthy) from the Agency for Healthcare Research and Quality. The content is solely the responsibility of the authors and does not necessarily represent the official views of the Agency for Healthcare Research and Quality. REDCap is supported at FSM by the Northwestern University Clinical and Translational Science (NUCATS) Institute. Research reported in this publication was supported, in part, by the National Institutes of Health's National Center for Advancing Translational Sciences, grant number UL1TR001422. The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Institutes of Health. Publisher Copyright: © 2019 John Wiley & Sons, Ltd.

PY - 2019/9/1

Y1 - 2019/9/1

N2 - Purpose: Patient-centered labels may improve safe medication use, but implementation challenges limit use. We assessed implementation of a patient-centered “PRN” (as needed) label entitled “Take-Wait-Stop” (TWS) with three deconstructed steps replacing traditional wording. Methods: As part of a larger investigation, patients received TWS prescriptions (eg, Take: 1 pill if you have pain; Wait: at least 4 h before taking again; Stop: do not take more than 6 pills in 24 h). Prescriptions labels recorded at follow-up were classified into three categories: (1) one-step wording (Take 1 pill every 4 h [without daily limits]), (2) two-step wording (Take 1 pill every 4 h; do not exceed 6 pills/day), and (3) three-step wording. There were three subtypes of three-step wording: (3a) three-step, not TWS (three deconstructed steps, not necessarily TWS wording), (3b) TWS format, employing three steps with leading verbs, but “with additions or replacements” (eg, replaced “do not take” with “do not exceed”), and (3c) verbatim TWS. Results: Two hundred eleven participants completed follow-up. Mean age was 44.3 years (SD 14.3); 44% were male. One-step bottles represented 12% (n = 25) of the sample, whereas 26% (n = 55) had two-step wording. The majority (44%, n = 93) had three-deconstructed steps, not TWS (3a); 16% (n = 34) retained TWS structure, but not verbatim (3b). Only 2% (n = 4) displayed verbatim TWS wording (3c). All category three labels (utilizing deconstructed instructions) were considered adequate implementation (62%). Conclusions: Exact intervention adherence was not achieved in the majority of cases, limiting impact. Nonetheless, community pharmacies were responsive to new instructions, but higher implementation reliability requires additional supports.

AB - Purpose: Patient-centered labels may improve safe medication use, but implementation challenges limit use. We assessed implementation of a patient-centered “PRN” (as needed) label entitled “Take-Wait-Stop” (TWS) with three deconstructed steps replacing traditional wording. Methods: As part of a larger investigation, patients received TWS prescriptions (eg, Take: 1 pill if you have pain; Wait: at least 4 h before taking again; Stop: do not take more than 6 pills in 24 h). Prescriptions labels recorded at follow-up were classified into three categories: (1) one-step wording (Take 1 pill every 4 h [without daily limits]), (2) two-step wording (Take 1 pill every 4 h; do not exceed 6 pills/day), and (3) three-step wording. There were three subtypes of three-step wording: (3a) three-step, not TWS (three deconstructed steps, not necessarily TWS wording), (3b) TWS format, employing three steps with leading verbs, but “with additions or replacements” (eg, replaced “do not take” with “do not exceed”), and (3c) verbatim TWS. Results: Two hundred eleven participants completed follow-up. Mean age was 44.3 years (SD 14.3); 44% were male. One-step bottles represented 12% (n = 25) of the sample, whereas 26% (n = 55) had two-step wording. The majority (44%, n = 93) had three-deconstructed steps, not TWS (3a); 16% (n = 34) retained TWS structure, but not verbatim (3b). Only 2% (n = 4) displayed verbatim TWS wording (3c). All category three labels (utilizing deconstructed instructions) were considered adequate implementation (62%). Conclusions: Exact intervention adherence was not achieved in the majority of cases, limiting impact. Nonetheless, community pharmacies were responsive to new instructions, but higher implementation reliability requires additional supports.

KW - acetaminophen-hydrocodone drug combination

KW - drug labeling

KW - health literacy

KW - pharmacies

KW - pharmacoepidemiology

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Implementation fidelity of patient-centered prescription label to promote opioid safe use

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