Evaluation of community pharmacists’ readiness to implement the Falsified Medicines Directive (Directive 2011/62/EC): an English cross-sectional survey with geospatial analysis

Research output: Contribution to journalArticle

Abstract

Objectives: to evaluate the readiness to implement the Falsified Medicines Directive (FMD) by community pharmacies in England. Eight secondary objectives were assessed. Setting: Community/Retail pharmacies.Participants: We invited pharmacists from 501 pharmacies to complete a survey. Non-contractors, non-pharmacists or pharmacists practising abroad were excluded. We randomly selected addresses, ensuring they were nationally representative. Interventions: We mailed the survey in October 2018 with a single follow-up in January 2019. Respondents were invited to provide self-reported answers. A prepaid self-addressed envelope was provided. We received favourable ethical approval.Results: 102 responses (20.44% response rate) were received. Readiness to implement was poor: 4 (3.9%) said very much, while 40 (39.2%) said not at all and 29 (28.4%) said not really. Increased workload and reduced profitability was anticipated, accompanied with improved patient safety. Prevalence of ‘Substandard and Falsified (SF) Medical Products’ was estimated at 1 to 5%, with erectile dysfunction at greatest risk of falsification. Different packaging would raise suspicions. Five (4.9%) had identified SFs (p<0.001 One sample binomial). Of these, three (2.9%) informed the medicines agency. None had been involved in any public health campaigns. Confidence and self-efficacy was low. Strategies to reduce SFs reaching the public are described. Pharmacist's role in combating SFs was elucidated. SFs were identified in deprived areas 4 (9%) more often than in affluent areas 1 (2%).Conclusions: Many pharmacies are not ready to implement FMD, potentially not capturing anticipated benefits of the directive, with greatest risk of harm in deprived area. We further validated a confidence scale. Limited public health campaigns may result in a lack of awareness amongst pharmacy professionals and patients. Limited awareness of technologies to identify falsified medicines exist, though further training is welcome. A worrying trend of underreporting maybe prevalent. A larger sample study using this survey would be valuable.
Original languageEnglish
Article numbere033405
JournalBMJ Open
Volume10
DOIs
Publication statusPublished - 9 Jan 2020

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Pharmacies
Pharmacists
Cross-Sectional Studies
Health Promotion
Public Health
Product Packaging
Erectile Dysfunction
Self Efficacy
Patient Safety
Workload
England
Technology
Surveys and Questionnaires

Bibliographical note

© Author(s) (or their employer(s)) 2020. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ. http://creativecommons.org/licenses/by-nc/4.0/. This is an open access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited, appropriate credit is given, any changes made indicated, and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/.

Cite this

@article{e7c24e17d46c4e61aa4506a6d4050de7,
title = "Evaluation of community pharmacists’ readiness to implement the Falsified Medicines Directive (Directive 2011/62/EC): an English cross-sectional survey with geospatial analysis",
abstract = "Objectives: to evaluate the readiness to implement the Falsified Medicines Directive (FMD) by community pharmacies in England. Eight secondary objectives were assessed. Setting: Community/Retail pharmacies.Participants: We invited pharmacists from 501 pharmacies to complete a survey. Non-contractors, non-pharmacists or pharmacists practising abroad were excluded. We randomly selected addresses, ensuring they were nationally representative. Interventions: We mailed the survey in October 2018 with a single follow-up in January 2019. Respondents were invited to provide self-reported answers. A prepaid self-addressed envelope was provided. We received favourable ethical approval.Results: 102 responses (20.44{\%} response rate) were received. Readiness to implement was poor: 4 (3.9{\%}) said very much, while 40 (39.2{\%}) said not at all and 29 (28.4{\%}) said not really. Increased workload and reduced profitability was anticipated, accompanied with improved patient safety. Prevalence of ‘Substandard and Falsified (SF) Medical Products’ was estimated at 1 to 5{\%}, with erectile dysfunction at greatest risk of falsification. Different packaging would raise suspicions. Five (4.9{\%}) had identified SFs (p<0.001 One sample binomial). Of these, three (2.9{\%}) informed the medicines agency. None had been involved in any public health campaigns. Confidence and self-efficacy was low. Strategies to reduce SFs reaching the public are described. Pharmacist's role in combating SFs was elucidated. SFs were identified in deprived areas 4 (9{\%}) more often than in affluent areas 1 (2{\%}).Conclusions: Many pharmacies are not ready to implement FMD, potentially not capturing anticipated benefits of the directive, with greatest risk of harm in deprived area. We further validated a confidence scale. Limited public health campaigns may result in a lack of awareness amongst pharmacy professionals and patients. Limited awareness of technologies to identify falsified medicines exist, though further training is welcome. A worrying trend of underreporting maybe prevalent. A larger sample study using this survey would be valuable.",
author = "Ravina Barrett",
note = "{\circledC} Author(s) (or their employer(s)) 2020. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ. http://creativecommons.org/licenses/by-nc/4.0/. This is an open access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited, appropriate credit is given, any changes made indicated, and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/.",
year = "2020",
month = "1",
day = "9",
doi = "10.1136/bmjopen-2019-033405",
language = "English",
volume = "10",
journal = "BMJ Open",
issn = "2044-6055",

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TY - JOUR

T1 - Evaluation of community pharmacists’ readiness to implement the Falsified Medicines Directive (Directive 2011/62/EC)

T2 - an English cross-sectional survey with geospatial analysis

AU - Barrett, Ravina

N1 - © Author(s) (or their employer(s)) 2020. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ. http://creativecommons.org/licenses/by-nc/4.0/. This is an open access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited, appropriate credit is given, any changes made indicated, and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/.

PY - 2020/1/9

Y1 - 2020/1/9

N2 - Objectives: to evaluate the readiness to implement the Falsified Medicines Directive (FMD) by community pharmacies in England. Eight secondary objectives were assessed. Setting: Community/Retail pharmacies.Participants: We invited pharmacists from 501 pharmacies to complete a survey. Non-contractors, non-pharmacists or pharmacists practising abroad were excluded. We randomly selected addresses, ensuring they were nationally representative. Interventions: We mailed the survey in October 2018 with a single follow-up in January 2019. Respondents were invited to provide self-reported answers. A prepaid self-addressed envelope was provided. We received favourable ethical approval.Results: 102 responses (20.44% response rate) were received. Readiness to implement was poor: 4 (3.9%) said very much, while 40 (39.2%) said not at all and 29 (28.4%) said not really. Increased workload and reduced profitability was anticipated, accompanied with improved patient safety. Prevalence of ‘Substandard and Falsified (SF) Medical Products’ was estimated at 1 to 5%, with erectile dysfunction at greatest risk of falsification. Different packaging would raise suspicions. Five (4.9%) had identified SFs (p<0.001 One sample binomial). Of these, three (2.9%) informed the medicines agency. None had been involved in any public health campaigns. Confidence and self-efficacy was low. Strategies to reduce SFs reaching the public are described. Pharmacist's role in combating SFs was elucidated. SFs were identified in deprived areas 4 (9%) more often than in affluent areas 1 (2%).Conclusions: Many pharmacies are not ready to implement FMD, potentially not capturing anticipated benefits of the directive, with greatest risk of harm in deprived area. We further validated a confidence scale. Limited public health campaigns may result in a lack of awareness amongst pharmacy professionals and patients. Limited awareness of technologies to identify falsified medicines exist, though further training is welcome. A worrying trend of underreporting maybe prevalent. A larger sample study using this survey would be valuable.

AB - Objectives: to evaluate the readiness to implement the Falsified Medicines Directive (FMD) by community pharmacies in England. Eight secondary objectives were assessed. Setting: Community/Retail pharmacies.Participants: We invited pharmacists from 501 pharmacies to complete a survey. Non-contractors, non-pharmacists or pharmacists practising abroad were excluded. We randomly selected addresses, ensuring they were nationally representative. Interventions: We mailed the survey in October 2018 with a single follow-up in January 2019. Respondents were invited to provide self-reported answers. A prepaid self-addressed envelope was provided. We received favourable ethical approval.Results: 102 responses (20.44% response rate) were received. Readiness to implement was poor: 4 (3.9%) said very much, while 40 (39.2%) said not at all and 29 (28.4%) said not really. Increased workload and reduced profitability was anticipated, accompanied with improved patient safety. Prevalence of ‘Substandard and Falsified (SF) Medical Products’ was estimated at 1 to 5%, with erectile dysfunction at greatest risk of falsification. Different packaging would raise suspicions. Five (4.9%) had identified SFs (p<0.001 One sample binomial). Of these, three (2.9%) informed the medicines agency. None had been involved in any public health campaigns. Confidence and self-efficacy was low. Strategies to reduce SFs reaching the public are described. Pharmacist's role in combating SFs was elucidated. SFs were identified in deprived areas 4 (9%) more often than in affluent areas 1 (2%).Conclusions: Many pharmacies are not ready to implement FMD, potentially not capturing anticipated benefits of the directive, with greatest risk of harm in deprived area. We further validated a confidence scale. Limited public health campaigns may result in a lack of awareness amongst pharmacy professionals and patients. Limited awareness of technologies to identify falsified medicines exist, though further training is welcome. A worrying trend of underreporting maybe prevalent. A larger sample study using this survey would be valuable.

U2 - 10.1136/bmjopen-2019-033405

DO - 10.1136/bmjopen-2019-033405

M3 - Article

VL - 10

JO - BMJ Open

JF - BMJ Open

SN - 2044-6055

M1 - e033405

ER -