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What should patients do if they miss a dose? A systematic review of patient information leaflets and summaries of product characteristics
PURPOSE: Medicines regulatory authorities advise that patient information leaflets (PILs) should provide specific advice on what actions to take if one or more doses are missed. We aimed to assess the content in this regard, of PILs and Summaries of Product Characteristics (SmPCs) of prescription on...
Autores principales: | , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
Springer Berlin Heidelberg
2020
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Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7803707/ https://www.ncbi.nlm.nih.gov/pubmed/32989529 http://dx.doi.org/10.1007/s00228-020-03003-x |
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author | Albassam, Abdullah Hughes, Dyfrig A. |
author_facet | Albassam, Abdullah Hughes, Dyfrig A. |
author_sort | Albassam, Abdullah |
collection | PubMed |
description | PURPOSE: Medicines regulatory authorities advise that patient information leaflets (PILs) should provide specific advice on what actions to take if one or more doses are missed. We aimed to assess the content in this regard, of PILs and Summaries of Product Characteristics (SmPCs) of prescription only medicines (POMs) marketed in the UK. METHODS: PILs and SmPCs were accessed via the electronic Medicines Compendium. The following terms were used in the advanced search facility: miss(ed), omit(ted), adhere(d), delay(ed), forgot, forget, lapse. Identified documents were screened for instructions on missed doses which were categorised according to level of specificity, and cross-referenced to the National Patient Safety Agency (NPSA) grading of risk of harm from omitted and delayed medicines. Any supporting clinical or pharmacological evidence was identified from SmPCs. RESULTS: Two thousand two hundred eighty-four documents were identified from 7248 PILs and SmPCs relating to 1501 POMs. Seven hundred eighty-three (52%) POMs had SmPCs or PILs with no instructions on missed doses; 487 POMs (32%) included non-specific advice (e.g. “take as soon as possible”); 138 (9%) provided specific instructions; and 93 (6%) referred patients to seek medical advice. SmPCs for only 13/138 (9%) of those which included specific instructions provided any supporting clinical or pharmacological evidence. Instructions were absent for several medicines where the NPSA assessed that dose omissions may result in significant risk of harm. CONCLUSIONS: Advice on missed doses is generally inadequate. Pharmaceutical companies and regulatory authorities should produce clear and concise instructions on what patients should do if they miss doses, with supporting evidence where necessary. |
format | Online Article Text |
id | pubmed-7803707 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2020 |
publisher | Springer Berlin Heidelberg |
record_format | MEDLINE/PubMed |
spelling | pubmed-78037072021-01-21 What should patients do if they miss a dose? A systematic review of patient information leaflets and summaries of product characteristics Albassam, Abdullah Hughes, Dyfrig A. Eur J Clin Pharmacol Pharmacoepidemiology and Prescription PURPOSE: Medicines regulatory authorities advise that patient information leaflets (PILs) should provide specific advice on what actions to take if one or more doses are missed. We aimed to assess the content in this regard, of PILs and Summaries of Product Characteristics (SmPCs) of prescription only medicines (POMs) marketed in the UK. METHODS: PILs and SmPCs were accessed via the electronic Medicines Compendium. The following terms were used in the advanced search facility: miss(ed), omit(ted), adhere(d), delay(ed), forgot, forget, lapse. Identified documents were screened for instructions on missed doses which were categorised according to level of specificity, and cross-referenced to the National Patient Safety Agency (NPSA) grading of risk of harm from omitted and delayed medicines. Any supporting clinical or pharmacological evidence was identified from SmPCs. RESULTS: Two thousand two hundred eighty-four documents were identified from 7248 PILs and SmPCs relating to 1501 POMs. Seven hundred eighty-three (52%) POMs had SmPCs or PILs with no instructions on missed doses; 487 POMs (32%) included non-specific advice (e.g. “take as soon as possible”); 138 (9%) provided specific instructions; and 93 (6%) referred patients to seek medical advice. SmPCs for only 13/138 (9%) of those which included specific instructions provided any supporting clinical or pharmacological evidence. Instructions were absent for several medicines where the NPSA assessed that dose omissions may result in significant risk of harm. CONCLUSIONS: Advice on missed doses is generally inadequate. Pharmaceutical companies and regulatory authorities should produce clear and concise instructions on what patients should do if they miss doses, with supporting evidence where necessary. Springer Berlin Heidelberg 2020-09-29 2021 /pmc/articles/PMC7803707/ /pubmed/32989529 http://dx.doi.org/10.1007/s00228-020-03003-x Text en © The Author(s) 2020 Open Access This article is licensed under a Creative Commons Attribution 4.0 International License, which permits use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate if changes were made. The images or other third party material in this article are included in the article's Creative Commons licence, unless indicated otherwise in a credit line to the material. If material is not included in the article's Creative Commons licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. To view a copy of this licence, visit http://creativecommons.org/licenses/by/4.0/. |
spellingShingle | Pharmacoepidemiology and Prescription Albassam, Abdullah Hughes, Dyfrig A. What should patients do if they miss a dose? A systematic review of patient information leaflets and summaries of product characteristics |
title | What should patients do if they miss a dose? A systematic review of patient information leaflets and summaries of product characteristics |
title_full | What should patients do if they miss a dose? A systematic review of patient information leaflets and summaries of product characteristics |
title_fullStr | What should patients do if they miss a dose? A systematic review of patient information leaflets and summaries of product characteristics |
title_full_unstemmed | What should patients do if they miss a dose? A systematic review of patient information leaflets and summaries of product characteristics |
title_short | What should patients do if they miss a dose? A systematic review of patient information leaflets and summaries of product characteristics |
title_sort | what should patients do if they miss a dose? a systematic review of patient information leaflets and summaries of product characteristics |
topic | Pharmacoepidemiology and Prescription |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7803707/ https://www.ncbi.nlm.nih.gov/pubmed/32989529 http://dx.doi.org/10.1007/s00228-020-03003-x |
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