The Effectiveness of the Summary of Product Characteristics (SmPC) and Recommendations for Improvement

Therapeutic Innovation and Regulatory Science

Volumn 48, Issue 2, 2014, Pages 255-265

  Raynor, David K ^a   Veene, Peter De ^b   Bryant, David ^c  

^a UNIVERSITY OF LEEDS   (United Kingdom)

^b ROCHE PRODUCTS LTD   (United Kingdom)

^c Luto Research   (United Kingdom)

Author keywords

drug information; readability; Summary of Product Characteristics (SmPC); user testing

Indexed keywords

MEFLOQUINE; MYCOPHENOLIC ACID 2 MORPHOLINOETHYL ESTER;

ADULT; ARTICLE; CLINICAL ARTICLE; DRUG CONTROL; DRUG LEGISLATION; FEMALE; GENERAL PRACTITIONER; HEALTH CARE PERSONNEL; HEALTH PRACTITIONER; HUMAN; INTERVIEW; MALE; MEDICAL INFORMATION; MIDDLE AGED; PATIENT INFORMATION; PRACTICE GUIDELINE; PRIMARY MEDICAL CARE; PRIORITY JOURNAL; QUESTIONNAIRE; READING; SUMMARY OF PRODUCT CHARACTERISTIC; TOTAL QUALITY MANAGEMENT;

EID: 84895450644     PISSN: 21684790     EISSN: 21649200     Source Type: Journal    
DOI: 10.1177/2168479013501311     Document Type: Article

References (22)

1. European Commission. A guideline on summary of product characteristics (SmPC). http://ec.europa.eu/health/files/eudralex/vol-2/c/smpc_guideline_rev2_en.pdf. Published September 2009. Accessed July 2, 2013.
2. Cave A,Arlett P,Lee E.Inhaled and nasal corticosteroids: factors affecting the risks of systemic adverse effects.Pharmacol Ther. 1999;83:153-179.
3. European Commission. Directive 2004/27/EC of the European Parliament and of the Council of 31 March 2004. http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=CELEX:32004L0027:EN:HTML. Accessed July 2, 2013.
4. Medicines and Healthcare Regulatory Agency. Best practice guidance on patient information leaflets. http://www.mhra.gov.uk/home/groups/pl-a/documents/websiteresources/con157151.pdfAccessed July 2, 2013.
5. Knapp P,Raynor DK,Silcock J,Parkinson B.Performance-based readability testing of participant information for a phase 3 IVF trail.Trials. 2009;10:79.
6. Savill N,Bushe C.A systematic review of the safety information contained within the summaries of product characteristics of medications licensed in the United Kingdom for attention deficit hyperactivity disorder: how does the safety prescribing advice compare with national guidance?.Child Adolesc Psychiatry Ment Health. 2012;6:2.
7. Arguello B,Fernandez-Llimos F.Clinical pharmacology information in summaries of product characteristics and package inserts.Clin Pharmacol Ther. 2007;82:566-571.
8. Bergk V,Haefeli WE,Gasse C,Brenner H,Martin-Facklam M.Information deficits in the summary of product characteristics preclude an optimal management of drug interactions: a comparison with evidence from the literature.Eur J Clin Pharmacol. 2005;61:327-335.
9. Wall A,Bateman DN,Waring WS.Variability in the quality of overdose advice in Summary of Product Characteristics (SPC) documents: gut decontamination recommendations for CNS drugs.Br J Clin Pharmacol. 2008;67:83-87.
10. San Miguel M,Alfredo Martinez J,Vargas E.Food-drug interactions in the summary of product characteristics of proprietary medicinal products.Eur J Clin Pharmacol. 2005;61:77-83.
11. Medicines and Healthcare Regulatory Agency. Review of the shortcomings of product information for medicines. www.mhra.gov.uk/Howweregulate/Medicines/Medicinesregulatorynews/CON228801. Published February 4, 2013. Accessed July 2, 2013.
12. European Commission. Guideline on the readability of the label and package leaflet of medicinal products for human use. http://ec.europa.eu/health/files/eudralex/vol-2/c/2009_01_12_readability_guideline_final_en.pdf. Revised January 12, 2009. Accessed July 2, 2013.
13. Raynor DK,Knapp P,Silcock J,Parkinson B.Feeney K. "User-testing" as a method for testing the fitness-for-purpose of written medicine information.Pat Educ Couns. 2011;83:404-410.
14. Sless D,Shrensky RWriting About Medicines for People. 3rd ed. Sydney, Australia: Australian Self-medication Industry; 2006. Sydney, Australia: Australian Self-medication Industry; 2006:.
15. Harris E,Enright D.New words for cautionary and advisory labels make them easily understood.Pharm J. 2011;286:278-279.
16. Knapp P,Raynor DK,Silcock J,Parkinson B.Can user testing of a clinical trial patient information sheet make it fit-for-purpose? A randomized controlled trial.BMC Med. 2011;9:89.
17. Brooke RE,Isherwood S,Herbert NC,Raynor DK,Knapp P.Hearing aid instruction booklets: employing usability testing to determine effectiveness.Am J Audiol. 2012;21:206-214.
18. RaynorDK. User testing in developing patient medication information in Europe. Research in Social and Administrative Pharmacy. http://dx.doi.org/10.1016/j.sapharm.2013.02.007. Published April 12, 2013. Accessed July 2, 2013.
19. Raynor DK,Dickinson D.Key principles to guide development of consumer medicine information-content analysis of information design texts.Ann Pharmacother. 2009;43:700-706.
20. Maxwell S,Eichler H-G,Bucsics A,Haefeli WE.Gustafsson LL. e-SPC-delivering drug information in the 21st century.Br J Clin Pharmacol. 2011;73:12-15.
21. Raynor DK,Blenkinsopp A,Knapp P, et al.A systematic review of quantitative and qualitative research on the role and effectiveness of written information available to patients about individual medicines.Health Technol Assess. 2007;11 (5): iii 1-160.
22. Drug Ther Bull. 2012;50:13.